Provision Language
Definitions
“CELL LINES” shall mean cell lines listed in Exhibit B hereto. Cell Lines shall also include any additional cell lines transferred to Company pursuant to Section 5.8 of this Agreement.
“FIELD” shall mean any use of GVAX-related products (including without limitation GVAX in combination with other elements) including, without limitation, human, veterinarian or diagnostic uses.
“LICENSED IP” means the Licensed Patent Rights, Licensed Technology, and Cell Lines. For clarity, Licensed IP shall not include (i) any information, technology, patent rights, materials, and cell lines already owned or controlled by Company or to which Company already has access, or independently developed by Company, (ii) any information, technology, patent rights, materials, and cell lines licensed to, provided to or to which access is given, or owned by the Company under an agreement other than this Agreement, and (iii) any intellectual property that is provided to Company as part of this Agreement, but is not accepted by Company or is removed from this Agreement by the Company by written thirty (30) days’ notice from the Company to JHU.
“LICENSED PATENT RIGHTS ” include (i) the patent applications listed in Exhibit A hereto, and (ii) any patent or patent application claiming priority thereto or common priority therewith including all divisions, continuations-in-part (but only to the extent that the claims of each such continuation-in-part application are directed to subject matter specifically described in (i)),and all divisions and continuations thereof, all U.S. patents issuing thereon and reissues, reexaminations, renewals and extensions thereof, any corresponding foreign patent applications, and any patents, or other equivalent foreign patent rights issuing, granted or registered thereon.
“LICENSED PRODUCT(S)” as used herein in either singular or plural shall mean any process or method, material, compositions, drug, or other product, the manufacture, use or sale of which by Company, its Affiliates and/or Sublicensees (i) would constitute, but for a license granted to Company, an infringement of a Valid Claim of Licensed Patent Rights (infringement shall include, but is not limited to, direct, contributory, or inducement to infringe) or (ii) necessarily uses or incorporates Licensed Technology and/or Cell Lines.
“LICENSED SERVICE(S)” as used herein in either singular or plural shall mean the performance on behalf of a third party by Company, its Affiliates and/or Sublicensees of any method or the manufacture of any product or the use of any product or composition which (i) would constitute, but for a license granted to Company, an infringement of a Valid Claim of Licensed Patent Rights (infringement shall include, but not be limited to, direct, contributory or inducement to infringe) or (ii) necessarily uses or incorporates Licensed Technology and/or Cell Lines.
“LICENSED TECHNOLOGY” as used herein includes all of JHU’s technology, to the extent reasonably required to practice or use, or otherwise specific to, the Licensed Patent Rights, Cell Lines, or GVAX including, without limitation, JHU’s unpatented, proprietary data, results, formulae, designs, specifications, methods, processes, formulations, techniques, know-how, technical information (including, without limitation, structural and functional information), process information, regulatory filings, drug master files, pre-clinical information, clinical information, and any and all proprietary biological, chemical, pharmacological, toxicological, pre-clinical, clinical, assay, chemistry, manufacturing and control data created, developed, and fixed in any tangible medium of expression solely by one or more of the JHU inventors prior to the Effective Date of this Agreement and that is owned by JHU and is not subject to any third party encumbrance that would prevent transfer to Company and to the extent that the provision of such information to Company does not violate the Health Insurance Portability and Accountability Act (HIPAA) privacy rules. Licensed Technology specifically excludes Licensed Patents and Cell Lines. While such information maybe provided as part of the Technology Transfer, Licensed Technology shall not include any information which: (a) is within the public domain prior to the time of provision by JHU or thereafter becomes within the public domain other than as a result of provision to a third party by Company or any of its representatives in violation of this Agreement; (b) was, on or before the date of provision to Company in the possession of Company as evidenced by records, however maintained; (c) is acquired by Company from a third party having the right to provide the same; or (d) is hereafter developed by Company, as evidenced by records, however maintained. Licensed Technology existing as of the Effective Date of this Agreement includes, without limitation, the Licensed Technology listed in Exhibit C hereto.
“TERRITORY” shall mean world-wide.
ARTICLE 2. LICENSE GRANT
2.1 Grant. Subject to the terms and conditions of this Agreement, JHU hereby grants to Company (i) an exclusive license with the right to grant sublicenses in accordance with Section 2.2, hereof, to the Licensed Patent Rights and (ii) an exclusive license with the right to grant sublicenses in accordance with Section 2.2, hereof, to JHU’s interest in Cell Lines; to make, have made, use, have used, sell, offer for sale, have sold, import, have imported, develop and commercialize, Licensed Products and to provide Licensed Services in the Territory for the Field and (iii) a nonexclusive license, with the right to grant sublicenses in accordance with Section 2.2, hereof, to use Licensed Technology to make, have made, use, have used, sell, offer for sale and have sold, import, have imported, develop and commercialize, Licensed Products and to provide Licensed Services in the Territory for the Field.
The grant of patent rights herein may be subject to rights retained by the United States government in accordance with 35 U.S.C. 200-205 and P.L. 96-517, as amended by P.L. 98-620, and subject to the retained right of JHU to make, have made, provide and use for its and The Johns Hopkins Health Systems’ noncommercial research, educational and clinical testing purposes Licensed Product and Licensed Service, including the ability to distribute any biological material covered under Licensed Patent Rights and/or Cell Lines for nonprofit academic research use to nonprofit entities as is customary in the scientific community. If such biological materials are shared for nonprofit academic research use by a third party, JHU will transfer the biological materials through an agreement that prohibits commercial use of the transferred material, as well as any progeny or derivatives, including, without limitation, master cell banks and working cell lines. In addition, the United States Government may have acquired a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the inventions described in Licensed Patent Rights throughout the world. The rights granted herein are additionally subject to: the requirement that any Licensed Product(s) produced for use or sale within the United States shall be substantially manufactured in the United States (unless a waiver under 35 USC § 204 or equivalent is granted by the appropriate United States government agency), and the right of the United States government to require JHU, or its licensees, including Company, to grant sublicenses to responsible applicants on reasonable terms when necessary to fulfill health or safety needs.
Company acknowledges that its rights are therefore subject to the foregoing paragraph.
2.2 Sublicense. Company may sublicense to one or more Sublicensees the rights granted by JHU under this Agreement, and upon notification to JHU, may extend the right to further sublicense such sublicensed rights subject to the terms and conditions of this Section 2. As a condition to its validity and enforceability, each sublicense agreement shall: (a) incorporate by reference the terms and conditions of this Agreement, (b) be consistent with the terms, conditions and limitations of this Agreement, (c) name JHU as an intended third-party beneficiary of the obligations of Sublicensee without imposition of obligation or liability on the part of JHU or its Inventors to the Sublicensee, and (d) specifically incorporate Sections 6.2 “Representations by JHU”, 7.1 “Indemnification”, 10.1 “Use of Name”, 10.4 “Product Liability” into the body of the sublicense agreement, and cause the terms used in therein to have the same meaning as in this Agreement. Company and its Sublicensee(s) shall provide to JHU each proposed sublicense agreement, executed by both Company and Sublicensee. To the extent that any terms, conditions or limitations of any sublicense agreement are inconsistent with this Agreement, those terms, conditions and limitations are null and void against JHU.
2.3 Other Third-party Obligations. JHU and Company agree that the rights granted to Company to the Cell Lines and Licensed IP are subject to the Third-party Obligations specifically identified in Exhibit B and D hereto.
2.4 Global Access for Essential Medicines. This Agreement is subject to the provisions of Exhibit E: GLOBAL ACCESS FOR ESSENTIAL MEDICINES.
2.5 Certain Developed IP. If JHU, working independently (including having obtained funding to conduct additional clinical trials), develops new and useful proprietary data, information and/or other intellectual property of any kind relating to the Licensed IP (“Developed IP“), to the extent that JHU has the right to offer to Company and grant a license to such Developed IP, JHU will disclose the Developed IP to Company and Company agrees to negotiate in good faith with JHU for the right to use the Developed IP as part of the development and commercialization of Licensed Products.
ARTICLE 5. OBLIGATIONS OF THE PARTIES
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5.3 Diligence. Company shall use commercially reasonable efforts to develop and to introduce the Licensed Product(s) and Licensed Service(s) into the commercial market as soon as practicable, consistent with sound and reasonable business practice and judgment; thereafter, until the expiration or termination of this Agreement, Company shall use commercially reasonable efforts to endeavor to keep Licensed Product(s) and Licensed Service(s) reasonably available to the public. Company shall also exercise commercially reasonable efforts to develop Licensed Product(s) suitable for different indications within the Field. In addition to the foregoing, Company shall use its commercially reasonable efforts to meet the following milestones. [Details redacted.]
In the event that unforeseen circumstances prevent the Company from achieving a diligence milestone, the Company and JHU will agree to discuss alternative commercially reasonable milestones. Company shall provide JHU with notice, as provided hereunder in Section 10.6, within [ * ] days of achieving each diligence milestone. The foregoing diligence obligations are the only obligations of the Company with respect to GVAX products.
5.4 Other Products. Beginning on [ * ] and thereafter, if JHU provides the Company in writing with clinical or other compelling scientific, safety and commercial evidence demonstrating a significant commercial opportunity within the Licensed Field which is not being developed or commercialized by Company, Company shall make reasonable efforts either to provide JHU with a development plan and start development or attempt to sublicense the particular market or use to a third party. If within [ * ] months of such notification by JHU, Company has not initiated reasonable efforts to finance, develop or sublicense that particular significant commercial opportunity, JHU may on written notice to the Company terminate this license, but only for the relevant indication, so long as JHU has (i) a bona fide offer to enter into a license for the development of the indication on terms which are consistent with the terms herein when considered in light of market rates and the breadth and scope of the license, along with a detailed development plan, (ii) JHU and Company have agreed in writing that development of the indication as planned will not adversely affect current or anticipated development and commercialization of Licensed Products and Licensed Services, and (iii) the proposed licensee can demonstrate it has sufficient current funding to fund the development for not less than [ * ] years. In addition, the termination of any indication permitted by thisSection shall not be effective until JHU enters into the proposed license and in any event any such license shall be executed by both the parties thereto within six (6) months of the initiation of negotiation. If the license is not executed prior to the end of such period, then the license shall not be granted by JHU and the termination of the relevant indication shall not be effective. If any license granted under this provision is terminated for any reason (in whole or in part), written notice of the same will be delivered to Company and the terminated rights shall be automatically restored as part of Company’s rights under this Agreement as of the date of termination, unless requested otherwise by the Company. For clarity, this Section shall not be applicable if Company reasonably demonstrates to JHU that commercializing such Licensed Product(s) or Licensed Service(s) or granting such a sublicense in said market or use would have a potentially adverse commercial effect upon development, marketing or sales, or future development, marketing or sales, of the Licensed Product(s).
5.5 Patent Acknowledgement. Company agrees that all packaging containing individual Licensed Products(s) sold by Company, Affiliates and Sublicensee(s) of Company will be marked with the number of the applicable patent(s) licensed hereunder in accordance with each country’s patent laws.
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.