“FIELD” shall mean the use of LICENSED PRODUCTS containing a polymer and a therapeutic agent for the treatment of cancer. Notwithstanding the foregoing, the FIELD shall specifically exclude the use of LICENSED PRODUCTS: (i) for the treatment of brain cancer; (ii) for therapeutic or prophylactic cancer vaccines, including where such vaccines incorporate an adjuvant but not an antigen; and (iii) for therapeutic or prophylactic vaccines for infectious diseases or allergies.
Upon the initiation of pre-IND toxicology studies with GMP material for a LICENSED PRODUCT (each a “CLINICAL DEVELOPMENT CANDIDATE”) in one of the following fields, LICENSEE has an option to expand the FIELD to include one of the below fields by written notification to YALE, and subject to any third party rights already granted prior to the date of such notification. The fields are: 1) cardiovascular disease, 2) inflammation (including using non-steroidal anti-inflammatory drugs); and 3) autoimmune disorders. LICENSEE shall pay a one-time option exercise fee of [***] for the addition of each such field to the FIELD (the “Option Exercise Fee”). Upon notice to YALE and payment of the Option Exercise Fee, the FIELD shall be automatically expanded to include such additional field.
During the TERM, YALE shall inform LICENSEE if any third party makes an offer for a license to the LICENSED PATENTS in any of these fields, in which case a) LICENSEE shall have [***] days to exercise its option and pay the Option Exercise Fee to include such field in the FIELD, provided that LICENSEE has a CLINICAL DEVELOPMENT CANDIDATE in such field; or b) in cases where LICENSEE does not have a CLINICAL DEVELOPMENT CANDIDATE in such field, LICENSEE shall have thirty (30) days to negotiate in good faith for terms under which such field may be included in the FIELD, and YALE will consider all such offers in good faith. “FIRST SALE” shall mean the first sale to a third party of any LICENSED PRODUCT or LICENSED METHOD that has been approved by the relevant regulatory authority for sale in that country.
“LICENSED PATENTS” shall mean the United States or foreign patent application(s) and patents(s) listed in Appendix A [appendix redacted] and owned or co-owned by YALE during the term of this Agreement, together with any continuations, divisionals, and continuations-in-part, to the extent the claims of any such patent or patent application are directed to subject matter specifically described in the patent applications listed on Appendix A; any reissues, re-examinations, or extensions thereof, or substitutes therefor; and the relevant international equivalents of any of the foregoing. Appendix A is incorporated into this Agreement.
“LICENSED TERRITORY” shall mean worldwide.
3. LICENSE GRANT AND TERM
3.1 Subject to all the terms and conditions of this Agreement, YALE hereby grants to LICENSEE an exclusive license, under the LICENSED PATENTS, with the right to sublicense through multiple tiers, to make, have made, use, have used, offer for sale, have offered for sale, sell, have sold, import, have imported, export or have exported LICENSED PRODUCTS, and to practice any LICENSED METHOD, within the FIELD in the LICENSED TERRITORY (the “LICENSE”).
3.2 To the extent that any invention included within the LICENSED PATENTS has been funded in whole or in part by the United States government, the United States government retains certain rights in such invention as set forth in 35 U.S.C. §200-212 and all regulations promulgated thereunder, as amended, and any successor statutes and regulations (the “Federal Patent Policy”). As a condition of the license granted hereby, LICENSEE acknowledges and shall comply with all aspects of the Federal Patent Policy applicable to the LICENSED PATENTS, including the obligation that LICENSED PRODUCTS used or sold in the United States he manufactured substantially in the United States. Nothing contained in this Agreement obligates or shall obligate YALE to take any action that would conflict in any respect with its past, present or future obligations to the United States Government under the Federal Patent Policy with respect to the LICENSED PATENTS.
3.3 The LICENSE is expressly made subject to YALE’s reservation of the right, on behalf of itself and all other non-profit academic research institutions, to make, use and practice the LICENSED PATENTS and LICENSED METHODS for research, clinical, teaching or other non-commercial purposes, and not for purposes of commercial development, use, manufacture or distribution. Nothing in this Agreement shall be construed to grant by implication, estoppel or otherwise any licenses under patents of YALE other than the LICENSED PATENTS.
3.5 Except as expressly provided in this Agreement, under no circumstances will LICENSEE, as a result of this Agreement, obtain any interest in or any other right to any technology, know-how, patents, patent applications, materials or other intellectual or proprietary property of YALE.
4.1 Any sublicense granted by LICENSEE shall include incorporate the terms of this agreement sufficient for LICENSEE to comply with this Agreement. LICENSEE will provide YALE with a copy of each Sublicense Agreement (and all amendments thereof) promptly after execution. LICENSEE shall also include provisions in all sublicenses to provide that in the event that SUBLICENSEE brings a PATENT CHALLENGE against YALE or assists another party in bringing a PATENT CHALLENGE against YALE (except as required under a court order or subpoena) then LICENSEE shall terminate the sublicense. LICENSEE shall remain responsible for the performance of all SUBLICENSEES under any such sublicense as if such performance were carried out by LICENSEE itself, including, without limitation, the payment of any royalties or other payments provided for hereunder, regardless of whether the terms of any sublicense provide for such amounts to be paid by the SUBLICENSEE directly to YALE. A breach of this provision shall constitute a material breach that is subject to Article 3.1(b).
4.2 LICENSEE shall pay royalties to YALE on NET SALES of SUBLICENSEES based on the same royalty rate as apply to NET SALES by LICENSEE and its AFFILIATES, regardless of the royalty rates payable by SUBLICENSEES to LICENSEE under a sublicense agreement. In addition, LICENSEE shall pay to YALE Forty Per Cent (40%) of any SUBLICENSE INCOME.
4.3 LICENSEE agrees that it has sole responsibility to promptly:
(a) provide YALE with a copy of any amendments to sublicenses granted by LICENSEE under this Agreement and to notify YALE of termination of any sublicense; and
(b) include summaries of SUBLICENSEE progress in accordance with Section 9.
(c) provide copies of sales reports provided to LICENSEE from the SUBLICENSEE in accordance with Section 9.
4.4 LICENSEE shall negotiate in good faith a sublicense to the LICENSED PATENTS on commercially reasonable terms with any interested third parties, excluding only third party products that are in direct competition with a LICENSED PRODUCT that has been disclosed to YALE and is identified by LICENSEE as a LICENSED PRODUCT subject to this Agreement.
4.5 LICENSEE shall be permitted to sublicense the LICENSE to its AFFILIATES on an AFFILIATE by AFFILIATE basis upon receipt by YALE of written notice from LICENSEE, but such sublicense rights to an AFFILIATE shall not flow automatically and shall only occur upon such written notice to YALE.
7. DUE DILIGENCE
7.1 LICENSEE, on its own behalf or through its AFFILIATES or SUBLICENSEES, shall use REASONABLE COMMERCIAL EFFORTS, within [***] days after the EFFECTIVE DATE of this Agreement, develop and commercialize one or more LICENSED PRODUCTS and LICENSED METHODS.
7.2 Within thirty (30) days of each anniversary of the EFFECTIVE DATE of this Agreement, LICENSEE shall provide a written report to YALE, indicating LICENSEE’s progress and problems to date in the development and commercialization of LICENSED PRODUCTS, and a forecast and schedule of major events required to market the LICENSED PRODUCTS. Such report shall clearly indicate which of LICENSEE’s products are LICENSED PRODUCTS and/or CLINICAL DEVELOPMENT CANDIDATES, as appropriate. Within thirty (30) days following any assignment by LICENSEE pursuant to Article 17.6, the assignee shall provide YALE with an updated and revised copy of the report.
7.3 LICENSEE shall immediately notify YALE if at any time LICENSEE (a) abandons or suspends its research, development or marketing of the LICENSED PRODUCTS and or LICENSED METHODS, or its intent to research, develop and market such products or methods, or (b) fails to comply with its due diligence obligations under this Article for a period exceeding [***] days.
7.4 LICENSEE agrees that YALE shall be entitled to terminate this Agreement in accordance with Article 13, subject to the terms thereof but subject to a ninety (90) day and not a sixty (60) day cure period, upon the occurrence of any of the following, after written notice and a failure of LICENSEE to cure:
(a) LICENSEE has failed to:
(i) Initiate a PHASE III CLINICAL TRIAL for a LICENSED PRODUCT by 2017; or
(ii) Receive NDA Approval for a LICENSED PRODUCT by 2020; or
(iii) Have at least one CLINICAL DEVELOPMENT CANDIDATE in the FIELD, and in each additional field added to the FIELD pursuant to Article 2.5; or
(iv) Conduct clinical studies for any LICENSED PRODUCT in the FIELD for a period in excess of [***].
Notwithstanding the foregoing in this Article 7.3, if LICENSEE has not employed REASONABLE COMMERCIAL EFFORTS in developing and selling LICENSED PRODUCTS or LICENSED METHODS within the TERRITORY, then YALE may, at its sole discretion, terminate this LICENSE pursuant to Article 13 herein.