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

Protecting & sharing information | Technology transfer

Summary of Approaches

What is included in the technology and/or materials to be transferred?
- The Materials to be transferred include any materials useful for the development and/or manufacturing of the COVID-19 Vaccine including the premaster virus seed for MVA-CoV2-S(3P) and unmodified derivatives.
- Transfer of Licensed Know-How will include plant visits and training, direct assistance on using the know-how for manufacturing vaccines, and consultation on using the know-how including for quality and regulatory matters.
What are the responsibilities of each party to in relation to the transfer of materials and/or technology?
- CSIC will use reasonable effort to provide Material and Licensed Know-how, as well as facilitating the transfer of Biofabri Material and Know-how, in each case upon request from the sublicensee.
- Materials must be paid for at manufacturing cost. CSIC will disclose the cost to the sublicensee and MPP upon request.
- Sublicensees must cover any travel and out-of-pocket costs to CSIC staff that are required for the transfer of materials and/or technology.
- Sublicensees must take actions to minimize the impact of technology transfer activities on the usual business activities of CSIC and Biofabri by accepting remote assistance where possible and allocating sufficient and capable personnel to the transfer activities.

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

Definitions

“Licensed Know-how” means all know-how, information, data, including without limitation clinical data, and other technical knowledge owned and/or controlled by CSIC now or in the future, that are useful or otherwise relevant for the development and/or manufacturing of the COVID 19 vaccine, which is set out in Schedule 3 hereto as available on the Effective Date, which shall be updated and complemented from time to time by CSIC.

“Material” means any materials useful for the development and/or manufacturing of COVID 19 Vaccine as defined above owned and/or controlled by CSIC, including the premaster virus seed for MVA-CoV2-S(3P) and unmodified derivatives.

5. KNOWLEDGE TRANSFER

5.1 CSIC shall use reasonable efforts to provide and/or to procure provision to the Sublicensees, upon the Sublicensee’s request, with the Material and Licensed Know-how in accordance with the details set out in Schedule 2 hereto. The Material will be provided at the manufacturing costs, which will be disclosed to MPP and the relevant Sublicensee upon request in advance.

5.2 CSIC shall use reasonable efforts to facilitate the transfer of Biofabri Material and Know-how, as CSIC’s manufacturing partner, upon the Sublicensee’s request.

5.3 MPP shall agree with the Sublicensees that they will cover any travel and out-of-pocket costs of CSIC staff required for the transfer of Licensed Technology. The effect on usual business activities of these entities produced by any request under this provision shall be minimized by the Sublicensee by:

a) accepting remote (telephone, e-mail, on-line, etc) assistance where applicable; and

b) allocating a sufficient and technically capable workload to knowledge transfer activities and ensuring that its contract manufacturer does the same.

Schedule 3: Licensed Know-how and Materials

a) Materials: Premaster virus seed for MVA-CoV2-S(3P) and derived materials, and any other Materials useful for the manufacturing and/or development of the Product owned and/or controlled by CSIC.

b) Licensed Know-how: as of the Effective Date is mostly related to scientific background and preclinical development of MVA-based COVID-19 vaccine candidate, MVA-CoV2-S(3P). Transfer of the Licensed Know-how will consist of the following items:

Technical support:
- Plant visits and training: training of Sublicensee technical engineers, at, as the case may be, the Sublicensee’s facilities or CSIC facilities that are developing or using the licensed process and/or making and selling the Product.
- Direct assistance: qualified and experienced professional from or on behalf of CSIC to advise the Sublicensee on the use of Licensed Know-how for manufacture of the Products.
- Consultation: Sublicensee shall have the right to contact CSIC by mail or telephone through representatives appointed by each party in relation to the use of Licensed Know-how, including without limitation for any quality and regulatory questions.

Timeline: each transfer shall be performed directly to the Sublicensee in the shortest time possible and in any case within 60 days from MPP’s request.

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