Master Alliance Provisions Guide (MAPGuide)

Elkurt – Ocean Biomedical, Malaria Vaccine, Exclusive License Agreement

  • Equitable Access | Ensuring continuity

<p><span style=”textdecoration: underline;”><strong>EXHIBIT E: Global Access for Essential Medicinesstrong>span>p>
<p><strong>1. DEFINITIONSstrong>p>
<p>1.1. “<strong>GAVI COUNTRYstrong>” shall mean any country listed as eligible to receive support from the GAVI Alliance (formerly known as the Global Alliance for Vaccines and Immunisation), as such list may be updated from time to time by the GAVI Alliance.p>
<p>1.2. “<strong>HUMANITARIAN PURPOSESstrong>” shall mean practice of PATENT RIGHTS in the prevention or treatment of disease in humans by or on behalf of any Qualified Humanitarian Organization (including, for clarity, practice of PATENT RIGHTS by contractors, manufactures or distributors acting for or on behalf of such Qualified Humanitarian Organizations on a feeforservice, feeforproduct or charitable basis) for the benefit of the developing world: (a) to use, manufacture, make, have made, produce, reproduce, distribute, copy, offer to sell and sell LICENSED PRODUCTS anywhere in the world for the sole and express purposes of distribution and use of such LICENSED PRODUCTS in one or more GAVI Countries, and (b) to sell or otherwise distribute LICENSED PRODUCTS for use solely in one or more GAVI Countries; provided, however, that sales and distribution of LICENSED PRODUCTS shall not be deemed made for Humanitarian Purposes unless products are distributed at locallyaffordable prices.p>
<p>1.3. “<strong>NONGAVI COUNTRYstrong>” shall mean any country that is not listed as eligible to receive support from the GAVI.p>
<p>1.4. “<strong>QUALIFIED HUMANITARIAN ORGANIZATIONstrong>” shall mean any governmental agency, nongovernmental agency or other notforprofit organization, including FNIH, that has as one of its bona fide missions to address the public health needs of underserved populations on a notforprofit basis. For clarity, Qualified Humanitarian Organizations do not include nongovernmental agencies and nonforprofit organizations that are formed or established for the benefit of any forprofit entity.p>
<p><span style=”textdecoration: underline;”><strong>2. GRANTstrong>span>p>
<p>The licensed <a href=”#kt“>Patent Rightsa> were developed with funding from FNIH. Subject to the provisions of Subsection 3 below, and in conjunction with the rights granted in that subsection, LICENSEE shall grant to FNIH a nonexclusive, irrevocable, perpetual, transferable, royalty free license with the right to sublicense, to use, manufacture, make, have made, produce, reproduce, distribute, copy, offer to sell, and sell solely for the benefit of the developing world, inventions of any SECONDARY PATENTS, to be exercised by FNIH at its sole discretion which FNIH has agreed FNIH will not undertake unless FNIH, after consultation with the LICENSEE, determines that the LICENSEE has not, within a reasonable time, made the FNIH supported invention and the subject of the SECONDARY PATENTS, available to the developing world in a manner consistent with the global access plan and the charitable objective of the FNIH funding.p>
<p><span style=”textdecoration: underline;”><strong>3. RETAINED RIGHTSstrong>span>p>
<p><strong>HUMANITARIAN PURPOSES.strong> Elkurt, (and for the benefit of RIH, SCRI and FNIH) retains the right to license the TECHNOLOGY, including LICENSED PATENT(S), to a QUALIFIED HUMANITARIAN ORGANIZATION, including FNIH, for HUMANITARIAN PURPOSES, provided that any such license shall be nonexclusive, and shall expressly prohibit the distribution or use of any LICENSED PRODUCT or LICENSED SERVICE in any NONGAVI country. Prior to entering such license, RIH will notify LICENSEE, who shall have the first right to negotiate a license direct to the organization.p>