Master Alliance Provisions Guide (MAPGuide)

Gates Foundation – Novavax, RSV Vaccine Global Access Commitments Agreement

  • Protecting & sharing information | Technology transfer

6. Global Access License


(d) Technology Transfer

(i) In connection with any Global Access License hereunder, such Global Access License shall be subject to the execution of the following reasonably acceptable written agreements between the Company and the recipient of the technology transfer (which recipient may be a Foundation sub–licensee or entities selected by the Foundation): quality agreement, safety data exchange agreement, and other customary agreements related to technology transfer of the Product; provided always that such entity shall not be required to pay any royalties, milestones or fees associated with such agreements. Company will cooperate with the Foundation in good faith to make available to the Foundation (or the entities of the Foundation’s choosing) (including providing electronic copies), all necessary intellectual property, technology, know–how and other information relating to the Product (including but not limited to master batch records, SOPs, QA/QC information, detailed bill of materials for the Product and other manufacturing documentation) for the purpose of permitting the Foundation (or its selected entities) to utilize its Global Access License and to continue to research and develop and manufacture the Product, and to enable the manufacture, licensure, sale, offer–for–sale, import, export, distribution, and use of such Product intended for use in the Developing Countries. For the purpose of facilitating Technology Transfer the Company shall provide electronic copies of all such applicable records and manufacturing documentation related to the Product for Maternal Immunization and the Foundation (or the entities of the Foundation’s choosing) and will be permitted to inspect the same for the purpose of assuring complete and accurate technology transfer by Company.

(ii) Company will continue to meet its Global Access Commitments towards and until completion of all intellectual property, know–how and information technology transfer associated with a Global Access License herein. Company and the Foundation will cooperate in good faith to effect an orderly and complete transition of any activities, including the research, development, manufacture, licensure, sale, offer–for–sale, distribution, import, export and use of the Product to the Foundation or its selected entities.

(iii) Company shall permit the Foundation (or its sublicenses) the right to access and cross–reference any applicable IND, BLA, WHO PQ or other regulatory file relating to the Product and shall, upon request, provide an electronic copy of each such file.

(iv) To the extent applicable, the Parties further agree to take all reasonable and diligent steps to eliminate or reduce any third party costs or royalties (set forth in Appendix D or otherwise attributable to the Product) associated with such Global Access License, including negotiation of any third party royalties and to negotiate access to such third party licenses by the Foundation (or its selected entities).

(v) The provisions of this Section will survive the Term, Extended Term, or any earlier termination of this GACA.