Provision Language
1. Charitable Purposes and Use of Funds
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The Company understands and acknowledges that a primary organizational objective of the Foundation is to provide funding to support the development of drugs and vaccines to address diseases that have a disproportionate impact on people within developing countries, and to ensure that such products can be made available and accessible at reasonable cost to people within developing countries (the “Global Access Objectives“). The Foundation is forming a strategic partnership with the Company in order to ensure (i) nonexclusive access to the Platform Technology for application to Developing World (defined below) vaccines, therapeutics and diagnostics and (ii) that resulting products (vaccines, therapeutics and diagnostics) are available and accessible at reasonable cost to people within the Developing World. “Developing World” means those countries listed on the attached Appendix 1. “Developed World” means all countries not included in “Developing World.”
3. Permitted Use of Platform Technology by Foundation and Foundation-Supported Entities
To ensure satisfaction of the Global Access Objectives, the Company will commit to the following as a condition to the Foundation making the BMGF Investment (the “Global Access Commitments“):
a. At the request of the Foundation, the Company will receive and process samples from the Foundation or Foundation-Supported Entities (as defined below) and use the Platform Technology to rapidly identify the repertoire of functional antibodies generated in an immune response related to Group 1, Group 2 and Group 3 Diseases and Conditions (the “Services“). The specific terms under which the Company will receive and process samples will be determined in connection with each project, which terms must be acceptable to the Company, the Foundation, and (as applicable) the Foundation-Supported entities providing such samples. For the avoidance of doubt, neither the Foundation nor the Company shall delay or hinder the implementation of this Letter Agreement by unreasonably objecting to such terms. The Services will further include research facilitation translation of the identified repertoire of functional antibodies into one or more clinical candidate for prophylaxis and/or therapy. For clarity, a “Foundation-Supported Entity” is a third party receiving funding from the Foundation, is collaborating with the Foundation, or both, for the purpose of accomplishing the Global Access Objectives. The Services will be subject to the following conditions:
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iii. Any product in the categories below that arises from such research, development, manufacture and is subject to such regulatory approvals may only be sold or distributed by the Foundation (or Foundation-Supported Entities) in accordance with the following (see Appendix II):
(a) For Group 1 Diseases, therapeutic or prophylactic products (both monoclonal/protein and vector/nucleic acid based), vaccines, and diagnostics may be sold or distributed in either the Developing World or the Developed World by the Foundation (or Foundation-Supported Entities) without any milestone payments, royalties or other monetary or non-monetary restrictions imposed on the Foundation (or any such Foundation-Supported Entities) by the Company so long as the Global Access Objectives are pursued by the Foundation (or any such Foundation Supported Entities).
(b) For Group 2 Diseases, therapeutic or prophylactic products (both monoclonal/protein and vector/nucleic acid based), vaccines, and diagnostics may only be sold or distributed in the Developing World by the Foundation (or Foundation-Supported Entities) without any milestone payments, royalties or other monetary or non-monetary restrictions imposed on the Foundation (or any such Foundation-Supported Entities) by the Company so long as the Global Access Objectives are pursued by the Foundation. For Group 2 Diseases, therapeutic or prophylactic products (both monoclonal/protein and vector/nucleic acid based), vaccines, and diagnostics may be sold or distributed in the Developed World by the Foundation (or Foundation-Supported Entities) only if written approval is provided by the Company and in accordance with such terms and conditions as the Company and the Foundation (or Foundation-Supported Entities) may agree.
(c) For Group 3 Diseases, therapeutic or prophylactic products (vector/nucleic acid based, but not including monoclonal/protein), vaccines, and diagnostics may only be sold or distributed in the Developing World by the Foundation (or Foundation-Supported Entities) without any milestone payments, royalties or other monetary or non-monetary restrictions imposed on the Foundation (or any such Foundation-Supported Entities) by the Company so long as the Global Access Objectives are pursued by the Foundation. For Group 3 Diseases, therapeutic or prophylactic products (vector/nucleic acid based, but not including monoclonal/protein), vaccines, and diagnostics may be sold or distributed in the Developed World by the Foundation (or Foundation-Supported Entities) only if written approval is provided by the Company and in accordance with such terms and conditions as the Company and the Foundation (or Foundation-Supported Entities) may agree.
4. Development Other than with BMGF
To the extent the Company utilizes the Platform Technology and successfully develops a vaccine, therapeutic or diagnostic for any of the diseases listed in the definition of Group 1, Group 2 or Group 3 Diseases (i.e., without support from the Foundation or Foundation-Supported Entities), the Company will use reasonably diligent efforts, that take into account both the Global Access Objectives and the Company’s profitability, enterprise value and other commercial interests, to make such product accessible to people most in need within the Developing World. For clarity, nothing in this Letter Agreement shall limit the right or ability of the Company to work, for itself or with a third party, to use the Platform Technology on any products, whether for human use or otherwise. The Company will report to the Foundation if it reasonably believes that a conflict in available capacity may arise as a result of work for itself or a third party. The Company will further report to the Foundation before entering into negotiations for any license or other transfer of rights in the Platform Technology to a third party.
