Provision Language
EXHIBIT E. GLOBAL ACCESS FOR ESSENTIAL MEDICINES
Subject to any requirements of relevant laws, rules, regulations, guidelines and standards of all relevant jurisdictions, as well as all obligations and retained rights applicable to the Licensed Patent Rights, including without limitation those set forth in Section 2.1 and 2.2 of this Agreement, the following terms shall be deemed to be a part of this Agreement. For clarity, this provision does not require Company to license, or permit JHU to license on its behalf, any of its information or intellectual property or products to any third party.
1. DEFINITIONS
“GAVI Country” shall mean any country listed as eligible to receive support from the GAVI Alliance (as such list may be amended from time to time, provided it shall not include any major market countries or Brazil, Russia, India or China.)
“Humanitarian Purpose” shall mean practice of the Licensed Patent Rights by a Qualified Humanitarian Organization to manufacture Licensed Products in GAVI Countries for which no reasonable alternatives exist in such GAVI Countries, for the sole and express purposes of distribution of such Licensed Products in one or more GAVI Countries solely in the Public Charitable Market for end use by low-income end users in such GAVI Country at actual cost (with no profit) or no cost to the end user or the end user’s governmental entities.
“Non-GAVI Country” shall mean any country that is not a GAVI Country.
“Qualified Humanitarian Organization” shall mean any not-for-profit organization that addresses the public health needs of underserved populations solely on a not-for-profit basis. For clarity, Qualified Humanitarian Organizations do not include governmental organizations, foundations, generic biological or pharmaceutical companies, and foundations or non-for-profit organizations that are formed or established for the benefit of, or which partner with, or support, any for-profit or governmental entity.
“Public Charitable Market” shall mean markets that, due to economic circumstance and public health emergency cannot afford to purchase Licensed Products at the cost for which such Licensed Products are available in their country. The Public Charitable Market shall not include product tender markets (such as PAHO or UNICEF) or private markets.
2. Limited Retained Rights. Should Company have no plans to commercialize Licensed Product in GAVI Countries, subject to all other terms and requirements herein, JHU has the right to grant a nonexclusive license to the Licensed Patent Rights (but not jointly-owned Licensed Patent Rights) to a Qualified Humanitarian Organization solely for Humanitarian Purposes in the Public Charitable Market, but only as needed to produce products for end use in GAVI Countries. Such a license shall not be granted until (i) Company has developed a Licensed Product or Licensed Service that is proven to be capable of scalable manufacture that permits distribution (including all relevant logistical considerations) and sale of the Licensed Product or Licensed Service in GAVI Countries at locally-affordable prices (with a reasonable profit and while reasonably protecting other markets) and with consistent quality, and (b) after the Company has a bona fide offer to do so with a viable manufacturing and commercial partner proven to be capable of effectively working in the GAVI Country in compliance with all relevant laws, rules, regulations, guidelines and standards, and the Company refuses such opportunity without a reasonable explanation as to the reasons why the same would not be commercially reasonable. The third-party license shall terminate automatically if (i) any Licensed Product (whether or not in development) is made available in any Non-GAVI Country directly or indirectly by the licensee, or if any other intellectual property of Company or JHU is infringed or misappropriated by the making, using, selling or importation of any relevant products, or (ii) a compulsory license is granted in such jurisdiction. Prior to entering any licenses with third parties pursuant to this provision, JHU will give at least twelve (12) months’ prior written notice to Company of JHU’s intent to consider or enter into such a license or manufacture and distribute in such market on its own, which notice will include all pertinent information concerning the opportunity, and Company shall have the first right to negotiate a license directly with the organization.
3. Expansion into New Markets. The Company shall consider how it might effectively and efficiently manufacture and sell Licensed Product and Licensed Services into GAVI Countries and whether such plans are reasonable and feasible in light of the logistical, quality, manufacturing, economic and scientific challenges related thereto, as well as the demonstrated need therefor in light of medical alternatives and other relevant factors. In connection therewith, JHU agrees to consider reasonable requests of Company for a commensurate reduction of royalty and sublicensing fees in circumstances where Company demonstrates to the satisfaction of JHU that Licensed Products are or will be made available in such developing nations at reduced cost, as compared to the U.S. market and taking into account a reasonable profit.