Item 1.01. Entry into a Material Definitive Agreement
On March 8, 2023, Amphastar Pharmaceuticals, Inc. (together with its
subsidiaries, the "Company") and Nanjing Hanxin Pharmaceutical Technology Co.,
Ltd. ("Hanxin") entered into an Amendment to that certain Contract Research
Agreement by and between the Company and Hanxin, dated July 5, 2022 (the
"Amendment"). Per the terms of the Amendment, Hanxin will perform scale-up
manufacturing process development using the Recombinant Human Insulin Research
Cell Banks ("RCBs") for the Company. Per the terms of the Agreement the Company
will own any confidential and proprietary information and technology produced
during the scale-up manufacturing, which shall include engineering, scientific
and practical information and formula, research data design and procedures and
others to develop and manufacture the RCBs. Each of the Company and Hanxin have
made customary representations, warranties and covenants in the Amendment. The
Amendment will remain in full force and effect for the same period as Contract
Research Agreement, currently July 5, 2025.
Payments under the Amendment will be made in Chinese yuan. The total cost of the
Amendment to the Company shall not exceed approximately $0.5 million, with
payments adjusted based on actual currency exchange rates. Any additional work
requested by the Company will be charged by Hanxin to the Company on a cost plus
basis, plus any applicable taxes. Any additional cost must be provided to
Company for approval prior to the work being performed.
The foregoing is a brief description of the material terms of the Amendment,
does not purport to be a complete description of the rights and obligations of
the parties thereunder, and is qualified in its entirety by reference to the
copy of the Amendment that will be filed as an exhibit to the Company's
Quarterly Report on Form 10-Q to be filed with the Securities and Exchange
Commission for the fiscal quarter ending March 31, 2023, and is incorporated
herein by reference.
As previously disclosed in the Company's Annual Report on Form 10-K for the
fiscal year ended December 31, 2022, Dr. Jack Zhang, Chief Executive Officer,
President, and Director of the Company, Dr. Mary Luo, Chairman, Chief Operating
Officer, and Director of the Company and certain members of their family
beneficially own a majority of the equity interest in Hanxin, and the Amendment
represents a related party transaction. Accordingly, the independent and
disinterested members of the Audit Committee of the Board of Directors of the
Company evaluated and approved the entry into the Amendment following their
review of applicable considerations.
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