DUE DILIGENCE AND RELATED MATTERS. A. Licensee, upon execution of this Agreement, shall use Commercially Reasonable Efforts in good faith to bring at least one (1) Licensed Product to market as soon as reasonably practicable, consistent with sound and legal business practices and judgment, through a program using Commercially Reasonable Efforts for the exploitation of the Patent Rights. Licensee shall use Commercially Reasonable Efforts to obtain all necessary government approvals for the manufacture, use, sale and distribution of Licensed Products. Thereafter, Licensee agrees that until expiration or termination of this Agreement, Licensee shall use Commercially Reasonable Efforts to keep Licensed Products reasonably available to the public, in quantities sufficient to meet market demand, in the Territory. In the event Licensee decides not to exploit, either directly or indirectly, a licensed Patent Right in a given country of the Territory, it shall promptly inform CMCC in writing and the license granted to it hereunder with respect to that Patent Right in that country in the Territory will immediately terminate. B. Licensee shall use Commercially Reasonable Efforts to accomplish the specific tasks set forth in Appendix 2 attached hereto in accordance with the timeframe set forth therein (such Appendix 2 is hereby incorporated by reference and is referred to herein as the “Development Plan”) C. Licensee shall use Commercially Reasonable Efforts to accomplish the specific requirements of the Development Plan, including the Diligence Specifications set forth in this Paragraph C (the “Diligence Specifications”). The Diligence Specifications shall be part of the Development Plan and the timeframes for such Diligence Specifications shall be treated as definitive. 1. Determine protective efficacy of Licensed Products in mouse colonization or systemic models within [* * *]. The Parties acknowledge and agree that Licensee has completed this Diligence Specification as of [* * *]. 2. Nominate top 2-3 Licensed Products for vaccine formulation within [* * *] of accomplishing Diligence Specification 1. 3. Final formulation of Licensed Product for pre-IND studies within [* * *] of accomplishing Diligence Specification 2. 4. Completion of toxicology lots of nominated Licensed Products for in vivo toxicology studies within [* * *] of accomplishing Diligence Specification 3. D. In the event Licensee fails to meet any of the objective(s) set forth in the Development Plan, including without limitation the Diligence Specifications, in a timely manner, CMCC shall notify Licensee thereof in writing, and Licensee shall have sixty (60) days following such notification to establish to the reasonable satisfaction of CMCC that (i) it has met such objective(s); or (ii) a revision to the Development Plan is necessary and appropriate as contemplated below in Paragraph E. In the event Licensee fails to establish the same to CMCC’s reasonable satisfaction, CMCC shall have the right in its sole discretion to terminate in whole or in part the license granted to Licensee under this Agreement effective immediately. E. Notwithstanding anything above to the contrary, CMCC shall not unreasonably withhold its consent to any revision of the objective(s) or timing of the Development Plan, when requested in writing in advance by Licensee and the request is supported by evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays that Licensee could not reasonably have avoided; (ii) that Licensee is proposing and will implement satisfactory and effective means of addressing such difficulties or delays, including sufficient financial and technical resources; and (iii) that Licensee, its Affiliates and/or Sublicensees have in good faith made Commercially Reasonable Efforts and expended commercially reasonable and adequate resources to meet said objective and will continue to do so. F. If, during the Term of this Agreement, Licensee makes any discovery or invention that Licensee reasonably believes to be patentable and is not within the scope of the license to the Patent Rights granted to it hereunder but is dominated by the Patent Rights, Licensee shall, as a condition of this license, confidentially disclose such discovery or invention to CMCC, on usual and customary terms necessary to protect its patentability or its confidentiality as a trade secret. CMCC shall have the right to review in advance of filing any related patent application by or on behalf of Licensee or any assignee of Licensee, for purposes of evaluating the relatedness to the Patent Rights. Recognizing that CMCC enters into this Agreement in furtherance of its charitable academic research mission, Licensee shall use good faith and reasonable efforts to enter into with CMCC a non-exclusive license or permit CMCC, as applicable, including for no more than a nominal fee, to practice such discovery or invention, whether or not patented, solely for CMCC internal and academic research purposes. For the avoidance of doubt, any license granted under this ARTICLE III, Paragraph F by Licensee to CMCC shall not grant CMCC, its Affiliates or its sublicensees any right to use or practice the licensed rights for commercial purposes.
Appears in 3 contracts
Samples: Exclusive License Agreement (Genocea Biosciences, Inc.), Exclusive License Agreement (Genocea Biosciences, Inc.), Exclusive License Agreement (Genocea Biosciences, Inc.)
DUE DILIGENCE AND RELATED MATTERS. A. Licensee, upon execution of this Agreement, shall use Commercially Reasonable Efforts in good faith to bring at least one (1) or more Licensed Product Products to market as soon as reasonably practicable, consistent with sound and legal business practices and judgment, through a program using Commercially Reasonable Efforts for the exploitation of the Patent Rights. Licensee shall use Commercially Reasonable Efforts to obtain all necessary government approvals for the manufacture, use, sale and distribution of Licensed Productsmarket. Thereafter, Licensee agrees that until expiration or termination of this Agreement, Licensee shall use Commercially Reasonable Efforts to keep Licensed Products reasonably available to the public, in quantities sufficient to meet market demand, in the Territory. In the event Licensee decides not to exploit, either directly or indirectly, a licensed Patent Right in a given country of the Territory, it shall promptly inform CMCC in writing on terms appropriate for public access and the license granted to it hereunder with respect to that Patent Right in that country in the Territory will immediately terminatepublic benefit.
B. In addition, Licensee shall use Commercially Reasonable Efforts to accomplish implement the specific tasks set forth in Appendix 2 attached hereto in accordance with the timeframe set forth therein written development plan that has been provided hereunder (such Appendix 2 is hereby incorporated by reference and is referred to herein as the “Development Plan”)) within the timeframes set forth therein, which may be amended from time to time pursuant to Paragraph C of this Article. Licensee’s initial Development Plan is attached hereto as Appendix 4 and is hereby incorporated herein by reference. Such Development Plan and revisions to such Development Plan under Paragraph C of this Article III disclosed to CMCC shall be considered Licensee’s Confidential Information, and shall be subject to the provisions set forth in Article VI.
C. Except for Diligence Specifications as defined in Paragraph D of this Article, CMCC shall not unreasonably withhold its consent to revision of the Development Plan or revision to the Diligence Specifications as defined in Paragraph D when requested in writing in advance by Licensee shall use and the request is supported by evidence reasonably acceptable to CMCC of legal or technical difficulties or delays in the clinical studies or regulatory process that could not reasonably have been avoided; provided that (i) Licensee is proposing and will implement reasonable means of addressing such difficulties or delays, including by procuring sufficient financial and technical resources; and (ii) that Licensee, its Affiliates and/or Sublicensees have in good faith made Commercially Reasonable Efforts and expended resources contemplated by the Development Plan.
D. Notwithstanding Paragraphs B and C of this Article III, Licensee agrees that Licensee’s failure to accomplish achieve the following specific requirements of the Development PlanPlan through itself, including the Diligence Specifications set forth in this Paragraph C its Affiliates or its Sublicensees (the “Diligence Specifications”). The Diligence Specifications ) shall be part sufficient grounds for the actions specified in this Paragraph D:
(i) initiate research on integrin target specified in the Development Plan, [***];
(ii) develop criteria of integrin full antagonism proof of concept in vitro in at least [***] with respect to the integrin target specified in the Development Plan and by [***];
(iii) enter into a definitive agreement to obtain additional financing of at least [***];
(iv) initiate research on second integrin target as specified in the timeframes Development Plan by [***];
(v) develop criteria of integrin full antagonism proof of concept in vivo in at least two (2) models with respect to the integrin target(s) specified in the Development Plan by [***];
(vi) assign [***] additional full-time persons on the research set forth in the Development Plan by [***]; and
(vii) develop criteria for such Diligence Specifications shall be treated as definitive.
1. Determine protective efficacy of Licensed Products in mouse colonization or systemic models within pre-clinical toxicology studies for the lead molecule, by [* * ***]. The Parties acknowledge and agree that Licensee has completed Licensee’s failure to achieve any of the Diligence Specifications listed in this Diligence Specification as of [* * *].
2. Nominate top 2-3 Licensed Products for vaccine formulation within [* * *] of accomplishing Diligence Specification 1.
3. Final formulation of paragraph will irreparably harm CMCC’s ability to ensure that a Licensed Product is timely developed for pre-IND studies within [* * *] of accomplishing Diligence Specification 2.
4the public benefit. Completion of toxicology lots of nominated Licensed Products for in vivo toxicology studies within [* * *] of accomplishing Diligence Specification 3.
D. In the event Licensee fails to meet any of the objective(s) Diligence Specifications set forth in the Development Plan, including without limitation the Diligence Specifications, this Paragraph D in a timely manner, CMCC shall notify Licensee thereof in writing, and Licensee shall have sixty (60) days [***]following the later of the milestone date, if applicable or the date of such notification to establish establish, through written response to CMCC in reasonably sufficient detail, to the reasonable satisfaction of CMCC that (i) it has met such objective(s); or (ii) a revision to the Development Plan Diligence Specification is necessary and appropriate as contemplated below above, which shall be established to CMCC’s reasonable satisfaction. If such failure is due to (x) legal or technical difficulties or (y) delays in Paragraph E. the clinical studies or regulatory process and such difficulties or delays could not reasonably have been avoided, or (z) other reasons beyond the reasonable control of Licensee where Licensee, its Affiliates and/or Sublicensees have in good faith made Commercially Reasonable Efforts and have expended resources contemplated by the Development Plan, then in each case of (x), (y) or (z), Licensee shall submit an action plan to address such difficulties or delays, including as applicable, by procuring sufficient financial and technical resources and CMCC shall reasonably accept such action plan. In the event Licensee fails to establish the same to CMCC’s reasonable satisfactionforegoing, CMCC shall have the right in its sole discretion to terminate in whole or in part the license granted to Licensee under this Agreement pursuant to Article XV effective immediately.
E. Notwithstanding anything above to the contrary, CMCC shall not unreasonably withhold its consent to any revision of the objective(s) or timing of the Development Plan, when requested in writing in advance by Licensee and the request is supported by evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays that Licensee could not reasonably have avoided; (ii) that Licensee is proposing and will implement satisfactory and effective means of addressing such difficulties or delays, including sufficient financial and technical resources; and (iii) that Licensee, its Affiliates and/or Sublicensees have in good faith made Commercially Reasonable Efforts and expended commercially reasonable and adequate resources to meet said objective and will continue to do so.
F. If, during the Term of this Agreement, Licensee makes any discovery or invention that Licensee reasonably believes to be patentable and is not within the scope of the license to the Patent Rights granted to it hereunder but is dominated by the Patent Rights, Licensee shall, as a condition of this license, confidentially disclose such discovery or invention to CMCC, on usual and customary terms necessary to protect its patentability or its confidentiality as a trade secret. CMCC shall have the right to review in advance of filing any related patent application by or on behalf of Licensee or any assignee of Licensee, for purposes of evaluating the relatedness to the Patent Rights. Recognizing that CMCC enters into this Agreement in furtherance of its charitable academic research mission, Licensee shall use good faith and reasonable efforts to enter into with CMCC a non-exclusive license or permit CMCC, as applicable, including for no more than a nominal fee, to practice such discovery or invention, whether or not patented, solely for CMCC internal and academic research purposes. For the avoidance of doubt, any license granted under this ARTICLE III, Paragraph F by Licensee to CMCC shall not grant CMCC, its Affiliates or its sublicensees any right to use or practice the licensed rights for commercial purposes.
Appears in 3 contracts
Samples: Exclusive License Agreement (Morphic Holding, Inc.), Exclusive License Agreement (Morphic Holding, Inc.), Exclusive License Agreement (Morphic Holding, Inc.)
DUE DILIGENCE AND RELATED MATTERS. A. Licensee, upon execution of this Agreement, shall use Commercially Reasonable Reasonably Diligent Efforts in good faith to bring at least one (1) Licensed Product to market as soon as reasonably practicablefaith, consistent with reasonable judgment, sound and legal business practices and judgmentthe terms of this Agreement, through a program using Commercially Reasonable Efforts for the exploitation of the Patent Rights. Licensee shall use Commercially Reasonable Efforts to bring one or more Licensed Products to market as soon as practicable and to obtain all necessary government approvals for the manufacture, use, sale and distribution of Licensed Products. Thereafter, Licensee agrees that until expiration or termination of this Agreement, Licensee shall continue to use Commercially Reasonable Reasonably Diligent Efforts to keep Licensed Products reasonably available to the public, in quantities sufficient to meet market demand, in the Field of Use and in the Territory. In the event Licensee decides not to exploit, either directly or indirectly, exploit a licensed Patent Right in a given country or Field of the TerritoryUse, it shall promptly inform CMCC in writing and the shall surrender to CMCC its license granted to it hereunder with respect to that Patent Right in that country in the Territory will immediately terminateor Field of Use.
B. The parties acknowledge that Licensee shall use Commercially Reasonable Efforts has provided to accomplish CMCC prior to the specific tasks set date of execution of this Agreement a written research and development plan (“Preliminary Development Plan”) setting forth generally (i) the initial indications and markets for Licensed Products, (ii) estimated time-delimited targets for pre-clinical development and iii) actual or projected financial resources and/or strategic alliances that will be required to implement the Development Plan. Licensee will submit updated Development Plans at the time of the closing by Licensee of its Series A Preferred Stock financing (and in any event within twelve (12) months after the Effective Date) and annually thereafter until no longer applicable. The first updated Development Plan will include (i) time delimited targets for clinical trials, regulatory approval, manufacturing and marketing to bring Licensed Products to the marketplace for each of bladder, kidney, vascular tissue and nervous tissues, The Preliminary Development Plan is attached hereto as Appendix 2 attached hereto in accordance with the timeframe set forth therein (such Appendix 2 and is hereby incorporated herein by reference and is referred to herein as the “Development Plan”)reference. * Confidential Treatment Requested 14
C. Licensee shall use Commercially Reasonable be deemed to have used Reasonably Diligent Efforts to accomplish during the specific one (1) year period commencing on the Effective Date if, during that period, Licensee shall have raised in connection with the Patent Rights and allocated for expenditure for efforts under the requirements of this Article III, cumulative total of investment capital and/or research and development funds of at least * dollars. In addition, Licensee shall be deemed to have used Reasonably Diligent Efforts during the three (3) year period commencing on the Effective Date, if Licensee shall have expended at least * dollars allocated to implement the Development Plan. Notwithstanding anything above to the contrary, including the Diligence Specifications set forth in this Paragraph C (the “Diligence Specifications”). The Diligence Specifications CMCC shall be part not unreasonably withhold its consent to any revision of the Development Plan and when requested in writing in advance by Licensee, where such request is supported by evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays in the timeframes for such Diligence Specifications shall be treated as definitive.
1. Determine protective efficacy of Licensed Products in mouse colonization clinical studies or systemic models within [* * *]. The Parties acknowledge and agree regulatory process that Licensee could not reasonably have been avoided; (ii) that Licensee has completed this Diligence Specification as identified and will implement satisfactory and effective means of [* * *].
2. Nominate top 2-3 Licensed Products for vaccine formulation within [* * *] of accomplishing Diligence Specification 1.
3. Final formulation of Licensed Product for pre-IND studies within [* * *] of accomplishing Diligence Specification 2.
4. Completion of toxicology lots of nominated Licensed Products for in vivo toxicology studies within [* * *] of accomplishing Diligence Specification 3addressing such difficulties or delays, including providing when necessary sufficient financial and technical resources; and (iii) that Licensee, its Affiliates and/or Sublicensees have used Reasonably Diligent Efforts to meet said objectives and will continue to do so.
D. In the event CMCC reasonably believes that Licensee fails to meet any of the objective(s) set forth in the Development Plan, including without limitation the Diligence Specifications, Plan in a timely manner, CMCC shall notify Licensee thereof in writing, and Licensee shall have sixty (60) days following the receipt of such notification to establish to the reasonable satisfaction of CMCC that (i) establish that it has met expended or is expending Reasonably Diligent Efforts to meet such objective(s); or (ii) establish that a revision to the Development Plan is necessary and appropriate as contemplated below above; or (iii) dispute any such claim by CMCC in Paragraph E. accordance with the provisions of Article XII hereof. If the arbitrator in any such dispute resolution determines that Licensee is not using Reasonably Diligent Efforts with regard to any Licensed Product or any subfield within the Field of Use, the sole remedy of CMCC shall be to cause Licensee to enter into a Field of Use Sublicense (as defined below) in accordance with the provisions of this subparagraph D. In the event Licensee fails to establish the same to CMCC’s reasonable satisfactionor commence such dispute resolution procedures within such sixty (60) day period, CMCC shall have the right in its sole discretion to terminate seek third parties interested in whole commercially exploiting the Patent Rights in the subfield within the Field of Use in which Licensee is not using Reasonably Diligent Efforts, subject to Licensee’s right to request that senior management of CMCC and Licensee convene (in person or by telephone) * Confidential Treatment Requested 15 within ten (10) business days after the end of such sixty (60) day period to review the determination of CMCC’s Intellectual Property Office that Licensee had failed to establish either of the circumstances described in part subparagraph D (i) above. Unless otherwise resolved by the agreement of senior management of CMCC and Licensee within ten (10) additional business days, CMCC shall direct any such third party candidate to Licensee for evaluation of a potential sublicense to practice the Patent Rights in the subfield within the Field of Use with respect to which Licensee has failed to use Reasonably Diligent Efforts as required hereunder (a “Field of Use Sublicense”). Under no circumstances shall Licensee have any obligation to license or grant any rights to CMCC or any third party with respect to its own technology or any of its related intellectual property rights, under this Agreement. Licensee shall, within thirty (30) days (the “Notice Period”), determine whether or not Licensee shall enter good faith negotiations with such candidate for a Field of Use Sublicense. If Licensee determines to negotiate such a Field of Use Sublicense with such candidate, Licensee shall notify CMCC within the Notice Period, in which case Licensee shall have six (6) months thereafter to conclude such negotiation; provided, that such six-month period may be extended for a reasonable period, not to exceed three (3) months, by the mutual agreement of Licensee and such candidate if necessary to complete their good faith negotiations, and Licensee shall notify CMCC thereof, within the initial six-month negotiation period (such six-month period and any extension, the “Negotiation Period”). If the negotiations are unsuccessful and Licensee determines it is unable to execute a Field of Use Sublicense within the Negotiation Period with such candidate, Licensee shall, within the Negotiation Period, notify CMCC in writing of its determination and reasons therefor. If Licensee determines not to enter into negotiations with such candidate for a Field of Use Sublicense, Licensee shall, within the Notice Period, notify CMCC in writing of its determination and reasons therefor. In the event Licensee does not enter into a Field of Use Sublicense with such candidate as described in subparagraph D (1) or determines not to enter into negotiations under subparagraph D (2), CMCC may also agree not to enter into negotiations with such candidate if it would be reasonable for a non-profit organization such as CMCC to do so under the circumstances and in compliance * Confidential Treatment Requested 16 with internal policy and government regulations and laws, if applicable. Otherwise, CMCC shall be free to negotiate a Field of Use Sublicense directly with such candidate subject to conducting negotiations within six (6) months of CMCC’s receipt of notice from Licensee under subparagraphs D (1) or (2) above or from the end of the Negotiation Period, as applicable; provided, that such six (6) month period may be extended for a reasonable period, not to exceed three (3) months, by the mutual agreement of CMCC and such candidate if necessary to complete their good faith negotiations, and CMCC shall notify Licensee thereof in writing, within the initial six (6) month negotiation period. If CMCC agrees with such candidate upon the terms and conditions of such Field of Use Sublicense within the required time periods, Licensee and such candidate shall enter into such Field of Use Sublicense; provided, that such Field of Use Sublicense (i) shall be on substantially similar terms (other than financial terms) as the terms of this Agreement, (ii) shall not obligate Licensee to spend money or dedicate resources to research and development, (iii) shall exclude any particular Licensed Product that has been or is under active development and/or being commercialized by Licensee, and (iv) shall be restricted to the Licensed Product or the subfieid within the Field of Use with respect to which Licensee failed to use Reasonably Diligent Efforts. Licensee must execute such Field of Use Sublicenses within ten (10) business days of CMCC’s providing a Field of Use Sublicense in such format. If Licensee does not execute any such Field of Use Sublicense or initiate good faith and bona fide dispute resolution procedures under Article XII within such ten (10) business day period, Licensee hereby grants CMCC irrevocable power-of-attorney to execute such Field of Use Sublicense on behalf of Licensee with the same force and effect as if Licensee shall have executed such Field of Use Sublicense itself. As a consequence of entering into a Field of Use Sublicense, such candidate shall become a Sublicensee hereunder, and thereafter the license granted and rights of Licensee to Licensee practice the Patent Rights under this Agreement effective immediatelywith respect to such Field of Use shall be and become subject to the exclusive license and rights granted to such Sublicensee under the Field of Use Sublicense. If an arbitrator finds that Licensee has initiated dispute resolution procedures under this subparagraph without reasonable factual and legal basis, or solely in order to delay further development, then the arbitrator shall have the power to order termination of the License within the pertinent subfield within the Field of Use. * Confidential Treatment Requested 17 In the event that CMCC and such candidate for any reason fail to agree upon the terms and conditions of such Field of Use Sublicense within six (6) months, plus any extension, in accordance with subparagraph D(1) through D(3), Licensee’s exclusive license and rights with respect to such Field of Use shall continue without any change or consequence, subject to the terms and conditions of this Agreement. Notwithstanding the foregoing, Licensee may extend the due date of any given performance milestone * upon payment of *. Such payment shall be paid upon the due date of each performance milestone.
E. Notwithstanding anything above to the contrary, CMCC shall not unreasonably withhold its consent to any revision of the objective(s) or timing of the Development Plan, when requested in writing in advance by Licensee and the request is supported by evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays that Licensee could not reasonably have avoided; (ii) that Licensee is proposing and will implement satisfactory and effective means of addressing such difficulties or delays, including sufficient financial and technical resources; and (iii) that Licensee, its Affiliates and/or Sublicensees have in good faith made Commercially Reasonable Efforts and expended commercially reasonable and adequate resources to meet said objective and will continue to do so.
F. If, during the Term course of this Agreement, Licensee makes discovers or develops any discovery or invention that Licensee reasonably believes to be patentable and is not within the scope of the license to the Patent Rights granted to it hereunder but is dominated by the Patent RightsImprovements, Licensee shall, as a condition of this license, shall confidentially disclose such discovery or invention Licensee Improvements to CMCC, on usual and customary terms necessary to protect its patentability or its confidentiality as a trade secret. CMCC shall have the right to review in advance of filing any related patent application by or on behalf of Licensee or any assignee of Licensee, for purposes of evaluating the relatedness to the Patent Rights. Recognizing that CMCC enters into this Agreement in furtherance of its charitable academic research mission, Licensee shall use good faith and reasonable efforts to enter into with CMCC a non-exclusive license or permit CMCC, as applicable, including for no more than a nominal fee, to practice such discovery or inventionLicensee Improvements, whether or not patented, solely for CMCC internal and academic research purposes; provided, however, that (i) this provision shall not be construed to require Licensee to enter into agreements with CMCC where doing so would violate contractual obligations of Licensee entered into before the Effective Date of this Agreement or any other requirements of law and (ii) CMCC shall have no right to assign, sublicense or further transfer to any third party any such Licensee Improvements or license or right thereto. For the avoidance of doubt, any Any such license granted under this ARTICLE III, Paragraph F by Licensee to CMCC hereunder shall not grant CMCC, require CMCC to convey to Licensee its Affiliates or its sublicensees any right ownership of intellectual property relating to use or practice the licensed rights for commercial purposessuch Licensee Improvement.
Appears in 2 contracts
Samples: Exclusive License Agreement (Tengion Inc), Exclusive License Agreement (Tengion Inc)
DUE DILIGENCE AND RELATED MATTERS. A. Licensee, upon execution of this Agreement, shall use Commercially Reasonable Efforts in good faith to bring at least one (1) or more Licensed Product Products to market as soon as reasonably practicable, consistent with sound and legal business practices and judgment, through a program using Commercially Reasonable Efforts for the exploitation of the Patent Rights. Licensee shall use Commercially Reasonable Efforts to obtain all necessary government approvals for the manufacture, use, sale and distribution of Licensed Productsmarket. Thereafter, Licensee agrees that until expiration or termination of this Agreement, Licensee shall use Commercially Reasonable Efforts to keep Licensed Products reasonably available to the public, in quantities sufficient to meet market demand, in the Territory. In the event Licensee decides not to exploit, either directly or indirectly, a licensed Patent Right in a given country of the Territory, it shall promptly inform CMCC in writing on terms appropriate for public access and the license granted to it hereunder with respect to that Patent Right in that country in the Territory will immediately terminatepublic benefit.
B. Licensee shall In addition to its general obligation to use Commercially Reasonable Efforts to accomplish the specific tasks set forth in Appendix 2 attached hereto in accordance with the timeframe set forth therein Efforts, Licensee shall implement a written development and commercialization plan (such Appendix 2 is hereby incorporated by reference and is referred to herein as the “Development Plan”)
C. Licensee shall use Commercially Reasonable Efforts , which may be amended from time to accomplish the specific requirements of the Development Plan, including the Diligence Specifications set forth in this time pursuant to Paragraph C (of this Article III Licensee’s Initial Development Plan is attached hereto as Appendix 2 and is hereby incorporated herein by reference. Absent CMCC’s consent as provided in Paragraph C of this Article III, the “Diligence Specifications”). The Diligence Specifications shall be part of timeframes and Licensee’s obligations described in the Development Plan and the timeframes for such Diligence Specifications shall be treated as definitive. Such Development Plan and revisions to such Development Plan under Paragraph C of this Article III disclosed to CMCC shall be considered Confidential Information, and shall be subject to the provisions contained in Article VI.
1. Determine protective efficacy of Licensed Products in mouse colonization or systemic models within [* * *]. The Parties acknowledge and agree that Licensee has completed this C. Except for Diligence Specification Specifications as of [* * *].
2. Nominate top 2-3 Licensed Products for vaccine formulation within [* * *] of accomplishing Diligence Specification 1.
3. Final formulation of Licensed Product for pre-IND studies within [* * *] of accomplishing Diligence Specification 2.
4. Completion of toxicology lots of nominated Licensed Products for in vivo toxicology studies within [* * *] of accomplishing Diligence Specification 3.
D. In the event Licensee fails to meet any of the objective(s) set forth in the Development Plan, including without limitation the Diligence Specifications, in a timely manner, CMCC shall notify Licensee thereof in writing, and Licensee shall have sixty (60) days following such notification to establish to the reasonable satisfaction of CMCC that (i) it has met such objective(s); or (ii) a revision to the Development Plan is necessary and appropriate as contemplated below defined in Paragraph E. In the event Licensee fails to establish the same to CMCC’s reasonable satisfaction, CMCC shall have the right in its sole discretion to terminate in whole or in part the license granted to Licensee under D of this Agreement effective immediately.
E. Notwithstanding anything above to the contraryArticle III, CMCC shall not unreasonably withhold withhold, condition or delay (it being understood that CMCC may reasonably condition its consent), its consent to any revision of the objective(s) or timing of the Development Plan, Plan when requested in writing in In advance by Licensee and the request is supported by evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays in the clinical studies or regulatory process that Licensee could not reasonably have been avoided; (ii) that Licensee is proposing and will implement satisfactory and effective means of addressing such difficulties or delays, including sufficient financial and technical resources; and (iii) that Licensee, its Affiliates and/or Sublicensees have in good faith made Commercially Reasonable Efforts and expended commercially reasonable resources contemplated by the Development Plan.
D. Notwithstanding Paragraphs B and adequate resources C of this Article III, Licensee agrees that Licensee’s failure to achieve the following specific requirements of the Development Plan (“Diligence Specifications”) shall be sufficient grounds for the actions specified in this paragraph:
(i) [***];
(ii) [***];
(iii) [***];
(iv) [***];
(v) [***]; and
(vi) [***]. The Parties agree that Licensee’s failure to achieve any of the Diligence Specifications will irreparably harm CMCC’s ability to ensure that a Licensed Product is timely developed for the public benefit. In the event Licensee falls to meet said objective and will continue to do so.
F. If, during the Term of this Agreement, Licensee makes any discovery or invention that Licensee reasonably believes to be patentable and is not within the scope of the license Diligence Specifications set forth in this Paragraph D in a timely manner, CMCC shall notify Licensee thereof in writing, and Licensee shall have sixty (60) days following such notification to the Patent Rights granted to it hereunder but is dominated by the Patent Rightsestablish, Licensee shall, as a condition of this license, confidentially disclose such discovery or invention through written response to CMCC, on usual to the reasonable satisfaction of CMCC that (i) It has met such objective(s); or (ii) a revision to the Diligence Specification is necessary and customary terms necessary appropriate as contemplated above. In the event Licensee falls to protect its patentability establish (i) or its confidentiality as a trade secret. (ii) in such 60-day period to CMCC’s reasonable satisfaction in CMCC’s sole discretion, CMCC shall have the right in its sole discretion to review terminate in advance of filing any related patent application by whole or on behalf of in part the license granted to Licensee or any assignee of Licensee, for purposes of evaluating the relatedness to the Patent Rights. Recognizing that CMCC enters into under this Agreement in furtherance of its charitable academic research mission, Licensee shall use good faith and reasonable efforts pursuant to enter into with CMCC a non-exclusive license or permit CMCC, as applicable, including for no more than a nominal fee, to practice such discovery or invention, whether or not patented, solely for CMCC internal and academic research purposes. For the avoidance of doubt, any license granted under this ARTICLE III, Paragraph F by Licensee to CMCC shall not grant CMCC, its Affiliates or its sublicensees any right to use or practice the licensed rights for commercial purposesArticle XV effective Immediately.
Appears in 2 contracts
Samples: Exclusive License Agreement (Scholar Rock Holding Corp), Exclusive License Agreement (Scholar Rock Holding Corp)
DUE DILIGENCE AND RELATED MATTERS. A. Licensee, upon execution of this Agreement, shall use Commercially Reasonable Efforts diligent efforts in good faith to bring at least one (1) or more Licensed Product Products to market as soon as reasonably practicable, consistent with sound and legal business practices and judgment, through a vigorous and diligent program using Commercially Reasonable Efforts for the exploitation of the Patent RightsRights taking into account the competitiveness of the marketplace, the proprietary position of the Licensed Product, the relative potential safety and efficacy of the Licensed Product, the cost of goods and availability of capacity to manufacture and supply the Licensed Product at commercial scale, the profitability of the applicable Licensed Product, and other relevant factors including, without limitation, technical, legal, scientific or medical factors. Licensee shall use Commercially Reasonable Efforts diligent efforts to obtain all necessary government approvals for the manufacture, use, sale and distribution of Licensed Products. Thereafter, Licensee agrees that until expiration or termination of this Agreement, Licensee shall use Commercially Reasonable Efforts commercially reasonable to continue active and diligent efforts to keep Licensed Products reasonably available to the public, in quantities sufficient to meet market demand, in the Territory. In the event Licensee decides not to exploit, either directly or indirectly, exploit a licensed Patent Right Right, or Field of Use, in a given country portion of the Territory, it shall promptly inform CMCC in writing and the shall surrender to CMCC its license granted to it hereunder with respect to that Patent Right or Field of Use in that country in the Territory will immediately terminateTerritory.
B. The parties acknowledge that Licensee shall use Commercially Reasonable Efforts has provided to accomplish CMCC prior to the specific tasks set forth in Appendix 2 attached hereto in accordance with the timeframe set forth therein date of execution of this Agreement a written development plan (such Appendix 2 is hereby incorporated by reference and is referred to herein as the “Development Plan”)) setting forth for a period of five (5) years beginning the Effective Date, projections for the initial indications and markets for Licensed Products and Licensed Processes for the subfield of SCI in the Field of Use, including (i) time-delimited targets for pre-clinical development, clinical trials, regulatory approval, manufacturing and marketing that represent reasonable efforts, consistent with industry norms for similar technology and applications, to bring Licensed Products to the marketplace; and (ii) actual or projected financial resources and/or strategic alliances that will be required to implement the Development Plan and (iii) identified project management structure calculated to meet the objectives and commitments in the Development Plan. The Development Plan is attached hereto as Appendix 2 and is hereby incorporated herein by reference. In addition, prior to submission of the first regulatory filing relating to the first Licensed Product, but in any event no later than five years from the Effective Date, Licensee shall submit a commercialization plan (“Commercialization Plan”) setting forth projected (i) time delimited commercialization milestones for bringing Licensed Products to the marketplace and (ii) strategic alliances (including but not limited to alliances with Distributors) required to achieve the goals outlined in the Commercialization Plan. The Commercialization Plan shall be attached to this Agreement as Appendix 3.
C. Licensee shall use Commercially Reasonable Efforts good faith and diligent efforts to accomplish the specific requirements of the Development Plan, including the Diligence Specifications milestones set forth in this Paragraph C (the “Diligence Specifications”). The Diligence Specifications shall be part of the Development Plan and the timeframes for such Diligence Specifications to manufacture and distribute Licensed Products.
D. Licensee shall be treated as definitivedeemed to be using diligent efforts during the one (1) year period after the Effective Date if Licensee has raised and allocated for expenditure for carrying out the Development Plan during the period commencing on September 26, 2006 and ending on the one (1) year anniversary date of the Effective Date a cumulative total of investment capital and/or research and development funds of at least $1,000,000. In addition, the Licensee shall be deemed to be using diligent efforts during the three (3) year period after the Effective Date, if the Licensee has expended at least $6,000,000 reasonably allocated during that period to implement the Development Plan.
1. Determine protective efficacy E. From and after the Effective Date, Licensee shall have full control and authority over the development and commercialization of Licensed Products in mouse colonization or systemic models within [* * *]the Field of Use in the Territory, including without limitation, (a) all activities related to human clinical trials (including all clinical studies), (b) all activities relating to manufacture and supply of all Licensed Products (including all required process development and scale up work with respect thereto), (c) all marketing, promotion, sales, distribution, import and export activities relating to any Licensed Product, and (d) all activities relating to any regulatory filings, registrations, applications and regulatory approvals relating to any of the foregoing. The Parties acknowledge Licensee shall own all data, results and agree that all other information arising from any such activities performed solely by Licensee has completed under this Diligence Specification as Agreement, and all of [* * *]the foregoing information, documentation and materials shall be considered Confidential Information and technology solely owned by Licensee.
2. Nominate top 2-3 Licensed Products for vaccine formulation within [* * *] of accomplishing Diligence Specification 1.
3. Final formulation of Licensed Product for pre-IND studies within [* * *] of accomplishing Diligence Specification 2.
4. Completion of toxicology lots of nominated Licensed Products for in vivo toxicology studies within [* * *] of accomplishing Diligence Specification 3.
D. In F. Notwithstanding anything above to the event Licensee fails contrary, CMCC shall not unreasonably withhold its consent to meet any revision of the objective(s) set forth in the Development PlanPlan when requested in writing in advance by Licensee and the request is supported by evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays in the clinical studies or regulatory process that Licensee could not reasonably have been avoided; (ii) Licensee is proposing and will implement satisfactory and effective means of addressing such difficulties or delays, including without limitation sufficient financial and technical resources; and (iii) that Licensee, its Affiliates and/or sublicensees have in good faith made diligent efforts and expended adequate resources to meet said objective and will continue to do so.
G. In the Diligence Specifications, event Licensee fails to meet the objective(s) set forth in the Development Plan in a timely manner, CMCC shall notify Licensee thereof in writing, and Licensee shall have sixty (60) days following such notification to establish to the reasonable satisfaction of CMCC that (i) it has met such objective(s); or (ii) a revision to the Development Plan is necessary and appropriate as contemplated below in Paragraph E. above. In the event Licensee fails to establish the same within the 60-day cure period, to CMCC’s reasonable satisfaction, CMCC shall have the right in its sole discretion to terminate in whole or in part the license granted to Licensee under this Agreement effective immediately.
E. Notwithstanding anything above to the contrary, CMCC shall not unreasonably withhold its consent to any revision of the objective(s) or timing of the Development Plan, when requested in writing in advance by Licensee and the request is supported by evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays that Licensee could not reasonably have avoided; (ii) that Licensee is proposing and will implement satisfactory and effective means of addressing such difficulties or delays, including sufficient financial and technical resources; and (iii) that Licensee, its Affiliates and/or Sublicensees have in good faith made Commercially Reasonable Efforts and expended commercially reasonable and adequate resources to meet said objective and will continue to do so.
F. H. If, during the Term course of this Agreement, Licensee makes any discovery or invention that Licensee reasonably believes to be patentable and is not within the scope of the license to the Patent Rights granted to it hereunder but is dominated by would not have been made but for the Patent Rights, Licensed Products or Licensed Processes licensed hereunder, Licensee shall, as a condition of this licenseLicense, confidentially disclose such discovery or invention to CMCC, on usual and customary terms necessary to protect its patentability or its confidentiality as a trade secret. CMCC shall have the right to review in advance of filing any related patent application by or on behalf of Licensee or any assignee of Licensee, for purposes of evaluating the relatedness to the Patent Rights. Recognizing that CMCC enters into this Agreement in furtherance of its charitable academic research mission, Licensee shall use good faith and reasonable efforts to enter into with CMCC a non-exclusive license or permit CMCCpermit, as applicable, including for no more than a nominal fee, to practice such discovery or invention, whether or not patented, solely for CMCC internal and academic research purposes. For the avoidance Any such license shall specifically exclude and prohibit commercialization of doubtsuch discoveries or inventions. CMCC on its own behalf, grants Licensee a thirty (30) calendar day exclusive right of first negotiation to license any license granted under this ARTICLE III, Paragraph F by Licensee to CMCC shall not grant CMCC, its Affiliates rights resulting from such discoveries or its sublicensees any right to use or practice the licensed rights for commercial purposesinventions.
Appears in 1 contract
Samples: Exclusive License Agreement (Invivo Therapeutics Holdings Corp.)
DUE DILIGENCE AND RELATED MATTERS. A. Licensee, upon execution of this Agreement, shall use Commercially Reasonable Efforts best efforts in good faith to bring at least one (1) or more Licensed Product Products to market as soon as reasonably practicable, consistent with sound and legal business practices and judgment, through a vigorous and diligent program using Commercially Reasonable Efforts for the exploitation of the Patent Rights. Licensee shall use Commercially Reasonable Efforts best efforts to obtain all necessary government approvals for the manufacture, use, sale and distribution of Licensed Products. Thereafter, Licensee agrees that until expiration or termination of this Agreement, Licensee shall use Commercially Reasonable Efforts continue active and diligent efforts to keep Licensed Products reasonably available to the public, in quantities sufficient to meet market demand, in the Territory. In the event Licensee decides not to exploit, either directly or indirectly, exploit a licensed Patent Right in a given country Right, or Field of the TerritoryUse, it shall promptly inform CMCC in writing and the shall surrender to CMCC its license granted to it hereunder with respect to that Patent Right in that country in the Territory will immediately terminateor Field of Use.
B. Licensee shall use Commercially Reasonable Efforts For the sake of clarity, the parties agree that three levels of diligence will apply to accomplish the specific tasks set forth technologies described in this Agreement, as further described in Appendix 2 attached hereto in accordance with the timeframe set forth therein (such Appendix 2 is hereby incorporated 7:
1- Group A: Technologies chosen by reference and is referred to herein Licensee or by a sublicensee for development as the “Development Plan”)
C. Licensee shall use Commercially Reasonable Efforts to accomplish the specific requirements of the Development Plan, including the Diligence Specifications set forth in this Paragraph C (the “Diligence Specifications”)a Licensed Product. The Diligence Specifications shall be part of the Development Plan and the timeframes for such Diligence Specifications shall be treated as definitive.
1. Determine protective efficacy of Licensed Products in mouse colonization or systemic models within [* * *]. The Parties acknowledge and agree that Licensee has completed this Diligence Specification as of [* * *].
2. Nominate top 2-3 Licensed Products for vaccine formulation within [* * *] of accomplishing Diligence Specification 1.
3. Final formulation of Licensed Product for pre-IND studies within [* * *] of accomplishing Diligence Specification 2.
4. Completion of toxicology lots of nominated Licensed Products for in vivo toxicology studies within [* * *] of accomplishing Diligence Specification 3.
D. In the event Licensee fails to meet any of the objective(s) set forth in the Development Plan, including without limitation the Diligence Specifications, in a timely manner, CMCC shall notify Licensee thereof in writing, and Licensee shall have sixty (60) days following such notification to establish Subject to the reasonable satisfaction of CMCC that diligence requirement as per Paragraph III (C) below. This group specifically includes (i) it has met such objective(s); or (ii) a revision to Technologies in the Development Plan is necessary and appropriate as contemplated below Existing Agreements listed in Paragraph E. In the event Licensee fails to establish the same to CMCC’s reasonable satisfaction, CMCC shall have the right in its sole discretion to terminate in whole or in part the license granted to Licensee under this Agreement effective immediately.
E. Notwithstanding anything above to the contrary, CMCC shall not unreasonably withhold its consent to any revision of the objective(s) or timing of the Development Plan, when requested in writing in advance by Licensee and the request is supported by evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays that Licensee could not reasonably have avoidedAppendix 1; (ii) Improvements. Group A specifically excludes Analogue Inventions.
2- Group B: Analogue Inventions: Subject to no diligence requirements, provided that Licensee is proposing and will implement satisfactory and effective means in compliance with the provisions of addressing such difficulties or delays, including sufficient financial and technical resources; and (iii) that Licensee, its Affiliates and/or Sublicensees have in good faith made Commercially Reasonable Efforts and expended commercially reasonable and adequate resources this Article applicable to meet said objective and will continue the proposed Licensed Product to do sowhich the Analogue Invention relates.
F. If, 3- Group C: New Developments. Subject to new due diligence requirements governed by a new license agreement between CMCC and Licensee if Licensee exercises the option as per Paragraph II A (4) above.
C. The parties acknowledge that Licensee has provided to CMCC prior to the date of execution of this Agreement a proposed written development plan ("Initial Development Plan") setting forth critical milestones to be accomplished by Licensee during the Term term of this Agreement. The Initial Development Plan is attached hereto as Appendix 5 and is hereby incorporated herein by reference. No later than [**] from the Effective Date of this Agreement, Licensee makes any discovery or invention that Licensee reasonably believes shall provide to be patentable and is not within the scope CMCC written notice of the license to the Patent Rights granted to it hereunder but is dominated which Positive and/or Negative Regulators covered by the Patent Rights, Licensee shall, as a condition of this license, confidentially disclose such discovery or invention to CMCC, on usual and customary terms necessary to protect its patentability or its confidentiality as a trade secret. CMCC shall have the right to review in advance of filing including any related patent application by or on behalf of Licensee or any assignee of Licensee, for purposes of evaluating the relatedness to the Patent Rights. Recognizing that CMCC enters into this Agreement in furtherance of its charitable academic research missionImprovements, Licensee shall use good faith intends to develop into Licensed Products, and reasonable efforts a selection of at least three subfields in the Field of Use. Such selection will define the technologies in Group A. In addition, such written notification will include a commercialization development plan ("Development Plan") setting forth the initial indications and markets for at least one Licensed Product in each one of the chosen subfields. The parties have agreed that although Licensee is licensing technologies both from Xx. Xxxxx Xxxxxxxx through this License Agreement and from Dr. Xxxxxxx Xx through a companion license agreement, Licensee is required to enter into with CMCC a non-exclusive provide only one Development Plan for both license or permit CMCC, as applicable, including for no more than a nominal fee, to practice such discovery or invention, whether or not patented, solely for CMCC internal and academic research purposesagreements in each chosen subfield. For the avoidance of doubt, any license granted under this ARTICLE III, Paragraph F by Licensee to CMCC shall not grant CMCC, its Affiliates or its sublicensees any right to use or practice the licensed rights for commercial purposes.Such Development Plan may include technologies (a) only from Xx. Xxxxxxxx' laboratory; (
Appears in 1 contract
Samples: Exclusive License Agreement (Boston Life Sciences Inc /De)
DUE DILIGENCE AND RELATED MATTERS. A. Licensee, upon execution of this Agreement, on its own behalf or through its Affiliates or Sublicensees, shall use Commercially Reasonable Reasonably Diligent Efforts in good faith to develop the Patent Rights and to bring at least one (1) or more Licensed Product Products to market as soon as reasonably practicable, consistent with sound and legal business practices and judgment, through a program using Commercially Reasonable Efforts for the exploitation of the Patent Rights. Licensee shall use Commercially Reasonable Reasonably Diligent Efforts to obtain all necessary government approvals for the manufacture, use, sale and distribution of Licensed Products. Thereafter, Licensee agrees that until expiration or termination of this Agreement, Licensee shall use Commercially Reasonable Efforts continue active and diligent efforts to keep Licensed Products reasonably available to the public, in quantities sufficient to meet market demand, in the Territory. In the event Licensee ***Confidential Treatment Requested*** decides not to exploit, either directly or indirectly, exploit a licensed Patent Right Right, or Field of Use, in a given country portion of the Territory, it shall promptly inform CMCC in writing and the shall surrender to CMCC its license granted to it hereunder with respect to that Patent Right or Field of Use in that country in portion of the Territory will immediately terminateTerritory.
B. The parties acknowledge that Licensee shall use Commercially Reasonable Efforts has provided to accomplish CMCC prior to the specific tasks set forth in Appendix 2 attached hereto in accordance with the timeframe set forth therein date of execution of this Agreement an initial written development plan (such Appendix 2 is hereby incorporated by reference and is referred to herein as the “Development Plan”)) setting forth overall objectives and the initial indications and markets for Licensed Products, including (i) time-delimited target dates for clinical candidate selection and development, (ii) time-delimited target dates for pre-clinical development, clinical trials, regulatory approval, manufacturing and marketing that represent Reasonably Diligent Efforts to bring Licensed Products to the marketplace. Licensee will submit an updated Development Plan periodically, and in any event within twelve (12) months after the Effective Date and annually thereafter in conjunction with an Annual Status Report as described in Article V (due January 31 each year) until launch of the first Licensed Product. The initial Development Plan is attached hereto as Appendix 3 and is hereby incorporated herein by reference.
C. For the first three (3) years Licensee shall use Commercially Reasonable be deemed to have used Reasonably Diligent Efforts to accomplish under this Article III as follows:
(1) during the specific one (1) year period after the Effective Date if, during that period, Licensee shall have raised in connection with the Patent Rights and allocated for expenditure for efforts under the requirements of this Article III(A) a cumulative total of investment capital and/or research and development funds of at least […***…] ($[…***…]) dollars and applied to activities under the Development Plan; (2) during the three (3) year period after the Effective Date, including during that period, Licensee shall have raised and expended aggregate funding of at least […***…] ($[…***…]) dollars to implement the Diligence Specifications set forth Development Plan; and (3) conduct activities described in the initial Development Plan attached to this Paragraph C Agreement as Appendix 3 as provided by Licensee. After the Effective Date Licensee will include in an Annual Status Report (the “Diligence Specifications”). The Diligence Specifications shall be part as defined in Article V of this Agreement) of activities conducted under the Development Plan a commercialization plan of activities that it has planned, including designated milestones and associated timelines for the timeframes clinical trials, regulatory approval and launch of the first product in the United States and European territories. At the time of filing the Investigational New Drug Application (“IND”) with the U.S. Food and Drug Administration (“FDA”) or equivalent with the European Medicines Evaluation Agency (“EMEA”), whichever occurs first for such Diligence Specifications shall be treated as definitive.
1. Determine protective efficacy of the first Licensed Products in mouse colonization or systemic models within [* * *]. The Parties acknowledge and agree that Product, the Licensee has completed this Diligence Specification as of [* * *].
2. Nominate top 2-3 Licensed Products will submit a revised plan for vaccine formulation within [* * *] of accomplishing Diligence Specification 1.
3. Final formulation of Licensed Product for pre-IND studies within [* * *] of accomplishing Diligence Specification 2.
4. Completion of toxicology lots of nominated Licensed Products for in vivo toxicology studies within [* * *] of accomplishing Diligence Specification 3commercialization.
D. In the event Licensee fails wishes to meet any amend the overall objectives set forth in the initial Development Plan attached as Appendix 3 to this Agreement, Licensee will notify CMCC in writing and will include with such notice a reasonably detailed explanation of the objective(s) set forth circumstances supporting such amendment. Promptly after receipt of such notice, CMCC will notify Licensee in writing whether it approves of such amendment, which approval will not be unreasonably withheld. In the event CMCC does not approve the amendment to objectives in the Development Plan, including without limitation and CMCC and Licensee are unable to reach resolution on this matter within a reasonable period of time, the Diligence Specificationsmatter will be handled in accordance with the dispute resolution terms set forth in Article XII of this Agreement. No rights of either party under this Agreement will be affected pending the outcome of proceedings in accordance with such Article XII. ***Confidential Treatment Requested***
E. In the event that, in a timely mannerthrough the Annual Status Report, Licensee fails to demonstrate that it has achieved the diligence requirements of this Article Ml, CMCC shall will notify Licensee thereof in writing, writing of any alleged deficiency and the basis for CMCC’s determination of same. Licensee shall will have sixty (60) […***…] days following such notification to establish that the required diligence has been achieved or to the reasonable satisfaction of CMCC that (i) it has met cure such objective(s); deficiency or (ii) a revision to the Development Plan is necessary and appropriate as contemplated below in Paragraph E. In the event Licensee fails to establish the same provide an explanation for any delay to CMCC’s reasonable satisfaction. If Licensee fails to do any of the above within such […***…]-day period, and subject to the dispute resolution terms set forth in Article XII of this Agreement, CMCC shall will have the right in its sole discretion to terminate in whole or in part convert the license granted to Licensee under this Agreement effective immediately.
E. from exclusive to non-exclusive on financial terms and conditions to be mutually agreed to by CMCC and Licensee. No rights of either party under this Agreement will be affected pending the outcome of proceedings in accordance with such Article XII. Notwithstanding anything above the foregoing, Licensee may extend the due date for achievement of any funding thresholds set out in Paragraph C of this Article III […***…] only by […***…] by making a payment to CMCC of […***…] dollars ($[…***…]) on or before the contrary, CMCC shall not unreasonably withhold its consent to any revision of the objective(sdate(s) or timing of the Development Plan, when requested in writing in advance by Licensee and the request is supported by evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays that Licensee could not reasonably have avoided; (ii) that Licensee is proposing and will implement satisfactory and effective means of addressing such difficulties or delays, including sufficient financial and technical resources; and (iii) that Licensee, its Affiliates and/or Sublicensees have in good faith made Commercially Reasonable Efforts and expended commercially reasonable and adequate resources to meet said objective and will continue to do sospecified.
F. If, during the Term course of this Agreement, Licensee makes any patentable discovery or invention within the Field of Use that Licensee reasonably believes to be patentable and is not within the scope of the license to Patent Rights but would not have been made but for the Patent Rights granted to it hereunder but is dominated by and/or the Patent Rights, Licensed Products licensed hereunder. Licensee shall, as a condition of this licenseLicense, confidentially disclose such patentable discovery or invention to the Intellectual Property Office of CMCC, on usual and customary terms necessary to protect its patentability or its confidentiality as a trade secret. CMCC shall have the right to review in advance of filing any related patent application by or on behalf of Licensee or any assignee of Licensee, for purposes of evaluating the relatedness to the Patent Rights. Recognizing that CMCC enters into this Agreement in furtherance of its charitable academic research mission, Licensee shall use good faith and reasonable efforts to enter into with CMCC a non-exclusive license or permit CMCCpermit, as applicable, including for no more than a nominal fee, for […***…] and/or anyone within her laboratory, to practice such discovery or invention, whether or not patentedinvention for which patent application has been filed, solely for CMCC internal and academic research purposes. For ; provided, however, that in the avoidance of doubtevent that a patented invention arises from such CMCC use, any license granted under this ARTICLE III, Paragraph F by Licensee to CMCC shall not grant CMCCto Licensee a fully paid-up non-exclusive license for internal research purposes, its Affiliates and at Licensee’s discretion either a non-exclusive or its sublicensees any right exclusive commercialization license to use or practice the licensed rights for commercial purposesinvention, subject to mutually agreeable terms.
Appears in 1 contract
Samples: Exclusive License Agreement
DUE DILIGENCE AND RELATED MATTERS. A. Licensee, upon execution of this Agreement, shall use Commercially Reasonable Efforts diligent efforts in good faith to bring at least one (1) or more Licensed Product Products to market as soon as reasonably practicable, consistent with sound and legal business practices and judgment, through a vigorous and diligent program using Commercially Reasonable Efforts for the exploitation of the Patent RightsRights taking into account the competitiveness of the marketplace, the proprietary position of the Licensed Product, the relative potential safety and efficacy of the Licensed Product, the cost of goods and availability of capacity to manufacture and supply the Licensed Product at commercial scale, the profitability of the applicable Licensed Product, and other relevant factors including, without limitation, technical, legal, scientific or medical factors. Licensee shall use Commercially Reasonable Efforts diligent efforts to obtain all necessary government approvals for the manufacture, use, sale and distribution of Licensed Products. Thereafter, Licensee agrees that until expiration or termination of this Agreement, Licensee shall use Commercially Reasonable Efforts commercially reasonable to continue active and diligent efforts to keep Licensed Products reasonably available to the public, in quantities sufficient to meet market demand, in the Territory. In the event Licensee decides not to exploit, either directly or indirectly, exploit a licensed Patent Right Right, or Field of Use, in a given country portion of the Territory, it shall promptly inform CMCC in writing and the shall surrender to CMCC its license granted to it hereunder with respect to that Patent Right or Field of Use in that country in the Territory will immediately terminateTerritory.
B. The parties acknowledge that Licensee shall use Commercially Reasonable Efforts has provided to accomplish CMCC prior to the specific tasks set forth in Appendix 2 attached hereto in accordance with the timeframe set forth therein date of execution of this Agreement a written development plan (such Appendix 2 is hereby incorporated by reference and is referred to herein as the “Development Plan”)) setting forth for a period of five (5) years beginning the Effective Date, projections for the initial indications and markets for Licensed Products and Licensed Processes for the subfield of SCI in the Field of Use, including (i) time-delimited targets for pre-clinical development, clinical trials, regulatory approval, manufacturing and marketing that represent reasonable efforts, consistent with industry norms for similar technology and applications, to bring Licensed Products to the marketplace; and (ii) actual or projected financial resources and/or strategic alliances that will be required to implement the Development Plan and (iii) identified project management structure calculated to meet the objectives and commitments in the Development Plan. The Development Plan is attached hereto as Appendix 2 and is hereby incorporated herein by reference. In addition, prior to submission of the first regulatory filing relating to the first Licensed Product, but in any event no later than five years from the Effective Date, Licensee shall submit a commercialization plan (“Commercialization Plan”) setting forth projected (i) time delimited commercialization milestones for bringing Licensed Products to the marketplace and (ii) strategic alliances (including but not limited to alliances with Distributors) required to achieve the goals outlined in the Commercialization Plan. The Commercialization Plan shall be attached to this Agreement as Appendix 3.
C. Licensee shall use Commercially Reasonable Efforts good faith and diligent efforts to accomplish the specific requirements of the Development Plan, including the Diligence Specifications milestones set forth in this Paragraph C (the “Diligence Specifications”). The Diligence Specifications shall be part of the Development Plan and the timeframes for such Diligence Specifications to manufacture and distribute Licensed Products.
D. Licensee shall be treated as definitivedeemed to be using diligent efforts during the one (1) year period after the Effective Date if Licensee has raised and allocated for expenditure for carrying out the Development Plan during the period commencing on September 26, 2006 and ending on the one (1) year anniversary date of the Effective Date a cumulative total of investment capital and/or research and development funds of at least $[****]. In addition, the Licensee shall be deemed to be using diligent efforts during the three (3) year period after the Effective Date, if the Licensee has expended at least $[****] reasonably allocated during that period to implement the Development Plan.
1. Determine protective efficacy E. From and after the Effective Date, Licensee shall have full control and authority over the development and commercialization of Licensed Products in mouse colonization or systemic models within [* * *]the Field of Use in the Territory, including without limitation, (a) all activities related to human clinical trials (including all clinical studies), (b) all activities relating to manufacture and supply of all Licensed Products (including all required process development and scale up work with respect thereto), (c) all marketing, promotion, sales, distribution, import and export activities relating to any Licensed Product, and (d) all activities relating to any regulatory filings, registrations, applications and regulatory approvals relating to any of the foregoing. The Parties acknowledge Licensee shall own all data, results and agree that all other information arising from any such activities performed solely by Licensee has completed under this Diligence Specification as Agreement, and all of [* * *]the foregoing information, documentation and materials shall be considered Confidential Information and technology solely owned by Licensee.
2. Nominate top 2-3 Licensed Products for vaccine formulation within [* * *] of accomplishing Diligence Specification 1.
3. Final formulation of Licensed Product for pre-IND studies within [* * *] of accomplishing Diligence Specification 2.
4. Completion of toxicology lots of nominated Licensed Products for in vivo toxicology studies within [* * *] of accomplishing Diligence Specification 3.
D. In F. Notwithstanding anything above to the event Licensee fails contrary, CMCC shall not unreasonably withhold its consent to meet any revision of the objective(s) set forth in the Development PlanPlan when requested in writing in advance by Licensee and the request is supported by evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays in the clinical studies or regulatory process that Licensee could not reasonably have been avoided; (ii) Licensee is proposing and will implement satisfactory and effective means of addressing such difficulties or delays, including without limitation sufficient financial and technical resources; and (iii) that Licensee, its Affiliates and/or sublicensees have in good faith made diligent efforts and expended adequate resources to meet said objective and will continue to do so.
G. In the Diligence Specifications, event Licensee fails to meet the objective(s) set forth in the Development Plan in a timely manner, CMCC shall notify Licensee thereof in writing, and Licensee shall have sixty (60) days following such notification to establish to the reasonable satisfaction of CMCC that (i) it has met such objective(s); or (ii) a revision to the Development Plan is necessary and appropriate as contemplated below in Paragraph E. above. In the event Licensee fails to establish the same within the 60-day cure period, to CMCC’s reasonable satisfaction, CMCC shall have the right in its sole discretion to terminate in whole or in part the license granted to Licensee under this Agreement effective immediately.
E. Notwithstanding anything above to the contrary, CMCC shall not unreasonably withhold its consent to any revision of the objective(s) or timing of the Development Plan, when requested in writing in advance by Licensee and the request is supported by evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays that Licensee could not reasonably have avoided; (ii) that Licensee is proposing and will implement satisfactory and effective means of addressing such difficulties or delays, including sufficient financial and technical resources; and (iii) that Licensee, its Affiliates and/or Sublicensees have in good faith made Commercially Reasonable Efforts and expended commercially reasonable and adequate resources to meet said objective and will continue to do so.
F. H. If, during the Term course of this Agreement, Licensee makes any discovery or invention that Licensee reasonably believes to be patentable and is not within the scope of the license to the Patent Rights granted to it hereunder but is dominated by would not have been made but for the Patent Rights, Licensed Products or Licensed Processes licensed hereunder, Licensee shall, as a condition of this licenseLicense, confidentially disclose such discovery or invention to CMCC, on usual and customary terms necessary to protect its patentability or its confidentiality as a trade secret. CMCC shall have the right to review in advance of filing any related patent application by or on behalf of Licensee or any assignee of Licensee, for purposes of evaluating the relatedness to the Patent Rights. Recognizing that CMCC enters into this Agreement in furtherance of its charitable academic research mission, Licensee shall use good faith and reasonable efforts to enter into with CMCC a non-exclusive license or permit CMCCpermit, as applicable, including for no more than a nominal fee, to practice such discovery or invention, whether or not patented, solely for CMCC internal and academic research purposes. For the avoidance Any such license shall specifically exclude and prohibit commercialization of doubtsuch discoveries or inventions. CMCC on its own behalf, grants Licensee a thirty (30) calendar day exclusive right of first negotiation to license any license granted under this ARTICLE III, Paragraph F by Licensee to CMCC shall not grant CMCC, its Affiliates rights resulting from such discoveries or its sublicensees any right to use or practice the licensed rights for commercial purposesinventions.
Appears in 1 contract
Samples: Exclusive License Agreement (Invivo Therapeutics Holdings Corp.)
DUE DILIGENCE AND RELATED MATTERS. A. Licensee, upon execution of this Agreement, shall use Commercially Reasonable Efforts best efforts in good faith to bring at least one (1) or more Licensed Product Products to market as soon as reasonably practicable, consistent with sound and legal business practices and judgment, through a vigorous and diligent program using Commercially Reasonable Efforts for the exploitation of the Patent Rights. Licensee shall use Commercially Reasonable Efforts best efforts to obtain all necessary government approvals for the manufacture, use, sale and distribution of Licensed Products. Thereafter, Licensee agrees that until expiration or termination of this Agreement, Licensee shall use Commercially Reasonable Efforts continue active and diligent efforts to keep Licensed Products reasonably available to the public, in quantities sufficient to meet market demand, in the Territory. In the event Licensee decides not to exploit, either directly or indirectly, exploit a licensed Patent Right in a given country Right, or Field of the TerritoryUse, it shall promptly inform CMCC in writing and the shall surrender to CMCC its license granted to it hereunder with respect to that Patent Right in that country in the Territory will immediately terminateor Field of Use.
B. Licensee shall use Commercially Reasonable Efforts For the sake of clarity, the parties agree that three levels of diligence will apply to accomplish the specific tasks set forth technologies described in this Agreement, as further described in Appendix 2 attached hereto in accordance with the timeframe set forth therein (such Appendix 2 is hereby incorporated 7:
1- Group A: Technologies chosen by reference and is referred to herein Licensee or by a sublicensee for development as the “Development Plan”)
C. Licensee shall use Commercially Reasonable Efforts to accomplish the specific requirements of the Development Plan, including the Diligence Specifications set forth in this Paragraph C (the “Diligence Specifications”)a Licensed Product. The Diligence Specifications shall be part of the Development Plan and the timeframes for such Diligence Specifications shall be treated as definitive.
1. Determine protective efficacy of Licensed Products in mouse colonization or systemic models within [* * *]. The Parties acknowledge and agree that Licensee has completed this Diligence Specification as of [* * *].
2. Nominate top 2-3 Licensed Products for vaccine formulation within [* * *] of accomplishing Diligence Specification 1.
3. Final formulation of Licensed Product for pre-IND studies within [* * *] of accomplishing Diligence Specification 2.
4. Completion of toxicology lots of nominated Licensed Products for in vivo toxicology studies within [* * *] of accomplishing Diligence Specification 3.
D. In the event Licensee fails to meet any of the objective(s) set forth in the Development Plan, including without limitation the Diligence Specifications, in a timely manner, CMCC shall notify Licensee thereof in writing, and Licensee shall have sixty (60) days following such notification to establish Subject to the reasonable satisfaction of CMCC that diligence requirement as per Paragraph III (C) below. This group specifically includes (i) it has met such objective(s); or (ii) a revision to the Development Plan is necessary and appropriate as contemplated below The existing technologies listed in Paragraph E. In the event Licensee fails to establish the same to CMCC’s reasonable satisfaction, CMCC shall have the right in its sole discretion to terminate in whole or in part the license granted to Licensee under this Agreement effective immediately.
E. Notwithstanding anything above to the contrary, CMCC shall not unreasonably withhold its consent to any revision of the objective(s) or timing of the Development Plan, when requested in writing in advance by Licensee and the request is supported by evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays that Licensee could not reasonably have avoidedAppendix 1; (ii) Improvements. Group A specifically excludes Analogue Inventions.
2- Group B: Analogue Inventions: Subject to no diligence requirements, provided that Licensee is proposing and will implement satisfactory and effective means in compliance with the provisions of addressing such difficulties or delays, including sufficient financial and technical resources; and (iii) that Licensee, its Affiliates and/or Sublicensees have in good faith made Commercially Reasonable Efforts and expended commercially reasonable and adequate resources this Article applicable to meet said objective and will continue the proposed Licensed Product to do sowhich the Analogue Invention relates.
F. If, 3- Group C: New Developments. Subject to new due diligence requirements governed by a new license agreement between CMCC and Licensee if Licensee exercises the option as per Paragraph II A (5) above.
C. The parties acknowledge that Licensee has provided to CMCC prior to the date of execution of this Agreement a proposed written development plan ("Initial Development Plan") setting forth critical milestones to be accomplished by Licensee during the Term term of this Agreement. The Initial Development Plan is attached hereto as Appendix 5 and is hereby incorporated herein by reference. No later than [**] from the Effective Date of this Agreement, Licensee makes any discovery or invention that Licensee reasonably believes shall provide to be patentable and is not within the scope CMCC written notice of the license to the Patent Rights granted to it hereunder but is dominated which Positive and/or Negative Regulators covered by the Patent Rights, including any Improvements, Licensee shallintends to develop into Licensed Products, as and a condition selection of at least three subfields in the Field of Use. Such selection will define the technologies in Group A. In addition, such written notification will include a commercialization development plan ("Development Plan") setting forth the initial indications and markets for at least one Licensed Product in each one of the chosen subfields. The parties have agreed that although Licensee is licensing technologies both from Dr. Xxxxxxx Xx through this licenseLicense Agreement and from Xx. Xxxxx Benowitz through a companion license agreement, confidentially disclose such discovery Licensee is required to provide only one Development Plan for both license agreements in each chosen subfield. Such Development Plan may include technologies (a) only from Dr. Xxxxxxx Xx' laboratory; (b) only from Xx. Xxxxx Xxxxxxxx's laboratory; or invention (c) a combination of both. The Development Plan will also include: (i) time-delimited targets for pre-clinical development, clinical trials, regulatory approval, manufacturing and marketing that represent reasonable efforts, consistent with industry norms for similar technology and applications, to bring Licensed Products and Licensed Processes to the marketplace; and (ii) actual or projected financial resources and/or strategic alliances that will be required to implement the Development Plan. The Development Plan and any amendments to the Development Plan shall be acceptable to CMCC. All rights granted herein to Patent Rights covering axonal growth factors in this group, either from Dr. Xxxxxxx Xx' or Xx. Xxxxx Xxxxxxxx's laboratory, for which Licensee has not submitted a Development Plan at the [**] anniversary of the Effective Date shall automatically revert back to CMCC, on usual and customary terms necessary to protect its patentability or its confidentiality as a trade secretwithout further action from CMCC. CMCC shall have the right be free to review in advance of filing license such rights to a third party without any related patent application by or on behalf of Licensee or any assignee of further obligations to Licensee, for purposes of evaluating the relatedness to the Patent Rights. Recognizing that CMCC enters into this Agreement in furtherance of its charitable academic research mission, Licensee shall use good faith and reasonable efforts to enter into with CMCC a non-exclusive license or permit CMCC, as applicable, including for no more than a nominal fee, to practice such discovery or invention, whether or not patented, solely for CMCC internal and academic research purposes. For the avoidance of doubt, any license granted under this ARTICLE III, Paragraph F by Licensee to CMCC shall not grant CMCC, its Affiliates or its sublicensees any right to use or practice the licensed rights for commercial purposes.
Appears in 1 contract
Samples: Exclusive License Agreement (Boston Life Sciences Inc /De)
DUE DILIGENCE AND RELATED MATTERS. A. Licensee, upon execution of this Agreement, shall use Commercially Reasonable Efforts in good faith to bring at least one (1) Licensed Product to market as soon as reasonably practicable, consistent with sound and legal business practices and judgment, through a program using Commercially Reasonable Efforts for the exploitation of the Patent Rights. Licensee shall use Commercially Reasonable Efforts to obtain all necessary government approvals for the manufacture, use, sale and distribution of Licensed Products. Thereafter, Licensee agrees that until expiration or termination of this Agreement, Licensee shall use Commercially Reasonable Efforts to keep Licensed Products reasonably available to the public, in quantities sufficient to meet market demand, in the Territory. In the event Licensee decides not to exploit, either directly or indirectly, a licensed Patent Right in a given country of the Territory, it shall promptly inform CMCC in writing and the license granted to it hereunder with respect to that Patent Right in that country in the Territory will immediately terminate.
B. Licensee shall use Commercially Reasonable Efforts to accomplish the specific tasks set forth in Appendix 2 attached hereto in accordance with the timeframe set forth therein (such Appendix 2 is hereby incorporated by reference and is referred to herein as the “"Development Plan”")
C. Licensee shall use Commercially Reasonable Efforts to accomplish the specific requirements of the Development Plan, including the Diligence Specifications set forth in this Paragraph C (the “"Diligence Specifications”"). The Diligence Specifications shall be part of the Development Plan and the timeframes for such Diligence Specifications shall be treated as definitive.
1. Determine protective efficacy of Licensed Products in mouse colonization or systemic models within [* * *]. The Parties acknowledge and agree that Licensee has completed this Diligence Specification as of [* * *].
2. Nominate top 2-3 Licensed Products for vaccine formulation within [* * *] of accomplishing Diligence Specification 1.
3. Final formulation of Licensed Product for pre-IND studies within [* * *] of accomplishing Diligence Specification 2.
4. Completion of toxicology lots of nominated Licensed Products for in vivo toxicology studies within [* * *] of accomplishing Diligence Specification 3.
D. In the event Licensee fails to meet any of the objective(s) set forth in the Development Plan, including without limitation the Diligence Specifications, in a timely manner, CMCC shall notify Licensee thereof in writing, and Licensee shall have sixty (60) days following such notification to establish to the reasonable satisfaction of CMCC that (i) it has met such objective(s); or (ii) a revision to the Development Plan is necessary and appropriate as contemplated below in Paragraph E. In the event Licensee fails to establish the same to CMCC’s 's reasonable satisfaction, CMCC shall have the right in its sole discretion to terminate in whole or in part the license granted to Licensee under this Agreement effective immediately.
E. Notwithstanding anything above to the contrary, CMCC shall not unreasonably withhold its consent to any revision of the objective(s) or timing of the Development Plan, when requested in writing in advance by Licensee and the request is supported by evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays that Licensee could not reasonably have avoided; (ii) that Licensee is proposing and will implement satisfactory and effective means of addressing such difficulties or delays, including sufficient financial and technical resources; and (iii) that Licensee, its Affiliates and/or Sublicensees have in good faith made Commercially Reasonable Efforts and expended commercially reasonable and adequate resources to meet said objective and will continue to do so.
F. If, during the Term of this Agreement, Licensee makes any discovery or invention that Licensee reasonably believes to be patentable and is not within the scope of the license to the Patent Rights granted to it hereunder but is dominated by the Patent Rights, Licensee shall, as a condition of this license, confidentially disclose such discovery or invention to CMCC, on usual and customary terms necessary to protect its patentability or its confidentiality as a trade secret. CMCC shall have the right to review in advance of filing any related patent application by or on behalf of Licensee or any assignee of Licensee, for purposes of evaluating the relatedness to the Patent Rights. Recognizing that CMCC enters into this Agreement in furtherance of its charitable academic research mission, Licensee shall use good faith and reasonable efforts to enter into with CMCC a non-exclusive license or permit CMCC, as applicable, including for no more than a nominal fee, to practice such discovery or invention, whether or not patented, solely for CMCC internal and academic research purposes. For the avoidance of doubt, any license granted under this ARTICLE III, Paragraph F by Licensee to CMCC shall not grant CMCC, its Affiliates or its sublicensees any right to use or practice the licensed rights for commercial purposes.
Appears in 1 contract
Samples: Exclusive License Agreement (Genocea Biosciences, Inc.)
DUE DILIGENCE AND RELATED MATTERS. A. Licensee, upon execution of this Agreement, on its own behalf or through its Affiliates or Sublicensees, shall use Commercially Reasonable Reasonably Diligent Efforts in good faith to develop the Patent Rights and to bring at least one (1) or more Licensed Product Products to market as soon as reasonably practicable, consistent with sound and legal business practices and judgment, through a program using Commercially Reasonable Efforts for the exploitation of the Patent Rights. Licensee shall use Commercially Reasonable Reasonably Diligent Efforts to obtain all necessary government approvals for the manufacture, use, sale and distribution of Licensed Products. Thereafter, Licensee agrees that until expiration or termination of this Agreement, Licensee shall use Commercially Reasonable Efforts continue active and diligent efforts to keep Licensed Products reasonably available to the public, in quantities sufficient to meet market demand, in the Territory. In the event Licensee decides not to exploit, either directly or indirectly, exploit a licensed Patent Right Right, or Field of Use, in a given country portion of the Territory, it shall promptly inform CMCC in writing and the shall surrender to CMCC its license granted to it hereunder with respect to that Patent Right or Field of Use in that country in portion of the Territory will immediately terminateTerritory.
B. The parties acknowledge that Licensee shall use Commercially Reasonable Efforts has provided to accomplish CMCC prior to the specific tasks set forth in Appendix 2 attached hereto in accordance with the timeframe set forth therein date of execution of this Agreement an initial written development plan (such Appendix 2 is hereby incorporated by reference and is referred to herein as the “Development Plan”)) setting forth overall objectives and the initial indications and markets for Licensed Products, including (i) time-delimited target dates for clinical candidate selection and development, (ii) time-delimited target dates for pre-clinical development, clinical trials, regulatory approval, manufacturing and marketing that represent Reasonably Diligent Efforts to bring Licensed Products to the marketplace. Licensee will submit an updated Development Plan periodically, and in any event within twelve (12) months after the Effective Date and annually thereafter in conjunction with an Annual Status Report as described in Article V (due January 31 each year) until launch of the first Licensed Product. The initial Development Plan is attached hereto as Appendix 3 and is hereby incorporated herein by reference.
C. For the first three (3) years Licensee shall use Commercially Reasonable be deemed to have used Reasonably Diligent Efforts to accomplish under this Article III as follows:
(1) during the specific one (1) year period after the Effective Date if, during that period, Licensee shall have raised in connection with the Patent Rights and allocated for expenditure for efforts under the requirements of this Article III(A) a cumulative total of investment capital and/or research and development funds of at least […***…] ($[…***…]) dollars and applied to activities under the Development Plan; (2) during the three (3) year period after the Effective Date, including during that period, Licensee shall have raised and expended aggregate funding of at least […***…] ($[…***…]) dollars to implement the Diligence Specifications set forth Development Plan; and (3) conduct activities described in the initial Development Plan attached to this Paragraph C Agreement as Appendix 3 as provided by Licensee. After the Effective Date Licensee will include in an Annual Status Report (the “Diligence Specifications”). The Diligence Specifications shall be part as defined in Article V of this Agreement) of activities conducted under the Development Plan a commercialization plan of activities that it has planned, including designated milestones and associated timelines for the timeframes clinical trials, regulatory approval and launch of the first product in the United States and European territories. At the time of filing the Investigational New Drug Application (“IND”) with the U.S. Food and Drug Administration (“FDA”) or equivalent with the European Medicines Evaluation Agency (“EMEA”), whichever occurs first for such Diligence Specifications shall be treated as definitive.
1. Determine protective efficacy of the first Licensed Products in mouse colonization or systemic models within [* * *]. The Parties acknowledge and agree that Product, the Licensee has completed this Diligence Specification as of [* * *].
2. Nominate top 2-3 Licensed Products will submit a revised plan for vaccine formulation within [* * *] of accomplishing Diligence Specification 1.
3. Final formulation of Licensed Product for pre-IND studies within [* * *] of accomplishing Diligence Specification 2.
4. Completion of toxicology lots of nominated Licensed Products for in vivo toxicology studies within [* * *] of accomplishing Diligence Specification 3commercialization.
D. In the event Licensee fails wishes to meet any amend the overall objectives set forth in the initial Development Plan attached as Appendix 3 to this Agreement, Licensee will notify CMCC in writing and will include with such notice a reasonably detailed explanation of the objective(s) set forth circumstances supporting such amendment. Promptly after receipt of such notice, CMCC will notify Licensee in writing whether it approves of such amendment, which approval will not be unreasonably withheld. In the event CMCC does not approve the amendment to objectives in the Development Plan, including without limitation and CMCC and Licensee are unable to reach resolution on this matter within a reasonable period of time, the Diligence Specificationsmatter will be handled in accordance with the dispute resolution terms set forth in Article XII of this Agreement. No rights of either party under this Agreement will be affected pending the outcome of proceedings in accordance with such Article XII.
E. In the event that, in a timely mannerthrough the Annual Status Report, Licensee fails to demonstrate that it has achieved the diligence requirements of this Article Ml, CMCC shall will notify Licensee thereof in writing, writing of any alleged deficiency and the basis for CMCC’s determination of same. Licensee shall will have sixty (60) […***…] days following such notification to establish that the required diligence has been achieved or to the reasonable satisfaction of CMCC that (i) it has met cure such objective(s); deficiency or (ii) a revision to the Development Plan is necessary and appropriate as contemplated below in Paragraph E. In the event Licensee fails to establish the same provide an explanation for any delay to CMCC’s reasonable satisfaction. If Licensee fails to do any of the above within such […***…]-day period, and subject to the dispute resolution terms set forth in Article XII of this Agreement, CMCC shall will have the right in its sole discretion to terminate in whole or in part convert the license granted to Licensee under this Agreement effective immediately.
E. from exclusive to non-exclusive on financial terms and conditions to be mutually agreed to by CMCC and Licensee. No rights of either party under this Agreement will be affected pending the outcome of proceedings in accordance with such Article XII. Notwithstanding anything above the foregoing, Licensee may extend the due date for achievement of any funding thresholds set out in Paragraph C of this Article III […***…] only by […***…] by making a payment to CMCC of […***…] dollars ($[…***…]) on or before the contrary, CMCC shall not unreasonably withhold its consent to any revision of the objective(sdate(s) or timing of the Development Plan, when requested in writing in advance by Licensee and the request is supported by evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays that Licensee could not reasonably have avoided; (ii) that Licensee is proposing and will implement satisfactory and effective means of addressing such difficulties or delays, including sufficient financial and technical resources; and (iii) that Licensee, its Affiliates and/or Sublicensees have in good faith made Commercially Reasonable Efforts and expended commercially reasonable and adequate resources to meet said objective and will continue to do sospecified.
F. If, during the Term course of this Agreement, Licensee makes any patentable discovery or invention within the Field of Use that Licensee reasonably believes to be patentable and is not within the scope of the license to Patent Rights but would not have been made but for the Patent Rights granted to it hereunder but is dominated by and/or the Patent Rights, Licensed Products licensed hereunder. Licensee shall, as a condition of this licenseLicense, confidentially disclose such patentable discovery or invention to the Intellectual Property Office of CMCC, on usual and customary terms necessary to protect its patentability or its confidentiality as a trade secret. CMCC shall have the right to review in advance of filing any related patent application by or on behalf of Licensee or any assignee of Licensee, for purposes of evaluating the relatedness to the Patent Rights. Recognizing that CMCC enters into this Agreement in furtherance of its charitable academic research mission, Licensee shall use good faith and reasonable efforts to enter into with CMCC a non-exclusive license or permit CMCCpermit, as applicable, including for no more than a nominal fee, for […***…] and/or anyone within her laboratory, to practice such discovery or invention, whether or not patentedinvention for which patent application has been filed, solely for CMCC internal and academic research purposes. For ; provided, however, that in the avoidance of doubtevent that a patented invention arises from such CMCC use, any license granted under this ARTICLE III, Paragraph F by Licensee to CMCC shall not grant CMCCto Licensee a fully paid-up non-exclusive license for internal research purposes, its Affiliates and at Licensee’s discretion either a non-exclusive or its sublicensees any right exclusive commercialization license to use or practice the licensed rights for commercial purposesinvention, subject to mutually agreeable terms.
Appears in 1 contract