NIH – MPP (C-TAP), COVID-19 Technologies, Patent and Biological Material License Agreement

Term & termination | Term of agreement

Annotations

This Patent and Biological Materials License agreement (“Agreement”) is between several Institutes and Centers of the U.S. National Institutes of Health (“NIH”, or “IC“) and the Medicines Patent Pool (“MPP”), a Swiss foundation that expands access to medicines globally by pooling and sublicensing IP for development and commercialization in lower and lower-middle income countries (“LMICs”). The Agreement governs an NIH license of patent rights and materials relating to research tools for COVID-19 vaccine, therapeutic and diagnostic development, early-stage diagnostics and a vaccine candidate. The purpose of the license is development and commercialization of COVID-19 products in connection with the World Health Organization (“WHO”) COVID-19 Technology Access Pool (“C-TAP”) program, which aims to expand access to COVID-19 technologies via IP sharing and pooling. The Agreement is effective as of May 11, 2022.

The core of the Agreement is its license and sublicense arrangements. The NIH license is non-exclusive and permits the MPP to sublicense to third parties for the development and commercialization of COVID-19 products in connection with C-TAP. The license territory is global and the licenses are royalty-free for development and sales in 49 “least developed countries.”

NIH retains some rights over sublicensing, including the right to review and approve sublicensees and a contractual prohibition on sublicensing for use in countries subject to U.S. government sanction. Sublicensees must provide products to NIH for research. Products used or sold in the U.S. must be manufactured in the U.S.

MPP must use reasonable commercial efforts to bring products derived from NIH background IP to practical application, such as manufacture. NIH assesses the performance of MPP and MPP sublicenses using benchmarks relating to a WHO C-TAP Development Plan attached to the Agreement. In a related agreement, also effective on May 11, 2022, NIH licensed patent rights concerning prefusion spike proteins and an additional vaccine candidate. The related agreement is substantially similar to this Patent and Biological Materials License, except that it does not include a materials transfer. Its royalty structure and rates also differ; some small royalties are required for use in least developed countries.

Provision Language

13. Term, Termination, And Modification Of Rights

13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.15 are not fulfilled, and shall extend to either the expiration of the last to expire of the Licensed Patent Rights or twenty (20) years, whichever is longer, unless sooner terminated as provided in this Article 13.

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