Master Alliance Provisions Guide (MAPGuide)

Gates Foundation – Novavax, RSV Vaccine Global Access Commitments Agreement

  • Equitable Access | Ensuring continuity

5. Obligations in the Event of Acquisition of Product or Company by Another

In the event Company, Company assets necessary to perform Company’s obligations hereunder are licensed to, transferred to, sold to or otherwise acquired by a third party, including as a result of a Change in Control (any such license, transfer, sale or acquisition, including a Change in Control, is referred to herein as a “Transfer”), Company will ensure all such obligations are assumed by the licensee, purchaser, transferee, acquirer or successor in a written agreement reasonably acceptable to the Foundation. Company will not grant to a third party any rights or enter into any arrangements that would prohibit, prevent or otherwise restrict Company or any purchaser, transferee, acquirer, or successor of Company assets or Company from fulfilling its obligations hereunder. For clarity, notwithstanding anything to the contrary herein, the Foundation’s rights hereunder which exist on the date of the Transfer shall not be terminated by such Transfer. A breach of this provision will constitute a Charitability Default.

6. Global Access License

(a) “Charitability Default” means that Company:

(i) fails to comply with the restrictions on the use of funds or the other related U.S. tax obligations set forth in the Grant Agreement or the requirements set forth in this GACA;

(ii) commits a material breach of term of the Grant Agreement or this GACA;

(iii) commits gross negligence, fraud or willful misconduct; or

(iv) makes a strategic decision to discontinue the Product development and/or commercialization of the Product which meets the Minimum TPP; or

(v) experiences a Change of Control or Transfer in violation of section 5 of this GACA; or

(vi) experiences any Force Majeure Event, failure to cure or nonperformance exceeding 150 days, unless otherwise agreed to by the Parties in writing.

(b) Notice of Charitability Default. Except as to Charitability Default under Section 6(a)(vi), each Party agrees that if it becomes aware of a Charitability Default it will promptly notify the other Party, and Company shall thereafter provide to the Foundation a proposed strategy to cure the Charitability Default within forty–five (45) days of notification. Notwithstanding anything in this GACA to the contrary, the Foundation will not lose any rights or remedies solely as a result of a failure to notify Company after it becomes aware of a Charitability Default, provided that such failure to notify shall not otherwise impede, prevent, or materially and detrimentally impact the ability and/or expense associated with Company’s cure of such Charitability Default. In addition, Company agrees to promptly notify the Foundation of any facts and circumstances which could reasonably cause a Charitability Default hereunder (including with respect to any Charitability Default under Section 6(a)(i) through (vi)). Subject to Section 15(b), if Company fails to either cure the Charitability Default within ninety (90) days of notice of a Charitability Default (the “Cure Period”) or if such Charitability Default requires additional time to be cured as agreed by the parties (“Extended Cure Period”) and the Company fails to use reasonable and diligent efforts to cure such Charitability Default, then the Foundation will immediately be granted the Global Access License rights set forth in this Section 6. For the avoidance of doubt, if the period of the Force Majeure event or any attempt to cure or any nonperformance (including due to Force Majeure) exceeds one hundred and fifty (150) days from the notice, unless otherwise agreed to by the Parties in writing, the Foundation shall immediately be granted the Global Access License as set forth in Section 6.

(c) License Triggers

(i) If a Charitability Default is not cured by the end of the Cure Period or Extended Cure Period, effective immediately, Company hereby grants a non–exclusive, irrevocable, perpetual, sublicenseable, royalty–free and fully–paid up, worldwide (subject to Section 6(c)(ii) below) license to the Foundation to all intellectual property, technology, know–how, and information owned, controlled or used (subject to reasonably sublicensability by third party licensor(s)) by the Company at the time of such Charitability Default that are necessary or useful to research, develop, make, have made, offer–for–sale, sell, import, export, distribute or use the Product, such license solely to research, develop, make, have made, offer–for–sale, sell, import, export, distribute or use Product for Maternal Immunization intended for the benefit of people in Developing Countries (“Global Access License”). Upon a Global Access License, Company may reasonably seek to assign any and all such intellectual property rights, including third–party licenses, to the Foundation or the Foundation’s licensee as appropriate, and the Foundation will reasonably work with the Company to accept such assignment.

(ii) The Parties agree and acknowledge that in order to achieve Global Access and make the Product available and accessible in Developing Countries, certain activities may be required to occur in one or more Developed Countries, such as manufacture, distribution, or sale (such as to an entity procuring Product for use in Developing Countries). For example, the manufacture of Product (intended for use in Developing Countries) may occur in a Developed Country. Similarly, certain aspects of the distribution or supply chain may occur in (or pass through) one or more Developed Countries, e.g. the Product may be transported through a Developed Country en route to the final destination of the Product in a Developing Country. Similarly, the procurement entities which may purchase Product (for or on behalf of a Developing Country) may be located in a Developed Country or the sales transactions related thereto may occur in a Developed Country, even though the final destination of the Product is a Developing Country. Accordingly, the Global Access License hereunder is intended to permit such Developed Country activities which are incidental or necessary to making the Product available and accessible in Developing Countries.

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

(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.