1. Charitable Purposes and Use of Funds
The Foundation is making the Foundation Investment as a “program-related investment” within the meaning of Section 4944(c) of the U.S.Internal Revenue Code (the “Code”). The Foundation’s primary purpose in making the Foundation Investment is to further significantly the accomplishment of the Foundation’s charitable purposes, including the relief of the poor and distressed or of the underprivileged, the advancement of science, or the promotion of health by seeking to (i) address global health challenges that disproportionately impact developing countries, and (ii) 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 (collectively, the “Charitability Requirement”).
The Foundation believes that the Platform Technology has potential broad application in a variety of Foundation Priority Areas (defined below), and that applications of and improvements to the Platform Technology, in conjunction with the Global Access Commitments described below, 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 and with all due speed to people within developing countries (the “Global Access Objectives”). The Foundation is forming a strategic relationship with the Company in order to further the Global Access Objectives by ensuring (i) access to the Platform Technology for application to products in Developing Countries (defined below), (ii) access to Disease Information that may be requested by the Foundation and (iii) that resulting products are available and accessible at reasonable cost to people within Developing Countries, in particular, all as set forth in this Letter Agreement. For the purposes of this Letter Agreement, “Developing Countries” means those countries listed on the attached Appendix 2, which list may be modified from time to time by mutual agreement between the Foundation and the Company. The Foundation and the Company shall in good faith discuss the appropriate allocation and coordination of commercial distribution rights in Developing Countries that have both public and private markets, while ensuring that the Global Access Objectives in Developing Countries are achieved. “Developed World” means all countries not included in the definition of Developing Countries. “Disease Information” means information generated by the Company or its research contractors related generally to diseases within Foundation Priority Areas, and shall specifically exclude the Platform Technology.
The Foundation has identified certain areas of global health as underinvested or disproportionately impacting poor and vulnerable populations. For purposes of this Letter Agreement, these areas are called “Foundation Priority Areas” and are currently the following: rotavirus, cholera, typhoid, Escherichia coli, shigella, hepatitis A & E, geohelminths, HIV/AIDS, malaria, pneumonia causing infectious diseases (including respiratory syncytial virus), tuberculosis, polio, meningitis, measles, diphtheria, tetanus, pertussis, influenza, Japanese encephalitis, dengue, African trypanosomiasis, visceralleishmaniasis, Guinea worm, onchocerciasis, lymphatic filariasis, cysticercosis, schistosomiasis, trachomoa, soil-transmitted helminthes, and humanpapillomavirus. The list of Foundation Priority Areas may be modified from time to time by mutual agreement between the Foundation and the Company.
2. Global Access Commitments
The following paragraphs ensure satisfaction of the Global Access Objectives and represent the Company’s “Global Access Commitments”.
Subject to the provisions of this Letter Agreement, the Company will not grant to a third-party any rights to or enter into any arrangements with respect to, the Platform Technology that would prohibit, prevent or otherwise significantly restrict the Company (or any acquirer of the Platform Technology) from fulfilling these Global Access Commitments.
(a) Unfunded Development Programs:
Other than with respect to the [**] Program and the Future Development Programs (which are addressed in subsection (c)), the Company hereby grants to the Foundation non-exclusive, sub-licensable license rights to any antibodies and Disease Information requested by the Foundation that the Company or its research contractors discover in Foundation Priority Areas within the longer of twelve (12) months following the consummation of a Sale Transaction (as such term is defined below) and the three (3) year period following the payment of the last Tranche of the Foundation Investment, including, for the avoidance of doubt, but not limited to, the Visterra Influenza Antibody. The foregoing non-exclusive license may be used worldwide by or on behalf of the Foundation (or Foundation–funded entities) and their respective sublicensees, in connection with (i) research and development (ii) manufacture, and (iii) regulatory approval processes so long as the principal focus of such activities is to ensure satisfaction of the Global Access Objectives in Foundation Priority Areas. Any product that arises from or is subject to such research, development and manufacturing activities may only be sold or distributed by or on behalf of the Foundation (or Foundation-supported Entities or sublicensee) in Developing Countries in Foundation Priority Areas without any milestone payments, royalties or other monetary or non-monetary restrictions imposed. For the purposes of this Letter Agreement, 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 Global Access Objectives.
The Foundation will notify the Company in writing if it desires to receive Disease Information. The Company will provide such Disease Information promptly to the Foundation and in a form and format to be mutually agreed. In the event the Company reasonably determines, in its good faith judgment, that any such Disease Information is confidential information of the Company, it shall be eligible for protection as provided for in a confidentiality agreement to be negotiated between the Company and the Foundation.
The Company will notify the Foundation in writing of the Company’s (alone or through a third party) intended development or commercialization of antibodies in the Foundation Priority Areas (other than with respect to the [**] Program and the Future Development Programs, which are addressed in subsection (c)).
In the event that the Company (alone or through a third party) is developing and commercializing the same antibodies in the Developed World as the Foundation (alone or through a third party) is developing, the Foundation and the Company agree to notify each other of such activities and, to the extent feasible, coordinate all activities with each other to ensure no negative impact on the research, development and commercialization of such antibodies being undertaken by the other party in the Developed World or Developing Countries, as the case may be. Notwithstanding the foregoing, (i) each of the Company and the Foundation shall have ultimate decision-making authority over such development and commercialization activities but shall consider in good faith the views of the other party, and (ii) if the Company is developing and/or commercializing any such antibodies with a major biopharmaceutical company (defined as a company which, together with its affiliates, had annual revenues in excess of $[**] in its latest fiscal year), and such biopharmaceutical company, in good faith, believes that such activities would have a negative impact on its development and commercialization of such antibodies, the Company shall provide written notice to the Foundation, and the Foundation, the Company and such biopharmaceutical company shall meet to discuss the issues raised by the biopharmaceutical company and such parties shall develop, acting in good faith, a written plan to resolve such issues. For the purpose of clarity, the Company and the Foundation agree that the sale or distribution of such antibodies or vaccines, therapeutics or other products embodying such antibodies at low or zero price in Developing Countries is consistent with the Global Access Objectives and does not and will not negatively impact commercialization of such antibodies, provided that the Foundation exercises diligent efforts to prevent the sale and distribution in the Developed World of antibodies intended for sale and distribution in Developing Countries.
Notwithstanding the foregoing, in the event that the Company intends to enter into an agreement with a major biopharmaceutical company (as defined above), with a demonstrable corporate commitment to serving patients in Developing Countries and a clear written plan for achieving the Global Access Objectives, for the development and commercialization of products in one or more Foundation Priority Areas in a manner consistent with the Global Access Objectives, upon written request of the Company, the Foundation shall relinquish its non-exclusive rights in the applicable Foundation Priority Area(s). The Company shall provide the Foundation with the applicable provisions of the agreement with such third party relating to the Global Access Objectives and shall consider in good faith suggestions from the Foundation relating to such agreement. Moreover, the Company shall report (or cause such third party to report) to the Foundation on a semi-annual basis regarding the progress of the Company and such third party in connection with the Global Access Objectives in such Foundation Priority Area(s). If the Foundation believes that the Global Access Objectives are not being met, it shall provide notice to the Company, and the Foundation, the Company and such third party shall meet to discuss the issues raised by the Foundation and such parties shall develop, acting in good faith, a written plan to resolve such issues. The non-exclusive rights in the applicable Foundation Priority Area(s) specified in this section shall be considered to be in force in favor of the Foundation if and when the agreement between theCompany and such major biopharmaceutical company is terminated.
(b) Funded Development Programs:
Currently, the [**] Program is the only Funded Development Program. Subject to additional financial support from the Foundation and on more specific terms to be determined in connection with each program, which terms must be mutually acceptable to both the Company and the Foundation, the Company will use the Platform Technology for antibody discovery efforts in mutually agreed upon Foundation Priority Areas, including, in particular, dengue and, potentially, further [**]-related programs (the “Future Development Programs”).
(c) [**] Program/Future Development Programs:
(i) Election: With respect to the [**] Program and any Future Development Program (each, a “Program”) (on a Program-by-Program basis) theCompany and the Foundation will mutually decide either (A) that the Company (alone or through a third party) will accomplish the Global Access Objectives for such Program as provided in subsection (ii) below (the “Diligence Election”), or (B) to provide the Foundation with the rights set forth in subsection (iii) below for such Program (the “Rights Grant Election”). Unless otherwise provided for in Appendix 1 or in similar appendices or documents pertaining to any Future Development Program, the Company and the Foundation shall make such election for each Program on or before the completion of the first Phase 2 clinical trial in such Program, provided that if the Company and Foundation are unable to agree, in good faith, on such an election for such Program within such timeframe, then the Company shall have the right to unilaterally make such election and shall notify the Foundation of such election in writing within thirty (30) days of making such election. In making such election, the Company shall consider in good faith the Foundation’s views on such Program.
(ii) Diligence Election: If the Diligence Election is made for a Program, the Company (alone or through a third party) shall use ReasonableEfforts to develop and commercialize at least one (1) product arising from such Program in Developing Countries in a manner consistent with the Global Access Objectives. The Company shall report to the Foundation on a semi-annual basis regarding the progress of the Company and any partners/licensees in connection with the applicable Program. In the event the Company discontinues work to develop and commercialize the product, or fails to exercise Reasonable Efforts to do so, the provisions of Sections 2(c)(iii) and (v) shall apply. As used herein, the term “Reasonable Efforts” means efforts that (a) are consistent with the Global Access Objectives and (b) would typically be devoted to the diligent research, development and commercialization of products in the Developing Countries that have attributes similar to those of the potential products in the applicable Program, including scientific attributes, safety and efficacy, product profile, availability of competitive products, proprietary position, regulatory pathways and manufacturing and cost considerations, all in the context of theGlobal Access Objectives. Efforts by partners or licensees of the Company shall be considered to constitute efforts by the Company.
(iii) General Provisions Governing Rights Grant Election: If the Rights Grant Election is taken, the following general provisions shall apply to the applicable Program:
A. Any antibodies that the Company controls wholly or in part relating to such Program (together with any applicable Platform Technology necessary to develop or commercialize such antibodies) may be used on a non-exclusive, worldwide basis (except as provided in subsection (iv)) by or on behalf of the Foundation (or Foundation-supported Entities) and their respective sublicensees in research, development, manufacture, sale, distribution, and regulatory approval processes in Foundation Priority Areas with respect to products arising out of such Program, without any milestone payments, royalties or other monetary or non-monetary restrictions imposed.
B. The Company agrees to use reasonable efforts to enable the Foundation, Foundation-supported Entities or others engaged in work on the Program on behalf of the Foundation to exercise their non-exclusive rights to use intellectual property in the manner provided for in Sections 2(c)(iii) and(iv). Such steps may include, as required, licensing of relevant intellectual property or agreements to not assert such intellectual property.
(iv) Company Continues Program Activities Post-Election: In the event the Company (alone or through a third party) continues to develop or commercialize a product after the Rights-Grant Election, products arising out of such Program may be sold or distributed by or on behalf of the Foundation (or Foundation-supported Entities) worldwide in Foundation Priority Areas in a manner that furthers the Global Access Objectives. The Foundation hereby grants to the Company non-exclusive license rights (with rights to sublicense) to any product that arises from or is subject to such research, development and manufacturing activities by or on behalf of the Foundation (“Foundation Products”) for research, development, manufacturing, regulatory approval processes, sale and distribution world-wide without any milestone payments, royalties or other monetary or non-monetary restrictions imposed on theCompany (or any of its licensees or sublicensees) by the Foundation. In the event that the Company (alone or through a third party) is developing and commercializing the same product in the Developed World as that being sold or distributed by the Foundation in Developing Countries, the Foundation and theCompany will, to the extent feasible, coordinate all activities with each other to ensure no negative impact on the research, development and commercialization of such Foundation Product by the Company or the Foundation in the Developed World or Developing Countries, respectively. For the purpose of clarity, the Company and the Foundation agree that the sale or distribution of such a product at low or zero prices in Developing Countries is consistent with the Global Access Objectives and would not negatively impact commercialization of such antibodies, provided that the Foundation exercises diligent efforts to prevent the sale and distribution in the Developed World of Foundation Products intended for sale and distribution in Developing Countries.In the event the Company discontinues Program activities to develop and commercialize the product or fails to exercise Reasonable Efforts to do so, the provisions of Sections 2(c)(iii) and (v) shall apply.
(v) Company Discontinues Program Activities Post-Election: In the event that the Company (alone or through a third party) does not continue to develop or commercialize at least one product from a Program after a Rights-Grant Election, the Products from such Program may be sold or distributed by or on behalf of the Foundation or Foundation-supported Entities, and each of their respective licensees), exclusively world-wide. Sales and distribution in Developing Countries in Foundation Priority Areas will be on terms and conditions that meet the Global Access Objectives.
(vi) Third Party Costs: The Foundation shall be solely responsible for all costs and liabilities arising out of its exercise of the licenses granted under Section 2 of this Letter Agreement, including all costs for intellectual property licenses. The Foundation agrees that it will, as a condition to the grant of any sublicense, obtain agreement by its sub-licensees to indemnify the Company for all costs, liabilities and expenses arising from the conduct of activities by or on behalf of such sub-licensees in exercising such sub-licenses.
Appendix 2: Developing Countries
Developing Country – A country eligible for GAVI support, plus Thailand and South Africa, currently including: Afghanistan, Bangladesh, Benin, Burkina Faso, Burundi, Cambodia, Cameroon, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Côte d’Ivoire, Djibouti, East-Timor, Eritrea, Ethiopia, Gambia, Ghana, Guinea, Guinea Bissau, Haiti, India, Kenya, DPR Korea, Kyrgyz Republic, PDR Lao, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mozambique, Myanmar, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Papua New Guinea, Rwanda, São Tomé e Príncipe, Senegal, Sierra Leone, Solomon Islands, Somalia, South Africa, Thailand, North Sudan, South Sudan, Tajikistan, Tanzania, Togo, Uganda, Uzbekistan, Viet Nam, Yemen, Zambia, and Zimbabwe.