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

Business model | Governance

Structural Questions

Do the parties govern the project through a joint steering committee (“JSC”)? If so, what are the parties expressly designated roles and responsibilities with respect to the JSC?
Are there other committees, important governance bodies, or designated individual positions? What are the parties’ roles and responsibilities with respect to them?
Are the parties required to meet in accordance with a defined schedule for decision-making and progress reporting activities?
What are the resolution mechanisms for disputes related to the agreement?
Are there any requirements for policies or procedures to manage potential conflicts of interest?

Summary of Approaches

What are the resolution mechanisms for disputes related to the agreement?
- The parties agree to settle disputes “amicably” excepting appeals from termination decisions. MPP must first attempt to settle any claim with a designated NIH official before exercising any administrative of judicial remedies.
- Before NIH terminates or modifies for any of the defaults that the Agreement deems material in section 13.5, it must provide MPP with a written notice and 90 days to respond.
- When considering whether to terminate due to MPP’s failure to meet its goals (or other deemed breaches), NIH must consider the normal course of development programs, reasonably business practices and the annual progress reports.

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

[…]

13.6 In making the determination referenced in Paragraph 13.5, IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, IC’s concerns as to the items referenced in 13.5(a)-13.5(h). If the Licensee fails to alleviate IC’s concerns as to the items referenced in 13.5(a)-13.5(h) or fails to initiate corrective action to IC’s satisfaction, IC may terminate this Agreement.

[…]

13.8 Within thirty (30) days of receipt of written notice of IC’s unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated IC official. The decision of the designated official shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be available.

14. General Provisions

[…]

14.5 The construction, validity, performance, and effect of this Agreement shall be governed by Federal law as applied by the Federal courts in the District of Columbia.

[…]

14.11 The Parties agree to attempt to settle amicably any controversy or claim arising under this Agreement or a breach of this Agreement, except for appeals of modifications or termination decisions provided for in Article 13. The Licensee agrees first to appeal any unsettled claims or controversies to the designated IC official, or designee, whose decision shall be considered the final agency decision. Thereafter, the Licensee may exercise any administrative or judicial remedies that may be available.

Download Full Agreement

Master Alliance Provisions Guide (MAPGuide)

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

Provision Language

Contact Us

Get In Touch

Browse

Contact Us

Get In Touch

Browse

Sign Up to Our Newsletter

Master Alliance Provisions Guide (MAPGuide)

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

Provision Language

Contact Us

Get In Touch

Browse

Contact Us

Get In Touch

Browse

Title

Sign Up to Our Newsletter

Agreement Type

Select Partner Type

Select Development Stage

Select Technology

Select Issue or Sub-issues