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

Equitable Access | Affordable pricing

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

8. ASSIGNMENT AND SUBLICENSES

[…]

8.2. Licences and sublicences

MPP and CSIC will discuss and agree upon the identities of interested and suitable Third Parties to whom MPP shall grant sublicences for the purposes of developing, fabricating and/or Commercialising the Product. MPP will require in the sublicences that sublicensee(s) use commercially reasonable efforts to ensure that the Product(s) be made available in LMICs at affordable pricing.

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

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