Master Alliance Provisions Guide (MAPGuide)

AXA Prime Impact Master Fund – Revelation Biosciences, Diagnostics & Therapeutics for Viral Infections, Global Health Agreement

  • Equitable Access | Access plans & principles

<p class=”p1“><span style=”textdecoration: underline;”><strong>4. ProgramRelated Investment Requirements<span class=”Appleconvertedspace“> span>strong>span>p>
<p class=”p1“>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:<span class=”Appleconvertedspace“> span>p>
<p class=”p1“><strong>(a) Purposes and Use of Funds<span class=”Appleconvertedspace“> span>strong>p>
<p class=”p1“>(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 LowerMiddle Income Countries (as defined by the World Bank and if approved by the Global Access Committee) (“<em><strong>Target Countriesstrong>em>”), and educate health practitioners and public health officials on costeffective technologies that will improve the health and safety of poor and lowincome individuals globally (the “<em><strong>Global Health Objectivesstrong>em>”). 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 “<em><strong>Use of Proceedsstrong>em>”).<span class=”Appleconvertedspace“> span>p>
<p class=”p1“>(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 Investors objectives. The Company confirms it has available personnel to provide available documents to assist in Target Countries, as approved by the Global Access Committee.<span class=”Appleconvertedspace“> span>p>
<p class=”p1“><strong>(b) Global Access Commitments<span class=”Appleconvertedspace“> span>strong>p>
<p class=”p1“>(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:<span class=”Appleconvertedspace“> span>p>
<p style=”paddingleft: 25px;”>(1) The Company shall use commercially reasonable efforts to obtain FDA approvals and clearances, as appropriate for the Program Products.p>
<p style=”paddingleft: 25px;”>(2) The Company shall make Program Products available to nonprofit organizations and publicsector purchasers in Target Countries (“<em><strong>Global Health Purchasersstrong>em>”) at a price of no more than 30% above the Companys COGS, in Low-Income Countries and in LowMiddleIncome Countries, if approved by the Global Access Committee (as defined below); provided, however, that any nonprofit organization and publicsector purchaser located in Brazil, India, South Africa and Mexico shall need to be approved by the Global Access Committee before qualifying as aGlobal Health Purchaserwithin the terms of this Global Health Agreement.p>
<p style=”paddingleft: 25px;”>(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 Companys 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.p>
<p style=”paddingleft: 25px;”>(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.p>
<p style=”paddingleft: 25px;”>(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 &amp; Melinda Gates Foundation (BMGF) and use commercially reasonable efforts to have the Program Products added to protocols and treatment guidelines.p>
<p class=”p1“>(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.<span class=”Appleconvertedspace“> span>p>
<p class=”p1“>(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.<span class=”Appleconvertedspace“> span>p>
<p><strong>(c) Global Access Committee and Global Access Coordinator strong>p>
<p><span style=”fontweight: 400;”>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 “<em><strong>Global Access Committeestrong>em>”) to oversee the Companys 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 (theAXA 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 Appointeespan>p>
<p><span style=”fontweight: 400;”>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 Companys 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 “<em><strong>Global Access Planstrong>em>”). The activities of the Global Access Coordinator, which activities shall be consistent with the Global Access Plan, shall be overseen jointly by the Companys senior management and the Global Access Committee.span>p>