CSIC – MPP (C-TAP), COVID-19 Vaccine, Patent and 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?

Annotations

This Patent and Material License Agreement is between the Spanish National Research Council (“CSIC”), a state agency of the Spanish government, and the Medicines Patent Pool (“MPP”), a United Nations-backed nongovernmental organization that pools licenses from intellectual property owners and sublicences technology for generic production and distribution in low-income and lower-middle-income countries (“LMICs”). MPP is the “implementing arm” of the World Health Organization’s COVID-19 Technology Access Pool (“C-TAP“), which facilitates equitable access to COVID-19 products. The Agreement concerns the MVA-CoV2-S(3P) vaccine (“COVID-19 Vaccine”) developed and owned by CSIC. The Agreement is effective as of July 2023.

The Agreement provides a worldwide, non-exclusive license that permits the MPP to sublicense CSIC patent rights, materials and know-how (“Licensed Technology”) to generic manufacturers who will develop and commercialize COVID-19 vaccines (“Products”) with the goal of making them accessible worldwide. The MPP and CSIC must agree on the selection of sublicensees, and MPP must include provisions in the sublicenses requiring the use of commercially reasonable efforts to make Products available in LMICs at an affordable price.

The Agreement also refers to materials and know-how related to the industrial manufacturing of the Vaccine in accordance with quality and regulatory requirements, which is owned by Biofabri, CSIC’s manufacturing partner. The Biofabri Know-How and Materials are not included in the scope of the license grant, but CSIC will facilitate transfer of both its own know-how and materials, and those of Biofabri upon request from a sublicensee. Sublicensees will pay travel and out-of-pocket expenses incurred by CSIC staff involved in technology transfer, they must also take actions to mitigate the impact of the technology transfer on the day-to-day business activities of CSIC and Biofabri.

Royalties will be payable directly from sublicensees to CSIC. The royalties payable on net sales will be: (i) 5% on sales to high-income countries where there is a patent right granted and in force; (ii) 1.5% on sales on sales to high-income countries for a period of 10 years where there is no patent right granted and in force, and (iii) 0% on sales for use in LMICs.

Provision Language

14. GOVERNING LAW AND JURISDICTION

14.1 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of Spain.

14.2 Jurisdiction and Dispute Resolution. The Parties shall use all reasonable efforts to solve any dispute, controversy or claim that may arise under this Agreement through good faith negotiations. In the event that the Parties are unable to resolve a dispute within sixty (60) calendar days from the date such dispute is first brought to the other Party’s attention, the Parties agree, with express resignation to any other jurisdiction that could correspond to them, to solve the differences under the exclusive jurisdiction of the Courts of the city of Madrid, Spain.

14.3 If there are any disputes in connection with this Agreement, including its termination under Clause 12, all rights and obligations of the Parties shall continue until such time as any dispute has been resolved in accordance with the provisions of this Clause.

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CSIC – MPP (C-TAP), COVID-19 Vaccine, Patent and Material License Agreement

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CSIC – MPP (C-TAP), COVID-19 Vaccine, Patent and Material License Agreement

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