Provision Language
2. PRI Requirements
In consideration of Adjuvant making the Investment on the terms and conditions stated in the Investment Documents (including this Global Health Agreement), and for other good and valuable consideration, the undersigned hereby irrevocably agree to the program-related investment requirements (“PRI Requirements”) as follows:
(a) Purposes and Use of Funds
(i) The charitable purposes of the Investment are to provide relief to the poor and distressed, advance science, and improve the health of those living in Target Countries around the world by, among other things, ensuring that innovative and affordable drugs to treat disease are made available for use in public health programs for the benefit of the poor and distressed and made available for purchase in the Target Countries (the “Global Health Objectives”). The proceeds of the Investment will be used by the Company in particular (A) to support the research and clinical development program for Epetraborole for infectious diseases and (B) to thereby facilitate the advancement of Epetraborole indicated for melioidosis, tuberculosis, and any other mutually agreed upon products and/or claims by Adjuvant and the Board of Directors of the Company (together, the “Global Access Products”), in order to further the Global Health Objectives and otherwise carry out the Global Access Commitments set forth below, without impairing the sustainability of the Company.
(ii) The Company acknowledges and understands that the purpose of Adjuvant making the Investment is to advance the Global Health Objectives while seeking a financial return consistent with Adjuvant’s charitable objectives. The Company confirms that, with the funding to be provided by the Investment, the Company has sufficient resources to comply with the PRI Requirements for a certain period of time.
(b) Global Access Commitments. The Company shall engage in the following activities in order to advance the Global Health Objectives (the “Global Access Commitments”).
(i) The Company acknowledges the importance of these Global Access Commitments and that their purpose is to ensure that innovative and affordable drugs to treat disease are made available for use in public health programs and private purchase in (i) melioidosis-endemic and melioidosis-at-risk countries and (ii) tuberculosis-endemic and tuberculosis-at-risk countries listed in Exhibit 1 (the “Target Countries”), as agreed to by the Company and Adjuvant.
(ii) The Company shall use its reasonably diligent endeavors to make the Global Access Products accessible to most people in need in the Target Countries, to the extent such access can be achieved on terms that are commercially reasonable for the Company. For the avoidance of doubt, the Company agrees that the maximum price of Global Access Products in the Target Countries will be capped at cost of sales plus 25%. In no event shall the Company be obligated to sell the Global Access Products at a loss.
(iii) In addition to the Investment, the Company shall also actively seek funding from government grants and other granting sources to advance the development of the Global Access Products. Furthermore, the Company shall also use its reasonably diligent endeavors to enter into good faith negotiations with the Gates Medical Research Institute.
(iv) The Company shall develop regulatory strategies for the Global Access Products that in the opinion of the Company and Adjuvant, acting reasonably advances the Global Health Objectives, and it shall pursue the necessary product registrations for its Global Access Products in the Target Countries.
(v) The Company shall make the Global Access Products available to both public and private purchasers in the Target Countries at a reasonable volume that is sufficient to meet the demands of non-profit organization and public-sector purchasers in accordance with a tiered pricing framework that is commercially reasonable for the Company, in the opinion of the Company and Adjuvant, acting reasonably, and that reflects the needs, including price sensitivity, of low-income patients in the Target Countries. The tiered pricing framework shall include pricing based on the type of buyer (public or private) and the geographic location of such buyer.
(vi) The Global Access Commitments set forth in this Section 2 shall continue with respect to each Global Access Product (i) until Adjuvant ceases to be a shareholder of the Company or (ii) 10 years following Epetraborole approval for each respective Global Access Product by a stringent regulatory authority such as the US Food and Drug Administration or the European Medicines Agency, to be selected by the Company in its reasonable discretion, whichever event ((i) or (ii)) occurs later, and shall be fully enforceable by Adjuvant, notwithstanding any other provisions of the Investment Documents. Thereafter, the Company will consider in good faith any recommendation of Adjuvant to make the Global Access Products available in the Target Countries in order to advance the Global Access Objectives.
(vii) The Company shall use best efforts to ensure that its licensees, partners, and distributors in the Target Countries, or any assignee or transferee of its Intellectual Property relating to the Global Access Products, agree to comply with the Global Access Commitments in connection with their access to or use of the Global Access Products.
(viii) In the event of the assignment, sale, exclusive license, or other transfer of the Global Access Products, and/or related technology, the Global Access Commitments shall survive and the Company shall ensure that the Global Access Commitments are assumed by the purchaser, transferee, licensee, or acquirer. Adjuvant shall have the right to review the provisions of the written agreement with such third party that relate to the assumption of the Global Access Commitments to confirm that the Global Access Commitments will survive and be assumed by the third party. The Company shall not grant to a third party any rights or enter into any arrangements, amendments, or agreements that would limit or restrict Adjuvant’s rights to enforce the Global Access Commitments or the Company’s obligations to satisfy the Global Access Commitments, unless such third party expressly assumes such Global Access Commitments to the satisfaction of Adjuvant.