4. Program-Related Investment Requirements
In consideration of the Investor making, or having made, the Investment on the terms and conditions stated herein and in the Investment Documents, and for other good and valuable consideration, the undersigned hereby agree as follows:
(a) Purposes and Use of Funds
(i) Certain key purposes of the Investment are to provide relief to the poor and distressed, improve the health of those living in Low and Lower-Middle Income Countries (as defined by the World Bank and if approved by the Global Access Committee) (“Target Countries”), and educate health practitioners and public health officials on cost-effective technologies that will improve the health and safety of poor and low-income individuals globally (the “Global Health Objectives”). A portion of proceeds of the Investment will be used by the Company to conduct clinical studies and achieve regulatory approvals for the Program Products, and to otherwise carry out the Global Access Commitments set forth below (collectively, the “Use of Proceeds”).
(ii) The Company acknowledges and understands that a key purpose of the Investor making the Investment is to advance the Global Heath Objectives while seeking a financial return consistent with the Investor’s objectives. The Company confirms it has available personnel to provide available documents to assist in Target Countries, as approved by the Global Access Committee.
(b) Global Access Commitments
(i) Beginning on the date of this Global Health Agreement, the Company shall conduct the following activities to advance the Global Health Objectives during the Term:
(1) The Company shall use commercially reasonable efforts to obtain FDA approvals and clearances, as appropriate for the Program Products.
(2) The Company shall make Program Products available to non-profit organizations and public-sector purchasers in Target Countries (“Global Health Purchasers”) at a price of no more than 30% above the Company’s COGS, in Low-Income Countries and in Low-Middle-Income Countries, if approved by the Global Access Committee (as defined below); provided, however, that any non-profit organization and public-sector purchaser located in Brazil, India, South Africa and Mexico shall need to be approved by the Global Access Committee before qualifying as a “Global Health Purchaser” within the terms of this Global Health Agreement.
(3) The volume of Program Products made available for the Global Health Purchasers under Section4(b)(i)(2) above shall meet the demands of the Global Health Purchasers, as confirmed by the Global Access Committee, up to 20% of the Company’s annual unit sales volume (unless adjusted jointly by a majority of the Board of Directors and Global Access Committee); it being understood, however, that the Company shall have the right to supply more at its sole discretion.
(4) Beginning in the year immediately following year in which any Program Product receives European or FDA approval/clearance, the Company shall allocate $50,000 per year to the Global Access Committee to work on training programs to be conducted by the Company or by partners approved by the Global Access Committee, such as the WHO, Gates Foundation and others, in Target Countries on the use of the Program Products with a target of training leading practitioners each year in the Target Countries, as defined by the Global Access Committee, as well as to work on access and promoting demand in the Target Countries.
(5) The Company shall work with global health authorities and partner organizations, including but not limited to the World Health Organization, the Clinton Health Access Initiative (CHAI), and the Bill & Melinda Gates Foundation (BMGF) and use commercially reasonable efforts to have the Program Products added to protocols and treatment guidelines.
(ii) The Global Access Commitments set forth in this Section 4 shall continue for the Term and shall be fully enforceable by the Investor, notwithstanding any other provision of the Investment Documents.
(iii) In the event that the Program Products are acquired directly or through an acquisition of the Company by a third party, the Global Access Commitments contained in this Global Health Agreement shall continue to survive for the Term and shall be assumed by the acquirer.
(c) Global Access Committee and Global Access Coordinator
Promptly following the execution of this Global Health Agreement or at an alternate time approved by the Company Board of Directors and the AXA board representative, the Company will form a joint steering committee (the “Global Access Committee”) to oversee the Company’s efforts in Target Countries. The Global Access Committee shall be comprised of up to four (4) members: (i) one individual appointed by the Company; (ii) one individual appointed by the Investor (the “AXA IM Prime Impact Fund Appointee”); and (iii) up to two additional individuals unaffiliated with the Company or the Investor, and appointed upon mutual agreement of the Company and the Investor. Decisions on the Global Access Committee shall be made by majority vote, including the affirmative vote of the AXA IM Impact Fund Appointee.
The Global Access Coordinator, who shall initially be David Shoultz (or another person mutually agreeable to the Company and AXA IM Impact Fund), will lead the Company’s efforts to market the Products to Global Health Purchasers in Target Countries and to ensure overall customer success in Target Countries, in accordance with a plan to be prepared by the Global Access Committee on or prior to March 31, 2021 (the “Global Access Plan”). The activities of the Global Access Coordinator, which activities shall be consistent with the Global Access Plan, shall be overseen jointly by the Company’s senior management and the Global Access Committee.