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

Business model | Product supply
Equitable Access | Territory access commitments

Structural Questions

Product supply

What are the specific commitments made by the parties to supply and purchase the products?
What actions must be taken by the supplier to ensure that it can fulfil the committed supply volume?
What are the remedies for actual or potential supply failures?

Territory access commitments

How should ‘territory’ be defined under the agreement? Should the definition make a distinction between different types of purchaser (e.g. public sector vs. private sector)?
Should the developer be required to apply for regulatory approval in priority access markets?
Should the developer be required to commit a proportion of the product manufactured to a certain country or purchasing organization?
Should the developer be required to identify a third party that could fulfill supply requirements for the access territories in the event that the developer does not?
Should the agreement include any anti-diversion provisions?

Summary of Approaches

Product supply

What are the specific commitments made by the parties to supply and purchase the products?
- MPP will provide reasonable quantities of products or materials available to NIH for research use prior to First Commercial Sale.
- MPP will require sublicensees to make reasonable quantities of the product available to patient assistance programs.

Territory access commitments

Should the developer be required to commit a proportion of the product manufactured to a certain country or purchasing organization?
- MPP will require sublicensees to make reasonable quantities of the product available to patient assistance programs.

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

5. Statutory And NIH Requirements And Reserved Government Rights

5.1 Prior to the First Commercial Sale, the Licensee agrees to provide the IC with reasonable quantities of Licensed Products or materials made through the Licensed Processes for the IC’s research use.

[…]

10. Performance

[…]

10.3 The Licensee agrees to require each of its Sublicensee(s), after that Sublicensee’s First Commercial Sale, to make reasonable quantities of Licensed Products or materials produced through the use of Licensed Processes available to patient assistance programs.

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Master Alliance Provisions Guide (MAPGuide)

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

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

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