LICENSEE’S PERFORMANCE. 5.1 LICENSEE agrees that during the period of this LICENSE any products embodying a LICENSED INVENTION or produced through the use of a LICENSED INVENTION for use or sale by LICENSEE or its SUB-LICENSEES in the UNITED STATES will be manufactured substantially in the UNITED STATES. Upon request of LICENSEE or any SUB-LICENSEE, LICENSORS agree to reasonably cooperate with LICENSEE or such SUB-LICENSEE to obtain a waiver of this requirement from the UNITED STATES government, and, in the event such waiver is obtained, LICENSORS will be deemed to have waived the obligations of this Section 5.1. (a) LICENSEE agrees to use reasonable commercial efforts to carry out, either directly or through one or more SUB-LICENSEES, the COMMERCIAL DEVELOPMENT PLAN to bring the LICENSED TNVENTION to PRACTICAL APPLICATION. For CLINICAL APPLICATIONS, LICENSEE will use reasonable commercial efforts, in its scientific and business judgment, to develop and commercialize CLINICAL PRODUCTS itself or through SUB-LICENSEES. LICENSEE will be deemed to be using reasonable commercial efforts if, in each calendar year during the TERM, commencing January 1, 2009, until the first commercial sale of a CLINICAL PRODUCT, LICENSEE and/or its SUB-LICENSEES expend no less than $*** on research and development directly relating to CLINICAL PRODUCT development. (b) Subject to the terms of Section 5.6 below, if LICENSEE has failed to demonstrate reasonable commercial efforts, either directly or through SUB-LICENSEE(s), as required by Section 5.2(a) above, LICENSORS may provide a written notice to LICENSEE specifying the basis for such notice. Upon receipt of such notice, LICENSEE shall develop and provide to LICENSORS a written plan to cure such failure within ninety (90) days of receipt of such notice. LICENSORS and LICENSEE will mutually agree upon a timetable for performance of such cure plan. If LICENSEE or the applicable SUB-LICENSEE fails to diligently implement such written cure plan, LICENSORS shall be entitled to provide written notice to terminate this LICENSE with respect to CLINICAL APPLICATIONS if such failure is not cured within a ninety (90) day period following receipt of such notice. Notwithstanding the foregoing, LICENSORS shall not unreasonably withhold their consent to any revision in the time periods under the COMMERCIAL DEVELOPMENT PLAN whenever requested in writing by LICENSEE and supported by evidence of technical difficulties or delays in regulatory processes that are outside of LICENSEE’S and any applicable SUB-LICENSEE’S reasonable control. LICENSEE may act by or through a SUB-LICENSEE with respect to the obligations of this Section 5.2. (c) Upon the first commercial sale of a CLINICAL PRODUCT, LICENSEE will be deemed to have satisfied all diligence obligations under this Section 5.2. LICENSEE will, thereafter, continue to make the benefits of the LICENSED INVENTION reasonably accessible to the public for the remainder of the period of this LICENSE. 5.4 LICENSORS acknowledge and agree that all due diligence obligations due to LICENSORS under the WYETH LICENSE AGREEMENTS and the XCYTE LICENSE were satisfied. 5.5 LICENSEE agrees to report to LICENSORS within thirty (30) days of LICENSEE’S discontinuance of making the benefits of the LICENSED INVENTION reasonably accessible to the United States public. 5.6 If LICENSEE is relying on a SUB-LICENSEE to perform certain diligence obligations under Section 5.2, and such SUB-LICENSEE defaults in such obligations, then, if LICENSEE terminates such SUB-LICENSEE, LICENSEE will be relieved of the diligence obligations for a period of twelve (12) months after termination of the SUB-LICENSE AGREEMENT with respect to which such default occurs. If at the end of such period, LICENSEE has not itself or through another SUB-LICENSEE complied with the diligence ***Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. obligations under Section 5.2, LICENSORS shall have the right to terminate the LICENSE in accordance with the terms of Section 10.5.
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Sources: Supply Agreement (Adaptimmune Therapeutics PLC), Sub License Agreement (Adaptimmune Therapeutics PLC)
LICENSEE’S PERFORMANCE. 5.1 LICENSEE agrees that during the period of this LICENSE any products embodying a LICENSED INVENTION or produced through the use of a LICENSED INVENTION for use or sale by LICENSEE or its SUB-LICENSEES in the UNITED STATES will be manufactured substantially in the UNITED STATES. Upon request of LICENSEE or any SUB-LICENSEE, LICENSORS agree to reasonably cooperate with LICENSEE or such SUB-LICENSEE to obtain a waiver of this requirement from the UNITED STATES government, and, in the event such waiver is obtained, LICENSORS will be deemed to have waived the obligations of this Section 5.1.
(a) LICENSEE agrees to use reasonable commercial efforts to carry outout the plan for development and marketing of the LICENSED INVENTIONS submitted with LICENSEE’S application for license dated June 28, either directly or through one or more SUB-LICENSEES, the COMMERCIAL DEVELOPMENT PLAN 1996 to bring the these LICENSED TNVENTION INVENTIONS to PRACTICAL APPLICATION. For CLINICAL APPLICATIONSpractical application as soon as commercially feasible, LICENSEE will use reasonable commercial efforts, in its scientific and business judgment, to develop and commercialize CLINICAL PRODUCTS itself or through SUB-LICENSEES. LICENSEE will be deemed to be using reasonable commercial efforts if, in each calendar year during the TERM, commencing January 1, 2009, until the first commercial sale of a CLINICAL PRODUCT, LICENSEE and/or its SUB-LICENSEES expend no less than $*** on research and development directly relating to CLINICAL PRODUCT development.
(b) Subject to the terms of Section 5.6 below, if LICENSEE has failed to demonstrate reasonable commercial efforts, either directly or through SUB-LICENSEE(s), as required by Section 5.2(a) above, LICENSORS may provide a written notice to LICENSEE specifying the basis for such notice. Upon receipt of such notice, LICENSEE shall develop and provide to LICENSORS a written plan to cure such failure within ninety (90) days of receipt of such notice. LICENSORS and LICENSEE will mutually agree upon a timetable for performance of such cure plan. If LICENSEE or the applicable SUB-LICENSEE fails to diligently implement such written cure plan, LICENSORS shall be entitled to provide written notice to terminate this LICENSE with respect to CLINICAL APPLICATIONS if such failure is not cured within a ninety (90) day period following receipt of such notice. Notwithstanding the foregoing, LICENSORS shall not unreasonably withhold their consent to any revision in the time periods under the COMMERCIAL DEVELOPMENT PLAN whenever requested in writing by LICENSEE and supported by evidence of technical difficulties or delays in regulatory processes that are outside of LICENSEE’S and any applicable SUB-LICENSEE’S reasonable control. LICENSEE may act by or through a SUB-LICENSEE with respect to the obligations of this Section 5.2.
(c) Upon the first commercial sale of a CLINICAL PRODUCT, LICENSEE will be deemed to have satisfied all diligence obligations under this Section 5.2. LICENSEE will, thereafter, continue to make the benefits of the these LICENSED INVENTION INVENTIONS reasonably accessible to the public for the remainder of the period of this LICENSE.
5.4 LICENSORS acknowledge and agree that all due diligence obligations due to LICENSORS under the WYETH LICENSE AGREEMENTS and the XCYTE LICENSE were satisfied.
5.5 . LICENSEE agrees to report spend not less than One Million Dollars ($1,000,000) per year, either internally or through AFFILIATES or SUBLICENSEES or other collaborators, on the research, development and marketing (and associated costs related thereto) of products in the [*], CTLA4 and/or B7 immune modulation area, which area includes, without limitation, the LICENSED INVENTIONS. LICENSEE agrees that during the period of this LICENSE any products embodying these LICENSED INVENTIONS or produced through the use of the LICENSED INVENTIONS for use or sale by LICENSEE or its AFFILIATES or SUBLICENSEES in the UNITED STATES will be manufactured substantially in the UNITED STATES. LICENSEE shall pay to LICENSORS within thirty the LICENSOR a non-refundable licensing fee in the amount of ONE HUNDRED THOUSAND DOLLARS (30$100,000) payable, at the LICENSOR’s election, either: (a) upon the execution of this LICENSE by LICENSEE or (b) at a later date during the term of this ‘LICENSE, upon ninety (90) days prior written notice to LICENSEE. LICENSEE agrees to pay to LICENSOR [*] of any sublicensing fee (other than running royalty payments or research and development reimbursements for research and/or development performed after the effective date of the applicable sublicense agreement) collected from any SUBLICENSEE. If LICENSEE is required to pay a portion of such sublicensing fee to a third party (other than the. University of Michigan (“MICHIGAN”) pursuant to a May 28, 1992 License Agreement, as amended, between MICHIGAN and GI’s predecessor in interest under such License Agreement, Repligen Corporation), then [*] of LICENSEE’S discontinuance of making the benefits of the LICENSED INVENTION reasonably accessible payments to the United States public.
5.6 If LICENSEE is relying such third party shall be deducted [*] Certain information on a SUB-LICENSEE to perform certain diligence obligations under Section 5.2, and such SUB-LICENSEE defaults in such obligations, then, if LICENSEE terminates such SUB-LICENSEE, LICENSEE will be relieved of the diligence obligations for a period of twelve (12) months after termination of the SUB-LICENSE AGREEMENT with respect to which such default occurs. If at the end of such period, LICENSEE has not itself or through another SUB-LICENSEE complied with the diligence ***Portions of this page have has been omitted pursuant to a request for Confidential Treatment and filed separately with the Securities & Exchange Commission. obligations under Section 5.2Confidential treatment has been requested with respect to the omitted portions. from the portion of the sublicensing fee payable to LICENSOR. However, LICENSORS in no event shall have LICENSOR’S share of any sublicensing fee be reduced below [*]. Payment will be made in the right manner prescribed in Article IV. LICENSEE agrees to terminate report promptly-to LICENSOR any changes in mailing address, name or company affiliation during the period of this LICENSE in accordance with and to report promptly discontinuance of LICENSEE’s making the terms benefits of Section 10.5these LICENSED INVENTIONS reasonably accessible to the UNITED STATES public.
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