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Common use of Diligence Clause in Contracts

Diligence. 5.1 LICENSEE shall use best efforts to bring LICENSED PRODUCTS to market or one or more LICENSED PROCESSES to commercial use through a thorough, vigorous and diligent program for exploiting the PATENT RIGHTS and to continue active, diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED PROCESSES throughout the life of this Agreement. LICENSEE has the responsibility to do all that is necessary to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. 5.2 As part of the diligence required by Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates: 1) Four years from Effective date: file 1st Investigational New Drug Application (IND) to the U.S Food and Drug Administration or a similar application to any foreign regulatory agency to commence clinical trials in their jurisdiction. 5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated and MICHIGAN shall have the sole discretion to determine the validity of a MILESTONE being reached. LICENSEE shall notify MICHIGAN in writing within ten (10) business days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article by the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement effective on thirty (30) days written notice, unless LICENSEE achieves the MILESTONE within this thirty-day period. Notwithstanding, MICHIGAN may terminate this Agreement immediately if LICENSEE fails to achieve a MILESTONE by the indicated date and does not provide the written notice to MICHIGAN referred to above. 5.4 This Agreement shall terminate immediately if the FIRST COMMERCIAL SALE does not occur on or before the date eight years after the Effective Date unless LICENSEE agrees in writing to pay an annual fee of $100,000, payable in quarterly monthly installments until the FIRST COMMERCIAL SALE, the first payment being due March 30, 2014.

Appears in 2 contracts

Samples: License Agreement (Glyconix Corp), License Agreement (Glyconix Corp)

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Diligence. 5.1 LICENSEE shall use best commercially reasonable efforts to bring one or more LICENSED PRODUCTS to market or one or more LICENSED PROCESSES to commercial use through a thorough, vigorous and diligent program for exploiting the PATENT RIGHTS same and to continue active, diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED PROCESSES throughout the life of this Agreement. LICENSEE has the responsibility to do all that is necessary use commercially reasonable efforts to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. 5.2 As part of the diligence required by Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the "MILESTONES'") by the 'he following dates: 1) Four years from Effective date: file 1st Investigational New Drug Application (INDCompletion of Phase I Clinical Trial on or before January 1, 2015. 2) to the U.S Food and Drug Administration Completion of Phase II Clinical Trial on or a similar application to any foreign regulatory agency to commence clinical trials in their jurisdictionbefore January 1, 2017. 3) Completion of Phase III Clinical Trial on or before January 1, 2019. 4) FIRST COMMERCIAL SALE on or before January 1, 2020. 5.3 LICENSEE must achieve each MILESTONE the MILESTONES on or before the deadline dates indicated and MICHIGAN shall have the sole discretion to determine the validity of a MILESTONE being reached. LICENSEE shall notify MICHIGAN in writing within ten (10) business days after each such deadline as to whether or not such MILESTONE was metindicated. If LICENSEE fails to meet any MILESTONE under this Article by the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and Paragraph 5.2 MICHIGAN may terminate the Agreement this AGREEMENT effective on thirty (30) days written notice, unless LICENSEE achieves the MILESTONE within this thirty-day period. Notwithstanding, MICHIGAN may terminate this Agreement immediately if LICENSEE fails to achieve a MILESTONE by the indicated date and does not provide the prior written notice to MICHIGAN referred LICENSEE, subject, however, to the rights of any SUBLICENSEE granted pursuant to Paragraph: provided, however , that any such termination shall not be effective if LICENSEE: (a) actually achieves such MILESTONE during such thirty (30) day period or (b) demonstrates that LICENSEE has used commercially reasonable efforts to achieve such MILESTONE over the entire course of this AGREEMENT. If, as of the close of such thirty (30) day period, there is a dispute as to whether LICENSEE has met the condition set forth in clause (a) or (b) of the preceding sentence, then such thirty (30) day period shall be automatically extended for thirty (30) days, during which time the parties shall hold good faith discussions in order to resolve such dispute. If the parties ultimately agree that LICENSEE has met the condition set forth in clause (b) above. 5.4 This Agreement shall terminate immediately if the FIRST COMMERCIAL SALE does not occur on or before the date eight years after the Effective Date unless LICENSEE agrees in writing to pay an annual fee of $100,000, payable in quarterly monthly installments until the FIRST COMMERCIAL SALE, the first payment being due March 30termination shall be deemed ineffective, 2014and the panics shall negotiate in good faith a revised deadline for achieving such MILESTONE. In addition, regardless of whether LICENSEE can demonstrate that LICENSEE has met the condition set forth in clause (b) above, LICENSEE shall have the opportunity to present a revised timeline for achieving the MILESTONE at issue, and the approval to revise the timeline from MICHIGAN shall not be unreasonably withheld, provided that LICENSEE is otherwise in compliance with its other obligations under this AGREEMENT.

Appears in 2 contracts

Samples: Exclusive License Agreement (Heat Biologics, Inc.), Exclusive License Agreement (Heat Biologics, Inc.)

Diligence. 5.1 LICENSEE shall use best commercially reasonable efforts to bring one or more LICENSED PRODUCTS to market or market, and/or one or more LICENSED PROCESSES to commercial use use, through a thorough, vigorous and diligent program for exploiting utilizing the PATENT RIGHTS and to continue active, diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED PROCESSES throughout the life of this Agreement, in each case consistent with prudent business practices and judgment. LICENSEE has the responsibility to do all that is necessary legally required and commercially reasonable to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES available. 5.2 As part of the diligence required by Without limiting Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates: 1) Four years from Effective date: file 1st Investigational New Drug Application (IND[XXX] 2) to [XXX] 3) [XXX] 4) [XXX] For the U.S Food and Drug Administration purposes of this Agreement, initiation of a clinical trial shall mean that date upon which the first patient or subject is treated with a similar application to any foreign LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has been manufactured according to commence clinical trials in their jurisdictionGood Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency. 5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated and MICHIGAN shall have the sole discretion to determine the validity of a MILESTONE being reachedabove. LICENSEE shall notify MICHIGAN in writing within ten thirty (1030) business days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article by the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement effective on thirty ninety (3090) days days’ written notice, unless LICENSEE achieves the MILESTONE within this thirty-ninety (90) day period. Notwithstanding, MICHIGAN may terminate this Agreement immediately if LICENSEE fails to achieve a MILESTONE by the indicated date and does not provide the written notice to MICHIGAN referred to above. 5.4 This Agreement shall terminate immediately if the FIRST COMMERCIAL SALE does not occur on or before the date eight years after the Effective Date unless LICENSEE agrees in writing to pay an annual fee of $100,000, payable in quarterly monthly installments until the FIRST COMMERCIAL SALE, the first payment being due March 30, 2014.

Appears in 2 contracts

Samples: Patent License Agreement (Solid Biosciences, LLC), Patent License Agreement (Solid Biosciences, LLC)

Diligence. 5.1 LICENSEE has the responsibility to do all that is necessary to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. 5.2 LICENSEE shall use best commercially reasonable efforts to bring one or more LICENSED PRODUCTS to market or one or more LICENSED PROCESSES to commercial use through a thorough, vigorous and diligent program for exploiting the PATENT RIGHTS and to continue active, diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED PROCESSES throughout the life of this Agreement. LICENSEE has the responsibility to do all that is necessary to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. 5.2 5.3 As part of the diligence required by Paragraph 5.15.2, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by set forth in Appendix C. (a) MICHIGAN acknowledges that the following dates: 1) Four years from technology licensed to LICENSEE is very early stage. Its successful commercialization into LICENSED PRODUCTS will require considerable additional research, testing, funding, regulatory approval, strategic alliances, and substantial commitments to third parties, and may require LICENSEE to secure additional intellectual property rights. The MILESTONES are believed to be appropriate and reasonable as of the Effective date: file 1st Investigational New Drug Application (IND) to Date of this Agreement, but are inherently speculative and based upon events that are not completely under the U.S Food and Drug Administration or a similar application to any foreign regulatory agency to commence clinical trials in their jurisdictioncontrol of LICENSEE. 5.3 (b) LICENSEE must will use reasonable efforts to achieve each MILESTONE the MILESTONES on or before the deadline dates indicated on Appendix C and MICHIGAN shall have the sole discretion to determine the validity of a MILESTONE being reached. LICENSEE shall notify MICHIGAN in writing within ten (10) business days after each if it appears that its achievement of such deadline as to whether or not such MILESTONE was metMILESTONES is unrealistic. If LICENSEE fails to meet any MILESTONE under this Article by on Appendix C, fails to provide a reasonable explanation for such failure, and fails to provide a commercially reasonable, adjusted schedule for achieving such MILESTONE, and if such failure continues for sixty (60) days after the date of any MILESTONE deadline (or revised MILESTONE deadline), LICENSEE will be deemed to be in material breach of this Agreement, Agreement and MICHIGAN may terminate the this Agreement effective on thirty (30) days written notice, unless LICENSEE achieves the MILESTONE within this thirty-thirty (30) day period. Notwithstanding, MICHIGAN may terminate this Agreement immediately if LICENSEE fails to achieve a MILESTONE by the indicated date and does not provide the written notice to MICHIGAN referred to above. 5.4 This Agreement shall terminate immediately if the FIRST COMMERCIAL SALE does not occur on period or before the date eight years after the Effective Date unless LICENSEE agrees in writing to pay an annual fee of $100,000, payable in quarterly monthly installments until reasonably disputes the FIRST COMMERCIAL SALE, basis for the first payment being due March 30, 2014termination.

Appears in 1 contract

Samples: License Agreement (Novelos Therapeutics, Inc.)

Diligence. 5.1 LICENSEE shall use best commercially reasonable efforts to bring develop and commercialize LICENSED PRODUCTS to market or one or more LICENSED PROCESSES to commercial use within the TERRITORY through a thorough, vigorous and diligent program for exploiting utilizing the PATENT RIGHTS and to continue active, employ active and diligent marketing efforts for one or more approved LICENSED PRODUCTS or LICENSED PROCESSES throughout the life of this AgreementPROCESSES. LICENSEE has the responsibility to do all that is necessary shall use commercially reasonable efforts to obtain and retain any governmental approvals necessary to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirements of this Paragraph 5.1 shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. 5.2 As part of the diligence required by Without limiting Paragraph 5.1, LICENSEE agrees to use reasonable efforts to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates: 1(a) Four years from Effective date: file 1st Investigational New Drug Application Initiation of Phase I Study by [*]. (INDb) to the U.S Food and Drug Administration or a similar application to any foreign regulatory agency to commence clinical trials in their jurisdictionInitiation of PHASE II STUDY by [*]. (c) Initiation of PHASE III STUDY by [*]. (d) FIRST COMMERICIAL SALE by [*]. 5.3 LICENSEE must use reasonable efforts to achieve each MILESTONE on or before the deadline dates indicated and MICHIGAN shall have the sole discretion to determine the validity of a MILESTONE being reachedabove. LICENSEE shall notify MICHIGAN in writing DUKE within ten (10) business days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article 5 by the date of any such MILESTONE deadlinedeadline and such failure results from LICENSEE’s failure to use reasonable efforts to achieve such MILESTONE, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN DUKE may terminate the Agreement effective on thirty (30) days days’ prior written notice, unless LICENSEE achieves the MILESTONE within this such thirty-day period. NotwithstandingFor clarity, MICHIGAN may terminate this Agreement immediately if LICENSEE fails to achieve the achievement of a MILESTONE by a SUBLICENSEE shall be deemed to be the indicated date and does achievement of such MILESTONE by LICENSEE. DUKE acknowledges that LICENSEE’s ability to timely achieve the MILESTONE may be impacted by delays outside of LICENSEE’s reasonable control. When LICENSEE identifies any such delays that will impact its ability to timely achieve the MILESTONE, LICENSEE shall promptly notify DUKE. DUKE shall not provide reasonably withhold or deny its consent to any revisions to milestone data for the written notice to MICHIGAN referred to aboveapplicable MILESTONE. 5.4 This Agreement shall terminate immediately if the FIRST COMMERCIAL SALE does not occur on or before the date eight years after the Effective Date unless LICENSEE agrees in writing to pay an annual fee of $100,000, payable in quarterly monthly installments until the FIRST COMMERCIAL SALE, the first payment being due March 30, 2014.

Appears in 1 contract

Samples: Patent License Agreement (Adaptin Bio, Inc.)

Diligence. 5.1 LICENSEE shall use best commercially reasonable efforts to bring a full scope of LICENSED PRODUCTS to market or one or more LICENSED PROCESSES to commercial use through a thorough, vigorous and diligent program for exploiting the PATENT RIGHTS and to continue active, diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED PROCESSES throughout the life of this Agreement. LICENSEE has the responsibility to do all that is necessary to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. 5.2 As part of the diligence required by Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates: 1) Four years Initiate Preclinical Animal Trials 12 months from Effective date: file 1st Investigational New Drug Application (INDDate 2) to Initiate Phase I clinical Trial 24 months from Effective Date 3) FIRST COMMERCIAL 48 months from Effective Date For the U.S Food and Drug Administration purposes of this Agreement, initiation of a clinical trial shall mean that date upon which the first patient or subject is treated with a similar application to any foreign LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has been manufactured according to commence clinical trials in their jurisdictionGood Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency. 5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated and MICHIGAN shall have the sole reasonable discretion to determine the validity of a MILESTONE being reached. LICENSEE shall notify MICHIGAN in writing within ten (10) business days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article by the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement effective on thirty (30) days written notice, unless LICENSEE achieves the MILESTONE within this thirty-thirty day period. Notwithstanding, MICHIGAN may terminate this Agreement immediately if LICENSEE fails to achieve a MILESTONE by the indicated date and does not provide the written notice to MICHIGAN referred to above. 5.4 This Agreement shall terminate immediately if the FIRST COMMERCIAL SALE does not occur on or before the date eight years after the Effective Date unless LICENSEE agrees in writing to pay an annual fee of $100,000, payable in quarterly monthly installments until the FIRST COMMERCIAL SALE, the first payment being due March 30, 2014.

Appears in 1 contract

Samples: License Agreement (LMF Acquisition Opportunities Inc)

Diligence. 5.1 LICENSEE shall 3.1. EXACT agrees to use best commercially reasonable efforts to bring LICENSED PRODUCTS to market or one or more LICENSED PROCESSES to commercial use through a thorough, vigorous make (i) Diagnostic Services,(ii) Licensed Reagents and diligent program (iii) Kits available for exploiting the PATENT RIGHTS benefit of the general public consistent with regulatory compliance and to continue active, diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED PROCESSES throughout the life of this Agreement. LICENSEE has the responsibility to do all that is necessary to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEESpublic safety. 5.2 As part 3.2. EXACT’s material failure to perform in accordance with any subsection of Section 3.1 above shall be grounds for Genzyme to terminate the diligence required license under Section 2.1 above with respect to Diagnostic Services, Licensed Reagents or Kits, as applicable, pursuant to Section 7.8 hereof by Paragraph 5.1delivering written notice of its intention to terminate to EXACT. If EXACT disputes Genzyme’s determination, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”i) by the following dates: 1) Four years from Effective date: file 1st Investigational New Drug Application (IND) to the U.S Food and Drug Administration or a similar application to any foreign regulatory agency to commence clinical trials in their jurisdiction. 5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated and MICHIGAN EXACT shall have the sole discretion to determine the validity deliver written notice of a MILESTONE being reached. LICENSEE shall notify MICHIGAN in writing such dispute within ten (10) business days after each such deadline its receipt of notice from Genzyme of its intent to terminate, (ii) the matter shall be referred to arbitration pursuant to Article 11hereof and (iii) EXACT’s license under Section 2.1 above to the Diagnostic Services, Licensed Reagents or Kits, as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article by the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreementapplicable, and MICHIGAN may terminate EXACT’s obligations with respect thereto shall continue in full force and effect until the Agreement effective on resolution of such arbitration. 3.3. Within thirty (30) days after the Original Effective Date and subsequently no later than May 1 and November 1 of each year, commencing on November 1, 1999, EXACT shall provide a written noticereport to Genzyme on its research, unless LICENSEE achieves development and commercialization efforts with respect to (i) Diagnostic Services, (ii)Licensed Reagents and (iii) Kits (each individually), which report shall cite specific goals and objectives in researching, developing and commercializing the MILESTONE licensed technology and methodology and progress in meeting these goals and objectives. If Genzyme does not receive any such report(s) in a timely manner, it shall notify EXACT of such delinquency in writing. EXACT shall have thirty (30) days from its receipt of such notice to provide Genzyme with any and all overdue report(s). Failure by EXACT to provide such overdue report(s) within this thirty-said thirty (30) day period. Notwithstanding, MICHIGAN period may terminate constitute grounds for termination of this Agreement immediately if LICENSEE fails to achieve a MILESTONE by Genzyme as provided for in Section 7.5 hereof; provided, however, that the indicated date and does not provide number of days elapsed since EXACT first received notice from Genzyme of the written notice to MICHIGAN referred to abovedelinquent reports shall be counted for purposes of determining the sixty (60) day period described in Section 7.5 hereof. 5.4 This Agreement shall terminate immediately if the FIRST COMMERCIAL SALE does not occur on or before the date eight years after the Effective Date unless LICENSEE agrees in writing to pay an annual fee of $100,000, payable in quarterly monthly installments until the FIRST COMMERCIAL SALE, the first payment being due March 30, 2014.

Appears in 1 contract

Samples: License Agreement (Exact Sciences Corp)

Diligence. 5.1 LICENSEE shall use best commercially reasonable efforts to bring one or more LICENSED PRODUCTS to market or market, and/or one or more LICENSED PROCESSES to commercial use use, through a thorough, vigorous and diligent program for exploiting utilizing the PATENT RIGHTS and to continue active, diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED PROCESSES throughout the life of this Agreement, in each case consistent with prudent business practices and judgment. LICENSEE has the responsibility to do all that is necessary legally required and commercially reasonable to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES available. 5.2 As part of the diligence required by Without limiting Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates: 1) Four years from Effective date: file 1st Investigational New Drug Application (IND[**] 2) to [**] 3) [**] 4) [**] For the U.S Food and Drug Administration purposes of this Agreement, initiation of a clinical trial shall mean that date upon which the first patient or subject is treated with a similar application to any foreign LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has been manufactured according to commence clinical trials in their jurisdictionGood Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency. 5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated and MICHIGAN shall have the sole discretion to determine the validity of a MILESTONE being reachedabove. LICENSEE shall notify MICHIGAN in writing within ten thirty (1030) business days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article by the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement effective on thirty ninety (3090) days days’ written notice, unless LICENSEE achieves the MILESTONE within this thirty-ninety (90) day period. Notwithstanding, MICHIGAN may terminate this Agreement immediately if LICENSEE fails to achieve a MILESTONE by the indicated date and does not provide the written notice to MICHIGAN referred to above. 5.4 This Agreement shall terminate immediately if the FIRST COMMERCIAL SALE does not occur on or before the date eight years after the Effective Date unless LICENSEE agrees in writing to pay an annual fee of $100,000, payable in quarterly monthly installments until the FIRST COMMERCIAL SALE, the first payment being due March 30, 2014.

Appears in 1 contract

Samples: Patent License Agreement (Solid Biosciences Inc.)

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Diligence. 5.1 LICENSEE shall Chondrial will use best efforts Commercially Reasonable Efforts to bring LICENSED PRODUCTS the Licensed Products to market or one or more LICENSED PROCESSES to commercial use through a thorough, vigorous exploitation of the Licensed Patents and diligent program for exploiting commercialization of the PATENT RIGHTS and to continue active, diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED PROCESSES throughout the life of this Agreement. LICENSEE has the responsibility to do all that is necessary to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEESLicensed Products. 5.2 As part Without limiting the generality of the diligence required by Paragraph 5.1provisions of Section 5.1 above, LICENSEE agrees to reach Chondrial will achieve (either itself of through its Affiliates and/or its Sublicensees) the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates:dates (“Milestones”): 1(a) Four years Chondrial will have at least two full-time equivalent personnel working on the development, manufacturing and marketing of the Licensed Products within the twelve (12) month period from the Effective date: file 1st Investigational New Drug Application Date and each subsequent year thereafter; (INDb) to Enrollment of the U.S Food and Drug Administration first patient in the first Phase I (or a similar application to any foreign regulatory agency to commence its non-U.S. equivalent) clinical trials in their jurisdiction. 5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated and MICHIGAN shall have the sole discretion to determine the validity trial of a MILESTONE being reached. LICENSEE shall notify MICHIGAN in writing Licensed Product within ten (10) business days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article by the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement effective on thirty (30) days months from the Effective Date; (c) Enrollment of the first patient in the first Phase II (or its non-U.S. equivalent) clinical trial of a Licensed Product within sixty (60) months from the Effective Date; 5.2.1 Chondrial will provide to IURTC (at the time of the next due report under Section 8) written noticenotice of the achievement of each Milestone in this Section 5.2 (and continued confirmation of Chondrial’s sustained achievement of Section 5.2(a)). 5.3 Chondrial will use Commercially Reasonable Efforts to have the Licensed Products cleared for marketing in those countries in which Chondrial, unless LICENSEE achieves the MILESTONE within this thirty-day period. Notwithstandingin its sole discretion, MICHIGAN may terminate this Agreement immediately if LICENSEE fails intends to achieve a MILESTONE sell Licensed Products by the indicated date responsible governmental agencies requiring such clearance. To accomplish such clearances at the earliest possible date, Chondrial will file, according to the usual practice of companies similarly situated to Chondrial, any necessary data with such governmental agencies. For clarity, the development and does not provide commercialization of the written notice to MICHIGAN referred to aboveLicensed Products outside of the U.S. is at Chondrial’s sole discretion. 5.4 This Agreement shall terminate immediately if If IURTC is approached by a bona fide third party about development of an application of the FIRST COMMERCIAL SALE does Licensed Patents that is within the Field but is not occur on or before currently being developed by Chondrial, IURTC will notify Chondrial of the date eight years after the Effective Date unless LICENSEE agrees in writing to pay an annual fee of $100,000, payable in quarterly monthly installments until the FIRST COMMERCIAL SALE, the first payment being due March 30, 2014inquiry.

Appears in 1 contract

Samples: License Agreement (Larimar Therapeutics, Inc.)

Diligence. 5.1 LICENSEE shall use best commercially reasonable efforts to bring a full scope of LICENSED PRODUCTS to market or one or more LICENSED PROCESSES to commercial use through a thorough, vigorous and diligent program for exploiting the PATENT RIGHTS and to continue active, diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED PROCESSES throughout the life of this Agreement. LICENSEE has the responsibility to do all that is necessary to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. 5.2 As part of the diligence required by Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates: 1) Four years from Effective date: file 1st Investigational New Drug Application (IND) to the U.S Food and Drug Administration or a similar application to any foreign regulatory agency to commence clinical trials in their jurisdiction. 5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated and MICHIGAN shall have the sole discretion to determine the validity of a MILESTONE being reached. LICENSEE shall notify MICHIGAN in writing within ten (10) business days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article by the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement effective on thirty (30) days written notice, unless LICENSEE achieves the MILESTONE within this thirty-thirty day period. Notwithstanding, MICHIGAN may terminate this Agreement immediately if LICENSEE fails to achieve a MILESTONE by the indicated date and does not provide the written notice to MICHIGAN referred to above. 5.4 This Agreement shall terminate immediately if the FIRST COMMERCIAL SALE does not occur on or before the date eight years after the Effective Date unless LICENSEE agrees in writing to pay an annual fee of $100,000, payable in quarterly monthly installments until the FIRST COMMERCIAL SALE, the first payment being due March 30, 2014.

Appears in 1 contract

Samples: License Agreement

Diligence. 5.1 LICENSEE shall use best commercially reasonable efforts to bring at least one LICENSED PRODUCTS PRODUCT to market or one or more LICENSED PROCESSES PROCESS to commercial use through a thorough, vigorous and commercially reasonable diligent program for exploiting the PATENT RIGHTS and to continue active, diligent marketing efforts using commercially reasonable efforts for one or more any LICENSED PRODUCTS or LICENSED PROCESSES PRODUCT that [***] = CONFIDENTIAL TREATMENT REQUESTED achieves regulatory approval throughout the life of this Agreement. LICENSEE has the responsibility to do all that is necessary use commercially reasonable efforts to obtain and retain any necessary governmental approvals that are required to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEESSUBLICENSEES . 5.2 As part of the diligence required by Paragraph 5.1, LICENSEE agrees to use commercially reasonable efforts to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following datesdates specified below. For the purposes of this Agreement, initiation of a clinical trial shall mean that date upon which the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has been manufactured according to Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency. The MILESTONES are: 1) Four years from Effective date: file 1st Investigational New Drug Application (IND) submitting an IND to the U.S Food FDA by August 31, 2013. 2) initiating a Phase I clinical trial by December 31, 2013. [***] MICHIGAN acknowledges and Drug Administration or a similar application to any foreign regulatory agency to commence clinical trials in their jurisdictionagrees that LICENSEE has fully satisfied its obligations regarding achievement of MILESTONES 1 and 2 above, and that no Delay Option (as defined below) was utilized. 5.3 LICENSEE shall have the right to extend by [***] the time it has to achieve the above diligence milestones, such date to be calculated from the dates shown in Paragraph 5.2, as applicable (“Delay Option”). To exercise the Delay Option, LICENSEE must: (i) give MICHIGAN notice in writing at least ten (10) days prior to the MILESTONE deadline that LICENSEE is exercising its Delay Option; and (ii) pay MICHIGAN a non-refundable and non-creditable fee of $[***], which shall be due with such notice, and upon such payment, all the above diligence milestone dates shall be extended by [***]. 5.4 Subject to Paragraph 5.3, LICENSEE must use commercially reasonable efforts to achieve each MILESTONE on or before the deadline dates indicated and MICHIGAN shall have the sole discretion to determine the validity of a MILESTONE being reachedindicated. LICENSEE shall notify MICHIGAN in writing within ten (10) business days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE believes that it is or will be unable to achieve any MILESTONE by such deadline (as the deadline may have been extended pursuant to Paragraph 5.3) despite its using commercially reasonable efforts, LICENSEE may request to amend or extend the MILESTONES, and MICHIGAN will not unreasonably withhold consent or approval of any such request to amend or extend the MILESTONE if such proposed request is supported by a detailed showing by LICENSEE of: (a) its commercially reasonable efforts to achieve such MILESTONE events during the Agreement (including the amount of monetary investment therein), (b) due diligence in its performance of research and development of LICENSED PRODUCTS and/or LICENSED PROCESSES, and (c) plans for future development and sale of LICENSED PRODUCTS and LICENSED PROCESSES. If LICENSEE fails to use commercially reasonable efforts to meet any MILESTONE under this Article Paragraph by the date of any [***] = CONFIDENTIAL TREATMENT REQUESTED the applicable MILESTONE deadlinedeadline (as extended), and MICHIGAN justifiably withholds consent to LICENSEE’S request to amend or extend as described in the previous sentence, then LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement effective on thirty (30) days written days’ notice, unless LICENSEE achieves commences using commercially reasonable efforts to achieve the MILESTONE within this thirty-thirty day period. Notwithstanding, MICHIGAN may terminate this Agreement immediately if LICENSEE fails to achieve a MILESTONE by the indicated date and does not provide the written notice to MICHIGAN referred to above. 5.4 This Agreement shall terminate immediately if the FIRST COMMERCIAL SALE does not occur on or before the date eight years after the Effective Date unless LICENSEE agrees in writing to pay an annual fee of $100,000, payable in quarterly monthly installments until the FIRST COMMERCIAL SALE, the first payment being due March 30, 2014.,

Appears in 1 contract

Samples: License Agreement (OvaScience, Inc.)

Diligence. 5.1 LICENSEE (a) Subject to the terms of Section 4.5, Licensee shall use best commercially reasonable efforts in pursuing the development, commercialization and marketing of Products. Without limiting the foregoing, Licensee shall be deemed to bring LICENSED PRODUCTS to market or one or more LICENSED PROCESSES to commercial use through a thoroughhave exercised commercially reasonable efforts, vigorous and diligent program for exploiting the PATENT RIGHTS and to continue active, diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED PROCESSES throughout the life diligence requirements of this Agreement. LICENSEE has the responsibility Section 2.2(a) shall be deemed to do all that is necessary have been met, and UWA may not issue a Diligence Breach Notice pursuant to obtain Section 2.2(b), if, on a Product-by-Product basis, Licensee, together with its Affiliates and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. 5.2 As part of the diligence required by Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following datessublicensees: (1) Four years from Effective date: file 1st Investigational New Drug Application is actively engaged in, or has plans to engage in, pre-clinical or clinical development efforts with respect to, or commercialization of, such Product in any country or jurisdiction within the Territory; (IND2) as to the U.S Food and Drug Administration or a similar application to any foreign regulatory agency to commence clinical trials in their jurisdiction. 5.3 LICENSEE must achieve each MILESTONE Product known as AVI-4658, meets the respective requirements set forth on or before the deadline dates indicated and MICHIGAN shall have the sole discretion to determine the validity of a MILESTONE being reached. LICENSEE shall notify MICHIGAN in writing within ten (10) business days after Schedule 2.2, with each such deadline requirement being deemed a separate and independent condition (each, a “Milestone”); provided that if patent infringement issues prevent Licensee from meeting any such Milestone, then the timing for such Milestone shall be tolled until such issues are resolved and the parties shall in good faith negotiate and agree on an appropriate modification to the timing of such Milestone, if necessary; (3) as to whether or not such MILESTONE was met. If LICENSEE the Product known as AVI-4658, fails to meet any MILESTONE Milestone designated in Schedule 2.2 hereto, but, after the parties meet to discuss the status of Licensee’s development efforts, Licensee demonstrates that Licensee’s efforts amounted to commercially reasonable efforts under this Article by the circumstances, in which case the parties shall in good faith negotiate and agree on an appropriate modification to the relevant Milestone(s); or (4) as to the Product known as AVI-4658, fails to meet any Milestone designated in Schedule 2.2 hereto, and the proviso in subsection (2) does not apply, but Licensee, its Affiliates or Sublicensees initiate a [†††] trial of a different Product within [†††] after the date upon which Licensee, its Affiliate or Sublicensee failed to meet such Milestone, in which case the Milestones obligations designated in Schedule 2.2 hereto shall apply with respect to such different Product instead of any MILESTONE deadline, LICENSEE will be deemed to be in material breach AVI-4658 for the purposes of this AgreementSection 2.2; provided that if patent infringement issues prevent Licensee from meeting any such Milestone for such different Product, then the timing for such Milestone shall be tolled until such patent infringement issues are resolved or the parties in good faith negotiate and MICHIGAN agree on an appropriate modification to the timing of such Milestone. (b) Subject to the terms of Section 2.2(a), if UWA believes that Licensee has failed to meet its diligence obligations as set forth in Section 2.2(a), UWA may terminate give Licensee written notice of the Agreement effective on thirty deficiency (30“Diligence Breach Notice”). Licensee shall thereafter have one hundred and twenty (120) days written notice, unless LICENSEE achieves to cure the MILESTONE deficiency. If Licensee fails to cure the deficiency within this thirty-such one hundred and twenty (120) day period. Notwithstanding, MICHIGAN UWA may terminate this Agreement immediately if LICENSEE fails with respect to achieve a MILESTONE by the indicated date and does not provide the relevant Product upon written notice to MICHIGAN referred Licensee, provided, however, that UWA may not terminate this Agreement with respect to aboveany Product as to which Licensee is actively engaged in, or has plans to engage in, pre-clinical or clinical development efforts or commercialization in any country or jurisdiction within the Territory. Such right to terminate this Agreement as to a given Product shall be UWA’s sole remedy for Licensee’s breach of this Section 2.2. 5.4 This Agreement shall terminate immediately if the FIRST COMMERCIAL SALE does not occur on or before the date eight years after the Effective Date unless LICENSEE agrees in writing to pay an annual fee of $100,000, payable in quarterly monthly installments until the FIRST COMMERCIAL SALE, the first payment being due March 30, 2014.

Appears in 1 contract

Samples: Exclusive License Agreement (Sarepta Therapeutics, Inc.)