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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 SEPTEMBER 30, 2025
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 001-36509
AMPHASTAR PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
Delaware |
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33-0702205 |
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer |
11570 6th Street |
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Rancho Cucamonga, CA |
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91730 |
(Address of principal executive offices) |
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(zip code) |
(909) 980-9484
(Registrant’s telephone number, including area code)
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, a 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 |
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⌧ |
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Accelerated filer |
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◻ |
Non-accelerated filer |
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◻ |
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Smaller reporting company |
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◻ |
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Emerging growth company |
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◻ |
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 ⌧
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
||
Common Stock, par value $0.0001 per share |
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AMPH |
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The NASDAQ Stock Market LLC |
||
The number of shares outstanding of the registrant’s only class of common stock as of October 31, 2025 was 45,952,174.
AMPHASTAR PHARMACEUTICALS, INC.
TABLE OF CONTENTS
FORM 10-Q FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2025
Special Note About Forward-Looking Statements
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PAGE |
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Condensed Consolidated Balance Sheets as of September 30, 2025 and December 31, 2024 |
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1 |
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2 |
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3 |
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4 |
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5 |
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6 |
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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30 |
Item 3. Quantitative and Qualitative Disclosure about Market Risk |
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40 |
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40 |
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41 |
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41 |
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds |
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45 |
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45 |
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45 |
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45 |
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47 |
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48 |
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SPECIAL NOTE ABOUT FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, or Quarterly Report, contains “forward-looking statements” that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements relate to future events or future financial performance or condition and involve known and unknown risks, uncertainties and other factors that could cause actual results, levels of activity, performance or achievement to differ materially from those expressed or implied by the forward-looking statements. These forward-looking statements include, but are not limited to, statements about:
| ● | our expectations regarding the sales and marketing of our products; |
| ● | our expectations regarding our manufacturing and production and the integrity of our supply chain for our products, including the risks associated with our single source suppliers; |
| ● | our business and operations in general, including: adverse impacts of global conflicts and challenging macroeconomic conditions and market uncertainty on our business, financial condition, operations, cash flows and liquidity; |
| ● | our ability to attract, hire, and retain highly skilled personnel; |
| ● | interruptions to our manufacturing and production as a result of natural catastrophic events or other causes beyond our control such as power disruptions, pandemics, wars, terrorist attacks or other events; |
| ● | the timing and likelihood of U.S. Food and Drug Administration, or the FDA, approvals and regulatory actions on our product candidates, manufacturing activities and product marketing activities; |
| ● | our ability to advance product candidates in our platforms into successful and completed clinical trials and our subsequent ability to successfully commercialize our product candidates; |
| ● | cost and delays resulting from the extensive pharmaceutical regulations to which we are subject; |
| ● | our ability to compete in the development and marketing of our products and product candidates; |
| ● | our expectations regarding the business of our Chinese subsidiary, Amphastar Nanjing Pharmaceuticals, Ltd., or ANP; |
| ● | the potential for adverse application of environmental, health and safety and other laws and regulations on our operations; |
| ● | our expectations for market acceptance of our new products and proprietary drug delivery technologies, as well as those of our active pharmaceutical ingredient, or API, customers; |
| ● | the effects of reforms in healthcare regulations and reductions in pharmaceutical pricing, reimbursement and coverage; |
| ● | our expectations in obtaining insurance coverage and adequate reimbursement for our products from third-party payers; |
| ● | the amount of price concessions or exclusion of suppliers adversely affecting our business; |
| ● | variations in intellectual property laws, our ability to establish and maintain intellectual property protection for our products and our ability to successfully defend our intellectual property in cases of alleged infringement; |
| ● | the implementation of our business strategies, product development strategies and technology utilization; |
| ● | the potential for exposure to product liability claims; |
| ● | our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions, divestitures or investments, including the anticipated benefits of such acquisitions, divestitures or investments; |
| ● | our ability to expand internationally; |
| ● | economic and industry trends and trend analysis; |
| ● | our ability to remain in compliance with laws and regulations that currently apply or become applicable to our business both in the United States and internationally; |
| ● | the impact of trade tariffs, export or import restrictions, or other trade barriers; |
| ● | the impact of the Patient Protection and Affordable Care Act (as amended) and other legislative and regulatory healthcare reforms in the countries in which we operate including the potential for drug price controls; |
| ● | the impact of global and domestic tax reforms; |
| ● | the timing for completion and the validation of the new construction at our ANP and Amphastar facilities; |
| ● | the timing and extent of share buybacks; and |
| ● | our financial performance expectations, including our expectations regarding our backlog, revenue, cost of revenue, gross profit or gross margin, operating expenses, including changes in research and development, sales and marketing and general and administrative expenses, and our ability to achieve and maintain future profitability. |
You should read this Quarterly Report and the documents that we reference elsewhere in this Quarterly Report completely and with the understanding that our actual results may differ materially from what we expect as expressed or implied by our forward-looking statements. In light of the significant risks and uncertainties to which our forward-looking statements are subject, you should not place undue reliance on or regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, or at all. We discuss many of these risks and uncertainties in greater detail in this Quarterly Report and in our Annual Report on Form 10-K for the year ended December 31, 2024, particularly in Item 1A.
“Risk Factors.” These forward-looking statements represent our estimates and assumptions only as of the date of this Quarterly Report regardless of the time of delivery of this Quarterly Report, and such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this Quarterly Report.
Unless expressly indicated or the context requires otherwise, references in this Quarterly Report to “Amphastar,” “the Company,” “we,” “our,” and “us” refer to Amphastar Pharmaceuticals, Inc. and our subsidiaries.
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
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September 30, |
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December 31, |
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2025 |
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2024 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
216,265 |
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$ |
151,609 |
Restricted cash |
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235 |
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235 |
Short-term investments |
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59,944 |
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70,036 |
Restricted short-term investments |
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2,200 |
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2,200 |
Accounts receivable, net |
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146,808 |
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136,289 |
Inventories, net |
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185,932 |
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153,741 |
Income tax refunds and deposits |
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2,065 |
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1,747 |
Prepaid expenses and other assets |
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26,021 |
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18,214 |
Total current assets |
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639,470 |
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534,071 |
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Property, plant, and equipment, net |
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308,689 |
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297,345 |
Finance lease right-of-use assets |
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259 |
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383 |
Operating lease right-of-use assets |
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44,577 |
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46,899 |
Goodwill and intangible assets, net |
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572,237 |
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590,660 |
Long-term investments |
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— |
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10,996 |
Other assets |
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29,866 |
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25,992 |
Deferred tax assets |
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71,124 |
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71,124 |
Total assets |
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$ |
1,666,222 |
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$ |
1,577,470 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable and accrued liabilities |
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$ |
190,844 |
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$ |
157,057 |
Income taxes payable |
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5,633 |
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9,664 |
Current portion of long-term debt |
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923 |
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234 |
Current portion of operating lease liabilities |
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7,827 |
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6,804 |
Total current liabilities |
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205,227 |
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173,759 |
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Long-term reserve for income tax liabilities |
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6,957 |
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6,957 |
Long-term debt, net of current portion and unamortized debt issuance costs |
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608,582 |
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601,630 |
Long-term operating lease liabilities, net of current portion |
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39,441 |
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41,881 |
Other long-term liabilities |
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29,269 |
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20,945 |
Total liabilities |
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889,476 |
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845,172 |
Commitments and contingencies (see Note 17) |
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Stockholders’ equity: |
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Preferred stock: par value $0.0001; 20,000,000 shares authorized; no shares issued and outstanding |
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— |
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— |
Common stock: par value $0.0001; 300,000,000 shares authorized; 61,677,781 and 46,348,863 shares issued and outstanding, respectively, as of September 30, 2025 and 60,847,124 and 47,617,691 shares issued and outstanding, respectively, as of December 31, 2024 |
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6 |
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6 |
Additional paid-in capital |
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527,215 |
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505,400 |
Retained earnings |
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642,451 |
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568,787 |
Accumulated other comprehensive loss |
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(5,273) |
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(9,181) |
Treasury stock |
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(387,653) |
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(332,714) |
Total stockholders' equity |
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776,746 |
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732,298 |
Total liabilities and stockholders’ equity |
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$ |
1,666,222 |
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$ |
1,577,470 |
See Accompanying Notes to Condensed Consolidated Financial Statements.
-1-
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited; in thousands, except per share data)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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Net revenues: |
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Product revenues, net |
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$ |
191,840 |
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$ |
188,819 |
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$ |
536,782 |
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$ |
525,836 |
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Other revenues |
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— |
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2,395 |
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— |
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19,608 |
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Total net revenues |
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191,840 |
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191,214 |
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536,782 |
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545,444 |
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Cost of revenues |
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93,194 |
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89,273 |
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266,395 |
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258,237 |
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Gross profit |
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98,646 |
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101,941 |
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270,387 |
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287,207 |
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Operating expenses: |
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Selling, distribution, and marketing |
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11,505 |
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8,995 |
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33,606 |
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27,378 |
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General and administrative |
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39,467 |
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14,821 |
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69,454 |
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43,782 |
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Research and development |
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22,354 |
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21,077 |
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62,530 |
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55,772 |
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Total operating expenses |
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73,326 |
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44,893 |
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165,590 |
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126,932 |
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Income from operations |
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25,320 |
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57,048 |
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104,797 |
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160,275 |
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Non-operating expenses: |
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Interest income |
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2,246 |
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2,427 |
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6,256 |
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8,320 |
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Interest expense |
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|
(6,284) |
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|
(6,698) |
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|
(18,851) |
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|
(23,918) |
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Other income (expenses), net |
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|
231 |
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|
(5,094) |
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(492) |
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|
1,125 |
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Total non-operating expenses, net |
|
|
(3,807) |
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|
(9,365) |
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|
(13,087) |
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(14,473) |
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|
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Income before income taxes |
|
|
21,513 |
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|
47,683 |
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|
91,710 |
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|
145,802 |
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Income tax provision |
|
|
4,163 |
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|
7,254 |
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|
18,045 |
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|
23,674 |
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Income before equity in losses of unconsolidated affiliate |
|
|
17,350 |
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|
40,429 |
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|
73,665 |
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|
122,128 |
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|
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Equity in losses of unconsolidated affiliate |
|
|
— |
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— |
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— |
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(573) |
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Net income |
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$ |
17,350 |
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$ |
40,429 |
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$ |
73,665 |
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$ |
121,555 |
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Net income per share: |
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Basic |
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$ |
0.38 |
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$ |
0.83 |
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$ |
1.57 |
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$ |
2.50 |
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Diluted |
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$ |
0.37 |
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$ |
0.78 |
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$ |
1.52 |
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$ |
2.32 |
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Weighted-average shares used to compute net income per share: |
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Basic |
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46,474 |
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48,621 |
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|
47,021 |
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48,580 |
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Diluted |
|
|
47,677 |
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|
51,862 |
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|
48,565 |
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|
52,307 |
|
See Accompanying Notes to Condensed Consolidated Financial Statements.
-2-
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(Unaudited; in thousands)
|
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Three Months Ended |
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Nine Months Ended |
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||||||||
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September 30, |
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September 30, |
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||||||||
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2025 |
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2024 |
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2025 |
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2024 |
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||||
Net income |
|
$ |
17,350 |
|
$ |
40,429 |
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$ |
73,665 |
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$ |
121,555 |
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|
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|
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Other comprehensive income (loss), net of income taxes |
|
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|
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|
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|
|
|
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Foreign currency translation adjustment |
|
|
88 |
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|
5 |
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|
3,908 |
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(343) |
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Total other comprehensive income (loss) |
|
|
88 |
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|
5 |
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|
3,908 |
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(343) |
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|
|
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|
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Total comprehensive income |
|
$ |
17,438 |
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$ |
40,434 |
|
$ |
77,573 |
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$ |
121,212 |
|
See Accompanying Notes to Condensed Consolidated Financial Statements.
-3-
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited; in thousands, except share data)
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Common Stock |
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Accumulated |
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Treasury Stock |
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Additional |
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Other |
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Paid-in |
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Retained |
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Comprehensive |
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|||
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Shares |
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Amount |
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Capital |
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Earnings |
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Loss |
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Shares |
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Amount |
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Total |
||||||
Balance as of December 31, 2024 |
|
60,847,124 |
|
$ |
6 |
|
$ |
505,400 |
|
$ |
568,787 |
|
$ |
(9,181) |
|
(13,229,433) |
|
$ |
(332,714) |
|
|
732,298 |
Net income |
|
— |
|
|
— |
|
|
— |
|
|
25,285 |
|
|
— |
|
— |
|
|
— |
|
|
25,285 |
Other comprehensive income |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,212 |
|
— |
|
|
— |
|
|
1,212 |
Purchase of treasury stock |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
(393,836) |
|
|
(11,219) |
|
|
(11,219) |
Issuance of common stock in connection with the Company's equity plans |
|
446,322 |
|
|
— |
|
|
(4,685) |
|
|
— |
|
|
— |
|
— |
|
|
— |
|
|
(4,685) |
Share-based compensation expense |
|
— |
|
|
— |
|
|
8,393 |
|
|
— |
|
|
— |
|
— |
|
|
— |
|
|
8,393 |
Balance as of March 31, 2025 |
|
61,293,446 |
|
$ |
6 |
|
$ |
509,108 |
|
$ |
594,071 |
|
$ |
(7,969) |
|
(13,623,269) |
|
$ |
(343,933) |
|
$ |
751,283 |
Net income |
|
— |
|
|
— |
|
|
— |
|
|
31,030 |
|
|
— |
|
— |
|
|
— |
|
|
31,030 |
Other comprehensive income |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
2,608 |
|
— |
|
|
— |
|
|
2,608 |
Purchase of treasury stock |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
(1,541,860) |
|
|
(39,000) |
|
|
(39,000) |
Issuance of treasury stock in connection with the Company's equity plans |
|
— |
|
|
— |
|
|
(88) |
|
|
— |
|
|
— |
|
6,131 |
|
|
88 |
|
|
— |
Issuance of common stock in connection with the Company's equity plans |
|
356,161 |
|
|
— |
|
|
5,179 |
|
|
— |
|
|
— |
|
— |
|
|
— |
|
|
5,179 |
Share-based compensation expense |
|
— |
|
|
— |
|
|
6,382 |
|
|
— |
|
|
— |
|
— |
|
|
— |
|
|
6,382 |
Balance as of June 30, 2025 |
|
61,649,607 |
|
$ |
6 |
|
$ |
520,581 |
|
$ |
625,102 |
|
$ |
(5,361) |
|
(15,158,998) |
|
$ |
(382,846) |
|
$ |
757,482 |
Net income |
|
— |
|
|
— |
|
|
— |
|
|
17,350 |
|
|
— |
|
— |
|
|
— |
|
|
17,350 |
Other comprehensive income |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
88 |
|
— |
|
|
— |
|
|
88 |
Purchase of treasury stock |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
(172,920) |
|
|
(4,850) |
|
|
(4,850) |
Issuance of treasury stock in connection with the Company's equity plans |
|
— |
|
|
— |
|
|
(42) |
|
|
— |
|
|
— |
|
3,000 |
|
|
42 |
|
|
— |
Issuance of common stock in connection with the Company's equity plans |
|
28,174 |
|
|
— |
|
|
379 |
|
|
— |
|
|
— |
|
— |
|
|
— |
|
|
379 |
Share-based compensation expense |
|
— |
|
|
— |
|
|
6,297 |
|
|
— |
|
|
— |
|
— |
|
|
— |
|
|
6,297 |
Balance as of September 30, 2025 |
|
61,677,781 |
|
$ |
6 |
|
$ |
527,215 |
|
$ |
642,451 |
|
$ |
(5,273) |
|
(15,328,918) |
|
$ |
(387,653) |
|
$ |
776,746 |
|
|
Common Stock |
|
|
|
|
|
|
|
Accumulated |
|
Treasury Stock |
|
|
|
|||||||
|
|
|
|
|
|
|
Additional |
|
|
|
|
Other |
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
Paid-in |
|
Retained |
|
Comprehensive |
|
|
|
|
|
|
|
|
|||
|
|
Shares |
|
Amount |
|
Capital |
|
Earnings |
|
Loss |
|
Shares |
|
Amount |
|
Total |
||||||
Balance as of December 31, 2023 |
|
59,390,194 |
|
$ |
6 |
|
$ |
486,056 |
|
$ |
409,268 |
|
$ |
(8,478) |
|
(11,321,313) |
|
$ |
(247,431) |
|
|
639,421 |
Net income |
|
— |
|
|
— |
|
|
— |
|
|
43,177 |
|
|
— |
|
— |
|
|
— |
|
|
43,177 |
Other comprehensive loss |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(291) |
|
— |
|
|
— |
|
|
(291) |
Issuance of treasury stock in connection with the Company's equity plans |
|
— |
|
|
— |
|
|
(33) |
|
|
— |
|
|
— |
|
2,197 |
|
|
33 |
|
|
— |
Issuance of common stock in connection with the Company's equity plans |
|
770,265 |
|
|
— |
|
|
(17,311) |
|
|
— |
|
|
— |
|
— |
|
|
— |
|
|
(17,311) |
Share-based compensation expense |
|
— |
|
|
— |
|
|
7,360 |
|
|
— |
|
|
— |
|
— |
|
|
— |
|
|
7,360 |
Balance as of March 31, 2024 |
|
60,160,459 |
|
$ |
6 |
|
$ |
476,072 |
|
$ |
452,445 |
|
$ |
(8,769) |
|
(11,319,116) |
|
$ |
(247,398) |
|
$ |
672,356 |
Net income |
|
— |
|
|
— |
|
|
— |
|
|
37,949 |
|
|
— |
|
— |
|
|
— |
|
|
37,949 |
Other comprehensive loss |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(57) |
|
— |
|
|
— |
|
|
(57) |
Purchase of treasury stock |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
(207,288) |
|
|
(8,498) |
|
|
(8,498) |
Issuance of treasury stock in connection with the Company's equity plans |
|
— |
|
|
— |
|
|
(97) |
|
|
— |
|
|
— |
|
6,363 |
|
|
97 |
|
|
— |
Issuance of common stock in connection with the Company's equity plans |
|
321,996 |
|
|
— |
|
|
5,816 |
|
|
— |
|
|
— |
|
— |
|
|
— |
|
|
5,816 |
Share-based compensation expense |
|
— |
|
|
— |
|
|
5,780 |
|
|
— |
|
|
— |
|
— |
|
|
— |
|
|
5,780 |
Balance as of June 30, 2024 |
|
60,482,455 |
|
$ |
6 |
|
$ |
487,571 |
|
$ |
490,394 |
|
$ |
(8,826) |
|
(11,520,041) |
|
$ |
(255,799) |
|
$ |
713,346 |
Net income |
|
— |
|
|
— |
|
|
— |
|
|
40,429 |
|
|
— |
|
— |
|
|
— |
|
|
40,429 |
Other comprehensive income |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
5 |
|
— |
|
|
— |
|
|
5 |
Purchase of treasury stock |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
(797,038) |
|
|
(34,958) |
|
|
(34,958) |
Issuance of common stock in connection with the Company's equity plans |
|
207,621 |
|
|
— |
|
|
3,260 |
|
|
— |
|
|
— |
|
— |
|
|
— |
|
|
3,260 |
Share-based compensation expense |
|
— |
|
|
— |
|
|
5,596 |
|
|
— |
|
|
— |
|
— |
|
|
— |
|
|
5,596 |
Balance as of September 30, 2024 |
|
60,690,076 |
|
$ |
6 |
|
$ |
496,427 |
|
$ |
530,823 |
|
$ |
(8,821) |
|
(12,317,079) |
|
$ |
(290,757) |
|
$ |
727,678 |
See Accompanying Notes to Condensed Consolidated Financial Statements.
-4-
AMPHASTAR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; in thousands)
|
|
Nine Months Ended |
||||
|
|
September 30, |
||||
|
|
2025 |
|
2024 |
||
Cash Flows From Operating Activities: |
|
|
|
|
|
|
Net income |
|
$ |
73,665 |
|
$ |
121,555 |
Reconciliation to net cash provided by operating activities: |
|
|
|
|
|
|
Loss on disposal of assets |
|
|
33 |
|
|
110 |
Loss on interest rate swaps and foreign currency transactions, net |
|
|
2,021 |
|
|
1,496 |
Depreciation of property, plant, and equipment |
|
|
23,576 |
|
|
20,992 |
Amortization of intangible assets |
|
|
18,778 |
|
|
18,539 |
Operating lease right-of-use asset amortization |
|
|
4,860 |
|
|
3,010 |
Amortization of discounts, premiums, and debt issuance costs |
|
|
2,489 |
|
|
5,308 |
Equity in losses of unconsolidated affiliate |
|
|
— |
|
|
573 |
Share-based compensation expense |
|
|
21,072 |
|
|
18,736 |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Accounts receivable, net |
|
|
(9,599) |
|
|
(24,577) |
Inventories |
|
|
(30,072) |
|
|
(24,329) |
Prepaid expenses and other assets |
|
|
(13,358) |
|
|
(10,489) |
Income tax refunds, deposits, and payable, net |
|
|
(4,345) |
|
|
(5,147) |
Operating lease liabilities |
|
|
(3,953) |
|
|
(2,866) |
Accounts payable and accrued liabilities |
|
|
38,085 |
|
|
61,451 |
Net cash provided by operating activities |
|
|
123,252 |
|
|
184,362 |
|
|
|
|
|
|
|
Cash Flows From Investing Activities: |
|
|
|
|
|
|
BAQSIMI® acquisition |
|
|
— |
|
|
(129,000) |
Purchases and construction of property, plant, and equipment |
|
|
(26,610) |
|
|
(28,630) |
Purchase of intangible assets |
|
|
(2,250) |
|
|
— |
Purchase of investments |
|
|
(50,825) |
|
|
(47,507) |
Maturity of investments |
|
|
73,849 |
|
|
118,538 |
Deposits and other assets |
|
|
(3,927) |
|
|
(2,653) |
Net cash used in investing activities |
|
|
(9,763) |
|
|
(89,252) |
|
|
|
|
|
|
|
Cash Flows From Financing Activities: |
|
|
|
|
|
|
Proceeds from equity plans, net of withholding tax payments |
|
|
873 |
|
|
(8,234) |
Purchase of treasury stock |
|
|
(55,070) |
|
|
(43,456) |
Debt issuance costs |
|
|
(679) |
|
|
(838) |
Proceeds from borrowing under lines of credit |
|
|
5,943 |
|
|
13,565 |
Principal payments on long-term debt |
|
|
(119) |
|
|
(8,148) |
Net cash used in financing activities |
|
|
(49,052) |
|
|
(47,111) |
|
|
|
|
|
|
|
Effect of exchange rate changes on cash |
|
|
219 |
|
|
(179) |
|
|
|
|
|
|
|
Net increase in cash, cash equivalents, and restricted cash |
|
|
64,656 |
|
|
47,820 |
|
|
|
|
|
|
|
Cash, cash equivalents, and restricted cash at beginning of period |
|
|
151,844 |
|
|
144,531 |
|
|
|
|
|
|
|
Cash, cash equivalents, and restricted cash at end of period |
|
$ |
216,500 |
|
$ |
192,351 |
|
|
|
|
|
|
|
Noncash Investing and Financing Activities: |
|
|
|
|
|
|
Capital expenditures included in accounts payable |
|
$ |
6,528 |
|
$ |
5,120 |
Operating lease right-of-use assets in exchange for operating lease liabilities |
|
$ |
2,537 |
|
$ |
2,386 |
|
|
|
|
|
|
|
Supplemental Disclosures of Cash Flow Information: |
|
|
|
|
|
|
Interest paid, net of capitalized interest |
|
$ |
19,137 |
|
$ |
22,389 |
Income taxes paid |
|
$ |
22,308 |
|
$ |
29,000 |
See Accompanying Notes to Condensed Consolidated Financial Statements.
-5-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 1. General
Amphastar Pharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, hereinafter referred to as the “Company”), is a biopharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products, including products with high technical barriers to market entry. Additionally, the Company sells insulin active pharmaceutical ingredient, or API, products. Most of the Company’s products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. The Company’s insulin API products are sold to other pharmaceutical companies for use in their own products and are being used by the Company in the development of injectable pharmaceutical products. The Company’s over-the-counter inhalation product, Primatene MIST®, is primarily distributed through drug retailers.
The unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements of the Company for the year ended December 31, 2024 and the notes thereto as filed with the Securities and Exchange Commission, or SEC, in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, have been condensed or omitted from the accompanying condensed consolidated financial statements. The accompanying year-end condensed consolidated balance sheet was derived from the audited financial statements. The accompanying interim financial statements are unaudited, but reflect all adjustments which are, in the opinion of management, necessary for a fair presentation of the Company’s consolidated financial position, results of operations, comprehensive income, stockholders’ equity, and cash flows for the periods presented. Unless otherwise noted, all such adjustments are of a normal, recurring nature. The Company’s results of operations, comprehensive income and cash flows for the interim periods are not necessarily indicative of the results of operations and cash flows that it may achieve in future periods.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries, and are prepared in accordance with GAAP. All intercompany activity has been eliminated in the preparation of the condensed consolidated financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, which are of a normal recurring nature, necessary to present fairly the consolidated financial position, results of operations, and cash flows of the Company.
The Company’s subsidiaries include: (1) International Medication Systems, Limited, or IMS, (2) Armstrong Pharmaceuticals, Inc., or Armstrong, (3) Amphastar Nanjing Pharmaceuticals Inc., or ANP, (4) Amphastar France Pharmaceuticals, S.A.S., or AFP, (5) Amphastar UK Ltd., or AUK, and (6) International Medication Systems (UK) Limited, or IMS UK.
Use of Estimates
The preparation of the condensed consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results could differ from those estimates. The principal accounting estimates include: fair value of financial instruments, allowance for credit losses, discounts, provision for chargebacks and rebates, provision for product returns, adjustment of inventory to its net realizable value, impairment of investments, long-lived and intangible assets and goodwill, litigation reserves, stock price volatility for share-based compensation expense, valuation allowances for deferred tax assets, and liabilities for uncertain income tax positions.
-6-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Foreign Currency
The functional currency of the Company, its domestic subsidiaries, its Chinese subsidiary ANP, and its U.K. subsidiary, AUK, is the U.S. Dollar, or USD. ANP maintains its books of record in Chinese yuan. These books are remeasured into the functional currency of USD using the current or historical exchange rates. The resulting currency remeasurement adjustments and other transactional foreign currency exchange gains and losses are reflected in the Company’s condensed consolidated statements of operations.
The Company’s French subsidiary, AFP, maintains its books of record in euros. AUK’s subsidiary, IMS UK, maintains its books of record in British pounds. These local currencies have been determined to be the subsidiaries’ respective functional currencies. Activities in the statements of operations are translated to USD using average exchange rates during the period. Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date. Equity is translated at the prevailing rate of exchange at the date of the equity transactions. Translation adjustments are reflected in stockholders’ equity and are included as a component of other comprehensive income. The unrealized gains or losses of intercompany foreign currency transactions that are of a long-term investment nature are reported in other accumulated comprehensive income.
The unrealized gains and losses of intercompany foreign currency transactions that are of a long-term investment nature were a $0.1 million gain and a $4.0 million gain for the three and nine months ended September 30, 2025, respectively. For the three and nine months ended September 30, 2024, the unrealized gains and losses of intercompany foreign currency transactions that are of a long-term investment nature were a $1.4 million gain and a $0.4 million gain, respectively.
Comprehensive Income
The Company’s comprehensive income includes foreign currency translation gains and losses.
Advertising Expense
Advertising expenses, primarily associated with Primatene MIST®, are recorded as they are incurred, except for expenses related to the development of a major commercial or media campaign, which are expensed in the period in which the commercial or campaign is first presented, and are reflected as a component of selling, distribution and marketing in the Company’s condensed consolidated statements of operations. For the three and nine months ended September 30, 2025, advertising expenses were $2.6 million and $8.1 million, respectively. For the three and nine months ended September 30, 2024, advertising expenses were $2.5 million and $7.8 million, respectively.
Financial Instruments
The Company’s accompanying condensed consolidated balance sheets include the following financial instruments: cash and cash equivalents, restricted cash, accounts receivable, accounts payable, accrued expenses, short-term borrowings, and long-term obligations. The Company considers the carrying amounts of current assets and liabilities on the condensed consolidated balance sheets to approximate the fair value of these financial instruments due to the short maturity of these items. The carrying value of the Company’s long-term obligations, with the exception of the convertible debt (see Note 13), approximates their fair value, as the stated borrowing rates are comparable to rates currently offered to the Company for instruments with similar maturities. The Company at times enters into interest rate swap contracts to manage its exposure to interest rate changes and its overall cost of long-term debt. The Company’s interest rate swap contracts exchange the variable interest rates for fixed interest rates.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash, money market accounts, certificates of deposit and highly liquid investments with original maturities of three months or less.
-7-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Investments
Investments as of September 30, 2025 and December 31, 2024 consisted of certificates of deposit and investment grade corporate, agency and municipal bonds with original maturity dates between three and nineteen months.
Restricted Cash
Restricted cash is collateral required for the Company to guarantee certain vendor payments in France. As of September 30, 2025 and December 31, 2024, the restricted cash balance was $0.2 million.
Restricted Short-Term Investments
Restricted short-term investments consist of certificates of deposit that are collateral for standby letters of credit to qualify for workers’ compensation self-insurance. The certificates of deposit have original maturities greater than three months, but less than one year. As of September 30, 2025 and December 31, 2024, the balance of restricted short-term investments was $2.2 million.
Deferred Income Taxes
The Company utilizes the liability method of accounting for income taxes, under which deferred taxes are determined based on the temporary differences between the financial statements and the tax basis of assets and liabilities using enacted tax rates. A valuation allowance is recorded when it is more likely than not that the deferred tax assets will not be realized.
Debt Issuance Costs
Debt issuance costs related to non-revolving debt are recognized as a reduction to the related debt balance in the accompanying condensed consolidated balance sheets and amortized to interest expense over the contractual term of the related debt using the effective interest method. Debt issuance costs associated with revolving debt are capitalized within other long-term assets on the condensed consolidated balance sheets and are amortized to interest expense over the term of the related revolving debt.
Convertible Debt
The Company accounts for its convertible debt instruments as a single unit of account, a liability, because the Company concluded that the conversion features do not require bifurcation as a derivative under Accounting Standards Codification, or ASC, 815-15, Derivatives and Hedging and the Company did not issue its convertible debt instruments at a substantial premium.
In accordance with Accounting Standards Update, or ASU, 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, the Company evaluates convertible debt instruments to determine if the conversion feature is freestanding or embedded. If the conversion feature does not require derivative treatment under ASC 815, the instrument is evaluated under ASC 470-20, “Debt with Conversion and Other Options” for consideration of any beneficial conversion features. If no beneficial conversion features exist that require separate recognition, convertible debt instruments are accounted for as a single liability measured at its amortized cost as long as no other features require separation and recognition as derivatives.
Capitalized Software Implementation Costs
The Company capitalizes certain software implementation costs incurred under a cloud computing arrangement that is a service contract. Costs incurred during the preliminary project phase or planning and research phase are expensed as incurred.
-8-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Costs incurred during the application development stage related to the implementation of the hosting arrangement are capitalized and included within other assets on the accompanying condensed consolidated balance sheets. Capitalized implementation costs are amortized on a straight-line basis over the term of the associated hosting arrangement when ready for its intended use. Capitalized implementation costs were $4.9 million as of September 30, 2025 and are included in other long-term assets in the Company’s condensed consolidated balance sheet. As of December 31, 2024, the Company did not have any capitalized implementation costs. For the three and nine months ended September 30, 2025 and 2024, the Company did not record any amortization expense for capitalized implementation costs.
Litigation, Commitments and Contingencies
Litigation, commitments and contingencies are accrued when management, after considering the facts and circumstances of each matter as then known, has determined it is probable a liability will be found to have been incurred and the amount of the loss can be reasonably estimated. When only a range of amounts is reasonably estimable and no amount within the range is more likely than another, the low end of the range is recorded. Legal fees are expensed as incurred. Due to the inherent uncertainties surrounding gain contingencies, the Company generally does not recognize potential gains until they are realized.
Recent Accounting Pronouncements
In December 2023, the Financial Accounting Standard Board, or FASB, issued ASU 2023-09, Income taxes (Topic 740): Improvements to Income Tax Disclosures, which requires entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation table, as well as disclosure of income taxes paid disaggregated by jurisdiction. The disclosure requirements will be applied prospectively, with retrospective application permitted. The standard is effective for the Company for fiscal years beginning after December 15, 2024, with early adoption permitted. The adoption will impact the Company’s disclosure, but is not expected to have a material impact on the Company’s results of operations or financial condition.
In November 2024, the FASB issued ASU 2024-03, Income Statement Reporting-Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40), Disaggregation of Income Statement Expenses. The standard update improves the disclosures about a public business entity’s expenses by requiring more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation and amortization) included within income statement expense captions. The guidance will be effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The standard updates are to be applied prospectively with the option for retrospective application. The Company is currently evaluating the impact of disclosure requirements related to the new standard on its financial statements.
In September 2025, the FASB issued ASU 2025-06, Intangibles - Goodwill and Other-Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software. The ASU amends the existing standard to remove all references to prescriptive and sequential software development project stages. Under this guidance, eligible software development costs will begin to be capitalized when management has authorized and committed to funding the software project, and it is probable that the project will be completed and the software will be used to perform the function intended. In evaluating whether it is probable the project will be completed; management is required to consider whether there is significant uncertainty associated with the development activities of the software. This guidance is effective for all annual periods beginning after December 15, 2027, and for interim periods within those annual reporting periods, with early adoption permitted. The guidance may be applied on a prospective basis, a modified basis for in-process projects, or a retrospective basis. The Company is currently evaluating the impact of disclosure requirements related to the new standard on its financial statements.
-9-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 3. Revenue Recognition
Product revenues, net
In accordance with ASC 606 Revenue from Contracts with Customers, revenue is recognized at the time that the Company’s customers obtain control of the promised goods and we satisfy the Company’s performance obligations, which is generally at the time of product delivery to the Company’s customers. In some cases, the Company’s performance obligation is satisfied, and revenue is recognized at the time of shipment when stipulated by the terms of the sale agreements.
The consideration to which the Company expects to be entitled includes a stated list price, less various forms of variable consideration including provision for chargebacks and rebates, accrual for product returns, prompt pay discounts, distributor fees, patient co-pay assistance, and other related deductions. These deductions to product sales are referred to as gross-to-net deductions and are estimated and recorded in the period in which the related product sales occur. Payment terms offered to customers generally range from 30 to 75 days; however, payment terms differ by jurisdiction, by customer and, in some instances, by type of product. Revenues from product sales, net of gross-to-net deductions, are recorded only to the extent a significant reversal in the amount of cumulative revenue recognized is not probable of occurring when the uncertainty associated with gross-to-net deductions is subsequently resolved. Taxes assessed by governmental authorities and collected from customers are excluded from product sales. If the Company expects, at contract inception, that the period between the transfer of control and corresponding payment from the customer will be one year or less, the amount of consideration is not adjusted for the effects of a financing component. Shipping and handling activities are considered to be fulfillment activities rather than a separate performance obligation and are recorded within selling, distribution and marketing expenses in the accompanying condensed consolidated statements of operations.
Provision for Chargebacks and Rebates: The provision for chargebacks and rebates is a significant estimate used in the recognition of revenue. Wholesaler chargebacks relate to sales terms under which the Company agrees to reimburse wholesalers for differences between the gross sales prices at which the Company sells its products to wholesalers and the actual prices of such products that wholesalers resell under the Company’s various contractual arrangements with third parties such as hospitals, group purchasing organizations and pharmacy benefit managers in the United States. Rebates include primarily amounts paid to retailers, payers, and providers in the United States, including those paid to Medicare and state Medicaid programs, and are based on contractual arrangements or statutory requirements. The Company estimates chargebacks and rebates using the expected value method at the time of sale to customers based on inventory stocking levels, historical chargeback and rebate rates, and current contract pricing.
The provision for chargebacks and rebates is reflected as a component of product revenues, net. The following table is an analysis of the chargeback and rebate provision:
|
|
Nine Months Ended |
||||
|
|
September 30, |
||||
|
|
2025 |
|
2024 |
||
|
|
(in thousands) |
||||
Beginning balance |
|
$ |
60,331 |
|
$ |
27,920 |
Provision for chargebacks and rebates |
|
|
299,315 |
|
|
211,791 |
Credits and payments issued to third parties |
|
|
(299,660) |
|
|
(178,834) |
Ending balance |
|
$ |
59,986 |
|
$ |
60,877 |
Changes in the chargeback provision from period to period are primarily dependent on the Company’s sales to its wholesalers, the level of inventory held by wholesalers, and the wholesalers’ customer mix. Changes in the rebate provision from period to period are primarily dependent on retailers’ and other indirect customers’ purchases. The approach that the Company uses to estimate chargebacks and rebates has been consistently applied for all periods presented. Variations in estimates have been historically small. The Company continually monitors the provision for chargebacks and rebates and makes adjustments when it believes that the actual chargebacks and rebates may differ from the estimates.
-10-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Accounts receivable and/or accounts payable and accrued liabilities are reduced and/or increased by the chargebacks and rebate amounts depending on whether the Company has the right to offset with the customer.
The provision for chargebacks and rebates is included in the following balance sheet accounts:
|
September 30, |
|
December 31, |
||
|
2025 |
|
2024 |
||
|
(in thousands) |
||||
Reduction to accounts receivable, net |
$ |
25,046 |
|
$ |
26,258 |
Accounts payable and accrued liabilities |
|
34,940 |
|
|
34,073 |
Total |
$ |
59,986 |
|
$ |
60,331 |
Accrual for Product Returns: The Company offers certain customers the right to return qualified excess or expired inventory for full or partial credit. The Company’s product returns primarily consist of the returns of expired products from sales made in prior periods. Returned products cannot be resold. At the time product revenue is recognized, the Company records an accrual for product returns estimated using the expected value method. The accrual is based, in part, upon the historical relationship of product returns to sales and customer contract terms. The Company also assesses other factors that could affect product returns including market conditions, product obsolescence, and new competition.
Prompt Pay Discounts: The Company provides its customers with a percentage discount on their invoice if the customers pay within the agreed upon timeframe. The Company generally expects that its customers will earn such prompt pay discounts. The Company estimates the probability of customers paying promptly based on the percentage of discount outlined in the purchase agreement between the two parties, and deducts the full amount of these discounts from gross product sales and accounts receivable at the time revenue is recognized.
Distributor Fees: The Company engages with wholesalers to distribute its products to end customers. The Company pays the wholesalers a fee for services such as: inventory management, chargeback administration, and service level commitments. The Company estimates the amount of distribution services fees to be paid and adjusts the transaction price with the amount of such estimate at the time of sale to the customer. An accrued liability is recorded for unpaid distribution service fees.
Patient Co-Pay Assistance: Co-pay assistance represents financial assistance to qualified patients, assisting them with prescription drug co-payments required by insurance. The accrual for co-pay is based on an estimate of claims and the cost per claim that the Company expects to receive associated with inventory that exists in the distribution channel at period end.
Revenues derived from contract manufacturing services are recognized when third-party products are shipped to customers. The Company’s accounting policy is to review each agreement involving contract development and manufacturing services to determine if there are multiple revenue-generating activities that constitute more than one unit of account. Revenues are recognized for each unit of account based on revenue recognition criteria relevant to that unit.
Service revenues derived from research and development contracts are recognized over time based on progress toward satisfaction of the performance obligation. For each performance obligation satisfied over time, the Company assesses the proper method to be used for revenue recognition, either an input method to measure progress toward the satisfaction of services or an output method of determining the progress of completion of performance obligation. For the three and nine months ended September 30, 2025, revenues from research and development services at ANP were $1.9 million and $2.3 million, respectively. For the three and nine months ended September 30, 2024, revenues from research and development services were $0.1 million and $2.0 million, respectively.
-11-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 4. Net Income per Share
Basic net income per share is calculated based upon the weighted-average number of shares outstanding during the period. Diluted net income per share gives effect to all potentially dilutive shares outstanding during the period, such as stock options, non-vested restricted stock units and shares issuable under the Company’s Employee Stock Purchase Plan, or ESPP, and potential shares of common stock issuable upon conversion of Convertible Notes of the Company, due March 2029, or the 2029 Convertible Notes.
For the three and nine months ended September 30, 2025, options to purchase 3,207,932 shares of stock, with a weighted-average exercise price of $35.01 per share, were excluded in the computation of diluted net income per share because their effect would be anti-dilutive. The 2029 Convertible Notes had no impact on the computation of diluted net income per share as the average stock price during the period was less than the conversion price.
For the three and nine months ended September 30, 2024, options to purchase 619,847 shares of stock, with a weighted-average exercise price of $46.63 per share, were excluded from the computation of diluted net income per share because their effect would be anti-dilutive. The 2029 Convertible Notes had no impact on the computation of diluted net income per share as the average stock price during the period was less than the conversion price.
The following table provides the calculation of basic and diluted net income per share for each of the periods presented:
|
|
Three Months Ended |
|
Nine Months Ended |
|
||||||||
|
|
September 30, |
|
September 30, |
|
||||||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
||||
|
|
(in thousands, except per share data) |
|
||||||||||
Basic and dilutive numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
17,350 |
|
$ |
40,429 |
|
$ |
73,665 |
|
$ |
121,555 |
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding — basic |
|
|
46,474 |
|
|
48,621 |
|
|
47,021 |
|
|
48,580 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Incremental shares from equity awards |
|
|
1,203 |
|
|
3,241 |
|
|
1,544 |
|
|
3,727 |
|
Weighted-average shares outstanding — diluted |
|
|
47,677 |
|
|
51,862 |
|
|
48,565 |
|
|
52,307 |
|
Net income per share — basic |
|
$ |
0.38 |
|
$ |
0.83 |
|
$ |
1.57 |
|
$ |
2.50 |
|
Net income per share — diluted |
|
$ |
0.37 |
|
$ |
0.78 |
|
$ |
1.52 |
|
$ |
2.32 |
|
Note 5. Segment Reporting
The Company’s business is the development, manufacture, and marketing of pharmaceutical products (see Note 1). The Company’s Chief Executive Officer is the Chief Operating Decision Maker, or CODM.
During the three and nine months ended September 30, 2025, the Company had one reportable segment. The measure of segment assets is reported on the condensed consolidated balance sheets as total assets.
-12-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Selected segment financial information is presented below. As a result of the change to one reportable segment in the fourth quarter of 2024, the Company has recast the segment information for the prior periods presented:
|
|
Three Months Ended |
|
Nine Months Ended |
|
||||||||
|
|
September 30, |
|
September 30, |
|
||||||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
||||
|
|
(in thousands) |
|
||||||||||
Net revenues: |
|
$ |
191,840 |
|
$ |
191,214 |
|
$ |
536,782 |
|
$ |
545,444 |
|
Less: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Payroll expense |
|
|
45,871 |
|
|
48,699 |
|
|
143,233 |
|
|
142,878 |
|
Materials and supplies |
|
|
7,648 |
|
|
13,451 |
|
|
29,344 |
|
|
34,667 |
|
Clinical trials expense |
|
|
352 |
|
|
9 |
|
|
1,489 |
|
|
292 |
|
Depreciation and amortization expense |
|
|
14,129 |
|
|
13,400 |
|
|
42,354 |
|
|
39,531 |
|
Stock-based compensation expense |
|
|
6,297 |
|
|
5,596 |
|
|
21,072 |
|
|
18,736 |
|
Consulting and outside services expense |
|
|
9,922 |
|
|
8,205 |
|
|
27,772 |
|
|
21,215 |
|
Advertising and promotional expense |
|
|
3,374 |
|
|
2,718 |
|
|
10,349 |
|
|
8,402 |
|
Other segment items(1) |
|
|
78,696 |
|
|
47,182 |
|
|
156,864 |
|
|
118,323 |
|
Interest income |
|
|
(2,246) |
|
|
(2,427) |
|
|
(6,256) |
|
|
(8,320) |
|
Interest expense |
|
|
6,284 |
|
|
6,698 |
|
|
18,851 |
|
|
23,918 |
|
Income tax provision |
|
|
4,163 |
|
|
7,254 |
|
|
18,045 |
|
|
23,674 |
|
Equity in losses of unconsolidated affiliate |
|
|
— |
|
|
— |
|
|
— |
|
|
573 |
|
Net income |
|
$ |
17,350 |
|
$ |
40,429 |
|
$ |
73,665 |
|
$ |
121,555 |
|
| 1) | Other segment items primarily include maintenance and repairs expense, travel expense, professional services expense, legal expense, rent expense, product costs, certain overhead expenses, manufacturing cost absorption and variances, inventory provisions, miscellaneous expenses, and foreign currency exchange gains and losses. |
Net revenues by product are presented below:
|
|
Three Months Ended |
|
Nine Months Ended |
|
||||||||
|
|
September 30, |
|
September 30, |
|
||||||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
||||
|
|
(in thousands) |
|
||||||||||
Product revenues, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
BAQSIMI® |
|
$ |
53,608 |
|
$ |
40,409 |
|
$ |
138,650 |
|
$ |
85,106 |
|
Primatene MIST® |
|
|
28,808 |
|
|
26,055 |
|
|
80,739 |
|
|
73,077 |
|
Glucagon |
|
|
13,558 |
|
|
26,792 |
|
|
55,003 |
|
|
82,700 |
|
Epinephrine |
|
|
18,789 |
|
|
21,341 |
|
|
53,556 |
|
|
75,392 |
|
Lidocaine |
|
|
12,932 |
|
|
15,884 |
|
|
41,575 |
|
|
41,457 |
|
Other products |
|
|
64,145 |
|
|
58,338 |
|
|
167,259 |
|
|
168,104 |
|
Total product revenues, net |
|
|
191,840 |
|
|
188,819 |
|
|
536,782 |
|
|
525,836 |
|
Other revenues |
|
|
— |
|
|
2,395 |
|
|
— |
|
|
19,608 |
|
Total net revenues |
|
$ |
191,840 |
|
$ |
191,214 |
|
$ |
536,782 |
|
$ |
545,444 |
|
-13-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Net revenues and carrying values of long-lived assets, which includes property, plant and equipment, as well as finance and operating lease right-of-use assets, by geographic region, based on where the Company conducts its operations are as follows:
|
|
Net Revenues |
|
Long-Lived Assets |
||||||||||||||
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
|
|
|
||||||||
|
|
September 30, |
|
September 30, |
|
September 30, |
|
December 31, |
||||||||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||||
|
|
(in thousands) |
||||||||||||||||
United States |
|
$ |
180,279 |
|
$ |
186,514 |
|
$ |
509,871 |
|
$ |
532,591 |
|
$ |
206,997 |
|
$ |
202,328 |
China |
|
|
1,879 |
|
|
178 |
|
|
2,259 |
|
|
2,145 |
|
|
109,635 |
|
|
107,887 |
France |
|
|
9,682 |
|
|
4,522 |
|
|
24,652 |
|
|
10,708 |
|
|
36,893 |
|
|
34,412 |
Total |
|
$ |
191,840 |
|
$ |
191,214 |
|
$ |
536,782 |
|
$ |
545,444 |
|
$ |
353,525 |
|
$ |
344,627 |
Note 6. Customer and Supplier Concentration
Customer Concentrations
The following table provides accounts receivable and net revenue information for the Company’s three major customers:
|
|
% of Total Accounts |
|
% of Net |
|
||||||||
|
|
Receivable |
|
Revenues |
|
||||||||
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
||||||
|
|
September 30, |
|
December 31, |
|
September 30, |
|
September 30, |
|
||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
McKesson |
|
26 |
% |
34 |
% |
22 |
% |
26 |
% |
23 |
% |
25 |
% |
Cencora |
|
30 |
% |
23 |
% |
22 |
% |
21 |
% |
22 |
% |
20 |
% |
Cardinal Health |
|
16 |
% |
16 |
% |
21 |
% |
20 |
% |
20 |
% |
20 |
% |
Supplier Concentrations
The Company depends on suppliers for raw materials, APIs, and other components that are subject to stringent FDA requirements. Some of these materials may only be available from one or a limited number of sources. Establishing additional or replacement suppliers for these materials may take a substantial period of time, as suppliers must be approved by the FDA. Furthermore, a significant portion of raw materials may only be available from foreign sources. If the Company is unable to secure, on a timely basis, sufficient quantities of the materials it depends on to manufacture and market its products, it could have a materially adverse effect on the Company’s business, financial condition, and results of operations.
Note 7. Fair Value Measurements
GAAP defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the principal or most advantageous market for the asset or liability at the measurement date (an exit price). These standards also establish a hierarchy that prioritizes observable and unobservable inputs used in measuring fair value of an asset or liability, as described below:
| ● | Level 1 – Inputs to measure fair value are based on quoted prices (unadjusted) in active markets on identical assets or liabilities; |
| ● | Level 2 – Inputs to measure fair value are based on the following: (a) quoted prices in active markets on similar assets or liabilities, (b) quoted prices for identical or similar instruments in inactive markets, or (c) observable (other than quoted prices) or collaborated observable market data used in a pricing model from which the fair value is derived; and |
-14-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
| ● | Level 3 – Inputs to measure fair value are unobservable and the assets or liabilities have little, if any, market activity; these inputs reflect the Company’s own assumptions about the assumptions that market participants would use in pricing the assets or liabilities based on best information available in the circumstances. |
As of September 30, 2025 and December 31, 2024, cash equivalents include money market accounts and corporate and municipal bonds with original maturities of less than three months. Investments consist of certificates of deposit as well as investment-grade corporate, agency and municipal bonds with original maturity dates between three and nineteen months. The certificates of deposit are carried at amortized cost in the Company’s condensed consolidated balance sheets, which approximates their fair value determined based on Level 2 inputs. The corporate, agency and municipal bonds are classified as held-to-maturity and are carried at amortized cost net of allowance for credit losses. The fair value of such bonds is disclosed in Note 8 and was determined based on Level 2 inputs. The restrictions on restricted cash and investments have an immaterial effect on the fair value of these financial assets.
The fair values of the Company’s financial assets and liabilities measured on a recurring basis as of September 30, 2025 and December 31, 2024, are as follows:
|
|
Total |
|
Level 1 |
|
Level 2 |
|
Level 3 |
||||
|
|
(in thousands) |
||||||||||
Cash equivalents |
|
$ |
156,083 |
|
$ |
156,083 |
|
$ |
— |
|
$ |
— |
Restricted cash |
|
|
235 |
|
|
235 |
|
|
— |
|
|
— |
Short-term investments |
|
|
16,426 |
|
|
— |
|
|
16,426 |
|
|
— |
Restricted short-term investments |
|
|
2,200 |
|
|
— |
|
|
2,200 |
|
|
— |
Interest rate swaps related to variable rate loans |
|
|
(4,802) |
|
|
— |
|
|
(4,802) |
|
|
— |
Total assets and liabilities measured at fair value as of September 30, 2025 |
|
$ |
170,142 |
|
$ |
156,318 |
|
$ |
13,824 |
|
$ |
— |
|
|
Total |
|
Level 1 |
|
Level 2 |
|
Level 3 |
||||
|
|
(in thousands) |
||||||||||
Cash equivalents |
|
$ |
102,059 |
|
$ |
102,059 |
|
$ |
— |
|
$ |
— |
Restricted cash |
|
|
235 |
|
|
235 |
|
|
— |
|
|
— |
Short-term investments |
|
|
26,629 |
|
|
— |
|
|
26,629 |
|
|
— |
Restricted short-term investments |
|
|
2,200 |
|
|
— |
|
|
2,200 |
|
|
— |
Interest rate swaps related to variable rate loans |
|
|
(234) |
|
|
— |
|
|
(234) |
|
|
— |
Total assets and liabilities measured at fair value as of December 31, 2024 |
|
$ |
130,889 |
|
$ |
102,294 |
|
$ |
28,595 |
|
$ |
— |
The Company does not hold any Level 3 instruments that are measured at fair value on a recurring basis.
Nonfinancial assets and liabilities are not measured at fair value on a recurring basis but are subject to fair value adjustments in certain circumstances. These items primarily include investments in unconsolidated affiliates, long-lived assets, goodwill, and intangible assets for which the fair value is determined as part of an impairment test. As of September 30, 2025 and December 31, 2024, there were no significant adjustments to fair value for nonfinancial assets or liabilities.
The Company’s deferred compensation plan assets are valued using the cash surrender value of the life insurance policies and are not included in the table above.
-15-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 8. Investments
The following is a summary of the Company’s investments that are classified as held-to-maturity:
|
|
|
|
Gross |
|
Gross |
|
|
||||
|
|
Amortized |
|
Unrealized |
|
Unrealized |
|
Fair |
||||
|
|
Cost |
|
Gains |
|
Losses |
|
Value |
||||
|
|
(in thousands) |
||||||||||
Corporate and agency bonds (due within 1 year) |
|
$ |
42,968 |
|
$ |
32 |
|
$ |
(11) |
|
$ |
42,989 |
Municipal bonds (due within 1 year) |
|
|
200 |
|
|
— |
|
|
— |
|
|
200 |
Total investments as of September 30, 2025 |
|
$ |
43,168 |
|
$ |
32 |
|
$ |
(11) |
|
$ |
43,189 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate and agency bonds (due within 1 year) |
|
$ |
42,907 |
|
$ |
34 |
|
$ |
(25) |
|
$ |
42,916 |
Corporate and agency bonds (due within 1 to 3 years) |
|
|
10,867 |
|
|
— |
|
|
(6) |
|
|
10,861 |
Municipal bonds (due within 1 year) |
|
|
199 |
|
|
— |
|
|
(1) |
|
|
198 |
Total investments as of December 31, 2024 |
|
$ |
53,973 |
|
$ |
34 |
|
$ |
(32) |
|
$ |
53,975 |
At each reporting period, the Company evaluates securities for impairment when the fair value of the investment is less than its amortized cost. The Company evaluated the underlying credit quality and credit ratings of the issuers, identifying neither a significant deterioration since purchase nor any other factors that would indicate a material credit loss.
The Company measures expected credit losses on held-to-maturity investments on a collective basis. All the Company’s held-to-maturity investments were considered to be one pool. The estimate for credit losses considers historical loss information that is adjusted for current conditions and reasonable and supportable forecasts. Expected credit losses on held-to-maturity investments were not material to the condensed consolidated financial statements.
Note 9. Goodwill and Intangible Assets
The table below shows the weighted-average life, original cost, accumulated amortization, and net book value by major intangible asset classification:
|
|
Weighted-Average |
|
|
|
|
Accumulated |
|
|
|
|
|
|
Life (Years) |
|
Original Cost |
|
Amortization |
|
Net Book Value |
|||
|
|
(in thousands) |
|||||||||
Definite-lived intangible assets |
|
|
|
|
|
|
|
|
|
|
|
BAQSIMI® product rights |
|
24 |
|
$ |
591,338 |
|
$ |
55,438 |
|
$ |
535,900 |
Land-use rights |
|
39 |
|
|
2,540 |
|
|
930 |
|
|
1,610 |
Other intangibles |
|
7 |
|
|
2,443 |
|
|
345 |
|
|
2,098 |
Subtotal |
|
24 |
|
|
596,321 |
|
|
56,713 |
|
|
539,608 |
Indefinite-lived intangible assets |
|
|
|
|
|
|
|
|
|
|
|
Trademark |
|
* |
|
|
29,225 |
|
|
— |
|
|
29,225 |
Goodwill |
|
* |
|
|
3,404 |
|
|
— |
|
|
3,404 |
Subtotal |
|
* |
|
|
32,629 |
|
|
— |
|
|
32,629 |
As of September 30, 2025 |
|
* |
|
$ |
628,950 |
|
$ |
56,713 |
|
$ |
572,237 |
-16-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
|
|
Weighted-Average |
|
|
|
|
Accumulated |
|
|
|
|
|
|
Life (Years) |
|
Original Cost |
|
Amortization |
|
Net Book Value |
|||
|
|
(in thousands) |
|||||||||
Definite-lived intangible assets |
|
|
|
|
|
|
|
|
|
|
|
BAQSIMI® product rights |
|
24 |
|
$ |
591,338 |
|
$ |
36,958 |
|
$ |
554,380 |
Land-use rights |
|
39 |
|
|
2,540 |
|
|
881 |
|
|
1,659 |
Other intangibles |
|
7 |
|
|
2,443 |
|
|
96 |
|
|
2,347 |
Subtotal |
|
24 |
|
|
596,321 |
|
|
37,935 |
|
|
558,386 |
Indefinite-lived intangible assets |
|
|
|
|
|
|
|
|
|
|
|
Trademark |
|
* |
|
|
29,225 |
|
|
— |
|
|
29,225 |
Goodwill |
|
* |
|
|
3,049 |
|
|
— |
|
|
3,049 |
Subtotal |
|
* |
|
|
32,274 |
|
|
— |
|
|
32,274 |
As of December 31, 2024 |
|
* |
|
$ |
628,595 |
|
$ |
37,935 |
|
$ |
590,660 |
* Intangible assets with indefinite lives have an indeterminable average life.
Goodwill
The changes in the carrying amounts of goodwill are as follows:
|
September 30, |
|
December 31, |
||
|
2025 |
|
2024 |
||
|
(in thousands) |
||||
Beginning balance |
$ |
3,049 |
|
$ |
3,216 |
Currency translation |
|
355 |
|
|
(167) |
Ending balance |
$ |
3,404 |
|
$ |
3,049 |
Note 10. Inventories
Inventories consist of the following:
|
September 30, |
|
December 31, |
||
|
2025 |
|
2024 |
||
|
(in thousands) |
||||
Raw materials and supplies |
$ |
105,759 |
|
$ |
81,511 |
Work in process |
|
42,459 |
|
|
32,807 |
Finished goods |
|
37,714 |
|
|
39,423 |
Total inventories |
$ |
185,932 |
|
$ |
153,741 |
Charges of $1.3 million and $4.2 million were included in the cost of revenues in the Company’s condensed consolidated statements of operations for the three and nine months ended September 30, 2025, respectively, to adjust the Company’s inventory and related firm purchase commitments to its net realizable value. For the three and nine months ended September 30, 2024, charges of $0.9 million and $10.1 million were included in the cost of revenues, respectively, to adjust the Company’s inventory and related firm purchase commitments to its net realizable value.
-17-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 11. Property, Plant, and Equipment
Property, plant, and equipment consist of the following:
|
September 30, |
|
December 31, |
||
|
2025 |
|
2024 |
||
|
(in thousands) |
||||
Buildings |
$ |
193,731 |
|
$ |
169,429 |
Leasehold improvements |
|
46,039 |
|
|
42,012 |
Land |
|
7,555 |
|
|
7,422 |
Machinery and equipment |
|
297,592 |
|
|
277,408 |
Furniture, fixtures, and automobiles |
|
38,024 |
|
|
35,976 |
Construction in progress |
|
24,039 |
|
|
36,685 |
Total property, plant, and equipment |
|
606,980 |
|
|
568,932 |
Less accumulated depreciation |
|
(298,291) |
|
|
(271,587) |
Total property, plant, and equipment, net |
$ |
308,689 |
|
$ |
297,345 |
Note 12. Accounts Payable and Accrued Liabilities
Accounts payable and accrued liabilities consisted of the following:
|
September 30, |
|
December 31, |
||
|
2025 |
|
2024 |
||
|
(in thousands) |
||||
Accrued customer fees and rebates |
$ |
54,169 |
|
$ |
53,993 |
Accrued payroll and related benefits |
|
31,238 |
|
|
26,010 |
Accrued product returns, current portion |
|
18,239 |
|
|
14,559 |
Accrued loss on firm purchase commitments |
|
100 |
|
|
413 |
Accrued litigation and settlements |
|
35,720 |
|
|
8,472 |
Other accrued liabilities |
|
10,838 |
|
|
23,096 |
Total accrued liabilities |
|
150,304 |
|
|
126,543 |
Accounts payable |
|
40,540 |
|
|
30,514 |
Total accounts payable and accrued liabilities |
$ |
190,844 |
|
$ |
157,057 |
-18-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 13. Debt
Debt consists of the following:
|
|
September 30, |
|
December 31, |
||
|
|
2025 |
|
2024 |
||
|
|
(in thousands) |
||||
Convertible Debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
2029 Convertible Notes |
|
$ |
345,000 |
|
$ |
345,000 |
|
|
|
|
|
|
|
Term Loan |
|
|
|
|
|
|
|
|
|
|
|
|
|
Wells Fargo Term Loan due June 2028 |
|
|
250,000 |
|
|
250,000 |
|
|
|
|
|
|
|
Other Loans and Payment Obligations |
|
|
|
|
|
|
|
|
|
|
|
|
|
French government loans due December 2026 |
|
|
120 |
|
|
99 |
|
|
|
|
|
|
|
Line of Credit Facilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
Line of credit facility with China Merchant Bank due October 2026 |
|
|
— |
|
|
— |
Wells Fargo Revolving line of credit facility due June 2028 |
|
|
— |
|
|
— |
Line of credit facility with ICBC Bank due November 2033 |
|
|
24,377 |
|
|
18,433 |
|
|
|
|
|
|
|
Equipment under Finance Leases |
|
|
301 |
|
|
432 |
Total debt |
|
|
619,798 |
|
|
613,964 |
Less current portion of long-term debt |
|
|
923 |
|
|
234 |
Less: Loan issuance costs |
|
|
10,293 |
|
|
12,100 |
Long-term debt, net of current portion and unamortized debt issuance costs |
|
$ |
608,582 |
|
$ |
601,630 |
Credit Agreement
2029 Convertible Notes
In September 2023, the Company issued the 2029 Convertible Notes, in the aggregate principal amount of $345.0 million in a private offering pursuant to Section 4(a)(2) and Rule 144A under the Securities Act of 1933, as amended. The Company used portions of the net proceeds from the 2029 Convertible Notes to (i) repay approximately $200.0 million of the Company’s borrowings under the Wells Fargo Term Loan and (ii) repurchase $50.0 million of the Company’s common stock.
In connection with the issuance of the 2029 Convertible Notes, the Company incurred approximately $10.8 million of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. Unamortized debt issuance costs related to the 2029 Convertible Notes were $6.8 million and $8.3 million as of September 30, 2025 and December 31, 2024, respectively. The fair value of the 2029 Convertible Notes was approximately $314.0 million as of September 30, 2025 based on Level 2 inputs.
For the three and nine months ended September 30, 2025, the total interest expense related to the 2029 Convertible Notes was $2.2 million and $6.7 million, with coupon interest expense of $1.7 million and $5.2 million, and the amortization of debt issuance cost of $0.5 million and $1.5 million, respectively. For the three and nine months ended September 30, 2024, the total interest expense related to the 2029 Convertible Notes was $2.5 million and $6.7 million, with coupon interest expense of $2.0 million and $5.2 million, and the amortization of debt issuance cost of $0.5 million and $1.5 million, respectively.
-19-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
The 2029 Convertible Notes are general senior, unsecured obligations and bear an interest rate of 2.0% per year. The 2029 Convertible Notes were issued pursuant to an indenture, dated September 15, 2023, or the Indenture, between the Company and U.S. Bank Trust Company, National Association, as trustee.
The 2029 Convertible Notes will rank senior in right of payment to all of the Company’s indebtedness that is expressly subordinated in right of payment to the 2029 Convertible Notes; equal in right of payment to all of the Company’s unsecured indebtedness that is not so subordinated; effectively junior to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness, including any amount outstanding under the Company’s credit facilities; and structurally junior to all indebtedness and other liabilities of the Company’s current or future subsidiaries, including trade payables.
Interest is payable semi-annually in arrears on March 15 and September 15 of each year. The 2029 Convertible Notes may bear additional interest under specified circumstances relating to the Company’s failure to comply with its reporting obligations under the Indenture or if the 2029 Convertible Notes are not freely tradeable as required by the Indenture.
The 2029 Convertible Notes will mature on March 15, 2029, unless earlier converted, repurchased or redeemed.
Conversions of the 2029 Convertible Notes will be settled in cash up to the aggregate principal amount of the 2029 Convertible Notes to be converted, and cash, shares of common stock or a combination of cash and shares of common stock, at the Company’s election, with respect to the remainder, if any, of the Company’s conversion obligation in excess of the aggregate principal amount.
Holders may convert their 2029 Convertible Notes at their option prior to the close of business on the business day immediately preceding December 15, 2028, in multiples of $1,000 principal amount, only under the following circumstances: (i) during any calendar quarter commencing after the calendar quarter ending on December 31, 2023 (and only during such calendar quarter), if the last reported sale price of the common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price for the 2029 Convertible Notes on each applicable trading day, (ii) during the five business day period after any five consecutive trading day period in which the trading price, as defined in the Indenture, per $1,000 principal amount of the 2029 Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day, (iii) if the Company calls the 2029 Convertible Notes for redemption, at any time prior to the close of business on the second scheduled trading day immediately preceding the redemption date, and (iv) upon the occurrence of specified corporate events defined in the Indenture.
On or after December 15, 2028, until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their 2029 Convertible Notes, in multiples of $1,000 principal amount, at the option of the holder regardless of the foregoing circumstances.
The Company may redeem the 2029 Convertible Notes, at its option, in whole or in part (subject to certain limitations), on or after September 20, 2026 and prior to the 41st scheduled trading day preceding the maturity date, if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on and including the trading day immediately preceding the date on which the Company provides notice of redemption at a redemption price equal to 100% of the principal amount of the 2029 Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.
The initial conversion rate is 15.8821 shares of the Company’s common stock per $1,000 principal amount of the 2029 Convertible Notes, which represents an initial conversion price of approximately $62.96 per share of common stock. The initial conversion price of $62.96 represents a premium of approximately 35.0% over the last reported sale price of the Company’s common stock on Nasdaq Global Select Market on September 12, 2023. The conversion rate is subject to adjustment under certain circumstances in accordance with the terms of the Indenture.
-20-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
If a fundamental change, as defined in the Indenture, occurs at any time prior to the maturity date, then, subject to certain conditions, holders of the 2029 Convertible Notes may require the Company to repurchase for cash all or any portion of their 2029 Convertible Notes at a repurchase price equal to 100% of the principal amount of the 2029 Convertible Notes to be repurchased, plus any accrued and unpaid interest. In addition, following certain specified corporate events or if the Company issues a notice of redemption, the Company will, under certain circumstances, increase the conversion rate for holders who convert their 2029 Convertible Notes in connection with such corporate event or during a redemption period.
Syndicated Line of Credit Facility with ICBC Bank – Due November 2033
In January 2024, the Company entered into a credit agreement with Industrial and Commercial Bank of China Limited, or ICBC Bank, acting as a lender and as agent for other lenders. The credit agreement allows the Company to borrow up to $40.0 million secured by equipment and buildings at ANP. The interest rate and other terms will be determined at the time of the borrowing, depending on the type of loan requested. The credit agreement expires in November 2033.
The loan bears interest at the prime rate as published by The People’s Bank of China minus 0.2%. Interest payments are due quarterly and repayment of the principal amount is biannual and begins in May 2026. As of September 30, 2025, the Company had $24.4 million of principal outstanding under this loan, which is recorded net of loan issuance costs of $1.3 million.
Interest Rate Swap Contract
As of September 30, 2025, the fair value of the loans listed above approximated their carrying amount based on Level 2 inputs, with the exception of the 2029 Convertible Notes. For the Wells Fargo Term Loan, the Company has entered into a fixed interest rate swap contract to exchange the variable interest rates for fixed interest rates. The interest rate swap contract is recorded at fair value in the other long-term liabilities line in the condensed consolidated balance sheets. Changes in the fair values of interest rate swaps resulted in an immaterial amount for the three months ended September 30, 2025. For the nine months ended September 30, 2025, the change in the fair values of interest rate swaps was a loss of $4.6 million. Changes in the fair values of interest rate swaps were a $7.4 million loss and a $1.6 million loss for the three and nine months ended September 30, 2024, respectively.
Covenants
At September 30, 2025 and December 31, 2024, the Company was in compliance with all of its debt covenants.
Note 14. Income Taxes
The following table sets forth the Company’s income tax provision for the periods indicated:
|
|
Three Months Ended |
|
Nine Months Ended |
|
||||||||
|
|
September 30, |
|
September 30, |
|
||||||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
||||
|
|
(in thousands) |
|
||||||||||
Income before taxes |
|
$ |
21,513 |
|
$ |
47,683 |
|
$ |
91,710 |
|
$ |
145,802 |
|
Income tax provision |
|
|
4,163 |
|
|
7,254 |
|
|
18,045 |
|
|
23,674 |
|
Income before equity in losses of unconsolidated affiliate |
|
$ |
17,350 |
|
$ |
40,429 |
|
$ |
73,665 |
|
$ |
122,128 |
|
Income tax provision as a percentage of income before income taxes |
|
|
19.4 |
% |
|
15.2 |
% |
|
19.7 |
% |
|
16.2 |
% |
-21-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Valuation Allowance
In assessing the need for a valuation allowance, management considers whether it is more likely than not that some portion or all of the deferred income tax assets will be realized. Ultimately, realization depends on the existence of future taxable income. Management considers sources of taxable income such as income in prior carryback periods, future reversal of existing deferred taxable temporary differences, tax-planning strategies, and projected future taxable income.
The Company continues to record a full valuation allowance on the net deferred income tax assets of its French subsidiary, AFP, and its U.K. subsidiaries, AUK and IMS UK, and will continue to do so until the subsidiaries generate sufficient taxable income to realize their respective deferred income tax assets.
The Company also records a valuation allowance on net deferred income tax assets in states where it files separately and will continue to do so until sufficient taxable income is generated to realize these state deferred income tax assets.
Tax Law Updates
On July 4, 2025, the One Big Beautiful Bill Act, or OBBBA, was enacted into law. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. As of September 30, 2025, the Company does not expect the provisions of the OBBBA will have a material impact on income tax expense, but the Company does expect certain provisions will change the timing of cash tax payments in the current year and future periods.
Note 15. Stockholders' Equity
Share Buyback Program
Pursuant to the Company’s existing share buyback program, the Company purchased 172,920 and 2,108,616 shares of its common stock, during the three and nine months ended September 30, 2025, for total consideration of $4.9 million and $54.9 million, respectively. The Company purchased 797,038 shares and 1,004,326 shares of its common stock during the three and nine months ended September 30, 2024, for total consideration of $35.0 million and $43.5 million, respectively.
In August 2025, the Company’s Board of Directors authorized a $50.0 million increase to the Company’s share buyback program, which is expected to continue for an indefinite period of time. Since the inception of the program, the Company’s Board of Directors have authorized a total of $435.0 million in the share buyback program. The primary goal of the program is to offset dilution created by the Company’s equity compensation programs.
Purchases are made through open market and private block transactions pursuant to Rule 10b5-1 plans, privately negotiated transactions or other means as determined by the Company’s management and in accordance with the requirements of the SEC and applicable laws. The timing and actual number of treasury share purchases will depend on a variety of factors including price, corporate and regulatory requirements, and other conditions. These treasury share purchases are accounted for under the cost method and are included as a component of treasury stock in the Company’s condensed consolidated balance sheets.
Amended and Restated 2015 Equity Incentive Plan
In February 2024, the Board of Directors approved the Company’s amended and restated 2015 Equity Incentive Plan, or the Amended 2015 Plan, which was subsequently approved by the Company’s stockholders, and accordingly, adopted by the Company in June 2024. The Amended 2015 Plan, among other things, extended the term of the 2015 Equity Incentive Plan, or the Original 2015 Plan, increased the number of shares available for issuance under the Original 2015 Plan, and removed the evergreen provision. The term of the Amended 2015 Plan will be extended indefinitely, however, the Company’s ability to grant incentive stock options thereunder will continue through February 2034.
-22-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
As of September 30, 2025, the Company reserved an aggregate of 6,614,915 shares of common stock for future issuance under the Amended 2015 Plan.
2014 Employee Stock Purchase Plan
As of September 30, 2025, the Company has issued 1,378,506 shares of common stock under the ESPP and 621,494 shares of its common stock remain available for issuance under the ESPP.
In May 2025, the Company issued 89,054 shares at a purchase price of $21.85 per share under the ESPP. For the three and nine months ended September 30, 2025, the Company recorded ESPP expense of $0.2 million and $0.9 million, respectively. For the three and nine months ended September 30, 2024, the Company recorded ESPP expense of $0.2 million and $0.9 million, respectively.
Share-Based Award Activity and Balances
The Company accounts for share-based compensation payments in accordance with ASC 718, which requires measurement and recognition of compensation expense at fair value for all share-based payment awards made to employees and directors. Under these standards, the fair value of option awards and the option components of the ESPP awards are estimated at the grant date using the Black-Scholes option-pricing model. The fair value of RSUs is estimated at the grant date using the Company’s common share price. The Company records share-based compensation expense net of expected forfeitures. Compensation cost for all share-based payments granted with service-based graded vesting schedules is recognized using the straight-line method over the requisite service period.
The weighted-averages for key assumptions used in determining the fair value of options granted are as follows:
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
||||
|
|
September 30, |
|
September 30, |
|
|
||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
|
Average volatility |
|
41.6 |
% |
— |
% |
40.9 |
% |
41.3 |
% |
|
Average risk-free interest rate |
|
4.1 |
% |
— |
% |
4.2 |
% |
4.2 |
% |
|
Weighted-average expected life in years |
|
6.0 |
|
— |
|
6.2 |
|
6.2 |
|
|
Dividend yield rate |
|
— |
% |
— |
% |
— |
% |
— |
% |
|
A summary of option activity under all plans for the nine months ended September 30, 2025, is presented below:
|
|
|
|
|
|
|
Weighted-Average |
|
|
|
|
|
|
|
|
Weighted-Average |
|
Remaining |
|
Aggregate |
|
||
|
|
|
|
Exercise |
|
Contractual |
|
Intrinsic |
|
||
|
|
Options |
|
Price |
|
Term (Years) |
|
Value(1) |
|
||
|
|
|
|
|
|
|
|
|
(in thousands) |
|
|
Outstanding as of December 31, 2024 |
|
6,655,225 |
|
$ |
23.75 |
|
|
|
|
|
|
Options granted |
|
1,201,455 |
|
|
28.17 |
|
|
|
|
|
|
Options exercised |
|
(907,457) |
|
|
14.50 |
|
|
|
|
|
|
Options forfeited |
|
(11,420) |
|
|
33.40 |
|
|
|
|
|
|
Options expired |
|
(7,422) |
|
|
24.66 |
|
|
|
|
|
|
Outstanding as of September 30, 2025 |
|
6,930,381 |
|
$ |
25.71 |
|
5.53 |
|
$ |
33,327 |
|
Exercisable as of September 30, 2025 |
|
4,769,069 |
|
|
22.14 |
|
4.10 |
|
$ |
33,144 |
|
Vested and expected to vest as of September 30, 2025 |
|
6,727,420 |
|
|
25.49 |
|
5.43 |
|
$ |
33,327 |
|
| (1) | The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the estimated fair value of the Company’s stock for those awards that have an exercise price below the estimated fair value at September 30, 2025. |
-23-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
For the three and nine months ended September 30, 2025, the Company recorded expense of $3.0 million and $10.2 million, respectively, related to stock options granted under all plans. For the three and nine months ended September 30, 2024, the Company recorded expense of $2.7 million and $9.0 million, respectively, related to stock options granted under all plans.
Information relating to option grants and exercises is as follows:
|
Three Months Ended |
|
Nine Months Ended |
|
||||||||
|
September 30, |
|
September 30, |
|
||||||||
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
||||
|
(in thousands, except per share data) |
|
||||||||||
Weighted-average grant date fair value per share |
$ |
12.46 |
|
$ |
— |
|
$ |
13.22 |
|
$ |
21.89 |
|
Intrinsic value of options exercised |
|
370 |
|
|
6,218 |
|
|
11,125 |
|
|
48,381 |
|
Cash received from options exercised |
|
411 |
|
|
3,332 |
|
|
5,797 |
|
|
10,400 |
|
Total fair value of the options vested during the period |
|
88 |
|
|
111 |
|
|
11,902 |
|
|
9,815 |
|
A summary of the status of the Company’s non-vested options as of September 30, 2025, and changes during the nine months ended September 30, 2025, are presented below:
|
|
|
|
Weighted-Average |
|
|
|
|
|
|
Grant Date |
|
|
|
|
Options |
|
Fair Value |
|
|
Non-vested as of December 31, 2024 |
|
1,803,684 |
|
$ |
16.76 |
|
Options granted |
|
1,201,455 |
|
|
13.22 |
|
Options vested |
|
(832,407) |
|
|
14.30 |
|
Options forfeited |
|
(11,420) |
|
|
15.51 |
|
Non-vested as of September 30, 2025 |
|
2,161,312 |
|
|
15.75 |
|
As of September 30, 2025, there was $23.9 million of total unrecognized compensation cost, net of forfeitures, related to non-vested stock option based compensation arrangements granted under all plans. The cost is expected to be recognized over a weighted-average period of 2.6 years and will be adjusted for future changes in estimated forfeitures.
Restricted Stock Units
The Company grants restricted stock units, or RSUs, to certain employees and members of the Board of Directors with a vesting period of up to four years. The grantee receives one share of common stock at a specified future date for each RSU awarded. The RSUs may not be sold or otherwise transferred until vested. The RSUs do not have any voting or dividend rights prior to the issuance of the underlying common stock. The share-based expense associated with these grants was based on the Company’s common stock fair value at the time of grant and is amortized over the requisite service period, which generally is the vesting period using the straight-line method. For the three and nine months ended September 30, 2025, the Company recorded total expenses of $3.0 million and $10.0 million, respectively, related to RSU awards granted under all plans. For the three and nine months ended September 30, 2024, the Company recorded expenses of $2.7 million and $8.8 million, respectively, related to RSU awards granted under all plans.
As of September 30, 2025, there was $25.4 million of total unrecognized compensation cost, net of forfeitures, related to non-vested RSU-based compensation arrangements granted under all plans. The cost is expected to be recognized over a weighted-average period of 2.6 years and will be adjusted for future changes in estimated forfeitures.
-24-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Information relating to RSU grants and deliveries is as follows:
|
|
|
|
Total Fair Market |
|
|
|
|
Total RSUs |
|
Value of RSUs |
|
|
|
|
Issued |
|
Issued(1) |
|
|
|
|
|
|
(in thousands) |
|
|
RSUs outstanding at December 31, 2024 |
|
825,421 |
|
|
|
|
RSUs granted |
|
563,378 |
|
$ |
15,874 |
|
RSUs forfeited |
|
(5,250) |
|
|
|
|
RSUs vested(2) |
|
(372,218) |
|
|
|
|
RSUs outstanding at September 30, 2025 |
|
1,011,331 |
|
|
|
|
| (1) | The total fair market value is derived from the number of RSUs granted times the current stock price on the date of grant. |
| (2) | Of the vested RSUs, 140,353 shares of common stock were surrendered to fulfill tax withholding obligations. |
Share-based Compensation Expense
The Company recorded share-based compensation expense, which is included in the Company’s condensed consolidated statement of operations, as follows:
|
|
Three Months Ended |
|
Nine Months Ended |
|
||||||||
|
|
September 30, |
|
September 30, |
|
||||||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
||||
|
|
(in thousands) |
|
||||||||||
Cost of revenues |
|
$ |
1,274 |
|
$ |
1,133 |
|
$ |
5,012 |
|
$ |
4,583 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, distribution, and marketing |
|
|
301 |
|
|
249 |
|
|
925 |
|
|
777 |
|
General and administrative |
|
|
4,140 |
|
|
3,710 |
|
|
12,777 |
|
|
11,239 |
|
Research and development |
|
|
582 |
|
|
504 |
|
|
2,358 |
|
|
2,137 |
|
Total share-based compensation |
|
$ |
6,297 |
|
$ |
5,596 |
|
$ |
21,072 |
|
$ |
18,736 |
|
Note 16. Employee Benefits
401(k) Plan
The Company has a defined contribution 401(k) plan, or the Plan, whereby eligible employees voluntarily contribute up to a defined percentage of their annual compensation. The Company matches contributions at a rate of 50% on the first 6% of employee contributions, and pays the administrative costs of the Plan. Total employer contributions for the three and nine months ended September 30, 2025 were approximately $0.6 million and $2.0 million, respectively, compared to the prior year expense of $0.6 million and $2.0 million for the three and nine months ended September 30, 2024, respectively.
Defined Benefit Pension Plan
The Company’s subsidiary, AFP, has an obligation associated with a defined-benefit plan for its eligible employees. This plan provides benefits to the employees from the date of retirement and is based on the employee’s length of time employed by the Company. The calculation is based on a statistical calculation combining a number of factors that include the employee’s age, length of service, and AFP employee turnover rate.
The liability under the plan is based on a discount rate of 3.40% as of September 30, 2025 and December 31, 2024. The liability is included in other long-term liabilities in the accompanying condensed consolidated balance sheets. The plan is currently unfunded, and the benefit obligation under the plan was $2.9 million and $2.6 million at September 30, 2025 and December 31, 2024, respectively. The Company recorded an immaterial amount of expense under the plan for each of the three and nine months ended September 30, 2025 and 2024.
-25-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Non-qualified Deferred Compensation Plan
In December 2019, the Company established a non-qualified deferred compensation plan. The plan allows certain eligible participants to defer a portion of their cash compensation and provides a matching contribution at the discretion of the Company. The plan obligations are payable upon retirement, termination of employment and/or certain other times in a lump-sum distribution or in installments, as elected by the participant in accordance with the plan. Participants can allocate their deferred compensation amongst various investment options with earnings accruing to the participant. The Company has established a Rabbi Trust to fund the plan obligations and to hold the plan assets. Eligible participants began contributing to the plan in January 2020. The plan assets were valued at approximately $13.3 million and $10.3 million as of September 30, 2025 and December 31, 2024, respectively. The plan liabilities were valued at approximately $13.8 million and $10.7 million as of September 30, 2025, and December 31, 2024, respectively. The plan assets and liabilities are included in other long-term assets and other long-term liabilities, respectively, on the Company’s condensed consolidated balance sheets.
Note 17. Commitments and Contingencies
New Real Estate Lease Agreement
In July 2025, the Company entered into an agreement to lease approximately 225,167 square feet of building space in Rancho Cucamonga, California. The non-cancelable lease term is approximately 10 years commencing on January 1, 2026 with a renewal option to extend the lease for two additional five-year periods. The monthly lease payments are $0.3 million subject to an annual increase of 3.25%. For the three and nine months ended September 30, 2025, the Company did not recognized any lease expense given that the lease has not yet commenced.
Licensing Agreement with Nanjing Anji Biotechnology Co., Ltd.
In August 2025, the Company and Nanjing Anji Biotechnology Co., Ltd., or Anji, entered into a License Agreement, or License Agreement, pursuant to which Anji has granted the Company an exclusive license to certain intellectual property to develop, make, use and commercialize products incorporating or comprising certain compounds, including three identified products, or Licensed Products, in the United States and Canada, or the Territory. Anji has also been granted a non-exclusive license under certain intellectual property controlled by the Company to develop, make, use and commercialize Licensed Products outside the Territory. During the second quarter of 2025, the Company made an earnest money payment of $0.7 million, which was recorded as research and development expense in the Company’s condensed consolidated statement of operations. Upon signing the License Agreement with Anji, the Company made an upfront payment of $5.3 million. For the three and nine months ended September 30, 2025, the Company paid $5.3 million and $6.0 million, respectively, relating to the agreement, which was recorded as a research and development expense in the Company’s condensed consolidated statement of operations.
The Company is also required to make payments to Anji of up to $42.0 million in development-based milestone payments and up to $225.0 million in sales-based milestone payments, subject to the achievement of the applicable development and sales milestone events respectively, and royalty payments of 5% on net sales, not to exceed a maximum annual amount of $22.5 million each calendar year for each Licensed Product and a maximum accumulated amount of $60.0 million for each Licensed Products. The Company is also required to pay Anji a certain percentage of sublicense income received from the sublicense transactions. The term of this License Agreement will expire, on a Licensed Product-by-Licensed Product and region-by-region basis, on the tenth anniversary of the first commercial sale of such Licensed Product in the applicable region in the Territory, with the Company having the right to extend the License Agreement until the earlier of ten additional years or the expiration, lapse, or invalidation of the last remaining valid claim of the patents licensed by Anji to the Company that covers the Licensed Products in the Territory.
-26-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 18. Related Party Transactions
Hanxin Pharmaceutical Technology, Co., Ltd.
The Company has an 11.5% ownership in Hanxin that is accounted for as an equity method investment. The Company maintains a seat on Hanxin’s board of directors, and Henry Zhang, the son of Dr. Jack Zhang, is an equity holder, the general manager, and the chairman of the board of directors of Hanxin. Additionally, Dr. Mary Luo and Dr. Jack Zhang, have an ownership interest in Hanxin through an affiliated entity. As a result, Hanxin is a related party.
Contract Manufacturing Agreements with Hanxin
The Company has various contract manufacturing agreements with Hanxin and its subsidiaries, whereby Hanxin will develop several active pharmaceutical ingredients and finished products for the Chinese market and will engage the Company to manufacture the products on a cost-plus basis.
During the three months ended September 30, 2025, the Company recognized an immaterial amount of revenue from manufacturing services provided to Hanxin. During the nine months ended September 30, 2025, the Company recognized $0.3 million of revenue from manufacturing services provided to Hanxin. During the three and nine months ended September 30, 2024, the Company recognized $0.1 million and $0.5 million, respectively, of revenue from manufacturing services provided to Hanxin. As of September 30, 2025 and December 31, 2024, the Company had receivables of approximately $0.5 million and $0.2 million from Hanxin under these agreements, respectively.
Contract Research Agreement with Hanxin
The Company has entered into various contract research agreements with Hanxin, a related party, whereby Hanxin will develop Recombinant Human Insulin Research Cell Banks and Recombinant Peptide Research Cell Banks, or RCBs, for the Company and license the RCBs to the Company subject to a fully paid, exclusive, perpetual, transferable, sub-licensable worldwide license. Hanxin will also perform scale-up manufacturing process development using the RCBs for the Company.
During the three and nine months ended September 30, 2025, the Company paid an immaterial amount under the agreements. During the three months ended September 30, 2024, the Company did not have any payments under the amended agreement and during the nine months ended September 30, 2024, the Company paid $0.2 million under the amended agreement. As of September 30, 2025 and December 31, 2024, the Company had an immaterial amount payable to Hanxin under this agreement.
Supply Agreement with Letop
In November 2022, the Company, entered into a supply agreement with Nanjing Letop Biotechnology Co., Ltd., or Letop, which is considered a related-party due to an ownership stake of Henry Zhang. Under the terms of the supply agreement Letop will manufacture and deliver chemical intermediates to the Company on a cost-plus basis. The agreement is effective for three years and the total cost of the agreement shall not exceed $1.5 million, with payments adjusted based on the then current exchange rates.
During the three months ended September 30, 2025, the Company did not make any payments under this agreement. During the nine months ended September 30, 2025, the Company paid an immaterial amount under this agreement. During the three and nine months ended September 30, 2024, the Company paid an immaterial amount under this agreement. As of September 30, 2025 and December 31, 2024, the Company did not have any amounts payable to Letop.
Primatene MIST® Distribution Agreement with Hong Kong Genreach Limited
In August 2024, the Company entered into a distribution agreement with Hong Kong Genreach Limited, or Genreach, a wholly owned subsidiary of Hanxin, a related party. Per the terms of the agreement, the Company has appointed Genreach as the exclusive distributor to market and sell Primatene MIST® in Mainland China, Taiwan, Hong Kong, and Macau in the Greater China region.
-27-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Genreach will be responsible for obtaining any and all regulatory approvals in the region for Primatene MIST®.
The term of the agreement is for ten years, with both parties having termination rights without cause after the completion of the second contract year.
During the three and nine months ended September 30, 2025, the Company did not recognize any revenue from the distribution agreement with Genreach. As of September 30, 2025 and December 31, 2024, the Company did not have any receivables from Genreach.
BAQSIMI® Distribution Agreement with Nanjing Chengong Pharmaceutical Co., Limited.
In October 2025, the Company entered into a distribution agreement with Nanjing Chengong Pharmaceutical Co., Limited, or Chengong, a wholly-owned subsidiary of Hanxin, a related party. Per the terms of the agreement, the Company will collaborate with Chengong to expand distribution of BAQSIMI®, in Mainland China, Taiwan, Hong Kong, and Macau in the Greater China region, and appoint Chengong as the exclusive distributor to market and sell BAQSIMI® in the Greater China Region. Chengong is responsible for obtaining any and all regulatory approvals in the Region, and performing the required post marketing clinical trials for BAQSIMI®.
The term of the agreement is for ten years, with both parties having termination rights without cause after the completion of the fourth contract year.
Note 19. Litigation
Employee Litigations
On April 15, 2024, a former employee initiated an employment litigation against Amphastar and IMS by filing a complaint, as amended, having individual and class action claims for alleged violations of the California Labor Code pertaining to California’s Private Attorneys General Act, or PAGA, wage and hour, and other state laws. This complaint was filed in the Superior Court of California for the County of Los Angeles. In the complaint, the plaintiff is seeking damages and related remedies under California Law, as well as various penalty payments under the California Labor Code. In November 2024, the court ordered the plaintiff to dismiss the individual and class claims, with only the PAGA claim remaining. The Company intends to vigorously defend itself against the complaint.
On June 20, 2024, a former employee initiated an employment litigation against Amphastar, IMS and Roth Staffing Companies L.P. by filing a complaint having individual and class action claims for alleged violations of the California Labor Code pertaining to wage and hour, and other state laws. This complaint was filed in the Superior Court of California for the County of Los Angeles. In the complaint, the plaintiff is seeking damages and related remedies under California Law, as well as various penalty payments under the California Labor Code. The Company intends to vigorously defend itself against the complaint.
Other Litigation
On August 23, 2023, the Company was subject to a personal injury lawsuit. A jury trial was held in the Superior Court of California, for the County of San Bernardino from September 2025 to October 2025. On October 22, 2025, the jury returned a verdict awarding the plaintiff $34.1 million, of which $11.0 million is covered by the Company’s insurance policies, and is recorded within prepaid expenses and other current assets with a corresponding accrued liability on the condensed consolidated balance sheet as of September 30, 2025. The remaining $23.1 million was accrued during the third quarter of 2025 within general and administrative expenses in the Company’s condensed consolidated statement of operations. As of December 31, 2024, the Company recorded $6.0 million in prepaids and other current assets with a corresponding accrued liability on the condensed consolidated balance sheet. The Company is currently exploring all post-verdict options, including an opportunity to appeal the decision of the court, and vigorously defend itself in this matter.
-28-
AMPHASTAR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
The Company is also subject to various other claims, arbitrations, investigations, and lawsuits from time to time arising in the ordinary course of business. In addition, third parties may, from time to time, assert claims against the Company in the forms of letters and other communications.
The Company records a provision for contingent losses when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. In the opinion of management, the ultimate resolution of any such matters is not expected to have a material adverse effect on its financial position, results of operations, or cash flows; however, the results of litigation and claims are inherently unpredictable and the Company’s view of these matters may change in the future. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors.
-29-
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following is a discussion and analysis of the consolidated operating results, financial condition, liquidity and cash flows of our company as of and for the periods presented below. The following discussion and analysis should be read in conjunction with the “Condensed Consolidated Financial Statements” and the related notes thereto included in this Quarterly Report on Form 10-Q, or Quarterly Report. This discussion contains forward-looking statements that are based on the beliefs of our management, as well as assumptions made by, and information currently available to, our management. Actual results could differ materially from those discussed in or implied by forward-looking statements. These risks, uncertainties, and other factors include, among others, those identified under the “Special Note About Forward-Looking Statements,” above and described in greater detail elsewhere in this Quarterly Report and in our Annual Report on Form 10-K for the year ended December 31, 2024, particularly in Item 1A. “Risk Factors”.
Overview
We are a biopharmaceutical company focusing primarily on developing, manufacturing, marketing and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products, as well as insulin API products. We currently manufacture and sell over 25 products.
Our largest products by net revenues currently include BAQSIMI®, Primatene MIST®, glucagon, epinephrine, and lidocaine.
We are currently developing a portfolio of generic abbreviated new drug applications, or ANDAs, biologics license applications, or BLAs, including biosimilar insulin product candidates, and proprietary product candidates, which are in various stages of development and target a variety of indications. Three of the ANDAs and one biosimilar insulin candidate are currently on file with the FDA.
To complement our internal growth and expertise, we have made several strategic acquisitions of companies, products and technologies. These acquisitions collectively have strengthened our core injectable and inhalation product technology infrastructure by providing additional manufacturing, marketing, and research and development capabilities, including the ability to manufacture raw materials, API, and other components for our products.
Macroeconomic Trends and Uncertainties
Recent worldwide events and macroeconomic factors, such as international trade relations, tariffs, new legislation and regulations, changes in administration, taxation or monetary policy changes, public sector budgetary cycles and funding authorization in the United States, political and civil unrest, global conflicts, supply chain disruptions, heightened inflationary pressures, and fluctuating interest rates, as well as rising healthcare costs among other factors, also increase volatility in the global economy and continue to pose challenges to our business. For example, there is significant uncertainty relating to tariffs. While all of our finished products and four of our APIs are manufactured in the United States, we import APIs, starting materials for APIs, and components from various countries.
See the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, for further discussion of the potential adverse impact of unfavorable global and geopolitical economic conditions on our business, results of operations and financial conditions.
Recent Developments
In August 2025, the FDA approved our Iron Sucrose Injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, which we launched in the third quarter of 2025.
In August 2025, we entered into a License Agreement with Nanjing Anji Biotechnology Co., Ltd., or Anji, pursuant to which Anji has granted an exclusive license to certain intellectual property controlled by Anji to develop, make, use and commercialize products incorporating or comprising certain compounds, including three identified products, or Licensed Products, in the United States and Canada. During the nine months ended September 30, 2025, we made an earnest payment and upfront payment totaling $6.0 million to Anji upon the signing of the License agreement. The agreement is also subject to potential development milestone payments, as well as sales milestone and royalty payments.
-30-
For more information regarding the Anji license agreement, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 17. Commitments and Contingencies.”
Business Segments
Our performance is assessed and resources are allocated based on one reportable segment, pharmaceutical products.
For more information regarding our segments, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 5. Segment Reporting.”
Results of Operations
Three Months Ended September 30, 2025 Compared to Three Months Ended September 30, 2024
Net revenues
|
|
Three Months Ended |
|
|
|
|
|||||||
|
|
September 30, |
|
Change |
|
|
|||||||
|
|
2025 |
|
2024 |
|
Dollars |
|
% |
|
|
|||
|
|
(in thousands) |
|
|
|
|
|||||||
Net revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues, net |
|
$ |
191,840 |
|
$ |
188,819 |
|
$ |
3,021 |
|
2 |
% |
|
Other revenues |
|
|
— |
|
|
2,395 |
|
|
(2,395) |
|
(100) |
% |
|
Total net revenues |
|
$ |
191,840 |
|
$ |
191,214 |
|
$ |
626 |
|
0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues |
|
$ |
93,194 |
|
$ |
89,273 |
|
$ |
3,921 |
|
4 |
% |
|
Gross profit |
|
$ |
98,646 |
|
$ |
101,941 |
|
$ |
(3,295) |
|
(3) |
% |
|
as % of net revenues |
|
|
51 |
% |
|
53 |
% |
|
|
|
|
|
|
The increase in product revenues, net, was primarily due to the following changes:
|
|
Three Months Ended |
|
|
|
|
|||||||
|
|
September 30, |
|
Change |
|
|
|||||||
|
|
2025 |
|
2024 |
|
Dollars |
|
% |
|
|
|||
|
|
(in thousands) |
|
|
|
|
|||||||
Product revenues, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
BAQSIMI® |
|
$ |
53,608 |
|
$ |
40,409 |
|
$ |
13,199 |
|
33 |
% |
|
Primatene MIST® |
|
|
28,808 |
|
|
26,055 |
|
|
2,753 |
|
11 |
% |
|
Epinephrine |
|
|
18,789 |
|
|
21,341 |
|
|
(2,552) |
|
(12) |
% |
|
Glucagon |
|
|
13,558 |
|
|
26,792 |
|
|
(13,234) |
|
(49) |
% |
|
Lidocaine |
|
|
12,932 |
|
|
15,884 |
|
|
(2,952) |
|
(19) |
% |
|
Other products |
|
|
64,145 |
|
|
58,338 |
|
|
5,807 |
|
10 |
% |
|
Total product revenues, net |
|
$ |
191,840 |
|
$ |
188,819 |
|
$ |
3,021 |
|
2 |
% |
|
Product Revenues, net
The increase in sales of BAQSIMI® was primarily due to growth in unit volumes as a result of an expanded marketing effort in the United States. Total BAQSIMI® sales growth, including units sold by Eli Lilly and Company, or Lilly, in 2024 which were accounted for in Other revenues, was 14%. Primatene MIST® sales increased due an increase in unit volumes driven by our continued marketing efforts. The decrease in sales of epinephrine was primarily due to a lower average selling price of the multi-dose vial product, causing a revenue reduction of $3.1 million, as a result of increased competition. This trend was partially offset by an increase in unit volumes for our epinephrine pre-filled syringe, as a result of an increase in demand caused by shortages from other suppliers during the quarter. The decrease in sales of glucagon was due to a lower average selling price, impacting sales of $7.0 million, as well as a decrease in unit volumes, impacting sales of $6.2 million, as a result of competition and the continued shift to ready-to-use glucagon products such as BAQSIMI®.
-31-
The decrease in sales of lidocaine was primarily due to a decrease in unit volumes as a result of other suppliers returning to their historical distribution level. The increase in other products was primarily due to a $4.7 million increase in sales of albuterol and $2.4 million sales of iron sucrose injection, which we launched in August 2025. This increase was partially offset by a decrease in unit volumes of enoxaparin and dextrose, due to increased competition.
We anticipate that sales of glucagon will continue to decline in the future due to competitive dynamics. We also anticipate that sales of epinephrine and other products will continue to fluctuate depending on the ability of our competitors to supply market demands.
Other Revenues
Other revenues in the previous period include the portion of BAQSIMI® sales made by Lilly on our behalf under the Transition Service Agreement, or TSA, which amounted to $2.4 million during the three months ended September 30, 2024, based on total BAQSIMI® sales of $6.4 million as reported to us by Lilly which was recognized on a net basis, similar to a royalty arrangement. As we completed the assumption of distribution responsibilities globally for BAQSIMI® at the beginning of 2025, all BAQSIMI® related revenues in the current period are recognized in Product revenues, net.
Backlog
A significant portion of our customer shipments in any period relate to orders received and shipped in the same period, generally resulting in low product backlog relative to total shipments at any time. We had no significant backlog as of September 30, 2025. Historically, our backlog has not been a meaningful indicator in any given period of our ability to achieve any particular level of overall revenue or financial performance.
Gross Margins
In 2024, under the TSA, the portion of revenues relating to BAQSIMI® sales made by Lilly on our behalf were reported on a net basis, similar to a royalty arrangement with no amount reported as cost of revenues resulting in increased gross margins for that period. Gross margins were also impacted by decrease in unit sales and pricing of glucagon, and lower pricing for our epinephrine multi-dose vial product, both of which are higher-margin products. Additionally, cost control efforts across the business partially offset the impact of pricing declines.
Selling, distribution and marketing, and general and administrative
|
|
Three Months Ended |
|
|
|
|
|||||||
|
|
September 30, |
|
Change |
|
|
|||||||
|
|
2025 |
|
2024 |
|
Dollars |
|
% |
|
|
|||
|
|
(in thousands) |
|
|
|
|
|||||||
Selling, distribution, and marketing |
|
$ |
11,505 |
|
$ |
8,995 |
|
$ |
2,510 |
|
28 |
% |
|
General and administrative |
|
$ |
39,467 |
|
$ |
14,821 |
|
$ |
24,646 |
|
166 |
% |
|
The increase in selling, distribution and marketing expenses was primarily related to the expansion of our sales and marketing efforts related to BAQSIMI®, including expenses related to our co-promotion contract with MannKind, and sales efforts related to Primatene MIST®. The increase in general and administrative expense was primarily related to a litigation provision, which increased expenses by $23.1 million.
We expect that selling, distribution and marketing expenses will continue to increase due to the increase in marketing expenditures for BAQSIMI® and Primatene MIST®. Legal fees may fluctuate from period to period due to the timing of patent challenges and other litigation matters.
-32-
Research and development
|
Three Months Ended |
|
|
|
|
|||||||
|
September 30, |
|
Change |
|
|
|||||||
|
2025 |
|
2024 |
|
Dollars |
|
% |
|
|
|||
|
(in thousands) |
|
|
|
|
|||||||
Salaries and personnel-related expenses |
$ |
8,291 |
|
$ |
7,768 |
|
$ |
523 |
|
7 |
% |
|
Clinical trials |
|
352 |
|
|
9 |
|
|
343 |
|
NM |
|
|
FDA fees |
|
45 |
|
|
34 |
|
|
11 |
|
32 |
% |
|
Materials and supplies |
|
1,035 |
|
|
5,852 |
|
|
(4,817) |
|
(82) |
% |
|
Depreciation |
|
3,627 |
|
|
3,278 |
|
|
349 |
|
11 |
% |
|
Other expenses(1) |
|
9,004 |
|
|
4,136 |
|
|
4,868 |
|
118 |
% |
|
Total research and development expenses |
$ |
22,354 |
|
$ |
21,077 |
|
$ |
1,277 |
|
6 |
% |
|
| (1) | Includes the upfront payment of $5.3 million relating to the licensing agreement with Anji. |
Research and development expenses consist primarily of costs associated with the research and development of our product candidates including the cost of developing APIs. We expense research and development costs as incurred.
Research and development expenses increased primarily due to the $5.3 million upfront payment for the licensing agreement that we entered into with Anji during the quarter, as well as an increase in clinical trial expense. This was partially offset by a decrease in material and supply expenses.
We have made, and expect to continue to make, substantial investments in research and development to expand our product portfolio and grow our business. We expect that research and development expenses will increase on an annual basis due to increased clinical trials costs related to our insulin and inhalation product candidates. These expenditures will include costs of APIs developed internally as well as APIs purchased externally, the cost of purchasing reference listed drugs and the costs of performing the clinical trials. As we undertake new and challenging research and development projects, we anticipate that the associated costs will increase significantly over the next several quarters and years.
Non-operating expenses, net
|
|
Three Months Ended |
|
|
|
|
|||||||
|
|
September 30, |
|
Change |
|
|
|||||||
|
|
2025 |
|
2024 |
|
Dollars |
|
% |
|
|
|||
|
|
(in thousands) |
|
|
|
|
|||||||
Non-operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
2,246 |
|
$ |
2,427 |
|
$ |
(181) |
|
(7) |
% |
|
Interest expense |
|
|
(6,284) |
|
|
(6,698) |
|
|
414 |
|
(6) |
% |
|
Other income (expenses), net |
|
|
231 |
|
|
(5,094) |
|
|
5,325 |
|
105 |
% |
|
Total non-operating expenses, net |
|
$ |
(3,807) |
|
$ |
(9,365) |
|
$ |
5,558 |
|
(59) |
% |
|
The change in non-operating expenses, net, is primarily due to a change to Other income (expenses), net, as a result of foreign currency fluctuation, as well as mark-to-market adjustments relating to our interest rate swap contracts during the three months ended September 30, 2025.
Income tax provision
|
|
Three Months Ended |
|
|
|
|
|||||||
|
|
September 30, |
|
Change |
|
|
|||||||
|
|
2025 |
|
2024 |
|
Dollars |
|
% |
|
|
|||
|
|
(in thousands) |
|
|
|
|
|||||||
Income tax provision |
|
$ |
4,163 |
|
$ |
7,254 |
|
$ |
(3,091) |
|
(43) |
% |
|
Effective tax rate |
|
|
19 |
% |
|
15 |
% |
|
|
|
|
|
|
-33-
Our effective tax rate for the three months ended September 30, 2025 increased in comparison to the three months ended September 30, 2024, primarily due to differences in pre-tax income positions, and timing of discrete tax items. For more information regarding our income taxes, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 14. Income Taxes.”
On July 4, 2025, the One Big Beautiful Bill Act, or OBBBA, was enacted into law. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. As of September 30, 2025, we do not expect the provisions of the OBBBA will have a material impact on income tax expense, but we do expect certain provisions will change the timing of cash tax payments in the current year and future periods.
Nine Months Ended September 30, 2025 Compared to Nine Months Ended September 30, 2024
Net revenues
|
|
Nine Months Ended |
|
|
|
|
|||||||
|
|
September 30, |
|
Change |
|
|
|||||||
|
|
2025 |
|
2024 |
|
Dollars |
|
% |
|
|
|||
|
|
(in thousands) |
|
|
|
|
|||||||
Net revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenues, net |
|
$ |
536,782 |
|
$ |
525,836 |
|
$ |
10,946 |
|
2 |
% |
|
Other revenues |
|
|
— |
|
|
19,608 |
|
|
(19,608) |
|
(100) |
% |
|
Total net revenues |
|
$ |
536,782 |
|
$ |
545,444 |
|
$ |
(8,662) |
|
(2) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues |
|
$ |
266,395 |
|
$ |
258,237 |
|
$ |
8,158 |
|
3 |
% |
|
Gross profit |
|
$ |
270,387 |
|
$ |
287,207 |
|
$ |
(16,820) |
|
(6) |
% |
|
as % of net revenues |
|
|
50 |
% |
|
53 |
% |
|
|
|
|
|
|
The increase in product revenues, net, was primarily due to the following changes:
|
|
Nine Months Ended |
|
|
|
|
|||||||
|
|
September 30, |
|
Change |
|
|
|||||||
|
|
2025 |
|
2024 |
|
Dollars |
|
% |
|
|
|||
|
|
(in thousands) |
|
|
|
|
|||||||
Product revenues, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
BAQSIMI® |
|
$ |
138,650 |
|
$ |
85,106 |
|
$ |
53,544 |
|
63 |
% |
|
Primatene MIST® |
|
|
80,739 |
|
|
73,077 |
|
|
7,662 |
|
10 |
% |
|
Glucagon |
|
|
55,003 |
|
|
82,700 |
|
|
(27,697) |
|
(33) |
% |
|
Epinephrine |
|
|
53,556 |
|
|
75,392 |
|
|
(21,836) |
|
(29) |
% |
|
Lidocaine |
|
|
41,575 |
|
|
41,457 |
|
|
118 |
|
0 |
% |
|
Other products |
|
|
167,259 |
|
|
168,104 |
|
|
(845) |
|
(1) |
% |
|
Total product revenues, net |
|
$ |
536,782 |
|
$ |
525,836 |
|
$ |
10,946 |
|
2 |
% |
|
Product Revenues, net
BAQSIMI® sales increased primarily due to an increase in unit volume, as we assumed full distribution responsibilities globally at the beginning of 2025. Total BAQSIMI® sales growth, including units sold by Lilly in 2024 which were accounted for in Other revenues, was 12%. Primatene MIST® sales increased primarily due to an increase in unit volumes driven by our continued marketing efforts. The decrease in sales of glucagon was due to a decrease in unit volumes, impacting sales of $14.3 million, as well as a decrease in average selling price, which impact sales of $13.4 million, as a result of competition and the continued shift to ready to use glucagon products such as BAQSIMI®. The decrease in sales of epinephrine was due to a decrease in unit volume, impacting sales of $13.4 million, as well as a decrease in average selling price, which impact sales of $8.4 million, primarily as a result of increased competition for our multi-dose epinephrine vial product. The decrease in other products was primarily due to a decrease in sales of enoxaparin, dextrose and naloxone, due to increased competition. This decrease was primarily offset by an increase of $10.5 million in albuterol sales, which was launched in August 2024, and $2.4 million in sales of iron sucrose injection, which we launched in August 2025.
-34-
We anticipate that sales of glucagon will continue to decline in the future due to competitive dynamics. We also anticipate that sales of epinephrine and other products will continue to fluctuate depending on the ability of our competitors to supply market demands.
Other Revenues
As we completed the assumption of distribution responsibilities globally for BAQSIMI® at the beginning of 2025, all BAQSIMI® related revenues in the current period are recognized in Product revenues, net. Other revenues in the previous period include the portion of BAQSIMI® sales made by Lilly on our behalf under the TSA, which amounted to $19.6 million during the nine months ended September 30, 2024, based on total BAQSIMI® sales of $38.6 million as reported to us by Lilly, which was recognized on a net basis, similar to a royalty arrangement.
Gross Margins
In 2024, under the TSA, the portion of revenues relating to BAQSIMI® sales made by Lilly on our behalf were reported on a net basis, similar to a royalty arrangement with no amount reported as cost of revenues resulting in increased gross margins for that period. Gross margins were also impacted by lower pricing for glucagon and epinephrine multi-dose vials, both of which are higher-margin products, as well as an increase in labor costs.
The decrease in gross margins was partially offset by the increase in sales of Primatene MIST®, which is a higher-margin product. Additionally, cost control efforts across the business partially offset the impact of pricing declines.
Selling, distribution and marketing, and general and administrative
|
|
Nine Months Ended |
|
|
|
|
|||||||
|
|
September 30, |
|
Change |
|
|
|||||||
|
|
2025 |
|
2024 |
|
Dollars |
|
% |
|
|
|||
|
|
(in thousands) |
|
|
|
|
|||||||
Selling, distribution, and marketing |
|
$ |
33,606 |
|
$ |
27,378 |
|
$ |
6,228 |
|
23 |
% |
|
General and administrative |
|
$ |
69,454 |
|
$ |
43,782 |
|
$ |
25,672 |
|
59 |
% |
|
The increase in selling, distribution and marketing expenses was primarily due to expenses related to the expansion of our sales and marketing efforts related to BAQSIMI®, including expenses related to our co-promotion contract with MannKind, and sales efforts related to Primatene MIST®. The increase in general and administrative expense was primarily related to a litigation provision, which increased expenses by $23.1 million.
We expect that selling, distribution and marketing expenses will continue to increase due to the increase in marketing expenditures for BAQSIMI® and Primatene MIST®. Legal fees may fluctuate from period to period due to the timing of patent challenges and other litigation matters.
Research and development
|
Nine Months Ended |
|
|
|
|
|||||||
|
September 30, |
|
Change |
|
|
|||||||
|
2025 |
|
2024 |
|
Dollars |
|
% |
|
|
|||
|
(in thousands) |
|
|
|
|
|||||||
Salaries and personnel-related expenses |
$ |
25,437 |
|
$ |
23,898 |
|
$ |
1,539 |
|
6 |
% |
|
Clinical trials |
|
1,489 |
|
|
292 |
|
|
1,197 |
|
NM |
|
|
FDA fees |
|
1,554 |
|
|
1,333 |
|
|
221 |
|
17 |
% |
|
Materials and supplies |
|
8,735 |
|
|
12,334 |
|
|
(3,599) |
|
(29) |
% |
|
Depreciation |
|
10,788 |
|
|
9,206 |
|
|
1,582 |
|
17 |
% |
|
Other expenses(1) |
|
14,527 |
|
|
8,709 |
|
|
5,818 |
|
67 |
% |
|
Total research and development expenses |
$ |
62,530 |
|
$ |
55,772 |
|
$ |
6,758 |
|
12 |
% |
|
| (1) | Includes the earnest payment and upfront payment totaling $6.0 million relating to the licensing agreement with Anji. |
-35-
Research and development expenses consist primarily of costs associated with the research and development of our product candidates including the cost of developing APIs. We expense research and development costs as incurred.
Research and development expenses increased primarily due to the $6.0 million payment for the licensing agreement that we entered into with Anji in the third quarter of 2025. Additionally, we had an increase in clinical trial expense, as well as an increase in depreciation expense. This was partially offset by a decrease in material and supply expenses.
We have made, and expect to continue to make, substantial investments in research and development to expand our product portfolio and grow our business. We expect that research and development expenses will increase on an annual basis due to increased clinical trials costs related to our insulin and inhalation product candidates. These expenditures will include costs of APIs developed internally as well as APIs purchased externally, the cost of purchasing reference listed drugs and the costs of performing the clinical trials. As we undertake new and challenging research and development projects, we anticipate that the associated costs will increase significantly over the next several quarters and years.
Non-operating expenses, net
|
|
Nine Months Ended |
|
|
|
|
|||||||
|
|
September 30, |
|
Change |
|
|
|||||||
|
|
2025 |
|
2024 |
|
Dollars |
|
% |
|
|
|||
|
|
(in thousands) |
|
|
|
|
|||||||
Non-operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
$ |
6,256 |
|
$ |
8,320 |
|
$ |
(2,064) |
|
(25) |
% |
|
Interest expense |
|
|
(18,851) |
|
|
(23,918) |
|
|
5,067 |
|
(21) |
% |
|
Other income (expenses), net |
|
|
(492) |
|
|
1,125 |
|
|
(1,617) |
|
(144) |
% |
|
Total non-operating expenses, net |
|
$ |
(13,087) |
|
$ |
(14,473) |
|
$ |
1,386 |
|
(10) |
% |
|
The change in non-operating expenses, net is primarily a result of:
| ● | A decrease in interest income resulting from a decrease in interest rates on our cash and investments accounts. |
| ● | A decrease in interest expense as a result of the repayment of the mortgage loan with East West Bank, as well as the accretion of the interest on the deferred payment for BAQSIMI®, both of which were paid in full in June 2024. For more information regarding our debt, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 13. Debt.” |
| ● | A change to Other income (expenses), net primarily as a result of foreign currency fluctuation, as well as mark-to-market adjustments relating to our interest rate swap contracts during the nine months ended September 30, 2025. |
Income tax provision
|
|
Nine Months Ended |
|
|
|
|
|||||||
|
|
September 30, |
|
Change |
|
|
|||||||
|
|
2025 |
|
2024 |
|
Dollars |
|
% |
|
|
|||
|
|
(in thousands) |
|
|
|
|
|||||||
Income tax provision |
|
$ |
18,045 |
|
$ |
23,674 |
|
$ |
(5,629) |
|
(24) |
% |
|
Effective tax rate |
|
|
20 |
% |
|
16 |
% |
|
|
|
|
|
|
Our effective tax rate for the nine months ended September 30, 2025 increased in comparison to the nine months ended September 30, 2024, primarily due to differences in pre-tax income positions and timing of discrete tax items. For more information regarding our income taxes, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 14. Income Taxes.”
-36-
Liquidity and Capital Resources
Cash Requirements and Sources
We need capital resources to maintain and expand our business. We expect our cash requirements to increase significantly in the foreseeable future as we may trigger milestone payments for our BAQSIMI® acquisition of up to an aggregate of $575 million contingent upon certain net sales milestones, sponsor clinical trials for, seek regulatory approvals of, and develop, manufacture and market our current development stage product candidates and pursue strategic acquisitions of businesses or assets. Our future capital expenditures include projects to upgrade, expand, and improve our manufacturing facilities in the United States and China, including a significant increase in capital expenditures over the next few years. We plan to fund this facility expansion with cash flows from operations. Our cash obligations include the principal and interest payments due on our existing loans and lease payments, as described below and throughout this Quarterly Report.
As of September 30, 2025, our foreign subsidiaries collectively held $15.3 million in cash and cash equivalents. Cash or cash equivalents held at foreign subsidiaries are not available to fund the parent company’s operations in the United States. We believe that our cash reserves, operating cash flows, and borrowing availability under our credit facilities will be sufficient to fund our operations for at least the next 12 months from the filing of this Quarterly Report on Form 10-Q. We expect additional cash flows to be generated in the longer term from future product launches, although there can be no assurance as to the receipt of regulatory approval for any product candidates that we are developing or the timing of any product launches, which could be lengthy or ultimately unsuccessful.
Working capital increased $73.9 million to $434.2 million at September 30, 2025, compared to $360.3 million at December 31, 2024.
Cash Flows from Operations
The following table summarizes our cash flows provided by and used in operating, investing, and financing activities for the nine months ended September 30, 2025 and 2024:
|
|
Nine Months Ended September 30, |
||||
|
|
2025 |
|
2024 |
||
|
|
(in thousands) |
||||
Statement of Cash Flow Data: |
|
|
|
|
|
|
Net cash provided by (used in) |
|
|
|
|
|
|
Operating activities |
|
$ |
123,252 |
|
$ |
184,362 |
Investing activities |
|
|
(9,763) |
|
|
(89,252) |
Financing activities |
|
|
(49,052) |
|
|
(47,111) |
Effect of exchange rate changes on cash |
|
|
219 |
|
|
(179) |
Net increase in cash, cash equivalents, and restricted cash |
|
$ |
64,656 |
|
$ |
47,820 |
Sources and Use of Cash
Operating Activities
Net cash provided by operating activities was $123.3 million for the nine months ended September 30, 2025, which included net income of $73.7 million. Non-cash items comprised primarily of $49.7 million of depreciation and amortization, which includes $23.5 million related to depreciation of property, plant and equipment; $18.8 million related to amortization of intangible assets; $4.9 million related to amortization of operating lease right-of-use assets; $2.5 million related to amortization of discounts, premiums, and debt issuance costs; and share-based compensation expense of $21.1 million.
Additionally, for the nine months ended September 30, 2025, there was a net cash outflow from changes in operating assets and liabilities of $23.2 million, which resulted primarily from an increase in inventories and an increase in accounts receivable. This was partially offset by an increase in accounts payable and accrued liabilities. The increase in inventories was primarily due to the increased purchases of finished product, raw materials and components for BAQSIMI®, as we assumed full responsibility for the supply chain from Lilly.
-37-
The increase in accounts receivables was primarily due to the timing of sales. Accounts payable and accrued liabilities increased primarily due to the increase in accrued customer fees and rebates, mainly associated with BAQSIMI® sales, as well as a legal accrual related to the personal injury lawsuit.
Net cash provided by operating activities was $184.4 million for the nine months ended September 30, 2024, which included net income of $121.6 million. Non-cash items comprised primarily of $47.8 million of depreciation and amortization, which includes $21.0 million related to depreciation of property, plant and equipment; $18.5 million related to amortization of product rights, trademarks and patents; $3.0 million related to amortization of operating lease right-of-use assets; $5.3 million related to amortization of discounts, premiums, and debt issuance costs; and share-based compensation expense of $18.7 million. Additionally, for the nine months ended September 30, 2024, there was a net cash outflow from changes in operating assets and liabilities of $6.0 million, which resulted primarily from an increase in accounts receivables, an increase in inventories, as well as an increase in prepaid expenses and other assets, which was partially offset by an increase in accounts payable and accrued liabilities. The increase in accounts receivables was primarily due to the increase in sales. The increase in inventories was primarily due to the increased purchases of certain raw materials and components. Accounts payable and accrued liabilities increased primarily due to the increase in accrued customer fees and rebates associated with BAQSIMI® sales, as we continue to assume distribution responsibilities for BAQSIMI® from Lilly to our customers in the United States and certain other countries.
Investing Activities
Net cash used in investing activities was $9.8 million for the nine months ended September 30, 2025, primarily as a result of $26.6 million in purchases of property, plant, and equipment, which included $16.9 million incurred in the United States, $2.0 million in France, and $7.7 million in China. This was partially offset by a net cash inflow of $23.0 million from sales and purchases of investments during the period.
Net cash used in investing activities was $89.3 million for the nine months ended September 30, 2024, primarily due to the payment of $129.0 million relating to the BAQSIMI® acquisition, $28.6 million in purchases of property, plant, and equipment, which included $10.2 million incurred in the United States, $2.4 million in France, and $15.9 million in China. This was partially offset by a net cash inflow of $71.0 million from sales and purchases of investments during the period.
Financing Activities
Net cash used in financing activities was $49.1 million for the nine months ended September 30, 2025, primarily as a result of $55.1 million used to purchase treasury stock. This was partially offset by $5.9 million of net proceeds from borrowings on our line of credit in China.
Net cash used in financing activities was $47.1 million for the nine months ended September 30, 2024, primarily as a result of $43.5 million used to purchase treasury stock and $8.2 million used to settle share-based compensation awards under our equity plan and for tax payments related to the net share settlement of options exercised. Additionally, we made $8.1 million in principal payments on our long-term debt, primarily as a result of paying off the mortgage loan with East West Bank. This was partially offset by $13.6 million of net proceeds from borrowings on our line of credit in China.
Indebtedness
For more information regarding our outstanding indebtedness, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 13. Debt”.
Critical Accounting Policies
The preparation of our condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and notes to the financial statements. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions.
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A summary of our critical accounting policies is presented in Part II, Item 7, of our Annual Report on Form 10-K for the year ended December 31, 2024. There have been no material changes to our critical accounting policies as compared to the critical accounting policies as described in our Annual Report on Form 10-K for the year ended December 31, 2024.
Recent Accounting Pronouncements
For information regarding recent accounting pronouncements, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 2. Summary of Significant Accounting Policies”.
Government Regulation
Our products and facilities are subject to regulation by a number of federal and state governmental agencies. The FDA, in particular, maintains oversight of the formulation, manufacture, distribution, packaging, and labeling of all of our products. The Drug Enforcement Administration, or DEA, maintains oversight over our products that are considered controlled substances.
Our manufacturing facilities as well as our CMOs are subject to periodic inspection by the FDA to ensure that they are operating in compliance with cGMP requirements. We believe that as of September 30, 2025, all of our manufacturing facilities and our CMOs are in compliance with all applicable regulations of federal and state governmental agencies, including all those of the FDA and DEA. During the nine months ended September 30, 2025, we had inspections conducted by various regulatory agencies at some of our manufacturing facilities, which resulted in no critical observations.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
Except for the broad, ongoing macroeconomic challenges facing the global economy and financial markets, there have been no material changes in market risk from the information provided in our Annual Report on Form 10-K for the year ended December 31, 2024. We are exposed to market risk in the ordinary course of business. Market risk represents the potential loss arising from adverse changes in the value of financial instruments. The risk of loss is assessed based on the likelihood of adverse changes in fair values, cash flows or future earnings. We are exposed to market risk for changes in the market values of our investments (Investment Risk), the impact of interest rate changes (Interest Rate Risk), and the impact of foreign currency exchange rate changes (Foreign Currency Exchange Risk).
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, our principal executive and principal financial officers, respectively, conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were effective (a) to ensure that information that we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms and (b) to include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in reports filed or submitted under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There have been no changes in our internal control over financial reporting that occurred during the quarter ended September 30, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act).
Inherent Limitations of Internal Controls
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management overriding of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
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PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
For information regarding legal proceedings, see “Part I – Item 1. Financial Statements – Notes to Condensed Consolidated Financial Statements – Note 19. Litigation.”
ITEM 1A. RISK FACTORS
Except as noted below, there were no material changes from the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025.
Because a portion of our manufacturing takes place in China, a significant disruption in the construction or operation of our manufacturing facility in China, political unrest in China, tariffs, impacts of outbreaks of health epidemics, or changes in social, political, trade, health, economic, environmental, or climate-related conditions or in laws, regulations and policies governing foreign trade could materially and adversely affect our business, financial condition and results of operations.
We currently manufacture the starting material for Amphadase® and enoxaparin as well as the APIs for isoproterenol, nitroprusside, and medroxyprogesterone at our manufacturing facility in China, and we plan to use this facility to manufacture several of the APIs for products in our pipeline. Additionally, we intend to continue to invest in the expansion of this manufacturing facility. Our manufacturing facility and operations in China involve significant risks, including:
• |
disruptions in the construction of the manufacturing facility; |
• |
interruptions to our operations in China or the inability of our manufacturing facility to produce adequate quantities of raw materials or APIs to meet our needs as a result of natural catastrophic events or other causes beyond our control such as power disruptions or widespread disease outbreaks, including the recent outbreaks that impact animal-derived products, such as the importation of pig-derived crude heparin from countries impacted by the African swine flu, and the COVID-19 pandemic, which resulted in import and export complications, and otherwise cause shortages in the supply of raw materials or cause disruptions in our manufacturing capability; |
• |
product supply disruptions and increased costs as a result of heightened exposure to changes in the policies of the Chinese government, political unrest or unstable economic conditions in China; |
• |
the imposition of additional tariffs, export controls or other trade barriers as a result of changes in social, political, and economic conditions or in laws, regulations, and policies governing foreign trade, including U.S. export controls impacting the ability to send certain products and technology, specifically related to semi-conductor manufacturing and supercomputing (including a prohibition on exports, reexports, and transfers to and within China without an export license, and the addition of new China-based entities to certain U.S. restricted party lists including the Entity List and Unverified List, trade sanctions and import laws and regulations, tariffs on various imports into the U.S. from China including those previously implemented and additional tariffs that may in the future be implemented by the U.S. government (including on imports of pharmaceutical products into the United States currently under investigation by the U.S. Department of Commerce, among other potential tariffs), the implementation, scope, and duration of which remain uncertain; |
• |
the imposition of retaliatory trade measures by China or other countries in response to new or escalated tariffs, export controls, or other trade measures by the United States (including those previously implemented by China and other countries, such as tariffs on U.S.-origin items and export controls on certain rare earth materials), which may affect the availability and/or price of materials used in our supply chain, and the implementation, scope, and duration of which remain uncertain; |
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• |
the nationalization or other expropriation of private enterprises or intellectual property by the Chinese government, which could result in the total loss of our investment in China; and |
• |
interruptions to our manufacturing or business operations resulting from geo-political actions, global conflicts, natural disasters including earthquakes, typhoons, floods, and fires, or outbreaks of health epidemics or outbreaks in livestock or animals that impact or restrict importation, use, or distribution of animal-derived products. |
Any of these matters could materially and adversely affect our business and results of operations. These interruptions or failures could impair our ability to operate our business, impede the commercialization of our product candidates or delay the introduction of new products, impact our product quality, or impair our competitive position. Any material adverse effect on our employees, suppliers, and logistics providers could have a material adverse effect on our manufacturing operations in China or the supply of raw materials or APIs originating from China.
Enhanced trade tariffs, import restrictions, export restrictions, Chinese regulations or other trade barriers may materially harm our business.
We are continuing to expand our international operations as part of our growth strategy. There is currently significant uncertainty about the future relationship between the United States and various other countries, most significantly China, with respect to trade policies, treaties, government regulations and tariffs. There is a possibility that the United States could continue to impose greater restrictions on international trade and significant increases in tariffs on goods imported into the United States. For example, since September 2018, the U.S. Trade Representative (the “USTR”) enacted Section 301 tariffs on certain commodities from certain U.S. trading partners, most prominently China and Brazil, affecting hundreds of billions of dollars of imports. In addition, since February 4, 2025, the U.S. government has imposed an additional “fentanyl-related” tariffs of 10% to 35% on the import of almost all Chinese-, Mexican-, and Canadian-origin items with an exception for items qualifying for duty-free treatment under the U.S.-Mexico-Canada Agreement, as well as additional “reciprocal” tariffs of 10% to 125% on certain products of most other U.S. trading partners, including China since April 2025, with exemptions for certain pharmaceuticals, semiconductors, and consumer electronics. Since March 2025, the U.S. government has also implemented new Section 232 tariffs of 10% to 50% on various commodities based on findings by the U.S. government that imports of these items threaten to impair U.S. national security, including with regard to imports of certain articles of steel and aluminum; passenger vehicles, trucks, and automotive components; certain articles of copper; and timber, lumber, and certain article of wood. These trade policies, including applicable items, tariff rates, countries, and exceptions, are subject to change. Additional tariffs may in the future also be implemented by the U.S. government (including on imports of pharmaceutical products into the United States currently under Section 232 investigation by the U.S. Department of Commerce, among other potential tariffs), the implementation, scope, and duration of which remain uncertain. Tariffs on imports of APIs and starting materials used in our products, or retaliatory trade measures taken by China or other countries, which could potentially include restricted access to APIs or starting materials used in our products, could result in us needing to raise prices, make changes to our products, or materially harm our business, financial condition and results of operations. Further, the continued threats of tariffs, trade restrictions, and trade barriers could have a generally disruptive impact on the global economy and, therefore, negatively impact our sales. Given the focus of the U.S. government on issues related to China, including the imposition of additional restrictions on exports related to semi-conductor manufacturing and supercomputing, the imposition of outbound investment controls affecting U.S. persons’ ability to invest in certain enterprises in China, and the addition of entities based in China to various restricted party lists, along with uncertainty regarding how the U.S. or foreign governments will act with respect to tariffs, international trade agreements and policies, a trade war, further governmental action related to tariffs or international trade policies, or additional tax or other regulatory changes in the future could occur and could directly and adversely impact our financial results and results of operations.
Our business and operations have been impacted in the past, and may be impacted in the future, in the event of system breach or failure.
We and our third-party service providers and other third parties with whom we do business, including our collaborators, third-party providers, distributors, customers and other contractors utilize information technology systems and networks to transmit, store and otherwise process electronic data in connection with our business activities, including our supply chain processes, operations and communications including, in some cases, our clinical data and business proprietary information, and electronic data interchange, on purchase orders, invoices, chargebacks, among other things.
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We and such third parties, including and our collaborators, third-party service providers, distributors and other contractors, also collect, transmit, store and otherwise process certain data relating to individuals, including about our personnel, business partners, and others, which may be subject to applicable data protection, security and privacy laws and regulations that require adoption of minimum information security standards. The cost of compliance with applicable data protection, security and privacy laws and regulations have increased and may increase in the future.
Despite our implementation of security measures to protect the confidentiality, integrity, and availability of the systems, networks and data within our control from various threats (e.g., threats of cyber-attacks, system breaches, and other security breaches and incidents, malware, viruses, hacking, fraudulent use, social engineering attacks, phishing attacks, ransomware attacks, credential-stuffing attacks, denial-of-service attacks, unauthorized access, insider threats, accidental disclosures, intellectual property theft and economic espionage, exploitable vulnerabilities, defects or bugs in our or our third-party service providers’ systems, natural disasters, war, terrorism, telecommunications and electrical outages, breakdowns, damage, outages, interruptions, and other cyber-events), we and certain of our third-party service providers have experienced and may continue to experience cyber-attacks, outages, interruptions, and other cyber-events of varying degrees from time to time. For example, in the first quarter of 2022, our Chinese subsidiary, ANP, was subject to a security incident that resulted in a temporary disruption to some of its internal computer systems. We worked with ANP to improve and implement additional security measures to its systems and networks. We incurred minimal costs to respond to the ANP incident. In addition, in the second quarter of 2020, we were subject to a security incident that resulted in a temporary disruption to some of our internal computer systems. In response to this incident, we engaged a third-party forensic expert to investigate, and determined that cyber criminals illegally obtained certain personal information of certain current and former employees. We notified affected individuals and regulators, as we deemed was required or appropriate. We incurred minimal cost to respond to this incident. Our systems and networks and the systems and networks of our third-party service providers, have been, and in the future may be, breached or disrupted due to the threats described above or otherwise. The size and complexity of our systems may make them potentially vulnerable to breakdown or interruption, whether due to computer viruses or other causes, which may result in loss of data or the impairment of production and other supply chain processes, adversely affecting our business.
Techniques used to sabotage or obtain unauthorized access to systems and networks are constantly evolving and, in some instances, are not identified until or after they are launched against a target. We and our third-party service providers may be unable to anticipate these techniques, discover threats and react in a timely manner, or implement adequate preventative or mitigating measures. Further, system breaches, malware, ransomware, computer hacking, and insider threats have become more prevalent. For example, companies have experienced an increase in phishing and social engineering attacks from third parties in connection with the increase in employees working remotely in recent years. We and our third-party service providers who may be operating with personnel in remote work environments may have increased security risks, due to increased use of home Wi-Fi networks and virtual private networks, as well as increased disbursement of physical machines. Also, due to political uncertainty and military actions such as Russia’s invasion of Ukraine or conflicts in the Middle East, we and our third-party service providers are vulnerable to heightened risks of cyber threats and cyber-attacks from or affiliated with nation-state actors, including attacks that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our products and services. While we implement security measures designed to reduce these risks, there is no guarantee that these measures will be adequate to safeguard all systems and networks. Any failure of ourselves or our third-party service providers to maintain performance, reliability, security and availability of our systems and networks, or other systems or networks on which our data is stored or processed, may result in accidental or unlawful destruction, damage, loss, unavailability, alteration, impairment, misuse, unauthorized disclosure of, or unauthorized access to our data, including personal information.
In addition, potential legal, regulatory, contractual, financial, operational, and reputational harm may arise from the accidental or unlawful destruction, damage, loss, unavailability, alteration, impairment, misuse, unauthorized disclosure of, or unauthorized access to our systems, networks, or data, including data which is transmitted, stored or otherwise processed by us or by third parties, including collaborators, third-party service providers, distributors, and other contractors on our behalf. For example:
| ● | The accidental or unlawful loss, unavailability, or alteration of clinical trial data from completed or ongoing clinical trials for any of our product candidates could affect our ability to operate, result in delays in our development and regulatory approval efforts, and significantly increase our costs to recover or reproduce the data. |
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| ● | Any security incident may require costly response and remediation efforts, trigger notification obligations under breach notification laws or contractual notification requirements, result in litigation or adverse regulatory action arising from or related to such an incident or event, damage our reputation, and result in significant additional expense to implement further data protection measures. Integrating the systems and data of any acquired entity may increase these risks due to unforeseen threats and vulnerabilities. |
| ● | Similarly, any security incident experienced by our collaborators, third-party providers, distributors and other contractors may hinder our product development, supply chain, other business operations, or our regulatory and contractual obligations to others and could also give rise to litigation or adverse regulatory action. |
In an effort to ensure appropriate oversight of cyber security issues and risks, management updates the Board of Directors on cyber security matters on a quarterly basis, and the Board of Directors has assigned oversight of cyber security to the Audit Committee. Additionally, the Company has a security training and compliance program, which employees with access to information technology, must complete annually or more often, if deemed necessary or appropriate.
There can be no assurance that we will be successful in preventing security incidents nor that we will be successful in mitigating their effects, despite the implementation of security measures for systems, networks and data within our control. Similarly, there can be no assurance that our collaborators, third-party service providers, distributors and other contractors will be successful in protecting our data on their systems or in protecting other systems upon which we may rely. Furthermore, breach notification laws are not consistent among jurisdictions, and compliance and other measures in the event of a security incident could result in a substantial cost and diversion of resources and distract management and technical personnel in efforts to investigate or correct the security incident, address and eliminate vulnerabilities and prevent future security incidents, and remediate the security incident, which repairing systems and responding to claims of damages for actual or asserted contract breaches. Any such security incident could have a material adverse effect on our business and prospects.
Although we maintain cyber insurance coverage that may cover certain of our losses in connection with a security incident, we cannot be certain our insurance coverage will be adequate for losses actually incurred, that insurance will continue to be available to us on commercially reasonable terms (if at all) or that any insurer will not deny coverage as to any future claim. The successful assertion of one or more large claims against us that exceed available insurance coverage, the occurrence of changes in our insurance policies, including premium increases or the imposition of large deductible or co-insurance requirements, or denials of coverage, could have a material adverse effect on our business, including our financial condition, results of operations and reputation.
Jack Y. Zhang and Mary Z. Luo have each pledged shares of our common stock to secure funds borrowed under existing credit lines from three financial institutions. Each of the lenders has varying rights as a lender, including one which has the right to conduct a forced sale at its sole discretion. An action by one of the lenders could include a sale of certain shares of our common stock pledged as collateral, the sale of which could cause the price of our common stock to decline. An action to cure and cover indebtedness by any one of the lenders could also have other negative impacts on our business.
Jack Y. Zhang and Mary Z. Luo have each pledged shares of our common stock to secure funds borrowed under existing credit lines by UBS Group and its affiliates, or UBS, East West Bank, or East West, and Cathay Bank. As of September 30, 2025, UBS had extended combined credit lines of $15.0 million to Applied Physics & Chemistry Laboratories, Inc., or APCL, which is controlled by Dr. Zhang and Dr. Luo, East West had agreed to a loan of up to $12.0 million to Drs. Zhang and Luo, and Cathay Bank had agreed to a loan of up to $30.0 million to APCL and Dr. Luo. The UBS credit lines are secured by a pledge of 801,156 shares of our common stock currently held by APCL, the East West loan is secured by a pledge of 800,000 shares of our common stock held by Dr. Zhang and the Cathay Bank loan is secured by a pledge of 2,000,000 shares of our common stock held by APCL and Dr. Luo. Interest on each of these loans accrues at market rates. UBS has an unlimited and unilateral right to call each of the credit lines for any reason whatsoever, and each of East West and Cathay Bank has acceleration rights to protect itself in the event of a default.
We have a pledging policy to restrict the pledging of shares by our executive officers and directors, which was created in 2021 and most recently amended in 2025. The policy prohibits our executive officers and directors from entering into any transaction whereby the executive officer or director, directly or indirectly, pledges, hypothecates, or otherwise encumbers more than forty (40) percent of shares of common stock held by the individual or more than ten (10) percent of our total outstanding shares of common stock as of the date of the transaction, whichever is lower, as collateral for indebtedness.
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This restriction extends to any hedging or similar transaction designed to decrease the risks associated with holding our securities.
While we are not a party to these loans, which are full recourse against APCL and each of Drs. Zhang and Luo, respectively, and are secured by pledges of a portion of the shares of our common stock currently held by APCL and each of Drs. Zhang and Luo, if the price of our common stock declines, Drs. Zhang and Luo may be forced by these financial institutions to provide additional collateral for the loans or to sell shares of our common stock held by them in order to remain within the margin limitations imposed under the terms of their loans. Furthermore, the pledged shares of our common stock may be acquired and sold by the lenders. These factors may limit Drs. Zhang and Luo’s ability to either pledge additional shares of our common stock or sell shares of our common stock held by them as a means to avoid or satisfy a margin call with respect to their pledged shares of our common stock in the event of a decline in our stock price that is large enough to trigger a margin call. Any significant sales of shares of our common stock by one or more of these three lenders could cause the price of our common stock to decline further.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
(c)Issuer Purchases of Equity Securities
The table below provides information with respect to repurchases of our common stock.
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Approximate Dollar Value of |
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|
|
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Total Number of Shares |
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Shares that May Yet Be |
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Average |
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Purchased as Part of |
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Purchased Under the Plans |
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||
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Total Number of Shares |
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Price Paid |
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Publicly Announced Plans |
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or Programs(1) |
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Period |
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Purchased |
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per Share |
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or Programs(1) |
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(in millions) |
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July 1 - July 31, 2025 |
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— |
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$ |
— |
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— |
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$ |
— |
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August 1 - August 31, 2025 |
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— |
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— |
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— |
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|
50.0 |
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September 1 - September 30, 2025 |
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172,920 |
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|
28.03 |
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172,920 |
|
|
45.2 |
|
| (1) | These repurchases were made under our previously authorized share buyback program (see “Part I – Item. 1. Financial Statements – Notes to the Condensed Consolidated Financial Statements – Note 15. Stockholders’ Equity – Share Buyback Program”). |
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Securities Trading Plans of Directors and Executive Officers
During our last fiscal quarter, the following officer and director, as defined in Rule 16a-1(f), adopted a Rule 10b5-1 trading arrangement, as defined in Regulation S-K Item 408, as follows:
On August 22, 2025, Jacob Liawatidewi, our Executive Vice President of Sales and Marketing and Corporate Administration Center, President of Amphastar France Pharmaceuticals, S.A.S., Corporate Secretary, and Director, adopted a Rule 10b5-1 trading arrangement providing for the sale from time to time of an aggregate of up to 41,520 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c). The duration of the trading arrangement is until December 1, 2026, or earlier if all transactions under the trading arrangement are completed.
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No other officers or directors, as defined in Rule 16a-1(f), adopted or terminated a Rule 10b5-1 trading arrangement, or a non-Rule 10b5-1 trading arrangement, each as defined in Regulation S-K Item 408.
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ITEM 6. EXHIBITS
Exhibit |
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Description |
10.1* |
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10.2* |
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10.3* |
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31.1 |
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31.2 |
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32.1# |
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32.2# |
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101.INS |
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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. |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema Document |
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101.CAL |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.LAB |
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Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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101.DEF |
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Inline XBRL Taxonomy Extension Definitions Linkbase Document |
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104 |
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Cover Page Interactive File (Formatted as Inline XBRL and contained in Exhibit 101) |
# |
The information in Exhibits 32.1 and 32.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act (including this Report), unless the Registrant specifically incorporates the foregoing information into those documents by reference. |
* |
Portions of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation S-K Item 601(b)(10). In addition, certain schedules (or similar attachments) have been omitted from this exhibit pursuant to Regulation S-K Item 61(a)(5). |
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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.
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AMPHASTAR PHARMACEUTICALS, INC. |
By: |
/s/ JACK Y. ZHANG |
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Jack Y. Zhang |
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Chief Executive Officer |
Date: November 6, 2025
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AMPHASTAR PHARMACEUTICALS, INC. |
By: |
/s/ WILLIAM J. PETERS |
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William J. Peters |
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Chief Financial Officer |
Date: November 6, 2025
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Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS ([***]), HAS BEEN OMITTED PURSUANT TO ITEM 601(B)(10)(IV) OF REGULATION S-K, BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL. IN ADDITION, CERTAIN SCHEDULES (OR SIMILAR ATTACHMENTS) HAVE BEEN OMITTED FROM THIS EXHIBIT PURSUANT TO ITEM 601(A)(5) OF REGULATION S-K.
DATED August 8th 2025
2025年 08 月 08 日
Nanjing Anji Biotechnology Co., Ltd.
南京安吉生物科技有限公司
-and-
与
Amphastar Pharmaceuticals, Inc.
Amphastar Pharmaceuticals, Inc.
_________________________________________________________
LICENSE AGREEMENT
许可协议
_________________________________________________________
LICENSE AGREEMENT
许可协议
This License Agreement (“Agreement”) is entered into as of August 8th, 2025 (the “Effective Date”, Los Angeles Time, UTC-7) by and between Nanjing Anji Biotechnology Co., Ltd. (南京安吉生物科技有限公司), a limited liability company duly incorporated and validly existing under the laws of the PRC, with the unified social credit code: [***] (“Licensor”) and Amphastar Pharmaceuticals, Inc., a company duly incorporated and validly existing under the laws of United States (hereinafter referred to as “Amphastar” or “Licensee”). Licensor and Licensee are each referred to individually as a “Party” and together as the “Parties.”
本许可协议（“本协议”）于2025年08月08日（“生效日”，洛杉矶时间，UTC-7）由南京安吉生物技术有限公司，一家根据中国法律合法成立并有效存续的有限责任公司，统一社会信用代码为 [***]（“许可方”），与Amphastar Pharmaceuticals, Inc.，一家根据美国法律合法成立并有效存续的公司（下称“Amphastar”或“被许可方”）签订。许可方和被许可方单称“一方”，合称“双方”。
Background
背景
Licensor Controls (as defined below) the Licensed IP (as defined below) relating to the Licensed Compounds (as defined below) and Licensed Products (as defined below). Licensee wishes to obtain, and Licensor wishes to grant, rights under the Licensed IP to develop, make, use and sell Licensed Products incorporating the Licensed Compounds.
许可方控制（定义见下文）与许可化合物（定义见下文）和许可产品（定义见下文）相关的许可知识产权（定义见下文）。被许可方希望获得且许可方希望授予许可知识产权项下的权利，以开发、生产、使用及销售含有许可化合物的许可产品。
For the purpose of facilitating the proposed licensing arrangement, both Parties have entered into a Memorandum of Understanding (the “MOU”) dated April 8, 2025, to outline key commercial terms and mutual commitments, followed by this Agreement as a definitive license agreement.
为促进拟议许可安排之目的，双方已于2025年4月8日签订一份谅解备忘录（“备忘录”），概述关键商业条款和共同承诺，继以达成本协议，作为最终许可协议。
Therefore, the Parties agree as follows:
因此，双方达成协议如下：
定义和释义
| 1.1 | Definitions. Unless the context otherwise requires, the terms in this Agreement with initial letters capitalized will have the meanings set forth below, or the meaning as designated in the indicated places throughout this Agreement. |
定义。除非上下文另有要求，本协议中的术语具有下文规定的含义或所示的本协议条款所指定的含义。
“Accounting Standards” means, U.S. GAAP (US Generally Accepted Accounting Principles), in each case as generally and consistently applied throughout the Party’s organization.
“会计准则”系指在一方机构内普遍和一贯适用的美国通用会计准则。
“Affiliate” means, with respect to a Party, any Person that controls, is controlled by, or is under common control with that Party. For the purpose of this definition, “control” will mean, direct or indirect ownership of 50% or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or 50% or more of the equity interest in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby the entity or Person controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity, or the ability to cause the direction of the management or policies of a corporation or other entity. In the case of entities organized under the laws of certain countries, the maximum percentage ownership permitted by law for a foreign investor may be less than 50%, and in such case such lower percentage will be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management and policies of such entity.
“关联方”就一方而言，系指控制该方、受该方控制或与该方共同受他方控制的任何主体。为本定义之目的，“控制”系指直接或间接拥有一家公司50%或以上有权投票选举董事的股份或任何其他类型的法律实体50%或以上的股权，或者作为任何合伙企业的普通合伙人，或者可使实体或主体控制或有权控制一家公司或其他实体的董事会或同等管理机构的任何其他安排，或者能够促成主导一家公司或其他实体的管理或政策。对于根据某些国家法律组建的实体，法律允许的外国投资者持股比例上限可能低于50%，在该等情况下，该较低比例将替代前句中规定的比例，但前提是该外国投资者有权主导该实体的管理和政策。
“Licensor Material” means the material identified on Exhibit C.
“许可方材料”系指附件C列明的材料。
“Applicable Law” means any national, provincial, federal, state, local or foreign law (including, common law), statute or ordinance, executive order, or any rule, regulation, judgment, order, writ or decree of or from any court, or other Regulatory Authority having jurisdiction over or related to the subject item that may be in effect from time to time, including, as applicable, GCP, GLP, and GMP.
“适用法律”系指可能不时有效的任何国家、省、联邦、州、地方或外国法律（包括普通法）、成文法或条例，行政命令，或对主题事项有管辖权的任何法院或其他监管机构的任何规则、法规、判决、命令、令状或法令，包括（按适用情形）药物临床试验质量管理规范、药物非临床研究质量管理规范和药品生产质量管理规范。
“Calendar Year” means a period of twelve (12) consecutive calendar months ending on December 31; provided, that the first Calendar Year of this Agreement shall commence on the Effective Date and end on December 31, 2025, and the last Calendar Year of this Agreement shall end on the date of expiration or termination of this Agreement in its entirety.
“日历年”系指截止于12月31日的连续十二（12）个日历月的期间；但是，本协议的第一个日历年应于生效日开始并于2025年12月31日结束，本协议的最后一个日历年应于本协议整体到期或终止之日结束。
“Change of Control” means, with respect to a Party, (a) a merger, reorganization, consolidation or other transaction involving such Party and any entity that is not an Affiliate of such Party as of the Effective Date, which results in the voting securities of such Party outstanding immediately prior thereto ceasing to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization, consolidation or other transaction, or (b) any entity that is not an Affiliate of such Party as of the Effective Date becoming the beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of such Party, or (c) any entity that is not an Affiliate of such Party as of the Effective Date acquiring the power (whether through ownership interest, contractual right, or otherwise, including the result of any government action) to direct or cause the direction of the management and policies of such Party.
“控制权变更”指，针对一方而言，发生以下任一情形：(a) 该方与在本协议生效日时并非其关联方的任何实体发生合并、重组、并入或其他交易，且在该等交易完成后，原由该方股东持有的有表决权股权不再代表合并后存续实体至少百分之五十（50%）的投票权（经合并计算）；或 (b) 在生效日并非该方关联方的任何实体成为该方已发行股份或权益中拥有合并投票权百分之五十（50%）或以上的实际受益人；或 (c) 在生效日并非该方关联方的任何实体通过股权、合同或其他方式（包括政府行为的结果）取得控制或导致控制该方经营管理和政策方向的权力。
“Claims” means all Third Party demands, claims, actions, proceedings and liability (whether criminal or civil, in contract, tort or otherwise) for losses, damages, reasonable legal costs, and other reasonable expenses of any nature whatsoever.
“权利主张”系指有关任何性质的损失、损害、合理法律费用及其他合理费用的所有第三方要求、权利主张、诉讼、程序和责任（无论是刑事或民事、合同、侵权或其他方面的）。
“Commercialize” means to manufacture for commercial use, market, promote, distribute, import, export, offer to sell or sell Licensed Products, engage with patient advocates, conduct pre-launch activities to prepare a market for potential sale, as well as conducting all associated post-launch regulatory activities, including medical affairs oversight and post-approval studies, and any activities directed to obtaining pricing or reimbursement approvals, and “Commercialization” means commercialization activities relating to Licensed Products.
“商业化”系指为商业用途而生产、营销、促销、分销、进口、出口、要约出售或销售许可产品，也包括与患者倡导者的互动、为潜在销售做市场准备的上市前活动，以及开展所有相关的上市后监管活动（包括医疗事务监督和批准后研究），以及旨在获得定价或医保审批的任何活动。“商业化活动”系指与许可产品相关的商业化活动。
“Commercially Reasonable Efforts” means, with respect to a Party, the carrying out of such activities with respect to the Licensed Products or the Licensed Compounds with such measure of efforts that is consistent with the efforts that are typically expended or used by a pharmaceutical company operating in the respective territory with similar resources and of comparable size in a program of a similar value, stage of development, life cycle and commercial potential, based on conditions then prevailing and taking into account issues of safety and efficacy, approved labelling, product, competitiveness of alternative Third Party products in the marketplace, the patent or other proprietary position of such Licensed Product, and the regulatory structure involved, as applicable, and other relevant scientific, technical, legal, operational and commercial factors, as determined on a jurisdiction-by-jurisdiction and indication-by-indication basis.
“商业上合理的努力”指就一方而言，就开展与许可产品或许可化合物相关的活动，其付出的努力程度应当与一家在对应区域内运营具有相似资源水平和可比规模的医药公司在具有相似价值、开发阶段、生命周期及商业潜力的项目中所通常投入或使用的努力相一致，基于当时实际情况，并综合考虑以下因素：安全性及有效性、获批的适应症标签、产品、第三方竞品的市场竞争力、许可产品的专利或其他专有权状态、相关监管框架（如适用），以及其他科学、技术、法律、运营和商业相关因素，且需按不同司法管辖区和适应症分别评估。
“Confidential Information” means all Know-How and other confidential or proprietary information and data of a financial, commercial or technical nature, including information comprising or relating to concepts, discoveries, inventions, data, designs or formulae, which the disclosing Party, its Affiliates, or its or their licensors has supplied or otherwise made available to the other Party or its Affiliates, prior to or during the Agreement Term, whether made available orally, in writing or in electronic form, pursuant to this Agreement.
“保密信息”系指在本协议期限之前或期间，披露方、其关联方或其各自的许可方根据本协议的规定已向另一方或其关联方提供的或以其他方式给予的（无论以口头、书面或电子形式提供）所有专有技术及其他保密或专有的财务、商业或技术性质的信息和资料，包括构成或涉及概念、发现、发明、数据、设计或配方的信息。
“Control” or “Controlled” means, with respect to any Know-How, Patent Rights, other intellectual property rights, or any proprietary or trade secret information, the legal authority or right (whether by ownership, license or otherwise, other than by a license granted under this Agreement) of a Party or its Affiliates, to grant a license or a sublicense of or under such Know- How, Patent Rights, or intellectual property rights to another Person, or to otherwise disclose such proprietary or trade secret information to another Person, without breaching the terms of any agreement with a Third Party or misappropriating the proprietary or trade secret information of a Third Party.
“控制”或“受控制”就任何专有技术、专利权、其他知识产权或任何专有或商业秘密信息而言，系指一方或其关联方具有法定权限或权利（无论通过所有权、许可或其他方式，但通过本协议项下授予的许可除外），在不违反与第三方的任何协议条款或盗用第三方的专有或商业秘密信息的情况下，向另一主体授予该等专有技术、专利权或知识产权的或其项下的许可或再许可，或以其他方式向另一主体披露该等专有或商业秘密信息。
“Cover”, “Covered” or “Covering” means, with respect to a Valid Claim of a Patent Right and a product or other subject matter, that, in the absence of ownership of, or a license under such Patent Right (i) with respect to a Valid Claim that is issued or granted, the manufacture, use, offer for sale, sale or importation of such product or other subject matter would infringe such Valid Claim of such Patent Right, or (ii) in the case of a Valid Claim that is pending, the manufacture, use, offer for sale, sale or importation of such product or other subject matter would infringe such Valid Claim if such Valid Claim were actually issued.
“涵盖”就专利权的有效权利要求和产品或其他标的而言，系指在不存在该专利权的所有权或许可的情况下，(i)就已颁发或授予的有效权利要求而言，该产品或其他标的的生产、使用、要约出售、销售或进口会侵犯该专利权的有效权利要求，或(ii)就申请中的有效权利要求而言，如果该有效权利要求已实际颁发，该产品或其他标的的生产、使用、要约出售、销售或进口会侵犯该有效权利要求。
“Develop” or “Development” means drug development activities, including, non-commercial manufacture of the Licensed Compounds or Licensed Products, analytical test method development and stability testing, audit development, pharmacology, pharmacokinetics, toxicology, formulation, manufacturing, quality assurance/quality control development, statistical analysis, pre-clinical studies, clinical studies, packaging development, regulatory affairs, and the preparation, filing, and prosecution of Regulatory Filings as necessary to obtain Regulatory Approval to market or sell a Licensed Product.
“开发”系指药物开发活动，包括许可化合物或许可产品的非商业化生产、分析测试方法开发和稳定性测试、稽查开发、药理学、药代动力学、毒物学、配方、生产、质量保证/质量控制开发、统计分析、临床前研究、临床研究、包装开发、监管事务，以及为获得许可产品营销或销售的监管批准所需的监管申报的准备、提交和推进。
“Encumbrance” means any claim, charge, equitable interest, hypothecation, lien, mortgage, pledge, option, license, assignment, power of sale, retention of title, right of pre-emption, right of first refusal or security interest of any kind.
“权利负担”系指任何权利主张、押记、衡平法权益、不转移占有的抵押、留置、抵押、质押、期权、许可、转让、销售权、所有权保留、优先权、优先购买权或任何种类的担保权益。
“FDA” means the United States Food and Drug Administration or any successor entity thereto.
“美国食药监局”系指美国食品药品监督管理局或其任何继任机构。
“Field” means any and all uses, including all prophylactic, therapeutic, palliative and diagnostic uses for all current and future indications in humans.
“适用范围”系指任何及所有用途，包括对于所有当前和将来的人类适应症的所有预防、治疗、缓解和诊断用途。
“First Commercial Sale” means, on a Region-by-Region and Licensed Product-by-Licensed Product basis, the first sale or transfer, in all cases through a bona fide arm’s-length transaction, or commercial use, of a Licensed Product by Licensee or its Affiliates or its sublicensees to a Third Party (including a governmental authority) in a Region after receipt of Regulatory Approval (to the extent applicable for Commercialization and Applicable Laws) of such Licensed Product in such Region, excluding Non-Commercial Sales as any Licensed Product transferred or disposed of as samples or for clinical trials or at or below costs of goods therefor for any so-called treatment investigational new drug sales, named patient sales, expanded access program, compassionate or emergency use sales or pre-license sales made for non-commercial, compassionate purposes, or any indigent program or promotional or educational purposes.
“首次商业销售”系指在逐一地区和逐一许可产品的基础上，被许可方及其关联方或分许可方在获得该地区相关监管批准（如适用于商业化及适用法律的范围内）后，向第三方（包括政府机构）以真实独立交易方式进行的以下任一首次行为：销售、转让许可产品，或将许可产品用于商业用途。但以下非商业销售不应视为首次商业销售：用于临床试验的转让或处置、样品提供、以不高于成本价进行的销售、治疗用试验新药（IND）相关销售、指定患者计划销售、扩大用药计划（EAP）销售、同情用药或紧急使用销售、获得上市许可前出于非商业目的或人道主义考虑的销售、针对贫困患者的援助计划销售，以及用于推广或教育目的的销售。
“FTE Rate” means, an hourly rate for Licensor’s employee providing technical assistance or other support to Licensee under this Agreement, which shall be categorized into three tiers: [***] per hour, [***] per hour or [***] per hour, categorized by the seniority of Licensor’s employee. The FTE rate shall apply through December 31, 2026. Thereafter, the FTE Rate may be changed no more than once per calendar year, by written notice from Licensor to Licensee, with the adjusted FTE Rate not to exceed the original FTE Rate multiplied by cumulative percentage increase in the Chinese Consumer Price Index (CPI) published by the National Bureau of Statistics of China (http://data.stats.gov.cn) between the Effective Date and the adjustment date.
“FTE费率”指许可方的员工向被许可方提供本协议项下技术协助或其他支持的小时费率，基于许可方的员工的资历等级，FTE费率分为三个级别，分别为每小时[***]、每小时 [***] 以及每小时 [***]，该费率适用于截至2026年12月31日期间。此后，许可方可通过书面通知被许可方每日历年调整至多一次FTE费率，但调整后的FTE费率不得超过自生效日起原始FTE费率按中国国家统计局发布的居民消费价格指数（CPI）自生效日至调整日的累计涨幅计算的金额。
“GCP” means the ethical, scientific, and quality standards required by the FDA for designing, conducting, recording, and reporting trials that involve the participation of human subjects, as set forth in FDA regulations in 21 C.F.R. Parts 11, 50, 54, 56, and 312 and related FDA guidance documents, and by the International Conference on Harmonization E6: Good Clinical Practices Consolidated Guideline, any similar regulations or guidelines as promulgated by Health Canada, or its predecessor, or as otherwise required by Applicable Laws in the Territory, each as may be amended and applicable from time to time.
“药物临床试验质量管理规范”系指美国食药监局对设计、实施、记录和报告有人类受试者参与的试验所要求的伦理、科学和质量标准，具体包括《美国联邦法规汇编》第21编第11、50、54、56和312部分及相关的美国食药监局指导性文件中的美国食药监局法规，国际人用药品注册技术协调会《E6：药物临床试验质量管理规范综合指南》，以及加拿大卫生部或其前身发布的或区域内适用法律另行规定的任何类似法规或指引，以及前述各项不时修订和适用的版本。
“GLP” means good laboratory practice as required by the FDA under 21 C.F.R. part 58 and all applicable FDA rules, regulations, orders and guidances, and the requirements with respect to current good laboratory practices prescribed by the ICH Guidelines, any similar regulations or guidelines as promulgated by Health Canada, or its predecessor, or as otherwise required by Applicable Laws in the Territory, each as may be amended and applicable from time to time.
“药物非临床研究质量管理规范”系指美国食药监局在《美国联邦法规汇编》第21编第58部分及所有适用的美国食药监局规则、法规、命令和指引项下所要求的良好实验室规范，国际人用药品注册技术协调会指南规定的关于现行良好实验室规范的要求，以及加拿大卫生部或其前身发布的或区域内适用法律另行规定的任何类似法规或指引，以及前述各项不时修订和适用的版本。
“GMP” means good manufacturing practices and regulations as required by the FDA under provisions of 21 C.F.R. parts 210 and 211 and all applicable FDA rules, regulations, orders and guidances, and the requirements with respect to current good manufacturing practices prescribed by Health Canada, or its predecessor, or as otherwise required by Applicable Laws in the Territory, each as may be amended and applicable from time to time.
“药品生产质量管理规范”系指美国食药监局在《美国联邦法规汇编》第21编第210和211部分及所有适用的美国食药监局规则、法规、命令和指引项下所要求的良好生产规范和法规，加拿大卫生部或其前身发布的关于现行良好生产规范的要求，以及区域内适用法律另行规定的任何类似法规或指引，以及前述各项不时修订和适用的版本。
“IND” means an application or submission filed with or submitted to a Regulatory Authority for approval to initiate human clinical trials in conformance with the requirements of such Regulatory Authority, including (a) for the United States, an Investigational New Drug application or any successor application or procedure filed with the FDA pursuant to 21 C.F.R. part 312, (b) any equivalent to the application or procedure referenced in clause (a) in other jurisdictions within the Territory outside the United States, and (c) all supplements and amendments that may be filed with respect to (a) or (b).
“新药研究申请”系指向监管机构提交的、旨在获准开展人类临床试验的申请或程序，该申请须符合相关监管机构的要求，包括(a)就美国而言，根据《美国联邦法规汇编》第21编第312部分的规定向美国食药监局提交的新药研究申请或任何后继替代申请或程序，(b)在美国境外但属于区域内的其他国家或地区，与第(a)项提及的申请或程序等同效力的申请或程序，及(c)可能就第(a)项或第(b)项提交的所有补充和修订。
“IND Acceptance” means with respect to an IND, (a) for an IND for a Licensed Product filed with the FDA, the earlier of (i) receipt by a Party or its Affiliate of a “may proceed” letter from a Regulatory Authority; or (ii) expiration of thirty (30) days from the IND submission date without the FDA issuing a clinical hold notice within that period or (b) for an IND filed with any Regulatory Authority outside the United States but within the Territory, an equivalent authorization to proceed with human clinical trials.
“新药临床研究申请受理”系指就一项新药研究申请而言，(a) 对于向美国食药监局提交的关于许可产品的新药研究申请，系指下列情况中较早发生者：(i)一方或其关联方从监管机构收到关于可进行该等新药研究申请项下的临床研究的“可开始临床研究”通知函；(ii) 自新药研究申请提交之日起三十(30)天期限届满
且未收到美国食药监局关于该新药研究申请被临床搁置的通知；或(b) 对于在美国境外但属于区域内的监管机构提交的新药研究申请，系指获得开展临床试验的同等效力的批准。
“Insolvency Event” means, with respect to a Party,
“破产事件”就一方而言，系指以下事件：
该方通过中止或终止业务的方式停止作为持续经营实体的运作；
该方进入代表该方或针对该方提起的自愿或非自愿破产程序（在九十（90）日内被驳回的非自愿破产程序除外）；
为该方指定行政接管人、接管人与管理人、临时接管人、保管人、查封人或类似人员；
在该方的董事或股东会议上通过对该方进行清算的决议；
该方或其董事通过决议，就该方的所有资产申请破产管理令或指定管理人；或
该方为其所有债权人的利益进行任何概括转让。
“Invoice” means an invoice in a form requesting payment for goods delivered or services rendered.
“发票”系指以请求已交付货物或已提供服务的付款为目的所开具的票据形式。
“Know-How” means all proprietary or confidential technical information, know-how and data, including inventions (whether patentable or not), discoveries, trade secrets, specifications, instructions, processes, formulae, materials, expertise and other technology for a compound or product or to its or their manufacture, regulatory approval, pricing and reimbursement approval, development, or commercialization, or methods of assaying or testing a compound or product, and including all biological, chemical, pharmacological, biochemical, toxicological, physical and analytical, safety, quality control, manufacturing, preclinical and clinical data, instructions, processes, formulae, expertise and information, regulatory filings and copies thereof.
“专有技术”系指所有专有或保密的技术信息、专有技术和资料，包括化合物或产品或其生产、监管批准、定价和医保审批、开发或商业化活动或者化合物或产品的化验或测试方法的发明（无论是否可获得专利）、发现、商业秘密、规
格、说明、工艺、配方、材料、专长及其他技术，包括所有生物、化学、药理、生化、毒理、物理及分析、安全、质量控制、生产、临床前及临床数据、说明、工艺、配方、专长及信息、监管申报及其副本。
“Licensed Compound(s)” means coded as “AJ005”, “sAJ005” and “sAJ005-L-C18” (collectively “AJ005”), “AJ007” (“AJ007”) and “AJ009” (“AJ009”) (each to be specified in Exhibit E), respectively, chemical structure thereof, and including all indications, any formulation, any dose amount, any dosage forms, any product presentation, any type of combination product, each of the foregoing is individually referred to as a “Licensed Compound”, and collectively the “Licensed Compounds”.
“许可化合物”系指编号分别为“AJ005”, “sAJ005”and “sAJ005-L-C18”（统称“AJ005”）、“AJ007”（“AJ007”）和“AJ009”（“AJ009”）（具体详见附件E），其各自化学结构，包括所有适应症、任何配方、剂量规格、剂型、产品包装形式、任何类型的组合产品，前述每一项单称及合称为“许可化合物”。
“Licensed IP” means the Licensed Know-How and the Licensed Patents.
“许可知识产权”系指许可专有技术及许可专利。
“Licensed Know-How” means all Know-How Controlled by Licensor or its Affiliates as of the Effective Date or at any time during the Agreement Term that is reasonably necessary or useful for the Development of the Licensed Compounds or the Licensed Products in the Field in the Territory. The Licensed Know-How existing as of the Effective Date consisting of thirty-two (32) reports are set forth on Exhibit B，C，E
“许可专有技术”系指许可方或其关联方截至生效日或在本协议期限内的任何时间控制的、对于许可化合物或许可产品在区域的适用范围内的开发活动合理必要或有用的所有专有技术。截至生效日存在的许可专有技术共计三十二(32)份报告列于附件 B，C，E
“Licensed Patents” means all Patents Rights Controlled by Licensor or its Affiliates as of the Effective Date set forth on Exhibit A that Cover the composition of matter, formulation, method of manufacture, use, sale or otherwise exploitation of the Licensed Compounds or the Licensed Products in the Field in the Territory.
“许可专利”系指许可方或其关联方截至生效日列于附件A控制的、涵盖许可化合物或许可产品在区域的适用范围内的物质组成、配方、生产、使用、销售或其他利用方法的所有专利权。
“Licensed Product(s)” [***]
“许可产品” [***]
“Licensing Term” means both the Initial Licensing Term and Extended Licensing Term (if applicable). For the purpose of this Agreement, the “Initial Licensing Term” means, on a Licensed Product-by-Licensed Product and Region-by-Region basis, the period commencing on the Effective Date and ending on the ten (10) year anniversary of the First Commercial Sale of such Licensed Product in such Region. The “Extended Licensing Term” means, if elected by Licensee to extend the Initial Licensing Term (Licensee has the right (but not the obligation) to extend the Initial Licensing Term at its sole discretion), the period commencing on the next day of the expiration date of the Initial Licensing Term and ending on the earlier of the following: (x) additional ten (10) years after the Initial Licensing Term, or (y) the expiration, lapse, or invalidation of the last remaining Valid Claim of the Licensed Patents that Covers the Licensed Products in the Territory.
“许可期限”是指初始许可期限和展期许可期限（如使用）。就本协议而言，“初始许可期限”是指，在逐个地区和逐个许可产品的基础上，自生效日起至该许可产品在该地区首次商业销售满十（10）周年止的期间。“展期许可期限”是指，如果被许可方选择延长初始许可期限（被许可方有权（但无义务）自行决定延长初始许可期限），从初始许可期限到期日的次日起至下列较早日期止的期限：(x) 初始许可期限届满后延期十（10）年，或 (y) 涵盖许可产品的许可专利的最后剩余的有效权利要求在区域内到期、失效或无效。
“MAA” means an application for the authorization to market Licensed Product in any country or group of countries outside the United States, as defined in the Applicable Laws and filed with the Regulatory Authority of a given country or group of countries.
“药品上市许可申请” 系指根据适用法律的规定向一个或多个国家的监管机构提交的许可产品在美国以外的一个或多个国家的上市许可申请。
“NDA” means a New Drug Application, as described in the FDA regulations, 21 C.F.R. § 314.50, submitted to the FDA.
“新药上市申请”系指根据《美国联邦法规汇编》第21编第314.50部分的美国食药监局法规向美国食药监局提交的新药上市申请。
“Net Sales” means, with respect to a Licensed Product, the gross amount invoiced for sales, in an arm’s length transaction, by Licensee, its Affiliates, and its sublicensees, to a Third Party, commencing with the First Commercial Sale of such Licensed Product, less the following deductions from such gross amounts which are actually incurred, allowed, accrued or specifically allocated, in accordance with the Accounting Standards of the applicable selling party, and not otherwise deducted in computing other amounts hereunder (without duplication):
“净销售额”就任何许可产品而言，系指被许可方及其关联方及其分许可方自该许可产品首次商业销售之时起在公平交易中向第三方进行的销售开具发票的总金额减去从该等总金额中扣除的按照适用销售方的会计准则实际发生的、允许的、累计的或专门分摊的以下金额后所得的金额，并且扣除金额属于在计算本协议项下其他金额时未被另行扣除（不得重复扣除）的部分：
针对损坏产品或退回或拒收的许可产品的赊销、价格调整或折让；
常规的贸易、现金及数量折扣、折让及赊销（在发票开具时已包含在发票总金额中的价格折扣除外）；
折扣、退款、回扣、退货款、有追溯效力的价格调整及任何其他给予第三方的实际降低净售价的折让；
任何已开具发票的运费、邮费、装运费、分销费、保险费及其他运输费用；
销售税、增值税、消费税、关税及其他与销售直接相关的税项（但不包括对来源于该销售的收入征收的税款）；
会计准则项下对不可收回金额一贯采用的实际销售冲销，前提是如果该等款项随后被收回，则相应金额应计入收回当期的净销售额。此外，本条款(f)项下的总扣减金额在任何一个日历季度内不得超过开具发票总金额的[***]；及
Amphastar在准备其向美国证券交易委员会提交的财务报表时为确定“净销售额”而普遍及一贯采用的根据美国通用会计准则进行的任何其他惯常调整。
Such amounts shall be determined from the books and records of the Licensee or its Affiliates or its sublicensees. For purposes of determining Net Sales, (i) sales of a Licensed Product shall not include transfers, uses or dispositions for charitable, promotional, pre-clinical, clinical, regulatory or governmental purposes, in each case, at or below cost, and (ii) sales between or among the Licensee and its Affiliates for re-sale shall be excluded from the computation of Net Sales, but subsequent sales by the Licensee or its Affiliates to third parties shall be included in the computation of Net Sales, and (iii) if a Licensed Product is delivered to the Third Party before being invoiced (or is not invoiced), Net Sales will be calculated at the time all the revenue recognition criteria under Licensee’s Accounting Standards are met.
上述金额应根据被许可方或其关联方或其分许可方的账簿及记录确定。为确定净销售额之目的，(i)许可产品的销售不包括为慈善、推广、临床前、临床、监管或政府目的进行的转让、使用或处置，且均不高于成本价；(ii)被许可方及其关联方之间为转售目的的销售不得包括在净销售额的计算中，但被许可方或其关联方对第三方的后续销售应包括在净销售额的计算中；及(iii)如果许可产品在开具发票前已交付第三方（或未开具发票），净销售额应在被许可方会计准则项下的所有收入确认条件均被满足之时计算。
Additionally, for computing Net Sales, (i) If a selling party sells the Licensed Product to a Third Party at a discount in “bundles” with other products or services (i.e., sold together in a single sales transaction with other products or services for which separate prices are charged in such transaction), or, if the amount invoiced for the Licensed Product represents a discount greater than the average discount for all products and services in the applicable “bundle,” then Net Sales for such “bundled” Licensed Product shall be determined using a sales price based on the average discount for all products and services in the applicable “bundle,” less applicable deductions as set forth above; (ii) No deductions shall be made for any other costs or expenses, including but not limited to commissions to independents, agents or those on Licensee’s, sublicensee’s or an Affiliate’s payroll or for the cost of collection; and (iii) Net Sales shall also include, with respect to a Licensed Product sold or otherwise disposed of for any consideration other than an exclusively monetary consideration on bona fide arms-length terms, an amount equal to the average sales price for the Licensed Product having the same dosage form and strength during the applicable reporting period in the country where such sale or other disposal occurred.
此外，在计算净销售额时，应遵循以下规定：(i) 如果销售方将许可产品与其他产品或服务打包销售（即在一次销售交易中将许可产品与其他产品或服务一起销售，并在该交易中分别计价）并给予折扣，或者许可产品的开票金额所体现的折扣高于该打包组合中所有产品和服务的平均折扣，则该“打包”许可产品的净销售额应按照适用“打包组合”中所有产品和服务的平均折扣计算销售价格，并按照上述规定扣除相关项目；(ii) 不得因任何其他成本或费用进行扣除，包括但不限于支付给独立第三方、代理人或许可方、分许可方或其关联方的佣金，或账款回收费用；(iii) 对于以非货币形式支付、但符合独立交易原则销售或处置的许可产品，其净销售额应计入一个金额，该金额等于在销售或处置发生的国家中、在相关报告期内具有相同剂型和规格的许可产品的平均销售价格。
“Party” or “Parties” has the meaning set forth in the preamble.
“一方”或“双方”具有前言中规定的含义。
“Patent Rights” means
“专利权”系指
在任何国家的所有专利申请，包括临时专利申请；
就第(a)项的该等专利申请或临时申请主张优先权的任何专利申请，包括所有的分案、接续、替代、部分接续、临时申请、转换临时申请及继续审查申请，或任何其他国家对应申请；
在任何上述专利申请（第(a)项和第(b)项）中已经颁发或未来颁发的任何专利，包括任何发明专利、实用新型专利、小专利、外观设计专利、发明证书，或任何其他国家对应权利；
任何上述专利或专利申请（第(a)项、第(b)项和第(c)项）的任何复审、再颁、增补、续期、延期、登记、补充保护证书，或任何其他国家对应程序；及
任何类似的权利，包括所谓的临时保护，或任何针对前述任一专利申请或专利的进口、恢复、确认或引进专利或注册专利，或任何上述专利申请或专利的增补专利。
“Person” means any individual, partnership, limited liability company, firm, corporation, association, trust, unincorporated organization or other entity.
“主体”系指任何个人、合伙、有限责任公司、商号、公司、协会、信托、非法人组织或其他实体。
“PRC” means People’s Republic of China, for the purpose of this Agreement, excluding the Hong Kong Special Administrative Region, the Macau Special Administrative Region and the islands of Taiwan.
“中国”系指中华人民共和国，为本协议之目的，不包括香港特别行政区、澳门特别行政区和台湾岛。
“Pricing and Reimbursement Approval” means the authorization or approval of reimbursement for a pharmaceutical product in a country or jurisdiction by the relevant Regulatory Authority, government agency, or other body responsible for such activities in such country or jurisdiction under Applicable Law.
“定价和医保审批” 系指在任何国家或司法管辖区的相关监管机构、政府部门或其他根据适用法律负责相关活动的机构授权或批准在该等国家或司法管辖区的药品报销。
“Region” means any individual country within the Territory.
“地区”系指区域内的任何单个国家。
“Regulatory Approval” means, with respect to a Licensed Product in any country or jurisdiction, any approval, registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is reasonably necessary to market and sell a Licensed Product in such country or jurisdiction.
“监管批准”就任何国家或司法管辖区的许可产品而言，系指从一个国家或其他司法管辖区的监管机构获得的、许可产品在该国或司法管辖区上市和销售而合理所需的任何批准、注册、许可或授权。
“Regulatory Authority” means any governmental authority or agency responsible for authorizing or approving the marketing or sale of pharmaceutical products in a jurisdiction (e.g., the FDA, European Commission, the NMPA, and corresponding national or regional regulatory agencies or organizations).
“监管机构”系指负责授权或批准药品在任何司法管辖区上市或销售的任何政府机构或部门（例如美国食药监局、欧盟委员会、中国药监局，以及相应的国家或地区监管机构或组织）。
“Regulatory Exclusivity” means, with respect to a Licensed Product in any country or jurisdiction, any one or more of data, market or other regulatory exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country or jurisdiction that confers exclusive marketing rights with respect to such Licensed Product in such country or jurisdiction, including without limitation orphan drug exclusivity, new chemical entity exclusivity, data exclusivity, pediatric exclusivity, rights conferred in the U.S. under the Hatch-Waxman Act or the FDA Modernization Act of 1997, in European Union member states under national implementations of Article 10 of Directive 2001/83/EC, and rights similar thereto in other country or jurisdiction.
“监管独占权”是指，就任何国家或司法管辖区中的一个许可产品而言，依据适用法律或该国或司法管辖区的监管机构授予或提供的任何一种或多种数据、市场或其他监管独占权（不包括专利独占权），该等独占权在该国或司法管辖区赋予该许可产品专属的市场销售权利，包括但不限于孤儿药独占权、新化学实体独占权、数据独占权、儿科独占权、美国根据《哈奇-瓦克斯曼法案》或《1997年食品药物管理局现代化法案》赋予的权利、欧盟成员国根据《2001/83/EC号指令》第10条的国家实施办法赋予的权利，以及其他国家或司法管辖区赋予的类似权利。
“Regulatory Filings” means, with respect to a Licensed Compound or Licensed Product, any submission to a Regulatory Authority of any appropriate regulatory application, and includes any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto. For the avoidance of doubt, Regulatory Filings will include any IND, CTA, NDA, MAA or the corresponding application in any other country or group of countries.
“监管申报”就许可化合物或许可产品而言，系指向监管机构提交的任何适当的监管申请，包括向监管咨询委员会提交的任何资料、上市许可申请及其任何补充或修改。为避免疑义，监管申报将包括任何新药研究申请、临床试验申请、新药上市申请、药品上市许可申请或在任何其他一个或多个国家的相应申请。
“Royalty Term” means, on a Licensed Product-by-Licensed Product and Region-by-Region basis, the period commencing on the First Commercial Sale of a Licensed Product upon the later of (i) [***] (ii) [***], or (iii) [***].
“许可费期限”系指在逐个许可产品和逐个地区的基础上，自许可产品首次商业销售开始至以下时间孰晚的期间：(i) [***]，(ii) [***]，或(iii) [***]。
“Sales & Royalty Report” means a written report or reports on the Licensed Product-by-Licensed Product and Region-by-Region basis showing each of:
“销售与许可费报告”系指显示以下各项按每个许可产品并分地区分别计算的书面报告：
报告期内被许可方、其关联方及其分许可方每一许可产品的净销售额（在所有情况下，按类别分项列明上文净销售额定义所述的为计算净销售额而从总金额中扣除的各项金额）； 以及
在本协议项下就该等净销售额累计的应付许可费（以美元计算，如销售货币非美元，则附带换算汇率及计算依据），并附有适用许可使用费率的计算明细。
“Senior Officers” means, for Licensor, its Chief Scientist or his or her designee, and for Amphastar, its Executive Vice President, or his or her designee as appointed by the Executive Vice President.
“高级管理人员”就许可方而言，系指首席科学家或其指定人；就Amphastar而言，系指其执行副总裁或执行副总裁指定的其他人。
“Sublicense Transaction” shall mean, in any Region of Territory, and in any part of Fields, (a) a sublicense granted to a Third Party by Licensee or its Affiliate under any Licensed IP (except for any sublicense granted to Subcontractors concurrently with engagement of such Subcontractors, but subject to the second paragraph of Section 2.2(c)); (b) an assignment to a Third Party by Licensee or its Affiliate of any rights to any Licensed IP (except for any such assignment made pursuant to Section 15.1 (Assignment) or by operation of law), or (c) the grant to a Third Party by Licensee or its Affiliate of an option to acquire any of the foregoing. For avoidance of doubt, any Change of Control of Licensee shall not be considered as Sublicense Transaction.
“分许可交易”是指，在本协议项下的区域内任何地区以及任何适用范围中，发生以下任一情形：(a) 被许可方或其关联方向第三方授予与任何许可知识产权相关的分许可（随分包合同同时授予分包商的分许可除外，但受限于第2.2(c)条第二段的约束）；(b) 被许可方或其关联方向第三方转让与任何许可知识产权相关的任何权利（根据第15.1条（转让）或依法进行的转让除外）；或 (c) 被许可方或其关联方向第三方授予获得前述任何权利的选择权。为免疑义，被许可方控制权变更不构成分许可交易。
“Territory” means the United States and Canada.
“区域”系指美国和加拿大。
“Third Party” means any Person other than a Party or an Affiliate of a Party.
“第三方”系指除任何一方或其关联方以外的任何主体。
“United States” or “US” means the United States of America, its territories and possessions.
“美国”系指美国、其领土及属地。
“USD” or “$” means US Dollars.
“美元”或“$” 系指美元。
“US Data Security Program” means US Executive Order 14117 and rules issued thereunder, including 28 C.F.R. Part 202, as amended from time to time.
“美国数据安全计划” 指美国第14117号行政命令及其颁布的相关规则，包括但不限于《联邦法规汇编》第28编第202部分及其不时修订的版本。
“Valid Claim” means
“有效权利要求”系指
| (a) | a claim of an issued and unexpired patent of a granted Licensed Patent (as may be extended through supplementary protection certificate or patent term extension or the like) that, in each case: |
已授权且未到期的许可专利（包括可通过补充保护证书、专利期限延长或类似方式延展的专利）的、符合下列情况的权利要求：
涵盖在相关司法管辖区内相关许可化合物或许可产品的开发、生产、使用、要约出售、销售或进口；
未被具有管辖权的法院或其他政府或裁判机构决定放弃、注销、撤回或废止（且该等否认或放弃不可撤销或不可上诉）或者认定为不可强制执行、不可授予专利或无效；及
未被监管机构通过重新公告、否认或其他方式被承认无效或不可强制执行；或
| (b) | a claim included in a pending patent application within the Licensed Patents that: |
许可专利中包含的未决专利申请中的、符合下列情况的权利要求：
| (i) | would Cover the Development, manufacture, use, offer for sale, sale or import of the relevant Licensed Compound or Licensed Product in the relevant jurisdiction if such claim were part of a pending patent application; and |
若该权利要求属于在申请中专利的一部分，则将涵盖相关许可化合物或许可产品在相关司法管辖区的开发、生产、使用、要约出售、销售或进口；及
| (ii) | has not been cancelled, withdrawn or abandoned, nor been pending for more than seven (7) years since its official filing date in the Region in which such patent application was filed. |
未被取消、撤回或放弃，且自提出该专利申请的正式申请日起未处于申请中状态超过七（7）年。
| 1.2 | Interpretation. In this agreement unless otherwise specified: |
解释。 在本协议中，除非另有说明：
| (a) | “includes” and “including” mean, respectively, includes without limitation and including without limitation; |
“包括”系指包括但不限于；
| (b) | a Party includes its permitted assignees and the respective successors in title to substantially the whole of its undertaking; |
一方包括其经允许的受让人及其各自实质上全部业务的所有权继承人；
| (c) | a statute or statutory instrument or any of their provisions is to be construed as a reference to that statute or statutory instrument or such provision as the same may have been or may from time to time hereafter be amended or re-enacted; |
法令或法定文书或其任何条款应解释为可能已经或此后可能不时修订或重新颁布的该等法令或法定文书或该等条款；
| (d) | words denoting the singular will include the plural and vice versa and words denoting any gender will include all genders; |
单数形式的词语包括复数形式，反之亦然，任何性别的词语包括所有性别；
| (e) | the Exhibits and other attachments form part of the operative provision of this Agreement and references to this Agreement shall, unless the context otherwise requires, include references to the Exhibits and attachments; |
附件及其他附录构成本协议执行条款的一部分，且除非上下文另有要求，提及本协议应包括附件和附录；
| (f) | the headings in this Agreement are for information only and will not be considered in the interpretation of this Agreement; |
本协议中的标题仅为参考而设，在解释本协议时不予考虑；
| (g) | general words will not be given a restrictive interpretation by reason of their being preceded or followed by words indicating a particular class of acts, matters or things; |
概括性的词语不会由于其前后为表明特定类别的行为、事项或事物的词语而被赋予限制性解释；
| (h) | references to days means calendar days unless otherwise indicated; and |
除非另行指明，提及的日系指日历日；及
| (i) | the terms of this Agreement are the result of negotiations between the Parties, and this Agreement will not be construed in favor of or against any Party by reason of the extent to which any Party participated in the preparation of this Agreement. |
本协议的条款系双方协商的结果，本协议不会因任何一方参与准备本协议的程度而以对任何一方有利或不利的方式进行解释。
知识产权许可
| 2.1 | License Grant. Subject to the terms of this Agreement, Licensor and its Affiliates hereby grant to Licensee an exclusive (even as to Licensor and its Affiliates), royalty-bearing license, sublicensable within the Licensing Term (with the right to sublicense in accordance with Section 2.2) in, to and under the Licensed IP in the Field and in the Territory, to (i) research, Develop, make and have made, use Licensed Compounds and Licensed Products; and (ii) to Commercialize Licensed Products. [***] |
许可授予。 受限于本协议的条款，许可方及其关联方特此授予被许可方一项在许可期限内有关许可知识产权的独占的（即使对许可方及其关联方而言）、需支付许可费的、可分许可的（根据第2.2款的规定享有分许可权利）的许可，以在区域的适用范围内进行：(1) 许可化合物和许可产品的研究、开发、生产和委托生产、使用；以及(2) 就许可产品进行商业化。[***]
| 2.2 | Sublicense and Subcontract Rights. |
分许可和分包权。
| (a) | Subject to the terms and conditions of this Agreement, Licensee may sublicense (through multiple tiers, including Sublicense Transaction) the license set forth in Section 2.1 at any time at its sole discretion: (i) to any Affiliate that is a majority-owned subsidiary of Licensee; and (ii) to Third Party, subject to Section 8.4 (Sublicense Transaction Revenue). |
在遵守本协议的条款和条件的前提下，被许可方可以（通过多层，包括分许可交易）随时自行决定将第2.1款中规定的许可：(i)分许可给被许可方拥有多数股权控制的子公司；以及(ii) 分许可给第三方，但受限于第8.4款的分许可交易收入约定。
| (b) | Each sublicense shall be subject to a written agreement that is consistent with the terms of this Agreement. Each sublicense of the Licensed IP shall be consistent with the terms of this Agreement. A copy of any sublicense agreement (or any supplements or amendments thereto) executed by Licensee shall be provided to Licensor within thirty (30) business days after the execution, provided that Licensee may redact any terms that are commercially sensitive which are unnecessary for Licensor to confirm compliance with this Agreement, notwithstanding of the foregoing, Licensee shall not redact or obscure any terms related to financial consideration (e.g., upfront payments, royalties, milestone payments, or pricing structure), sublicense scope, field of use limitations, or termination rights, which are necessary for Licensor to confirm compliance with this Agreement. |
每项分许可均应受限于一份与本协议的条款保持一致的书面协议。许可知识产权的每次分许可均应符合本协议的条款。被许可方应在签署
任何分许可协议（或其任何补充或修订）后三十(30)个工作日内向许可方提供一份该协议的副本，但被许可方有权对涉及商业敏感信息且许可方无需用于确认合规性的条款进行删节处理，尽管有前述规定，被许可方不得对任何涉及财务对价的条款（如预付款、特许权使用费、里程碑付款或价格结构）、分许可范围、使用领域限制或终止权利的内容（为许可方确认本协议合规性所必需的条款）进行删减或遮蔽。
| (c) | Licensee may engage subcontractors, including but not limited to Third Party contract research organization (“CRO”), Third Party contract manufacturing organization (“CMO”) and Third Party contract sales organization (“CSO”) (such subcontractor(s) individually and collectively, “Subcontractor(s)”) to exercise its rights or perform its obligations under this Agreement; provided that such subcontracting will be pursuant to a written and executed subcontracting agreement that does not conflict with and is subject to the terms of this Agreement, and shall not relieve Licensee of its obligations hereunder, and Licensee shall be directly responsible for any act or omission of its Subcontractor. |
被许可方有权聘请分包商，包括但不限于第三方合同研发组织(CRO)、第三方合同生产公司(CMO)以及第三方合同销售组织(CSO)（此类分包商单独及合称为“分包商”）行使其在本协议项下的权利或履行其在本协议项下的义务，但该等分包应依据已签署的书面分包协议进行，该协议不得与本协议条款冲突且应受本协议条款约束，且不免除被许可方在本协议项下的义务，且被许可方应对其分包商的任何作为或不作为直接负责。
Amphastar hereby confirms that it will not purposefully enter into any subcontracting transaction which in substance constitutes a Sublicense Transaction solely for purpose of circumventing the obligation of sublicense revenue sharing pursuant to Section 8.4 hereof.
Amphastar特此确认，其不会仅出于规避本协议第8.4条项下分许可收入分成义务之目的，故意订立任何实质上构成分许可交易的分包交易。
| (d) | Licensee shall remain directly responsible for all of its obligations under this Agreement that have been delegated or sublicensed to any sublicensee or other Subcontractor. Any sublicensee or Subcontractor conduct, act, omission or state of affairs that would have constituted a breach of this Agreement shall be imputed to Licensee and deemed a breach of this Agreement as if such conduct, act, omission or state of affairs had been directly attributable to Licensee. Licensee shall not grant a sublicense to any sublicensee or engage the services of any Subcontractor that has been debarred or disqualified by a Regulatory Authority. |
被许可方应继续直接对其在本协议下的所有义务负责，即便这些义务已委托或分包给任何分许可方或其他分包商。任何分许可方或分包商的行为、作为、不作为或事务状态，如构成对本协议的违反，应归咎于被许可方，并视为对本协议的违反，如同该行为、作为、不作为或事务状态直接归咎于被许可方一样。被许可方不得向任何被监管机构禁止或取消资格的分许可方或分包商授予分许可或聘用其提供服务。
| 2.3 | Cross-license. [***] |
交叉许可。 [***]
[***]
[***]
| 2.4 | Retained Rights; No Implied Licenses. Except for the licenses expressly granted to the other Party pursuant to this Agreement, the Parties on behalf of itself and its Affiliates (and on behalf of its sublicensees) and contractors) grant no other rights or licenses, including any other rights or licenses under the Licensed IP and Cross-License Patents, whether by implication, estoppel or otherwise. For clarity, on behalf of itself and its Affiliates (and on behalf of its sublicensees and contractors), Licensor retains (a) exclusive rights to research, Develop, make and have made, use, seek Regulatory Approval for and Commercialize each Licensed Product and Licensed Compound, as well as the Licensed IP outside the Territory, and (b) rights under Licensed IP to the extent necessary for the performance of its obligations under this Agreement. |
保留权利；无默示许可。 除根据本协议明确授予另一方的许可外，双方（代表其自身及其关联方，并代表各自分许可方及分包商）不授予任何其他权利或许可（无论是通过默示、禁止反言或其他方式），包括许可知识产权和交叉许可专利项下的任何其他权利或许可。为避免歧义，许可方特此声明，其代表自身及其关联方（以及其分许可方和分包商）保留以下权利：(a) 在区域外，对每一个许可产品、许可化合物以及许可知识产权进行研究、开发、制造和委托制造、使用、申请监管批准和商业化的专属权利；和(b) 利用许可知识产权，为履行本协议项下义务开展活动所必须的权利。
| 2.5 | No Diversion. Unless otherwise agreed in Section 6 (Manufacturing), Licensee shall not, and shall not permit any of its Affiliates or sublicensees or any Third Party to, Develop, manufacture (including having manufactured) distribute, market, promote, offer for sale, or sell the Licensed Product, directly or indirectly, (i) to any Person for use outside the Territory or (ii) to any Person that Licensee or any of its Affiliates or its sublicensees knows (A) is reasonably likely to Develop, manufacture (including having manufactured), distribute, market, promote, offer for sale, or sell any Licensed Product for use outside the Territory or assist another Person to do so, or (B) has directly or indirectly Develop, manufacture (including having manufactured), distributed, marketed, promoted, offered for sale, or sold any Licensed Product for use outside the Territory or assisted another Person to do so. |
不得转用。除本协议第6条（生产）另有约定外，被许可方不得，且不得允许其任何关联方、分许可方或任何第三方，直接或间接地开发、生产（包括委托他人生产）分销、销售、推广、推销、要约销售或出售许可产品给，(i) 任何将许可产品用于许可区域之外的人员；或 (ii) 被许可方或其任何关联方或分许可方知悉的以下人员：(A) 合理可能开发、生产（包括委托他人生产）、分销、销售、推广、推销、要约销售许可产品以用于许可区域之外，或协助他人如此实施的；或(B) 已直接或间接开发、生产（包括委托他人生产）、分销、销售、推广、推销、要约销售或出售许可产品以用于许可区域之外，或协助他人如此实施的。
治理。
合作项目管理人。在生效日后的三十（30）日内，每一方应任命一名对医药开发有全面了解的资深代表担任其在本协议项下的合作项目管理人（“合作项目管理人”）（并向另一方通知其具体身份）。合作项目管理人将(a) 担任双方之间的联络人，向许可方提供被许可方许可化合物和许可产品的开发进度信息；及(b) 受限于第13.3(c)款的规定，主要负责促进信息交流及以其他方式促进沟通、协调，以及许可方根据第4条的规定向被许可方进行的许可专有技术转移；(c) 促进任何争议的及时解决。每一方可经书面通知另一方更换其合作项目管理人。
会议。
| (a) | On a Licensed Product-by-Licensed Product, during the period commencing on the Effective Date until the IND Acceptance, the Alliance Managers shall meet once every month, during the period between IND Acceptance to NDA Acceptance, the Alliance Managers shall meet once every 3 months, and after the NDA Acceptance, the Alliance Manager shall meet once every 6 months. |
在逐个许可产品的基础上，自生效日起至新药临床研究申请受理期间，合作项目管理人应每月召开一次会议，在新药临床研究申请受理至新药上市申请受理期间，合作项目管理人应每3个月召开一次会议，在新药上市申请受理之后，合作项目管理人应每6个月召开一次会议。
| (b) | Licensee shall submit to Licensor, no less than three (3) business days prior to each meeting, a written report with any major and key progress that is relevant to the Licensed Product’s status or the parties’ contractual obligations: |
被许可方应在每次项目管理人会议前至少三（3）个工作日向许可方提交书面报告，包含与许可产品进展或双方合同义务相关的重大及核心进展：
| (i) | progress against the Development Milestone, delays (if any) along with root cause analysis (if available) and further actions; |
开发里程碑的完成情况，以及延误情况（如有）及根本原因分析（如有）以及进一步行动；
| (ii) | its then-current clinical trial plans and protocols for Licensed Compound and Licensed Product, and an implementation status report for such plans; |
许可化合物和许可产品的最新临床试验方案以及前述方案的实施进展报告；
| (iii) | clinical trial updates, including enrollment data, protocol modifications, and interim safety/efficacy findings; |
临床试验的进度，包括受试者入组数据、方案修改情况、中期安全性和有效性的结果；
| (iv) | the development milestone status related to the Licensed Compound and Licensed Product; |
许可化合物及许可产品的开发里程碑进展；
| (v) | in compliance with Applicable Law, share adverse event reports and any regulatory correspondence that is related to the Development Milestones; and |
在符合适用法律的前提下，分享与开发里程碑相关的不良反应事件报告，以及其他与监管机构的往来函件；以及
| (vi) | any additional material issues identified by the Alliance Manager that require mutual discussion between the Parties, and in compliance with Applicable Law. |
其他合作项目管理人认为需要双方共同讨论的、符合适用法律的实质性议题。
最终决定。对于许可产品和许可化合物在区域的适用范围内的开发、制造、以其他方式利用以及许可产品在区域的适用范围内的商业化，被许可方将全权负责，并在受限于本协议的条款的前提下拥有最终决策权，但条件是被许可方行使该最终决策权时，不得以对区域外适用范围内开发、制造、商业化及以其他方式利用许可产品及许可化合物产生重大不利影响的方式行事。
许可专有技术的披露与合作
许可专有技术、许可方材料及其他文件的转移。
| (a) | Within fifteen (15) days (or the timeline otherwise specified in Exhibit B) after its receipt of the Development Milestone Payment for execution of this Agreement (Development Milestone No.2) set forth in Section 8.1, Licensor shall provide to Licensee a copy (in electronic format if it is available in electronic format or a hard copy upon written request if it is not available in electronic format) of the documentation listed on Exhibit B. All documentation and information within the Licensed Know-How will be provided in the language such documentation was generated and will not be translated. |
在收到第8.1款规定的与签署本协议相应的开发里程碑付款（第二个开发里程碑）后的十五（15）日内（或根据附件B所列明的时间），许可方应向被许可方提供附件B所列文件的一份副本（如有电子格式，应提供电子格式，如无电子格式，应按书面要求提供纸质副本）。许可专
有技术中的所有文件和信息将以生成该等文件的语言提供，且不进行翻译。
| (b) | If any Party reasonably identifies specific documents that constitute Licensed Know-How Controlled by Licensor that were used for or arose from the Development of any Licensed Compound or Licensed Product which is not included on Exhibit B, Licensor shall locate and provide such documents to Licensee within fifteen (15) days thereafter, and the content of such documents shall be deemed to be Licensed Know-How and licensed for Licensee’s use under this Agreement, subject to Sections 2. |
如果任何一方合理发现构成用于或源于任何许可化合物或许可产品开发的由许可方控制的、但未列入附件B的许可专有技术的特定文件，则许可方应在其后的十五（15）日内找到并向被许可方提供该等文件，该等文件的内容应被视为许可专有技术，并根据第2条许可被许可方在本协议项下使用。
| (c) | Within fifteen (15) days after receipt of the Development Milestone Payment for execution of this Agreement (Development Milestone No.2) set forth in Section 8.1, Licensor shall provide to Licensee the Licensor Material specifically identified on each of Exhibit C, at no cost to Licensee, in the form and quantities set forth on each of Exhibit C. |
在收到第8.1款规定的与签署本协议相应的开发里程碑付款（第二个开发里程碑）后的十五（15）日内，许可方应以附件 C所列明的相关格式和数量，向被许可方无偿提供附件 C所列明的许可方材料。
| (d) | In addition to the Licensed Know-How and Licensor Materials, Licensor will use Commercially Reasonable Efforts to provide other necessary assistance, which are reasonably required for the proper use and understanding of the aforementioned Licensed Know-How and Licensor Material or the Development of Licensed Compounds and Licensed Products, for avoidance of any doubts, excluding any assistance relating to knowledge innovation, derivative improvements, or the research and development of new products (whether or not based on the Licensed Know-How), unless otherwise provided under this Agreement. Licensee shall bear all costs incurred in connection therewith (including any expenses charged by Licensor in accordance with Section 4.4). |
除许可专有技术及许可方材料外，为正确使用和理解上述许可专有技术及许可方材料或开发许可化合物和许可产品，许可方还将使用商业上合理的努力提供其他必要的协助，为避免疑问，此类协助不包括任何涉及知识成果创新、改进或新产品研发的协助（无论是否基于现有许可技术），除非本协议另有其他约定。被许可方应承担与之相关发生的所有费用（包括根据第4.4款所约定的由许可方收取的费用）。
第三方供应商及服务提供商. 在被许可方拟就许可化合物或许可产品在区域内的生产聘用一个或多个分包商的情况下，应被许可方的书面要求，在符合本协议条款和条件的前提下，许可方将签发一份授权书，使被许可方能够根据被许可方与该等分包商另行协商并订立的书面协议要求查阅或复制由许可方的供应商或服务提供商持有的许可化合物或许可产品相关的许可知识产权。特别地，如果被许可方希望通过许可方引荐任何分包商的（无论是否在区域内），许可方可以善意推荐，但被许可方应当自行与该等分包商达成合作安排，且任何情况下，许可方不对该等分包商的服务质量作出任何承诺，也不承担与其有关的任何责任和义务。
无任何保证。所有许可专有技术、许可方材料、其他信息或协助是在不提供任何明示或暗示保证的前提下向被许可方提供的，包括不提供对适销性或特定用途适用性的任何保证。除本协议另行规定的之外，被许可方在此确认并同意，许可方所提供的所有许可专有技术、许可方材料、其他信息或协助是“按现状”提供的，不附带任何形式的明示或暗示保证，包括但不限于适销性和特定用途适用性。双方确认该等技术本身可能不足以使被许可方在区域内获得相关监管批准或实现授权产品的商业化。本协议提供专有技术之目的，系协助被许可方在区域内开发授权产品、取得监管批准并进行商业化实施。双方确认，可能仍需补充其他数据及信息。
协助与人力成本。根据被许可方的请求，许可方应向被许可方提供合理的技术协助，以帮助其理解和使用许可方的许可专有技术及许可化合物，用于本协议适用范围内在区域内开发许可产品，为避免疑问，此类协助不包括任何涉及知
识成果创新、改进或新产品研发的协助（无论是否基于现有许可技术）。[***]
监管；开发
开发和监管。 许可方确认，截至生效日，许可方及其关联方均未在区域内就适用范围内的任何许可化合物或许可产品提交任何新药研究申请、临床试验申请（“临床试验申请”）（即作为监管申报文件的申办方）或同等的监管申报。受限于本协议的条款与条件，被许可方有排他性的权利（但无义务）准备、提交和控制区域内的所有该等监管申报。自生效日起，被许可方将独自负责区域内的适用范围内的许可化合物和许可产品的开发，以及与之相关在区域的适用范围内产生的所有监管事项，并自行承担相关费用和支出（被许可方将保留对任何新药上市申请、药品上市许可申请及其他监管申报和监管批准的所有权）。
开发计划。有关生效日起至新药临床研究申请受理前的开发计划已作为初始开发计划（“开发计划”）附于本协议附件 D。被许可方及其关联方在本协议项下保留自行决定不时更新开发计划和时间表的权利。
After the execution of this Agreement, the Parties may further discuss and enter into a written document regarding the development plan following the IND Acceptance.
本协议签署后，双方可进一步就新药临床研究申请受理后的开发计划进行讨论并达成书面文件。
Licensee shall use Commercially Reasonable Efforts to execute the Development Plan and to each relevant research program appropriate resources and allocate personnel with an appropriate level of education, experience and training, and shall use Commercially Reasonable Efforts to submit IND to the FDA for the Licensed Products by no later than [***]; for clarity, the foregoing timeline represents a good faith estimate of Licensee and shall not constitute an absolute guarantee made by Licensee. Notwithstanding, if Licensee fails to complete any of the foregoing tasks within such timeframe, any further extension shall be subject to friendly discussion between both Parties and formal mutual written agreement (provided that Licensor shall not unreasonably withhold such consent).
被许可方应使用商业上合理的努力实施开发计划，为各相关研发项目投入适当资源，并配备具备相应学历、经验和培训水平的人员，以使得 [***] 之前就许可产品向美国食药监局提交新药研究申请；为明确起见，前述时间表代表了被许可方的善意预估，不是被许可方的绝对保证。尽管如此，如果被许可方无法在前述时间内完成前述各项工作的，任何进一步的延期都需要经过双方友好讨论并达成正式的一致书面意见（但许可方不应不合理地拒绝给予该等同意）。
开发记录和开发报告。在本协议期限内，直至每一个许可产品的首次商业销售，被许可方应完整并准确地保存其自身、其关联方或代表其开展的所有开发活动的记录，以及根据适用法律由此产生的所有数据和其他信息。
数据交换与获取。在不限制第5.3款的前提下，且受限于本协议第10条（保密）在一方在提出合理请求时，基于另一方的同意，另一方应及时向其提供由其开展的许可产品开发活动所产生的数据及结果的副本，以及支持性文件（例如研究方案、病例报告表、分析计划）。根据本协议的条款和条件，被许可方有权使用许可方提供的数据，以在区域的适用范围内为许可产品和许可化合物获得及维持监管批准；许可方有权使用被许可方提供的数据，以在区域外满足适用法律的要求。未经被许可方书面同意，许可方不得向任何第三方披露被许可方提供的任何数据。
生产
生产。 自生效日起，被许可方将自行负责在区域内生产许可化合物和许可产品并将在符合本协议规定的情况下拥有与之相关的最终决策权，并自行承担相关费用和支出。为明确起见，只要许可产品仅在区域内进行商业化，则允许被许可方和/或其关联方和/或分许可方在区域外生产许可化合物及许可产品。
被许可方及其关联方不得在区域内或者区域外将药物活性成分（“药物活性成分”）作为独立商品进行任何形式的销售、赠予或转让，但前提是，被许可方及其关联方可以自行或通过任何分包商，在区域内为后续生产许可产品之目的而制造或转移药物活性成分。被许可方可通过其在区域外的关联方、分许可方或分包商生产药物活性成分，并且需满足以下所有条件： (1) 生产的药物活性成分必须专门且全部用于被许可方、其关联方、分许可方或分包商在区域内生产许可产品；(2) 用该等药物活性成分及其所生产的许可产品不会被转售至区域外。
商业化活动
| 7.1. | Commercialization. Subject to the terms and conditions of this Agreement, from and after the Effective Date, Licensee will be solely responsible and shall exercise sole discretion for all aspects of Commercialization of Licensed Products in the Field and in the Territory, including planning and implementation, distribution, marketing, booking of sales, pricing, and reimbursement. |
商业化活动。 受限于本协议的条款与条件，自生效日起，被许可方将自行负责并自主决定许可产品在区域的适用范围内的商业化活动的所有方面，包括规划和实施、分销、营销、销售确认、定价和医保报销。
| 7.2. | Commercialization Diligence. Licensee (and its Affiliates and sublicensees) shall use Commercially Reasonable Efforts, upon granting by the relevant Regulatory Authority of the NDA or MAA for each Licensed Product (and, where applicable, pricing and reimbursement approvals) in the Territory, to Commercialize such Licensed Product in the Field in the Territory. |
商业化勤勉义务。被许可方（及其关联方和分许可方）应尽其商业上合理的努力以在相关监管机构授予许可产品在区域内适用范围的新药上市申请或药品上市许可申请（如适用，包括定价和报销批准）后，在该区域内对该许可产品进行商业化。
| 7.3. | Commercialization Records and Commercialization Reports. Licensee, its Affiliates and sublicensees shall maintain complete and accurate books and records pertaining to Commercialization of Licensed Products hereunder, reasonably detailed for the verification of the Licensee, its Affiliates and sublicensees’ compliance with its obligations under this Agreement, which shall be in compliance with Applicable Law and properly reflect all work done and results achieved in the performance of its Commercialization activities. Such records shall be retained by Licensee (and on behalf of its Affiliates and sublicensees) for a period required by Applicable Law (but in no event less than three (3) years after their creation for verification of calculation of Net Sales hereunder). |
商业化记录和商业化报告。被许可方、其关联方和分许可方应保留完整且准确的与本协议项下许可产品商业化相关的账簿和记录，记录应具有合理的详细程度，以供验证被许可方、其分许可方和关联方是否遵守其在本协议项下的义务，且应符合适用法律的规定，真实反映所开展的工作及商业化活动中取得的成果。上述记录应由被许可方（并代表其关联方和分许可方）保存，保存期限应符合适用法律的要求（但在任何情况下不得少于自记录生成之日起三(3)年，以用于本协议项下净销售额计算的核查）。
财务条款
开发里程碑付款.
| (a) | During the Initial Licensing Term, upon achievement of each of the Milestones corresponding to each Licensed Product set forth below (each a “Development Milestone”) by or on behalf of Licensee or its Affiliates or its sublicensees (and without regard to whether or not the same Development Milestone for any other Licensed Product has been achieved), the corresponding non-refundable, and non-creditable Milestone Payment (a “Development Milestone Payment”) will be payable to Licensor in USD: |
在初始许可期限内，在以下针对每一许可产品的每一对应的里程碑（均称为“开发里程碑”）由或代表被许可方或其关联方或分许可方实现之时（且不考虑其他许可产品的同一开发里程碑是否实现），相应的不可退还且不可抵扣的里程碑付款（“开发里程碑付款”）将以美元支付给许可方：
|
No. 序号 |
Development Milestone 开发里程碑 |
Development Milestone Payment (US $ Million) 开发里程碑付款 （百万美元） |
|||
|
AJ005 Product AJ005产品 |
AJ007 Product AJ007产品 |
AJ009 Product AJ009品 |
Subtotal 小计 |
||
1 |
Execution of the MOU (Earnest Money Deposit) 签署备忘录（保证金） |
[***] |
[***] |
||
2 |
Execution of this Agreement 签署本协议 |
[***] |
[***] |
||
3 |
IND Acceptance for such Licensed Product, and approval (or implied approval) issued to commence clinical trial by the FDA or Health Canada 就该许可产品，获得新药临床研究申请受理，并且美国食药监局或加拿大卫生部签发启动临床试验的批文（或者默示许可） |
[***] |
[***] |
[***] |
[***] |
4 |
4.1 For such Licensed Product, the first dosing in human in the phase I trial in the Territory 就该许可产品，在授权区域内I期试验中实现首个病人给药 |
[***] |
[***] |
[***] |
[***] |
|
4.2 For such Licensed Product, successful completion of phase I trial in the Territory, and FDA (or Health Canada) has no objection to start phase II trial in the United States (or Canada) 就该许可产品，在授权区域内成功完成I期试验，且美国食药监局（或加拿大卫生部）未拒绝在美国（或加拿大）开启II期试验 |
[***] |
[***] |
[***] |
[***] |
|
|
4.3 For such Licensed Product, the first dosing in human in the phase II trial in the Territory 就该许可产品，在授权区域内II期试验中实现首个病人给药 |
[***] |
[***] |
[***] |
[***] |
|
|
4.4 For such Licensed Product, successful completion of phase II trial (if applicable, IIa and IIb) in the Territory, and FDA (or Health Canada) has no objection to start phase III trial in the United States (or Canada) 就该许可产品，在授权区域内成功完成II期试验（如适用，IIa期和IIb期）且美国食药监局（或加拿 |
[***] |
[***] |
[***] |
[***] |
|
|
大卫生部）未拒绝在美国（或加拿大）开启III期试验 |
|||||
5 |
5.1 For such Licensed Product, the first dosing in human in the phase III trial in the Territory 就该许可产品，在授权区域内III期试验中实现首个病人给药 |
[***] |
[***] |
[***] |
[***] |
|
5.2 For such Licensed Product, successful completion of phase III trial (i.e. FDA or Health Canada agrees for a Pre-NDA meeting) in the Territory 就该许可产品，在授权区域内成功完成III期试验（即美国食药监局或加拿大卫生部同意召开新药上市申请前会议） |
[***] |
[***] |
[***] |
[***] |
|
6 |
For such Licensed Product, NDA filing accepted for review by FDA or Health Canada 就该许可产品，新药上市申请被美国食药监局或加拿大卫生部受理审查 |
[***] |
[***] |
[***] |
[***] |
7 |
For such Licensed Product, NDA Approval by FDA or Health Canada 就该许可产品，美国食药监局或加拿大卫生部批准新药上市申请 |
[***] |
[***] |
[***] |
[***] |
|
Maximum Development Milestone Payment 开发里程碑付款上限 |
[***] |
||||
| (b) | Each Development Milestone Payment in the table above will be paid not more than once; for further clarity, if a Development Milestone is firstly triggered in Canada, the corresponding Development Milestone Payment shall become due and payable, and Licensee will not make any payment for the same Development Milestone again which is later triggered in the United States. The Parties hereby confirm that the Development Milestone Payment for execution of the MOU (Earnest Money Deposit) has been paid in accordance with the terms in the MOU. Accordingly, unless otherwise agreed in this Agreement, in no event shall the Licensee or its Affiliates pay the Licensor more than [***] in the aggregate pursuant to Section 8.1(a). Licensee will provide Licensor with written notice of the achievement of each Development Milestone within ten (10) days after such Milestone is achieved by or on behalf of Licensee or its Affiliates or its sublicensees. Licensor shall following receipt of such notice issue an Invoice to Licensee in respect of the relevant Development Milestone Payment. Licensee shall pay such invoice to Licensor within thirty (30) days after the date of its receipt of such invoice, with the exception of Development Milestone No.2, which shall be within ten (10) business days after receipt of such invoice. |
上表中每项开发里程碑付款的支付次数不得超过一次。为进一步澄清起见，如果一个开发里程碑首次在加拿大被触发，该开发里程碑款付款应当被支付，但被许可方无需为了同样的开发里程碑之后在美国触发而再次支付任何款项。双方确认与签署备忘录（保证金）相应的开发里程碑付款已根据备忘录完成支付。因此，除非本协议另有约定，被许可方或其关联方根据第8.1(a)款向许可方支付的总额在任何情况下不得超过 [***]。在每一开发里程碑由或代表被许可方或其关联方或其
分许可方实现后的十（10）日内，被许可方将向许可方书面通知该等里程碑的实现。在收到该等通知后，许可方应就相关开发里程碑付款向被许可方出具发票。被许可方应在收到该等发票之日起三十(30)日内向许可方支付该等发票金额（第二个开发里程碑除外，该笔款项应在收到该等发票之日起十(10)个工作日内支付）。
| (c) | For each Development Milestone 3# to 7#, if any Development Milestone event is bypassed and a later Development Milestone event is achieved for such Licensed Product, the payment corresponding to any such bypassed Development Milestone event shall be due at the same time that payment is due for the achievement of such later Development Milestone event. |
对于开发里程碑事件3#至7#，如某一开发里程碑事件被跳过，且后续的某一开发里程碑事件已达成，则被跳过的开发里程碑事件所对应的付款应与该后续开发里程碑事件应付款项的时间同时支付。
销售里程碑付款.
| (a) | During the Licensing Term, upon achievement of the Net Sales amount of respective Licensed Product in any one (1) Calendar Year period in the Territory set forth below (each a “Sales Milestone”, collectively with the Development Milestones, the “Milestones”) by or on behalf of Licensee and its Affiliates and its sublicensees (and without regard to whether or not the same Sales Milestone for any other Licensed Product has been achieved), the following corresponding non-refundable, and non-creditable Milestone Payment (a “Sales Milestone Payment”, collectively with the Development Milestone Payment, the “Milestone Payments”) will be payable to Licensor in USD: |
在许可期限内，在相应许可产品于任何一（1）个日历年在区域内的下述净销售额（均称为“销售里程碑”，与开发里程碑合称“里程碑”）由或代表被许可方和其关联方和其分许可方实现之时（且不考虑其他许可产品的同一销售里程碑是否实现），以下相应的不可退还且不可抵扣里程碑付款（“销售里程碑付款”，与开发里程碑付款合称“里程碑付款”）将以美元支付给许可方：
|
No. 序号 |
Sales Milestone 销售里程碑 |
Sales Milestone Payment (US $ Million) 销售里程碑付款 （百万美元） |
|||
|
AJ005 Product AJ005产品 |
AJ007 Product AJ007产品 |
AJ009 Product AJ009产品 |
Subtotal 小计 |
||
1 |
Annual Net Sales amount throughout the Territory reaching [***] 整个区域的年度净销售额达到[***] |
[***] |
[***] |
[***] |
[***] |
2 |
Annual Net Sales amount throughout the Territory reaching [***] 整个区域的年度净销售额达到[***] |
[***] |
[***] |
[***] |
[***] |
3 |
Annual Net Sales amount throughout the Territory reaching [***] |
[***] |
[***] |
[***] |
[***] |
整个区域的年度净销售额达到[***] |
|||||
4 |
Annual Net Sales amount throughout the Territory reaching [***] 整个区域的年度净销售额达到[***] |
[***] |
[***] |
[***] |
[***] |
5 |
Annual Net Sales amount throughout the Territory reaching [***] 整个区域的年度净销售额达到[***] |
[***] |
[***] |
[***] |
[***] |
|
Maximum Sales Milestone Payment 销售里程碑付款上限 |
[***] |
[***] |
[***] |
[***] |
|
| (b) | Each Sales Milestone Payment in the table above will be paid not more than once. Accordingly, unless otherwise agreed in this Agreement, in no event shall the Licensee or its Affiliates pay the Licensor more than [***] in the aggregate pursuant to Section 8.2(a). Licensee will provide Licensor with written notice of the achievement of each Sales Milestone and the corresponding Sales & Royalty Report before March 31st of the next Calendar Year after such Milestone is achieved by or on behalf of Licensee and its Affiliates and its sublicensees. Licensor shall following receipt of such notice issue an Invoice to Licensee in respect of the relevant Sales Milestone Payment. Licensee shall pay such invoice to Licensor within thirty (30) days after the date of its receipt of such invoice. For clarity, for each Licensed Product, if multiple Sales Milestone Events are achieved in the same Calendar Year, then each applicable Sales Milestone Payment associated with such Sales Milestone events would nonetheless be owed to Licensor in full after the end of such Calendar Year in accordance with this Section 8.2(b). |
上表中每项销售里程碑付款的支付次数不得超过一次。因此，除非本协议另有约定，被许可方或其关联方根据第8.2(a)款向许可方支付的总额在任何情况下不得超过 [***]。在每一销售里程碑由或代表被许可方和其关联方和其分许可方实现后的下一日历年的3月31日前，被许可方将向许可方书面通知该等里程碑的实现以及对应的销售与许可费报告。在收到该等通知后，许可方应就相关销售里程碑付款向被许可方出具发票。被许可方应在收到该等发票之日起三十（30）日内向许可方支付该等发票金额。为避免歧义，对于每一许可产品而言，如在同一日历年度内达成多个销售里程碑事件，则与该等销售里程碑事件相关的每一项应付款项，均应在该日历年度结束后根据本第8.2(b)款全额支付给许可方。
许可费付款.
| (a) | In further consideration of the licenses and rights granted to Licensee hereunder, each Calendar Year during the Royalty Term, Licensee will make royalty payments (“Royalty Payment”) to Licensor on annual Net Sales in the Territory by Licensee and its Affiliates and its sublicensees at the rates set forth below. |
作为本协议项下授予被许可方的许可和权利的进一步对价，在许可费 期限内的每一日历年，被许可方将就被许可方及其关联方和分许可方在区域内实现的年度净销售额按下述费率向许可方支付许可费（“许可费付款”）。
|
No. 序号 |
Royalty Payment based on annual Net Sales in the Territory 基于区域内年度净销售额的许可费付款 |
Royalty Payment 许可费付款 |
||
|
AJ005 Product AJ005产品 |
AJ007 Product AJ007产品 |
AJ009 Product AJ009产品 |
||
1 |
Royalty rate 许可费费率 |
[***] |
[***] |
[***] |
| (b) | The Royalty Payment (excluding any Milestone Payment) shall be subject to a maximum annual amount of [***] each Calendar year for each of AJ005 Product, AJ007 Product and AJ009 Product (the “Maximum Annual Royalty Payment”) and a maximum accumulated amount of [***] for each of AJ005 Product, AJ007 Product, and AJ009 Product, and in total [***] for all three Licensed Products (the “Maximum Accumulated Royalty Payment”). Once the Maximum Accumulated Royalty Payment has been paid for any Licensed Product, the Royalty Payment obligation for such Licensed Product shall be deemed to be terminated; for clarity, such termination of royalty obligations for a particular Licensed Product shall not relieve Licensee of its payment obligations under Section 8.4 of this Agreement. |
AJ005产品、AJ007产品和AJ009产品的许可费付款（不包括任何里程碑付款）年度上限均为每个日历年 [***]（“年度许可费付款上限”），AJ005产品、AJ007产品和AJ009产品的许可费付款累计上限均为 [***]，所有三项许可产品的累计上限总计 [***]（“累计许可费付款上限”）。一旦就任一许可产品已支付的金额达到累计许可费付款上限，则被许可方针对该特定许可产品的许可费付款义务应终止；为免歧义，针对该特定许可产品的许可费付款义务的该等终止不影响被许可方在本协议第8.4款项下的付款义务。
| (c) | Before March 31st of the next Calendar Year, Licensee shall provide a Sales & Royalty Report of the previous Calendar Year to Licensor. Licensor shall submit an Invoice to Licensee with respect to the royalty amount shown therein. Licensee shall pay such royalty amount to Licensor within thirty (30) days after the date of receipt of the Invoice. |
在下一日历年的3月31日前，被许可方应向许可方提供上一日历年的销售与许可费报告。许可方应就该报告显示的许可费金额向被许可方提交发票。被许可方应在收到发票之日起三十(30)日内向许可方支付该许可费金额。
分许可交易收入。
In further consideration of the licenses and other rights granted to Licensee by Licensor under this Agreement, and in addition to Licensee’s payment obligations set forth in Sections 8.1 through Section 8.3, [***]
作为许可方根据本协议授予被许可方的许可及其他权利的进一步对价，并且除被许可方在第8.1条至第8.3条项下的付款义务[***]。
付款.
| (a) | All payments from Licensee to Licensor will be made by wire transfer in USD to the credit of such bank account as may be designated by Licensor in this Agreement or in writing to Licensee. Any payment which falls due on a date which is not a business day in the location from which the payment may be made shall occur on the next succeeding business day in such location. Licensor shall be solely responsible for obtaining all applicable permits necessary for receiving all payments required to be made under this Agreement. Licensee shall not be responsible nor required to reissue any amounts, whether whole or partial, for any payments issued by Licensee pursuant to Licensor’s written instruction(s). |
被许可方向许可方支付的所有款项应以美元电汇至许可方在本协议中指定的或向被许可方书面指定的银行账户。任何款项的到期日如为付款来源地的非工作日，则应在该地的下一个工作日到期。许可方应自行负责取得收取本协议项下要求支付的所有款项所需的所有适用许可。被许可方对于根据许可方书面指令支付的所有款项（无论全额或部分）均不承担任何责任，且无义务进行任何形式的重新支付。
| (b) | In case that Licensee fails to provide Licensor with such notice of any Milestones within such time period as set forth under Section 8.1(b) and Section 8.2(b), while Licensor believes that any Milestone has been achieved, it shall have the right to notify Licensee in writing of the same and issue an invoice for the Milestone Payments to Licensee, and in the case the Milestone was actually achieved, Licensee shall make the corresponding Milestone Payments to Licensor within thirty (30) days thereafter for the relevant Milestone Payments. If Licensee disputes this matter, Licensee will notify Licensor within thirty (30) days from receipt of Licensor’s notice, and both Parties shall resolve the dispute in accordance with Section 15.5. |
若被许可方未能在第8.1(b)条和第8.2(b)条规定的期限内向许可方提供任一里程碑通知，但许可方认为任何里程碑已达成，许可方有权书面通知被许可方该事实并向被许可方开具里程碑付款的发票；若该里程碑确已达成，被许可方应在收到发票后三十(30)日内向许可方支付相应的里程碑付款。如被许可方对此事项存在异议，应自收到许可方通知之日起三十（30）日内告知许可方，双方应按照第15.5款规定解决争议。
| (c) | All payments under this Agreement shall be made in U.S. dollars. Payments shall be made by electronic wire transfer of immediately available funds to the account of Licensor. Licensee will booked all Net Sales in accordance with the Accounting Standards. |
本协议项下的所有付款均应以美元支付。付款应通过电子电汇方式将可即刻使用的资金汇入许可方书面指定的账户。被许可方应按照会计准则确认所有净销售额。
| (d) | [***] |
[***]
| (e) | [***] |
[***]
| (f) | Each Party shall each bear any and all taxes levied against such Party on account of any payment received by such Party under this Agreement. All amounts payable by the Licensee to Licensor under this Agreement shall be deemed to be inclusive of all applicable taxes, levies, duties, or similar governmental charges, including without limitation any income tax, gross receipts tax, value-added tax, sales tax, use tax, or other tax of a similar nature that may be imposed by any governmental authority in connection with or arising out of the receipt of such payments by the Licensor. The Licensee shall have no obligation to gross up or otherwise pay any additional amount to Licensor to account for or compensate Licensor for any tax, deduction or withholding assessed or imposed on such payments, except to the extent otherwise expressly provided in this Agreement. |
双方应各自承担因其根据本协议收到的任何付款而对其征收的任何及所有税款。被许可方根据本协议应向许可方支付的所有金额，均应被视为包含任何适用的税款、规费、关税或类似政府性收费，包括但不限于任何政府机关就许可方收取该等款项可能征收的所得税、营业税、增值税、销售税、使用税或其他类似的税费。除非本协议另有明确约定，对于就该等付款所征收或施加的任何税负、扣减或预提税，被许可方无义务通过补足或其他方式向许可方支付任何额外税额补偿，以弥补或补偿许可方。
| (g) | If any withholding tax is required to be withheld by Licensee under the Applicable Law of any jurisdiction, including extra-territorial taxation and is paid over to the applicable tax authority, Licensee will deduct the withholding tax from the payment made to Licensor and such payment shall be treated as having been paid to Licensor for all purposes under this Agreement. Licensee will reasonably assist Licensor in lawfully claiming exemption from or minimizing such withholding tax under double taxation laws including but not limited to the submission or issuance of requisite forms. |
如果根据任何司法管辖区的适用法律（包括域外征税）应由被许可方预扣任何预提税且该等预提税已缴纳给相关税务机构，被许可方将从支付给许可方的款项中扣除该等预提税，且在本协议项下，该等款项就各方面而言应被视为已支付给许可方。被许可方将合理协助许可方根据避免双重征税法律合法主张免除或尽可能减少该等预提税，包括但不限于提交或出具必要的表格。
| (h) | Other than as provided in Section 8.5(g), each Party shall be responsible for its own taxes, including any tax, fee, assessment or other charge based on or measured by the capital or net income, or any other tax imposed by any jurisdiction and neither Party shall have any obligation towards the other Party for the taxes of the other Party. |
除第8.5(g)款规定的以外，每一方应自行负责缴纳其税额，包括任何税项、费用、核定税额或其他基于资本或净收入或以资本或净收入计量的费用，或任何司法管辖区征收的任何其他税项，且任何一方均不对另一方的税项负有任何义务。
| (i) | Any undisputed payments or portions thereof due hereunder that are not paid on the date such payments are due under this Agreement shall bear interest at a rate equal to the lesser of: (i) [***] percentage points above the prime rate as published by The Wall Street Journal or any successor thereto on the first day of each Calendar Quarter in which such payments are overdue or (ii) the maximum rate permitted by Applicable Laws; in each case calculated on the number of days such payment is delinquent, compounded monthly. |
本协议项下任何未按期支付的无争议款项或其部分，均应自逾期之日起按以下较低者计算利息：(i)《华尔街日报》或其继任机构在该日历季度第一天公布的基本利率上浮[***]个百分点，或(ii) 适用法律允许的最高利率；在上述任一情况下，利息应按逾期天数计算，并按月复利计息。
| (j) | With respect to any amounts owed under this Agreement by a Party to the other Party for which no other invoicing and payment procedure is specified herein, the Party owing such payment obligation will provide to the other Party an invoice, together with reasonable supporting documentation, for such amounts owed and such other Party will pay any undisputed amounts within thirty (30) days after receipt of the invoice. |
对于本协议项下一方应向另一方支付的、且本协议中未另行规定开票和付款程序的任何款项，负有付款义务的一方应向另一方提供发票及合理的支持性文件，另一方应在收到发票后三十（30）日内支付无争议的款项。
| (k) | Licensee shall be solely responsible for obtaining all applicable permits necessary for making all payments required to be made under Sections 8.1 to 8.4 and will bear all costs associated with such payments. |
被许可方应自行负责取得支付第8.1款至第8.4款项下要求支付的所有款项所需的所有适用许可，并承担与该等付款有关的所有费用。
记录。
| (a) | Licensee will keep, and will require its Affiliates to keep, complete, true and accurate books and records in accordance with its Accounting Standards in relation to Milestones, Net Sales and Royalty Payments payable to Licensor hereunder with respect to Licensed Compounds and Licensed Products. |
被许可方将根据其会计准则就里程碑、净销售额和本协议项下就许可化合物和许可产品应向许可方支付的许可费保存并要求其关联方保存完整、真实和准确的账簿和记录。
| (b) | Subject to Section 13.3(c), Licensee will, and will require its Affiliates and its sublicensees to, make their records available for inspection by Licensor’s designated third-party auditor (the “Auditor”) (subject to confidentiality obligations and shall only disclose the results to Licensor), during regular business hours at such place or places where such records are customarily kept, upon receipt of notice at least thirty (30) days in advance from Licensor. The records will be reviewed to solely verify the accuracy of the Sales & Royalty Reports, the statement or other reports provided by Licensee and to verify the accuracy of the payments due hereunder accounted for in accordance with applicable Accounting Standards for any Calendar Year(s). Such inspection right will not be exercised more than once in any Calendar Year and not more frequently than once with respect to records covering any specific period of time. Licensor is entitled to inspect Licensee’s records dating back at least for two (2) years (or such longer period as required by Applicable Law) from the |
| date of Licensor’s request for inspection. In the event Licensor requests to inspect records beyond the aforementioned period, Licensor may only do so upon mutual agreement between the Parties. Licensor shall be responsible for the auditor’s costs, unless the auditor certifies that an underpayment by Licensee that resulted from a discrepancy in a report that Licensee provided to Licensor during the applicable audit period, which underpayment was more than [***] of the amount set forth in such report, in which case Licensee shall bear the full cost of such audit. If such accounting firm correctly identifies a discrepancy made during such period, any unpaid amounts or overpaid amounts that are discovered shall be paid/refunded promptly but in any event within thirty (30) days of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. Licensor and any auditor engaged by it will hold in confidence all Confidential Information received and all Confidential Information learned in the course of inspection, except to the extent necessary to enforce its rights under this Agreement or if disclosure is required by Applicable Law. |
根据本协议第13.3(c)款，被许可方将且将要求其关联方和分许可方在收到许可方至少提前三十（30）日发出的通知后，在通常保存该等记录的一个或多个地点的正常工作时间内提供该等记录，以供许可方指定的第三方审计师（“审计方”）（受限于保密义务，且应仅向许可方披露结果）检查。检查该等记录的目的仅为核实销售与许可费报告、被许可方提供的报表或其他报告，以及核实本协议项下所应支付款项在任何一个或多个日历年度内依据适用会计准则进行核算的准确性。该等检查权的行使次数在任何日历年内不得超过一次，且对涉及任何特定期间的记录的行使次数不得超过一次。许可方有权检查被许可方自检查要求提出之日向前追溯至少两(2)年（或适用法律要求的更长期限）内的记录。若许可方要求检查超过前述期限的记录，则须经双方协商一致方可进行。许可方应承担审计费用，除非审计师确认，在相关审计期间内，由于被许可方向许可方提供的报告存在差异，导致被许可方少付的金额超过该报告所列金额的[***]。在此情形下，被许可方应承担该次审计的全部费用。许可方及其聘请的审计师将对收到的所有保密信息和在检查过程中获悉的所有保密信息保密，但为强制执行其在本协议项下的权利或适用法律要求进行披露的除外。
无预测.。许可方和被许可方确认，本协议的任何内容不应被解释为代表对任何许可产品预期销售额的估计或预测，且本协议上文或其他条款规定的或双方另行协商的里程碑和净销售额水平仅旨在确定在相关里程碑或净销售额水平实现之时对许可方的里程碑付款和许可费义务。被许可方未作出任何明示或默示的陈述或保证，表明其将能够成功实现任何许可产品的商业化，或者在实现商业化的情况下，该许可产品将实现任何特定的净销售额水平。
| 8.8 | Royalty for Amphastar. |
Amphastar许可费.
| (a) | Each Calendar Year during the Amphastar Royalty Term, for the license of Cross-license Patents, Licensor will pay [***] royalty to Amphastar from the Net Sales (calculated in the same principle as the “Net Sale” of the Licensed Products) of the commercial sales of products that are based on such Cross-license Patents (the “Royalty for Amphastar”). |
在Amphastar许可费期限内的每一个日历年，对于交叉许可专利的许可，许可方将向Amphastar支付基于该等交叉许可专利的产品的商业销售净销售额（根据许可产品“净销售额”的相同原则计算）[***] 的许可费（“Amphastar许可费”）。
“Amphastar Royalty Term” means, on a product-by-product and region-by-region basis, the period commencing on the First Commercial Sale of a product upon the latest of (i) [***], (ii) [***], and (iii) [***].
“Amphastar许可费期限”是指，在逐个产品和逐个地区的基础上，自产品首次商业销售开始至以下时间孰晚的期间：(i) [***]，(ii) [***]，及(iii) [***]。
| (b) | During the Amphastar Royalty Term, before March 31st of every Calendar Year, Licensor shall provide a sales & royalty report (prepared in the same principle as the “Sales & Royalty Report” of the Licensed Products) of the previous Calendar Year to Amphastar. Amphastar shall submit an Invoice to Licensor with respect to the royalty amount shown therein. Licensor shall pay such royalty amount to Amphastar within thirty (30) calendar days after the date of receipt of the Invoice by wire transfer in RMB to the credit of such bank account as may be designated by Amphastar. |
在Amphastar许可费期限内，在每一日历年的3月31日前，许可方应向Amphastar提供上一日历年的销售与许可费报告（根据许可产品“销售与许可费报告”的相同原则编制）。Amphastar应就其中所示许可费金额向许可方提交发票。许可方应在收到发票之日起三十（30）日内向Amphastar支付该许可费金额，具体支付方式为以人民币电汇至Amphastar指定的银行账户。
| (c) | Licensor shall be solely responsible for obtaining all applicable permits necessary for making all payments required to be made under this Section 8.8 and will bear all costs associated with such payments. |
许可方应自行负责取得支付本第8.8款项下要求支付的所有款项所需的所有适用许可，并承担与该等付款有关的所有费用。
| (d) | Section 8.5 and 8.6 shall apply to Licensor mutatis mutandis with respect to the payment of Royalty for Amphastar. |
就支付Amphastar的许可费而言，第8.5及8.6款在细节上作必要修改后应适用于许可方。
知识产权。
背景知识产权的所有权。就双方之间而言，(a) 许可方应单独拥有并保留对任何及所有许可知识产权及基于该等许可知识产权由许可方作出的改进的全部权利、所有权和权益；且 (b) 每一方应单独拥有并保留其自身或其关联方、或其分许可方（如适用）在本协议之外所拥有或以其他方式控制的所有专有技术、发明、专利及其他知识产权的全部权利、所有权和权益。
衍生产品知识产权。
| (a) | During the Agreement Term, unless otherwise agreed by the Parties, neither Party shall modify, alter, derivatize or improve the chemical structure of Licensed Compounds or Licensed Products. Notwithstanding anything of the foregoing, either Party shall solely own and retain all right, title and interest in and to any and all Know-How, inventions, Patent Rights and other intellectual property rights related to modifying, altering, derivatizing or improving the chemical structure of Licensed Compounds or Licensed Products invented or generated by or on behalf of the other Party and its Affiliates and sublicensees. |
在本协议期限内，除非双方另行协商约定，双方均不得修改、改变、衍生或改进许可化合物或许可产品的化学结构。尽管有前述约定，任一方单独拥有并保留另一方或其关联方、或其分许可方发明或产生的与修改、改变、衍生或改进许可化合物或许可产品的化学结构有关的任何及所有专有技术、发明、专利及其他知识产权的全部权利、所有权和权益。
| (b) | All Developments in the Territory involving dosage forms, formulations, drug-drug combinations, drug-device combinations for the particular three Licensed Products shall be developed by the Licensee. Any intellectual property resulting from such Development is referred to as “Arising Product IP”. |
在区域内，涉及为该等特定三款许可产品而开发剂型、制剂配方、药物联用、药物-设备联用的开发应由被许可方进行。任何通过该等开发所形成的知识产权称为“衍生产品知识产权”。
| (c) | All Arising Product IP (including but not limited to inventions, whether or not patentable or reduced to practice, trademarks, copyrights and Know-How) developed pursuant to this Section (b) will be owned by Licensee, subject to the following conditions: |
根据第(b)条开发产生的所有衍生产品知识产权（包括但不限于发明，无论是否可专利化或已投入实践、商标、著作权和专有技术），在满足下列条件的前提下，归被许可方所有：
| (i) | Notwithstanding anything to the contrary, any Arising Product IP that (x) relates to modifications of the chemical structure of Licensed Compounds or Licensed Products, or (y) is derived from activities prohibited under Section 9.2(a), shall be exclusively owned by Licensor worldwide. |
尽管有上述约定，符合以下情形的衍生产品知识产权均由许可方全球独家所有：（x）涉及许可化合物或许可产品的化学结构修改；或（y）源于违反本条第(a)款禁止性规定的活动所产生的技术。
| (ii) | Licensee’s ownership of Arising Product IP is contingent upon such Development being conducted in strict compliance with Section 2.3. |
被许可方对衍生产品知识产权的所有权，取决于其严格遵循本协议第2.3条为条件。
| (iii) | If any Arising Product IP is erroneously deemed owned by Licensee but subsequently determined to fall under Licensor’s ownership rights per Section (a), Licensee shall promptly assign all rights (including patents and applications) to Licensor. |
若任何衍生产品知识产权初始误归属于被许可方，但后续被认定应依据本条第(a)款归许可方所有，被许可方应立即将相关权利（包括专利及申请权）全部转让给许可方。
成果和数据的所有权。 被许可方在本协议项下的活动（包括由或代表被许可方或其关联方开展的活动）所产生的所有数据和成果，包括为与许可化合物或许可产品相关的监管目的而产生的开发、临床及监管数据和信息，将归被许可方单独所有。
生效日后的专利申请和维护。
| (a) | Licensor will control prosecution and maintenance of the Licensed Patents outside the Territory at Licensor’s sole cost and expense and in the Territory at Licensee’s sole cost and expense. Licensor will use Commercially Reasonable Efforts to keep Licensee informed of matters relating to the prosecution and maintenance of the Licensed Patents in the Territory, and will provide Licensee with copies of documents relevant to such prosecution and maintenance in sufficient time. With respect to communications issued by competent patent offices within the Territory concerning the Licensed Patents, Licensor will use Commercially Reasonable Efforts to notify Licensee of said communications but no later than forty-five (45) days after their issuance. With respect to documents to be filed at competent patent offices within the Territory concerning Licensed Patents, Licensor will use Commercially Reasonable Efforts to notify Licensee but no later than thirty (30) days prior to the filing of such documents to allow for review and comment by Licensee, and Licensor will reasonably consider Licensee’s comments in good faith. Licensor will notify Licensee of any decision not to continue to pay the expenses of prosecution and maintenance of any Licensed Patent within the Territory, which notice must be delivered at least ninety (90) days prior to any payment due date or the relevant action’s due date. Licensee will provide Licensor, at Licensee’s expense, with all reasonable assistance and cooperation in relation to Licensor’s prosecution and maintenance of Licensed Patents in the Territory, including providing any necessary powers of attorney and any other documents or instruments required therefor. Licensor shall have |
| no obligation to continue to prosecute any Licensed Patents in the Territory. If Licensor elects not to prosecute any Licensed Patent in the Territory, Licensor shall notify Licensee of any decision to cease prosecution of any Licensed Patents in the Territory. Licensee shall have the right to continue the prosecution and maintenance of such Licensed Patent in such Region at its own cost. If Licensee undertakes such prosecution and maintenance, (i) Licensor will provide Licensee, with all reasonable assistance and cooperation in relation thereto, including providing any necessary powers of attorney and any other documents or instruments required therefor, and (ii) the expenses of such prosecution and maintenance necessary to preserve the validity of the Licensed Patents in relevant Region shall be borne by Licensee. Such assistance and cooperation by Licensor shall not be unreasonably withheld, delayed or conditioned upon. |
许可方应负责在全球范围（除区域外）对许可专利的申请和维护，并承担全部费用；在区域内，则由被许可方承担全部费用。许可方将尽商业上合理的努力告知被许可方许可专利在区域内的申请和维护的相关事项，并提前充足时间向被许可方提供该等申请和维护相关文件的副本。对于区域内主管专利局发布的有关许可专利的信息，许可方将尽商业上合理的努力但不迟于发布后的四十五（45）天通知被许可方。对于向区域内主管专利局提交的有关许可专利的文件，许可方将尽商业上合理的努力但不迟于提交前三十（30）天通知被许可方，以便被许可方审阅并提出意见，且许可方将基于善意合理考虑被许可方的意见。许可方将通知被许可方关于不再继续支付任何区域内许可专利的申请和维护费用的任何决定，该通知必须在任何付款到期日或相关行动到期日前至少九十（90）天送达被许可方。被许可方在区域内将向许可方提供与许可方申请和维护许可专利有关的所有合理协助和配合，包括提供任何必要的委托书及任何其他所需的文件或文书，相关费用由被许可方承担。许可方没有义务继续申请或推进任何区域内的许可专利的审查程序。如果许可方选择不再推进区域内任何许可专利的申请，许可方应通知被许可方其决定在区域内停止推进该许可专利的申请程序。此被许可方有权自行决定在该地区继续申请和维护该许可专利。如果被许可方进行该等申请和维护，(a)许可方将向被许可方提供与之相关的所有合理协助和配合，包括提供任何必要的委托书及任何其他所需的文件或文书，(b)该等为维持相关地区许可专利的有效性所必需的申请和维护的费用应由被许可方承担，许可方不得无理拒绝、拖延或附加条件地提供此类协助与配合。
| (b) | Licensee shall be solely responsible for the prosecution, maintenance, defense, and enforcement against infringement of Arising Product IP in the Territory and Licensor shall be solely responsible for the prosecution, maintenance, defense, and enforcement against infringement of Arising Product IP outside the Territory, provided that, neither Party shall have the right to use and disclose other Party’s Know-How to support applications for Patent Rights of Arising Product IP unless otherwise obtaining prior written consent from the other Party. |
被许可方应自行负责衍生产品知识产权在区域内的申请、维护、抗辩和侵权执行。许可方应自行负责衍生产品知识产权在区域外的申请、维护、抗辩和侵权执行。但条件是任何一方均不得使用和披露另一方的专有技术，以支持衍生产品知识产权的专利权申请，除非获得另一方的事先书面同意。
第三方侵权。
| (a) | Each Party will promptly notify the other of any infringement by a Third Party of any of the Licensed Patents or misappropriation of any Licensed Know-How in the Territory of which it becomes aware, including any filing of an Abbreviated New Drug Application (“ANDA”) in the United States or such similar filing under Applicable Law in jurisdictions in the Territory other than the United States. Each Party shall provide the other Party with all available evidence supporting such infringement, suspected infringement, unauthorized use or misappropriation or suspected unauthorized use or misappropriation (collectively, “Third Party Infringement”). |
一方将立即通知另一方其获悉的第三方在区域内侵犯任何许可专利或盗用任何许可专有技术的任何行为，包括在美国境内提交简化新药上市申请（“简化新药上市申请”）或根据适用法律在美国以外的区域内的司法辖区提交该等类似申请。一方应向另一方提供所有可获得的支持该等侵权、涉嫌侵权、未经授权的使用或盗用或涉嫌未经授权的使用或盗用（合称“第三方侵权”）的证据。
| (b) | As between the Parties, Licensee shall have the right to bring and control any legal action in connection with the Third Party Infringement in the Territory relating to any Licensed Patent at its own expense as it reasonably determines appropriate, and Licensor will have the right (but not the obligation), at its own expense, to be represented in any such action by counsel of its own choice. If Licensee does not bring such legal action within sixty (60) days after its aware of such Third Party Infringement, Licensor shall have the right to bring and control any legal action in connection with such Third Party Infringement in the Territory at its own expense as it reasonably determines appropriate. |
在双方之间，被许可方有权在其合理认为适当的情况下就与任何许可专利相关的区域内的第三方侵权自费提起并控制任何法律诉讼，许可方有权（但无义务）自费由自己选择的律师代理任何该等诉讼。如果被许可方未在知悉该等第三方侵权后的六十(60)日内提起此类法律诉讼，则许可方应有权在其合理认为适当的情况下，自费提起并控制与该第三方侵权有关的区域内的任何法律诉讼。
| (c) | At the request of the Party controlling the Third Party Infringement claim, the other Party will provide assistance in connection therewith, including by executing reasonably appropriate documents, access to such Party’s employees, cooperating reasonably in discovery and joining as a party to the action if required. |
经控制第三方侵权权利主张的一方要求，另一方将提供相关协助，包括签署合理适当的文件，接触该方的员工，合理配合调查取证，以及在必要时作为一方加入诉讼。
| (d) | In connection with any such proceeding, neither Party will enter into any settlement admitting the invalidity of, or otherwise impairing any Party’s rights in, the Licensed IP without the prior written consent of the other Party, which will not be unreasonably withheld or delayed. |
就任何该等程序而言，未经另一方事先书面同意（该等同意不得无理拒给或延迟），一方不得达成承认许可知识产权无效或以其他方式损害任何一方拥有的许可知识产权权利的任何和解。
| (e) | Any recoveries resulting from such an action relating to a Third Party Infringement shall be first applied against payment of each Party’s costs and |
| expenses in connection therewith, and any recoveries in excess of such costs and expenses (i) in the case Licensee is the enforcing Party, shall be deemed Net Sales and subject to the Royalty Payment obligations set forth in Section 8.3 in this Agreement, and (ii) in the case Licensor is the enforcing party, Licensor shall retain all of the recoveries. |
因该等第三方侵权诉讼而获得的任何赔偿，应首先用于支付双方在该等诉讼中产生的各自费用和支出，超过该等费用和支出的部分：(i) 若由被许可方作为执行方，则该部分赔偿应视为净销售额，并需按照本协议第8.3条履行支付许可使用费的义务；(ii) 若由许可方作为执行方，则许可方有权保留全部赔偿款项。
| (f) | Licensor shall have the exclusive right to bring and control any legal action to enforce the Licensed IP against any infringement that is not a Third Party Infringement in the Territory, at its own expense and as it reasonably determines appropriate, and shall have the right to retain all recoveries. |
许可方有权自费并在其合理认为适当的情况下，独家提起并控制任何并非区域内第三方侵权的法律诉讼，并有权保留所有收回的款项。
第三方专利无效权利主张。 如果第三方在任何时间提出一项任何许可专利在区域内无效或以其他方式不可强制执行的权利主张（“无效权利主张”），无论是作为一方根据第9.5款提起的侵权诉讼中的抗辩，还是作为宣告式判决诉讼或世界上任何地方的任何专利局程序（例如多方复审）中的抗辩，第9.5款的规定在细节上作适当修正后将适用于该无效权利主张，如同适用于第三方侵权诉讼。
许可知识产权侵权权利主张的抗辩。受限于第14.1款，如果任何第三方针对一方（或其任何关联方）提出权利主张、要求、诉求、诉讼或程序，声称由或代表被许可方或其任何关联方生产或销售的任何许可产品或者使用或实施许可知识产权侵犯、盗用或违反任何主体在区域内的知识产权（任何该等权利主张、要求、诉求、诉讼或程序称为“侵权权利主张”），首先收到侵权权利主张通知的一方应立即书面通知另一方，在已知的范围内以合理的细节说明事实，并且以下条款应适用：
如果任何该等侵权权利主张单独针对任何一方或共同针对许可方和被许可方，在每种情况下，就许可产品而言，被许可方应控制对该等侵权权利主张的抗辩。双方应平均分担抗辩费用。经被许可方要求，如果适用法律规定，许可方将参加任何该等诉讼，在任何情况下许可方将与被许可方合理地合作。许可方有权就该等侵权权利主张与被许可方进行协商，自费参加被许可方作为一方的任何诉讼，并由独立律师代理该等诉讼。如果被许可方选择不进行抗辩或控制抗辩，或未能在上述期限内启动和维持任何此类侵权索赔的抗辩，以使许可方不因任何延迟而受到损害，许可方可进行和控制此类侵权索赔的抗辩，费用和开支由许可方自行承担。
未经许可方书面同意，被许可方无权就任何侵权权利主张达成和解（但前提是，如果和解仅涉及款项支付，且被许可方支付所有该等款项，且该解决不会对许可方在本协议项下的权利和利益造成不利影响或减少，也不会对许可方在本协议项下的任何义务造成任何新的义务或不利影响，则被许可方无需该等同意即可就该诉讼达成和解）。
在该等侵权权利主张未决期间以及在该等侵权权利主张得到解决后，双方应平均分担与该等侵权权利主张相关发生的所有费用（包括诉讼费用、律师费、和解费用），包括损害赔偿，以及由此产生的任何其他款项，但前提是，如果该等侵权权利主张可归于许可知识产权，则许可方应就被许可方及其关联方遭受的任何损失补偿被许可方。
根据第9.7条的规定，被许可方在侵权权利主张中获得的任何赔偿金应首先用于补偿双方的合理成本和费用，然后由控制抗辩的一方保留。如
果被许可方是控制方，受限于本协议第8.3条的许可使用费支付义务，扣除上述费用后的剩余赔偿金应计入净销售额。
Licensor shall have the exclusive right to control the defense of such Infringement Claim outside the Territory, at its own expense and as it reasonably determines appropriate.
许可方有权自费并在其合理认为适当的情况下，控制任何区域外的侵权权利主张的抗辩。
商标。 被许可方有权使用被许可方的相关商标以及被许可方控制并确定在区域内适合许可产品的任何其他商标和商号（“产品标志”）来建立许可产品的品牌，产品标志可能因国家而异或在一国内也有所不同。被许可方将在区域内拥有产品标志的所有权利，并将在被许可方确定合理必要的区域内国家和地区注册和维持产品标志。
发明人报酬义务。 在双方之间，许可方应自行负责向许可专利的具名发明人支付适用法律规定的任何发明奖励和报酬。
保密
保密义务. 受限于本第10条的其他规定，在本协议期限内至协议期限届至后七(7)年，接收方将对一方或其关联方在本协议项下披露的所有保密信息进行保密并以其他方式加以保护。接收方仅可根据本协议项下授予接收方的权利为本协议之目的使用保密信息。受限于本第10条的其他规定，每一方将采用与该接收方保护自己的保密信息相同的方式和措施，对另一方或其关联方的保密信息保密。受限于本第10条的其他规定，接收方仅可为本协议之目的以及为根据本协议承办的事项合理必要的范围内，将另一方的保密信息披露给该方及其关联方的员工、代理人、承包商、顾问和咨询人员以及第三方；但前提是，该等主体有义务以符合本协议的保密规定的方式对保密信息进行保密。
例外情形. 本第10条项下的义务不适用于接收方能够以有效证据证明的任何信息，该等信息：
非因接收方或其关联方违反本协议而在披露时为公众所知或在披露后成为公共领域的一部分；
在披露方或其任何关联方披露前为接收方或其关联方所知或以其他方式掌握；
由有权披露该等信息的第三方在非保密基础上向接收方或其关联方披露，且该第三方未违反向披露方或其任何关联方承担的任何保密义务；或
由或代表接收方或其关联方独立开发（以书面记录为证），且接收方或其关联方未使用、依赖或参考由披露方或其关联方在本协议项下披露的保密信息。
Specific aspects or details of Confidential Information will not be deemed to be within the public domain or in the possession of the recipient Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the recipient Party. Further, any combination of Confidential Information will not be considered in the public domain or in the possession of the recipient Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the recipient Party unless the combination and its principles are in the public domain or in the possession of the recipient Party.
保密信息的具体方面或细节不会仅仅因为保密信息包含在处于公共领域或被接收方掌握的更广泛信息中而被视为处于公共领域或被接收方掌握。此外，保密信息的任何组合不会仅仅因为该等保密信息的个别要素处于公共领域或被接收方掌握而被视为处于公共领域或被接收方掌握，除非该组合及其原理已处于公共领域或被接收方掌握。
授权披露。
| (a) | Except as otherwise required by Applicable Law and/or Regulatory Authorities, neither Party shall issue any press release, trade announcement or make any other public announcement or statement with regard to the transactions contemplated by this Agreement without the other Party’s prior written consent, which shall not be unreasonably withheld or delayed. If either Party is required to disclose this Agreement or other Confidential Information related to this Agreement as required by Applicable Law and/or Regulatory Authorities, the Party obligated to make the disclosure shall provide the other Party a copy of the proposed disclosure. The other Party shall provide comments and proposed redactions within two (2) business days of receiving the proposed disclosure. The Party obligated to make the disclosure shall consider all comments in good faith; make reasonable efforts to minimize such disclosure; and make reasonable efforts to obtain confidential treatment for any Confidential Information it is required to disclose. No press release can be made before the payment of the Development Milestone No. 2 under Section 8.1(a) of this Agreement. |
除适用法律和/或监管机构另有要求外，未经另一方事先书面同意（该等同意不得无理拒给或延迟），任何一方不得就本协议拟议的交易发布任何新闻稿、交易公告或作出任何其他公告或声明。如果根据适用法律或监管机构的要求，任何一方必须披露本协议或与本协议相关的其他保密信息，则有义务披露的一方应向另一方提供一份拟议披露的副本。另一方应在收到拟披露内容后二（2）个工作日内提出意见和编辑建议。有义务披露信息的一方应善意考虑所有意见，做出合理努力尽量减少此类披露，并做出合理努力为其必须披露的任何保密信息获得保密处理。在本协议第8.1款规定的第二个开发里程碑被支付之前，不得发布任何新闻稿。
| (b) | In addition to disclosures permitted pursuant to Sections 10.1 and 10.2, either Party may disclose Confidential Information without notice to or consent from the other Party, belonging to the other Party or its Affiliates, to the extent such disclosure is necessary in the following instances: (i) filing or prosecuting Patent Rights Covering Licensed Products to a patent authority as may be reasonably necessary or useful for purposes of obtaining or enforcing a Patent as permitted by this Agreement, provided that reasonable measures shall be taken to assure confidential treatment of such information; (ii) in connection with Regulatory Filings with Regulatory Authority for Licensed Products; (iii) prosecuting or defending litigation as permitted by this Agreement (in which case, notice and/or consent shall be required as otherwise contemplated in this Agreement); (iv) complying with applicable court orders, governmental regulations, or the inquiries of Regulatory Authorities; (v) in connection with an offering of securities or securities law disclosure requirements if counsel determines that such disclosure is required; (vi) to the extent otherwise necessary or appropriate in connection with exercising the license and other rights granted to it hereunder; (vii) to bona fide potential investors, licensees, licensors, collaborators, lenders and acquirors/acquirees, and to such Party’s consultants and advisors, in connection with a proposed equity or debt financing of such Party, an actual or proposed license, collaboration or similar arrangement, or a proposed acquisition or business combination, so long as such recipients are bound in writing to maintain the confidentiality of such information in accordance with the terms of this Agreement; or (viii) to distributors, so long as such recipients are bound in writing to maintain the confidentiality of such information in accordance with the terms of this Agreement. |
除根据第10.1款和第10.2款允许进行的披露之外，一方可以在下列情况下未经通知另一方或另一方书面同意在必要的范围内披露属于另一方或其关联方的保密信息：(i)在本协议允许的情况下，有权为获得或执行专利之目的，向专利主管机关提交或提起涵盖许可产品的专利权申请（如合理必要或有益），但前提是应采取合理措施确保此类信息的保密处理；(ii)就许可产品的监管申报向监管机构进行披露；(iii)在本协议允许的情况下提起诉讼或进行抗辩（在此情况下，应按照本协议其他相关规定发出通知和/或取得同意）；(iv)遵守适用的法院命令、政府法规或监管机构的质询；(v)如果法律顾问决定需要披露，就证券发行或证券法披露要求进行披露；(vi)在另行需要或适当的范围内，就行使本协议项下授予该方的许可和其他权利进行披露；(vii)就任一方的拟议股权或债务融资、实际或拟议的许可、合作或类似安排或拟议的收购或业务合并，向善意的潜在投资者、被许可方、许可方、合作者、贷款人及收购方/被收购方以及向该方的顾问和咨询人员进行披露，但前提是，该等接收方以书面形式受到约束，根据本协议的条款对该等信息保密；或(viii)向经销商进行披露，但前提是，该等接收方以书面形式受到约束，根据本协议的条款对该等信息保密。
| (c) | If the recipient Party is required to disclose Confidential Information of the disclosing Party by law or in connection with a bona fide legal process, such disclosure will not be a breach of this Agreement; provided that the recipient Party (i) informs the disclosing Party as soon as reasonably practicable of the required disclosure; (ii) limits the disclosure to the required purpose; and (iii) at the disclosing Party’s request and expense, assists in an attempt to object to or limit the required disclosure or to otherwise receive “confidential” or “trade secret” treatment with respect to relevant portions of such disclosure. The disclosing Party shall not be required to complete the requirements outlined in this paragraph if the disclosing Party’s use of the Confidential Information is |
| pursuant to the disclosing Party’s performance obligation(s) contemplated herein. |
如果根据法律或就善意的法律程序而言，接收方被要求对披露方的保密信息进行披露，该等披露不违反本协议；但前提是，接收方(i)在合理可行的情况下尽快通知披露方要求进行的披露；(ii)将披露限制于要求之目的；及(iii)在披露方提出要求和承担费用时，协助尝试反对或限制要求进行的披露或就该等披露的相关部分以其他方式获得“保密”或“商业秘密”处理。披露方依据本协议履行其合同义务而使用机密信息的，无需履行本款规定的相关要求。
学术发表。 未经Amphastar事先书面批准，许可方不得公布或以其他形式公开披露许可产品的开发活动（包括临床试验）计划、进展或成果，如公开口头介绍、原稿或摘要。未经许可方事先书面批准，Amphastar不得公布或以其他形式公开披露许可方的保密信息，如公开口头介绍、原稿或摘要。任何拟进行的该等发表或公开披露均须事先提交另一方审查并获得其书面同意，且双方应本着诚信原则协商解决与作者署名、保密相关的任何问题，之后方可发表
持续性保密义务。 在本协议由于任何原因提前终止时，每一方及其关联方将向另一方立即归还或销毁由另一方披露的任何保密信息，但为存档之目的在保密文档中可能保留的副本除外。
期限和终止
本协议期限.
On a Licensed Product-by-Licensed Product and Region-by-Region basis, upon expiration (but not early termination) of the Royalty Term with respect to a particular Licensed Product in a particular Region, the licenses granted under Section 2.1 (License) shall convert to an exclusive, perpetual, irrevocable, sublicensable (through multiple tiers) and fully-paid up (without prejudice to the payment as listed in Section 8.4) license to Licensee.
在逐个地区和逐个许可产品的基础上，本协议的期限将在生效日开始，除非根据本第11条提前终止，本协议的期限应在区域内所有许可产品的许可期限届满时到期。自生效日起至本协议全部届满之日或提前终止之日止的期限在本协议中称为“本协议期限”。
在逐个地区和逐个许可产品的基础上，在特定地区内针对特定许可产品的许可费期限到期（而非提前终止）的情况下，第2.1条项下授予的许可应转换为一个对被许可方而言排他的、永久的、不可撤销的、可分许可（通过多层分许可）和许可费充分付讫（但第8.4款的付款义务不受此限）的许可。
受限于本协议第12.1款(b)项的要求，如果本协议到期或任何一方根据本第11条的约定终止本协议，且截至终止的生效日许可化合物或许可产品的临床试验仍在进行，双方应善意协商就该临床试验的结束或移交采取的适当措施，且在任何情况下均不得要求发起临床试验的一方违反任何适用法律或关于研究对象治疗的伦理要求。
| 11.2 | Termination by Licensor. In the event Licensee fails to pay undisputed amount due and payable hereunder for a period of ninety (90) days from the due date, Licensor shall have the right, at its sole discretion, (a) to terminate this Agreement in its entirety; or (b) to terminate only the affected Licensed Product(s) on a Licensed Product-by-Licensed Product basis. |
许可方终止权。若被许可方未支付本协议项下到期应付的无争议的款项，且该等逾期超过九十（90）日的，许可方有权自行决定采取以下任一措施：(a) 完整终止本协议；(b)仅针对发生违约的单（多）个许可产品予以终止。
| 11.3 | Termination by Licensee. Unless otherwise provided under this Agreement, Licensee may only terminate this Agreement for cause, in whole or in part, at any time during the Development stage of any Licensed Product, on a Licensed Product-by-Licensed Product and Region-by-Region basis, by providing at least one hundred and eighty (180) days’ prior written notice to Licensor, due to any one of the following reasons: |
被许可方终止权。除非本协议另有明确约定，被许可方仅可在任一许可产品的开发阶段，在逐个许可产品和逐个地区的基础上，提前至少一百八十（180）日向许可方发出书面通知后，基于违约全部或部分终止本协议。该等终止须基于以下任一原因：
| (i) | Efficacy or safety do not meet the regulatory requirement and rejected by FDA; |
疗效或安全性不符合监管要求，并且被FDA拒绝；
| (ii) | In the event the stability (i.e. product shelf life) of the Licensed Products(s) cannot meet the Regulatory Authority requirements after intensive efforts by Licensee, and [***]-month after Licensor’s efforts |
| to provide Licensee with formulation that will meet the Regulatory Authority requirements; |
经被许可方努力改进后，许可产品的稳定性（即药品货架期）仍无法达到监管机构要求，且在许可方努力向被许可方提供符合监管要求的配方改进方案后的 [***] 个月未能解决该问题；
| (iii) | Any other force majeure causes. |
其他不可抗力原因。
| 11.4 | Insolvency. If an Insolvency Event occurs, (a) the Party subject to the Insolvency Event will give immediate (not longer than three (3) business days’) notice to the other Party of such occurrence, and (b) the other Party will have the right to immediately terminate this Agreement by giving written notice to the Party that is subject to the Insolvency Event. In the event that Licensor is the insolvent Party, and Licensee does not elect to terminate this Agreement pursuant to this Section 11.4, Licensee is entitled to, (i) request Licensor to continue to perform this Agreement, and (ii) if Licensor is unable to perform this Agreement or this Agreement is otherwise terminated, Licensee shall have the right to purchase the Licensed IP in its entirety at the fair market value appraised by a Third Party appraisal agency. The Parties hereby acknowledge and agree that, to the extent permitted by Applicable Laws, Licensee shall have the right of first refusal to purchase the Licensed IP under same terms and conditions in the event of any bona fide offers from third parties. To the extent permitted under Applicable Law, Licensor will provide any and all assistance to facilitate Licensee's achievement of the foregoing objectives. |
破产。 如果发生破产事件，(a)发生破产事件的一方将立即（不超过三（3）个工作日）向另一方发出该事件的通知，及(b)另一方有权向发生破产事件的一方发出书面通知立即终止本协议。如果许可方是破产一方，且被许可方未根据本第11.4款选择终止本协议的，则被许可方有权：(i) 要求许可方继续履行本协议；及(ii) 如果许可方无法履行本协议或者本协议被终止的，被许可方有权以第三方评估机构评定的公允市场价值购买许可知识产权。双方特此确认和同意，在适用法律允许的前提下，若存在任何善意第三方要约，被许可方对许可知识产权享有同等条款下的优先购买权。在适用法律允许的范围内，许可方将提供一切必要协助以促成被许可方实现上述目标。
| 11.5 | Termination for Sanctions. Licensee may terminate this Agreement immediately or upon such other date as may be designated by the Licensee in its written notice, if: (a) Licensor is added to any US or non-US sanctions- or export-related restricted party list, including without limitation the US Department of the Treasure Office of Foreign Assets Control's List of Specially Designated Nationals and Blocked Persons and the US Commerce Department Bureau of Industry and Security’s Entity List or Denied Persons List; or (c) the purpose of this Agreement is prohibited or materially limited by any Applicable Laws (including the US BIOSECURE Act and similar legislation, if passed). This Agreement will automatically and immediately terminate without action by either Party if the performance of the Agreement would be in violation of Applicable Laws because of the Licensor’s status under US sanctions laws. Notwithstanding anything to the contrary in this Agreement, neither Party shall have any liability to the other whatsoever for termination of the Agreement pursuant to this Section 11.5 (Termination for Sanctions). |
因制裁终止。出现以下情形时，被许可方有权立即终止本协议，或在书面通知中指定其他终止日期：(a)许可方被列入任何美国或非美国制裁或出口相关的限制方名单，包括但不限于美国财政部外国资产控制办公室特别指定国民与被封锁人员名单、美国商务部工业与安全局实体清单或拒绝交易人员名单；或(b)本协议目的被任何适用法律（包括美国《生物安全法案》及类似立法，如获通过）禁止或受到重大限制。若因许可方受美国制裁法律约束导致履行本协议将违反适用法律，则本协议自动立即终止，无需任何一方采取行动。即使本
协议有任何相反约定，任一方均无需就根据第11.5款（因制裁终止）终止协议向另一方承担任何责任。
| 11.6 | Termination for Patent Challenge. Licensor will have the right to terminate this Agreement in full or in part upon thirty (30) days’ prior written notice to Licensee if Licensee or any of its Affiliates directly challenges in a legal or administrative proceeding the patentability, enforceability or validity of any Licensed Patent or Licensed Know-How (“Challenge”), provided that, if Licensee’s sublicensees participate in a Challenge and Licensee does not terminate its sublicense with such sublicensee upon written notice from Licensor, Licensor shall have the right to terminate this Agreement upon thirty (30) days’ written notice. Notwithstanding the foregoing, none of the following activities shall be a Challenge and Licensor shall not have a right to terminate this Agreement with respect to: (A) any actions undertaken by an Affiliate of Licensee that becomes such an Affiliate as a result of an acquisition and where such new Affiliate was participating in the Challenge prior to such acquisition (provided that such Challenge has been promptly terminated upon written notice to Licensee from Licensor after consummation of such acquisition, but only under the precondition and to the extent that Licensee owns a majority of the voting power necessary to elect a majority of the board of directors of such Affiliate and is able to direct the business decision of terminating the Challenge by such Affiliate); (B) situations where Licensee is to participate in a challenge to the scope, validity or enforceability of, or otherwise oppose, any Licensed Patent pursuant to a subpoena or court order or participates in a proceeding that is initiated by a patent office and not at the instigation of Licensee or its Affiliates. For clarity, this Section 11.6 shall not apply to arguments made by Licensee, its Affiliates or Sublicensees that distinguish the inventions claimed in any Licensed Patents from those claimed in the patents or patent applications controlled by Licensee or its Affiliates or Sublicensees. |
因专利挑战而终止。若被许可方或其任何关联方在法律或行政程序中直接挑战任何许可专利或许可专有技术的专利性、可执行性或有效性（“专利挑战”），许可方有权通过提前三十（30）日书面通知被许可方，终止本协议的全部或部分内容，但前提是，若被许可方的分许可方参与专利挑战，且被许可方在收到许可方书面通知后未终止与该分许可方的授权关系，则许可方有权提前三十（30）日书面通知终止本协议。尽管如此，下列情形不应视为专利挑战，且许可方无权据此终止本协议：(A) 被许可方因并购成为其关联方的实体在并购前已参与的专利挑战行为（但条件是并购完成后该等专利挑战已在许可方书面通知被许可方后立即终止，但前提是被许可方拥有有权委派该关联方的过半数董事的多数投票权并且有权主导该关联方的该等终止专利挑战的业务决策）；(B) 被许可方根据法院传票或命令对许可专利的权利范围、有效性或可执行性提出质疑，或参与由专利局（而非被许可方或其关联方发起）的行政程序。为明确起见，本第11.6条不适用于被许可方、其关联方或分许可方为区分许可专利权利要求与自身控制专利/专利申请的权利要求而提出的主张。
| 11.7 | Termination for Discontinuation of Development or Commercialization Activities. On a Licensed Product-by-Licensed Product basis, if, at any time during the Agreement Term, Licensee does not carry out any Development or Commercialization activities for a Licensed Product for a consecutive period of twelve (12) months, except for any termination, discontinuation or delays attributable to reasons beyond Licensee’s reasonable control, such as, a force majeure or a clinical hold required by any Regulatory Authority, or Licensee waiting for Regulatory Authority response, then Licensor may treat such lack of activity as material breach of this Agreement and exercise the right to terminate such Licensed Product . |
终止开发或商业化活动。在逐个许可产品的基础上，如果在本协议期限内的任何时候，被许可方连续十二(12)个月未对该许可产品进行任何开发或商业化活动，且非因被许可方合理控制范围之外的原因所致的终止或延迟，例如不可抗
力事件或监管机构要求的临床暂停，或被许可方正在等待监管机构答复期间，则许可方可将这种缺乏活动的行为视为严重违反本协议，并行使终止该许可产品的相关协议的权利。
终止的效力
| 12.1 | Effect of Termination. Upon termination of this Agreement: |
终止的效力. 本协议终止后：
| (a) | Licenses. The licenses and other rights granted by a Party to the other Party under the Licensed IP or Cross-license Patents will terminate; |
许可。一方在许可知识产权或交叉许可专利项下授予另一方的许可和其他权利将终止；
| (b) | Clinical Trials. Licensee will responsibly wind-down, in accordance with accepted pharmaceutical industry norms and ethical practices and all legal and regulatory requirements, any on-going clinical trials for which it has responsibility hereunder in which patient dosing has commenced |
临床试验。被许可方应根据公认的制药行业规范与伦理实践，以及所有法律和监管要求，负责、有序地终止其在本协议项下负责的所有已开始给药的正在进行的临床试验；
| (c) | Licensor Material. Except as prohibited by Applicable Law, within thirty (30) days after the effective date of termination (or such later date as Licensor may request), Licensee shall return to Licensor or its designee all quantities of Licensor Materials then in its possession or control in accordance with Licensor’s shipping and delivery instructions; |
许可方材料。除适用法律禁止的情形外，在终止的生效日（或许可方可能要求的较晚日期）后的三十（30）天内，根据许可方的装运和交付指示，被许可方应向许可方或其指定人返还届时占有或控制的全部数量的许可方材料；
| (d) | Sublicense. If any sublicense granted under this Agreement exists as of the effective termination of this Agreement, then a termination of this Agreement will automatically terminate any sublicense granted by Licensee pursuant to Section 2.2, unless (i) such sublicensee is not in breach of such sublicense agreement, and (ii) such sublicensee did not cause such termination of this Agreement, in which case all rights under such sublicense shall be deemed to survive termination as long as sublicensee complies with its obligations thereunder, and provided that in no event will Licensor be obligated to fulfil any of Licensor’s obligations under such sublicense (other than the granting of rights under the Licensed IP). Licensor shall grant a direct license to such sublicensee of any such surviving sublicense, and the sublicensee continue to pay to Licensor the milestones, royalties, Sublicense Transaction Revenue and other payments that would have been due to Licensor under this Agreement based on such sublicensee’s activities had this Agreement not been terminated. [***]; |
分许可。如果本协议项下授予的任何分许可在本协议有效终止时存在，则本协议的终止将自动终止被许可方根据第2.2条授予的任何分许可，但以下情形除外：(i) 该分许可方未违反其分许可协议的约定；且 (ii)该分许可方并未导致本协议的终止。在此情况下，只要该分许可方遵守其
分许可协议项下的义务，该分许可项下的所有权利应视为在协议终止后继续有效，且前提是许可方在任何情况下均无义务履行该分许可协议项下除许可知识产权授权以外的其他义务。许可方应向该分许可方授予一项直接许可，且该分许可方应继续根据其相关活动，向许可方支付本协议项下本应由许可方收取的里程碑付款、许可费、分许可交易收入及其他相关费用，仿如本协议并未终止一般。[***];
| (e) | Return of Confidential Information. At the disclosing Party’s election, the receiving Party shall return or destroy all tangible materials to the extent comprising or containing any Confidential Information of the disclosing Party that are in receiving Party’s or its Affiliates’ possession or control and provide written certification of such destruction, provided that the receiving Party may retain one (1) copy of such Confidential Information for its archives solely to monitor compliance with its obligations herein; |
保密信息归还。根据披露方的选择，接收方应将其本人或其关联方拥有或控制的、构成或包含披露方任何保密信息的所有有形材料予以归还或销毁，并提供书面销毁证明。但前提是：接收方可保留一(1)份该等保密信息用于档案存档，仅用于监督其在本协议项下义务的履行情况；
| (f) | Regulatory Approvals. Subject to Section 12.1(l), upon Licensor’s request, and if allowed by Applicable Law, all Regulatory Approvals and other regulatory filings and communications owned (in whole or in part) or otherwise controlled by Licensee and its Affiliates, and sublicensees (subject to Section 12.1(d)), and all other documents, in all cases specific to the Licensed Product, as such items exist as of the effective date of such termination (including all documents related to completed and ongoing clinical trials) (collectively, the “Transferred Regulatory Materials”) will be assigned to Licensor to the extent practicable (or, if not so assigned, Licensee shall make the benefit of the foregoing reasonably available to Licensor), and Licensee will provide to Licensor a copy of the foregoing and all documents contained in or referenced in any such items, together with the raw and summarized data for any clinical trials; |
监管批准。受限于第12.1(l)条的约定，根据许可方的请求且在适用法律允许的情况下，所有由被许可方及其关联方和分许可方（须遵守第12.1(d)条规定）全部或部分拥有或以其他方式控制的、与许可产品相关的监管批准文件及其他监管申报文件与交流资料，以及截至本协议终止生效之日存在的、与许可产品特定相关的所有其他文件（包括已完成及正在进行的临床试验的所有相关文件，统称为“移交的监管资料”），在可行范围内应转让给许可方（如无法转让，则被许可方应在合理范围内使许可方能够获得上述资料的权益）。此外，被许可方应向许可方提供上述资料及所有包含或引用于其中的文件，并提供所有临床试验的原始数据与汇总数据；
| (g) | Third Party Agreements. Subject to Section 12.1(l), if Licensor so requests, and with the consents by the Third Party, Licensee shall use Commercially Reasonable Efforts to assign to Licensor or any Third Party agreements solely relating to a Licensed Product to which Licensee is a party; |
第三方协议。受限于第12.1(l)条的约定，如许可方提出请求且经第三方同意，被许可方应尽其商业上合理的努力，将其作为一方、且仅与某一许可产品相关的任何第三方协议转让给许可方；
| (h) | Licensed Product Trademarks. Subject to Section 12.1(l), upon Licensor’s request, Licensee will assign (or, if applicable, will cause its Affiliates or sublicensees to assign) to Licensor all of Licensee’s (and such Affiliates’ and |
| sublicensees’) right, title and interest in and to any registered or unregistered trademarks or internet domain names that are specific to the Licensed Product(s); |
许可产品商标。受限于第12.1(l)条的约定，根据许可方的请求，被许可方应将其（或在适用情况下，促使其关联方或分许可方）对任何与许可产品专属相关的注册或未注册商标或互联网域名所享有的全部权利、所有权和权益转让给许可方；
| (i) | Assistance. Subject to Section 12.1(l), Licensee shall use Commercially Reasonable Efforts to provide, at Licensor’s reasonable expense, any other assistance reasonably requested by Licensor for the purpose of allowing Licensor or its designee to proceed expeditiously with the exploitation of Licensed Products in the Territory; and |
协助。受限于第12.1(l)条的约定，被许可方应尽其商业上合理的努力，在许可方合理承担费用的前提下，提供许可方为在区域内加快许可产品的开发利用而合理请求的任何其他协助；
| (j) | Cooperation. Subject to Section 12.1(l), Licensee shall execute all documents and use Commercially Reasonable Efforts to take all such further actions, as may be reasonably requested by Licensor in order to give effect to the foregoing clauses. Licensor shall bear Licensee’s reasonable expense incurred |
合作。受限于第12.1(l)条的约定，被许可方应在许可方的合理要求下，签署所有文件并尽商业上合理的努力采取所有进一步的行动，以使上述条款得到有效执行。许可方应承担被许可方在此过程中的合理费用。
| (k) | Except as set forth in this Section 12.1 and in Section 12.3, the rights and obligations of the Parties hereunder will terminate as of the date of such termination. |
除本第12.1款和第12.3款规定的之外，双方在本协议项下的权利和义务将于该等终止日终止。
| (l) | Notwithstanding anything to the contrary, the Parties agree that the foregoing termination consequences set forth under Section 12.1(f), 12.1(g), 12.1(h), 12.1(i) and 12.1(j) will only apply in the event that this Agreement is terminated in accordance with Section 11.6 or Section 11.7. |
无论是否有相反约定，双方特此同意，第12.1(f)条、第12.1(g)条、第12.1(h)条、第12.1(i)条及第12.1(j)条规定的终止后果，仅在本协议根据第11.6条或第11.7条规定终止时适用。
| 12.2 | Consequences of Termination in Part. Upon any termination of this Agreement by a Party pursuant to Section 11 not in whole, but in part with view to one or more Licensed Products, or one or more Regions, Section 12.1 shall apply accordingly, but solely with view to the terminated Licensed Product or terminated Region (as applicable). |
部分终止的后果。 一方根据第11条终止本协议的任何行为并非全部发生，而是针对一个或多个许可产品或者一个或多个地区部分发生，第12.1款应相应地适用，但仅针对被终止的许可产品或被终止的地区（按适用情形）。
| 12.3 | Survival. Expiration or termination of this Agreement will not relieve the Parties of any obligation accruing prior to such expiration or termination. Without limiting the foregoing, Articles 1, 8, 9, 12, 14 and 15will survive the expiration or termination of this Agreement for any reason. Article 10 (Confidentiality) of this Agreement will survive the termination or expiration of this Agreement for a period of seven (7) years after the effective date of termination or expiration (as the case may be). |
继续有效。 本协议到期或终止不得免除双方在该等到期或终止前产生的任何义务。在不限制上述规定的情况下，第1条、第8条、第9条、第12条、第14条、第15条将在本协议到期或由于任何原因终止后继续有效。本协议第10条（保密）将在本协议终止的生效日或到期（视情况而定）后的七(7)年期内继续有效。
| 12.4 | Termination Not Sole Remedy. Termination is not the sole remedy under this Agreement and, whether or not termination is effected and notwithstanding anything contained in this Agreement to the contrary, all other remedies will remain available except as agreed to otherwise herein. For the avoidance of doubt, nothing in this Agreement shall obligate a Party to terminate this Agreement if the other Party breaches any obligation under this Agreement, and failure to terminate this Agreement shall not prohibit or modify the recovery of damages available to it pursuant to Section 15.5 or at law. |
终止非唯一救济。 终止并非本协议项下的唯一救济，无论终止是否发生，尽管本协议有任何相反的规定，所有其他救济仍可获得，但本协议另行约定的除外。为避免疑义，本协议的任何规定不得使一方有义务在另一方违反本协议项下的任何义务的情况下终止本协议，且未能终止本协议的行为不得禁止或修改该方根据第15.5款或法律可获得的损害赔偿金。
陈述、保证和承诺
| 13.1 | Representations and Warranties by Each Party. Each Party represents and warrants to the other as of the Effective Date that: |
每一方的陈述和保证. 在生效日，一方向另一方陈述并保证：
该方是一家根据成立所在司法辖区的法律正式组建、有效存续且声誉良好的公司；
该方拥有充分的公司权力和权限以签署、交付和履行本协议，并已采取法律和其组织文件规定的所有公司行动以授权本协议的签署和交付以及完成本协议拟议的交易；
本协议构成一份有效且具有约束力的协议，可根据其条款针对该方强制执行，但可强制执行性可能受到对债权人的权利具有一般相关性或影响的破产、欺诈性转让、资不抵债、重组、延期偿还和其他法律以及受到一般衡平法原则和公共政策约束（包括责任限制或免除、竞争法律、处罚和管辖权问题，包括法律冲突）限制的除外；
该方就本协议需要取得的所有政府机构或其他第三方的所有同意、批准和授权均已取得；
签署和交付本协议以及根据本协议需要签署的所有其他文书和文件以及完成本协议拟议的交易目前和将来均不(i)抵触或导致违反该方组织文件的任何规定；(ii)导致违反该方作为一方的任何协议；或(iii)违反任何适用法律；
该方不知悉由任何主体或政府机构提起的质疑或可能质疑本协议有效性的任何诉求、诉讼、质询或调查；
该方以及（据该方实际所知）目前或将来参与开发或生产任何许可化合物或许可产品的该方的任何员工、代理人或分包商均未在《联邦食品、药品和化妆品法案》（《美国法典》第21编第335a章）第306条第(a)款或第(b)款或者中华人民共和国或其他地方的适用法律项下的任何同等或类似规定项下被禁止从业；及
该方或其关联方以及各方的任何现任和前任董事、管理人员、员工和代理人均未违反相关和适用的反贿赂和反腐败法律、法规和国际公约（包括但不限于美国《1977年反海外腐败法》以及中国《中华人民共和国刑法》和《中华人民共和国反不正当竞争法》），为获得任何不当或非法利益之目的，直接或间接地向任何政府官员或代理人提供、给予或承诺提供任何有价馈赠（与金钱价值无关）。
| 13.2 | Additional Representations and Warranties by Licensor. Licensor represents and warrants to Licensee as of the Effective Date that: |
许可方的额外陈述和保证。截至本协议生效日，许可方向被许可方陈述并保证：
| (a) | Exhibit A and Exhibit B set forth a true, complete and correct list of all intellectual properties Controlled by Licensor or its Affiliates as of the Effective Date that claim the composition or method of use of Licensed Compounds; |
附件A和附件B真实、完整且正确地列出了许可方或其关联方截至生效日控制的所有说明许可化合物的构成或使用方法的知识产权；
| (b) | each Person who has or has had any rights in or to any Licensed IP has assigned by virtue of employment or written assignment its entire right, title and interest in and to such Licensed IP to Licensor or its Affiliates; |
过去或现在拥有任何许可知识产权权利的每一主体已经通过雇用或书面转让方式向许可方或其关联方转让该主体拥有的该等许可知识产权的全部权利、权属和权益；
| (c) | Licensor and its Affiliates are the sole and exclusive owners of the entire right, title and interest in, to and under the Licensed IP, free and clear of all liens, encumbrances, security interests, claims, restrictions, licenses, options, or any other third-party rights that would interfere with Licensee’s rights, and have not granted any license or other right under the Licensed IP that is in conflict with the license hereunder or prejudices Amphastar’s rights granted hereunder; Licensor has procured all of its Affiliates to have exclusively licensed or assigned to Licensor all of their right, title, and interest in and to the Licensed IP as of the Effective Date hereof (if necessary); |
许可方及其关联方是许可知识产权的全部权利、权属和权益的唯一和独家所有人，不附带所有留置权、权利负担、担保权益、权利主张、限制、许可、选择权或会妨碍被许可方权利的任何其他第三方权利，并且未授予与本协议项下的许可相冲突或损害在本协议项下授予的Amphastar权利的许可知识产权项下的任何许可或其他权利；许可方已促使其所有关联方向许可方排他性地许可或转让其关联方截至本协议的生效日拥有的许可知识产权的全部权利、权属和权益（如有必要）；
| (d) | each of the Licensed Patents properly identifies each and every inventor of the claims thereof as determined in accordance with the Applicable Laws of the jurisdiction in which such Licensed Patent is issued or patent application is pending; provided, however, that if a Licensed Patent does not properly identify each and every inventor in accordance with the foregoing, Licensor shall be responsible for correcting the inventorship of such Licensed Patent at its sole cost and expense; |
每项许可专利均适当标明根据颁发该许可专利或专利申请待批的司法辖区的适用法律确定的该许可专利的权利要求的每一发明人；但前提是，如果一项许可专利并未根据上述规定适当标明每一发明人，许可方应负责自费纠正该许可专利的发明人身份；
| (e) | Licensor has filed and prosecuted patent applications within the Licensed Patents in good faith and complied with all duties of disclosure with respect thereto; |
许可方已善意地提交并提起许可专利内的专利申请，并已遵守与之相关的披露义务；
据许可方所知，不存在可能构成许可专利无效或不可强制执行依据的任何事实；
许可方并未提起或参与其声称任何第三方现在或过去侵犯或盗用与许可化合物或许可产品相关的任何许可知识产权的任何程序或权利主张，也未提起或参与已经导致或经合理预期会导致金钱赔偿或许可知识产权的知识产权变更或损害Amphastar对许可化合物或许可产品进行使用和商业化能力的任何其他程序或权利主张；
据许可方所知，不存在由第三方开展的会构成侵犯或盗用许可专利的任何活动（就待批的专利申请，按已获授权的标准进行评估）；
据许可方所知，许可专利的开发过程未复制或侵犯第三方知识产权，且许可方未收到针对许可专利的书面侵权指控，许可方不就其他事项（包括但不限于许可专有技术、候选化合物及概念验证分子）作出任何侵权相关陈述或保证；
许可方并未与第三方签订与在本协议项下授予被许可方的权利相冲突的任何协议，也未采取会阻止许可方授予在本协议项下授予被许可方的权利的任何行动，或会以其他方式与在本协议项下授予被许可方的权利发生重大冲突或对在本协议项下授予被许可方的权利产生重大不利影响的任何行动；
许可方及其关联方已采取合理的预防措施保护许可专有技术的保密性，包括确保许可方及其关联方的所有员工、顾问、代理人和独立承包商就许可专有技术签订具有约束力的书面保密协议。许可方及其关联方的任何员工、顾问、代理人和独立承包商均未违反任何该等协议的条款，也未以其他方式擅自使用或盗用任何许可知识产权。负有竞业禁止义务的许可方及其关联方的任何员工和顾问均未违反任何该等协议的条款，也未以其他方式实施会对许可方在本协议项下授予许可知识产权的任何许可的权利或会对被许可方在本协议项下使用任何许可知识产权的权利产生不利影响的任何行动；及
据许可方所知，许可方及/或其关联方根据本协议向被许可方提供的所有核心信息与核心数据在重大方面均真实、完整、准确、未篡改且不具误导性；且许可方及其关联方未保留、删除或以其他方式隐瞒被许可方实施本协议项下许可所必需的有关许可知识产权的任何重大信息。
| 13.3 | Covenants of Licensor. Licensor covenants that: |
许可方的承诺。 许可方承诺：
许可方不会授予与本协议的条款不一致或以其他方式相冲突的许可知识产权的任何权益；
如果在本协议签署后的任何时间，许可方获悉其或参与开发或生产许可化合物或许可产品的许可方的任何员工、代理人或分包商被列入或加入美国食药监局排除清单或美国食药监局的任何临床研究人员执行名单，许可方将在获悉该事实后的十（10）个工作日内书面通知被许可方。
许可方理解并同意，即使本协议存在任何其他条款规定，许可方或代表许可方行事的任何实体（包括审计方及许可方合作项目管理人）均不得向Amphastar、其关联方或分许可方要求或接收，且Amphastar、其关联方或分许可方亦无义务提供美国数据安全计划所定义的任何“政府相关数据”或“美国敏感个人数据批量信息”的“访问权限”。许可方同意，在本协议履行过程中不会规避、违反或试图违反美国数据安全计划规定的任何禁令。
| 13.4 | Covenants of Licensee. Licensee covenants that: |
被许可方的承诺。被许可方承诺：
| (a) | Licensee understands and agrees that, notwithstanding any other provision of this Agreement, neither Licensee nor any entity acting on behalf of Licensee, including the Auditor and Licensee’s Alliance Manager, shall request or accept from Licensor, its affiliates or its sublicensees, and |
| Licensor, its affiliates or its sublicensees is not obligated to provide any data in violation of Chinese data security laws and regulations. Licensee agrees to not evade or avoid, cause a violation of, or attempt to violate any of the prohibitions set forth in Chinese data security laws and regulations in connection with this Agreement. |
被许可方理解并同意，即使本协议存在任何其他条款规定，被许可方或代表被许可方行事的任何实体（包括审计方及被许可方合作项目管理人）均不得向许可方、其关联方或分许可方要求或接收，且许可方、其关联方或分许可方亦无义务提供任何违反中国数据安全法律法规的数据。被许可方同意，在本协议履行过程中不会规避、违反或试图违反中国数据安全法律法规。
赔偿；责任
| 14.1 | Indemnification by Licensor. Licensor will indemnify and hold Licensee, its Affiliates, and their respective officers, directors and employees (“Licensee Indemnitees”) harmless from and against any Claims against them to the extent arising or resulting from: |
许可方的赔偿。 许可方将赔偿被许可方、其关联方及其各自的管理人员、董事和员工（“被许可方受偿方”）由下列事项引起或导致的针对被许可方受偿方提出的任何权利主张，并使其免受损害：
| (a) | the breach of any of the obligations, covenants, warranties or representations made by Licensor to Licensee under this Agreement; or |
违反许可方在本协议项下向被许可方作出的任何义务、承诺、保证或陈述；或
| (b) | any activities conducted by Licensor or its Affiliates in the Territory with respect to the Licensed Compound or Licensed Products prior to the Effective Date; |
许可方或其关联方在生效日前在区域内就许可化合物或许可产品开展的任何活动；
provided, however, that Licensor will not be obliged to so indemnify, defend and hold harmless the Licensee Indemnitees for any Claims to the extent Licensee has an obligation to indemnify the Licensor Indemnitees pursuant to Section 14.2 or to the extent that such Claims arise from the breach, negligence or wilful misconduct of Licensee or the Licensee Indemnitees.
但前提是，如果被许可方根据第14.2款有义务赔偿许可方受偿方，或如果任何权利主张是由被许可方或被许可方受偿方的违约、过失或故意不当行为引起，则许可方无义务就该等权利主张赔偿被许可方受偿方，为其抗辩，并使其免受损害。
| 14.2 | Indemnification by Licensee. Licensee will indemnify and hold Licensor, its Affiliates, and their respective officers, directors and employees (“Licensor Indemnitees”) harmless from and against any Claims against them to the extent arising or resulting from: |
被许可方的赔偿。 被许可方将赔偿许可方、其关联方及其各自的管理人员、董事和员工（“许可方受偿方”）由下列事项引起或导致的针对许可方受偿方提出的任何权利主张，并使其免受损害：
| (a) | actions by Licensee, its Affiliates, its sublicensees, and their respective employees, agents and Subcontractors, in connection with the Development, manufacture or Commercialization of any Licensed Compound or Licensed Products by Licensee in the Territory after the Effective Date; or |
被许可方、其关联方、其分许可方及其各自的员工、代理人和分包商就被许可方在生效日后在区域内进行的任何许可化合物或许可产品的开发、生产或商业化活动采取的行动；或
| (b) | the breach of any of the obligations, covenants, warranties or representations made by Licensee to Licensor under this Agreement; |
违反被许可方在本协议项下向许可方作出的任何义务、承诺、保证或陈述；
provided, however, that Licensee will not be obliged to so indemnify, defend and hold harmless the Licensor Indemnitees for any Claims to the extent Licensor has an obligation to indemnify the Licensee Indemnitees pursuant to Section 14.1 or to the extent that such Claims arise from the breach, negligence or wilful misconduct of Licensor or the Licensor Indemnitees.
但前提是，如果许可方根据第14.1款有义务赔偿被许可方受偿方，或如果任何权利主张是由许可方或许可方受偿方的违约、过失或故意不当行为引起，则被许可方无义务就该等权利主张赔偿许可方受偿方，为其抗辩，并使其免受损害。
| 14.3 | Indemnification Procedure. |
赔偿程序。
| (a) | For the avoidance of doubt, all indemnification claims in respect of a Licensee Indemnitee or Licensor Indemnitee will be made solely by Licensee or Licensor, respectively. |
为避免疑义，与被许可方受偿方或许可方受偿方相关的所有赔偿权利主张将由被许可方或许可方单独提出。
| (b) | A Party seeking indemnification hereunder (“Indemnified Party”) will notify the other Party (“Indemnifying Party”) in writing reasonably promptly after the assertion against the Indemnified Party of any Claim or fact in respect of which the Indemnified Party intends to base a claim for indemnification hereunder (“Indemnification Claim Notice”), but the failure or delay to so notify the Indemnifying Party will not relieve the Indemnifying Party of any obligation or liability that it may have to the Indemnified Party, except to the extent that the Indemnifying Party demonstrates that its ability to defend or resolve such Claim is adversely affected thereby. The Indemnification Claim Notice will contain a description of the Claim and the nature and amount of the Claim (to the extent that the nature and amount of such Claim is known at such time). Upon the request of the Indemnifying Party, the Indemnified Party will furnish promptly to the Indemnifying Party copies of all correspondence, communications and official documents (including court documents) received or sent in respect of such Claim. |
寻求本协议项下赔偿的一方（“受偿方”）将在针对受偿方提出任何权利主张或事实（受偿方拟议就该权利主张或事实提出本协议项下的赔偿权利主张）后，合理迅速地书面通知（“赔偿权利主张通知”）另一方（“赔偿方”），但未能或迟延通知赔偿方不会免除赔偿方对受偿方可能承担的任何义务或责任，除非赔偿方证明其抗辩或解决该权利主张的能力因此受到不利影响。赔偿权利主张通知将包含对权利主张的描述以及权利主张的性质和金额（在该权利主张的性质和金额届时已
知的范围内）。经赔偿方要求，受偿方将立即向赔偿方提供就该权利主张收到或发送的所有通信、通讯和官方文件（包括法院文件）的副本。
| (c) | Subject to the provisions of Sections 14.3(d) and 14.3(e), the Indemnifying Party will have the right, upon written notice given to the Indemnified Party within thirty (30) days after receipt of the Indemnification Claim Notice, to assume the defense and handling of such Claim, at the Indemnifying Party’s sole expense, in which case the provisions of Section 14.3(d) will govern. The assumption of the defense of a Claim by the Indemnifying Party will not be construed as acknowledgement that the Indemnifying Party is liable to indemnify any indemnitee in respect of the Claim, nor will it constitute a waiver by the Indemnifying Party of any defenses it may assert against any Indemnified Party’s claim for indemnification. If it is ultimately decided that the Indemnifying Party is not obligated to indemnify or hold an indemnitee harmless from and against the Claim, the Indemnified Party will reimburse the Indemnifying Party for any and all costs and expenses (including attorneys’ fees and costs of suit) and any losses incurred by the Indemnifying Party in its defense of the Claim. If the Indemnifying Party does not give written notice to the Indemnified Party, within thirty (30) days after receipt of the Indemnification Claim Notice, of the Indemnifying Party’s election to assume the defense and handling of such Claim, the provisions of Section 14.3(e) will govern. |
受限于第14.3(d)款和第14.3(e)款的规定，赔偿方有权在收到赔偿权利主张通知后的三十（30）天内，通过向受偿方发出书面通知，承担该权利主张的抗辩和处理，费用由赔偿方自行承担，在该等情况下，第14.3(d)款的规定将适用。赔偿方承担一项权利主张的抗辩不得被解释为确认赔偿方有责任就该权利主张赔偿任何受偿方，也不得构成赔偿方放弃其针对任何受偿方的赔偿权利主张可能提出的任何抗辩。如果最终判决赔偿方无义务就该权利主张赔偿受偿方或使其免受损害，受偿方将偿付赔偿方在对该权利主张进行抗辩的过程中发生的任何和所有费用和支出（包括律师费和诉讼费）以及任何损失。如果赔偿方未在收到赔偿权利主张通知后的三十（30）天内向受偿方发出书面通知，说明赔偿方选择承担该权利主张的抗辩和处理，第14.3(e)款的规定将适用。
| (d) | Upon assumption of the defense of a Claim by the Indemnifying Party: (i) the Indemnifying Party will have the right to and will assume sole control and responsibility for dealing with the Claim; (ii) the Indemnifying Party may, at its own cost, appoint as counsel in connection with conducting the defense and handling of such Claim any law firm or counsel reasonably selected by the Indemnifying Party; (iii) the Indemnifying Party will keep the Indemnified Party informed of the status of such Claim; and (iv) the Indemnifying Party will have the right to settle the Claim on any terms the Indemnifying Party chooses; provided, however, that it will not, without the prior written consent of the Indemnified Party, agree to a settlement of any Claim which will admit any liability or fault by the Indemnified Party, could harm the Indemnified Party’s reputation or goodwill, could lead to liability or create any financial or other obligation on the part of the Indemnified Party for which the Indemnified Party is not entitled to indemnification hereunder or which admits any wrongdoing or responsibility for the claim on behalf of the Indemnified Party. The Indemnified Party will cooperate with the Indemnifying Party and will be entitled to participate in, but not control, the defense of such Claim with its own counsel and at its own expense. In |
| particular, the Indemnified Party will furnish such records, information and testimony, provide witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation will include access during normal business hours by the Indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Claim, and making the Indemnified Party and its employees and agents available on a mutually convenient basis to provide additional information and explanation of any records or information provided. |
在赔偿方承担一项权利主张的抗辩后：(i)赔偿方有权并将独自控制和负责处理该权利主张；(ii)赔偿方可自费聘请赔偿方合理选择的任何律师事务所或法律顾问作为进行该权利主张的抗辩和处理的律师；(iii)赔偿方将随时告知受偿方该权利主张的状况；及(iv)赔偿方有权根据赔偿方选择的任何条款就该权利主张达成和解；但前提是，如果任何权利主张的和解将承认受偿方的责任或过错、可能损害受偿方商誉或声誉、可能导致受偿方承担责任或任何财务或其他义务（而受偿方无权就该等责任或义务获得本协议项下的赔偿），或者该等和解代表受偿方就该权利主张承认任何不当行为或责任，则未经受偿方事先书面同意，赔偿方不得就该权利主张达成和解。受偿方将与赔偿方合作，并有权通过自己的律师自费参与但不控制对该权利主张的抗辩。特别是，受偿方将提供合理要求的相关记录、信息和证词，提供证人并参加合理要求的相关会议、调查取证程序、听证、审理和上诉。该等合作将包括赔偿方在正常营业时间内查阅与该权利主张合理相关的记录和信息，以及受偿方合理保留与该权利主张合理相关的记录和信息，并使受偿方及其员工和代理人在相互方便的基础上提供额外信息和对已提供的任何记录或信息的解释。
| (e) | If the Indemnifying Party does not give written notice to the Indemnified Party as set forth in Section 14.3(c) or fails to conduct the defense and handling of any Claim in good faith after having assumed such, the Indemnified Party may, at the Indemnifying Party’s expense, select counsel reasonably acceptable to the Indemnifying Party in connection with conducting the defense and handling of such Claim and defend or handle such Claim in such manner as it may deem appropriate. In such event, the Indemnified Party will keep the Indemnifying Party timely apprised of the status of such Claim and will not settle such Claim without the prior written consent of the Indemnifying Party, which consent will not be unreasonably withheld. If the Indemnified Party defends or handles such Claim, the Indemnifying Party will cooperate with the Indemnified Party, at the Indemnified Party’s request but at no expense to the Indemnified Party, and will be entitled to participate in the defense and handling of such Claim with its own counsel and at its own expense. |
如果赔偿方未根据第14.3(c)款的规定向受偿方发出书面通知，或未能在承担后善意地进行任何权利主张的抗辩和处理，受偿方可以在赔偿方承担费用的情况下就进行该权利主张的抗辩和处理选择赔偿方可合理接受的律师，并以其认为适当的方式对该权利主张进行抗辩或处理。在该等情况下，受偿方将及时告知赔偿方该权利主张的状况，未经赔偿方事先书面同意（该等同意不得无理拒绝），受偿方不得就该权利主张达成和解。如果受偿方对该权利主张进行抗辩或处理，经受偿方要求，赔偿方将与受偿方合作，但不向受偿方收取任何费用，并且赔偿方有权通过自己的律师自费参与对该权利主张的抗辩和处理。
| 14.4 | Mitigation of Loss. Each Indemnified Party will take and will procure that its Affiliates take all such reasonable steps and action as are necessary or as the |
| Indemnifying Party may reasonably require in order to mitigate any Claims (or potential losses or damages) under this Article 14. Nothing in this Agreement will or will be deemed to relieve any Party of any common law or other duty to mitigate any losses incurred by it. |
减轻损失。 每一受偿方将采取并将促使其关联方采取需要的或赔偿方可能合理要求的所有合理措施和行动，以减轻本第14条项下的任何权利主张（或潜在的损失或损害）。本协议的任何规定不得也不得被视为免除任何一方减轻该方遭受的任何损失的任何普通法或其他责任。
| 14.5 | Special, Indirect and Other Losses. NO PARTY NOR ANY OF SUCH PARTY’S AFFILIATES SHALL BE LIABLE IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OR FOR ANY ECONOMIC LOSS OR LOSS OF PROFITS SUFFERED BY THE OTHER PARTY, EXCEPT TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS ARTICLE 14 OR FOR A BREACH OF SECTION 2.1, ARTICLE 9 OR ARTICLE 10. |
特殊、间接和其他损失。 任何一方以及该方的任何关联方均不对另一方遭受的任何特殊、间接、附带、惩罚性或后果性损害或者任何经济损失或利润损失承担合同、侵权、过失、违反法定义务或其他方面的责任，除非该等损害属于根据本第14条项下由一方进行赔偿的第三方索赔的一部分，或源于对第2.1条、第9条或第10条的违反。
一般规定
| 15.1 | Assignment. This Agreement may not be assigned or otherwise transferred (however structured, whether by merger, acquisition, sale of all or substantially all of its assets to which this Agreement relates or otherwise), in whole or in part, nor, except as expressly provided hereunder, may any right or obligation hereunder be assigned or transferred, by either Party without the prior written consent of the other Party; provided, however, that (i) either Party may, without such consent, assign this Agreement and its rights and obligations hereunder, in whole or in part, to any of its Affiliates; provided that the assigning Party shall continue to remain fully responsible for the actions or inactions of such Affiliate, and (ii) either Party may, without such consent, assign this Agreement and its rights and obligations hereunder, to its successor in interest in connection with (x) a Change of Control or (y) a sale of all or substantially all of its assets to which this Agreement relates, or in connection with a merger, acquisition or similar transaction. Written notice of any permitted assignment of this Agreement shall be promptly provided to the non-assigning Party promptly following consummation and any permitted assignee shall assume all rights and obligations of its assignor under this Agreement. Any permitted assignee will assume all obligations of its assignor under this Agreement. Subject to the terms of this Agreement, this Agreement will be binding upon and inure to the benefit of the Parties and their respective successors, heirs and permitted assigns. |
转让。本协议不得被全部或部分转让或以其他方式转移（无论以何种形式，包括通过合并、收购、出售本协议所涉及的全部或实质性资产或其他方式），任何一方亦不得转让或转移本协议项下的任何权利或义务，除非事先获得另一方的书面同意；但前提是：(i) 任一方可在无需获得对方同意的情况下，将本协议及其在本协议项下的权利和义务全部或部分转让给其任何关联方；但
该转让方应继续对该关联方的作为或不作为承担全部责任；并且 (ii) 任一方可在无需获得对方同意的情况下，在以下情形中将本协议及其项下的权利和义务转让给其权益继承人： (x) 控制权变更，或 (y) 出售本协议相关的全部或实质性全部资产，或是基于兼并、收购或类似交易。在完成任何被允许的转让后，转让方应及时向非转让方提供书面通知，且任何被允许的受让方应承担其转让方在本协议项下的所有权利与义务。受限于本协议的条款，本协议将对双方及其各自的继承人、继受人和获准受让人具有约束力，并及于其利益。
| 15.2 | Extension to Affiliates. Each Party will have the right to extend the rights, immunities and obligations granted in this Agreement to one or more of its Affiliates. All applicable terms of this Agreement will apply to any such Affiliate to which this Agreement has been extended to the same extent as such terms apply to Licensee. Licensor and Licensee will remain primarily liable for any acts or omissions of its Affiliates. |
延伸至关联方。 每一方有权将本协议中授予的权利、豁免和义务延伸至其一个或多个关联方。本协议的所有适用条款将适用于本协议已延伸至的任何该等关联方，与该等条款适用于被许可方的范围相同。许可方和被许可方将对其关联方的任何作为或不作为持续承担主要责任。
| 15.3 | Severability. Should one or more provisions of this Agreement become void or unenforceable as a matter of law, then this Agreement will be construed as if such provision were not contained herein and the remainder of this Agreement will be in full force and effect, and the Parties will use their commercially reasonable efforts to substitute for the invalid or unenforceable provision a valid and enforceable provision which conforms as nearly as possible with the original intent of the Parties. |
可分割性。 如果本协议的一项或多项规定作为法律问题无效或不可强制执行，则对本协议进行解释，如同该规定不包含在本协议中，本协议的其余规定将完全有效，且双方将尽其商业上的合理努力以尽可能符合双方最初意图的有效且可强制执行的规定替代该无效或不可强制执行的规定。
| 15.4 | Governing Law and Jurisdiction. This Agreement will be governed by and construed under the laws of Singapore, without giving effect to the conflicts of laws provision thereof. |
适用法律和管辖权. 本协议将受新加坡法律管辖并依其解释，但其法律冲突规定不予实行。
| 15.5 | Dispute Resolution. |
争议解决。
| (a) | In the event of a dispute relating to, arising out of or in any way connected with this Agreement or any term hereof, or the performance by either Party of its obligations hereunder (a “Dispute”), the Parties will refer the Dispute to the Alliance Managers for discussion and resolution. If the Alliance Managers are unable to resolve the Dispute within thirty (30) days after the Dispute is referred to them, either Party may require that the Parties forward the Dispute to the Senior Officers (or designees with similar authority to resolve such Dispute), who will attempt in good faith to resolve the Dispute. If the Senior Officers cannot resolve the Dispute within thirty (30) days after the Dispute is referred to them, either Party will be free to initiate the arbitration proceeding set forth in Section 15.5(b) to resolve the Dispute. |
如果发生由本协议或本协议的任何条款或任何一方对其在本协议项下义务的履行引起或与之相关或以任何方式相关连的争议（“争议”），双方应将该争议提交合作项目管理人讨论解决。如果合作项目管理人无法在该争议提交后的三十（30）天内解决该争议，任何一方可要求双方将该争议提交高级管理人员（或拥有解决该争议类似权限的指定人），高级管理人员将善意地尝试解决该争议。如果高级管理人员无法在该争议提交后的三十（30）天内解决该争议，任何一方将自由启动第15.5(b)款规定的仲裁程序解决该争议。
| (b) | Any unresolved Disputes between the Parties, whether arising before or after termination of this Agreement, will be resolved by final and binding arbitration. Whenever a Party decides to institute arbitration proceedings, it will give written notice to that effect to the other Party. Arbitration will be held by the International Chamber of Commerce (“ICC”) in accordance with the ICC Rules in force when the notice of arbitration is submitted, as may be amended by this Section 15. The seat of arbitration shall be Singapore. The arbitration will be conducted by a panel of three (3) arbitrators appointed in accordance with ICC Rules; provided that each Party will, within fifteen (15) days after the institution of the arbitration proceedings, appoint an arbitrator, and such arbitrators will together, within thirty (30) days, select a third arbitrator as the chair of the arbitration panel, and each arbitrator will have significant experience in the biopharmaceutical industry. If the two initial arbitrators are unable to select a third arbitrator with in such thirty (30) day period, the third arbitrator will be appointed in accordance with the ICC Rules. Decisions of the panel of arbitrators will be final and binding on the Parties. |
双方之间未解决的任何争议，无论是在本协议终止之前还是之后产生，将通过具有约束力的终局仲裁解决。只要一方决定启动仲裁程序，该方将向另一方发出书面通知。仲裁将由国际商会（“国际商会”）根据提交仲裁通知时有效的国际商会规则（以及根据本第15条可能作出的修订）进行。仲裁地点应为新加坡。仲裁将由根据国际商会规则指定的三（3）名仲裁员组成的仲裁庭进行；但前提是，每一方将在仲裁程序启动后的十五（15）天内指定一名仲裁员，该等仲裁员将在三十（30）天内共同选择第三名仲裁员担任仲裁庭主席，且每名仲裁员将
具有丰富的生物制药行业经验。如果最初的两名仲裁员无法在该三十（30）天期间内选择第三名仲裁员，第三名仲裁员将根据国际商会规则指定。仲裁庭的决定将是终局的并对双方具有约束力。
Notwithstanding Section 15.4 and Section 15.5(b) and without prejudice to the Parties’ agreement to submit Disputes to arbitration, (a) either Party has the right to submit any dispute, controversy or claim relating to the scope, validity, enforceability or infringement of any Patent Right Covering the manufacture, use, importation, offer for sale or sale of any Licensed Compound or Licensed Product or of any trademark rights relating to any Licensed Product to a court of competent jurisdiction in the country in which such Patent Right or trademark rights were granted or arose, and (b) either Party whose rights in Confidential Information have been infringed shall have the right to seek from a court of competent jurisdiction an injunction or other similar forms of relief necessary to protect its such rights to the extent permitted by applicable laws in the jurisdiction in question.
尽管有第15.4款和第15.5(b)款的规定，在不影响双方将争议提交仲裁的约定的情况下，(a)任何一方有权将与涵盖任何许可化合物或许可产品的生产、使用、进口、要约销售或销售的任何专利权或与任何许可产品相关的任何商标权的范围、有效性、可强制执行性或侵权相关的任何争议、纠纷或权利主张提交授予或产生该等专利权或商标权所在国家的有管辖权的法院，及(b)保密信息权利已被侵犯的任何一方有权在相关司法辖区的适用法律允许的范围内，向有管辖权的法院寻求保护该等权利需要的禁令或其他类似形式的救济。
| 15.6 | Force Majeure. If either Party is prevented from performing its obligations under this Agreement as a result of any contingency beyond its reasonable control (“Force Majeure”), including any actions of governmental authorities or agencies, war, hostilities between nations, civil commotions, riots, sabotage, energy shortages, fire, floods and acts of nature such as typhoons, hurricanes, earthquakes, or tsunamis, the Party so affected will not be responsible to the other Party for any delay or failure of performance of its obligations hereunder, for so long as Force Majeure prevents such performance. In the event of Force Majeure, the Party immediately affected thereby will give prompt written notice to the other Party specifying the Force Majeure event complained of, and will use diligent efforts to cure such failure or omission as soon as is practicable after the occurrence of the Force Majeure event. Notwithstanding the foregoing, if such Force Majeure induced delay or failure of performance continues for more than ninety (90) days, either Party may terminate this Agreement upon written notice to the other Party without penalty, liability, liquidated damages, termination fees or any other costs incurred as a result of the early termination of this Agreement. |
不可抗力。 如果任何一方由于超出其合理控制的任何意外事件（“不可抗力”）而被阻止履行其在本协议项下的义务，包括政府机构或部门的任何行动、战争、国家之间的敌对行为、民变、暴动、蓄意破坏、能源短缺、火灾、水灾以及台风、飓风、地震或海啸等自然灾害，只要不可抗力阻止受影响的一方延迟履行或未履行其在本协议项下义务，则受影响的一方不会就该等延迟履行或未履行行为对另一方承担责任。如果发生不可抗力，立即受影响的一方将及时向另一方发出书面通知说明不可抗力事件，并将尽勤勉努力在不可抗力事件发生后尽快纠正该等未履行或不履行行为。尽管有上述规定，如果该不可抗力导致的延迟履行或未履行行为的持续期限超过九十（90）天，任何一方可以向另一方发出书面通知终止本协议，且无需承担任何违约金、赔偿责任、损害赔偿、终止费用或因本协议提前终止而产生的其他任何费用。
| 15.7 | Waivers and Amendments. The failure of any Party to assert a right hereunder or to insist upon compliance with any particular term of this Agreement will not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term by the other Party. No waiver will be effective unless it has been given in writing and signed by the Party giving such waiver. No provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives of each Party. |
放弃和修订。 任何一方未主张本协议项下的权利或未坚持对本协议的任何特定条款的遵守不得构成对该权利的放弃或对另一方以后类似未履行任何该等条款的免责。任何放弃除非以书面形式作出并由放弃一方签署方可生效。本协议的任何规定不得进行修订或修改，但由每一方的授权代表签署书面文件的除外。
| 15.8 | Relationship of the Parties. Nothing contained in this Agreement will be deemed to constitute a partnership, joint venture, or legal entity of any type between Licensor and Licensee, or to constitute one as the agent of the other. Moreover, each Party will not construe this Agreement, or any of the transactions contemplated hereby, as a partnership for any tax purposes. Each Party will act solely as an independent contractor, and nothing in this Agreement will be construed to give any Party the power or authority to act for, bind, or commit the other. |
双方的关系。 本协议的任何规定不得被视为构成许可方和被许可方之间的合伙、合资或任何类型的法律实体，也不得被视为构成一方作为另一方的代理人。此外，每一方不得为任何税务目的将本协议或本协议拟议的任何交易解释为合伙关系。每一方将仅作为独立的承包商行事，本协议的任何规定不得被解释为授予任何一方代表另一方行事、约束另一方或使另一方作出承诺的权力或权限。
| 15.9 | Non-Solicitation. Each Party agrees that during the Licensing Term and for twelve (12) months thereafter, each Party will not, either directly or through others, solicit or encourage or attempt to solicit or encourage any employee or consultant of the other Party to terminate his or her relationship with such Party in order to become an employee, consultant or independent contractor to or for any other person or entity. |
不招揽。双方同意，在许可期限内及其后十二 (12) 个月内，一方不得直接或通过他人招揽或鼓励或试图招揽或鼓励另一方的任何雇员或顾问终止与该方的关系，以成为任何其他个人或实体的雇员、顾问或独立承包商。
| 15.10 | Notices. All notices, consents, waivers, and other communications under this Agreement must be in writing and will be deemed to have been duly given when: (a) delivered by hand (with written confirmation of receipt); (b) received by the addressee, if sent by an internationally recognized overnight delivery service (receipt requested); or (c) immediately upon electronic delivery with receipt for confirmation of delivery, in each case to the appropriate addresses set forth below (or to such other addresses as a Party may designate by notice): |
通知。 本协议项下的所有通知、同意、放弃及其他通讯必须以书面形式作出，(a)在专人递送（书面确认收到）时将被视为已正式送达；(b)如果通过国际认可的次日递送服务（索要收据）发送，在收件人收到时将被视为已正式送达；或(c)通过电子方式交付并取得送达回执确认后立即视为送达。在每种情况下，送达至下列适当地址（或一方通过通知可能指定的其他地址）：
If to Licensee:
致被许可方：
Amphastar Pharmaceuticals, Inc.
Address: 11570 Sixth Street
Rancho Cucamonga, CA 91730
U.S.A.
Attn: [***]
Email: [***]
With a copy to:
Legal Department
Email: [***]
Amphastar Pharmaceuticals, Inc.
地址：11570 Sixth Street
Rancho Cucamonga, CA 91730
U.S.A.
收件人：[***]
电子邮件： [***]
抄送：法律部
电子邮件：[***]
If to Licensor:
致许可方：
Nanjing Anji Biotechnology Co., Ltd.
Address: [***]
Attn: [***]
Phone: [***]
Email: [***]
With a copy to: [***]
南京安吉生物科技有限公司
地址：[***]
收件人：[***]
电话：[***]
电子邮件：[***]
抄送：[***]
| 15.11 | Further Assurances. Licensee and Licensor will execute, acknowledge and deliver any and all such other documents and take any such other action as may be reasonably necessary to carry out the intent and purposes of this Agreement. |
进一步保证。 被许可方和许可方将签署、确认并交付实现本协议意图和目的合理需要的任何及所有其他文件，并采取实现本协议意图和目的合理需要的其他行动。
| 15.12 | Compliance with Law. Each Party will perform its obligations under this Agreement in accordance with all Applicable Laws. No Party will, or will be required to, undertake any activity under or in connection with this Agreement |
| which violates, or which it believes, in good faith, may violate, any Applicable Law. To the extent that registration or record-filing of this Agreement with a governmental authority is required under the Technology Import and Export Administrative Regulations of the People’s Republic of China in respect of any of the licenses granted or envisaged hereunder, Licensor shall take necessary steps to register or record-file a redacted version of this Agreement or a summary thereof, using reasonable efforts to seek confidential treatment for the terms of this Agreement or all other Confidential Information, with the relevant governmental authority in consultation with Licensee. |
遵守法律。 每一方将根据所有适用法律履行其在本协议项下的义务。任何一方不得且不得被要求从事本协议项下或与本协议相关的违反或（该方善意认为）可能违反任何适用法律的任何活动。如果《中华人民共和国技术进出口管理条例》就本协议项下授予或拟议的任何许可规定在政府机构对本协议进行登记或备案，许可方应采取必要措施，与被许可方协商后，在相关政府机构登记或备案本协议的编辑版本或摘要，尽合理努力寻求对本协议的条款或所有其他保密信息的保密处理。
| 15.13 | No Third Party Beneficiary Rights. The provisions of this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and they will not be construed as conferring any rights to any Third Party (including any third party beneficiary rights). |
无第三方受益权。 本协议的规定仅为双方及其承继方和获准受让方之利益，且不得被解释为授予任何第三方任何权利（包括任何第三方受益权）。
| 15.14 | Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each will be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law. |
累积救济。 本协议中提及的任何救济均不具有排他性，但每项救济将为累积救济，并作为本协议中提及的或法律项下可另行获得的任何其他救济的补充。
| 15.15 | Expenses. Except as otherwise expressly provided in this Agreement, each Party will pay the fees and expenses of its respective lawyers and other experts and all other expenses and costs incurred by such Party incidental to the negotiation, preparation, execution and delivery of this Agreement. |
费用。 除非本协议另有明确规定，每一方将支付各自的律师和其他专家的费用和支出，以及该方与本协议的谈判、准备、签署和交付相关发生的所有其他费用和支出。
| 15.16 | Entire Agreement. This Agreement, together with its Exhibits and schedules, sets forth the entire agreement and understanding of the Parties as to the subject matter hereof and supersedes all proposals, oral or written, and all other prior communications between the Parties with respect to such subject matter. In the event of any conflict between a substantive provision of this Agreement and any Exhibit or schedule hereto, the substantive provisions of this Agreement will prevail. |
完整协议。 本协议及其附件和附录构成双方就本协议主题事项达成的完整协议和谅解，并取代双方先前就该等主题事项达成的所有口头或书面建议书和所有其他通讯。如果本协议的实质性条款与本协议的任何附件或附录发生任何冲突，则以本协议的实质性条款为准。
| 15.17 | Counterparts. This Agreement may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. Signatures provided by facsimile transmission or in Adobe Portable Document Format (.pdf) sent by electronic mail shall be deemed to be original signatures. |
文本。 本协议可签署两份或多份文本，每份文本将被视为原件，但所有文本将共同构成同一份文件。通过传真或以Adobe便携式文档格式（.pdf）通过电子邮件发送的签名应被视为亲笔签名。
| 15.18 | Language. This Agreement is written in English and Chinese with both languages equally binding. |
语言。 本协议以英文和中文书就，且具有相同法律效力。
[SIGNATURE PAGE FOLLOWS]
[下接签字页]
THIS AGREEMENT IS EXECUTED by the authorised representatives of the Parties as of the date first written above.
本协议由双方的授权代表于文首所述日期签署。
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Nanjing Anji Biotechnology Co., Ltd. 南京安吉生物科技有限公司 (seal/公章) |
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Amphastar Pharmaceuticals, Inc. Amphastar Pharmaceuticals, Inc. |
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By/签署: |
/s/Chen Cheng Li |
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By/签署: |
/s/Jacob Liawatidewi |
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Name/姓名: |
Chen Cheng Li |
|
Name/姓名: |
Jacob Liawatidewi |
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Title/职位: |
R&D Director |
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Title/职位: |
EVP Corporate Administration Center |
[Signature page to the License Agreement]
[许可协议签字页]
EXHIBIT A
附件A
LIST OF LICENSED PATENT
许可专利清单
[***]
EXHIBIT B
附件B
LIST OF LICENSED KNOW-HOW
许可专有技术清单
[***]
EXHIBIT C
附件C
LIST OF LICENSOR MATERIALS
许可方材料清单
[***]
EXHIBIT D
附件D
DEVELOPMENT PLAN
开发计划
[***]
EXHIBIT E
附件E
LICENSED COMPOUNDS
许可化合物
[***]
Exhibit 10.2
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS ([***]), HAS BEEN OMITTED PURSUANT TO ITEM 601(B)(10)(IV) OF REGULATION S-K, BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL. IN ADDITION, CERTAIN SCHEDULES (OR SIMILAR ATTACHMENTS) HAVE BEEN OMITTED FROM THIS EXHIBIT PURSUANT TO ITEM 601(A)(5) OF REGULATION S-K.
CONTRACT RESEARCH AGREEMENT
委托开发协议
This Contract Research Agreement (this “Agreement”) is entered into by and between the following parties on September 15, 2025 (the “Effective Date”):
本委托开发协议（“本协议”）由以下双方于2025年 9 月 15 日（“生效日”）签订：
| (1) | 南京汉欣医药科技有限公司，一家根据中国法律正式成立并有效存续的有限责任公司，统一社会信用代码为：[***]（“HX”）；及 |
| (2) | Amphastar Pharmaceuticals, Inc.，一家根据美国特拉华州法律成立并存续的公司（与其关联方合称为“委托方”）。 |
HX and the Customer are sometimes referred to herein collectively as the “Parties” and individually as a “Party”.
HX与委托方在本协议中合称为“双方”，单称为“一方”。
Whereas, the Customer intends to engage HX to research and develop certain active pharmaceutical ingredients based on specifications provided by the Customer, and HX intends to accept such engagement.
鉴于，委托方有意委托HX根据委托方提供的规格研发某些活性药物成分，且HX拟接受该等委托。
Therefore, based on the principle of good faith, the Parties hereby agree as follows:
因此，基于诚实信用的原则，双方特此达成协议如下：
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| 1. | General |
| 1. | 总则 |
| 1.1 | Headings or titles of this Agreement are used solely for convenience and shall be given no effect in the construction or interpretation of this Agreement. |
| 1.1 | 本协议的标题仅为方便查阅而设，不影响对本协议的解读或解释。 |
| 1.2 | Additional agreements necessary to effectuate this Agreement may be executed between the Parties. In the event of conflicting terms, the terms of this Agreement shall prevail. |
| 1.2 | 双方可签署为实现本协议所必需的其他协议。如条款有冲突，以本协议的约定为准。 |
| 1.3 | When used in this Agreement, the following terms shall have the meanings set forth in this section: |
| 1.3 | 本协议中使用的下列术语应具有本条中规定的含义： |
| (a) | “Affiliate” means any person or entity which controls, is controlled by or is under the common control of a Party. As used in this Agreement, “control” means (i) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors, or (ii) in the case of non-corporate entities, the direct or indirect power to manage, direct or cause the direction of the management and policies of the non-corporate entity. |
| (a) | “关联方”指控制一方、受一方控制或共同受一方控制的任何个人或实体。本协议中使用的“控制”指(i)就公司实体而言，直接或间接拥有至少百分之五十（50%）的具有选举董事的投票权的股票或股份，或(ii)就非公司实体而言，直接或间接拥有管理、指导或促使他人指导该非公司实体的管理和政策的权力。 |
| (b) | “Applicable Law” means any international, national, federal, state, provincial, commonwealth, or local government law, statute, rule, requirement, code, regulation, or ordinance that applies to either Party, the Product, services hereunder or this Agreement, where applicable, rules governing distribution practice, manufacturing practice and good laboratory practice, as amended from time-to-time. |
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| (b) | “适用法律”指适用于任一方、产品、本协议项下的服务或本协议的、经不时修订的任何国际、国家、联邦、州、省、联盟或当地政府的法律、法令、规定、要求、法典、法规或条例，以及销售规范、生产规范和实验室管理规范(如适用)。 |
| (c) | “Business Day” means any day other than Saturday, Sunday, and other days on which banks, as required or authorized by Applicable Law, are temporarily closed for business in the PRC, United States of America. |
| (c) | “工作日”指除了周六、周日以及适用法律要求或银行在中国、美国暂停营业的其他日期以外的任何日期。 |
| (d) | “Confidential Information” means technical and business information relating to inventions, proprietary ideas and/or patentable ideas, patent applications, background intellectual property, techniques, scientific knowledge, know-how processes, existing and/or contemplated products and services, software, biological material, schematics, research and development, production, costs, profit and margin information, finances and financial projections, customers, clients, licensees, marketing, and current or future business plans and models, regardless of whether such information is designated as “Confidential Information” at the time of disclosure. The term “Confidential Information” does not include such information which: |
| (d) | “保密信息”指与发明、专有思想和/或可转化为专利思想、专利申请、背景知识产权、技术、科学知识、专有技术、工艺、现有的和/或预期的产品和服务、软件、生物材料、图表、研究和开发、生产、成本、利润和利润率信息、财务和财务预测、顾客、客户、被许可人、营销以及当前或未来的商业计划和模式的技术和商业信息，无论该等信息在披露时是否被指定为“保密信息”。“保密信息”一词不包括下列信息： |
| (i) | is or becomes generally available to the public, other than through the receiving party’s disclosure, |
| (i) | 并非通过接收方的披露而为公众普遍可获得的信息； |
| (ii) | was within the receiving party’s possession prior to it being furnished by or on behalf of the disclosing party, provided that receiving party’s source had no obligation of confidentiality to the disclosing party, |
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| (ii) | 在披露方或其代表提供之前已由接收方掌握的信息，前提是接收方的信息来源对披露方不承担保密义务； |
| (iii) | becomes available to the receiving party on a non-confidential basis from an information provider other than the disclosing party, provided that the information provider did not have a duty of confidentiality to the disclosing party, or |
| (iii) | 接收方从除披露方之外的其他信息提供者处以非保密的方式获得的信息，前提是该信息提供者对披露方不承担保密义务；或 |
| (iv) | is or becomes independently developed by an employee of the receiving party without access to the Confidential Information and without violating any of the receiving party’s obligations under this Agreement, as can be demonstrated by the receiving party’s written records. |
| (iv) | 由接收方的雇员在未接触保密信息且未违反接收方在本协议项下的任何义务的情况下独立开发获得的信息，且有接收方的书面记录作为证明。 |
| (e) | “Force Majeure” means an event beyond the reasonable control of a Party including but not limited to, a breakdown of machinery or equipment, fire, flood, sabotage, shipwreck, embargo, strike, explosion, labor trouble, pandemic and related restrictions, accident, riot, act of governmental authority (including without limitation, acts relating to raw material or product allocation, and government drug files), acts of God, acts of war and delays or failures in obtaining materials, supplies, equipment or transportation. |
| (e) | “不可抗力”指超出一方合理控制范围的事件，包括但不限于机器或设备故障、火灾、水灾、蓄意破坏、海难、禁运、罢工、爆炸、劳资纠纷、流行病和相关限制、事故、暴动、政府部门的行为（包括但不限于与原材料或产品分配有关的行为以及政府药品备案）、天灾、战争以及材料、供给品、设备或运输的延迟或损坏。 |
| (f) | [***] |
| (f) | [***] |
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| (g) | “Know-How” means confidential and proprietary information, technology regarding development and Manufacturing of the RCB, which shall include engineering, scientific and practical information and formula, research data, design, and procedures and others to develop and Manufacture the RCB, in use or developed by HX, in sufficient detail that enables the Customer to Manufacture the Product in its facility. |
| (g) | “专有技术”指与RCB的开发和制造有关的保密和专有信息和技术，该等信息和技术应包括由HX使用或开发的用于开发和制造RCB的工程、科学和实用信息、配方、研究数据、设计、程序及其他技术，且该等信息和技术足够详细，使委托方能够在其设施中制造产品。 |
| (h) | “Licensed Technology” means all present and further intellectual property rights (including but not limited to patents and/or patent applications) held by HX, to practice HX’s process, procedures, or plan to the extent necessary or useful to Manufacture, use, promote, market, sell, sub-license or distribute the RCB and/or the Product. |
| (h) | “许可技术”指HX持有的、用以实施在制造、使用、推广、营销、销售、再许可或分销RCB和/或产品时所必要或有用的流程、程序或计划的所有现有和进一步的知识产权权利（包括但不限于专利和/或专利申请）。 |
| (i) | “Manufacture” and “Manufacturing” means any steps, processes and activities necessary to produce any product, including without limitation, the manufacturing, processing, quality control testing, release and storage of any product; specifically with respect to the Product, “Manufacture” and “Manufacturing” shall include any steps, processes and activities necessary to produce any Product from the RCB. |
| (i) | “制造”指生产任何产品所需的任何步骤、工序和活动，包括但不限于任何产品的制造、加工、质量监控检测、发布和存储；就产品而言，“制造”应包括从RCB开始生产任何产品所需的任何步骤、工序和活动。 |
| (j) | “PRC” means the People’s Republic of China (for the purpose of this Agreement, excluding Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan). |
| (j) | “中国”指中华人民共和国(为本协议之目的，不包括香港特别行政区、澳门特别行政区和台湾)。 |
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| (k) | “Product” means peptide with the primary structure [***], that meets the Specifications, whether in the active pharmaceutical ingredient form or finished pharmaceutical product form. |
| (k) | “产品”指一级结构为 [***]，且符合规格（包括参考产品的规格）的重组多肽，无论为活性药物成分形式或药物成品形式。 |
| (l) | “Scope of Work” means the work that HX shall perform for the Customer to research and develop the RCB and to Manufacture the Product, as provided in Appendix A. |
| (l) | “工作范围”指本协议附件A中规定的、HX应为委托方研发RCB和制造产品而开展的工作。 |
| (m) | “Specifications” means the specifications set forth in Appendix B hereof. The specifications may be adjusted from time to time by mutual written consent of the Parties. |
| (m) | “规格”指本协议附件B中列明的规格，可经由双方共同书面同意不时调整。 |
| (n) | “Technology Transfer Commencement Date” shall mean the date agreed upon by the Parties, on which HX commences the transfer of technology to Customer. The commencement date shall be no later than six (6) months after the Effective Date. |
| (n) | “技术转让起始日”指双方约定的、HX向委托方开始进行技术转让之日，该起始日应不迟于生效日后（6）个月。 |
| (o) | “Term” means the period during which this Agreement is in effect as set forth in section 7. |
| (o) | “协议期限”指本协议第7条中所约定的本协议的生效期限。 |
| (p) | “Territory” means all countries, worldwide, without any restrictions. |
| (p) | “区域”指世界范围内的所有国家，不受任何限制。 |
| 2. | Provision of Services |
| 2. | 提供服务 |
| 2.1 | HX shall provide services to the Customer in accordance with the Scope of Work. HX shall use its professional judgment, ability, skill and due diligence to perform services and relevant obligations under this Agreement and the Scope of Work to the best of its ability with the professionalism not lower than that of professional institutions providing similar services in the industry. |
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| 2.1 | HX应根据工作范围向委托方提供服务。HX应运用其专业判断、能力、技巧和勤勉，以不低于行业内提供类似服务的专业机构的专业水准，尽其所能地履行本协议和工作范围项下之服务及相关义务。 |
| 2.2 | HX shall keep the Customer informed of the progress of development and research set forth in the Scope of Work, and shall provide the Customer with written reports at least once per month, within ten (10) Business Days of the start of the succeeding month or at any other time the Customer may direct, unless otherwise expressed in the Scope of Work. Matters to be included in such reports shall be from designated by the Customer from time to time. |
| 2.2 | HX应使委托方知悉服务范围内列明的研发进程，并应至少每月、在下一个月开始后十（10）个工作日内或在委托方可能指示的任何其他时间内向委托方提供书面报告，除非工作范围另有规定。该等报告所包含的事项应由委托方不时指定。 |
| 2.3 | In the event that HX expects or foresees any delay of the schedule in performing its obligations under this Agreement or the Scope of Work, HX shall immediately notify the Customer of such expectation or foreseeing and reasons thereof in writing, and follow the instructions given by the Customer. Delay of part or all of the services for more than sixty (60) Business Days shall be deemed as a material breach of this Agreement. |
| 2.3 | 如果HX预期或预见其履行本协议或任何工作范围项下义务的时间表将发生任何延迟，HX应立即书面通知委托方该等预期或预见及其原因，并遵循委托方作出的指示。服务的部分或全部延迟超过六十（60）个工作日应视为对本协议的重大违反。 |
| 2.4 | HX and the Customer agree that any change to the details of the Scope of Work or the assumptions upon which such Scope of Work is based may require changes to budget, estimated timelines, or payment schedule. HX shall perform the change as instructed or requested by the Customer. Any such required changes shall be reflected as a written amendment to the Scope of Work. |
| 2.4 | HX和委托方同意，对工作范围的细节或该等工作范围所依据的假设作出的任何变更可能需要对预算、预计时限或付款时间表作出变更。HX应按照委托方的指示或要求执行该等变更。任何该等变更应以对工作范围的书面修订的方式呈现。 |
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| 3. | Technology Transfer |
| 3. | 技术转让 |
| 3.1 | Transfer of the Know-How. All the Know-How researched and developed by HX in conducting any work or providing any service for the Customer hereunder, whether or not patentable, shall be owned and/or controlled exclusively by the Customer and HX shall acquire no rights or interests whatsoever in or to any such Know-How. During the continuance of this Agreement and thereafter, HX shall not take, or permit any other person, firm, corporation or other entity to take, any action that may limit or impair the Customer’s sole ownership of all rights, title and interests in and to any or all of the Know-How. HX shall furnish to the Customer in print and electronic format a copy of the Know-How as provided in Appendix C, as of the Technology Transfer Commencement Date and promptly and expeditiously transfer such Know-How to the Customer on such date. HX shall be responsible for obtaining all licenses, permits, authorizations and approvals and making all filings, notifications and reports to all government authorities that are necessary or appropriate for such transfer of the Know-How. For the avoidance of doubt, HX will file the technology exportation filing with the local branch of the PRC Ministry of Commerce. |
| 3.1 | 转让专有技术. HX在本协议项下为委托方开展任何工作或提供任何服务的过程中研发的所有专有技术（无论是否可申请专利）均应由委托方独家拥有和/或控制，HX不得取得蕴含于任何该等专有技术之中或针对任何该等专有技术的任何权利或权益。在本协议的存续期间及之后，HX不得采取，或允许任何其他人、企业、公司或其他实体采取任何可能限制或损害委托方对蕴含于任何及所有专有技术之中的或针对任何或所有专有技术的所有权利、所有权和利益的独家所有权的任何行动。HX应于技术转让起始日以书面和电子形式向委托方提供附件C中约定的专有技术副本，并于技术转让起始日立即向委托方转让该等专有技术。HX应负责获得转让该等专有技术所必需或适宜的所有证照、许可、授权和批准，并完成向政府部门作出转让该等专有技术所必需或适宜的所有备案、通知和报告。为避免疑义，汉欣将向中国商务部的地方分支机构进行技术出口备案。 |
| 3.2 | Provision of the Research Cell Banks. Title to the Research Cell Banks developed, prepared and produced by HX in conducting research and development pursuant to this Agreement shall reside with the Customer. Immediately after completion of the transfer of the Know-How as set forth herein (or such earlier time agreed to by the Parties), HX shall promptly and expeditiously provide the Customer with the Research Cell Banks in sufficient quantities as provided in Appendix A for |
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| the Customer to Manufacture the Product. HX shall be responsible for obtaining all licenses, permits, authorizations and approvals and making all filings, notifications and reports to all government authorities that are necessary or appropriate for such provision of the Research Cell Banks, including but not limited to the approval for border crossing of special goods issued by competent customs. |
| 3.2 | 提供研究细胞库. HX根据本协议进行研发过程中开发、制备并生产的研究细胞库的所有权应归委托方所有。在紧接本协议约定的专有技术转让完成后（或双方同意的更早期限），HX应及时、迅速地向委托方提供如附件A所示数量充足的研究细胞库，以供委托方制造产品。HX应负责获得就提供该等研究细胞库的所必需或适宜的所有证照、许可、授权和批准，并就向委托方提供该等研究细胞库完成向政府部门所必需或适宜的所有备案、通知和报告，包括但不限于主管海关出具的特殊物品进出境审批。 |
| 3.3 | License. Subject to the terms and conditions of this Agreement, HX hereby grants to the Customer a fully paid, exclusive, perpetual, transferable, sub-licensable license in the Territory, in and to all Licensed Technology. |
| 3.3 | 许可. 受限于本协议的条款和条件，HX特此向委托方授予一项对所有许可技术在区域内的对价已完全支付的、排他的、永久的、可转让的、可分许可的许可。 |
| 3.4 | Improved and Derived Technology. Notwithstanding any contrary provisions herein, all intellectual property rights of inventions, designs, copyrights and any other intellectual property rights derived from or any improvements to the Know-How and the Licensed Technology (“Improved and Derived Technology”) shall be the exclusive property of Customer. The Customer will have the right to seek protection, including patents, trademarks, trade secret, copyright, or any other protection the Customer deems necessary, in the Customer’s sole and exclusive discretion, to protect the Improved and Derived Technology. The Customer may offer to HX a non-exclusive license to such Improved and Derived Technology for a price to be determined in the future. HX shall take all actions, and shall execute and deliver to the Customer, or file with appropriate government authorities, all documents and other materials, as reasonably requested by the Customer, in order to permit the Customer (or any third party assignee designated by the Customer) to perfect and protect its ownership of all rights, title and interests in and to the Improved and Derived Technology therein. Except as specifically provided in this Agreement, HX shall not, either during the continuance of this Agreement or thereafter, claim or represent to any other person, firm, corporation or other entity, that HX has any right, title or interest in or to any of Improved |
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| and Derived Technology therein. |
| 3.4 | 改进和衍生技术. 尽管本协议有任何相反约定，在专有技术和许可技术的基础上改进或衍生的发明、设计、版权的所有知识产权及任何其他知识产权（“改进和衍生技术”）应为委托方的专有财产。委托方有权自行决定寻求保护，包括专利、商标、商业秘密、版权或委托方认为必要的任何其他保护，以保护改进和衍生技术。委托方可向HX提供使用该等改进和衍生技术的非排他许可，价格待日后商定。HX应采取委托方合理要求的一切行动，并签署和向委托方交付或向适宜的政府部门提交委托方合理要求的一切文件及其他资料，以使得委托方（或委托方指定的任何第三方受让方）能够完善和保护其对蕴含于本协议项下改进和衍生技术中的和针对本协议项下改进和衍生技术的所有权利、所有权及利益的所有权。除本协议另有特别约定外，HX不得在本协议存续期内或之后，向任何其他人士、公司、企业或其他实体主张或声称HX拥有任何蕴含于本协议项下改进和衍生技术中的或针对本协议项下改进和衍生技术的任何权利、所有权或利益。 |
| 3.5 | Non-Enforcement and Covenant Not To Sue. HX agrees not to, and shall cause its Affiliates not to bring any action against the Customer for infringement or misappropriation of any intellectual property rights in connection with this Agreement used by the Customer in accordance with the terms of this Agreement. |
| 3.5 | 不执行及不起诉承诺. HX同意其不得，并应促使其关联方不得，就侵犯或盗用委托方根据本协议条款使用的与本协议有关的任何知识产权而对委托方提起任何诉讼。 |
| 3.6 | HX shall not, directly or indirectly, manufacture, use, promote, market, sell, license, sub-license or distribute the RCB and/or the Product in the Territory |
| 3.6 | HX不得在区域内直接或间接地制造、使用、推广、营销、销售、许可、再许可或分销RCB和/或产品。 |
| 3.7 | HX shall not, without the Customer’s prior written consent, use the data or information generated or obtained in the performance of this Agreement or any of the Customer’s Confidential Information and intellectual property rights following the completion of service hereunder. |
| 3.7 | 未经委托方事先书面同意，HX不得在本协议项下的服务完成后使用在履行本协议过程中产生或获得的资料或信息或委托方的任何保密信息和知识产权。 |
| 3.8 | HX shall ensure that no third party’s intellectual property right are infringed on throughout the |
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| performance of this Agreement. |
| 3.8 | HX应确保在本协议履行过程中不侵犯任何第三方的知识产权。 |
| 3.9 | The Customer will retain ownership of all its Confidential Information that may be shared with HX during the Term of this Agreement, including retention of any manufacturing and production processes for the Product (and all Know-How of such processes). |
| 3.9 | 委托方将保留在本协议期限内可能与HX共享的所有保密信息的所有权，包括保留产品的任何制造和生产工艺（及该等工艺的所有专有技术）。 |
| 4. | Consultation Service |
| 4. | 咨询服务 |
| 4.1 | Consultative Visit by HX Personnel to the Customer’s Facility. Upon the Customer’s written request, and at a time mutually agreed upon by the Parties, HX shall provide on-site consulting support to the Customer with respect to the Manufacture and validation of the manufacturing process at the Customer’s premises or at the Customer’s manufacturing site. The Customer shall pay HX a reasonable fee for such consultative visit, as mutually agreed in writing by the Parties prior to the consultative visit. |
| 4.1 | HX人员对委托方场地的咨询性访问. 经委托方书面要求且在双方一致同意的时间，HX应在委托方的场所或委托方的生产场地向委托方提供与制造和制造工艺验证相关的现场咨询支持。委托方应向HX支付双方在咨询性访问之前一致书面同意的该等咨询性访问的合理费用。 |
| 5. | Payment |
| 5. | 付款 |
| 5.1 | The Customer shall make the following payments to HX with respect to HX’s performance of the Scope of Works |
| 5.1 | 就HX对工作范围的履行而言，委托方应向HX支付下列款项： |
| (a) | The Customer shall pay HX CNY __2,000,767___ as of the Effective Date; |
| (a) | 委托方应于生效日向HX支付人民币__2,000,767___元； |
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| HX shall submit to the Customer an invoice and provide the Customer with all evidential documents related to the payment at the end of each calendar quarter, and the Customer shall make payment within thirty (30) days after receipt of such invoice and inspection of all relevant evidential documents; provided however that, if the Customer disagrees with any part of the invoice, the Customer will notify HX in writing, noting its objection to the disputed item(s) with specificity within ten (10) Business Days upon receipt of the invoice and evidential documents, and pay the undisputed portion in accordance with the aforementioned period, and the Parties shall discuss and agree in good faith the remaining unpaid amount as soon as possible. The non-payment of any items disputed in good faith hereunder shall not constitute a breach of this Agreement, and HX shall not suspend the performance of services due to such non-payment. |
| (b) | HX应在每个公历季度末向委托方提交发票，并向委托方提供与付款相关的所有证明文件，委托方应在收悉该等发票并验证所有相关证明文件之日起三十（30）日内付款；如委托方对发票的任何部分有异议，委托方将在收到发票和证明文件后的十（10）个工作日内书面通知HX，指明其对争议事项的具体异议，并根据前述期限支付无争议部分的款项，双方应尽快善意讨论剩余未付金额并就此达成一致。根据本条对于任何善意争议款项的不予支付不应构成委托方对本协议的违反，且HX不得因该等未支付行为而中止提供服务。 |
| (c) | Total payment made from the Customer to HX shall not exceed CNY 20,007,666.42 (Payment from Customer to HX will be adjusted from CNY to USD, based on actual currency exchange rate as reported by the Bloomberg Currency Spot Exchange Rate the date of which the invoice is issued by HX). |
| (c) | 委托方向HX支付的总金额不得超过人民币20,007,666.42元（委托方向HX支付的款项将从人民币调整为美元，以HX发票开具之日公布的彭博货币即期汇率的实际货币兑换率计算）。 |
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| (d) | Any additional work or changes to the Scope of Work that the Customer is requesting from HX will be charged by HX to the Customer in the amount equal to the sum of (i) HX’s direct costs for such additional work, plus (ii) [***]% of the amount of such direct costs plus any applicable taxes. Any additional cost must be provided to Customer for approval prior to the work being performed. |
| (d) | 委托方要求HX进行的任何额外工作或对工作范围的变更将由HX向委托方收取金额相当于如下各项之和的款项：(i)HX开展该等额外工作的直接支出，加上(ii)该等直接支出的[***]%再加上任何适用的税款。任何额外费用必须在开展工作前提供予委托方供批准。 |
| 6. | Regulatory Matters |
| 6. | 监管事项 |
| 6.1 | The Customer is responsible for filing and obtaining any marketing authorization that is required for the marketing and sale of the Product. HX shall reasonably cooperate with the Customer in requests related to such activities. |
| 6.1 | 委托方负责申请并取得上市和销售产品所需的任何上市许可。HX应合理地配合委托方提出的与该等活动相关的要求。 |
| 6.2 | HX shall obtain, and maintain in full force and effect throughout the Term of this Agreement, all licenses, permits, authorizations and approvals required under all Applicable Laws, regulations and government orders, and shall make all filings, notifications and reports to all government agencies that are necessary or appropriate for the performance by HX of all of its obligations under this Agreement. If any approval, license or permit received by HX is conditioned upon any modification or amendment to this Agreement that is unacceptable to the Customer, the Customer shall have the right to terminate this Agreement with immediate effect without any further obligations whatsoever hereunder to HX. HX shall comply with all applicable industry standards, including industry regulations, operation specifications and procedures, code of conduct, etc. during the performance of this Agreement. HX shall not, through any form of act or omission, violate any applicable industry standards. |
| 6.2 | HX应取得所有适用法律、法规和政府命令项下要求的一切证照、许可、授权和批准，并在本协议期限内保持该等证照、许可、授权和批准始终完全有效，同时应向所有政府部门进行对HX履行其在本协议项下所有义务所必需或适宜的所有备案、通知和报告。如果 |
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| HX取得的任何批准、证照或许可系以对本协议的变更或修订为前提，且该等变更或修订令委托方无法接受，则委托方有权立即终止本协议，而无须在本协议项下对HX承担任何进一步义务。在履行本协议的期间，HX应遵守所有适用的行业标准，包括行业法规、操作规范和程序、行为准则等。HX不得通过任何形式的作为或不作为违反任何适用的行业标准。 |
| 7. | Term, Amendment and Termination |
| 7. | 协议期限、变更和终止 |
| 7.1 | This Agreement will remain in full force and effect for a period of three (3) years from the Effective Date. |
| 7.1 | 本协议将自生效日起三（3）年内保持完全有效。 |
| 7.2 | During the Term, due to changes in laws and regulations, Specifications, Manufacturing procedures or other substantive conditions, this Agreement may be amended by the mutual written consent of the Parties. Any Amendment to this Agreement and its appendices hereto shall come into force with an instrument in writing signed by the Parties. |
| 7.2 | 于协议期限内，因法律法规、规格、生产规程或其他实质性条件发生变化，本协议可经双方共同书面同意予以修订。对本协议及其附件的任何修订，须经双方签署书面协议方能生效。 |
| 7.3 | Unless otherwise provided for herein, either Party (the “Terminating Party”) may immediately terminate this Agreement by notifying the other Party (the “Terminated Party”) in writing when one of the following situations occurs: |
| 7.3 | 除本协议另有规定外，任一方（“终止方”）可在出现下述情形之一时书面通知另一方（“被终止方”）立即终止本协议： |
| (a) | The Terminated Party breaches this Agreement and (i) does not rectify its default within thirty (30) days on the date of receiving written notice from the Terminating Party requiring for rectification; or (ii) there is no realistic possibility to rectify such default; or (iii) such default has resulted in the inability to achieve the purpose of this Agreement; |
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| (a) | 被终止方违反本协议且(i)在收悉终止方书面通知要求其纠正违约行为之日起三十（30）日内未纠正其违约行为的；或(ii)不存在纠正该违约行为的现实可能性；或(iii)该违约导致本协议的目的无法实现； |
| (b) | The Terminated Party suffers a Force Majeure event which makes it impossible to achieve the purpose of this Agreement; |
| (b) | 被终止方遭遇不可抗力事件，致使不能实现本协议的目的； |
| (c) | The Terminated Party expresses clearly or by behavior that it will not perform its obligations hereunder, or delays the performance of its obligations and has not fully performed the obligations after being notified; |
| (c) | 被终止方明确表示或以行为表明其将不履行本协议项下义务，或迟延履行本协议义务且经催告后仍未全面履行的； |
| (d) | The Terminated Party loses the ability to perform its obligations hereunder, including but not limited to, entering bankruptcy proceedings, liquidation proceedings, being dissolved, being winding up, being revoked, or losing appropriate qualifications. |
| (d) | 被终止方丧失履行本协议项下义务的能力，包括但不限于进入破产程序、清算程序、被解散、被注销、被吊销、丧失相应资质。 |
| 7.4 | This Agreement may be terminated by mutual written consent of the Parties. |
| 7.4 | 本协议可经双方共同书面同意而终止。 |
| 7.5 | Termination or expiration of this Agreement shall not relieve either Party of any obligation accruing prior to such termination or expiration, including, without limitation, any breach of such obligation, or from any surviving obligation under this Agreement. |
| 7.5 | 本协议的终止或到期不得免除任何一方在该等终止或届满前已产生的任何义务，包括但不限于对该等义务的任何违反，或本协议项下的任何存续义务。 |
| 7.6 | Either Party shall return or destroy all documents and materials in its possession which contain Confidential Information of the other Party within thirty (30) days after termination or expiration of this Agreement. The receiving party may retain one copy of documents and materials which contain the disclosing party's Confidential Information for the purpose of verifying the receiving |
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| party's compliance with its obligations under this Agreement but for no other purpose whatsoever. |
| 7.6 | 任何一方应在本协议终止或到期后三十（30）日内归还或销毁其持有的包含另一方保密信息的所有文件和材料。接收方可以保留包含披露方保密信息的文件和材料的一份副本，以核实接收方是否遵守其在本协议项下的义务，但不得以任何其他目的。 |
| 7.7 | Unless otherwise provided for herein, after termination or expiration of this Agreement, section 1 (General), this section 7 (Term, Amendment and Termination), section 8 (Warranties), section 9 (Indemnities), section 10 (Confidential Information), section 11 (Force Majeure), section 12 (Notices), section 13 (Binding Effect), section 14 (Governing Law and Dispute Resolution), section 15 (Assignment), section 16 (Severability), section 17 (Entire Agreement), section 18 (Waiver), section 19 (Publicity), section 20 (Appendices), section 21 (Limitation of liability), section 22 (Counterparts and Language) shall survive. |
| 7.7 | 除本协议另有规定外，在本协议终止或到期后，本协议第1条（总则）、本第7条（协议期限、变更和终止）、第8条（保证）、第9条（赔偿）、第10条（保密信息）、第11条（不可抗力）、第12条（通知）、第13条（约束力）、第14条（适用法律和争议解决）、第15条（转让）、第16条（可分割性）、第17条（完整协议）、第18条（弃权）、第19条（宣传）、第20条（附件）、第21条（责任限制）和第22条（副本和语言）应继续有效。 |
| 8. | Warranties |
| 8. | 保证 |
| 8.1 | HX warrants that the RCB delivered to the Customer and pursuant to this Agreement shall at the time of such delivery not be adulterated or misbranded within the meaning of the Applicable Law, and fully meeting the Specifications. HX represents and warrants that it will comply with all present and future Applicable Laws relating to development, manufacture, and supply of the RCB being provided hereunder, including without limitation, those enforced by the United States Food and Drug Administration. |
| 8.1 | HX保证，根据本协议向委托方交付的RCB应在该等交付时不存在适用法律所指的假冒伪劣，且完全符合规格。HX陈述并保证，其将遵守与本协议项下约定的RCB的开发、生产和供应相关的所有现行和未来的适用法律，包括但不限于美国食品和药物管理局执行的适用法律。 |
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| 8.2 | Each party represents and warrants to the other that it is not under any obligation to any person, contractual or otherwise, that is conflicting or inconsistent in any respect with the terms of this Agreement or that would impede the diligent and complete fulfillment of its obligations hereunder. |
| 8.2 | 每一方向另一方陈述并保证，该方不对任何人承担任何与本协议条款在任何方面存在冲突或不一致的，或可能妨碍其勤勉、完全地履行其在本协议项下的义务（无论是合同义务还是其他义务）。 |
| 8.3 | HX represents and warrants that (i) it employs adequate numbers of skilled and experienced research, supervisory, and administrative personnel to perform works hereunder in a safe, competent, and efficient manner; (ii) it will perform works hereunder in a safe, competent, and efficient manner consistent with a high standard of workmanship and good laboratory or plant practices; (iii) it, including its facilities in which works hereunder will be conducted is, and during the Term of this Agreement shall remain, in full compliance with all Applicable Laws and regulations including but not limited to laws and regulations of PRC and of local and regional governments or ministries thereof in respect of environmental, health, safety, labor, import, export, Customs, human genetic resources, etc.; and (iv) all employees, agents, consultants or other personnel who work on the Customer’s projects hereunder, have assigned or otherwise provided all of their respective rights in any technology to HX or to the Customer. |
| 8.3 | HX陈述并保证，(i)HX雇佣了足够数量的熟练且经验丰富的研发、监督和管理人员以安全、称职、高效地开展本协议项下的工作；(ii)HX将采取较高的工艺标准以及良好的实验或生产操作规范以安全、称职、高效地开展本协议项下的工作；(iii)HX（包括其开展本协议项下工作所需的设施）目前且在本协议期限内应始终保持符合所有适用法律法规的规定，包括但不限于中国及地方和地区政府或部委关于环境、卫生、安全、劳动、进口、出口、海关、人类遗传资源等方面的法律和法规；及(iv)就本协议项下的委托方项目开展工作的所有雇员、代理人、顾问或其他人员均已将其对任何技术的一切相应权利转让或以其他方式提供予HX或委托方。 |
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| 9. | Indemnities |
| 9. | 赔偿 |
| 9.1 | Unless arising from the willful misconduct of HX, the Customer will defend, indemnify and hold HX and its Affiliates and their respective employees, servants and agents harmless against any liability, judgment, demand, action, suit, loss, damage, cost or other expense (including reasonable attorneys’ fees and other costs of defense) resulting from: (i) the Customer’s material breach of this Agreement or (ii) the Customer’s breach of any warranty made under this Agreement. |
| 9.1 | 除非因HX故意不当行为引起，当(i)委托方严重违反本协议，或(ii)委托方违反其在本协议项下作出的任何保证，委托方应为HX及HX关联方、HX及其关联方的雇员、服务人员、代理人提供抗辩及赔偿，以使得HX及HX前述主体免受任何责任、判决、要求、行动、诉讼、损失、损害、成本或其他费用支出（包括合理的律师费及其他辩护费用）。 |
| 9.2 | Unless arising from the willful misconduct of the Customer, HX will defend, indemnify and hold the Customer and its respective employees, servants and agents harmless against any liability, judgment, demand, action, suit, loss, damage, cost or other expense (including reasonable attorneys’ fees and other costs of defense) resulting from (i) HX’s gross negligence in the research, development, manufacture, storage or delivery of RCB; (ii) HX’s material breach of this Agreement; or (iii) HX’s breach of any warranty made under this Agreement. |
| 9.2 | 除非因委托方故意不当行为引起，当(i)HX在研发、生产、存储或运输RCB时存在重大过失；(ii)HX严重违反本协议；或(iii)HX违反其在本协议项下作出的任何保证，HX应为委托方及其雇员、服务人员、代理人提供抗辩及赔偿，以使得委托方及委托方前述主体免受任何责任、判决、要求、行为、诉讼、损失、损害或其他费用支出（包括合理的律师费及其他辩护费用）。 |
| 9.3 | Each indemnified party agrees to give the indemnifying party prompt written notice of any matter upon which such indemnified party intends to base a claim for indemnification (an “Indemnity Claim”) under section 9. The indemnifying party will have the right to participate jointly with the indemnified party in the indemnified party’s defense, settlement or other disposition of any Indemnity Claim. With respect to any Indemnity Claim relating solely to the payment of money damages and which could not result in the indemnified party’s becoming subject to injunctive or other equitable relief or otherwise adversely affect the business of the indemnified party in any manner, and as to which the indemnifying party will have acknowledged in writing the obligation |
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| to indemnify the indemnified party hereunder, the indemnifying party will have the sole right to defend, settle or otherwise dispose of such Indemnity Claim, on such terms as the indemnifying party, in its sole discretion, will deem appropriate, provided that the indemnifying party will provide reasonable evidence of its ability to pay any damages claimed and with respect to any such settlement will have obtained the written release of the indemnified party from the Indemnity Claim. The indemnifying party shall apply for a written release from the indemnified party prior to ceasing to defend, settling or otherwise disposing of any Indemnity Claim. If as a result thereof the indemnified party has been subject to injunctive or other equitable relief or the business of the indemnified party has been adversely affected in any matter, the application for exemption will be rejected. |
| 9.3 | 受偿方同意立即书面通知赔偿方，其根据本协议第9条拟提起的赔偿主张（“赔偿主张”）。赔偿方有权参与受偿方对任何赔偿主张进行的辩护、和解或其他方式处理赔偿主张的活动。对于任何仅与经济赔偿有关且不会导致受偿方受限于禁令或其他衡平法救济，也不会以任何形式对受偿方的业务活动产生不利影响的赔偿主张，同时赔偿方已通过书面形式确认了其在本协议项下对受偿方的赔偿义务，则赔偿方拥有以其自行认为合理的方式辩护、和解或以其他方式处理上述赔偿主张的权利，但前提是赔偿方提供合理的证据证明其有能力支付任何被主张的损害赔偿，并且就任何此类和解已获得受偿方的书面免责声明。赔偿方应在辩护、和解或其他处理方式结束之前，向受偿方申请书面免责声明，若受偿方已获得禁令、衡平法救济或其业务活动已受到不利影响，免责申请将被拒绝。 |
| 10. | Confidential Information |
| 10. | 保密信息 |
| 10.1 | The receiving party will treat as confidential and secret all information which has been or may hereafter be disclosed by the disclosing party, directly or indirectly, to the receiving party, either orally, in writing or through inspection. The receiving party shall use the Confidential Information received only to the extent necessary and for the Purpose of this Agreement. The receiving party will not disclose to anyone any Confidential Information received from the disclosing party, and will use the same degree of care, but no less than a reasonable degree of care, to prevent the disclosure of the Confidential Information to others as it uses to prevent the disclosure of its own Confidential Information. Upon request from the disclosing party, the receiving party will promptly return to the disclosing party or destroy all drawings, data, memoranda and information in physical form relating to the Confidential Information. |
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| 10.1 | 接收方应将披露方已经或之后向接收方直接或间接地披露的所有信息视为保密信息进行保密，无论该等披露是通过口头、书面或检查的方式进行。接收方应仅在必要的范围内为本协议的目的使用收悉的保密信息。接收方不得向任何人披露其从披露方处收悉的任何保密信息，并将以接收方防止其自身保密信息披露而采取的相同程度的谨慎（但不得低于合理的谨慎程度）防止该等保密信息披露给他人。经披露方要求后，接收方应立即向披露方归还或销毁与保密信息有关的所有图纸、数据、备忘录和实物形式的信息。 |
| 10.2 | Each Party agrees to keep the Confidential Information confidential, which includes (but is not limited to) not disclosing the disclosing party’s Confidential Information, or any part thereof (except as otherwise may be provided herein), absent the disclosing party’s prior written consent, unless required to do so by Applicable Law, act or a valid order of a court or other governing, regulatory body with authority over the receiving party (“Required Disclosure”); provided that the receiving party will first give reasonable written notice to the disclosing party prior to any Required Disclosure and will exercise its best efforts to obtain an order or other reliable assurance that the Confidential Information disclosed will be treated at the highest level of confidentiality. Upon receipt of notice from the receiving party of any Required Disclosure, the disclosing party may, at the disclosing party’s expense, seek to quash or restrict the disclosure of the disclosing party’s Confidential Information and the receiving party will not oppose or seek to impede the disclosing party’s efforts to obtain such relief. |
| 10.2 | 每一方同意对保密信息予以保密，包括（但不限于）未经披露方事先书面同意，不得披露披露方的保密信息或其任何部分（除非本协议另有规定），除非根据适用法律、法令或对接收方有管辖权的法院或其他管辖、监管机构的有效命令要求披露（“必要披露”），但前提是接收方应在任何必要披露前首先向披露方发出合理的书面通知，且需尽其最大努力获得法令或其他可靠保证以确保所披露的保密信息得到最高级别的保密处理。在收悉接收方发出的任何必要披露的通知时，披露方可在自行承担费用的情况下寻求撤销或限制对披露方保密信息的披露，接收方不得反对或阻碍披露方获得该等救济。 |
| 10.3 | This provision of confidentiality is not intended to grant or transfer any rights to the Confidential Information to the receiving party and does not transfer or convey any rights under a patent, trademark, copyright, or other intellectual property right to or in the Confidential Information. All Confidential Information (including all copies thereof) will at all times remain the property of the disclosing party. Further, and unless otherwise provided in this Agreement, the disclosure of Confidential Information to a receiving party does not create, and is not intended to |
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| create, any form or type of agency by and between the disclosing party and the receiving party. |
| 10.3 | 本保密条款无意向接收方授予或转让任何保密信息的任何权利，也无意转让或让与关于保密信息的专利、商标、版权或其他知识产权项下的任何权利。所有保密信息（包括其所有副本）将始终为披露方所有。此外，除非本协议另有规定，向接收方披露保密信息并不构成也不旨在构成披露方和接收方之间的任何形式或类型的代理关系。 |
| 10.4 | The receiving party agrees that its obligations hereunder are necessary and reasonable to protect the disclosing party, and expressly agrees that monetary damages would be inadequate to compensate the disclosing party for any breach of any covenant or agreement set forth herein and that, in addition to any and all other remedies available at law or in equity, the disclosing party will be entitled to seek equitable relief, including injunction and specific performance, as a remedy for any actual or threatened breach of this Agreement, and no bond or other security will be required in connection with any such equitable relief. In the event of litigation relating to this Agreement, if a court of competent jurisdiction determines that a Party has breached this Agreement, then the non-breaching party may seek recovery of its reasonable legal fees, including any appeal, in addition to any other remedies to which the non-breaching party may be entitled. |
| 10.4 | 接收方同意，其在本协议下的义务对于保护披露方而言是必要和合理的，如违反本协议约定，不仅应赔偿披露方经济损失，除法律或衡平法可获得的任何和所有其他救济之外，披露方将有权寻求衡平法救济，包括禁令和特别履行，并且无需对该等衡平法救济提供任何保函或担保。如发生与本协议有关的诉讼，如果有管辖权的法院判定一方违反了本协议，则守约方有权要求获得合理的律师费（含上诉）及采取其他补救措施。 |
| 11. | Force Majeure |
| 11. | 不可抗力 |
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| 12. | Notices |
| 12. | 通知 |
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If to HX: HX： |
Address: [***] 地址：[***] Attn: General Manager 收件人：总经理 Post Code: [***] 邮编：[***] |
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If to the Customer: 委托方： |
Address: Amphastar Pharmaceuticals, Inc. 11570 Sixth Street Rancho Cucamonga, CA 91730 USA 地址：Amphastar Pharmaceuticals, Inc. 11570 Sixth Street Rancho Cucamonga, CA 91730 |
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USA Attn: Head of Administration Center 收件人：管理中心负责人 |
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| 15. | Assignment |
| 15. | 转让 |
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| 16. | Severability |
| 16. | 可分割性 |
| 17. | Entire Agreement |
| 17. | 完整协议 |
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| 18. | Waiver |
| 18. | 弃权 |
| 19. | Publicity |
| 19. | 宣传 |
| 20. | Appendices |
| 20. | 附件 |
| 21. | Limitation of Liability |
| 21. | 责任限制 |
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| 22. | Counterparts and Language |
| 22. | 副本和语言 |
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In Witness whereof, the Parties have executed this Agreement by their duly authorized representatives.
有鉴于此，本协议由双方授权代表正式签署。
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Amphastar Pharmaceuticals, Inc. |
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Nanjing Hanxin Pharmaceutical Technology Co., Ltd. 南京汉欣医药科技有限公司 |
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By/签署: |
/s/Jacob Liawatidewi |
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By/签署: |
/s/Bao Haitao |
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Name/姓名: |
Jacob Liawatidewi |
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Name/姓名: |
Bao Haitao |
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Title/职位: |
EVP Corporate Administration Center |
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Title/职位: |
General Manager |
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Date/日期: |
September 15, 2025 |
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Date/日期: |
September 15, 2025 |
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APPENDIX A: SCOPE OF WORK
附件A：工作范围
As provided in the HX Proposal dated ___________________
根据[2025年__月___日]的HX提案
Provision of the RCBs – HX will supply the Customer with [***] vials of the RCB. After HX provides the Customer with [***] vials of the RCB, HX will keep [***] vials of the RCB in stock. HX will supply the remaining [***] vials, upon the request of the Customer, at no additional cost. The Customer is responsible for the shipment/transportation costs for provision of all of the RCBs.
RCB的提供 – HX将向委托方提供 [***] 支RCB。在HX向委托方提供[***] 支RCB后，HX将储备 [***] 支RCB的库存。提供少于[***] 支的 RCB不需要额外费用。委托方应承担提供全部RCB的装运/运输费用。 APPENDIX C: LIST OF THE KNOW-HOW
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APPENDIX B: SPECIFICATIONS
附件B：规格
Part of the Product development work.
产品开发工作的一部分。
附件C：专有技术清单
1. Product Research Cell bank (RCB) Research and Characterization and Report
1. 重组多肽研究细胞库（RCB）的研究和表征及报告
2. Product Process Research and Development and Report
2. 重组多肽工艺的研究和开发及报告
3. Product Lab-scale and Production Scale Sample Test and Structure Characterization and Report
3. 重组多肽实验室规模样品测试和结构表征及报告
4. Product Reference Standard Test and Structure Characterization and Report This DISTRIBUTION AGREEMENT (this “Agreement”) is entered into on October 21, 2025 (the “Effective Date”) by and between the following parties:
4. 重组多肽参比标准品测试和结构表征及报告
Exhibit 10.3
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS ([***]), HAS BEEN OMITTED PURSUANT TO ITEM 601(B)(10)(IV) OF REGULATION S-K, BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL. IN ADDITION, CERTAIN SCHEDULES (OR SIMILAR ATTACHMENTS) HAVE BEEN OMITTED FROM THIS EXHIBIT PURSUANT TO ITEM 601(A)(5) OF REGULATION S-K.
Distribution Agreement
经销协议
本经销协议（以下简称“本协议”）由以下双方于2025年_10_月__21_日（以下简称“生效日期”）签订：
(1) |
Amphastar Pharmaceuticals, Inc., a company incorporated under the laws of the State of Delaware, with its principal place of business located at 11570 Sixth Street, Rancho Cucamonga, California (“AMPHASTAR”); and |
Amphastar Pharmaceuticals, Inc.，一家根据美国特拉华州法律注册成立的公司，其主要营业地址位于加利福尼亚州兰乔库卡蒙加市第六街11570号（以下简称“AMPHASTAR”）；及
(2) |
Nanjing Chengong Pharmaceutical Co., Ltd., a company incorporated under the laws of People's Republic of China (“China”, solely for the purpose of this Agreement, not including Hong Kong, Macao or Taiwan), with its registered place located at No.20, Xingang Avenue, Nanjing Economic and Technological Development Zone, Nanjing, Jiangsu Province, China (“CG” or “Distributor”). |
南京臣功制药股份有限公司，一家根据中华人民共和国（以下简称“中国”，仅为本协议之目的，不包括香港特别行政区、澳门特别行政区或台湾地区）法律注册成立的公司，注册地址为中国江苏省南京市南京经济技术开发区新港大道20号（以下简称“CG”或“经销商”）。
AMPHASTAR and CG are hereinafter collectively referred to as the “Parties”, and each as a “Party”.
AMPHASTAR和CG以下统称为“双方”，各自称为“一方”。
THE PARTIES AGREE AS FOLLOWS:
双方同意如下：
1 |
Definition |
定义
1.1 |
Affiliate means, in this Agreement means, with respect to any specified entity, any other entity that directly, or indirectly through one or more intermediaries, Controls, is Controlled by, or is under common Control with, such specified person. |
关联方是指，在本协议中，就任何特定实体而言，直接或通过一个或多个中间人间接控制该实体、受其控制或与该实体共同控制的任何其他实体。
1.2 |
Control of a person (including the terms “Controlled by” and “under common Control with”) means, (i) ownership of more than 50% of the shares or economic interests of such person; (ii) the power, directly or indirectly and whether exercised or not, to direct the management or policies of such person, whether through the ownership of more than 50% of the voting power of such person, through the power to appoint a majority of the members of the board of directors or similar governing body of such person, through contractual arrangements or otherwise, or (iii) ownership of the largest amount of shares of such person. |
对实体的控制（包括“受控于”和“与他人共同控制”）是指，(i) 拥有该实体50%以上的股份或经济利益；(ii) 无论行使与否，拥有直接或间接影响该实体管理层或政策制定的权力，无论该权力的取得是通过拥有该实体50%以上的投票权，还是通过任命该实体的董事会或类似管理机构大多数人的权力，还是通过合同安排或其他方式，或(iii) 是该实体所有股东中持股最多的股东。
1.3 |
Collaboration Region means Mainland China, Taiwan, Hong Kong, and Macau in the Greater China region. |
合作区域是指大中华地区，包括中国大陆，中国台湾，中国香港，中国澳门。
1.4 |
Contract Year means each consecutive twelve (12) month period during the Term, the first of which shall commence on the Effective Date and shall end on the first anniversary thereof. |
合同年是指有效期内的每一连续十二（12）个月，第一个合同年从生效日期开始至其第一个周年之日结束。
1.5 |
Intellectual Property means any design, patent (including invention, utility model and design patent; including patent application, reissue, division, continuation and extension thereof), copyright, trade marks, trade names, service marks, business names, trade secret, mask work right, idea, algorithm, concept, structure, logic, know-how, invention, discovery, improvement, document, product, system, practice, rule, tool, method, ingredient, process, device, procedure, software, drawing and sketch, specification, technical description, and all other intellectual property or similar proprietary rights of whatever nature, whether registered, filed, patented or not, which may now or in the future subsist anywhere in the world. |
知识产权是指任何设计、专利（包括发明、实用新型和外观设计；包括专利申请、再授权、分案、续案和延伸等）、版权、商标、商品名称、服务标识、企业名称、商业秘密、集成电路布图设计权、想法、算法、概念、结构、逻辑、专有技术、发明、发现、改进、文件、产品、系统、实践、规则、工具、方法、成分、过程、设备、程序、软件、图纸和草图、规格、技术说明，以及现在或将来在世界任何地方存在的所有其他知识产权或类似的专有权利，无论其性质如何，也无论其是否注册、备案、获得专利。
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1.6 |
Product B means Baqsimi (glucagon) nasal powder owned by AMPHASTAR, a prescription medication approved by the NMPA in China, which comes in single dose nasal powder device, with each dose containing 3mg of glucagon, and is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 4 years and above. |
产品B是指AMPHASTAR持有的Baqsimi（胰高血糖素）鼻用粉雾剂，是中国国家药品监督管理局批准的处方药，为单剂鼻用粉剂，每剂含 3 毫克胰高血糖素，适用于治疗4岁及以上糖尿病患者的严重低血糖症状。
1.7 |
NMPA means National Medical Products Administration of the PRC. |
NMPA是指中国国家药品监督管理局。
2 |
Distribution |
经销
2.1 |
Appointment of Distributor. AMPHASTAR hereby appoints the Distributor, and the Distributor hereby agrees to accept the appointment, to act for AMPHASTAR as its exclusive distributor to market and sell Product B within the Collaboration Region subject to the Distributor’s compliance with the terms and conditions of this Agreement. |
经销商的任命。AMPHASTAR特此任命经销商，经销商特此同意接受任命，在经销商遵守本协议条款和条件的前提下，作为AMPHASTAR的独家经销商，在合作区域内推广和销售产品B。
For avoidance of doubt, the Distributor shall be solely responsible to ensure that Product B is shipped, marketed, and distributed in the Collaboration Region, and shall not be distributed in any country such as the United States and/or any other country or region outside the Collaboration Region.
为免疑义，经销商应独立负责确保其接收的产品B仅在合作区域内进行运输、市场推广和销售，并且不得在美国等合作区域以外的任何其他国家或地区进行销售。
2.2 |
Other Obligations of Distributor. The Distributor hereby agrees to: |
经销商的其他义务。经销商同意：
(1) |
exercise its best efforts to obtain and promote the sale of Product B in the Collaboration Region; |
尽其最大努力在合作区域获得和促进产品B的销售；
(2) |
maintain adequate staff at all times, including but not limited to adequate sales staff; |
始终保持充足的员工，包括但不限于充足的销售人员；
(3) |
abide by each of AMPHASTAR’s policies, procedures or other rules, and applicable laws and regulations regarding the purchase and sale and distribution of Product B, and storage and transport of Product B; |
遵守AMPHASTAR有关购买、销售、经销、储存和运输产品B的各项政策、程序或其他规定以及适用的法律法规；
3
(4) |
conduct its business in a manner that is favorable to and promotional of AMPHASTAR and Product B and to not disparage, tarnish, or imply poor favor of the name, reputation or goodwill of AMPHASTAR; |
以有利于和促进AMPHASTAR和产品B的方式开展业务，不诋毁、玷污或对AMPHASTAR的名称、声誉或商誉作出不利的暗示；
(5) |
accept reasonable advices from AMPHASTAR on the sales and distribution of Product B; |
接受AMPHASTAR对于销售和经销产品B的合理建议；
(6) |
promptly notify AMPHASTAR upon becoming aware of any alleged or actual breach of its obligations under this Agreement, or any circumstances or matters that are reasonably likely to give rise to any such breach; |
在意识到任何涉嫌或实际违反其在本协议项下义务的行为，或合理可能导致任何此类违约的任何情况或事项时，立即通知AMPHASTAR；
(7) |
not sell or distribute any products that compete with Product B with respect to the same symptom, indication or therapeutic area; |
不得销售或分销与产品B在症状、适应症或治疗领域存在竞争的任何产品；
(8) |
not sell or distribute any products that infringe on any AMPHASTAR Intellectual Property, promptly notify AMPHASTAR upon becoming aware of any such products or infringement on any AMPHASTAR Intellectual Property and, upon AMPHASTAR’s request, promptly provide all necessary information, cooperation and assistance for defense of infringement; |
不销售和经销任何侵犯AMPHASTAR知识产权的产品，在意识到任何此类产品或对AMPHASTAR知识产权的侵权时，立即通知AMPHASTAR，并经AMPHASTAR的要求立即提供所有侵权辩护的必要信息、合作和协助；
(9) |
cooperate fully with and provide any necessary assistance and information to AMPHASTAR in implementing any recall, withdrawal, seizure or destruction of Product B initiated by AMPHASTAR; |
与AMPHASTAR充分合作，并向AMPHASTAR提供任何必要的协助和信息，以实施AMPHASTAR发起的任何产品B的召回、撤回、扣押或销毁；
(10)Comply with Safety Data Exchange Agreement (SDEA) as set forth in Appendix A; and
遵守本协议附件A所列示的《安全数据交换协议》(SDEA)；及
(11)Comply with Quality Agreement (Quality Agreement) as set forth in Appendix B.
遵守本协议附件B所列示的《质量协议》(Quality Agreement)。
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2.3 |
Sub-Distributors. The Distributor shall be entitled to appoint, at its sole discretion, sub-distributors and/or agents or representatives (the “Sub-Distributor”) for the sale, resale and/or retail of Product B under such terms and conditions as the Distributor may consider appropriate; provided, however, that (i) the Distributor’s appointment shall not exceed the Term of this Agreement or otherwise violate any terms or conditions thereof, (ii) the Sub-Distributors shall distribute Product B only within the Collaboration Region, which means each Sub-Distributor shall, and shall cause its downstream resellers and retailers to be prohibited from selling or otherwise transferring, directly or indirectly, Product B to any party outside of the Collaboration Region, and vice versa, (iii) the Distributor shall sign written agreements with all of its Sub-Distributors incorporating the terms and conditions in respect of distribution provided under this Agreement, and (iv) any engagement of Sub-Distributors shall not relieve Distributor of any liability under this Agreement and Distributor shall remain liable for the acts and omissions of such Sub-Distributor. |
分销商。经销商有权自行决定任命次级分销商和/或代理或代表（以下简称“次级分销商”），次级分销商根据经销商认为合适的条款和条件进行产品B的销售、转售和/或零售；但需符合下列条件，包括(i) 经销商的任命不得超过本协议的有效期或以其他方式违反本协议的任何条款或条件；(ii) 次级分销商应只在合作区域内进行产品B的分销，因此每一次级分销商均不得、且应禁止其下游分销商和零售商直接或间接向任何合作区域以外的主体销售或以任何其他方式转售产品B，反之亦然；(iii) 经销商应与所有次级分销商签订书面协议，将本协议规定的经销条款和条件纳入相关书面协议中，以及(iv) 任何与次级分销商的合作均不免除经销商在本协议项下的任何责任，且经销商仍应对此类次级分销商的行为和疏忽负责。
3 |
No Employment or Representation |
非雇佣或代理
3.1 |
Nothing in this Agreement shall be construed as to create an employment relationship between AMPHASTAR and the Distributor. The Distributor has no authority or power to bind AMPHASTAR or contract in the name of AMPHASTAR. |
本协议的任何内容均不得解释为在AMPHASTAR与经销商之间建立雇佣关系。经销商没有授权或权利约束AMPHASTAR或以AMPHASTAR的名义订立合同。
3.2 |
The Distributor, its employees and its representatives must refrain from any act that might create the false impression that they are employees, agents, or representatives of AMPHASTAR. Whenever the Distributor describes its relationship with AMPHASTAR it shall make it clear that it is an independent distributor and not an agent, representative or person having the authority to enter into contracts on behalf of AMPHASTAR or incur obligations binding on AMPHASTAR. |
经销商及其员工和代表必须避免任何可能造成他们是AMPHASTAR员工、代理或代表的错误印象的行为。当经销商描述其与AMPHASTAR的关系时，应明确说明其为独立经销商，而非代理、代表或有权代表AMPHASTAR订立合同或为AMPHASTAR设置有约束力的义务的人士。
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4 |
Clinical Plan |
开发计划
4.1 |
The Parties hereby agree that the post marketing clinical trial (the “Clinical Trials”) as required by the NMPA for Product B will be performed by the Distributor. The Distributor shall also be responsible for the following (collectively, the “Other Governmental Procedures”): |
(x) preparation of documents and materials for obtaining permit, certificate, registration, approval, filing or other relevant procedure (“Regulatory Approval”) related to drug registration renewal of Product B; and
(y) any other necessary procedures to meet the NMPA requirements for Product B (including but not limited to surveillance and reporting of adverse reactions, preparation of annual report related to manufacture and sale, post-market studies, risk management of Product B, etc.).
双方特此同意，产品B上市后的临床试验（“临床试验”）将按照 NMPA的要求由经销商进行和支付。经销商还应负责以下事项（合称“其他政府程序”）：
（x）为产品B的药品再注册准备相关许可、证书、注册、批准、备案或其他相关程序（以下简称“监管批准”）所需的文件和材料；及
（y）为满足NMPA对产品B要求的任何其他必要程序（包括但不限于产品B的不良反应监测与报告、编制生产和销售年度报告、上市后研究、风险管理等）。
4.2 |
The Distributor shall be responsible for all the costs and fees of the Clinical Trials of Product B and Other Governmental Procedures for Product B, and AMPHASTAR shall have the right (but not obligation) to review all clinical data and other relevant materials. For avoidance of doubt, AMPHASTAR is not obligated to perform any clinical or other studies for the drug registration renewal of Product B. |
经销商应承担产品B的临床试验以及其他政府程序中的所有成本和费用，AMPHASTAR有权（但无义务）审查所有临床数据和其他相关材料。为免疑义，AMPHASTAR无义务为产品B的药品再注册开展任何临床或其他研究。
4.3 |
AMPHASTAR shall provide the Distributor with the necessary documentation for the Clinical Trials and Other Governmental Procedures as aforementioned, including but not limited to CMC (Chemistry, Manufacturing, and Controls) data and clinical data, to the legally permissible extent and as long as AMPHASTAR has the requested documents. |
AMPHASTAR在法律允许的范围内，且AMPHASTAR拥有所要求的文件的前提下，向经销商提供临床试验及其他政府程序所需的资料，包括但不限于CMC资料、临床资料。
4.4 |
The arrangements for Clinical Trials and Other Governmental Procedures regarding Product B shall be subject to this Agreement, and any changes shall be subject to a separate written agreement after consultation between CG and AMPHASTAR. |
关于产品B的临床试验及其他政府程序以本协议为准，如需变更，经CG和AMPHASTAR双方协商后，另行签订书面协议。
6
5 |
Sales Forecasts and Minimum Purchase Amount |
销售预测和最低购买量
5.1 |
Sale Forecasts. The parties agree that the sale forecasts of Product B during the term of this Agreement are as follows: |
销售预测。双方同意，在本协议有效期内，产品B的销售预测如下：
|
Year 年度 |
Contract Year Sale (Units) 合同年销售量（支） |
Contract Year 1/第一个合同年 |
[***] |
Contract Year 2 and after /第二个合同年及之后 |
[***] |
5.2 |
Minimum Purchase Amount. During the term of this Agreement, except for the Contract Year 1, the purchase amount of Product B of the Distributor from AMPHASTAR shall be no less than one (1) batch (approximately [***] units) per Contract Year (“Minimum Purchase Amount”). In case the aggregate amount of actual purchase by the Distributor of Product B from AMPHASTAR in a Contract Year falls below the Minimum Purchase Amount, the Distributor shall be deemed to have materially breached this Agreement and AMPHASTAR is entitled to terminate this Agreement in accordance with Section 11.2. |
最低购买量。在本协议有效期内，除首个合同年度外，经销商从AMPHASTAR购买产品B的每一合同年购买量应不少于一（1）个生产批次（大约[***]支）（以下简称“最低购买量”）。如果经销商从AMPHASTAR购买产品B的某一合同年购买总量低于最低购买量，经销商应被视为实质违反本协议，AMPHASTAR有权根据第11.2条终止本协议。
6 |
Supply and Delivery |
供应和交付
6.1 |
Delivery Terms. EXW rules (facility of AMPHASTAR in the United States) shall apply to the delivery of Product B. The Distributor shall assume all applicable risks immediately after being provided the requested Product B at AMPHASTAR’s facility, whether onto a conveyor/transport system or otherwise. |
交付条款。产品B的交付应适用EXW规则（AMPHASTAR在美国的工厂）。经销商在AMPHASTAR工厂收到经要求的产品B后应承担立即出现的所有适用风险，无论是通过承运方/运输系统还是其他方式。
For purposes of this Agreement, trade terms (e.g., EXW) used to describe the rights and obligations of the Parties shall have the meanings assigned to them by Incoterms 2020 published by the International Chamber of Commerce.
为本协议之目的，本协议中使用的描述双方权利与义务的贸易术语（如EXW）应具有国际商会出版的《国际贸易术语解释通则（2020）》赋予它们的含义。
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6.2 |
Supply Price. The supply price of Product B from AMPHASTAR to the Distributor is EXW price USD [***] per unit (“Supply Price”). For avoidance of doubt, all transport costs and customs clearance costs shall be borne by the Distributor. |
供应价格。AMPHASTAR向经销商供应产品B的价格为 [***] 美元/支（EXW价格，以下简称“供应价格”）。为免疑义，所有运输费用和海关清关费用应由经销商承担。
Notwithstanding aforesaid, AMPHASTAR reserves the right to increase the Supply Price of no more than one (1) time per Contract Year. Such increase of the Supply Price shall be no more than [***] on an annual basis except in the circumstance that AMPHASTAR’s standard costs of Product B has increased by more than [***].
尽管有上述规定，AMPHASTAR保留每一合同年最多一（1）次上调供应价格的权利。除非AMPHASTAR对产品B的标准成本增加了[***] 以上，否则供应价格的年增长率不得超过[***]。
6.3 |
Purchase Order. The Distributor shall issue purchase orders to AMPHASTAR. The purchase order shall specify the quantity, expected delivery date and other matters mutually agreed by the Parties. The Parties hereby agree that the Distributor shall provide AMPHASTAR with a delivery period of no less than ninety (90) days. |
采购订单。经销商应向AMPHASTAR发出采购订单。采购订单应明确采购数量、预期交付日期和双方共同商定的其他事项。双方特此同意，经销商应向AMPHASTAR提供不少于九十（90）天的交付期。
6.4 |
Payment. The Distributor shall pay for Product B within thirty (30) days from the date of invoice provided by AMPHASTAR to the Distributor. Distributor shall make payment in US dollars, unless otherwise as directed in the applicable invoice, provided that Distributor reserves the right to dispute the accuracy of any invoice presented by AMPHASTAR within ten (10) days of Distributor’s receipt of such invoice by providing written notice of such dispute to AMPHASTAR. In the event of a disputed invoice, the Parties shall negotiate the disputed amount in good faith, and Distributor shall pay such undisputed amounts pursuant to the terms herein. In the event Distributor’s dispute about any amount is determined by the Parties to have been unjustified, AMPHASTAR shall be entitled to charge Distributor interest on such disputed amount at the rate of [***]% per month from the initial due date until the actual date of payment. If any payment is not received by AMPHASTAR by its due date, then AMPHASTAR may, in addition to any other remedies available at equity or in law, charge interest on the outstanding sum from the due date (both before and after any judgment) at [***]% per month until paid in full (or, if less, the maximum amount permitted by applicable laws) and suspend any further performance under this Agreement until such default is cured, without such suspension releasing Distributor from its obligations under this Agreement. |
付款。经销商应于AMPHASTAR向其提供发票之日起三十（30）天之内支付产品B的价款。经销商应以美元支付款项，除非适用发票中另有指示；但经销商保留在收到发票后十（10）日内通过向AMPHASTAR提交书面异议通知对发票准确性提出争议的权利。若发票存在争议，双方应诚信协商争议金额，且经销商应按本协议条款支付无争议部分的款项。若双方最终认定经销商对金额的异议不成立，AMPHASTAR有权按每月[***]%的利率就该争议金额自原应付日期起至实际支付日期止计收利息。若AMPHASTAR未在应付日期收到款项，则AMPHASTAR除享有衡平法或法律规定的其他救济外，还可就未付金额自到期日起（含判决前后）按每月[***]%计收利息直至全额付清（以适用法律允许的最高利率为限），并有权中止履行本协议项下义务直至违约得到补救，但该中止不免除经销商在本协议项下的义务。
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6.5 |
Supply Shortage. If, at any time, AMPHASTAR’s supply of Product B is insufficient to meet total requirements of the Distributor (“Supply Shortage”), AMPHASTAR is entitled to cancel or postpone the delivery of Product B to the Distributor on its own discretion. In such situation AMPHASTAR shall not be liable to the Distributor for any claims, losses, damages or expenses related to any failure by AMPHASTAR to supply, including without limitation any direct, indirect, special, incidental or consequential claims, losses, damages or expenses (including, without limitation, any cost of cover or lost revenues or profits), whether or not the possibility or extent of any such damages are foreseen or foreseeable. After such Supply Shortage has occurred, the Parties will meet together as soon as practicable and engage in friendly discussions in order to allow AMPHASTAR to recover such Supply Shortage within a reasonable period of time. |
供应短缺。如果在任何时候，AMPHASTAR供应的产品B不足以满足经销商的全部要求（以下简称“供应短缺”），AMPHASTAR有权自行决定取消或推迟向经销商交付产品B。在这种情况下，AMPHASTAR不对经销商承担与AMPHASTAR供应失败有关的任何索赔、损失、损害或费用，包括但不限于任何直接、间接、特殊、附带或后果性索赔、损失、损害或费用（包括但不限于任何保险费用或收入或利润损失），无论任何此类损害的可能性或程度是否已预见或可预见。在供应短缺问题发生后，双方将在可行的情况下尽快会晤并进行友好协商，以便AMPHASTAR在合理的时间内补足供应短缺。
6.6 |
Profit Sharing. CG shall pay AMPHASTAR Profit Sharing. “Profit Sharing” is calculated based on CG Earnings. “CG Earnings” is defined as CG’s per unit net revenue for Product B during a Calculation Period (i.e. the total revenue during a Calculation Period minus Supply Price and Distribution Costs as defined in Section 7.1 during such Calculation Period, then divided by total sold units amount during such Calculation Period). |
The Profit Sharing shall be calculated as follow:
利润分成。CG应向AMPHASTAR支付利润分成，该等“利润分成”将根据CG收益进行计算。“CG收益”指在一个计算期间内CG单支产品B的净收入（即某一计算期间内CG总收入减去该计算期间内供应价格、以及本协议第7.1条定义的销售成本，再除以该计算期间内总销售数量）。
利润分成具体计算方式如下：
6.6.1 |
For CG Earnings that is more than USD[***] per unit of Product B, CG shall pay [***]% Profit Sharing regarding the part above USD[***]. |
For example: if CG Earnings is USD[***] per unit with [***] units sold in a Calculation Period, then AMPHASTAR shall earn Profit Sharing as follow: (USD[***] – USD[***]) x [***]% x [***] = USD[***]
当每一支产品B的CG收益高于[***]美元，CG应就超过[***]美元的部分支付[***]%的利润分成。
例如，如果CG某计算期间共销售[***]支，每一支的CG收益为[***]美元，那么AMPHASTAR应收取的利润分成为：([***]美元-[***]美元) x [***]% x [***]支= [***]美元。
6.6.2 |
There will be no Profit Sharing earned if CG Earnings is USD[***] or less per unit of Product B. |
当每一支产品B的CG收益小于或等于[***]美元，则CG无需支付利润分成。
9
Profit Sharing is calculated and payable every [***] period (the “Calculation Period”). CG shall provide AMPHASTAR with all necessary data and supporting documents to calculate the Profit Sharing amount within twenty (20) days after expiration of each Contract Year. After confirmation of the Profit Sharing amount by AMPHASTAR, CG shall pay the Profit Sharing amount within thirty (30) days from the date of invoice provided by AMPHASTAR to CG. If AMPHASTAR has any query or disagreement with the Profit Sharing amount, AMPHASTAR has the right to request CG to provide additional supporting materials, and to inspect relevant accounting books and other documents of CG.
该等利润分成每[***]（“计算期间”）进行计算并支付。CG应在每个合同年度结束后的二十（20）日内向AMPHASTAR提供计算利润分成金额所需的所有必要数据和支持文件。在AMPHASTAR确认利润分成金额后，CG应在AMPHASTAR向其提供的发票日期起三十（30）日内支付利润分成金额。如AMPHASTAR对利润分成金额有疑问或异议，AMPHASTAR有权要求CG提供进一步补充材料，并有权对CG相关会计账簿等文件进行检查。
6.7 |
Returns. Distributer will not be allowed to make returns of Product B. |
退货。经销商不得就产品B进行退货。
6.8 |
Residual Validity. Product B delivered by AMPHASTAR shall have a residual validity period of not less than 18 months. |
有效期。AMPHASTAR交付的产品B的剩余有效期不得少于 18 个月。
7 |
Distribution Costs and Additional Fees |
销售成本和额外费用
7.1 |
Distribution Costs. The Distributor shall be solely responsible and bear all the distribution costs of Product B (“Distribution Costs”), including all the costs and expenses incurred for the purpose of (i) obtaining any Regulatory Approval required for the drug registration renewal of Product B with NMPA, (ii) marketing and Clinical Trials costs of Product B in the Collaboration Region, (iii) warehousing and transportation costs, and (iv) other costs incurred for or in relation to the sales and distribution of Product B. For avoidance of doubt, the Distribution Costs are not included in the Supply Price paid to AMPHASTAR. |
销售成本。经销商应独立负责并自行承担产品B的所有销售成本（以下简称“销售成本”），包括为以下目的而产生的所有成本和费用：(i) 获得NMPA药品再注册所需的任何监管批准；(ii) 在合作区域内产品B的推广和临床试验成本；(iii) 仓储和运输费用；及(iv) 因销售和分销产品B而发生的或与之相关的其他成本。为免疑义，经销商支付给AMPHASTAR的供应价格中不包含销售成本。
7.2 |
Additional Fees. In the case the Distributor requires additional supports from AMPHASTAR, such as personnel supports, the Distributor shall pay additional fees to AMPHASTAR, which will be negotiated separately. |
额外费用。如果经销商要求AMPHASTAR提供额外的支持，如人员支持，经销商应向AMPHASTAR支付额外费用，额外费用由双方另行协商。
10
8Intellectual Property, License and Trademarks
知识产权、许可和商标
8.1 |
AMPHASTAR Intellectual Property. The Distributor hereby acknowledges that (i) all Intellectual Property in relation to and developed for Product B, and (ii) any Intellectual Property further generated in the context of Product B, including but not limited to those generated or improved during any Clinical Trials or marketing activities on behalf of the Distributor, and any other peripheral technologies shall solely belong to AMPHASTAR, regardless of whether such Intellectual Property have been registered or not (the “AMPHASTAR Intellectual Property”). |
AMPHASTAR知识产权。经销商确认，(i) 与产品B有关的和为产品B而开发的所有知识产权；及(ii) 在产品B的背景下进一步产生的任何知识产权，包括但不限于经销商在任何临床试验或市场推广活动中产生或改进的知识产权，以及所有周边技术，均应由AMPHASTAR单独所有，无论这些知识产权是否已经注册（以下简称“AMPHASTAR知识产权”）。
8.2 |
License to the Distributor. AMPHASTAR hereby grants to the Distributor and the Distributor hereby accepts a non-exclusive, non-transferrable, non-sublicensable, royalty-free and revocable license to use AMPHASTAR Intellectual Property solely in connection with (i) the distribution and promotion of Product B in the Collaboration Region within the term of this Agreement, and (ii) application for necessary Regulatory Approval for the drug registration renewal of Product B with the NMPA, with the right to sublicense to permitted Sub-Distributors to use AMPHASTAR Intellectual Property solely in connection with the distribution and promotion of Product B in the Collaboration Region within the term of this Agreement. |
对经销商的许可。AMPHASTAR向经销商授予且经销商接受一项使用AMPHASTAR知识产权的非独占、不可转让、不可分许可、免许可费且可撤销的许可。经销商使用AMPHASTAR知识产权仅可用于(i) 在本协议有效期内在合作地区内经销和推广产品B，及(ii) 为申请NMPA药品再注册必要的监管批准。经销商有权分许可给本协议允许的次级分销商，仅用于在本协议有效期内在合作地区内分销和推广产品B而使用AMPHASTAR知识产权。
8.3 |
Limitation of Use of AMPHASTAR Intellectual Property. Without the express written consent from AMPHASTAR, the Distributor shall not manufacture, market or sell any product that contains Product B or embodies any of AMPHASTAR’s Intellectual Property for purposes other than to perform this Agreement. The Distributor shall not use (other than pursuant to this Agreement), assist any other third party or seek to register or apply for statutory protection any of AMPHASTAR’s Intellectual Property, or any Intellectual Property that may impair, compete with, disturb, interfere or otherwise impede with AMPHASTAR’s rights, remedies or the protection to AMPHASTAR Intellectual Property. The Distributor shall immediately notify AMPHASTAR if it becomes aware of a possible or actual infringement of AMPHASTAR’s Intellectual Property. |
AMPHASTAR知识产权的使用限制。未经AMPHASTAR明确书面同意，经销商不得为履行本协议以外的目的制造、推广或销售任何含有产品B或包含AMPHASTAR的知识产权的产品。经销商不得使用（根据本协议的使用除外）、协助第三方或自行寻求注册或申请任何AMPHASTAR的知识产权，或可能损害、竞争、干扰、妨碍或以其他方式阻碍AMPHASTAR权利、救济措施或知识产权保护的任何知识产权。如果经销商发现AMPHASTAR的知识产权可能或实际受到侵犯，应立即通知AMPHASTAR。
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8.4 |
No Exclusiveness When Breach. Notwithstanding the foregoing, the exclusive license granted in Section 2.1 of this Agreement is immediately suspended and AMPHASTAR shall retain the right to market and sell the Product B anywhere in the world through third parties in the event that the Distributor is in violation of any terms, conditions, covenants, representations or warranties contemplated in this Agreement. |
违约时无排他性。尽管有上述规定，如果经销商违反本协议的任何条款、条件、承诺、陈述或保证，根据本协议第2.1条授予的独家授权将被立即取消，AMPHASTAR应保留通过第三方在世界任何地方推广和销售产品B的权利。
9 |
Representations, Warranties and Liabilities |
声明、保证和责任
9.1 |
General Representations and Warranties. Each Party respectively represents and warrants to the other Party that: (i) it is a corporation duly incorporated, validly existing, and in good standing under the applicable law; (ii) it has full right, power, and authority to enter into this Agreement and to perform its obligations hereunder; no consent of, approval from, authorization of, designation of, declaration from or filing with any governmental authority is required in connection with the valid execution, delivery and performance of this Agreement; and it has no current legal arrangement with any other party that would conflict with this Agreement; (iii) the representative entrusted by it to execute this Agreement has been duly authorized to do so; (iv) upon execution, this Agreement shall become a lawful, valid, and binding obligation of such Party, enforceable against it in accordance with its terms; (v) it shall not enter into any agreement or make any commitment or take any other action that would impair its ability to perform its obligations under this Agreement, and (vi) it shall not intentionally, knowingly, maliciously or willfully commit any violation of any applicable laws, codes, orders, statutes, ordinances, rules and regulations of any foreign, international, federal, state, county and municipal authorities with appropriate jurisdiction over the Parties, including any orders by a court of competent jurisdiction or directive rendered by a government entity or regulatory agency with appropriate jurisdiction. |
一般声明和保证。双方分别向对方声明并保证：(i) 其是根据适用法律正式成立、有效存续且信誉良好的公司；(ii) 其拥有签订本协议并履行其在本协议项下义务的全部权利、权力和权限；本协议的有效签署、交付和履行不需要任何政府机构的同意、认证、授权、指定、声明或备案；其目前与任何其他方没有与本协议相冲突的法律安排；(iii) 其委托签署本协议的代表已获得正式授权；(iv) 签署后，本协议将成为其合法、有效且具有约束力的合同义务，可根据其条款对其强制执行；(v) 其不会订立任何协议或做出任何承诺或采取任何其他行动以损害其履行本协议项下义务的能力；及（vi）其不得故意、明知、恶意或蓄意违反任何对双方拥有适当管辖权的外国、国际、联邦、州、县及市政当局颁布的适用法律、法规、命令、成文法、条例、规则和规章，包括有管辖权的法院作出的任何命令或拥有适当管辖权的政府实体或监管机构发布的指令。
9.2 |
Compliance with Law. The Distributor shall comply with all legislations, rules, regulations and statutory requirements existing from time to time in the jurisdiction where Product B is being sold that are applicable to the sale and distribution of Product B. This Section 9.2 shall also apply to any and all applicable anti-bribery laws such as the United States Foreign Corrupt Practices Act, including Exhibit A, and the Anti-Unfair Competition Law enacted and amended by the People’s Republic of China. The Distributor shall be responsible for obtaining all necessary authorizations, consents, approvals, licenses and permits in relation to the performance by them of their obligations under this Agreement and for making any necessary filling, record or registration of this Agreement and shall, upon request, provide |
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AMPHASTAR satisfactory evidence thereof as reasonably required by AMPHASTAR from time to time. The Distributor shall indemnify, defend and hold AMPHASTAR and its Affiliates and their respective employees, servants and agents and harmless from and against any loss, suit, claim, liability, expense (including and without limitation reasonable attorney’s fees), proceeding or damage (on an after-tax basis) to persons or property arising out of or related to a violation of this Section 9.2, and any warehousing, transportation, distribution, sale, marketing of Product B in the Collaboration Region by Distributor, or any of its Affiliates, Sub-Distributors, agents, service providers, vendors, or delegates.
遵守法律。经销商应遵守产品B销售所在司法管辖区内不时存在的适用于产品B的销售和经销的所有立法、规则、条例和法定要求。本第9.2条同样适用于所有适用的反贿赂法律，包括但不限于《美国反海外腐败法》及中华人民共和国颁布并修订的《反不正当竞争法》。经销商应负责获得与其履行本协议项下义务有关的所有必要的授权、同意、批准、执照和许可，并负责对本协议进行任何必要的备案、记录或登记，并根据AMPHASTAR不时提出的合理要求，向AMPHASTAR提供令AMPHASTAR满意的证明。经销商应赔偿AMPHASTAR及其关联方及其各自的雇员、职员和代理并为其辩护，使其免受因经销商或其关联方、次级分销商、代理商、服务提供商、供应商或受托方违反本第9.2条或在合作区域内仓储、运输、经销、销售、市场宣传产品B而产生的任何损失、诉讼、索赔、责任、费用（包括但不限于合理的律师费）、诉讼或对人身或财产造成的损害（在税后基础上）。
9.3 |
LIMITED WARRANTIES AND DISCLAIMER. |
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, AMPHASTAR MAKES NO WARRANTY TO THE DISTRIBUTOR WITH RESPECT TO PRODUCT B AND EXCLUDES ALL OTHER EXPRESS AND IMPLIED WARRANTIES, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR PARTICULAR PURPOSE, NONINFRINGEMENT, QUIET ENJOYMENT, AND ANY IMPLIED WARRANTY ARISING FROM THE COURSE OF DEALING OR THE COURSE OF PERFORMANCE.
有限保证和免责声明。
除本协议明确规定外，AMPHASTAR就产品B对经销商不作任何保证，并且排除所有其他明示和暗示的保证，包括但不限于对适销性、特定用途的适用性、不侵权、平静受益的暗示保证，以及因交易过程或履约过程而产生的任何暗示保证。
9.4 |
Delays of AMPHASTAR. In the event that delays solely caused by AMPHASTAR’s failure to fulfill its cooperation obligations, with no direct or indirect fault of CG, result in insufficient time for CG to complete Clinical Trials and Other Governmental Procedures for Product B, thereby causing the failure of drug registration renewal of Product B, CG shall not be held liable for such failure. AMPHASTAR agrees not to pursue any claims, penalties, or damages against CG arising from such failure of drug registration renewal. For the avoidance of doubt, CG shall clearly specify in advance the tasks and timelines requiring AMPHASTAR’s cooperation to ensure the timely completion of Clinical Trials and Other Governmental Procedures. Throughout the process, CG shall actively and regularly provide AMPHASTAR with progress updates and promptly communicate any issues encountered. In the event of any delays, both Parties shall engage in good faith discussions to negotiate and agree on a mutually acceptable solution. |
AMPHASTAR方延误。如因AMPHASTAR未履行其配合义务（且CG无任何直接或间接过错）导致CG没有足够时间完成产品B的临床试验及其他政府程序，进而造成产品B药品再注册失败，CG无需对此承担任何责任。AMPHASTAR同意不就该等情形下的药品再注册失败向CG提出任何索赔、处罚或损害赔偿要求。为免疑义，CG应事先明确说明需要AMPHASTAR配合的具
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体工作及时间节点，以确保临床试验及其他政府程序的及时完成。在整个过程中，CG应积极主动定期向AMPHASTAR提供进展汇报，并及时沟通遇到的问题。若发生任何延误，双方应善意协商达成双方认可的解决方案。
10 |
Indemnification |
赔偿
10.1 |
Indemnity. Each Party, on behalf of itself, and its respective Affiliates, agents, delegates, vendors and service providers (and the Distributor, also on behalf of its Sub-Distributors), (collectively, the “Indemnifying Party”) shall indemnify, defend and hold the other Party and its Affiliates and their respective employees, servants and agents and harmless from and against any loss, suit, claim, liability, expense (including and without limitation reasonable attorney’s fees), proceeding or damage (on an after-tax basis) to persons or property arising out of or related to (a) any acts, whether of omission or commission, that may be committed by the Indemnifying Party; and (b) any alleged or actual breach by the Indemnifying Party of this Agreement, including any warranties, representations, covenants and obligations contemplated under this Agreement. The provisions of this Section 10.1 shall survive the termination of this Agreement. |
赔偿。每一方，代表其自身及其各自关联方、代理商、受托方、供应商及服务提供商（经销商还代表其次级分销商）（与该方合称“赔偿方”），应赔偿另一方及其关联方及其各自的雇员、职员和代理并为其辩护，使其免受因以下情况产生的任何损失、诉讼、索赔、责任、费用（包括但不限于合理的律师费）、仲裁或对人身或财产造成的损害（在税后基础上）：(a) 赔偿方可能实施的任何行为（无论是作为或不作为）；(b) 赔偿方涉嫌或实际违反本协议，包括其在本协议项下的保证、声明、约定和义务。本第10.1条在本协议终止后继续有效。
11 |
Term and Termination |
有效期和终止
11.1 |
Term. This Agreement shall be effective upon the Effective Date, and shall be binding upon and inure to the benefit of the Parties and their respective assigns and successors in interest. The term of this Agreement (the “Term”) shall be ten (10) years commencing on the Effective Date herein. The Parties may negotiate on extension of this Agreement commencing six (6) months prior to the expiration. |
有效期。本协议的自生效日期起生效，对双方及其各自的受让人和利益继承人具有约束力并以其为受益人。本协议的有效期（以下简称“有效期”）为十（10）年，自生效日期起计算。双方可在本协议到期前六（6）个月就本协议的延期进行谈判为十（10）年，自生效之日起计算。双方可在本协议有效期满前六（6）个月就本协议的延期进行协商。
Except as expressly contemplated in this Agreement, AMPHASTAR hereby agrees and commits that it shall not terminate this Agreement solely for the purpose of replacing CG as the distribution partner in collaboration region, unless CG has breached this Agreement or for any other permitted reason identified in this Article 11 or as otherwise permissible in this Agreement.
除本协议另有明确约定外，AMPHASTAR特此同意并承诺，除非CG严重违反本协议或发生本第11条或本协议其他条款允许的其他情形，否则AMPHASTAR不得仅为替换CG作为在合作区域内的分销合作伙伴的目的终止本协议。
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11.2 |
Termination. This Agreement may be terminated before the expiration in any of the following events: |
终止。在下列任何一种情况下，本协议可在有效期满前终止：
(1) |
After the completion of Contract Year 4, either party is entitled to terminate this Agreement without cause by giving a six (6) months’ prior written notice; |
四（4）个合同年后，任何一方有权经提前六（6）个月书面通知无理由终止本协议；
(2) |
If any party breaches this Agreement, the other party is entitled to terminate this Agreement by giving a two (2) months’ prior written notice; |
如一方违反本协议，另一方有权经提前两（2）个月书面通知终止本协议；
(3) |
If the Distributor fails to reach the sales forecasts in Section 5.1 herein for two (2) consecutive Contract Years, AMPHASTAR is entitled to terminate this Agreement immediately; and |
如经销商连续两（2）个合同年无法达到第5.1条规定的销售预测，AMPHASTAR有权立即终止本协议；及
(4) |
If the Distributor fails to purchase [***] units of Product B from AMPHASTAR in any Contract Year (except in Contract Year 1), AMPHASTAR is entitled to terminate this Agreement immediately. |
如经销商在任何合同年未能向AMPHASTAR购买[***]支产品B（合同年度1除外），AMPHASTAR有权立即终止本协议。
11.3 |
Effect of Termination for Parties. Except as expressly provided herein, no Party shall incur any liability to the other party for terminating this Agreement in accordance with this Section 11, and no such termination shall limit the contemporaneous or subsequent exercise of any other rights and remedies such Party may have. Nothing herein shall be construed to release any Party from any obligation that accrued prior to the date of termination, except as expressly provided in this Agreement. Without limitation, (i) all accrued but unpaid amounts that may be owing from a Party to the other Party shall survive termination and (ii) any claim for breach or damages arising prior to or as a result of the termination shall survive (including an claim for any breach or damages continuing after termination). |
终止对双方的效力。除本协议明确规定外，任何一方均不得因根据本协议本第11条的规定终止本协议而对另一方产生任何责任，因此种方式终止本协议也不会限制该方可能同时或随后行使的任何其他权利和补救措施。除本协议明确规定外，此处的任何表述均不得解释为免除任何一方在终止日期之前产生的任何义务。不能限制对方行使的权利和不久措施还包括：(i) 一方欠另一方的所有已产生但尚未支付的款项应在终止后继续支付；及(ii) 在本协议终止之前或因终止而产生的任何违约或损害索赔继续存在（包括对本协议终止后继续存在的任何违约或损害提出索赔）。
Upon termination of this Agreement, AMPHASTAR may, without limiting any other right or remedy:
本协议终止后，AMPHASTAR可在不限制任何其他权利或补救措施的情况下：
(1) |
AMPHASTAR suspend the supply of all Product B (including under purchase orders not yet fulfilled) to Distributor; |
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AMPHASTAR暂停向经销商供应所有产品B（包括尚未履行完毕的采购订单）；
(2) |
AMPHASTAR require Distributor and its Affiliates to promptly return to AMPHASTAR all Product B in the possession, custody or control of Distributor or its Affiliates; and |
要求经销商及其关联方立即将其拥有、保管或控制的所有产品B退还给AMPHASTAR；及
(3) |
AMPHASTAR sell, or engage a third party distributor to sell, all Product B manufactured under purchase order of Distributor to a third party, and recover from Distributor any costs and expenses reasonably incurred by AMPHASTAR in doing so. |
AMPHASTAR向第三方出售或委托第三方经销商销售根据经销商的采购订单生产的所有产品B，并要求经销商弥补AMPHASTAR因此而合理产生的任何成本和费用。
(4) |
Distributor shall pay AMPHASTAR all invoiced amounts outstanding hereunder, plus, upon receipt of invoice therefor, for any (i) Product B that has been shipped pursuant to purchase orders but not yet invoiced, and (ii) Product B processed pursuant to purchase orders that has been completed but not yet shipped. |
经销商应向AMPHASTAR支付本协议项下所有未付的发票金额，以及（在收到相关发票后）下列款项：（i）已根据采购订单发货但尚未开具发票的产品B；及（ii）已根据采购订单完成生产但尚未发货的产品B。
12 |
Confidentiality. |
保密
12.1 |
The receiving party shall treat as confidential and secret all information which has been or may hereafter be disclosed by the disclosing party, directly or indirectly, to the receiving party, either orally, in writing or through inspection. The receiving party shall use the Confidential Information received only to the extent necessary to execute the Purpose of this Agreement. The receiving party shall not disclose to anyone any Confidential Information received from the disclosing party, and shall use the same degree of care, but no less than a reasonable degree of care, to prevent the disclosure of the Confidential Information to others as it uses to prevent the disclosure of its own Confidential Information. Upon request from the disclosing party, the receiving party shall promptly return to the disclosing party or destroy all drawings, data, memoranda and information in physical form relating to the Confidential Information. |
接收方应将披露方已经或今后可能以口头、书面或检查的方式直接或间接向接收方披露的所有信息视为保密信息。接收方只能为执行本协议目的所必需的范围内使用所收到的保密信息。接收方不得向任何人披露从披露方收到的任何保密信息，并应采用与防止披露其自身保密信息相同的谨慎程度，但不得低于合理的谨慎程度，以防止向他人披露保密信息。应披露方的要求，接收方应及时向披露方归还或销毁与保密信息有关的所有实物形式的图纸、数据、备忘录和信息。
“Confidential Information” means technical and business information relating to inventions, proprietary ideas and/or patentable ideas, patent applications, background intellectual property, techniques, scientific knowledge, know-how processes, existing and/or contemplated products and services, software, biological material, schematics, research and development, production, costs, profit and margin information, finances and financial projections, customers, clients, licensees, marketing, and current or future business plans and models, or other subject matters of this Agreement, regardless of whether such information is designated as “Confidential Information” at the time of disclosure.
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The term “Confidential Information” does not include such information which:
“保密信息”是指与发明、专有构思和/或可申请专利的构思、专利申请、背景知识产权、技术、科学知识、专有技术工艺、现有和/或计划中的产品和服务、软件、生物材料、示意图、研发、生产、成本、利润和利润率信息、财务和财务预测、客户、顾客、被许可人、市场推广以及当前或未来的商业计划和模式、或本协议的其他主题有关的技术和商业信息，无论这些信息在披露时是否被指定为保密信息。保密信息不包括以下信息：
(i) |
is or becomes generally available to the public, other than through the receiving party’s disclosure, |
未经接收方披露，公众普遍可以获得的信息；
(ii) |
was within the receiving party’s possession prior to it being furnished by or on behalf of the disclosing party, provided that receiving party’s source had no obligation of confidentiality to the disclosing party, |
在由披露方提供或代表披露方提供之前，接收方已获得的信息，前提是接收方的信息来源对披露方不承担保密义务；
(iii) |
becomes available to the receiving party on a non-confidential basis from an information provider other than the disclosing party, provided that the information provider did not have a duty of confidentiality to the disclosing party, or |
接收方可从信息披露方以外的信息提供方获得的非保密信息，前提是信息提供方对披露方不承担保密义务；或
(iv) |
is or becomes independently developed the receiving party without access to the Confidential Information and without violating any of the receiving party’s obligations under this Agreement, as can be demonstrated by the receiving party’s written records. |
接收方在未获得保密信息且未违反本协议规定的接收方任何义务的情况下独立开发的信息，并且可以被接收方的书面记录证明。
12.2 |
Each Party agrees to keep the Confidential Information confidential, which includes (but is not limited to) not disclosing the disclosing party’s Confidential Information, or any part thereof (except as otherwise may be provided herein), absent the disclosing party’s prior written consent, unless required to do so by Applicable Law, act or a valid order of a court or other governing, regulatory body with authority over the receiving party (“Required Disclosure”); provided that the receiving party shall first give reasonable written notice to the disclosing party prior to any Required Disclosure and shall exercise its best efforts to obtain an order or other reliable assurance that the Confidential Information disclosed will be treated at the highest level of confidentiality. Upon receipt of notice from the receiving party of any Required Disclosure, the disclosing party may, at the disclosing party’s expense, seek to quash or restrict the disclosure of the disclosing party’s Confidential Information and the receiving party shall not oppose or seek to impede the disclosing party’s efforts to obtain such relief. |
双方同意对保密信息保密，包括（但不限于）未经披露方事先书面同意，不披露披露方的保密信息或其任何部分（本协议另有规定的除外），除非适用法律、法令、或法院或其他对接收方有权管理的监管机构的有效命令要求接收方披露（“被要求的披露”）；但接收方应在进行任何被要求的披露之前，首先向披露方发出合理书面通知，并应尽最大努力获得命令或其
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他可靠保证，确保所披露的保密信息得到最高级别的保密处理。在收到接收方关于任何被要求的披露的通知后，披露方可寻求撤销或限制保密信息的披露，费用由披露方承担，接收方不得反对或阻碍披露方获得此类救济的努力。
13 |
Notice |
通知
13.1 |
All notices and communications between the parties must be in writing and addressed to the receiving party as follows: |
双方之间的所有通知和通信必须采用书面形式，并按以下地址寄给接收方：
If to AMPHASTAR:
AMPHASTAR：
Address:11570 Sixth Street, Rancho Cucamonga, CA 91730, U.S.A.
地址：11570 Sixth Street, Rancho Cucamonga, CA 91730, U.S.A.
Email: [***]
With a copy to: Legals@amphastar.com
邮箱：[***]
抄送：Legals@amphastar.com
Tel:1-909-980-9484
电话：1-909-980-9484
If to the Distributor:
经销商：
Address: NO.20, XINGANG AVENUE, NANJING ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, NANJING, JIANGSU PROVINCE, CHINA.
地址：中国江苏省南京市南京经济技术开发区新港大道20号
Email: [***]
With a copy to: [***]
邮箱：[***]
抄送：[***]
Tel: [***]
电话：[***]
18
14Governing Law and Dispute Resolution
适用法律和争议解决
14.1 |
Governing Law. This Agreement shall be governed by, and construed in accordance with the laws of China, excluding provisions relating to conflict of laws or rules that would require the application of the laws of any other jurisdiction and the Convention on Contracts for the International Sale of Goods. |
适用法律。本协议应受中国法律管辖并据其解释，但不包括与法律冲突相关的或要求适用其他任何司法管辖区域的法律和《联合国国际货物销售合同公约》的规定。
14.2 |
Dispute Resolution. This Agreement and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) (the “Disputes”) shall first be resolved through consultation. If the Disputes cannot be resolved through negotiation, the Disputes (including a Dispute in connection with the validity or continuity of this Agreement) shall be submitted to arbitration in Shanghai International Arbitration Centre with its then effective arbitration rules. The arbitration tribunal shall be consisted by three (3) members. One (1) arbitrator shall be appointed by the Party initiating the arbitration, one (1) arbitrator shall be appointed by the other Party, and the third arbitrator shall be jointly selected by the two (2) appointed arbitrators. The award of the arbitration tribunal shall be final and binding upon the Parties, and each Party may apply to a court of competent jurisdiction for enforcement of such award. Except for matters in the Dispute during a Dispute which is being resolved in accordance with this Agreement, the Parties shall continue to perform their obligations hereunder. |
争议解决。本协议以及因本协议或其标的物或其订立而产生的或与之相关的任何争议或索赔（包括非合同争议或索赔）（以下简称“争议”）应首先通过协商解决。如果争议无法通过协商解决，争议（包括与本协议的有效性或持续性有关的争议）应提交上海国际仲裁中心根据其当时有效的仲裁规则进行仲裁。仲裁庭由三（3）名仲裁员组成。一（1）名仲裁员由提起仲裁的一方指定，一（1）名仲裁员由另一方指定，第三名仲裁员由两（2）名指定的仲裁员共同选定。仲裁庭的裁决应为终局裁决，对双方均有约束力，双方均可向有管辖权的法院申请执行该裁决。除根据本协议解决争议期间的争议事项外，双方应继续履行其在本协议下的义务。
15General Provisions
一般条款
15.1 |
Taxes. Each Party shall assume full responsibility for the proper reporting and payment of all national, state or local taxes, value-added or other taxes, contributions and/or special levies imposed or required under income tax and/or other laws or regulations, with respect to its performance under this Agreement. |
税收。双方应根据所得税和/或其他法律或法规的规定，各自承担其因履行本协议所需申报和支付的所有国家、州或地方税、增值税或其他税款、缴款和/或特别征税。
15.2 |
Amendment. This Agreement may be amended only in writing signed by both Parties. Any term or condition in other contracts or agreements between the Parties that conflict in whole or in part with the provisions in this Agreement shall be of no force or effect and the provisions of this Agreement shall prevail in any such circumstance. |
修改。本协议只能以双方签署的书面形式进行修改。双方之间的其他合同或协议中的任何条款或条件与本协议条款的全部或部分冲突均无效，在任何此类情况下均应以本协议条款为准。
19
15.3 |
Assignment. Each Party’s rights and obligations under this Agreement are not transferable and assignable without the prior written consent of the other Party. Except, however, neither Party is required to obtain the other Party’s prior, written consent in the event such assignment is to a Party’s successor in connection with a transition, merger, acquisition, or sale of all or substantially all of its assets, or transition of some of the assets or where such transfer or assignment is to a Party’s Affiliate, subsidiary or related entity. |
转让。未经另一方事先书面同意，一方在本协议项下的权利和义务不得转让。但任何一方在以下情况下的转让无需事先获得另一方书面同意：因转移、合并、收购或出售全部或实质全部资产或转移部分资产而向该方的承继人进行的转让；或向该方的关联方、子公司或关联实体进行的转让。
15.4 |
Severability. If any term, provision, covenant, or condition of this Agreement is held by a court of competent jurisdiction to be invalid, void or unenforceable, the remainder of the provisions shall remain in full force and effect and shall in no way be affected, impaired or invalidated, provided that the Agreement remains substantially capable of performance without adversely affecting the rights of the Parties. |
可分割性。如果本协议的任何条款、规定、约定或条件被具有管辖权的法院裁定为无效或不可执行，则其余规定应保持完全有效，并且不得以任何方式受到影响、损害或无效，前提是本协议实质上仍然能够履行而不会对双方的权利产生不利影响。
15.5 |
Survival. Sections 10, 11.3, 12, 14 and 15 shall survive the termination of this Agreement. |
存续。本协议第10、11.3、12、14和15条应在本协议终止后继续有效。
15.6 |
Waiver. The failure of a Party to enforce, at any time or for any period of time, any provision of this Agreement shall not be construed as a waiver of such provision or the right of such a Party to enforce such provision thereafter. |
放弃。一方未能在任何时间或任何时间段内执行本协议的任何条款，不应解释为放弃该条款或此后执行该条款的权利。
15.7 |
Force Majeure. A Party shall not be responsible for any default in performing this Agreement due to unforeseen circumstances or causes beyond its reasonable control (the “Force Majeure”), including but not limited to earthquake, typhoon, flood, or other acts of nature, pandemic (excluding those related to the COVID-19 pandemic subsisting as at the date of this Agreement which have not materially escalated afterwards), fire, terrorism, war and riots. The Party claiming Force Majeure shall notify the other Party in writing within thirty (30) days after the occurrence of such event, take appropriate means to minimize or remove the effects of Force Majeure and make attempts to expeditiously and diligently resume performance of its obligations affected by the Force Majeure. If the Party claiming Force Majeure is unable to perform all or part of this Agreement for three (3) months after the occurrence of such event, the other Party may terminate this Agreement. |
不可抗力。由于不可预见的情况或超出其合理控制范围的原因（以下简称“不可抗力”），包括但不限于地震、台风、洪水或其他自然灾害、流行病（不包括在本协议签署之日存在的COVID-19流行病相关的，且此后没有实质性升级的情况）、火灾、恐怖主义、战争和骚乱，一方不应就其对本协议的违反承担责任。主张不可抗力的一方应在此类事件发生后三十（30）天内以书面形式通知另一方，采取适当的方式尽量减少或消除不可抗力的影响，并迅速且勤
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勉地努力恢复履行其受不可抗力影响的义务。如果主张不可抗力的一方在该事件发生后三（3）个月内无法履行本协议的全部或部分内容，另一方可终止本协议。
15.8 |
Execution in Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same instrument. This Agreement shall become binding when any one or more counterparts thereof, individually or taken together, bear the signature of both Parties thereto. For the purposes hereof, a facsimile copy of this Agreement, including the signature pages thereto, shall be deemed an original. |
份数。本协议可签署一份或多份，每份均为原件，共同构成同一份协议。当本协议的任何一份或多份（单独或合并）由双方签字时，本协议即具有约束力。为此目的，本协议的传真件，包括其签字页，应被视为原件。
15.9 |
Language. This Agreement is written in English and Chinese. Should there be any discrepancy between the English version and Chinese version, the English version shall prevail. |
语言。本协议以英文和中文书就。如英文版本和中文版本之间有任何分歧，以英文版本为准。
[The below is intentionally left blank]
[以下无正文]
21
IN WITNESS WHEREOF, each of the Parties hereto has caused this Agreement to be executed by their representatives, duly authorized hereunto, on the date first above written.
本协议的每一方都已安排由其正式授权的代表在上述日期签署本协议，以昭信守。
|
For and on behalf of 谨代表 Amphastar Pharmaceuticals, Inc.: | |
By/签署: |
/s/Jacob Liawatidewi |
Name/姓名: |
Jacob Liawatidewi |
Title/职务: |
EVP Corporate Administration Center |
|
For and on behalf of 谨代表 Nanjing Chengong Pharmaceutical Co., Ltd.: (南京臣功制药股份有限公司) (Seal): | |
By/签署: |
/s/Haoning Zhang |
Name/姓名: |
Haoning Zhang |
Title/职务: |
General Manager |
22
Exhibit A
Anti-corruption Laws and Amphastar’s Policies
1. |
Compliance: |
a. |
Distributor is familiar with and understands the U.S. Foreign Corrupt Practices Act and all other applicable anti-corruption laws and regulations (“Anti-Corruption Laws”). |
b. |
Distributor has received and understands Amphastar’s Global Anti-Bribery and Anti-Corruption Policy (available online at www.Amphastar.com , which is subject to change from time-to-time without notice), and shall comply with it and shall also cause all of Distributor’s officers, directors, and employees to comply with it. |
c. |
Distributor covenants that it and any party acting on its behalf will not take any action that violates any Anti-Corruption Law or Amphastar’s Anti-Corruption Policy while performing work under this Agreement. Distributor also will not cause Amphastar to violate any Anti-Corruption Law or Amphastar policy. Distributor shall not engage any subcontractors to perform its duties under this Agreement or assign its rights, duties, or obligations under this Agreement without Amphastar’s prior written consent. If Amphastar consents in writing, then Distributor agrees that it will require that this Agreement bind Distributor’s subcontractors, agents, successors, and assigns. Distributor will remain jointly and severally liable for any acts or omissions of those entities in connection with this Agreement. |
2. |
Audit Rights: |
a. |
Upon ten business days’ notice, or sooner if required by a request from a Government Agency, Distributor shall provide Amphastar with electronic copies (unless in a format otherwise agreed to by the parties) of all relevant records related to Distributor’s work under this Agreement. Distributor shall cooperate with any audit or investigation that Amphastar conducts. Amphastar may use a third party that will act at Amphastar’s direction when conducting any audit or investigation. |
3. |
Distributor shall promptly notify Amphastar in writing if: |
a. |
Distributor learns or suspects that it or any of its officers, directors, employees, or other person associated with it or acting on its behalf has violated any Anti-Corruption Law or Amphastar’s Anti-Corruption Policy or is being investigated by any Government Agency in relation to corrupt practices or breach of Anti-Corruption Laws in connection with its activities under this Agreement. |
Distributor learns or suspects that it or any of its officers, directors, employees, or other person associated with it or acting on its behalf related to this agreement has received a request for a bribe or other payment that would violate any Anti-Corruption Law.
4. |
All references to Distributor in this Exhibit shall include any entity that performs Distributor’s activities under this Agreement. |
5. |
For purposes of this Exhibit: |
a. |
“Government Agency” means any: (a) government or other regulatory entity; (b) government-owned or controlled entity, (including state-owned or state-controlled businesses or quasi-government entities); (c) commission, board, or legislative body; (d) political party; (e) royal family; (f) court, tribunal, or judicial body, including any arbitrator or arbitration panel; or (g) public international organization (e.g., the World Bank or Red Cross). |
b. |
“Government Official” means any: (a) officer, agent, or employee of a Government Agency; (b) person acting in an official capacity for or on behalf of a Government Agency; (c) candidate for government or political office; or (d) member of a royal family. |
Exhibit 31.1
CERTIFICATION PURSUANT TO RULE 13a-14(a) OR 15d-14a OF
THE SECURITIES EXCHANGE ACT OF 1934
AS ADOPTED PURSUANT TO SECTION 302
OF THE SARBANES OXLEY ACT OF 2002
I, Jack Y. Zhang, Ph.D., certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q of Amphastar Pharmaceuticals, 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 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 functions): |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 6, 2025 |
By: |
/s/ JACK Y. ZHANG |
|
|
|
Jack Y. Zhang |
|
|
|
Chief Executive Officer |
|
|
|
(Principal Executive Officer) |
|
Exhibit 31.2
CERTIFICATION PURSUANT TO RULE 13a-14(a) OR 15d-14a OF
THE SECURITIES EXCHANGE ACT OF 1934
AS ADOPTED PURSUANT TO SECTION 302
OF THE SARBANES OXLEY ACT OF 2002
I, William J. Peters, certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q of Amphastar Pharmaceuticals, 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 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 functions): |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 6, 2025 |
By: |
/s/ WILLIAM J. PETERS |
|
|
|
William J. Peters |
|
|
|
Chief Financial Officer |
|
|
|
(Principal Financial and Accounting Officer) |
|
Exhibit 32.1
CERTIFICATIONS OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
The undersigned officer of Amphastar Pharmaceuticals, Inc. (the “Company”), hereby certifies, to the best of such officer’s knowledge, that:
(i) the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2025 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 and
(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company at the dates and for the periods indicated.
Date: November 6, 2025 |
By: |
/s/ JACK Y. ZHANG |
|
|
|
Jack Y. Zhang |
|
|
|
Chief Executive Officer |
|
|
|
(Principal Executive Officer) |
|
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. §1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Exhibit 32.2
CERTIFICATIONS OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
The undersigned officer of Amphastar Pharmaceuticals, Inc. (the “Company”), hereby certifies, to the best of such officer’s knowledge, that:
(i) the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2025 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 and
(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company at the dates and for the periods indicated.
Date: November 6, 2025 |
By: |
/s/ WILLIAM J. PETERS |
|
|
|
William J. Peters |
|
|
|
Chief Financial Officer |
|
|
|
(Principal Financial and Accounting Officer) |
|
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. §1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.