Provision Language
EXHIBIT E: Global Access for Essential Medicines
1. DEFINITIONS
1.1. “GAVI COUNTRY” 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.
1.2. “HUMANITARIAN PURPOSES” 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 fee–for–service, fee–for–product 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 locally–affordable prices.
1.3. “NON–GAVI COUNTRY” shall mean any country that is not listed as eligible to receive support from the GAVI.
1.4. “QUALIFIED HUMANITARIAN ORGANIZATION” shall mean any governmental agency, non–governmental agency or other not–for–profit organization, including FNIH, that has as one of its bona fide missions to address the public health needs of underserved populations on a not–for–profit basis. For clarity, Qualified Humanitarian Organizations do not include non–governmental agencies and non–for–profit organizations that are formed or established for the benefit of any for–profit entity.
2. GRANT
The licensed Patent Rights 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.
3. RETAINED RIGHTS
HUMANITARIAN PURPOSES. 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 non–exclusive, and shall expressly prohibit the distribution or use of any LICENSED PRODUCT or LICENSED SERVICE in any NON–GAVI country. Prior to entering such license, RIH will notify LICENSEE, who shall have the first right to negotiate a license direct to the organization.
4. SUBLICENSING
4.1. The Parties will cooperate such that essential medicines which may be developed under this License can be made available in economically disadvantaged nations. Elkurt agrees to consider reasonable requests of LICENSEE for a commensurate reduction of royalty and sublicensing fees in circumstances where LICENSEE demonstrates to the satisfaction of Elkurt (and RIH, SCRI and FNIH as the case may be) that LICENSED PRODUCTS are or will be made available in such nations at reduced cost.