Provision Language
1. Charitable Purposes and Use of Funds
The Foundation is making the BMGF Investment as a “program-related investment” within the meaning of Section 4944(c) of the U.S. Internal Revenue Code (the “Code“), and the Foundation’s primary purpose in making the BMGF Investment is to further significantly the accomplishment of its charitable purposes, including the relief of the poor and distressed, by seeking to (a) address global health challenges that disproportionately impact developing countries and (b) increase the access of poor and distressed individuals and families in the developing world to life-saving and other important vaccines and drugs, that can improve their health care (“Charitability Requirement“). The Company shall use proceeds from the BMGF Investment for the charitable purposes described herein by supporting development of the Company’s technology to perform single-cell analyses of immune responses, including (a) rapidly identifying the repertoire of functional antibodies generated in an immune response by using DNA barcoding to enable high-throughput sequencing of paired immunoglobulin heavy and light chain genes from individual activated B cells generated in an immune response; (b) rapidly identifying T cell repertoires generated in an immune response by using DNA barcoding to enable high-throughput sequencing of paired T cell receptor genes (such as alpha/beta and gamma/delta TCRs) from individual T cells generated in an immune response; and (c) rapidly profiling gene expression by using molecular barcoding to enable high-throughput sequencing and quantification of nucleic acids from individual lymphocytes (the “Platform Technology“) necessary for the Company to make the Global Access Commitments (as defined in Section 3). The Foundation believes that because of the broad applicability of the Platform Technology to the development of vaccines, drugs and diagnostics necessary to address global health concerns, the further development and improvements of the Platform Technology, in conjunction with the Global Access Commitments (defined in Section 3), will achieve the Charitability Requirement.
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.”
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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:
i. The Services will be funded by a grant or contract from the Foundation or Foundation-Supported Entities.
ii. The results of the Services provided by the Company to the Foundation or Foundation-Supported Entities per each project plan may be used worldwide by the Foundation (or Foundation-Supported Entities) in research, development, manufacture and regulatory approval processes 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), subject to Section 3.a.iii.
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.
iv. Immediately following the execution of this Agreement, the Company will reserve for the Foundation and Foundation-Supported Entities a capacity of sample processing and sequence generation for single-cell analysis of at least 3,000 lymphocytes per week, and a capacity of 10,000 lymphocytes per week for discrete periods of time with a three-month advance notice and commitment by the Foundation to the Company to utilize such increased capacity.
v. The Company agrees to set a price for the Services that is commercially reasonable and that reflects the needs, including price sensitivity, of people most in need within the Developing World.
b. Within the Developing World, the Foundation has rights to manufacture or have manufactured and the rights to develop and commercialize the vaccines, therapeutics and diagnostics for diseases and conditions that are not Group 1, Group 2 or Group 3 Diseases that arise from information gained through Services provided by Company to the Foundation or Foundation-Supported Entities, so long as the Global Access Objectives are pursued by the Foundation, and in accordance with such terms and conditions as the Company and the Foundation (or Foundation-Supported Entities) may agree. Within the Developed World, the Foundation’s rights to manufacture or have manufactured and the rights to develop and commercialize the vaccines, therapeutics and diagnostics for diseases and conditions that are not Group 1, Group 2 or Group 3 Diseases that arise from information gained through Services provided by Company to the Foundation or Foundation-Supported Entities are subject to written approval by the Company and may be open to negotiations on a case-by-case basis.
c. The Company agrees to use commercially reasonable efforts to enable the Foundation or Foundation-Supported Entities to exercise their rights to use the results of the Services provided by the Company in research, development, manufacture and regulatory approval processes and in connection with the permitted sale or distribution of products in accordance with this Section 3.
