“Development and Commercialization Milestones” means the development and commercialization milestones set forth in Exhibit A to this Agreement.
“Development and Commercialization Plan” means the plan for the development and commercialization of Licensed Products attached hereto as Exhibit B [redacted], as such plan may be adjusted from time to time pursuant to Section 3.2.
“Know-How” means all RIH proprietary expertise, knowledge, trade secrets, formulas, processes, ideas, information and documentation pertaining to the research, development and commercialization of Licensed Products, in each case only to the extent developed under the direction of Researcher(s) prior to the Effective Date of the Elkurt license from RIH. A list of said Know-How is attached hereto as Exhibit D.
“Licensed Product” means: (a) any product or service, for use in the Field, the making, using, selling or importation of which would, but for the license granted herein, directly or indirectly infringe a Valid Claim in the country in which the product is made, used, sold or imported, (b) any product or service, for use in the Field, that incorporates or otherwise utilizes, whether in its manufacture, use or otherwise, the Know-How, or (c) any materials sold for use in conjunction with (a) or (b).
“Licensed Rights” means the Patent Rights and the Know-How.
2.1 License Grant. Subject to the terms and conditions set forth in this Agreement, and subject to the terms of the license agreement from RIH to Elkurt, Elkurt hereby grants to Licensee an exclusive, royalty-bearing license throughout the Territory to the Patent Rights and a non-exclusive, royalty-bearing license throughout the Territory to Know-How, solely to make, have made, market, offer for sale, use and sell Licensed Products for use in the Field. Licensee shall have no right to grant Sublicenses under such license, except as specifically set forth in Section 2.3.
2.1.1. Elkurt retains for itself, and Licensee recognizes that RIH and SCRI have retained the right, for themselves and for other not-for-profit research organizations, to practice the rights licensed hereunder solely for research (including clinical research), teaching, educational and scholarly purposes.
2.1.2. Elkurt retains for itself, and Licensee recognizes that RIH and SCRI have retained the right to submit for publication the scientific findings from research conducted by or through Elkurt or its investigators (including the Researcher(s)) related to the Licensed Rights.
2.2. Exploitation of Licensed Rights by Affiliates. The license granted to Licensee under Section 2.1 includes the right to have any or all of Licensee’s rights and/or obligations under this Agreement exercised and/or performed by one or more of Licensee’s Affiliates on Licensee’s behalf provided that:
2.2.1. no such Affiliate will be entitled to grant, directly or indirectly, to any third party any right of whatever nature under, or with respect to, or permitting any use or exploitation of, any of the Licensed Rights;
2.2.2. any act or omission taken or made by an Affiliate of Licensee under this Agreement shall be deemed an act or omission byLicensee under this Agreement; and
2.2.3. an Affiliate may only practice such rights during the time that it remains an Affiliate of Licensee.
2.3.1. Sublicense Grant. Licensee will be entitled to grant Sublicenses to third parties under the license granted pursuant to Section 2.1 subject to the terms of this Section 2.3. Any such Sublicense shall be on terms and conditions in compliance with and not inconsistent with the terms of this Agreement. The grant of a Sublicense shall not in any way diminish or alter Licensee’s obligations under this Agreement.
2.3.2. Sublicense Agreements. Licensee shall grant sublicenses pursuant to written agreements, which will be subject and subordinate to the terms and conditions of this Agreement. Such Sublicense agreements will contain, among other things, the following:
220.127.116.11. all provisions necessary to ensure Licensee’s ability to perform its obligations under this Agreement;
18.104.22.168. a section substantially the same as Section 9of this Agreement, which also will state that the Indemnitees (as defined in Section 9) are intended third party beneficiaries of such Sublicense agreement for the purpose of enforcing such indemnification;
22.214.171.124. a provision clarifying that, in the event of termination of the license set forth in Section 2.1, any existing Sublicense agreement shall terminate to the extent of such terminated license;
126.96.36.199. a provision prohibiting the Sublicensee from assigning the Sublicense agreement without the prior written consent of Elkurt and RIH, except that Sublicensee may assign the Sublicense agreement to a successor in connection with the merger, consolidation or sale of all or substantially all of its assets or that portion of its business to which the Sublicense agreement relates; provided, however, that any permitted assignee agrees in writing to be bound by the terms of such Sublicense agreement.
188.8.131.52. Such Provisions as are required in the license granted to Elkurt by RIH.
2.3.3. Delivery of Sublicense Agreement. Licensee shall furnish Elkurt with a fully executed copy of any Sublicense agreement, promptly after its execution. Elkurt shall keep such agreement in its confidential files and shall use it solely for the purpose of monitoring Licensee’s and Sublicensees’ compliance with their obligations hereunder and enforcing Elkurt’s rights under this Agreement and the Sublicense, and may provide a copy to RIH as required in the RIH license.
2.3.4. Breach by Sublicensee. Licensee shall be responsible for any breach of a Sublicense by any Sublicensee that results in a material breach of this Agreement. Without limiting the foregoing, Licensee shall (a) cure such breach in accordance with Section 10.2.2 of this Agreement or (b) enforce its rights by terminating such Sublicense agreement in accordance with the terms thereof.
3. Development and Commercialization
3.1 Diligence. Licensee shall use commercially reasonable efforts and shall cause its Sublicensees to use commercially reasonable efforts: (a) to develop Licensed Products in accordance with the Development and Commercialization Plan, which may be amended from time to time by mutual agreement of the Parties; (b) to introduce Licensed Products into the commercial market; and (c) to market Licensed Products following such introduction into the market. In addition, Licensee, by itself or through its Affiliates or Sublicensees, shall use commercially reasonable efforts to achieve the Development and Commercialization Milestones.
3.2. Adjustments of Development Plan. Licensee will be entitled, from time to time, to make such adjustments to the then applicable Development and Commercialization Plan as Licensee believes, in its good faith judgment, are needed in order to improve Licensee’s ability to meet the Development and Commercialization Milestones. Licensee shall inform Elkurt of any such adjustments in writing.
Exhibit A – Development and Commercialization Milestone Payments
Milestone [payment amounts redacted]
(Separate milestone payments are due on a Licensed Product-by-Licensed Product basis)
Filing of an IND or the equivalent outside the U.S.
Enrollment of first patient in a Phase I clinical trial in the U.S. or the equivalent trial outside the U.S.
Enrollment of first patient in a Phase II clinical trial in the U.S. or the equivalent trial outside the U.S.
Enrollment of first patient in a Phase III clinical trial in the U.S. or the equivalent trial outside the U.S.
First Regulatory Approval of Licensed Product in each of the U.S., Europe and Asia (milestone payment due up to three times total; onetime for each such regulatory approval)
EXHIBIT E: Global Access for Essential Medicines
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.
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.