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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

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

For the quarterly period ended June 30, 2024

or

☐ 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: 000-29089

Agenus Inc.

(exact name of registrant as specified in its charter)

 

 

Delaware

 

06-1562417

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

3 Forbes Road, Lexington, Massachusetts 02421

(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code:

(781) 674-4400

 

Securities registered or to be 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, par value $0.01

AGEN

The Nasdaq Capital 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.

 

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

 

 

 

 

Emerging growth company

 

 

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 outstanding of the issuer’s Common Stock as of August 5, 2024: 21,571,941 shares.

 

 


 

 

Agenus Inc.

Six Months Ended June 30, 2024

Table of Contents

 

 

 

 

Page

PART I

 

 

ITEM 1.

 

Financial Statements:

 

2

 

 

Condensed Consolidated Balance Sheets as of June 30, 2024 (Unaudited) and December 31, 2023

 

2

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2024 and 2023 (Unaudited)

 

3

 

 

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Deficit for the three and six months ended June 30, 2024 and 2023 (Unaudited)

 

4

 

 

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2024 and 2023 (Unaudited)

 

6

 

 

Notes to Unaudited Condensed Consolidated Financial Statements

 

8

ITEM 2.

 

Management's Discussion and Analysis of Financial Condition and Results of Operations

 

21

ITEM 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

27

ITEM 4.

 

Controls and Procedures

 

27

 

 

 

PART II

 

 

ITEM 1.

 

Legal Proceedings

 

29

ITEM 1A.

 

Risk Factors

 

29

ITEM 5.

 

Other Information

 

30

ITEM 6.

 

Exhibits

 

31

 

 

Signatures

 

34

 

 

 

 


 

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

AGENUS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Amounts in thousands, except share and per share amounts)

 

 

June 30, 2024
(unaudited)

 

 

December 31, 2023

 

ASSETS

 

 

 

 

 

 

Cash and cash equivalents

 

$

93,723

 

 

$

76,110

 

Accounts receivable

 

 

719

 

 

 

25,836

 

Prepaid expenses

 

 

2,207

 

 

 

8,098

 

Other current assets

 

 

3,355

 

 

 

2,372

 

Total current assets

 

 

100,004

 

 

 

112,416

 

Property, plant and equipment, net of accumulated amortization and depreciation of
   $68,137 and $61,943 at June 30, 2024 and December 31, 2023, respectively

 

 

127,569

 

 

 

133,421

 

Operating lease right-of-use assets

 

 

28,964

 

 

 

29,606

 

Goodwill

 

 

24,748

 

 

 

24,723

 

Acquired intangible assets, net of accumulated amortization of $18,032 and
   $17,688 at June 30, 2024 and December 31, 2023, respectively

 

 

4,136

 

 

 

4,411

 

Other long-term assets

 

 

6,994

 

 

 

9,336

 

Total assets

 

$

292,415

 

 

$

313,913

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

Current portion, long-term debt

 

$

13,425

 

 

$

146

 

Current portion, liability related to sale of future royalties and milestones

 

 

146,549

 

 

 

132,502

 

Current portion, deferred revenue

 

 

9

 

 

 

18

 

Current portion, operating lease liabilities

 

 

2,296

 

 

 

2,587

 

Accounts payable

 

 

50,843

 

 

 

61,446

 

Accrued liabilities

 

 

41,208

 

 

 

45,283

 

Other current liabilities

 

 

16,336

 

 

 

13,915

 

Total current liabilities

 

 

270,666

 

 

 

255,897

 

Long-term debt, net of current portion

 

 

 

 

 

12,768

 

Liability related to sale of future royalties and milestones, net of current portion

 

 

184,169

 

 

 

124,556

 

Deferred revenue, net of current portion

 

 

1,143

 

 

 

1,143

 

Operating lease liabilities, net of current portion

 

 

55,786

 

 

 

62,511

 

Other long-term liabilities

 

 

1,490

 

 

 

5,420

 

Commitments and contingencies

 

 

 

 

 

 

STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

Series A-1 convertible preferred stock; 31,620 shares designated, issued, and
   outstanding at June 30, 2024 and December 31, 2023; liquidation value
   of $33,993 at June 30, 2024

 

 

0

 

 

 

0

 

Common stock, par value $0.01 per share; 800,000,000 shares authorized;
   21,126,226 and 19,718,662 shares issued and outstanding at
   June 30, 2024 and December 31, 2023, respectively

 

 

211

 

 

 

197

 

Additional paid-in capital

 

 

1,830,114

 

 

 

1,796,095

 

Accumulated other comprehensive loss

 

 

(1,001

)

 

 

(955

)

Accumulated deficit

 

 

(2,070,635

)

 

 

(1,955,668

)

Total stockholders’ deficit attributable to Agenus Inc.

 

 

(241,311

)

 

 

(160,331

)

Non-controlling interest

 

 

20,472

 

 

 

11,949

 

Total stockholders’ deficit

 

 

(220,839

)

 

 

(148,382

)

Total liabilities and stockholders’ deficit

 

$

292,415

 

 

$

313,913

 

See accompanying notes to unaudited condensed consolidated financial statements.

2


 

AGENUS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(Amounts in thousands, except per share amounts)

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

267

 

 

$

2,489

 

 

$

267

 

 

$

5,101

 

Service revenue

 

 

660

 

 

 

739

 

 

 

898

 

 

 

1,923

 

Non-cash royalty revenue related to the sale of future royalties

 

 

22,582

 

 

 

22,068

 

 

 

50,349

 

 

 

41,174

 

Total revenues

 

 

23,509

 

 

 

25,296

 

 

 

51,514

 

 

 

48,198

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of service revenue

 

 

(115

)

 

 

(254

)

 

 

(222

)

 

 

(2,548

)

Research and development

 

 

(36,771

)

 

 

(59,285

)

 

 

(80,696

)

 

 

(116,402

)

General and administrative

 

 

(16,816

)

 

 

(20,415

)

 

 

(33,672

)

 

 

(38,653

)

Contingent purchase price consideration fair value adjustment

 

 

 

 

 

(8

)

 

 

 

 

 

398

 

Operating loss

 

 

(30,193

)

 

 

(54,666

)

 

 

(63,076

)

 

 

(109,007

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Non-operating income (expense)

 

 

7,141

 

 

 

(244

)

 

 

6,036

 

 

 

(204

)

Interest expense, net

 

 

(31,745

)

 

 

(18,520

)

 

 

(61,211

)

 

 

(35,112

)

Net loss

 

 

(54,797

)

 

 

(73,430

)

 

 

(118,251

)

 

 

(144,323

)

Dividends on Series A-1 convertible preferred stock

 

 

(54

)

 

 

(53

)

 

 

(107

)

 

 

(107

)

Less: net loss attributable to non-controlling interest

 

 

(1,716

)

 

 

(4,414

)

 

 

(3,284

)

 

 

(7,053

)

Net loss attributable to Agenus Inc. common stockholders

 

$

(53,135

)

 

$

(69,069

)

 

$

(115,074

)

 

$

(137,377

)

Per common share data:

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss attributable to Agenus Inc. common stockholders

 

$

(2.52

)

 

$

(3.93

)

 

$

(5.56

)

 

$

(8.22

)

Weighted average number of Agenus Inc. common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

21,062

 

 

 

17,569

 

 

 

20,715

 

 

 

16,717

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation income (loss)

 

$

70

 

 

$

(1,634

)

 

$

(46

)

 

$

(1,632

)

Other comprehensive income (loss)

 

 

70

 

 

 

(1,634

)

 

 

(46

)

 

 

(1,632

)

Comprehensive loss

 

$

(53,065

)

 

$

(70,703

)

 

$

(115,120

)

 

$

(139,009

)

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

3


 

AGENUS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT

(Unaudited)

(Amounts in thousands)

 

 

 

Series A-1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Convertible

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preferred Stock

 

 

Common Stock

 

 

 

 

 

Treasury Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Number of
Shares

 

 

Par
Value

 

 

Number of
Shares

 

 

Par
Value

 

 

Additional
Paid-In
Capital

 

 

Number
of Shares

 

 

Amount

 

 

Accumulated
Other
Comprehensive
Income (Loss)

 

 

Non-controlling
Interest

 

 

Accumulated
Deficit

 

 

Total

 

Balance at December 31, 2023

 

 

32

 

 

$

0

 

 

 

19,718

 

 

$

197

 

 

$

1,796,095

 

 

 

 

 

$

 

 

$

(955

)

 

$

11,949

 

 

$

(1,955,668

)

 

 

(148,382

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,568

)

 

 

(61,886

)

 

 

(63,454

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(116

)

 

 

 

 

 

 

 

 

(116

)

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,477

 

 

 

 

 

 

 

 

 

 

 

 

719

 

 

 

 

 

 

4,196

 

Shares sold at the market

 

 

 

 

 

 

 

 

1,249

 

 

 

13

 

 

 

17,158

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

17,171

 

Payment of CEO payroll in shares

 

 

 

 

 

 

 

 

7

 

 

 

 

 

 

89

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

89

 

Vesting of nonvested shares

 

 

 

 

 

 

 

 

8

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options and employee share purchases

 

 

 

 

 

 

 

 

12

 

 

 

 

 

 

166

 

 

 

 

 

 

 

 

 

 

 

 

7

 

 

 

 

 

 

173

 

Balance at March 31, 2024

 

 

32

 

 

$

0

 

 

 

20,994

 

 

$

210

 

 

$

1,816,985

 

 

 

 

 

$

 

 

$

(1,071

)

 

$

11,107

 

 

$

(2,017,554

)

 

$

(190,323

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,716

)

 

 

(53,081

)

 

 

(54,797

)

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

70

 

 

 

 

 

 

 

 

 

70

 

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,449

 

 

 

 

 

 

 

 

 

 

 

 

841

 

 

 

 

 

 

9,290

 

Shares sold at the market

 

 

 

 

 

 

 

 

117

 

 

 

1

 

 

 

1,989

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,990

 

Issuance of warrants, net of expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,983

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,983

 

Vesting of nonvested shares

 

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Payment of CEO payroll in shares

 

 

 

 

 

 

 

 

11

 

 

 

 

 

 

114

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

114

 

MiNK private placement stock sale

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,434

)

 

 

 

 

 

 

 

 

 

 

 

10,234

 

 

 

 

 

 

5,800

 

Exercise of stock options

 

 

 

 

 

 

 

 

2

 

 

 

 

 

 

28

 

 

 

 

 

 

 

 

 

 

 

 

6

 

 

 

 

 

 

34

 

Balance at June 30, 2024

 

 

32

 

 

$

0

 

 

 

21,126

 

 

$

211

 

 

$

1,830,114

 

 

 

 

 

$

 

 

$

(1,001

)

 

$

20,472

 

 

$

(2,070,635

)

 

$

(220,839

)

 

See accompanying notes to unaudited condensed consolidated financial statements.

4


 

AGENUS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT

(Unaudited)

(Amounts in thousands)

 

 

 

 

Series A-1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Convertible

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preferred Stock

 

 

Common Stock

 

 

 

 

 

Treasury Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Number of
Shares

 

 

Par
Value

 

 

Number of
Shares

 

 

Par
Value

 

 

Additional
Paid-In
Capital

 

 

Number
of Shares

 

 

Amount

 

 

Accumulated
Other
Comprehensive
Income (Loss)

 

 

Non-controlling
Interest

 

 

Accumulated
Deficit

 

 

Total

 

Balance at December 31, 2022

 

 

32

 

 

$

0

 

 

 

15,278

 

 

$

153

 

 

$

1,647,561

 

 

 

 

 

$

 

 

$

915

 

 

$

6,376

 

 

$

(1,709,907

)

 

$

(54,902

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,639

)

 

 

(68,254

)

 

 

(70,893

)

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

2

 

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,566

 

 

 

 

 

 

 

 

 

 

 

 

919

 

 

 

 

 

 

5,485

 

Shares sold at the market

 

 

 

 

 

 

 

 

1,689

 

 

 

17

 

 

 

60,566

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

60,583

 

Issuance of director deferred shares

 

 

 

 

 

 

 

 

13

 

 

 

1

 

 

 

982

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

983

 

Issuance of shares for services

 

 

 

 

 

 

 

 

7

 

 

 

 

 

 

318

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

318

 

Vesting of nonvested shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options and employee share purchases

 

 

 

 

 

 

 

 

10

 

 

 

 

 

 

329

 

 

 

 

 

 

 

 

 

 

 

 

45

 

 

 

 

 

 

374

 

Issuance of subsidiary shares for employee bonus

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

726

 

 

 

 

 

 

726

 

Issuance of shares for employee bonus

 

 

 

 

 

 

 

 

136

 

 

 

1

 

 

 

4,224

 

 

 

(1

)

 

 

(2,429

)

 

 

 

 

 

 

 

 

 

 

 

1,796

 

Retirement of treasury shares

 

 

 

 

 

 

 

 

(50

)

 

 

(1

)

 

 

(9

)

 

 

1

 

 

 

2,429

 

 

 

 

 

 

 

 

 

 

 

 

2,419

 

Balance at March 31, 2023

 

 

32

 

 

$

0

 

 

 

17,083

 

 

$

171

 

 

$

1,718,537

 

 

 

 

 

$

 

 

$

917

 

 

$

5,427

 

 

$

(1,778,161

)

 

$

(53,109

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,414

)

 

 

(69,016

)

 

 

(73,430

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,634

)

 

 

 

 

 

 

 

 

(1,634

)

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,154

 

 

 

 

 

 

 

 

 

 

 

 

888

 

 

 

 

 

 

6,042

 

Shares sold at the market

 

 

 

 

 

 

 

 

1,227

 

 

 

12

 

 

 

42,235

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

42,247

 

Vesting of nonvested shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MiNK stock dividend

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(14,888

)

 

 

 

 

 

 

 

 

 

 

 

14,888

 

 

 

 

 

 

 

MiNK stock purchases

 

 

 

 

 

 

 

 

 

 

 

 

 

 

405

 

 

 

 

 

 

 

 

 

 

 

 

(640

)

 

 

 

 

 

(235

)

Issuance of subsidiary shares for employee bonus

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

285

 

 

 

 

 

 

285

 

Issuance of shares for employee bonus

 

 

 

 

 

 

 

 

96

 

 

 

1

 

 

 

3,079

 

 

 

 

 

 

(1,642

)

 

 

 

 

 

 

 

 

 

 

 

1,438

 

Retirement of treasury shares

 

 

 

 

 

 

 

 

(33

)

 

 

 

 

 

(7

)

 

 

 

 

 

1,642

 

 

 

 

 

 

 

 

 

 

 

 

1,635

 

Balance at June 30, 2023

 

 

32

 

 

$

0

 

 

 

18,373

 

 

$

184

 

 

$

1,754,515

 

 

 

 

 

$

 

 

$

(717

)

 

$

16,434

 

 

$

(1,847,177

)

 

$

(76,761

)

 

See accompanying notes to unaudited condensed consolidated financial statements.

5


 

AGENUS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(Amounts in thousands, except per share amounts)

 

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(118,251

)

 

$

(144,323

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation and amortization

 

 

6,737

 

 

 

5,535

 

Share-based compensation

 

 

8,185

 

 

 

11,527

 

Non-cash royalty revenue

 

 

(50,349

)

 

 

(41,174

)

Non-cash interest expense

 

 

61,263

 

 

 

36,920

 

Loss on disposal of assets, net

 

 

9

 

 

 

49

 

Gain on lease terminations

 

 

(5,475

)

 

 

 

Other, net

 

 

1,056

 

 

 

(149

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

25,121

 

 

 

1,021

 

Prepaid expenses

 

 

5,890

 

 

 

5,427

 

Accounts payable

 

 

(8,718

)

 

 

7,969

 

Deferred revenue

 

 

(9

)

 

 

(4,439

)

Accrued liabilities and other current liabilities

 

 

(386

)

 

 

8,135

 

Other operating assets and liabilities

 

 

(1,444

)

 

 

(5,067

)

Net cash used in operating activities

 

 

(76,371

)

 

 

(118,569

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of plant and equipment

 

 

(496

)

 

 

(6,279

)

Proceeds from sale of plant and equipment

 

 

 

 

 

350

 

Purchase of long-term investment

 

 

 

 

 

(5,396

)

Sale of long-term investment

 

 

488

 

 

 

 

Purchases of available-for-sale securities

 

 

 

 

 

(14,647

)

Proceeds from sale of available-for-sale securities

 

 

 

 

 

15,000

 

Net cash provided by (used in) investing activities

 

 

(8

)

 

 

(10,972

)

Cash flows from financing activities:

 

 

 

 

 

 

Net proceeds from sale of equity

 

 

19,161

 

 

 

102,829

 

Net proceeds from sale of subsidiary shares in private placement

 

 

5,800

 

 

 

 

Proceeds from Ligand Purchase Agreement, net of expenses

 

 

73,851

 

 

 

 

Proceeds from employee stock purchases and option exercises

 

 

207

 

 

 

397

 

Purchase of treasury shares to satisfy tax withholdings

 

 

 

 

 

(4,566

)

Purchase of subsidiary shares

 

 

 

 

 

(236

)

Payment of finance lease obligation

 

 

(5,106

)

 

 

(3,911

)

Net cash provided by financing activities

 

 

93,913

 

 

 

94,513

 

Effect of exchange rate changes on cash

 

 

44

 

 

 

(441

)

Net increase (decrease) in cash, cash equivalents and restricted cash

 

 

17,578

 

 

 

(35,469

)

Cash, cash equivalents and restricted cash, beginning of period

 

 

79,779

 

 

 

181,343

 

Cash, cash equivalents and restricted cash, end of period

 

$

97,357

 

 

$

145,874

 

Supplemental cash flow information:

 

 

 

 

 

 

Cash paid for interest

 

$

1,193

 

 

$

1,705

 

Supplemental disclosures - non-cash activities:

 

 

 

 

 

 

Purchases of plant and equipment in accounts payable and
   accrued liabilities

 

$

 

 

$

4,762

 

Issuance of common stock, $0.01 par value, in connection with payment for services

 

 

 

 

 

318

 

Insurance financing agreement

 

 

612

 

 

 

707

 

Issuance of stock options for payment of certain employee bonuses

 

 

4,966

 

 

 

 

Issuance of common stock, $0.01 par value, for payment of certain employee bonuses

 

 

 

 

 

7,288

 

Issuance of subsidiary stock options for payment of certain employee bonuses

 

 

540

 

 

 

 

Issuance of subsidiary shares for certain employee bonuses

 

 

 

 

 

1,011

 

Lease right-of-use assets obtained in exchange for new operating lease liabilities

 

 

105

 

 

 

287

 

Lease right-of-use assets obtained in exchange for new finance lease liabilities

 

 

122

 

 

 

4,635

 

 

6


 

See accompanying notes to unaudited condensed consolidated financial statements.

7


 

AGENUS INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2024

 

Note A – Business, Liquidity and Basis of Presentation

Agenus Inc. (including its subsidiaries, collectively referred to as “Agenus,” the “Company,” “we,” “us,” and “our”) is a leading clinical-stage biotechnology company developing therapies targeting cancer with a robust pipeline of immunological agents. Our mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through our subsidiary MiNK Therapeutics, Inc. (“MiNK”)), and vaccine adjuvants (through our subsidiary SaponiQx, Inc. (“SaponiQx”)). We believe that combination therapies and a deep understanding of each patient’s cancer will significantly expand the patient population benefiting from immuno-oncology (“I-O”) treatments.

In addition to our diverse pipeline, we have established fully integrated capabilities encompassing novel target discovery, antibody generation, cell line development, and current good manufacturing practice ("cGMP") manufacturing. We believe these integrated capabilities enable us to develop and, if approved, commercialize novel candidates on accelerated timelines compared to industry standards. Through independent development and strategic partnerships, we leverage our scientific expertise and capabilities to drive innovation in the I-O field.

Our I-O portfolio is driven by several platforms and programs, which we plan to utilize individually and in combination:

Multiple antibody discovery platforms, including proprietary display technologies, to identify future antibody candidates.
Antibody candidate programs, including our lead assets, botensilimab (a multifunctional immune cell activator and human Fc-enhanced cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibody, also known as AGEN1811) and balstilimab (a programmed death receptor-1 (PD-1) blocking antibody).
Our saponin-based vaccine adjuvant platform, primarily centered around our STIMULON™ cultured plant cell (“cpc”) QS-21 adjuvant (“STIMULON cpcQS-21”).
A pipeline of novel allogeneic invariant natural killer T cell therapies for treating cancer and other immune-mediated diseases, controlled by MiNK.

Our business activities include product research, preclinical and clinical development, intellectual property prosecution, manufacturing, regulatory and clinical affairs, corporate finance and development activities, and support of our collaborations. Our product candidates require successful clinical trials and approvals from regulatory agencies, as well as acceptance in the marketplace. Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing arrangements with academic and corporate collaborators and licensees and by entering into new collaborations.

Our cash and cash equivalents at June 30, 2024 were $93.7 million, an increase of $17.6 million from December 31, 2023. Cash and cash equivalents of our subsidiary, MiNK, at March 31, 2024, were $5.8 million. MiNK cash can only be accessed by Agenus through a declaration of a dividend by the MiNK Board of Directors or through settlement of intercompany balances.

As of June 30, 2024, we had an accumulated deficit of $2.1 billion and $13.0 million of subordinated notes maturing in February 2025. Since our founding we have financed our operations principally through income and revenues generated from corporate partnerships, advance royalty sales and proceeds from equity issuances. Based on our current plans and projections, we believe that our cash resources of $93.7 million at June 30, 2024, plus additional funding we may receive from multiple other sources, including out-licensing and/or partnering opportunities, will be sufficient to satisfy our liquidity requirements through the end of the year and into 2025. We are also in discussions with other parties to participate in the Purchase and Sale Agreement (see Note F) for up to an additional $125.0 million under the same terms as the Ligand transaction. In addition, we are in discussions with several potential corporate collaborators. These transactions could also extend our cash resources. However, because the completion of such transactions is not entirely within our control, in accordance with accounting guidance we are required to disclose that substantial doubt exists about our ability to continue as a going concern for a period of one year after the date of filing of this Quarterly Report on Form 10-Q. The financial statements have been prepared on a basis that assumes Agenus will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.

Management continues to address the Company’s liquidity needs and can exercise its flexibility to adjust spending as needed in order to preserve liquidity. In August 2023, we prioritized and focused our resources to accelerate the development, registration, and commercialization of our lead asset postponing all preclinical and other clinical programs and reducing our workforce by approximately 25%. Our CEO, Dr. Garo Armen has elected to receive his base salary and any potential bonus payments in stock rather than cash. We continuously evaluate the likelihood of success of our programs. As such, our decisions to continue to fund or eliminate funding of each of our programs are predicated on these determinations, on an ongoing basis. We expect our sources of funding to include payments from current collaborations which include out-licensing and/or partnering opportunities for our portfolio programs and product candidates with multiple parties; additional third-party agreements; asset sales; further royalty monetization; project financing, and/or sales of equity securities.

8


 

The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with the instructions to Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete annual consolidated financial statements. In the opinion of our management, the condensed consolidated financial statements include all normal and recurring adjustments considered necessary for a fair presentation of our financial position and operating results. All significant intercompany transactions and accounts have been eliminated in consolidation. Operating results for the six months ended June 30, 2024, are not necessarily indicative of the results that may be expected for the year ending December 31, 2024. For further information, refer to our consolidated financial statements and footnotes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”).

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances. Actual results could differ materially from those estimates.

For our foreign subsidiaries, the local currency is the functional currency. Assets and liabilities of our foreign subsidiaries are translated into U.S. dollars using rates in effect at the balance sheet date while revenues and expenses are translated into U.S. dollars using average exchange rates during the period. The cumulative translation adjustment resulting from changes in exchange rates are included in the consolidated balance sheets as a component of accumulated other comprehensive income (loss) in total stockholders’ deficit.

On April 4, 2024, we executed a reverse stock split of our issued and outstanding common stock, par value $0.01, at a ratio of 1-for-20 with a record date of April 12, 2024 (the “Reverse Stock Split”). All common share, per share and related information included in the accompanying financial statements and footnote disclosures have been adjusted retroactively, where applicable, to reflect the Reverse Stock Split. See Note L for further details.

In the quarters ended June 30, 2024 and 2023, we deconsolidated certain foreign subsidiaries and recognized gains of approximately $185,000 and $132,000, respectively, included in "Other income (expense)" on our condensed consolidated statements of operations and comprehensive loss.

Note B – Net Loss Per Share

Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding (including common shares issuable under our Amended and Restated Directors’ Deferred Compensation Plan, or “DDCP”). Diluted loss per common share is calculated by dividing loss attributable to common stockholders by the weighted average number of common shares outstanding (including common shares issuable under our DDCP) plus the dilutive effect of outstanding instruments such as warrants, stock options, non-vested shares and convertible preferred stock. Because we reported a net loss attributable to common stockholders for all periods presented, diluted loss per common share is the same as basic loss per common share, as the effect of utilizing the fully diluted share count would have reduced the net loss per common share. The following securities (listed on an as-if-converted-to-Common-Stock basis) have been excluded from the computation of diluted weighted average shares outstanding as of June 30, 2024 and 2023, as they would be anti-dilutive (in thousands):

 

 

 

Three and Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

Warrants

 

 

965

 

 

 

99

 

Stock options

 

 

3,367

 

 

 

2,220

 

Non-vested shares

 

 

38

 

 

 

27

 

Series A-1 convertible preferred stock

 

 

17

 

 

 

17

 

 

9


 

Note C – Investments

Cash equivalents and short-term investments consisted of the following as of June 30, 2024 and December 31, 2023 (in thousands):

 

 

June 30, 2024

 

 

December 31, 2023

 

 

 

Cost

 

 

Estimated
Fair Value

 

 

Cost

 

 

Estimated
Fair Value

 

Institutional money market funds

 

$

92,243

 

 

$

92,243

 

 

$

70,485

 

 

$

70,485

 

Total

 

$

92,243

 

 

$

92,243

 

 

$

70,485

 

 

$

70,485

 

As a result of the short-term nature of these investments, there were minimal unrealized holding gains or losses for the three and six months ended June 30, 2024 and 2023.

As of both June 30, 2024 and December 31, 2023, all of the investments listed above were classified as cash equivalents on our condensed consolidated balance sheets.

Note D – Goodwill and Acquired Intangible Assets

The following table sets forth the changes in the carrying amount of goodwill for the six months ended June 30, 2024 (in thousands):

Balance, December 31, 2023

 

$

24,723

 

Effect of foreign currency

 

 

25

 

Balance, June 30, 2024

 

$

24,748

 

 

Acquired intangible assets consisted of the following as of June 30, 2024 and December 31, 2023 (in thousands):

 

 

As of June 30, 2024

 

 

 

Amortization
period
 (years)

 

Gross carrying
amount

 

 

Accumulated
amortization

 

 

Net carrying
amount

 

Intellectual property

 

7-15 years

 

$

16,841

 

 

$

(15,354

)

 

$

1,487

 

Trademarks

 

4-4.5 years

 

 

1,226

 

 

 

(1,226

)

 

 

 

Other

 

2-7 years

 

 

2,044

 

 

 

(1,452

)

 

 

592

 

In-process research and development

 

Indefinite

 

 

2,057

 

 

 

 

 

 

2,057

 

Total

 

 

 

$

22,168

 

 

$

(18,032

)

 

$

4,136

 

 

 

 

As of December 31, 2023

 

 

 

Amortization
period
 (years)

 

Gross carrying
amount

 

 

Accumulated
amortization

 

 

Net carrying
amount

 

Intellectual property

 

7-15 years

 

$

16,841

 

 

$

(15,184

)

 

$

1,657

 

Trademarks

 

4-4.5 years

 

 

1,213

 

 

 

(1,185

)

 

 

28

 

Other

 

2-7 years

 

 

1,988

 

 

 

(1,319

)

 

 

669

 

In-process research and development

 

Indefinite

 

 

2,057

 

 

 

 

 

 

2,057

 

Total

 

 

 

$

22,099

 

 

$

(17,688

)

 

$

4,411

 

 

The weighted average amortization period of our finite-lived intangible assets is 9 years. Amortization expense related to acquired intangibles is estimated at $0.3 million for the remainder of 2024, $0.5 million for the years ending December 31, 2025 and 2026, $0.4 million for the year ending December 31, 2027 and $0.3 million for the year ending December 31, 2028.

 

10


 

Note E – Debt

Debt obligations consisted of the following as of June 30, 2024 and December 31, 2023 (in thousands):

 

Debt instrument

 

Balance at
June 30,
2024

 

Current Portion:

 

 

 

Debentures

 

$

146

 

2015 Subordinated Notes

 

 

12,866

 

Other

 

 

413

 

Total

 

$

13,425

 

 

Debt instrument

 

Balance at
December 31,
2023

 

Current Portion:

 

 

 

Debentures

 

$

146

 

Long-term Portion:

 

 

 

2015 Subordinated Notes

 

 

12,768

 

Total

 

$

12,914

 

 

As of June 30, 2024 and December 31, 2023, the principal amount of our outstanding debt balance was $13.6 million and $13.1 million, respectively.

 

Note F – Liability Related to the Sale of Future Royalties and Milestones

 

The following table shows the activity within the liability account in the six months ended June 30, 2024 (in thousands):

 

 

 

Period from
December 31, 2023 to
June 30, 2024

 

Liability related to sale of future royalties and milestones - beginning balance

 

$

257,296

 

Proceeds from sale of future royalties and milestones

 

 

63,879

 

Non-cash royalty revenue

 

 

(50,349

)

Non-cash interest expense recognized

 

 

61,134

 

Liability related to sale of future royalties and milestones - ending balance

 

 

331,960

 

Less: unamortized transaction costs

 

 

(1,242

)

Liability related to sale of future royalties and milestones, net

 

$

330,718

 

 

Healthcare Royalty Partners

In January 2018, we, through our wholly-owned subsidiary Antigenics, LLC (“Antigenics”), entered into a Royalty Purchase Agreement (the “HCR Royalty Purchase Agreement”) with Healthcare Royalty Partners III, L.P. and certain of its affiliates (collectively, “HCR”). Pursuant to the terms of the HCR Royalty Purchase Agreement, we sold to HCR 100% of Antigenics’ worldwide rights to receive royalties from GlaxoSmithKline (“GSK”) on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant. At closing, we received gross proceeds of $190.0 million from HCR. Although we sold all of our rights to receive royalties on sales of GSK’s vaccines containing QS-21, as a result of our obligation to HCR, we are required to account for the $190.0 million in proceeds from this transaction as a liability on our condensed consolidated balance sheet that will be recognized into revenue in proportion to the royalty payments from GSK to HCR over the estimated life of the HCR Royalty Purchase Agreement. The liability is classified between the current and non-current portion of liability related to sale of future royalties and milestones in the condensed consolidated balance sheets based on the estimated royalty payments to be received by HCR in the next 12 months from the financial statement reporting date.

During the six months ended June 30, 2024, we recognized $50.3 million of non-cash royalty revenue, and we recorded $59.6 million of related non-cash interest expense related to the HCR Royalty Purchase Agreement.

11


 

As royalties are remitted to HCR from GSK, the balance of the recorded liability will be effectively repaid over the life of the HCR Royalty Purchase Agreement. To determine the amortization of the recorded liability, we are required to estimate the total amount of future royalty payments to be received by HCR. The sum of these amounts less the $190.0 million proceeds we received will be recorded as interest expense over the life of the HCR Royalty Purchase Agreement. Periodically, we assess the estimated royalty payments to be paid to HCR from GSK, and to the extent the amount or timing of the payments is materially different from our original estimates, we will prospectively adjust the amortization of the liability, and the related recognition of interest expense. During the six months ended June 30, 2024, our estimate of the effective annual interest rate over the life of the agreement decreased to 48.6%, which results in a life of contract interest rate of 26.6%.

Ligand Pharmaceuticals

In May 2024, we and certain wholly-owned subsidiaries, entered into a Purchase and Sale agreement (the "Ligand Purchase Agreement") with Ligand Pharmaceuticals Incorporated ("Ligand"). Pursuant to the terms of the Ligand Purchase Agreement, Ligand will receive (i) 31.875% of the development, regulatory and commercial milestone payments we were then eligible to receive under our agreements with Bristol-Myers Squibb Company ("BMS"), UroGen Pharma Ltd., Gilead Sciences, Inc. ("Gilead"), Merck Sharpe & Dohme and Incyte Corporation ("Incyte"), (the “Covered License Agreements”) (ii) 18.75% of the royalties the Company receives under the Covered License Agreements; and (iii) a 2.625% synthetic royalty on worldwide net sales of botensilimab and balstilimab (collectively the “Purchased Assets”).

The total amounts payable to Ligand are subject to a 50% reduction in the event total payments to Ligand exceed a specified return hurdle. The synthetic royalty is subject to a reduction if annual worldwide net sales exceed a specified level, and a cap on annual worldwide net sales if annual worldwide net sales exceed a higher specified level. The synthetic royalty can increase by 1% based on the occurrence of certain future events.

In consideration for the sale of the Purchased Assets, we received gross proceeds of $75.0 million, less $0.9 million in reimbursable expenses, on the closing date. In addition, Ligand has a time-based option to invest an additional $25.0 million on a pro rata basis ("Purchaser Upsize Option").

In connection with the sale of the Purchased Assets, we issued to Ligand a warrant (the "Ligand Warrant") to purchase 867,052 shares of our common stock, at an exercise price equal to $17.30 per share. See Note L - Equity for further detail.

The $75.0 million in gross proceeds was allocated to the identified components as follows:

 

 

June 30, 2024

 

Liability related to sale of future royalties and milestones

 

$

63,879

 

Ligand Warrant

 

 

7,098

 

Purchaser Upsize Option

 

 

4,023

 

Total Ligand Purchase Agreement gross proceeds

 

$

75,000

 

As a result of our significant continuing involvement in the generation of the cash flows of the Purchased Assets, we are required to account for $63.9 million of the proceeds from this transaction as a liability on our condensed consolidated balance sheet that will be recognized into revenue in proportion to the royalty and milestone payments paid to Ligand over the estimated life of the Ligand Purchase Agreement.

The Purchaser Upsize Option is considered a freestanding financial instrument as it is separately exercisable and can be legally transferred from the Ligand Purchase Agreement. As such, it is accounted for as a written option which is accounted for as a liability at fair value and remeasured at each balance sheet date with changes in fair value recorded in earnings.

The Ligand Warrant is considered a freestanding financial instrument that as it is separately exercisable and can be legally transferred from the Ligand Purchase Agreement was determined to be equity-classified under ASC 815.

To allocate the proceeds, the Purchaser Upsize Option liability and equity-classified Ligand Warrants were recognized based on their fair values and the residual was allocated to a liability related to the sale of future royalties and milestones on our condensed consolidated balance sheets.

During the three and six months ended June 30, 2024, we recorded $1.6 million of non-cash interest expense related to the Ligand Purchase Agreement.

As royalties are remitted to us and milestone and sales are earned from the Purchased Assets, the balance of the recorded liability will be effectively repaid over the life of the Ligand Purchase Agreement. To determine the amortization of the recorded liability, we are required to estimate the total amount of future payments to be received under the Ligand Purchase Agreement. The sum of these amounts less the $63.9 million proceeds allocated to the liability related to sale of future royalties and milestones will be recorded as interest expense over the life of the Ligand Purchase Agreement. Periodically, we assess the estimated royalty and milestone payments to be received and sales to be earned under the Ligand Purchase Agreement, and to the extent the amount or timing of the payments is materially different from our original estimates, we will prospectively adjust the amortization of the liability, and the related recognition of interest expense.

12


 

As of June 30, 2024, our estimate of the effective annual interest rate over the life of the agreement was 27.9%.

 

Note G – Accrued and Other Current Liabilities

Accrued liabilities consisted of the following as of June 30, 2024 and December 31, 2023 (in thousands):

 

 

June 30, 2024

 

 

December 31, 2023

 

Payroll

 

$

12,685

 

 

$

14,512

 

Professional fees

 

 

5,818

 

 

 

7,101

 

Contract manufacturing costs

 

 

7,595

 

 

 

7,613

 

Research services

 

 

8,037

 

 

 

10,807

 

Other

 

 

7,073

 

 

 

5,250

 

Total

 

$

41,208

 

 

$

45,283

 

 

Other current liabilities consisted of the following as of June 30, 2024 and December 31, 2023 (in thousands):

 

 

 

June 30, 2024

 

 

December 31, 2023

 

Finance lease liabilities

 

$

9,367

 

 

$

10,457

 

Other

 

 

6,969

 

 

 

3,458

 

Total

 

$

16,336

 

 

$

13,915

 

 

Note H – Fair Value Measurements

Assets and liabilities measured at fair value are summarized below (in thousands):

Description

 

June 30, 2024

 

 

Quoted Prices in
Active
Markets for
Identical Assets
(Level 1)

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents (Note C)

 

$

92,243

 

 

$

92,243

 

 

$

 

 

$

 

Long-term investments

 

 

1,493

 

 

 

1,493

 

 

 

 

 

 

 

Total

 

$

93,736

 

 

$

93,736

 

 

$

 

 

$

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Ligand purchaser upsize option (Note F)

 

$

4,023

 

 

$

 

 

$

 

 

$

4,023

 

Contingent purchase price considerations

 

 

318

 

 

 

 

 

 

 

 

 

318

 

Total

 

$

4,341

 

 

$

 

 

$

 

 

$

4,341

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Description

 

December 31, 2023

 

 

Quoted Prices in
Active
Markets for
Identical Assets
(Level 1)

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents (Note C)

 

$

70,485

 

 

$

70,485

 

 

$

 

 

$

 

Long-term investments

 

 

3,222

 

 

 

3,222

 

 

 

 

 

 

 

Total

 

$

73,707

 

 

$

73,707

 

 

$

 

 

$

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Contingent purchase price consideration

 

$

318

 

 

$

 

 

$

 

 

$

318

 

Total

 

$

318

 

 

$

 

 

$

 

 

$

318

 

Long-term investments are included in "Other long-term assets" in our condensed consolidated balance sheets.

We are required to measure the Purchaser Upsize Option issued under the Ligand Purchase Agreement at fair value. The fair value of the Purchaser Upsize Option at June 30, 2024 included in "Other current liabilities" in our condensed consolidated balance sheets, is based on significant inputs not observable in the market, which require it to be reported as a Level 3 liability within the fair value hierarchy.

13


 

The valuation of this liability is determined based on a scenario analysis and uses assumptions we believe would be made by a market participant.

We measure our contingent purchase price considerations at fair value. The fair values of our contingent purchase price considerations at both June 30, 2024 and December 31, 2023, of $0.3 million, included in "Other long-term liabilities" in our condensed consolidated balance sheets, are based on significant inputs not observable in the market, which require them to be reported as Level 3 liabilities within the fair value hierarchy. The valuation of these liabilities use assumptions we believe would be made by a market participant and are mainly based on estimates from a Monte Carlo simulation of our share price, as well as other factors impacting the probability of triggering the milestone payments. Share price was evolved using a geometric Brownian motion, calculated daily for the life of the contingent purchase price considerations.

The fair value of our outstanding debt balance at June 30, 2024 and December 31, 2023 was $13.4 million and $13.0 million, respectively, based on the Level 2 valuation hierarchy of the fair value measurements standard using a present value methodology that was derived by evaluating the nature and terms of each note and considering the prevailing economic and market conditions at the balance sheet date. The principal amount of our outstanding debt balance at June 30, 2024 and December 31, 2023 was $13.6 million and $13.1 million, respectively.

 

Note I – Revenue from Contracts with Customers

Gilead Collaboration Agreement

On December 20, 2018, we entered into a series of agreements with Gilead Sciences, Inc. (“Gilead”) focused on the development and commercialization of up to five novel immuno-oncology therapies. Pursuant to the terms of the license agreement, the option and license agreements and the stock purchase agreement we entered into with Gilead (collectively, the “Gilead Collaboration Agreements”), at the closing of the transaction on January 23, 2019, we received an upfront cash payment from Gilead of $120.0 million and Gilead made a $30.0 million equity investment in Agenus. On November 6, 2020, we received notice from Gilead that it was returning AGEN1423 to us and voluntarily terminating the applicable license agreement. The termination was effective as of February 4, 2021. In the third quarter of 2021 we ceased development of AGEN1223 and in October 2021 the AGEN1223 option and license agreement was formally terminated. The AGEN2373 option and license agreement and the stock purchase agreement remain in full force and effect. As of June 30, 2024, we remained eligible to receive a $50.0 million exercise fee and, if exercised, up to $520.0 million in aggregate potential milestones. On August 5, 2024, Gilead elected not to exercise the option to license AGEN2373 and the option and license agreement was formally terminated, see Note P.

Collaboration Revenue

No revenue was recognized for the three and six months ended June 30, 2024. For the three and six months ended June 30, 2023, we recognized approximately $2.0 million and $4.4 million, respectively, of research and development revenue based on the partial satisfaction of the over time performance obligations as of quarter end.

Disaggregation of Revenue

The following table presents revenue (in thousands) for the three and six months ended June 30, 2024 and 2023, disaggregated by geographic region and revenue type. Revenue by geographic region is allocated based on the domicile of our respective business operations.

 

14


 

 

 

Three months ended June 30, 2024

 

 

 

United States

 

 

Rest of World

 

 

Total

 

Revenue Type

 

 

 

 

 

 

 

 

 

Clinical product revenue

 

$

267

 

 

$

 

 

$

267

 

Other services

 

 

 

 

 

660

 

 

 

660

 

Non-cash royalties

 

 

22,582

 

 

 

 

 

 

22,582

 

 

 

$

22,849

 

 

$

660

 

 

$

23,509

 

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended June 30, 2023

 

Revenue Type

 

 

 

 

 

 

 

 

 

Research and development services

 

$

444

 

 

$

 

 

$

444

 

Other services

 

 

 

 

 

739

 

 

 

739

 

Recognition of deferred revenue

 

 

2,045

 

 

 

 

 

 

2,045

 

Non-cash royalties

 

 

22,068

 

 

 

 

 

 

22,068

 

 

 

$

24,557

 

 

$

739

 

 

$

25,296

 

 

 

 

Six months ended June 30, 2024

 

 

 

United States

 

 

Rest of World

 

 

Total

 

Revenue Type

 

 

 

 

 

 

 

 

 

Clinical product revenue

 

$

267

 

 

$

 

 

$

267

 

Other services

 

 

 

 

 

898

 

 

 

898

 

Non-cash royalties

 

 

50,349

 

 

 

 

 

 

50,349

 

 

 

$

50,616

 

 

$

898

 

 

$

51,514

 

 

 

 

 

 

 

 

 

 

 

 

 

Six months ended June 30, 2023

 

Revenue Type

 

 

 

 

 

 

 

 

 

Research and development services

 

$

711

 

 

$

 

 

$

711

 

Other services

 

 

 

 

 

1,923

 

 

 

1,923

 

Recognition of deferred revenue

 

 

4,390

 

 

 

 

 

 

4,390

 

Non-cash royalties

 

 

41,174

 

 

 

 

 

 

41,174

 

 

 

$

46,275

 

 

$

1,923

 

 

$

48,198

 

Contract Balances

Contract assets primarily relate to our rights to consideration for work completed in relation to our research and development services performed but not billed at the reporting date. The contract assets are transferred to receivables when the rights become unconditional. Currently, we do not have any contract assets which have not transferred to a receivable. We had no asset impairment charges related to contract assets in the period. Contract liabilities primarily relate to contracts where we received payments but have not yet satisfied the related performance obligations. The advance consideration received from customers for research and development services or licenses bundled with other promises is a contract liability until the underlying performance obligations are transferred to the customer.

The following table provides information about contract liabilities from contracts with customers (in thousands):

 

Six months ended June 30, 2024

 

Balance at beginning of period

 

 

Additions

 

 

Deductions

 

 

Balance at end of period

 

Contract liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Deferred revenue

 

$

1,161

 

 

$

5

 

 

$

(14

)

 

$

1,152

 

During the six months ended June 30, 2024, we did not recognize any revenue from amounts included in the contract asset or the contract liability balances from performance obligations satisfied in previous periods. None of the costs to obtain or fulfill a contract were capitalized.

 

15


 

Note J – Share-based Compensation Plans

 

In June 2024, our stockholders approved an amendment to our Amended and Restated 2019 Equity Incentive Plan (the "2019 EIP") that increased the maximum number of shares of our common stock available for issuance under our 2019 EIP by 3.0 million shares.

We primarily use the Black-Scholes option pricing model to value stock options granted to employees and non-employees, including stock options granted to members of our Board of Directors. However, the fair value of stock option market-based awards is calculated based on a Monte Carlo simulation as of the date of issuance. All stock options have 10-year terms and generally vest ratably over a 3 or 4-year period.

A summary of option activity for the six months ended June 30, 2024 is presented below:

 

 

Options

 

 

Weighted
Average
Exercise
Price

 

 

Weighted
Average
Remaining
Contractual
Term
(in years)

 

 

Aggregate
Intrinsic
Value

 

Outstanding at December 31, 2023

 

 

2,141,360

 

 

$

65.00

 

 

 

 

 

 

 

Granted

 

 

1,344,896

 

 

 

12.87

 

 

 

 

 

 

 

Exercised

 

 

(2,204

)

 

 

12.26

 

 

 

 

 

 

 

Forfeited

 

 

(18,392

)

 

 

47.60

 

 

 

 

 

 

 

Expired

 

 

(98,369

)

 

 

63.39

 

 

 

 

 

 

 

Outstanding at June 30, 2024

 

 

3,367,291

 

 

$

44.17

 

 

 

7.49

 

 

$

5,572,918

 

Vested or expected to vest at June 30, 2024

 

 

3,367,291

 

 

$

44.17

 

 

 

7.49

 

 

$

5,572,918

 

Exercisable at June 30, 2024

 

 

2,022,962

 

 

$

57.29

 

 

 

6.49

 

 

$

1,832,720

 

 

The weighted average grant-date fair values of stock options granted during the six months ended June 30, 2024 and 2023 were $11.53 and $29.80, respectively.

During the six months ended June 30, 2024, all options were granted with exercise prices equal to the market value of the underlying shares of common stock on the grant date other than certain awards dated January 16, 2024 and January 17, 2024. In January 2024, our Board of Directors approved certain awards subject to forfeiture in the event stockholder approval was not obtained for an amendment to our 2019 EIP. This approval was obtained in June 2024. Accordingly, these awards have a grant date of June 2024, with an exercise price as of the date the Board of Director's approved the awards in January 2024.

As of June 30, 2024, there was approximately $24.7 million of total unrecognized share-based compensation expense related to these stock options and stock options granted under subsidiary plans which, if all milestones are achieved, will be recognized over a weighted average period of 1.5 years.

Certain employees and consultants have been granted non-vested stock. The fair value of non-vested market-based awards is calculated based on a Monte Carlo simulation as of the date of issuance. The fair value of other non-vested stock is calculated based on the closing sale price of our common stock on the date of issuance.

A summary of non-vested stock activity for the six months ended June 30, 2024 is presented below:

 

 

Non-vested
Shares

 

 

Weighted
Average
Grant Date
Fair Value

 

Outstanding at December 31, 2023

 

 

27,163

 

 

$

37.20

 

Granted

 

 

24,906

 

 

 

14.38

 

Vested

 

 

(10,154

)

 

 

31.17

 

Forfeited

 

 

(4,000

)

 

 

41.72

 

Outstanding at June 30, 2024

 

 

37,915

 

 

$

23.35

 

 

As of June 30, 2024, there was approximately $1.4 million of unrecognized share-based compensation expense related to these non-vested shares and non-vested shares granted under subsidiary plans which will be recognized over a period of 3.3 years.

16


 

During the six months ended June 30, 2024, 11,816 shares were issued under the 2019 Employee Stock Purchase Plan, 10,152 shares were issued as a result of the vesting of non-vested stock and 2,204 shares were issued as a result of stock option exercises.

The impact on our results of operations from share-based compensation for the three and six months ended June 30, 2024 and 2023, was as follows (in thousands):

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Research and development

 

$

4,722

 

 

$

1,656

 

 

$

6,036

 

 

$

3,389

 

General and administrative

 

 

4,568

 

 

 

4,386

 

 

 

7,450

 

 

 

8,138

 

Total share-based compensation expense

 

$

9,290

 

 

$

6,042

 

 

$

13,486

 

 

$

11,527

 

 

Note K – Restricted Cash

As of June 30, 2024, and December 31, 2023, we maintained non-current restricted cash of $3.6 million and $3.7 million, respectively. This amount is included within “Other long-term assets” in our condensed consolidated balance sheets and is comprised of deposits under letters of credit required under our facility leases.

The following table provides a reconciliation of cash, cash equivalents and restricted cash that sums to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands):

 

 

 

Six Months Ended June 30, 2024

 

 

Six Months Ended June 30, 2023

 

 

 

Beginning of Period

 

 

End of Period

 

 

Beginning of Period

 

 

End of Period

 

Cash and cash equivalents

 

$

76,110

 

 

$

93,723

 

 

$

178,674

 

 

$

143,205

 

Restricted cash

 

 

3,669

 

 

 

3,634

 

 

 

2,669

 

 

 

2,669

 

Cash, cash equivalents and restricted cash

 

$

79,779

 

 

$

97,357

 

 

$

181,343

 

 

$

145,874

 

 

Note L – Equity

On March 14, 2024, we filed a Post-effective Amendment to an Automatic Shelf Registration Statement on Form POSASR (file no. 333-272911) and a Post-Effective Amendments for Registration Statement on Form POS AM (file no. 333-272911) (together, the “Registration Statement”). The Registration Statement included both a base prospectus that covered the potential offering, issuance and sale from time to time of up to $300.0 million of common stock, preferred stock, warrants, debt securities and units of Agenus and a prospectus supplement for the potential offer and sale of up to 6,725,642 shares of common stock (the “Placement Shares”) in “at the market” offerings pursuant to an At Market Issuance Sales Agreement by and between Agenus and B. Riley Securities, Inc. (the “Sales Agent”), dated as of July 22, 2020 (the “Sales Agreement”). Sales pursuant to the Sales Agreement will be made only upon our instruction to the Sales Agent, and we cannot provide assurances that we will issue any additional Placement Shares pursuant to the Sales Agreement.

During the three and six months ended June 30, 2024, we received net proceeds of approximately $2.0 million and $19.2 million, from the sale of approximately 117,000 and 1.4 million shares of our common stock, respectively, in at-the-market offerings under the Sales Agreement.

On April 3, 2024, our stockholders approved a proposal to amend our Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), to effect a reverse stock split of our issued and outstanding common stock at a ratio of 1-for-20 (the “Reverse Stock Split”). On April 4, 2024, we filed a Certificate of Eighth Amendment (the “Certificate of Amendment”) to our Certificate of Incorporation with the Secretary of State of the State of Delaware to effect the Reverse Stock Split. Pursuant to the Certificate of Amendment, the Reverse Stock Split became effective at 12:01 a.m., Eastern Time, on April 12, 2024. As of the opening of trading on April 12, 2024, our common stock began trading on a post-split basis under CUSIP number 00847G 804.

All common share, per share and related information included in the accompanying financial statements and footnote disclosures have been adjusted retroactively, where applicable, to reflect the Reverse Stock Split.

In connection with the Purchase Agreement described in Note F, on May 6, 2024, we issued to Ligand a warrant to purchase 867,052 shares of our common stock, at an exercise price equal to $17.30 per share. The exercise price of the Ligand Warrant and the number of shares issuable upon exercise of the Ligand Warrant are subject to adjustments for stock splits, combinations, stock dividends or similar events.

17


 

The Ligand Warrant is exercisable until May 6, 2029.

Note M – Non-controlling Interest

 

Non-controlling interest recorded in our condensed consolidated financial statements as of June 30, 2024 and December 31, 2023, relates to the following approximate interests in certain consolidated subsidiaries, which we do not own.

 

 

June 30, 2024

 

 

December 31, 2023

 

MiNK Therapeutics, Inc.

 

 

45

%

 

 

37

%

SaponiQx, Inc.

 

 

30

%

 

 

30

%

Changes in non-controlling interest for the periods ended June 30, 2024 and December 31, 2023, were as follows (in thousands):

 

 

June 30, 2024

 

 

December 31, 2023

 

Beginning balance

 

$

11,949

 

 

$

6,376

 

 

 

 

 

 

 

 

Net loss attributable to non-controlling interest

 

 

(3,284

)

 

 

(11,676

)

 

 

 

 

 

 

 

Other items:

 

 

 

 

 

 

Sale of subsidiary shares in private placement

 

 

10,234

 

 

 

 

Distribution of subsidiary shares to Agenus stockholders

 

 

 

 

 

14,888

 

Purchase of subsidiary shares

 

 

 

 

 

(2,546

)

Issuance of subsidiary shares for employee bonus

 

 

 

 

 

1,011

 

Issuance of subsidiary shares for employee stock purchase plan and exercise of options

 

 

13

 

 

 

71

 

Subsidiary share-based compensation

 

 

1,560

 

 

 

3,825

 

Total other items

 

 

11,807

 

 

 

17,249

 

 

 

 

 

 

 

 

Ending balance

 

$

20,472

 

 

$

11,949

 

Sale of subsidiary shares in private placement

On May 13, 2024, MiNK entered into a Stock Purchase Agreement with a certain investor (the “Purchaser”), pursuant to which MiNK issued and sold an aggregate of 4,640,000 shares of its Common Stock (the “MiNK Common Shares”), at a purchase price of $1.25 per share. The aggregate purchase price paid by the Purchaser for the MiNK Common Shares was approximately $5.8 million, net of offering expenses. The transaction closed on May 14, 2024.

Distribution of subsidiary shares to Agenus stockholders

On March 29, 2023, our Board of Directors declared a stock dividend (the "Dividend") consisting of an aggregate of 5.0 million shares (the "Dividend Stock") of common stock, par value $0.00001 per share, of MiNK held by Agenus to record holders of Agenus' common stock, par value $0.01 per share as of the close of business on April 17, 2023 (the "Record Date").

On May 1, 2023, we paid the Dividend and distributed 0.292 of a share of the Dividend Stock for each share of Agenus common stock outstanding as of the close of business on the Record Date. No fractional shares were issued in connection with the Dividend and the shareholders of Agenus who were entitled to receive fractional shares of the Dividend Stock received cash (without interest) in lieu of such fractional shares. Subsequent to the distribution of the Dividend Stock, we maintained a controlling voting interest in MiNK.

Purchase of subsidiary shares

During the year ended December 31, 2023, we purchased 446,494 shares of MiNK common stock in multiple open market transactions.

Note N – Related Party Transactions

In 2023, our Audit and Finance Committee approved a contract between Avillion Life Sciences LTD ("Avillion") and Agenus for the performance of up to $450,000 of clinical consulting services. Allison Jeynes, a former member of our Board of Directors, is chief executive officer of Avillion.

18


 

No expenses were incurred in the three and six months ended June 30, 2024. For the three and six months ended June 30, 2023, approximately $222,000 and $450,000, respectively, related to these services is included in “Research and development” expense in our condensed consolidated statements of operations.

 

Note O – Recent Accounting Pronouncements

 

Recently Issued, Not Yet Adopted

In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 requires incremental annual and quarterly disclosures about segment measures of profit or loss as well as significant segment expenditures. It also requires public entities with a single reportable segment to provide all segment disclosures required by the amendments and all existing segment disclosures in Topic 280. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. As we have a single reportable segment, we expect the adoption of this standard to result in increased disclosures in the notes to our consolidated financial statements.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 requires incremental annual disclosures around income tax rate reconciliations, income taxes paid and other related disclosures. For public business entities, ASU 2023-09 is effective for fiscal years beginning after December 15, 2024. Early adoption is permitted for any annual periods for which financial statements have not been issued or made available for issuance. We are currently evaluating the impact that ASU 2023-09 will have on the notes to our consolidated financial statements.

No other new accounting pronouncement issued or effective during the six months ended June 30, 2024 had or is expected to have a material impact on our consolidated financial statements or disclosures.

 

 

Note P – Subsequent Events

At the Market Offerings

During the period of July 1, 2024 through August 5, 2024, we sold approximately 405,000 shares of our common stock under the Sales Agreement, totaling net proceeds of approximately $6.2 million.

BMS License Agreement Termination

In May 2021, we entered into a License, Development and Commercialization Agreement with BMS (the “BMS License Agreement”) pursuant to which we granted BMS an exclusive license to develop, manufacture and commercialize our proprietary TIGIT bispecific antibody program AGEN1777. Pursuant to the BMS License Agreement, we received a non-refundable upfront cash payment of $200.0 million.

On July 30, 2024 we received notice from BMS that it is returning AGEN1777 back to Agenus and voluntarily terminating the BMS License Agreement, effective as of January 26, 2025.

Under the terms of the BMS License Agreement, BMS has granted us, effective as of January 26, 2025 an exclusive, royalty-free and fully paid-up, worldwide, and sublicensable license to BMS’ know-how and patent rights that arose from activities performed under the BMS License Agreement to develop and manufacture AGEN1777. Additionally, BMS will assign to us all regulatory registrations, applications, authorizations, and approvals that BMS holds in connection with AGEN1777. We will not incur any early termination penalties as a result of the termination.

Incyte Collaboration Agreement

In January 2015, we entered into a collaboration with Incyte to discover, develop and commercialize novel immuno-therapeutics using our antibody platforms. The collaboration was initially focused on four immunotherapy programs targeting GITR, OX40, TIM-3 and LAG-3, and in November 2015, we expanded the alliance by adding three novel undisclosed immunotherapy targets. Pursuant to the terms of the original agreement, Incyte paid us $25.0 million in upfront cash. Targets under the collaboration were designated as either profit-share programs, where the parties shared all costs and profits equally, or royalty-bearing programs, where Incyte funded all costs, and we were eligible to receive milestones and royalties. Under the original collaboration agreement, programs targeting GITR, OX40 and two of the undisclosed targets were designated as profit-share programs, while the other targets were royalty-bearing programs. For each profit-share product, we were eligible to receive up to $20.0 million in future contingent development milestones. For each royalty-bearing product, we were eligible to receive (i) up to $155.0 million in future contingent development, regulatory, and commercialization milestones and (ii) tiered royalties on global net sales at rates generally ranging from 6%-12%. In February 2017, we and Incyte amended the terms of the original collaboration agreement to, among other things, convert the GITR and OX40 programs from profit-share to royalty-bearing programs with royalties on global net sales at a flat 15% rate for each. In addition, the profit-share programs relating to two undisclosed targets were removed from the collaboration, with one reverting to Incyte and one to Agenus (the latter being our Fc enhanced TIGIT program), each with royalties on global net sales at a flat 15% rate.

19


 

The remaining three royalty-bearing programs in the collaboration targeting TIM-3, LAG-3 and one undisclosed target remain unchanged, and there are no more profit-share programs under the collaboration. Pursuant to the amended agreement, we received accelerated milestone payments of $20.0 million from Incyte related to the clinical development of INCAGN1876 (GITR agonist) and INCAGN1949 (OX40 agonist). Incyte terminated the OX40 program, effective October 2023, and terminated both the GITR program and undisclosed program, effective May 2024. Upon termination, the rights to the OX40, GITR, and undisclosed programs reverted back to us.

On July 30, 2024, Incyte announced that it would discontinue further development of the LAG-3 and TIM-3 monoclonal antibodies.

Gilead Option and License Agreement Termination

In December 2018, we entered into a series of agreements with Gilead to collaborate on the development and commercialization of up to five novel I-O therapies. Pursuant to the collaboration agreements, Gilead received (i) worldwide exclusive rights to AGEN1423, a bispecific antibody, (ii) the exclusive option to license exclusively AGEN1223, a bispecific antibody, and AGEN2373, a monospecific antibody, and (iii) the right of first negotiation for two additional, undisclosed programs. Gilead had the exclusive right to develop and commercialize AGEN1423, and we were eligible to receive potential development and commercial milestones of up to $552.5 million in the aggregate. In November 2020, Gilead elected to return AGEN1423 to us and voluntarily terminated the license agreement effective as of February 4, 2021. In October of 2021, Gilead elected to terminate the option to license AGEN1223.

On August 5, 2024 Gilead elected not to exercise the option to license AGEN2373 and the option and license agreement was formally terminated.

20


 

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

Forward Looking Statements

This Quarterly Report on Form 10-Q and other written and oral statements we make from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). You can identify these forward-looking statements by the fact they use words such as “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will,” “potential,” “opportunity,” “future” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. You can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements relate to, among other things, our business strategy, our research and development, our product development efforts, our ability to commercialize our product candidates, the activities of our licensees, our prospects for initiating partnerships or collaborations, the timing of the introduction of products, the effect of new accounting pronouncements, uncertainty regarding our future operating results and our profitability, anticipated sources of funds as well as our plans, objectives, expectations, and intentions.

More detailed descriptions of these risks and uncertainties and other risks and uncertainties applicable to our business that we believe could cause actual results to differ materially from any forward-looking statements are included in in Part I-Item 1A “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in Part II-Item 1A within this Form 10-Q. We encourage you to read those descriptions carefully. Although we believe we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved. We caution investors not to place significant reliance on forward-looking statements contained in this document; such statements need to be evaluated in light of all the information contained in this document. Furthermore, the statements speak only as of the date of this document, and we undertake no obligation to update or revise these statements.

ASV®, Agenus™, MiNK™, Prophage™, Retrocyte Display™ and STIMULON™ are trademarks of Agenus Inc. and its subsidiaries. All rights reserved.

Overview

We are a leading clinical-stage biotechnology company developing therapies targeting cancer with a robust pipeline of immunological agents. Our mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through our subsidiary MiNK Therapeutics, Inc. (“MiNK”)), and vaccine adjuvants (through our subsidiary SaponiQx, Inc. (“SaponiQx”)). We believe that combination therapies and a deep understanding of each patient’s cancer will significantly expand the patient population benefiting from immuno-oncology (“I-O”) treatments.

In addition to our diverse pipeline, we have established fully integrated capabilities encompassing novel target discovery, antibody generation, cell line development, and current good manufacturing practice ("cGMP") manufacturing. We believe these integrated capabilities enable us to develop and, if approved, commercialize novel candidates on accelerated timelines compared to industry standards. Through independent development and strategic partnerships, we leverage our scientific expertise and capabilities to drive innovation in the I-O field.

Our I-O portfolio is driven by several platforms and programs, which we plan to utilize individually and in combination:

Multiple antibody discovery platforms, including proprietary display technologies, to identify future antibody candidates.
Antibody candidate programs, including our lead assets, botensilimab (a multifunctional immune cell activator and human Fc-enhanced cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibody, also known as AGEN1811) and balstilimab (a programmed death receptor-1 (PD-1) blocking antibody).
Our saponin-based vaccine adjuvant platform, primarily centered around our STIMULON™ cultured plant cell (“cpc”) QS-21 adjuvant (“STIMULON cpcQS-21”).
A pipeline of novel allogeneic invariant natural killer T cell (“iNKT”) therapies for treating cancer and other immune-mediated diseases, controlled by MiNK.

We regularly evaluate development, commercialization, and partnering strategies for each product candidate based on various factors, including pre-clinical and clinical trial results, competitive positioning, funding requirements, and available resources. Our lead program, botensilimab (AGEN1181), is progressing through multiple clinical programs designed to support accelerated development as a monotherapy and in combination with balstilimab.

21


 

In April 2023, botensilimab in combination with balstilimab received Fast Track designation from the U.S. Food and Drug Administration ("FDA") for the treatment of patients with not-microsatellite instability-high ("MSI-H")/deficient mismatch repair ("dMMR") metastatic colorectal cancer with no active liver involvement. Patients targeted with this designation are heavily pretreated with standard of care chemotherapy, anti-VEGF and anti-EGFR if RAS wild type. We completed enrollment of patients with refractory MSS mCRC non-active liver metastases ("NLM") in a Phase 1 trial (n~150) and randomized Phase 2 trial (n~230) in October 2023. We are exploring all potential accelerated approval pathways and intend to initiate a Phase 3 study with plans to ensure continued funding via partnering activities.

We have established collaborations with several companies, including Bristol-Myers Squibb Company (“BMS”), Betta Pharmaceuticals Co., Ltd. (“Betta”), UroGen Pharma Ltd. ("UroGen"), Gilead Sciences, Inc. (“Gilead”), Incyte Corporation (“Incyte”), and Merck Sharpe & Dohme (“Merck”). These collaborations, along with our internal programs, have resulted in over a dozen antibody pre-clinical or clinical development programs.

Pursuant to our collaboration agreement with Incyte, we have exclusively licensed to Incyte monospecific antibodies targeting GITR, OX40, TIM-3 and LAG-3, which Incyte is currently advancing in various clinical trials, as well as an additional undisclosed target that Incyte is advancing in preclinical studies. Under the terms of our agreement, Incyte is responsible for all future development expenses, and we are eligible to receive up to an additional $315.0 million in potential milestone payments plus royalties on any future sales. Incyte has terminated the OX40 program, effective October 2023, and both the GITR program and undisclosed program, effective May 2024. Upon termination, the rights to the OX40, GITR, and undisclosed programs reverted back to us. On July 30, 2024, Incyte announced that it would discontinue further development of the LAG-3 and TIM-3 monoclonal antibodies.

Pursuant to our collaboration and license agreement with Merck, we exclusively licensed to Merck a monospecific antibody targeting ILT4 (MK-4830), which Merck advanced in a Phase 2 clinical trial. Merck is responsible for all future development expenses, and we are eligible to receive up to an additional $85.0 million in potential milestone payments, as well as royalties on future sales. In 2024 Merck notified us that the further clinical development of MK-4830 will be limited to a neoadjuvant ovarian study of MK-4830 in combination with pembrolizumab and chemotherapy with or without bevacizumab that is ongoing.

In September 2018, we, through our wholly-owned subsidiary, Agenus Royalty Fund, LLC, entered into a royalty purchase agreement (the “XOMA Royalty Purchase Agreement”) with XOMA (US) LLC (“XOMA”). Pursuant to the terms of the XOMA Royalty Purchase Agreement, XOMA purchased 33% of all future royalties and 10% of all future milestone payments that we are entitled to receive from Incyte and Merck, net of certain of our obligations to a third party.

In December 2018, we entered into collaboration agreements with Gilead for the development and commercialization of up to five novel I-O therapies (the “Gilead Collaboration Agreements”). Gilead received worldwide exclusive rights to our bispecific antibody, AGEN1423, and the exclusive option to license AGEN1223, a bispecific antibody, and AGEN2373, a monospecific antibody. Gilead elected to return AGEN1423 to us in November 2020 and terminated the license agreement. We ceased development of AGEN1223 in the third quarter of 2021, and the option and license agreement for AGEN1223 were formally terminated in October 2021. The AGEN2373 option agreement remains in place, and we are responsible for developing the program until the option decision point. If Gilead exercises the option, we may opt-in to share development and commercialization costs in the United States in exchange for a 50:50 profit (loss) share and revised milestone payments. In March 2022, we received a $5.0 million clinical milestone under the AGEN2373 option agreement. Pursuant to the terms of the AGEN2373 option agreement, as of June 30, 2024, we remained eligible to receive a $50.0 million option exercise fee and up to an additional $520.0 million in aggregate milestone payments, as well as royalties on future sales. On August 5, 2024, Gilead elected not to exercise the option to license AGEN2373 and the option and license agreement was formally terminated.

In November 2019, we entered into a license agreement with UroGen, granting them an exclusive, worldwide license (not including Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions) to develop, manufacture, and commercialize zalifrelimab for the treatment of cancers of the urinary tract via intravesical delivery. We received an upfront payment of $10.0 million and are eligible to receive up to $200.0 million in milestone payments, as well as royalties on future sales.

In June 2020, we entered into a license and collaboration agreement (the “Betta License Agreement”) with Betta, pursuant to which we granted Betta an exclusive license to develop, manufacture and commercialize balstilimab and zalifrelimab in Republic of China, Hong Kong, Macau and Taiwan (“Greater China”). Under the terms of the Betta License Agreement, we received $15.0 million upfront and are eligible to receive up to $100.0 million in milestone payments plus royalties on any future sales in Greater China.

In May 2021, we entered into a License, Development, and Commercialization Agreement with BMS for our pre-clinical anti-TIGIT bispecific antibody program, AGEN1777. BMS received an exclusive worldwide license to develop, manufacture, and commercialize AGEN1777 and its derivatives.

22


 

We retained an option to access the licensed antibodies for use in clinical studies in combination with certain pipeline assets. We received a non-refundable upfront cash payment of $200.0 million and, as of June 30, 2024, were eligible to receive up to $1.32 billion in development, regulatory, and commercial milestone payments, along with tiered royalties. BMS is responsible for all associated costs, and we have the option to co-fund a minority of global development costs in exchange for increased tiered royalties. We also have the option to co-promote AGEN1777 in the U.S. In October 2021, we achieved a $20.0 million milestone upon the dosing of the first patient in the AGEN1777 Phase 1 clinical trial and in December 2023, we announced that the first patient was dosed in an AGEN1777 Phase 2 clinical trial, triggering the achievement of a $25.0 million milestone. We received this milestone in January 2024. On July 30, 2024, we received notice from BMS that it is returning AGEN1777 back to Agenus and voluntarily terminating the BMS License Agreement, effective as of January 26, 2025.

In May 2024, we, and certain wholly-owned subsidiaries, entered into a Purchase and Sale Agreement (the “Ligand Purchase Agreement”) with Ligand Pharmaceuticals Incorporated (“Ligand”) for the sale to Ligand of (i) 31.875% of the development, regulatory and commercial milestone payments we are eligible to receive under our agreements with BMS, UroGen, Gilead, Merck and Incyte, (the “Covered License Agreements”) (ii) 18.75% of the royalties we receive under the Covered License Agreements; and (iii) a 2.625% synthetic royalty on worldwide net sales of botensilimab and balstilimab (collectively the “Purchased Assets”). The total amounts payable to Ligand are subject to a 50% reduction in the event total payments to Ligand exceed a specified return hurdle. The synthetic royalty is subject to a reduction if annual worldwide net sales exceed a specified level, and a cap on annual worldwide net sales if annual worldwide net sales exceed a higher specified level. The synthetic royalty can increase by 1% based on the occurrence of certain future events. After taking into account our obligations under the Ligand Purchase Agreement, XOMA Royalty Purchase Agreement and the recent status of our collaboration agreements, we remain eligible to receive up to approximately $136.3 million, $49.4 million and $183.1 million in potential development, regulatory, and commercial milestones from UroGen, Merck and Incyte, respectively.

In September 2021, we launched SaponiQx to lead innovation in novel adjuvant discovery and vaccine design, focusing on our saponin-based adjuvants. We are particularly dedicated to the development of the next-generation cultured plant cell QS-21. To support this initiative, we partnered with Ginkgo Bioworks, Inc. to develop SaponiQx’s saponin products from sustainably sourced raw materials. Our goal is to meet the demands of the vaccine industry, especially for pandemic vaccines.

Our bark extract QS-21 adjuvant is partnered with GSK and plays a vital role in multiple GSK vaccine programs. These programs are at various stages, including GSK’s approved shingles and RSV vaccines, SHINGRIX and AREXVY, which received FDA approval in the United States in October 2017 and May 2023, respectively.

In January 2018, we entered into a Royalty Purchase Agreement with Healthcare Royalty Partners III, L.P. and its affiliates (“HCR”). HCR purchased our worldwide rights to receive royalties from GSK on GSK’s sales of vaccines containing our QS-21 adjuvant. We do not incur clinical development costs for products partnered with GSK.

Under the agreement with HCR, we were entitled to receive milestone payments based on GSK’s vaccine sales. These milestones include $15.1 million upon GSK reaching $2.0 billion in last-twelve-months net sales prior to 2024 (the “First HCR Milestone”) and $25.25 million upon GSK reaching $2.75 billion in last-twelve-months net sales prior to 2026 (the “Second HCR Milestone”). We received the First HCR Milestone after GSK’s net sales of SHINGRIX for the twelve months ended December 31, 2019, exceeded $2.0 billion, and we received the Second HCR Milestone after GSK’s net sales of SHINGRIX for the twelve months ended June 30, 2022, exceeded $2.75 billion.

Our business activities include product research and preclinical and clinical development, intellectual property prosecution, manufacturing, regulatory and clinical affairs, corporate finance and development activities, and support of our collaborations. Our product candidates require successful clinical trials and approvals from regulatory agencies, as well as acceptance in the marketplace. Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing arrangements with academic and corporate collaborators and licensees and by entering into new collaborations.

In October 2021, we completed the initial public offering (“IPO”) of MiNK, which trades on the Nasdaq Capital Market under the ticker symbol “INKT”. MiNK is a clinical stage biopharmaceutical company focused on developing allogeneic invariant natural killer T (“iNKT”) cell therapies to treat cancer and other life-threatening immune diseases. MiNK’s most advanced product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy. MiNK is currently expanding its clinical programs, with a notable externally funded Phase 2 trial in second-line gastric cancer actively enrolling at Memorial Sloan Kettering Cancer Center. Additionally, MiNK is evaluating agenT-797 as a variant-agnostic therapy for patients with viral acute respiratory distress syndrome (“ARDS”) in planning for a randomized phase 2 study through a predominantly externally financed program. Recently, MiNK secured a $5.8 million private placement financing at a 25% premium, led by GKCC, LLC. This funding will propel the clinical development of MiNK-215, its leading allogeneic CAR-iNKT cell therapy targeting fibroblast activation protein (“FAP”) in solid tumors, which is scheduled to enter clinical trials in early 2025.

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In addition to its lead clinical program, MiNK has announced a collaboration with ImmunoScape, Inc. (“ImmunoScape”) to discover and develop next-generation T-cell receptor therapies targeting novel solid tumor antigens. This partnership leverages MiNK's proprietary library of T cell antigens and ImmunoScape’s platform for rapid discovery of novel T cell receptors.

Historical Results of Operations

Three months ended June 30, 2024 compared to the three months ended June 30, 2023

Research and development revenue

We recognized research and development revenue of approximately $0.3 and $2.5 million during the three months ended June 30, 2024 and 2023, respectively. Research and development revenues in the second quarter of 2023 primarily consisted of $2.0 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements.

Non-cash royalty revenue related to the sale of future royalties

In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant to HCR. As described in Note F to our Condensed Consolidated Financial Statements, this transaction has been recorded as a liability that amortizes over the estimated life of our Royalty Purchase Agreement with HCR. As a result of this liability accounting, even though the royalties are remitted directly to HCR, we record these royalties from GSK as revenue. Non-cash royalty revenue related to our agreement with GSK increased $0.5 million, to approximately $22.6 million for the three months ended June 30, 2024, from $22.1 million for the three months ended June 30, 2023, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant, including net sales of AREXVY, that GSK launched in the third quarter of 2023.

Research and development expense

Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of consultants, and administrative costs. Research and development expense decreased 38% to $36.8 million for the three months ended June 30, 2024 from $59.3 million for the three months ended June 30, 2023. Decreased expenses in the three months ended June 30, 2024 primarily relate to a $14.3 million decrease in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs, a $3.8 million decrease in personnel related expenses, mainly due to a decrease in headcount, and a $6.1 million decrease in expenses attributable to the activities of our subsidiaries. These decreases were partially offset by a $1.8 million increase in other research and development expenses.

General and administrative expense

General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 18% to $16.8 million for the three months ended June 30, 2024 from $20.4 million for the three months ended June 30, 2023. Decreased expenses in the three months ended June 30, 2024 primarily relate to a $2.3 million decrease in personnel related expenses, mainly due to decreased share based compensation expense, a $0.5 million decrease in professional fees and a $0.9 million decrease in expenses attributable to the activities of our subsidiaries. These decreases were partially offset by a $0.1 million increase in other general and administrative expenses.

Non-operating income (expense)

Non-operating income increased $7.4 million for the three months ended June 30, 2024, from expense of $0.2 million for the three months ended June 30, 2023 to income of $7.1 million for the three months ended June 30, 2024, primarily due to the recognition of a $5.5 million gain on the early termination of two operating leases and the recognition of R&D tax credits in the UK in the three months ended June 30, 2024, compared to de minimis activity in the three months ended June 30, 2023.

Interest expense, net

Interest expense, net increased to approximately $31.7 million for the three months ended June 30, 2024 from $18.5 million for the three months ended June 30, 2023, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR and the addition of non-cash interest expense recorded in connection with our Ligand Purchase Agreement.

Six months ended June 30, 2024 compared to the six months ended June 30, 2023

Research and development revenue

We recognized research and development revenue of approximately $0.3 million and $5.1 million during the six months ended June 30, 2024 and 2023, respectively. Research and development revenues in the first half of 2023 primarily consisted of $4.4 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements.

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Non-cash royalty revenue related to the sale of future royalties

In January 2018, we sold 100% of our worldwide rights to receive royalties from GSK on sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant to HCR. As described in Note F to our Condensed Consolidated Financial Statements, this transaction has been recorded as a liability that amortizes over the estimated life of our Royalty Purchase Agreement with HCR. As a result of this liability accounting, even though the royalties are remitted directly to HCR, we record these royalties from GSK as revenue. Non-cash royalty revenue related to our agreement with GSK increased $9.2 million, to approximately $50.3 million for the six months ended June 30, 2024, from $41.2 million for the six months ended June 30, 2023, due to increased net sales of GSK’s vaccines containing our STIMULON QS-21 adjuvant, including net sales of AREXVY, that GSK launched in the third quarter of 2023.

Research and development expense

Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of consultants, and administrative costs. Research and development expense decreased 31% to $80.7 million for the six months ended June 30, 2024 from $116.4 million for the six months ended June 30, 2023. Decreased expenses in the six months ended June 30, 2024 primarily relate to a $21.7 million decrease in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs, a $5.9 million decrease in personnel related expenses, mainly due to a decrease in headcount, and a $10.5 million decrease in expenses attributable to the activities of our subsidiaries. These decreases were partially offset by a $2.5 million increase in other research and development expenses.

General and administrative expense

General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees. General and administrative expenses decreased 13% to $33.7 million for the six months ended June 30, 2024 from $38.7 million for the six months ended June 30, 2023. Decreased expenses in the six months ended June 30, 2024 primarily relate to a $2.3 million decrease in personnel related expenses, mainly due to decreased share based compensation expense, a $0.8 million decrease in professional fees and a $2.4 million decrease in expenses attributable to the activities of our subsidiaries. These decreases were partially offset by a $0.4 million increase in other general and administrative expenses.

Non-operating income (expense)

Non-operating income increased $6.2 million for the six months ended June 30, 2024, from expense of $0.2 million for the six months ended June 30, 2023 to income of $6.0 million for the six months ended June 30, 2024, primarily due to the recognition of a $5.5 million gain on the early termination of two operating leases and the recognition of R&D tax credits in the UK in the six months ended June 30, 2024, compared to de minimis activity in the six months ended June 30, 2023.

Interest expense, net

Interest expense, net increased to approximately $61.2 million for the six months ended June 30, 2024 from $35.1 million for the six months ended June 30, 2023, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR and the addition of non-cash interest expense recorded in connection with our Ligand Purchase Agreement.

Research and Development Programs

 

For the six months ended June 30, 2024, our research and development programs consisted largely of our antibody programs as indicated in the following table (in thousands).

 

 

 

 

Six Months Ended June 30,

 

 

Year Ended December 31,

 

Research and
Development Program

 

Product

 

2024

 

 

2023

 

 

2022

 

 

2021

 

Antibody programs

 

Various

 

$

54,807

 

 

$

178,445

 

 

$

133,108

 

 

$

141,266

 

Vaccine adjuvant

 

STIMULON cpcQS-21

 

 

1,373

 

 

 

10,296

 

 

 

10,789

 

 

 

5,912

 

Cell therapies

 

Various

 

 

4,638

 

 

 

16,283

 

 

 

24,300

 

 

 

15,507

 

Other research and development programs

 

Various

 

 

19,878

 

 

 

29,545

 

 

 

18,494

 

 

 

15,923

 

Total research and development expenses

 

 

 

$

80,696

 

 

$

234,569

 

 

$

186,691

 

 

$

178,608

 

 

Research and development program costs include compensation and other direct costs plus an allocation of indirect costs, based on certain assumptions and our review of the status of each program. Our product candidates are in various stages of development and significant additional expenditures will be required if we start new clinical trials, encounter delays in our programs, apply for regulatory approvals, continue development of our technologies, expand our operations, and/or bring our product candidates to market.

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The total cost of any particular clinical trial is dependent on a number of factors such as trial design, length of the trial, number of clinical sites, number of patients, and trial sponsorship. The process of obtaining and maintaining regulatory approvals for new therapeutic products is lengthy, expensive, and uncertain. Because of the current stage of our product candidates, among other factors, we are unable to reliably estimate the cost of completing our research and development programs or the timing for bringing such programs to various markets or substantial partnering or out-licensing arrangements, and, therefore, when, if ever, material cash inflows are likely to commence.

Liquidity and Capital Resources

We have incurred annual operating losses since inception, and we had an accumulated deficit of $2.1 billion as of June 30, 2024. We expect to incur significant losses over the next several years as we continue development of our technologies and product candidates, manage our regulatory processes, initiate and continue clinical trials, and prepare for potential commercialization of products. To date, we have financed our operations primarily through corporate partnerships, advance royalty sales and the issuance of equity. From our inception through June 30, 2024, we have raised aggregate net proceeds of approximately $2.0 billion through the sale of common and preferred stock, the exercise of stock options and warrants, proceeds from our Employee Stock Purchase Plan, royalty monetization transactions, and the issuance of convertible and other notes.

We maintain an effective registration statement (the “Registration Statement”) covering up to $300.0 million of common stock, preferred stock, warrants, debt securities and units. The Registration Statement includes prospectuses covering the offer, issuance and sale of up to 6.7 million shares of our common stock from time to time in “at-the-market offerings” pursuant to an At Market Issuance Sales Agreement (the “Sales Agreement”) with B. Riley Securities, Inc. as our sales agent. We sold approximately 1.4 million and 405,000 shares of our common stock pursuant to the Sales Agreement during the six months ended June 30, 2024 and the period of July 1, 2024 through August 5, 2024, respectively, and received aggregate net proceeds totaling $25.3 million. As of August 5, 2024, approximately 6.2 million shares remained available for sale under the Sales Agreement.

We have funded our operations largely from cash received from partners, royalty financing transactions and equity offerings. We transact at-the-market sales from time to time in order to manage our cash balances to make sure cash balances do not drop below a certain level based on our anticipated uses of cash. We execute at-the-market offerings based on market conditions and our stock price. We do not have in place a program whereby at-the-market offerings are executed automatically based on our trading volume.

As of June 30, 2024, we had debt outstanding of $13.6 million in principal due February 2025.

Our cash and cash equivalents at June 30, 2024 were $93.7 million, an increase of $17.6 million from December 31, 2023. Cash and cash equivalents of our subsidiary, MiNK, at March 31, 2024, were $5.8 million. MiNK cash can only be accessed by Agenus through a declaration of a dividend by the MiNK Board of Directors or through settlement of intercompany balances.

Since our founding we have financed our operations principally through income and revenues generated from corporate partnerships, advance royalty sales and proceeds from equity issuances. Based on our current plans and projections, we believe that our cash resources of $93.7 million as of June 30, 2024, plus additional funding we may receive from multiple other sources, including out-licensing and/or partnering opportunities, will be sufficient to satisfy our liquidity requirements through the end of the year and into 2025. We are also in discussions with other parties to participate in the Purchase and Sale Agreement (see Note F) for up to an additional $125.0 million under the same terms as the Ligand transaction. In addition, we are in discussions with several potential corporate collaborators. These transactions could also extend our cash resources. However, because the completion of such transactions is not entirely within our control, in accordance with accounting guidance we are required to disclose that substantial doubt exists about our ability to continue as a going concern for a period of one year after the date of filing of this Quarterly Report on Form 10-Q. The financial statements have been prepared on a basis that assumes Agenus will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.

Management continues to address the Company’s liquidity needs and can exercise its flexibility to adjust spending as needed in order to preserve liquidity. In August 2023, we prioritized and focused our resources to accelerate the development, registration, and commercialization of our lead asset postponing all preclinical and other clinical programs and reducing our workforce by approximately 25%. Our CEO, Dr. Garo Armen has elected to receive his base salary and any potential bonus payments in stock rather than cash. We continuously evaluate the likelihood of success of our programs. As such, our decisions to continue to fund or eliminate funding of each of our programs are predicated on these determinations, on an ongoing basis. We expect our sources of funding to include payments from current collaborations which include out-licensing and/or partnering opportunities for our portfolio programs and product candidates with multiple parties; additional third-party agreements; asset sales; further royalty monetization; project financing, and/or sales of equity securities.

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Our future cash requirements include, but are not limited to, supporting clinical trial and regulatory efforts and continuing our other research and development programs. Since inception, we have entered into various agreements with contract manufacturers, institutions, and clinical research organizations (collectively “third party providers”) to perform pre-clinical activities and to conduct and monitor our clinical studies and trials. Under these agreements, subject to the enrollment of patients and performance by the applicable third-party provider, we have estimated our total payments to be $663.4 million over the term of the related activities. Through June 30, 2024, we have expensed $582.9 million as research and development expenses and $541.9 million has been paid under these agreements. The timing of expense recognition and future payments related to these agreements is subject to the enrollment of patients and performance by the applicable third-party provider. We plan to enter into additional agreements with third party providers and we anticipate significant additional expenditures will be required to initiate and advance our various programs.

Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing collaboration arrangements with academic and collaboration partners and licensees and by entering into new collaborations. As a result of our collaboration agreements, we will not completely control the efforts to attempt to bring those product candidates to market.

Net cash used in operating activities for the six months ended June 30, 2024 and 2023 was $76.4 million and $118.6 million, respectively. Our future ability to generate cash from operations will depend on achieving regulatory approval and market acceptance of our product candidates, achieving benchmarks as defined in existing collaboration agreements, and our ability to enter into new collaborations. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Forward Looking Statements” in Part I, Item 2 of this Quarterly Report on Form 10-Q and the risks highlighted in Part I, Item 1A "Risk Factors" of our 2023 Form 10-K.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our primary market risk exposure is foreign currency exchange rate risk. International revenues and expenses are generally transacted by our foreign subsidiaries and are denominated in local currency. Approximately 1.5% and 1.0% of our cash used in operations for the six months ended June 30, 2024 and the year ended December 31, 2023, respectively, was from our foreign subsidiaries. We are exposed to foreign currency exchange rate fluctuation risk related to our transactions denominated in foreign currencies. We do not currently employ specific strategies, such as the use of derivative instruments or hedging, to manage these exposures. Our currency exposures vary but are primarily concentrated in the British Pound and Euro, in large part due to our subsidiaries, Agenus UK Limited and AgenTus Therapeutics Limited, both with operations in England, and AgenTus Therapeutics SA, a company formerly with operations in Belgium.

We had cash and cash equivalents at June 30, 2024 of $93.7 million, which are exposed to the impact of interest rate changes, and our interest income fluctuates as interest rates change. Additionally, in the normal course of business, we are exposed to fluctuations in interest rates as we seek debt financing and invest excess cash. Due to the short-term nature of our investments in money market funds, our carrying value approximates the fair value of these investments at June 30, 2024.

There has been no material change to our interest rate exposure and our approach toward interest rate and foreign currency exchange rate exposures, as described in our Annual Report on Form 10-K for the year ended December 31, 2023.

We invest our cash and cash equivalents in accordance with our investment policy. The primary objectives of our investment policy are to preserve principal, maintain proper liquidity to meet operating needs, and maximize yields. We review our investment policy periodically and amend it as deemed necessary. Currently, the investment policy prohibits investing in any structured investment vehicles and asset-backed commercial paper. Although our investments are subject to credit risk, our investment policy specifies credit quality standards for our investments and limits the amount of credit exposure from any single issue, issuer, or type of investment. We do not invest in derivative financial instruments. Accordingly, we do not believe that there is currently any material market risk exposure with respect to derivatives or other financial instruments that would require disclosure under this item.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our Principal Executive Officer and Principal Financial Officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) and Rule 15d-15(e) promulgated under the Exchange Act. Based on this evaluation, our Principal Executive Officer and our Principal Financial Officer concluded that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were effective and were designed to ensure that information we are required to disclose in the reports that we file or submit under the Exchange Act is accumulated and communicated to management, including our Principal Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure, and is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms.

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It should be noted that any system of controls is designed to provide reasonable, but not absolute, assurances that the system will achieve its stated goals under all reasonably foreseeable circumstances. Our Principal Executive Officer and Principal Financial Officer have each concluded that our disclosure controls and procedures as of the end of the period covered by this report are effective at a level that provides such reasonable assurances.

Changes in Internal Control Over Financial Reporting

There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the three months ended June 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II - OTHER INFORMATION

We are not currently a party to any material legal proceedings. From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Regardless of the outcome, litigation can have a material adverse effect on us because of defense and settlement costs, diversion of management resources and other factors.

Item 1A. Risk Factors

Our results of operations and financial condition are subject to numerous risks and uncertainties described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. In addition to the risk factors described in Part I, Item 1A "Risk Factors" of our 2023 Form 10-K, please note the updated Risk Factors included below.

The risk factor entitled “Our business is highly dependent on the success of our clinical stage programs, including botensilimab and related combination therapy programs, which still require significant additional clinical development” set forth in our 2023 Form 10-K is hereby updated to state the following.

Our business and future success depends in large part on our ability to obtain regulatory approval of, and then successfully launch and commercialize, our product candidates. Our timelines are aggressive and subject to various factors outside of our control, including regulatory review and approval. Although we have engaged with the FDA on our regulatory programs and protocols, there is no guarantee that our BLA submissions, if any, will be approved, or that we will be able to successfully commercialize these assets. If the botensilimab programs (including combination therapies with botensilimab) encounter safety, efficacy, supply or manufacturing problems, developmental delays, regulatory or commercialization issues or other problems, our development plans and business may be significantly harmed.

Even though we have observed positive results to date, they may not necessarily be predictive of the final results of the trials or future clinical trials or otherwise be sufficient to support an approval. Many companies in the pharmaceutical, biopharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving positive results, and we cannot be certain that we will not face similar setbacks.

The FDA may disagree that our data and development program are sufficient to support BLA filing or approval. For example, the FDA discouraged submission of our Phase 2 results in support of an Accelerated Approval based on the observed magnitude of effect, remaining questions about contributions of the components of the combination product, and their view that objective response rates may not translate to survival benefit, and they recommended the inclusion of a BOT monotherapy arm in the planned Phase 3 study. Furthermore, because botensilimab and balstilimab are both novel agents, and are being used in combination, any BLA submission for the combination will require significant information on each agent as well as the combination.

All of our other product candidates are in earlier stages of development and will require additional nonclinical and/or clinical development, regulatory review and approval in multiple jurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing and commercial efforts before we can generate any revenue from product sales.

The risk factor entitled “We are dependent upon our collaborations with BMS, Gilead, Incyte and Betta to further develop and commercialize certain of our antibody programs. If we or BMS, Gilead, Incyte or Betta Pharmaceuticals fail to perform as expected, the potential for us to generate future revenues under such collaborations could be significantly reduced, the development and/or commercialization of these antibodies may be terminated or substantially delayed, and our business could be adversely affected” set forth in our 2023 Form 10-K is hereby updated to reflect that BMS notified us in July 2024 that it will terminate the BMS license agreement effective January 26, 2025 and that in August 2024 Gilead elected to terminate the option to license AGEN2373. As a result, the clinical development, manufacturing, regulatory approval, and commercialization efforts related to AGEN1777 and AGEN2373 could be delayed or terminated and we will not be entitled to any future milestone payments or royalties from BMS or Gilead.

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Item 5. Other Information

Trading Plans of Our Directors and Officers

During the quarter ended June 30, 2024, none of our directors or executive officers adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each item is defined in Item 408 of Regulation S-K.

Gilead Option and License Agreement Termination

In December 2018, we entered into a series of agreements with Gilead to collaborate on the development and commercialization of up to five novel I-O therapies. Pursuant to the collaboration agreements, Gilead received (i) worldwide exclusive rights to AGEN1423, a bispecific antibody, (ii) the exclusive option to license exclusively AGEN1223, a bispecific antibody, and AGEN2373, a monospecific antibody, and (iii) the right of first negotiation for two additional, undisclosed programs. Gilead had the exclusive right to develop and commercialize AGEN1423, and we were eligible to receive potential development and commercial milestones of up to $552.5 million in the aggregate. In November 2020, Gilead elected to return AGEN1423 to us and voluntarily terminated the license agreement effective as of February 4, 2021. In October of 2021, Gilead elected to terminate the option to license AGEN1223.

On August 5, 2024 Gilead elected not to exercise the option to license AGEN2373 and the option and license agreement was formally terminated.

 

30


 

Item 6. Exhibits

 

31


 

Exhibit No.

 

Description

 

 

 

3.1

 

Amended and Restated Certificate of Incorporation of Antigenics Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 0-29089) filed on June 10, 2002 and incorporated herein by reference.

 

 

 

3.2

 

Certificate Amendment to the Amended and Restated Certificate of Incorporation of Agenus Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 0-29089) filed on June 11, 2007 and incorporated herein by reference.

 

 

 

3.3

 

Certificate of Ownership and Merger changing the name of the corporation to Agenus Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 0-29089) filed on January 6, 2011 and incorporated herein by reference.

 

 

 

3.4

 

Certificate of Second Amendment to the Amended and Restated Certificate of Incorporation of Agenus Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 0-29089) filed on September 30, 2011 and incorporated herein by reference.

 

 

 

3.5

 

Certificate of Third Amendment to the Amended and Restated Certificate of Incorporation of Agenus Inc. Filed as Exhibit 3.1 to our Quarterly Report on Form 10-Q (File No. 0-29089) for the quarter ended June 30, 2012 and incorporated herein by reference.

 

 

 

3.6

 

Certificate of Fourth Amendment to the Amended and Restated Certificate of Incorporation of Agenus Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 0-29089) filed on April 25, 2014 and incorporated herein by reference.

 

 

 

3.7

 

Certificate of Fifth Amendment to the Amended and Restated Certificate of Incorporation of Agenus Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 0-29089) filed on June 16, 2016 and incorporated herein by reference.

 

 

 

3.8

 

Certificate of Sixth Amendment to the Amended and Restated Certificate of Incorporation of Agenus Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 0-29089) filed on June 24, 2019 and incorporated herein by reference.

 

 

 

3.9

 

Certificate of Seventh Amendment to the Amended and Restated Certificate of Incorporation of Agenus Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 0-29089) filed on August 5, 2022 and incorporated herein by reference.

 

 

 

3.10

 

Certificate of Eighth Amendment to the Amended and Restated Certificate of Incorporation of Agenus Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K (File No. 0-29089) filed on April 5, 2024 and incorporated herein by reference.

 

 

 

4.1

 

Form of 2024 A Warrant dated as of May 6, 2024, by and between Agenus Inc. and Ligand Pharmaceuticals Incorporated. Filed as Exhibit 4.1 to our Current Report on Form 8-K (File No. 0-29089) filed on May 7, 2024 and incorporated herein by reference.

 

 

 

10.1(1)

 

Purchase and Sale Agreement, dated as of May 6, 2024, by and between Agenus Inc., Agenus Royalty Fund, LLC, Agenus Holdings 2024, LLC, and Ligand Pharmaceuticals Incorporated. Filed herewith.

 

 

 

31.1

 

Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended. Filed herewith.

 

 

 

31.2

 

Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended. Filed herewith.

 

 

 

32.1

 

Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Submitted herewith.

 

 

 

101.INS

 

XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)

 

 

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document

 

 

 

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document

 

 

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101)

 

 

 

32


 

(1)

 

Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit were omitted by means of marking such portions with an asterisk because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.

33


 

AGENUS INC.

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.

 

Date:

 

August 8, 2024

 

AGENUS INC.

 

 

 

 

 

 

 

 

 

/s/ CHRISTINE M. KLASKIN

 

 

 

 

Christine M. Klaskin

VP, Finance, Principal Financial Officer, Principal Accounting Officer

 

 

34


EX-10.1 2 agen-ex10_1.htm EX-10.1 EX-10.1

Exhibit 10.1

Execution Version

PURCHASE AND SALE AGREEMENT

 

 

dated as of May 6, 2024

 

 

by and among

 

 

AGENUS INC., AGENUS ROYALTY FUND, LLC, AGENUS HOLDINGS 2024, LLC

 

 

and

 

 

LIGAND PHARMACEUTICALS INCORPORATED

 

 

 

SPECIFIC TERMS IN THIS AGREEMENT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THESE REDACTED TERMS HAVE BEEN MARKED IN THIS AGREEMENT WITH THREE ASTERISKS [***].

 

 

 

 

 

 

 


TABLE OF CONTENTS

 

Page

 

ARTICLE I DEFINED TERMS AND RULES OF CONSTRUCTION

1

Section 1.1 Defined Terms

1

Section 1.2 Rules of Construction

19

ARTICLE II PURCHASE AND SALE OF THE PURCHASED RECEIVABLES

20

Section 2.1 Purchase and Sale.

20

Section 2.2 Payment of the Purchase Price

21

Section 2.3 Payment of Purchased Receivables to Purchaser

21

Section 2.4 Payment Direction Letters

22

Section 2.5 No Assumed Obligations

22

Section 2.6 Excluded Assets

23

ARTICLE III REPRESENTATIONS AND WARRANTIES OF THE SELLERS

23

Section 3.1 Organization

23

Section 3.2 No Conflicts.

23

Section 3.3 Authorization

24

Section 3.4 Ownership

24

Section 3.5 Governmental and Third-Party Authorizations

25

Section 3.6 No Litigation

25

Section 3.7 Indebtedness; Solvency

25

Section 3.8 Tax Matters

26

Section 3.9 No Brokers’ Fees

26

Section 3.10 Compliance with Laws

26

Section 3.11 Intellectual Property Matters

26

Section 3.12 Regulatory Approval and Marketing.

28

Section 3.13 In-Licenses

30

Section 3.14 Counterparty Agreements.

31

Section 3.15 UCC Matters

32

Section 3.16 Set-off and Other Sources of Royalty Reduction

32

Section 3.17 Margin Stock

32

ARTICLE IV REPRESENTATIONS AND WARRANTIES OF THE PURCHASER

33

Section 4.1 Organization

33

Section 4.2 No Conflicts

33

Section 4.3 Authorization

33

 

i

 

 


TABLE OF CONTENTS

(continued)

Page

 

Section 4.4 Governmental and Third Party Authorizations

33

Section 4.5 No Litigation

33

Section 4.6 Access to Information

34

Section 4.7 Funds Available

34

ARTICLE V COVENANTS

34

Section 5.1 Books and Records; Notices.

34

Section 5.2 Public Announcement

36

Section 5.3 Further Assurances.

36

Section 5.4 Payments on Account of the Covered License Milestones and Covered License Royalties.

37

Section 5.5 Covered License Agreements.

38

Section 5.6 Patent Prosecution, Enforcement and Defense.

40

Section 5.7 Termination of the Covered License Agreements.

41

Section 5.8 Audits

42

Section 5.9 Diligence

43

Section 5.10 Tax Matters.

43

Section 5.11 Existence

44

Section 5.12 Additional Covenants relating to Royalty Fund

44

Section 5.13 Additional Sales; Liens

45

Section 5.14 Change of Control

45

Section 5.15 In-Licenses.

45

Section 5.16 Out-Licenses for Company Products.

46

Section 5.17 Amendment to Disclosure Schedule

46

Section 5.18

Product Sub Organizational Documents

47

Section 5.19 Counterparty Consent

47

Section 5.20 Other Matters

47

Section 5.21 Syndication.

47

ARTICLE VI THE CLOSING

48

Section 6.1 Closing

48

Section 6.2 Closing Deliverables of the Seller

48

Section 6.3 Closing Deliverables of the Purchaser

49

Section 6.4 Lockbox Account; Account Control Agreement.

50

 

ii

 

 


TABLE OF CONTENTS

(continued)

Page

 

ARTICLE VII INDEMNIFICATION

51

Section 7.1 Indemnification by the Seller

51

Section 7.2 Indemnification by the Purchaser

51

Section 7.3 Claims

51

Section 7.4 Survival

51

Section 7.5 Remedies

52

Section 7.6 Limitations

52

Section 7.7 Tax Treatment of Indemnification Payments

52

ARTICLE VIII CONFIDENTIALITY

52

Section 8.1 Confidentiality

52

Section 8.2 Termination of Confidentiality Agreement

53

Section 8.3 Permitted Disclosure

53

Section 8.4 Other Relevant Obligations

54

ARTICLE IX TERMINATION

54

Section 9.1 Pre-Closing Termination

54

Section 9.2 Termination of Agreement Following the Closing.

55

ARTICLE X MISCELLANEOUS

55

Section 10.1 Specific Performance

55

Section 10.2 Notices

55

Section 10.3 Successors and Assigns

56

Section 10.4 Independent Nature of Relationship

56

Section 10.5 Entire Agreement

57

Section 10.6 Governing Law.

57

Section 10.7 Waiver of Jury Trial

57

Section 10.8 Severability

58

Section 10.9 Counterparts

58

Section 10.10 Amendments; No Waivers

58

Section 10.11 No Third Party Rights

58

Section 10.12 Table of Contents and Headings

58

 

iii

 

 


 

Exhibits

Exhibit A-1: Form of Closing Date Bill of Sale – Company

Exhibit A-2: Form of Closing Date Bill of Sale – Royalty Fund

Exhibit B: Form of Contribution Agreement

Exhibit C: Disclosure Schedule

Exhibit D: Form of Pledge and Security Agreement

Exhibit E: Form of Intercompany License Agreement

Exhibit F: [RESERVED]

Exhibit G-1: Form of BOT/BAL Security Agreement

Exhibit G-2: Form of Security Agreement

Exhibit H-1 LICR Agreements

Exhibit H-2 Selexis Agreements

Exhibit I-1: BMS Agreement

Exhibit I-2: Gilead Agreement

Exhibit I-3: Incyte Agreement

Exhibit I-4: Merck Agreement

Exhibit I-5: UroGen Agreement

Exhibit J: Sellers Account

Exhibit L: XOMA Consent

 

 

iv

 

 

 


 

PURCHASE AND SALE AGREEMENT

Exhibit K: Form of Product Sub Operating Agreement This PURCHASE AND SALE AGREEMENT (this “Agreement”), dated as of May 6, 2024, is by and between AGENUS, INC., a Delaware corporation (the “Company”), AGENUS ROYALTY FUND, LLC, a Delaware limited liability company (“Royalty Fund” and together with the Company, each a “Seller” and collectively, the “Sellers”), AGENUS HOLDINGS 2024, LLC, a Delaware limited liability company (“Product Sub”, and together with the Sellers, the “Seller Parties”), and LIGAND PHARMACEUTICALS INCORPORATED, a Delaware corporation (the “Purchaser”).

W I T N E S S E T H :

WHEREAS, the Company holds, directly and indirectly through Royalty Fund, certain assets and rights relating to the Licensed Products;

WHEREAS, the Company is developing and intends to commercialize the Company Products; and

WHEREAS, the Sellers desires to sell, contribute, assign, transfer, convey and grant to the Purchaser, and the Purchaser desires to purchase, acquire and accept from the Sellers, the Purchased Receivables described herein, upon and subject to the terms and conditions set forth in this Agreement.

NOW, THEREFORE, in consideration of the premises and the mutual agreements, representations and warranties set forth herein and of other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties covenant and agree as follows:

ARTICLE IDEFINED TERMS AND RULES OF CONSTRUCTION

Section 1.1 Defined Terms. The following terms, as used herein, shall have the following respective meanings:

“Account Bank” means [***], or such other bank or financial institution approved by each of the Purchaser and the Sellers.

“Account Control Agreement” means any agreement entered into by the Account Bank, the Company and the Purchaser in form and substance reasonably satisfactory to the Purchaser, pursuant to which, among other things, the Purchaser shall have control over the Lockbox Accounts and the Collection Account within the meaning of Section 9-104 of the UCC.

“Additional Co-Investor” has the meaning set forth in Section 5.21(a).

“Agreement” has the meaning set forth in the preamble.

“Affiliate” means, with respect to any designated Person, any other Person that, directly or indirectly, controls, is controlled by or is under common control with such designated Person. For purposes of this definition, “control” of a Person means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of Equity Interests, by contract or otherwise, and the terms “controlled” and “controlling” have meanings correlative to the foregoing.

1

 


 

“Applicable Law” means, with respect to any Person, all laws, rules, regulations and orders of Governmental Authorities applicable to such Person, the conduct of its business, or any of its properties, products or assets.

“Applicable Percentage” means, for each product specified below,

prior to the occurrence of the Step-Down Event, the factor set forth below:

Product

Receivable

Applicable Percentage

Licensed Products

Covered License Milestones

31.875%

Covered License Royalties

18.75%

Company Products

Net Sales up to $[***]

2.625% (“Base Rate”)

Net Sales between $[***] and $[***]

25% of the Base Rate

Net Sales in excess of $[***]

0%

 

and from and after the occurrence of the Step-Down Event, the factor set forth below:

Product

Receivable

Applicable Percentage

Licensed Products

Covered License Milestones

15.9375%

Covered License Royalties

9.375%

Company Products

Net Sales up to $[***]

1.3125% (“Step-Down Base Rate”)

Net Sales between $[***] and $[***]

25% of the Step-Down Base Rate

Net Sales in excess of $[***]

0%

 

provided, however, that

(x) if the First Commercial Sale of the Company Product has not occurred by [***], the Base Rate and Step-Down Base Rate with respect to Net Sales in the United States shall increase to [***]% and [***]%, respectively;

(y) if the Company has not entered into an [***] in accordance with Section 5.16 for [***] or consummated or effected a Change of Control permitted by Section 5.14 by [***], the Applicable Percentage with respect to Net Sales between $[***] and $[***] shall, subject to clause (z) below, equal the Base Rate or Step-Down Base Rate, as applicable, and

(z) if by [***] two distinct Licensed Products have received Regulatory Approval from the FDA, the Applicable Percentage with respect to annual Net Sales between $[***] and $[***] shall [***]% of the Base Rate or the Step-Down Base Rate, as applicable.

2

 


 

For the avoidance of doubt, the two distinct Licensed Products referenced in the preceding sentence must be (i) [***].

“balstilimab” means the Company’s antibody targeting programmed death receptor 1 identified by Chemical Abstract Service Registry Number 2148321-77-9 and internally referenced by Agenus as “AGEN2034.”

“Bankruptcy Event” means the occurrence of any of the following in respect of any Person: (a) an admission in writing by such Person of its inability to pay its debts as they become due or a general assignment by such Person for the benefit of creditors; (b) the filing of any petition or answer by such Person seeking to adjudicate itself as bankrupt or insolvent, or seeking for itself any liquidation, winding-up, reorganization, arrangement, adjustment, protection, relief or composition of such Person or its debts under any law relating to bankruptcy, insolvency, receivership, winding-up, liquidation, reorganization, examination, relief of debtors or other similar law now or hereafter in effect, or seeking, consenting to or acquiescing in the entry of an order for relief in any case under any such law, or the appointment of or taking possession by a receiver, trustee, custodian, liquidator, examiner, assignee, sequestrator or other similar official for such Person or for any substantial part of its property; (c) corporate or other entity action taken by such Person to authorize any of the actions set forth in clause (a) or (b) of this definition; or (d) without the consent or acquiescence of such Person, the entering of an order for relief or approving a petition for relief or reorganization or any other petition seeking any reorganization, arrangement, composition, readjustment, liquidation, dissolution or other similar relief under any present or future bankruptcy, insolvency or similar statute, law or regulation, or the filing of any such petition against such Person, or, without the consent or acquiescence of such Person, the entering of an order appointing a trustee, custodian, receiver or liquidator of such Person or of all or any substantial part of the property of such Person, in each case where such petition or order shall remain unstayed or shall not have been stayed or dismissed within [***] from entry thereof.

“Betta Agreement” means that certain License and Collaboration Agreement, dated as of June 20, 2020, between the Company and Betta Pharmaceuticals Co., Ltd.

“Betta Territory” has the meaning given to the term “Territory” in the Betta Agreement.

“BMS” means Bristol-Myers Squibb Company, a Delaware corporation, its Affiliates and any successors in interest and assigns under the BMS Agreement.

“BMS Agreement” means that certain License, Development and Commercialization Agreement, dated as of May 17, 2021, by and between the Company and BMS, as amended from time to time (but subject to the terms of this Agreement with respect to the amendment thereof).

“BOT/BAL Security Agreement” shall mean the Security Agreement by between and Product Sub and the Purchaser, substantially in the form of Exhibit G-1.

“botensilimab” means the Company’s multifunctional immune cell activator and human Fc-enhanced cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibody identified by Chemical Abstract Service Registry Number 2408310-37-0 or internally referenced by Agenus as AGEN1811.

“Business Day” means any day that is not a Saturday, Sunday or other day on which commercial banks in New York City are authorized or required by Applicable Law to remain closed.

3

 


 

“Change of Control” means any (w) reorganization, recapitalization, consolidation or merger (or similar transaction or series of related transactions) of the Company or issuance, sale or exchange of shares (or similar transaction or series of related transactions) of the Company in which the holders of the Company’s outstanding shares immediately before consummation of such transaction or series of related transactions do not, immediately after consummation of such transaction or series of related transactions, retain shares representing more than 50.0% of the voting power of the surviving entity of such transaction or series of related transactions (or the parent of such surviving entity if such surviving entity is wholly owned by such parent), in each case without regard to whether the Company is the surviving entity, (x) Disposition of all or substantially all of the properties or assets of the Company or (y) Disposition of all or substantially all of the Product Rights.

“Closing” has the meaning set forth in Section 6.1.

“Closing Date” has the meaning set forth in Section 6.1.

“Closing Date Bills of Sale - Purchaser” means those certain bills of sale, dated as of the Closing Date, executed by the Purchaser and each of the Company and Royalty Fund, substantially in the form of Exhibit A-1.

“Closing Date Bill of Sale – Product Sub” means that certain bill of sale, dated as of the Closing Date, executed by Product Sub and the Company pursuant to the Contribution Agreement with respect to the Transferred Assets, substantially in the form of Exhibit A-2.

“Closing Date Bills of Sale” means, collectively, the Closing Date Bills of Sale – Purchaser and the Closing Date Bill of Sale – Product Sub.

“Closing Payment” has the meaning set forth in Section 2.2.

“Code” means the U.S. Internal Revenue Code of 1986, as amended, and the regulations thereunder.

“Collection Account” means a segregated deposit account of the Company established and maintained at an Account Bank pursuant to an Account Control Agreement for the purpose of receiving remittances from the Company Product Lockbox Account.

“Combination Product” means a product that consists of a Company Product and other active compounds or active ingredients sold as a single formulation or any combination of a Company Product sold together with an Other Product.

“Commercially Reasonable Efforts” or “Commercially Reasonable Actions” means,

(a) with respect to any Intellectual Property Rights in any country, efforts or actions that would be commercially reasonable for an owner and licensor of such Intellectual Property Rights in such country, which owner and licensor is entitled to the full economic benefit of such Intellectual Property Rights without regard to the transactions contemplated by this Agreement or any other business of, or assets owned by, such owner and licensor;

(b) for purposes of Section 5.7(a) and Section 5.15(b), with respect to the efforts to be expended, or considerations to be undertaken, by the Company or its Affiliate with respect to any objective, activity or decision to be undertaken hereunder, reasonable, good faith efforts to accomplish such objective, activity or decision as a single product pharmaceutical company (where single product is a non-fixed dose combination regimen with two novel proprietary agents or a product covered by a Covered License Agreement) would normally use to accomplish a similar objective, activity or decision under similar circumstances;

4

 


 

(c) for purposes of Section 5.9, with respect to the efforts to be expended, or considerations to be undertaken, by the Company or its Affiliate with respect to any objective, activity or decision to be undertaken hereunder, reasonable, good faith efforts to accomplish such objective, activity or decision as a similarly situated pharmaceutical company (including with respect to size, scale and resources) would normally use to accomplish a similar objective, activity or decision under similar circumstances, it being understood and agreed that with respect to the research, study, development, formulation, processing, engineering, manufacture, testing, seeking and obtaining regulatory approval, or commercialization of the Company Products, the Company may take into account: (a) issues of efficacy, safety, and expected and actual approved labeling, (b) the expected and actual competitiveness of alternative products sold by third parties in the marketplace, (c) the expected and actual product profile of the Company Product, (d) the expected and actual patent and other proprietary position of the Company Products, (e) the likelihood of regulatory approval and/or pricing approval or pricing restrictions given the regulatory structure involved, including regulatory or data exclusivity, and (f) the expected and actual profitability and return on investment of the Company Products, taking into consideration amounts owed hereunder.

“Company” has the meaning set forth in the preamble.

“Company Product” means any product, including investigational product, that constitutes, incorporates, comprises or contains botensilimab, balstilimab, or a combination of botensilimab and balstilimab (alone together or with other active ingredients) for use in the Territory in the Field in all forms, presentations, formulations and dosage forms.

“Company Product Lockbox Account” means a segregated deposit account of the Company established and maintained at an Account Bank pursuant to an Account Control Agreement for the purpose of receiving payments owed to the Company in respect of the Company Product.

“Company Product Revenue Payment” means, for each calendar quarter from and after April 1, 2024, the Applicable Percentage of all aggregate Net Sales in the Territory during such calendar quarter.

“Company Royalty Report” has the meaning set forth in Section 5.1(b).

“Confidential Information” has the meaning set forth in Section 8.1.

“Contribution Agreement” means the Contribution and Servicing Agreement, dated as of the Closing Date, between the Company and Product Sub, substantially in the form of Exhibit B attached hereto.

“Counterparty” means, as the context requires, BMS, Gilead, Incyte, Merck, or UroGen.

“Covered License Agreements” means, collectively, the BMS Agreement, the Gilead Agreement, the Incyte Agreement, the Merck Agreement and the UroGen Agreement. In accordance with Section 5.16, any Out-License for a Company Product entered into following the date hereof shall be deemed to be a Covered License Agreement. In accordance with Section 5.7, any New Arrangement entered into following the date hereof shall be deemed to be a Covered License Agreement.

“Covered License Milestones” means, collectively, the Covered Company License Milestones and the Covered Royalty Fund License Milestones.

5

 


 

“Covered Company License Milestones” shall mean (A) the Gilead Option Fee Portion and (B) one hundred percent (100%) of all future milestone payments that become owed, accrued or otherwise payable to Company after the Closing pursuant to Sections 9.6 and 9.7 of the Gilead Agreement, Section 9.2 of the UroGen Agreement, and Sections 8.2 and 8.3 of the BMS Agreement including, without limitation, all clinical, regulatory, commercial and sales milestones pursuant to such sections (collectively, the “Company Milestone Payments”), and any future sums accrued, paid or due, other than Company Milestone Payments, that are (i) in lieu of the Company Milestone Payments (which shall not consist of securities without Purchaser’s prior written consent); (ii) in satisfaction of the obligation to pay the Company Milestone Payments; or (iii) indemnity payments, recoveries, damages, settlement or other amounts to which Sellers are or may become entitled to pursuant to or in connection with the Gilead Agreement, the UroGen Agreement or the BMS Agreement, as applicable, or any Licensed Patent thereunder, whether based on actual or alleged infringement, breach, or other circumstance, in each case described in this clause (iii) to the extent such infringement, breach, default or other circumstance has resulted or would result in a reduction in, or such payment is made in lieu of, the Company Milestone Payments; and (iv) all proceeds (including any damages, monetary awards or other amounts recovered, whether by judgment or settlement) paid, owed, accrued or otherwise payable with respect to any of the foregoing of any suit, proceeding or other legal action taken to enforce the right to receive any of the foregoing (other than amounts awarded or recovered in connection with any judgment or settlement for reimbursement of the costs and expenses (including attorneys’ fees) of the party bringing such suit or proceeding or taking such other legal action). For the avoidance of doubt, Covered Company License Milestones shall include all upfront, milestone and similar payments due, payable or paid to the Company or its Affiliates by one or more licensees or sublicensees pursuant to any New Arrangement with respect to a Licensed Product.

“Covered Royalty Fund License Milestones” shall mean one hundred percent (100%) of all future milestone payments that become owed, accrued or otherwise payable to Royalty Fund after the Closing pursuant to Section 5.4 of the Merck Agreement and Section 7.5 of the Incyte Agreement including, without limitation, all clinical, regulatory, commercial and sales milestones pursuant to such sections (collectively, the “Royalty Fund Milestone Payments”), and any future sums accrued, paid or due, other than Royalty Fund Milestone Payments, that are (i) in lieu of the Royalty Fund Milestone Payments (which shall not consist of securities without Purchaser’s prior written consent); (ii) in satisfaction of the obligation to pay the Royalty Fund Milestone Payments; or (iii) indemnity payments, recoveries, damages, settlement or other amounts to which Sellers are or may become entitled to pursuant to or in connection with the Incyte Agreement or the Merck Agreement, as applicable, or any Licensed Patent thereunder, whether based on actual or alleged infringement, breach, or other circumstance, in each case described in this clause (iii) to the extent such infringement, breach, default or other circumstance has resulted or would result in a reduction in, or such payment is made in lieu of, Royalty Fund Milestone Payments; and (iv) all proceeds (including any damages, monetary awards or other amounts recovered, whether by judgment or settlement) paid, owed, accrued or otherwise payable with respect to any of the foregoing of any suit, proceeding or other legal action taken to enforce the right to receive any of the foregoing (other than amounts awarded or recovered in connection with any judgment or settlement for reimbursement of the costs and expenses (including attorneys’ fees) of the party bringing such suit or proceeding or taking such other legal action). [***].

“Covered License Royalties” means, collectively, the Covered Company License Royalties and the Covered Royalty Fund License Royalties.

6

 


 

“Covered Company License Royalties” shall mean without duplication, (a) one hundred percent (100%) of all royalties paid, owed, accrued or otherwise payable to the Company after the Closing by Gilead pursuant to Section 9.8 of the Gilead Agreement with respect to Net Sales of any applicable Licensed Product thereunder, (b) all royalties paid, owed, accrued or otherwise payable after the Closing by BMS pursuant to Section 8.5 of the BMS Agreement with respect to Net Sales of any applicable Licensed Product thereunder, (c) all royalties paid, owed, accrued or otherwise payable after the Closing by UroGen pursuant to Section 9.3 and Section 9.5 of the UroGen Agreement with respect to Net Sales of any applicable Licensed Product thereunder, (collectively (a), (b) and (c) are hereinafter referred to as “Company Royalty Payments”), (d) any sums accrued, paid or due, other than Company Royalty Payments, that are (i) in lieu of the Company Royalty Payments (which shall not consist of securities without Purchaser’s prior written consent); (ii) in satisfaction of the obligation to pay the Company Royalty Payments; or (iii) indemnity payments, recoveries, damages, settlement or other amounts to which Sellers are or may become entitled to pursuant to or in connection with the BMS Agreement, Gilead Agreement or UroGen Agreement, as applicable, or any Licensed Patent thereunder, whether based on actual or alleged infringement, breach, default or other circumstance, in each case described in this clause (iii) to the extent such infringement, breach, or other circumstance has resulted or would result in a reduction in, or such payment is made in lieu of, Company Royalty Payments; and (e) all proceeds (including any damages, monetary awards or other amounts recovered, whether by judgment or settlement) paid, owed, accrued or otherwise payable with respect to any of the foregoing of any suit, proceeding or other legal action taken to enforce the right to receive any of the foregoing (other than amounts awarded or recovered in connection with any judgment or settlement for reimbursement of the costs and expenses (including attorneys’ fees) of the party bringing such suit or proceeding or taking such other legal action). For the avoidance of doubt, Covered Company License Royalties shall include all royalty payments due, payable or paid to the Company or its Affiliates by one or more licensees or sublicensees pursuant to any New Arrangement with respect to a Licensed Product.

“Covered Royalty Fund License Royalties” shall mean without duplication, (a) one hundred percent (100%) of all royalties paid, owed, accrued or otherwise payable after the Closing by Incyte pursuant to Section 7.6 of the Incyte Agreement with respect to Net Sales of any applicable Licensed Product thereunder, (b) all royalties paid, owed, accrued or otherwise payable after the Closing by Merck pursuant to Section 5.5 of the Merck Agreement with respect to Net Sales of any applicable Licensed Product thereunder (collectively (a) and (b) are hereinafter referred to as “Royalty Fund Royalty Payments”), (c) any sums accrued, paid or due, other than Royalty Fund Royalty Payments, that are (i) in lieu of the Royalty Fund Royalty Payments (which shall not consist of securities without Purchaser’s prior written consent); (ii) in satisfaction of the obligation to pay the Royalty Fund Royalty Payments; or (iii) indemnity payments, recoveries, damages, settlement or other amounts to which Sellers are or may become entitled to pursuant to or in connection with the Incyte Agreement or the Merck Agreement, as applicable, or any Licensed Patent thereunder, whether based on actual or alleged infringement, breach, default or other circumstance, in each case described in this clause (iii) to the extent such infringement, breach, or other circumstance has resulted or would result in a reduction in, or such payment is made in lieu of, Royalty Fund Royalty Payments; and (d) all proceeds (including any damages, monetary awards or other amounts recovered, whether by judgment or settlement) paid, owed, accrued or otherwise payable with respect to any of the foregoing of any suit, proceeding or other legal action taken to enforce the right to receive any of the foregoing (other than amounts awarded or recovered in connection with any judgment or settlement for reimbursement of the costs and expenses (including attorneys’ fees) of the party bringing such suit or proceeding or taking such other legal action). [***].

“Covered Products” means the Company Products and the Licensed Products.

“Co-Investment Vehicle” has the meaning set forth in Section 5.21(b).

“Defaulting Party” has the meaning set forth in Section 5.5(d).

“Disclosing Party” has the meaning set forth in Section 8.1.

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“Disclosure Schedule” means the Disclosure Schedule, dated as of the date hereof and attached hereto as Exhibit C.

“Disposition” or “Dispose” means, with respect to any Person, directly or indirectly, the sale, assignment, conveyance, transfer, license, sublicense or other disposition (whether in a single transaction or a series of related transactions) (including by way of a sale and leaseback transaction) of property or assets by any Person.

“Disputes” has the meaning set forth in Section 3.11(h).

“Dollar” or the sign “$” means United States dollars.

“Equity Interests” means, with respect to any Person, all of the (i) shares of capital stock of (or other ownership or profit interests in) such Person, (ii) warrants, options or other rights for the purchase or acquisition from such Person of shares of capital stock of (or other ownership or profit interests in) such Person, (iii) securities convertible into or exchangeable for shares of capital stock of (or other ownership or profit interests in) such Person or warrants, rights or options for the purchase or acquisition from such Person of such shares (or such other interests), and (iv) other ownership or profit interests in such Person (including partnership, member, membership or trust interests therein), whether voting or nonvoting, and whether or not such shares, warrants, options, rights or other interests are outstanding on any date of determination.

“Excluded Liabilities and Obligations” has the meaning set forth in Section 2.5.

“Existing Confidentiality Agreement” means that certain letter agreement, dated May 24, 2023, by and between the Company and Purchaser.

“Exploit” and “Exploitation” shall mean, with respect to a product such as a Licensed Product or the Company Product, the research, study, development, formulation, processing, engineering, manufacture, testing, use, sale, offer for sale (including marketing and promotion), sale and distribution (including importing, exporting, transporting, customs clearance, warehousing, invoicing, handling and delivering) or other commercialization of such product.

“FDA” means the U.S. Food and Drug Administration and any successor agency thereto.

“Field” means all uses, including the prevention, treatment or control of any disease, disorder or condition.

“First Commercial Sale” means, with respect to the Company Product, the first sale for end use or commercial consumption of the Company Product. For the avoidance of doubt, disposal of any Company Product for, or use of any Company Product in, clinical trials, as free samples, or under compassionate use, patient assistance, named patient or test marketing programs or non-registrational studies or other similar programs or studies where Company Product is supplied or delivered without charge, shall not constitute a First Commercial Sale, nor shall any Company Product donated to non-profit institutions or government agencies for a non-commercial purpose shall constitute a First Commercial Sale. Similarly, no free Company Product that is supplied to a Third Party in conjunction with the offer for sale, or sale of any Company Product (such free Company Product being in an amount customary in the industry) will result in a First Commercial Sale, nor will the use of any Company Product by Company or one of its Affiliates or sublicensees for research and development purposes constitute a First Commercial Sale.

“Funding Commitment” has the meaning set forth in Section 5.21(a).

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“Gilead” means Gilead Sciences, Inc., a Delaware corporation, its Affiliates and any successors in interest and assigns under the Gilead Agreement.

“Gilead Agreement” means that certain Option and License Agreement (AGEN2373), dated as of December 20, 2018, by and between the Company and Gilead, as amended from time to time (but subject to the terms of this Agreement with respect to the amendment thereof).

“Gilead Option Fee Portion” means $[***], to the extent that Gilead exercises its option under Section 9.2 of the Gilead Agreement.

“GAAP” means generally accepted accounting principles in effect in the United States from time to time.

“Governmental Authority” means the government of the United States, any other nation or any political subdivision thereof, whether state or local, and any agency, authority (including supranational authority), commission, instrumentality, regulatory body, court, central bank or other Person exercising executive, legislative, judicial, taxing, regulatory or administrative powers or functions of or pertaining to government, including each Patent Office, the FDA and any other government authority in any country.

“Indebtedness” of any Person means (a) any obligation of such Person for borrowed money, (b) any obligation of such Person evidenced by a bond, debenture, note or other similar instrument, (c) any obligation of such Person to pay the deferred purchase price of property or services [***], (d) any obligation of such Person as lessee under a capital lease (under GAAP as in effect on the date hereof), (e) any obligation of such Person to purchase securities or other property that arises out of or in connection with the sale of the same or substantially similar securities or property, (f) any non-contingent obligation of such Person to reimburse any other Person in respect of amounts paid under a letter of credit or other guaranty issued by such other Person, (g) any Indebtedness of others secured by a Lien on any asset of such Person, and (h) any Indebtedness of others guaranteed by such Person; provided that intercompany loans among the Company and its Affiliates shall not constitute Indebtedness.

“Incyte” means Incyte Europe Sarl, a Swiss limited liability company, its Affiliates and any successors-in-interest and assigns under the Incyte Agreement.

“Incyte Agreement” means that certain License, Development and Commercialization Agreement dated as of January 9, 2015, by and between Incyte and Company, as amended effective February 14, 2017, as further amended effective October 25, 2019, and as may be further amended from time to time (but subject to the terms of this Agreement with respect to the amendment thereof), together with the following letter agreements: letter dated November 6, 2015, Side Letter No. 1 dated February 2, 2016, Side Letter No. 2 dated April 20, 2016 and Side Letter No. 3 dated December 21, 2017.

“In-License” means each license, settlement agreement or other agreement or arrangement between the Company or any of its Affiliates and any Third Party pursuant to which the Company or any of its Affiliates obtains a license or sublicense or a covenant not to sue or similar grant of rights to any patents or other intellectual property rights of such Third Party that is necessary for the Exploitation of a Covered Product.

“Intellectual Property Rights” means any and all of the following: (a) the Patents, (b) all Know-How and all registered and unregistered trademarks, trademark applications, service marks, trade names, logos, packaging design, slogans and internet domain names, in each case, used in, relating to or necessary for the Exploitation of the Covered Products that is owned or controlled by the Sellers, and including, for the avoidance of doubt, all intellectual property licensed to the applicable Counterparty under the Covered License Agreements to the extent used in or necessary for the Exploitation of the Licensed Products.

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“Intercompany License Agreement” means the Intercompany License Agreement, by and between the Company and Product Sub, substantially in the form of Exhibit E attached hereto.

“Knowledge” means, with respect to the Sellers, the actual knowledge, as of the date of this Agreement, of any of the persons identified on Section 1 of the Disclosure Schedule, after due inquiry by each such person of each of his or her direct reports.

“Know-How” means, any and all technical, scientific, regulatory, and other information, results, knowledge, techniques and data, in whatever form and whether or not confidential, patented or patentable, including Inventions, invention disclosures, discoveries, plans, processes, practices, methods, knowledge, trade secrets, know-how, instructions, skill, experience, ideas, concepts, data (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, safety, quality control, and pre-clinical and clinical data), formulae, formulations, compositions, specifications, marketing, pricing, distribution, cost, sales and manufacturing data or descriptions, and all chemical or biological materials and other tangible materials. Know-How does not include any Patent claiming any of the foregoing.

“Licensed Products” means, collectively, (i) “Royalty Bearing Products” as defined in the Incyte Agreement, (ii) “Products” as defined in the Merck Agreement, (iii) “Licensed Products” as defined in the Gilead Agreement, (iv) “Licensed Products” as defined in the UroGen Agreement and (v) “Licensed Products” as defined in the BMS Agreement, in each case, excluding any product for which a notice of termination has been delivered to the Seller on or prior to the date hereof.

“Licensed Product Lockbox Account” means a segregated deposit account of the Company established and maintained at an Account Bank pursuant to an Account Control Agreement for the purpose of receiving proceeds from the sale of Licensed Products.

“LICR” shall mean the Ludwig Institute for Cancer Research Ltd., a non-profit corporation organized under the laws of Switzerland, its Affiliates and any successors-in-interest and assigns under the LICR Agreement.

“LICR 2014 Agreement” shall mean that certain License Agreement dated as of December 5, 2014, by and between LICR and Company, and as may be further amended from time to time in the future.

“LICR 2016 Agreement” shall mean that certain License Agreement dated as of December 5, 2014, by and between LICR and Company, and as may be further amended from time to time in the future.

“LICR Agreements” means, collectively, the LICR 2014 Agreement and the LICR 2016 Agreement.

“Lien” means any security interest, mortgage, pledge, hypothecation, assignment, deposit arrangement, encumbrance, lien (statutory or otherwise), charge against or interest in property or other priority or preferential arrangement of any kind or nature whatsoever, including any conditional sale or any sale with recourse, or any other restriction on transfer.

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“Loss” means any loss, liability, cost, expense (including reasonable costs of investigation and defense and reasonable attorneys’ fees and expenses), charge, fine, penalty, obligation, judgment, award, assessment, claim or cause of action.

“Major Market” means the [***] and the [***].

“Material Adverse Effect” means a material adverse effect on (a) the legality, validity or enforceability of any of the Transaction Documents, [***] or the Covered License Agreements, (b) the ability of the Seller Parties to perform their obligations under any of the Transaction Documents, [***] or the Covered License Agreements, (c) the rights or remedies of the Purchaser under any of the Transaction Documents or the Covered License Agreements, (d) the right of the Purchaser to receive the Purchased Receivables, the timing, amount or duration of the Purchased Receivables, or the right to receive royalty reports and other information (including audit information) on the terms set forth in the Covered License Agreements and this Agreement, or (e) the business of the Seller Parties and their Subsidiaries, taken as a whole.

“Merck” means Merck Sharp & Dohme Corp., a New Jersey corporation, its Affiliates and any successors-in-interest and assigns under the Merck Agreement.

“Merck Agreement” means that certain License and Research Collaboration Agreement dated as of April 25, 2013, by and between Merck and Company, as amended effective April 25, 2015, and February 6, 2017, and as may be further amended from time to time (but subject to the terms of this Agreement with respect to the amendment thereof).

“Net Sales” means, [***]

“New Arrangement” has the meaning set forth in Section 5.7(a).

“Other Product” means any product that is not a Company Product, but excluding drug delivery vehicles, cytotoxic compounds or other therapeutically active ingredients conjugated, engineered or otherwise linked to a Company Product, adjuvant, excipient or diagnostic compound.

“Out-License” means each license, settlement agreement or other agreement or arrangement between the Company or any of its Affiliates and any Third Party pursuant to which the Company or any of its Affiliates grants a license, sublicense or similar grant of any Intellectual Property Right that is necessary for the Exploitation of a Covered Product.

“Outside Date” has the meaning set forth in Section 9.1(a)(ii).

“Party” shall mean the Seller Parties or the Purchaser, as the context requires, and “Parties” shall mean, together, the Seller Parties and the Purchaser.

“Patent Office” means the applicable patent office, including the United States Patent and Trademark Office and any comparable foreign patent office, for any Intellectual Property Rights that are Patents.

“Patents” means any and all issued patents and pending patent applications, including without limitation, all provisional applications, substitutions, continuations, continuations-in part, divisions, and renewals, all letters patent granted thereon, and all patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms (including regulatory extensions), and all supplementary protection certificates, together with any foreign counterparts thereof anywhere, claiming or covering the Covered Products, or composition of matter, formulation, or methods of manufacture or use thereof, that are issued or filed on or after the date of this Agreement, in each such case, which are owned or controlled by, issued or licensed to, licensed by, or hereafter acquired or licensed by, the Sellers or any of their Affiliates, and including, for the avoidance of doubt, the Patents listed on Section 3.11(a) of the Disclosure Schedule.

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“Payment Direction Letter” means, with respect to each Counterparty, a payment direction letter in form and substance reasonably satisfactory to the Purchaser.

“Payment Direction Letters” means, collectively, the Payment Direction Letters required to be delivered pursuant to this Agreement.

“Permitted Convertible Notes” means unsecured Indebtedness of the Company to be issued in the form of notes that are convertible into a number (subject to customary anti-dilution adjustments, “make whole” increases and other customary changes thereto) of shares of common stock of the Company (or other securities or property following a merger event or other change of the common stock of the Company), cash or any combination thereof (with the amount of such cash or such combination determined by reference to the market price of such common stock or other securities); provided that: [***]

“Permitted Debt” means any of the following Indebtedness of the Company and its Subsidiaries (which, for purposes of determining whether such Indebtedness exceeds any maximum amount provided in the applicable clause below, shall be calculated on a consolidated basis with respect to the Company and its Subsidiaries):

(a) the Indebtedness of the Company and its Subsidiaries existing as of the date hereof and set forth on Schedule 1.2.

(b) Indebtedness under the Transaction Documents;

(c) Indebtedness of the Company and its Subsidiaries in respect of any Permitted Debt Facility;

(d) unsecured Indebtedness to trade creditors incurred in the ordinary course of business;

(e) unsecured intercompany debt between two or more of the Company and its subsidiaries;

(f) guarantees of the Company and its Subsidiaries in respect of Indebtedness and other obligations of the Company and any Subsidiary otherwise expressly permitted hereunder;

(g) Indebtedness incurred by the Company or its Subsidiaries consisting of (i) the financing of the payment of insurance premiums (ii) take or pay obligations contained in supply agreements, in each case, in the ordinary course of business or consistent with past practice, (iii) deferred compensation or equity based compensation to current or former officers, directors, consultants, advisors or employees thereof, in each case in the ordinary course of business and (iv) customer deposits and advance payments received in the ordinary course of business or consistent with past practice from customers for goods or services purchased in the ordinary course of business or consistent with past practice;

(h) Indebtedness owed to any Person providing worker’s compensation, health, disability or other employee benefits or property, casualty or liability insurance to the Company or any Subsidiary incurred in connection with such Person providing such benefits or insurance pursuant to customary reimbursement or indemnification obligations to such Person;

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(i) Indebtedness in respect of performance, indemnity, bid, stay, customs, appeal, replevin and surety bonds, performance and completion guarantees and other similar bonds or guarantees, trade contracts, government contracts and leases, in each case, incurred in the ordinary course of business but excluding guaranties with respect to any obligations for borrowed money;

(j) Indebtedness arising from the honoring by a bank or other financial institution of a check, draft, or similar instrument drawn against insufficient funds in the ordinary course of business or other cash management services in the ordinary course of business provided that such Indebtedness is extinguished within [***] of notification to the Company of its incurrence;

(k) letters of credit, bankers’ acceptances, guarantees or other similar instruments or obligations issued or relating to liabilities or obligations incurred in the ordinary course of business; provided, [***];

(l) judgments, decrees, attachments or awards (to the extent that they would be deemed Indebtedness) that do not constitute an Event of Default;

(m) Indebtedness in the form of (i) guarantees of loans and advances to officers, directors, consultants, managers and employees, in an aggregate amount not to exceed $[***], and (ii) reimbursements owed to officers, directors, managers, consultants and employees of the Company or any Subsidiary for business expenses of the Company or any Subsidiary;

(n) Indebtedness consisting of capitalized lease obligations and purchase money Indebtedness, in each case incurred to finance the acquisition, repair, improvement or construction of fixed or capital assets of such person, provided that the principal amount of such Indebtedness does not exceed the lower of the cost or fair market value of the property so acquired or built or of such repairs or improvements financed with such Indebtedness (each measured at the time of such acquisition, repair, improvement or construction is made); provided, [***];

(o) Indebtedness in respect of hedging agreements; provided, that, [***]

(p) other unsecured Indebtedness not otherwise permitted hereunder, provided that under no circumstances shall the aggregate outstanding principal amount of such Indebtedness permitted shall not exceed $[***]; and

(q) [***].

“Permitted Debt Facility” means an unsecured credit facility provided under the Permitted Convertible Notes.

“Permitted Tax Withholding” means (a) in the case of the Incyte Agreement, any Tax withholding expressly permitted under Section 9.10.2(b) of the Incyte Agreement, (b) in the case of the Merck Agreement, any Tax withholding expressly permitted under Section 5.9.1 of the Merck Agreement, (c) in the case of the Gilead Agreement, any Tax withholding expressly permitted under Section 9.10.2(b) of the Gilead Agreement, (d) in the case of the UroGen Agreement, any Tax withholding expressly permitted under Section 9.8 of the UroGen Agreement, and (e) in the case of the BMS Agreement, any Tax withholding expressly permitted under Section 8.12.2 of the BMS Agreement.

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“Person” means any natural person, firm, corporation, limited liability company, partnership, joint venture, association, joint-stock company, trust, unincorporated organization, Governmental Authority or any other legal entity, including public bodies, whether acting in an individual, fiduciary or other capacity.

“Pledge and Security Agreement” means the Pledge and Security Agreement, substantially in the form of Exhibit D attached hereto.

“Product Application” means an application for Regulatory Approval to research, study, develop, formulate, process, engineer, manufacture, test, use, market, sell, offer for sale and distribute a product or drug in a country or region, including (a) a Biologics License Application, (b) a New Drug Application, (c) an Investigational New Drug Application, (d) any corresponding foreign application in any country or jurisdiction in the world, and (e) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.

“Product Rights” means any and all of the following, as they exist throughout the Territory: (a) Intellectual Property Rights, (b) regulatory filings, submissions and approvals, with or from any Regulatory Agencies with respect to any of the Covered Products, including all Product Applications, (c) In-Licenses and (d) Out-Licenses.

“Product Sub” has the meaning set forth in the preamble.

“Purchase Price” means $75,000,000.

“Purchased Company Receivables” means, (a) the Gilead Option Fee Portion and the Applicable Percentage of the Covered Company License Milestones, (b) the Applicable Percentage of the Covered Company License Agreement Royalties, (c) the Company Product Revenue Payments, and (d) in the case of each of (a), (b) and (c), all “accounts” ( as such term is defined in the UCC) of Company with respect to the Covered Company License Milestones, the Covered Company License Royalties and the Company Product Revenue Payments. For the avoidance of doubt, Purchased Company Receivables shall be calculated without giving effect to any outbound amounts paid, owed, accrued or otherwise payable by Company or its Affiliates under the LICR Agreements or the Selexis Agreements.

“Purchased Receivables” means, collectively, the Purchased Royalty Fund Receivables and the Purchased Company Receivables.

“Purchased Royalty Fund Receivables” means, (a) the Applicable Percentage of the Covered Royalty Fund License Milestones (without giving effect to any outbound royalties paid, owed, accrued or otherwise payable by Royalty Fund, the Company or their Affiliates to LICR under the LICR 2014 Agreement), (b) the Applicable Percentage of the Covered Royalty Fund License Royalties and (c) in the case of each of (a) and (b), all “accounts” (as such term is defined in the UCC) of Royalty Fund with respect to the Covered Royalty Fund License Milestones and the Covered Royalty Fund License Royalties. For the avoidance of doubt, Purchased Royalty Fund Receivables shall be calculated without giving effect to any outbound amounts paid, owed, accrued or otherwise payable by Royalty Fund, the Company or its Affiliates under the LICR Agreements or the Selexis Agreements.

“Purchaser” has the meaning set forth in the preamble.

“Purchaser Account” has the meaning set forth in Section 5.4(b).

“Purchaser Connection Tax” means any Tax to the extent that it would not be imposed but for (i) Purchaser being organized in or having a permanent establishment (or otherwise actively conducting a business in) in (other than in connection arising from this Agreement and/or any transactions contemplated hereby) the jurisdiction of the applicable taxing authority or (ii) any failure of the Purchaser to provide any applicable documentation that is reasonably requested by the applicable withholding agent and that the Purchaser is legally eligible to provide.

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“Purchaser Expenses” means all documented third-party expenses incurred by the Purchaser in connection with the transactions contemplated by this Agreement on or prior to the Closing.

“Purchaser Indemnified Party” has the meaning set forth in Section 7.1.

“Purchaser Indemnified Tax” means any withholding Tax (other than a Purchaser Connection Tax and, except as provided below, a Permitted Tax Withholding) withheld by any licensee, sublicensee, the Sellers, or any other applicable withholding agent in respect of any payment made to the Purchaser pursuant to this Agreement or to Sellers (or their Affiliates) that are attributable to the Purchased Company Receivables; provided that notwithstanding the foregoing, Purchaser Indemnified Tax shall include any tax resulting from or attributable any action taken or caused to be taken by Sellers or their Affiliates or any failure of such Persons to provide any information that is necessary to establish an exemption or reduction from such Permitted Tax Withholding that such Person is legally eligible to deliver, after the effective date hereof, that results in any additional withholding or deduction, which would not have resulted absent Seller or any of its Affiliates taking, causing to be taken, or failing to take such action.

“Qualified Party” means: (i) a pharmaceutical or biotech company with (a) annual revenue for its most recently completed fiscal year of at least $[***]and (b) a market capitalization or enterprise value (as determined in good faith by the Company) in excess of $[***] at the time of determination; or (ii) any other Person designated as such in writing by the Purchaser.

“Receiving Party” has the meaning set forth in Section 8.1.

“Regulatory Agency” means a Governmental Authority with responsibility for the approval, permission or allowance of the research, study, development, formulation, processing, engineering, manufacturing, testing, use, marketing and sale or offering for sale of pharmaceuticals or other regulation of pharmaceuticals in any country.

“Regulatory Approval” means, collectively, all regulatory approvals, licenses, permissions, allowances, registrations, certificates, authorizations, permits and supplements thereto, as well as associated materials (including the product dossier) pursuant to which the Covered Products may be researched, studied, developed, formulated, processed, engineered, manufactured, tested, used, marketed, sold, offered for sale and distributed by Counterparties or the Company, as the case may be, in a jurisdiction, issued by the appropriate Regulatory Agency, including, to the extent required by Applicable Law for the sale of the Covered Product, all pricing approvals and pricing restrictions, and governmental reimbursement approvals and restrictions.

“Royalty Payment Date” has the meaning set forth in Section 2.3(a).

“Royalty Reduction” has the meaning set forth in Section 3.14(f).

“Royalty Reports” means, collectively, means (a) in the case of the Incyte Agreement, the reports required under Section 7.7 of the Incyte Agreement, (b) in the case of the Merck Agreement, the reports required under Section 5.6 of the Merck Agreement, (c) in the case of the BMS Agreement, the reports required under Section 8.10 of the BMS Agreement, (d) in the case of the Gilead Agreement, the reports required under Section 9.9 of the Gilead Agreement and (e) in the case of the UroGen Agreement, the reports required under Section 9.6 of the UroGen Agreement.

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“Royalty Fund” has the meaning set forth in the preamble.

“SEC” means the U.S. Securities and Exchange Commission.

“Security Agreement” shall mean the Security Agreement by and among the Company, Royalty Fund and the Purchaser, substantially in the form of Exhibit G.

“Security Agreements” means the Security Agreement and the BOT/BAL Security Agreement.

“Security Release Event” shall mean that the Company has achieved a [***]

“Selexis Agreements” means, [***]

“Seller” and “Sellers” have the meaning set forth in the preamble.

“Sellers Account” has the meaning set forth in Section 5.4(d).

“Seller Indemnified Party” has the meaning set forth in Section 7.2.

“Set-off” means any set-off or off-set.

[***]

“Step-Down Event” [***]

“Subsidiary” means, with respect to any Person, any other Person of which more than 50% of the outstanding Equity Interests of such other Person (irrespective of whether at the time Equity Interests of any other class or classes of such other Person shall or might have voting power upon the occurrence of any contingency) is at the time directly or indirectly owned or controlled by such Person, by such Person and one or more other Subsidiaries of such Person or by one or more other Subsidiaries of such Person. For purposes of this Agreement, all representations and warranties in Article III related to MiNK are given to the best of Sellers’ Knowledge, and all covenants herein that are applicable to MiNK shall only apply to this Agreement to the extent that any such action or inaction required under a covenant contemplated is within the control of the Company.

“Syndication Period” has the meaning set forth in Section 5.21(a).

“Tax” or “Taxes” means any U.S. federal, state, local or non-U.S. income, gross receipts, license, payroll, employment, excise, severance, occupation, premium, windfall profits, environmental, customs duties, capital stock, franchise, profits, withholding, social security, unemployment, disability, real property, personal property, escheat or unclaimed property, sales, use, value added, alternative or add-on minimum, estimated or other tax of any kind whatsoever, including, in each case, (a) any interest, penalty or addition thereto and (b) whether disputed or not.

“Territory” means worldwide.

 

“Third Party” means any Person that is not a Party.

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“Third Party Claim” means any claim, action, suit or proceeding by a Third Party, including any investigation by any Governmental Authority.

“Transaction Documents” means this Agreement, the Account Control Agreements, the Security Agreements, the Contribution Agreement, the Pledge and Security Agreement, the XOMA Consent, the Closing Date Bills of Sale, and the Payment Direction Letters.

“Transferred Assets” has the meaning set forth in the Contribution Agreement.

“UCC” means the Uniform Commercial Code as in effect from time to time in the State of Delaware; provided, that if, with respect to any financing statement or by reason of any provisions of law, the perfection or the effect of perfection or non-perfection of the back-up security interest or any portion thereof granted pursuant to Section 2.1(d) is governed by the Uniform Commercial Code as in effect in a jurisdiction of the United States other than the State of Delaware, then “UCC” means the Uniform Commercial Code as in effect from time to time in such other jurisdiction for purposes of the provisions of this Agreement and any financing statement relating to such perfection or effect of perfection or non-perfection.

“UroGen” means UroGen Pharma Ltd., a company organized under the laws of the State of Israel, its Affiliates and any successors in interest and assigns under the UroGen Agreement.

“UroGen License Agreement” means that certain License Agreement (AGEN1884), dated as of November 8, 2019, by and between the Company and UroGen, as amended from time to time (but subject to the terms of this Agreement with respect to the amendment thereof).

“U.S.” or “United States” means the United States of America, its 50 states, each territory thereof and the District of Columbia.

“XOMA” means XOMA (US) LLC, a Delaware limited liability company.

“XOMA Agreement” means that certain Royalty Purchase Agreement, dated as of September 20, 2018 by and among Company, Royalty Fund and XOMA.

“XOMA Consent” means the consent from XOMA with respect to the transactions contemplated by this Agreement, attached hereto at Exhibit L.

“XOMA Escrow Agreement” means that certain Escrow Agreement, among XOMA, Royalty Fund and The Bank of New York Mellon, dated as of December 5, 2019.

Section 1.2 Rules of Construction.

(a) Unless the context otherwise requires, in this Agreement:

(i) a term has the meaning assigned to it and an accounting term not otherwise defined has the meaning assigned to it in accordance with GAAP;

(ii) unless otherwise defined, all terms that are defined in the UCC shall have the meanings stated in the UCC;

(iii) words of the masculine, feminine or neuter gender shall mean and include the correlative words of other genders; (iv) the terms “include,” “including” and similar terms shall be construed as if followed by the phrase “without limitation”;

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(v) unless otherwise specified, references to a contract or agreement include references to such contract or agreement as from time to time amended, restated, reformed, supplemented or otherwise modified in accordance with its terms (subject to any restrictions on such amendments, restatements, reformations, supplements or modifications set forth herein), and include any annexes, exhibits and schedules hereto or thereto, as the case may be;

(vi) any reference to any Person shall be construed to include such Person’s successors and assigns (subject to any restrictions on assignment, transfer or delegation set forth herein or in any of the other Transaction Document) and any reference to a Person in a particular capacity excludes such Person in other capacities;

(vii) references to any Applicable Law shall include such Applicable Law as from time to time in effect, including any amendment, modification, codification, replacement, or reenactment thereof or any substitution therefor;

(viii) the word “will” shall be construed to have the same meaning and effect as the word “shall”;

(ix) the words “hereof,” “herein,” “hereunder” and similar terms shall refer to this Agreement as a whole and not to any particular provision hereof, and Article, Section and Exhibit references herein are references to Articles and Sections of, and Exhibits to, this Agreement unless otherwise specified;

(x) the definitions of terms shall apply equally to the singular and plural forms of the terms defined;

(xi) in the computation of a period of time from a specified date to a later specified date, the word “from” means “from and including” and each of the words “to” and “until” means “to but excluding”; and

(xii) where any payment is to be made, any funds are to be applied or any calculation is to be made under this Agreement on a day that is not a Business Day, unless this Agreement otherwise provides, such payment shall be made, such funds shall be applied and such calculation shall be made on the succeeding Business Day, and payments shall be adjusted accordingly.

(b) The provisions of this Agreement shall be construed according to their fair meaning and neither for nor against any Party irrespective of which Party caused such provisions to be drafted. Each Party acknowledges that it has been represented by an attorney in connection with the preparation and execution of this Agreement and the other Transaction Documents.

ARTICLE IIPURCHASE AND SALE OF THE PURCHASED RECEIVABLES

Section 2.1 Purchase and Sale.

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(a) Subject to the terms and conditions of this Agreement, on the Closing Date, (i) Company hereby sells, contributes, assigns, transfers, conveys and grants to the Purchaser, and the Purchaser hereby purchases, acquires and accepts from Company, all of Company’s rights, title and interest in and to the Purchased Company Receivables, free and clear of any and all Liens, other than those Liens created under the Transaction Documents, and (ii) Royalty Fund hereby sells, contributes, assigns, transfers, conveys and grants to the Purchaser, and the Purchaser hereby purchases, acquires and accepts from Royalty Fund, all of Royalty Fund’s rights, title and interest in and to the Purchased Royalty Fund Receivables, free and clear of any and all Liens, other than those Liens created under the Transaction Documents.

(b) The Sellers and the Purchaser intend and agree that the sale, contribution, assignment, transfer, conveyance and granting of the Purchased Receivables under this Agreement shall be, and are, a true, complete, absolute and irrevocable assignment and sale by the Sellers to the Purchaser of the Purchased Receivables (including for U.S. federal income tax purposes) and that such assignment and sale shall provide the Purchaser with the full benefits of ownership of the Purchased Receivables. Neither the Sellers nor the Purchaser intends the transactions contemplated hereby to be, or for any purpose (including U.S. federal income tax purposes) characterized as, a loan from the Purchaser to the Sellers or a pledge or assignment or a security agreement. The Sellers waive any right to contest or otherwise assert that this Agreement does not constitute a true, complete, absolute and irrevocable sale and assignment by the Sellers to the Purchaser of the Purchased Receivables under Applicable Law, which waiver shall be enforceable against the Sellers in any Bankruptcy Event in respect of the Sellers. The sale, assignment, transfer, conveyance and granting of the Purchased Receivables shall be reflected on the Company’s financial statements and other records as a sale of assets to the Purchaser (except to the extent GAAP or the rules of the SEC require otherwise with respect to the Sellers’ consolidated financial statements).

(c) The Sellers hereby authorize the Purchaser and its agents and representatives to execute, record and file, and consents to the Purchaser and its agents and representatives executing, recording and filing, at the Purchaser’s sole cost and expense, financing statements in the appropriate filing offices under the UCC (and continuation statements with respect to such financing statements when applicable), and amendments thereto, in such manner and in such jurisdictions as are necessary or appropriate to evidence or perfect the sale, assignment, transfer, conveyance and grant by the Sellers to the Purchaser, and the Purchaser’s first priority security interest in and to all of the Sellers’ right, title and interest in, to and under the Purchased Receivables.

(d) Notwithstanding that the Sellers and the Purchaser expressly intend for the sale, assignment, transfer, conveyance and granting of the Purchased Receivables to be a true, complete, absolute and irrevocable sale and assignment, the Sellers hereby assigns, conveys, grants and pledges to the Purchaser, as security for their obligations created hereunder in the event that the transfer of the Purchased Receivables contemplated by this Agreement is held not to be a sale, a first priority security interest in and to all of the Sellers’ right, title and interest in, to and under the Purchased Receivables and, in such event, this Agreement shall constitute a security agreement.

Section 2.2 Payment of the Purchase Price. In full consideration for the sale, transfer, conveyance and granting of the Purchased Receivables, and subject to the terms and conditions set forth herein, at the Closing, Purchaser shall pay to the Sellers an amount equal to Purchase Price minus the Purchaser Expenses, in immediately available funds by wire transfer to the Sellers Account (the “Closing Payment”). Sellers and Purchaser agree to work together to develop within two (2) days prior to Closing a mutually agreeable funds flow that reflects the Closing Payment (i.e., the Purchase Price), the Purchase Expenses and any other payments to be made directly out of the Closing Payment.

Purchaser shall have the right at any time on or prior to [***] to increase the amount of its investment by up to $25 million (the “Purchaser Upsize Option”) by delivering notice of such investment to the Company 10 days prior to Purchaser’s desired funding date. If the Purchaser Upside Option is exercised, the Sellers and Purchaser agree to amend this Agreement, substantially concurrently with the closing of such additional investment, to (a) increase the Purchase Price by the amount of such additional funding, (b) proportionately increase the Applicable Percentages based on the amount of such additional funding, (c) proportionately increase the amount of the Gilead Option Fee Portion and (d) such other changes as are necessary to account for the additional investment amount.

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Section 2.3 Payment of Purchased Receivables to Purchaser.

(a) In consideration of the Purchaser paying the Purchase Price hereunder from time to time pursuant to this Agreement, the Company shall pay to the Purchaser, by wire transfer of immediately available funds in U.S. dollars to the Purchaser Account, without any setoff or offset (subject, in each case, to Section 5.10), the Company Product Revenue Payments for each calendar quarter (commencing with the calendar quarter beginning April 1, 2024) promptly, but in any event no later than [***] (each such date, a “Royalty Payment Date”).

(b) A late fee of [***] (calculated on a per annum basis) will accrue on all unpaid amounts with respect to any Company Product Revenue Payment from the applicable Royalty Payment Date. The imposition and payment of a late fee shall not constitute a waiver of the Purchaser’s rights with respect to such payment default. Such accrued late fee will be compounded annually. Payment of such accrued late fee shall accompany payment of the outstanding Royalty Payment.

(c) On or prior to each Royalty Payment Date, the Company shall provide to the Purchaser a written report pursuant to Section 5.1(c).

Section 2.4 Payment Direction Letters.

(a) At the Closing, the Company shall deliver to each Counterparty (other than Merck and Incyte) a duly executed Payment Direction Letter in accordance with the notice provisions of the applicable Covered License Agreement and also by e-mail (with the Payment Direction Letter attached thereto as a PDF attachment), and such e-mail shall include a request that each such Counterparty confirm receipt thereof by e-mail reply. The Sellers shall not amend any Payment Direction Letter or deliver any subsequent payment direction or instruction letter to a Counterparty without the prior written consent of the Purchaser (not to be unreasonably withheld, conditioned or delayed).

(b) As promptly as practicable following the Closing, the Sellers shall use their reasonable best efforts to cause that certain Escrow Agreement, among XOMA, Royalty Fund and The Bank of New York Mellon, dated as of December 5, 2019 (the “XOMA Escrow Agreement”) to be amended to, among other things, (x) add the Purchaser, as a party, (y) provide for Purchaser to receive Purchased Royalty Fund Receivables directly from the escrow account and (z) such other changes as are mutually agreed by Agenus and Purchaser. If, notwithstanding the foregoing, the Sellers are unable to cause such an amendment to the XOMA Escrow Agreement prior to October 1, 2024, the Sellers and the Purchaser shall work in good faith to secure alternative direct payment mechanics to the Purchaser of the Purchased Royalty Fund Receivables. Prior to any such amendment or alternative payment mechanics, all amounts received by Sellers out of the XOMA Escrow Account shall flow into the Lockbox Account, once established pursuant to Section 6.4. The Sellers shall indemnify the Purchaser for any delays in receipt of any Purchased Royalty Fund Receivables as a result of amounts held up in the escrow account established by the XOMA Escrow Agreement to the extent any such delayed disbursements are a result of any disputes or disagreements between the Sellers and XOMA or other reasons unrelated to the Purchaser.

Section 2.5 No Assumed Obligations. Notwithstanding any provision in this Agreement or any other writing to the contrary, the Purchaser is purchasing, acquiring and accepting only the Purchased Receivables and is not assuming any liability or obligation of the Sellers or any of the Sellers’ Affiliates of whatever nature, whether presently in existence or arising or asserted hereafter, including any liability or obligation of the Sellers under the Covered License Agreements.

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All such liabilities and obligations shall be retained by, and remain liabilities and obligations of, the Sellers or the Sellers’ Affiliates, as the case may be (the “Excluded Liabilities and Obligations”).

Section 2.6 Excluded Assets. The Purchaser does not, by purchase, acquisition or acceptance of the right, title or interest granted hereunder or otherwise pursuant to any of the Transaction Documents, purchase, acquire or accept any assets or contract rights of the Sellers under any of the Covered License Agreements, other than the Purchased Receivables, or any other assets of the Sellers.

ARTICLE IIIREPRESENTATIONS AND WARRANTIES OF THE SELLER PARTIES

Except as set forth on the Disclosure Schedule, the Seller Parties, jointly and severally, hereby make each of the following representations and warranties to the Purchaser as of the date hereof and as of the Closing Date:

Section 3.1 Organization.

(a) The Company is a corporation duly incorporated, validly existing and in good standing under the laws of the State of Delaware and has all corporate power and authority, and all licenses, permits, registrations, franchises, authorizations, consents and approvals of all Governmental Authorities, required to own its property and conduct its business, as now conducted, and to exercise its rights and to perform its obligations under the Covered License Agreements, the LICR Agreements, the Selexis Agrements and the XOMA Agreement. The Company is duly qualified to transact business and is in good standing in every jurisdiction in which such qualification or good standing is required by Applicable Law (except where the failure to be so qualified or in good standing would not have a Material Adverse Effect).

(b) Royalty Fund is a limited liability company duly organized, validly existing and in good standing under the laws of the State of Delaware and has all limited liability company power and authority, and all licenses, permits, franchises, authorizations, consents and approvals of all Governmental Authorities, required to own its property and conduct its business, as now conducted, and to exercise its rights and to perform its obligations under the Merck Agreement, the Incyte Agreement and the XOMA Agreement.

(c) Product Sub is a limited liability company duly organized, validly existing and in good standing under the laws of the State of Delaware and has all limited liability company power and authority, and all licenses, permits, franchises, authorizations, consents and approvals of all Governmental Authorities, required to own its property and conduct its business, as now conducted, and to exercise its rights and to perform its obligations under the LICR Agreements.

(d) The Seller Parties are duly qualified to transact business and is in good standing in every jurisdiction in which such qualification or good standing is required by Applicable Law (except where the failure to be so qualified or in good standing would not have a Material Adverse Effect).

(e) Neither MiNK Therapeutics, Inc., SaponiQx, Inc. or any of their respective subsidiaries has any ownership interest in, or assets relating to, the Covered Products.

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Section 3.2 No Conflicts.

(a) Except as set forth on Section 3.2(a) of the Disclosure schedules, the execution and delivery by the Seller Parties of any of the Transaction Documents, the performance by the Seller Parties of their obligations hereunder or thereunder or the consummation by the Seller Parties of the transactions contemplated hereby or thereby will not (i) contravene, conflict with or violate any term or provision of any of the organizational documents of the Seller Parties or any of their Subsidiaries, (ii) contravene, conflict with or violate, or give any Governmental Authority or other Person the right to exercise any remedy or obtain any relief under, any Applicable Law or any judgment, order, writ, decree, permit or license of any Governmental Authority to which the Seller Parties or any of their Subsidiaries or any of their respective assets or properties may be subject or bound, except as would not have a Material Adverse Effect, (iii) result in a breach or violation of, constitute a default (with or without notice or lapse of time, or both) under, or give any Person the right to exercise any remedy or obtain any additional rights under, or accelerate the maturity or performance of, or payment under, or cancel or terminate, (A) except as would not be reasonably expected to result in a Material Adverse Effect, to any contract, agreement, indenture, lease, license, deed, commitment, obligation or instrument to which the Seller Parties or any of their Subsidiaries is a party or by which the Seller Parties or any of their Subsidiaries or any of their respective assets or properties is bound or committed (other than any Covered License Agreement, the LICR Agreements, the Selexis Agrements and the XOMA Agreement) or (B) any Covered License Agreement, the XOMA Agreement, the Selexis Agreement or the LICR Agreements and (iv) except as provided in any of the Transaction Documents, result in or require the creation or imposition of any Lien on the Intellectual Property Rights, the Covered Products, the Covered License Agreements or the Purchased Receivables.

(b) Except for Liens created under the XOMA Agreement or as set forth on Section 3.2(b) of the Disclosure Schedules, the Seller Parties have not granted, nor does there exist, any Lien on or relating to the Covered License Agreements, the Intellectual Property Rights, or the Covered Products. Except for Liens created under the Transaction Documents and the XOMA Agreement, Seller Parties have neither granted, nor does there exist, any Lien on or relating to the Purchased Receivables. Except for the licenses granted by the Seller Parties to each Counterparty under the Covered License Agreements (and the sublicenses granted thereunder and set forth on Section 3.13(k) of the Disclosure Schedule), there are no licenses, sublicenses or other rights under the Intellectual Property Rights that have been granted by the Seller Parties to any Third Party with respect to the Exploitation of the Licensed Products in the Territory.

Section 3.3 Authorization. The Company has all necessary corporate power and authority to execute and deliver the Transaction Documents, to perform its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby. The execution and delivery of each of the Transaction Documents and the performance by the Company of its obligations hereunder and thereunder have been duly authorized by all necessary corporate action on the part of the Company. Royalty Fund has all necessary limited liability company power and authority to execute and deliver the Transaction Documents, to perform its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby. The execution and delivery of each of the Transaction Documents and the performance by Royalty Fund of its obligations hereunder and thereunder have been duly authorized by all necessary limited liability company action on the part of Royalty Fund. Product Sub has all necessary limited liability company power and authority to execute and deliver the Transaction Documents, to perform its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby. The execution and delivery of each of the Transaction Documents and the performance by Product Sub of its obligations hereunder and thereunder have been duly authorized by all necessary limited liability company action on the part of Product Sub. This Agreement has been, and on or prior to Closing each of the Transaction Documents will be, duly executed and delivered by an authorized officer of the Seller Parties. This Agreement constitutes, and as of the Closing each of the Transaction Documents will constitute, the legal, valid and binding obligation of the Seller Parties, enforceable against the Seller Parties in accordance with their respective terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally, general equitable principles and principles of public policy.

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Section 3.4 Ownership. Except as set forth on Section 3.4 of the Disclosure Schedules, the Seller Parties are collectively the exclusive owner, or exclusive licensee, of the entire right, title (legal and equitable) and interest in, to and under the Purchased Receivables and, solely with respect to the Exploitation of the Company Products, the Intellectual Property Rights. The Purchased Receivables sold, assigned, transferred, conveyed and granted to the Purchaser have not been pledged, sold, assigned, transferred, conveyed or granted by the Sellers to any other Person. The Sellers have full right to sell, assign, transfer, convey and grant the Purchased Receivables to the Purchaser. Upon the sale, assignment, transfer, conveyance and granting by the Sellers of the Purchased Receivables to the Purchaser, the Purchaser shall acquire good and marketable title to the Purchased Receivables free and clear of all Liens, other than those Liens created under the Transaction Documents, and shall be the exclusive owner of the Purchased Receivables.

Section 3.5 Governmental and Third-Party Authorizations. The execution and delivery by the Seller Parties of the Transaction Documents, the performance by the Seller Parties of their respective obligations hereunder and thereunder and the consummation by the Seller Parties of the transactions contemplated hereby and thereby do not require any consent, approval, license, order, authorization or declaration from, notice to, action or registration by, or filing with, any Governmental Authority or any other Person, except for (i) the filing of a Current Report on Form 8-K with the SEC, (ii) the filing of UCC financing statements, (iii) the XOMA Consent, and (iv) the delivery of the Payment Direction Letters to the Counterparties.

Section 3.6 No Litigation.

(a) There is no action, suit, arbitration proceeding, claim, demand, citation, summons, subpoena or other proceeding (whether civil, criminal, administrative, regulatory or informal) (i) pending or, to the Knowledge of the Sellers, threatened by or against the Seller Parties or any of their Subsidiaries or (ii) to the Knowledge of the Sellers, pending or threatened by or against any Counterparty, their Affiliates, or any of their sublicensees, in each case, in respect of the Covered License Agreements, the Intellectual Property Rights, the Covered Products or the Purchased Receivables, at law or in equity, that (i) would reasonably be expected to result in a liability to the Seller Parties in excess of $1,000,000 or (ii) challenges or seeks to prevent or delay the consummation of any of the transactions contemplated by any of the Transaction Documents to which the Seller Parties are party.

(b) There is no inquiry or investigation (whether civil, criminal, administrative, regulatory, investigative or informal) by or before a Governmental Authority (i) pending or, to the Knowledge of the Sellers, threatened against the Seller Parties or any of their Subsidiaries or (ii) to the Knowledge of the Sellers, pending or threatened by or against any Counterparty, in each case in respect of the Covered License Agreements, the Intellectual Property Rights, the Covered Products or the Purchased Receivables that (i) would reasonably be expected to result in a liability to the Seller Parties in excess of $1,000,000 or (ii) challenges or seeks to prevent or delay the consummation of any of the transactions contemplated by any of the Transaction Documents to which the Sellers are party.

(c) To the Knowledge of the Sellers, no event has occurred or circumstance exists that would reasonably be expected to give rise to or serve as a basis for the commencement of any such action, suit, arbitration proceeding, claim, investigation, proceeding, inquiry or investigation referred to in Section 3.6(a) or 3.6(b).

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Section 3.7 Indebtedness; Solvency.

(a) Schedule 3.7(a) sets forth a complete list of all outstanding Indebtedness of the Company and its Subsidiaries (other than MiNK and SaponiQx) in excess of $100,000.

(b) No Bankruptcy Event has occurred with respect to the Company and its Subsidiaries.

(c) Immediately after giving effect to the consummation of the transactions contemplated by the Transaction Documents and the application of the proceeds therefrom, (i) the fair value of the Seller Parties’ assets will be greater than the sum of its debts, liabilities and other obligations, including contingent liabilities, (ii) the present fair saleable value of the Seller Parties’ assets, including, for the avoidance of doubt, the Intellectual Property Rights, will be greater than the amount that would be required to pay its probable liabilities on its existing debts, liabilities and other obligations, including contingent liabilities, as they become absolute and matured in the normal course of business, (iii) the Seller Parties will be able to realize upon its assets and pay its debts, liabilities and other obligations, including contingent obligations, as they mature, (iv) the Seller Parties will have free cash on hand with which to engage in its business as now conducted, (v) the Seller Parties do not have any present plans or intentions to incur debts or other obligations or liabilities beyond its ability to pay such debts or other obligations or liabilities as they become absolute and matured, (vi) the Seller Parties will not have become subject to any Bankruptcy Event and (vii) the Seller Parties will not have been rendered insolvent within the meaning of Section 101(32) of Title 11 of the United States Code. For purposes of this Section 3.7(b), the amount of all contingent obligations at any time shall be computed as the amount that, in light of all facts and circumstances existing at such time, can reasonably be expected to become an actual or matured liability.

Section 3.8 Tax Matters.

(a) No deduction or withholding for or on account of any Tax has been made from any payment to the Seller Parties or any of their Affiliates under any Covered License Agreement. No applicable withholding agent under any Covered License Agreement or any taxing authority has ever notified the Seller Parties that any such withholding was required or would have been required absent the Sellers’ qualification for benefits under an applicable income Tax treaty. Seller Parties have filed (or caused to be filed) all material tax returns and material tax reports required to be filed under Applicable Law and have paid all material taxes required to be paid by them (including, in each case, in its capacity as a withholding agent), except for any such taxes that are being contested in good faith by appropriate proceedings and for which adequate reserves have been provided in accordance with the generally accepted accounting principles applicable to Seller Parties, as in effect from time to time.

(b) There are no existing Liens for Taxes on the Purchased Receivables (or any portion thereof).

(c) Since its formation, each of Royalty Fund and Product Sub has been and will continue to be treated as an entity that is disregarded from the Company for U.S. federal income tax purposes.

Section 3.9 No Brokers’ Fees. The Seller Parties have not taken any action that would entitle any person or entity to any commission or broker’s fee in connection with the transactions contemplated by this Agreement.

Section 3.10 Compliance with Laws. None of the Seller Parties nor any of their Subsidiaries (a) has violated or is in violation of, has been given notice of any violation of, or, to the Knowledge of the Sellers, is under investigation with respect to or has been threatened to be charged with, any material violation of, any Applicable Law or any judgment, order, writ, decree, injunction, stipulation, consent order, permit, registration or license granted, issued or entered by any Governmental Authority or (b) is subject to any judgment, order, writ, decree, injunction, stipulation or consent order issued or entered by any Governmental Authority, in each case, in a manner that would be reasonably expected to materially affect the Covered Products.

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Section 3.11 Intellectual Property Matters.

(a) Section 3.11(a) of the Disclosure Schedule sets forth an accurate and complete list of all issued Patents and pending Patent applications. For each Patent listed on Section 3.11(a) of the Disclosure Schedule the Seller Parties have indicated (i) the countries in which such Patent is pending, allowed, granted or issued, (ii) including a notation of any term extensions, the patent number and/or patent application serial number, (iii) the scheduled expiration date of each such issued Patent, (iv) the expected scheduled expiration date of each Patent issuing from such pending Patent application once issued and (v) the registered owner thereof.

(b) Except as otherwise set forth on Schedule 3.11(a) of the Disclosure Schedule, the Company is the sole and exclusive owner of each of the Patents listed on Section 3.11(a) of the Disclosure Schedule and each of the inventions claimed in such Patents.

(c) To the Knowledge of the Sellers, in each Patent listed on Section 3.11(a) of the Disclosure Schedule, there is at least one valid claim (treating pending claim as if issued) that would be infringed by the Exploitation of the Covered Products, as applicable.

(d) There are no unpaid maintenance or renewal fees payable by the Seller Parties to any Third Party that currently are overdue for any of the Patents. No Patents listed on Section 3.11(a) of the Disclosure Schedule have lapsed or been abandoned, cancelled or expired.

(e) To the Knowledge of the Sellers, each Person who has or has had any rights in or to the Patents, including each inventor named on the Patents, has executed a contract assigning his, her or its entire right, title and interest in and to such Patents and the inventions embodied, described and or claimed therein, to the owner thereof, and each such contract has been duly recorded in each Patent Office wherein it would be necessary or advisable, as determined by the Seller Parties in their commercially reasonable judgement, to document such assignment.

(f) To the Knowledge of the Sellers, each individual associated with the filing and prosecution of the Patents, including the named inventors of the Patents, has complied in all material respects with all applicable duties of candor and good faith in dealing with any Patent Office, including any duty to disclose to any Patent Office all information known by such inventors to be material to the patentability of the Patents (including any relevant prior art), in each case, in those jurisdictions where such duties exist.

(g) Subsequent to the issuance of each Patent, neither the Seller Parties nor, to the Knowledge of the Sellers, any Counterparty, has filed any disclaimer or made or permitted any other voluntary reduction in the scope of such Patent.

(h) There is no pending or, to the Knowledge of the Sellers, threatened opposition, interference, reexamination, injunction, claim, suit, action, citation, summon, subpoena, hearing, inquiry, investigation (by the International Trade Commission or otherwise), complaint, arbitration, mediation, demand, decree or other dispute, disagreement, proceeding or claim (collectively, “Disputes”) challenging the legality, validity, scope, enforceability or ownership of any of the Intellectual Property Rights or that would give rise to any Royalty Reduction against the payments due to the Sellers under the Covered License Agreements.

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To the Knowledge of the Sellers, there are no pending or threatened Disputes by any Counterparty, or their Affiliates or sublicensees, challenging the legality, validity, scope, enforceability or ownership of any of the Intellectual Property Rights or that would give rise to any Royalty Reduction against the payments due to the Sellers under the Covered License Agreements. There are no Disputes by or with any Third Party against the Seller Parties involving any of the Covered Products or, to the Knowledge of the Sellers, any Counterparty or any of its sublicensees involving any of the Licensed Products. The Intellectual Property Rights are not subject to any outstanding injunction, judgment, order, decree, ruling, change, settlement or other disposition of a Dispute. There are no proceedings, other than proceedings in the ordinary course of patent prosecution with respect to the Patents listed on Section 3.11(a) of the Disclosure Schedule.

(i) There is no pending action, suit, proceeding, investigation or claim related to the Covered Products. To the Knowledge of the Sellers, there is no pending action, suit, proceeding, investigation, or claim, related to the Licensed Products. To the Knowledge of the Sellers, there is no threatened action, suit, proceeding, investigation or claim, and, to the Knowledge of the Sellers, no event has occurred or circumstance exists that (with or without notice or lapse of time, or both) would reasonably be expected to give rise to or serve as a basis for any action, suit, proceeding, investigation or claim by any Person that claims that the manufacture, use, marketing, sale, offer for sale, importation or distribution of any Covered Product does or could infringe on any patent or other intellectual property rights of any Third Party or constitute misappropriation of any other Person’s trade secrets or other intellectual property rights.

(j) To the Knowledge of the Sellers, there are no patents issued, and no pending patent applications with claims reasonably likely to issue, owned by any Third Party, that (i) the Counterparties, as applicable, do not have a right to use (A) that would be infringed by Counterparty’s Exploitation of a Licensed Product, as applicable, but for Counterparty’s rights in such patents and patent applications, or (B) that would give rise to any Royalty Reduction against the payments due to the Sellers under the Covered License Agreements or (ii) the Company does not have a right to use that would be infringed by the Company’s Exploitation of a Company Product but for Company’s rights in such patents and patent applications.

(k) To the Knowledge of the Sellers, there is no Person infringing any of the Intellectual Property Rights, and neither of the Sellers has received any notice under any of the Covered License Agreements or put any Person on notice, of actual or alleged infringement of any of the Intellectual Property Rights.

(l) Each of the Sellers and, to the Knowledge of the Sellers, each Counterparty has taken all reasonable precautions to protect the secrecy, confidentiality and/or value of the applicable Know-How.

(m) The Intellectual Property Rights constitute all of the intellectual property owned or licensed by the Seller Parties or any of their Affiliates that is, to the Sellers’ Knowledge, necessary or useful for the manufacture, use or sale of the Covered Products.

(n) No legal opinion concerning or with respect to any Third Party intellectual property rights relating to the Covered Products, including any freedom-to-operate, product clearance, patentability, validity or right-to-use opinion, has been delivered to the Seller Parties.

(o) To the Knowledge of the Sellers, there is no Person who is or claims to be an inventor under any Patent who is not a named inventor thereof and the list of inventors named in each issued and unexpired Patent listed on Section 3.11(a) of the Disclosure Schedule is current and complete.

(p) [***]

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Section 3.12 Regulatory Approval and Marketing.

(a) To the Knowledge of the Sellers, each Counterparty is in compliance with its material obligations to seek, obtain and maintain Regulatory Approval for the Licensed Products to the extent required by the applicable Covered License Agreement.

(b) The Company and its Subsidiaries are in compliance with their material obligations to seek, obtain and maintain Regulatory Approval for the Company Products.

(c) The Company and its Subsidiaries possess all material permits, licenses, registrations and permissions, including Regulatory Approvals from the FDA and other Governmental Authorities required for the conduct of their business as currently conducted and for the development and Exploitation of the Covered Products, and all such permits, licenses, registrations, authorizations and permissions are in full force and effect;

(d) The Company and its Subsidiaries have not received any written communication from any Governmental Authority alleging any failure of the Company or its Subsidiaries to materially comply with any Applicable Laws, including any terms or requirements of any Regulatory Approval and, to the Knowledge of the Sellers, there are no facts or circumstances that are reasonably likely to give rise to any revocation, withdrawal, suspension, hold or clinical hold, cancellation, material limitation, material termination or adverse modification of any Regulatory Approval;

(e) To the Knowledge of the Sellers, none of the officers, directors, employees or, or to the Knowledge of the Sellers, Affiliates of the Company or any Subsidiary involved in any Product Application, has been:

(i) convicted of any crime or engaged in any conduct for which debarment or suspension is authorized by 21 U.S.C. § 335a nor, to the Knowledge of the Sellers, are any debarment proceedings or investigations pending or threatened against the Company or any Subsidiary or any of their respective officers, employees or agents;

(ii) charged, named in a complaint, convicted, or otherwise found liable in any Proceeding that falls within the ambit of 21 U.S.C. § 331, 21 U.S.C. § 333, 21 U.S.C. § 334, 21 U.S.C. § 335a, 21 U.S.C. § 335b, 42 U.S.C. § 1320a - 7, 31 U.S.C. §§ 3729 – 3733, 42 U.S.C. § 1320a-7a, or any other Applicable Law; or

(iii) disqualified or deemed ineligible pursuant to 21 C.F.R. §312.70 or otherwise restricted, in whole or in part, or subject to an assurance.

(f) To the Knowledge of the Sellers, none of the officers, directors, employees or Affiliates of the Company or any Subsidiary or any of their agents or consultants has (A) made an untrue statement of material fact or fraudulent statement to any Regulatory Agency or failed to disclose a material fact required to be disclosed to a Regulatory Agency; or (B) committed an act, made a statement, or failed to make a statement that would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991);

(g) All applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for Regulatory Approval from the FDA or other Governmental Authority for Company Products, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental Authority;

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(h) All preclinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries the results of which have been submitted to any Governmental Authority, including the FDA and its counterparts worldwide, in connection with any request for a Regulatory Approval, are being or have been conducted in compliance in all material respects with all Applicable Laws;

(i) All Company Products and, to the Knowledge of Sellers, all Licensed Products, have since January 1, 2021 been, manufactured, transported and held, in all material respects in accordance with all permits, and Applicable Laws;

(j) Neither the Company nor any Subsidiary has received any written notice from a Governmental Authority that such Governmental Authority, including without limitation the FDA, the Office of the Inspector General of the United States Department of Health and Human Services or the United States Department of Justice has commenced or threatened to initiate any action against the Company or a Subsidiary, any action to enjoin the Company or a Subsidiary, its officers, directors, employees, agents and Affiliates from conducting its business at any facility owned or used by it, or any action for any material civil penalty, injunction, seizure or criminal action; and

(k) Neither the Company nor any Subsidiary has received from the FDA at any time since January 1, 2021, a Warning Letter, Form FDA-483, “Untitled Letter,” notice of an investigation, request for corrective or remedial action, notice of other adverse finding or similar written correspondence or notice alleging violations of Applicable Laws enforced by the FDA or any comparable written correspondence from any other Governmental Authority, in each case, with regard to any Company Product or the research, study, development, formulation, processing, engineering, manufacture, testing, packaging, labeling, storage, handling, holding, transport, distribution, use, sale, offer for sale or promotion thereof.

Section 3.13 In-Licenses.

(a) Except for the LICR Agreements and the Selexis Agreements, (i) there are no In-Licenses and (ii) there are no other contracts, agreements or other arrangements (whether written or oral) to which the Sellers or any of their Subsidiaries is a party or by which any of their respective assets or properties is bound or committed pursuant to which the Sellers or any of their Subsidiaries has rights under any patent or intellectual property rights of any Third Party that are material to the Exploitation of the Covered Products. Attached as Exhibit H-1 are true, correct and complete copies of the LICR Agreements. Attached as Exhibit H-2 are true, correct and complete copies of the Selexis Agreements.

(b) Each of the LICR Agreements is in full force and effect and is the legal, valid and binding obligation of the Sellers and, to the Knowledge of the Sellers, LICR, enforceable against the Sellers and, to the Knowledge of the Sellers, LICR in accordance with its terms, subject, as to enforceability, to bankruptcy, insolvency, reorganization, moratorium or similar laws now or hereafter in effect relating to or affecting creditors’ rights generally, general equitable principles and principles of public policy. The Sellers are not in breach or violation of or in default under any of the LICR Agreements. There is no event or circumstance that, upon notice or the passage of time, or both, would constitute or give rise to any breach or default in the performance of any of the LICR Agreements by the Sellers or, to the Knowledge of the Sellers, LICR.

(c) The Sellers have not waived any rights or defaults under the LICR Agreements or released LICR, in whole or in part, from any of its obligations under any of the LICR Agreements. There are no oral waivers or modifications (or pending requests therefor) in respect of any of the LICR Agreements.

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Neither the Sellers nor LICR has agreed to amend or waive any provision of the LICR Agreements, and the Sellers have not received or submitted any proposal to do so.

(d) No event has occurred that would give the Sellers or, to the Knowledge of the Sellers, LICR, the right to terminate any of the LICR Agreements. The Sellers have not received any notice of an intention by LICR to terminate or breach any of the LICR Agreements, in whole or in part, or challenging the validity or enforceability of any of the LICR Agreements, or alleging that the Sellers or LICR is currently in default of its obligations under any of the LICR Agreements. To the Knowledge of the Sellers, there is and has been no default, violation or breach of LICR under any of the LICR Agreements.

(e) Each of the Selexis Agreements is in full force and effect and is the legal, valid and binding obligation of the Sellers and, to the Knowledge of the Sellers, Selexis, enforceable against the Sellers and, to the Knowledge of the Sellers, Selexis in accordance with its terms, subject, as to enforceability, to bankruptcy, insolvency, reorganization, moratorium or similar laws now or hereafter in effect relating to or affecting creditors’ rights generally, general equitable principles and principles of public policy. The Sellers are not in breach or violation of or in default under any of the Selexis Agreements. There is no event or circumstance that, upon notice or the passage of time, or both, would constitute or give rise to any breach or default in the performance of any of the Selexis Agreements by the Sellers or, to the Knowledge of the Sellers, Selexis.

(f) The Sellers have not waived any rights or defaults under the Selexis Agreements or released Selexis, in whole or in part, from any of its obligations under any of the Selexis Agreements. There are no oral waivers or modifications (or pending requests therefor) in respect of any of the Selexis Agreements. Neither the Sellers nor Selexis has agreed to amend or waive any provision of the Selexis Agreements, and the Sellers have not received or submitted any proposal to do so.

(g) No event has occurred that would give the Sellers or, to the Knowledge of the Sellers, Selexis, the right to terminate any of the Selexis Agreements. The Sellers have not received any notice of an intention by Selexis to terminate or breach any of the Selexis Agreements, in whole or in part, or challenging the validity or enforceability of any of the Selexis Agreements, or alleging that the Sellers or Selexis is currently in default of its obligations under any of the Selexis Agreements. To the Knowledge of the Sellers, there is and has been no default, violation or breach of Selexis under any of the Selexis Agreements.

Section 3.14 Counterparty Agreements.

(a) Except as set forth on the Disclosure Schedule, other than the Transaction Documents, the XOMA Agreement and the Covered License Agreements, (i) there are no Out-Licenses, and (ii) there are no other contract, agreement or other arrangement (whether written or oral) to which the Sellers or any of their Subsidiaries is a party or to the Knowledge of the Sellers by which any of their respective assets or properties is bound or committed that affects or otherwise relates to the Purchased Receivables, the Covered License Agreements or the Intellectual Property Rights with respect to the Exploitation of the Covered Products and that are material to the interest of the Purchaser.

(b) Attached as Exhibits I-1, I-2, I-3, I-4 and I-5 are true, correct and complete copies of the Covered License Agreements. The Sellers have provided to the Purchaser true, correct and complete copies of (i) all Counterparty Royalty Reports and (ii) all material notices and correspondence delivered to the Sellers by the Counterparties or by the Sellers to the Counterparties pursuant to, or relating to, the Covered License Agreements, to the extent permitted by their terms.

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(c) Each of the Covered License Agreements is in full force and effect and is the legal, valid and binding obligation of the Sellers and, to the Knowledge of the Sellers, each Counterparty, enforceable against the Sellers and, to the Knowledge of the Sellers, each Counterparty in accordance with its terms, subject, as to enforceability, to bankruptcy, insolvency, reorganization, moratorium or similar laws now or hereafter in effect relating to or affecting creditors’ rights generally, general equitable principles and principles of public policy. The Sellers are not in breach or violation of or in default under any of the Covered License Agreements. There is no event or circumstance that, upon notice or the passage of time, or both, would constitute or give rise to any breach or default in the performance of any of the Covered License Agreements by the Sellers or, to the Knowledge of the Sellers, any Counterparty.

(d) The Sellers have not waived any rights or defaults under the Covered License Agreements or released any Counterparty, in whole or in part, from any of its obligations under any of the Covered License Agreements. There are no oral waivers or modifications by any Seller (or pending requests therefor) in respect of any of the Covered License Agreements.

(e) No event has occurred that would give the Sellers or, to the Knowledge of the Sellers, any Counterparty, the right to terminate any of the Covered License Agreements or cease paying Purchased Receivables under any of the Covered License Agreements. The Sellers have not received any notice of an intention by any Counterparty to terminate or breach any of the Covered License Agreements, in whole or in part, or challenging the validity or enforceability of any of the Covered License Agreements or the obligation to pay the Purchased Receivables under any of the Covered License Agreements, or alleging that the Sellers or any Counterparty is currently in default of its obligations under any of the Covered License Agreements. To the Knowledge of the Sellers, there is and has been no default, violation or breach of any Counterparty under any of the Covered License Agreements. The Sellers have no intention of terminating any of the Covered License Agreements and has not given any Counterparty any notice of termination of any of the Covered License Agreements, in whole or in part.

(f) Except as provided in the Covered License Agreements, the Sellers are not a party to any agreement providing for any sharing of, or providing for or permitting any right of counterclaim, credit, reduction or deduction by contract or otherwise (a “Royalty Reduction”) or permitting any Set-off against, the Purchased Receivables.

(g) The Sellers have not consented to an assignment by any Counterparty of any of such Counterparty’s rights or obligations under any Covered License Agreement, and the Sellers do not have Knowledge of any such assignment by any Counterparty. Except as contemplated by Section 2.1(a) and Section 2.1(d), the Sellers have not assigned, in whole or in part, nor granted, incurred or suffered to exist any Lien on, the Covered License Agreements or any of the Sellers’ rights, title or interest in or to the Intellectual Property Rights or the Licensed Products in the Territory.

(h) Neither the Sellers nor any Counterparty have made any claim of indemnification under any of the Covered License Agreements.

(i) The Sellers have not exercised their rights to conduct an audit under any of the Covered License Agreements.

(j) To the Knowledge of the Sellers, the Sellers have received all amounts owed to them under the Covered License Agreements.

(k) To the Knowledge of the Sellers, except as set forth in Section 3.13(k) of the Disclosure Schedule, no Counterparty to any Covered License Agreement has granted (and the Sellers have not received any written notice that any such Counterparty has granted) a sublicense to any other Person.

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Section 3.15 UCC Matters. The Company’s exact legal name is, and since 2011 has been, “Agenus Inc.”. The Company’s principal place of business is located in the State of Massachusetts. The Company’s jurisdiction of formation is, and since formation has been, the State of Delaware. Royalty Fund’s exact legal name is, and since formation has been, “Agenus Royalty Fund, LLC”. Royalty Fund’s principal place of business is, and since formation has been, located in the State of Massachusetts. Royalty Fund’s jurisdiction of formation is, and since formation has been, the State of Delaware. Product Sub’s exact legal name is, and since formation has been, “Agenus Holdings 2024, LLC”. Product Sub’s principal place of business is, and since formation has been, located in the State of Massachusetts.

Section 3.16 Set-off and Other Sources of Royalty Reduction. No Counterparty has exercised, and, to the Knowledge of the Sellers, no Counterparty has had the right to exercise, and no event or condition exists that, upon notice or passage of time, or both, would permit any Counterparty to exercise, any Royalty Reduction or Set-off against the Purchased Receivables or any other amounts payable to the Sellers under any of the Covered License Agreements. To the Knowledge of the Sellers, there are no Third Party patents that would provide a basis for a Royalty Reduction. There are no compulsory licenses granted or, to the Knowledge of the Sellers, threatened to be granted with respect to the Intellectual Property Rights with respect to the Exploitation of the Licensed Products in the Territory.

Section 3.17 Margin Stock. The Sellers are not engaged in the business of extending credit for the purpose of buying or carrying margin stock, and no portion of the Purchase Price shall be used by the Sellers for a purpose that violates Regulation T, U or X promulgated by the Board of Governors of the Federal Reserve System from time to time.

ARTICLE IVREPRESENTATIONS AND WARRANTIES OF THE PURCHASER

The Purchaser hereby represents and warrants to the Seller Parties as follows:

Section 4.1 Organization. The Purchaser is a corporation duly organized, validly existing and in good standing under the laws of Delaware.

Section 4.2 No Conflicts. The execution and delivery by the Purchaser of any of the Transaction Documents to which the Purchaser is a party, the performance by the Purchaser of its obligations hereunder or thereunder or the consummation by the Purchaser of the transactions contemplated hereby or thereby will not (i) contravene, conflict with or violate any term or provision of any of the organizational documents of the Purchaser, (ii) contravene, conflict with or violate, or give any Governmental Authority or other Person the right to exercise any remedy or obtain any relief under, in any material respect, any Applicable Law or any judgment, order, writ, decree, permit or license of any Governmental Authority to which the Purchaser or any of its assets or properties may be subject or bound or (iii) result in a breach or violation of, constitute a default (with or without notice or lapse of time, or both) under, or give any Person any right to exercise any remedy, or accelerate the maturity or performance of, in any material respect, any contract, agreement, indenture, lease, license, deed, commitment, obligation or instrument to which the Purchaser is a party or by which the Purchaser or any of its assets or properties is bound or committed.

Section 4.3 Authorization. The Purchaser has all necessary corporate power and authority to execute and deliver the Transaction Documents to which the Purchaser is a party, to perform its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby. The execution and delivery of each of the Transaction Documents to which the Purchaser is a party and the performance by the Purchaser of its obligations hereunder and thereunder have been duly authorized by the Purchaser. Each of the Transaction Documents to which the Purchaser is a party has been duly executed and delivered by the Purchaser.

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Each of the Transaction Documents to which the Purchaser is a party constitutes the legal, valid and binding obligation of the Purchaser, enforceable against the Purchaser in accordance with its respective terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally, and general equitable principles.

Section 4.4 Governmental and Third Party Authorizations. The execution and delivery by the Purchaser of the Transaction Documents to which the Purchaser is a party, the performance by the Purchaser of its obligations hereunder and thereunder and the consummation of the transactions contemplated hereby and thereby do not require any consent, approval, license, order, authorization or declaration from, notice to, action or registration by, or filing with, any Governmental Authority or any other Person, except for (i) the filing of UCC financing statements, (ii) the XOMA Consent, and (iii) the delivery of the Payment Direction Letters to the Counterparties.

Section 4.5 No Litigation. There is no (a) action, suit, arbitration proceeding, claim, demand, citation, summons, subpoena, investigation or other proceeding (whether civil, criminal, administrative, regulatory, investigative or informal) pending or, to the knowledge of the Purchaser, threatened by or against the Purchaser, at law or in equity, or (b) inquiry or investigation (whether civil, criminal, administrative, regulatory, investigative or informal) by or before a Governmental Authority pending or, to the knowledge of the Purchaser, threatened against the Purchaser, that, in any case challenges or seeks to prevent or delay the consummation of any of the transactions contemplated by any of the Transaction Documents.

Section 4.6 Access to Information. The Purchaser acknowledges that it has (a) reviewed such documents and information relating to the Intellectual Property Rights and the Covered Products and (b) had the opportunity to ask questions of, and to receive answers from, representatives of the Sellers concerning the Intellectual Property Rights and the Covered Products, in each case, as it deemed necessary to make an informed decision to purchase, acquire and accept the Purchased Receivables in accordance with the terms of this Agreement. The Purchaser has knowledge, sophistication and experience in financial and business matters that it is capable of evaluating the risks and merits of purchasing, acquiring and accepting the Purchased Receivables in accordance with the terms of this Agreement.

Section 4.7 Funds Available. As of the date hereof, the Purchaser has sufficient funds on hand to satisfy its obligations to pay the Closing Payment due and payable within the time period specified in Section 2.2. The Purchaser acknowledges and agrees that its obligations under this Agreement are not contingent on obtaining financing.

ARTICLE VCOVENANTS

The Parties covenant and agree as follows:

Section 5.1 Books and Records; Notices.
 

(a) The Sellers shall keep and maintain, or cause to be kept and maintained, at all times, full and accurate books and records adequate to reflect accurately (i) all financial information received and all amounts paid or received under the Covered License Agreements in respect of the Purchased Receivables and (ii) all material information (financial and otherwise) in respect of the Exploitation of the Company Products and the Company Product Revenue Payments.

 

(b) On or prior to each Royalty Payment Date, the Company shall prepare and deliver a report to the Company (the “Company Royalty Report”) setting forth in reasonable detail (and in the case of the Covered License Agreements in respect of the Purchased Receivables, solely to the extent the Company receives such information):

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(i) the calculation of Net Sales for the applicable calendar quarter and calendar year to date, on a country-by-country basis within the Territory;

(ii) the calculation of Purchased Company Receivables and Purchased Royalty Fund Receivables for the applicable calendar quarter and calendar year to date, on a country-by-country and Counterparty-by-Counterparty basis within the Territory (including a detailed breakdown of Covered License Milestones and Covered License Royalties);

(iii) for the applicable calendar quarter and calendar year to date, on a Product-by-Product and country-by-country basis within the Territory, of each Covered Product sold by the Company, its Affiliates and, to the extent received from the Counterparty, each Counterparty; and

(iv) for the applicable calendar quarter and calendar year to date, the calculation of the Company Product Revenue Payment payable to the Purchaser; and

(v) with respect to the Company Products, on a Product-by-Product and country-by-country basis within the Territory, the foreign currency exchange rate used to calculate the Company Product Revenue Payment (which shall be the rate of exchange determined in a manner consistent with the Company’s method for calculating rates of exchange in preparation of the Company’s annual financial statements in accordance with GAAP).

Each Company Royalty Report shall be accompanied by the Royalty Reports delivered to the Sellers by the applicable Counterparties, to the extent permitted by the applicable Covered License Agreement.

(c) In addition to the quarterly Company Royalty Reports to be delivered to the Purchaser pursuant to Section 5.1(b), the Company shall, on a semi-annual basis, provide a written update to the Purchaser regarding the Exploitation of the Covered Products, which shall include without limitation (i) all material information and reports received by Sellers from the Counterparties relating to the Exploitation of the Licensed Products to the extent permitted by the applicable Covered License Agreement and (ii) all information relating to the Company’s Exploitation of the Company Products as the Purchase shall reasonably request from time to time. Upon the delivery of such semi-annual update by the Company to the Purchaser, either the Company or the Purchaser may reasonably request to hold one videoconference for the purpose of discussing such semi-annual update. In addition to the foregoing, the Purchaser shall have the right, no more than once per calendar year, to request an in-person meeting at the Company’s office. Any such videoconference or meeting shall be at a mutually agreeable reasonable date and time and shall include an executive officer of each of the Company, the Royalty Fund and the Purchaser. Each of the Company, the Royalty Fund and the Purchaser shall be solely responsible for their own costs and expenses associated with such videoconferences and meetings, including all travel and accommodations.

(d) [***] after receipt by the Seller Parties of (i) (x) notice of the commencement by any Third Party of, or (y) written notice from any Third Party threatening to commence, in either case any action, suit, arbitration proceeding, claim, demand, investigation or other proceeding relating to this Agreement, any of the other Transaction Documents, any Covered License Agreement, the LICR Agreements, the Selexis Agreements, any transaction contemplated hereby or thereby or the Purchased Receivables (in any case other than any notice contemplated in Section 5.1(e)), or (ii) any other correspondence relating to the foregoing, the Seller Parties shall (A) notify the Purchaser in writing of the receipt of such notice or

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correspondence and (B) provide the Purchaser with a written summary of all material details thereof or, to the extent not prohibited by obligations of confidentiality contained in the Covered License Agreements, the LICR Agreements or the Selexis Agreements, respectively, if such notice is in writing, furnish the Purchaser with a copy thereof and any materials reasonably related thereto.

(e) Subject to Sections 5.5(a) and 5.5(b), within [***] after receipt by the Seller Parties of any material written notice, certificate, offer, proposal, correspondence, report or other communication from the applicable Counterparty relating to any Covered License Agreement, the Intellectual Property Rights, the Purchased Receivables, any Licensed Product in the Territory, the LICR Agreements or the Selexis Agreements (in any case, other than any notice contemplated by Section 5.1(b) or 5.1(e)), the Seller Parties shall (i) notify the Purchaser in writing of the receipt thereof and provide the Purchaser with a written summary of all material details thereof and (ii) to the extent not prohibited by obligations of confidentiality contained in the Covered License Agreements, the LICR Agreements or the Selexis Agreements, respectively, furnish the Purchaser with a copy thereof.

(f) The Seller Parties shall provide the Purchaser with written notice within [***] after obtaining Knowledge of any of the following:

(i) the occurrence of any Bankruptcy Event in respect of the Seller Parties;

(ii) any material breach or default by the Seller Parties of or under any material covenant, agreement or other provision of any Transaction Document;

(iii) the Seller Parties, any Counterparty or any other Third Party receiving any notice of audit or regulatory action by Regulatory Agency in the Territory impacting in any material respect any of the Licensed Products or the timing, amount or duration of the Purchased Receivables;

(iv) any representation or warranty made by the Seller Parties in this Agreement or any of the other Transaction Documents (or in any certificate delivered by the Seller Parties to the Purchaser pursuant to this Agreement) shall prove to be untrue, inaccurate or incomplete in any material respect on the date as of which made; or

(v) the occurrence or existence of any change, effect, event, occurrence, state of facts, development or condition that has had, or would reasonably be expected to have, a Material Adverse Effect.

(g) The Seller Parties shall notify the Purchaser in writing [***] to any change in, or amendment or alteration of, the Seller Parties’ (i) legal name, (ii) form or type of organizational structure or (iii) jurisdiction of organization.

(h) The Seller Parties shall notify the Purchaser in writing [***] after becoming aware that any Tax may be required to withheld with respect to any payment under any Covered License Agreement or otherwise to the Purchaser pursuant to the Agreement.

Section 5.2 Public Announcement. No Party shall, and each Party shall cause its Affiliates not to, without the prior written consent of the other Parties (which consent shall not be unreasonably withheld or delayed), issue any press release or make any other public disclosure with respect to this Agreement or any of the other Transaction Documents or any of the transactions contemplated hereby or thereby, except if and to the extent that any such release or disclosure is required by Applicable Law, by the rules and regulations of any securities exchange or market on which any security of such Party may be listed or traded or by any Governmental Authority of competent jurisdiction, in which case, the Party proposing to issue such press release or make such public disclosure shall, to the extent reasonably practicable, (a) provide to the other Parties a copy of such proposed release or disclosure and (b) consider in good faith any comments or changes that the other Party may propose or suggest; provided that a Party may freely make any public disclosure identical to a disclosure previously reviewed by the other Party in accordance with the foregoing clauses (a) and (b).

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Notwithstanding the foregoing, the Purchaser understands and agrees that the Company intends to file with the SEC a Current Report on Form 8-K describing the material terms of the transactions contemplated by this Agreement and the other Transaction Documents and some or all of the Transaction Documents as exhibits thereto or to another filing with the SEC, provided, that the Sellers shall (a) provide to the Purchaser a draft of such filings with the SEC and (b) consider in good faith any comments or changes that the Purchaser may propose or suggest. The Seller Parties and the Purchaser shall jointly prepare a press release for dissemination promptly following the Closing, such press release to be agreed upon by the Purchaser and the Sellers.

Section 5.3 Further Assurances.

(a) Subject to the terms and conditions of this Agreement, each Party shall use commercially reasonable efforts to execute and deliver such other documents, certificates, instruments, agreements and other writings, take such other actions and perform such additional acts under Applicable Law as may be reasonably requested by the other Party and necessary to implement expeditiously the transactions contemplated by, and to carry out the purposes and intent of the provisions of, this Agreement and the other Transaction Documents, including to (i) perfect the sale, contribution, assignment, transfer, conveyance and granting of the Purchased Receivables to the Purchaser pursuant to this Agreement, (ii) perfect, protect, more fully evidence, vest and maintain in the Purchaser good, valid and marketable rights and interests in and to the Purchased Receivables free and clear of all Liens (other than Liens under the Transaction Documents), (iii) create, evidence and perfect the Purchaser’s back-up security interest granted pursuant to Section 2.1(d), and (iv) enable the Purchaser to exercise or enforce any of the Purchaser’s rights under any Transaction Document to which the Purchaser is a party.

(b) The Sellers and the Purchaser shall cooperate and provide assistance as reasonably requested by any other Party, at the expense of such other Party (except as otherwise set forth herein), in connection with any litigation, arbitration, investigation or other proceeding (whether threatened, existing, initiated or contemplated prior to, on or after the Closing Date) to which the other Party, any of its Affiliates or controlling persons or any of their respective officers, directors, managers, employees or controlling persons is or may become a party or is or may become otherwise directly or indirectly affected or as to which any such Persons have a direct or indirect interest, in each case relating to any Transaction Document, the transactions contemplated hereby or thereby or the Purchased Receivables, but in all cases excluding any litigation brought by the Sellers (for themselves or on behalf of any Seller Indemnified Party) against the Purchaser or brought by the Purchaser (in each case, for itself or on behalf of any Purchaser Indemnified Party) against the Sellers.

(c) Each Seller Party shall use its commercially reasonable efforts to comply in all material respects with all Applicable Laws with respect to the Transaction Documents, the Covered License Agreements and the Purchased Receivables, except where compliance therewith is being contested by such Seller in good faith by appropriate proceedings.

(d) The Seller Parties shall not enter into any contract, agreement or other legally binding arrangement (whether written or oral), or grant any right to any other Person, in any case that would reasonably be expected to conflict with the Transaction Documents or serve or operate to limit, circumscribe or alter any of the Purchaser’s rights under the Transaction Documents (or the Purchaser’s ability to exercise any such rights).

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Section 5.4 Payments on Account of the Covered License Milestones and Covered License Royalties.

(a) If, notwithstanding the terms of the Payment Direction Letters and the Account Control Agreements, any Counterparty, any of its Affiliates, any of its sublicensees, or any other Person makes any future payment of the Purchased Receivables to the Sellers or any of their Subsidiaries, then (i) such amount shall be held by the Sellers (or such Subsidiaries) in trust for the benefit of the Purchaser, (ii) the Sellers (or such Subsidiaries) shall have no right, title or interest whatsoever in such portion of such payment and shall not create or suffer to exist any Lien thereon and (iii) the Sellers (or such Subsidiaries) [***], shall remit such portion of such payment to the Purchaser Account pursuant to Section 5.4(b) in the exact form received with all necessary endorsements.

(b) All payments required to be made to the Purchaser pursuant to this Agreement shall be made by wire transfer of immediately available funds, without Set-off or deduction, to the account provided by the Purchaser in writing (or to such other account as the Purchaser shall notify the Sellers in writing from time to time) (the “Purchaser Account”).

(c) If, notwithstanding the terms of the Payment Direction Letters and the Account Control Agreements, any Counterparty, any of its Affiliates, any of its sublicensees or any other Person makes any payment to the Purchaser that does not consist entirely of Purchased Receivables, then (i) the portion of such payment that does not constitute Purchased Receivables shall be held by the Purchaser in trust for the benefit of the Sellers, (ii) the Purchaser shall have no right, title or interest whatsoever in such payment and shall not create or suffer to exist any Lien thereon and (iii) the Purchaser promptly, [***], shall remit such payment to the Sellers Account pursuant to Section 5.4(d) in the exact form received with all necessary endorsements.

(d) The Purchaser shall make all payments required to be made by it to the Sellers pursuant to this Agreement by wire transfer of immediately available funds, without Set-off or deduction to the account set forth on Exhibit G (or to such other account as the Sellers shall notify the Purchaser in writing from time to time) (the “Sellers Account”).

(e) If any Counterparty takes any Set-off against the Purchased Receivables (other than for any prior overpayment of Purchased Receivables actually made to the Purchaser) for any liability, debt or other obligation that the Sellers owe or allegedly owe to such Counterparty then the Sellers shall cause the amount of such Set-off to be paid promptly [***] such Set-off to the Purchaser Account. If such Counterparty subsequently makes a payment to the Purchaser in respect of a Set-off previously taken against the Purchased Receivables and the Sellers previously made a payment to the Purchaser in the amount of such Set-off pursuant to the foregoing sentence, then the Purchaser shall promptly [***] after the Purchaser receives such payment by such Counterparty, pay to the Sellers the amount of such payment.

Section 5.5 Covered License Agreements.

(a) Each Seller, as applicable, (i) shall perform and comply with in all material respects its obligations under the Covered License Agreements, (ii) shall not, except with the Purchaser’s consent, (A) forgive, release or compromise any Purchased Receivables payable by the applicable Counterparty under any Covered License Agreement, or (B) amend, modify, supplement, restate, waive, cancel or terminate (or consent to any cancellation or termination of), in whole or in part, any provision of or right under any Covered License Agreement in a manner that would adversely affect the Purchaser’s right under this Agreement (including the timing, amount or duration of the Purchased Receivables), (iii) except as otherwise permitted pursuant to this Agreement, enter into any new contract, agreement or legally binding arrangement in respect of the Covered License Milestones, Covered License Royalties, the Intellectual Property Rights with respect to the Exploitation of the Licensed Products, or the Licensed Products and (iv) shall not agree to do any of the foregoing.

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The Sellers shall promptly [***] deliver to the Purchaser copies of all fully-executed or definitive writings related to the matters set forth in clauses (ii), (iii) and (iv) of the immediately preceding sentence.

(b) Except as otherwise expressly set forth in this ARTICLE V and except as otherwise consented to by the Purchaser, the Sellers shall not grant or withhold any consent, exercise or waive any right or option, fail to exercise any right or option or deliver to any Counterparty any notice under any Covered License Agreement. The Sellers shall promptly [***] to the Purchaser copies of all fully-executed or definitive writings related to the matters set forth in the immediately preceding sentence.

(c) Promptly [***] after (i) receiving (x) notice from any Counterparty, including any notice terminating any Covered License Agreement (in whole or in part), alleging any breach of or default under any Covered License Agreement by the Sellers related to the Purchased Receivables, or any other material breach or default, or asserting the existence of any facts, circumstances or events that, alone or together with other facts, circumstances or events, would reasonably be expected (with or without the giving of notice or passage of time, or both) to give rise to a breach of or default under any Covered License Agreement by the Sellers related to the Purchased Receivables, or any other material breach or default, or the right to terminate any Covered License Agreement (in whole or in part) by such Counterparty, or (y) any other correspondence relating to the foregoing; or (ii) the Sellers otherwise has Knowledge of any fact, circumstance or event that, alone or together with other facts, circumstances or events, would reasonably be expected (with or without the giving of notice or passage of time, or both) to give rise to a breach of or default under any Covered License Agreement by the Sellers related to the Purchased Receivables, or any other material breach or default, or the right to terminate any Covered License Agreement (in whole or in part) by any Counterparty, in each case the Sellers shall (A) (x) give written notice thereof to the Purchaser and provide the Purchaser with a written summary of all material details thereof, (y) to the extent not prohibited by obligations of confidentiality contained in the Covered License Agreements, include a copy of any written notice received from such Counterparty, and (z) in the case of any such breach or default or alleged breach or default by the Sellers, describe in reasonable detail any corrective action the Sellers propose to take in respect of such breach or default; and (B) in the case of any such breach or default or alleged breach or default by the Sellers, use commercially reasonable efforts to cure such breach or default and give written notice to the Purchaser upon curing such breach or default.

(d) Promptly after the Sellers obtain Knowledge of any actual or alleged breach of or default that relates to the Purchased Receivables or any other actual or alleged material breach of or default under any Covered License Agreement by the applicable Counterparty (each, a “Defaulting Party”) or of the existence of any facts, circumstances or events that, alone or together with other facts, circumstances or events, would reasonably be expected (with or without the giving of notice or passage of time, or both) to give rise to any such breach of or default or the right to terminate any Covered License Agreement (in whole or in part) by the Sellers, in each case the Sellers shall promptly [***] give written notice thereof to the Purchaser and provide the Purchaser with a written summary of all material details thereof and act as mutually agreed to take such permissible actions (including commencing legal action against the Defaulting Party and the selection of legal counsel reasonably satisfactory to the Purchaser) to enforce compliance by the Defaulting Party with the relevant provisions of the applicable Covered License Agreement and to exercise any or all of the Sellers’ rights and remedies, whether under such Covered License Agreement or by operation of law, with respect thereto. If the Sellers are required to act as directed by the Purchaser pursuant to this Section 5.5(d), then the Purchaser shall reimburse the Sellers, promptly on demand, for all out-of-pocket costs and expenses (including the reasonable fees and expenses of the Sellers’ counsel) incurred by the Sellers in connection with the Sellers’ actions and exercise of rights and remedies pursuant to clause (ii) of the immediately preceding sentence; provided, however, that such out-of-pocket costs and expenses (including the reasonable fees and expenses of the Sellers’ counsel) shall be borne by the Sellers if (x) such breach, default or termination event or alleged breach, default or termination event results from a breach of or default under any Covered License Agreement by the Sellers or (y) the Sellers act without or contrary to the Purchaser’s direction.

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The Purchaser shall, except to the extent prohibited by the obligations of confidentiality contained in the Covered License Agreements, have the right, at its sole cost and expense, to attend (or, if the Sellers are required to act as directed by the Purchaser pursuant to this Section 5.5(d), participate in) any meeting, discussion, action, suit or other proceeding relating to any such breach, default or termination event or alleged breach, default or termination event, including any counterclaim, settlement discussions or meetings; provided, however, that the Purchaser shall have no such right to attend or participate, as applicable, if the exercise thereof would adversely affect the maintenance by the Sellers of any applicable attorney-client privilege (and, in such event, the Parties agree to use commercially reasonable efforts to effect such other arrangements to preserve such privilege, including negotiating to enter into a mutually acceptable joint defense agreement). Notwithstanding anything to the contrary contained in this ARTICLE V, nothing herein shall prevent, restrict or limit the Purchaser from directly enforcing, at the Purchaser’s sole cost and expense, a Defaulting Party’s payment obligations in respect of the Purchased Receivables with counsel selected by the Purchaser in its sole discretion; provided, however, that the Sellers shall, except to the extent prohibited by obligations of confidentiality contained in the Covered License Agreements, make available its relevant records and personnel to the Purchaser in connection with any such enforcement and provide reasonable assistance and authority to file and bring any legal action in connection therewith, including, if required, being joined as a party plaintiff, and the Purchaser shall reimburse the Sellers, promptly on demand, for all out-of-pocket costs and expenses incurred by the Sellers in connection therewith, (x) unless the Defaulting Party’s breach, default or termination event or alleged breach, default or termination event results from a breach of or default under any Covered License Agreement by the Sellers or (y) the Sellers act without or contrary to the Purchaser’s direction in respect of any such breach or default or alleged breach or default (if the Sellers are required to act as directed by the Purchaser pursuant to this Section 5.5(d)).

Section 5.6 Patent Prosecution, Enforcement and Defense.

(a) With respect to the Intellectual Property Rights relating to the Licensed Products,

(i) to the extent required by the applicable Covered License Agreements, the Sellers shall, at the Sellers’ expense, take any and all actions, and prepare, execute, deliver and file any and all agreements, documents and instruments, that are reasonably necessary or desirable to diligently preserve and maintain the applicable Intellectual Property Rights, including payment of maintenance fees or annuities. In connection with any actions or decisions by the Sellers not to act in respect of matters contemplated by the foregoing sentence, to the extent such action or decision would reasonably be expected to have a Material Adverse Effect, the Sellers shall provide advance written notice of all such actions or decisions not to act in order to consult with the Purchaser, and the Sellers shall, in good faith, give due consideration to any reasonable suggestions of, the Purchaser.

(ii) to the extent required by the applicable Covered License Agreements, the Sellers shall, at the Sellers’ expense, (A) diligently defend and enforce the applicable Intellectual Property Rights against infringement or interference by any other Person, and against any claims of invalidity or unenforceability, in any jurisdiction (including by bringing any legal action for infringement or defending any counterclaim of invalidity or action of any other Person for declaratory judgment of non-infringement or non-interference) and (B) when available in respect of any applicable Licensed Product, obtain patents and any corrections, substitutions, reissues and reexaminations thereof and obtain patent term extensions and any other forms of patent term restoration in any country. In connection with the Sellers’ actions or decisions not to act in respect of matters contemplated by the foregoing sentence, the Sellers shall provide advance written notice of all such actions or decisions not to act in order to consult with the Purchaser, if applicable, and, if applicable, allow the Purchaser sufficient time to issue instructions.

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The Sellers shall promptly [***] provide to the Purchaser a copy of any written notice or other documentation received in connection with any such legal action, suit or other proceeding.

(iii) the Sellers shall, except to the extent prohibited by obligations of confidentiality contained in the Covered License Agreements, promptly [***] after receipt thereof, provide to the Purchaser a copy of all substantive written notices or other documentation relating to the patentability, enforceability, validity, scope or term of the Patents, and shall provide the Purchaser with a copy of drafts of any written material proposed to be filed in response thereto.

(b) With respect to the Intellectual Property Rights relating to the Company Products,

(i) Product Sub shall, at Product Sub’s expense, take any and all actions, and prepare, execute, deliver and file any and all agreements, documents and instruments, that are reasonably necessary to diligently preserve and maintain the applicable Intellectual Property Rights, including payment of maintenance fees or annuities. In connection with any actions or decisions by Product Sub not to act in respect of matters contemplated by the foregoing sentence, to the extent such action or decision would reasonably be expected to have a Material Adverse Effect, Product Sub shall provide advance written notice of all such actions or decisions not to act in order to consult with the Purchaser, and Product Sub shall, in good faith, give due consideration to any reasonable suggestions of, the Purchaser.

(ii) Product Sub shall, at Product Sub’s expense, (A) diligently defend and enforce the applicable Intellectual Property Rights against infringement or interference by any other Person, and against any claims of invalidity or unenforceability, in any jurisdiction (including by bringing any legal action for infringement or defending any counterclaim of invalidity or action of any other Person for declaratory judgment of non-infringement or non-interference) and (B) when available and material in respect of any applicable Company Product, obtain patents and any corrections, substitutions, reissues and reexaminations thereof and obtain patent term extensions and any other forms of patent term restoration. In connection with Product Sub’s actions or decisions not to act in respect of matters contemplated by the foregoing sentence, Product Sub shall provide advance written notice of all such actions or decisions not to act in order to consult with the Purchaser, if applicable, and, if applicable, allow the Purchaser sufficient time to issue instructions. Product Sub shall promptly [***] provide to the Purchaser a copy of any written notice or other documentation received in connection with any such legal action, suit or other proceeding.

(iii) the Company shall promptly [***] after receipt thereof, provide to the Purchaser a copy of all substantive written notices or other documentation relating to the patentability, enforceability, validity, scope or term of the Patents, and shall provide the Purchaser with a copy of drafts of any written material proposed to be filed in response thereto.

(c) The Seller Parties shall not disclaim or abandon, or fail to take any Commercially Reasonable Action necessary or desirable to prevent the disclaimer or abandonment of, any material Intellectual Property Rights.

(d) The Parties shall bear their own costs and expenses in connection with the actions pursuant to this Section 5.6.

Section 5.7 Termination of the Covered License Agreements.

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(a) Without limiting the provisions of Section 5.5 or any other rights or remedies the Purchaser may have under this Agreement, if a Counterparty terminates or provides written notice of termination of a Covered License Agreement or a Covered License Agreement otherwise terminates (whether in whole or in part), in any case during the term of such Covered License Agreement, then the Sellers shall, at the Purchaser’s request and direction, use Commercially Reasonable Efforts [***]

(b) Should the Sellers or Purchaser identify any New Arrangement pursuant to Section 5.7(a), the Sellers agree to exercise commercially reasonable efforts to promptly duly execute and deliver a new license agreement effecting such New Arrangement that satisfies the foregoing requirements.

(c) Each of the Sellers and the Purchaser shall bear its own costs and expenses in connection with any New Arrangement.

(d) Any New Arrangement entered into by the Sellers in accordance with this Section 5.7 shall be deemed to be a “Covered License Agreement” for all purposes under this Agreement.

Section 5.8 Audits.

(a) The Sellers shall, with notice to the Purchaser, be entitled to cause an inspection or audit of any Counterparty’s books and records to be conducted pursuant to and in accordance with the terms of any Covered License Agreement. From time to time, but not more frequently than once per calendar year, the Purchaser may request the Sellers to, and the Sellers shall, subject to and in accordance with the terms of any Covered License Agreement, cause an inspection or audit of any Counterparty’s books and records in respect of the Purchased Receivables to be conducted pursuant to and in accordance with the terms of any Covered License Agreement. For the purposes of exercising the Purchaser’s rights pursuant to this Section 5.8(a) in respect of the Covered License Agreements, the Sellers shall appoint such public accounting firm of nationally recognized standing as the Purchaser shall select for such purpose (it being understood and agreed that any such public accounting firm shall, pursuant to the Covered License Agreements, be reasonably acceptable to the applicable Counterparty). The Sellers and the Purchaser agree that all of the expenses of, and amounts payable to the applicable Counterparty as a result of any inspection or audit carried out at the request of the Purchaser pursuant to this Section 5.8(a) that would other-wise be borne by the Seller pursuant to the applicable Covered License Agreement shall instead be borne by the Purchaser and reimbursed to the Sellers promptly on demand, including such reasonable fees and expenses of such public accounting firm as are to be borne by the Sellers pursuant to the terms of the applicable Covered License Agreement together with the Sellers’ out-of-pocket costs and expenses incurred in connection with such inspection or audit; provided that the Purchas-er shall be reimbursed by the Sellers for any such fees and expenses to the extent the Sellers are entitled to receive reimbursement from the applicable Counterparty; provided, further, that for the avoidance of doubt, any audit caused by the Sellers pursuant to the first sentence of this Section 5.8(a) shall not be deemed to be carried out at the request of the Purchaser and the Purchaser shall have no obligation to reimburse the Sellers, pursuant to this sentence, for any fees, costs or expenses incurred by the Seller in connection therewith. The Seller shall, to the extent not prohibited by obligations of confidentiality contained in the Covered License Agreement pursuant to which an inspection or audit in respect of the Covered License Milestones or the Covered License Royalties is conducted, promptly [***] furnish to the Purchaser any inspection or audit report prepared in connection with such inspection or audit.

(b) In the event that any inspection or audit conducted pursuant to Section 5.8(a) uncovers that the amounts actually paid to the Purchaser for any period in respect of the Purchased Receivables were greater than the amounts that should have been paid to the Purchaser for such period in respect of the Purchased Receivables, the Purchaser shall cause the amount of such overpayment to be paid to the applicable Counterparty promptly [***] after delivery to the Purchaser, pursuant to Section 5.8(a), of the applicable inspection or audit report or certificate, as the case may be, showing such overpayment.

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In the event that any inspection or audit conducted pursuant to Section 5.8(a) uncovers that the amounts actually paid to the Purchaser for any period in respect of the Purchased Receivables were less than the amounts that should have been paid to the Purchaser for such period in respect of the Purchased Receivables, the Sellers shall cooperate and provide assistance as reasonably requested by the Purchaser to cause the amount of such underpayment to be paid to the Purchaser by the applicable Counterparty in accordance with the timeframe set forth in the applicable License Agreement promptly after delivery to the Purchaser, pursuant to Section 5.8(a), of the applicable inspection or audit report or certificate, as the case may be, showing such underpayment.

Section 5.9 Diligence. The Company shall use Commercially Reasonable Efforts to prepare, execute, deliver and file any and all agreements, documents or instruments that are necessary or desirable to secure and maintain Regulatory Approval for the Company Products in the Territory (other than the Betta Territory for so long as the Betta Agreement is in effect). The Company shall use Commercially Reasonable Efforts not to withdraw or abandon, or fail to take any action necessary to prevent the withdrawal or abandonment of, any Regulatory Approval once obtained. Following receipt of Regulatory Approval in any country, the Company shall use Commercially Reasonable Efforts to Exploit the Company Products in each such country. The Company shall maintain, and cause its Subsidiaries to maintain, compliance in all material respects with all Applicable Laws and Regulatory Approvals.

Section 5.10 Tax Matters.

(a) Purchaser and Sellers acknowledge and agree that, under Applicable Law as of the date of this Agreement, no taxes are expected to be deducted or withheld from payments under this Agreement. All payments to the Purchaser under this Agreement shall be made without any deduction or withholding for or on account of any Tax unless required by Applicable Law; provided that if any deduction or withholding for or on account of any Purchaser Indemnified Tax is required by Applicable Law to be made, and is made, by any applicable withholding agent in respect of any payment to the Purchaser under this Agreement or to Sellers (or their Affiliates) that are attributable to the Purchased Company Receivables, then the Sellers shall, [***] after such deduction or withholding is made, make a payment to the Purchaser so that, after all such required deductions and withholdings are made by any applicable withholding agent (including any deductions and withholdings required with respect to any additional payments under this Section 5.10(a)), the Purchaser receives an amount equal to the amount that it would have received had no withholding of such Purchaser Indemnified Taxes been made.

(b) The Sellers shall notify the Purchaser in writing promptly [***] following the receipt of any written notification by any Counterparty or by an Affiliate of such Counterparty that such Counterparty intends to make any Permitted Tax Withholding. The Parties shall cooperate reasonably and in good faith to reduce or eliminate any such Permitted Tax Withholding, including by providing to the applicable withholding agent certificates and such other information that is necessary to establish an exemption or reduction from such Permitted Tax Withholding that the payee is legally eligible to deliver. In addition, the Sellers shall, upon the reasonable request of the Purchaser and at the Purchaser’s expense, reasonably cooperate with the Purchaser and use its commercially reasonable efforts to make such filings and take such other actions as may be reasonably necessary and specified by the Purchaser in order to allow an exemption from or reduction of any Permitted Tax Withholding.

(c) The Parties agree not to take any position that is inconsistent with the provisions of Section 2.1(b) on any Tax return or in any Tax audit or other administrative or judicial proceeding unless required by Applicable Law or final determination within the meaning of Section 1313 of the Code. If there is an inquiry by any Governmental Authority of the Sellers or the Purchaser related to the treatment described in Section 2.1(b), the Parties shall cooperate with each other in responding to such inquiry in a commercially reasonable manner that is consistent with Section 2.1(b).

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Section 5.11 Existence. Each Seller Party shall (a) preserve and maintain its existence (provided, however, that nothing in this Section 5.11 shall prohibit the Seller Parties from entering into any merger or consolidation that is otherwise permitted by this Agreement, or, subject to obtaining Purchaser’s prior written consent, which shall not be unreasonably withheld, conditioned or delayed (it being understood that it shall be deemed unreasonable for Purchaser to withhold consent with respect to any such change that does not adversely impact Purchaser’s Liens, the intent of the structure of the transactions contemplated by the Transaction Documents, or Purchaser’s economic rights under the Transaction Documents) any change in corporate form or reincorporation in any jurisdiction for the purpose of optimizing Seller Parties’ structure for tax or transfer pricing purposes), (b) preserve and maintain its rights, franchises and privileges unless failure to do any of the foregoing would not reasonably be expected to have a Material Adverse Effect, (c) qualify and remain qualified in good standing in each jurisdiction where the failure to preserve and maintain such qualifications would reasonably be expected to have a Material Adverse Effect, including appointing and employing such agents or attorneys in each jurisdiction where it shall be necessary to take action under this Agreement, and (d) comply with its organizational documents, except, in the case of this clause (d), for any non-compliance that would not reasonably be expected to have a Material Adverse Effect. The Purchaser acknowledges and agrees (to the maximum extent permitted under Applicable Law), that it shall not, and shall not cause any other Person to, petition for the bankruptcy of the Seller Parties.

Section 5.12 Additional Covenants relating to Royalty Fund and Product Sub.

Each of Royalty Fund and Product Sub shall:

(a) only enter into contracts in its own name as a legal entity separate from the owners of its Equity Interests and from any other Person;

(b) not commingle its assets with assets of any other Person, except in connection with, and for the limited purposes of, the Lockbox Accounts, and, with respect to Royalty Fund, in connection with the XOMA Agreement;

(c) conduct its business only in its own name and comply with all organizational formalities necessary to maintain its separate existence;

(d) maintain separate books and records, showing its assets and liabilities separate and apart from those of any other person and not have its assets listed on any financial statement of any other person; provided, however, that Royalty Fund’s assets and Product Sub’s assets may be included in consolidated financial statements of the Company in conformity with the applicable provisions of GAAP (provided that such assets are also listed on Royalty Fund’s own separate balance sheet and Product Sub’s own separate balance sheet, respectively);

(e) pay its own liabilities and expenses only out of its own funds; provided that the foregoing shall not prohibit the payment of liabilities and expenses by the Company on behalf of Royalty Fund or Product Sub so long as such payments are subject to reimbursement or are otherwise recorded as capital contributions or intercompany loans;

(f) maintain adequate (as determined in good faith by Royalty Fund or Product Sub, as applicable) capital in light of its contemplated business purpose, transactions and liabilities; and (g) cause the representatives of Royalty Fund and Product Sub to act at all times with respect to the Sellers consistently and not in a manner opposed to the foregoing.

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Section 5.13 Additional Sales; Liens.

(a) The Seller Parties shall not create, incur, sell, issue, assume, enforce or suffer to exist any additional revenue interests (or similar economic equivalents) with respect to the Covered License Milestones, the Covered License Royalties or Net Sales of the Company Products unless such additional revenue interests (or such economic equivalents) are subordinated to the Purchased Receivables as to payment, security and enforcement. For the avoidance of doubt, subject to compliance with this Section 5.13(a), the Seller Parties may create, incur, sell, issue, assume, enforce or suffer to exist any additional revenue interests (or similar economic equivalents) with respect to the Covered License Milestones, the Covered License Royalties or Net Sales of the Company Products without the consent of Purchaser.

(b) Except as permitted pursuant to Section 5.7(a) (Termination of the Covered License Agreements), Section 5.15 (Change of Control), Section 5.17 (Out-Licenses for Company Products), the Seller Parties shall not dispose of, assign or otherwise transfer, in whole or in part, any Covered License Agreement, the Purchased Receivables or any of the Seller Parties’ right, title or interest in or to the Regulatory Approvals or In-Licenses. Except as permitted pursuant to Section 5.7(a) (Termination of the Covered License Agreements) and Section 5.16 (Out-Licenses for Company Products), and except for Liens granted pursuant to the Betta Agreement, the Seller Parties shall not transfer, encumber or grant any Lien on the Intellectual Property Rights in the Territory or the Covered License Agreements.

(c) [***]

(d) Upon the occurrence of the Security Release Event, the Purchaser agrees that Liens granted to Purchaser pursuant to the Pledge and Security Agreement and the BOT/BAL Security Agreement shall be automatically terminated and hereby authorizes the Seller Parties to file termination statements as are necessary to remove such liens of record (including without limitation UCC-3 termination statements and filings with the Patent Office).

Section 5.14 Change of Control. The Company shall not, directly or indirectly, effectuate or consummate a Change of Control; provided, however, that the Company may, directly or indirectly, effectuate or consummate if (i) the acquiring Person in such Change of Control (if other than the Company) is a Qualified Party and (ii) to the extent that the Company is party to such Change of Control and is not the surviving Person, such surviving Person expressly assumes all the obligations of the Company under the Transaction Documents to which the Company is party, in which case such surviving Person shall succeed to, and be substituted for, the Company under the Transaction Documents to which the Company is party and the Company shall automatically be released and discharged from its obligations under the Transaction Documents to which the Company is party.

Section 5.15 In-Licenses.

(a) The Company shall promptly [***] provide the Purchaser with (i) executed copies of any In-License entered into by the Company or its Affiliates, and (ii) executed copies of each amendment, supplement, modification or written waiver of any provision of any In-License.

(b) The Company shall comply in all material respects with its obligations under the LICR Agreements, the Selexis Agreements, and any In-Licenses it enters into and shall not take any action or forego any action that would reasonably be expected to result in a material breach thereof. Promptly, [***] after receipt of any written or oral notice by the Company or any of its Affiliates with respect to an alleged material breach under any In-License, the Company shall provide the Purchaser a copy (or, in the case of oral notices, a written summary) thereof.

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The Company shall use its Commercially Reasonable Efforts to cure any material breaches by it under any In-License and shall give written notice to the Purchaser upon curing any such breach. The Company shall provide the Purchaser with written notice following [***] becoming aware of a counterparty’s material breach of its obligations under any In-License. The Company shall not terminate (i) any In-License without providing the Purchaser prior written notice, (ii) the LICR Agreements or (iii) the Selexis Agreements. The Company shall not make or enter into any amendment, supplement or modification to, or grant any waiver under any provision of, the LICR Agreements or the Selexis Agreements without the Purchaser’s prior written consent (which consent shall not be unreasonably withheld, conditioned or delayed) to the extent that such amendment, supplement, modification or grant would reasonably be expected to have a material adverse effect on the timing, amount or duration of the Royalty Payments. Promptly, [***] the Company’s notice to a counterparty to any In-License of an alleged breach by such counterparty under any such In-License, the Company shall provide the Purchaser a copy thereof.

Section 5.16 Out-Licenses for Company Products.

(a) Subject to compliance with this Section 5.16 and, with respect to Licensed Products, Section 5.7, the Company may enter into Out-Licenses with one or more Qualified Parties without the Purchaser’s prior written consent. Except as set forth in the proviso, the Seller Parties and their Affiliates may not enter into any other Out-Licenses without the Purchaser’s prior written consent; provided that the Seller Parties and their Affiliates may, without Purchaser’s consent, enter into non-exclusive Out-Licenses in any country that is not a Major Market in connection with the establishment of strategic co-marketing, co-promotion and distribution agreements whether or not such counterparty is a Qualified Party, [***]. In addition, Purchaser hereby agrees to release or modify any liens to the extent reasonably necessary in connection with an Out-License with a Qualified Party.

(b) The Company shall promptly [***] provide the Purchaser with (i) executed copies of each Out-License, and (ii) executed copies of each amendment, supplement, modification or written waiver of any material provision of an Out-License.

(c) The Company shall include in all Out-Licenses (i) provisions permitting the Company to audit such Licensee and to share royalty reports with the Purchaser (it being understood that Purchaser need not be named by name) (ii) provisions directing that amounts owed to the Company be paid to the Company Product Lockbox Account.

(d) The Company shall provide the Purchaser prompt [***] written notice of a Licensee’s material breach of its obligations under any Out-License of which any of the individuals named in the definition of “Knowledge” (or the successors of such Person at the Company) becomes aware.

(e) The Company shall provide the Purchaser with written notice promptly [***] following the termination of any Out-License.

(f) Any Out-License entered into by the Sellers in accordance with this Section 5.16 shall be deemed to be a Covered License Agreement for all purposes hereunder, and Purchaser shall have a first lien security interest in such Out-License and the receivables thereunder pursuant to the Security Agreement.

Section 5.17 Amendment to Disclosure Schedule. At least five (5) Business Days prior to the anticipated Closing Date, the Seller Parties shall deliver to the Purchaser amendments to the Disclosure Schedule with respect to any event or matter which occurs after the Closing Date, if any, or confirm in writing that the Seller Parties make no amendments to the Disclosure Schedule.

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With respect to any amendment of the Disclosure Schedule (and the underlying events with respect to such disclosure), if such disclosure and underlying event would constitute or reasonably be expected to result in a Material Adverse Effect, the Purchaser shall have the right to terminate this Agreement. If the Purchaser does not exercise its right to terminate this Agreement within the five Business Day period preceding the anticipated Closing Date, the Purchaser shall be deemed to have waived such right with respect to such event or matter and the applicable representations shall be deemed to have been qualified as set forth in the amended Disclosure Schedule for purposes of satisfying the conditions to the Closing set forth in Section 6.2.

Section 5.18 Product Sub Organizational Documents. Prior to the Closing, the Company and Product Sub shall amend and restate the limited liability company operating agreement of Product Sub in substantially the form attached hereto as Exhibit J.

Section 5.19 Counterparty Consent. Company shall use its reasonable best efforts (without the obligation to incur any expense) to obtain the consent of Gilead to the transactions contemplated by this Agreement on or prior to the Closing Date, provided, however, Gilead’s consent shall not be condition to Closing, and provided, further, that if such consent has not been obtained as of the Closing, the Company shall continue to use its reasonable best efforts (without the obligation to incur any expense) to obtain such consent [***].

Section 5.20 Other Matters. [***]

Section 5.21 Syndication.

(a) The Company shall have the right at any time between the date of this Agreement [***] (the “Syndication Period”) to obtain a written commitment for additional funding (a “Funding Commitment”) from one or more Third Parties (each an “Additional Co-Investor”) in an aggregate amount up to $125,000,000. Notwithstanding the foregoing, in no event shall any Additional Co-Investor (together with any of such Additional Co-Investor’s Affiliates) be permitted to invest more than [***]. Any such written commitment shall be subject to the terms and conditions of this Agreement, including this Section 5.21. The Company is entitled to accept or reject any proposed additional investment for any reason in its sole discretion. The Company may request Purchaser’s consent to an extension of the Syndication Period for any prospective Additional Co-Investor who is actively evaluating a Funding Commitment as of the last day of the Syndication Period, which consent may be granted or withheld in Purchaser’s sole discretion.

(b) Any such additional investment will be made through a co-investment special purpose entity (a “Co-Investment Vehicle”) established and controlled at all times by the Purchaser for the purpose of facilitating additional funding by an Additional Co-Investor(s). For each additional investment, this Agreement would, substantially concurrently with the closing of each additional investment, be amended to (a) increase the Purchase Price by the amount of such additional funding, (b) proportionately increase the Applicable Percentages based on the amount of such additional funding, (c) proportionately increase the amount of the Gilead Option Payment and (d) such other changes as are mutually agreed as are necessary to account for the additional funding amount. If an additional investment is made pursuant to this Section 5.21, Purchaser shall, if required, assign this Agreement to the Co-Investment Vehicle.

(c) The purpose of this agreed structure is to insure that the Purchaser maintains control over decisions relating to the taking or not taking actions under this Agreement and the other Transaction Documents, with any such Additional Co-Investors being passive investors with the right to receive the same economics as the Purchaser. If the structure of such additional funding contemplated by this Section 5.21 is not feasible for tax, regulatory or other legal reasons, then the Parties shall cooperate to effect such additional funding in a manner that achieves the intentions set forth herein. Any such alternative structure shall be subject to the consent of the Company and the Purchaser, not to be unreasonably withheld, conditioned or delayed.

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(d) In the event that during the Syndication Period, multiple Additional Co-Investors provide Funding Commitments, the Parties will cooperate to schedule a single additional closing to effect such additional fundings on a mutually agreeable date.

ARTICLE VITHE CLOSING

Section 6.1 Closing. The closing of the transactions contemplated hereby (the “Closing”) shall take place at 9:00 a.m., Eastern Standard Time, five (5) Business Days following the date the conditions set forth in Sections 6.2 and 6.3 are satisfied (the “Closing Date”) by electronic exchange of signatures, or on such other date, at such other time or at such other place, in each case as the Parties mutually agree.

Section 6.2 Closing Deliverables of the Sellers. At the Closing, the Seller Parties shall deliver or cause to be delivered to the Purchaser the following:

(a) a counterpart signature page to the Closing Date Bills of Sale, each duly executed by the Company and the Royalty Fund, as applicable;

(b) a counterpart signature page to each of the Gilead Payment Direction Letter, the UroGen Payment Direction Letter and the BMS Payment Direction Letter, each duly executed by the Company;

(c) an opinion of Meister Seelig & Fein, counsel to the Sellers, in form and substance reasonably satisfactory to the Purchaser;

(d) a duly executed certificate of an executive officer of the Seller Parties dated as of the Closing Date and (i) attaching copies, certified by such officer as true and complete, of (x) the organizational documents of the Seller Parties and (y) resolutions of the governing body of the Sellers authorizing and approving the execution, delivery and performance by the Seller Parties of the Transaction Documents and the transactions contemplated hereby and thereby, (ii) setting forth the incumbency of the officer or officers of the Seller Parties who have executed and delivered the Transaction Documents, including therein a signature specimen of each such officer or officers and (iii) attaching a copy, certified by such officer as true and complete, of a good standing certificate of the appropriate Governmental Authority of the Seller Parties’ jurisdictions of organization, stating that the Seller Parties are in good standing under the laws of such jurisdictions;

(e) a duly executed certificate of an executive officer of the Company certifying that (i) no Material Adverse Effect shall have occurred and (ii) the representations and warranties of the Seller Parties in Sections 3.1, 3.2, 3.3, 3.4, 3.6, 3.7(b), 3.10, 3.13 and 3.14, as amended pursuant to Section 5.17, if applicable, shall be true, correct and complete in all respects and (iii) the representations and warranties of the Seller Parties in ARTICLE III (other than those specified in Section 6.2(e)(ii)), shall be true, correct and complete in all respects except where the failure to be true, correct or complete would not reasonably be expected to have a Material Adverse Effect;

(f) a counterpart signature page to the Security Agreements duly executed by each of the Company, the Royalty Fund and Product Sub;

(g) a counterparty signature page to the Pledge and Security Agreement duly executed by the Company; (h) fully executed copies of the Contribution Agreement and the Intercompany License Agreement;

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(i) UCC-1 financing statements to evidence and perfect the sale, assignment, transfer, conveyance and grant of the Purchased Receivables pursuant to Section 2.1 and the back-up security interest granted pursuant to Section 2.1(d); and

(j) duly executed IRS Form W-9s from each of the Company and Royalty Fund certifying that such Party is a United States person as defined in Section 7701(a)(30) of the Code and exempt from U.S. federal backup withholding.

Section 6.3 Closing Deliverables of the Purchaser. At the Closing, the Purchaser shall deliver or cause to be delivered to the Seller Parties the following:

(a) a counterpart signature page to the Closing Date Bill of Sale – Purchaser, duly executed by the Purchaser;

(b) a counterpart signature page to the Security Agreements, duly executed by the Purchaser;

(c) a counterpart signature page to the Pledge and Security Agreement, duly executed by the Purchaser;

(d) the Closing Payment in accordance with Section 2.2;

(e) a duly executed IRS Form W-9 from the Purchaser certifying it is a United States person as defined in Section 7701(a)(30) of the Code and exempt from U.S. federal backup withholding; and

(f) a duly executed certificate of an executive officer of the Purchaser dated as of the Closing Date and setting forth the incumbency of the officer or officers of the Purchaser who have executed and delivered the Transaction Documents to which the Purchaser is a party, including therein a signature specimen of each such officer or officers.

Section 6.4 Lockbox Accounts; Collection Account; Account Control Agreements.

(a) The Company will establish the Licensed Product Lockbox Account [***] for the purpose of depositing all payments to be made by any Counterparty pursuant to each Covered License Agreement for Licensed Products, which payments shall include all Purchased Receivables (including distributions from the XOMA Escrow Agreement but excluding Company Product Revenue Payments) payable to the Purchaser pursuant to this Agreement.

(b) The Company shall pay all fees, expenses and charges of the Account Bank pursuant to the terms of the Account Control Agreement by depositing sufficient funds into the Licensed Product Lockbox Account when such fees, charges and expenses are due. The Sellers agree that all Purchased Receivables deposited into the Licensed Product Lockbox Account are to be held in trust for the benefit of the Purchaser, and that the Sellers disclaim and waive any claim or interest in such Purchased Receivables, so that the Purchaser may be assured of receiving the Purchased Receivables owned by the Purchaser.

(c) The Company will establish the Company Product Lockbox Account [***] for the purpose of depositing all payments to be made by any licensees and account debtors with respect to proceeds arising from sales of Company Products or any other payments relating to Company Products. The Company will instruct all such licensees and account debtors (including any parties to an Out-License entered into pursuant to Section 5.16) to remit any amounts owed to the Company in respect of the Company Products to the Company Product Lockbox Account.

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To the extent any proceeds arising from sales of Company Products or any other payments related to Company Products are paid directly to the Company, the Company shall remit to the Company Product Lockbox Account all such amounts no less than quarterly.

(d) The Company will establish the Company Product Collection Account at least [***] and cause all funds on deposit in the Company Product Lockbox Account to be swept daily to the Company Product Collection Account. With respect to any amounts that are deposited in the Collection Account, so long as all payment obligations of any Seller Party to Purchaser under this Agreement have been made, (i) [***] and (ii) any remaining amounts may be disbursed to another account of the Company from time to time at the direction of the Company. On each Royalty Payment Date, the Company shall instruct the Account Bank to disburse to the Purchaser an amount equal to the lesser of (x) the funds on deposit in the Collateral Account and (y) the Company Product Revenue Payment for such Royalty Payment Date. If the amount to be disbursed to the Purchaser on any Royalty Payment Date pursuant to the preceding sentence is less than the Company Product Revenue Payment to which the Purchaser is entitled, the Company shall pay the amount of such shortfall to the Purchaser on such Royalty Payment Date.

(e) [***]

(f) The Company shall pay all fees, expenses and charges of the Account Bank pursuant to the terms of the Account Control Agreement by depositing sufficient funds into the Company Product Lockbox Account when such fees, charges and expenses are due. The Company agrees that all Purchased Receivables deposited into the Product Sub Lockbox Account are to be held in trust for the benefit of the Purchaser, and that the Company disclaims and waives any claim or interest in such Purchased Receivables, so that the Purchaser may be assured of receiving the Purchased Receivables owned by the Purchaser.

(g) The Sellers shall have no right to terminate the Lockbox Accounts or the Company Product Collection Account without the Purchaser’s prior written consent.

(h) The Company undertakes to account for ex-U.S. sales of the Company Product in a manner consistent with the spirit of the provisions of this Section 6.4, which may include, [***]

ARTICLE VIIINDEMNIFICATION

Section 7.1 Indemnification by the Sellers. The Sellers jointly and severally agree to indemnify, defend and hold harmless the Purchaser and its Affiliates and any or all of their respective partners, directors, trustees, officers, managers, employees, members, agents and controlling persons (each, a “Purchaser Indemnified Party”) harmless from and against, and will pay to each Purchaser Indemnified Party the amount of, any and all Losses awarded against or incurred or suffered by such Purchaser Indemnified Party, whether or not involving a Third Party Claim, arising out of or resulting from (a) any breach of any representation or warranty made by the Sellers in any of the Transaction Documents or in any certificate delivered by the Sellers to the Purchaser in writing pursuant to this Agreement, (b) any breach of or default under any covenant or agreement of the Sellers in any of the Transaction Documents or License Agreements, (c) any Excluded Liabilities and Obligations, (d) any product liability claims relating to a Covered Product, (e) any claims of infringement or misappropriation of any Intellectual Property Rights by any Third Parties against the Purchaser or any of its Affiliates or LICR or (f) any brokerage or finder’s fees or commissions or similar amounts incurred or owed by the Sellers or any of their Affiliates to any brokers, financial advisors or comparable other Persons retained or employed by any of them in connection with the transactions contemplated by this Agreement. Any amounts due to any Purchaser Indemnified Party hereunder shall be payable by the Sellers to such Purchaser Indemnified Party upon demand.

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Section 7.2 Indemnification by the Purchaser. The Purchaser agrees to indemnify and hold each of the Sellers and their Affiliates and any or all of their respective partners, directors, officers, managers, members, employees, agents and controlling Persons (each, a “Seller Indemnified Party”) harmless from and against, and will pay to each Seller Indemnified Party the amount of, any and all Losses awarded against or incurred or suffered by such Seller Indemnified Party, whether or not involving a Third Party Claim, arising out of (a) any breach of any representation or warranty made by the Purchaser in any of the Transaction Documents or any certificate delivered by the Purchaser to the Sellers in writing pursuant to this Agreement, (b) any breach of or default under any covenant or agreement of the Purchaser in any Transaction Document to which the Purchaser is a party or (c) any brokerage or finder’s fees or commissions or similar amounts incurred or owed by the Purchaser to any brokers, financial advisors or comparable other Persons retained or employed by it in connection with the transactions contemplated by this Agreement. Any amounts due to any Seller Indemnified Party hereunder shall be payable by the Purchaser to such Seller Indemnified Party upon demand.

Section 7.3 Claims. A claim by an indemnified party under this ARTICLE VII for any matter in respect of which such indemnified party would be entitled to indemnification hereunder may be made by delivering, in good faith, a written notice of demand to the indemnifying party, which notice shall contain (a) a description and the amount of any Losses incurred or suffered or reasonably expected to be incurred or suffered by the indemnified party, (b) a statement that the indemnified party is entitled to indemnification under this ARTICLE VII for such Losses and a reasonable explanation of the basis therefor, and (c) a demand for payment in the amount of such Losses. For all purposes of this Section 7.3, the Sellers shall be entitled to deliver such notice of demand to the Purchaser on behalf of the Seller Indemnified Parties, and the Purchaser shall be entitled to deliver such notice of demand to the Sellers on behalf of the Purchaser Indemnified Parties.

Section 7.4 Survival. All representations, warranties and covenants made in this Agreement, in any other Transaction Document or in any certificate delivered pursuant to this Agreement shall survive the execution and delivery of this Agreement and the Closing. The rights hereunder to indemnification, payment of Losses or other remedies based on any such representation, warranty or covenant shall not be affected by any investigation conducted with respect to, or any knowledge acquired (or capable of being acquired) at any time (whether before or after the execution and delivery of this Agreement or the Closing) in respect of the accuracy or inaccuracy of or compliance with, any such representation, warranty or covenant.

Section 7.5 Remedies. Except in the case of actual fraud, intentional misrepresentation, intentional wrongful acts, intentional breach, bad faith or willful misconduct and except as set forth in Section 10.1 or in the other Transaction Documents, (a) the indemnification afforded by this ARTICLE VII shall be the sole and exclusive remedy for any and all Losses awarded against or incurred or suffered by a Party in connection with any breach of any representation or warranty made by a Party in any of the Transaction Documents or any certificate delivered by a Party to the other Party in writing pursuant to this Agreement or any breach of or default under any covenant or agreement by a Party pursuant to any Transaction Document and (b) the Purchaser acknowledges and agrees that the Purchaser, together with its Affiliates and representatives, has made its own investigation of the Purchased Receivables and the transactions contemplated by the Transaction Documents and is not relying on, and shall have no remedies in respect of, any implied warranties or upon any representation or warranty whatsoever as to the future amount or potential amount of the Purchased Receivables, or as to the creditworthiness of any Counterparty (or any of their respective Affiliates).

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Section 7.6 Limitations. Neither any Seller Indemnified Party nor the Purchaser Indemnified Party shall have any liability for, or Losses be deemed to include, any special, punitive or exemplary damages, or any lost profits, whether in contract or tort, regardless of whether the other Party shall be advised, shall have reason to know, or in fact shall know of the possibility of such damages suffered or incurred by any such Seller Indemnified Party or the Purchaser Indemnified Party in connection with this Agreement any of the other Transaction Documents or any of the transactions contemplated hereby or thereby, except to the extent any such damages are actually paid to a Third Party in accordance with Section 7.3. Notwithstanding the foregoing, the limitations set forth in this Section 7.6 shall not apply to any claim for indemnification hereunder in the case of actual fraud, intentional misrepresentation, intentional wrongful acts, intentional breach, bad faith or willful misconduct. The aggregate amount of Losses for which the Purchaser Indemnified Parties shall be entitled to indemnification pursuant to this Article VII will not exceed [***]. The Parties acknowledge and agree that (a) the Purchaser’s Losses, if any, for any indemnifiable events under this Agreement will typically include Losses for Purchased Receivables that the Purchaser was entitled to receive in respect of its ownership of the Purchased Receivables but did not receive timely or at all due to such indemnifiable event and (b) subject to this Section 7.6, the Purchaser shall be entitled to make indemnification claims for all such missing or delayed Purchased Receivables that the Purchaser was entitled to receive in respect of its ownership of the Purchased Receivables as Losses hereunder (which claims shall be reviewed and assessed by the Parties in accordance with the procedures set forth in this ARTICLE VII), and such missing or delayed Purchased Receivables shall not be deemed special, punitive or exemplary damages, or lost profits for any purpose of this Agreement.

Section 7.7 Tax Treatment of Indemnification Payments. For all purposes hereunder, any indemnification payments made pursuant to this ARTICLE VII will be treated as an adjustment to the Purchase Price for all Tax purposes to the fullest extent permitted by Applicable Law.

ARTICLE VIIICONFIDENTIALITY

Section 8.1 Confidentiality. Except as provided in this ARTICLE VIII or otherwise agreed in writing by the Parties, the Parties agree that, during the term of this Agreement and until the tenth (10th) anniversary of the date of termination of this Agreement, each Party (the “Receiving Party”) shall keep confidential, and shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement (which includes the exercise of any rights or the performance of any obligations hereunder), any information (whether written or oral, or in electronic or other form) furnished to it by or on behalf of the other Party (the “Disclosing Party”) pursuant to the Existing Confidentiality Agreement or this Agreement, including the terms of this Agreement (such information, “Confidential Information” of the Disclosing Party), except for that portion of such information that:

(a) was already in the Receiving Party’s possession on a non-confidential basis prior to its disclosure to it by the Disclosing Party, or becomes known to the Receiving Party from a source other than the Disclosing Party and its representatives without any breach of this Agreement, in each case as evidenced by written records (provided that if such information was disclosed to the Receiving Party on a non-confidential basis by a source that is not the Disclosing Party, such source to the knowledge of the Receiving Party had the right to disclose such information to the Receiving Party without any legal, contractual or fiduciary obligation to, any person with respect to such information);

(b) is or becomes generally available to the public other than as a result of an act or omission by the Receiving Party or its Affiliates in breach of this Agreement; or

(c) was independently developed by the Receiving Party, as evidenced by written records, without use of or reference to the Confidential Information or in violation of the terms of this Agreement.

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Section 8.2 Termination of Confidentiality Agreement. Effective upon the date hereof, the Existing Confidentiality Agreement shall terminate and be of no further force or effect, and shall be superseded by the provisions of this Article VIII.

Section 8.3 Permitted Disclosure. In the event that the Receiving Party or its Affiliates or any of its or its Affiliates’ representatives are requested by a governmental or regulatory authority or required by Applicable Law, regulation or legal process (including the regulations of a stock exchange or governmental or regulatory authority or the order or ruling of a court, administrative agency or other government or regulatory body of competent jurisdiction) to disclose any Confidential Information, the Receiving Party shall promptly, to the extent permitted by Applicable Law, notify the Disclosing Party in writing of such request or requirement so that the Disclosing Party may seek an appropriate protective order or other appropriate remedy (and if the Disclosing Party seeks such an order or other remedy, the Receiving Party will provide such cooperation, at the Receiving Party’s sole expense, as the Disclosing Party shall reasonably request). If no such protective order or other remedy is obtained and the Receiving Party or its Affiliates or its or its Affiliates’ representatives are, in the view of their respective counsel (which may include their respective internal counsel), legally required to disclose Confidential Information, the Receiving Party or its Affiliates or its or its Affiliates’ representatives, as the case may be, shall only disclose that portion of the Confidential Information that their respective counsel advises that the Receiving Party or its Affiliates or its or its Affiliates’ representatives, as the case may be, are required to disclose and will exercise commercially reasonable efforts, at the Disclosing Party’s sole expense, to obtain reliable assurance that confidential treatment will be accorded to that portion of the Confidential Information that is being disclosed. In any event, the Receiving Party will not oppose action by the Disclosing Party to obtain an appropriate protective order or other reliable assurance that confidential treatment will be accorded the Confidential Information. Notwithstanding the foregoing, notice to the Disclosing Party shall not be required where disclosure is made (i) in response to a request by a governmental or regulatory authority having competent jurisdiction over the Receiving Party, its Affiliates or its or its Affiliates’ representatives, as the case may be, or (ii) in connection with a routine examination by a regulatory examiner, where in each case such request or examination does not expressly reference the Disclosing Party, its Affiliates, the Purchased Receivables or this Agreement. The Receiving Party may disclose Confidential Information to its Affiliates, its and their employees, directors, officers, contractors, agents, and representatives, and to potential or actual acquirers, merger partners, permitted assignees, investment bankers, investors, limited partners, partners, lenders, or other financing sources (including, in the case of the Sellers, any party evaluating the acquisition of any portion of the Purchased Receivables that are not included in the Purchased Receivables), and their respective directors, employees, contractors and agents; provided that such person or entity agrees to confidentiality and non-use obligations with respect thereto at least as stringent as those specified for in this Article VIII. Further, notwithstanding anything contained in this Article VIII to the contrary, the Sellers may disclose Confidential Information to the extent such disclosure is reasonably necessary to comply with the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, or with any rule, regulation or legal process promulgated by the SEC or a stock exchange, subject to the Sellers’ obligations set forth in Section 5.2.

Section 8.4 Other Relevant Obligations. In addition to, and without limiting, the Purchaser’s obligations under this Article VIII, the Purchaser shall fully comply with any confidentiality obligations of the Sellers or any of their Affiliates under the Covered License Agreements that are applicable to the Confidential Information.

ARTICLE IXTERMINATION

Section 9.1 Pre-Closing Termination.

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(a) This Agreement may be terminated and the transactions contemplated hereunder abandoned at any time prior to the Closing:

(i) by mutual written consent of the Purchaser and the Company;

(ii) by the Purchaser or the Company if the Closing does not occur on or before July 31, 2024 (the “Outside Date”); provided that the right to terminate this Agreement under this Section 9.1(a)(ii) shall not be available to any Party whose breach of a representation, warranty, covenant or agreement set forth in this Agreement has been the cause of or resulted in the failure of the Closing to occur on or before such date;

(iii) by the Purchaser, upon a breach of or failure to perform any covenant or agreement on the part of the Sellers set forth in this Agreement, or if any representation or warranty contained in ARTICLE III shall have become untrue, in either case, such that any of the conditions set forth in Section 6.2 would not be satisfied; provided, however, Purchaser may not terminate this Agreement pursuant to and in accordance with this Section 9.1(a)(iii) if such breach is curable and is cured by the earlier of the Outside Date and the date that is [***] after Purchaser notifies the Company in writing of such breach, failure to perform or inaccuracy;

(iv) by the Company, upon a breach of or failure to perform any covenant or agreement on the part of Purchaser set forth in this Agreement, or if any representation or warranty contained in ARTICLE IV shall have become untrue, in either case, such that any of the conditions set forth in Section 6.3 would not be satisfied; provided, however, the Company may not terminate this Agreement pursuant to and in accordance with this Section 9.1(a)(iv) if such breach is curable and is cured by the earlier of the Outside Date and the date that is [***] after the Company notifies Purchaser in writing of such breach, failure to perform or inaccuracy;

(b) Effect of Termination. In the event of a termination of this Agreement pursuant to and in accordance with Section 9.1, this Agreement shall immediately become void and of no further force and effect (other than Section 5.2, ARTICLE VII, ARTICLE VIII, this ARTICLE IX and ARTICLE X, which shall survive the termination of this Agreement) without any liability or obligation on the part of any Party, (i) other than liabilities and obligations under the Confidentiality Agreement and (ii) except that no such termination shall relieve any Party of any liability for Losses resulting from any actual fraud, intentional misrepresentation, intentional wrongful acts, intentional breach, bad faith or willful misconduct by such Party of this Agreement.

Section 9.2 Termination of Agreement Following the Closing.

(a) This Agreement shall terminate six (6) months following receipt by Purchaser of all payments of the Purchased Receivables to which it is entitled hereunder.

(b) Effect of Termination. Upon the termination of this Agreement pursuant to Section 9.2(a), this Agreement shall become void and of no further force and effect; provided, however, that (a) the provisions of Section 5.2, ARTICLE VII, ARTICLE VIII, this ARTICLE IX and ARTICLE X shall survive such termination and shall remain in full force and effect, and (b) nothing contained in this Section 9.2 shall relieve any Party from liability for any breach of this Agreement that occurs prior to such termination.

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ARTICLE XMISCELLANEOUS

Section 10.1 Specific Performance. Each Party acknowledges and agrees that, if it fails to perform any of its obligations under any of the Transaction Documents, the other Parties will have no adequate remedy at law. In such event, each Party agrees that the other Parties shall have the right, in addition to any other rights it may have (whether at law or in equity), to specific performance of this Agreement.

Section 10.2 Notices. All notices, consents, waivers and other communications hereunder shall be in writing and shall be effective (a) upon receipt when sent by registered or certified mail, return receipt requested, postage prepaid, with such receipt to be effective the date of delivery indicated on the return receipt, (b) upon receipt when sent by an overnight courier (costs prepaid and receipt requested), (c) on the date personally delivered to an authorized officer of the Party to which sent or (d) on the date transmitted by e-mail with a confirmation of receipt, addressed to the recipient as follows:

if to the Sellers, to:

Agenus Inc.

3 Forbes Road

Lexington, Massachusetts 02421-7305, USA

Attention: Chief Executive Officer
 

with copies to (which shall not constitute notice):

 

Agenus Inc.

3 Forbes Road

Lexington, Massachusetts 02421-7305, USA

Attention: General Counsel

E-mail: [***]

 

and

 

Meister Seelig & Fein PLLC

125 Park Avenue, 7th Floor

New York, NY 10017
Attention: Mark J. Seelig and Denis A. Dufresne
Email: [***]

 

if to the Purchaser, to:


Ligand Pharmaceuticals Incorporated
555 Heritage Drive, Suite 200

Jupiter, FL 92121
Attention: Chief Executive Officer
Email: [***]

with copy to (which shall not constitute notice):

Ligand Pharmaceuticals Incorporated
101 Huntington, Suite 250

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Boston, MA 02199
Attention: Senior Vice President, Investments and Business Development
Email: [***]

Ligand Pharmaceuticals Incorporated
3911 Sorrento Valley Boulevard, Suite 110

San Diego, CA 92121
Attention: General Counsel
Email: [***]

and

Morgan, Lewis & Bockius LLP
2222 Market Street
Philadelphia, PA 19103
Attention: Conor F. Larkin; Andrew R. Mariniello
Email: [***]

Each Party may, by notice given in accordance herewith to the other Party, designate any further or different address to which subsequent notices, consents, waivers and other communications shall be sent.

Section 10.3 Successors and Assigns. The Sellers shall not be entitled to assign any of its rights or delegate any of its obligations under this Agreement without the prior written consent of the Purchaser, subject to the proviso in clause (a) of Section 5.7. The Purchaser may, without the consent of the Sellers, assign any of its rights and delegate any of its obligations under this Agreement without restriction to any entity or entities; provided that in connection with any such assignment the Sellers shall be provided with an IRS Form W-9 or applicable IRS Form W-8, as appropriate, with respect to such assignee. Each Party shall give written notice to the other Parties of any assignment permitted by this Section 10.3 promptly[***] . The Sellers shall be under no obligation to reaffirm any representations, warranties or covenants made in this Agreement or any of the other Transaction Documents or take any other action in connection with any such assignment by the Purchaser. Any purported assignment of rights or delegation of obligations in violation of this Section 10.3 will be void. Subject to the foregoing, this Agreement will apply to, be binding upon, and inure to the benefit of, the successors and permitted assigns of the Parties.

Section 10.4 Independent Nature of Relationship. The relationship between the Sellers and the Purchaser is solely that of seller and purchaser, and neither the Sellers nor the Purchaser has any fiduciary or other special relationship with the other Party or any of its Affiliates. This Agreement is not a partnership or similar agreement, and nothing contained herein or in any other Transaction Document shall be deemed to constitute the Sellers and the Purchaser as a partnership, an association, a joint venture or any other kind of entity or legal form for any purposes, including any Tax purposes. The Parties agree that they shall not take any inconsistent position with respect to such treatment in a filing with any Governmental Authority.

Section 10.5 Entire Agreement. This Agreement, together with the Exhibits and Schedules hereto and the other Transaction Documents, constitute a complete and exclusive statement of the terms of agreement between the Parties, and supersede all prior agreements, understandings and negotiations, both written and oral, between the Parties, with respect to the subject matter of this Agreement. No representation, inducement, promise, understanding, condition or warranty not set forth herein (or in the Exhibits or Schedules hereto or the other Transaction Documents) has been made or relied upon by any Party.

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Section 10.6 Governing Law.

(a) THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE INTERNAL SUBSTANTIVE LAWS OF THE STATE OF NEW YORK WITHOUT REFERENCE TO THE RULES THEREOF RELATING TO CONFLICTS OF LAW OTHER THAN SECTION 5-1401 OF THE GENERAL OBLIGATIONS LAW OF THE STATE OF NEW YORK, AND THE OBLIGATIONS, RIGHTS AND REMEDIES OF THE PARTIES HEREUNDER SHALL BE DETERMINED IN ACCORDANCE WITH SUCH LAWS.

(b) Each Party irrevocably and unconditionally submits, for itself and its property, to the exclusive jurisdiction of (i) the United States District Court for the Southern District of New York and (ii) the Supreme Court of the State of New York, Borough of Manhattan, for purposes of any claim, action, suit or proceeding arising out of this Agreement, any of the other Transaction Documents or any of the transactions contemplated hereby or thereby, and agrees that all claims in respect thereof shall be heard and determined only in such courts. Each Party agrees to commence any such claim, action, suit or proceeding only in the United States District Court for the Southern District of New York or, if such claim, action, suit or proceeding cannot be brought in such court for jurisdictional reasons, in the Supreme Court of the State of New York, Borough of Manhattan, and agrees not to bring any such claim, action, suit or proceeding in any other court. Each Party hereby waives, and agrees not to assert in any such claim, action, suit or proceeding, to the fullest extent permitted by Applicable Law, any claim that (i) such Party is not personally subject to the jurisdiction of such courts, (ii) such Party and such Party’s property is immune from any legal process issued by such courts or (iii) any claim, action, suit or proceeding commenced in such courts is brought in an inconvenient forum. Each Party agrees that a final judgment in any such claim, action, suit or proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Applicable Law. Each Party acknowledges and agrees that this Section 10.6(b) constitutes a voluntary and bargained-for agreement between the Parties.

(c) The Parties agree that service of process in any claim, action, suit or proceeding referred to in Section 10.6(b) may be served on any Party anywhere in the world, including by sending or delivering a copy of such process to such Party in any manner provided for the giving of notices in Section 10.2. Nothing in this Agreement will affect the right of any Party to serve process in any other manner permitted by Applicable Law. Each Party waives personal service of any summons, complaint or other process, which may be made by any other means permitted by New York law.

Section 10.7 Waiver of Jury Trial. EACH PARTY HERETO HEREBY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY LEGAL PROCEEDING DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS AGREEMENT, OR THE TRANSACTIONS CONTEMPLATED HEREBY (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER THEORY). EACH PARTY HERETO (A) CERTIFIES THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF THE OTHER PARTY HERETO HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT THE OTHER PARTY HERETO WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTY HERETO HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 10.7.

Section 10.8 Severability. If one or more provisions of this Agreement are held to be invalid or unenforceable by a court of competent jurisdiction, such provision shall be excluded from this Agreement and the balance of this Agreement shall be interpreted as if such provision were so excluded and shall remain in full force and effect and be enforceable in accordance with its terms. Any provision of this Agreement held invalid or unenforceable only in part or degree by a court of competent jurisdiction shall remain in full force and effect to the extent not held invalid or unenforceable.

55

 


 

Section 10.9 Counterparts. This Agreement may be signed in any number of counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. This Agreement shall become effective when each Party shall have received a counterpart hereof signed by the other Party. Any counterpart may be executed by facsimile or other similar means of electronic transmission, including “PDF”, and such facsimile or other electronic transmission shall be deemed an original.

Section 10.10 Amendments; No Waivers. Neither this Agreement nor any term or provision hereof may be amended, supplemented, restated, waived, changed or modified except with the written consent of the Parties. No failure or delay by any Party in exercising any right, power or privilege hereunder shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege. No notice to or demand on any Party in any case shall entitle it to any notice or demand in similar or other circumstances. No waiver or approval hereunder shall, except as may otherwise be stated in such waiver or approval, be applicable to subsequent transactions. No waiver or approval hereunder shall require any similar or dissimilar waiver or approval thereafter to be granted hereunder. The rights and remedies herein provided shall be cumulative and not exclusive of any rights or remedies provided by Applicable Law.

Section 10.11 No Third Party Rights. Other than the Parties, no Person will have any legal or equitable right, remedy or claim under or with respect to this Agreement or any of the other Transaction Documents. This Agreement may be amended or terminated, and any provision of this Agreement may be waived, without the consent of any Person who is not a Party. The Sellers shall enforce any legal or equitable right, remedy or claim under or with respect to this Agreement for the benefit of the Seller Indemnified Parties and the Purchaser shall enforce any legal or equitable right, remedy or claim under or with respect to this Agreement for the benefit of the Purchaser Indemnified Parties.

Section 10.12 Table of Contents and Headings. The Table of Contents and headings of the Articles and Sections of this Agreement have been inserted for convenience of reference only, are not to be considered a part hereof and shall in no way modify or restrict any of the terms or provisions hereof.

{SIGNATURE PAGE FOLLOWS}

 

56

 


 

IN WITNESS WHEREOF, the Parties have executed this Agreement as of the day and year first written above.

SELLER PARTIES:

AGENUS, INC., a Delaware Corporation


By:
Name: Garo H. Armen, PhD
Title: Chairman and Chief Executive Officer
 

AGENUS ROYALTY FUND, LLC, a Delaware limited liability company


By:
Name: Garo H. Armen, PhD
Title: President
 

AGENUS HOLDINGS 2024, LLC, a Delaware limited liability company


By:
Name: Garo H. Armen, PhD
Title: President

 

 

[Signature Page to Purchase and Sale Agreement]

 


 

PURCHASER:

 

LIGAND PHARMACEUTICALS INCORPORATED

 

 

 

 

By: __________________________________________

Name: Todd Davis

Title: Chief Executive Officer

 

 

 

[Signature Page to Purchase and Sale Agreement]


 

Exhibit A-1

 

Form of Closing Date Bill of Sale – Company

 

 

[***]

 

 

 

 


 

Exhibit A-2

 

Form of Closing Date Bill of Sale – Royalty Fund

 

 

[***]

 

 

 

 


 

Exhibit B

 

Form of Contribution Agreement

 

 

[***]

 

 

 

 


 

Exhibit C

 

Disclosure Schedules

 

 

[***]

 

 

 

 


 

Exhibit D

 

Form of Pledge and Security Agreement

 

 

[***]

 

 

 

 


 

Exhibit E

 

Form of Intercompany License Agreement

 

 

[***]

 

 

 

 


 

Exhibit F

 

[***]

 

 

 

 

 

 


 

Exhibit G-1

 

Form of BOT/BAL Security Agreement

 

 

[***]

 

 

 

 


 

Exhibit G-2

 

Form of Security Agreement

 

 

[***]

 

 

 

 


 

Exhibit H-1

 

LICR Agreements

 

 

[***]

 

 

 

 


 

Exhibit H-2

 

Selexis Agreements

 

 

[***]

 

 

 

 


 

Exhibit I-1

 

BMS Agreement

 

 

[***]

 

 

 

 


 

Exhibit I-2

 

Gilead Agreement

 

 

[***]

 

 

 

 


 

Exhibit I-3

 

Incyte Agreement

 

 

[***]

 

 

 

 


 

Exhibit I-4

 

Merck Agreement

 

 

[***]

 

 

 

 


 

Exhibit I-5

 

UroGen Agreement

 

 

[***]

 

 

 

 


 

Exhibit J

 

Sellers Account

 

 

[***]

 

 

 

 


 

Exhibit K

 

Form of Product Sub Operating Agreement

 

 

[***]

 

 

 

 


 

Exhibit L

 

[***]

 

[***]

 

 

 

 


 

Schedule 1.1

 

 

 [***]

 [***]

 [***]

 [***]

 [***]

 [***]

 

 

 

 


 

 

Schedule 1.2

 

[***]

 

 

 

 


 

 

Schedule 1.3

 

[***]

 

 

 


EX-31.1 3 agen-ex31_1.htm EX-31.1 EX-31.1

 

Exhibit 31.1

Certification Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended

I, Garo H. Armen, certify that:

1.
I have reviewed this Quarterly Report on Form 10-Q of Agenus Inc.;
2.
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;
3.
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;
4.
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 U.S. 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
5.
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 function):
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 8, 2024

 

/s/ GARO H. ARMEN, PH.D.

 

 

 

Garo H. Armen, Ph.D.

 

 

 

Chief Executive Officer and Principal Executive Officer

 

 


EX-31.2 4 agen-ex31_2.htm EX-31.2 EX-31.2

 

Exhibit 31.2

Certification Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended

I, Christine M. Klaskin, certify that:

1.
I have reviewed this Quarterly Report on Form 10-Q of Agenus Inc.;
2.
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;
3.
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;
4.
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 U.S. 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
5.
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 function):
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 8, 2024

 

/s/ CHRISTINE M. KLASKIN

 

 

 

Christine M. Klaskin

 

 

 

VP, Finance and Principal Financial Officer

 

 


EX-32.1 5 agen-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 Agenus Inc. (the “Company”) for the quarterly period ended June 30, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned to his/her knowledge hereby certifies, pursuant to 18 U.S.C. Section 1350, that:

(i)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(ii)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

/s/ GARO H. ARMEN, PH.D.

 

Garo H. Armen, Ph.D.

 

Chief Executive Officer and Principal Executive Officer

 

 

 

/s/ CHRISTINE M. KLASKIN

 

Christine M. Klaskin

 

VP, Finance and Principal Financial Officer

Date: August 8, 2024

A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

The foregoing certification is being furnished to the Securities and Exchange Commission as an exhibit to the Report and should not be considered filed as part of the Report.