Gates Foundation – CureVac, RNA Rotavirus Vaccine R&D Collaboration 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?

Annotations

This Definitive Agreement and Project Collaboration Plan for Assessment of RNA Vaccine Technology for Non-live Rotavirus Vaccines in Pre-clinical Models (“Agreement“) between the Gates Foundation (“Foundation“) and CureVac GmbH (“CureVac“) is effective May 2014. The Agreement was signed pursuant to a separate Framework Agreement for Cooperation between the parties under which they agreed to cooperate in establishing projects for the R&D of new candidate vaccines.

Under the terms of the Agreement and subsequent amendments, the Foundation will provide up to USD $3 million in funding for CureVac to perform activities under a Project Collaboration Plan set out in Appendix 1 to the Agreement (“Activities“). The Activities include a global access plan recognizing the overarching goal of making products more available and accessible in Developing Countries (defined as countries eligible for Gavi support), as well as ensuring the broad dissemination of data and results.

CureVac will own intellectual property created in the performance of the Activities (“Project IPR“) but must manage it in a way that will best achieve the project’s global access objectives. This may include sublicensing the Project IPR at CureVac’s discretion. If the project success criteria are met and CureVac elects not to participate in further development, the Parties will enter into good faith negotiations for an agreement allowing the Foundation and its partners or grantees to proceed. Such an agreement must include licenses under necessary CureVac intellectual property, as well as access and permissions to use data generated under the Agreement.

Provision Language

25. Institutional Review Board (IRB) and Other Ethical Committee Approval

CUREVAC agrees to obtain the review and approval of all final protocols by the appropriate Institutional Animal Care and Use Committee (or equivalent competent institution) approval of studies involving animals, and Institutional Biosafety Committee for biohazards and recombinant DNA. CUREVAC agrees to provide prompt notice to the Foundation if the facts and circumstances change regarding the approval status of such committees for any final protocol(s).

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Gates Foundation – CureVac, RNA Rotavirus Vaccine R&D Collaboration Agreement

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