BARDA – Moderna, COVID-19 Vaccine Development Agreement

Equitable Access | Ensuring continuity

Structural Questions

Under what circumstances can the continuity rights be exercised? (What are the conditions precedent?)
What is an appropriate scope for the continuity rights? What are the rights and obligations of each party?
Should related license grants vest upon execution of the agreement, or at a later stage in development?
Should there be an escrow requirement?
Should there be any restrictions on the developer’s ability to transfer project-related intellectual property to a third party?

Annotations

This Moderna – BARDA (Biomedical Advanced Research and Development Authority) Agreement (Agreement No. HHSO100201600029C, Contract No. 75A50122C00034), dated as of April 16, 2020, as amended on May 24, 2020, June 16, 2020, July 25, 2020, August 31, 2020 and September 15, 2020, is an agreement for the development and supply of an mRNA vaccine to licensure in the U.S. for the prevention of COVID-19.

This agreement was entered into in April 2020, with an aim to speedily develop a vaccine based on Moderna’s mRNA platform to meet the urgent need of public health. Under this Agreement, Moderna will perform all work required to support the advanced development, scale-up manufacturing and FDA licensure of its lead COVID-19 vaccine candidates.

At the time of the agreement, Moderna’s vaccine candidate was being evaluated in pre-clinical studies and Phase I clinical trials sponsored by NIAID. In August, 2020, ModernaTX, Inc., a wholly-owned subsidiary of Moderna, Inc., entered into an agreement with the Army Contracting Command of the U.S. Department of Defense (“DoD”) for the supply of its mRNA COVID-19 vaccine, as part of the collaboration between DoD and BARDA in connection with Operation Warp Speed (the “U.S. Supply Agreement”). Please refer to the separate provisions and analysis of the U.S. Supply Agreement in the MAPGuide.

Provision Language

C2. Statement of Work

(h) March–In Rights

The Contractor acknowledges that, with respect to any subject invention in which it has retained ownership, the agency has the right to require licensing pursuant to 35 U.S.C. 203 and 210(c), and in accordance with the procedures in 37 CFR 401.6 and any supplemental regulations of the agency in effect on the date of contract award.

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Master Alliance Provisions Guide (MAPGuide)

BARDA – Moderna, COVID-19 Vaccine Development Agreement

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BARDA – Moderna, COVID-19 Vaccine Development Agreement

Provision Language

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