| Item 1.01 | Entry into a Material Definitive Agreement. |
On March16, 2023, Coya Therapeutics, Inc. (the “Company”) entered into an exclusive License and Supply Agreement (the “License Agreement”) with Dr. Reddy’s Laboratories Limited (“DRL”). The License Agreement will become effective on April 1, 2023. Pursuant to the terms of the License Agreement, the Company will in-license DRL’s proposed Abatacept biosimilar to be used in the development and commercialization of COYA 302 in the United States, Canada, Mexico, South America, the European Union, the United Kingdom, and Japan. COYA 302 is the Company’s proprietary biologic combination product candidate being developed for the treatment of certain neurodegenerative diseases. COYA 302 is comprised of two components – COYA 301 and DRL’s proposed Abatacept biosimilar. COYA 301 is the Company’s low dose IL-2.
Pursuant to the License Agreement, within 30 days of execution, the Company will pay a one-time, non-refundable upfront payment of $350,000. The Company will pay to DRL single-digit royalties on net sales and up to an aggregate of approximately $22.7 million in potential development, regulatory and sales milestone payments, plus a low-six figure milestone payment per additional indication.
The License Agreement also provides for the license of COYA 301 to DRL to permit the commercialization by DRL of COYA 302 in territories not otherwise granted to the Company pursuant to the License Agreement. The Company will be eligible to receive single-digit royalties on net sales of COYA 302 by DRL in such territories.
Pursuant to the License Agreement, the Company maintains responsibility for the development of COYA 302, while DRL is responsible for the manufacture and supply of the proposed biosimilar Abatacept. The Company and DRL are each responsible for regulatory approval of COYA 302 in its respective territory. The Company and DRL have also agreed that within 36 months before the anticipated date of the regulatory application for COYA 302, the parties will in good faith negotiate the terms and conditions for the supply of commercial quantities of DRL’s biosimilar Abatacept for use in COYA 302.
The initial term of the License Agreement is 25 years, and automatically renews for successive 2 year terms unless a party provides notice of non-renewal. The License Agreement contains termination provisions for cause, insolvency, and regulatory approval issues. The License Agreement also contains customary representations, warranties and covenants, as well as customary provisions relating to exclusivity, indemnification, confidentiality and other matters.
A copy of the License Agreement will be filed as an exhibit in a subsequent periodic report to be filed under the Securities Exchange Act of 1934, as amended.
