ボアバイオファーマの四半期報告

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2025


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from __________________ to __________________

Commission File Number: 001-39979

VOR BIOPHARMA INC.

(Exact Name of Registrant as Specified in its Charter)


Delaware	81-1591163
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
P.O. Box 380121 Cambridge, Massachusetts	02238
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (617) 655-6580

100 Cambridgepark Drive, Suite 101

Cambridge, Massachusetts 02140

(Former name or former address, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

     Title of each class

     Trading
Symbol(s)

     Name of each exchange on which registered

     Common Stock, $0.0001 par value per share

     VOR

     Nasdaq Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

Number of shares of the registrant’s Common Stock outstanding as of August 6, 2025 was 126,683,111.

Table of Contents


		Page
PART I.	FINANCIAL INFORMATION	1

Item 1.	Financial Statements (Unaudited)	1
	Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024	1
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2025 and 2024	2
	Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the Three and Six Months Ended June 30, 2025 and 2024	3
	Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2025 and 2024	4
	Notes to Condensed Consolidated Financial Statements (Unaudited)	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	16
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	41
Item 4.	Controls and Procedures	41

PART II.	OTHER INFORMATION	43

Item 1.	Legal Proceedings	43
Item 1A.	Risk Factors	43
Item 5.	Other Information	83
Item 6.	Exhibits	85
Signatures		87

Note Regarding Company References

Throughout this Quarterly Report on Form 10-Q, the “Company,” “Vor,” “Vor Bio,” “Vor Biopharma Inc.,” “we,” “us,” and “our,” except where the context requires otherwise, refer to Vor Biopharma Inc. and its consolidated subsidiary, and “our board of directors” refers to the board of directors of Vor Biopharma Inc.

Special Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “might,” “intend,” “target,” “ongoing,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions intended to identify statements about the future. These statements speak only as of the date of this Quarterly Report on Form 10-Q and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements include, without limitation, statements about:

•

the timing, progress and results of our clinical trials of our product candidate and preclinical and clinical trials for any future product candidates, including statements regarding the timing and pace of initiation, enrollment and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and plans with respect to our research and development programs;

•

the timing of any submission of filings for regulatory approval of, and our ability to obtain and maintain regulatory approvals for, our product candidate and any future product candidates for any indication;

•

our ability to identify patients with the diseases treated by our product candidate and any future product candidates, and to enroll patients in clinical trials;

•

our expectations regarding the market acceptance and opportunity for and clinical utility of our product candidate and any future product candidates, if approved for commercial use;

•

our expectations regarding the scope of any approved indication for any product candidate;

•

our ability to successfully commercialize our product candidate or any future product candidates;

•

our estimates of our expenses, ongoing losses, future revenue and capital requirements and our need for or ability to obtain additional funding;

•

our ability to establish or maintain collaborations or strategic relationships;

•

our ability to identify, recruit and retain key personnel, including executive officers and members of management;

•

our reliance upon intellectual property licensed from third parties and our ability to obtain such licenses on commercially reasonable terms or at all;

•

our ability to protect and enforce our intellectual property position for our product candidate or any future product candidates, and the scope of such protection;

•

our financial performance;

•

the period over which we estimate our existing cash, cash equivalents and marketable securities will be sufficient to fund our future operating expenses and capital expenditure requirements;

•

our competitive position and the development of and projections relating to our competition or our industry;

•

the impact of laws and regulations; and

•

our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012.

You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements contained in this Quarterly Report on Form 10-Q are made as of the date of this Quarterly Report on Form 10-Q, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

You should refer to the “Risk Factors” section in this Quarterly Report and the “Summary Risk Factors” and “Risk Factors” sections in our Annual Report on Form 10-K for the year ended December 31, 2024 for a discussion of material factors that could cause actual results or events to differ materially from the forward-looking statements that we make.

This Quarterly Report on Form 10-Q includes statistical and other industry and market data, which we obtained from our own internal estimates and research, as well as from industry and general publications and research, surveys, and studies conducted by third parties. Industry publications, studies, and surveys generally state that they have been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe that each of these studies and publications is reliable, we have not independently verified market and industry data from third-party sources. While we believe our internal company research is reliable and the market definitions are appropriate, neither such research nor these definitions have been verified by any independent source.

All brand names or trademarks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners.

Summary Risk Factors

Our business is subject to a number of risks that if realized could materially affect our business, financial condition, results of operations, cash flows and access to liquidity. These risks are discussed more fully in the “Risk Factors” section of this Quarterly Report. Our principal risks include the following:

•

We have incurred significant net losses since inception. We expect to incur net losses for the foreseeable future and may never achieve or maintain profitability.

•

We will need substantial additional funding. If we are unable to raise capital when needed, we would be forced to delay, reduce or eliminate our research and product development programs or future commercialization efforts.

•

We have a limited operating history, have not yet completed any clinical trials and have no history of commercializing products, which may make it difficult to evaluate the success of our business to date and to assess our future viability.

•

We are substantially dependent on the success of our lead product candidate, telitacicept. If we are unable to complete development of, obtain approval for and commercialize telitacicept in a timely manner, our business will be harmed.

•

We may derive results and data for telitacicept from clinical trials conducted by RemeGen in China; our access to the clinical results and data may be limited and there is no assurance that the clinical data from any such trials will be accepted or considered by the FDA, or other comparable regulatory authorities.

•

We are dependent on third parties accurately generating and reporting data related to our product candidate, and their conduct could adversely affect our business.

•

We face significant competition in an environment of rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer or more advanced or effective than ours, which may harm our financial condition and our ability to successfully market or commercialize our product candidates, if approved.

•

Success in preclinical studies or clinical trials may not be indicative of results in future clinical trials, particularly for our clinical trials that involve only a small number of patients.

•

If we experience significant delays or difficulties in the enrollment or retention of patients in clinical trials, the cost of developing product candidates could increase and our receipt of necessary regulatory approvals could be delayed or prevented.

•

We will contract with third parties for the manufacture and supply of materials for development of our product candidates and advancement of our current clinical trials, as well as our research programs and preclinical studies, and we expect to continue to do so for future clinical trials and for commercialization of our product candidates. This reliance on third parties increases the risk that we will not have sufficient quantities and quality of such materials, product candidates or any products that we may develop and commercialize, or that such supply will not be available to us at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

•

We are highly dependent on intellectual property licensed from third parties and termination of these licenses could result in the loss of significant rights, which would harm our business.

iii

•

Third-party claims of intellectual property infringement, misappropriation or other violations may prevent or delay our product discovery and development efforts and have a material adverse effect on our business.

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited).

VOR BIOPHARMA INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)


	June 30,			December 31,
(in thousands, except share and per share amounts)	2025			2024
Assets
Current assets:
Cash and cash equivalents	$	190,574		$	81,949
Restricted cash equivalents		2,413			—
Marketable securities		9,991			9,977
Prepaid expenses		1,500			4,201
Other current assets		449			380
Total current assets		204,927			96,507
Restricted cash, less current portion		—			2,413
Property and equipment, net		—			6,581
Operating lease right-of-use assets		24			35,007
Other assets		420			2,383
Total assets	$	205,371		$	142,891
Liabilities and stockholders’ equity (deficit)
Current liabilities:
Accounts payable	$	669		$	1,505
Accrued liabilities		58,104			12,892
Operating lease liabilities		—			4,215
Total current liabilities		58,773			18,612
Long-term liabilities:
Operating lease liabilities—non-current		—			27,615
Warrant liabilities		1,652,298			—
Total liabilities		1,711,071			46,227
Stockholders’ equity (deficit):
Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of June 30, 2025 and December 31, 2024; 0 shares issued and outstanding as of June 30, 2025 and December 31, 2024		—			—
Common stock, $0.0001 par value; 800,000,000 and 400,000,000 shares authorized as of June 30, 2025 and December 31, 2024, respectively; 125,645,952 and 124,776,152 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively		13			13
Additional paid-in capital		557,422			553,623
Accumulated other comprehensive income		14			22
Accumulated deficit		(2,063,149	)		(456,994	)
Total stockholders’ equity (deficit)		(1,505,700	)		96,664
Total liabilities and stockholders’ equity (deficit)	$	205,371		$	142,891

The accompanying notes are an integral part of these condensed consolidated financial statements.

VOR BIOPHARMA INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)


	Three Months Ended June 30,						Six Months Ended June 30,
(in thousands, except share and per share amounts)	2025			2024			2025			2024
Operating expenses:
Research and development	$	261,499		$	21,823		$	288,200		$	46,145
General and administrative		12,785			7,212			19,375			15,216
Total operating expenses	$	274,284		$	29,035		$	307,575		$	61,361
Loss from operations		(274,284	)		(29,035	)		(307,575	)		(61,361	)
Other income (expense):
Interest income		537			1,196			1,342			2,718
Change in fair value of warrant liabilities		(1,299,922	)		—			(1,299,922	)		—
Total other (expense) income		(1,299,385	)		1,196			(1,298,580	)		2,718
Net loss	$	(1,573,669	)	$	(27,839	)	$	(1,606,155	)	$	(58,643	)
Net loss per share attributable to common stockholders, basic and diluted	$	(12.56	)	$	(0.41	)	$	(12.84	)	$	(0.86	)
Weighted-average common shares outstanding, basic and diluted		125,271,447			68,299,170			125,049,032			68,165,068

Other comprehensive income (loss):
Unrealized (loss) gain on available for sale marketable securities		(9	)		17			(8	)		7
Total other comprehensive (loss) income:		(9	)		17			(8	)		7
Comprehensive loss	$	(1,573,678	)	$	(27,822	)	$	(1,606,163	)	$	(58,636	)

The accompanying notes are an integral part of these condensed consolidated financial statements.

VOR BIOPHARMA INC.

CONDENSED CONSOLIDATED STATEMENTS OFSTOCKHOLDERS’ EQUITY (DEFICIT)

(UNAUDITED)


	Common Stock				Additional Paid-In			Accumulated other comprehensive			Accumulated			Total Stockholders’
(in thousands, except share amounts)	Shares		Amount		Capital			income			Deficit			Equity (Deficit)
Balance at December 31, 2024		124,776,152	$	13	$	553,623		$	22		$	(456,994	)	$	96,664
Issuance of common stock upon vesting of RSUs, net of shares withheld for taxes		75,395		—		(55	)		—			—			(55	)
Issuance costs for private placement		—		—		12			—			—			12
Stock-based compensation expense		—		—		1,933			—			—			1,933
Other comprehensive income		—		—		—			1			—			1
Net loss		—		—		—			—			(32,486	)		(32,486	)
Balance at March 31, 2025		124,851,547	$	13	$	555,513		$	23		$	(489,480	)	$	66,069
Issuance of common stock upon vesting of RSUs, net of shares withheld for taxes, exercise of stock options, and issuance of common stock under ESPP		794,405		—		65			—			—			65
Stock-based compensation expense		—		—		1,844			—			—			1,844
Other comprehensive income		—		—		—			(9	)		—			(9	)
Net loss		—		—		—			—			(1,573,669	)		(1,573,669	)
Balance at June 30, 2025		125,645,952	$	13	$	557,422		$	14		$	(2,063,149	)	$	(1,505,700	)


	Common Stock				Additional Paid-In			Accumulated other comprehensive			Accumulated			Total Stockholders’
(in thousands, except share amounts)	Shares		Amount		Capital			loss			Deficit			Equity
Balance at December 31, 2023		67,891,311	$	7	$	490,874		$	(77	)	$	(340,080	)	$	150,724
Issuance of common stock upon vesting of RSUs, net of shares withheld for taxes, and exercise of stock options		184,998		—		(169	)		—			—			(169	)
Issuance of common stock from at-the-market sales agreement		139,462		—		213			—			—			213
Stock-based compensation expense		—		—		3,081			—			—			3,081
Other comprehensive loss		—		—		—			(10	)		—			(10	)
Net loss		—		—		—			—			(30,804	)		(30,804	)
Balance at March 31, 2024		68,215,771	$	7	$	493,999		$	(87	)	$	(370,884	)	$	123,035
Issuance of common stock upon vesting of RSUs, net of shares withheld for taxes, exercise of stock options, and issuance of common stock under ESPP		142,113		—		74			—			—			74
Stock-based compensation expense		—		—		2,793			—			—			2,793
Other comprehensive income		—		—		—			17			—			17
Net loss		—		—		—			—			(27,839	)		(27,839	)
Balance at June 30, 2024		68,357,884	$	7	$	496,866		$	(70	)	$	(398,723	)	$	98,080

The accompanying notes are an integral part of these condensed consolidated financial statements.

VOR BIOPHARMA INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)


	Six Months Ended June 30,
(in thousands)	2025			2024
Cash flows from operating activities
Net loss	$	(1,606,155	)	$	(58,643	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense		2,862			1,812
Non-cash lease expense		5,480			2,483
Stock-based compensation		3,777			5,874
Change in fair value of warrant liabilities		1,299,922			—
Interest amortization on marketable securities		(22	)		(1,126	)
Loss on sale of property and equipment		3,303			—
Acquisition of in-process research and development		222,592			—
Changes in operating assets and liabilities:
Operating lease liabilities		(2,327	)		(1,840	)
Prepaid expenses and other current assets		2,632			(690	)
Accounts payable, accrued liabilities and other current liabilities		(277	)		(1,931	)
Other assets		1,963			1,749
Net cash used in operating activities		(66,250	)		(52,312	)
Cash flows from investing activities
Purchases of marketable securities		—			(9,914	)
Proceeds from maturities of marketable securities		—			107,000
Purchases of property and equipment		(383	)		(123	)
Proceeds from sales of property and equipment		799			—
Net cash provided by investing activities		416			96,963
Cash flows from financing activities
Payment of issuance costs related to private placement		(551	)		—
Proceeds from the issuance of pre-funded warrants		175,000			—
Proceeds from the issuance of common stock from at-the-market sales agreement, net of issuance costs		—			186
Repurchases of shares for tax withholdings upon vesting of restricted stock unit awards		(87	)		(233	)
Proceeds from stock option exercises and the issuance of shares under ESPP		97			112
Net cash provided by financing activities		174,459			65
Net increase in cash, cash equivalents and restricted cash equivalents		108,625			44,716
Cash, cash equivalents and restricted cash equivalents, beginning of period	$	84,362		$	33,773
Cash, cash equivalents and restricted cash equivalents, end of period	$	192,987		$	78,489
Supplemental disclosure of non-cash activities
Financing costs associated with the sale of pre-funded warrants included in accounts payable and accrued expenses	$	643		$	—
Unpaid license payments included in accounts payable and accrued expenses	$	45,000		$	—

A reconciliation of the cash, cash equivalents and restricted cash equivalents reported within the condensed consolidated balance sheets that sum to the total of the same amounts shown in the statements of cash flows is as follows:


	For the Six Months Ended June 30,
(in thousands)	2025		2024
Cash and cash equivalents	$	190,574	$	76,076
Restricted cash equivalents		2,413		2,413
Total cash, cash equivalents and restricted cash equivalents as shown on the statements of cash flows	$	192,987	$	78,489

The accompanying notes are an integral part of these condensed consolidated financial statements.

VOR BIOPHARMA INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

1. Nature of the Business

Vor Biopharma Inc. (the “Company”) is a clinical-stage company advancing telitacicept, a novel, dual-target recombinant fusion protein that inhibits both BLyS (BAFF) and APRIL—two key cytokines involved in B cell survival and autoantibody production. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology. The Company is headquartered in Massachusetts. The Company was incorporated on December 30, 2015.

Risks and Uncertainties

The Company is subject to a number of risks common to development stage companies in the biotechnology industry, including, but not limited to, risks of failure of clinical trials, dependence on key personnel, protection of proprietary technology, reliance on third party organizations, uncertainty of obtaining regulatory approval for any product candidate that it may develop, development by competitors of technological innovations, compliance with government regulations, adverse macroeconomic conditions and the need to obtain additional financing.

The Company anticipates that it will continue to incur significant operating losses for the next several years as it continues to develop its product candidate and any future product candidates. As a result, the Company’s continued operations are dependent on its ability to raise additional funding. If the Company is unable to obtain additional funding on a timely basis, it may be forced to significantly curtail, delay, or discontinue one or more of its clinical trials or be unable to expand its operations.

Liquidity and Capital Resources

As of June 30, 2025, the Company had $200.6 million of cash, cash equivalents and marketable securities and an accumulated deficit of $2,063.1 million. The Company anticipates that it will continue to incur significant operating losses for the next several years as it continues to develop, and if approved commercialize, its product candidate and any future product candidates. As a result, the Company’s continued operations are dependent on its ability to raise additional funding. In June 2025, the Company raised $174.4 million in net cash proceeds through the issuance of the 2025 PIPE Warrants (as defined below). Refer to Note 7 for additional information on the 2025 PIPE Warrants.

The Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued. As a result of the issuance of the 2025 Warrants and receipt of the associated net cash proceeds, the Company has alleviated the substantial doubt that previously existed and management believes, based on its current operating plans, the Company has sufficient liquidity to satisfy its obligations over the next twelve months from the date of issuance of these condensed consolidated financial statements.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) issued by the Financial Accounting Standards Board (“FASB”).

Use of Estimates

The preparation of the condensed consolidated financial statements in conformity with GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the condensed consolidated financial statements and the reported amount of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies in developing the estimates and assumptions that are used in the preparation of the condensed consolidated financial statements. Management must apply significant judgment in this process. Management’s estimation process often may yield a range of potentially reasonable estimates and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: accrued expenses, stock-based compensation expense, the fair value of financial instruments including warrants, and research and development expenses.

Unaudited Interim Financial Information

The condensed consolidated financial statements of the Company included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany transactions and balances have been eliminated in consolidation. In the opinion of management, the information furnished reflects all adjustments, all of which are of a normal and recurring nature, necessary for a fair presentation of the results for the reported interim periods. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period.

The accompanying condensed consolidated balance sheet as of December 31, 2024 has been derived from the Company’s audited consolidated financial statements for the year ended December 31, 2024. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to GAAP or the rules and regulations of the SEC. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited annual consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 (the “2024 Annual Report”).

Other than the policies listed below, there have been no material changes to the Company’s significant accounting policies as described in the 2024 Annual Report.

Warrants

The Company accounts for warrants to purchase its common stock based on an assessment of the warrant’s specific terms and applicable authoritative guidance in ASC Topic 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC Topic 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the liability classification requirements pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own stock, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent period end date while the warrants are outstanding.

Warrants classified as equity are recorded at fair value as of the date of issuance on the Company’s condensed consolidated balance sheets and no further adjustments to their initial valuation will be subsequently made. Warrants that require separate accounting as liabilities are recorded on the Company’s condensed consolidated balance sheets at their fair value on the date of issuance and are revalued at each subsequent balance sheet date until such instruments are exercised or expired, or meet the criteria to become equity-classified, with any changes in the fair value between reporting periods recorded as a component of other income (expense) on the condensed consolidated statement of operations and comprehensive loss.

As of June 30, 2025, the Company has both equity-classified and liability-classified warrants outstanding.

Restructuring Costs

Employee severance costs are recorded based on whether the termination benefits are provided under an on-going benefit arrangement or under a one-time benefit arrangement. The Company accounts for on-going termination benefit arrangements, such as those arising from employment agreements, applicable regulations or past practices, in accordance with ASC 712, Compensation-Nonretirement Postemployment Benefits. Under ASC 712, liabilities for post-employment benefits are recorded at the time the obligations are probable of being incurred and can be reasonably estimated. The Company accounts for one-time employment benefit arrangements in accordance with ASC 420, Exit or Disposal Cost Obligations. One-time termination benefits are expensed at the date the entity notifies the employee, unless the employee must provide future service over a period extending past the minimum notification period, in which case the benefits are expensed ratably over the future service period. Other associated costs are recognized in the period in which the liability is incurred. See Note 12 for additional information on the severance expense that the Company recognized for employees terminated in connection with the Restructuring Plan (as defined below).

3. Marketable Securities

The amortized cost and estimated fair value of marketable securities, by remaining contractual maturity, are as follows:


	June 30, 2025
(in thousands)	Amortized Cost		Gross Unrealized Holding Gains		Gross Unrealized Holding Losses		Fair Value

Maturing in one year or less
U.S. Treasuries	$	9,977	$	14	$	—	$	9,991
Total	$	9,977	$	14	$	—	$	9,991


	December 31, 2024
(in thousands)	Amortized Cost		Gross Unrealized Holding Gains		Gross Unrealized Holding Losses		Fair Value

Maturing in one year or less
U.S. Treasuries	$	4,981	$	12	$	—	$	4,993
Maturing after one year through five years
U.S. Treasuries		4,974		10		—		4,984
Total	$	9,955	$	22	$	—	$	9,977

The Company did not have any individual securities in an unrealized loss position as of either June 30, 2025 or December 31, 2024. Additionally, the Company did not record any impairments to marketable securities or reserves for credit losses related to its marketable debt securities during the periods presented.

4. Fair Value Measurements

The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis:


	June 30, 2025
(in thousands)	Level 1		Level 2		Level 3		Total

Cash equivalents
Money market funds	$	190,508	$	—	$	—	$	190,508
Marketable securities
U.S. Treasuries		—		9,991		—		9,991
Restricted cash equivalents
Money market funds		2,413		—		—		2,413
Liabilities
Warrant liabilities		—		1,652,298		—		1,652,298


	December 31, 2024
(in thousands)	Level 1		Level 2		Level 3		Total

Cash equivalents
Money market funds	$	81,718	$	—	$	—	$	81,718
Marketable securities
U.S. Treasuries		—		9,977		—		9,977
Restricted cash equivalents
Money market funds		2,413		—		—		2,413

The fair value of the Company’s cash equivalents and restricted cash equivalents is determined based on quoted market prices in active markets with no valuation adjustment. The fair value of marketable securities and warrant liabilities is determined based on observable market inputs. There were no transfers between levels during the six months ended June 30, 2025.

Prepaid expenses, accounts payable and accrued expenses are stated at their respective historical carrying values, which approximate fair value due to their short-term nature.

5. Property and Equipment, Net

Property and equipment, net consisted of the following:


	June 30,		December 31,
(in thousands)	2025		2024
Laboratory equipment	$	—	$	9,625
Manufacturing equipment		—		7,082
Computer equipment		—		446
Furniture, fixtures and other		—		606
Construction in progress		—		36
Total		—		17,795
Less: Accumulated depreciation		—		(11,214	)
Property and equipment, net	$	—	$	6,581

Depreciation expense for the three and six months ended June 30, 2025 and 2024 was $2.1 million and $2.9 million, respectively, and for the three and six months ended June 30, 2024 was and $0.9 million and $1.8 million, respectively.

In connection with the Restructuring Plan, during the three and six months ended June 30, 2025, the Company recognized a $3.3 million loss on disposal of certain long-lived assets including equipment and leasehold improvements which was recognized as research and development expense in the condensed consolidated statements of operations and comprehensive loss. Additionally, the Company abandoned certain long-lived assets, resulting in the acceleration of depreciation expense in the amount of approximately $1.5 million during the three and six months ended June 30, 2025, of which approximately $1.2 million and $0.3 million was recorded as research and development expense and general and administrative expense, respectively, in the condensed consolidated statements of operations and comprehensive loss.

6. Accrued Liabilities

Accrued liabilities consisted of the following:


	June 30,		December 31,
(in thousands)	2025		2024
Employee-related expenses, including Restructuring Liability (Note 12)	$	11,136	$	5,852
Professional fees		1,615		1,461
Clinical expenses		79		3,835
Manufacturing expenses		50		516
Research and development expenses		83		872
Accrued up-front license payment (Note 10)		45,000		—
Other		141		356
Total accrued liabilities	$	58,104	$	12,892

7. Stockholders' Equity and Warrants

2024 Private Placement

On December 27, 2024, the Company entered into a purchase agreement with certain institutional investors (collectively, the “2024 Purchasers”), pursuant to which the Company issued and sold to the 2024 Purchasers in a private placement an aggregate of (i) 55,871,260 shares of the Company's common stock and (ii) warrants to purchase up to 69,839,075 shares of the Company's common stock (the “2024 Warrants”) at the closing of the private placement on December 30, 2024. Net proceeds from the private placement were $52.7 million, after deducting placement fees and issuance costs payable by the Company.

The 2024 Warrants have an exercise price of $0.838 per share and are immediately exercisable, subject to certain limitations on exercise set forth in the 2024 Warrants. The 2024 Warrants will terminate seven years from issuance on December 30, 2031.

The Company determined that the 2024 Warrants are freestanding instruments that do not meet the definition of a liability or derivative. The 2024 Warrants are indexed to the Company’s common stock and meet all other conditions for equity classification.

Accordingly, the 2024 Warrants are classified as equity and accounted for as a component of additional paid-in capital at the time issued.

2025 Private Placement

On June 25, 2025, the Company entered into a purchase agreement with certain institutional investors (collectively, the “2025 Purchasers”), pursuant to which the Company issued and sold to the 2025 Purchasers in a private placement warrants to purchase up to an aggregate of 700,000,000 shares of the Company's common stock (the “2025 PIPE Warrants”) at the closing on June 27, 2025. Net proceeds from the private placement were $174.4 million, after deducting issuance costs payable by the Company. In addition to the 2025 PIPE Warrants, on June 25, 2025 the Company issued a warrant to purchase up to 320,000,000 shares of the Company’s common stock as partial consideration for the Telitacicept License Agreement to a subsidiary of RemeGen (“RemeGen Warrants”). Refer to Note 10 for additional information on the license arrangement. The 2025 PIPE Warrants and RemeGen Warrants are collectively referred to as the 2025 Warrants.

The 2025 Warrants have an exercise price of $0.0001 per share and are exercisable upon stockholder approval of the issuance of the underlying shares and an amendment to the certificate of incorporation to increase the number of authorized shares, subject to certain limitations on exercise set forth in the 2025 Warrants. The 2025 Warrants do not expire.

Upon issuance, the 2025 Warrants were liability-classified as they are not considered indexed to the Company’s common stock. The 2025 Warrants are measured at fair value each period with changes in fair value presented within the condensed consolidated statements of operations and comprehensive loss. The initial carrying value of the 2025 PIPE Warrants and the RemeGen Warrants at issuance was $175.0 million and $177.4 million, respectively. Issuance costs related to the 2025 PIPE Warrants were expensed as incurred. As of June 30, 2025, the 2025 Warrants were outstanding with a fair value of $1,652.3 million, representing an increase of $1,299.9 million that was recognized as a change in fair value of warrant liabilities in the condensed consolidated statements of operations and comprehensive loss. The valuation of the warrants is classified within Level 2 of the fair value hierarchy due to the use of observable market inputs, primarily the quoted price of the Company’s common stock underlying the warrants.

The Company also determined that both the 2024 Warrants and 2025 Warrants should be included in the determination of diluted net loss per share if their impact is dilutive. However, they are not included within diluted net loss per share for the period ended June 30, 2025 as the effect would be antidilutive. As of June 30, 2025, none of the 2024 Warrants or 2025 Warrants have been exercised.

8. Stock-Based Compensation

2023 Inducement Plan

As of June 30, 2025, the Company had 69,668,889 shares of its common stock available for future issuance under the 2023 Inducement Plan.

Amended and Restated 2021 Equity Incentive Plan

As of June 30, 2025, the Company had 6,027,849 shares of its common stock available for future issuance under its Amended and Restated 2021 Equity Incentive Plan.

Stock Options

The Company’s stock options generally vest ratably over a four-year period and have a contractual term of ten years. The weighted-average assumptions used principally in determining the fair value of new options granted during the periods presented were as follows:


	Six Months Ended June 30,
	2025			2024
Expected term (in years)		6.1			5.9
Expected volatility		98.9	%		89.8	%
Risk-free interest rate		3.9	%		4.2	%
Dividend yield		—			—

During the six months ended June 30, 2025 and 2024, the Company granted new stock options to purchase 87,549,888 shares and 1,722,725 shares of its common stock, respectively, with a weighted-average grant-date fair value of $0.73 and $1.74 per share, respectively. As of June 30, 2025, total unrecognized compensation expense related to stock options was $66.3 million, which is expected to be recognized over a weighted-average period of 2.1 years.

The intrinsic value of stock options exercised during the six months ended June 30, 2025 was immaterial.

As of June 30, 2025, there were no shares that were both exercised and unvested.

Option Repricing

On February 3, 2025, the Company's board of directors approved a stock option repricing (the “Option Repricing”) whereby the exercise price of certain outstanding options to purchase shares of the Company’s common stock was reduced to $1.34 per share. The repricing applied to options to purchase shares of the Company’s common stock held by continuing employees as of February 3, 2025 that had an exercise price per share greater than $1.34; provided that holders of repriced options must remain in continuous service with the Company through February 3, 2026 or, if earlier, a change in control of the Company or 30 days prior to the applicable repriced option’s original expiration date (the “Retention Period”). If any such repriced option is exercised prior to the end of the Retention Period, the exercise price per share will be the original exercise price per share, and not the repriced exercise price. The total number of shares underlying all repriced options was approximately 6.76 million shares. The repriced options previously had exercise prices ranging from $1.36 to $44.96 per share.

Management determined that the Option Repricing represents a modification of share-based awards and calculated incremental compensation cost of approximately $1.9 million resulting from the modification. However, as the conditions of the modified terms are not expected to be met as of June 30, 2025, the Company reversed any previously recognized incremental compensation cost associated with the modification during the quarter ended June 30, 2025.

Restricted Stock Units

During the six months ended June 30, 2025 and 2024, the Company granted 1,224,000 restricted stock units and 1,119,149 restricted stock units, respectively, with a weighted-average grant date fair value of $1.33 and $2.38 per share, respectively. As of June 30, 2025, total unrecognized compensation expense related to restricted stock units was $2.9 million, which is expected to be recognized over a weighted-average period of 2.3 years.

Employee Stock Purchase Plan

As of June 30, 2025, the Company had 2,318,649 shares of its common stock available for issuance under its Employee Stock Purchase Plan (“ESPP”). During the six months ended June 30, 2025, the Company issued 669,888 shares with a weighted-average purchase price of $0.15 under the ESPP, which resulted in an immaterial amount of compensation expense. During the six months ended June 30, 2024, the Company issued 74,326 shares with a weighted-average purchase price of $1.48 under the ESPP, which resulted in an immaterial amount of compensation expense.

Equity Award Modification

In connection with the Restructuring Plan, the Company executed an equity award modification which accelerated the vesting of the former Chief Executive Officer’s restricted stock units and options as a part of his consulting and separation agreement. The modification additionally extended the period for which vested options can be exercised following the employee’s final day of employment. During the six months ended June 30, 2025, the Company recognized $0.5 million of stock-based compensation expense related to the equity award modification as general and administrative expense within the condensed consolidated statement of operations and comprehensive loss.

Stock-Based Compensation

Stock-based compensation expense was allocated as follows:


	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2025		2024		2025		2024
Research and development	$	599	$	1,272	$	1,641	$	2,677
General and administrative		1,245		1,521		2,136		3,197
Total stock-based compensation expense	$	1,844	$	2,793	$	3,777	$	5,874

9. Leases

Cambridgepark Lease Amendments

In December 2019, the Company entered into a lease agreement for office and laboratory space (the “Cambridgepark Lease”) in Cambridge, Massachusetts with PPF Off 100 Cambridge Park Drive, LLC (the “Landlord”). During 2021 and 2022, the Company entered into various lease amendments with the Landlord to obtain additional leased space (the “Lease Amendments”).

In connection with the Restructuring Plan, the Company entered into an early termination agreement with the Landlord on June 20, 2025, pursuant to which the parties agreed to terminate the lease, effective August 4, 2025. Per the terms of such agreement, the Company made a non-refundable termination fee in the amount of $8.5 million to the Landlord. The early termination was treated as a lease modification for accounting purposes. As a result of the modification, the Company remeasured the lease liability and recognized a corresponding adjustment to the right-of-use asset as of the date of the modification. Additionally, as of June 30, 2025, the space was determined to be abandoned, thus the Company has accelerated amortization of the right-of-use asset and de-recognized any remaining balances during the period.

In conjunction with the Cambridgepark Lease, the Company was required to execute an irrevocable standby letter of credit of $2.4 million for the benefit of the Landlord. As of June 30, 2025, the funds securing the letter of credit were presented as restricted cash equivalents on the condensed consolidated balance sheets. The funds were released to the Company in July 2025.

The elements of lease expense were as follows:


	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands)	2025		2024		2025		2024
Operating lease cost	$	13,085	$	1,951	$	15,036	$	3,902
Variable lease cost		774		679		1,485		1,209
Total lease cost	$	13,859	$	2,630	$	16,521	$	5,111

Amounts reported in the condensed consolidated balance sheets and the weighted-average lease term and discount rate information were as follows:


(in thousands except weighted-average amounts)	June 30, 2025			December 31, 2024
Assets
Operating lease right-of-use assets	$	24		$		35,007
Liabilities
Operating lease liabilities, current	$	—		$		4,215
Operating lease liabilities, non-current		—				27,615
Total lease liabilities	$	—		$		31,830
Weighted-Average Lease Term and Discount Rate
Weighted-average remaining lease term (years)		0.1			5.7
Weighted-average discount rate		7.0	%			8.2	%

The following table represents other lease activity:


	Six Months Ended June 30,
(in thousands)	2025		2024
Other Information
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows for operating leases	$	11,884	$	3,258

10. Significant Agreements

Telitacicept License Agreement

On June 25, 2025, the Company and RemeGen Co., Ltd. (“RemeGen”) entered into a license agreement (the “Telitacicept License Agreement”) granting the Company exclusive rights to develop and commercialize RemeGen’s proprietary fusion protein compound, telitacicept (the “Licensed Compound”), outside of the People’s Republic of China, Hong Kong, Macau and Taiwan (collectively, “Greater China”). RemeGen retains all rights to the Licensed Compound in Greater China.

Under the License Agreement, the Company received an exclusive (even as to RemeGen) license under RemeGen’s patents and know-how to exploit, develop and commercialize the Licensed Compound in all territories other than Greater China, with the right to grant sublicenses. The Company also received a non-exclusive license to manufacture the Licensed Compound and any resulting licensed products (“Licensed Products”) worldwide solely for use in the licensed territory. The Company is responsible for all development, regulatory and commercialization activities and costs in the licensed territory, including the conduct of clinical trials and regulatory submissions. The Telitacicept License Agreement established a joint steering committee (“JSC”) to oversee the ongoing development and commercialization of telitacicept. The JSC comprises an equal number of senior-level executives from each party; however, final decision-making authority as it relates to the development and commercialization of the Licensed Compound outside Greater China lies with the Company.

As consideration for the rights granted, the Company agreed to make an upfront cash payment in the amount of $45.0 million and issued the RemeGen Warrants to a subsidiary of RemeGen, which were initially valued at $177.4 million. Refer to Note 7 for details on the terms of the RemeGen Warrants. The $45.0 million cash payment due to RemeGen has been accrued for within accrued liabilities on the condensed consolidated balance sheets as of June 30, 2025. The Company incurred $0.2 million in transaction costs related to the Telitacicept License Agreement.

The Company accounted for the Telitacicept License Agreement as an asset acquisition as substantially all of the value received was concentrated in the Licensed Compound which does not have an alternate future use as it is not yet approved for commercial sale in the licensed territory. The Company recognized a $222.6 million charge to research and development expense on the condensed consolidated statement of operations and comprehensive loss at the time of the completion of the asset acquisition during the quarter ended June 30, 2025. The Company has elected to classify the $222.6 million charge as an operating cash outflow on the condensed consolidated statement of cash flows.

Pursuant to the terms of the Telitacicept License Agreement, RemeGen is eligible to receive up to $330 million in regulatory milestone payments and up to $3.775 billion in sales milestone payments. In addition, RemeGen is entitled to receive tiered royalties on net sales of the Licensed Products in the licensed territory, ranging from high single digit to mid-teen percentages of net sales, subject to customary reductions. If the Company enters into a sublicense or divests rights to the Licensed Products prior to a specified development event and other than in connection with a change of control, RemeGen is entitled to receive a single digit percentage of certain net proceeds from such transactions. The Telitacicept License Agreement also provides for technology transfer, mutual indemnification and confidentiality. As of June 30, 2025, no milestone or royalty payments have been accrued for as the consideration is not yet payable per the terms of the Agreement.

The Telitacicept License Agreement may be terminated, in its entirety or on a region-by-region basis, by either party for material breach (subject to cure periods and dispute resolution) or insolvency of the other party, by the Company for convenience with advance notice, or by RemeGen if the Company challenges the validity of licensed patents. Upon termination, all rights and licenses in the terminated region will revert to RemeGen, with a wind-down period for the Company to cease activities.

Since December 31, 2024, there have been no additional material changes to the key terms of the Company’s other license agreements. For further information regarding the Company’s other license agreements, refer to Note 10 to the consolidated financial statements included in the 2024 Annual Report.

11. Net Loss Per Share

The following table sets forth the computation of the Company’s basic and diluted net loss per share for the three and six months ended June 30, 2025 and 2024:


	Three Months Ended June 30,						Six Months Ended June 30,
(in thousands, except share and per share amounts)	2025			2024			2025			2024
Numerator:
Net loss attributable to common stockholders	$	(1,573,669	)	$	(27,839	)	$	(1,606,155	)	$	(58,643	)
Denominator:
Weighted-average number of common shares outstanding, basic and diluted		125,271,447			68,299,170			125,049,032			68,165,068
Net loss per share attributable to common stockholders, basic and diluted	$	(12.56	)	$	(0.41	)	$	(12.84	)	$	(0.86	)

The Company’s potentially dilutive securities were stock options, unvested restricted stock, restricted stock units, and warrants. Based on the amounts outstanding as of June 30, 2025 and 2024, the Company excluded the following potential common shares from the computation of diluted net loss per share attributable to common stockholders because including them would have had an anti-dilutive effect:


	As of June 30,
	2025		2024
Options to purchase common stock		94,640,388		9,365,552
Unvested restricted stock		—		5,150
Restricted stock units		1,909,136		1,643,576
Warrants		1,089,839,075		—

12. Restructuring Plan

On May 5, 2025, the Company’s board of directors approved the wind down of the Company’s then clinical and manufacturing operations and the initiation of a process to explore strategic alternatives to maximize shareholder value (referred to as the “Restructuring Plan”). The Company publicly announced this plan on May 8, 2025.

In conjunction with the Restructuring Plan, the Company announced a reduction of its workforce by 154 full-time employees, or approximately 99% of the Company’s then-current employee base. Total severance and benefit costs incurred as of June 30, 2025 were $14.1 million. These costs were recognized in accordance with either ASC 712 or ASC 420, depending on the agreements with impacted employees. An additional $0.2 million of costs will be recognized in future periods through August 15, 2025, for certain costs which met the criteria for one-time termination benefits and require employees to provide future service.

As discussed in Notes 5 and 9, in connection with the Restructuring Plan, the Company sold certain long-lived assets as well as abandoned a right-of-use asset and other property and equipment. The disposals and abandonments resulted in a loss on disposal of $3.3 million, accelerated depreciation of $1.5 million, and accelerated amortization of right-of-use assets of $11.2 million, all of which were incurred during the three months ended June 30, 2025. Management concluded that the disposals do not meet the criteria for discontinued operations as they do not represent a strategic shift that will have a major effect on the Company’s operations and financial results.

Restructuring Costs

The Company incurred a total of $30.7 million of restructuring costs in the three and six months ended June 30, 2025. A summary of the restructuring costs recorded in the condensed consolidated statements of operations and comprehensive loss for both the three and six months ended June 30, 2025 is as follows:


	Three and Six Months Ended June 30, 2025
(in thousands)	Severance and Benefits Costs		Stock-based Compensation		Accelerated Depreciation on Long-lived Assets		Accelerated Amortization on Right-of-use Assets		Loss on Disposal of Long-lived Assets		Total Restructuring Cost Recorded
Research and development expense	$	8,957	$	—	$	1,230	$	10,159	$	3,303	$	20,346
General and administrative expense		5,188		549		284		1,064		—		10,388
Total restructuring costs	$	14,145	$	549	$	1,514	$	11,223	$	3,303	$	30,734

Restructuring Liability

The following table provides details of the severance and benefit costs with the remaining balance of the liability recorded in accrued liabilities on the condensed consolidated balance sheets as of June 30, 2025 (in millions):


(in thousands)	Restructuring Liability
Restructuring costs	$	14,145
Cash payments		(2,631	)
Liability included in accrued liabilities at June 30, 2025	$	11,514

13. Segments

The Company operates and manages its business as one reportable and operating segment, centered around the commercial development of its product candidates. The Company’s chief operating decision maker (“CODM”) is the Chief Executive Officer (“CEO”). On June 25, 2025, the Company appointed a new CEO who has taken over the role of CODM from the previous CEO.

The Company’s CODM reviews consolidated operating results, manages the business on a consolidated basis and utilizes consolidated net loss from the condensed consolidated statements of operations and comprehensive loss to make decisions about allocating resources and assessing performance for the entire Company. Consolidated net loss is also used to monitor budget to actual results. The CODM is additionally regularly provided with more detailed expense information at the program level. Through the date of issuance of these financial statements, the CODM has not been provided with any modified information other than what has been provided and reviewed historically by the previous CEO.

The following table is a summary of the segment profit or loss, including significant segment expenses (in thousands):


	Three Months Ended June 30,						Six Months Ended June 30,
	2025			2024			2025			2024
Segment expenses:
Trem-cel(a)	$	3,095		$	3,619		$	9,477		$	8,480
VCAR33(a)		2,419			1,762			6,055			4,362
Other research and development(a)		225,144			3,177			228,139			6,294
Salaries and benefits		17,863			10,404			29,476			22,517
General corporate activities		16,694			4,947			21,863			10,246
Other segment items(b)		1,308,454			3,930			1,311,145			6,744
Segment expenses:		1,573,669			27,839			1,606,155			58,643
Segment net loss	$	(1,573,669	)	$	(27,839	)	$	(1,606,155	)	$	(58,643	)

(a) Includes only external research and development expenditures.

(b) Other segment items are primarily comprised of taxes, interest income on marketable securities and certain non-cash expenses such as change in fair value of warrant liabilities, stock-based compensation, depreciation expense, and non-cash lease expense.

The measure of segment assets is reported on the condensed consolidated balance sheets as total assets. The CODM additionally reviews cash, cash equivalents and marketable securities when reviewing segment assets. As of June 30, 2025, the Company’s cash, cash equivalents and marketable securities were $200.6 million. The Company does not provide its CODM with any more detailed segment asset information than what is included on the Company’s condensed consolidated balance sheets.

14. Related Party Transactions

2025 Private Placement

As discussed in Note 7, on June 25, 2025, the Company entered into a purchase agreement with certain institutional investors pursuant to which the Company issued and sold warrants to purchase the Company's common stock. RA Capital Healthcare Fund, L.P. purchased warrants to purchase up to 200,000,000 shares of the Company's common stock for gross proceeds of $50.0 million. RA Capital Healthcare Fund, L.P. and its affiliates hold more than 5% of the Company’s common stock. Joshua Resnick, M.D., a member of the Company’s board of directors, is a managing director at RA Capital Management, an affiliate of RA Capital Healthcare Fund, L.P. The terms of the warrants are further described in Note 7 and none of the warrants have been exercised as of June 30, 2025.

15. Subsequent Events

On August 12, 2025, the Company entered into a lease agreement with 500 Boylston & 222 Berkeley Owner (DC) LLC, pursuant to which the Company agreed to lease approximately 8,391 square feet of office space in Boston, Massachusetts. The commencement date of the lease is the earlier of when the Company enters into possession of the premises or September 1, 2025 (the “Term Commencement Date”), and the lease will expire 72 full calendar months after the Term Commencement Date (the “Initial Term”), unless terminated earlier in accordance with the lease agreement. The Company expects to make an aggregate amount of base rental payments of $3.8 million during the Initial Term.

The Company has the option to extend the term for one additional five-year period.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with the unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and with the consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2024 (the “2024 Annual Report”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the section titled “Risk Factors” in our 2024 Annual Report and in other reports we have filed or may file with the SEC, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

Vor Bio is a clinical-stage biopharmaceutical company focused on developing a novel therapy in the treatment of autoimmune diseases. In June 2025, we in-licensed telitacicept from RemeGen Co., Ltd. (“RemeGen”). Telitacicept is approved in China for the treatment of systemic lupus erythematosus (“SLE”), rheumatoid arthritis (“RA”), and generalized myasthenia gravis (“gMG”). A global Phase 3 clinical trial in gMG is currently underway across the United States, Europe, South America, and Asia including Japan to support potential approval in the United States, Europe, and Japan.

Telitacicept is a novel fusion protein for treating autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (“TACI”) receptor and the fragment crystallizable (“Fc”) domain of human immunoglobulin G (“IgG”). Telitacicept targets and acts on two cell signaling molecules critical for B lymphocyte development: B cell lymphocyte stimulator (“BLyS”), also known as B cell activating factor (“BAFF”), and a proliferation inducing ligand (“APRIL”), which allows it to effectively reduce B cell mediated autoimmune responses that are implicated in several autoimmune diseases.

Pursuant to our license agreement with RemeGen, we were granted an exclusive license to develop and commercialize telitacicept outside of the Greater China region, which includes mainland China, Hong Kong, Macau and Taiwan. RemeGen retains development and commercialization rights in Greater China. The terms of the license agreement are more fully described in our Current Report on Form 8-K filed with the SEC on June 26, 2025. A copy of the license agreement is filed herewith as Exhibit 10.9.

Our Clinical Development Programs & Pipeline

Our broader development plan includes exploring development of telitacicept in additional autoantibody-driven diseases where BAFF / APRIL signaling is a validated target, supported by prior clinical experience and mechanistic rationale.

Our Team

We are led by a seasoned management team with deep expertise in autoimmune disease drug development, commercialization, and corporate leadership.

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Jean-Paul Kress, M.D., Chief Executive Officer (“CEO”) and Chairman of the Board, was appointed in June 2025. Dr. Kress most recently served as Chief Executive Officer of MorphoSys AG from September 2019 until August 2024 when it was acquired by Novartis. Dr. Kress currently serves the board of directors of Sanofi and previously served as chairman of the board of Erytech Pharma from June 2019 until June 2023. He served as President and Chief Executive Officer of Syntimmune Inc. from January 2018 until November 2018. Prior to joining Syntimmune, Dr. Kress served as Executive Vice President of International and Head of Global Therapeutic Operations at Biogen Inc from June 2017 to January 2018. He previously served as a member of the board of directors of Sarepta Therapeutics, Inc. from September 2015 to June 2017. From September 2015 to June 2017, Dr. Kress served as Senior Vice President, Head of North America at Sanofi Genzyme. From July 2011 to September 2015, Dr. Kress served as President and Chief Executive Officer of Sanofi Pasteur MSD, one of the leading European vaccine companies. Prior to then, Dr. Kress worked at Gilead, Abbvie and Eli Lilly in senior commercial and business development roles in the United States and in Europe. Dr. Kress holds an M.D. degree from Faculté Necker-Enfants Malades in Paris, and graduate and post-graduate degrees in pharmacology and immunology from École Normale Supérieure in Paris.

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Sandy Mahatme, J.D., LL.M., Chief Financial Officer and Chief Business Officer, joined the Company in July 2025. Mr. Mahatme most recently served as President, Chief Operating Officer and Chief Financial Officer of National Resilience Inc., a technology focused biomanufacturing company dedicated to broadening access to complex medicines from July 2020 to June 2024. From November 2012 to July 2020, Mr. Mahatme served in various executive positions, including as Executive Vice President, Chief Financial Officer and Chief Business Officer of Sarepta Therapeutics, Inc., a publicly traded biopharmaceutical company. Prior to those roles, he worked at Celgene Corporation, where he served in various positions including Senior Vice President of Corporate Development, Senior Vice President of Finance, Corporate Treasurer and Head of Tax.

Mr. Mahatme served in senior roles in business development and corporate finance at Pfizer after starting his career at Ernst & Young LLP. Mr. Mahatme has served as a director of Idorsia Pharmaceuticals Ltd. since May 2020 and of CRISPR Therapeutics AG since May 2024. In addition, Mr. Mahatme previously served as a director on the boards of Aeglea Bio Therapeutics, Inc. from June 2015 to July 2022 and Flexion Therapeutics, Inc. from July 2014 to June 2021. Mr. Mahatme earned Master of Laws degrees from Cornell Law School and the New York University School of Law and is a member of the New York State Bar Association.

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Qing Zuraw, M.D., M.P.H., M.B.A., Chief Development Officer, joined the Company in July 2025. Dr. Zuraw joins Vor Bio with over 25 years of experience leading complex global and U.S. clinical development programs across autoimmune, inflammatory, and immunologic diseases. Most recently, she served as Chief Development Officer and Head of Global Clinical Development for Autoimmune Diseases at RemeGen Co., Ltd. from December 2022 to July 2025, where she was one of the key leaders of the successful development and execution of clinical trials for telitacicept across three key indications—SLE, Sjögren’s syndrome, and myasthenia gravis (“MG”)—Dr. Zuraw has also previously held senior leadership roles at Janssen Research & Development from December 2018 to December 2022, Teva Pharmaceutical Industries Ltd. from August 2017 to December 2018, and Akebia Therapeutics, Inc. from June 2015 to July 2017, where she led global clinical development programs across rheumatology, nephrology, respiratory, and immunology. She played a key role in the U.S. FDA approval of Guselkumab for psoriatic arthritis and contributed to multiple NDA and BLA submissions across therapeutic areas. Dr. Zuraw earned her M.D. from Shandong University Cheeloo College of Medicine, M.P.H from Johns Hopkins University and M.B.A. from Drexel University.

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Dallan Murray, M.B.A., Chief Commercial Officer, joined the Company in August 2025. Mr. Murray brings over 20 years of commercial leadership experience in the biopharmaceutical industry. Most recently, he worked at Sarepta Therapeutics Inc. from October 2013 to August 2025, serving in various roles including Senior Vice President and Chief Commercial Officer. Mr. Murray has also previously held multiple positions at Vertex Pharmaceuticals Inc. from April 2010 to October 2013, including Senior Director of HCV Marketing. Other roles included Director, Hepatitis Marketing Team at Gilead Sciences Inc. from March 2008 to April 2010, Associate Director at Biogen Inc. from December 2004 to March 2008, and multiple product roles at Janssen-Ortho Inc. from February 1999 to December 2004. Mr. Murray earned his M.B.A. from Queen’s University.

Our Strategy

Vor Bio is executing a focused strategy to become a leading global company in autoimmune therapeutics. Our strategic priorities include:

Rapid Global Development of Telitacicept: We are advancing telitacicept through global Phase 3 trials, with the near-term goal of regulatory approval in the United States, the European Union and Japan for gMG. Our strategy leverages clinical de-risking from prior trials of telitacicept conducted in China by RemeGen.

Pipeline Expansion: Telitacicept’s dual inhibition of BAFF/APRIL provides a platform to address a broad range of B cell-driven autoimmune diseases. We are evaluating opportunities to develop telitacicept in additional indications based on scientific rationale and unmet market need.

Global Commercial Preparedness: With telitacicept already approved in China for SLE, RA and gMG and a registrational program underway in major global markets, we are building commercial capabilities and infrastructure to support potential launches.

Our Product Candidate

Telitacicept

Telitacicept is approved in China for the treatment of SLE, RA and gMG. A global Phase 3 clinical trial in gMG is currently underway across the United States, Europe, South America, and Asia including Japan to support potential approval in the United States, Europe, and Japan.

gMG is a rare, chronic autoimmune neuromuscular disorder characterized by fluctuating skeletal muscle weakness resulting from pathogenic autoantibodies, most frequently the targeting components of the neuromuscular junction. These autoantibodies, about 85% of which are acetylcholine receptor (“AChR”) and 5-8% of which are muscle-specific tyrosine kinase (“MuSK”), impair synaptic transmission, leading to a disabling and potentially life-threatening condition that requires long-term immunomodulation to control disease activity.

gMG has a prevalence of approximately 150 to 250 individuals per million worldwide, with a rising incidence among aging populations. In the United States, based on a 2021 claims analysis, the prevalence is thought to be comparable to Europe at approximately 370 individuals per million, and it is estimated that approximately 100,000 individuals have MG in the United States.

The treatment goals for gMG include achieving minimal symptoms while minimizing treatment side effects. Even with newer treatments, MG poses significant physical, psychological, and economic impacts despite available treatments, with potential for exacerbations, myasthenia crises which could be life threatening, and complications such as infections or autoimmune comorbidities. Drug therapy for gMG typically begins with acetylcholinesterase inhibitors (such as pyridostigmine). However, as acetylcholinesterase inhibitors may improve symptoms, they are often insufficient. Traditional immunosuppressive therapies, such as corticosteroids, azathioprine, and mycophenolate mofetil, remained first-line treatments for decades, despite their delayed onset of action, cumulative toxicity, and inconsistent disease control. Recent biologics have introduced targeted immune modulation with improved clinical outcomes. Currently there are two classes of biologics in clinical development that have already obtained approval: neonatal fragment crystallizable receptor (“FcRn”) antagonists and complement inhibitors.

FcRn antagonists enhance immunoglobulin G (“IgG”) catabolism and have demonstrated clinical benefit in AChR antibody positive patients. They are administered in cycles of four weeks or six weeks due to the deep reduction in IgG level, which increases the potential for severe infection. Complement inhibitors block terminal complement activation and have shown efficacy in reducing disease severity. However, complement inhibitors carry a black box warning on the label, which requires a Risk Evaluation and Mitigation Strategies (“REMS”) program requiring patients to be vaccinated to prevent serious brain infection prior to initiating the therapy. Most recently, a monoclonal antibody targeting CD19, depleting a broad range of B-cells, showed clinical benefit in Phase 3 clinical trials.

However, none of these agents directly modulates the cytokine environment that sustains autoreactive B cells and plasma cells. B cell maturation and plasma cell survival are critically regulated by two cytokines of the TNF ligand superfamily: BAFF and APRIL. Elevated circulating levels of BAFF and APRIL have been detected in autoimmune diseases, including gMG. In gMG specifically, BAFF has been shown to be elevated in both serum and thymic tissues of patients with active disease and correlates with higher anti-AChR antibody titers.

Telitacicept is a novel recombinant fusion protein. By binding to both BAFF and APRIL, telitacicept selectively inhibits B cell survival and plasma cell function. This dual-targeting approach has demonstrated clinical benefit in autoimmune conditions, including SLE, RA, IgA nephropathy, primary Sjögren’s syndrome (“pSS”), and gMG.

Phase 3 Clinical Trial in patients with gMG in China

Telitacicept was evaluated by RemeGen in a Phase 3 clinical trial in patients with gMG in China. The trial enrolled 114 patients and consisted of a double-blind treatment period (“Part A”) and an open-label treatment period (“Part B”). In Part A, patients were randomized 1:1 to receive either subcutaneous telitacicept 240 mg or placebo once a week for 24 doses. After completing Part A, patients were automatically entered into Part B, in which all patients receive weekly subcutaneous telitacicept 240 mg for 24 weeks.

The primary endpoint of the trial was change from baseline in the Myasthenia Gravis Activities of Daily Living (“MG-ADL”) score at week 24 of Part A. MG-ADL is an 8-item patient-reported scale that measures MG symptoms and functional status. Each item ranges from 0-3 for a total score range of 0-24. The MG-ADL scale quantifies the impact of MG symptoms on daily life quality, focusing on patients’ subjective experience and daily function. A secondary endpoint was change from baseline in the Quantitative Myasthenia Gravis (“QMG”) score, which is a 13-item scale used to quantify disease severity in MG, with total QMG scores ranging from 0-39. The QMG score assesses the strength and endurance of the whole body muscle group, focusing on objective measurement. There is a strong correlation between MG-ADL and QMG in evaluating treatment response, and the combination of MG-ADL and QMG can comprehensively reflect the disease severity.

The data from the results of the Phase 3 trial were presented at the 2025 American Academy of Neurology (“AAN”) meeting in April 2025 and in European Academy of Neurology in June 2025. The data at week 24 demonstrated:

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The “MG-ADL score decreased by 5.74 points from baseline in the telitacicept group, compared to a decrease of 0.91 points in the placebo group (note: missing data imputed as non-response).

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The QMG score decreased by 8.66 points from baseline in the telitacicept group, compared to a decrease of 2.27 points in the placebo group.

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98.1% of patients in the telitacicept group demonstrated a ≥ 3-point improvement in MG-ADL score, compared to 12.0% in the placebo group.

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87.0% of patients in the telitacicept group demonstrated a ≥ 5-point improvement in QMG score, compared to 16.0% in the placebo group.

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The overall adverse event (“AE”) rate in the telitacicept group was comparable to that in the placebo group, indicating telitacicept was well-tolerated.

Global Phase 3 Clinical Trial in patients with gMG:

Telitacicept is currently being evaluated in a global Phase 3 clinical trial, for which we will assume responsibility from RemeGen in connection with the license agreement, for the treatment of gMG. The trial is currently recruiting in the United States, Canada, Europe, Australia and South America. The trial is a randomized, double-blind, placebo controlled trial with an open-label extension period. The primary endpoint is change from baseline in MG-ADL at week 24. Key secondary endpoints include change from baseline in QMG score, proportion of patients achieving MG-ADL score reduction of at least 2 points, QMG score reduction of at least 3 points at week 24 and change from baseline in MG Quality of Life (“MG-QOL15r”) scale at week 24. The MG-QoL15r is a 15-item patient-reported outcome measure designed to assess quality of life in patients with MG. Each item in the scale is scored on a 0-2 point scale, with the total score ranging from 0 to 30. Higher scores indicate a more severe impact of the disease on aspects of the patient's life. A decrease from baseline score indicates improvement.

In July 2024, the clinical trial enrolled the first patient in the United States.

Regulatory Overview

Telitacicept has received Orphan Drug Designation (“ODD”) from both the U.S. Food and Drug Administration (“FDA”) and European Medicines Agency (“EMA”) for the treatment of gMG and is now the first in class, dual inhibitor of BAFF and APRIL biologic drug for gMG with ODD from both FDA and EMA.

In January 2024, the FDA cleared the Investigational New Drug (“IND”) application for the global multi-center Phase 3 clinical trial of telitacicept for the treatment of adult patients with pSS. In March 2024, telitacicept received Fast-Track Designation (“FTD”) from the FDA for the treatment of adult patients with pSS.

Sales and Marketing

Given our stage of development, we have not yet established a commercial organization or distribution capabilities. We plan to build focused capabilities in various regions worldwide (the United States, South America, Europe, Japan, the Middle East and North Africa) to commercialize our product candidate, if approved. We plan to focus our efforts in these regions because we believe the patient populations and medical specialists for the indications we are targeting are sufficiently concentrated to allow us to effectively promote our product candidate, if approved for commercial sale, with a targeted sales team.

Manufacturing

We plan to rely on third-party contract manufacturers for clinical manufacturing of required raw materials, manufacturing devices, active pharmaceutical ingredients and finished product for our research and clinical manufacturing. We do not have long-term agreements with any of these third parties. We also do not have any current contractual relationship for the manufacture of material for clinical trials beyond Phase 3 or commercial supplies. We intend to enter into agreements with third-party contract manufacturers and one or more backup manufacturers for future production. We continue to analyze the feasibility of building additional manufacturing capabilities for future development and commercial quantities of any products that we develop. Such products will need to be manufactured in facilities, and by processes, that comply with the requirements of the FDA and the regulatory authorities of other jurisdictions in which we are seeking approval.

Competition

The autoimmune field is a competitive landscape involving multiple monoclonal antibodies, other biologics, chimeric antigen receptor (CAR) T cells and small molecules either already marketed or in development by many different companies including, but not limited to Alexion, Amgen, Argenx, Dianthus, Johnson & Johnson, and UCB.

Intellectual Property

The patent portfolio licensed from RemeGen includes a first patent family directed to the telitacicept composition of matter, with a granted patent in each of the United States, China, Europe, Japan, Korea, Russia, Brazil, and India. The patents granted in this family outside of China are expected to expire in 2028, absent any applicable patent term extensions.

Three additional families licensed from RemeGen are directed to formulations of telitacicept. A first family covering aqueous liquid formulations includes applications pending in the United States, Canada, Brazil, India, Singapore, Korea, and Hong Kong with granted patents in each of Australia, Russia, China, Japan, and Europe. Any patents that grant from applications claiming priority to this patent family would be expected to expire in 2040, absent any applicable patent term extensions.

A second family covering liquid preparations includes applications pending in the United States, China, Russia, Australia, Europe, India, Brazil, Japan, China, Indonesia, Mexico, Korea, Israel, and Singapore, with a granted patent in Taiwan. Any patents that grant from applications claiming priority to this patent family would be expected to expire in 2043, absent any applicable patent term extensions. A third family covering protected liquid formulations of telitacicept includes a pending PCT international application and a pending application in Taiwan.

Any patents that grant from applications claiming priority to this patent family would be expected to expire in 2044, absent any applicable patent term extensions.

Ten additional families licensed from RemeGen are directed to methods and uses of telitacicept for the treatment of specific conditions. A first family covering the treatment of systemic lupus erythematosus includes applications filed in the United States, Australia, Canada, Korea, and Singapore, with granted patents in Russia and Australia. Any patents that grant from applications claiming priority to this patent family would be expected to expire in 2039, absent any applicable patent term extensions.

A second family covering the treatment of IgA nephropathy includes applications filed in the United States, Russia, Australia, Canada, Brazil, Europe, Korea, Singapore, Hong Kong, and Taiwan, with a granted patent in Japan. A third family covering the treatment of Sjogren's syndrome includes applications filed in the United States, Australia, Canada, Brazil, Europe, Korea, Japan, Singapore, Hong Kong, and Taiwan, with a granted patent in Russia. Any patents that grant from applications claiming priority to these patent families would be expected to expire in 2042, absent any applicable patent term extensions.

A fourth family covering the treatment of myasthenia gravis includes applications filed in the United States, Canada, Australia, Russia, Europe, Brazil, Japan, China, Singapore, Korea, Indonesia, Mexico, Israel, and Hong Kong, with a granted patent in Taiwan. A fifth family covering the treatment of membranous nephropathy includes application filed in the United States, Taiwan, China, Europe, and Japan. Any patents that grant from applications claiming priority to these patent families would be expected to expire in 2043, absent any applicable patent term extensions.

Five additional families covering the treatment of IgG4-related disease, anca-associated vasculitis, antibody-mediated rejection, autoimmune encephalitis, and antiphospholipid syndrome each include pending PCT international applications and applications in Taiwan. Any patents that grant from applications claiming priority to these patent families would be expected to expire between 2043 and 2045, absent any applicable patent term extensions.

Government Regulation

Government authorities in the United States at the federal, state and local level and in other countries and jurisdictions, including the European Union, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of drug and biological products, such as our investigational medicines and any future investigational medicines. Generally, before a new drug or biologic can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific for each regulatory authority, submitted for review and approved by the regulatory authority.

Regulatory Approval in the United States

In the United States, pharmaceutical products are subject to extensive regulation by the FDA. The Federal Food, Drug and Cosmetic Act (“FDCA”), and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post- approval monitoring and reporting, sampling, and import and export of pharmaceutical products. Biological products used for the prevention, treatment or cure of a disease or condition of a human being are subject to regulation under the FDCA, except that they are approved, or licensed, for marketing under provisions of the Public Health Service Act (“PHSA”) via a BLA. The application process and requirements for approval of BLAs for reference biological products are similar to those for New Drug Applications for new chemical entities. Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as clinical hold, FDA refusal to approve pending BLAs, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties, and criminal prosecution.

Our investigational medicines and any future investigational medicines must be approved by the FDA pursuant to a BLA before they may be legally marketed in the United States. The process generally involves the following:

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completion of extensive preclinical laboratory and animal studies in accordance with applicable regulations, including studies conducted in accordance with good laboratory practices (“GLP”) requirements;

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submission to the FDA of an Investigational New Drug Application (“IND”), which must become effective before human clinical trials may begin;

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approval of the protocol and related documents by an institutional review board (“IRB”) or independent ethics committee at each clinical trial site before each clinical trial may be commenced;

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performance of adequate and well controlled human clinical trials in accordance with applicable IND regulations, GCP requirements and other clinical trial-related regulations to establish the safety and efficacy of the investigational product for each proposed indication; preparation of and submission to the FDA of a BLA for marketing approval that includes sufficient evidence of establishing the safety, purity, and potency of the proposed biological product for its intended indication, including from results of nonclinical testing and clinical trials;

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payment of any user fees for FDA review of the BLA;

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a determination by the FDA within 60 days of its receipt of a BLA to accept the filing for review;

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satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the biologic, or components thereof, will be produced to assess compliance with current cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, strength, quality and purity;

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satisfactory completion of any potential FDA audits of the clinical trial sites that generated the data in support of the BLA to assure compliance with GCPs and integrity of the clinical data;

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potential FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the BLA;

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FDA review and approval of the BLA, including consideration of the views of any FDA advisory committee; and

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compliance with any post-approval requirements, including a REMS, where applicable, and post- approval studies required by the FDA as a condition of approval.

The preclinical and clinical testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product candidates will be granted on a timely basis, or at all.

Preclinical studies

Before testing any biological product candidates in humans, the product candidate must undergo rigorous preclinical testing. Preclinical studies include laboratory evaluation of product chemistry and formulation, as well as in vitro and animal studies to assess the potential for adverse events and in some cases to establish a rationale for therapeutic use. The conduct of preclinical studies is subject to federal regulations and requirements, including GLP regulations for safety/toxicology studies.

Prior to beginning the first clinical trial with a product candidate in the United States, an IND must be submitted to the FDA and the FDA must allow the IND to proceed. An IND is an exemption from the FDCA that allows an unapproved product candidate to be shipped in interstate commerce for use in an investigational clinical trial and a request for FDA allowance that such investigational product may be administered to humans in connection with such trial. Such authorization must be secured prior to interstate shipment and administration. In support of a request for an IND, applicants must submit a protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. An IND sponsor must also submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and plans for clinical trials, among other things, to the FDA as part of an IND. Some long-term preclinical testing may continue after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to one or more proposed clinical trials and places the trial on clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.

Clinical trials

The clinical stage of development involves the administration of the investigational product to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control. Clinical trials must be conducted: (i) in compliance with federal regulations; (ii) in compliance with GCPs, an international standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors; as well as (iii) under protocols detailing, among other things, the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated in the trial. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the FDA as part of the IND.

Furthermore, each clinical trial must be reviewed and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed. An IRB must operate in compliance with FDA regulations. An IRB can suspend or terminate approval of a clinical trial at its institution, or an institution it represents, if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the product candidate has been associated with unexpected serious harm to patients.

Some trials are overseen by an independent group of qualified experts organized by the trial sponsor, known as a data safety monitoring board or committee (“DSMB”). This group provides authorization as to whether or not a trial may move forward at designated check points based on access that only the group maintains to available data from the study.

There also are requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries. Information about certain clinical trials, including clinical trial results, must be submitted within specific timeframes for publication on the www.clinicaltrials.gov website. Information related to the product, patient population, phase of investigation, clinical trial sites and investigators and other aspects of the clinical trial is then made public as part of the registration. Disclosure of the results of these clinical trials can be delayed in certain circumstances for up to two years after the date of completion of the trial.

A sponsor who wishes to conduct a clinical trial outside of the United States may, but need not, obtain FDA authorization to conduct the clinical trial under an IND. If a foreign clinical trial is not conducted under an IND, the sponsor may submit data from the clinical trial to the FDA in support of a BLA. The FDA will accept a well-designed and well-conducted foreign clinical trial not conducted under an IND if the clinical trial was conducted in accordance with GCP requirements, and the FDA is able to validate the data through an onsite inspection if deemed necessary.

Clinical trials are generally conducted in three sequential phases, known as Phase 1, Phase 2 and Phase 3:

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Phase 1 clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the metabolism, pharmacokinetics, pharmacologic action, side effect tolerability, safety of the product candidate, and, if possible, early evidence of effectiveness.

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Phase 2 clinical trials generally involve studies in disease-affected patients to evaluate proof of concept and/or determine the dosing regimen(s) for subsequent investigations. At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety risks are identified, and a preliminary evaluation of efficacy is conducted.

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Phase 3 clinical trials generally involve a large number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product and provide an adequate basis for product labeling. In most cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the biologic.

These Phases may overlap or be combined. For example, a Phase 1/2 clinical trial may contain both a dose-escalation stage and a dose-expansion stage, the latter of which may confirm tolerability at the recommended dose for expansion in future clinical trials.

A single Phase 3 or Phase 2 trial with other confirmatory evidence may be sufficient in rare instances to provide substantial evidence of effectiveness (generally subject to the requirement of additional post-approval studies).

In some cases, FDA may require, or firms may voluntarily pursue, post-approval clinical trials, sometimes referred to as Phase 4 clinical trials, after initial marketing approval. These clinical trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up.

During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data, and clinical trial investigators. Annual progress reports detailing the results of the clinical trials must be submitted to the FDA. Written IND safety reports must be promptly submitted to the FDA and the investigators for serious and unexpected adverse events, any findings from other studies, tests in laboratory animals or in vitro testing that suggest a significant risk for human subjects, or any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within seven calendar days after the sponsor’s initial receipt of the information.

Phase 1, Phase 2, Phase 3 and other types of clinical trials may not be completed successfully within any specified period, if at all. The FDA, the IRB, or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including non-compliance with regulatory requirements or a finding that the patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug or biologic has been associated with unexpected serious harm to patients.

Concurrent with clinical trials, companies usually complete additional animal studies and also must develop additional information about the chemistry and physical characteristics of the drug or biologic as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product and, among other things, companies must develop methods for testing the identity, strength, quality, potency and purity of the final product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the investigational medicines do not undergo unacceptable deterioration over their shelf life.

FDA review processes

Following completion of the clinical trials, the results of preclinical studies and clinical trials are submitted to the FDA as part of a BLA, along with proposed labeling, chemistry and manufacturing information to ensure product quality and other relevant data. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the investigational product to the satisfaction of the FDA. FDA approval of a BLA must be obtained before a biologic may be marketed in the United States.

The cost of preparing and submitting a BLA is substantial. Under the Prescription Drug User Fee Act (“PDUFA”), each BLA must be accompanied by a user fee. The FDA adjusts the PDUFA user fees on an annual basis. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Additionally, no user fees are assessed on BLAs for products designated as orphan drugs, unless the product also includes a non-orphan indication. The applicant under an approved BLA is also subject to an annual program fee.

Within 60 days following submission of the application, the FDA reviews a BLA submitted to determine if it is substantially complete before the FDA accepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information. In this event, the BLA must be resubmitted with the additional information. The resubmitted application also is subject to review to determine if it is substantially complete before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth review of the BLA. The FDA reviews the BLA to determine, among other things, whether the proposed product is safe, pure and potent, for its intended use, and whether the product is being manufactured in accordance with cGMP to ensure its continued safety, purity and potency.

Under the goals and policies agreed to by the FDA under PDUFA, the FDA has 10 months, from the filing date, in which to complete its initial review of a BLA and respond to the applicant, and six months from the filing date of a BLA designated for priority review. The review process for both standard and priority review may be extended by the FDA for three additional months to consider certain late-submitted information, or information intended to clarify information already provided in the submission. The FDA does not always meet its PDUFA goal dates for standard and priority BLAs, and the review process can be extended by FDA requests for additional information or clarification.

Before approving a BLA, the FDA will conduct a pre-approval inspection of the manufacturing facilities for the new product to determine whether they comply with cGMP requirements and to ensure they can supply the market demand once approved. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.

The FDA also may audit data from clinical trials to ensure compliance with GCP requirements and the integrity of the data supporting safety and efficacy. Additionally, the FDA may refer applications for novel products or products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions, if any. The FDA is not bound by recommendations of an advisory committee, but it generally follows such recommendations when making decisions on approval. The FDA likely will reanalyze the clinical trial data, which could result in extensive discussions between the FDA and the applicant during the review process.

After the FDA evaluates a BLA, it will issue either an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the biologic with specific prescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete and the application will not be approved in its present form. A Complete Response Letter generally outlines the deficiencies in the BLA and may require additional clinical data, additional pivotal clinical trial(s) and/or other significant and time-consuming requirements related to clinical trials, preclinical studies or manufacturing in order for FDA to reconsider the application. If a Complete Response Letter is issued, the applicant may either resubmit the BLA, addressing all of the deficiencies identified in the letter, or withdraw the application or request an opportunity for a hearing. The FDA has committed to reviewing such resubmissions in two or six months, depending on the type of information included. Even if such data and information are submitted, the FDA may decide that the BLA does not satisfy the criteria for approval.

If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, including to subpopulations of patients, which could restrict the commercial value of the product. Furthermore, as a condition of BLA approval, the FDA may require a REMS to help ensure that the benefits of the biologic outweigh the potential risks to patients. A REMS can include medication guides, communication plans for healthcare professionals and elements to assure a product’s safe use (“ETASU”). An ETASU can include, but is not limited to, special training or certification for prescribing or dispensing the product, dispensing the product only under certain circumstances, special monitoring and the use of patient-specific registries. The requirement for a REMS can materially affect the potential market and profitability of the product. Moreover, the FDA may require substantial post-approval testing and surveillance to monitor the product’s safety or efficacy.

Orphan drug designation

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biological product intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States but for which there is no reasonable expectation that the cost of developing and making the product for this type of disease or condition will be recovered from sales of the product in the United States.

Orphan drug designation must be requested before submitting a BLA. After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation on its own does not convey any advantage in or shorten the duration of the regulatory review and approval process.

If a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications to market the same product for the same indication for seven years from the date of such approval, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity by means of greater effectiveness, greater safety, or providing a major contribution to patient care, or in instances of drug supply issues. A designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation. Orphan drug exclusivity may be lost if the FDA later determines that the request for designation was materially defective. Further, competitors may receive approval of either a different product for the same indication or the same product for a different indication. In the latter case, because healthcare professionals are free to prescribe products for off-label uses, the competitor’s product could be used for the orphan indication despite another product’s orphan exclusivity.

Expedited development and review programs

The FDA is authorized to designate certain products for expedited review if they are intended to address an unmet medical need in the treatment of a serious or life-threatening disease or condition.

Fast track designation may be granted for products that are intended to treat a serious or life-threatening disease or condition for which there is no effective treatment and preclinical or clinical data demonstrate the potential to address unmet medical needs for the condition. Fast track designation applies to both the product and the specific indication for which it is being studied. The sponsor of a new biologic candidate can request the FDA to designate the candidate for a specific indication for fast track status concurrent with, or after, the submission of the IND for the candidate. The FDA must determine if the biologic candidate qualifies for fast track designation within 60 days of receipt of the sponsor’s request. For fast track products, sponsors may have greater interactions with the FDA and the FDA may initiate review of sections of a fast track product’s BLA before the application is complete. This “rolling review” is available if the FDA determines, after preliminary evaluation of clinical data submitted by the sponsor, that a fast track product may be effective. The sponsor must also provide, and the FDA must approve, a schedule for the submission of the remaining information and the sponsor must pay applicable user fees. Any product submitted to the FDA for marketing, including under a fast track program, may be eligible for other types of FDA programs intended to expedite development and review, such as priority review and accelerated approval.

Breakthrough therapy designation may be granted for products that are intended, alone or in combination with one or more other products, to treat a serious or life-threatening condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over currently approved therapies on one or more clinically significant endpoints. Under the breakthrough therapy program, the sponsor of a new biologic candidate may request that the FDA designate the candidate for a specific indication as a breakthrough therapy concurrent with, or after, the submission of the IND for the biologic candidate. The FDA must determine if the biological product qualifies for breakthrough therapy designation within 60 days of receipt of the sponsor’s request. The FDA may take certain actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout the development process, providing timely advice to the product sponsor regarding development and approval, involving more senior staff in the review process, assigning a cross-disciplinary project lead for the review team and taking other steps to design the clinical trials in an efficient manner.

Priority review may be granted for products that are intended to treat a serious or life-threatening condition and, if approved, would provide a significant improvement in safety and effectiveness compared to available therapies. The FDA will attempt to direct additional resources to the evaluation of an application designated for priority review in an effort to facilitate the review. Under priority review, the FDA’s goal is to review an application in six months once it is filed, compared to ten months for a standard review. Priority review designation does not change the standard for approval or the quality of evidence necessary to support approval.

Accelerated approval may be granted for products that are intended to treat a serious or life-threatening condition and that generally provide a meaningful therapeutic advantage to patients over existing treatments. A product eligible for accelerated approval may be approved on the basis of either a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments. In clinical trials, a surrogate endpoint is a measurement of laboratory or clinical signs of a disease or condition that substitutes for a direct measurement of how a patient feels, functions or survives.

The accelerated approval pathway is most often used in settings in which the course of a disease is long, and an extended period of time is required to measure the intended clinical benefit of a product, even if the effect on the surrogate or intermediate clinical endpoint occurs rapidly. Use of the accelerated approval pathway entails submission of a BLA with the surrogate or intermediate clinical endpoint data while continuing to conduct the trial(s) to completion and is contingent on a sponsor’s agreement to complete and/or conduct additional post-approval confirmatory studies to verify and describe the product’s clinical benefit. These confirmatory trials must be completed with due diligence and, in some cases, the FDA may require that the trial be designed, initiated and/or fully enrolled prior to approval. Failure to conduct required post-approval studies, or to confirm a clinical benefit during post-marketing studies, would allow the FDA to withdraw the product from the market on an expedited basis. All promotional materials for product candidates approved under accelerated regulations are subject to prior review by the FDA.

Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or the time period for FDA review or approval may not be shortened. Furthermore, fast track designation, breakthrough therapy designation, priority review and accelerated approval do not change the standards for approval, but may expedite the development or approval process.

Additional controls for biologics

To help reduce the increased risk of the introduction of adventitious agents, the PHSA emphasizes the importance of manufacturing controls for products whose attributes cannot be precisely defined. The PHSA also provides authority to the FDA to immediately suspend licenses in situations where there exists a danger to public health, to prepare or procure products in the event of shortages and critical public health needs, and to authorize the creation and enforcement of regulations to prevent the introduction or spread of communicable diseases in the United States and between states.

After a BLA is approved, the product may also be subject to official lot release as a condition of approval. As part of the manufacturing process, the manufacturer is required to perform certain tests on each lot of the product before it is released for distribution. If the product is subject to official release by the FDA, the manufacturer submits samples of each lot of product to the FDA together with a release protocol showing a summary of the history of manufacture of the lot and the results of all of the manufacturer’s tests performed on the lot. The FDA may also perform certain confirmatory tests on lots of some products, such as viral vaccines, before releasing the lots for distribution by the manufacturer. In addition, the FDA conducts laboratory research related to the regulatory standards on the safety, purity, potency and effectiveness of biological products. As with drugs, after approval of biologics, manufacturers must address any safety issues that arise, are subject to recalls or a halt in manufacturing, and are subject to periodic inspection after approval.

Post-approval requirements

Once a BLA is approved, a product may be subject to certain post-approval requirements. For instance, the FDA closely regulates the post-approval marketing and promotion of biologics, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the Internet. Biologics may be marketed only for the approved indications and in a manner consistent with the provisions of the approved labeling. Although physicians may prescribe products for off-label uses as the FDA and other regulatory authorities do not regulate a physician’s choice of drug treatment made in the physician’s independent medical judgment, they do restrict promotional communications from companies or their sales force with respect to off-label uses of products for which marketing clearance has not been issued. Companies may only share truthful and not misleading information that is otherwise consistent with a product’s FDA approved labeling.

Adverse event reporting and submission of periodic safety summary reports is required following FDA approval of a BLA. The FDA also may require post-marketing testing, known as Phase 4 testing, REMS, and surveillance to monitor the effects of an approved product, or the FDA may place conditions on an approval that could restrict the distribution or use of the product. In addition, quality control, biological product manufacture, packaging and labeling procedures must continue to conform to cGMPs after approval. Biologic manufacturers and certain of their subcontractors are required to register their establishments with the FDA and certain state agencies. Registration with the FDA subjects entities to periodic unannounced inspections by the FDA, during which the agency inspects a biologic product’s manufacturing facilities to assess compliance with cGMPs. Accordingly, manufacturers must continue to expend time, money and effort in the areas of production and quality-control to maintain compliance with cGMPs. Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with required regulatory standards, if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered.

Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, imposition of post-market studies or clinical trials to assess new safety risks or imposition of distribution or other restrictions under a REMS program.

Other potential consequences include, among other things:

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restrictions on the marketing or manufacturing of the product, suspension of the approval, complete withdrawal of the product from the market or product recalls;

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fines, warning or other enforcement-related letters or holds on post-approval clinical trials;

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refusal of the FDA to approve pending BLAs or supplements to approved BLAs, or suspension or revocation of product license approvals;

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product seizure or detention, or refusal to permit the import or export of products; or

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injunctions or the imposition of civil or criminal penalties.

U.S. marketing exclusivity

The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) created an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product. Biosimilarity, which requires that the biological product be highly similar to the reference product notwithstanding minor differences in clinically inactive components and that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency, can be shown through analytical studies, animal studies and a clinical trial or trials. Interchangeability requires that a biological product be biosimilar to the reference product and that the product can be expected to produce the same clinical results as the reference product in any given patient and, for products administered multiple times to an individual, that the product and the reference product may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biological product without such alternation or switch.

A reference biological product is granted 12 years of data exclusivity from the time of first licensure of the product and the FDA will not accept an application for a biosimilar or interchangeable product based on the reference biological product until four years after the date of first licensure of the reference product. “First licensure” typically means the initial date the particular product at issue was licensed in the United States. Date of first licensure does not include the date of licensure of (and a new period of exclusivity is not available for) a biological product if the licensure is for a supplement for the biological product or for a subsequent application by the same sponsor or manufacturer of the biological product (or licensor, predecessor in interest or other related entity) for a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength, or for a modification to the structure of the biological product that does not result in a change in safety, purity or potency.

Regulatory approval in the European Union

The EMA is a decentralized scientific agency of the European Union (“EU”). It coordinates the evaluation and monitoring of centrally authorized medicinal products. It is responsible for the scientific evaluation of applications for EU marketing authorizations, as well as the development of technical guidance and the provision of scientific advice to sponsors. The EMA decentralizes its scientific assessment of medicines by working through a network of about 4,500 experts throughout the European Union, nominated by the Member States. The EMA draws on resources of over 40 national competent authorities of European Union Member States.

The process regarding approval of medicinal products in the European Union follows roughly the same lines as in the United States and likewise generally involves satisfactorily completing each of the following:

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preclinical laboratory tests, animal studies and formulation studies all performed in accordance with the applicable EU Good Laboratory Practice regulations;

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submission of a single clinical trial application (“CTA”) through the Clinical Trials Information System (“CTIS”) to the relevant national authorities of EU Member States in which a clinical trial is planned to be conducted, which must be approved by such national authorities and the subject of a positive opinion from at least one independent ethics committee before the trial may begin in each country where the clinical trial is planned;

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performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed indication;

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submission to the relevant competent authorities of a marketing authorization application (“MAA”) which includes the data supporting safety and efficacy as well as detailed information on the manufacture and composition of the product in clinical development and proposed labelling; satisfactory completion of an inspection by the relevant competent national authorities of EU Member States of the manufacturing facility or facilities, including those of third parties, at which the product is produced to assess compliance with strictly enforced cGMP;

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potential audits of the non-clinical and clinical trial sites that generated the data in support of the MAA; and

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review and approval by the relevant competent authority of the MAA before any commercial marketing, sale or shipment of the product.

Preclinical studies

Preclinical tests include laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate toxicity in animal studies, in order to assess the quality and potential safety and efficacy of the product. The conduct of the preclinical tests and formulation of the compounds for testing must comply with the relevant international, EU and national legislation, regulations and guidelines. The results of the preclinical tests, together with relevant manufacturing information and analytical data, are submitted as part of the CTA.

Clinical trials

Similarly to the United States, the various phases of non-clinical and clinical research in the EU are subject to significant regulatory controls.

In the EU, clinical trials are governed by the Clinical Trials Regulation (EU) No. 536/2014 (“CTR”), which entered into application on January 31, 2022 repealing and replacing the former Clinical Trials Directive 2001/20 (“CTD”).

The CTR is intended to harmonize and streamline clinical trial authorizations, simplify adverse-event reporting procedures, improve the supervision of clinical trials and increase transparency. Specifically, the Regulation, which is directly applicable in all EU Member States, introduces a streamlined application procedure through a single-entry point, the "EU portal", the CTIS; a single set of documents to be prepared and submitted for the application; as well as simplified reporting procedures for clinical trial sponsors. A harmonized procedure for the assessment of applications for clinical trials has been introduced and is divided into two parts. Part I assessment is led by the competent authorities of a reference Member State selected by the trial sponsor and relates to clinical trial aspects that are considered to be scientifically harmonized across EU Member States. This assessment is then submitted to the competent authorities of all concerned Member States in which the trial is to be conducted for their review. Part II is assessed separately by the competent authorities and Ethics Committees in each concerned EU Member State. Individual EU Member States retain the power to authorize the conduct of clinical trials on their territory.

The CTR foresaw a three-year transition period that ended on January 31, 2025. Since this date, all new or ongoing trials are subject to the provisions of the CTR.

Review and approval

In the EU, medicinal products can only be commercialized after a related marketing authorization (“MA”) has been granted. To obtain an MA for a product in the EU, an applicant must submit a Marketing Authorization Application (“MAA”), either under a centralized procedure administered by the EMA, or one of the procedures administered by the competent authorities of EU Member States (decentralized procedure, national procedure or mutual recognition procedure). An MA may be granted only to an applicant established in the EU.

The centralized procedure provides for the grant of a single MA by the European Commission that is valid throughout the European Economic Area (“EEA”), which is comprised of the 27 EU Member States plus Iceland, Liechtenstein and Norway. Pursuant to Regulation (“EC”) No 726/2004, the centralized procedure is compulsory for specific products, including for (i) medicinal products derived from biotechnological processes, (ii) products designated as orphan medicinal products, (iii) advanced therapy medicinal products (“ATMPs”), and (iv) products with a new active substance indicated for the treatment of HIV/AIDS, cancer, neurodegenerative diseases, diabetes, auto-immune and other immune dysfunctions and viral diseases. For products with a new active substance indicated for the treatment of other diseases and products that are highly innovative or for which a centralized process is in the interest of patients, authorization through the centralized procedure is optional on related approval.

Under the centralized authorization procedure, the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) conducts the initial assessment of a product. The CHMP is composed of experts nominated by each member state’s national drug authority, with one of them appointed to act as Rapporteur for the co-ordination of the evaluation with the possible assistance of a further member of the CHMP acting as a Co-Rapporteur. After approval, the Rapporteur(s) continue to monitor the product throughout its life cycle. The CHMP is required to issue an opinion within 210 days of receipt of a valid application, though the clock is stopped if it is necessary to ask the applicant for clarification or further supporting data. Clock stops may extend the timeframe of evaluation of a marketing authorization application considerably beyond 210 days. The process is complex and involves extensive consultation with the regulatory authorities of Member States and a number of experts. Once the procedure is completed, a European Public Assessment Report is produced.

If the CHMP concludes that the quality, safety and efficacy of the medicinal product is sufficiently proven, it adopts a positive opinion. The CHMP’s opinion is sent to the European Commission, which uses the opinion as the basis for its decision whether or not to grant a marketing authorization. The European Commission’s decision is issued within 67 days of receipt of the CHMP’s recommendation. If the opinion is negative, information is given as to the grounds on which this conclusion was reached.

After a drug has been authorized and launched, it is a condition of maintaining the marketing authorization that all aspects relating to its quality, safety and efficacy must be kept under review. Sanctions may be imposed for failure to adhere to the conditions of the marketing authorization. In extreme cases, the authorization may be revoked, resulting in withdrawal of the product from sale.

Validity of marketing authorizations

A marketing authorization has, in principle, an initial validity of five years. The market authorization may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the EMA or by the competent authority of the EU Member State in which the original MA was granted. To support the application, the market authorization holder must provide the EMA or the competent authority with a consolidated version of the Common Technical Document providing up-to-date data concerning the quality, safety and efficacy of the product, including all variations introduced since the marketing authorization was granted, at least nine months before the marketing authorization ceases to be valid. The European Commission or the competent authorities of the EU Member States may decide, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal period for the marketing authorization. Once subsequently definitively renewed, the MA shall be valid for an unlimited period. Any authorization which is not followed by the actual placing of the medicinal product on the EU market (for a centralized procedure marketing authorization) or on the market of the authorizing EU Member State within three years after authorization ceases to be valid (the so-called sunset clause).

Manufacturing regulation in the EU

In addition to a marketing authorization, various other requirements apply to the manufacturing and placing on the EU market of medicinal products. The manufacturing of medicinal products in the EU requires a manufacturing authorization and import of medicinal products into the EU requires a manufacturing authorization allowing for import. The manufacturing authorization holder must comply with various requirements set out in the applicable EU laws, regulations and guidance, including EU cGMP standards. Similarly, the distribution of medicinal products within the EU is subject to compliance with the applicable EU laws, regulations and guidelines, including the requirement to hold appropriate authorizations for distribution granted by the competent authorities of EU Member States. Marketing authorization holders and/or manufacturing and import authorization, or marketing authorization holders and/or distribution authorization holders may be subject to civil, criminal or administrative sanctions, including suspension of manufacturing authorization, in case of non-compliance with the EU or EU Member States’ requirements applicable to the manufacturing of medicinal products.

Data and market exclusivity

The EU provides opportunities for data and market exclusivity related to marketing authorizations. Upon receiving a marketing authorization, innovative medicinal products are generally entitled to receive eight years of data exclusivity and 10 years of market exclusivity. Data exclusivity, if granted, prevents regulatory authorities in the EU from referencing the innovator’s data to assess a generic application or biosimilar application for eight years from the date of authorization of the innovative product, after which a generic or biosimilar MAA can be submitted, and the innovator’s data may be referenced. The market exclusivity period prevents a successful generic or biosimilar applicant from commercializing its product in the EU until 10 years have elapsed from the initial marketing authorization of the reference product in the EU. The overall ten-year period may, occasionally, be extended for a further year to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies. However, there is no guarantee that a product will be considered by the EU’s regulatory authorities to be a new chemical/biological entity, and products may not qualify for data exclusivity.

In the EU, there is a special regime for biosimilars, or biological medicinal products that are similar to a reference medicinal product but that do not meet the definition of a generic medicinal product. For such products, the results of appropriate preclinical or clinical trials must be provided in support of an application for marketing authorization. Guidelines from the EMA detail the type of quantity of supplementary data to be provided for different types of biological product.

Orphan drug designation

In the EU, Regulation (EC) No. 141/2000, as implemented by Regulation (EC) No.

847/2000 provides that a medicinal product can be designated as an orphan medicinal product by the European Commission if its sponsor can establish that (i) the product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition; (ii) either (a) such condition affects not more than five in 10,000 persons in the European Union when the application is made, or, (b) the product without the benefits derived from orphan status, would not generate sufficient return in the European Union to justify the necessary investment in its development; and (iii) there exists no satisfactory authorized method of diagnosis, prevention or treatment of the condition in question that has been authorized in the European Union or even, if such method exists, the product will be of significant benefit to those affected by that condition.

Regulation (EC) No. 847/2000 sets out further provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product. An application for designation as an orphan product can be made any time prior to the submission of an MAA. A marketing authorization for an orphan medicinal product may only include indications designated as orphan. For non-orphan indications treated with the same active pharmaceutical ingredient, a separate marketing authorization has to be sought.

Orphan medicinal product designation entitles an applicant to incentives such as fee reductions or fee waivers, protocol assistance, and access to the centralized marketing authorization procedure. Upon a grant of marketing authorization, orphan medicinal products are entitled to a 10-year period of market exclusivity for the approved therapeutic indication, which means that the EMA cannot accept another marketing authorization application or accept an application to extend for a similar product and the European Commission cannot grant a marketing authorization for the same indication for a period of ten years. The period of market exclusivity is extended by two years for orphan medicinal products that have also complied with an agreed PIP. No extension to any supplementary protection certificate can be granted on the basis of pediatric studies for orphan indications. Orphan medicinal product designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. The period of market exclusivity may, however, be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria on the basis of which it received orphan medicinal product designation, including where it can be demonstrated on the basis of available evidence that the original orphan medicinal product is sufficiently profitable not to justify maintenance of market exclusivity or where the prevalence of the condition has increased above the threshold. Additionally, an MA may be granted to a similar medicinal product with the same orphan indication during the 10-year period if (i) the applicant consents to a second original orphan medicinal product application, (ii) if the manufacturer of the original orphan medicinal product is unable to supply sufficient quantities; or (iii) if the second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior to the original orphan medicinal product. A company may voluntarily remove a product from the register of orphan products.

Post-authorization requirements

Where an MA is granted in relation to a medicinal product in the EU, the holder of the MA is required to comply with a range of regulatory requirements applicable to the manufacturing, marketing, promotion and sale of medicinal products. Similar to the United States, both MA holders and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the EMA, the European Commission and/or the competent regulatory authorities of the individual EU Member States. The holder of an MA must establish and maintain a pharmacovigilance system and appoint an individual qualified person for pharmacovigilance who is responsible for oversight of that system. Key obligations include expedited reporting of suspected serious adverse reactions and submission of periodic safety update reports (PSURs).

All new MAAs must include a risk management plan (RMP) describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition of the MA. Such risk- minimization measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical trials or post-authorization safety studies.

In the EU, the advertising and promotion of medicinal products are subject to both EU and EU Member States’ laws governing promotion of medicinal products, interactions with physicians and other healthcare professionals, misleading and comparative advertising and unfair commercial practices. General requirements for advertising and promotion of medicinal products, such as direct-to-consumer advertising of prescription medicinal products are established in EU law. However, the details are governed by regulations in individual EU Member States and can differ from one country to another. For example, applicable laws require that promotional materials and advertising in relation to medicinal products comply with the product’s Summary of Product Characteristics (SmPC), which may require approval by the competent national authorities in connection with an MA. The SmPC is the document that provides information to physicians and other health care professionals concerning the safe and effective use of the product. Promotional activity that does not comply with the SmPC is considered off-label and is prohibited in the EU.

European data collection and processing

The collection, receipt, storage, generation, transfer, access, protection, securing, disposal, transmittal, sharing, use, disclosure and other processing (commonly referred to as processing) of health-related and other personal data about clinical trials participants and other individuals in Europe is governed by the European Union’s General Data Protection Regulation (“EU GDPR”).

The EU GDPR requires companies to, among other things, give detailed disclosures about how they are processing personal data; ensure any consents relied on to process personal data (including special categories of personal data, such as health information) meet the strict EU GDPR requirements; contractually impose data protection measures on vendors entrusted with personal data; maintain adequate data security measures; notify regulators and affected individuals of certain data breaches; meet extensive privacy governance and documentation requirements; honor individuals’ data protection rights, including their rights to access, correct and delete their personal data; and refrain from transferring personal data from Europe to most other countries unless specific safeguards can be implemented. Companies that violate the EU GDPR can face private litigation, prohibitions on data processing and heavy fines. Complying with the EU GDPR may be costly and require us to limit our activities in Europe. If our efforts to comply are not successful, we may face litigation, reputational harm, significant penalties and other liabilities.

Marketing

Much like the Anti-Kickback Statute prohibition in the United States, as described below, the provision of benefits or advantages to physicians and other health care professionals to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is also prohibited in the EU. Interactions between pharmaceutical companies and health care professionals are governed by strict laws, such as national anti-bribery laws of European countries, national sunshine rules, regulations, industry self-regulation codes of conduct and physicians’ codes of professional conduct. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment. Infringement of related laws could result in substantial fines and imprisonment.

Payments made to physicians and other health care professionals in certain European Union Member States must be publicly disclosed. Moreover, agreements with health care professionals may require prior notification or approval by the health care professional’s employer, his or her competent professional organization and/or the regulatory authorities of the individual European Union Member States. These requirements are provided in the national laws, industry codes or professional codes of conduct, applicable in the European Union Member States. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.

International regulation

In addition to regulations in the United States and Europe, a variety of foreign regulations govern clinical trials, commercial sales and distribution of product candidates. The approval process varies from country to country and the time to approval may be longer or shorter than that required for FDA or European Commission approval.

Other healthcare laws and regulations and legislative reform

Healthcare providers and third-party payors will play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval. Our operations, including any arrangements with healthcare providers, third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws that may affect the business or financial arrangements and relationships through which we conduct research and would market, sell and distribute our products. The healthcare laws that may affect our ability to operate include, but are not limited to:

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The federal Anti-Kickback Statute, which prohibits any person or entity from, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of an item or service reimbursable, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value. The federal Anti-Kickback Statute has also been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other hand. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection. Additionally, the intent standard under the federal Anti-Kickback Statute was amended by the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, Affordable Care Act), to a stricter standard such that a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. Further, the Affordable Care Act codified case law that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act.

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Federal civil and criminal false claims laws, such as the False Claims Act, which can be enforced by private citizens through civil qui tam actions, and civil monetary penalty laws prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment of federal funds, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government. For example, pharmaceutical companies have been prosecuted under the False Claims Act in connection with their alleged off-label promotion of drugs, purportedly concealing price concessions in the pricing information submitted to the government for government price reporting purposes, and allegedly providing free product to customers with the expectation that the customers would bill federal healthcare programs for the product.

In addition, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S. government. In addition, manufacturers can be held liable under the False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims.

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The federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), among other things, imposes criminal liability for executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and creates federal criminal laws that prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services.

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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), and their implementing regulations, which impose privacy, security and data breach reporting obligations with respect to individually identifiable health information upon entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers, known as covered entities, and their respective business associates and subcontractors that perform services for them that involve individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in U.S. federal courts to enforce HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.

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Federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.

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The federal transparency requirements under the Physician Payments Sunshine Act, created under the Affordable Care Act, which requires, among other things, certain manufacturers of drugs, devices, biologics and medical supplies reimbursed under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to the Centers for Medicare & Medicaid Services (CMS) information related to payments and other transfers of value provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other health care professionals (such as physician assistants and nurse practitioners) and teaching hospitals, as well as information regarding ownership and investment interests held by physicians and their immediate family members.

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State and foreign laws that are analogous to each of the above federal laws, such as anti-kickback and false claims laws, that may impose similar or more prohibitive restrictions, and may apply to items or services reimbursed by non-governmental third-party payors, including private insurers.

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State and foreign laws that require pharmaceutical companies to implement compliance programs, comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the government, or to track and report gifts, compensation and other remuneration provided to physicians and other healthcare professionals; state and foreign laws that require the reporting of marketing expenditures or drug pricing, including information pertaining to and justifying price increases; state and local laws that require the registration of pharmaceutical sales representatives; state and foreign laws that prohibit various marketing-related activities, such as the provision of certain kinds of gifts or meals; state and foreign laws that require the posting of information relating to clinical trials and their outcomes; and other federal, state and foreign laws that govern the privacy and security of health information or personal data in certain circumstances, including state health information privacy and data breach notification laws which govern the processing of health-related and other personal data, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus requiring additional compliance efforts.

If our operations are found to be in violation of any of these laws or any other current or future healthcare laws that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, or comparable foreign programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations, any of which could substantially disrupt our operations. Although effective compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, these risks cannot be entirely eliminated. Any action against us for an alleged or suspected violation could cause us to incur significant legal expenses and could divert our management’s attention from the operation of our business, even if our defense is successful. In addition, if any of the physicians or other healthcare professionals or entities with whom we expect to do business is found not to be in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

Legislative reform

We operate in a highly regulated industry, and new laws, regulations and judicial decisions, or new interpretations of existing laws, regulations and decisions, related to healthcare availability, the method of delivery and payment for healthcare products and services could negatively affect our business, financial condition and prospects. There is significant interest in promoting healthcare reforms, and it is likely that federal and state legislatures within the United States and the governments of other countries will continue to consider changes to existing healthcare legislation.

For example, the United States and state governments continue to propose and pass legislation designed to reduce the cost of healthcare. The Affordable Care Act, among other things, substantially changed the way healthcare is financed by both governmental and private insurers, and significantly affected the pharmaceutical industry.

There have been executive, judicial and congressional challenges and amendments to certain aspects of the Affordable Care Act. For example, on August 16, 2022, the Inflation Reduction Act of 2022 (the “IRA”) was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program. It is possible that the Affordable Care Act will be subject to judicial or Congressional challenges in the future. It is unclear how such challenges and the healthcare reform measures of the current administration will impact the Affordable Care Act. Additionally, on July 4, 2025, the annual reconciliation bill, the “One Big Beautiful Bill Act” (OBBBA), was signed into law which is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program. OBBBA also narrows access to Affordable Care Act marketplace exchange enrollment and declines to extend the Affordable Care Act enhanced advanced premium tax credits, set to expire in 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance.

In addition, there have been and continue to be a number of initiatives at the United States federal and state levels that seek to reduce healthcare costs. In 2011, the U.S. Congress enacted the Budget Control Act, which included provisions intended to reduce the federal deficit. The Budget Control Act resulted in the imposition of 2% reductions in Medicare payments to providers beginning in 2013 and, due to subsequent legislative amendments to the statute, including the Infrastructure Investment and Jobs Act, will remain in effect through 2032, absent additional congressional action. Additionally, on March 11, 2021, the American Rescue Plan Act of 2021 was signed into law, which eliminated the statutory Medicaid drug rebate cap, previously set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, effective January 1, 2024. If government spending is further reduced, anticipated budgetary shortfalls may also impact the ability of relevant agencies, such as the FDA, to continue to function at current levels, which may impact the ability of relevant agencies to timely review and approve research and development, manufacturing and marketing activities, which may delay our ability to develop, market and sell any product candidates we may develop. In addition, any significant spending reductions affecting Medicare, Medicaid or other publicly funded or subsidized health programs that may be implemented, or any significant taxes or fees that may be imposed on us, as part of any broader deficit reduction effort or legislative replacement to the Budget Control Act, could have an adverse impact on our anticipated product revenues.

Furthermore, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several congressional inquiries and proposed legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient assistance programs and reform government program reimbursement methodologies for drug products. For example, the IRA, among other things, (i) directs the U.S. Department of Health and Human Services (“HHS”) to negotiate the price of certain high-expenditure, single-source biologics covered under Medicare that have been on the market for at least 11 years, and subject drug manufacturers to civil monetary penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated “maximum fair price” for such drugs and biologics under the law (the “Medicare Drug Price Negotiation Program”), and (ii) imposes rebates with respect to certain drugs and biologics covered under Medicare Part B or Medicare Part D to penalize price increases that outpace inflation. The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. These provisions began to take effect progressively in fiscal year 2023. On August 15, 2024, HHS announced the agreed-upon price of the first ten drugs that were subject to price negotiations, although the Medicare Drug Price Negotiation Program is currently subject to legal challenges. On January 17, 2025, HHS selected fifteen additional products covered under Part D for price negotiation in 2025. Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program. Further, on December 7, 2023, an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act was announced. On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework.

Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs.

Further, the current presidential administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, CMS and related agencies. These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business. These actions and proposals include, for example, (1) reducing agency workforce and cutting programs; (2) rescinding a previous executive order tasking the Center for Medicare and Medicaid Innovation to consider new payment and healthcare models to limit drug spending; (3) eliminating the previous executive order that directed HHS to establish an AI task force and develop a strategic plan; (4) directing HHS, other agencies, and pharmaceutical manufacturers to lower prescription drug costs for Medicare through a variety of initiatives, including by improving upon the Medicare Drug Price Negotiation Program and establishing Most-Favored-Nation pricing for pharmaceutical products; (5) imposing tariffs on imported pharmaceutical products; and (6) directing certain federal agencies to enforce existing law regarding hospital and plan price transparency and by standardizing prices across hospitals and health plans. Additionally, in its June 2024 decision in Loper Bright Enterprises v. Raimondo, the U.S. Supreme Court overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes. The Loper Bright decision could result in additional legal challenges to current regulations and guidance issued by federal agencies applicable to our operations, including those issued by the FDA. Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program created under the IRA. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. It is difficult to predict the future legislative landscape in healthcare and the effect on our business, results of operations, financial condition and prospects. However, we expect that additional state and federal healthcare reform measures will be adopted in the future.

Environmental, health and safety laws and regulations

We and our third-party contractors are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the use, generation, manufacture, distribution, storage, handling, treatment, remediation and disposal of hazardous materials and wastes. Hazardous chemicals, including flammable and biological materials, are involved in certain aspects of our business, and we cannot eliminate the risk of injury or contamination from the use, generation, manufacture, distribution, storage, handling, treatment or disposal of hazardous materials and wastes. In particular, our product candidates use PBDs, which are highly potent cytotoxins that require special handling by our and our contractors’ staff. In the event of contamination or injury, or failure to comply with environmental, health and safety laws and regulations, we could be held liable for any resulting damages, fines and penalties associated with such liability could exceed our assets and resources. Environmental, health and safety laws and regulations are becoming increasingly more stringent. We may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations.

Pharmaceutical coverage, pricing and reimbursement

The availability and extent of coverage and adequate reimbursement by governmental and private third-party payors are essential for most patients to be able to afford expensive medical treatments. In both domestic and foreign markets, sales of our product candidates will depend substantially on the extent to which the costs of our product candidates will be covered by third- party payors, such as government health programs, commercial insurance and managed healthcare organizations. These third-party payors decide which products will be covered and establish reimbursement levels for those products.

Coverage and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product is:

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a covered benefit under its health plan;

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safe, effective and medically necessary;

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appropriate for the specific patient;

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cost-effective; and

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neither experimental nor investigational.

Obtaining coverage approval and reimbursement for a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products to the payor. We may not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement at a satisfactory level.

If coverage and adequate reimbursement of our future products, if any, are unavailable or limited in scope or amount, such as may result where alternative or generic treatments are available, we may be unable to achieve or sustain profitability. Adverse coverage and reimbursement limitations may hinder our ability to recoup our investment in our product candidates, even if such product candidates obtain regulatory approval.

There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products. There is no uniform policy for coverage and reimbursement in the United States and, as a result, coverage and reimbursement can differ significantly from payor to payor. In the United States, the principal decisions about reimbursement for new medicines are typically made by the CMS, which decides whether and to what extent a new medicine will be covered and reimbursed under Medicare. Private payors often, but not always, follow the CMS’s decisions regarding coverage and reimbursement. It is difficult to predict what third-party payors will decide with respect to coverage and reimbursement for fundamentally novel products such as ours, as there is no body of established practices and precedents for these new products. Further, one payor’s determination to provide coverage and adequate reimbursement for a product does not assure that other payors will also provide coverage and adequate reimbursement for that product. We may need to conduct expensive pharmaco-economic studies in order to demonstrate the medical necessity and cost-effectiveness of our product candidates. There can be no assurance that our product candidates will be considered medically necessary or cost-effective. Therefore, it is possible that any of our product candidates, even if approved, may not be covered by third-party payors or the reimbursement limit may be so restrictive that we cannot commercialize the product candidates profitably.

Reimbursement authorities in Europe may be more restrictive than payors in the United States. In Europe, pricing and reimbursement schemes vary widely from country to country. For example, some countries provide that products may be marketed only after an agreement on reimbursement price has been reached. Such pricing negotiations with governmental authorities can take considerable time after receipt of marketing approval for a product. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. In addition, the European Union provides options for its Member States to restrict the range of products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. European Union Member States may approve a specific price for a product, may adopt a system of direct or indirect controls on the profitability of the company placing the product on the market. Other EU Member States allow companies to fix their own prices for product but monitor and control prescription volumes and issue guidance to physicians to limit prescriptions. In addition, some EU Member States may require the completion of additional studies that compare the cost-effectiveness of a particular medicinal product candidate to currently available therapies. This Health Technology Assessment (HTA) process is conducted to assess the public health impact, therapeutic impact, and the economic and societal impact of use of a given medicinal product in the national healthcare systems of individual countries. The outcome of HTA regarding specific medicinal products will often influence the pricing and reimbursement status granted to these medicinal products by the competent authorities of individual EU Member States. In December 2021, Regulation No. 2021/2282 on Health Technology Assessment, or HTA Regulation, was adopted. The HTA Regulation is intended to boost cooperation among EU Member States in assessing health technologies, including new medicinal products, and providing the basis for cooperation at EU level for joint clinical assessments in these areas. The HTA Regulation has applied from January 12, 2025 although it will enter into force iteratively and initially apply to new active substances to treat cancer and to all advanced therapy medicinal products (“ATMPs”), it will then be expanded to orphan medicinal products in January 2028, and to all centrally authorized medicinal products as of 2030. Selected high-risk medical devices will also be assessed under the HTA Regulation as of 2026.

Reference pricing used by various European Union Member States and parallel distribution, or arbitrage between low-priced and high-priced Member States, can further reduce prices. Furthermore, many Member States in the European Union have increased the amount of discounts required on pharmaceutical products, and these efforts could continue as countries attempt to manage healthcare expenditures, especially in light of the severe fiscal and debt crises experienced by many Member States in the European Union. The downward pressure on healthcare costs in general, and prescription products in particular, has become increasingly intense. As a result, there are increasingly higher barriers to entry for new products. There can be no assurance that any country that has reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products, if approved in those countries. Accordingly, the reimbursement for any products in Europe may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenues and profits.

Furthermore, the containment of healthcare costs has become a priority of foreign and domestic governments as well as private third-party payors. The prices of drugs have been a focus in this effort. Governments and private third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications, which could affect our ability to sell our product candidates profitably. We also expect to experience pricing pressures due to the trend towards managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. These and other cost-control initiatives could cause us to decrease the price we might establish for products, which could result in lower-than-anticipated product revenues. In addition, the publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries. If pricing is set at unsatisfactory levels or if coverage and adequate reimbursement of our products is unavailable or limited in scope or amount, our revenues and the potential profitability of our product candidates in those countries would be negatively affected.

Restructuring Plan

On May 5, 2025, the Company’s board of directors approved the wind down of the Company’s existing clinical and manufacturing operations focused on previous product candidates (the “Restructuring Plan”). The Company publicly announced this plan on May 8, 2025. In conjunction with the Restructuring Plan, the Company announced a reduction of its workforce by 154 full-time employees, or approximately 99% of the Company’s then-current employee base.

During the three and six months ended June 30, 2025, we incurred restructuring costs of $30.7 million which is comprised of severance payments, stock-based compensation modifications, loss on disposal of long-lived assets and accelerated depreciation and amortization on long-lived assets and right-of-use assets. We expect to incur an aggregate of $30.9 million of restructuring costs, with the additional $0.2 million of costs recognized in the third quarter of 2025 for certain costs which met the criteria for one-time termination benefits and require employees to provide future service.

We have incurred significant operating losses since inception, including net losses of $1,573.7 million and $1,606.2 million for the three and six months ended June 30, 2025, respectively and $116.9 million for the year ended December 31, 2024. As of June 30, 2025, we had an accumulated deficit of $2,063.1 million.

As of June 30, 2025, we had cash, cash equivalents and marketable securities of $200.6 million. Based on our current operating plan, we expect that our cash, cash equivalents and marketable securities at June 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2027.

Critical Accounting Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles. The preparation of our condensed consolidated financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, costs, and expenses, and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, and experience. The effects of material revisions in estimates, if any, will be reflected in the condensed consolidated financial statements prospectively from the date of change in estimates. As of June 30, 2025, in connection with our decision to wind down clinical and manufacturing operations related to previous product candidates, we have revised certain estimates related to accrued research and development. There have been no other material changes to our critical accounting estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2024 Annual Report.

Financial Operations Overview

Revenue

We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products in the near future, if at all. If our development efforts for our current or future product candidates are successful and result in marketing approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from such agreements.

Expenses

Research and Development Expenses

Research and development expenses consist primarily of external and internal expenses incurred in connection with our research and development activities, including our drug discovery efforts and the development of our product candidates. External expenses include:

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research and development expenses incurred under agreements with clinical research organizations (“CROs”) and other scientific development services;

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costs of consultants, including their fees and related travel expenses;

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costs related to compliance with quality and regulatory requirements;

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costs of laboratory supplies and acquiring and developing preclinical and clinical trial materials, including expenses associated with our clinical manufacturing organizations (“CMOs”); and

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payments made and consideration issued under third party licensing agreements.

Internal expenses include:

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personnel-related expenses, including salaries, bonuses, benefits and stock-based compensation expenses, for employees involved in research and development activities; and

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facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent, insurance, and other internal operating costs, and internal manufacturing expenses.

We expense research and development costs as incurred. We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our condensed consolidated financial statements as prepaid expenses or accrued research and development expenses. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized, even when there is no alternative future use for the research and development. The capitalized amounts are expensed as the related goods are delivered or the services are performed.

A significant portion of our research and development costs have been external costs, which we track by program.

Research and development activities are central to our business model. We expect that our research and development expenses will increase significantly for the foreseeable future as we continue to identify and develop product candidates, particularly as our product candidate continues through the later stages of clinical development.

The successful development of our product candidates in the future is highly uncertain. Therefore, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development and commercialization of any of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from the sale of our product candidates, if approved. This is due to the numerous risks and uncertainties associated with developing product candidates, many of which are outside of our control, including the uncertainty of:

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the timing and progress of clinical development activities;

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the number and scope of clinical programs we decide to pursue;

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our ability to maintain our current research and development programs and to establish new ones;

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establishing an appropriate safety profile with IND-enabling studies;

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the number of sites and patients included in the clinical trials;

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the countries in which the clinical trials are conducted;

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per patient trial costs;

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successful patient enrollment in, and the initiation of, clinical trials, as well as drop out or discontinuation rates or complications with donors;

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the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority;

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the number of trials required for regulatory approval;

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the timing, receipt and terms of any regulatory approvals from applicable regulatory authorities;

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our ability to establish new licensing or collaboration arrangements;

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the performance of our current and future collaborators, if any;

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establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;

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significant and changing government regulation and regulatory guidance;

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the impact of any business interruptions to our operations or to those of the third parties with whom we work;

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obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;

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launching commercial sales of our product candidate or any future product candidates, if approved, whether alone or in collaboration with others; and

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maintaining a continued acceptable safety profile of our product candidate or any future product candidates following approval.

Any changes in the outcome of any of these variables could mean a significant change in the costs and timing associated with the development of our product candidate or any future product candidate.

General and Administrative Expenses

General and administrative expenses consist primarily of personnel-related costs, including salaries, bonuses, benefits and stock-based compensation expenses for employees involved in our executive, finance, corporate, business development and administrative functions, as well as expenses for outside professional services, including legal, audit, accounting and tax-related services and other consulting fees, facility-related expenses, which include depreciation costs and other allocated expenses for rent and maintenance of facilities, insurance costs, recruiting costs, travel expenses and other general administrative expenses.

We expect that our general and administrative expenses will increase as our business expands and we hire additional personnel to support the development of telitacicept.

Other Income (Expense), net

Interest Income

Interest income consists of interest income earned on our cash, cash equivalents, restricted cash equivalents and marketable securities held in financial institutions.

Change in Fair Value of Warrant Liabilities

Change in fair value of warrant liabilities represents the change in the fair value of liability-classified warrants due to changes in their intrinsic value resulting from changes in the quoted price of the Company’s common stock underlying the warrants.

Results of Operations

Comparison of Three and Six Months Ended June 30, 2025 and 2024

The following table summarizes our results of operations for the periods indicated (amounts in thousands):


	Three Months Ended June 30,
	2025			2024			Change
Operating expenses:
Research and development	$	261,499		$	21,823		$	239,676
General and administrative		12,785			7,212			5,573
Total operating expenses		274,284			29,035			245,249
Loss from operations		(274,284	)		(29,035	)		(245,249	)
Other income (expense):
Interest income		537			1,196			(659	)
Change in fair value of warrant liabilities		(1,299,922	)		—			(1,299,922	)
Total other (expense) income		(1,299,385	)		1,196			(1,300,581	)
Net loss	$	(1,573,669	)	$	(27,839	)	$	(1,545,830	)


	Six Months Ended June 30,
	2025			2024			Change
Operating expenses:
Research and development	$	288,200		$	46,145		$	242,055
General and administrative		19,375			15,216			4,159
Total operating expenses		307,575			61,361			246,214
Loss from operations		(307,575	)		(61,361	)		(246,214	)
Other income (expense):
Interest income		1,342			2,718			(1,376	)
Change in fair value of warrant liabilities		(1,299,922	)		—			(1,299,922	)
Total other (expense) income		(1,298,580	)		2,718			(1,301,298	)
Net loss	$	(1,606,155	)	$	(58,643	)	$	(1,547,512	)

Research and Development Expenses

The following table summarizes our research and development expenses incurred for the periods indicated (amounts in thousands):


	Three Months Ended June 30,
	2025		2024		Change
External research expenses:
Trem-cel	$	3,095	$	3,619	$	(524	)
VCAR33		2,419		1,762		657
Other research and development		225,144		3,177		221,967
Internal research expenses:
Salaries and benefits (including stock-based compensation)		12,341		9,105		3,236
Manufacturing, facilities, and other research expenses		18,500		4,160		14,340
Total research and development expenses	$	261,499	$	21,823	$	239,676


	Six Months Ended June 30,
	2025		2024		Change
External research expenses:
Trem-cel	$	9,477	$	8,480	$	997
VCAR33		6,055		4,362		1,693
Other research and development		228,139		6,294		221,845
Internal research expenses:
Salaries and benefits (including stock-based compensation)		22,440		19,573		2,867
Manufacturing, facilities, and other research expenses		22,089		7,436		14,653
Total research and development expenses	$	288,200	$	46,145	$	242,055

Research and development expenses were $261.5 million for the three months ended June 30, 2025, compared to $21.8 million for the three months ended June 30, 2024. The increase of $239.7 million was primarily due to the upfront consideration transferred for the Telitacicept License Agreement of $222.6 million, $3.3 million in loss on disposal of long-lived assets, and $11.2 million in accelerated depreciation and amortization due to the abandonment of long-lived assets (including the right-of-use asset) and the early termination penalty for the lease.

Research and development expenses were $288.2 million for the six months ended June 30, 2025, compared to $46.1 million for the six months ended June 30, 2024. The increase of $242.1 million was primarily due to the upfront consideration transferred for the Telitacicept License Agreement of $222.6 million, $3.3 million in loss on disposal of long-lived assets, and $11.2 million in accelerated depreciation and amortization due to the abandonment of long-lived assets (including the right-of-use asset) and the early termination penalty for the lease.

General and Administrative Expenses

General and administrative expenses were $12.8 million for the three months ended June 30, 2025, compared to $7.2 million for the three months ended June 30, 2024. The increase of $5.6 million was primarily due to an increase in personnel costs from the termination payments owed to employees subject to the reduction in force, and an increase in facilities and other expenses from accelerated depreciation and loss on disposals of long-lived assets.

General and administrative expenses were $19.4 million for the six months ended June 30, 2025, compared to $15.2 million for the six months ended June 30, 2024. The increase of $4.2 million was primarily due to an increase in personnel costs from the termination payments owed to employees subject to the reduction in force, and an increase in facilities and other expenses from accelerated depreciation and loss on disposals of long-lived assets.

Other Income (Expense)

Other income (expense) decreased by $1,300.6 million during the three months ended June 30, 2025, compared to the three months ended June 30, 2024. Other income (expense) decreased by $1,301.3 million during the six months ended June 30, 2025, compared to the six months ended June 30, 2024. The decrease in other income (expense) in both periods was due to the issuance of liability-classified warrants and the subsequent change in fair value of the warrant liabilities resulting from changes in the quoted price of the Company’s common stock underlying the warrants.

Liquidity and Capital Resources

Sources of Liquidity

Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. We have funded our operations primarily through the sale of equity securities and have received aggregate net proceeds from financing transactions of approximately $691.5 million as of June 30, 2025.

On March 20, 2025, we filed a universal shelf registration statement (the “Shelf Registration Statement”), to provide for aggregate offerings of up to $350.0 million of common stock, preferred stock, debt securities, warrants or any combination thereof. As of June 30, 2025, $350.0 million remains available under this Shelf Registration Statement, including $119.7 million reserved for at-the market offerings discussed below.

At-the-Market Sales Agreement

In December 2022, we entered into a Sales Agreement with Stifel, Nicolaus & Company, Incorporated (“Stifel”) as the agent (the "Stifel ATM Facility"). Pursuant to the Stifel ATM Facility, we may offer and sell shares of common stock with an aggregate value of up to $125.0 million, subject to our filing a prospectus supplement to the base prospectus included in our Shelf Registration Statement covering the offer and sale of shares of our common stock pursuant to the Stifel ATM Facility. We will pay Stifel a commission of up to 3.0% of the gross proceeds of any common stock sold through Stifel. We did not sell any shares of our common stock under the Stifel ATM Facility during the six months ended June 30, 2025. As of June 30, 2025, $119.7 million remained available to be sold under the Stifel ATM Facility.

Cash Requirements

As of June 30, 2025, we had cash, cash equivalents and marketable securities of $200.6 million. We will need to raise additional capital in the future to fund our planned future operations. However, we cannot guarantee that we will be able to obtain sufficient additional funding or that if we do obtain additional funding, that such funding will be obtainable on terms satisfactory to us. In the event that we are unable to obtain sufficient additional funding, there can be no assurance that we will be able to continue as a going concern.

Based on our current operating plan, we expect that our existing cash, cash equivalents and marketable securities at June 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2027. We have based this estimate on assumptions that may prove to be wrong and we could exhaust our capital resources sooner than we expect.

We expect our expenses to increase substantially if, and as, we:

•

continue research and clinical development of our product candidate and any future product candidate, including in particular the expenses associated with our clinical trials;

•

incur both internal and third party manufacturing costs to support our clinical trials of our product candidate and any future product candidate and, if approved, their commercialization;

•

seek to identify and develop additional product candidates;

•

seek regulatory and marketing approvals for our product candidate and any future product candidates;

•

establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates;

•

adapt our regulatory compliance efforts to incorporate requirements to applicable marketed products;

•

acquire or in-license products, product candidates, or technologies;

•

maintain, expand, enforce, defend and protect our intellectual property;

•

hire additional clinical, quality control, manufacturing and other scientific personnel;

•

add operational, financial and management information systems and personnel;

•

acquire and expand office facilities; and

•

experience any delays or encounter any issues with any of the above.

In addition, we expect to continue to incur costs associated with operating as a public company, including significant legal, audit, accounting, investor and public relations, regulatory, tax-related, director and officer insurance premiums, investor relations and other expenses. Developing pharmaceutical products, including conducting clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval for any product candidates or generate revenue from the sale of any product candidate for which we may obtain marketing approval.

In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for at least several years, if ever.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the public or private sale of our equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. To the extent that we raise additional capital through the sale of our equity or convertible debt securities, including through the use of the Stifel ATM Facility, the ownership interest of our shareholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain additional funding, we could be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or any commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. If we raise funds through strategic collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to our platform technology, future revenue streams, research programs or product candidates or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. Our ability to raise additional funds may be adversely impacted by worsening global economic conditions and disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from geopolitical tensions and adverse macroeconomic conditions or otherwise. Because of the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of increased expenses, and there is no assurance that we will ever be profitable or generate positive cash flow from operating activities.

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements that have or are reasonably likely to have a material current or future effect on our financial condition, revenues or expenses, results of operations, liquidity, cash requirements or capital resources.

Cash Flows

The following table provides information regarding our cash flows for the periods presented (in thousands):


	Six Months Ended June 30,
	2025			2024
Net cash used in operating activities	$	(66,250	)	$	(52,312	)
Net cash provided by investing activities		416			96,963
Net cash provided by financing activities		174,459			65
Net increase in cash, cash equivalents and restricted cash equivalents	$	108,625		$	44,716

Operating Activities

Net cash used in operating activities was $66.3 million for the six months ended June 30, 2025, reflecting a net loss of $1,606.2 million, offset by changes in operating assets and liabilities of $2.0 million and non-cash charges of $1,537.9 million. The non-cash charges primarily consisted of the change in fair value of warrant liabilities of $1,299.9 million and the acquisition of in-process research and development of $222.6 million.

Net cash used in operating activities was $52.3 million for the six months ended June 30, 2024, reflecting a net loss of $58.6 million and net cash used of $2.7 million for operating assets and liabilities, which were offset by non-cash charges of $9.0 million. The non-cash charges primarily consisted of stock-based compensation expense of $5.9 million, non-cash lease expense of $2.5 million and depreciation expense of $1.8 million, offset by $1.1 million of non-cash interest earned on marketable securities.

The $14.0 million increase in net cash used in operating activities for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was due to an increase in net loss, partially offset by differences in the timing of payments for costs incurred during each respective period and an increase in non-cash charges from the acquired in-process research and development and change in fair value of warrant liabilities.

Investing Activities

Net cash provided by investing activities was $0.4 million for the six months ended June 30, 2025, which consisted of proceeds from the sales of property and equipment of $0.8 million, offset by $0.4 million in purchases of property and equipment. Net cash provided by investing activities was $97.0 million for the six months ended June 30, 2024, which consisted of proceeds of $107.0 million from the maturity of marketable securities, offset by purchases of $9.9 million of marketable securities and $0.1 million of property and equipment.

Financing Activities

Net cash provided by financing activities was $174.5 million for the six months ended June 30, 2025, which consisted of $175.0 million in proceeds from the issuance of pre-funded warrants, offset by $0.6 million of issuance costs related to the December 2024 private placement. Net cash provided by financing activities was $0.1 million for the six months ended June 30, 2024, which consisted of proceeds from the issuance of common stock under the Stifel ATM Facility of $0.2 million and proceeds from exercise of stock options and issuance of shares under the ESPP of $0.1 million, offset by $0.2 million of taxes paid related to net share settlement of equity awards.

Contractual Obligations and Other Commitments

As noted in Note 9 to the unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q, we amended our lease for corporate office and laboratory real estate space to terminate on August 4, 2025. On June 30, 2025, we abandoned such space and have no remaining contractual payments related to the leased space. As noted in Note 15 to the unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q, on August 12, 2025, we entered into a non-cancellable lease relating to corporate office space, with a term expiring in August 2031.

Other commitments include license and collaboration agreements we have entered into with certain parties including the Telitacicept License Agreement discussed in Note 10 to the unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. Such arrangements require ongoing payments, including payments upon the achievement of certain development, regulatory and commercial milestones, receipt of sublicense income, as well as royalties on commercial sales. Payments under these arrangements will generally be expensed as incurred.

Other than the changes discussed above, during the six months ended June 30, 2025, there were no additional significant changes in contractual obligations and commitments from that described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual Obligations and Other Commitments” in our 2024 Annual Report.

We also have agreements with certain vendors for various services, including services related to clinical operations and support, which we are not contractually able to terminate for convenience and avoid any and all future obligations to the vendors. Under such agreements, we are contractually obligated to make certain payments to vendors to reimburse them for their unrecoverable outlays incurred prior to cancellation. The exact amounts of such obligations are dependent on the timing of termination and the exact terms of the relevant agreement and cannot be reasonably estimated. We do not include these payments in this summary as they are not fixed and estimable.

Recent Accounting Pronouncements

There are no new significant recent accounting pronouncements which may materially impact our financial statements.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

We are a smaller reporting company as defined by Item 10 of Regulation S-K and are not required to provide the information otherwise required under this item.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated, as of the end of the period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Based on the evaluation of our disclosure controls and procedures as of June 30, 2025, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures as of such date were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended June 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

We are not currently a party to any material legal proceedings. From time to time, we may become involved in other litigation or legal proceedings relating to claims arising from the ordinary course of business.

Item 1A. Risk Factors.

The following risk factors and other information included in this Quarterly Report on Form 10-Q (“Quarterly Report”), including our condensed consolidated financial statements and related notes thereto, as well as our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (“Annual Report”), including our financial statements and related notes thereto, should be carefully considered. The risks and uncertainties described below are not the only risks and uncertainties we face. Additional risks and uncertainties not presently known to us or that we presently deem less significant may also impair our business operations. Please see the discussion regarding some of the forward-looking statements that are qualified by these risk factors contained elsewhere in this Quarterly Report. If any of the following risks occur, our business, financial condition, results of operations and future growth prospects could be materially and adversely affected.

Risks Related to Our Financial Position and Need for Additional Capital

We have incurred significant net losses since inception. We expect to incur net losses for the foreseeable future and may never achieve or maintain profitability.

Since inception, we have not generated any revenue and have incurred significant operating losses. For the six months ended June 30, 2025 and 2024, our net loss was $1,606.2 million and $58.6 million, respectively. As of June 30, 2025, we had an accumulated deficit of $2,063.1 million. We have financed our operations primarily through the sale of our capital stock, including the sale of warrants to purchase our common stock. We have devoted all of our efforts to organizing and staffing our company, business and scientific planning, raising capital, acquiring and developing technology, identifying potential product candidates, undertaking studies of potential product candidates and evaluating a clinical path for our pipeline programs. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses we incur may fluctuate significantly from quarter to quarter. We anticipate that our expenses will increase substantially if and as we:

•

advance and complete clinical trials of telitacicept in gMG;

•

initiate clinical development of telitacicept in additional indications;

•

initiate additional research programs and development of other potential product candidates;

•

initiate preclinical testing and clinical trials for any other product candidates we identify and develop;

•

maintain, expand, enforce, defend and protect our intellectual property portfolio and provide reimbursement of third-party expenses related to our patent portfolio;

•

seek marketing approvals for any product candidates that successfully complete clinical trials;

•

adapt our regulatory compliance efforts to incorporate requirements applicable to marketed products;

•

hire additional research and development and clinical personnel;

•

hire commercial personnel and advance market access and reimbursement strategies;

•

add operational, financial and management information systems and personnel, including personnel to support our product development;

•

acquire or in-license product candidates, intellectual property and technologies;

•

develop or in-license manufacturing and distribution technologies;

•

rely on collaborators or other third parties to manufacture current good manufacturing practices (“cGMP”) material for clinical trials or potential commercial sales;

•

establish a commercialization infrastructure and develop internal and external manufacturing and distribution capabilities to commercialize any product candidates for which we may obtain regulatory approval;

•

should we decide to do so and receive approval for any of our product candidates, build and maintain, or purchase and validate, commercial-scale manufacturing facilities designed to comply with cGMP requirements; and operate as a public company.

•

We have not completed clinical development of any product candidate and expect that it will be years, if ever, before we have a product candidate ready for commercialization. To become and remain profitable, we must develop and, either directly or through collaborators, eventually commercialize a product or products with significant market potential. This will require us to be successful in a range of challenging activities, including identifying product candidates, completing preclinical testing and clinical trials of product candidates, obtaining marketing approval for these product candidates, manufacturing, marketing and selling those products for which we may obtain marketing approval and satisfying any post-marketing requirements. We may never succeed in these activities and, even if we do, may never generate revenues that are significant or large enough to achieve profitability. Our product candidate and research programs are currently in clinical development. Because of the numerous risks and uncertainties associated with developing product candidates, we are unable to predict the extent of any future losses or when we will become profitable, if at all. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. A decline in the value of our company could also cause our stockholders to lose all or part of their investments in us.

We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the clinical development of telitacicept for the treatment of gMG and initiate clinical development of telitacicept in additional indications, and otherwise continue to advance our research programs in support of our pipeline. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of a collaborator. Further, we expect to continue to incur significant additional costs associated with operating as a public company this year and in future years. Accordingly, we will need to obtain substantial additional funding in order to maintain our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and product development programs or future commercialization efforts.

As of June 30, 2025, our cash, cash equivalents and marketable securities were $200.6 million. We expect that our existing cash, cash equivalents and marketable securities as of June 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2027. However, our operating plan may change as a result of factors currently unknown to us, and we may need to seek funding sooner than planned. Our future capital requirements will depend on many factors, including:

•

the progress, results and costs of clinical trials for telitacicept;

•

the costs of researching, developing, and initiating clinical trials of telitacicept in additional indications;

•

the scope, progress, results, costs of discovery, acquisition or in-licensing, preclinical development, formulation, development and clinical trials for other product candidates;

•

the costs of acquiring and expanding facilities to accommodate corporate, laboratory, and manufacturing needs;

•

the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights and defending intellectual property-related claims in the United States and internationally;

•

the costs, timing and outcome of regulatory review of any product candidates;

•

the costs of future activities, including product sales, medical affairs, marketing, manufacturing, distribution, coverage and reimbursement for any product candidates for which we receive regulatory approval;

•

our ability to establish and maintain collaborations on favorable terms, if at all;

•

the success of our collaborations, including ones we may establish, and of our license agreements;

•

the achievement of milestones or occurrence of other developments that trigger payments under any collaboration agreements we enter;

•

the extent to which we acquire or in-license product candidates, intellectual property and technologies;

•

the extent to which we develop or in-license manufacturing and distribution technologies; and

•

the costs of operating as a public company.

Conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, even if we successfully develop product candidates and those are approved, we may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for years, if at all. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives.

Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize product candidates. We cannot be certain that additional funding will be available on acceptable terms, or at all. We have no committed source of additional capital and, if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of product candidates or other research and development initiatives. Our license agreements and any future collaboration agreements may also be terminated if we are unable to meet the payment or other obligations under the agreements. We could be required to seek collaborators for product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to product candidates in markets where we otherwise would seek to pursue development or commercialization ourselves.

If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any product candidate, or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations. Any of the above events could significantly harm our business, prospects, financial condition and results of operations and cause the price of our common stock to decline.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, government or private party grants, debt financings, collaborations, strategic alliances and licensing arrangements. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, including through the use of our at-the-market facility, our stockholders’ ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends and possibly other restrictions.

For example, we have raised substantial amounts of capital through the issuance of warrants to purchase shares of our common stock. In December 2024, we issued and sold to certain institutional investors an aggregate of (i) 55,871,260 shares of common stock and (ii) warrants to purchase up to 69,839,075 shares of common stock (the “2024 Warrants”). In June 2025, we issued and sold to certain institutional investors warrants to purchase up to 700,000,000 shares of common stock (the “2025 PIPE Warrants”), and we also issued a warrant to purchase up to 320,000,000 shares of common stock (the “RemeGen Warrant”) as partial consideration for the Telitacicept License Agreement to a subsidiary of RemeGen. As of June 30, 2025, the 2024 Warrants, 2025 PIPE Warrants and RemeGen Warrant remained outstanding and unexercised. In addition, as of June 30, 2025, we have outstanding options to purchase 94,640,388 shares of common stock and 1,909,136 restricted stock units, and we have 69,668,889 shares of common stock available for future issuance under our 2023 Inducement Plan, 6,027,849 shares of common stock available for future issuance under our Amended and Restated 2021 Equity Incentive Plan and 2,318,649 shares of common stock available for issuance under our Employee Stock Purchase Plan. Should all of these shares be issued, you would experience substantial dilution in ownership of our common stock.

If we raise funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or we may have to grant licenses on terms that may not be favorable to us or commit to providing us with future payment streams. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Market volatility may further adversely impact our ability to access capital as and when needed.

We are a clinical-stage company with no products approved for marketing. We were founded in December 2015 and commenced operations in February 2016. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, acquiring and developing our platform and technology, identifying product candidates and undertaking studies. Prior to our in-license of telitacicept in June 2025, our efforts were focused on developing engineered hematopoietic stem cell transplants, chimeric antigen receptor-T cell therapies and antibody drug conjugates for the treatment of acute myeloid leukemia. We are currently developing telitacicept in a global Phase 3 clinical trial for the treatment of gMG. The risk of failure for these activities is high. We have not yet demonstrated an ability to successfully complete any clinical trials, including large-scale, pivotal clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf or conduct sales and marketing activities necessary for successful commercialization. Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a longer operating history.

Our limited operating history may make it difficult to evaluate our technology and industry and predict our future performance. Our short history as an operating company makes any assessment of our future success or viability subject to significant uncertainty. We expect to encounter risks and difficulties frequently experienced by early stage companies in new and rapidly evolving fields. If we do not address these risks and difficulties successfully, our business could suffer.

In addition, we may encounter other unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We will need to transition from a company with a research focus to a company capable of supporting commercial activities. We may not be successful in such a transition.

We have never generated revenue from product sales and may never become profitable.

Our ability to generate revenue from product sales and achieve profitability depends on our ability, alone or with collaborators, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, product candidates. We do not anticipate generating revenues from product sales for the next several years, if ever. Our ability to generate future revenue from product sales depends heavily on our, or our current or future collaborators’, ability to successfully:

•

advance and complete clinical trials of our product candidates, including telitacicept;

•

complete research and preclinical and clinical development of any other product candidates we may identify;

•

seek and obtain regulatory and marketing approvals for any product candidates for which we complete clinical trials;

•

launch and commercialize any product candidates for which we obtain regulatory and marketing approval by establishing a sales force, marketing and distribution infrastructure or, alternatively, collaborating with a commercialization partner;

•

qualify for coverage and adequate reimbursement by government and third-party payors for any product candidates for which we obtain regulatory and marketing approval;

•

establish and maintain supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and the market demand for any product candidates for which we obtain regulatory and marketing approval;

•

obtain market acceptance of product candidates as viable treatment options;

•

address competing technological and market developments;

•

implement internal systems and infrastructure, as needed;

•

negotiate favorable terms in any collaboration, licensing or other arrangements into which we may enter and perform our obligations in such arrangements;

•

maintain, protect, enforce, defend and expand our portfolio of intellectual property rights, including patents, trade secrets and know-how, in the United States and internationally;

•

avoid and defend against third-party interference, infringement and other intellectual property claims in the United States and internationally; and

•

attract, hire and retain qualified personnel.

Even if one or more of the product candidates we develop are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Our expenses could increase beyond expectations if we are required by the U.S. Food and Drug Administration (the “FDA”), the European Medicines Agency (the “EMA”) or other regulatory authorities to perform clinical and other studies in addition to those that we currently anticipate. Even if we are able to generate revenues from the sale of any approved product candidates, we may not become profitable and may need to obtain additional funding to continue operations.

Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations. A decline in the value of our company also could cause stockholders to lose all or part of their investment in us.

Our ability to utilize our net operating loss carryforwards and certain other tax attributes to offset taxable income or taxes may be limited.

As of December 31, 2024, we had gross federal net operating loss carryforwards of $243.9 million including $242.0 million that had an indefinite carryforward period and $1.9 million that were subject to expiration at various dates through 2037. Furthermore, we have state and local net operating loss carryforwards of $234.7 million which will expire at various dates through 2044. Portions of these net operating loss carryforwards could expire unused and be unavailable to offset future income tax liabilities. Under the legislation enacted in 2017, informally titled the Tax Cuts and Jobs Act (the “Tax Act”), as modified by the Coronavirus Aid, Relief, and Economic Security (the “CARES Act”) U.S. federal net operating losses incurred in taxable years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of such federal net operating losses in taxable years beginning after December 31, 2020, may be limited. It is uncertain how various states will respond to the Tax Act and the CARES Act. For state income tax purposes, there may be periods during which the use of net operating loss carryforwards is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Code”), and corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in its equity ownership over a three-year period, the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income or taxes may be limited. The completion of our initial public offering, together with private placements and other transactions that have occurred since our inception, may trigger such an ownership change pursuant to Section 382 of the Code. We have not yet completed a Section 382 analysis, and therefore, there can be no assurances that our net operating losses are not already limited. We may experience ownership changes as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. If an ownership change occurs and our ability to use our net operating loss carryforwards is materially limited, it would harm our future operating results by effectively increasing our future tax obligations. There is a full valuation allowance for net deferred tax assets, including net operating loss carryforwards.

Risks Related to Discovery, Development, Manufacturing and Commercialization

Our future success is dependent on our ability to timely advance and complete clinical trials, obtain marketing approval for and successfully commercialize our lead product candidate, telitacicept. We are investing significant efforts and financial resources in the research and development of telitacicept. Telitacicept is currently in a global Phase 3 clinical trial for the treatment of gMG, and will require additional clinical development, evaluation of clinical and manufacturing activities, marketing approval from government regulators, substantial investment and significant marketing efforts before we can generate any revenues from product sales. We are not permitted to market or promote telitacicept or any other product candidate before we receive marketing approval from the FDA and comparable foreign regulatory authorities, and we may never receive such marketing approvals.

The success of telitacicept will depend on several factors, including the following:

•

the approval or acceptance to initiate clinical trials by the applicable regulatory authorities in each country where we plan to conduct clinical trials;

•

the acceptance of individual investigational review boards (“IRBs”) and scientific review committees at each clinical trial site as to the adequacy of the preclinical data package to support clinical development of telitacicept and their overall general agreement with the use of telitacicept in the intended patient population in the intended manner;

•

the willingness of clinical investigators to place patients in clinical trials, and the willingness of patients to enroll in clinical trials; the successful and timely completion of the global Phase 3 clinical trial of telitacicept in gMG;

•

the initiation and successful patient enrollment and completion of additional clinical trials of telitacicept on a timely basis;

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maintaining and establishing relationships with contract research organizations (“CROs”) and clinical sites for the clinical development of these programs both in the United States and internationally;

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the frequency and severity of adverse events in the clinical trials;

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the results of clinical trials conducted by third parties, including RemeGen, in autoimmune disorders if such trials result in changes to the standard of care for autoimmune disorders;

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the efficacy, safety and tolerability profiles that are satisfactory to the FDA, the EMA or any comparable foreign regulatory authority for marketing approval;

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the timely receipt of marketing approvals for our programs from applicable regulatory authorities;

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the extent of any required post-marketing approval commitments to applicable regulatory authorities;

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the maintenance of existing or the establishment of new supply arrangements with third-party suppliers and manufacturers for clinical development of our programs;

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our ability to obtain and maintain arrangements with third-party manufacturers to produce finished products that are appropriate for commercial sale of our programs, if approved;

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obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;

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the protection of our rights in our intellectual property portfolio;

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the successful launch of commercial sales following any marketing approval;

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a continued acceptable safety profile following any marketing approval;

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commercial acceptance by patients, the medical community and third-party payors;

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our ability to obtain coverage and adequate reimbursement from third-party payors for our products and patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement; and

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our ability to compete with other treatments.

We do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and the manufacturing, marketing, distribution and sales efforts of any future collaborator. If we are not successful with respect to one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize telitacicept, which would materially harm our business. If we do not receive marketing approval for telitacicept, we may not be able to continue our operations.

RemeGen has received regulatory approval in China for telitacicept for the treatment of gMG, RA and SLE, and RemeGen is developing telitacicept in clinical trials in China in additional indications. While these trials may provide us with clinical data that can inform our future development strategy, we do not have control over the protocols, administration, or conduct of the trials or their compliance with regulatory requirements. There is also no assurance that the clinical data from any such clinical trials will be accepted or considered by the FDA or other comparable regulatory authorities. We have no control over the conduct and timing of, and communications with the National Medical Products Administration (“NMPA”) or other foreign regulatory agencies in Greater China with respect to, the trials that RemeGen is conducting for telitacicept. Any data integrity issues or patient safety issues arising out of any of these trials would be beyond our control, yet could adversely affect our reputation and damage the clinical and commercial prospects for our product candidates.

We are dependent on third parties accurately generating and reporting data related to our product candidates, and their conduct could adversely affect our business.

We have and may in the future acquire or in-license our product candidates at various stages of development. For example, we in-licensed telitacicept from RemeGen. Our assumptions about the potential of telitacicept are partially based on data generated from preclinical studies and clinical trials conducted by RemeGen.

We are dependent on RemeGen having conducted its research and development in accordance with the applicable protocols, informed consent, legal and regulatory requirements, and scientific standards, having accurately reported the results of all studies conducted, and having correctly collected the data from these studies. If these activities were not compliant, accurate or correct, the clinical development, regulatory approval or commercialization of telitacicept will be adversely affected.

Additionally, in cases where third parties conduct clinical trials using our product candidates through partnership or licensing agreements, we face additional risks related to the conduct and outcome of those trials that are outside of our direct control. For example, issues such as poor data integrity, safety concerns, protocol violations, or failure to meet endpoints in these third-party trials could adversely impact the development timeline and regulatory approval process for those product candidates in other indications or territories, require additional studies, create negative market perception affecting future commercial potential, impact our ability to pursue strategic alternatives for such product candidates, or result in increased regulatory scrutiny across our programs.

Our clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects may be identified during the development of our product candidates, which could increase our costs or necessitate the abandonment or limitation of the development of our product candidates.

If our product candidates are associated with side effects in clinical trials or have characteristics that are unexpected, our costs could increase or we may need to abandon their development or limit development to more narrow uses in which the side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. The FDA or an IRB may also require that we suspend, discontinue, or limit our clinical trials based on safety information. Such findings could further result in regulatory authorities failing to provide marketing authorization for our product candidates. Many product candidates that initially showed promise in early-stage testing have later been found to cause side effects that prevented further development of the product candidate.

Before we can obtain marketing approvals for the commercial sale of our product candidates, we must demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that our product candidates are both safe and effective for use in each target indication, and failures can occur at any stage of testing. Clinical trials often fail to demonstrate safety and efficacy of the product candidate studied for the target indication.

Additionally, if we or others identify undesirable side effects caused by our product candidates, a number of potentially significant negative consequences could result, including:

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we may need to abandon the development or limit the further development of our product candidates, including in various populations and for certain indications;

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regulatory authorities may withdraw approval to market such product;

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regulatory authorities may require additional warnings on the labels;

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a medication guide outlining the risks of such side effects for distribution to patients may be required;

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we could be sued and held liable for harm caused to patients; and

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our reputation and physician or patient acceptance of our product candidates, if approved, may suffer.

Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more subject data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publicly disclose interim, topline or preliminary data from our clinical trials, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a full analysis of all data related to the particular trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. In addition, we may report preliminary analyses of only certain endpoints rather than all endpoints. As a result, the interim, topline or preliminary results that we report may differ from future results of the same trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim, topline and preliminary data should be viewed with caution until the final data are available. We may also disclose interim data from our clinical trials. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as subject enrollment continues and more subject data become available. Adverse differences between interim, topline or preliminary data and final data could significantly harm our reputation and business prospects.

Further, disclosure of interim, topline or preliminary data by us or by our competitors could result in volatility in the price of our common stock.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the potential of the particular program, the likelihood of marketing approval or commercialization of the particular product candidate, any approved product, and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is derived from information that is typically extensive, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular program, product candidate or our business.

If the interim, topline or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to further develop, obtain marketing approval for and/or commercialize our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Because we have limited financial and managerial resources, we focus on product candidates and research programs that we identify for specific indications among many potential options. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future product candidates and research and development programs for specific indications may not yield any commercially viable products. For example, in May 2025, we announced that, based on the available clinical data from our then-key clinical programs and a challenging fundraising environment, we were initiating a process to explore strategic alternatives and winding down our then-ongoing clinical and manufacturing operations and clinical trials. Further, if we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate. Any such event could have a material adverse effect on our business, financial condition, results of operations and prospects.

Even if a product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

The commercial success of our product candidates, if approved, will depend upon their degree of market acceptance by physicians, patients, third-party payors and others in the medical community. Even if any product candidate we develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, healthcare payors and others in the medical community. The degree of market acceptance of any product candidate we develop, if approved for commercial sale, will depend on a number of factors, including:

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the efficacy and safety of such product candidate as demonstrated in clinical trials;

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the efficacy and safety of other products that are used in combination or in sequence with our product;

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the potential and perceived advantages of our product candidates compared to alternative treatments;

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the limitation to our targeted patient population and limitations or warnings contained in approved labeling by the FDA or other regulatory authorities;

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the ability to offer our products for sale at competitive prices;

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convenience and ease of administration compared to alternative treatments;

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the clinical indications for which the product candidate is approved by the FDA, the EMA or other regulatory authorities;

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the willingness of the target patient population to try novel biologics and of physicians to prescribe these treatments, as well as their willingness to accept an intervention that involves the alteration of the patient’s gene;

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product labeling or product insert requirements of the FDA, the EMA or other regulatory authorities, including any limitations or warnings contained in a product’s approved labeling;

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relative convenience and ease of administration; the timing of market introduction of competitive products;

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publicity concerning our products or competing products and treatments;

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the strength of marketing and distribution support;

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availability of third-party coverage and sufficiency of reimbursement; and

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the prevalence and severity of any side effects.

Even if a product candidate is approved, such product may not achieve an adequate level of acceptance, we may not generate significant product revenues, and we may not become profitable.

If, in the future, we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our product candidates, we may not be successful in commercializing those product candidates if and when they are approved.

We do not have a sales or marketing infrastructure and have limited experience in the sale, marketing or distribution of pharmaceutical products. To achieve commercial success for any approved product for which we retain sales and marketing responsibilities, we must either develop a sales and marketing organization or outsource these functions to third parties. In the future, we may choose to build a focused sales, marketing and commercial support infrastructure to sell, or participate in sales activities with our collaborators for, some of our product candidates if and when they are approved.

There are risks involved with both establishing our own commercial capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force or reimbursement specialists is expensive and time consuming and could delay any product launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing and other commercialization capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our commercialization personnel.

Factors that may inhibit our efforts to commercialize our product candidates on our own include:

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our inability to recruit and retain adequate numbers of effective sales, marketing, reimbursement, customer service, medical affairs and other support personnel;

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the inability of sales personnel to obtain access to physicians or educate adequate numbers of physicians on the benefits of prescribing any future products;

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the inability of reimbursement professionals to negotiate arrangements for formulary access, reimbursement and other acceptance by payors;

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restricted or closed distribution channels that make it difficult to distribute our product candidates to segments of the patient population;

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the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and

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unforeseen costs and expenses associated with creating an independent commercialization organization.

If we enter into arrangements with third parties to perform sales, marketing, commercial support and distribution services, our product revenues or the profitability of these product revenues to us may be lower than if we were to market and sell products ourselves. In addition, we may not be successful in entering into arrangements with third parties to commercialize our product candidates or may be unable to do so on terms that are favorable to us. We may have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively. If we do not establish commercialization capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates.

The development and commercialization of new drug and biologic products is highly competitive. We will face competition with respect to our product candidates that we develop or commercialize in the future from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide.

Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

Competition in the autoimmune field is intense and involves multiple monoclonal antibodies (mAbs), other biologics and small molecules either already marketed or in development by many different companies including large pharmaceutical companies such as AbbVie, Inc. (Humira/rheumatoid arthritis), Amgen, Inc. (Uplinza/Myasthenia Gravis, Enbrel/rheumatoid arthritis), Argenx (VYVGART), Biogen Inc, (Tysabri/multiple sclerosis), GlaxoSmithKline plc (Benlysta/lupus), F. Hoffman-La Roche AG (Rituxan/often used off label) and Johnson & Johnson (Imaavy/Myasthenia Gravis, Remicade/rheumatoid arthritis and Stelara/psoriasis).

We face and expect to continue to face intense competition from other biopharmaceutical companies, who have launched or are developing products for the treatment of gMG and other autoimmune diseases. Competition for other indications is also fierce, with significant development in almost all of the indications we may develop for our product candidates. For example, we are aware of several neonatal Fc receptor (FcRn) inhibitors that are in clinical development and one FcRn inhibitor, Rystiggo (rozanolixizumab-noli), which was approved in June 2023, and another, Imaavy (nipocalimab-aahu), which was approved in April 2025 for the treatment of adults and pediatric patients age 12 and above with gMG who are AChR-AB+ or MuSK-AB+. We are also aware that AstraZeneca PLC is selling Soliris and Ultomiris for the treatment of adult patients with gMG who are AChR-AB+ and that UCB is selling Rystiggo for the treatment of adult patients with gMG who are AChR-AB+ or MuSK-AB+ and Zilbrysq for the treatment of adult patients with gMG who are AChR-AB+. Novartis AG, CSL Behring, Grifols, S.A., Curavac, Inc., Takeda Pharmaceutical Co Ltd, Immunovant, Inc., Cartesian Therapeutics, Inc., Amgen, and Regeneron Pharmaceuticals Inc./Alnylam Pharmaceuticals, Inc., among others, are developing drugs that may have utility for the treatment of myasthenia gravis (MG).

Any product candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future that are approved to treat the same diseases for which we may obtain approval for our product candidates. This may include other types of therapies, such as small molecule, antibody and/or protein therapies.

Many of our current or potential competitors, either alone or with their collaboration partners, may have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. Mergers and acquisitions in the pharmaceutical, biotechnology and gene therapy industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize product candidates that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than our product candidates or that would render our product candidates obsolete or non-competitive. Our competitors also may obtain FDA or other regulatory approval for their product candidates more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. Additionally, technologies developed by our competitors may render our product candidates uneconomical or obsolete, and we may not be successful in marketing any product candidates against competitors.

In addition, as a result of the expiration or successful challenge of our patent rights, we could face more litigation with respect to the validity and/or scope of patents relating to our competitors’ products. The availability of our competitors’ products could limit the demand, and the price we are able to charge, for our product candidates, if approved.

Negative developments in the field of protein-based therapies, including in particular fusion protein therapies or approved therapies or therapies in development for the treatment of B cell-mediated autoimmune diseases, could damage public perception of our product candidate and negatively affect our business.

The commercial success of our product candidate will depend in part on public acceptance of the use of fusion protein therapies constructed by joining two or more domains encoded by different genes, as well as protein-based therapies more generally, including in particular approved therapies or therapies that are in development for the treatment of B cell-mediated autoimmune diseases. Telitacicept is a novel fusion protein in development for treating B cell mediated autoimmune diseases that inhibits both BLyS (BAFF) and APRIL. Adverse events in post marketing use in any country in any approved indication or off label use, in clinical trials of our product candidate or in clinical trials of others developing similar product candidates, including RemeGen, and the resulting publicity, as well as any other negative developments that may occur in the future, including in connection with competitors’ therapies, could result in a decrease in demand for our product candidate. These events could also result in the suspension, discontinuation, or clinical hold of, or modifications to, our clinical trials. Our product candidate may not be accepted by the general public or the medical community and potential clinical trial subjects may be discouraged from enrolling in our clinical trials or early terminated from the clinical trials.

As a result, we may not be able to continue, or may be delayed in conducting, our development programs.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.

We face an inherent risk of product liability exposure related to the testing in human clinical trials of our product candidates and will face an even greater risk if we commercially sell any products that we may develop. For example, we may be sued if our product candidates cause, or are perceived to cause, injury or are found to be otherwise unsuitable during clinical trials, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

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the inability to commercialize any products that we may develop;

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decreased demand for our product candidates or products that we may develop;

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injury to our reputation and significant negative media attention;

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withdrawal of clinical trial participants;

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significant time and costs to defend the related litigation;

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substantial monetary awards to trial participants or patients; and

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loss of revenue.

Insurance coverage is also increasingly expensive and we may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Fusion protein therapies are novel, complex and difficult to manufacture. We could experience manufacturing problems that result in delays in the development or commercialization of telitacicept or other product candidates or otherwise harm our business.

The manufacture of fusion proteins, such as telitacicept, is technically complex and necessitates substantial expertise and capital investment. Production difficulties caused by unforeseen events may delay the availability of material for clinical trials and commercial products for telitacicept, if approved, or any fusion protein product that we may develop in the future. Additionally, because biologic products are complex, the manufacture of such product candidates is more difficult and costly. We may not be able to have such products reliably manufactured in accordance with the applicable regulatory requirements in sufficient quantities to support our development programs and, if ultimately approved, commercial supply.

There are a limited number of contract manufacturers who specialize in the manufacture of biologic products and those that do may still be developing appropriate processes, controls and facilities for large-scale production. While we believe that there will be sufficient sources of supply that can satisfy our clinical and commercial requirements, we cannot be certain that we will be able to identify and establish additional relationships with such sources, if necessary, in a timely manner or at all, and what the terms and costs of such new arrangements would be, or that such suppliers would be able to supply our potential commercial needs. Furthermore, in the event our primary manufacturer cannot meet our needs, any switch to an alternative manufacturer, if available, would result in a significant delay, would require FDA approval, and cause material additional costs.

The manufacturers of biologic products must comply with strictly enforced cGMP requirements, state and federal regulations, as well as foreign requirements when applicable. Any failure by us or our contract manufacturing organizations to adhere to or document compliance with such regulatory requirements could lead to a delay or interruption in the availability of drug product for clinical trials or commercial use, among other consequences. If we or our manufacturers fail to comply with the FDA, EMA, or other regulatory authorities, it could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, clinical holds or termination of clinical trials, Form 483s, warning or untitled letters, regulatory communications warning the public about safety issues with a product, import or export refusals, license revocation, seizures, detentions, or recalls of product candidates or product, operating restrictions, criminal prosecutions or debarment, suits under the civil False Claims Act, corporate integrity agreements, or consent decrees any of which could significantly and adversely affect supplies of our product candidates and our business, financial conditions and results of operations could be materially adversely affected.

Our current dependence upon others for the manufacture of our product candidates may also adversely affect our business, results of operations, financial condition, and our ability to commercialize any product candidates that receive regulatory approval on a timely and competitive basis.

If we or any contract manufacturers and suppliers that we engage fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.

We and any contract manufacturers and suppliers we engage are subject to numerous federal, state and local environmental, health and safety laws, regulations and permitting requirements, including those governing laboratory procedures; the generation, handling, use, storage, treatment and disposal of hazardous and regulated materials and wastes; the emission and discharge of hazardous materials into the ground, air and water; and employee health and safety. Under certain environmental laws, we could be held responsible for costs relating to any contamination at our current or past facilities and at third-party facilities. We also could incur significant costs associated with civil or criminal fines and penalties.

Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair our product development and research efforts. In addition, we cannot eliminate the risk of accidental injury or contamination from these materials or wastes. Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not carry specific biological or hazardous waste insurance coverage, and our property, casualty and general liability insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination. Accordingly, in the event of contamination or injury, we could be held liable for damages or be penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

In addition, we may incur substantial costs to comply with current or future environmental, health and safety laws, regulations and permitting requirements. These current or future laws, regulations and permitting requirements may impair our research, development or production efforts. Failure to comply with these laws, regulations and permitting requirements also may result in substantial fines, penalties or other sanctions or business disruption, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

Any third-party contract manufacturers and suppliers we engage will also be subject to these and other environmental, health and safety laws and regulations. Liabilities they incur pursuant to these laws and regulations could result in significant costs or an interruption in operations, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

Success in preclinical studies or clinical trials may not be indicative of results in future clinical trials, particularly for clinical trials that involve only a small number of patients.

Results from preclinical studies are not necessarily predictive of future clinical trial results, and interim results of a clinical trial are not necessarily indicative of final results. This risk is heightened when clinical trials involve only a small number of patients, which makes it difficult to predict whether early results from these trials will be indicative of the final results of the trials or be replicated in future trials. Further, success in preclinical studies and earlier stage clinical trials of telitacicept conducted by RemeGen, or the fact that telitacicept has received marketing approval in China in multiple indications, does not ensure that later clinical trials conducted by us will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate. Our product candidates may fail to show the desired safety and efficacy in clinical development despite positive results in preclinical studies or having successfully advanced through initial clinical trials. This failure to establish sufficient efficacy and safety could cause us to abandon clinical development of our product candidates.

Risks Related to Regulatory Review

If clinical trials of any of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of such product candidates.

Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing.

The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results.

Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses. Many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their product candidates.

We and our collaborators, if any, may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing approval or commercialize any product candidates, including:

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delays in reaching a consensus with regulators on clinical development plans, trial designs or regulatory approval data packages;

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regulators, IRBs, independent ethics committees or scientific review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

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delays in reaching or failing to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective CROs, and clinical trial sites;

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clinical trials of product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development or research programs;

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difficulty in designing well-controlled clinical trials due to ethical considerations which may render it inappropriate to conduct a trial with a control arm that can be effectively compared to a treatment arm;

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difficulty in designing clinical trials and selecting endpoints for diseases that have not been well-studied and for which the natural history and course of the disease is poorly understood;

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the number of patients required for clinical trials may be larger than we anticipate; enrollment of suitable participants in these clinical trials, which may be particularly challenging for some of the rare diseases we are targeting in our most advanced programs, may be delayed or slower than we anticipate; or patients may drop out of these clinical trials at a higher rate than we anticipate;

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our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

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regulators, IRBs or independent ethics committees may require that we or our investigators suspend or terminate clinical research or clinical trials for various reasons, including noncompliance with regulatory requirements, a finding of undesirable side effects or other unexpected characteristics, or that the participants are being exposed to unacceptable health risks or after an inspection of our clinical trial operations or trial sites;

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the cost of clinical trials may be greater than we anticipate;

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the supply or quality of product candidates or other materials necessary to conduct clinical trials may be insufficient or inadequate, including as a result of delays in the testing, validation, manufacturing and delivery of product candidates to the clinical sites by us or by third parties with whom we have contracted to perform certain of those functions;

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delays in having patients complete participation in a trial or return for post-treatment follow-up;

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clinical trial sites dropping out of a trial;

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selection of clinical endpoints that require prolonged periods of clinical observation or analysis of the resulting data;

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occurrence of serious adverse events associated with product candidates that are viewed to outweigh their potential benefits;

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occurrence of serious adverse events in trials of the same class of agents conducted by other sponsors;

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changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;

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disruption in the supply or availability of drug product; and

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changes in the standard of care treatment guidelines.

If we or our collaborators are required to conduct additional clinical trials or other testing of product candidates beyond those that we currently contemplate, if we or our collaborators are unable to successfully complete clinical trials or other testing of product candidates, or if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we or our collaborators may:

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be delayed in obtaining marketing approval for any such product candidates or not obtain marketing approval at all;

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obtain approval for indications or patient populations that are not as broad as intended or desired;

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obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;

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be subject to changes in the way the product is administered;

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be required to perform additional clinical trials to support approval or be subject to additional post-marketing testing requirements;

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have regulatory authorities withdraw or suspend their approval of the product or impose restrictions on its distribution in the form of a REMS or through modification to an existing REMS;

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be sued; or

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experience damage to our reputation.

Product development costs will also increase if we or our collaborators experience delays in clinical trials or other testing or in obtaining marketing approvals. We do not know whether any clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize product candidates, could allow our competitors to bring products to market before we do and could impair our ability to successfully commercialize product candidates, any of which may harm our business, financial condition, results of operations and prospects.

Even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize telitacicept or any other product candidate we may develop in the United States or any other jurisdiction, and any such approval may be for a more narrow indication than we seek.

We cannot commercialize a product candidate until the appropriate regulatory authorities have reviewed and approved the product candidate. Even if our product candidates meet their safety and efficacy endpoints in clinical trials, the regulatory authorities may not complete their review processes in a timely manner, or we may not be able to obtain regulatory approval. Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends non-approval or restrictions on approval. In addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory authority policy during the period of product development, clinical trials and the review process.

Regulatory authorities also may approve a product candidate for more limited indications than requested or they may impose significant limitations in the form of narrow indications, warnings or a REMS. These regulatory authorities may require labeling that includes precautions or contra-indications with respect to conditions of use, or they may grant approval subject to the performance of costly post-marketing clinical trials. In addition, regulatory authorities may not approve the labeling claims that are necessary or desirable for the successful commercialization of our product candidates. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates and materially adversely affect our business, financial condition, results of operations and prospects.

Marketing approval by the FDA in the United States, if obtained, does not ensure approval by regulatory authorities in other countries or jurisdictions. In addition, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not guarantee regulatory approval in any other country. Approval processes vary among countries and can involve additional product candidate testing and validation and additional administrative review periods. Seeking foreign regulatory approval could result in difficulties and costs for us and require additional preclinical studies or clinical trials which could be costly and time-consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our product candidates in those countries. The foreign regulatory approval process involves all of the risks associated with FDA approval. We do not have any product candidates approved for sale in any jurisdiction, including international markets, and we do not have experience in obtaining regulatory approval in international markets. If we fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approvals in international markets are delayed, our target market will be reduced and our ability to realize the full market potential of our product candidates will be unrealized.

Patient enrollment is a significant factor in the timing of clinical trials. The timing of our clinical trials depends, in part, on the speed at which we can recruit patients to participate in our trials. We or our collaborators may not be able to advance clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA, the EMA or other analogous regulatory authorities outside the United States, or as needed to provide appropriate statistical power for a given trial. Patients may be unwilling to participate in our clinical trials because of negative publicity from adverse events related to the biotechnology field, RemeGen’s telitacicept products or clinical trials, competitive clinical trials for similar patient populations, clinical trials in competing products or for other reasons. As a result, the timeline for recruiting patients, conducting trials and obtaining regulatory approval of product candidates could be delayed. In addition, if an unexpected number of patients drop out from a trial early, it would negatively impact the integrity of the trial results.

Patient enrollment and retention is also affected by other factors, including:

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severity of the disease under investigation;

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size of the patient population and process for identifying patients;

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design of the trial protocol;

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ability to obtain and maintain patient informed consent;

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risk that enrolled patients will drop out before completion of the trial, including due to side effects or characteristics that are unrelated to our product candidate;

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eligibility and exclusion criteria for the trial in question;

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perceived risks and benefits of the product candidate under trial;

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efforts to facilitate timely enrollment in clinical trials;

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patient referral practices of physicians;

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ability to monitor patients adequately during and after treatment;

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new therapies that are or become approved and available to the same patient population; and

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changes in standard of care treatment guidelines.

Significant enrollment delays or poor patient retention in our clinical trials may result in increased development costs for our product candidates, which would cause the value of our company to decline and limit our ability to obtain additional financing. If we or our collaborators have difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, or have difficulty retaining patients, we may need to delay, limit or terminate ongoing or planned clinical trials, any of which would have an adverse effect on our business, financial condition, results of operations and prospects.

Risks Related to Our Relationships with Third Parties

We rely on third parties for some aspects of our research and preclinical testing, and we rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or testing.

We rely on third parties to conduct some aspects of our research and preclinical testing, and we rely on third parties, such as CROs, clinical data management organizations, and clinical investigators, to conduct our clinical trials. Any of these third parties may terminate their engagements with us at any time under certain criteria. If we need to enter into alternative arrangements, it may delay our product development activities.

Our reliance on these third parties for research and development and clinical activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA, EMA and other regulatory authorities require us to comply with standards, commonly referred to as Good Clinical Practices, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. In the United States, we also are required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within certain timeframes.

Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

Although we intend to design the future clinical trials for our product candidates, CROs will conduct some or all of the clinical trials. As a result, many important aspects of our development programs, including their conduct and timing, will be outside of our direct control. Our reliance on third parties to conduct future preclinical studies and clinical trials will also result in less direct control over the management of data developed through preclinical studies and clinical trials than would be the case if we were relying entirely upon our own staff. Communicating with outside parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. Outside parties may:

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have staffing difficulties;

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fail to comply with contractual obligations;

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experience regulatory compliance issues;

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undergo changes in priorities or become financially distressed; or

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form relationships with other entities, some of which may be our competitors.

These factors may materially adversely affect the willingness or ability of third parties to conduct our preclinical studies and clinical trials and may subject us to unexpected cost increases that are beyond our control. If the CROs and other third parties do not perform preclinical studies and future clinical trials in a satisfactory manner, breach their obligations to us or fail to comply with regulatory requirements, the development, regulatory approval and commercialization of our product candidates may be delayed, we may not be able to obtain regulatory approval and commercialize our product candidates, or our development programs may be materially and irreversibly harmed. If we are unable to rely on preclinical and clinical data collected by our CROs and other third parties, we could be required to repeat, extend the duration of or increase the size of any preclinical studies or clinical trials we conduct and this could significantly delay commercialization and require greater expenditures.

Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the trial. The FDA or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable foreign regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of our product candidates.

We also rely on other third parties to store and distribute drug supplies for our clinical trials. Any performance failure on the part of our distributors could delay clinical development or marketing approval of our product candidates or commercialization of our products, producing additional losses and depriving us of potential product revenue.

We will rely on third-party manufacturers, including certain single source suppliers, for the manufacture and supply of materials for development of our product candidates and advancement of our current clinical trial, as well as our research programs and preclinical studies, and expect to continue to do so for future clinical testing and for commercial supply of our product candidates and for which we or any future collaborators obtain marketing approval. We do not have a long-term agreement with many of these third-party manufacturers or suppliers. We may be unable to establish any agreements with third-party manufacturers or suppliers or to do so on acceptable terms. Even if we are able to establish agreements with third-party manufacturers or suppliers, reliance on third-party manufacturers entails additional risks, including:

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the possible breach of the manufacturing or supply agreement by the third party;

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the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us; and reliance on the third party for regulatory compliance, quality assurance, safety and pharmacovigilance and related reporting.

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Third-party manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers or suppliers, to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocations, seizures or recalls of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products and harm our business, financial condition, results of operations and prospects.

Our product candidates may compete with other product candidates and products for access to manufacturing facilities and other supplies. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us. Also, prior to the approval of our product candidates, we would need to identify a contract manufacturer that could produce our products at a commercial scale and that could successfully complete FDA pre-approval inspection and inspections by other health authorities. Agreements with such manufacturers or suppliers may not be available to us at the time we would need to have that capability and capacity.

Any performance failure on the part of our existing or future manufacturers or suppliers, or any decision by a manufacturer or supplier to remove its products from the market or restrict access to its products, could delay clinical development or marketing approval. Although we believe that there are several potential alternative manufacturers who could replace our contract manufacturers, we may incur added costs and delays in identifying and qualifying any such replacement.

Our current and anticipated future dependence upon others for the manufacture of our product candidates and the materials used in our clinical trials may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis.

We have and may enter into collaborations with third parties for the research, development and commercialization of our product candidates. If any such collaborations are not successful, we may not be able to capitalize on the market potential of those product candidates.

We have and may seek third-party collaborators for the research, development and commercialization of certain our product candidates. If we enter into any such arrangements with any third parties in the future, we will likely have limited control over the amount and timing of resources that our collaborators dedicate to the development or commercialization our product candidates. Our ability to generate revenues from these arrangements will depend on our collaborators’ abilities to successfully perform the functions assigned to them in these arrangements. We cannot predict the success of collaborations that we have entered into or may enter into in the future.

Collaborations involving our current or future product candidates or research programs pose numerous risks to us, including the following:

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Collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations.

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Collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus or available funding or external factors such as an acquisition that diverts resources or creates competing priorities.

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Collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing.

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Collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours.

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Collaborators with marketing and distribution rights to one or more products may not commit sufficient resources to the marketing and distribution of such products.

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Collaborators may not properly obtain, maintain, enforce or defend our intellectual property or proprietary rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation.

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Disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our products or product candidates or that result in costly litigation or arbitration that diverts management attention and resources.

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We may lose certain valuable rights under circumstances identified in our collaborations, including if we undergo a change of control.

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Collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates.

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Collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all. If a present or future collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program under such collaboration could be delayed, diminished or terminated.

If our collaborations do not result in the successful development and commercialization of product candidates, or if one of our collaborators terminates its agreement with us, we may not receive any future research funding or milestone or royalty payments under the collaboration. If we do not receive the funding we expect under these agreements, our development of product candidates could be delayed, and we may need additional resources to develop product candidates. In addition, if one of our collaborators terminates its agreement with us, we may find it more difficult to find a suitable replacement collaborator or attract new collaborators, and our development programs may be delayed or the perception of us in the business and financial communities could be adversely affected. All of the risks relating to product development, regulatory approval and commercialization described in this “Risk Factors” section apply to the activities of our collaborators.

These relationships, or those like them, may require us to incur non-recurring and other charges, increase our near- and long-term expenditures, issue securities that dilute our existing stockholders, or disrupt our management and business. In addition, we could face significant competition in seeking appropriate collaborators, and the negotiation process is time-consuming and complex. Our ability to reach a definitive collaboration agreement will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration, and the proposed collaborator’s evaluation of several factors. If we license rights to our product candidates, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture.

If we are not able to establish collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.

Our product development and research programs and the potential commercialization of our product candidates will require substantial additional cash to fund expenses. For some of the product candidates, we may decide to collaborate with other pharmaceutical and biotechnology companies for the development and potential commercialization of those product candidates.

We would face significant competition in seeking appropriate collaborators. Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration, and the proposed collaborator’s evaluation of a number of factors. Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA, the EMA or similar regulatory authorities outside the United States, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing products, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge, and industry and market conditions generally. The collaborator may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us.

We may also be restricted under collaboration agreements from entering into future agreements on certain terms with potential collaborators. Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators.

We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have to curtail the development of the product candidate for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all.

If we do not have sufficient funds, we may not be able to develop product candidates or bring them to market and generate product revenue.

Risks Related to Our Intellectual Property

We are highly dependent on intellectual property licensed from third parties and termination of these licenses could result in the loss of significant rights, which would harm our business.

In June 2025, we entered into a license agreement with RemeGen granting us an exclusive (even as to RemeGen) license under RemeGen’s patents and know-how to exploit, develop and commercialize telitacicept in all territories other than Greater China, with the right to grant sublicenses, and a non-exclusive license to manufacture the telitacicept worldwide for use in the licensed territory.

We are dependent on the patents, know-how and proprietary technology licensed from RemeGen for the development and, if approved, commercialization of telitacicept. Any termination of this license, or a finding that such intellectual property lacks legal effect, could result in the loss of significant rights and could harm our ability to commercialize our product candidate.

The RemeGen license agreement imposes certain obligations on us, and non-compliance with such obligations may result in termination of the license agreement or in legal and financial consequences. If RemeGen terminates the license agreement, we may not be able to develop, commercialize or sell our product candidate covered by the agreement. Such an occurrence could materially adversely affect the value of the product candidate being developed under the agreement or using rights granted under such agreement. Termination of our license agreement or reduction or elimination of our rights thereunder may result in our having to negotiate a new or reinstated agreement, which may not be available to us on equally favorable terms, or at all, which may mean we are unable to develop, commercialize or sell the affected product candidate or may cause us to lose our rights under the agreement.

In addition, our licensors may make decisions in prosecuting, maintaining, enforcing and defending any licensed intellectual property rights, for example, any licensed patents or patent applications, that may not be in our best interest. Moreover, if our licensors take any action with respect to any licensed intellectual property rights, for example, any licensed patents or patent applications, that results in a successful challenge to the licensed intellectual property by a third party, such patents may be invalidated or held to be unenforceable, and we may lose our rights under such patents, which could materially harm our business.

Further, license agreements under which we license intellectual property from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. Accordingly, disputes may arise between us and our licensors regarding intellectual property subject to a license agreement, including those relating to:

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the scope of rights, if any, granted under the license agreement and other interpretation-related issues;

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whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the license agreement;

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whether our licensor or its licensor had the right to grant the license agreement;

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whether third parties are entitled to compensation or equitable relief, such as an injunction, for our use of the intellectual property without their authorization;

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our right to sublicense patent and other rights to third parties under collaborative development relationships;

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whether we are complying with our obligations with respect to the use of the licensed technology in relation to our development and commercialization of product candidates;

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our involvement in the prosecution and enforcement of the licensed patents and our licensors’ overall patent prosecution and enforcement strategy;

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the allocation of ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and by us and any future partners or collaborators; and

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the amounts of royalties, milestones or other payments due under the license agreement.

The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement.

If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, or are insufficient to provide us the necessary rights to use the intellectual property, we may be unable to successfully develop and commercialize the affected product candidates.

If we or any of our licensors fail to adequately protect this intellectual property, our ability to commercialize our products could suffer. Any disputes with our licensors or any termination of the licenses on which we depend could have a material adverse effect on our business, financial condition, results of operations and prospects.

Our commercial success depends on our ability to obtain, maintain and protect our intellectual property and proprietary technology.

Our commercial success depends in large part on our ability to obtain, maintain and protect intellectual property rights through patents, trademarks and trade secrets in the United States and other countries with respect to our proprietary product candidates. If we do not adequately protect our intellectual property rights, competitors may be able to erode, negate or preempt any competitive advantage we may have, which could harm our business and ability to achieve profitability.

To protect our proprietary position, we own and have in-licensed certain intellectual property rights, including certain issued patents and patent applications, and have filed and may file provisional and non-provisional patent applications in the United States or abroad related to our product candidates that are important to our business. Provisional patent applications are not eligible to become issued patents until, among other things, we file a non-provisional patent application within 12 months of the filing of one or more of our related provisional patent applications. If we do not timely file non-provisional patent applications, we may lose our priority date with respect to our provisional patent applications and any patent protection on the inventions disclosed in our provisional patent applications. While we intend to timely file non-provisional patent applications relating to our provisional patent applications, we cannot predict whether any such patent applications will result in the issuance of patents that provide us with any competitive advantage. Moreover, the patent application and approval process is expensive and time-consuming. We may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner.

The patent application, prosecution and enforcement processes are subject to numerous risks and uncertainties, and there can be no assurance that we, our licensors, or any of our current or future collaborators will be successful in protecting our product candidates by obtaining, defending and/or asserting patent rights. These risks and uncertainties include the following:

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the U.S. Patent and Trademark Office (the “USPTO”) and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case;

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patent applications may not result in any patents being issued;

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patents that may be issued or in-licensed may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage;

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our competitors, many of whom have substantially greater resources and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate our ability to make, use, and sell our potential product candidates;

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there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and

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countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates.

In some instances, agreements through which we license intellectual property rights may not give us control over patent prosecution or maintenance, so that we may not be able to control which claims or arguments are presented, how claims are amended, and may not be able to secure, maintain, or successfully enforce necessary or desirable patent protection from those patent rights. While we have the first right to prosecute patents and patent applications we license under our license agreement with RemeGen in the licensed territory, RemeGen retains the right to prosecute these patents and patent applications in the remaining territory, and therefore we cannot guarantee that these patents and applications will be prosecuted or maintained in a manner consistent with the best interests of our business. We cannot be certain that patent prosecution and maintenance activities by our licensors have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents.

Moreover, some of our in-licensed patents and patent applications may be, and some of our future owned and licensed patents may be, co-owned with third parties. If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In addition, we may need the cooperation of any such co-owners of our patents in order to enforce such patents against third parties, and such cooperation may not be provided to us.

The patent protection we obtain for our product candidates may not be sufficient to provide us with any competitive advantage or our patents may be challenged.

Our owned and licensed patents and pending patent applications, if issued, may not provide us with any meaningful protection or may not prevent competitors from designing around our patent claims to circumvent our patents by developing similar or alternative technologies or therapeutics in a non-infringing manner. For example, a third party may develop a competitive product that provides benefits similar to one or more of our product candidates but falls outside the scope of our patent protection or license rights. If the patent protection provided by the patents and patent applications we hold or pursue with respect to our product candidates is not sufficiently broad to impede such competition, our ability to successfully commercialize our product candidates could be negatively affected, which would harm our business. Currently, a significant portion of our patents and patent applications are in-licensed, though similar risks would apply to any patents or patent applications that we now own or may own or in-license in the future.

It is possible that defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, for example with respect to proper priority claims, inventorship, claim scope, or requests for patent term adjustments. If we or our partners, collaborators, licensees, or licensors, whether current or future, fail to establish, maintain or protect such patents and other intellectual property rights, such rights may be reduced or eliminated. If our partners, collaborators, licensees, or licensors, are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised. If there are material defects in the form, preparation, prosecution, or enforcement of our patents or patent applications, such patents may be invalid and/or unenforceable, and such applications may never result in valid, enforceable patents. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.

In addition, the determination of patent rights with respect to clinical compositions of matter and treatment methods commonly involves complex legal and factual questions, which are dependent upon the current legal and intellectual property context, extant legal precedent and interpretations of the law by individuals. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are characterized by uncertainty.

Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection. In addition, the laws of foreign countries may not protect our rights to the same extent or in the same manner as the laws of the United States. For example, patent laws in various jurisdictions, including significant commercial markets such as Europe, restrict the patentability of methods of treatment of the human body more than U.S. law does. If these changes were to occur, they could have a material adverse effect on our ability to generate revenue.

Pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from such applications. Assuming the other requirements for patentability are met, currently, the first party to file a patent application is generally entitled to the patent. However, prior to March 16, 2013, in the United States the first party to invent was entitled to the patent. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are not published until 18 months after filing, or in some cases not at all. Therefore, we cannot be certain that we were the first to make the inventions claimed in our patents or pending patent applications, or that we were the first to file for patent protection of such inventions. Similarly, we cannot be certain that parties from whom we do or may license or purchase patent rights were the first to make relevant claimed inventions, or were the first to file for patent protection for them. If third parties have filed prior patent applications on inventions claimed in our patents or applications that were filed on or before March 15, 2013, an interference proceeding in the United States can be initiated by such third parties to determine who was the first to invent any of the subject matter covered by the patent claims of our applications. If third parties have filed such prior applications after March 15, 2013, a derivation proceeding in the United States can be initiated by such third parties to determine whether our invention was derived from theirs.

Moreover, because the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, our owned and licensed patents or pending patent applications may be challenged in the courts or patent offices in the United States and abroad. There is no assurance that all of the potentially relevant prior art relating to our patents and patent applications has been found. If such prior art exists, it may be used to invalidate a patent, or may prevent a patent from issuing from a pending patent application. For example, such patent filings may be subject to a third-party submission of prior art to the USPTO, or to other patent offices around the world.

Alternately or additionally, we may become involved in post-grant review procedures, oppositions, derivation proceedings, ex parte reexaminations, inter partes review, supplemental examinations, or interference proceedings or challenges in district court, in the United States or in various foreign patent offices, including both national and regional, challenging patents or patent applications in which we have rights, including patents on which we rely to protect our business. An adverse determination in any such challenges may result in loss of the patent or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, or in denial of the patent application or loss or reduction in the scope of one or more claims of the patent application, any of which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products. In addition, given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

Issued patents that we have or may obtain or license may not provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner. Our competitors may also seek approval to market their own products similar to or otherwise competitive with our products. Alternatively, our competitors may seek to market generic versions of any approved products, for example, by submitting a Section 351(k) Biologics License Application (”BLA”) to the FDA, or pursue similar strategies in the United States or other jurisdictions, in which they claim that patents owned or licensed by us are invalid, unenforceable or not infringed. In these circumstances, we may need to defend or assert our patents, or both, including by filing lawsuits alleging patent infringement. In any of these types of proceedings, a court or other agency with jurisdiction may find our patents invalid or unenforceable, or that our competitors are competing in a non-infringing manner. Thus, even if we have valid and enforceable patents, these patents still may not provide protection against competing products or processes sufficient to achieve our business objectives. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

Other parties have developed or may develop technologies that may be related to or competitive with our approach, and may have filed or may file patent applications and may have been issued or may be issued patents with claims that overlap or conflict with our patent applications, either by claiming the same materials, formulations or methods, or by claiming subject matter that could dominate our patent position. In addition, certain parts or all of the patent portfolios licensed to us are, or may be, licensed to third parties and such third parties may have or may obtain certain enforcement rights. If the scope of the patent protection we or our licensors obtain is not sufficiently broad, we may not be able to prevent others from developing and commercializing technology and products similar or identical to ours. The degree of patent protection we require to successfully compete in the marketplace may be unavailable or severely limited in some cases and may not adequately protect our rights or permit us to gain or keep any competitive advantage. We cannot provide any assurances that any of our licensed patents have, or that any of our pending owned or licensed patent applications that mature into issued patents will include, claims with a scope sufficient to protect our product candidates or otherwise provide any competitive advantage, nor can we provide any assurance that our licenses will remain in force.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.

In addition to the protection afforded by patents, we rely upon trade secret protection, know-how and continuing technological innovation to develop and maintain our competitive position. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our contractors, collaborators, scientific advisors, employees and consultants and invention assignment agreements with our consultants and employees. However, we may not obtain these agreements in all circumstances, and individuals with whom we have these agreements may not comply with their terms. The assignment of intellectual property rights under these agreements may not be self-executing or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. In addition, we may not be able to prevent the unauthorized disclosure or use of our technical know-how or other trade secrets by the parties to these agreements despite the existence of confidentiality agreements and other contractual restrictions. Monitoring unauthorized uses and disclosures is difficult and we do not know whether the steps we have taken to protect our proprietary technologies will be effective. If any of the contractors, collaborators, scientific advisors, employees and consultants who are parties to these agreements breaches or violates the terms of any of these agreements, we may not have adequate remedies for any such breach or violation. As a result, we could lose our trade secrets. Enforcing a claim against a third party that illegally obtained and is using our trade secrets, like patent litigation, is expensive and time-consuming and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing or unwilling to protect trade secrets. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Moreover, our trade secrets could otherwise become known or be independently discovered by our competitors or other third parties. Competitors and other third parties could attempt to replicate some or all of the competitive advantages we derive from our development efforts, willfully infringe our intellectual property rights, design around our protected technology or develop their own competitive technologies that fall outside of our intellectual property rights. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with us.

If our trade secrets are not adequately protected or sufficient to provide an advantage over our competitors, our competitive position could be adversely affected, as could our business. Additionally, if the steps taken to maintain our trade secrets are deemed inadequate, we may have insufficient recourse against third parties for misappropriating our trade secrets.

We may not be successful in acquiring or in-licensing necessary rights to key technologies underlying our product candidates.

We currently have rights to intellectual property, through licenses from third parties, to develop our product candidates, and we expect to seek to expand our intellectual property footprint related to our product candidate pipeline in part by in-licensing the rights to key technologies. The future growth of our business will depend in part on our ability to in-license or otherwise acquire the rights to develop additional product candidates and technologies. Although we have succeeded in licensing technologies from third party licensors, including RemeGen, in the past, we can give no assurance that we will be able to in-license or acquire the rights to other technologies relevant to our product candidates from third parties on acceptable terms or at all.

In order to market our product candidates, we may find it necessary or prudent to obtain licenses from such third party intellectual property holders. However, it may be unclear who owns the rights to intellectual property we wish to obtain, or we may be unable to secure such licenses or otherwise acquire or in-license intellectual property rights from third parties that we identify as necessary for our product candidates and technology we employ. We currently conduct our preclinical research and clinical trials under 35 U.S.C. § 271(e)(1), which provides a safe harbor from patent infringement for uses of patented technology reasonably related to the development and submission of information under a federal law which regulates the manufacture, use, or sale of drugs.

The licensing or acquisition of third party intellectual property rights is a highly competitive area, and other companies may pursue strategies to license or acquire third party intellectual property rights that we may consider attractive or necessary. Such companies may have a competitive advantage over us, e.g., due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. If we are unable to successfully obtain rights to required third party intellectual property rights or maintain the existing intellectual property rights we have, we may have to abandon development of the relevant program or product candidate, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

Even if we were able to obtain such a license, it could be non-exclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments. If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, we may be unable to commercialize our product candidates or such commercialization efforts may be significantly delayed, which could in turn significantly harm our business.

Our commercial success depends in part on our avoiding infringement, misappropriation and other violations of the patents and proprietary rights of third parties. There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology and pharmaceutical industries, as well as administrative proceedings for challenging patents, including interference and reexamination proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions. Recently, under U.S. patent reform, new procedures including inter partes review and post grant review have been implemented. This reform will bring uncertainty to the possibility of challenge to our patents in the future. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing our product candidates, and third parties may allege they have patent rights encompassing our product candidates, technologies or methods. Third parties may assert that we are employing their proprietary technology without authorization and may file patent infringement claims or lawsuits against us, and if we are found to infringe such third-party patents, we may be required to pay damages, cease commercialization of the infringing technology or obtain a license from such third parties, which may not be available on commercially reasonable terms or at all.

There may also be third-party patents of which we are currently unaware with patent rights to materials, formulations, methods of manufacture or methods of treatment related to the use or manufacture of our product candidates. Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. Further, we or our licensors may fail to identify even those relevant third-party patents that have issued or may incorrectly interpret the relevance, scope or expiration of such patents. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or scope of a patent or a pending application may be incorrect.

If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of our product candidates, materials used in or formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block our ability to commercialize the product candidate unless we obtained a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our materials, formulations or methods, including without limitation, combination therapy or patient selection methods, the holders of any such patent may be able to block our ability to develop and commercialize the product candidate unless we obtained a license or until such patent expires or is finally determined to be held invalid or unenforceable.

Parties making claims against us may seek and obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize our product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would involve a substantial diversion of employee resources from our business. We may not have sufficient resources to bring these actions to a successful conclusion, which may result in significant cost and may impede our inability to pursue any affected products or product candidates. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of shares of our common stock.

In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event, our competitors might be able to enter the market earlier than would otherwise have been the case, which would have a material adverse effect on our business.

Some intellectual property that we have in-licensed may have been discovered through government funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.

Any of the intellectual property rights that we have licensed or we may license in the future and that have been generated through the use of U.S. government funding are subject to certain federal regulations. As a result, the U.S. government may have certain rights to intellectual property embodied in our current or future product candidates pursuant to the Bayh-Dole Act of 1980 (the “Bayh-Dole Act”). These U.S. government rights in certain inventions developed under a government-funded program include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right to require us to grant exclusive, partially exclusive, or non-exclusive licenses to any such intellectual property rights to a third party if it determines that: (i) adequate steps have not been taken to commercialize the invention; (ii) government action is necessary to meet public health or safety needs; or (iii) government action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in rights”). The U.S. government also has the right to take title to such intellectual property rights if we, or the applicable licensor, fail to disclose the invention to the government and fail to file an application to register the intellectual property within specified time limits. Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require us or the applicable licensor to expend substantial resources. We cannot be certain that our current or future licensors will comply with the disclosure or reporting requirements of the Bayh-Dole Act at all times, or be able to rectify any lapse in compliance with these requirements.

In addition, the U.S. government requires that any products embodying the subject invention or produced through the use of the subject invention be manufactured substantially in the United States. The manufacturing preference requirement can be waived if the owner of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible.

This preference for U.S. manufacturers may limit our ability to contract with non-U.S. product manufacturers for products covered by such intellectual property. To the extent any of our current or future intellectual property is generated through the use of U.S. government funding, the provisions of the Bayh-Dole Act may similarly apply.

We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.

Competitors may infringe our patents, trademarks, copyrights or other intellectual property. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming and divert the time and attention of our management and scientific personnel. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents, in addition to counterclaims asserting that our patents are invalid or unenforceable, or both. In any patent infringement proceeding, there is a risk that a court will decide that a patent of ours is invalid or unenforceable, in whole or in part, and that we do not have the right to stop the other party from using the invention at issue. There is also a risk that, even if the validity of such patents is upheld, the court will construe the patent’s claims narrowly or decide that we do not have the right to stop the other party from using the invention at issue on the grounds that our patent claims do not cover the invention. An adverse outcome in a litigation or proceeding involving our patents could limit our ability to assert our patents against those parties or other competitors, and may curtail or preclude our ability to exclude third parties from making and selling similar or competitive products. Any of these occurrences could adversely affect our competitive business position, business prospects and financial condition. Similarly, if we assert trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks.

Even if we establish infringement, the court may decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may or may not be an adequate remedy. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of shares of our common stock. Moreover, there can be no assurance that we will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years before they are concluded. Even if we ultimately prevail in such claims, the monetary cost of such litigation and the diversion of the attention of our management and scientific personnel could outweigh any benefit we receive as a result of the proceedings. Any of the foregoing may have a material adverse effect on our business, financial condition, results of operations and prospects.

Changes to patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.

As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involves both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. For example, in the case, Assoc. for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court held that certain claims to DNA molecules are not patentable. In addition, the case Amgen Inc. v. Sanofi affects the way antibody claims are examined and litigated. While we do not believe that any of the patents owned or licensed by us will be found invalid based on these decisions, we cannot predict how future decisions by the courts, the Congress or the USPTO may impact the value of our patents.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting, maintaining, defending and enforcing patents on our product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own drugs and may export otherwise infringing drugs to territories where we have patent protection, but enforcement rights are not as strong as those in the United States.

These drugs may compete with our product candidates and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of some countries do not favor the enforcement of patents and other intellectual property protection, which could make it difficult for us to stop the infringement of our patents generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

Many countries have compulsory licensing laws under which a patent owner may be compelled under specified circumstances to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of those patents. This could limit our potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license, which could adversely affect our business, financial condition, results of operations, and prospects.

Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest filing date of a non-provisional application to which the patent claims priority. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired for a product candidate, we may be open to competition from competitive medications, including generic medications. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such product candidates might expire before or shortly after such product candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing product candidates similar or identical to ours.

If we do not obtain patent term extension and data exclusivity for patents related to any of our product candidates, our business may be materially harmed.

Depending upon the timing, duration and conditions of any FDA marketing approval of our product candidates, one or more of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments, and similar legislation in the European Union. The Hatch-Waxman Amendments permit a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process. However, we may not receive an extension if we fail to exercise due diligence during the testing phase or regulatory review process, fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request. Only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years from approval and only those claims covering the approved drug, a method for using it or a method for manufacturing it may be extended. If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for the applicable product candidate will be shortened and our competitors may obtain approval to market competing products sooner. As a result, our revenue from applicable products could be reduced. Further, if this occurs, our competitors may take advantage of our investment in development and trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case, and our competitive position, business, financial condition, results of operations, and prospects could be materially harmed.

Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.

We employ individuals who were previously employed at universities or other biopharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees and consultants do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of a former employer or other third parties. We may also be subject to claims that patents and applications that we may file to protect inventions of our employees or consultants are rightfully owned by their former employers or other third parties. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.

Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. Any of the foregoing would harm our business, financial condition, results of operations, and prospects.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest. At times, competitors or other third parties may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our business, financial condition, results of operations and growth prospects.

Intellectual property rights do not necessarily address all potential threats.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

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Our product candidates may eventually become available in generic or biosimilar product forms;

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others may be able to make products that are similar to our product candidates or utilize similar technology but that are not covered by the claims of the patents that we license or own;

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we, or our current or future licensors might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or own;

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we, or our current or future licensors might not have been the first to file patent applications covering certain of our or their inventions;

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we, or our license partners or current or future collaborators, may fail to meet our obligations to the U.S. government regarding any in-licensed patents and patent applications funded by U.S. government grants, leading to the loss or unenforceability of patent rights;

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others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights;

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it is possible that our pending, owned or licensed patent applications or those that we may own in the future will not lead to issued patents;

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it is possible that there are prior public disclosures that could invalidate our owned or in-licensed patents, or parts of our owned or in-licensed patents;

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it is possible that there are unpublished applications or patent applications maintained in secrecy that may later issue with claims covering our product candidates or technology similar to ours;

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it is possible that our owned or in-licensed patents or patent applications omit individual(s) that should be listed as inventor(s) or include individual(s) that should not be listed as inventor(s), which may cause these patents or patents issuing from these patent applications to be held invalid or unenforceable;

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it is possible that our pending owned or licensed patent applications or those that we may own or license in the future will not lead to issued patents;

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issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;

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the claims of our owned or in-licensed issued patents or patent applications, if and when issued, may not cover our product candidates; the laws of foreign countries may not protect our proprietary rights or the proprietary rights of license partners or current or future collaborators to the same extent as the laws of the United States;

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the inventors of our owned or in-licensed patents or patent applications may become involved with competitors, develop products or processes that design around our patents or become hostile to us or the patents or patent applications on which they are named as inventors;

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our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

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we have engaged in scientific collaborations in the past and will continue to do so in the future and our collaborators may develop adjacent or competing products that are outside the scope of our patents;

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we may not develop additional proprietary technologies that are patentable;

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any product candidates we develop may be covered by third parties’ patents or other exclusive rights;

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the patents of others may harm our business; and

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we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

Should any of these events occur, they could harm our business, financial condition, results of operations, and prospects.

Risks Related to Regulatory and Other Legal Compliance Matters

Failure to obtain marketing approval in foreign jurisdictions would prevent product candidates from being marketed in such jurisdictions, which, in turn, would materially impair our ability to generate revenue.

In order to market and sell product candidates in the European Union and other foreign jurisdictions, we or our third-party collaborators must obtain separate marketing approvals (a single one for the European Union) and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ substantially from that required to obtain FDA approval. The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA approval. In addition, in many countries outside the United States, it is required that the product candidate be approved for reimbursement before the product candidate can be approved for sale in that country. We or these third parties may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our products in any jurisdiction, which would materially impair our ability to generate revenue.

Even if we, or any collaborators we may have, obtain marketing approvals for our product candidates, the terms of approvals and ongoing regulation of our product candidates could require the substantial expenditure of resources and may limit how we, or they, manufacture and market our product candidates, which could materially impair our ability to generate revenue.

Any product candidate for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA, EMA, the Competent Authorities of the Member States of the European Union and other regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, facility registration and drug listing requirements, cGMP requirements relating to quality control, quality assurance and corresponding maintenance of records and documents, and requirements regarding the distribution of samples to physicians and recordkeeping. Even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product. The FDA and other regulatory authorities may restrict the use of our products to certain specialists and/or institutions and require formal reporting and approval of a REMS program. Such restrictions or requirements could deter use of our products by certain individuals or institutions.

Accordingly, assuming we, or any of our collaborators, receive marketing approval for one or more product candidates, we, such collaborators and our and their contract manufacturers will continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance and quality control. If we and such collaborators are not able to comply with post-approval regulatory requirements, we and such collaborators could have the marketing approvals for our products withdrawn by regulatory authorities and our, or such collaborators’, ability to market any future products could be limited, which could adversely affect our ability to achieve or sustain profitability.

Further, the cost of compliance with post-approval regulations may have a negative effect on our business, operating results, financial condition and prospects.

Even if we receive regulatory approval for any product candidate, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates for which we obtain marketing approval could be subject to labeling and other restrictions or withdrawal from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.

If the FDA or a comparable foreign regulatory authority approves any of our product candidates, the manufacturing processes, testing, safety, efficacy, labeling, packaging, distribution, import, export, adverse event reporting, storage, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and GCPs for any clinical trials that we conduct post-approval, all of which may result in significant expense and limit our ability to commercialize such products. In addition, any regulatory approvals that we receive for our product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product candidate.

The FDA, the EMA, the Competent Authorities of the Member States of the European Union and other regulatory authorities closely regulate the post-approval marketing and promotion of products to ensure that they are marketed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA, the Competent Authorities of the Member States of the European Union and other regulatory authorities impose stringent restrictions on manufacturers’ communications regarding off-label use, and if we market our products for off-label use, we may be subject to enforcement action for off-label marketing by the FDA and other federal and state enforcement agencies, including the Department of Justice. While physicians may prescribe products for off-label uses as the FDA and other U.S. regulatory agencies do not regulate a physician’s choice of drug treatment made in the physician’s independent medical judgment, they do restrict promotional communications from companies or their sales force with respect to off-label uses of products for which marketing clearance has not been issued. Companies may only share truthful and not misleading information that is otherwise consistent with a product’s FDA approved labeling. Violation of the Federal Food, Product, and Cosmetic Act and other statutes, including the False Claims Act and equivalent legislation in other countries relating to the promotion and advertising of prescription products may also lead to investigations or allegations of violations of federal and state and other countries’ health care fraud and abuse laws and state consumer protection laws. Even if it is later determined we were not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our actions and have to divert significant management resources from other matters.

In addition, later discovery of previously unknown problems with our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various negative consequences, including:

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restrictions on such products, manufacturers or manufacturing processes;

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restrictions on the labeling or marketing of a product;

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restrictions on the distribution or use of a product;

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requirements to conduct post-marketing clinical trials;

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receipt of warning or untitled letters;

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withdrawal of the products from the market;

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refusal to approve pending applications or supplements to approved applications that we submit;

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recall of products;

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fines, restitution or disgorgement of profits or revenue;

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restrictions on future procurements with governmental authorities;

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suspension or withdrawal of marketing approvals;

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suspension of any ongoing clinical trials;

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refusal to permit the import or export of our products; Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity.

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product seizure; and

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injunctions or the imposition of civil or criminal penalties.

The occurrence of any event or penalty described above may inhibit our ability to commercialize any of our product candidates, if approved, and adversely affect our business, financial condition, results of operations and prospects.

Moreover, the policies of the FDA and of comparable foreign regulatory authorities may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. For example, the U.S. Supreme Court’s June 2024 decision in Loper Bright Enterprises v. Raimondo overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes. The Loper decision could result in additional legal challenges to regulations and decisions issued by federal agencies, including the FDA, on which we rely. Any such legal challenges, if successful, could have a material impact on our business. Additionally, the Loper decision may result in increased regulatory uncertainty, inconsistent judicial interpretations, and other impacts to the agency rulemaking process, any of which could adversely impact our business and operations. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may be subject to enforcement action and we may not achieve or sustain profitability.

Disruptions at the FDA and other government agencies caused by funding shortages, layoffs, shifting priorities under the new administration or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, layoffs, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions. Average review times at the agency have fluctuated in recent years as a result. Disruptions at the FDA and other agencies may also slow the time necessary for new biologics or modifications to cleared or approved biologics to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. In addition, the Trump administration has discussed several changes to the reach and oversight of the FDA, which could affect its relationship with the pharmaceutical industry, transparency in decision making and ultimately the cost and availability of prescription drugs. Additionally, over the last several years, the U.S. government has shut down multiple times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA and other government employees and stop critical activities. If funding for the FDA is reduced, FDA priorities change, or a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Our relationships with healthcare providers, including physicians, and third-party payors will be subject to applicable anti-kickback, fraud and abuse, health data privacy, transparency, anti-bribery and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Healthcare providers and third-party payors play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval. Our current and future arrangements with healthcare providers, third-party payors and customers may expose us to broadly applicable federal and state fraud and abuse, transparency, health data privacy, and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we research as well as market, sell and distribute our products for which we obtain marketing approval.

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. Given the breadth of the laws and regulations and evolving government interpretations of the laws and regulations, governmental authorities may possibly conclude that our business practices, including certain of our advisory board arrangements with physicians, some of whom are compensated in the form of stock or stock options, may not comply with healthcare laws and regulations. If our operations are found to be in violation of any healthcare laws or any other federal or state government regulations that apply to us, we may be subject to significant penalties, including administrative, civil and criminal penalties, damages, fines, disgorgement, exclusion from participation in government health care programs, such as Medicare and Medicaid, imprisonment, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our business, financial condition, results of operations, and prospects.

For a more detailed discussion of U.S. healthcare laws that may affect our business, see "Business—Other U.S. Healthcare Laws and Compliance Requirements” in Part I, Item 1 of this Annual Report.

Healthcare and other reform legislation, may increase the difficulty and cost for us and any collaborators we may have to obtain marketing approval of and commercialize our product candidates, if approved, and affect the prices we, or they, may obtain.

In the United States and some foreign jurisdictions, there have been and continue to be ongoing efforts to implement legislative and regulatory changes regarding the healthcare system. Such changes could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product candidates for which we obtain marketing approval. Although we cannot predict what healthcare or other reform efforts will be successful, such efforts may result in more rigorous coverage criteria, in additional downward pressure on the price that we, or our future collaborators, may receive for any approved products or in other consequences that may adversely affect our ability to achieve or maintain profitability.

Within the United States, the federal government and individual states have aggressively pursued healthcare reform, as evidenced by the passing of the ACA. The ACA substantially changed the way healthcare is financed by both governmental and private insurers and contains a number of provisions that affect coverage and reimbursement of drug products and/or that could potentially reduce the demand for pharmaceutical products. There have been executive, judicial and Congressional challenges and amendments, to certain aspects of the ACA. For example, on August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. We cannot predict the ultimate content, timing or effect of any such challenges or changes to the ACA or other federal and state reform efforts. There is no assurance that federal or state health care reform will not adversely affect our future business and financial results, and we cannot predict how future federal or state legislative, judicial or administrative changes relating to healthcare reform will affect our business.

Federal and state governments have shown significant interest in implementing cost-containment programs to limit the growth of government-paid healthcare costs. For example, the IRA also, among other things, (1) directs the U.S. Department of Health and Human Services (“HHS”), to negotiate the price of certain high expenditure single-source biologics that have been on the market for at least 11 years covered under Medicare (the “Medicare Drug Price Negotiation Program”), and (2) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions began to take effect progressively in fiscal year 2023. On August 15, 2024, HHS announced the agreed-upon price of the first ten products that were subject to price negotiations, although the Medicare Drug Price Negotiation Program is currently subject to legal challenges. On January 17, 2025, HHS selected fifteen additional products covered under Part D for price negotiation in 2025. Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program. Further, on December 7, 2023, an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act was announced. On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework.

We are unable to predict what additional legislation, regulations or policies, if any, relating to the healthcare industry or third party coverage and reimbursement may be enacted in the future, particularly in light of the recent U.S. Presidential and Congressional elections, or what effect such legislation, regulations or policies would have on our business. Any cost containment measures could significantly decrease the available coverage and the price we might establish for our potential products, which would have an adverse effect on our net revenues and operating results. For a more detailed discussion of U.S. healthcare reforms that may affect our business, see “Business—Healthcare Reform” in Part I, Item 1 of this Annual Report.

Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.

We are exposed to the risk of fraud or other misconduct by our employees, consultants and commercial partners, and, if we commence clinical trials, our principal investigators. Misconduct by these parties could include intentional failures to comply with FDA regulations or the regulations applicable in the European Union and other jurisdictions, provide accurate information to the FDA, the EMA and other regulatory authorities, comply with healthcare fraud and abuse laws and regulations in the United States and abroad, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices.

These laws and regulations restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Such misconduct also could involve the improper use of information obtained in the course of clinical trials or interactions with the FDA, the EMA or other regulatory authorities, which could result in regulatory sanctions and cause serious harm to our reputation. We have adopted a code of conduct applicable to all of our employees, but it is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from government investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, financial condition, results of operations, and prospects, including the imposition of significant fines or other sanctions.

Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain product candidates outside of the United States and require us to develop and implement costly compliance programs.

We may be subject to numerous laws and regulations in each jurisdiction outside the United States in which we may operate. The creation, implementation and maintenance of international business practices compliance programs is costly and such programs are difficult to enforce, particularly where reliance on third parties is required.

The Foreign Corrupt Practices Act (the “FCPA”) prohibits any U.S. individual or business from paying, offering, authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. The anti-bribery provisions of the FCPA are enforced primarily by the Department of Justice. The SEC is involved with enforcement of the books and records provisions of the FCPA.

Similarly, the U.K. Bribery Act 2010 has extra-territorial effect for companies and individuals having a connection with the United Kingdom. The U.K. Bribery Act prohibits inducements both to public officials and private individuals and organizations. Compliance with the FCPA and the U.K. Bribery Act is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.

Various laws, regulations and executive orders also restrict the use and dissemination outside of the United States, or the sharing with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products. Our expansion outside of the United States has required, and will continue to require, us to dedicate additional resources to comply with these laws, and these laws may preclude us from developing, manufacturing or selling certain product candidates outside of the United States, which could limit our growth potential and increase our development costs. The failure to comply with laws governing international business practices may result in substantial penalties, including suspension or debarment from government contracting. Violation of the FCPA can result in significant civil and criminal penalties. Indictment alone under the FCPA can lead to suspension of the right to do business with the U.S. government until the pending claims are resolved. Conviction of a violation of the FCPA can result in long-term disqualification as a government contractor. The termination of a government contract or relationship as a result of our failure to satisfy any of our obligations under laws governing international business practices would have a negative impact on our operations and harm our reputation and ability to procure government contracts. The SEC also may suspend or bar issuers from trading securities on U.S. exchanges for violations of the FCPA’s accounting provisions.

We and the third parties with whom we work are subject to stringent and evolving privacy and information security laws, regulations, industry standards, policies, contractual obligations and other obligations related to privacy and information security. Our (or the third parties with whom we work) actual or perceived failure to comply with such obligations could adversely affect our business.

In the ordinary course of business, we collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, “process”) personal data and other sensitive information, including proprietary and confidential business data, trade secrets, intellectual property, sensitive third-party data, business plans, transactions, information about patients and clinical trial data (collectively, sensitive data).

Our data processing activities subject us to numerous data privacy and security laws and regulations, which among other things, impose certain requirements relating to the privacy, security and transmission of personal data. The legislative and regulatory landscape for privacy and data protection continues to evolve in jurisdictions worldwide, and there has been an increasing focus on privacy and data protection issues with the potential to affect our business. Actual or perceived failure to comply with any of these laws and regulations could result in enforcement action against us, including fines, imprisonment of company officials and public censure, claims for damages by affected individuals, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations or prospects.

In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), and other similar laws (e.g., wiretapping laws). For example, the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), imposes specific requirements relating to the privacy, security, and transmission of individually identifiable protected health information. In addition, numerous U.S. states have enacted comprehensive privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal data. These state laws allow for statutory fines for noncompliance. For example, the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act of 2020 (collectively, “CCPA”), applies to personal data of consumers, business representatives, and employees who are California residents, and requires businesses to provide specific disclosures in privacy notices and honor requests of such individuals to exercise certain privacy rights. Although there are minimum revenue thresholds for companies to be subject to these laws and there are limited exemptions for clinical trial data under the CCPA and similar state comprehensive privacy laws, such laws may impact (possibly significantly) our business activities depending on how they are interpreted, should we become subject to the CCPA or such state comprehensive privacy laws in the future. Similar laws are being considered in several other states, as well as at the federal and local levels, and we expect more states to pass similar laws in the future. These developments may further complicate compliance efforts and increase legal risk and compliance costs for us and the third parties with whom we work.

Our employees and personnel use generative artificial intelligence (“AI”) technologies to perform their work, and the disclosure and use of personal data in generative AI technologies is subject to various privacy laws and other privacy obligations. Governments have passed and are likely to pass additional laws regulating generative AI. Our use of this technology could result in additional compliance costs, regulatory investigations and actions, and lawsuits. If we are unable to use generative AI, it could make our business less efficient and result in competitive disadvantages.

In addition to data privacy and security laws, we are bound by other contractual obligations related to data privacy and security, and our efforts to comply with such obligations may not be successful. Regulators are increasingly scrutinizing these statements, and if these policies, materials, or statements are found to be deficient, lacking in transparency, deceptive, unfair, misleading, or misrepresentative of our practices, we may be subject to investigation, enforcement actions by regulators, or other adverse consequences.

Obligations related to data privacy and security (and consumers’ data privacy expectations) are quickly changing, becoming increasingly stringent, and creating uncertainty. Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions. We may at times fail (or be perceived to have failed) in our efforts to comply with our data privacy and security obligations. Moreover, despite our efforts, our personnel or third parties with whom we work may fail to comply with such obligations, which could negatively impact our business operations. If we are unable to properly protect the privacy and security of sensitive data in our possession, we could be found to have breached our contracts. Further, if we fail to comply with applicable privacy and security laws, including applicable HIPAA privacy and security standards, we could face significant consequences, including but not limited to: government enforcement actions (e.g., administrative, civil and criminal penalties, investigations, audits, inspections, and similar); litigation (including class-action claims); additional reporting requirements and/or oversight; bans on processing personal data (including clinical trial data); and orders to destroy or not use personal data. In addition, our ongoing efforts to comply with evolving privacy and data security laws and regulations have been and may in the future be costly and require ongoing modifications to our policies, procedures and systems.

Risks Related to Employee Matters, Managing Growth and Information Technology

Our future success depends on our ability to retain our Chief Executive Officer and other key executives and to attract, retain and motivate qualified personnel.

We are highly dependent on Jean-Paul Kress, our Chief Executive Officer, as well as the other principal members of our management and scientific teams. Dr. Kress and such other principal members are employed “at will,” meaning we or they may terminate the employment at any time. We do not maintain “key person” insurance for any of our executives or other employees. The loss of the services of any of these persons could impede the achievement of our research, development and commercialization objectives.

Recruiting and retaining qualified scientific and clinical personnel and, if we progress the development of our product candidates toward scaling up for commercialization, manufacturing and sales and marketing personnel will also be critical to our success. We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors, including our scientific founder, may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. The inability to recruit, or loss of services of certain executives, key employees, consultants or advisors, may impede the progress of our research, development and commercialization objectives and have a material adverse effect on our business, financial condition, results of operations and prospects.

We expect to expand our development, regulatory and future sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

In connection with the growth and advancement of our pipeline, we expect to increase the number of our employees and the scope of our operations, particularly in the areas of drug development, regulatory affairs, manufacturing and, as our product candidates advance through later stages of clinical development, sales and marketing. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expected expansion of our operations or recruit and train additional qualified personnel. Moreover, the expected physical expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

As a growing biotechnology company, we are actively pursuing new platforms and product candidates in many therapeutic areas and across a wide range of diseases. Successfully developing product candidates for and fully understanding the regulatory and manufacturing pathways to all of these therapeutic areas and disease states requires a significant depth of talent, resources and corporate processes in order to allow simultaneous execution across multiple areas. Due to our limited resources, we may not be able to effectively manage this simultaneous execution and the expansion of our operations or recruit and train additional qualified personnel. This may result in weaknesses in our infrastructure, give rise to operational mistakes, legal or regulatory compliance failures, loss of business opportunities, loss of employees and reduced productivity among remaining employees. The physical expansion of our operations may lead to significant costs and may divert financial resources from other projects, such as the development of our product candidates. If our management is unable to effectively manage our expected development and expansion, our expenses may increase more than expected, our ability to generate or increase our revenue could be reduced and we may not be able to implement our business strategy. Our future financial performance and our ability to compete effectively and commercialize our product candidates, if approved, will depend in part on our ability to effectively manage the future development and expansion of our company.

Our insurance policies may be inadequate and potentially expose us to unrecoverable risks.

We have limited director and officer insurance and commercial insurance policies. Any significant insurance claims would have a material adverse effect on our business, financial condition and results of operations. Insurance availability, coverage terms and pricing continue to vary with market conditions. We endeavor to obtain appropriate insurance coverage for insurable risks that we identify; however, we may fail to correctly anticipate or quantify insurable risks, we may not be able to obtain appropriate insurance coverage, and insurers may not respond as we intend to cover insurable events that may occur. We have observed rapidly changing conditions in the insurance markets relating to nearly all areas of traditional corporate insurance. Such conditions have resulted in higher premium costs, higher policy deductibles and lower coverage limits.

For some risks, we may not have or maintain insurance coverage because of cost or availability.

If our information technology systems, or those of our third-party vendors, collaborators, or other contractors or consultants or other third parties with whom we work, or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to a material disruption of our product development programs, regulatory investigations or actions, litigation, fines and penalties, reputational harm and other adverse consequences.

In the ordinary course of our business, we and the third parties with whom we work process sensitive data, and, as a result, we and such third parties face a variety of evolving threats that could cause security incidents. Our information technology systems and those of our current and any future third-party vendors, collaborators, consultants or other third parties with whom we work are subject to damage or interruption from a variety of evolving threats, including but not limited to social-engineering attacks (including through deep fakes, which are increasingly more difficult to identify as fake, and phishing attacks), computer viruses, computer hackers, malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), employee theft or misuse, denial-of-service attacks, credential stuffing, credential harvesting, ransomware attacks, adware, attacks enhanced or facilitated by AI, sophisticated nation-state and nation-state-supported actors, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. In particular, severe ransomware attacks are becoming increasingly prevalent and can lead to significant interruptions in our operations, ability to provide our products or services, loss of sensitive data and income, reputational harm, and diversion of funds. Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments.

Remote work has increased risks to our information technology systems and data, as more of our employees utilize network connections, computers, and devices outside our premises or network, including working at home, while in transit and in public locations. Additionally, future or past business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies. Furthermore, we may discover security issues that were not found during due diligence of such acquired or integrated entities, and it may be difficult to integrate companies into our information technology environment and security program.

While we seek to protect our information technology systems from system failure, accident and security breach, if such an event were to occur and cause interruptions in our operations, it could result in a disruption of our development programs and our business operations, whether due to a loss of our trade secrets or other sensitive data or other disruptions. For example, the loss of clinical trial data from completed, ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. If we were to experience a significant cybersecurity breach of our information systems or sensitive data, the costs associated with the investigation, remediation and potential notification of the breach to counterparties and data subjects could be material. In addition, our remediation efforts may not be successful. If we are unable to build and sustain the proper technology and cybersecurity infrastructure, we could suffer significant business disruption, including transaction errors, supply chain or manufacturing interruptions, processing inefficiencies, or the loss of or damage to sensitive data.

Although we have implemented security measures designed to help protect sensitive data from unauthorized access or disclosure, our information technology and infrastructure may be vulnerable in the future to attacks by hackers or viruses, failures, or breaches due to third-party action, employee negligence or error, malfeasance, or other incidents or disruptions. For example, we have been the target of phishing attacks in the past and we expect such attacks will continue in the future. Furthermore, while we have implemented data privacy and security measures that are designed to comply with applicable laws and regulations relating to privacy and data protection, some health-related and other personal information or confidential information may be transmitted to us or processed by third parties, who may not implement adequate security and privacy measures, and it is possible that laws, rules and regulations relating to privacy, data protection, or information security may be interpreted and applied in a manner that is inconsistent with our practices or those of third parties who transmit health-related and other personal information or confidential information to us or process such information on our behalf. While we may be entitled to damages if our third-party service providers fail to satisfy their privacy or security-related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such award.

We take steps designed to detect, mitigate, and remediate vulnerabilities in our information systems (such as our hardware and/or software, including that of third parties with whom we work). We may not, however, detect and remediate all such vulnerabilities including on a timely basis. Further, we may experience delays in deploying remedial measures and patches designed to address identified vulnerabilities. Vulnerabilities could be exploited and result in a security incident. We have in the past and may in the future expend significant resources or modify our business activities to try to protect against security incidents.

Additionally, certain data privacy and security obligations may require us to implement and maintain specific security measures or industry-standard or reasonable security measures to protect our information technology systems and sensitive data.

To the extent that we or third parties with whom we work are found to have violated data security laws, rules or regulations or if we (or a third party with whom we work) experience a security incident or are perceived to have experienced a security incident, including an incident that results in a loss of, or damage to, our or our third-party vendors’, collaborators’, consultants’ or other third parties with whom we work data or systems, or inappropriate disclosure of confidential or proprietary information, we could experience material adverse consequences including but not limited to litigation exposure, penalties and fines, regulatory actions or investigations, restrictions on processing sensitive data (including clinical trial data), reputational harm; monetary fund diversions, diversion of management attention, our competitive position could be harmed and the further development and commercialization of our product candidates could be delayed. Any of the above could have a material adverse effect on our business, financial condition, results of operations or prospects.

Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations. We cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or to mitigate liabilities arising out of our privacy and security practices, that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.

In addition to experiencing a security incident, third parties may gather, collect, or infer sensitive data about us from public sources, data brokers, or other means that reveals competitively sensitive details about our organization and could be used to undermine our competitive advantage or market position.

Risks Related to the Ownership of Our Common Stock

An active trading market for our common stock may not be sustained.

Our shares of common stock began trading on the Nasdaq Global Select Market on February 5, 2021. Given the limited trading history of our common stock, there is a risk that an active trading market for our shares will not be sustained, which could put downward pressure on the market price of our common stock and thereby affect the ability of our stockholders to sell their shares.

The market price of our common stock may be volatile.

Our stock price is, and is likely to continue to be, volatile. For example, our stock traded within a range of a high price of $63.62 and a low price of $0.13 per share for the period of February 5, 2021, our first day of trading on the Nasdaq Global Select Market, through August 6, 2025. As a result of volatility, our stockholders may not be able to sell their common stock at or above the prices at which they purchased their shares. Some of the factors that may cause the market price of our common stock to fluctuate include:

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the success of existing or new competitive product candidates or technologies;

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the timing and results of preclinical studies and clinical trials for our product candidates;

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announcements by RemeGen of clinical trial results for telitacicept in RemeGen’s development programs in Greater China;

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failure or discontinuation of any of our product development and research programs;

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results of preclinical studies, clinical trials or regulatory approvals of product candidates of our competitors, or announcements about new research programs or product candidates of our competitors;

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commencement or termination of collaborations for our product development and research programs;

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regulatory or legal developments in the United States and other countries;

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developments or disputes concerning patent applications, issued patents or other proprietary rights;

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the recruitment or departure of key personnel;

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the level of expenses related to any of our research programs, product candidates or clinical development programs;

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the results of our efforts to develop additional product candidates or products;

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actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; announcement or expectation of additional financing efforts;

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sales of our common stock by us, our insiders or other stockholders;

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variations in our financial results or those of companies that are perceived to be similar to us;

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changes in estimates or recommendations by securities analysts, if any, that cover our stock;

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changes in the structure of healthcare payment systems;

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market conditions in the pharmaceutical and biotechnology sectors;

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global or regional public health emergencies, and political instability, including terrorist attacks, civil unrest and actual or threatened armed conflict, such as the Russia-Ukraine and Israel-Hamas wars;

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general economic, industry and market conditions, including heightened interest rates and inflation; and

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the other factors described in this “Risk Factors” section.

In recent years, the stock market in general, and the market for pharmaceutical and biotechnology companies in particular, has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to changes in the operating performance of the companies whose stock is experiencing those price and volume fluctuations. Broad market and industry factors may seriously affect the market price of our common stock, regardless of our actual operating performance. Following periods of such volatility in the market price of a company’s securities, securities class action litigation has often been brought against that company. Because of the potential volatility of our stock price, we may become the target of securities litigation in the future, which could result in substantial costs and divert management’s attention and resources from our business.

If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline.

The trading market for our common stock will be influenced by the research and reports that industry or financial analysts publish about us or our business. If one or more of the analysts covering our business downgrade their evaluations of our stock, the price of our stock could decline. If one or more of these analysts cease to cover our stock, we could lose visibility in the market for our stock, which in turn could cause our stock price to decline.

A significant portion of our total outstanding shares may be sold into the market in the near future, which could cause the market price of our common stock to decline significantly, even if our business is doing well.

Sales of a substantial number of shares of our common stock in the public market could occur at any time. These sales, or the perception in the market that the holders of a large number of shares of common stock intend to sell shares, could reduce the market price of our common stock. Our outstanding shares of common stock may be freely sold in the public market at any time to the extent permitted by Rules 144 and 701 under the Securities Act of 1933, as amended (the “Securities Act”), or to the extent such shares have already been registered under the Securities Act and are held by non-affiliates.

Moreover, holders of a substantial number of shares of our common stock have rights, subject to conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. For example, in December 2022 we filed a registration statement on Form S-3 to register the resale of up to 11,627,907 shares of common stock held by RA Capital Healthcare Fund L.P. which were purchased from us in a private placement, and in January 2025 we filed a registration statement on Form S-3 to register the resale of up to an aggregate of 125,710,335 shares of common stock held by Reprogrammed Interchange LLC and entities affiliated with RA Capital Management, L.P., consisting of (i) 55,871,260 shares of common stock and (ii) 69,839,075 shares of common stock issuable upon the exercise of outstanding warrants to purchase shares of common stock, which were purchased from us in a private placement. In addition, after our special meeting of stockholders that we expect to hold in the third quarter of 2025, assuming our stockholders approve certain of the proposals at the meeting, we will be required to file a registration statement on Form S-3 to register the resale of up to 700,000,000 shares of common stock issuable upon exercise of outstanding warrants, which were purchased from us by certain institutional investors in a private placement, and 320,000,000 shares of common stock that are issuable upon exercise of a warrant to purchase common stock issued to RemeGen as partial consideration for our license agreement with RemeGen.

We have also registered or will register all shares of common stock that we may issue under our equity compensation plans or that are issuable upon exercise of outstanding options on a registration statement on Form S-8 and will continue to register any additional shares that become available under such plans due to any annual, automatic increases under the terms of those plans. These shares can be freely sold in the public market upon issuance and once vested, subject to volume limitations applicable to affiliates. If any of these additional shares are sold, or if it is perceived that they will be sold, in the public market, the market price of our common stock could decline.

Insiders have substantial control over our company, which could limit the ability of our other stockholders to affect the outcome of key transactions, including a change of control.

Our executive officers and directors, combined with our stockholders who own more than 5% of our outstanding common stock, and their affiliates, in the aggregate, beneficially own shares representing a substantial amount of our outstanding common stock. In particular, our two largest stockholders, RA Capital Management, L.P. and Reprogrammed Interchange LLC, together with their affiliates, collectively hold approximately 63.0% of our outstanding common stock, as well as warrants to purchase shares of our common stock warrants, which, if exercised, would result in such stockholders owning an even larger percentage of our outstanding common stock. As a result, these stockholders, if they act together, may be able to influence our management and affairs and would control all matters requiring stockholder approval, including the election of directors and approval of significant corporate transactions, such as a merger or other sale of our company or its assets. This concentration of ownership may have the effect of delaying or preventing a change in control of our company or discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control, even if that change in control would benefit our other stockholders. This significant concentration of ownership may also adversely affect the trading price for our common stock because investors often perceive disadvantages in owning stock in companies with controlling stockholders.

If we fail to establish and maintain proper and effective internal control over financial reporting, our operating results and our ability to operate our business could be harmed.

Ensuring that we have adequate internal financial and accounting controls and procedures in place so that we can produce accurate financial statements on a timely basis is a costly and time-consuming effort that needs to be re-evaluated frequently. Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with generally accepted accounting principles.

Implementing any appropriate changes to our internal controls may distract our officers and employees, entail substantial costs to modify our existing processes and take significant time to complete. These changes may not, however, be effective in maintaining the adequacy of our internal controls, and any failure to maintain that adequacy, or consequent inability to produce accurate financial statements on a timely basis, could increase our operating costs and harm our business. In addition, investors’ perceptions that our internal controls are inadequate or that we are unable to produce accurate financial statements on a timely basis may harm our common share price.

We are an “emerging growth company” and a “smaller reporting company,” and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). We will be an emerging growth company during this year and may remain an emerging growth company until 2026. For so long as we remain an emerging growth company, we are permitted and plan to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (“SOX”), not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, reduced disclosure obligations regarding executive compensation, exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved, and being permitted to provide only two years of audited financial statements. As a result, the information we provide stockholders will be different than the information that is available with respect to other public companies. For example, we did not include all of the executive compensation related information in this Annual Report that would be required if we were not an emerging growth company. We cannot predict whether investors will find our common stock less attractive if we rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock, and our stock price may be more volatile.

In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have availed ourselves of this extended transition period and we cannot predict whether investors will find our common stock less attractive due to this election.

We are also a “smaller reporting company” and we may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

We will continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.

As a public company, and particularly after we are no longer an “emerging growth company,” we will continue to incur significant legal, accounting and other expenses that we did not incur as a private company. The Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the Nasdaq Global Select Market and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. We expect that we will need to continue to hire additional accounting, finance and other personnel in connection with our efforts to comply with the requirements of being, a public company, and our management and other personnel will need to continue to devote a substantial amount of time towards maintaining compliance with these requirements. These requirements have increased and will continue to increase our legal and financial compliance costs and make some activities more time-consuming and costly. These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

Pursuant to SOX Section 404, we are required to furnish a report by our management on our internal control over financial reporting, but while we remain an emerging growth or a smaller reporting company with less than $100 million in annual revenue, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To maintain compliance with SOX Section 404 and achieve compliance within the prescribed period for the attestation report by our independent registered public accounting firm, we have and will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants, adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe or at all, that our internal control over financial reporting is effective as required by SOX Section 404. If we identify one or more material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

Our management team has broad discretion in the use of our cash reserves and may not use them effectively.

Our management has broad discretion to use our cash reserves and could use our cash reserves in ways that do not improve our results of operations or enhance the value of our common stock. The failure by our management to apply these funds effectively could harm our business, financial condition, results of operations and prospects. Pending their use, we may invest our cash reserves in a manner that does not produce income or that loses value.

We do not expect to pay any dividends for the foreseeable future. Accordingly our stockholders must rely on capital appreciation, if any, for any return on their investment.

We have never declared or paid any cash dividends on our equity securities. We do not anticipate that we will pay any dividends to holders of our common stock in the foreseeable future. Instead, we plan to retain any earnings to maintain and expand our existing operations. In addition, any future credit facility that we enter into may contain terms prohibiting or limiting the amount of dividends that may be declared or paid on our common stock. As a result, capital appreciation, if any, of our common stock will be stockholders’ sole source of gain for the foreseeable future.

Unfavorable global economic conditions, new tariffs or bank closures could adversely affect our business, financial condition or results of operations.

Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets, including as a result of heightened inflation and interest rates. A severe or prolonged economic downturn, or additional global financial crises, including related to potential future pandemics or the Russia-Ukraine and Israel-Hamas armed conflicts, could result in a variety of risks to our business, including weakened demand for our product candidates, if approved, or our ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy could also strain our suppliers, possibly resulting in supply disruption. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.

Significant political, trade, or regulatory developments in the jurisdictions in which we sell our products, such as those stemming from the change in U.S. federal administration, are difficult to predict and may have a material adverse effect on us. Similarly, changes in U.S. federal policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business operations. We could also be affected by new and increased tariffs between the United States and other countries. These additional tariffs and any retaliatory tariffs by other countries, could substantially increase our costs associated with the manufacture and supply of our product candidates. The global trade environment is rapidly evolving, and the United States and other countries may impose additional new tariffs, the scope of which we are unable to predict but that may adversely impact our business. If our or the activities of our third party suppliers or service providers fall within the scope of any of these or other tariffs, our costs may increase significantly. Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets. Any changes in political, trade, regulatory, and economic conditions, including U.S. trade policies, could have a material adverse effect on our financial condition or results of operations.

In addition, our available cash and cash equivalents are held in accounts managed by third party financial institutions and consist of cash in our operating accounts and cash invested in money market funds. At any point in time, the funds in our operating accounts may exceed the Federal Deposit Insurance Corporation insurance limits. While we monitor the cash balances in our operating accounts and adjust the cash balances as appropriate, these cash balances could be impacted if the underlying financial institutions fail. We can provide no assurances that access to our operating cash or invested cash and cash equivalents will not be impacted by adverse conditions in the financial markets.

Provisions in our certificate of incorporation and bylaws and under Delaware law could make a change in control of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.

Provisions in our amended and restated certificate of incorporation and our amended and restated bylaws may discourage, delay or prevent a merger, acquisition or other change in control of us that stockholders may consider favorable, including transactions in which our stockholders might otherwise receive a premium for their shares. These provisions also could limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. In addition, because our board of directors is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Among other things, these provisions:

•

establish a classified board of directors such that not all members of the board are elected at one time;

•

allow the authorized number of our directors to be changed only by resolution of our board of directors;

•

limit the manner in which stockholders can remove directors from the board;

•

establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and nominations to our board of directors;

•

require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent;

•

limit who may call stockholder meetings;

•

authorize our board of directors to issue preferred stock without stockholder approval, which could be used to institute a stockholder rights plan, or so-called “poison pill,” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors; and require the approval of the holders of at least 662⁄3% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws.

•

Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law (the “DGCL”), which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner. We have not elected to opt out of DGCL Section 203. These provisions could discourage potential acquisition proposals and could delay or prevent a change in control transaction. They could also have the effect of discouraging others from making tender offers for our common stock, including transactions that may be in our stockholders’ best interests. These provisions may also prevent changes in our management or limit the price that investors are willing to pay for our common stock.

Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law:

•

any derivative action or proceeding brought on our behalf;

•

any action asserting a breach of fiduciary duty;

•

any action asserting a claim against us arising under the DGCL, our amended and restated certificate of incorporation or our amended and restated bylaws; and

•

any action asserting a claim against us that is governed by the internal-affairs doctrine.

This provision would not apply to suits brought to enforce a duty or liability created by the Securities Exchange Act of 1934, as amended. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims. To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, our amended and restated certificate of incorporation further provides that the federal district courts of the United States will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions. In such instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of our amended and restated certificate of incorporation. This may require significant additional costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.

These exclusive forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage lawsuits against us and our directors, officers and other employees. If a court were to find either exclusive-forum provision in our amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving the dispute in other jurisdictions, which could seriously harm our business.

Item 5. Other Information

Director and Officer Trading Arrangements

During the quarter ended June 30, 2025, no director or officer, as defined in Rule 16a-1(f), adopted or terminated a "Rule 10b5-1 trading arrangement" or a "non-Rule 10b5-1 trading arrangement," each as defined in Regulation S-K Item 408, except as follows:

•

On April 24, 2025, Eyal C. Attar, M.D., the Company’s former Chief Medical Officer, terminated a Rule 10b5-1 trading arrangement intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act for the sale of 9,478 shares of common stock between June 3, 2024 and June 30, 2025 (the “Sales Period”) plus up to 36,562 additional shares of common stock that may be acquired by Dr. Attar in connection with the settlement of restricted stock units during the Sales Period, net of shares withheld to satisfy tax withholding obligations, so long as the market price of the Company’s common stock is higher than certain minimum thresholds specified in the trading plan.

Lease Agreement

On August 12, 2025, we entered into a lease agreement (the “Lease Agreement”) with 500 Boylston & 222 Berkeley Owner (DE) LLC with respect to 8,391 square feet of office space located at 500 Boylston Street, Boston, MA 02116 (the “Premises”) for our principal executive offices. The commencement date of the lease is the earlier of when we enter into possession of the Premises or September 1, 2025 (the “Term Commencement Date”), and the lease will expire 72 full calendar months after the Term Commencement Date (the “Initial Term”), unless terminated earlier in accordance with the Lease Agreement.

The annual base rent under the Lease Agreement initially will be $440,000 for the first year of the Initial Term, $530,400 for the second year, $698,400 for the third year, and then will increase by 2% per year for each year of the Initial Term thereafter. We will also be responsible for the payment of additional rent to cover our proportionate share of the annual operating and tax expenses for the Premises. In connection with entering into the Lease Agreement, we executed and delivered a letter of credit in the amount of $167,820 to secure our obligations under the Lease Agreement.

We have the option to extend the term for one additional five-year period, which is exercisable by written notice delivered not less than 12 months and not more than 15 months prior to the expiration of the Initial Term and subject to customary conditions, including that no default under the Lease Agreement exists.

The foregoing description of the Lease Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Lease Agreement, a copy of which is filed as Exhibit 10.10 to this Quarterly Report on 10-Q.

Item 6. Exhibits.

      
     Incorporated by Reference

     Exhibit
Number

     Description

     Form

     File No.

     Exhibit Number

     Filing Date

     Filed Herewith

     3.1

     Amended and Restated Certificate of Incorporation of the Registrant

     8-K

     001-39979

     3.1

     February 9, 2021

     3.2

     Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Registrant

     8-K

     001-39979 

     3.1

     May 23, 2025

     3.3

     Amended and Restated Bylaws of the Registrant

     8-K

     001-39979

     3.2

     February 9, 2021

     4.1

     Form of Common Stock Certificate of the Registrant

     S-1/A

     333-252175

     4.1

     February 1, 2021

     4.2

     Amended and Restated Investors’ Rights Agreement, by and among the Registrant and certain of its stockholders, dated June  30, 2020

     S-1/A

     333-252175

     4.2

     February 1, 2021

     4.3

     Form of Pre-Funded Warrant to Purchase Common Stock

     8-K
 
     001-39979

     10.1

     June 25, 2025

     10.1*

     Form of Securities Purchase Agreement, dated June 25, 2025, by and between the Registrant and Yantai Rongpu Investment Partnership (Limited Partnership)

     8-K

     001-39979

     10.2

     June 25, 2025

     10.2

     Form of Securities Purchase Agreement, dated June 25, 2025, by and between the Registrant and the investors named therein

     8-K

     001-39979

     10.3

     June 25, 2025

     10.3

     Form of Registration Rights Agreement, dated June 25, 2025, by and between the Registrant and the investors named therein

     8-K

     001-39979

     10.4

     June 25, 2025

     10.4

     Form of Support Agreement, dated June 25, 2025, by and between the Registrant and the stockholders named therein

     8-K

     001-39979

     10.5

     June 25, 2025

     10.5+

     Transition Agreement, dated as of June 25, 2025, by and between the Registrant and Robert Ang

     8-K

     001-39979

     10.6

     June 25, 2025

     10.6+

     Employment Agreement, dated as of June 25, 2025, by and between the Registrant and Jean-Paul Kress

     8-K

     001-39979

     10.7

     June 25, 2025

     10.7+

     Employment Agreement, dated as of July 9, 2025, by and between the Registrant and Sandesh Mahatme

     8-K

     001-39979

     10.1

     July 10, 2025

     10.8+

     Employment Agreement, dated as of July 17, 2025, by and between the Registrant and Qing Zuraw

     8-K

     001-39979

     10.1

     July 22, 2025

     10.9*

     License Agreement, dated as of June 25, 2025, by and between RemeGen Co, Ltd. and the Registrant

     X

     10.10^

     Lease Agreement, dated August 5, 2025, by and between the Company and 500 Boylston & 222 Berkeley Owner (DE) LLC

     X

     31.1

     Certification of Principal Executive and Financial Officer pursuant to Rules 13a-14(a)/15d-14(a) under the Securities Exchange Act of 1934, as amended, as 

     X

      
     adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

     32.1†

     Certification of Principal Executive and Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

     X

     101.INS

     Inline XBRL Instance Document
 
     X

     101.SCH

     Inline XBRL Taxonomy Extension Schema Document
 
     X

     101.CAL

     Inline XBRL Taxonomy Extension Calculation Linkbase Document
 
     X

     101.DEF
 
     Inline XBRL Taxonomy Extension Definition Linkbase Document
 
     X

     101.LAB
 
     Inline XBRL Taxonomy Extension Label Linkbase Document
 
     X

     101.PRE

     Inline XBRL Taxonomy Extension Presentation Linkbase Document
 
     X

     104

     The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, formatted in Inline XBRL.

+ Indicates management contract or compensatory plan.

* Portions of the exhibit have been omitted as the Registrant has determined that: (i) the omitted information is not material; and (ii) the omitted information is the type that the Registrant treats as private or confidential.

^ Schedules and similar attachments have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Registrant will furnish a supplemental copy of any omitted schedule or similar attachment to the SEC upon request.

† The certifications furnished in Exhibit 32.1 hereto are deemed to be furnished with this Quarterly Report on Form 10-Q and will not be deemed to be “filed” for purposes of Section 18 of the Exchange Act. Such certifications will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent that the Registrant specifically incorporates it by reference.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


	VOR BIOPHARMA INC.

Date: August 12, 2025	By:	/s/ Jean-Paul Kress
		Jean-Paul Kress President and Chief Executive Officer (Principal Executive Officer)



Date: August 12, 2025	By:	/s/ Sandy Mahatme
		Sandy Mahatme Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

EX-10.9 2 vor-ex10_9.htm EX-10.9 EX-10.9

Portions of this agreement (indicated by “[***]”) have been omitted as the Registrant has determined that: (i) the omitted information is not material; and (ii) the omitted information is the type that the Registrant treats as private or confidential.

      
Exhibit 10.9

     LICENSE AGREEMENT
By and Between
RemeGen Co, Ltd.
and
Vor Biopharma Inc.
Dated as of June 25, 2025

    


TABLE OF CONTENTS
	Page


ARTICLE 1 DEFINITIONS	1
1.1 Definitions	1
ARTICLE 2 GRANT OF RIGHTS	17
2.1 License Grants to the Company	17
2.2 License Grants to the Licensor	17
2.3 Sublicenses	18
2.4 IP Acquired by Licensor after Effective Date	18
2.5 IP Acquired by Company after Effective Date	19
2.6 Retention of Rights	19
2.7 Transfer of Licensed Know-How.	19
2.8 Registration of Patent License	20
ARTICLE 3 DEVELOPMENT, REGULATORY, MEDICAL AFFAIRS AND MANUFACTURING ACTIVITIES	20
3.1 Development.	20
3.2 Regulatory Matters.	23
3.3 Data Exchange	26
3.4 Development and Regulatory Costs	26
3.5 Medical Affairs	26
3.6 Manufacturing	27
ARTICLE 4 COMMERCIALIZATION	28
4.1 In General	28
4.2 Commercialization Diligence	28
4.3 Booking of Sales; Distribution	28
4.4 No Unauthorized Sales	28
4.5 Trademarks	28
ARTICLE 5 GOVERNANCE	29
5.1 Alliance Managers	29
5.2 Joint Steering Committee.	29
5.3 Subcommittees.	30


	- i -


5.4 Decision Making	31
5.5 Cooperation	32
ARTICLE 6 FINANCIAL TERMS	32
6.1 Equity Issuance	32
6.2 Upfront Fee	32
6.3 Milestones.	32
6.4 Royalties.	34
6.5 Royalty Reduction.	35
6.6 Royalty Payments and Reports	35
6.7 Triggering Transaction Consideration	36
6.8 Mode of Payment	36
6.9 Disputes regarding Milestone Events and Payments	36
6.10 Taxes.	36
6.11 Interest on Late Payments	37
6.12 Financial Records	37
6.13 Audit.	37
ARTICLE 7 INTELLECTUAL PROPERTY	38
7.1 Ownership of Intellectual Property.	38
7.2 Prosecution.	39
7.3 Enforcement.	40
7.4 Patent Listing	41
7.5 Infringement of Third Party IP.	41
ARTICLE 8 CONFIDENTIALITY; PRESS RELEASE	42
8.1 Confidentiality Obligations	42
8.2 Exceptions	42
8.3 Permitted Disclosures	43
8.4 Use of Name	44
8.5 Public Announcements	44
8.6 Return of Confidential Information	44
8.7 Publications	45
ARTICLE 9 REPRESENTATIONS AND WARRANTIES	45
9.1 Mutual Representations and Warranties	45


	- ii -


9.2 Additional Representations and Warranties of Licensor	46
9.3 Compliance with Law	47
9.4 Mutual Covenants	48
9.5 DISCLAIMER OF WARRANTIES	48
9.6 Anti-Bribery and Anti-Corruption Compliance	48
ARTICLE 10 INDEMNITY	49
10.1 Indemnification of the Company	49
10.2 Indemnification of Licensor	50
10.3 Indemnification Procedures.	50
10.4 Special, Indirect and Other Losses	52
10.5 Insurance	52
ARTICLE 11 TERM AND TERMINATION	52
11.1 Term and Expiration	52
11.2 Termination.	52
11.3 Rights in Bankruptcy	54
11.4 Consequences of Termination	54
11.5 Remedies	55
11.6 Accrued Rights; Surviving Obligations	55
ARTICLE 12 MISCELLANEOUS	56
12.1 Force Majeure	56
12.2 Export Control	56
12.3 Assignment	56
12.4 Performance by Affiliates	57
12.5 Severability	57
12.6 Governing Law	58
12.7 Dispute Resolution.	58
12.8 Notices	59
12.9 Entire Agreement; Amendments	60
12.10 English Language	60
12.11 Equitable Relief	60
12.12 Waiver and Non-Exclusion of Remedies	60
12.13 Further Assurance	61


	- iii -


12.14 No Benefit to Third Parties	61
12.15 Relationship of the Parties	61
12.16 References	61
12.17 Construction	61
12.18 Counterparts	62

SCHEDULES AND EXHIBITS

Schedule 8.5 Press Release

Schedule 9.2 Disclosure Schedule

Schedule 9.2(c) Existing Patents

Exhibit A [***]


	- iv -

THIS LICENSE AGREEMENT (the “Agreement”) is made and entered into effective as of June 25, 2025 (the “Effective Date”) by and between RemeGen Co., Ltd., a joint stock limited company organized under the laws of the People’s Republic of China whose principal place of business is at 58 Middle Beijing Road, Yantai Pilot Free Trade Zone, Yantai, Shandong Province, China 264006 (the “Licensor”) and Vor Biopharma Inc., a Delaware corporation whose principal place of business is at 100 Cambridgepark Drive, Suite 101, Cambridge, Massachusetts 02140 (the “Company”). The Company and Licensor are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

RECITALS

WHEREAS, Licensor, a biopharmaceutical company, owns or controls certain intellectual property rights with respect to a first-in-class recombinant B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL) dual-target novel fusion protein product known as telitacicept; and

WHEREAS, the Company wishes to obtain from Licensor, and Licensor is willing to grant to the Company, certain rights to develop and commercialize the Licensed Compound (as defined herein) and the Licensed Products (as defined herein) in the Field in the Licensed Territory.

NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:

ARTICLE 1 DEFINITIONS

1.1 Definitions. Unless otherwise specifically provided herein, the following initially capitalized terms, whether used in the singular or plural, shall have the following meanings:

“Accounting Standards” means (a) International Financial Reporting Standards (IFRS) or (b) U.S. generally accepted accounting principles (GAAP), in each case ((a) or (b)), consistently applied throughout an entity’s organization.

“Acquisition” means, with respect to a Party, a merger, consolidation, acquisition (whether of all of the stock or all or substantially all of the assets of a Person or any operating or business division of a Person) or similar transaction by or with such Party.

“Additional Assistance” has the meaning set forth in Section 2.7(c).

“Additional Cure Period” has the meaning set forth in Section 11.2(a)(iii).

“Affiliate” means, with respect to a Party, any Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party but only so long as such control exists. For purposes of this definition, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” means: (a) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance or otherwise; or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity).

“Agreement” has the meaning set forth in the preamble hereto.

“Alliance Manager” has the meaning set forth in Section 5.1.

“Ancillary Agreement” means any Pharmacovigilance Agreement, Clinical Supply Agreement, Commercial Supply Agreement, Clinical Trial Collaboration Agreement, Master Services Agreement, Data Processing Agreement and any other agreement entered into by the Parties with respect to the activities contemplated by this Agreement.

“Anti-Corruption Laws” means the PRC Criminal Law and the PRC Anti-unfair Competition Law, the U.S. Foreign Corrupt Practices Act, as amended, and any other applicable anti-corruption laws and laws for the prevention of fraud, racketeering, money laundering or terrorism.

“Applicable Law” means applicable laws, rules and regulations, including any rules, regulations, guidelines or other requirements of the Regulatory Authorities, that may be in effect from time to time, which shall be deemed to include the applicable regulations and guidance of the NMPA or the FDA that constitute good laboratory practices, good manufacturing practices and good clinical practices (and, if and as appropriate under the circumstances, International Conference on Harmonization (ICH) guidance or other comparable regulation and guidance of any applicable Regulatory Authority).

“Applicable Territory” means (a) with respect to Company, the Licensed Territory, and (b) with respect to Licensor, the Retained Territory.

“APRIL” means (a) A proliferation-inducing ligand (alternatively known as tumor necrosis factor ligand superfamily member 13) (OMIM ID: No. 604472); and (b) any naturally occurring variants thereof, in each case including any isoforms, polymorphisms, alternative splice variants, truncated forms, soluble forms and secreted forms and in each case to the extent such variant, isoform, polymorphism, alternative splice variant, truncated form, soluble form and secreted form are encoded by an allele of the same TNFSF13 gene.

“Arbitration Rules” has the meaning set forth in Section 12.7(a).

“Asian Market” means any country or jurisdiction in the Asia-Pacific region but outside of the Retained Territory.

“Assign” has the meaning set forth in Section 12.3.

“Biosimilar Product” means, with respect to a particular Licensed Product in a particular country, a biological product (a) sold in such country by a Third Party that is not a Sublicensee, subcontractor or Distributor of Company, and did not purchase or acquire such product in a chain of distribution that included any of Company or its Affiliates or Sublicensees, (b) the licensing, approval or marketing authorization for which relies in whole or in part on a prior Marketing Approval granted to such Licensed Product, and (c) that (i) is “biosimilar” to such Licensed Product, as the term “biosimilar” is defined in 42 U.S.C.

§ 262(i)(2) or successor law, or other analogous Applicable Law outside of the United States, (ii) is determined by the applicable Regulatory Authority to be interchangeable with such Licensed Product, as set forth at 42 U.S.C. § 262(k)(4) or successor law, or other analogous Applicable Law outside of the United States; or (iii) would have been Covered by a claim of an issued Patent included in the Licensed Patents, but for the expiration of such Patent.

“BLA” means Biologics License Application as described in 21 C.F.R. § 601.2, or equivalent FDA application.

“BLyS” means (a) B Lymphocyte Stimulator (alternatively known as B-cell activating factor or tumor necrosis factor ligand superfamily member 13B) (OMIM ID: No. 603969); and (b) any naturally occurring variants thereof, in each case including any isoforms, polymorphisms, alternative splice variants, truncated forms, soluble forms and secreted forms and in each case to the extent such variant, isoform, polymorphism, alternative splice variant, truncated form, soluble form and secreted form are encoded by an allele of the same TNFSF13B gene.

“Breaching Party” has the meaning set forth in Section 11.2(a).

“Business Day” means a day other than a Saturday or Sunday or a day on which banking institutions in San Francisco, California or the PRC are permitted or required to be closed.

“Calendar Quarter” means each successive period of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31; provided, that, the first Calendar Quarter of the Term shall commence on the Effective Date and end on the last day of the calendar quarter in which the Effective Date falls and that the last Calendar Quarter of the Term shall end on the last day of the Term.

“Calendar Year” means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.

“cGMP” means all applicable current Good Manufacturing Practices including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and Eudralex 4, (c) the principles detailed in the ICH Q7 guidelines, and (d) the equivalent Applicable Laws in any relevant country or region, each as may be amended and applicable from time to time.

“Change of Control” means, with respect to Company: (a) any sale, exchange, transfer, or issuance to or acquisition by a Third Party (or Third Parties) of shares representing more than 50% of the aggregate ordinary voting power entitled to vote for the election of directors represented by the issued and outstanding stock of Company, whether such sale, exchange, transfer, issuance or acquisition is made directly or indirectly, beneficially or of record or in one transaction or a series of related transactions; or (b) a merger or consolidation under Applicable Law with a Third Party in which the shareholders of Company immediately prior to such merger or consolidation do not continue to hold immediately following the closing of such merger or consolidation at least 50% of the aggregate ordinary voting power entitled to vote for the election of directors represented by the issued and outstanding stock of the entity surviving or resulting from such consolidation; provided that for any transaction or series of related transactions, (x) neither Licensor nor any of its Affiliates is an equity holder of the Company at the time that is immediately prior to such transaction(s), or (y) as a result of and in connection with such transaction(s) Licensor or any of its Affiliates receives compensation in its capacity as an equity holder of Company.

“Clinical Supply Agreement” has the meaning set forth in Section 3.6(a).

“Clinical Quality Agreement” has the meaning set forth in Section 3.6(a).

“Clinical Trial” means any clinical trial of a product in human subjects as defined in 21 C.F.R. §312.21, as amended from time to time, or as prescribed by the Regulatory Authorities in any jurisdiction outside the U.S.

“Clinical Collaboration Agreement” has the meaning set forth in Section 3.1(f)(i).

“CMO” means any Third Party contract manufacturing organization.

“Code” has the meaning set forth in Section 11.3.

“Collaboration IP” means any invention, data, Know-How, process, method, composition of matter, article of manufacture, discovery or finding, whether or not patentable, that is conceived, reduced to practice, discovered, developed or otherwise made by or on behalf of a Party or jointly by or on behalf of the Parties in the course of the research, Development, Manufacture, and Commercialization of the Licensed Compound and Licensed Products in the Field during the Term under this Agreement, whether directly or through one or more of its Affiliates, agents or independent contractors, including all rights, title and interest in and to the Intellectual Property therein, but excluding any invention, data, Know-How, process, method, composition of matter, article of manufacture, discovery or finding, whether or not patentable, that is directed to any Other Product.

“Collaboration Know-How” means any Know-How within the Collaboration IP.

“Collaboration Patent” means any Patent within the Collaboration IP.

“Combination Product” means a Licensed Product sold in the form of a combination product containing both the Licensed Compound and one (1) or more other therapeutically active compounds or ingredients as a unit at a single price.

“Commercial Supply Agreement” has the meaning set forth in Section 3.6(c).

“Commercial Quality Agreement” has the meaning set forth in Section 3.6(c).

“Commercialization” means any and all activities directed to the preparation for sale of, offering for sale of or sale of a Licensed Product, including activities related to pre-launch, launch, marketing, advertising, promoting, distributing, using, importing and otherwise commercializing such Licensed Product (including pre-launch activities to prepare a market for potential sales, modeling and pharmaco-economic studies, epidemiological studies, government affairs, and public policy activities, patient services, patient advocacy engagement, and activities related to pricing and reimbursement), and interacting with Regulatory Authorities regarding any of the foregoing, but excluding, in each case, any activities directed to Manufacturing, or Development and excluding Medical Affairs Activities. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization.

“Commercially Reasonable Efforts” means (a) where applied to carrying out specific tasks and obligations of a Party under this Agreement, expending (on its own and/or acting through any of its Affiliates, sublicensees or subcontractors) reasonable, diligent, good faith efforts and resources to accomplish such task or obligation as a similarly situated company would normally use to accomplish a similar task or obligation under similar circumstances; and (b) where applied to the Development and/or Commercialization of the Product under this Agreement, the use of reasonable, diligent, good faith efforts and resources, in an active and ongoing program, as normally used by a biopharmaceutical company for a product, which product is at a similar stage of development or life cycle and is of similar market potential, taking into account relevant factors including measures of patent coverage, relative safety and efficacy, approved labeling, product profile, the competitiveness of the marketplace, approved pricing, expected and actual profitability (but without taking into consideration any amounts paid or payable under this Agreement), the proprietary position of such product, the regulatory structure involved, and other relevant factors. “Commercially Reasonable Efforts” shall require that such Party (on its own and/or acting through any of its Affiliates, sublicensees or subcontractors), at a minimum: [***].

“Company” has the meaning set forth in the preamble.

“Company Controlled Patents” has the meaning set forth in Section 7.2(a).

“Company Future Acquired IP” has the meaning set forth in Section 2.5.

“Company Indemnitees” has the meaning set forth in Section 10.1.

“Company IP” means, subject to Section 2.5, all rights in Intellectual Property that are (i) Controlled by the Company or its Affiliates during the Term (other than through the licenses granted by Licensor under Section 2.1 of this Agreement); and (ii) necessary or reasonably useful for the Exploitation of the Licensed Compound or Licensed Products in the Retained Territory or the Manufacture of the Licensed Compound or Licensed Products.

“Compromise” has the meaning set forth in Section 10.3(d).

“Confidential Information” means any technical, business or other non-public or proprietary information provided by or on behalf of one Party to the other Party or its Affiliates in connection with this Agreement, whether prior to, on or after the Effective Date, including the terms of this Agreement, information relating to the Licensed Compound or any Licensed Product (including the Dossiers and royalty reports), any Development or Commercialization of the Licensed Compound or any Licensed Product, any Know-How with respect thereto developed by or on behalf of the Disclosing Party or its Affiliates or, in the case of the Company, its or their Sublicensees, or the scientific, regulatory or business affairs or other activities of either Party.

“Control” or “Controlled” means, with respect to any Intellectual Property right or Regulatory Materials, possession of the right, whether directly or indirectly and whether by ownership, license or otherwise (other than by operation of the license and other grants under this Agreement), to grant a license, sublicense or other right to or under (or to access or use) such Intellectual Property right or Regulatory Material as provided for herein (including the Right of Reference to the Dossier) without violating the terms of any agreement with any Third Party. Notwithstanding the foregoing, a Party and its Affiliates will not be deemed to “Control” any Intellectual Property right or Regulatory Materials that is owned or in-licensed by a Third Party that becomes an Affiliate of such Party (the “Acquired Party”) after the Effective Date as a result of the Acquisition of the Acquired Party by such Third Party or an Affiliate of such Third Party unless (a) prior to the consummation of such Acquisition, the Acquired Party or any of its then-existing Affiliates also Controlled such Intellectual Property right or Regulatory Material, or (b) the Intellectual Property right or Regulatory Material owned or in-licensed by the applicable Third Party were not used in the performance of activities under this Agreement prior to the consummation of such Acquisition, but after the consummation of such Acquisition, the Acquired Party or any of its Affiliates uses any such Intellectual Property right or Regulatory Material in the performance of its obligations or exercise of its rights under this Agreement, in each of which cases ((a) and (b)), such Intellectual Property right or Regulatory Material (including the Right of Reference to the Dossier) will be “Controlled” by such Party for purposes of this Agreement.

“Cover”, “Covers”, or “Covered” means, with respect to a Licensed Product or other subject matter at issue and a relevant Patent, that Exploitation or Manufacture of such Licensed Product or other subject matter by such Person would, absent a license thereto, infringe such Patent (or, in the case of a claim of a patent application that has not yet issued, would infringe such claim if it were to issue without change).

“Data Processing Agreement” has the meaning set forth in Section 3.3.

“Data Protection Laws” means any Applicable Law that relates to the protection of individuals with regards to the Processing of Personal Data to which a Party is subject.

“Development” means all activities related to research, development, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, profiling, characterization, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, CMC activities, clinical studies, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of Marketing Approval applications and other regulatory submissions, data or information to Regulatory Authorities and all interactions with Regulatory Authorities in connection therewith, regulatory affairs, and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining, supporting, expanding, or maintaining a Marketing Approval for a Licensed Product together with all activities related to pharmacokinetic profiling, design, and conduct of clinical trials of such product, pharmacovigilance activities, adverse event reporting, statistical analysis, report writing, investigator initiated research, including in each case the services of outside advisors and consultants in connection therewith.

When used as a verb, “Develop” means to engage in Development.

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“Development Plan” has the meaning set forth in Section 3.1(c)(ii).

“Disclosing Party” has the meaning set forth in Section 8.1.

“Dispute” has the meaning set forth in Section 12.7(a).

“Distributor” means any Person(s) appointed by the Company or any of its Affiliates to distribute, market and sell Licensed Product(s), with or without packaging rights, in one or more countries in the Licensed Territory, in circumstances where the Person purchases [***] Licensed Product(s) from the Company or its Affiliates but does not otherwise make any royalty or other payment to the Company or its Affiliates with respect to such Licensed Product(s).

“Dollars” or “$” means United States Dollars.

“Dossier” means all (a) investigator brochures and study protocols; (b) all applications (including all INDs and Marketing Approval applications), registrations, licenses, authorizations and approvals (including Marketing Approvals) anywhere in the world (excluding the information provided in the foregoing (a)); (c) correspondence and reports submitted to or received from Regulatory Authorities anywhere in the world, including meeting minutes and official contact reports relating to any communications with any Regulatory Authority (e.g., FDA Type A meetings, Type B meetings, end-of-phase meetings, and Type C meetings, together with the meeting requests, meeting packages, preliminary responses, and final meeting minutes therefor) and all supporting documents with respect thereto, including all adverse event files and complaint files; (d) clinical and other data contained or relied upon in any of the foregoing; and (e) data and study reports (including pre-clinical, clinical, technical, chemical, safety, and scientific data and information), Know-How and other results generated by or resulting from or in connection with the conduct of Development activities by a Party or its Affiliates, the licensees, or Sublicensees with respect to Licensed Compound or Licensed Products throughout the world, including, to the extent requested by a Party (and subject to the non-requesting Party’s agreement to provide the requested information), relevant laboratory notebook information, screening data, regulatory data and synthesis schemes, in each case ((a)‑(e)) relating to the Licensed Compound or any Licensed Product.

“Effective Date” has the meaning set forth in the preamble hereto.

“EMA” means the European Medicines Agency and any successor agency thereto.

“Embargoed Countries” has the meaning set forth in Section 12.2.

“European Market” means (a) the economic, scientific, and political organization of member states of the European Union at any particular time; and (b) the United Kingdom, Switzerland, Iceland, Liechtenstein and Norway, and any country (or jurisdiction) that was officially recognized as a member state of the EU even if such European state has left the EU or ceases to be a member of the EU during the term of this Agreement.

For clarity, as of the Effective Date, the European Market consists of Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom of Great Britain and Northern Ireland, and that certain portion of Cyprus included in the EU as of the Effective Date.

“Exchange Rate” means, with respect to the conversion of any amount expressed in a foreign currency into Dollars equivalent for the purposes of Section 6.6 and Section 6.8, an exchange rate equal to [***].

“Executive Officers” has the meaning set forth in Section 5.4(a).

“Existing Patents” has the meaning set forth in Section 9.2(c).

“Existing Regulatory Material” has the meaning set forth in Section 9.2(h).

“Expert” has the meaning set forth in Exhibit A.

“Expert Determination Matter” has the meaning set forth in Exhibit A.

“Expert Resolution Notice” has the meaning set forth in Exhibit A.

“Exploit” or “Exploiting” means to research, Develop, Commercialize, conduct Medical Affairs Activities for, register, seek Regulatory Approval for, hold or keep (whether for disposal or otherwise), use, have used, import, export, transport, distribute, promote, market, sell, offer for sale, have sold or otherwise dispose of, or otherwise exploit. For clarity, “Exploit” excludes the right to Manufacture or have Manufactured. “Exploitation” means the act of Exploiting a compound, product or process.

“Export Control Laws” means all export control laws and regulations of PRC, the United States and all applicable jurisdictions in which either Party conducts business, which govern exports of controlled commodities, software or technology, embargoes, sanctions and boycotts, including, but not limited to, the Export Administration Regulations, the International Traffic in Arms Regulations, regulations administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury, and International Boycott Provisions of Section 999 of the U.S. Internal Revenue Code.

“FDA” means the United States Food and Drug Administration and any successor agency thereto.

“Field” means any and all uses.

“First Commercial Sale” means, with respect to a Licensed Product, the first sale for monetary value to a Third Party for use or consumption by the end user of such Licensed Product in the Licensed Territory after Marketing Approval for such Licensed Product has been obtained in any country or jurisdiction in the Licensed Territory.

Sales prior to receipt of Marketing Approval for such Licensed Product or as so-called “treatment IND sales,” “named patient sales,” and “compassionate use sales,” (including as part of a named patient program or single patient program), in each case, shall not be construed as a First Commercial Sale. First Commercial Sale also excludes transfers of Licensed Product to Third Parties at or below cost as bona fide samples, as donations, for the performance of clinical trials, or for similar purposes in accordance with Applicable Law pertaining to any expanded access program or indigent program.

“Force Majeure” has the meaning set forth in Section 12.1.

“FTE” means a full time equivalent employee (i.e., one fully-committed or multiple partially-committed employees aggregating to one full-time employee) employed or contracted by Licensor or its Affiliates and assigned to perform specified work hereunder, where “full-time” is considered [***] hours.

“FTE Costs” means the product of (a) the number of FTEs (proportionately, on a per-FTE basis) used by a Party or its Affiliates in performing the applicable activities, and (b) the FTE Rate.

“FTE Rate” means [***].

“Global Clinical Trial” has the meaning set forth in Section 3.1(f)(ii).

“Governmental Authority” means any applicable government authority, court, tribunal, arbitrator, agency, department, legislative body, commission or other instrumentality of (a) any government of any country or territory, (b) any nation, state, province, county, city or other political subdivision thereof or (c) any supranational body.

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“IND” means (a) an investigational new drug application filed with the FDA for authorization to commence clinical studies, and with regard to human clinical studies conducted in other countries, its equivalent in such country or jurisdiction, and (b) all supplements and amendments that may be filed with respect to the foregoing.

“Indemnification Claim Notice” has the meaning set forth in Section 10.3(a).

“Indemnified Party” has the meaning set forth in Section 10.3(a).

“Indication” means an illness, sickness, interruption, cessation or disorder of a particular bodily function, system, tissue type or organ, or sign or symptom of any such items or conditions, regardless of the severity, frequency or route of any treatment, treatment of regimen, dosage strength or patient class, for which a separate and distinct Marketing Approval application is being sought and which will be referenced on any Licensed Product labelling in any country. For clarity, [***].

“Indirect Taxes” has the meaning set forth in Section 6.10(a).

“Infringement” has the meaning set forth in Section 7.3(a).

“Intellectual Property” means any and all (a) Patent rights, (b) proprietary rights in Know-How, including trade secret rights, (c) proprietary rights associated with works of authorship and software, including copyrights, moral rights, and copyrightable works, and all applications, registrations, and renewals relating thereto, and derivative works thereof, and (d) all other forms of proprietary or intellectual property rights however denominated throughout the world, but excluding Trademarks.

“Interim Period” has the meaning set forth in Section 3.1(f)(i).

“Joint Development Committee” or “JDC” has the meaning set forth in Section 3.1(f)(iv).

“Joint Steering Committee” or “JSC” has the meaning set forth in Section 5.2(a).

“Know-How” means all confidential, technical, scientific or other know-how and information, trade secrets, knowledge, technology, discoveries, inventions, invention disclosures, diagnostic tools or biomarkers thereto, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, reports, inventory, results and other materials, including: (a) biological, chemical, biochemical, pharmacological, toxicological, pharmaceutical, physical, analytical, technical, non-technical, pre-clinical, clinical, assay control, safety, regulatory, and manufacturing and quality control data, materials, and information; (b) cell lines and hybridomas; (c) study designs and protocols, assays and biological methodology and regulatory documentation, regulatory filings; (d) preclinical and clinical data, information relating to the results of tests, assays, methods, and processes, and specifications or other documents containing information and related data, in each case (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed.

“Knowledge” means, with respect to Licensor, the actual knowledge of [***].

“Licensed Compound” means Licensor’s proprietary novel fusion protein product dual-targeting BLyS and APRIL formally known as telitacicept or internally known as RC18.

“Licensed IP” means the Licensed Patents and the Licensed Know-How.

“Licensed Know-How” means, subject to Section 2.4, any Know-How that is Controlled by Licensor or any of its Affiliates as of the Effective Date, or Controlled by Licensor or any of its Affiliates during the Term (including Licensor’s or its Affiliates’ interest in any Collaboration Know-How), that are necessary or reasonably useful for the Exploitation or Manufacture of the Licensed Compound or Licensed Products in the Licensed Territory.

“Licensed Patents” means, subject to Section 2.4, any Patents that are Controlled by Licensor or any of its Affiliates as of the Effective Date, or Controlled by Licensor or any of its Affiliates during the Term (including Licensor’s or its Affiliates’ interest in any Collaboration Patents), that (a) Cover the composition of matter, formulation, or a method of using the Licensed Compound or Licensed Products, or (b) are otherwise necessary or reasonably useful for the Exploitation or Manufacture of the Licensed Compound or Licensed Products in the Licensed Territory.

For clarity, “Licensed Patents” include the Existing Patents listed on Schedule 9.2(c) as of the Effective Date.

“Licensed Product(s)” means any product(s) containing or comprising the Licensed Compound as an active ingredient, either alone or in combination with one (1) or more other molecules, agents or ingredients, in any and all (current and future) forms, formulations, dosages and delivery modes.

“Licensed Territory” means worldwide, other than the Retained Territory.

“Licensed Territory Development Plan” has the meaning set forth in Section 3.1(c)(i).

“Licensor” has the meaning set forth in the preamble.

“Licensor Controlled Patents” has the meaning set forth in Section 7.2(c).

“Licensor Future Acquired IP” has the meaning set forth in Section 2.4.

“Licensor Indemnitees” has the meaning set forth in Section 10.2.

“Losses” has the meaning set forth in Section 10.1.

“Major European Market” means any of the United Kingdom, France, Germany, Italy, or Spain.

“Major Market” means [***].

“Manufacture” and “Manufacturing” and “Manufactured” means all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping, supply, and holding of any Licensed Product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, release quality assurance and quality control, but excluding any activities directed to Commercialization or Development.

“Master Services Agreement” has the meaning set forth in Section 2.7(c).

“Marketing Approval” means any and all approvals, licenses, registrations, or authorizations of any Regulatory Authority necessary to commercially market or sell a Licensed Product, including pricing or reimbursement approval where required in order to sell such pharmaceutical or biologic product. Marketing Approval includes approval of a BLA and any emergency use authorization granted by the FDA under Section 564 of the Federal Food, Drug, and Cosmetic Act. Marketing Approval granted by EMA will be deemed to include pricing or reimbursement approval by a local Regulatory Authority where required in order to sell such pharmaceutical or biologic product.

“Material Breach” has the meaning set forth in Section 11.2(a).

“Material Breach Dispute” has the meaning set forth in Section 11.2(a).

“Medical Affairs Activities” means activities designed to ensure or improve appropriate medical use of, conduct medical education of, or further research regarding, any Licensed Product, including by way of example: (a) activities of medical scientific liaisons, (b) grants to support continuing medical education, symposia, or Third Party research related to any Licensed Product, and (c) conducting medical advisory board meetings or other consultant programs or meetings with key opinion leaders.

“MG Indication” means myasthenia gravis (as such disorder is defined in the G70 block of the ICD-10).

“Net Proceeds” means [***].

“Net Sales” means, [***]. In the event that a given Licensed Product is sold in any region in the form of a Combination Product, then the Net Sales for such Combination Product in such region shall be calculated as follows: [***]. If the Parties are unable to agree upon such determination of Net Sales, then the Parties shall resolve the issue pursuant to [***] pursuant to Exhibit A.

“NMPA” means the National Medical Products Administration or any successor agency thereto.

“Non-Breaching Party” has the meaning set forth in Section 11.2(a).

“Notice Period” has the meaning set forth in Section 11.2(a).

“Officials” has the meaning set forth in Section 9.6(b).

“Ongoing Global Clinical Trial” has the meaning set forth in Section 3.1(f)(i).

“Other Product” means, with respect to a Combination Product, such therapeutically active pharmaceutical compounds or ingredients referenced in the definition of Combination Product, other than the Licensed Compound.

“Party” or “Parties” has the meaning set forth in the preamble.

“Patent Challenge” has the meaning set forth in Section 11.2(b).

“Patents” means: (a) all national, regional and international patents and patent applications, including provisional patent applications, non-provisional patent applications, and patent cooperation treaty (PCT) applications; (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority (in whole or in part) from either of these, including substitutions, renewals, divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications; (c) any and all patents that have issued or in the future issue from the foregoing patent applications, including method, process, utility, model, and design patents and certificates of invention, including utility models, petty patents, innovation patents and design patents and certificates of invention; (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b) and (c)); and (e) any similar rights, including inventor’s certificates, letters patent, so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents.

“Payment” has the meaning set forth in Section 9.6(b).

“Payment Dispute” has the meaning set forth in Section 6.9.

“Permitted Assignment” has the meaning set forth in Section 12.3.

“Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.

“Personal Data” means any information that constitutes “personal information” or “personal data” under one or more Data Protection Laws or is otherwise governed, regulated, or protected by one or more Data Protection Laws.

“Pharmacovigilance Agreement” has the meaning set forth in Section 3.2(g)(ii).

“PRC” means the People’s Republic of China excluding, solely for the purposes of this Agreement, the Hong Kong Special Administrative Region, the Macao Special Administrative Region and Taiwan.

“Processing” has the meaning given to such term in the Data Protection Laws, and “Process” and “Processed” shall be construed accordingly.

“Prohibited Party Lists” has the meaning set forth in Section 12.2.

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“Prosecution” means, with respect to a Patent, the filing, preparation, prosecution (including conducting all correspondence and interactions with any patent office and seeking, conducting and defending all any interferences, inter partes reviews, reissue proceedings, reexaminations, and oppositions and similar proceedings), and maintenance thereof, including obtaining patent term extensions, regulatory exclusivity, supplemental protection certificates, or their equivalents with respect thereto. When used as a verb, “Prosecute” and “Prosecuting” mean to engage in Prosecution. “Prosecution,” “Prosecute,” and “Prosecuting” exclude any enforcement action with respect to a Patent.

“Purple Book” means the electronic or hard copy version of the FDA’s publication, Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, and any successor publication thereto or equivalent publication thereof.

“Quality Agreement” has the meaning set forth in Section 3.6(c).

“Receiving Party” has the meaning set forth in Section 8.1.

“Region” means each of (a) North America, (b) the European Market, (c) Japan, and (d) the rest of the world.

“Regulatory Approvals” means all approvals, licenses, registrations or authorizations of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other Regulatory Authority (and in each case any supplements and amendments thereto), necessary for the Development or Commercialization of the Licensed Compound or a Licensed Product in a given regulatory jurisdiction or country, including Manufacture, distribution, use or sale of such Licensed Compound or Licensed Product in such regulatory jurisdiction or country, including any IND and Marketing Approval.

“Regulatory Authority” means any applicable Governmental Authority regulating or otherwise exercising authority with respect to any pharmaceutical or biologic product throughout the world, including the FDA and EMA.

“Regulatory Exclusivity” means any market protection, other than Patent protection, granted by a Regulatory Authority in a country or jurisdiction which is designed to provide a Person with the exclusive right to market and sell, and to prevent any unauthorized Third Party from marketing or selling, a given Licensed Product in such country or jurisdiction.

“Regulatory Materials” means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority that are necessary or reasonably desirable in order to Manufacture or Exploit the Licensed Compound or a Licensed Product in a particular country, territory or regulatory jurisdiction. Regulatory Materials include clinical trial applications and Marketing Approval applications.

“Regulatory Milestone Payment” has the meaning set forth in Section 6.3(a).

“RemeGen SPA” means that certain Securities Purchase Agreement, by and between Licensor (or one of its Affiliates) and Company, dated on or around the date hereof.

“Retained Right” has the meaning set forth in Section 2.6.

“Retained Territory” means the PRC, the Hong Kong Special Administrative Region, the Macao Special Administrative Region and Taiwan.

“Retained Territory Development Plan” has the meaning set forth in 3.1(c)(ii).

“Retained Territory IP” means any and all Patents and Know-How that are Controlled by Licensor as of the Effective Date or during the Term that are necessary or reasonably useful for the clinical development of the Licensed Compound or Licensed Products in the Field in the Retained Territory.

“Reversion IP” means, with respect to the Licensed Compound and Terminated Territory, (a) any Know-How that is Controlled by the Company or any of its Affiliates as of the effective date of the applicable termination that is necessary or actually used by the Company or any of its Affiliates or Sublicensees to Exploit or Manufacture the Licensed Compound or any Licensed Product in such Terminated Territory and (b) any Patents in such Terminated Territory that are Controlled by the Company or any of its Affiliates as of the effective date of the applicable termination that Cover the Licensed Compound or any Licensed Product.

“Right of Reference” has the meaning set forth in Section 3.2(c).

“Royalty Term” means, with respect to a Licensed Product and a country in the Licensed Territory, the period commencing on the date of the First Commercial Sale of such Licensed Product in such country and continuing until the latest of (a) the expiration date of the last-to-expire Valid Claim of a Licensed Patent or Collaboration Patent owned (solely or jointly) by Licensor that Covers such Licensed Product in such country; (b) the expiration date of the last-to-expire Regulatory Exclusivity for such Licensed Product in such country; or (c) the date which is twelve (12) years after the First Commercial Sale of such Licensed Product in such country.

“Sales Milestone Payment” has the meaning set forth in Section 6.3(b).

“Sublicensee” means a Person, other than an Affiliate, Distributor or subcontractors performing Development, Manufacturing or Commercialization activities solely for the benefit of a Party or any of its Affiliates or Sublicensees, in each case on a fee-for-service basis, that is granted a sublicense (a) by the Company or its Affiliates under the grants in Section 2.1 or Section 3.2(c) or (b) by Licensor or its Affiliates under the grants in Section 2.2 or Section 3.2(c), in each case as provided in Section 2.3.

“Technology Transfer Plan” has the meaning set forth in Section 2.7(a).

“Term” has the meaning set forth in Section 11.1.

“Terminated Territory” means (a) if this Agreement is terminated in its entirety, the Licensed Territory as a whole; or (b) if this Agreement is terminated with respect to one (1) or more Region(s) in the Licensed Territory (but not in its entirety), the Region(s), as applicable, with respect to which this Agreement has been terminated, as applicable.

“Termination Notice” has the meaning set forth in Section 11.2(a).

“Third Party” means any Person other than Licensor, the Company and their respective Affiliates.

“Third Party Claims” has the meaning set forth in Section 10.1.

“Trademark” means any word, name, symbol, color, shape, designation or any combination thereof, including any trademark, service mark, trade name, brand name, sub-brand name, trade dress, product configuration, program name, delivery form name, certification mark, collective mark, logo, tagline, slogan, design or business symbol, that functions as an identifier of source or origin, whether or not registered and all statutory and common law rights therein and all registrations and applications therefor, together with all goodwill associated with, or symbolized by, any of the foregoing.

“Tribunal” has the meaning set forth in Section 12.7(a).

“Triggering Transaction” has the meaning set forth in Section 6.7(a).

“Triggering Transaction Agreement” has the meaning set forth in Section 6.7(a).

“Triggering Transaction Consideration” has the meaning set forth in Section 6.7(a).

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“United States” or “U.S.” means the United States of America and its territories.

“Upfront Fee” has the meaning set forth in Section 6.2.

“Valid Claim” means (a) a claim of any issued and unexpired Licensed Patent (including a supplemental patent certificate or patent extension) whose validity, enforceability or patentability has not been affected by any of the following: (i) irretrievable lapse, abandonment, revocation, dedication to the public or disclaimer or (ii) a holding, finding or decision of invalidity, unenforceability or non-patentability by a court, governmental agency, national or regional patent office or other appropriate body that has competent jurisdiction, such holding, finding or decision being final and unappealable or not appealed within the time allowed for appeal or (b) a claim of a pending Licensed Patent application that was filed and has been pending and is being prosecuted in good faith and has not been pending [***], or abandoned or finally disallowed without the possibility of appeal or re-filing of the application.

ARTICLE 2 GRANT OF RIGHTS

2.1 License Grants to the Company. Subject to the terms and conditions of this Agreement, Licensor, on behalf of itself and any Affiliates which Control any Licensed IP, hereby grants to the Company:

(a) an exclusive (including with respect to Licensor and its Affiliates) license, with the right to grant sublicenses in accordance with Section 2.3, under the Licensed IP to Exploit the Licensed Compound and Licensed Products in the Field in the Licensed Territory;

(b) a non-exclusive license, with the right to grant sublicenses in accordance with Section 2.3, under the Licensed IP to Manufacture and have Manufactured the Licensed Compound and Licensed Products in the Field anywhere in the world solely for the Exploitation of the Licensed Compound and Licensed Products in the Field in the Licensed Territory; and (c) a non-exclusive license, with the right to grant sublicenses in accordance with Section 2.3, under Retained Territory IP to conduct a Global Clinical Trial for the Licensed Compound and Licensed Products in the Field in the Retained Territory pursuant to Section 3.1(f) under the Master Services Agreement or Clinical Collaboration Agreement (and solely to the extent the Licensor is not conducting such Global Clinical Trial in the Retained Territory pursuant to Section 3.1(f)).

Notwithstanding the foregoing, the licenses to the Company under this Section 2.1 for any Combination Product do not include rights to any Other Product, in each case other than the Licensed Compound.

2.2 License Grants to the Licensor. As partial consideration for the rights granted to the Company hereunder, subject to the terms and conditions of this Agreement, the Company, on behalf of itself and any Affiliates which Control any Company IP, hereby grants to Licensor and its Affiliates:

(a) an exclusive (including with respect to Company and its Affiliates), perpetual and irrevocable license, with the right to grant sublicenses in accordance with Section 2.3, under the Company IP to Exploit the Licensed Compound and Licensed Products in the Field in the Retained Territory; and

(b) a non-exclusive, fully paid up (subject to Section 2.4), perpetual and irrevocable license, with the right to grant sublicenses in accordance with Section 2.3, under the Company IP to Manufacture and have Manufactured the Licensed Compound and Licensed Products in the Field anywhere in the world solely for the Exploitation of the Licensed Compound and Licensed Products in the Field in the Retained Territory, or to perform its obligations under this Agreement, the Clinical Supply Agreement or the Commercial Supply Agreement.

Notwithstanding the foregoing, the licenses to Licensor under this Section 2.2 for any Combination Product do not include rights to any Other Product, in each case other than the Licensed Compound.

2.3 Sublicenses. Each Party shall have the right to grant sublicenses (or further rights of reference), through multiple tiers of Sublicensees and to subcontractors, under the licenses granted in Section 2.1 or Section 2.2, as applicable, or Section 3.2(c), to other Persons; provided that:

(a) any such sublicense shall be consistent with and subject to the terms and conditions of this Agreement (including for clarity, if Company is granting the sublicense, that (i) if sales by such Persons are included in Net Sales hereunder, such Persons shall permit audit rights to Company with respect to its reporting of Net Sales that are consistent with those given by the Company hereunder with respect to its sales included in Net Sales and (ii) Company shall obtain sufficient rights from such Person under any Company IP that is Controlled by such Persons to enable the Company to grant a license thereunder to Licensor and its Affiliates pursuant to Section 2.2; (b) such Persons shall comply with all the obligations of such Party under this Agreement applicable to such Sublicensee as if, for the purposes of this Section 2.3(b), they were direct parties to the applicable provisions of this Agreement;

(c) such Party’s grant of any sublicense will not relieve such Party from any of its obligations under this Agreement (including, for clarity, obligations under Section 3.1(i) and Section 4.2); and such Party shall remain responsible for its and such Persons’ full compliance with this Agreement as if, for the purposes of this Section 2.3(c), any action or omission of such Persons were an action or omission of such Party under this Agreement;

(d) such Party shall ensure that such Sublicensee shall have the expertise and resources (at least commensurate with those of such Party) to perform its applicable obligations under this Agreement; and

(e) such Party shall promptly provide to the other Party in writing the names of any Sublicensees and a copy of the sublicense with any Sublicensee promptly (but in any case within [***] days) after the grant of such sublicense; provided that such Party shall have the right to redact from such copy any confidential or commercially sensitive terms to the extent not pertinent to either Party’s rights or obligations under this Agreement or verification of compliance with the requirements of this Agreement.

2.4 IP Acquired by Licensor after Effective Date. Notwithstanding any provision in this Agreement to the contrary, to the extent that Licensor or any of its Affiliates acquires (including by way of an Acquisition), directly or indirectly, ownership of or the rights to practice any Intellectual Property (including Know-How and Patents, and any Intellectual Property rights in any Dossier) from a Third Party after the Effective Date which may otherwise be included in the definition of Licensed IP if developed by Licensor itself (“Licensor Future Acquired IP”), it shall promptly notify the Company; and the Licensor Future Acquired IP shall only constitute any of the Licensed IP if and when the Company notifies Licensor in writing that it wishes to obtain a sublicense under such Licensor Future Acquired IP and agrees to comply with the upstream obligations attributable to Company’s, or its Affiliates’ or Sublicensees’, practice of such sublicense in the course of its Exploitation and Manufacture of the Licensed Compound and Licensed Products in the Field in the Licensed Territory (including [***]).

2.5 IP Acquired by Company after Effective Date. Notwithstanding any provision in this Agreement to the contrary, to the extent that Company or any of its Affiliates acquires (including by way of an Acquisition), directly or indirectly, ownership of or the rights to practice any Intellectual Property (including Know-How and Patents, and any Intellectual Property rights in any Dossier) from a Third Party after the Effective Date which may otherwise be included in the definition of Company IP if developed by Company itself (“Company Future Acquired IP”), it shall promptly notify the Licensor, and all such Company Future Acquired IP shall only constitute Company IP if and when the Licensor notifies Company in writing that it wishes to obtain a sublicense under such Company Future Acquired IP and agrees to comply with the upstream obligations attributable to Licensor’s, or its Affiliates’ or licensees’, practice of such sublicense in the course of its Exploitation and Manufacture of the Licensed Compound and Licensed Products in the Field in the Retained Territory (including [***]).

2.6 Retention of Rights. Except as expressly provided herein, neither Party grants any other right or license (including any rights or licenses under the Licensed Patents or the Licensed Know-How or the Company IP, as applicable) (“Retained Right”). For clarity and without limiting the foregoing sentence, Licensor may exploit, including by granting a license to any other Person to exploit, any Retained Right of Licensor in the Retained Territory and/or the Licensed Territory.

2.7 Transfer of Licensed Know-How.

(a) Initial Technology Transfer. Within [***] (or such other timeframe as is agreed by the Parties), Licensor and the Company shall discuss and agree on a written plan (the “Technology Transfer Plan”) specifying information, materials, or copies of the Licensed Know-How existing as of the Effective Date to be transferred or otherwise made available to the Company, but for clarity excluding [***]. Licensor will use [***] efforts to complete the transfer of such Licensed Know-How in accordance with the Technology Transfer Plan, and all documentation shall be provided in its original language unless otherwise specified in the Technology Transfer Plan.

(b) Costs of Initial Technology Transfer and Support. Unless otherwise provided by the Technology Transfer Plan, Licensor will conduct all transfer activities included in the Technology Transfer Plan at no cost to the Company. At the Company’s request, Licensor will provide to the Company technical assistance to enable the Company to use or otherwise Exploit the transferred Licensed Know-How at the Company’s sole cost and expense (including FTE Costs and out-of-pocket costs incurred by Licensor in connection with such technical assistance).

(c) Subsequent Know-How Transfer. If Licensor or any of its Affiliates generates new data, inventions or other Know-How as part of the Licensed Know-How following the Effective Date, Licensor shall provide such Licensed Know-How that has not been previously transferred to Company as set forth in Section 3.3. Such documentation shall be provided in its original language. If the Company requests in writing any additional technical assistance in connection with the transfer of such additional Licensed Know-How following the Effective Date (“Additional Assistance”), Licensor shall promptly provide such Additional Assistance to the Company at the Company’s sole cost and expense (including FTE Costs and out-of-pocket costs incurred by Licensor in connection with such Additional Assistance). The details of such Additional Assistance shall be set forth in and governed by a master services agreement (the “Master Services Agreement”) to be entered into by the Parties.

2.8 Registration of Patent License. The Company is, if it would so desire, entitled, at its costs and expense, to register the license to the Licensed Patents with the appropriate patent offices in the Licensed Territory in such (extracted and/or redacted) form as may be reasonably requested by the Company for purposes of recording such licenses with such patent offices in the Licensed Territory as the Company considers appropriate that are consistent with the rights expressly granted to the Company under this Agreement.

ARTICLE 3 DEVELOPMENT, REGULATORY, MEDICAL AFFAIRS AND MANUFACTURING ACTIVITIES

3.1 Development.

(a) Overview. Each Party, subject to the terms and conditions of this Agreement, shall have the sole right to Develop the Licensed Compound and Licensed Products in the Field in its Applicable Territory; provided that, with respect to certain Global Clinical Trials, the Parties may wish to collaborate across the Licensed Territory and the Retained Territory.

(b) Responsibility. Each Party shall have the sole right and responsibility, at its sole expense, for all aspects of the Development of the Licensed Compound and Licensed Products (including the conduct of Clinical Trials) in the Field in its Applicable Territory in accordance with the Development Plan.

(i) Within [***], the Company shall provide an initial development plan (which shall include the proposed material Development activities for the Licensed Compound in the Field in the Licensed Territory to be conducted by the Company under this Agreement) (the “Licensed Territory Development Plan”) and submit such Licensed Territory Development Plan to the JSC for review and discussion in accordance with the provisions of Section 5.2 and Section 5.4. The Licensed Territory Development Plan may be updated from time to time by the Company in accordance with Section 3.1(d). Notwithstanding any provision in this Agreement to the contrary, if the terms of the Licensed Territory Development Plan contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement (including, for clarity, Section 3.1(i)) shall govern, except that the Licensed Territory Development Plan shall govern with respect to matters relating to the [***] in the Licensed Territory.

(ii) From time to time, at the reasonable request of either Party, the Parties may, in accordance with the provisions of Section 5.2 and Section 5.4, discuss at the JSC Licensor’s proposed material Development activities for the Licensed Compound and Licensed Products in the Field in the Retained Territory (the “Retained Territory Development Plan”, and such plan and the Licensed Territory Development Plan may each be referred to as the “Development Plan”). The Retained Territory Development Plan may be updated from time to time by the Licensor in accordance with Section 3.1(d).

(d) Updates to the Development Plan.

(i) Company will prepare updates to the Licensed Territory Development Plan from time to time (but not less than [***]) in accordance with this Section 3.1(d). With respect to each proposed update of the Licensed Territory Development Plan, the Company shall submit the updated Licensed Territory Development Plan to the JSC for review and discussion. Each updated or amended Licensed Territory Development Plan shall become effective and supersede the previous plan as of the date of the JSC’s approval of the same or at such other time as decided by the JSC. All matters relating to the Licensed Territory Development Plan shall be handled by the JSC in accordance with the provisions of Section 5.2 and Section 5.4.

(ii) From time to time, at the reasonable request of either Party, the Parties may, in accordance with the provisions of Section 5.2 and Section 5.4, discuss material updates or amendments by the Licensor to the then-effective Retained Territory Development Plan. The Parties will consult via the JSC in good faith regarding such material amendment or update.

(e) Subcontracting. The Company shall have the right to subcontract any of its Development activities to a Third Party; provided that no such permitted subcontracting shall relieve the Company of any obligation hereunder.

(f) Global Clinical Trials.

(i) Ongoing Global Clinical Trial. Licensor will transfer the conduct of the RC18G006 global clinical study for MG that is ongoing as of the Effective Date (the “Ongoing Global Clinical Trial”) to the Company [***]. (A) During the period between the Effective Date and the full transfer of the Ongoing Global Clinical Trial to the Company (the “Interim Period”), Licensor shall continue to conduct the Ongoing Global Clinical Trial, and (B) after the Interim Period, the Company shall be responsible for conducting the Ongoing Global Clinical Trial at its sole cost and expense, provided that the Company may request Licensor to conduct the Ongoing Global Clinical Trial in the Retained Territory or provide other technical or operational assistance and support reasonably requested by the Company, and, in each case of (A) and (B), to the extent Licensor conducts any portion of the Ongoing Global Clinical Trial or provides any technical or operational assistance and support, such activities shall be set forth in and governed by the Master Services Agreement or a separate agreement between the Parties for the joint conduct of a Clinical Trial (a “Clinical Collaboration Agreement”), and the Company shall reimburse Licensor for all costs and expenses (including FTE Costs and out-of-pocket costs) incurred by Licensor in connection therewith.

(ii) Future Global Clinical Trials. Other than the Ongoing Global Clinical Trial, subject to the terms of this Section 3.1(f), the Company may conduct additional global Clinical Trials with Clinical Trial sites in both the Licensed Territory and the Retained Territory (each such Clinical Trial, a “Global Clinical Trial”), including any Global Clinical Trial that is necessary for obtaining Marketing Approval for the Licensed Products in the Licensed Territory but not necessary for obtaining Marketing Approval for the Licensed Products in the Retained Territory (the “Company Global Clinical Trial”), and any Global Clinical Trial the Parties have elected to collaborate on in order to enable both Parties to obtain Marketing Approval for the Licensed Products in each Party’s Applicable Territory (the “Collaboration Global Clinical Trial”).

(iii) Clinical Collaboration. If the Parties, through their representatives on the JSC, or the JDC, as applicable, decide to collaborate or provide services to the other Party for the conduct any Global Clinical Trial, the Parties will either provide services in respect to the Global Clinical Trial pursuant to the Master Services Agreement or will enter into a Clinical Collaboration Agreement, provided that, unless expressly provided otherwise in the Master Services Agreement or any applicable Clinical Collaboration Agreement, (A) the Company shall be responsible for conducting any Company Global Clinical Trial at its sole cost and expense, provided that the Company may request Licensor to conduct such Company Global Clinical Trial in the Retained Territory, in which case the Company shall reimburse Licensor for all costs and expenses (including FTE Costs and out-of-pocket costs) incurred by Licensor in connection therewith, and (B) with respect to any Collaboration Global Clinical Trial, (1) Licensor shall be solely responsible for, itself or through an Affiliate or subcontractor, enrolling the number of patients from the Retained Territory (or the percentage of patients from the Retained Territory relative to global enrollment) agreed by the Parties and conduct such Collaboration Global Clinical Trial on such patients in the Retained Territory, at Licensor’s sole cost and expense; and (2) Company shall be solely responsible for, itself or through an Affiliate or subcontractor, enrolling the number of patients from the Licensed Territory (or the percentage of patients from the Licensed Territory relative to global enrollment) agreed by the Parties and conduct such Collaboration Global Clinical Trial on such patients in the Licensed Territory, at Company’s sole cost and expense. If the terms of the Master Services Agreement or any Clinical Collaboration Agreement contradict, or create inconsistencies or ambiguities with the terms of this Agreement, then the terms of this Agreement shall govern, except that the Master Services Agreement or Clinical Collaboration Agreement, as applicable, shall govern with respect to matters relating to the design and conduct of the preclinical study, Global Clinical Trial or the protocol for such preclinical study or Global Clinical Trial. Any portion of a proposed Global Clinical Trial to be conducted by Company in the Retained Territory outside of the Master Services Agreement or any Clinical Collaboration Agreement will be subject to approval of the JSC and pursuant to Licensor’s final decision making authority consistent with Section 5.4(c)(i)(C).

(iv) Joint Development Committee. If, and for so long as the Parties conduct the Ongoing Global Clinical Trial or any Global Clinical Trial in accordance with the Master Services Agreement or any Clinical Collaboration Agreement, the Parties, through the JSC, shall form a joint Development committee (the “Joint Development Committee” or “JDC”) to oversee and coordinate such Development activities.

(g) Development Records. Each Party shall, and shall cause its Affiliates and its and their licensees or Sublicensees, to maintain complete, current and accurate books and records of all Development activities conducted by it hereunder, and all data and other Know-How resulting from such activities, in accordance with its own internal policies and in accordance with Applicable Law. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and Patent purposes and shall not include or be commingled with records of activities outside the scope of this Agreement. In addition, each Party shall document all non-clinical studies and clinical trials in formal written study reports according to Applicable Law and national and international guidelines (e.g., ICH, GCP, GLP, and cGMP). The records shall be retained by the applicable Party for at least the period as may be required by its own internal policies or for such longer period as may be required by Applicable Law.

(h) Development Reports.

(i) [***] prior to each regularly scheduled JSC and JDC meeting, the Company shall provide the JSC or JDC, as applicable, with regular reports summarizing the

Development activities conducted by the Company under this Agreement, and the results of such activities since the prior (sub)committee meeting. The Parties shall discuss the status, progress and results of the Company’s Development activities under the Licensed Territory Development Plan, as applicable, at such meetings.

(ii) Any time during the Term, upon reasonable request of the other Party, each Party shall provide the other Party with a high level written summary of its material Development activities in process with regard to the Licensed Compound and Licensed Products, including, all material Know-How generated in such Development period by or on behalf of such Party or its Affiliates in connection with the Development of the Licensed Compound and Licensed Products in the Field in the Licensed Territory to the extent not previously provided to the other Party.

(i) Development Diligence. The Company shall use Commercially Reasonable Efforts to Develop the Licensed Compound and shall conduct Development activities set forth in the Licensed Territory Development Plan, as updated from time to time pursuant to Section 3.1(d). Without limiting the foregoing, the Company shall (itself, or with or through its Affiliates or Sublicensees) use Commercially Reasonable Efforts to Develop at least one Licensed Product for the MG Indication and [***] in the Field [***].

3.2 Regulatory Matters.

(a) Regulatory Activities.

(i) As between the Parties, each Party shall (A) have the sole right and responsibility, at its sole cost and expense, to file all Regulatory Approval applications and make all other filings with the Regulatory Authorities, and to otherwise seek all Regulatory Approvals, as well as to conduct all correspondence and communications with Regulatory Authorities regarding such matters, and (B) own and hold, and have the sole right to prepare, obtain and maintain Regulatory Approvals and applications therefor (including the setting of the overall regulatory strategy therefor) and other submissions, including INDs, in such Party’s name (or the name of such Party’s designee) in its Applicable Territory. Each Party shall share with the other Party any label-enabling Regulatory Approval submissions prepared by such Party, and, prior to the receipt of the first Regulatory Approval for a Licensed Product, Licensor shall have the right to review, comment on and be consulted with regarding any Regulatory Materials prepared by the Company. The Company may request from Licensor, and Licensor will provide, reasonable assistance and cooperation, at the Company’s cost, for Regulatory Approval applications and other submissions in the Licensed Territory.

(ii) Regulatory Materials. All Dossiers (including all Marketing Approvals) relating to the Licensed Products with respect to the Licensed Territory that are generated during the Term by or on behalf of the Company or its Affiliate, Sublicensee or designee, as well as all other Regulatory Materials that have been generated and filed by the Company or its Affiliate, Sublicensee or designee during the Term in the Licensed Territory, shall be owned by and shall be the sole property and held in the name of, the Company or its Affiliate, Sublicensee or designee.

(b) Regulatory Updates. Through the JSC or a regulatory subcommittee to be formed by the JSC, the Parties shall keep each other reasonably informed of any material regulatory developments related to the Licensed Products in the Parties’ Applicable Territory.

(c) Right of Reference. Subject to the terms and conditions of this Agreement, each Party hereby grants, and will cause its Affiliates, and will use reasonable efforts to procure from licensees, and Sublicensees to grant, to the other Party, their Affiliates, their licensees, and their Sublicensees (i) a “Right of Reference”, as that term is defined in 21 C.F.R. § 314.3(b) and any foreign counterpart to such regulation, to any Dossier submitted to any Regulatory Authority that is Controlled by such Party or any of its Affiliates, licensees or Sublicensees, as applicable, and (ii) a right to reference (at no cost to such Party or any of its Affiliates or its or their Sublicensees), any and all regulatory data and Marketing Approvals for the Licensed Products owned or Controlled by such Party or its Affiliates, licensees or Sublicensees, as applicable, worldwide, in each case ((i) and (ii)), to the extent necessary or reasonably useful and solely for the purpose of, Exploitation and Manufacture of Licensed Products (but excluding Combination Products with respect to any Other Product) in the Field in such Party’s Applicable Territory. Each Party shall, and shall cause its Affiliates, licensees, or Sublicensees to, provide a signed statement to this effect, if requested by the other Party or the other Party’s Affiliate, the Company, or Sublicensee, in accordance with 21 C.F.R. § 314.50(g)(3) or any foreign counterpart to such regulation.

(d) Recalls, Suspensions, or Withdrawals. As between the Parties, each Party shall have the right to make the final determination whether to voluntarily implement any recall, market suspension or market withdrawal with respect to any Licensed Product in its Applicable Territory; provided that such Party shall, where possible, promptly notify the other Party of such recalls, market suspension or market withdrawal before implementation of the same. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Licensed Territory, as between the Parties, the Company shall initiate and control such a recall, market suspension or market withdrawal in compliance with Applicable Law. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Retained Territory, as between the Parties, Licensor shall initiate and control such a recall, market suspension or market withdrawal in compliance with Applicable Law. Each Party shall maintain complete and accurate records of any recall of the Licensed Products in its Applicable Territory for such periods as may be required by Applicable Law, but in no event for less than [***]. The costs and expenses of any such recall, field correction, or withdrawal shall be borne by the Party implementing such recall in its Applicable Territory.

(e) Regulatory Non-Compliance. The Parties shall, through the JSC or a regulatory sub-committee, disclose without undue delay any information pertaining to notices received by a Party from Regulatory Authorities in the Licensed Territory or the Retained Territory (as applicable) of noncompliance with Applicable Law in connection with any Licensed Products including, receipt of a warning letter or other notice of alleged non-compliance, or any clinical hold or suspension or termination or clinical trial from any Regulatory Authority relating to any Licensed Product. Each Party will also share without undue delay, through the JSC, any information or results regarding any critical or major internal or Third Party audit findings or other information of any material non-compliance with Applicable Law in connection with the Licensed Products in the Licensed Territory and the Retained Territory.

(f) Regulatory Inspection or Audit. If a Regulatory Authority desires to conduct an inspection or audit of a Party’s facility or its subcontractor’s facility with regard to the Development or Manufacture of any Licensed Product in the Licensed Territory or the Retained Territory, such Party shall cooperate and cause the contract facility to cooperate with such Regulatory Authority during such inspection or audit. Following receipt of the inspection or audit report of such Regulatory Authority (a copy of which the applicable Party will immediately provide to the other Party), the Party that is being inspected or audited shall prepare and submit the response to any such observations.

(g) Safety Data.

(i) Safety Database. The Company shall establish, hold and maintain (at the Company’s cost and expense) the safety database for the Licensed Products in the Licensed Territory, shall be responsible for monitoring of all related clinical experiences, safety monitoring, pharmacovigilance surveillance and compliance and filing of all required safety reports to all Regulatory Authorities in connection therewith and shall comply with its pharmacovigilance responsibilities in the Licensed Territory, including, as applicable, with respect to any adverse drug experiences (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. sections 312.32 or 314.80 or to foreign Regulatory Authorities under corresponding Applicable Law outside the United States). Licensor shall establish, hold and maintain (at Licensor’s cost and expense) the safety database for the Licensed Products in the Retained Territory, shall be responsible for monitoring of all related clinical experiences, safety monitoring, pharmacovigilance surveillance and compliance and filing of all required safety reports to all Regulatory Authorities in connection therewith and shall comply with its pharmacovigilance responsibilities in the Retained Territory. The Parties will communicate and exchange data between their respective safety databases in accordance with the Pharmacovigilance Agreement set forth in Section 3.2(g)(ii).

(ii) Pharmacovigilance Agreement. The Parties shall cooperate to develop methods or procedures for monitoring and sharing information relating to clinical experiences in connection with the Exploitation of the Licensed Compound and Licensed Products in its Applicable Territory and to enable each Party to comply with safety reporting requirements of the respective Regulatory Authorities in its Applicable Territory. Specific details regarding the exchange and management of information of adverse events related to the clinical development and the use of the Licensed Compound and Licensed Products in the Licensed Territory and Retained Territory will be delineated in a separate pharmacovigilance agreement that shall be agreed to by the Parties (the “Pharmacovigilance Agreement”).

(iii) Use of Safety Data. Subject to compliance with Applicable Laws, each Party shall have the right to use the safety data resulting from Development activities performed by the other Party, without compensation to such performing Party, in each case as reasonably necessary for the using Party to comply with its safety reporting obligations in its Applicable Territory.

(h) Communications with Regulatory Authority. The Company shall lead all interactions with Regulatory Authorities in the Licensed Territory with respect to Licensed Products. The Company shall not communicate with any Regulatory Authority in the Retained Territory regarding the Licensed Compound or any Licensed Product, unless [***]. Licensor shall not communicate regarding the Licensed Compound or any Licensed Product with any Regulatory Authority in the Licensed Territory, unless [***].

3.3 Data Exchange. Without limiting Section 2.7, Section 3.1(h), Section 3.2(b), or Section 3.2(c), each Party shall provide the other Party with copies of all data and other Know-How, including clinical study reports and clinical data, generated by or on behalf of such Party in the course of performing its assigned activities under the applicable Development Plan, in each case on a periodic basis established by the JSC or the JDC, as applicable. The Party receiving such data shall have the rights to use and reference such data for the purpose of obtaining and maintaining Regulatory Approval for any Licensed Product in its Applicable Territory. Each Party shall ensure that all informed consent forms for Clinical Trials conducted by or on behalf of such Party for any Licensed Product shall permit the transfer of clinical data generated in such Clinical Trials to the other Party as contemplated under this Agreement in compliance with Applicable Law; provided that [***]. Further, to the extent required by Applicable Law for the sharing of any information, data or results pursuant to this Agreement or any Ancillary Agreement, the Parties will negotiate and enter into a data processing agreement (“Data Processing Agreement”).

3.4 Development and Regulatory Costs. Unless otherwise specified in this Agreement (including under Section 3.1(f)) or agreed between the Parties, the Company shall be solely responsible for all costs and expenses incurred in connection with the Development activities and with all regulatory matters arising under this Agreement in or for the Licensed Territory.

3.5 Medical Affairs. Each Party will conduct all Medical Affairs Activities in its Applicable Territory in a professional and ethical business manner and in compliance with Applicable Law and applicable professional requirements. The Parties, through the JSC, shall keep each other informed of and jointly discuss and coordinate the Parties’ activities with respect to Medical Affairs Activities related to any Licensed Product across the Licensed Territory and the Retained Territory, including, if permitted under Applicable Law, attending and inviting key opinion leaders to the other Party’s events in such other Party’s Applicable Territory.

3.6 Manufacturing.

(a) Responsibility. Company may request that Licensor (itself or through one or more Affiliates or CMOs [***] Manufacture and supply the Licensed Compound and Licensed Products (including the drug substance and finished product of Licensed Products) for Development (including use in Clinical Trials) and Commercialization by Company and its Affiliates and Sublicensees in or for the Licensed Territory.

(b) Clinical Supply Agreement. [***], the Parties shall negotiate in good faith and enter into a clinical supply agreement governing such Manufacture and supply of Licensed Products by or on behalf of Licensor for Company in or for the Licensed Territory [***] (as may be amended in accordance with its terms, the “Clinical Supply Agreement”). The Clinical Supply Agreement will include customary terms and conditions for such clinical supply, including shipping terms, Company’s audit and inspection rights, and remedies in the event of supply failure or shortfalls. In connection with the Clinical Supply Agreement, the Parties shall enter into a clinical quality agreement (the “Clinical Quality Agreement”) governing the quality aspects of the supply of Licensed Products.

(c) Commercial Supply. Upon Company’s request, the Parties shall negotiate in good faith and enter into a commercial supply agreement governing such Manufacture and supply of Licensed Products by or on behalf of Licensor for Company in or for the Licensed Territory [***] (as may be amended in accordance with its terms, the “Commercial Supply Agreement”). The Commercial Supply Agreement will include customary terms and conditions for such commercial supply, including shipping terms, Company’s audit and inspection rights, and remedies in the event of supply failure or shortfalls. In connection with the Commercial Supply Agreement, the Parties shall enter into a commercial quality agreement (the “Commercial Quality Agreement” and together with the Clinical Quality Agreement, the “Quality Agreements”) governing the quality aspects of the supply of Licensed Products.

(d) Manufacturing Technology Transfer. Upon Company’s request, the Parties shall coordinate and agree to a plan pursuant to which Licensor shall transfer Manufacturing-related records and data and provide the Company with reasonable technical assistance to enable the Company or its designated Third Party contract manufacturer to Manufacture the Licensed Products in the Licensed Territory (the “Manufacturing Technology Transfer”). The Company will reimburse Licensor for any FTE Costs and out-of-pocket costs incurred by Licensor to conduct such transfer or provide such technical assistance.

(e) Licensor Activities in the Licensed Territory. Licensor will keep Company reasonably informed, which may be done through the JSC, of its Manufacturing activities in the Licensed Territory, including the names and locations of any Third Party Manufacturing the Licensed Compound or any Licensed Product within the Licensed Territory.

ARTICLE 4 COMMERCIALIZATION

4.1 In General. As between the Parties, the Company (itself or through its Affiliates or its or their Sublicensees) shall have the sole right and responsibility to Commercialize the Licensed Compound and the Licensed Products in the Field in the Licensed Territory at its sole cost and expense.

4.2 Commercialization Diligence. Subject to obtaining Marketing Approval in the applicable jurisdiction, the Company shall (itself or through its Affiliates or Sublicensees) use Commercially Reasonable Efforts to Commercialize at least one Licensed Product in the MG Indication and [***].

4.3 Booking of Sales; Distribution. As between the Parties, the Company shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehouse and distribute the Licensed Products in the Licensed Territory and perform or cause to be performed all related services. Subject to Section 3.2(d), as between the Parties, (a) the Company shall handle all returns, recalls or withdrawals, order processing, invoicing, collection, distribution, and inventory management with respect to the Licensed Products in the Licensed Territory and (b) Licensor shall handle all returns, recalls or withdrawals, order processing, invoicing, collection, distribution, and inventory management with respect to the Licensed Products in the Retained Territory.

4.4 No Unauthorized Sales. Each Party hereby covenants and agrees that it and its Affiliates shall not, and it shall contractually obligate (and use Commercially Reasonable Efforts to enforce such contractual obligation) its distributors and Sublicensees not to, directly or indirectly, promote, market, distribute, import, offer for sale, sell, have sold or otherwise Commercialize any Licensed Product, including via the internet or mail order, to any Third Party in the other Party’s Applicable Territory. Neither Party shall engage, nor permit its Affiliates, distributors and Sublicensees to engage, in any advertising or promotional activities relating to any Licensed Product for use directed primarily to customers or other buyers or users of such Licensed Product located in any country or jurisdiction in the other Party’s Applicable Territory or solicit orders from any prospective purchaser located in any country or jurisdiction in the other Party’s Applicable Territory. If a Party, its Affiliates or its or their Sublicensees receives any order for any Licensed Product for use from a prospective purchaser located in a country or jurisdiction in the other Party’s Applicable Territory, such Party shall immediately refer that order to such other Party and shall not accept any such orders.

4.5 Trademarks. The Company shall have the right to brand the Licensed Products in the Licensed Territory using Trademarks it determines appropriate for the Licensed Products, which may vary by region or within a region. The Company shall own all rights in the Trademarks for the Licensed Products in the Licensed Territory and may register and maintain such Trademarks in the Licensed Territory that it determines reasonably necessary.

ARTICLE 5 GOVERNANCE

5.1 Alliance Managers. Each Party shall, within [***], appoint an appropriately qualified individual to serve as an alliance manager for such Party under this Agreement (each, an “Alliance Manager”). Each Party may change its designated Alliance Manager from time to time upon written notice to the other Party. The Alliance Managers shall discuss the performance of the Parties under this Agreement. They may attend meetings of the JSC and subcommittees under this Agreement and may raise issues for the applicable (sub)committee(s) for discussion. Each Alliance Manager will be charged with creating and maintaining clear, responsive, and effective communication within and among the Parties. For clarity, the Alliance Managers do not have voting rights with regard to any matter within the purview of the JSC or any subcommittee.

5.2 Joint Steering Committee.

(a) Formation. Within [***], the Parties shall establish a joint steering committee (the “Joint Steering Committee” or the “JSC”), composed of the Alliance Managers plus an equal number of senior level representatives of each Party, with appropriate knowledge and expertise, to oversee the overall direction of the collaboration between the Parties under this Agreement. Each Party shall appoint one (1) of its representatives on the JSC to act as a co-chairperson of the JSC. Each Party may change one (1) or more of its representatives serving on the JSC at any time upon reasonably prior written notice to the other Party.

(b) Principles; Limitations of JSC Authority. The JSC shall serve as a forum for the Parties to share information regarding the Exploitation and Manufacture of the Licensed Compound and Licensed Products in the Field in the Licensed Territory and to facilitate coordination between the Parties. The JSC shall only have the powers expressly assigned to it in this Article 5 and elsewhere in this Agreement and shall not have (i) the authority to modify or amend the terms and conditions of this Agreement; (ii) waive or determine either Party’s compliance or non-compliance with the terms and conditions under this Agreement; or (iii) decide any such issue in a manner that would conflict with the express terms and conditions of this Agreement. In addition, notwithstanding any provision to the contrary set forth in this Agreement, no decision of the JSC or a Party (in the exercise of its final decision-making authority on any such matters as set forth in Section 5.4(c)), in each case, may take or decline to take any action that would result in the other Party being required to violate any Applicable Law, the requirements of any Regulatory Authority, or that would result in the infringement or misappropriation of any Intellectual Property of any Third Party.

(c) Responsibilities. The JSC shall in particular: (i) oversee and provide strategic oversight for the Exploitation of the Licensed Compound and Licensed Products in or for the Licensed Territory under this Agreement and the Manufacture of the Licensed Compound and Licensed Products in or for the Licensed Territory under this Agreement; (ii) provide a forum for and facilitate communications between the Parties with respect to their collaboration; (iii) keep each Party informed of all Development activities related to the Licensed Compound to ensure overall alignment of development of the Licensed Compound; (iv) review and discuss (and in the case of amendments to the Licensed Territory Development Plan, approve) the initial Licensed Territory Development Plan provided by the Company and any updates or amendments to the then-effective Licensed Territory Development Plan and Retained Territory Development Plan, and oversee the execution of each such Development Plan by the applicable Party; (v) review and discuss any proposed Global Clinical Trial, and decide whether the Parties shall collaborate for the conduct of such Global Clinical Trial; (vi) with respect to any Global Clinical Trial to be collaborated by the Parties, discuss and, develop a plan for such Global Clinical Trial to serve as the basis for a Clinical Collaboration Agreement or statement of work pursuant to the Master Services Agreement; (vii) keep each Party informed of all Development results and regulatory activities related to the Licensed Compound and Licensed Products in the Licensed Territory, including all matters relating to Regulatory Approvals; (viii) discuss a supply strategy to ensure the commercial supply of the Licensed Products for the Licensed Territory; (ix) establish subcommittees as it deems necessary or advisable to further the collaboration of the Parties under this Agreement; (x) oversee the operation of any subcommittees (including the JDC), including resolving any disputed matters arising in such other subcommittees; and (xi) perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or allocated to the JSC by the Parties in writing.

(d) Meetings. The JSC shall hold its initial meeting no later than [***] (or such other date as mutually agreed by the Parties), establishing its operating procedures, and shall, thereafter, meet at such times and frequency mutually agreed by the Parties at locations mutually agreed by the Parties, but no less frequently than [***] during the Term; provided that such meetings may be held in person or by audio or video teleconference. In person meetings shall be held at locations selected alternatively by the Parties. Each Party shall bear its own costs and expenses associated with the attendance of its representatives at such meetings. No action taken at any meeting of the JSC shall be effective unless there is present at a meeting at least one (1) representative appointed by each Party. All meetings of the JSC and any subcommittees will be conducted in English.

(e) Agendas and Minutes. The co-chairpersons of the JSC shall be responsible for calling meetings on no less than [***] notice unless exigent circumstances require shorter notice. Each Party shall make proposals for agenda items at least [***] in advance of the applicable meeting, including providing all appropriate information with respect to such proposed items. The responsibility to keep minutes of the JSC meetings, which shall record in English all decisions taken and all actions recommended or agreed in reasonable detail, shall alternate between the co-chairpersons (or their designees) of the Parties. The co-chairperson responsible for the minutes of a given meeting shall circulate a draft of the minutes no later than [***] after each meeting and each member of the JSC shall have the opportunity to comment on the draft minutes. The role of the co-chairpersons shall be to convene and preside at meetings of the JSC. The co-chairpersons shall have no additional powers or rights beyond those held by the other JSC representatives.

5.3 Subcommittees.

(a) Formation of Subcommittees. In addition to the JDC pursuant to Section 3.1(f)(iv), the JSC may, from time to time, establish subcommittees as it deems necessary or advisable to further the collaboration of the Parties, and shall define responsibilities of each such subcommittee in writing. The topics for such subcommittees may include CMC/quality and other topics as the Parties may agree from time to time. Within [***], each Party shall appoint an equal number of representatives as mutually agreed by the Parties, each with appropriate knowledge and expertise, by providing written notice to the other Party.

(b) Meetings of Subcommittees. Each subcommittee shall meet in person or by means of telephone or video conference at least [***], or with such other frequency as the subcommittee may agree. Each Party may replace its representatives on any subcommittee at any time by providing reasonably prior written notice to the other Party. Each subcommittee shall be led by a chairperson where the Parties will alternate in appointing the chairperson, with the first chairperson to be appointed by Licensor, and each chairperson will remain in place for [***]. The role of the chairperson shall be to convene and preside at meetings of such subcommittee. The chairperson shall have no additional powers or rights beyond those held by the other subcommittee representatives. Each of the subcommittees shall continue to exist until the JSC decides to disband such subcommittee.

5.4 Decision Making.

(a) Voting. All decisions of the JSC or any subcommittee (including the JDC) shall be made by unanimous vote, with each Party’s representatives collectively having one (1) vote, and such decisions shall be set forth in the respective meeting minutes. If, after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC or any subcommittee that is within its authority, the representatives of the Parties cannot reach unanimous agreement as to such matter within [***], such disagreement shall (except as otherwise expressly provided under this Agreement), in the case of disagreement of any subcommittee, be referred to the JSC for resolution, and, in the case of disagreement of the JSC, be referred to [***] and [***] (together, the “Executive Officers”) for resolution in accordance with Section 5.4(b).

(b) Referral to and Decision by Executive Officers. With respect to disputes arising from the JSC pursuant to Section 5.4(a), if the JSC is unable to resolve any dispute within [***], either Party may, by written notice to the other Party, have such dispute referred to the Executive Officers for attempted resolution by good faith negotiations within [***]. Any final decision mutually agreed to by the Executive Officers shall be conclusive and binding on the Parties. If the Executive Officers are not able to resolve such dispute within such [***], then such dispute shall be resolved in accordance with Section 5.4(c). For clarity, Disputes arising between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith, and that are outside of the jurisdiction of the JSC, shall be resolved pursuant to Section 12.7.

5.5 Cooperation. Each Party shall provide the JSC such information as required under this Agreement or as otherwise reasonably requested by the other Party and reasonably available to such Party to enable the other Party to perform its obligations under this Agreement.

ARTICLE 6 FINANCIAL TERMS

6.1 Equity Issuance. In partial consideration of the rights granted by Licensor to the Company hereunder, concurrently with the execution of this Agreement, the Company shall issue certain securities of the Company to Licensor or one of its Affiliates in accordance with the RemeGen SPA.

6.2 Upfront Fee. In partial consideration of the rights granted by Licensor to the Company hereunder, within [***], the Company shall pay a one-time fee of forty five million Dollars ($45,000,000) (the “Upfront Fee”) in cash to Licensor which shall be non-creditable and non-refundable.

6.3 Milestones.

(a) Regulatory Milestones. In partial consideration of the rights granted by Licensor to the Company hereunder, the Company shall pay to Licensor (or its designated affiliate) each of the following one-time, non-refundable and non-creditable milestone payments (each a “Regulatory Milestone Payment”), calculated as follows and regardless of whether such milestone has been achieved by or on behalf of the Company, its Affiliates or its or their Sublicensees:


No.	Milestone Event	Milestone Payment
1	[***]	[***]
2	[***]	[***]


No.	Milestone Event	Milestone Payment
3	[***]	[***]
4	[***]	[***]
5	[***]	[***]
6	[***]	[***]
7	[***]	[***]
8	[***]	[***]
9	[***]	[***]
	Total for all Licensed Products	Three hundred thirty million Dollars ($330,000,000)

For the avoidance of doubt, each milestone payment set forth in the table above shall be payable once, and no additional Regulatory Milestone Payments will be payable for any subsequent achievement of any such regulatory milestone event, including by any other Licensed Product. The maximum of all Regulatory Milestone Payments payable by Company to Licensor under this Section 6.3(a) for all Licensed Products shall not exceed three hundred thirty million Dollars ($330,000,000) in total regardless of the number of Licensed Products developed under this Agreement. Each Regulatory Milestone Payment shall be non-refundable and non-creditable against any other payments due hereunder. The Company shall give Licensor written notice of the achievement of each milestone event in this Section 6.3(a) no later than [***]. Licensor shall submit an invoice to the Company promptly following receipt of such notice for the full amount of the corresponding milestone, which amount shall be payable within [***].

(b) Sales Milestones. In partial consideration of the rights granted by Licensor to the Company hereunder, the Company shall make one-time, non-refundable and non-creditable sales milestone payments to Licensor (or its designated affiliate) after the end of the Calendar Quarter in which aggregated Net Sales of all Licensed Products in all countries in the Licensed Territory in a Calendar Year reach the corresponding thresholds for the first time (as set forth in the left column of the table below) (each a “Sales Milestone Payment”) as follows:


No.	Milestone Event	Milestone Payment
1	[***]	[***]
2	[***]	[***]
3	[***]	[***]


No.	Milestone Event	Milestone Payment
4	[***]	[***]
5	[***]	[***]
6	[***]	[***]
7	[***]	[***]
	Total for all Licensed Products	Three billion seven hundred seventy five million Dollars ($3,775,000,000)

Each Sales Milestone Payment in this Section 6.3(b) shall be payable only once upon the first achievement of such milestone in a given Calendar Year, and no amounts shall be due for subsequent or repeated achievements of such milestone in a subsequent Calendar Year. In the event that in a given Calendar Year more than one (1) of the foregoing milestone events set forth in the table above of this Section 6.3(b) is achieved for the first time, the Company shall pay to Licensor (or its designated affiliate) the corresponding Sales Milestone Payment with respect to each such milestone event that is achieved (and not previously paid) in such Calendar Year. The maximum of all Sales Milestone Payments payable by Company to Licensor under this Section 6.3(b) for all Licensed Products shall not exceed three billion seven hundred seventy-five million Dollars ($3,775,000,000) in total regardless of the number of Licensed Products developed under this Agreement. The Company shall give Licensor written notice of the achievement of each milestone event in this Section 6.3(b) no later [***]. Following receipt of such notice, Licensor shall promptly from receipt of notice, submit an invoice to the Company for the full amount of the corresponding Sales Milestone Payment(s) payable under this Section 6.3(b). Each such Sales Milestone Payment shall be due within [***].

6.4 Royalties.

As further consideration for the rights granted to the Company hereunder, during the Royalty Term, the Company shall pay to Licensor (or its designated affiliate), on a Licensed Product-by-Licensed Product basis, a non-refundable, non-creditable, running royalty on the aggregate Calendar Year Net Sales by the Company or any of its Affiliates or its or their Sublicensees of such Licensed Product in the Licensed Territory at the following rates:


No.	For that portion of aggregate Net Sales of a Licensed Product in the Licensed Territory in a given Calendar Year	Royalty Rate
1	[***]	[***]
2	[***]	[***]
3	[***]	[***]


4	[***]	[***]

The Company’s obligation to pay royalties will, on a Licensed Product-by-Licensed Product and country-by-country basis in the Licensed Territory, commence from the First Commercial Sale of such Licensed Product in such country and will expire upon the expiration of the Royalty Term for such Licensed Product in such country.

6.5 Royalty Reduction.

(a) Lack of Valid Claim and Regulatory Exclusivity. If, on a Licensed Product-by-Licensed Product and country-by-country basis, there is no Valid Claim of a Licensed Patent Covering such Licensed Product in such country, either at the time of First Commercial Sale or anytime thereafter during the Royalty Term, and Regulatory Exclusivity has expired with respect to any such Licensed Product, then the royalties payable to Licensor on Net Sales of such Licensed Product in such country set forth in Section 6.4 shall be [***] for the remainder of the Royalty Term for such Licensed Product in such country.

(b) Biosimilar Competition. If, on a Licensed Product-by-Licensed Product and country-by-country basis, (i) there is no Valid Claim of a Licensed Patent Covering such Licensed Product in such country, either at the time of First Commercial Sale or anytime thereafter during the Royalty Term, and Regulatory Exclusivity has expired with respect to any such Licensed Product, and (ii) a Biosimilar Product with respect to such Licensed Product is launched by a Third Party in such country and the Net Sales of such Licensed Product declines [***], then the royalties payable to Licensor on Net Sales of such Licensed Product in such country set forth in Section 6.4 shall be [***] for the remainder of the Royalty Term for such Licensed Product in such country.

(c) Third Party License. The Company may deduct from the royalties payable to Licensor as set forth in Section 6.4 [***] actually paid by Company or its Affiliates or Sublicensees (i) for any Patent within Licensor Future Acquired IP under Section 2.4, or (ii) under any agreement with a Third Party with respect to any Patent, in each case ((i) and (ii)) that Covers the Licensed Compound, and is necessary for the Exploitation or Manufacture of (A) the Licensed Compound or (B) any Licensed Product containing the Licensed Compound in the form it exists as of the Effective Date and in accordance with its applicable specifications existing as of the Effective Date in the Licensed Territory.

(d) Royalty Floor. Notwithstanding anything contained in this Agreement to the contrary, the reductions and offsets to royalties provided in Sections 6.5(a) through Section 6.5(c), may not, individually or in combination, reduce the royalties payable with respect to Net Sales of any Licensed Product sold by the Company, its Affiliates and its and their Sublicensees in any country during a Calendar Quarter during the applicable Royalty Term by more than [***].

6.6 Royalty Payments and Reports. The Company shall calculate all Net Sales thresholds and tiers, and all royalty amounts payable to Licensor pursuant to Section 6.4 at the end of each Calendar Quarter, which amounts shall be converted to Dollars, in accordance with the Exchange Rate. Company shall pay such converted Dollars amount within [***] after the end of each Calendar Quarter. Each payment of royalties due to Licensor shall be accompanied by a written statement of the royalty amounts due with respect to a given Calendar Quarter of aggregate Net Sales of all Licensed Products in the Licensed Territory during such Calendar Quarter, which statement shall be in a mutually agreed format and shall include the Net Sales of all Licensed Products subject to royalty payments sold by the Company, its Affiliates and its or their Sublicensees in the Licensed Territory during the reporting period and the royalties payable on Net Sales under this Agreement in accordance with Section 6.4.

6.7 Triggering Transaction Consideration.

(a) As further consideration for the rights granted to the Company hereunder, if Company enters into a definitive agreement pursuant to which Company grants a sublicense, sells or otherwise divests any rights to Develop and/or Commercialize the Licensed Products to any Third Party (other than sublicenses granted to subcontractors performing Development or Commercialization activities for the benefit of Company or any of its Affiliates) (such transaction, a “Triggering Transaction” and such agreement, a “Triggering Transaction Agreement”) prior to [***], Licensor shall be entitled to [***] (“Triggering Transaction Consideration”) in accordance with the following provisions of this Section 6.7. For clarity, a Triggering Transaction [***].

(b) [***]

(d) [***]

6.8 Mode of Payment. All payments under this Agreement shall be made by the Company by deposit or wire transfer of Dollars in the requisite amount (without any right of offset, set off, deduction or (other than pursuant to and subject to Section 6.10(b)) withholding) to such bank account as Licensor may from time to time designate by notice to the Company. The Company shall convert any amount expressed in a foreign currency into Dollar equivalents using the Exchange Rate.

6.9 Disputes regarding Milestone Events and Payments. For clarity, the Company’s obligations to make payments to the Licensor under this Agreement shall not be prejudiced by the Company’s failure to provide written notice to Licensor with respect to the achievement of a payment or milestone event in accordance with Section 6.3(a), Section 6.3(a), and Section 6.3(b). If Licensor believes any such payment or milestone event has occurred, it has the right to so notify the Company in writing and provide to the Company data, documentation, or other information that supports its belief. Any Dispute that relates to (a) whether or not a payment or milestone event has occurred or (b) the royalty amounts payable by the Company to Licensor subject to Section 6.4 (“Payment Dispute”) shall be resolved in accordance with Section 12.7; provided that with respect to a Payment Dispute, all undisputed amounts shall be paid promptly when due and any amount subject to the Payment Dispute shall be paid promptly after resolution of the Payment Dispute; provided further that no Dispute other than a Payment Dispute shall affect any payment obligation of the Company accrued under this Agreement pending the resolution of such Dispute.

6.10 Taxes.

(a) Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes and other similar taxes (the “Indirect Taxes”). If any Indirect Taxes are chargeable in respect of any payments, the paying Party shall pay such Indirect Taxes at the applicable rate in respect of such payments following receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by the receiving Party in respect of those payments. The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes. The paying Party shall only be responsible for any Indirect Taxes not recoverable by the receiving Party (or any principal or representative member of an Indirect Taxes group of which the receiving Party is a part) taking all reasonable steps to recover such Indirect Taxes as may be practicable.

(b) Withholding Taxes. Where any sum due to be paid to any Party hereunder is subject to any withholding or similar tax, the Parties shall use their commercially reasonable efforts to do all such acts and things and to sign all such documents as will enable them to take advantage of any applicable double taxation agreement or treaty. In the event there is no applicable double taxation agreement or treaty, or if an applicable double taxation agreement or treaty reduces but does not eliminate such withholding or similar tax, the payor shall pay such withholding or similar tax to the appropriate Governmental Authority, deduct the amount paid from the amount due to payee hereunder, and secure and send to payee the best available evidence of such payment. Any such amounts deducted by the payor in respect of such withholding or similar tax shall be treated as having been paid by the payor for purposes of this Agreement. Each Party will provide to the other any tax forms, certificates, application or other documents or evidence that may be reasonably necessary in order for a Party to determine whether to withhold tax or to withhold tax on any payments or whether an applicable double taxation agreement or treaty applies that reduces or eliminates any withholding tax on any such payments.

(c) Tax Cooperation. The Company and Licensor shall use commercially reasonable efforts to cooperate with each other in relation to any reasonable request in connection with any tax liability arising from the payments due under this Agreement, including information required for the preparation and filing of any tax return or the conduct of any audit, investigation, dispute or appeal or any other communication with any Governmental Authority, in each case if and to the extent: (i) legally permissible; and (ii) that such disclosure would not breach any duty of confidentiality or waive any privilege. The requesting Party shall be responsible for any Third Party costs properly incurred by the other Party in complying with this Section 6.10(c).

6.11 Interest on Late Payments. If any undisputed payment due to either Party under this Agreement is not paid when due, then such paying Party shall pay interest thereon from the day payment was initially due at [***]; provided, however, that in no case will such interest rate exceed the highest rate permitted by Applicable Laws. The payment of such interest will not foreclose a Party from exercising any other rights it may have because any payment is overdue.

6.12 Financial Records. The Company shall and shall cause its Affiliates and its or their Sublicensees to, keep complete and accurate financial books and records pertaining to the Commercialization of Licensed Products hereunder (including Net Sales of Licensed Products) to the extent required to calculate and verify all amounts payable hereunder. the Company shall, and shall cause its Affiliates and its or their Sublicensees to, retain such books and records until [***] or for such longer period as may be required by Applicable Law.

6.13 Audit.

(a) Procedures. At the request of Licensor, the Company shall, and shall cause its Affiliates, and shall use reasonable efforts to require its or their Sublicensees to, permit an independent auditor designated by Licensor and reasonably acceptable to the Company (or its Affiliate or its or their Sublicensee, as applicable), at reasonable times and upon reasonable notice, to audit the books and records maintained pursuant to Section 6.12 to ensure the accuracy of all reports and payments made hereunder. Such examinations may not be conducted more than [***] and Licensor may audit books and records covering a specific period of time [***]. The cost of this audit shall be borne by Licensor, unless such audit uncovers an underpayment of amount payable by the Company that exceeds [***] then the fees of such accounting firm shall be paid by the Company. If such audit shows that additional amounts were owed by the Company, the Company shall pay the additional amounts, with interest from the date originally due, within [***].

(b) Confidentiality. The receiving Party shall treat all information subject to review under this Article 6 in accordance with the confidentiality provisions of Article 8 and the Parties shall cause any independent auditor engaged under Section 6.13(a) to enter into a reasonably acceptable confidentiality agreement with the audited Party obligating such firm or Third Party to retain all such financial information in confidence pursuant to such confidentiality agreement and to only provide to Licensor such information that Licensor is entitled to receive pursuant to this Article 6.

ARTICLE 7 INTELLECTUAL PROPERTY

7.1 Ownership of Intellectual Property.

(a) Collaboration IP. Ownership of Collaboration IP conceived, reduced to practice, discovered, developed or otherwise made under this Agreement shall be determined by inventorship. The determination of inventorship and whether Collaboration IP is conceived, reduced to practice, discovered, developed or otherwise made under this Agreement solely by a Party or jointly with the other Party for the purpose of allocating proprietary rights (including Patent, copyright or other Intellectual Property rights) therein, shall, for purposes of this Agreement, be made in accordance with the United States patent law and other Applicable Law in the United States irrespective of where such conception, reduction to practice, discovery, development or making occurs.

(b) Licensed IP. Licensor shall, as between the Parties, own and retain all right, title and interest in and to all Licensed IP, whether Controlled by Licensor before or after the Effective Date.

(c) Disclosure; Further Assurances. Each Party shall promptly disclose to the other Party in writing, the creation or development of any of its Collaboration IP. Licensor shall promptly disclose to the Company in writing, the creation or development of any of its Licensed IP (other than the Collaboration IP) to the extent necessary or reasonably useful for the Exploitation or Manufacture of the Licensed Compound in the Licensed Territory and coming into Licensor’s Control after the Effective Date.

7.2 Prosecution.

(a) Company Controlled Patents. As between the Parties, the Company shall have the first right, but not the obligation, to Prosecute all Licensed Patents in the Licensed Territory (collectively, the “Company Controlled Patents”) using counsel of Company’s choice and reasonably acceptable to Licensor, and at Company’s sole cost and expense. Company will (i) keep Licensor reasonably informed of all progress with regard to the Prosecution of the Company Controlled Patents; (ii) provide to Licensor copies of all patent office submissions and correspondence with respect to the Company Controlled Patents; and (iii) provide to Licensor copies of drafts of all patent office submissions and correspondence with respect to the Company Controlled Patents in advance of submitting such submissions and correspondence so as to allow Licensor a reasonable opportunity to comment thereon, and Company will consider incorporating any timely comments in good faith.

(b) Licensor Step-in Rights. In the event that Company intends to abandon or cease the Prosecution of any Company Controlled Patent, Company will provide reasonable prior written notice to Licensor of such intention to abandon or cease such Prosecution (which notice will be given no later than [***] prior to the next deadline for any action that must be taken with respect to any such Company Controlled Patent in the relevant patent office). In such case, at Licensor’s request, Licensor shall have the right, but not the obligation, to assume responsibility for Prosecution of such Company Controlled Patent. Upon such assumption, Licensor shall control the Prosecution of such Company Controlled Patent subject to the same terms and conditions set forth in Section 7.2(a), as applicable to Company, using counsel of Licensor’s choice at its cost and expense.

(c) Licensor Controlled Patents. As between the Parties, Licensor shall have the sole right, but not the obligation, to Prosecute all Licensed Patents in the Retained Territory (collectively, the “Licensor Controlled Patents”) using counsel of Licensor’s choice and at Licensor’s sole cost and expense. Licensor will (i) keep Company reasonably informed of all progress with regard to the Prosecution of the Licensor Controlled Patents Covering the composition of matter, formulation, or a method of making or using the Licensed Compound or Licensed Products; (ii) provide to Company copies of all patent office submissions and correspondence with respect to such Licensor Controlled Patents; and (iii) provide to Company copies of drafts of all patent office submissions and correspondence with respect to such Licensor Controlled Patents in advance of submitting such submissions and correspondence so as to allow Company a reasonable opportunity to comment thereon, and Licensor will consider incorporating any timely comments in good faith.

(d) Cooperation. Each Party will cooperate with the other Party in connection with all activities relating to the Prosecution of the Licensed Patents undertaken by such other Party pursuant to this Section 7.2, including: (i) executing all papers and instruments, or requiring its employees or contractors, to execute such papers and instruments, so as to effectuate the ownership of Collaboration IP set forth in Section 7.1, and Patents claiming such Collaboration IP, and to enable the other Party to Prosecute the Licensed Patents as permitted by this Section 7.2; and (ii) promptly informing the other Party of any matters coming to such Party’s attention that may materially affect the Prosecution of any Licensed Patent. Each Party will also promptly provide to the other Party all information reasonably requested by such other Party with regard to such Party’s activities pursuant to this Section 7.2.

(e) Patent Term Extension and Supplementary Protection Certificate. Where applicable to a Licensed Product in the Licensed Territory, Company will have the right and obligation to file for a patent term extension for a Licensed Patent, and to select the Licensed Patents for which it will request such patent term extension. Where applicable to a Licensed Product in the Retained Territory, Licensor will have the right and discretion to determine whether to file for a patent term extension for any Licensed Patents, and to select the Licensed Patents for which it will request such patent term extension. Licensor and the Company shall reasonably cooperate with respect to such decisions regarding, and applications for, such patent term extensions in the Licensed Territory and the Retained Territory, including extensions pursuant to 35 U.S.C. §156 et. seq. At the other Party’s reasonable request, each Party shall provide prompt and reasonable assistance to the requesting Party, including by taking such action as the patent holder as is required under any Applicable Law to obtain such patent term extension or supplementary protection certificate in the Licensed Territory and the Retained Territory.

7.3 Enforcement.

(a) Notice. Each Party shall promptly notify the other Party in writing of (i) any alleged, threatened, or actual infringement of any Licensed IP by a Third Party in any jurisdiction in the Licensed Territory or the Retained Territory in each case of which such Party becomes aware (an “Infringement”) or (ii) any alleged or threatened assertion of invalidity or unenforceability of any of the Licensed Patents by a Third Party of which such Party becomes aware.

(b) Company Controlled Patents. As between the Parties, Company will have the first right, but not the obligation, to bring and control any action or proceeding regarding any Infringement by a Third Party product that is [***] or claim of invalidity or unenforceability of any Company Controlled Patent in connection with such Infringement, or to defend against any challenge to any of the foregoing, at Company’s sole cost and expense, using counsel of its own choice. Company will keep Licensor reasonably informed of the status and progress of such action or proceeding. Licensor shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense. If (i) Company elects not to commence such action or proceeding, or settle or otherwise secure the abatement of such Infringement, or (ii) Company fails to commence any such action or proceeding within [***] then Licensor will have the right to bring and control any such action or proceeding, at its own expense and by counsel of its own choice, and Company will have the right, at its own expense, to be represented in any such action by counsel of its own choice; provided that [***].

(c) Licensor Controlled Patents. As between the Parties, Licensor will have the sole right, but not the obligation, to bring and control any action or proceeding regarding any Infringement or claim of invalidity or unenforceability of any Licensor Controlled Patent, or to defend against any challenge to any of the foregoing, at Licensor’s sole cost and expense, using counsel of its own choice.

(d) Cooperation. The Parties agree to cooperate fully in any action or proceeding regarding any Infringement or claim of invalidity or unenforceability pursuant to this Section 7.3, including in the case of Licensor, by making the inventors, applicable records and documents (including laboratory notebooks) in respect of the relevant Licensed Patents available to Company upon Company’s written request. Where a Party controls such an action, the other Party shall, and shall cause its Affiliates to, assist and cooperate with the controlling Party, as such controlling Party may reasonably request from time to time, in connection with its activities set forth in this Section 7.3, including where necessary, furnishing a power of attorney solely for such purpose or joining in, or being named as a necessary party to, such action, providing access to relevant documents and other evidence and making its employees available at reasonable business hours; provided that the controlling Party shall reimburse such other Party for its reasonable and verifiable out-of-pocket costs and expenses incurred in connection therewith. Unless otherwise set forth herein, the Party entitled to bring any patent infringement litigation in accordance with this Section 7.3 shall have the right to settle such claim; provided that neither Party shall have the right to settle any litigation under this Section 7.3 in a manner that has a material adverse effect on the rights or interest of the other Party or in a manner that imposes any costs or liability on or involves any admission by the other Party, without the express written consent of such other Party (which consent shall not be unreasonably withheld, conditioned, or delayed). In connection with any activities with respect to any action or proceeding controlled by a Party pursuant to this Section 7.3, the Party controlling such action shall (i) consult with the other Party as to the strategy for the prosecution of such claim, suit or proceeding, (ii) consider in good faith any comments from the other Party with respect thereto, and (iii) keep the other Party reasonably informed of any material steps taken and provide copies of all material documents filed, in connection with such action, provided that with respect to any action controlled by a Sublicensee of Company, Company shall only provide such information to Licensor to the extent it receives such information from such Sublicensee.

(e) Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement, any recovery realized as a result of such litigation described above in this Section 7.3 (whether by way of settlement or otherwise) shall be [***].

(f) Counterclaims or Defenses. For clarity and notwithstanding anything to the contrary in this Section 7.3, (i) any counter‑claims or defenses in any Infringement action brought by a Party pursuant to this Section 7.3, or (ii) any action by a Third Party in response to an Infringement action brought by a Party, in both cases ((i) and (ii)), will be controlled by the Party that brought such Infringement action under this Section 7.3.

7.4 Patent Listing. The Parties shall discuss and agree to the approach for the listing of any Licensed Patent in the then-current edition of the Purple Book in connection with the Marketing Approval of any Licensed Product, or in equivalent patent listings in any other country within the Licensed Territory. At the Company’s expense, Licensor will cooperate with the Company’s reasonable requests in connection therewith, to the extent required or permitted under Applicable Law.

7.5 Infringement of Third Party IP.

(a) Notice. If the Licensed Compound or any Licensed Product becomes the subject of a Third Party’s claim or assertion of infringement of a Patent within the Licensed Territory or the Retained Territory, then the Party first having notice of the claim or assertion will promptly notify the other Party.

(b) Defense.

(i) Except as otherwise provided in Article 10, Company will have the sole right, but not the obligation, to defend any such Third Party claim or assertion of infringement of a Patent with respect to the Licensed Compound or any Licensed Product in the Licensed Territory, at Company’s expense. Licensor will reasonably cooperate with Company in connection with conducting the defense of the Third Party claim or assertion, including if required to conduct such defense, furnishing a power of attorney.

(ii) Licensor will have the sole right, but not the obligation, to defend any such Third Party claim or assertion of infringement of a Patent with respect to the Licensed Compound or any Licensed Product in the Retained Territory, at Licensor’s expense.

ARTICLE 8 CONFIDENTIALITY; PRESS RELEASE

8.1 Confidentiality Obligations. At all times during the Term and for a period of [***], each Party (the “Receiving Party”) shall and shall cause its officers, directors, employees and agents to, keep confidential and not publish or otherwise disclose to a Third Party and not use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by or on behalf of the other Party (the “Disclosing Party”), except to the extent such disclosure or use is (a) expressly permitted by the terms of this Agreement or (b) reasonably necessary to exercise its rights or perform its obligations under this Agreement, in which case the Receiving Party may disclose Confidential Information of the Disclosing Party to its employees, Affiliates, Sublicensees, and subcontractors, consultants, or agents who have a need to know such Confidential Information in order to exercise the Receiving Party’s rights or perform the Receiving Party’s obligations under this Agreement, all of whom will be similarly bound by written confidentiality, non-disclosure, and non-use provisions at least as restrictive or protective of the Parties as those set forth in this Agreement. The Receiving Party will use commercially reasonable efforts to cause the foregoing Persons to comply with the restrictions on use and disclosure set forth in this Section 8.1, and will be responsible for ensuring that such Persons maintain the Disclosing Party’s Confidential Information in accordance with this Article 8. Each Party will promptly notify the other Party of any unauthorized use or disclosure of the other Party’s Confidential Information. Notwithstanding the foregoing, the terms of this Agreement and any technical information specifically relating to the Licensed Compound and/or Licensed Products (but not any Other Product) shall be deemed to be the Confidential Information of both Parties (and both Parties shall be deemed to be the Receiving Party and the Disclosing Party with respect thereto) and for the avoidance of doubt, any information contained in any royalty report shared by a Party with the other Party shall be deemed to be the Confidential Information of the sharing Party.

8.2 Exceptions. Notwithstanding the foregoing, the confidentiality and non-use obligations under Section 8.1 will not apply to the following information (and such information will not be considered Confidential Information hereunder) that the Receiving Party can demonstrate by competent written evidence:

(a) is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no breach of this Agreement by the Receiving Party;

(b) was in the Receiving Party’s possession prior to disclosure by the Disclosing Party without any obligation of confidentiality with respect to such information, as evidenced by its pre‑existing written records;

(c) is subsequently received by the Receiving Party from a Third Party rightfully in possession of such information who is not bound by any obligation of confidentiality with respect to such information; or

(d) is independently developed by or for the Receiving Party without use of or reference to any of the Disclosing Party’s Confidential Information, as evidenced by the Receiving Party’s contemporaneously maintained written records.

Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the Receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the Receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Receiving Party unless the combination and its principles are in the public domain or in the possession of the Receiving Party.

8.3 Permitted Disclosures. In addition to the exceptions contained in Section 8.2, the Receiving Party may disclose Confidential Information of the Disclosing Party to the extent (and solely to the extent) that such disclosure is reasonably necessary in the following instances:

(a) such disclosure is made in response to a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental or regulatory body of competent jurisdiction or, if in the reasonable opinion of the Receiving Party’s legal counsel, such disclosure is otherwise required by Applicable Law, including by reason of filing with securities regulators; provided, however, that the Receiving Party shall first have given notice to the Disclosing Party and given the Disclosing Party a reasonable opportunity to quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or agency or, if disclosed, be used only for the purposes for which the order was issued; and provided, further, that the Confidential Information disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order;

(b) (i) the Prosecution, defense and enforcement of Licensed Patents, in each case, as contemplated by this Agreement; or (ii) regulatory submissions and other filings with Governmental Authorities (including Regulatory Authorities), as necessary for the Exploitation or Manufacture of a Licensed Product as contemplated by this Agreement; and

(c) disclosure of the existence and applicable terms of this Agreement and the status and results of Exploitation or Manufacture of one or more Licensed Products to (i) actual or bona fide potential investors, acquirors, Sublicensees, collaborators, lenders, and other financial or commercial partners, and their respective attorneys, accountants, banks, investors, and advisors, solely for the purpose of evaluating or carrying out an actual or potential investment, acquisition, sublicense, debt transaction, or collaboration; provided that, in each such case, (A) such Persons are bound by written obligations of confidentiality, non-disclosure, and non-use provisions at least as restrictive or protective of the Parties as those set forth in this Agreement or otherwise customary for such type and scope of disclosure, and (B) any such disclosure is limited to the maximum extent practicable for the particular context in which it is being disclosed, or (ii) any Governmental Authorities for tax purposes or for the purpose of applying for or benefitting from any governmental grants or subsidies.

If and whenever any Confidential Information is disclosed in accordance with this Section 8.3, such disclosure will not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure of such information (other than by breach of this Agreement).

8.4 Use of Name. Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo or Trademark of the other Party or any of its Affiliates or any of its or their Sublicensees (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material or other form of publicity without the prior written approval of such other Party in each instance. The restrictions imposed by this Section 8.4 shall not prohibit (a) a Party from making any disclosure identifying the other Party to the extent required in connection with its exercise of its rights or obligations under this Agreement and (b) either Party from making any disclosure identifying the other Party that is required by Applicable Law or the rules of a stock exchange on which the securities of the Disclosing Party are listed (or to which an application for listing has been submitted).

8.5 Public Announcements. Neither Party shall issue any public announcement, press release or other public disclosure regarding this Agreement or its subject matter without the other Party’s prior written consent, except for any such disclosure that is, in the opinion of the disclosing Party’s counsel, required by Applicable Law or the rules of a stock exchange on which the securities of the Disclosing Party are listed (or to which an application for listing has been submitted). The Parties have agreed to issue a press release on the Effective Date in the form attached as Schedule 8.5.

8.6 Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, any technical information specifically relating to Licensed Compound and/or Licensed Products (but not any Other Product) shall be Licensor’s sole Confidential Information and no longer be deemed Confidential Information of both Parties. Upon the effective date of the termination of this Agreement for any reason, either Party may request in writing and the non-requesting Party shall either, with respect to Confidential Information solely owned by such requesting Party to which such non-requesting Party does not retain rights under the surviving provisions of this Agreement: (a) promptly destroy all copies of such Confidential Information in the possession or control of the non-requesting Party and confirm such destruction in writing to the requesting Party; or (b) promptly deliver to the requesting Party, at the requesting Party’s sole cost and expense, all copies of such Confidential Information in the possession or control of the non-requesting Party. Notwithstanding the foregoing, the non-requesting Party shall be permitted to retain such Confidential Information (i) to the extent necessary or useful for purposes of performing any continuing obligations or exercising any ongoing rights hereunder and, in any event, a single copy of such Confidential Information for archival purposes, and (ii) any computer records or files containing such Confidential Information that have been created solely by such non-requesting Party’s automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such non-requesting Party’s standard archiving and back-up procedures, but not for any other uses or purposes. All retained or archived Confidential Information shall continue to be subject to the confidentiality and non-use obligations under this Agreement for the period set forth in Section 8.1.

8.7 Publications. Neither Party may publish clinical data, peer reviewed manuscripts or give other forms of public disclosure such as abstracts and presentations, of results of studies carried out with respect to the Licensed Compound or any Licensed Product under this Agreement, without the opportunity for prior review by the other Party. Each Party (if it seeks publications, the “publishing Party”) shall provide the other Party (the “non-publishing Party”) with the opportunity to review and comment on any proposed manuscripts or presentations which relate to the Licensed Compound or any Licensed Product at least [***]. Each publishing Party shall ensure that any of its publications will not adversely affect any of the non-publishing Party’s Intellectual Property strategies. Each non-publishing Party shall provide the publishing Party with its comments in writing, if any, within [***]. Each publishing Party shall consider any such reasonable comments of the non-publishing Party in good faith and shall remove any and all of the non-publishing Party’s Confidential Information at the request of the non-publishing Party. In addition, each publishing Party shall delay the submission for a period up to [***] in the event that the non-publishing Party can demonstrate reasonable need for such delay for the preparation and filing of a patent application. If the non-publishing Party fails to provide its comments to the publishing Party within [***] the non-publishing Party shall be deemed to not have any comments, and the publishing Party shall be free to publish in accordance with this Section 8.7 after [***] has elapsed. The publishing Party shall provide the non-publishing Party with a copy of the manuscript at the time of the submission. The publishing Party shall not have the right to publish or present the non-publishing Party’s Confidential Information (other than, for clarity, [***]) without the prior written consent of the non-publishing Party, except as expressly permitted in this Agreement. In addition, if permitted and practicable, a Party will provide the other Party a reasonable opportunity to review publications by university or institutional Third Parties with respect to the Licensed Compound or any Licensed Product in connection with a Clinical Trial or research conducted with such Party.

ARTICLE 9 REPRESENTATIONS AND WARRANTIES

9.1 Mutual Representations and Warranties. Licensor and the Company each represents and warrants to the other, as of the Effective Date, that:

(a) it is a corporation or company duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization and has all requisite power and authority, corporate or otherwise, to execute, deliver and perform this Agreement;

(b) the execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action and do not violate: (i) such Party’s charter documents, bylaws or other organizational documents; (ii) in any material respect, any agreement, instrument or contractual obligation to which such Party is bound; (iii) any requirement of any Applicable Law; or (iv) any order, writ, judgment, injunction, decree, determination or award of any court or governmental agency presently in effect applicable to such Party;

(c) this Agreement is a legal, valid and binding obligation of such Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance and general principles of equity (whether enforceability is considered a proceeding at law or equity); and

(d) neither it nor any of its Affiliates or its directors (i) has been debarred or is subject to debarment and neither it nor any of its Affiliates will use in any capacity, in connection with the services to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the United States Food, Drug, and Cosmetic Act, as amended from time to time or who is the subject of a conviction described in such section, (ii) is designated on, or 50% or more owned or otherwise controlled by persons designated on, a Prohibited Party List; (iii) has been prohibited from contracting with or obtaining funding from U.S. federal government agencies; or (iv) has been convicted of any crime for which a Person could be so debarred or that is a felony listed among the exclusion authorities set forth on the U.S. Department of Health and Human Services, Office of Inspector General website.

9.2 Additional Representations and Warranties of Licensor. Licensor further represents and warrants to the Company, as of the Effective Date, as follows (except as otherwise disclosed in Schedule 9.2):

(a) Licensor and its Affiliates have the full right, power and authority to grant the licenses and other rights purported to be granted to the Company under this Agreement;

(b) Licensor and its Affiliates are the sole and exclusive owners of the Licensed IP, free of any lien, encumbrance, charge, mortgage, liability, security interest or claim of ownership by any Third Party;

(c) All Licensed Patents existing as of the Effective Date (“Existing Patents”) are (i) listed on Schedule 9.2(c), (ii) subsisting and are not, to Licensor’s Knowledge, invalid or unenforceable, in whole or in part.

The pending applications included in Existing Patents are being diligently prosecuted in the respective patent offices in accordance with Applicable Law, and all applicable fees have been paid on or before the due date for payment;

(d) Licensor has obtained, or caused its Affiliates, as applicable, to obtain, assignments from the inventors of all inventorship rights to all Existing Patents, and to Licensor’s Knowledge, all such assignments are valid and enforceable;

(e) There are no pending, or to Licensor’s Knowledge, alleged or threatened in writing, (i) inter partes reviews, post-grant reviews, interferences, re-examinations or oppositions involving the Existing Patents, or (ii) any inventorship challenges involving the Existing Patents that are in or before any patent office (or other Governmental Authority performing similar functions);

(f) As of the Effective Date, the Existing Patents represent all Patents that Licensor or its Affiliates own or otherwise have rights to with claims directed to or that Cover the Licensed Compound or a Licensed Product, or the Exploitation or Manufacture thereof. To Licensor’s Knowledge, there is no Know-How owned by or otherwise in the possession or control of Licensor or any of its Affiliates that relates to the Licensed Compound or a Licensed Product that is not within the Licensed Know-How;

(g) Licensor has made available to Company all material information and data relating to the results of all pre-clinical and clinical studies, including Clinical Trials, on the Licensed Compound and Licensed Products in Licensor’s possession or control, including information regarding the safety or efficacy of the Licensed Compound or Licensed Products, in its possession or Control, and all such information and data is accurate in all material respects;

(h) Neither Licensor nor any of its Affiliates has previously entered into any definitive agreement, whether in writing or otherwise, (i) with respect to or otherwise assigned, transferred, licensed, conveyed or otherwise encumbered its right, title or interest in or to the Licensed Patents or Licensed Know-How, (ii) granted any Third Party any rights of reference under or access to the Regulatory Materials existing as of the Effective Date (“Existing Regulatory Material”), in each case for use in connection with the Exploitation of the Licensed Compound or any Licensed Product in the Licensed Territory;

(i) There are no claims, judgments, or settlements against or owed by Licensor or pending legal claims or litigation, alleging that (i) the Existing Patents are invalid or unenforceable or (ii) the Exploitation or Manufacture of the Licensed Compound or Licensed Products as contemplated herein, violates, infringes, misappropriates or would violate, infringe or misappropriate any intellectual property or proprietary right of any Person, and Licensor is not aware of any fact or circumstance that would give rise to any such claims, judgments, or settlements;

(j) To Licensor’s Knowledge, the Exploitation or Manufacture of the Licensed Compound as contemplated as of the Effective Date does not infringe, misappropriate, or otherwise violate any intellectual property right or proprietary right of any Third Party; (k) The Development of the Licensed Compound and Licensed Products conducted by Licensor and its Affiliates, and their respective subcontractors, including any and all pre-clinical studies and Clinical Trials related thereto, have all been conducted in accordance with Applicable Law in all material respects and Licensor has the right to provide Company all data and results from each such Clinical Trial; and

(l) [***].

9.3 Compliance with Law. Each Party agrees that in performing its obligations or exercising its rights under this Agreement, it shall (a) comply with all Applicable Law (including Export Control Laws), applicable national and international (e.g., ICH, GCP, GLP, and cGMP) guidelines and applicable regulations governing Exploitation and promotional activities and interactions with healthcare professionals and patient organizations including industry codes of conduct and any applicable transparency regulations; and (b) not employ or engage any Person who meets any of the criteria set forth in any of clause (i) through (iv) in Section 9.1(d) in the performance of activities under this Agreement, or, to such Party’s knowledge, is the subject of any proceeding relating to any of clause (i) through (iv) in Section 9.1(d), and shall promptly notify the other Party if it becomes aware of any Person employed or engaged to perform any activities under this Agreement that meets any such criteria.

9.4 Mutual Covenants.

(a) From and after the Effective Date, each Party shall, and shall cause its Affiliates and applicable Sublicensees to, in connection with the performance of this Agreement comply at all times with the Data Protection Laws for all Personal Data collected, Processed, hosted, or transmitted in performance of this Agreement, including if required, by entering into a Data Processing Agreement.

(b) Notwithstanding the foregoing, to the extent any of the covenants in Section 9.4(a) require a Party to obtain the consent of any Third Party or a Governmental Authority, such Party shall use Commercially Reasonable Efforts to obtain such consent.

9.5 DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.

9.6 Anti-Bribery and Anti-Corruption Compliance. Each Party represents, warrants, and covenants to the other Party in connection with this Agreement that:

(a) it shall, and shall cause its Affiliates and its and their Sublicensees and subcontractors to, conduct their activities and exercise their rights under this Agreement in a manner that complies with Applicable Law, including the Anti-Corruption Laws, and good business ethics.

(b) it shall not, and shall cause its Affiliates and its and their Sublicensees and subcontractors not to, directly or indirectly, in connection with its activities under this Agreement pay, offer or promise to pay, or authorize the payment of any money, or give, offer or promise to give, or authorize the giving of anything of value (collectively, a “Payment”) to any official or employee of any government, or any department, agency, or instrumentality thereof; political party or political party official; official or employee of any international public organizations; candidates for public office; or persons acting on behalf of any of the foregoing (collectively, “Officials”) if such Payment would constitute a violation of any Anti-Corruption Law. In addition, regardless of legality, neither Party shall, and each Party shall cause its Affiliates and its and their Sublicensees and subcontractors not to, make any Payment, directly or indirectly, in connection with its activities under this Agreement, to any Official if such Payment is for the purpose of (i) improperly influencing or rewarding any act or decision of such Official, (ii) inducing such Official to do or omit to do any act in violation of his or her lawful duty, (iii) improperly inducing such Official to use its or his influence with a government or instrumentality thereof to affect or influence any act or decision of such government or instrumentality, or (iv) securing any improper advantage for either Party.

(c) Each Party shall promptly notify the other Party upon becoming aware of and shall keep the other Party reasonably apprised of, (i) any allegation or violation of, or any notice, subpoena, demand, or other communication (oral or written) from any Governmental Authority regarding such Party’s actual, alleged, or possible failure to comply with, any Anti-Corruption Laws or any other Applicable Law by such Party or any of its Affiliates or those acting on such Party’s behalf, (ii) any confirmed or corroborated violation of Anti-Corruption Laws or any other Applicable Law that are the result of an internal inquiry, in each case ((i) and (ii)), in connection with the matters that are the subject of this Agreement and the performance by such Party of its obligations hereunder; and (iii) the occurrence of any fact or event that would render any representation, warranty, covenant, or undertaking in Section 9.6(b) or Section 9.6(c) incorrect or misleading. Following such notification, such Party shall keep the other Party reasonably apprised of the matters described in this Section 9.6(c) throughout the duration of such matters.

(d) If there is any actual, alleged, or potential breach by a Party or any of its Affiliates or those acting on such Party’s behalf of Section 9.6(a) or Section 9.6(b), then (i) if such breach is caused by any employee, consultant, subcontractor or any representative of such Party or its Affiliates, then such Party shall, and shall cause such Affiliate to, implement the relevant corporate compliance program with respect to such violation, (ii) if such breach is caused by a systemic problem, then such Party shall implement a remedial plan with respect thereto, and (iii) if following either or both of the foregoing (i) or (ii), such Party does not cure the applicable breach, then the other Party may terminate this Agreement [***] written notice to the breaching Party.

ARTICLE 10 INDEMNITY

10.1 Indemnification of the Company. Subject to Section 10.3, Licensor shall indemnify the Company, its Affiliates and its or their respective directors, officers, employees and agents (the “Company Indemnitees”) and defend and hold each of them harmless, from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) (collectively, “Losses”) resulting from any and all suits, investigations, claims or demands of Third Parties (collectively, “Third Party Claims”) against a Company Indemnitee arising from or occurring as a result of: (a) the breach of any representation, warranty, covenant or other term of this Agreement by Licensor; (b) the fraud, gross negligence or willful misconduct on the part of Licensor or its Affiliates or its or their Sublicensees, subcontractors, distributors or its or their respective directors, officers, employees or agents in performing its or their obligations or exercising its or their rights under this Agreement; or (c) the Exploitation by or on behalf of Licensor or any of its Affiliates or its or their Sublicensees, subcontractors or distributors of the Licensed Compound or Licensed Products, including prior to the Effective Date and during the Term in the Retained Territory, or after the effective date of termination of this Agreement, except, in each case, to the extent such Losses arise from or occur as a result of an act, omission or event described in clause (a) through (c) of Section 10.2 for which Company is obligated to indemnify the Licensor Indemnitees.

10.2 Indemnification of Licensor. Subject to Section 10.3, the Company shall indemnify Licensor, its Affiliates, its or their respective directors, officers, employees and agents (the “Licensor Indemnitees”) and defend and hold each of them harmless, from and against any and all Losses resulting from any and all Third Party Claims against a Licensor Indemnitee arising from or occurring as a result of: (a) the breach of any representation, warranty, covenant or other term of this Agreement by the Company; (b) the fraud, gross negligence or willful misconduct on the part of the Company or its Affiliates or its or their Sublicensees, subcontractors, distributors or its or their respective directors, officers, employees or agents in performing its or their obligations or exercising its or their rights under this Agreement; or (c) the Exploitation by or on behalf of the Company or any of its Affiliates or its or their Sublicensees, subcontractors or distributors of the Licensed Compound or Licensed Products during the Term in the Licensed Territory, except, in each case, to the extent such Losses arise from or occur as a result of an act, omission or event described in clause (a) through (c) of Section 10.1, for which Licensor is obligated to indemnify the Company Indemnitees.

10.3 Indemnification Procedures.

(a) Notice of Claim. All indemnification claims in respect of a Party, its Affiliates or its or their Sublicensees or its or their respective directors, officers, employees and agents shall be made solely by such Party to this Agreement (the “Indemnified Party”). The Indemnified Party shall give the indemnifying Party prompt written notice (an “Indemnification Claim Notice”) of any Losses or discovery of fact upon which such Indemnified Party intends to base a request for indemnification under this Article 10, but in no event shall the indemnifying Party be liable for any Losses that result solely from any delay in providing such notice. Each Indemnification Claim Notice must contain a description of the claim for indemnification and the nature and amount of such Loss (to the extent that the nature and amount of such Loss is known at such time). The Indemnified Party shall furnish promptly to the indemnifying Party copies of all papers and official documents received in respect of any Losses and Third Party Claims.

(b) Control of Defense. At its option, the indemnifying Party may assume the defense of any Third Party Claim by giving written notice to the Indemnified Party thirty (30) days after the indemnifying Party’s receipt of an Indemnification Claim Notice. The assumption of the defense of a Third Party Claim by the indemnifying Party shall not be construed as an acknowledgment that the indemnifying Party is liable to indemnify the Indemnified Party in respect of the Third Party Claim, nor shall it constitute a waiver by the indemnifying Party of any defenses it may assert against the Indemnified Party’s claim for indemnification. Upon assuming the defense of a Third Party Claim, the indemnifying Party may appoint as lead counsel in the defense of the Third Party Claim any legal counsel reasonably selected by the indemnifying Party; provided that it obtains the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld, conditioned or delayed). In the event the indemnifying Party assumes the defense of a Third Party Claim, the Indemnified Party shall immediately deliver to the indemnifying Party all original notices and documents (including court papers) received by the Indemnified Party in connection with the Third Party Claim. Should the indemnifying Party assume the defense of a Third Party Claim, except as provided in Section 10.3(c), the indemnifying Party shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party in connection with the analysis, defense, or settlement of the Third Party Claim unless and only to the extent specifically requested in writing by the indemnifying Party. In the event that it is ultimately determined that the indemnifying Party is not obligated to indemnify, defend, or hold harmless the Indemnified Party from and against the Third Party Claim, the Indemnified Party shall reimburse the indemnifying Party for any and all reasonable and documented costs and expenses (including attorneys’ fees and costs of suit) and any Losses incurred by the indemnifying Party in its defense of the Third Party Claim.

(c) Right to Participate in Defense. Any Indemnified Party shall be entitled to participate in, but not control, the defense of such Third Party Claim and to employ counsel of its choice for such purpose; provided, however, that such employment shall be at the Indemnified Party’s sole cost and expense unless (i) the payment therefor has been specifically authorized in writing by the indemnifying Party, (ii) the named parties to any such proceeding (including any impleaded parties) include both the indemnifying Party and the Indemnified Party and representation of both Parties by the same counsel would be inappropriate due to actual or potential differing interests between them, or (iii) the indemnifying Party has failed to assume the defense and employ counsel in accordance with Section 10.3(b) (in which case the Indemnified Party shall control the defense).

(d) Settlement. If the indemnifying Party has assumed the defense of the Third Party Claim in accordance with Section 10.3(b), the indemnifying Party shall have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss (each, a “Compromise”) where any Losses relating solely to the payment of money damages; provided that if a Compromise (i) commits the Indemnified Party to take, or forbear to take, any action, (ii) involves equitable or other non-monetary relief, or (iii) includes admission of liability in respect of any Third Party Claim, then the indemnifying Party shall have the right to enter a Compromise only if it obtains the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld, conditioned, or delayed). If the indemnifying Party does not assume and conduct the defense of a Third Party Claim as provided above, the Indemnified Party may defend against such Third Party Claim; provided that the Indemnified Party shall not enter any Compromise without the prior written consent of the indemnifying Party (which consent shall not be unreasonably withheld, conditioned or delayed).

(e) Cooperation. Regardless of whether the indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall and shall cause each indemnitee to, cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours afforded to the indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Third Party Claim and making indemnitees and other employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder and the indemnifying Party shall reimburse the Indemnified Party for all its reasonable and verifiable out-of-pocket expenses in connection therewith.

(f) Expenses. Except as provided above, the costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any claim of indemnification shall be reimbursed on a Calendar Quarter basis by the indemnifying Party, without prejudice to the indemnifying Party’s right to contest the Indemnified Party’s right to indemnification and subject to prompt refund in the event the indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party.

10.4 Special, Indirect and Other Losses. NEITHER PARTY NOR ANY OF ITS AFFILIATES OR SUBLICENSEES SHALL BE LIABLE IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY INDIRECT, SPECIAL, PUNITIVE, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OR FOR LOSS OF PROFITS SUFFERED BY THE OTHER PARTY ARISING UNDER OR IN CONNECTION WITH THIS AGREEMENT, EVEN IF SUCH PARTY HAS BEEN INFORMED OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES, EXCEPT THAT NOTHING IN THIS SECTION 10.4 WILL LIMIT OR RESTRICT: (A) THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER THIS Article 10; (B) DAMAGES AVAILABLE FOR A PARTY’S BREACH OF A PARTY’S OBLIGATIONS UNDER ARTICLE 8; OR (C) DAMAGES AVAILABLE FOR A PARTY’S FRAUD, GROSS NEGLIGENCE OR WILLFUL MISCONDUCT.

10.5 Insurance. Each Party shall have and maintain such types and amounts of insurance as is (a) normal and customary in the pharmaceutical industry generally for parties similarly situated, and (b) otherwise required by Applicable Law. Upon first request by a Party, the other Party shall provide to the requesting Party evidence of its insurance coverage. Each Party shall maintain such insurance after the expiration or termination of this Agreement in its entirety for a period of [***] following termination or expiration of this Agreement in its entirety.

ARTICLE 11 TERM AND TERMINATION

11.1 Term and Expiration. This Agreement shall commence on the Effective Date and, unless earlier terminated in accordance herewith, shall continue in full force and effect until the date of expiration of all payment obligations for each Licensed Product (such period, the “Term”). Upon the expiration of all payment obligations for a Licensed Product in a country in the Licensed Territory, the licenses granted to the Company under Section 2.1 with respect to the Exploitation and Manufacture of such Licensed Product in such country will automatically become fully paid-up, perpetual, irrevocable, and royalty-free.

11.2 Termination.

(a) Material Breach.

(i) In the event that either Party (the “Breaching Party”) shall be in material breach in the performance of any of its material obligations under this Agreement (a “Material Breach”), in addition to any other right and remedy the other Party (the “Non-Breaching Party”) may have, the Non-Breaching Party may terminate this Agreement by providing [***] (the “Notice Period”) prior written notice (the “Termination Notice”) to the Breaching Party and specifying the Material Breach and its claim of right to terminate; provided that the termination shall not become effective at the end of the Notice Period if the Breaching Party cures the Material Breach specified in the Termination Notice during the Notice Period (or, if such Material Breach cannot be cured within the Notice Period, if the Breaching Party commences actions to cure such Material Breach within the Notice Period and thereafter diligently continues such actions); provided further that, if the Material Breach and the subsequent failure to cure is with respect to one or more Regions in the Licensed Territory, but not all Regions in the Licensed Territory, then Licensor shall not have the right to terminate this Agreement in its entirety, but shall have the right to terminate this Agreement solely with respect to the Region in which such Material Breach and failure to cure occurred, and this Agreement shall remain in full force and effect with respect to all other countries in the Licensed Territory.

(ii) For the avoidance of doubt and without limiting the circumstances where a Material Breach may occur with respect to the Company (as a Breaching Party), a Material Breach is deemed to have occurred to the Company if the Company fails to pay the Licensor any undisputed amount which is payable to the Licensor under this Agreement that has fallen due or if it has been established that the Company has materially breached its obligation under Section 3.1(i) or Section 4.2.

(iii) If the Breaching Party disputes in good faith the existence or materiality of a Material Breach or whether such Material Breach has been cured, then the issue of whether the Non-Breaching Party may properly terminate this Agreement on expiration of the applicable Notice Period as provided under Section 11.2(a) (a “Material Breach Dispute”) will be resolved in accordance with Section 12.7(c). If as a result of such Material Breach Dispute resolution process, it is determined that the Breaching Party committed a Material Breach and the Breaching Party does not cure such Material Breach within [***] (the “Additional Cure Period”), then such termination will be effective as of the expiration of the Additional Cure Period.

This Agreement will remain in full force and effect during the pendency of any such dispute resolution proceeding and the Notice Period set forth in Section 11.2(a) and any Additional Cure Period, in each case, will be tolled during any such dispute resolution proceeding, such proceeding will not suspend any obligations of either Party hereunder, and each Party will use reasonable efforts to mitigate any damage. If as a result of such dispute resolution proceeding it is determined that the Breaching Party did not commit such Material Breach (or such Material Breach was cured in accordance with Section 11.2(a)(i) or (iii)), then no termination will be effective, and this Agreement will continue in full force and effect.

(b) Termination for Challenge of Licensed Patents. If the Company or any of its Affiliates commences, or voluntarily assists any Sublicensee or Third Party in commencing, any legal or administrative proceeding that challenges the validity or enforceability of any Licensed Patent (a “Patent Challenge”), then Licensor shall have the right to terminate this Agreement upon [***] prior written notice, unless such Patent Challenge is withdrawn, dismissed or otherwise abandoned during [***] period.

(c) Termination by Company. Company may terminate this Agreement in its entirety or on a Region-by-Region basis, for any or no reason, upon [***] prior written notice to Licensor.

(d) Termination for Insolvency. In the event that either Party (i) files for protection under bankruptcy or insolvency laws, (ii) makes an assignment for the benefit of creditors, (iii) appoints or suffers appointment of a receiver or trustee over substantially all of its property that is not stayed or discharged within [***], (iv) proposes a written agreement of composition or extension of its debts, (v) proposes or is a party to any dissolution or liquidation, (vi) files a petition under any bankruptcy or insolvency act or has any such petition filed against that is not stayed or discharged within [***] or (vii) admits in writing its inability generally to meet its obligations as they fall due in the general course, then the other Party may terminate this Agreement in its entirety effective immediately upon written notice to such Party.

11.3 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by the Company or Licensor are and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code (the “Code”) or any analogous provisions in any other country (or jurisdiction), licenses of right to “intellectual property” as defined under Section 101 of the Code. The Parties agree that the Parties, as licensees of such rights under this Agreement, shall retain and may fully exercise all of their rights and elections under the Code or any analogous provisions.

11.4 Consequences of Termination. In the event of a termination of this Agreement in its entirety or on a Region-by-Region basis:

(a) subject to Section 11.4(c), all rights and licenses with respect to the Terminated Territory granted by Licensor to the Company hereunder, and if the Agreement is terminated in its entirety, all rights and licenses granted by Licensor to the Company with respect to the Retained Territory, shall immediately terminate; (b) subject to Section 11.4(c), the Company shall not, and shall not permit any of its Affiliates or any of its and their Sublicensees or Distributors to, distribute, market, promote, offer for sale or sell any Licensed Product directly or indirectly to any Person for commercial use in the Terminated Territory;

(c) notwithstanding the termination of this Agreement, the Company shall have the right for [***] to wind down its activities in connection with the Licensed Products in the Terminated Territory, as though this Agreement had not terminated and such activities shall be licensed for such [***] period and shall not constitute infringement of any of Licensor’s or its Affiliates’ Patents or other Intellectual Property rights. For the avoidance of doubt, any sale pursuant to such activities shall be Net Sales and subject to Article 6;

(d) the Company shall and hereby does, and shall cause its Affiliates and its and their Sublicensees to, effective as of the effective date of termination, assign to Licensor all of its right, title and interest (if any) in and to all Dossiers and Regulatory Materials (including any Regulatory Approvals) specifically related to the Licensed Compound or any Licensed Product in the Terminated Territory. To the extent that the Company is unable to assign to Licensor any of the foregoing, the Company shall and hereby does, and shall cause its Affiliates and its and their Sublicensees to, effective as of the effective date of termination, grant Licensor an exclusive, perpetual right of reference, with the right to grant multiple tiers of further rights of reference, in and to all Regulatory Materials (including any Regulatory Approvals) specifically related to the Licensed Compound or any Licensed Product in the Terminated Territory to enable Licensor to Exploit the Licensed Compound or any Licensed Product in the Terminated Territory;

(e) the Company shall disclose promptly to Licensor in writing any agreements with a Third Party specifically relating to the Licensed Compound or any Licensed Product in the Terminated Territory, and at Licensor’s written request, the Company shall, and shall cause its Affiliates and its and their Sublicensees to, (i) assign to Licensor or its designee all such agreements that solely relate to the Licensed Compound or any Licensed Product in the Terminated Territory, and (ii) with respect to any other such agreements, provide such assistance as reasonably requested by Licensor to enter into agreements on substantially the same terms with the applicable counterparty;

(f) effective upon the effective date of termination of this Agreement, the Company hereby grants to Licensor an exclusive, fully paid-up, royalty-free license (with the right to grant sublicenses through multiple tiers) under the Reversion IP for Licensor (i) to Exploit and Manufacture the Licensed Compound and Licensed Products in the Field in the Terminated Territory, or (ii) if the Agreement is terminated as a whole by the Company, to Exploit and Manufacture the Licensed Compound and Licensed Products in the Field in the Licensed Territory;

(g) [***]; and

(h) notwithstanding the foregoing, in no event will Company be obligated to assign or otherwise grant to Licensor any rights in or to any Other Product or provide to Licensor any information or materials directed to any Other Product.

11.5 Remedies. Except as otherwise expressly provided herein, termination of this Agreement in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity.

11.6 Accrued Rights; Surviving Obligations. Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Terms of any Ancillary Agreement will survive termination or expiration as set forth therein. Section 7.3 will survive the expiration of this Agreement, but will not survive in the case of termination. Without limiting the foregoing, the following terms of this Agreement shall survive the termination or expiration of this Agreement for any reason for the period set forth therein, or indefinitely if no period of time is specified: Article 1 (Definitions); 2.2 (License Grants to the Licensor), except [***]; Section 3.1(g) (Development Records); Section 3.2(c) (Right of Reference); Article 6 (Financial Terms) but only in respect of payments accrued during the Term but unpaid as of expiration or termination or during any applicable wind-down period under Section 11.4(c) (Consequences of Termination); Section 6.12 (Financial Records); Section 6.13 (Audits); Section 7.1 (Ownership of Intellectual Property); Section 7.3(d) (Collaboration) and Section 7.3(e) (Expenses and Recoveries), solely with respect to any pending enforcement action initiated during the Term under Section 7.3 (Enforcement); Section 9.4(a) (Mutual Covenants) solely to the extent required by the Data Protection Laws; Section 9.5 (Disclaimer of Warranties); Article 10 (Indemnity); Article 8 (Confidentiality; Press Release); Section 11.4 (Consequences of Termination); Section 11.5 (Remedies); Section 11.6 (Accrued Rights; Surviving Obligations); and Article 12 (Miscellaneous).

ARTICLE 12 MISCELLANEOUS

12.1 Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement (other than an obligation to make payments) when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, shortages, pandemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, general strikes, lockouts or other labor disturbances (whether involving the workforce of the non-performing Party or of any other Person), or acts, orders, omissions or delays in acting by any Governmental Authority (except to the extent such delay results solely from the breach by the non-performing Party or any of its Affiliates of any term or condition of this Agreement) (“Force Majeure”). The non-performing Party shall notify the other Party of such Force Majeure within [***] after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration and any action being taken by the non-performing Party to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is reasonably necessary and the non-performing Party shall use Commercially Reasonable Efforts to remedy its inability to perform.

12.2 Export Control. This Agreement is made subject to Export Control Laws. Each Party agrees that it will not export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate Governmental Authority in accordance with Applicable Law (including Export Control Laws). Each Party further agrees that, except as permitted by applicable government license or authorization, in performance of its obligations under the Agreement, it shall not engage in any direct or indirect transactions or dealings with any country or territory that is the subject of an embargo by the U.S. government (currently, Cuba, Iran, North Korea, Syria, and the Crimea, Donetsk People’s Republic, and Luhansk People’s Republic regions of Ukraine) (collectively, the “Embargoed Countries”), any person that is located in, acting on behalf of, or directly or indirectly owned or controlled by any governmental entity of, any Embargoed Country, or any person identified on, or 50% or more owned or otherwise controlled by persons identified on, any list of prohibited parties maintained by the government of the United States or other applicable jurisdiction (“Prohibited Party Lists”), including, but not limited to, the Specially Designated Nationals and Blocked Persons List or Foreign Sanctions Evaders List, which are maintained by the Office of Foreign Assets Control of the U.S. Treasury Department, or the Entity List, Denied Persons List, or Unverified List, which are maintained by the Bureau of Industry and Security of the U.S. Commerce Department.

12.3 Assignment. Neither Party may sell, transfer, assign or otherwise dispose of (for the purposes of this Section 12.3, “Assign”) any of its rights, title and interest under this Agreement, whether by operation of law or otherwise, in whole or in part without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned, or delayed, except that each Party shall have the right, without such consent, to Assign all of its rights, title and interest under this Agreement, concurrently with the delegation of all of its obligations hereunder (a “Permitted Assignment”) to (a) any of its Affiliates; or (b) any successor in interest (whether by merger, acquisition, asset purchase or otherwise) to all or substantially all of the business of such Party to which this Agreement relates; provided that, in each case of sub-section (a) or (b) above, the proposed successor in interest or assignee of the Party shall have at least a comparable level of expertise, resources and capabilities as such Party at the time of the proposed Assignment; provided further that such Party shall provide prior written notice to the other Party no later [***], together with an acknowledgement and undertaking in writing of the proposed successor in interest or assignee of such Party that it will assume all of such Party’s obligations hereunder upon consummation of the Permitted Assignment. Any permitted successor of a Party or any permitted assignee of all of a Party’s rights under this Agreement that has also assumed all of such Party’s obligations hereunder in writing shall, upon any such succession or assignment and assumption, be deemed to be a party to this Agreement as though named herein in substitution for the assigning Party, whereupon the assigning Party shall cease to be a party to this Agreement. All such validly assigned rights of a Party shall inure to the benefit of and be enforceable by, and all such validly delegated obligations of such Party shall be binding on and be enforceable against, the permitted successors and assigns of such Party. Any attempted assignment or delegation in violation of this Section 12.3 shall be void and of no effect.

12.4 Performance by Affiliates. Notwithstanding any provision to the contrary set forth in this Agreement, each Party will have the right to perform any or all of its obligations and exercise any or all of its rights under this Agreement through any Affiliate; provided that such Party will be and remain responsible and liable for the prompt payment and performance of such obligations. Each Party hereby guarantees the performance by any Affiliates of such Party’s obligations under this Agreement and will cause any such performing Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement will be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.

12.5 Severability. If one or more of the terms or provisions of this Agreement is held by a court of competent jurisdiction to be void, invalid or unenforceable in any situation in any jurisdiction, such holding will not affect the validity or enforceability of the remaining terms and provisions hereof or the validity or enforceability of the void, invalid or unenforceable term or provision in any other situation or in any other jurisdiction, and the term or provision will be considered severed from this Agreement solely for purposes of such situation and solely in such jurisdiction. If the final judgment of a court of competent jurisdiction holds that any term or provision hereof is void, invalid or unenforceable, the Parties agree to: (a) reduce the scope, duration, area or applicability of the term or provision or to delete specific words or phrases to the minimum extent necessary to cause such term or provision as so reduced or amended to be enforceable; and (b) make a good faith effort to replace any void, invalid or unenforceable term or provision with a valid and enforceable term or provision such that the objectives contemplated by the Parties when entering this Agreement may be realized.

12.6 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.

12.7 Dispute Resolution.

(a) Disputes; Jurisdiction and Venue. Except as provided in Section 5.4(c) or Section 12.11 or with respect to an Expert Determination Matter, if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a “Dispute”), then either Party shall have the right to refer such Dispute to its respective Executive Officer for attempted resolution by good faith negotiations during a period of [***]. Any final decision mutually agreed to by the Executive Officers shall be conclusive and binding on the Parties. If such Executive Officers are unable to resolve any such Dispute within such [***] period, upon written notice to the other Party, either Party shall be free to institute arbitration whereby the Parties consent to the [***] then in effect (“Arbitration Rules”). The Arbitration Rules are deemed to be incorporated by reference into this provision and may be amended by the rest of this provision. The seat of the arbitration shall be New York, New York. The arbitration tribunal shall consist of [***] (the “Tribunal”). The language to be used in the arbitral proceedings shall be English. Any arbitration award shall also be given in English. The Tribunal will be required to render the decision in writing and to comply with, and the award will be limited by, any express provisions of this Agreement relating to damages or the limitation thereof. Any award of the Tribunal shall be final and binding upon the Parties. The Parties undertake to carry out each and every arbitral award without delay. Each Party shall bear its own attorneys’ fees and costs, and other costs arising out of the arbitration, and shall pay an equal share of arbitration administrative fees and Tribunal member fees and costs; provided, however, that the Tribunal, in its award, shall be authorized to determine whether a Party is the prevailing Party, and if so, to award to that prevailing Party reimbursement for its reasonable attorneys’ fees and costs, and other costs arising out of the arbitration, arbitration administrative fees and Tribunal member fees and costs.

(b) Equitable Relief. Nothing in this Section 12.7 shall be construed as preventing a Party from seeking interim relief from any court of competent jurisdiction, including a temporary restraining order, preliminary injunction or other interim equitable relief, concerning a dispute either prior to or during any proceeding if necessary to protect the interests of such Party or to preserve the status quo pending the proceeding.

(c) Material Breach Dispute. In the event of a Material Breach Dispute, then such Party shall have the right to refer such Dispute to expedited arbitration under the Arbitration Rules by written notice to the other Party to the extent that such expedited arbitration is available under the Arbitration Rules.

(d) Confidentiality. The Parties agree that all negotiations and the arbitration will be confidential and shall be treated as compromise and settlement negotiations for purposes of applicable rules of evidence. The Parties further agree that the arbitration shall be kept confidential and that the existence of the arbitration proceeding and any element of it (including but not limited to any pleadings, briefs or other documents submitted or exchanged, any testimony or other oral submissions, and any awards) shall not be disclosed beyond the Tribunal, [***], the Parties, their counsel, accountants and auditors, insurers and re-insurers, and any person or entity necessary to the conduct of the proceeding. The confidentiality obligations in this Section 12.7(d) shall not apply (i) if disclosure is required by Applicable Law, or in judicial or administrative proceedings, or (ii) as far as disclosure is necessary to enforce the rights arising out of the arbitration award.

12.8 Notices. All demands, notices, consents, approvals, reports, requests and other communications hereunder shall be in writing, in English, and shall be deemed to have been duly given only if delivered personally, by mail (first class, postage prepaid), or by overnight delivery using a globally-recognized carrier, to the Parties at the following addresses:

     Company

     To: 

     With a copy to (which shall not constitute effective notice):

      

     Vor Biopharma Inc.
[***]
Attn: Jean-Paul Kress, M.D.
[***]

     Vor Biopharma Inc.
[***]
Attn: Sandy Mahatme
[***]
 
Brown Rudnick LLP
1900 N Street NW 
4th Floor 
Washington, D.C. 20036 
Attn: Elizabeth Parsons
Email: eparsons@brownrudnick.com

    

     Licensor

     To:

     With a copy to (which shall not constitute effective notice):

      

     RemeGen Co., Ltd. 
58 Middle Beijing Road
Yantai Pilot Free Trade Zone,
Yantai, Shandong Province, China 264006
Attn: CEO
Email: [***]

     RemeGen Biosciences, Inc.
[***]
Attn: VP of International Legal Affairs
[***]
 
 
Cooley LLP
3175 Hanover Street
Palo Alto, CA 94304-1130
Attn:  Lila Hope
Email:  lhope@cooley.com

    

or to such other address as the addressee shall have last furnished in writing in accordance with this provision. All notices shall be deemed effective upon receipt by the addressee.

12.9 Entire Agreement; Amendments. This Agreement, together with the Ancillary Agreements and the Schedules and Exhibits attached hereto and thereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises and representations, whether written or oral, with respect thereto are superseded hereby. Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement. No amendment, modification, release or discharge shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties. In the event of any inconsistencies between this Agreement and any schedules or other attachments hereto, the terms of this Agreement shall control.

12.10 English Language. This Agreement shall be written and executed in and all other communications under or in connection with this Agreement shall be in the English language unless expressly stated otherwise herein. Any translation into any other language shall not be an official version thereof and in the event of any conflict in interpretation between the English version and such translation, the English version shall control. It is agreed that any Patent information to be provided by Licensor to the Company hereunder may be in the original language and the Company shall bear the costs of translation.

12.11 Equitable Relief. Each Party acknowledges and agrees that the restrictions set forth in Article 7 and Article 8 are reasonable and necessary to protect the legitimate interests of the other Party and that such other Party would not have entered into this Agreement in the absence of such restrictions and that any breach or threatened breach of any provision of such Section or Articles may result in irreparable injury to such other Party for which there will be no adequate remedy at law. In the event of a breach or threatened breach of any provision of such Section or Articles, the non-breaching Party shall be authorized and entitled to seek from any court of competent jurisdiction non-monetary (but not monetary) injunctive relief, whether preliminary or permanent and specific performance, which rights shall be cumulative and in addition to any other rights or remedies to which such non-breaching Party may be entitled in law or equity. Both Parties agree to waive any requirement that the other (a) post a bond or other security as a condition for obtaining any such relief and (b) show irreparable harm, balancing of harms, consideration of the public interest, or inadequacy of monetary damages as a remedy. Nothing in this Section 12.11 is intended or should be construed, to limit either Party’s right to equitable relief or any other remedy for a breach of any other provision of this Agreement.

12.12 Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein.

12.13 Further Assurance. Each Party shall duly execute and deliver or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof or to better assure and confirm unto such other Party its rights and remedies under this Agreement.

12.14 No Benefit to Third Parties. Except as provided in Article 10, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties and their successors and permitted assigns and they shall not be construed as conferring any rights on any other Persons.

12.15 Relationship of the Parties. It is expressly agreed that Licensor, on the one hand, and the Company, on the other hand, shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture, or agency. Neither Licensor, on the one hand, nor the Company, on the other hand, shall have the authority to make any statements, representations or commitments of any kind, or to take any action that will be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such first Party.

12.16 References. Unless otherwise specified, (a) references in this Agreement to any Article, Section or Schedule shall mean references to such Article, Section or Schedule of this Agreement, (b) references in any Section to any clause are references to such clause of such Section and (c) references to any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently amended, replaced or supplemented from time to time, as so amended, replaced or supplemented and in effect at the relevant time of reference thereto (subject to any restrictions on such amendments, replacements or supplements set forth herein).

12.17 Construction. Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders, and the word “or” is used in the inclusive sense (and/or). Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term “including,” “include,” or “includes” as used herein shall mean including, without limitation and without limiting the generality of any description preceding such term. Except where the context otherwise requires, (a) the word “will” will be construed to have the same meaning and effect as the word “shall,” (b) any reference herein to any person or entity will be construed to include the person’s or entity’s successors and assigns, (c) the words “herein,” “hereof,” and “hereunder”, and words of similar import, will be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (d) the word “notice” means notice in writing (whether or not specifically stated) and will include notices, consents, approvals and other written communications contemplated under this Agreement, (e) provisions that require that a Party or the Parties “agree,” “consent,” or “approve” or the like will require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging), and (f) references to any specific law, rule or regulation, or article, section or other division thereof, will be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against either Party hereto.

12.18 Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may be executed by facsimile, PDF format via email or other electronically transmitted signatures and such signatures shall be deemed to bind each Party hereto as if they were original signatures.

[SIGNATURE PAGE FOLLOWS.]

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.


RemeGen Co., Ltd.		Vor Biopharma Inc.
By:	/s/ Jianmin Fang	By:	/s/ Robert Ang
Name:	Jianmin Fang, Ph.D.	Name:	Robert Ang
Title:	CEO	Title:	Chief Executive Officer

[Signature Page to License Agreement]

EX-10.10 3 vor-ex10_10.htm EX-10.10 EX-10.10

Exhibit 10.10

500 BOYLSTON STREET

BOSTON, MA

OFFICE LEASE AGREEMENT

BETWEEN

500 BOYLSTON & 222 BERKELEY OWNER (DE) LLC,

a Delaware limited liability company,

AS LANDLORD

AND

VOR BIOPHARMA, INC.,

a Delaware corporation,

AS TENANT

OFFICE LEASE AGREEMENT

TABLE OF CONTENTS


1.	Basic Lease Information.	1
2.	Lease Grant.	3
3.	Term and Commencement Date.	4
4.	Rent.	5
5.	Compliance with Laws; Use.	5
6.	Guaranty and Letter of Credit.	6
7.	Building Services.	6
8.	Alterations	8
9.	Repairs and Maintenance.	9
10.	Entry by Landlord.	10
11.	Assignment and Subletting.	10
12.	Notices.	12
13.	Indemnity and Insurance.	12
14.	Casualty Damage.	14
15.	Condemnation.	15
16.	Events of Default.	15
17.	Limitation of Liability.	18
18.	Relocation.	20
19.	Holding Over.	20
20.	Surrender of Premises.	20
21.	Subordination to Mortgages; Estoppel Certificate.	20
22.	Miscellaneous.	21

OFFICE LEASE AGREEMENT

This Office Lease Agreement (this “Lease”) is made and entered into as of August 5, 2025 (the “Effective Date”), by and between 500 BOYLSTON & 222 BERKELEY OWNER (DE) LLC, a Delaware limited liability company (“Landlord”), and VOR BIOPHARMA, INC., a Delaware corporation (“Tenant”).

1.Basic Lease Information.

1.01 “Building” shall mean the 25-story building (consisting of a 6-story low-rise portion, a 19-story high-rise portion, and 3 levels of parking space below grade) located at 500 Boylston Street, Boston, MA 02116 and commonly known as 500 Boylston Street. The “Rentable Floor Area of the Building” is deemed to be 684,433 square feet.

1.02 “Premises” shall mean the area shown on Exhibit A to this Lease. The Premises are located on the thirteenth (13th) floor of the Building and known as Suite 1350 containing 8,391 square feet of Rentable Floor Area.

1.03 “Rentable Floor Area of the Premises”: 8,391 square feet.

1.04 “Estimated Term Commencement Date”: September 1, 2025.

1.05 “Term Commencement Date”: See Section 3.01.

1.06 Intentionally Deleted.

1.07 “Term Expiration Date”: The date that is seventy-two (72) full calendar months after the Term Commencement Date.

1.08 “Base Rent”:


Period	Annual Base Rent	Monthly Base Rent
Lease Year 1	$440,000.00	$36,666.67
Lease Year 2	$530,400.00	$44,200.00
Lease Year 3	$698,399.71	$58,199.98
Lease Year 4	$712,367.71	$59,363.98
Lease Year 5	$726,615.06	$60,551.26
Lease Year 6	$741,147.36	$61,762.28

As used above, the first “Lease Year” shall commence on the Term Commencement Date and end on the day immediately preceding the first anniversary thereof (provided that if the Term Commencement Date does not occur on the first day of a calendar month, the first Lease Year shall further include the balance of the calendar month such first anniversary occurs), and each subsequent Lease Year shall mean each successive period of twelve (12) calendar months following the first Lease Year during the initial Term, provided that the last Lease Year of the initial Term shall end on the Term Expiration Date set forth above for the initial Term.

1.09 “Tenant’s Proportionate Share”: 1.23%, subject to Exhibit B.

1.10 “Additional Rent” for Expenses and Taxes: See Section 4.01.

1.11 Tenant Work Allowance: None.

1.12 Additional Provisions: See Exhibit F.

1. Parking

2. Extension Option

1.13 “Guarantor”: None.

1.14 “Security Deposit” shall mean the cash security deposit or the letter of credit in the amount of $167,820.00, as provided in Section 6 and Exhibit H attached hereto.

1.15 “Broker”: CBRE, Inc., which represented Tenant in connection with this Lease.

1.16 “Permitted Use”: Executive, professional or corporate offices, including ancillary uses thereof, but specifically excluding medical or dental offices, utility company offices, employment agency offices (other than executive or professional search firms), governmental or quasi-governmental offices, or a provider of temporary office space or facilities on a contract basis. For purposes hereof, uses ancillary to the Permitted Uses shall include customary coffee stations for use only by the employees and business invitees of Tenant.

1.17 “Notice Address(es)”:


For Landlord:	For Tenant:

500 Boylston & 222 Berkeley Owner (DE) LLC c/o Oxford Properties Group 125 Summer Street Boston, Massachusetts 02110 Attention: Director of Leasing With a copy to: 500 Boylston & 222 Berkeley Owner (DE) LLC c/o Oxford Properties Group 50 Hudson Yards, 73rd Floor New York, NY 10001 Attention: Legal Department Email: [***]	Prior to the Term Commencement Date: Vor Bio Attention: Adi Osovsky [*] From and after the Term Commencement Date: Vor Bio 500 Boylston Street, Boston, MA 02116 Attention: Adi Osovsky [*]

1.18 “Business Day(s)” are Monday through Friday of each week, exclusive of New Year’s Day, Presidents Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day and Christmas Day (“Holidays”). Landlord may designate additional Holidays that are commonly recognized by other office buildings in the area where the Building is located. “Building Service Hours” are 8:00 a.m. to 6:00 p.m. on Business Days.

1.19 “Property” means the Building and the parcel(s) of land on which it is located and, at Landlord’s discretion, the parking facilities and other improvements, if any, serving the Building and the parcel(s) of land on which they are located. “Office Section” means that portion of the Building from time to time dedicated to office uses. “Retail Section” means that portion of the Building from time to time dedicated to retail uses.

1.20 “Project” shall mean the Property together with the adjoining building and other improvements commonly known as 222 Berkeley Street and the parcel(s) of land in which they are located, including the parking facilities from time to time serving the Building and such other building and the common areas and facilities in or about such buildings that from time to time serve both buildings in common.

1.21 Other Defined Terms: Other capitalized terms shall have the meanings set forth in the Lease and its Exhibits below. References in this Lease to numbered Sections shall be deemed to refer to the numbered Sections of this Lease, unless otherwise specified.

1.22 Exhibits: The following exhibits and attachments are incorporated into and made a part of this Lease:

Exhibit A (Outline and Location of Premises)

Exhibit B (Expenses and Taxes)

Exhibit C (Form of Bill of Sale)

Exhibit D (Commencement Letter)

Exhibit E (Building Rules and Regulations)

Exhibit F (Additional Provisions)

Exhibit G (Intentionally Deleted)

Exhibit H (Letter of Credit)

Exhibit I (Intentionally Deleted)

Exhibit J (Cleaning Specifications)

Exhibit K (“Green” Lease Rider)

2.Lease Grant.

2.01 Premises. Landlord hereby leases the Premises to Tenant and Tenant hereby leases the Premises from Landlord. The Premises exclude the exterior faces of exterior walls, the common stairways and stairwells, elevators and elevator wells, fan rooms, electric and telephone closets, janitor closets, freight elevator vestibules, and pipes, ducts, conduits, wires and appurtenant fixtures serving other parts of the Building (exclusively or in common), and other Common Areas (as defined below) of the Building. If the Premises include the entire rentable area of any floor, the common corridors, elevator lobby, and restroom facilities located on such full floor(s) shall be considered part of the Premises.

2.02 Appurtenant Rights. During the Term, Tenant shall have, as appurtenant to the Premises, the non-exclusive rights to use in common (subject to reasonable rules of general applicability to tenants and other users of the Building from time to time made by Landlord of which Tenant is given notice): (a) the common lobbies, corridors, stairways, elevators and loading platform of the Building, and the pipes, ducts, conduits, wires and appurtenant meters and equipment serving the Premises in common with others; (b) common driveways and walkways necessary for access to the Building; (c) if the Premises include less than the entire rentable floor area of any floor, the common corridors, elevator lobby, and restroom facilities located on such floor; and (d) all other areas or facilities in or about the Project from time to time designated for general use in common by Tenant, other Project tenants, and Landlord (collectively, the “Common Areas”).

3.Term and Commencement Date.

3.01 Term. The “Term” of this Lease shall begin at 12:01 a.m. (Eastern) on the earlier to occur of the following dates under clauses (a) or (b), which date shall be the “Term Commencement Date”:

(a) The date on which Tenant first enters into possession of all or any portion of the Premises for the regular conduct of its business; or

(b) The Estimated Term Commencement Date.

The Term of this Lease shall end at 11:59 p.m. (Eastern) on the Term Expiration Date set forth in Section 1, unless sooner terminated in accordance with the provisions of this Lease. Promptly after the determination of the Term Commencement Date, Landlord and Tenant shall execute and deliver a commencement letter in the form attached as Exhibit D (the “Commencement Letter”). Tenant’s failure to execute and return the Commencement Letter, or to provide written objection to the statements contained in the Commencement Letter, within thirty (30) days after its delivery to Tenant shall be deemed an approval by Tenant of the statements contained therein.

3.02 “As Is” Condition. The Premises shall be leased by Tenant in their current “as is” condition and configuration without any representations or warranties by Landlord, except that Landlord shall deliver the Premises to Tenant with all Base Building systems and utilities not exclusively serving the Premises in working order and condition.

3.03 Delivery. By taking possession of the Premises, Tenant agrees that the Premises are in good order and satisfactory condition. Landlord shall not be liable for any delay or failure to deliver possession of the Premises or any other space due to the holdover or unlawful possession of such space by another party or other reason, provided, however, Landlord shall use reasonable efforts to obtain possession of any such space. Any delay in the delivery of the Premises or in the occurrence of the Term Commencement Date shall not give rise to any liability or default by Landlord or affect any of the terms of this Lease or Tenant’s obligation to accept the Premises when delivered. Except as otherwise provided in this Lease, Tenant shall not be permitted to take possession of or enter the Premises before the Term Commencement Date without Landlord’s permission. If Tenant takes possession of or enters the Premises before the Term Commencement Date, Tenant’s possession or entry before the Term Commencement Date shall be subject to the terms and conditions of this Lease; provided, however, except for the cost of services used or requested by Tenant (e.g., after-hours HVAC service), Tenant shall not be required to pay Rent for any such possession or entry before the Term Commencement Date during which Tenant, with Landlord’s approval, has entered, or is in possession of, the Premises for the sole purpose of performing improvements or installing furniture, equipment, Cabling (as defined in Section 8.01) or other personal property.

Tenant acknowledges and agrees that, concurrently with Tenant’s and Landlord’s execution and delivery of this Lease, Landlord is conveying, selling, assigning and transferring to Tenant, and Tenant is purchasing, assuming and accepting from Landlord, all furniture, fixtures, and equipment located at the Premises as of the Effective Date (the “Purchased Furniture”) by way of a bill of sale, the form of which bill of sale is attached hereto as Exhibit C (the “Bill of Sale”). A list of the Purchased Furniture is attached to the Bill of Sale as Schedule 1. Tenant shall use the Purchased Furniture only for the purposes for which such Purchased Furniture was intended and in accordance with all manufacturers’ specifications and requirements, and Tenant shall maintain the Purchased Furniture in good order, condition and repair and shall, as necessary, replace the Purchased Furniture, at Tenant’s sole cost and expense. Tenant shall insure the Purchased Furniture along with all other Tenant’s Property as required by this Lease. Tenant acknowledges that Landlord has not made, does not make, and specifically disclaims any representations or warranties, whether express or implied, written or oral, past, present or future, as to, concerning, or with respect to the Purchased Furniture including, without limitation, the condition, suitability, quality, habitability, merchantability, fitness for a particular purpose of same, and adverse claim(s) of ownership.

The Purchased Furniture shall be delivered to Tenant in its “as-is, where-is, with all faults” condition, and Landlord shall have absolutely no liability or obligation with respect to the Purchased Furniture.

3.04 Early Access. Notwithstanding anything to the contrary in this Article 3, during the period between the Effective Date and the Term Commencement Date, Tenant may access the Premises for the installation of wiring, furniture, equipment, and personal property prior to commencing the regular conduct of business in the Premises, provided that such early access and installation shall be subject in each case to the terms and conditions of Section 8 of the Lease, including without limitation (i) Landlord’s approval of Tenant’s contractors in accordance with Section 8 of the Lease, (ii) Landlord’s receipt from Tenant of copies of all necessary permits for any such installations, and (iii) customary insurance certificates from Tenant’s contractors, subcontractors, and other parties acting under or through Tenant with respect to the applicable work in accordance with Section 8 of the Lease. Tenant shall be responsible for any damage to the Premises caused by Tenant or its employees, agents, contractors, subcontractors, material suppliers and laborers. Any entry into the Premises by Tenant (or its contractors, subcontractors, or other persons acting under or through Tenant) prior to the Term Commencement Date shall be subject to all of the provisions of the Lease that are applicable to the Premises during the Term, except for the obligation to pay Base Rent and Expense Excess and Tax Excess charges.

4.Rent.

4.01 Base Rent and Additional Rent. Tenant hereby covenants and agrees to pay to Landlord, without any setoff or deduction (except to the extent expressly set forth in this Lease), (a) all Base Rent (as provided in Section 1), (b) Tenant’s Proportionate Share of Expenses and Taxes (as provided in Exhibit B attached hereto), and (c) all other Additional Rent due for the Term (collectively referred to as “Rent”). “Additional Rent” means all sums (exclusive of Base Rent) that Tenant is required to pay to Landlord from time to time under this Lease.

4.02 Manner and Timing of Payments. Base Rent and other recurring monthly charges of Additional Rent shall be due and payable in advance on the first day of each calendar month without notice or demand. All other items of Rent shall be due and payable by Tenant within thirty (30) days after billing by Landlord. Rent shall be made payable to the entity, and sent to the address, that Landlord from time to time designates for such purposes and shall be paid by Tenant by electronic or wire transfer to an account from time to time designated by Landlord. Landlord’s acceptance of less than the entire amount of Rent shall be considered, unless otherwise specified by Landlord, a payment on account of the oldest obligation due from Tenant hereunder, notwithstanding any statement to the contrary contained on or accompanying any such payment from Tenant. Rent for any partial month during the Term shall be prorated on a per diem basis. Tenant shall pay and be liable for all rental, sales and use taxes (but excluding income taxes), if any, imposed upon or measured by Rent. No endorsement or statement on or accompanying payment shall be considered an accord and satisfaction.

5.Compliance with Laws; Use.

Tenant shall use the Premises only for the Permitted Use and shall not use or permit the use of the Premises for any other purpose. Tenant shall comply with all statutes, codes, ordinances, orders, rules and regulations of any municipal or governmental entity whether in effect now or later, including the Americans with Disabilities Act (“Law(s)”), regarding the operation of Tenant’s business and the use, condition, configuration, and occupancy of the Premises and the Building systems located in or exclusively serving the Premises. In addition, Tenant shall, at its sole cost and expense, promptly comply with any Laws that relate to the Base Building (defined below), but only to the extent such obligations are triggered by Tenant’s use of the Premises (other than for general office use in accordance with the terms of this Lease) or Alterations (as defined in Section 8.01) in or about the Premises performed or requested by Tenant.

“Base Building” shall include the structural portions of the Building, the common restrooms, and the Building mechanical, electrical, and plumbing systems and equipment located in the internal core of the Building on the floor or floors on which the Premises are located. Tenant shall promptly provide Landlord with copies of any notices it receives regarding an alleged violation of Law. Tenant shall not exceed the standard density limit for the Building. Tenant shall not use or permit the use of any portion of the Premises in a manner that results in objectionable noise, odors, or vibrations emanating from the Premises or any equipment installed by Tenant or any party acting under or through Tenant, or which violates or conflicts with Landlord’s Sustainability Practices Standards (as defined in Exhibit K) or certification for the Building. Without limiting the generality of the foregoing sentence, Tenant shall not use any portion of the Premises for a personal fitness or exercise area or install or use any exercise equipment therein. Tenant shall comply with the rules and regulations of the Building attached as Exhibit E and such other reasonable rules and regulations adopted by Landlord from time to time, including rules and regulations for the performance of Alterations. If the Premises or any portion thereof are located on a multi-tenant floor, Tenant shall cause all portions of such Premises that are visible from the Common Areas on such floors to be arranged, furnished, and lighted in a manner in which such Premises appears at all times to be occupied for the Permitted Use.

6.Security Deposit – Cash or Letter of Credit.

Concurrently with Tenant’s execution and delivery of this Lease, Tenant shall deliver to Landlord a clean, irrevocable letter of credit in the amount set forth in Section 1, which shall comply with, and may be drawn by Landlord in accordance with, the provisions of Exhibit H attached hereto (such letter of credit, together with any renewal or replacement thereof in accordance herewith, being referred to herein as the “Letter of Credit”). Notwithstanding the preceding sentence, if Tenant has not delivered the Letter of Credit to Landlord concurrently with Tenant’s execution and delivery of this Lease, then (a) concurrently with Tenant’s execution and delivery of this Lease, Tenant shall deliver to Landlord a cash security deposit in the amount set forth in Section 1 for the amount of the Letter of Credit (which cash security deposit shall be held and applied by Landlord in accordance with the provisions of Exhibit H that are applicable to a cash security deposit, subject to the terms of this sentence), (b) within one hundred eighty (180) days after Tenant’s execution and delivery of this Lease, Tenant shall deliver to Landlord the Letter of Credit required under the preceding sentence, and (c) within three (3) Business Days after such delivery of the Letter of Credit to Landlord, Landlord shall return to Tenant the cash security deposit provided under this sentence (to the extent not applied), without interest.

7.Building Services.

7.01 Building Services. Landlord shall furnish Tenant with the following services: (a) water for use in the Base Building restrooms, the kitchen area in the Premises, and the shower and bathroom located in the Premises; (b) customary heat and air conditioning in season during Building Service Hours; (c) standard janitorial service on Business Days and substantially consistent with the specifications set forth on Exhibit J attached hereto; (d) elevator service; (e) electricity in accordance with the terms and conditions in Section 7.02; (f) access to the Building for Tenant and its employees 24 hours per day/7 days per week, subject to the terms of this Lease and such protective services or monitoring systems, if any, as Landlord may from time to time impose, including, without limitation, sign-in procedures and/or presentation of identification cards; and (g) such other services as Landlord reasonably determines are necessary or appropriate for the Property. In addition, Tenant shall have the right to receive HVAC service during hours other than Building Service Hours by paying Landlord’s then-standard charge for additional HVAC service and providing such prior notice as is reasonably specified by Landlord. If Tenant is permitted to connect any supplemental HVAC units to the Building’s condenser water loop or chilled water line, such permission shall be conditioned upon Landlord having adequate excess capacity from time to time and such connection and use shall be subject to Landlord’s reasonable approval and reasonable restrictions imposed by Landlord, and Landlord shall have the right to charge Tenant a connection fee and/or a monthly usage fee, as reasonably determined by Landlord. If, at Tenant’s request, Landlord, or an affiliated or third party service provider, provides any services that are not Landlord’s express obligation under this Lease, including, without limitation, any repairs which are Tenant’s responsibility pursuant to Section 9 below, Tenant shall pay to the applicable service provider the cost of such services plus a reasonable administrative charge.

7.02 Tenant Electricity. To the extent that the electricity service for any portion of the Premises (including, without limitation, air handling units or other HVAC equipment serving the Premises) or any other equipment exclusively serving the Premises is from time to time metered directly by the utility company to the Premises, Tenant shall timely pay the separate charges for such electricity service directly to the applicable utility company and, if requested by Landlord from time to time, provide copies of such utility company invoices and evidence of such payments. To the extent that the electricity service for any portion of the Premises (including, without limitation, air handling units or other HVAC equipment serving the Premises) or any other equipment serving the Premises, whether exclusively or in common, is not metered directly by the utility company to the applicable portion of the Premises, Tenant shall pay to Landlord, as Additional Rent with no mark-up or surcharge, the costs of such electricity by a separate charge payable by Tenant to Landlord based on check-meters installed for the applicable portion of the Premises or equipment serving the Premises or, for any portion of the Premises or equipment that from time to time does not have operational check-meters, based on reasonable allocations prepared by Landlord’s building engineer for the space and period in question. If utility service to the Premises is not separately metered, Tenant shall make estimated monthly payments for any electricity charges payable to Landlord hereunder, in advance on the first day of each month or partial month of the Term, based on amounts estimated by Landlord from time to time for such electricity charges, subject to quarterly reconciliations based on actual check-meter readings and utility rates for the space and period in question. Without the consent of Landlord, Tenant’s use of electrical service shall not exceed the Building standard usage, per square foot, as reasonably determined by Landlord, based upon the Building standard electrical design load and Tenant shall comply with Landlord’s Sustainability Practices Standards. For any electricity service that is not metered directly by the utility company to the Premises, Landlord shall have the right to measure electrical usage by commonly accepted methods, including the installation of measuring devices such as submeters and check-meters, which to the extent not in place prior to the Effective Date shall be installed at Tenant’s expense. If it is determined, for any electrical service that is not directly metered by the utility company to the Premises and is not separately check-metered to Tenant pursuant to the foregoing provisions, that Tenant is using electricity in such quantities or during such periods as to cause the total cost of Tenant’s electrical usage, on a monthly, per-rentable-square-foot basis, to materially exceed that which Landlord reasonably deems to be standard for the Building, Tenant shall pay Landlord Additional Rent for the cost of such excess electrical usage and, if applicable, for the cost of purchasing and installing the measuring device(s).

7.03 Interruption of Services. Landlord’s failure to furnish, or any interruption, diminishment or termination of services due to the application of Laws, the failure of any equipment, the performance of maintenance, repairs, improvements or alterations, utility interruptions or the occurrence of an event of Force Majeure (defined in Section 22.07) (collectively a “Service Failure”) shall not render Landlord liable to Tenant, constitute a constructive eviction of Tenant, give rise to an abatement of Rent, nor relieve Tenant from the obligation to fulfill any covenant or agreement, except as provided in the next sentence. If the Premises, or a material portion of the Premises, are made untenantable for a period in excess of five (5) consecutive Business Days as a result of a Service Failure that is reasonably within the control of Landlord to correct, then Tenant, as its sole remedy, shall be entitled to receive an abatement of Rent payable hereunder during the period following such five-(5)-Business-Day period and ending on the day the service has been restored. If the entire Premises has not been rendered untenantable by the Service Failure, the amount of abatement shall be equitably prorated. This Section shall not apply to any Service Failure arising from a casualty event governed by Section 14 below.

7.04 Reservations. Without limiting the generality of the foregoing, Landlord reserves the right from time to time to modify components of the access procedures for the Building or other portions of the Property, to change the number of lobby attendants, or to institute, modify, supplement, or discontinue any particular access control procedures or equipment for the Building, whether during or after business hours. Landlord does not warrant or guarantee the effectiveness of any such system or procedures. Tenant expressly disclaims any such warranty, guarantee, or undertaking by Landlord with respect thereto and acknowledges that access control procedures from time to time in effect are solely for the convenience of tenants generally and are not intended to secure the Premises or to guarantee the physical safety of any persons in or about the Premises or the Property. Tenant shall be responsible for securing the Premises, including without limitation by Tenant’s installation of access card readers or other security equipment for the Premises in accordance with Section 8 and by restricting or monitoring access into and from the Premises by its employees or other invitees. At the time that any Tenant employee (or other person acting under or through Tenant) who has been issued a Building access card is terminated or otherwise ceases to work at the Premises, Tenant shall retrieve and destroy the Building access card for such person and, in accordance with the Building’s standard procedures, notify the Building’s property manager that such person should be removed from the active list for Building access cards.

8.Alterations

8.01 Alterations. Tenant shall not make alterations, repairs, additions or improvements or install any Cable (collectively referred to as “Alterations”) in the Premises, without first obtaining the written consent of Landlord in each instance, which consent shall not be unreasonably withheld or delayed. “Cable” shall mean and refer to any electronic, fiber, phone and data cabling and related equipment that is installed by or for the exclusive benefit of Tenant or any party acting under or through Tenant. Prior to starting work on any Alterations, Tenant shall furnish Landlord with plans and specifications (which shall be in CAD format if requested by Landlord); names of contractors reasonably acceptable to Landlord (provided that Landlord may designate specific contractors with respect to Base Building and vertical Cable, as may be described more fully below); required permits and approvals; evidence of contractor’s and subcontractor’s insurance in amounts reasonably required by Landlord and naming as additional insureds the Landlord, the managing agent for the Building, and such other Additional Insured Parties (as defined in Section 13) as Landlord may designate for such purposes; and any security for performance in amounts reasonably required by Landlord. Landlord may designate specific contractors with respect to oversight, installation, repair, connection to, and removal of vertical Cable. All Cable shall be clearly marked with adhesive plastic labels (or plastic tags attached to such Cable with wire) to show Tenant’s name, suite number, and the purpose of such Cable (i) every 6 feet outside the Premises (specifically including, but not limited to, the electrical room risers and any Common Areas), and (ii) at the termination point(s) of such Cable. Changes to the plans and specifications must also be submitted to Landlord for its approval. Alterations shall be constructed in a good and workmanlike manner using materials of a quality reasonably approved by Landlord and in compliance with Landlord’s Sustainability Practices Standards, and Tenant shall ensure that no Alteration impairs any Building system or Landlord’s ability to perform its obligations hereunder. Tenant shall reimburse Landlord for any third-party expenses incurred by Landlord in connection with the review, inspection, and coordination of Tenant’s plans for Alterations and Tenant’s performance thereof and pay to Landlord or its managing agent a fee for Landlord’s administrative oversight and coordination of any Alterations equal to 2.5% of the hard costs of the Alterations. Upon completion, Tenant shall furnish “as-built” plans (in CAD format, if requested by Landlord) for Alterations, customary AIA completion affidavits, full and final waivers of lien, any applicable certificate of occupancy for the space affected by such Alterations, and any other items required under the Building’s construction rules and regulations for closing out the particular work in question. Landlord’s approval of an Alteration shall not be deemed to be a representation by Landlord that the Alteration complies with Law or will not adversely affect any Building system. If any Alteration requires any change to the Base Building, any Building system, or any Common Area, then such changes shall be made at Tenant’s sole cost and expense and performed, at Landlord’s election, either by Tenant’s contractor or a contractor engaged by Landlord. Notwithstanding the foregoing, Landlord’s consent shall not be required for any Alteration that satisfies all of the following criteria (a “Cosmetic Alteration”): (a) is of a cosmetic nature such as painting, wallpapering, hanging pictures and installing carpeting; (b) is not visible from the exterior of the Premises or Building; (c) will not affect the Base Building (defined in Section 5); (d) does not require a building permit; and (e) does not require work to be performed inside the walls or above the ceiling of the Premises. Cosmetic Alterations shall be subject to all the other provisions of this Section 8.03, to the extent applicable thereto.

8.02 Liens. Tenant shall not cause or permit any mechanics’ or other liens to be placed upon the Property, the Premises, or Tenant’s leasehold interest hereunder in connection with any work or service done or purportedly done by or for the benefit of Tenant, its subtenants, or any other party acting under or through Tenant. Tenant shall give Landlord notice at least fifteen (15) days prior to the commencement of any work in the Premises to afford Landlord the opportunity, where applicable, to post and record notices of non-responsibility. Tenant, within ten (10) days after notice from Landlord, shall fully discharge any such lien by settlement, by bonding or by insuring over the lien in the manner prescribed by the applicable lien Law. If Tenant fails to timely discharge such lien within such period, Tenant shall be deemed in Default under this Lease and, in addition to any other remedies available to Landlord as a result of such Default by Tenant, Landlord, at its option, may bond, insure over or otherwise discharge the lien. Tenant shall reimburse Landlord for any amount paid by Landlord to discharge such lien, including, without limitation, reasonable attorneys’ fees. Landlord shall have the right to require Tenant to post a performance or payment bond in connection with any work or service done or purportedly done by or for the benefit of Tenant. Tenant acknowledges and agrees that all such work or service is being performed for the sole benefit of Tenant and not for the benefit of Landlord.

8.03 Leasehold Improvements. All Leasehold Improvements shall, except as expressly provided in this Lease, remain upon the Premises at the end of the Term without compensation to Tenant. “Leasehold Improvements” shall mean and include all leasehold improvements from time to time existing in or to the Premises, including without limitation any such leasehold improvements (if any) that exist as of the Term Commencement Date under this Lease or that are made by or for the benefit of Tenant (or any party acting under or through Tenant) before the Term Commencement Date or thereafter from time to time during the Term. Landlord, by written notice to Tenant at least thirty (30) days prior to the Term Expiration Date, may require Tenant, at Tenant’s expense, to remove any Leasehold Improvements or other affixed installations that, in Landlord’s reasonable judgment, are of a nature that would require removal and repair costs that are materially in excess of the removal and repair costs associated with standard office improvements (“Required Removables”). Required Removables shall include, without limitation, internal stairways, raised floors, private baths and showers, vaults, rolling file systems, structural alterations and modifications and any Cable installed by or on behalf of Tenant. Landlord shall, within twenty (20) days after receipt of Tenant’s written request for approval of a proposed Alteration, advise Tenant in writing whether the approved Alteration or any portions thereof or other improvements are Required Removables. If Landlord fails to inform Tenant within such twenty (20) day period, such requested Alteration or improvement shall be deemed not to be a Required Removable. The Required Removables shall be removed by Tenant before the expiration or earlier termination of this Lease in accordance with Section 20.

9.Repairs and Maintenance.

9.01 Tenant Obligations. Tenant shall periodically inspect the Premises to identify any conditions that are dangerous or in need of maintenance or repair. Tenant shall promptly provide Landlord with notice of any such conditions. Tenant, at its sole cost and expense, shall perform all maintenance and repairs to the Premises that are not Landlord’s express responsibility under this Lease, and keep the Premises in good condition and repair, reasonable wear and tear excepted. Tenant’s repair and maintenance obligations include, without limitation, repairs to: (a) floor covering; (b) interior partitions; (c) doors; (d) the interior side of demising walls; (e) Alterations (described in Section 8); (f) supplemental air conditioning units, kitchens, including hot water heaters, plumbing, and similar facilities exclusively serving the Premises or any portion thereof, whether such items are installed by Tenant or are currently existing in the Premises; and (g) any Cable. Tenant shall maintain in effect throughout the Term maintenance contracts for any such supplemental air conditioning units or other specialty equipment exclusively serving the Premises and, from time to time upon Landlord’s request, provide Landlord with a copy of such maintenance contract and reasonable evidence of its service record. All repairs and other work performed by Tenant or its contractors, including that involving Cable, shall be subject to the terms of Section 8.01 above. If Tenant fails to make any repairs to the Premises for more than fifteen (15) days after notice from Landlord (although notice shall not be required in an emergency), Landlord may make the repairs, and, within thirty (30) days after demand, Tenant shall pay to Landlord the reasonable cost of the repairs, together with an administrative charge in an amount equal to ten percent (10%) of the cost of the repairs.

9.02 Landlord Obligations. Landlord shall keep and maintain in good repair and working order and perform maintenance upon (a) the structural elements of the Building; (b) the mechanical (including HVAC), electrical, plumbing and fire/life safety systems serving the Building in general; (c) the Common Areas; (d) the roof of the Building; (e) the exterior windows of the Building; and (f) the elevators serving the Building. Subject to reasonable wear and tear, Landlord shall from time to time make repairs for which Landlord is responsible hereunder.

10.Entry by Landlord.

Landlord may enter the Premises to inspect, show or clean the Premises or to perform or facilitate the performance of repairs, alterations or additions to the Premises or any portion of the Building. Except in emergencies or to provide Building services, Landlord shall provide Tenant with at least twenty-four (24) hours’ prior verbal notice of entry. In connection with any such entry for non-emergency work performed during Building Service Hours, Landlord shall use reasonable efforts, consistent with the operation of a first-class high rise building, not to unreasonably interfere with Tenant’s use of the Premises. If reasonably necessary, Landlord may temporarily close all or a portion of the Premises to perform repairs, alterations and additions; provided, that, except in emergencies, any such work that would unreasonably prevent the use of a substantial portion of the Premises during Building Service Hours will be performed on weekends or after Building Service Hours. Any such entry by Landlord shall not constitute a constructive eviction or entitle Tenant to an abatement or reduction of Rent.

11.Assignment and Subletting.

11.01 Transfers. Except in connection with a Permitted Transfer (defined in Section 11.04), Tenant shall not assign, sublease, transfer or encumber any interest in this Lease or allow any third party to use all or any portion of the Premises (in each such case, collectively or individually, a “Transfer” to a “Transferee”) without the prior written consent of Landlord, which consent shall not be unreasonably withheld, conditioned or delayed if Landlord does not exercise its recapture rights under Section 11.02. Without limitation, it is agreed that Landlord’s consent shall not be considered unreasonably withheld if the proposed Transferee (a) is a governmental entity, (b) is an occupant of the Project, (c) whether or not an occupant of the Project, has been in discussions with Landlord regarding the leasing of space within the Project within the preceding nine (9) months, (d) is incompatible with the character of occupancy of the Project, (e) is an entity with which the payment for the sublease or assignment is determined in whole or in part based upon its net income or profits, or (f) would subject the Premises to a use which would: (i) involve increased personnel or wear upon the Project; (ii) violate any exclusive right granted to another tenant of the Project; (iii) require any addition to or modification of the Premises or the Project in order to comply with building code or other governmental requirements; or (iv) involve a violation of the Permitted Use clauses of this Lease. If the entity(ies) that directly or indirectly controls the voting shares/rights of Tenant (other than through the ownership of voting securities listed on a recognized securities exchange) changes at any time, such change of ownership or control shall constitute a Transfer. Any Transfer in violation of this Section shall, at Landlord’s option, be deemed a Default by Tenant as described in Section 16.01, and shall be voidable by Landlord. In no event shall any Transfer, including a Permitted Transfer (defined in Section 11.04), release or relieve Tenant from any obligation under this Lease, and the Tenant originally named in this Lease shall remain primarily liable for the performance of the tenant’s obligations under this Lease, as amended from time to time.

11.02 Process. Tenant shall provide Landlord with financial statements for the proposed Transferee (or, in the case of a change of ownership or control, for the proposed new controlling entity(ies)), a fully executed copy of the proposed assignment, sublease, or other Transfer documentation, and such other information as Landlord may reasonably request. Within fifteen (15) Business Days after receipt of the required information and documentation, Landlord shall either: (a) consent to the Transfer by execution of a consent agreement in a form reasonably designated by Landlord; (b) reasonably refuse to consent to the Transfer in writing; or (c) in the event of a proposed assignment of this Lease or subletting of all or part of the Premises, recapture the portion of the Premises that Tenant is proposing to Transfer. If Landlord exercises its right to recapture (the “Recapture Notice”), this Lease shall automatically be amended (or terminated if the entire Premises is being assigned or sublet) to delete the applicable portion of the Premises effective on the proposed effective date of the Transfer, although Landlord may require Tenant to execute a reasonable amendment or other document reflecting such reduction or termination. Tenant shall pay to Landlord the reasonable costs and attorneys’ fees incurred by Landlord in connection with such requested Transfer, up to an amount not to exceed $3,500 per requested Transfer.

11.03 Excess Payments. In the event, if any, that (i) all rent and other consideration which Tenant receives as a result of a Transfer exceeds (ii) the Rent payable to Landlord for the portion of the Premises and Term covered by the Transfer, then Tenant shall, at Landlord’s election, pay to Landlord an amount equal to fifty percent (50%) of such excess, from time to time on a monthly basis upon Tenant’s receipt of such excess; provided that in determining any such excess, Tenant may deduct from the excess all reasonable and customary expenses directly incurred by Tenant in connection with such Transfer, except that any construction costs incurred by Tenant in connection with such Transfer shall be deducted on a straight-line basis over the term of the applicable Transfer. If Tenant is in Default, Landlord may require that all sublease payments be made directly to Landlord, in which case Tenant shall receive a credit against Rent in the amount of Tenant’s share of payments received by Landlord.

11.04 Permitted Transfers. Tenant may assign this Lease to a successor to Tenant by merger, consolidation, or the purchase of all or substantially all of Tenant’s assets, or assign this Lease or sublet all or a portion of the Premises to an Affiliate (defined below), without the consent of Landlord, provided that all of the following conditions are satisfied (a “Permitted Transfer”): (a) Tenant must not be in Default; (b) Tenant must give Landlord written notice at least fifteen (15) Business Days before such Transfer; and (c) except in the case of a sublease to an Affiliate, the Credit Requirement (defined below) must be satisfied. Tenant’s notice to Landlord shall include information and documentation evidencing that the Transfer qualifies as a Permitted Transfer hereunder and that each of the above conditions has been satisfied. If requested by Landlord, Tenant’s successor under this Section 11.04 shall sign and deliver to Landlord a commercially reasonable form of assumption agreement. “Affiliate” shall mean an entity controlled by, controlling or under common control with Tenant. The “Credit Requirement” shall be deemed satisfied if, as of the date immediately preceding the date of the Permitted Transfer, the financial strength of (i) the entity with which Tenant is to merge or consolidate or to which the Lease is otherwise to be assigned or (ii) the purchaser of all or substantially all of the assets of Tenant is not less than that of Tenant, as determined (x) based on credit ratings of such entity and Tenant by both Moody’s and Standard & Poor’s (or by either such agency alone, if applicable ratings by the other agency do not exist), or (y) if such credit ratings do not exist, then in accordance with certified financial statements for such entity and Tenant covering their last two fiscal years ending before the Transfer. In the event that, at any time after a Permitted Transfer, the Affiliate to which the Permitted Transfer is made ceases to qualify as an Affiliate of the original Tenant, such event shall be deemed a Transfer that is subject to the provisions of Sections 11.01, 11.02, and 11.03 above.

11.05 Prohibited Matters. Without limiting Landlord’s right to withhold its consent to any transfer by Tenant, and regardless of whether Landlord shall have consented to any such transfer, neither Tenant nor any other person having an interest in the possession, use or occupancy of the Premises or any part thereof shall enter into any lease, sublease, license, concession, assignment or other transfer or agreement for possession, use or occupancy of all or any portion of the Premises which provides for rent or other payment for such use, occupancy or utilization based, in whole or in part, on the net income or profits derived by any person or entity from the space so leased, used or occupied, and any such purported lease, sublease, license, concession, assignment or other transfer or agreement shall be absolutely void and ineffective as a conveyance of any right or interest in the possession, use or occupancy of all or any part of the Premises.

12.Notices.

All demands, approvals, consents or notices (collectively referred to as a “notice”) shall be in writing and delivered by hand or sent by registered, express, or certified mail, with return receipt requested or with delivery confirmation requested from the U.S. postal service, or sent by overnight or same day courier service at the party’s respective Notice Address(es) set forth in Section 1; provided, however, notices sent by Landlord regarding general Building operational matters may be posted in the Building mailroom or the general Building newsletter or sent via e-mail to the e-mail address provided by Tenant to Landlord for such purpose. In addition, if the Building is closed (whether due to emergency, governmental order or any other reason), then any notice address at the Building shall not be deemed a required notice address during such closure, and, unless Tenant has provided an alternative valid notice address to Landlord for use during such closure, any notices sent during such closure may be sent via e-mail or in any other practical manner reasonably designed to ensure receipt by the intended recipient. Each notice shall be deemed to have been received on the earlier to occur of actual delivery or the date on which delivery is refused, or, if Tenant has vacated the Premises or any other Notice Address of Tenant without providing a new Notice Address, three (3) Business Days after notice is deposited in the U.S. mail or with a courier service in the manner described above. Either party may, at any time, change its Notice Address (other than to a post office box address) by giving the other party written notice of the new address.

13.Indemnity and Insurance.

13.01 Indemnification. Except to the extent caused by the negligence or willful misconduct of Landlord or any Landlord Related Parties (defined below), and to the maximum extent permitted under applicable law, Tenant shall indemnify, defend and hold Landlord and Landlord Related Parties harmless against and from all liabilities, obligations, damages, penalties, claims, actions, costs, charges and expenses, including, without limitation, reasonable attorneys’ fees and other professional fees (collectively referred to as “Losses”), which may be imposed upon, incurred by or asserted against Landlord or any of the Landlord Related Parties by any third party and arising out of or in connection with any damage or injury occurring in the Premises or any acts or omissions (including violations of Law) of Tenant, its trustees, managers, members, principals, beneficiaries, partners, officers, directors, employees and agents (the “Tenant Related Parties”) or any of Tenant’s transferees, contractors or licensees. To the maximum extent permitted under applicable law, Tenant hereby waives all claims against and releases Landlord and its trustees, managers, members, principals, beneficiaries, partners, officers, directors, employees, Mortgagees (defined in Section 21) and agents (the “Landlord Related Parties”) from all claims for any injury to or death of persons, damage to property or business loss in any manner related to (a) Force Majeure, (b) acts of third parties, (c) the bursting or leaking of any tank, water closet, drain or other pipe (except to the extent caused by the negligence or willful misconduct of Landlord, its employees or agents), or (d) the inadequacy or failure of any security or protective services, personnel or equipment (except to the extent caused by the gross negligence or willful misconduct of Landlord, its employees or agents).

Subject to the provisions of the Lease, including without limitation Section 7.03 and this Section 13, Landlord shall indemnify, defend, and hold Tenant and the applicable Tenant Related Parties harmless from and against any third-party claim for personal injury or property damage occurring in the Common Areas, to the extent caused by the negligence or willful misconduct of Landlord or any Landlord Related Parties.

13.02 Tenant’s Insurance. Tenant shall maintain the following coverages in the following amounts throughout the Term (and during any other periods before or after the Term during which Tenant or any Tenant Related Party enters into or occupies all or any portion of the Premises):

(a) Commercial General Liability Insurance covering claims of bodily injury, personal injury and property damage arising out of Tenant’s operations and contractual liabilities, including coverage formerly known as broad form, on an occurrence basis, with minimum primary limits of $1,000,000 each occurrence and $2,000,000 annual aggregate and a minimum excess/umbrella limit of $5,000,000.00.

(b) Property insurance covering (i) Tenant’s Property (as defined below), and (ii) any Leasehold Improvements in the Premises, whether installed by or for the benefit of Tenant under this Lease or any prior lease or other agreement to which Tenant was a party or otherwise (“Tenant-Insured Improvements”). Such insurance shall be written on a special cause of loss form for physical loss or damage, for the full replacement cost value (subject to reasonable deductible amounts) without deduction for depreciation of the covered items and in amounts that meet any co-insurance clauses of the policies of insurance, and shall include coverage for damage or other loss caused by fire or other peril, including vandalism and malicious mischief, theft, water damage of any type, including sprinkler leakage, bursting or stoppage of pipes, and explosion, and providing business interruption coverage for a period of one year.

The minimum limits of insurance required to be carried by Tenant shall not limit Tenant’s liability. Such insurance shall (i) be issued by an insurance company that has an A.M. Best rating of not less than A-VIII; (ii) be in form and content reasonably acceptable to Landlord; and (iii) provide that it shall not be canceled or materially changed without thirty (30) days’ prior notice to Landlord, except that ten (10) days’ prior notice may be given in the case of nonpayment of premiums. Tenant’s Commercial General Liability Insurance shall (a) name Landlord, Landlord’s managing agent, and any other party designated by Landlord (“Additional Insured Parties”) as additional insureds; and (b) be primary insurance as to all claims thereunder and provide that any insurance carried by Landlord is excess and non-contributing with Tenant’s insurance. Landlord shall be designated as a loss payee with respect to Tenant’s property insurance on any Tenant-Insured Improvements. Tenant shall deliver to Landlord, on or before the Term Commencement Date and at least fifteen (15) days before the expiration dates thereof, certificates from Tenant’s insurance company on the forms currently designated “ACORD 28” (Evidence of Commercial Property Insurance) and “ACORD 25-S” (Certificate of Liability Insurance) or the equivalent. Attached to the ACORD 25-S (or equivalent) there shall be an endorsement naming the Additional Insured Parties as additional insureds which shall be binding on Tenant’s insurance company and shall expressly require the insurance company to notify each Additional Insured Party in writing at least thirty (30) days before any termination or material change to the policies, except that ten (10) days’ prior notice may be given in the case of nonpayment of premiums. Notwithstanding the foregoing, if the foregoing requirement that the insurance company provide prior notice to Landlord of cancellation or material change of the applicable policy cannot reasonably be obtained based on then-prevailing insurance industry practices, Tenant shall so advise Landlord of such unavailability and shall instead provide Landlord with notice of any such cancellation or material change as provided above. Upon Landlord’s request, Tenant shall deliver to Landlord, in lieu of such certificates, copies of the policies of insurance required to be carried under Section 13.02 showing that the Additional Insured Parties are named as additional insureds.

Tenant shall maintain such increased amounts of the insurance required to be carried by Tenant under this Section 13.02, and such other types and amounts of insurance covering the Premises and Tenant’s operations therein, as may be reasonably requested by Landlord, but not in excess of the amounts and types of insurance then being required by landlords of buildings comparable to and in the vicinity of the Building.

13.03 Landlord Insurance. Landlord shall, during the Term, maintain so-called “All Risk” property insurance on the Building at replacement cost value with an Agreed Amount endorsement to satisfy co-insurance requirements as reasonably estimated by Landlord, together with such other insurance coverages and deductibles as are required by Landlord’s first mortgagee or as Landlord, in its reasonable judgment, may elect to maintain from time to time; provided that Landlord shall not be obligated to insure any furniture, equipment, machinery, goods or supplies which Tenant may keep or maintain in the Premises, or any Leasehold Improvements.

13.04 Tenant’s Property. All furnishings, fixtures, equipment, and other personal property and effects of Tenant and of all persons claiming through Tenant which from time to time may be on the Premises or elsewhere in the Project or in transit thereto or therefrom including, without limitation, the Purchased Furniture (collectively, “Tenant’s Property”) shall be at the sole risk of Tenant to the maximum extent permitted by law and shall be kept insured by Tenant throughout the Term (and during any other periods before or after the Term during which Tenant or any Tenant Related Party enters into or occupies all or any portion of the Premises) at Tenant’s expense in accordance with Section 13.02. Tenant’s Property expressly includes all business fixtures and equipment, including without limitation any security or access control systems installed for the Premises, filing cabinets and racks, removable cubicles and partitions, kitchen equipment, computers and related equipment, raised flooring, supplemental cooling equipment, audiovisual and telecommunications equipment, non-building standard signage, and other tenant equipment installations, in each case including related conduits, cabling, and brackets or mounting components therefor and any connectors to base building systems and in each case whether installed or affixed in or about the Premises, in building core areas, or elsewhere in the Project.

13.05 Waiver of Subrogation. Subject to Section 14, each party waives, and shall cause its insurance carrier to waive, any right of recovery against the other for any loss of or damage to property which loss or damage is (or, if the insurance required hereunder had been carried, would have been) covered by insurance. For purposes of this Section 13.05, any deductible or self-insured retention with respect to a party’s insurance shall be deemed covered by, and recoverable by such party under, valid and collectable policies of insurance.

14.Casualty Damage.

14.01 Casualty. If all or any portion of the Premises becomes untenantable or inaccessible by fire or other casualty to the Premises or the Common Areas (collectively a “Casualty”), Landlord, with reasonable promptness, shall cause a general contractor selected by Landlord to provide Landlord with a written estimate of the amount of time required, using standard working methods, to substantially complete the repair and restoration of the Premises and any Common Areas necessary to provide access to the Premises (“Completion Estimate”). Landlord shall promptly forward a copy of the Completion Estimate to Tenant. If the Completion Estimate indicates that the Premises or any Common Areas necessary to provide access to the Premises cannot be made tenantable within two hundred seventy (270) days from the date the repair is started, then either party shall have the right to terminate this Lease upon written notice to the other within ten (10) days after Tenant’s receipt of the Completion Estimate. Tenant, however, shall not have the right to terminate this Lease if the Casualty was caused by the negligence or intentional misconduct of Tenant or any Tenant Related Parties. In addition, Landlord, by notice to Tenant within ninety (90) days after the date of the Casualty, shall have the right to terminate this Lease if: (1) the Premises have been materially damaged and less than two (2) years of the Term remain after the date of the Casualty; (2) any Mortgagee requires that the insurance proceeds be applied to the payment of the mortgage debt; or (3) a material uninsured loss to the Building or Premises occurs.

14.02 Restoration. If this Lease is not terminated, Landlord shall promptly and diligently, subject to reasonable delays for insurance adjustment or other matters beyond Landlord’s reasonable control, restore the Premises and Common Areas, subject to the following provisions. Such restoration shall be to substantially the same condition that existed prior to the Casualty, except for modifications required by Law or any other modifications to the Common Areas deemed desirable by Landlord. Notwithstanding Section 13.05, upon notice from Landlord, Tenant shall assign or endorse over to Landlord (or to any party designated by Landlord) all property insurance proceeds payable to Tenant under Tenant’s insurance with respect to any Leasehold Improvements; provided if the estimated cost to repair such Leasehold Improvements exceeds the amount of insurance proceeds received by Landlord from Tenant’s insurance carrier, the excess cost of such repairs shall be paid by Tenant to Landlord prior to Landlord’s commencement of repairs. Within fifteen (15) days after demand, Tenant shall also pay Landlord for any additional excess costs that are determined during the performance of the repairs to such Leasehold Improvements. In no event shall Landlord be required to spend more for the restoration of the Premises and Common Areas than the proceeds received by Landlord, whether from Landlord’s insurance proceeds or proceeds from Tenant. Landlord shall not be liable for any inconvenience to Tenant, or injury to Tenant’s business resulting in any way from the Casualty or the repair thereof. Provided that Tenant is not in Default, during any period of time that all or a material portion of the Premises is rendered untenantable as a result of a Casualty, the Rent shall abate for the portion of the Premises that is untenantable and not used by Tenant. Notwithstanding the foregoing, Landlord may, at its election, require Tenant to perform the restoration work for the Leasehold Improvements, in which event Tenant shall be responsible for performing the restoration work (including any revisions thereto that Tenant may wish to make, pursuant to plans approved by Landlord under Section 8) and the rent abatement period under the preceding sentence shall not exceed the period of time required to diligently perform the restoration of the existing Leasehold Improvements.

14.03 Insurance Proceeds. If this Lease is terminated by either party on account of any Casualty as provided in this Article 14, then Tenant shall pay to Landlord (by assignment or otherwise) the insurance proceeds paid or payable to Tenant under the policy(ies) referred to in Section 13.02 (b) on account of the damage to or loss of the Leasehold Improvements in the Premises; however, from any such proceeds actually received by Tenant, Tenant shall be entitled to retain an amount equal to the unamortized portion (amortized over the initial Term on a straight-line basis) of the hard costs paid by Tenant to perform such Leasehold Improvements (after deduction of the Tenant Work Allowance and any other work allowance or contribution paid by Landlord for such Leasehold Improvements).

15.Condemnation.

Either party may terminate this Lease if any material part of the Premises is taken or condemned for any public or quasi-public use under Law, by eminent domain or private purchase in lieu thereof (a “Taking”). Landlord shall also have the right to terminate this Lease if there is a Taking of any portion of the Building or Property which would have a material adverse effect on Landlord’s ability to profitably operate the remainder of the Building. The terminating party shall provide written notice of termination to the other party within forty-five (45) days after it first receives notice of the Taking. The termination shall be effective as of the effective date of any order granting possession to, or vesting legal title in, the condemning authority. If this Lease is not terminated, Base Rent and Tenant’s Proportionate Share shall be appropriately adjusted to account for any reduction in the square footage of the Building or Premises. All compensation awarded for a Taking shall be the property of Landlord. The right to receive compensation or proceeds are expressly waived by Tenant, provided, however, Tenant may file a separate claim for Tenant’s Property and Tenant’s reasonable relocation expenses, provided the filing of the claim does not diminish the amount of Landlord’s award. If only a part of the Premises is subject to a Taking and this Lease is not terminated, Landlord, with reasonable diligence, will restore the remaining portion of the Premises as nearly as practicable to the condition immediately prior to the Taking.

16.Events of Default.

16.01 Default. In addition to any other Default specifically described in this Lease, each of the following occurrences shall be a “Default”: (a) Tenant’s failure to pay any portion of Rent when due, if the failure continues for five (5) Business Days after written notice to Tenant (“Monetary Default”); (b) Tenant’s failure (other than a Monetary Default) to comply with any term, provision, condition or covenant of this Lease, if the failure is not cured within thirty (30) days after written notice to Tenant provided, however, if Tenant’s failure to comply cannot reasonably be cured within such thirty-(30)-day period, Tenant shall be allowed additional time (not to exceed an additional sixty (60) days) as is reasonably necessary to cure the failure so long as Tenant begins the cure within such thirty-(30)-day period and diligently pursues the cure to completion; (c) Tenant effects or permits a Transfer without Landlord’s required approval or otherwise in violation of Section 11 of this Lease; (d) Tenant becomes insolvent, makes a transfer in fraud of creditors, makes an assignment for the benefit of creditors, admits in writing its inability to pay its debts when due or forfeits or loses its right to conduct business; (e) the leasehold estate is taken by process or operation of Law; (f) if a receiver, guardian, conservator, trustee in bankruptcy or similar officer shall be appointed by a court of competent jurisdiction to take charge of all or any part of Tenant’s property and such appointment is not discharged within ninety (90) days thereafter, or if a petition including, without limitation, a petition for reorganization or arrangement is filed by Tenant under any bankruptcy law or is filed against Tenant and the same shall not be dismissed within ninety (90) days from the date upon which it is filed, or (g) Tenant is in default beyond any notice and cure period under any other lease or agreement with Landlord at the Project. In addition, if Landlord provides Tenant with notice of Tenant’s failure to comply with any specific provision of this Lease on two (2) separate occasions during any twelve-(12)-month period, any subsequent violation of such provision within such twelve-(12)-month period shall, at Landlord’s option, constitute a Default by Tenant without the requirement of any further notice or cure period as provided above. All notices sent under this Section shall be in satisfaction of, and not in addition to, any notice required by Law.

16.02 Remedies. Upon the occurrence of any Default, Landlord may, immediately or at any time thereafter, elect to terminate this Lease by notice of termination, by entry, or by any other means available under law and may recover possession of the Premises as provided herein. Upon termination by notice, by entry, or by any other means available under law, Landlord shall be entitled immediately, in the case of termination by notice or entry, and otherwise in accordance with the provisions of law to recover possession of the Premises from Tenant and those claiming through or under the Tenant. Such termination of this Lease and repossession of the Premises shall be without prejudice to any remedies which Landlord might otherwise have for arrears of rent or for a prior breach of the provisions of this Lease. Tenant waives any statutory notice to quit and equitable rights in the nature of further cure or redemption, and Tenant agrees that upon Landlord’s termination of this Lease Landlord shall be entitled to re-entry and possession in accordance with the terms hereof. Landlord may, without notice, store Tenant’s personal property (and those of any person claiming under Tenant) at the expense and risk of Tenant or, if Landlord so elects, Landlord may sell such personal property at public auction or auctions or at private sale or sales after thirty (30) days’ notice to Tenant and apply the net proceeds to the earliest of installments of rent or other charges owing Landlord. Tenant agrees that a notice by Landlord alleging any default shall, at Landlord’s option (the exercise of such option shall be indicated by the inclusion of the words “notice to quit” in such notice), constitute a statutory notice to quit. If Landlord exercises its option to designate a notice of default hereunder as a statutory notice to quit, any grace periods provided for herein shall run concurrently with any statutory notice periods. Tenant further agrees that it shall not interpose any counterclaim or set-off in any summary proceeding or in any action based in whole or in part on non-payment of Rent, unless Tenant would have no right to commence an independent proceeding to seek to recover on account of such claim.

16.03 Reimbursement of Expenses. In the case of termination of this Lease pursuant to this Section 16, Tenant shall reimburse Landlord for all expenses arising out of such termination, including without limitation, all costs incurred in collecting amounts due from Tenant under this Lease (including attorneys’ fees, costs of litigation and the like); all out-of-pocket expenses incurred by Landlord in attempting to relet the Premises or parts thereof (including advertisements, brokerage commissions, Tenant’s allowances, costs of preparing space, and the like); all of Landlord’s then unamortized costs of any work allowances provided to Tenant for the Premises; and all Landlord’s other reasonable expenditures necessitated by the termination. The reimbursement from Tenant shall be due and payable immediately from time to time upon notice from Landlord that an expense has been incurred, without regard to whether the expense was incurred before or after the termination.

16.04 Damages. Landlord may elect by written notice to Tenant within one (1) year following such termination to be indemnified for loss of rent by a lump sum payment representing the then present value of the amount of rent and additional charges which would have been paid in accordance with this Lease for the remainder of the Term minus the then present value of the aggregate fair market rent and additional charges payable for the Premises for the remainder of the Term (if less than the rent and additional charges payable hereunder), estimated as of the date of the termination, and taking into account reasonable projections of vacancy and time required to re-lease the Premises. (For the purposes of calculating the rent which would have been paid hereunder for the lump sum payment calculation described herein, the last full year’s Additional Rent under Section 4 is to be deemed constant for each year thereafter. The Federal Reserve discount rate (or equivalent) shall be used in calculating present values.) Should the parties be unable to agree on a fair market rent, the matter shall be submitted, upon the demand of either party, to the Boston, Massachusetts office of the American Arbitration Association, with a request for arbitration in accordance with the rules of the Association by a single arbitrator who shall be an MAI appraiser with at least ten years’ experience as an appraiser of major office buildings in downtown Boston. The parties agree that a decision of the arbitrator shall be conclusive and binding upon them. If, at the end of the Term, the rent which Landlord has actually received from the Premises is less than the aggregate fair market rent estimated as aforesaid, Tenant shall thereupon pay Landlord the amount of such difference. If and for so long as Landlord does not make the election provided for in this Section 16.04 above, Tenant shall indemnify Landlord for the loss of rent by a payment at the end of each month which would have been included in the Term, representing the excess of the rent which would have been paid in accordance with this Lease (i.e., Base Rent and Additional Rent that would have been payable to be ascertained monthly) over the rent actually derived from the Premises by Landlord for such month (the amount of rent deemed derived shall be the actual amount less any portion thereof attributable to Landlord’s reletting expenses described in Section 16.03 which have not been reimbursed by Tenant thereunder).

In lieu of the damages, indemnity, and full recovery by Landlord of the sums payable under the foregoing provisions of this Section 16.04, Landlord may, by written notice to Tenant within six (6) months after termination under any of the provisions contained in Section 16 and before such full recovery, elect to recover, and Tenant shall thereupon pay, as minimum liquidated damages under this Section 16.04, an amount equal to (i) the aggregate of the Base Rent and Additional Rent for the twelve-month period ending one year after the termination date (or, if lesser, for the balance of the Term had it not been terminated), plus (ii) the amount of Base Rent and Additional Rent of any kind accrued and unpaid at the time of termination, and minus (iii) the amount of any recovery by Landlord under the foregoing provisions of this Section 16 up to the time of payment of such liquidated damages (but reduced by any amounts of reimbursement under Section 16.03). The amount under clause (i) represents a reasonable forecast of the minimum damages expected to occur in the event of a breach, taking into account the uncertainty, time and cost of determining elements relevant to actual damages, such as fair market rent, time and costs that may be required to re-lease the Premises, and other factors. Liquidated damages hereunder shall not be in lieu of any claims for reimbursement under Section 16.03.

Free rent amounts, rent holidays, rent waivers, rent forgivenesses and the like (collectively “Free Rent Amounts”), if any, have been agreed to by Landlord as inducements for Tenant to enter into and faithfully to perform all of its obligations contained in this Lease. For all purposes under this Lease, upon the occurrence of any event under Section 16.01 and the lapse of any applicable grace or notice period, any Free Rent Amounts set forth in this Lease shall be deemed void as of the date of execution hereof as though such Free Rent Amounts had never been included in this Lease, and calculations of amounts due hereunder, damages and the like shall be determined accordingly. The foregoing shall occur automatically without the requirement of any further notice or action by Landlord not specifically required by Section 16.01, whether or not this Lease is then or thereafter terminated on account of the event in question, and whether or not Tenant thereafter corrects or cures any such event.

Any obligation imposed by law upon Landlord to relet the Premises after any termination of the Lease shall be subject to the reasonable requirements of Landlord to lease to high quality tenants on such terms as Landlord may from time to time deem appropriate and to develop the Project in a harmonious manner with an appropriate mix of uses, tenants, floor areas and terms of tenancies, and the like, and Landlord shall not be obligated to relet the Premises to any party to whom Landlord or its affiliate may desire to lease other available space in the Project.

16.05 Curative Action. If Tenant is in Default of any of its non-monetary obligations under this Lease, Landlord shall have the right, but not the obligation, to perform any such obligation. Tenant shall reimburse Landlord for the cost of such performance upon demand, together with an administrative charge equal to ten percent (10%) of the cost of the work performed by Landlord.

16.06 Claims in Bankruptcy. Nothing herein shall limit or prejudice the right of Landlord to prove and obtain in a proceeding for bankruptcy, insolvency, arrangement or reorganization, by reason of the termination, an amount equal to the maximum allowed by a statute or law in effect at the time when, and governing the proceedings in which, the damages are to be proved, whether or not the amount is greater to, equal to, or less than the amount of the loss or damage which Landlord has suffered.

16.07 Late Charges and Fees. If Tenant does not pay any Rent when due hereunder, then without notice and in addition to all other remedies hereunder, Tenant shall pay to Landlord an administration fee in the amount of four percent (4%) of the unpaid Rent, plus interest on such unpaid amount at the rate of one and one-half percent (1.5%) per month from the date such amount was due until the date paid (which interest, as accrued to date, shall be payable from time to time upon Landlord’s demand); provided, however, in no event shall such interest exceed the maximum amount permitted to be charged by applicable law. Notwithstanding the foregoing, Tenant shall be entitled to a grace period of five (5) days for the first late payment of Rent in any twelve-(12)-month period prior to the imposition of the foregoing amounts. In addition, Tenant shall pay to Landlord a reasonable fee for any payments returned by Tenant’s bank for any reason.

16.08 Enforcement Costs. Tenant shall pay to Landlord, as Additional Rent, the out-of-pocket costs and expenses, including reasonable attorneys’ fees, incurred in enforcing any obligations of Tenant under this Lease with which Tenant has failed to comply.

16.09 General. The repossession or re-entering of all or any part of the Premises shall not relieve Tenant of its liabilities and obligations under this Lease. No right or remedy of Landlord shall be exclusive of any other right or remedy, and each right and remedy shall be cumulative and in addition to any other right and remedy now or subsequently available to Landlord at law or in equity. Without limiting the generality of the foregoing, in addition to the other remedies provided in this Lease, Landlord shall be entitled to the restraint by court order of the violation or attempted or threatened violation of any of the provisions of this Lease or of applicable Law or to a decree compelling specific performance of any such provisions.

17.Limitation of Liability.

17.01 Landlord’s Liability. Tenant agrees from time to time to look only to Landlord’s interest in the Building for satisfaction of any claim against Landlord hereunder or under any other instrument related to the Lease (including any separate agreements among the parties and any notices or certificates delivered by Landlord) and not to any other property or assets of Landlord. If Landlord from time to time transfers its interest in the Building (or part thereof which includes the Premises), then from and after each such transfer Tenant shall look solely to the interests in the Building of each of Landlord’s transferees for the performance of all of the obligations of Landlord hereunder (or under any related instrument). The obligations of Landlord shall not be binding on any direct or indirect partners (or members, trustees or beneficiaries) of Landlord or of any successor, individually, but only upon Landlord’s or such successor’s interest described above. If Landlord shall refuse or fail to provide any consent or approval for any matter for which Landlord’s consent or approval is required under this Lease or is otherwise requested by Tenant, Landlord shall not be liable for damages as a result thereof, and Tenant’s sole remedy to enforce any alleged obligation of Landlord to provide such consent or approval shall be an action for specific performance, injunction, or declaratory relief.

17.02 Assignment of Rents.

(a) With reference to any assignment by Landlord of Landlord’s interest in this Lease, or the rents payable hereunder, conditional in nature or otherwise, which assignment is made to the holder of a mortgage on property which includes the Premises, Tenant agrees that the execution thereof by Landlord, and the acceptance thereof by the holder of such mortgage shall never be treated as an assumption by such holder of any of the obligations of Landlord hereunder unless such holder shall, by notice sent to Tenant, specifically otherwise elect and, except as aforesaid, such holder shall be treated as having assumed Landlord’s obligations hereunder only upon foreclosure of such holder’s mortgage and the taking of possession of the Premises.

(b) In no event shall the acquisition of Landlord’s interest in the Property by a purchaser which, simultaneously therewith, leases Landlord’s entire interest in the Property back to the seller thereof be treated as an assumption by operation of law or otherwise, of Landlord’s obligations hereunder, but Tenant shall look solely to such seller‑lessee, and its successors from time to time in title, for performance of Landlord’s obligations hereunder. In any such event, this Lease shall be subject and subordinate to the lease to such purchaser. For all purposes, such seller‑lessee, and its successors in title, shall be the Landlord hereunder unless and until Landlord’s position shall have been assumed by such purchaser‑lessor.

(c) Except as provided in paragraph (b) of this Section 17.02, in the event of any transfer of title to the Property by Landlord, Landlord shall thereafter be entirely freed and relieved from the performance and observance of all covenants and obligations hereunder. Tenant hereby agrees to enter into such agreements or instruments as may, from time to time, be requested in confirmation of the foregoing.

17.03 Landlord Default. In the event Tenant alleges that Landlord is in default under any of Landlord’s obligations under this Lease, Tenant agrees to give any Mortgagee (as defined in Section 21), by certified mail, a copy of any notice of default which is served upon the Landlord, provided that prior to such notice, Tenant has been notified, in writing (whether by way of notice of an assignment of lease, request to execute an estoppel letter, or otherwise), of the address of any such Mortgagee. Tenant further agrees that if Landlord shall have failed to cure such default within sixty (60) days from the date of such notice, or such other time as provided by law or such additional time as may be provided in this Lease or such notice to Landlord, such Mortgagee shall have a period of thirty (30) days after the last date on which Landlord could have cured such default within which such Mortgagee will be permitted, but not be obligated, to cure such default. If such default cannot be cured within such thirty-(30)-day period, then such Mortgagee shall have such additional time as may be necessary to cure such default, if prior to the end of such thirty-(30)-day period such Mortgagee has commenced and is diligently pursuing such cure or the remedies under the Mortgage necessary for Mortgagee to be able to effect such cure, in which event Tenant shall have no right with respect to such default while such cure and remedies are being diligently pursued by such Mortgagee. Except as may be expressly provided in this Lease, in no event shall Tenant have the right to terminate the Lease nor shall Tenant’s obligation to pay Base Rent or other charges under this Lease abate based upon any default by Landlord of its obligations under the Lease. In no event shall Landlord or any Landlord Related Party ever be liable to Tenant for loss of profits, loss of business, or indirect or consequential damages suffered by Tenant from whatever cause.

18.Relocation. Intentionally Deleted.

19.Holding Over.

If Tenant fails to surrender all or any part of the Premises at the expiration or earlier termination of this Lease, any such occupancy of all or any part of the Premises after such expiration or termination shall be that of a tenancy at sufferance. Any such occupancy after such expiration or termination shall be subject to all the terms and provisions of this Lease, except that Tenant shall pay an amount for such occupancy (on a per month basis without reduction for partial months during the holdover) equal to (A) for the first thirty (30) days of such holdover occupancy, one hundred fifty percent (150%) of the greater of (i) the Rent due for the month immediately preceding the holdover or (ii) the fair market rent then being obtained for comparable space in the Building, and (B) from and after the thirty-first (31st) day of such holdover occupancy, two times the greater of (i) the Rent due for the month immediately preceding the holdover or (ii) the fair market rent then being obtained for comparable space in the Building. No holdover by Tenant or payment by Tenant after the expiration or earlier termination of this Lease shall be construed to extend the Term or prevent Landlord from immediate recovery of possession of the Premises by summary proceedings or otherwise. In addition, if as a result of such holdover, Landlord is unable to deliver possession of space to a new tenant or to perform improvements therein for a new tenant due to Tenant’s failure to timely vacate all or part of the Premises, Tenant shall be liable to Landlord for all damages and losses that Landlord suffers from the holdover.

20.Surrender of Premises.

At the expiration or earlier termination of this Lease or Tenant’s right of possession hereunder, Tenant shall remove all Tenant’s Property from the Premises, remove all Required Removables (if any) under Section 8.03, and quit and surrender the Premises to Landlord, broom clean, and in good order, condition and repair, ordinary wear and tear and damage which Landlord is obligated to repair hereunder excepted. Tenant shall repair any damage caused by the installation or removal of Tenant’s Property or Required Removables. If Tenant fails to remove any of Tenant’s Property or to restore or repair the Premises to the required condition as provided herein upon the expiration of the Term of this Lease (or, as applicable, within two (2) days after any earlier termination of this Lease or Tenant’s right to possession hereunder), then Landlord, at Tenant’s sole cost and expense, shall be entitled, but not obligated, to remove and store Tenant’s Property and/or perform such restoration or repair of the Premises. Landlord shall not be responsible for the value, preservation, or safekeeping of Tenant’s Property, and Tenant shall pay to Landlord, upon demand, the expenses and storage charges so incurred. If Tenant fails to remove Tenant’s Property from the Premises or storage, within thirty (30) days after notice, Landlord may deem all or any part of Tenant’s Property to be abandoned and, at Landlord’s option, title to Tenant’s Property shall vest in Landlord or Landlord may dispose of Tenant’s Property in any manner Landlord deems appropriate.

21.Subordination to Mortgages; Estoppel Certificate.

21.01 Subordination. This Lease is and shall be subject and subordinate to any mortgage(s), deed(s) of trust, deeds to secure debt, ground lease(s) or other lien(s) now or subsequently arising upon the Premises, the Building or the Project, and to all renewals, modifications, refinancings, and extensions thereof (collectively referred to as a “Mortgage”). The party having the benefit of a Mortgage shall be referred to as a “Mortgagee”. This clause shall be self-operative, but upon request from Landlord or a Mortgagee, Tenant shall execute a subordination agreement in favor of the Mortgagee in such Mortgagee’s standard form, with such commercially reasonable changes as Tenant may request that are acceptable to Mortgagee for other comparable leases in the Building. As an alternative, any Mortgagee shall have the right at any time to subordinate its Mortgage to this Lease. Notwithstanding anything in this Article to the contrary, as a condition precedent to the subordination of this Lease to a future Mortgage, Landlord shall be required to provide Tenant with a non-disturbance, subordination, and attornment agreement in favor of Tenant from such future Mortgagee on such Mortgagee’s standard form, with such commercially reasonable modifications as Tenant may reasonably request that are reasonably acceptable to such future Mortgagee. Upon request, Tenant, without charge, shall attorn to any successor to Landlord’s interest in this Lease. In the event Mortgagee enforces it rights under the Mortgage, Tenant, at Mortgagee’s option, will attorn to Mortgagee or its successor; provided, however, that Mortgagee or its successor shall not be liable for or bound by (i) any payment of any Rent installment which may have been made more than thirty (30) days before the due date of such installment, (ii) any act or omission of or default by Landlord under this Lease (but Mortgagee, or such successor, shall be subject to the continuing obligations of landlord under the Lease arising from and after such succession, but only to the extent of Mortgagee’s, or such successor’s, interest in the Property as provided in Section 17), (iii) any credits, claims, setoffs or defenses which Tenant may have against Landlord, or (iv) any obligation under this Lease to maintain a fitness facility at the Project, if any. Tenant, upon the reasonable request by Mortgagee or such successor in interest, shall execute and deliver an instrument or instruments confirming such attornment. Landlord will use commercially reasonable efforts to obtain a subordination, non-disturbance and attornment agreement (an “SNDA”) from the existing Mortgagee on such existing Mortgagee’s standard form, with such commercially reasonable modifications as Tenant may reasonably request that are reasonably acceptable to such existing Mortgagee; provided that failure to obtain such SNDA shall not be a default of Landlord hereunder, prohibit the mortgaging of the Project by Landlord, or limit the subordination provisions of this Section 21.01. Tenant shall be responsible for paying all fees and expenses charged by a Mortgagee in connection with the negotiation of such Mortgagee’s SNDA or other subordination agreement.

21.02 Modification of Lease. If any Mortgagee requires a modification of this Lease, which modification will not cause an increased cost or expense to Tenant, or in any other way materially and adversely change the rights and obligations of Tenant hereunder, Tenant agrees that this Lease may be so modified and agrees to execute whatever documents are reasonably required therefor and to deliver the same to Landlord within ten (10) Business Days following a request therefor. At the request of Landlord or any Mortgagee, Tenant agrees to execute a short form of this Lease and deliver the same to Landlord within ten (10) Business Days following the request therefor.

21.03 Estoppel Certificate. Tenant shall, within ten (10) days after receipt of a written request, execute and deliver a commercially reasonable estoppel certificate addressed to Landlord and any parties reasonably requested by Landlord, such as a current or prospective Mortgagee or purchaser of the Building. Without limitation, such estoppel certificate may include a certification as to the status of this Lease and any particular obligations thereunder, the existence of any defaults, and the amount of Rent that is then due and payable.

21.04 Tenant Information. Upon Landlord’s request from time to time, but in no event more than once per calendar year, except in connection with the sale, financing, or refinancing of the Building or Landlord’s interest therein or following a Default, Tenant shall provide to Landlord the financial statements for Tenant for its most recent fiscal year and fiscal quarter. Financial statements for each fiscal year shall be prepared and reviewed by a certified public accountant and certified by Tenant’s chief financial officer; financial statements for each quarter shall be prepared and certified by Tenant’s chief financial officer. If requested by Tenant, such financial statements shall be furnished pursuant to a confidentiality agreement in a form reasonably provided by Landlord for such purpose.

22.Miscellaneous.

22.01 Measurement of Floor Area. Landlord and Tenant stipulate and agree that the Rentable Floor Area of the Premises originally leased to Tenant shall be conclusively deemed to be as specified in Section 1 and that the Rentable Floor Area of the Office Section of the Building is as specified in Exhibit B as of the date hereof. Any change in the Rentable Floor Area of the Premises on account of expansion shall be conclusively deemed to be as specified in any applicable expansion provisions under Exhibit F (if any) or in any amendment hereafter executed by Landlord and Tenant in connection with such expansion (if any). Any other change in the Rentable Floor Area of the Premises on account of casualty, condemnation, or the like shall be determined in accordance with the measurement standard that was originally used to determine the stipulated Rentable Floor Area for the space in question. Any change in the Rentable Floor Area of the Office Section of the Building on account of casualty, condemnation, or other changes to the Building shall be determined from time to time by Landlord based on area computations supplied by Landlord’s architect, which determinations shall be conclusive. References in this Lease to floor area measurements and square footage shall mean Rentable Floor Area unless the reference explicitly provides otherwise.

22.02 Notice of Lease. Tenant shall not record this Lease or any memorandum or notice without Landlord’s prior written consent; provided, however, that Landlord agrees to consent to the recording of a memorandum or notice of this Lease, at Tenant’s cost and expense and in a form reasonably satisfactory to Landlord, if the initial term of this Lease together with any extension terms granted hereunder (if any) exceed, in the aggregate, the applicable statutory period for notice of leases in the state in which the Building is located. If this Lease is terminated before the Term expires, upon Landlord’s request the parties shall execute, deliver and record an instrument acknowledging such termination date of this Lease, and Tenant appoints Landlord its attorney-in-fact in its name and behalf to execute the instrument if Tenant shall fail to execute and deliver the instrument after Landlord’s request therefor within ten (10) days.

22.03 Governing Law, Etc. This Lease shall be interpreted and enforced in accordance with the Laws of the Commonwealth of Massachusetts and Landlord and Tenant hereby irrevocably consent to the jurisdiction and proper venue of such Commonwealth. This Lease contains all of the agreements and understandings between Landlord and Tenant with respect to the Premises and supersedes all prior writings and dealings between them with respect thereto, including all lease proposals, letters of intent and other documents. Neither party is relying upon any warranty, statement or representation not contained in this Lease. If any term or provision of this Lease shall to any extent be void or unenforceable, the remainder of this Lease shall not be affected. This Lease may be amended only by a writing signed by all of the parties hereto. The titles are for convenience only and shall not be considered a part of the Lease. Where the phrases “persons acting under Tenant” or “persons claiming under Tenant” or similar phrases are used, such persons shall include subtenants, sub-subtenants, and licensees, and all employees, agents, independent contractors and invitees of Tenant or of such other parties. The enumeration of specific examples of or inclusions in a general provision shall not be construed as a limitation of the general provision. If Tenant is granted any extension option, expansion option, or other right or option, the exercise of such right or option (and notice thereof) must be unconditional to be effective, time always being of the essence to the exercise of such right or option; and if Tenant purports to condition the exercise of any option or to vary its terms in any manner, then the option granted shall be void and the purported exercise shall be ineffective. Unless otherwise stated herein, any consent or approval required hereunder may be given or withheld in the sole absolute discretion of the party whose consent or approval is required. Nothing herein shall be construed as creating the relationship between Landlord and Tenant of principal and agent, or of partners or joint venturers, or any relationship other than landlord and tenant. If there is more than one Tenant or if Tenant is comprised of more than one party or entity, the obligations imposed upon Tenant shall be joint and several obligations of all such parties and entities, any requests or demands from any one person or entity comprising Tenant shall be deemed to have been made by all such persons or entities, and notices to any one person or entity comprising Tenant shall be deemed to have been given to all such persons and entities. Tenant’s covenants contained in this Lease are independent and not dependent, and Tenant hereby waives the benefit of any statute or judicial law to the contrary. Tenant’s obligation to pay Rent shall not be discharged or otherwise affected by any law or regulation now or hereafter applicable to the Premises, or any other restriction on Tenant’s use, or (except as expressly provided in this Lease) any casualty or taking, or any failure by Landlord to perform any covenant contained herein, or any other occurrence; and no termination or abatement remedy that is not expressly provided for in this Lease for any breach or failure by Landlord to perform any obligation under this Lease shall be implied or applicable as a matter of law.

22.04 Tenant Representations. Tenant represents and warrants to Landlord, and agrees, that each individual executing this Lease on behalf of Tenant is authorized to do so on behalf of Tenant and that the entity(ies) or individual(s) constituting Tenant, or which may own or control Tenant, or which may be owned or controlled by Tenant, or any of Tenant’s affiliates, or any of their respective partners, members, shareholders or other equity owners, and their respective employees, officers, directors, representatives or agents are not and at no time will be (i) in violation of any Laws relating to terrorism or money laundering, or (ii) among the individuals or entities with whom U.S. persons or entities are restricted from doing business under regulations of the Office of Foreign Assets Control (“OFAC”) of the Department of the Treasury (including those named on OFAC’s Specially Designated Nationals and Blocked Persons List for the purpose of identifying suspected terrorists or on the most current list published by the U.S. Treasury Department Office of Foreign Assets Control at its official website, http://www.treasury.gov/resource-center/sanctions/SDN-List/Pages/default.aspx or any replacement website or other replacement official publication of such list) or under any statute, executive order (including the September 24, 2001, Executive Order Blocking Property and Prohibiting Transactions with Persons Who Commit, Threaten to Commit, or Support Terrorism, known as Executive Order 13224), or other governmental action and Tenant will not Transfer this Lease to, contract with or otherwise engage in any dealings or transactions or be otherwise associated with such persons or entities.

22.05 Landlord Representations. Landlord represents and warrants to Tenant, and agrees, that, to Landlord’s knowledge as of the Effective Date, the entity(ies) or individual(s) constituting Landlord or which may own or control Landlord or which may be owned or controlled by Landlord are not and at no time will be (i) in violation of any Laws relating to terrorism or money laundering, or (ii) among the individuals or entities identified on any list compiled pursuant to Executive Order 13224 for the purpose of identifying suspected terrorists or on the most current list published by the U.S. Treasury Department Office of Foreign Assets Control at its official website, http://www.treasury.gov/resource-center/sanctions/SDN-List/Pages/default.aspx or any replacement website or other replacement official publication of such list.

22.06 Waiver of Trial by Jury; No Other Waiver. Landlord and Tenant hereby waive any right to trial by jury in any proceeding based upon a breach of this Lease. No failure by either party to declare a default immediately upon its occurrence, nor any delay by either party in taking action for a default, nor Landlord’s acceptance of Rent with knowledge of a default by Tenant, shall constitute a waiver of the default, nor shall it constitute an estoppel. The delivery of keys to Landlord or to Landlord’s property manager shall not operate as a termination of this Lease or a surrender of the Premises.

22.07 Time Periods. Whenever a period of time is prescribed for the taking of an action by Landlord or Tenant (other than the payment of the Security Deposit or Rent), the period of time for the performance of such action shall be extended by the number of days that the performance is actually delayed due to strikes, acts of God, shortages of labor or materials, war, terrorist acts, pandemics, civil disturbances and other causes beyond the reasonable control of the performing party (“Force Majeure”).

22.08 Transfer of the Property. Landlord shall have the right from time to time to transfer and assign, in whole or in part, all of its rights and obligations under this Lease and in the Building and Project. Upon transfer, Landlord shall be released from any further obligations hereunder and Tenant agrees to look solely to the successor in interest of Landlord for the performance of such obligations, to the extent that any successor pursuant to a voluntary, third party transfer (but not as part of an involuntary transfer resulting from a foreclosure or deed in lieu thereof) shall have assumed Landlord’s obligations under this Lease from and after the date of the transfer.

22.09 Submission. The submission of this Lease to Tenant or a summary of some or all of its provisions for examination does not constitute a reservation of or option for the Premises or an offer to lease, and no legal obligations shall arise with respect to the Premises or other matters herein unless and until such time as this Lease is executed and delivered by Landlord and Tenant and approved by the holder of any mortgage on the Building having the right to approve this Lease.

22.10 Brokers. Tenant represents that it has dealt directly with and only with the Broker as a broker, agent or finder in connection with this Lease. Tenant shall indemnify and hold Landlord and the Landlord Related Parties harmless from all claims of any other brokers, agents or finders claiming to have represented Tenant in connection with this Lease. Landlord shall indemnify and hold Tenant and the Tenant Related Parties harmless from all claims of any brokers, agents or finders claiming to have represented Landlord in connection with this Lease. Any assistance rendered by any agent or employee of Landlord in connection with this Lease or any subsequent amendment or modification or any other document related hereto has been or will be made as an accommodation to Tenant solely in furtherance of consummating the transaction on behalf of Landlord, and not as agent for Tenant.

22.11 Survival. The expiration of the Term, whether by lapse of time, termination or otherwise, shall not relieve either party of any obligations that accrued prior to or which may continue to accrue after the expiration or termination of this Lease.

22.12 Quiet Enjoyment. This Lease is subject to all easements, restrictions, agreements, and encumbrances of record to the extent in force and applicable. Landlord covenants that Tenant, on paying the Rent and performing the tenant obligations in this Lease, shall peacefully and quietly have, hold and enjoy the Premises, free from any claim by Landlord or persons claiming under Landlord, but subject to all of the terms and provisions hereof, provisions of Law, and rights of record to which this Lease is or may become subordinate. This covenant is in lieu of any other so-called quiet enjoyment covenant, either express or implied. This covenant shall be binding upon Landlord and its successors only during its or their respective periods of ownership of the Building.

22.13 Reservations. This Lease does not grant any rights to light or air over or about the Project. Landlord excepts and reserves exclusively to itself any and all rights not specifically granted to Tenant under this Lease. Landlord reserves the right to make changes to the Project as Landlord deems appropriate. Wherever this Lease requires Landlord to provide a customary service or to act in a reasonable manner (whether in incurring an expense, establishing a rule or regulation, providing an approval or consent, or performing any other act), this Lease shall be deemed also to provide that whether such service is customary or such conduct is reasonable shall be determined by reference to the practices of owners of buildings that (i) are comparable to the Building in size, age, class, quality and location, and (ii) at Landlord’s option, have been, or are being prepared to be, certified under the U.S. Green Building Council’s Leadership in Energy and Environmental Design (“LEED”) rating system or a similar rating system.

22.14 Rents from Real Property. Landlord and Tenant agree that all rental payable by Tenant to Landlord, which includes all sums, charges, or amounts of whatever nature to be paid by Tenant to Landlord in accordance with the provisions of this Lease, shall qualify as “rents from real property” within the meaning of both Sections 512(b)(3) and 856(d) of the Internal Revenue Code of 1986, as amended (the “Code”) and the U.S. Department of Treasury Regulations promulgated thereunder (the “Regulations”). In the event that Landlord, in its sole discretion, determines that there is any risk that all or part of any rental shall not qualify as “rents from real property” for the purposes of Sections 512(b)(3) or 856(d) of the Code and the Regulations promulgated thereunder, Tenant agrees (i) to cooperate with Landlord by entering into such amendment or amendments as Landlord deems necessary to qualify all payments as “rents from real property,” (ii) to permit an assignment of this Lease and (iii) to allow Landlord to assign any and all obligations that Landlord has under this Lease to a third party; provided, however, that any adjustments required pursuant to this paragraph shall be made so as to produce the equivalent rental payments (in economic terms) payable prior to such adjustment.

22.15 Unrelated Business Taxable Income. Landlord shall have the right at any time and from time to time to unilaterally amend the provisions of this Lease, if Landlord is advised by its counsel that all or any portion of the monies paid by Tenant to Landlord hereunder are, or may be deemed to be, unrelated business income within the meaning of the Code or the Regulations, and Tenant agrees that it will execute all documents or instruments necessary to effect such amendment or amendments, provided that no such amendment shall result in Tenant having to pay in the aggregate more money on account of its occupancy of the Premises under the terms of this Lease, as so amended, and provided further that no such contract shall result in Tenant having materially greater obligations or receiving less services, or services of a lesser quality than it is presently entitled to receive under this Lease. Any services which Landlord is required to furnish pursuant to the provisions of this Lease may, at Landlord’s option, be furnished from time to time, in whole or in part, by employees of Landlord or Landlord’s managing agent or its employees or by one or more third parties hired by Landlord or Landlord’s managing agent. Tenant agrees that upon Landlord’s written request it will enter into direct agreements with Landlord’s managing agent or other parties designated by Landlord for the furnishing of any such services required to be furnished by Landlord hereunder, in the form and content approved by Landlord, provided however that no such contract shall result in Tenant having to pay in the aggregate more money on account of its occupancy of the Premises under the terms of this Lease, and provided further that no such contract shall result in Tenant having materially greater obligations or receiving less services, or services of a lesser quality than it is presently entitled to receive under this Lease.

22.16 ERISA. Tenant represents that (a) neither Tenant nor any entity controlling or controlled by Tenant owns a ten percent (10%) or more interest (within the meaning of Prohibited Transaction Class Exemption 84-14) in JPMorgan Chase Bank, N.A. (“JPMorgan”) or any of JPMorgan’s affiliates, and (b) neither JPMorgan, nor, to Tenant’s actual knowledge (after having used reasonable efforts to ascertain the accuracy of such information), any of its affiliates, owns a ten percent (10%) or more interest in Tenant or any entity controlling or controlled by Tenant.

22.17 Execution. This Lease may be executed in one or more counterparts and, when executed by each party, shall constitute an agreement binding on all parties notwithstanding that all parties are not signatories to the original or the same counterpart provided that all parties are furnished a copy or copies thereof reflecting the signature of all parties. Transmission of a facsimile or by email of a pdf copy of the signed counterpart of the Lease shall be deemed the equivalent of the delivery of the original, and any party so delivering a facsimile or pdf copy of the signed counterpart of the Lease by email transmission shall in all events deliver to the other party an original signature promptly upon request.

[Signatures on Following Page]

Landlord and Tenant have executed this Lease as a sealed Massachusetts instrument in two or more counterparts as of the Effective Date of this Lease set forth above.


	LANDLORD:

	500 BOYLSTON & 222 BERKELEY OWNER (DE) LLC, a Delaware limited liability company By:_/s/ Kristen Binck_______________ Name: Kristen Binck Title: Vice President By:_/s/ Brian Barriero____________ Name: Brian Barriero Title: Vice President

	TENANT:
	VOR BIOPHARMA, INC., a Delaware corporation By: /s/ Jean-Paul Kress_______________ Name: Jean-Paul Kress Title: Chief Executive Officer

EXHIBIT A

OUTLINE AND LOCATION OF PREMISES

A-1

EXHIBIT B

EXPENSES AND TAXES

This Exhibit is attached to and made a part of the Office Lease Agreement (the “Lease”) by and between 500 BOYLSTON & 222 BERKELEY OWNER (DE) LLC, a Delaware limited liability company (“Landlord”), and VOR BIOPHARMA, INC., a Delaware corporation (“Tenant”), for space in the Building located at 500 Boylston Street, Boston, MA 02116. Capitalized terms used but not defined herein shall have the meanings given in the Lease.

1. Payments.

1.01 Expenses and Taxes. Tenant shall pay Tenant’s Proportionate Share of (a) the amount of Expenses (defined below) for each calendar year during the Term and (b) the amount of Taxes (defined below) for each calendar year during the Term. Landlord shall provide Tenant with a good faith estimate of the Expenses and Taxes for each calendar year during the Term. On or before the first day of each month, Tenant shall pay to Landlord a monthly installment equal to one-twelfth of Tenant’s Proportionate Share of Landlord’s estimate of the Expenses and Taxes. If Landlord determines that its good faith estimate of the Expenses or of the Taxes was incorrect by a material amount, Landlord may from time to time provide Tenant with a revised estimate. After its receipt of the revised estimate, Tenant’s monthly payments shall be based upon the revised estimate. If Landlord does not provide Tenant with an estimate of the Expenses or the Taxes by January 1 of a calendar year, Tenant shall continue to pay monthly installments based on the previous year’s estimate(s) until Landlord provides Tenant with the new estimate. Upon delivery of the new estimate, an adjustment shall be made for any month for which Tenant paid monthly installments based on the previous year’s estimate. Tenant shall pay Landlord the amount of any underpayment within thirty (30) days after receipt of the new estimate. Any overpayment shall be refunded to Tenant within thirty (30) days or credited against the next due future installment(s) of Additional Rent. Appropriate adjustments (including adjustments in the amounts of Expenses and Taxes, which are calculated on an annual basis as set forth above) shall be made for any portion of a year at the beginning or end of the Term or for any year during which changes occur in the percentage of occupancy of the Building or in the Rentable Floor Area to which Landlord furnishes particular services.

1.02 Reconciliation. As soon as is practical following the end of each calendar year, Landlord shall furnish Tenant with a statement of the actual Expenses and the actual Taxes for the prior calendar year. If the amount of estimated Expenses or estimated Taxes for the prior calendar year is more than the actual Expenses or actual Taxes, as the case may be, for the prior calendar year, Landlord shall either provide Tenant with a refund or apply any overpayment by Tenant against Additional Rent due or next becoming due, provided that, if the Term expires before the determination of the overpayment, Landlord shall refund any overpayment to Tenant after first deducting the amount of Rent due. If the amount of estimated Expenses or estimated Taxes for the prior calendar year is less than the actual Expenses or actual Taxes, as the case may be, for such prior year, Tenant shall pay Landlord, within thirty (30) days after its receipt of the statement of Expenses or Taxes, any underpayment for the prior calendar year. Landlord’s annual statement with respect to Expenses and Taxes, or any other statement regarding other Additional Rent, shall be binding upon, and may not be disputed by, Tenant unless the statement is incorrect and is disputed by Tenant, within sixty (60) days after Tenant’s receipt of Landlord’s statement, by a notice to Landlord specifically stating the grounds for dispute. Tenant’s failure so to dispute Landlord’s statement shall constitute a waiver of Tenant’s right to dispute the statement. Notwithstanding any dispute concerning any Landlord’s statement, payments shall be made by the parties in accordance with Landlord’s statement at the time and in the manner set forth above, and if necessary, there shall be a further adjustment between the parties at the time the dispute is resolved.

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2. Property Operating Expenses.

2.01 “Expenses” means all costs and expenses incurred in each calendar year in connection with operating, maintaining, repairing, and managing the Building, the Property, and the Common Areas of the Project, subject to the provisions of this Section 2. Expenses include, without limitation: (a) all labor and labor related costs, including wages, salaries, bonuses, taxes, insurance, uniforms, training, retirement plans, pension plans and other employee benefits (which shall be equitably prorated by Landlord between the Building and other buildings or properties to which the applicable employee is providing services); (b) management fees in an amount equal to ten percent (10%) the gross revenues of the Building; (c) the cost of equipping, staffing and operating an on-site and/or off-site management office for the Building (including, without limitation, the market rental for the management office located in the Building), provided if the management office services one or more other buildings or properties, the shared costs and expenses of equipping, staffing and operating such management office(s) shall be equitably prorated and apportioned by Landlord between the Building and the other buildings or properties; (d) costs of accounting and IT services (which shall be equitably prorated by Landlord between the Building and other buildings or properties to which such services are provided); (e) the cost of services (which shall be equitably prorated by Landlord between the Building and other buildings or properties to which such services are provided); (f) rental and purchase cost of parts, supplies, tools and equipment (which shall be equitably prorated by Landlord between the Building and other buildings or properties where such parts, supplies, tools and equipment are used); (g) insurance premiums and deductibles; (h) electricity, gas and other utility costs; (i) those costs set forth in Exhibit K to this Lease, including without limitation, (1) all costs of energy and water audits and commissioning of the Building for the purpose of improving efficiency and/or complying with legislation; (2) all costs associated with property improvements for the purpose of improving efficiency and/or complying with environmental legislation; (3) all costs of maintaining, managing, and reporting and applying for energy efficiency and green building certifications; (4) or above standard usage, all costs associated with energy and water submetering; and (5) all costs associated with energy efficiency and emission assessments, levies, taxes, and fees; (j) the amortized cost of capital improvements (as distinguished from replacement parts or components installed in the ordinary course of business) that are: (1) intended to effect economies in the operation or maintenance of the Property, reduce current or future Expenses, enhance the safety or security of the Property or its occupants or the Common Areas of the Project, or enhance the environmental sustainability of the Property’s operations, (2) replacements or modifications of nonstructural items located in the Base Building or Common Areas that are required to keep the Base Building or Common Areas in good condition, or (3) required under any Law. The cost of capital improvements shall be amortized by Landlord over the lesser of the Payback Period (defined below) or the useful life of the capital improvement as reasonably determined by Landlord. The amortized cost of capital improvements may, at Landlord’s option, include actual or imputed interest at the rate that Landlord would reasonably be required to pay to finance the cost of the capital improvement. “Payback Period” means the reasonably estimated period of time that it takes for the cost savings resulting from a capital improvement to equal the total cost of the capital improvement. Landlord, by itself or through an affiliate, shall have the right to directly perform, provide and be compensated for any services under the Lease. If Landlord incurs Expenses for the Common Areas of the Project or for the Building or Property together with one or more other buildings or properties, whether pursuant to a reciprocal easement agreement, common area agreement or otherwise, the shared costs and expenses shall be equitably prorated and apportioned by Landlord between the Building and Property and the other buildings or properties.

B-2

2.02 Exclusions. Expenses shall not include: those costs and expenses which are specifically attributable to and separately paid by the tenants of the Retail Section of the Building and not provided to Tenant hereunder; that portion of the costs and expenses relating to the loading dock facilities and other Common Areas that exclusively serve the Retail Section of the Building or is paid by the tenants in the Retail Section of the Building; the cost of capital improvements (except as set forth above); depreciation; principal and interest payments of mortgage and other non-operating debts of Landlord; the cost of repairs or other work to the extent Landlord is reimbursed by insurance or condemnation proceeds; costs in connection with leasing space in the Building, including brokerage commissions, lease concessions, rental abatements, and construction allowances granted to specific tenants; costs incurred in connection with the sale, financing or refinancing of the Building; fines, interest and penalties incurred due to the late payment of Taxes or Expenses; organizational expenses associated with the creation and operation of the entity which constitutes Landlord; any penalties or damages that Landlord pays to Tenant under this Lease or to other tenants in the Building under their respective leases; salaries and benefits of personnel above the grade of the Building’s general manager; costs of operating, maintaining, repairing, and managing the garage serving the Building; ground lease rent; costs of electricity provided to tenants’ premises, if and to the extent that Tenant is charged for such electricity services under other provisions of this Lease; costs of special services that are separately chargeable to Tenant and other tenants; and charitable or political contributions.

2.03 Adjustments. If at any time during a calendar year the Building is not at least 95% occupied and receiving Landlord services hereunder (or if a service provided by Landlord to tenants of the Building generally is not provided by Landlord to particular tenant(s) due to self-provided services or other circumstances), Expenses shall be determined as if the Building had been 95% occupied (and all services provided by Landlord to tenants of the Building generally had been provided by Landlord to tenants occupying 95% of the entire Building) during that calendar year. Notwithstanding the foregoing, Landlord may calculate the extrapolation of Expenses under this Section based on 100% occupancy and service so long as such percentage is used consistently for each year of the Term.

2.04 Related Definitions. As used herein, “Tenant’s Proportionate Share” shall initially be as specified in Section 1 of the Lease, subject to adjustment from time to time to reflect the ratio in which the Rentable Floor Area of the Premises bears to the greater of (i) the total Rentable Floor Area of the Office Section of the Building, or (ii) the Total Leased Rentable Floor Area. The “Total Leased Rentable Floor Area” shall mean the sum of the Rentable Floor Area leased to all tenants of the Office Section of the Building over the course of a year, determined on the basis of a weighted averaging of the sum of the Rentable Floor Area leased to and occupied by all tenants of the Office Section of the Building receiving standard building services on each day of that year. Landlord reserves the right from time to time to change or recalculate the total Rentable Floor Area of the Office Section as provided in Section 22.01 of the Lease and the Total Leased Rentable Floor Area of the Office Section of the Building based on changes in occupancy from time to time.

3. Property Taxes.

“Taxes” shall mean, subject to the following provisions hereof: (a) all real property taxes and other assessments on the Building and/or Property, including, but not limited to, gross receipts taxes, assessments for special improvement districts and business improvement districts, governmental charges, fees and assessments for police, fire, traffic mitigation or other governmental service of purported benefit to the Property, taxes and assessments levied in substitution or supplementation in whole or in part of any such taxes and assessments and the Property’s share of any real estate taxes and assessments under any reciprocal easement agreement, common area agreement, or similar agreement as to the Property; (b) all personal property taxes for property that is owned by Landlord and used in connection with the operation, maintenance and repair of the Property; and (c) all costs and fees incurred in connection with seeking reductions in any tax liabilities described in (a) and (b), including, without limitation, any costs incurred by Landlord for compliance, review, and appeal of tax liabilities. Without limitation, Taxes shall be determined without regard to any “green building” credit and shall not include any income, capital levy, transfer, capital stock, gift, estate, or inheritance tax. Taxes shall further exclude that portion of the items enumerated in this Section which is allocated by Landlord to the Retail Section and the garage serving the Building. If a change in Taxes is obtained for any year of the Term during which Tenant paid Tenant’s Proportionate Share of Taxes, then Taxes for that year will be retroactively adjusted and Landlord shall provide Tenant with a credit, if any, based on the adjustment.

B-3

Tenant shall pay Landlord the amount of Tenant’s Proportionate Share of any such increase in Taxes within thirty (30) days after Tenant’s receipt of a statement from Landlord. For the purpose of determining Taxes for any given calendar year, the amount to be included in Taxes for such year shall be as follows: (1) with respect to any special assessment that is payable in installments, Taxes for such year shall include the amount of the installment (and any interest) due and payable during such calendar year; and (2) with respect to all other real estate taxes, Taxes for such year shall, at Landlord’s election, include either the amount accrued, assessed, or otherwise imposed for such calendar year, provided that Landlord’s election shall be applied consistently throughout the Term of the Lease.

4. Audit Rights.

Within sixty (60) days after receiving Landlord’s annual reconciliation statement of Expenses (each such period is referred to as the “Review Notice Period”), Tenant may give Landlord written notice (“Review Notice”) that Tenant intends to review Landlord’s records of the Expenses for the calendar year to which the statement applies, identifying, with a reasonable degree of specificity, the information that Tenant desires to review (the “Request for Information”). Within a reasonable time after Landlord’s receipt of a timely Request for Information and executed Audit Confidentiality Agreement (referenced below), Landlord, as determined by Landlord, shall forward to Tenant, or make available for inspection on site at such location deemed reasonably appropriate by Landlord, such records (or copies thereof) for the applicable calendar year that are reasonably necessary for Tenant to conduct its review of the information appropriately identified in the Request for Information. Within sixty (60) days after any particular records are made available to Tenant (such period is referred to as the “Objection Period”), Tenant shall have the right to give Landlord written notice (an “Objection Notice”) stating in reasonable detail any objection to Landlord’s statement of Expenses for that year which relates to the records that have been made available to Tenant. If Tenant provides Landlord with a timely Objection Notice and the parties agree that Expenses for the calendar year are less than reported, then Landlord shall provide Tenant with a credit against the next installment of Rent in the amount of the overpayment by Tenant. If the parties agree that Expenses for the calendar year are greater than reported, Tenant shall pay Landlord the amount of any underpayment within thirty (30) days. If Tenant fails to give Landlord an Objection Notice with respect to any records that have been made available to Tenant prior to expiration of the Objection Period applicable to the records which have been provided to Tenant, Tenant shall be deemed to have approved Landlord’s statement of Expenses with respect to the matters reflected in such records and shall be barred from raising any claims regarding the Expenses relating to such records for that year. If Tenant fails to timely provide Landlord with a Review Notice and the Request for Information Period described above, Tenant shall be deemed to have approved Landlord’s statement of Expenses and shall be barred from raising any claims regarding the Expenses for that year.

If Tenant retains an agent to review Landlord’s records, the agent must be with a certified public accounting firm licensed to do business in the Commonwealth of Massachusetts. Tenant shall be solely responsible for all costs, expenses and fees incurred for the audit, and Tenant shall not directly or indirectly engage such agent or any other party in connection with such review whose compensation or fees are charged in whole or in part on a contingency basis. The records and related information obtained by Tenant shall be treated as confidential, and applicable only to the Building, by Tenant and its auditors, consultants and other parties reviewing such records on behalf of Tenant (collectively, “Tenant’s Auditors”), and, prior to making any records available to Tenant or Tenant’s Auditors, Landlord may require Tenant and Tenant’s Auditors to each execute a confidentiality agreement in a form reasonably provided by Landlord (“Audit Confidentiality Agreement”) in accordance with the foregoing. In no event shall Tenant be permitted to examine Landlord’s records or to dispute any statement of Expenses unless Tenant has paid and continues to pay all Rent when due.

B-4

EXHIBIT C

FORM OF BILL OF SALE

D-1

EXHIBIT D

COMMENCEMENT LETTER

D-2

EXHIBIT E

BUILDING RULES AND REGULATIONS

E-1

EXHIBIT F

ADDITIONAL PROVISIONS

1. Parking.

(a) During the initial Term, Landlord shall lease to Tenant, or cause the operator (the “Operator”) of the garage serving the Building (the “Garage”) to lease to Tenant, and Tenant shall lease from Landlord or such Operator, four (4) unreserved parking spaces in the Garage (the “Spaces”) for the use of Tenant and its employees. The Spaces shall be leased at the rate of $465 unreserved/$685 reserved per Space, per month, plus applicable tax thereon, as such rate may be adjusted from time to time to reflect the then current rate for parking in the Garage.

(b) No deductions or allowances shall be made for days when Tenant or any of its employees does not utilize the parking facilities or for Tenant utilizing less than all of the Spaces. Tenant shall not have the right to lease or otherwise use more than the number of unreserved Spaces set forth above.

(c) Except for particular spaces and areas designated by Landlord or the Operator for reserved parking, all parking in the Garage shall be on an unreserved, first-come, first-served basis.

(d) Neither Landlord nor the Operator shall be responsible for money, jewelry, automobiles or other personal property lost in or stolen from the Garage regardless of whether such loss or theft occurs when the Garage or other areas therein are locked or otherwise secured. Except as caused by the negligence or willful misconduct of Landlord and without limiting the terms of the preceding sentence, Landlord shall not be liable for any loss, injury or damage to persons using the Garage or automobiles or other property therein, it being agreed that, to the fullest extent permitted by law, the use of the Spaces shall be at the sole risk of Tenant and its employees.

(e) Landlord or its Operator shall have the right from time to time to designate the location of the Spaces and to promulgate reasonable rules and regulations regarding the Garage, the Spaces and the use thereof, including, but not limited to, rules and regulations controlling the flow of traffic to and from various parking areas, the angle and direction of parking and the like. Tenant shall comply with and cause its employees to comply with all such rules and regulations and all reasonable additions and amendments thereto.

(f) Tenant shall not store or permit its employees to store any automobiles in the Garage without the prior written consent of Landlord. Except for emergency repairs, Tenant and its employees shall not perform any work on any automobiles while located in the Garage or on the Property. If it is necessary for Tenant or its employees to leave an automobile in the Garage overnight, Tenant shall provide Landlord with prior notice thereof designating the license plate number and model of such automobile.

(g) Landlord or the Operator shall have the right to temporarily close the Garage or certain areas therein in order to perform necessary repairs, maintenance and improvements to the Garage.

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(h) Tenant shall not assign or sublease any of the Spaces without the consent of Landlord. Landlord shall have the right to terminate Tenant’s parking rights with respect to any Spaces that Tenant desires to sublet or assign.

(i) Landlord or Operator may elect to provide parking cards or keys to control access to the Garage. In such event, Landlord or Operator, as the case may be, shall provide Tenant with one card or key for each Space that Tenant is leasing hereunder, provided that Landlord or Operator, as the case may be, shall have the right to require Tenant or its employees to place a deposit on such access cards or keys and to pay a fee for any lost or damages cards or keys.

(j) In addition to the Spaces, Tenant’s employees will have the right to use up to six (6) additional unreserved parking spaces in the Garage, subject to availability, on a month-to-month basis (the “MTM Spaces”). Landlord or Operator, as the case may be, shall provide thirty (30) days’ notice in each instance prior to recapturing any MTM Space(s). All terms of this Section 1 shall apply to the MTM Spaces and the use thereof by Tenant’s employees.

2. Extension Option. Tenant shall have the option (the “Extension Option”) to extend the Term for one extension term of five (5) years commencing at the expiration of the initial Term (the “Extension Term”). Any extension of the Term shall be applicable to the entire Premises (as the same may be expanded). If Tenant fails timely to exercise the Extension Option, Tenant shall have no further extension rights hereunder. If Tenant timely exercises the Extension Option as provided below, the Term shall be extended for the Extension Term, and Tenant shall pay Base Rent for the Premises during the Extension Term, in accordance with the terms and conditions of Section 4.02 of the Lease, at a Base Rent rate equal to the Fair Market Rent Rate (as defined below) for the Premises for the Extension Term as determined in accordance with the provisions of this Section set forth below (the “Extension Rent Rate”). Time is of the essence with respect to Tenant’s timely exercise of the Extension Option as provided herein. Any notice exercising the Extension Option must be unconditional and irrevocable in order to be effective. Except as set forth herein, Tenant’s lease of the Premises during the Extension Term shall be on all of the terms and conditions in effect for the Premises immediately prior to such extension, except that Tenant shall have no further option to extend the Term after the end of the Extension Term.

The procedures for Tenant to exercise the Extension Option, and for the applicable Extension Rent Rate applicable to the Extension Term to be determined, are as follows:

(a) Tenant’s Exercise Notice. If Tenant wishes to exercise the Extension Option, Tenant shall so notify Landlord in writing no more than fifteen (15) months, and no less than twelve (12) months, prior to the date the initial Term is then scheduled to expire. Failure by Tenant timely to send such written notice under this subparagraph (a) shall constitute an irrevocable waiver of Tenant’s right to extend the Term.

(b) Landlord’s Response. If Tenant timely delivers a notice under subparagraph (a) above, Landlord shall furnish Tenant with Landlord’s estimate of the Extension Rent Rate for the Extension Term no later than nine (9) months prior to the date the Term is then scheduled to expire.

(c) Tenant’s Exercise Notice. If Tenant timely notifies Landlord in writing pursuant to subparagraph (a) above, on or before the date that is fifteen (15) Business Days after Landlord furnishes its estimate of the Extension Rent Rate to Tenant pursuant to subparagraph (b) above, Tenant shall, by written notice delivered to Landlord, either give Landlord a written notice (i) accepting Landlord’s estimate of the Extension Rent Rate for the Extension Term, or (ii) disputing Landlord’s estimate of such applicable Extension Rent Rate, which notice under clause (ii) shall state Tenant’s estimate of the Extension Rent Rate. Failure timely to give a notice disputing Landlord’s estimate of such applicable Extension Rent Rate shall constitute an acceptance of Landlord’s determination of such applicable Extension Rent Rate.

F-2

(d) Confirmatory Instrument. If Tenant shall exercise the Extension Option in accordance with this Section, the provisions of this Section shall be self-operative, but upon request by either party after determination of the Extension Rent Rate for the Extension Term, the parties shall execute an agreement specifying the Extension Rent Rate for the Extension Term and acknowledging the extension of the Term.

(e) Arbitration. If Tenant disputes Landlord’s determination of the Extension Rent Rate under subparagraph (c)(ii) above and the dispute over the Extension Rent Rate is not resolved within thirty (30) days after such dispute notice is delivered, then either party may cause the matter of the Fair Market Rent Rate to be submitted to arbitration as set forth below, by giving notice of such submission to the other party. Each of Landlord and Tenant, within twenty (20) days after notice of such submission to arbitration, shall appoint as an arbitrator a commercial real estate broker with at least ten (10) years’ experience as a broker for first-class high-rise office buildings in downtown Boston, Massachusetts, and shall give notice of such appointment to the other party. If either Landlord or Tenant shall fail timely to appoint an arbitrator, the other may apply to the Boston Office of the American Arbitration Association (“AAA”) for appointment of such an arbitrator five (5) Business Days after notice of such failure to the delinquent party if such arbitrator has not then been appointed. The two arbitrators shall, within five (5) Business Days after appointment of the second arbitrator, appoint a third arbitrator who shall be similarly qualified. If the two arbitrators are unable to agree timely on the selection of the third arbitrator, then either arbitrator on behalf of both may request such appointment from the Boston office of the AAA. The Fair Market Rent Rate of the Premises for the Extension Term shall be determined by the method commonly known as Baseball Arbitration, whereby Landlord’s selected arbitrator and Tenant’s selected arbitrator shall each set forth its respective determination of the Fair Market Rent Rate of the Premises, and the third arbitrator must select one or the other (it being understood that the third arbitrator shall be expressly prohibited from selecting a compromise figure). Landlord’s selected arbitrator and Tenant’s selected arbitrator shall deliver their determinations of the Fair Market Rent Rate of the Premises to the third arbitrator within five (5) Business Days of the appointment of the third arbitrator and the third arbitrator shall render his or her decision within ten (10) days after receipt of both of the other two determinations of the Fair Market Rent Rate of the Premises. The third arbitrator’s decision shall be binding on both Landlord and Tenant. Each party shall bear the costs of its appointed arbitrator; otherwise, the cost of the arbitration (exclusive of each party’s witness and attorneys’ fees, which shall be paid by such party) shall be borne equally by the parties. If the AAA shall cease to provide arbitration for commercial disputes in Boston, the second or third arbitrator, as the case may be, shall be appointed by any successor organization providing substantially the same services, and in the absence of such an organization, by a court of competent jurisdiction under the arbitration act of The Commonwealth of Massachusetts. For any period during which the Extension Rent Rate is in dispute hereunder, Tenant shall make payment on account of Extension Rent Rate at the rate estimated by Landlord as the Extension Rent Rate, and the parties shall adjust for overpayments or underpayments within thirty (30) days after the decision of the arbitrators is announced.

(f) Fair Market Rent Rate. The “Fair Market Rent Rate” for the Extension Term shall mean the annual fair market rent per square foot for the Premises, determined for a term coterminous with the Extension Term under the terms of this Lease, as though the Premises were in the condition then existing or in such better condition as such space is required to be maintained hereunder. In making such determination, reference shall be made to lease transactions for comparable office space in the Building and comparable first-class high-rise buildings in the Back Bay district of Boston, and appropriate adjustments to the rent rates in such comparable transactions shall be made for any relevant factors, including, without limitation, the timing of the transaction, the location and condition of the space, the quality of the Building, and any free rent or other tenant concessions. Without limiting the generality of the foregoing adjustments, if the rent rate in a comparable transaction was determined based on a percentage discount to fair market rent, then the amount of such discount shall be disregarded (i.e., added back into the rental rate) for purposes of determining the Fair Market Rent Rate hereunder.

F-3

(g) General. Notwithstanding any provision of this Section to the contrary, the Extension Option shall be void, at Landlord’s election, if (i) Tenant is in default hereunder, after any applicable notice and cure periods have expired, at the time Tenant elects to extend the Term or at the time the Term would expire but for such extension, or (ii) any Transfer has occurred under Article 11 of the Lease (other than a Permitted Transfer).

F-4

EXHIBIT G

INTENTIONALLY DELETED

G-1

EXHIBIT H

LETTER OF CREDIT REQUIREMENTS

The Letter of Credit (as defined in the Lease) shall be for the amount set forth in Section 1 of the Lease, subject to the terms of Section 6 of the Lease. The Letter of Credit (i) shall be irrevocable and shall be issued by a commercial bank that has a financial condition reasonably acceptable to Landlord and has an office in Boston, Massachusetts or New York City that accepts requests for draws on the Letter of Credit, (ii) shall require only the presentation to the issuer of a certificate of the holder of the Letter of Credit stating that Landlord is entitled to draw on the Letter of Credit pursuant to the terms of the Lease, (iii) shall be payable to Landlord or its successors in interest as the Landlord and shall be freely transferable without cost to any such successor or any lender holding a collateral assignment of Landlord’s interest in the Lease, (iv) shall be for an initial term of not less than one year and contain a provision that such term shall be automatically renewed for successive one-year periods unless the issuer shall, at least forty-five (45) days prior to the scheduled expiration date, give Landlord notice of such nonrenewal, and (v) shall otherwise be in form and substance reasonably acceptable to Landlord. Notwithstanding the foregoing, the term of the Letter of Credit for the final period shall be for a term ending not earlier than the date forty-five (45) days after the last day of the Term. In the event that the issuer ceases to be reasonably acceptable to Landlord, due to a deterioration in its financial condition or change in status that threatens to compromise Landlord’s ability to draw on the Letter of Credit as determined in good faith by Landlord, then Tenant shall provide a replacement Letter of Credit from an issuer satisfying the terms of this Exhibit within thirty (30) days after Landlord’s notice of such event.

Landlord shall be entitled to draw upon the Letter of Credit for its full amount or any portion thereof if (a) Tenant shall fail to perform any of its obligations under the Lease after the expiration of any applicable notice and cure period, or fail to perform any of its obligations under the Lease and transmittal of a default notice or the running of any cure period is barred or tolled by applicable law, or fail to perform any of its obligations under the Lease and any applicable notice and cure period would expire after the expiration of the Letter of Credit, or (b) not less than thirty (30) days before the scheduled expiration of the Letter of Credit, Tenant has not delivered to Landlord a new Letter of Credit in accordance with this Exhibit. Without limiting the generality of the foregoing, Landlord may, but shall not be obligated to, draw on the Letter of Credit from time to time in the event of a bankruptcy filing by or against Tenant and/or to compensate Landlord, in such order as Landlord may determine, for all or any part of any unpaid rent, any damages arising from any termination of the Lease in accordance with the terms of the Lease, and/or any damages arising from any rejection of the Lease in a bankruptcy proceeding commenced by or against Tenant. Landlord may, but shall not be obligated to, apply the amount so drawn to the extent necessary to cure Tenant’s failure.

Any amount of the Letter of Credit drawn in excess of the amount applied by Landlord to cure any such failure shall be held by Landlord as a cash security deposit for the performance by Tenant of its obligations under the Lease. Any cash security deposit may be mingled with other funds of Landlord and no fiduciary relationship shall be created with respect to such deposit, nor shall Landlord be liable to pay Tenant interest thereon. If Tenant shall fail to perform any of its obligations under the Lease, Landlord may, but shall not be obliged to, apply the cash security deposit to the extent necessary to cure Tenant’s failure. After any such application by Landlord of the Letter of Credit or cash security deposit, as the case may be, Tenant shall reinstate the Letter of Credit to the amount originally required to be maintained under the Lease, upon demand.

H-1

Provided that Tenant is not then in default under the Lease, and no condition exists or event has occurred which after the expiration of any applicable notice or cure period would constitute such a default, within forty-five (45) days after the later to occur of (i) the payment of the final Rent due from Tenant or (ii) the later to occur of the Term Expiration Date or the date on which Tenant surrenders the Premises to Landlord in compliance with Section 20 of the Lease, the Letter of Credit and any cash security deposit, to the extent not applied, shall be returned to the Tenant, without interest.

In the event of a sale of the Building or lease, conveyance or transfer of the Building, Landlord shall transfer the Letter of Credit or cash security deposit to the transferee. Upon such transfer, the transferring Landlord shall be released by Tenant from all liability for the return of such security, and Tenant agrees to look to the transferee solely for the return of said security. The provisions hereof shall apply to every transfer or assignment made of the security to such a transferee. Tenant further covenants that it will not assign or encumber or attempt to assign or encumber the Letter of Credit or the monies deposited herein as security, and that neither Landlord nor its successors or assigns shall be bound by any assignment, encumbrance, attempted assignment or attempted encumbrance.

H-2

EXHIBIT I

INTENTIONALLY DELETED

EXHIBIT J

CLEANING SPECIFICATIONS

EXHIBIT K

“GREEN” LEASE RIDER

THIS “GREEN” LEASE RIDER (this “Rider”) is hereby incorporated into and made a part of that certain Office Lease Agreement (the “Lease”) by and between 500 BOYLSTON & 222 BERKELEY OWNER (DE) LLC, a Delaware limited liability company (“Landlord”), and VOR BIOPHARMA, INC., a Delaware corporation (“Tenant”), demising Suite 1350 containing 8,391 square feet of Rentable Floor Area on the thirteenth (13th) floor of that certain office building located at 500 Boylston Street, Boston, MA 02116 (the “Building”). Capitalized terms used but not defined herein shall have the meanings given in the Lease. In the event of any conflicts between the terms and conditions of this Rider and the terms and conditions of the Lease, the terms and conditions of the Lease shall control.

1. Sustainability Practices.

Tenant acknowledges that Landlord may elect, in Landlord’s sole discretion, to implement energy, water and waste efficiency, and environmentally sustainable practices (collectively, the “Sustainability Practices”) and, in furtherance of same, may pursue an environmental sustainability monitoring and certification program and/or rating program such as ENERGY STAR, Green Globes-CIEB, LEED, BREEAM, IREM CSP, Fitwel, Fitwel VRM, WELL, WELL Health & Safety or similar programs (“Green Building Certification and Health & Safety Certification”). Tenant agrees that, throughout the Term of this Lease (as the same may be extended): Tenant shall reasonably cooperate with Landlord and, to the extent reasonably practicable, comply with Landlord’s Sustainability Practices standards for the Building and/or Landlord’s efforts to obtain or maintain Green Building Certification and Health & Safety Certification including, without limitation, (i) matters addressing operations and maintenance, including indoor air quality, energy efficiency, water efficiency, water quality, wellness, health safety, recycling programs, exterior maintenance program, transportation and occupant satisfaction surveys, sustainable procurement practices, and systems upgrades subject to Landlord’s obligation to keep such information confidential pursuant to the terms and conditions of the Lease; (ii) all monitoring and data collection, maintenance, access, documentation and reporting requirements set forth therein. Tenant will make available to Landlord, within ten (10) Business Days following Landlord’s written request, any information in Tenant’s possession or control concerning matters necessary or desirable in Landlord’s efforts to obtain or maintain Green Building Certification and Health & Safety Certification including transportation and occupant satisfaction surveys and sustainable procurement practices, subject to Landlord’s obligation to keep such information confidential pursuant to the terms and conditions of the Lease. Both parties shall designate one point of contact for all sustainability matters. Tenant acknowledges that Landlord may elect to establish a forum for dialogue on sustainability matters, challenges and updates for the purpose of sharing information, reviewing the performance, and identifying opportunities for improvement.

2. Consumption Data.

Within ten (10) Business Days following written request by Landlord, but only to the extent such information or data is then in Tenant’s possession and control, Tenant shall provide Landlord with consumption data in form reasonably required by Landlord: (i) for any utility billed directly to Tenant and any subtenant or licensee of the Premises; and (ii) for any submetered or separately metered utility supplied to the Premises for which Landlord is not responsible for reading under the Lease. If Tenant utilizes separate services from those of Landlord as permitted under the Lease, Tenant hereby consents to (a) Landlord obtaining the information directly from such service providers and, upon ten (10) Business Days’ prior written request, Tenant shall execute and deliver to Landlord and the service providers such commercially reasonable written releases as the service providers may request evidencing Tenant’s consent to deliver the data to Landlord; and (b) installing smart meter(s) at Tenant’s expense. Any information provided hereunder shall be held confidential except for its limited use to evidence compliance with laws and any sustainability standards, subject, in all events, to the confidentiality provisions of the Lease.

Consumption data will cover:

 Electricity consumption

 Electricity tariff

 Purchased renewable energy credits

 Gas consumption

 Other fuel consumption

 Water consumption

Landlord may use this consumption data for the purpose of:

 Monitoring and improving the performance of the Property and/or building

 Measuring the performance of the Property and/or Building against any agreed targets

 Reporting on the performance of the Property and/or Building internally or externally, where data will not be disclosed at an asset level save for as required under local regulation, or at the necessary request of Capital Partner.

3. Above Standard Usage.

Landlord has the right to install additional meters at Tenant’s expense if in Landlord’s reasonable opinion Tenant is using more energy or water than other tenants in the Building and bill Tenant for such usage plus a reasonable administrative fee. Landlord has the right to install supplemental HVAC to the Premises (at Tenant’s expense) if Tenant requires above Building standard operating hours or additional cooling. The use of space heaters is prohibited.

4. Use.

Tenant shall not knowingly and willfully use or operate the Premises in any manner that will cause the Building or any part thereof not to conform with Landlord’s Sustainability Practices standards or certification of the Building in accordance with Green Building Certification and Health & Safety Certification, as may be reasonably determined by Landlord; provided, however, that Tenant shall have received, in writing, a complete statement of Landlord’s Sustainability Practices standards for the Building, including, without limitation, those standards which relate to alterations or improvements in and to the Premises. Tenant shall use all reasonable endeavors to ensure the efficient use of energy and water in the Premises and in respect of its use of any Common Areas of the Building.

In relation to Smart Building Technology, where the Building or the Premises incorporates smart building technology being any advanced technology which obtains and collates data and uses that data to identify measures to optimize the performance of the Building or the Premises Tenant must ensure that it complies with any relevant guidelines.

5. Compliance with Laws.

In addition to Tenant’s obligation to comply with all applicable present and future Laws as set forth in the Lease, Tenant agrees to comply with, and reasonably cooperate with Landlord’s efforts to comply with, energy and water disclosure and efficiency, green building certification, submetering, and/or carbon reduction laws, including without limitation occupant, water, energy, waste, and transportation related surveys, laws, and ordinances within the city, county, state or any other jurisdiction.

In locations where the Building is subject to penalties as a result of a greenhouse gas (“GHG”) emissions limit, if the Building is found in violation of the limit, Landlord may determine the portion of the penalties that are attributable to Tenant and hold Tenant accountable for its portion of the penalty that has been levied on the Building. Landlord shall have the burden to demonstrate to Tenant, the portion of the penalty attributable to Tenant. The portion may be determined using the collection of data from submeters to determine Tenant’s actual, measurable energy consumption and emissions, calculations based on the floor area of tenants’ respective leased spaces, number and frequency of occupants and/or visitors in a leased space, and/or Tenant’s operating hours within the Building, a combination of both submetering and calculations, or other methods.

6. On-site Renewable Energy Use.

In instances where Energy Systems on the roof and other parts of the Building or Building Common Area (as applicable, “Designated RES Areas”) are present, the following terms shall apply to any such system:

 Utilization of Power Generated from the Renewable Energy System. Tenant agrees to utilize power generated from the Renewable Energy System.

 Cost allocation. The costs associated with the Renewable Energy System shall be allocated as part of the overall Building operating expenses, in accordance with the terms of this Lease.

 Power Purchase Agreements. Tenant agrees to execute power purchase agreements or similar documentation requested by Landlord or the Renewable Energy Developer.

 General Cooperation with Permitting. Tenant agrees to reasonably cooperate with Landlord in connection with the necessary approvals and permits for the development and operation of the Renewable Energy System, including the submission of applications related to the interconnection and net metering of the Renewable Energy System.

7. Recycling and Waste Management.

Tenant agrees, at its sole cost and expense (except to the extent any of the following services are provided by the Property Manager and/or Landlord’s janitorial vendor or Landlord’s employees, in which event Tenant may only be responsible for its pro-rata share of the costs thereof, as set forth in the Lease): (i) to comply with all present and future laws, orders and regulations of the Federal, State, county, municipal or other governing authorities, departments, commissions, agencies and boards regarding the collection, sorting, separation, and recycling of garbage, trash, rubbish and other refuse (collectively, “trash”); (ii) if and when applicable, to comply with Landlord’s recycling policy as part of Landlord’s Sustainability Practices standards where it may be more stringent than applicable Law; (iii) to sort and separate its trash and recycling into such categories as are provided by Law or Landlord’s Sustainability Practices standards: and (iv) that Tenant shall, within ten (10) Business Days following invoicing by Landlord, pay all costs, expenses, fines, penalties or damages that may be imposed on Landlord or Tenant by reason of Tenant’s failure to comply with the provisions of this Section. Upon request by Landlord, but in no event more than once per year during the Term, Tenant shall provide Landlord with copies of waste manifests for all waste that leaves the Building that is within Tenant’s direct control, including but not limited to off-site paper shredding and electronic waste; provided, however, that the foregoing requirement shall not apply if the Property Manager and/or Landlord’s janitorial vendor or Landlord’s employees are responsible for the removal of trash and recycling materials (including, without limitation, paper) from the Building.

8. Services.

All maintenance (including without limitation janitorial services and pest control services) and repairs made by Tenant shall comply with Landlord’s Sustainability Practices standards, including any third-party rating system concerning the environmental compliance of the Building or the Premises, as the same may change from time to time. The foregoing provision shall not apply if the Property Manager and/or Landlord’s vendor or Landlord’s employees are providing the services to the Premises.

9. Construction/Alterations.

Notwithstanding local ordinances and building codes, any and all improvements, alterations or additions performed by Tenant will be performed in accordance with Landlord’s Sustainability Practices standards, including any third-party rating system concerning the environmental compliance of the Building or the Premises, as the same may change from time to time, and in accordance with Landlord’s Energy and Sustainability Construction Guidelines & Requirements which are available upon request, and any modifications thereto by Landlord.

10. Moisture and Mold Control Instructions.

Because exercising proper ventilation and moisture control precautions will help maintain Tenant’s comfort and prevent mold growth in the Premises, Tenant agrees to adopt and implement the following guidelines, to avoid encouraging excessive moisture or mold growth:

(i) Report any maintenance problems involving water, moist conditions, or mold to the Property Manager promptly and conduct its required activities in a manner that prevents unusual moisture conditions or mold growth.

(ii) Do not block or inhibit the flow of return or make up air into the HVAC system. Maintain the Premises at a consistent temperature and humidity level in accordance with the Property Manager’s instructions.

(iii) Regularly conduct janitorial activities, especially in bathrooms, kitchens, and janitorial spaces, to remove mildew and prevent or correct moist conditions, but only to the extent such janitorial services are not already provided by Landlord’s janitorial vendor or employees pursuant to the terms and conditions of the Lease.

11. Energy.

Landlord shall have the right to install on-site power generation (i.e., solar or small wind) and/or storage (batteries) at the Building or Project. Tenant agrees to cooperate with Landlord in connection with the installation and on-going operation of such on-site power and/or storage. Tenant shall have no right to any renewable energy credits or similar resulting from on-site energy generation or storage, even if Tenant uses such energy. Landlord may retain or assign such renewable energy credits in Landlord’s sole discretion.

Landlord may provide a forum for Tenant to engage with Landlord to improve the environmental performance of the Premises or the Building. Tenant agrees to cooperate.

12. Smoking.

Smoking, including e-cigarettes, is not allowed anywhere in the Building. Smoking is allowed only in Landlord-designated smoking areas, and no less than twenty-five (25) feet from all entrances, public walkways, the Building’s outdoor air intakes or operable windows.

13. Notice and Cure.

Notwithstanding anything contained in this Rider to the contrary, any failure by Tenant to comply with the terms and conditions of this Rider shall be governed by the terms and conditions of the Lease, including, without limitation, any and all applicable notice and cure provisions set forth therein.

14. Expense Recovery.

Landlord may recover expenses incurred for any of the above items, as set forth in Exhibit B to this Lease.

15. Social Impact.

Landlord and Tenant will co-operate with each other in responding to occasional surveys related to Social Impact.

In performing their obligations under this Lease, Landlord and Tenant must comply with all applicable anti-slavery and human trafficking laws, Acts, regulations, rules and codes from time to time in force. In performing their obligations under this Lease, Landlord and Tenant must comply with all applicable anti-slavery and human trafficking laws, Acts, regulations, rules and codes from time to time in force, including with respect to the delivery of, goods or services to the Premises and the Building.

EX-31.1 4 vor-ex31_1.htm EX-31.1 EX-31.1

Exhibit 31.1

CERTIFICATIONS

I, Jean-Paul Kress, certify that:

I have reviewed this Quarterly Report on Form 10-Q of Vor Biopharma Inc.;

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)

Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.


Date: August 12, 2025	By:	/s/ Jean-Paul Kress
		Jean-Paul Kress
		President and Chief Executive Officer (Principal Executive Officer)

EX-31.2 5 vor-ex31_2.htm EX-31.2 EX-31.2

Exhibit 31.2

CERTIFICATIONS

I, Sandy Mahatme, certify that:

I have reviewed this Quarterly Report on Form 10-Q of Vor Biopharma Inc.;

(a)

(b)

(c)

(d)

(a)

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.


Date: August 12, 2025	By:	/s/ Sandy Mahatme
		Sandy Mahatme
		Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

EX-32.1 6 vor-ex32_1.htm EX-32.1 EX-32.1

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of Vor Biopharma Inc. (the “Company”) for the period ended June 30, 2025, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned officers of the Company hereby certifies, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:

(1)

The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.


Date: August 12, 2025	By:	/s/ Jean-Paul Kress
		Jean-Paul Kress President and Chief Executive Officer (Principal Executive Officer)


Date: August 12, 2025	By:	/s/ Sandy Mahatme
		Sandy Mahatme Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Vor Biopharma Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of this Form 10-Q), irrespective of any general incorporation language contained in such filing.