Diligence. 7.1 LICENSEE will use commercially reasonable and diligent efforts to research, develop and market Licensed Products and or Licensed Services for commercial sale and distribution throughout the Licensed Territory, and to such end, such efforts will include the following: 7.1.1 Within [***] after the Effective Date of this Agreement, LICENSEE will provide an updated financing and business plan for the research, development and marketing of Licensed Products and Licensed Services reasonably acceptable to REGENTS. 7.2 In addition, LICENSEE, an Affiliate of LICENSEE or a Sublicensee will meet the following milestones: [***] 7.3 No less than [***] after the Effective Date of this Agreement, LICENSEE will submit to REGENTS a written report on progress made toward the diligence objectives set forth above, including updated business plans, together with the amount of research and development monies related to Licensed Products and/or Licensed Services and expended during that time period. 7.4 Without limiting the foregoing, in the event that LICENSEE Is unable to complete the milestones and diligence requirements set forth in Paragraphs 7.1 and 7.2, despite using its diligent efforts to do so, due to delays which are out of the reasonable control of LICENSEE (e.g., changes to the regulatory pathways or other regulatory delays, problems with clinical trial protocols or designs or adverse events and the like), LICENSORS agree to grant reasonable extensions of the timeline for the applicable diligence milestones. Subject to the foregoing, failure by LICENSEE to achieve any of the diligence obligations under this Article 7 will result in LICENSORS in their sole discretion having the option of terminating all of the exclusive licenses granted under Article 3, in accordance with Article 18 of this Agreement, or converting any or all of such exclusive licenses to nonexclusive licenses; provided that prior to any such termination, LICENSORS, at LICENSEE’s request, shall negotiate in good faith for at least [***] days regarding amendment of this Agreement and maintaining the exclusive licenses granted to LICENSEE.
Appears in 3 contracts
Samples: Exclusive License Agreement (Caribou Biosciences, Inc.), Exclusive License (Caribou Biosciences, Inc.), Exclusive License Agreement (Caribou Biosciences, Inc.)
Diligence. 7.1 LICENSEE 6.1 Licensee will use commercially reasonable diligently proceed with the development, manufacture, marketing, and diligent efforts to researchSale of Licensed Products, develop and market Licensed Products and or Methods, and/or Licensed Services for commercial sale and distribution throughout in quantities sufficient to meet the Licensed Territorymarket demand.
6.2 In addition to Licensee’s obligations under Paragraph 6.1, and to such end, such efforts Licensee will include accomplish the followingfollowing milestones in Licensee’s activities under this Agreement:
7.1.1 Within (a) [***]; and
(b) [***].
6.3 If Licensee is unable to meet any of its diligence obligations set forth in Paragraphs 6.1 and 6.2, then The Regents will so notify Licensee of failure to perform. Licensee will CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. have the right and option to extend the target date of any such diligence obligation for a period of [***] after upon the Effective Date payment of this Agreement, LICENSEE will provide an updated financing and business plan for the research, development and marketing of Licensed Products and Licensed Services reasonably acceptable to REGENTS.
7.2 In addition, LICENSEE, an Affiliate of LICENSEE or a Sublicensee will meet the following milestones: [***] dollars ($[***]
7.3 No less than ) within the thirty (30)-day period prior to the date to be extended, for each such extension option exercised by Licensee. Licensee may further extend the target date of any diligence obligation for an additional [***] after the Effective Date upon payment of this Agreement, LICENSEE will submit to REGENTS a written report on progress made toward the diligence objectives set forth above, including updated business plans, together with the amount of research and development monies related to Licensed Products and/or Licensed Services and expended during that time period.
7.4 Without limiting the foregoing, in the event that LICENSEE Is unable to complete the milestones and diligence requirements set forth in Paragraphs 7.1 and 7.2, despite using its diligent efforts to do so, due to delays which are out of the reasonable control of LICENSEE (e.g., changes to the regulatory pathways or other regulatory delays, problems with clinical trial protocols or designs or adverse events and the like), LICENSORS agree to grant reasonable extensions of the timeline for the applicable diligence milestones. Subject to the foregoing, failure by LICENSEE to achieve any of the diligence obligations under this Article 7 will result in LICENSORS in their sole discretion having the option of terminating all of the exclusive licenses granted under Article 3, in accordance with Article 18 of this Agreement, or converting any or all of such exclusive licenses to nonexclusive licenses; provided that prior to any such termination, LICENSORS, at LICENSEE’s request, shall negotiate in good faith for at least an additional [***] days regarding amendment dollars ($[***]). Additional extensions may be granted only by written agreement of the Parties. These payments are in addition to any other payments owed under this Agreement. Should Licensee opt not to extend the obligation or fail to meet the obligation by the extended target date, then The Regents will have the right and option either to terminate this Agreement and maintaining or to reduce Licensee’s exclusive license to a nonexclusive license. This right, if exercised by The Regents, supersedes the rights granted in Article 2 (Grant).
6.4 To exercise either the right to terminate this Agreement or to reduce the license to a non-exclusive licenses granted license for lack of diligence under Paragraph 6.1 or 6.2, The Regents will give Licensee written notice of the deficiency. Licensee thereafter will have sixty (60) days to LICENSEEcure the deficiency. If The Regents has not received satisfactory written evidence that the deficiency has been cured by the end of the sixty (60)-day period, then The Regents may, at its option, either terminate the Agreement or reduce Licensee’s exclusive license to a non-exclusive license by giving written notice to Licensee. These notices will be subject to Article 22 (Notices).
Appears in 2 contracts
Samples: Exclusive License Agreement (Sage Therapeutics, Inc.), Exclusive License Agreement (Sage Therapeutics, Inc.)
Diligence. 7.1 3.1 LICENSEE will and its sublicensees shall use commercially reasonable and diligent efforts to research, develop and market bring Licensed Products and or Licensed Services Processes to market through a [ * ] exploitation of the Patent Rights. Non-compliance with this Section 3.1 shall be grounds for commercial sale termination.
3.2 in addition, LICENSEE and distribution throughout the Licensed Territory, and to such end, such efforts will include UNIVERSITY shall adhere is the following:
7.1.1 Within [***(a) LICENSEE shall deliver to UNIVERSITY within [ * ] after the of Effective Date of this Agreement, LICENSEE will provide an updated financing and Agreement a business plan including [ * ], to the extent formed by LICENSEE. Similar reports shall be provided to UNIVERSITY within [ * ] to relay update and status information on LICENSEE’s progress on development of the Patent Rights, including projections of activity anticipated for the research, development and marketing of Licensed Products and Licensed Services reasonably acceptable to REGENTSnext reporting year.
7.2 In addition(b) LICENSEE shall be responsible for diligently and promptly taking all reasonable steps to secure all required and/or necessary governmental approvals to sell, LICENSEEexploit, an Affiliate of LICENSEE or a Sublicensee will meet the following milestones: [***]
7.3 No less than [***] after the Effective Date of this Agreement, LICENSEE will submit to REGENTS a written report on progress made toward the diligence objectives set forth above, including updated business plans, together with the amount of research market any and development monies related to all Licensed Products and/or Licensed Services and expended during that time period.
7.4 Without limiting the foregoing, in the event that LICENSEE Is unable to complete the milestones and diligence requirements set forth in Paragraphs 7.1 and 7.2, despite using its diligent efforts to do so, due to delays which are out of the reasonable control of LICENSEE (e.g., changes to the regulatory pathways or other regulatory delays, problems with clinical trial protocols or designs or adverse events and the like), LICENSORS agree to grant reasonable extensions of the timeline for the applicable diligence milestonesProducts. Subject to the foregoing, failure by LICENSEE to achieve any terms and conditions of the diligence obligations under this Article 7 will result Research Agreement, the Licensee shall meet the Milestones set forth below. Licensee can request extension of each Milestone deadline for a period of one (1) year upon payment of a fee of [ * ] for each extension requested (“Extended Deadline”).
(i) If Licensee fails to [ * ], or within the Extended Deadline, than the licenses set forth in LICENSORS in their sole discretion having Section 2.1 for that particular Licensed Product shall terminate and be no longer valid, unless Licensee shall have earlier demonstrated to the option of terminating all satisfaction of the exclusive licenses granted under Article 3, in accordance with Article 18 of this AgreementUniversity that there is a valid cause for delaying the [ * ].
(ii) If Licensee fails to [ * ], or converting any or all within the Extended Deadline, than the licenses set forth in Section 2.1 for that particular Licensed Product shall terminate and be no longer valid, unless Licensee shall have earlier demonstrated to the satisfaction of such exclusive licenses the University that there is a valid cause for delaying the [ * ].
(c) UNIVERSITY agrees to nonexclusive licenses; provide existing back-up data and documentation as may be required by regulatory agencies for purposes of supporting applications under government review.
(d) LICENSEE shall advise UNIVERSITY, through [ * ] reports to be provided that prior [ * ] pursuant to any such terminationSection 5.2 below, LICENSORS, at LICENSEE’s request, shall negotiate in good faith of its program of development for at least [***] days regarding amendment and status of this Agreement and maintaining the exclusive licenses granted to LICENSEEobtaining said approvals.
Appears in 2 contracts
Samples: Exclusive License Agreement (Quark Pharmaceuticals Inc), Exclusive License Agreement (Quark Pharmaceuticals Inc)
Diligence. 7.1 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 use commercially reasonable and diligent efforts be deemed to research, develop and market Licensed Products and or Licensed Services for commercial sale and distribution throughout the Licensed Territorybe 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 such end, such efforts will include achieve a MILESTONE by the following:indicated date and does not provide the written notice to MICHIGAN referred to above.
7.1.1 Within [***] 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 this Agreement$100,000, LICENSEE will provide an updated financing and business plan for payable in quarterly monthly installments until the researchFIRST COMMERCIAL SALE, development and marketing of Licensed Products and Licensed Services reasonably acceptable to REGENTSthe first payment being due March 30, 2014.
7.2 In addition, LICENSEE, an Affiliate of LICENSEE or a Sublicensee will meet the following milestones: [***]
7.3 No less than [***] after the Effective Date of this Agreement, LICENSEE will submit to REGENTS a written report on progress made toward the diligence objectives set forth above, including updated business plans, together with the amount of research and development monies related to Licensed Products and/or Licensed Services and expended during that time period.
7.4 Without limiting the foregoing, in the event that LICENSEE Is unable to complete the milestones and diligence requirements set forth in Paragraphs 7.1 and 7.2, despite using its diligent efforts to do so, due to delays which are out of the reasonable control of LICENSEE (e.g., changes to the regulatory pathways or other regulatory delays, problems with clinical trial protocols or designs or adverse events and the like), LICENSORS agree to grant reasonable extensions of the timeline for the applicable diligence milestones. Subject to the foregoing, failure by LICENSEE to achieve any of the diligence obligations under this Article 7 will result in LICENSORS in their sole discretion having the option of terminating all of the exclusive licenses granted under Article 3, in accordance with Article 18 of this Agreement, or converting any or all of such exclusive licenses to nonexclusive licenses; provided that prior to any such termination, LICENSORS, at LICENSEE’s request, shall negotiate in good faith for at least [***] days regarding amendment of this Agreement and maintaining the exclusive licenses granted to LICENSEE.
Appears in 2 contracts
Samples: License Agreement (Glyconix Corp), License Agreement (Glyconix Corp)
Diligence. 7.1 LICENSEE 8.1 Licensee and/or its Sublicensees, promptly upon execution of this Agreement, shall diligently proceed with, or engage others to proceed with, the research, development, manufacture, marketing and/or sale of Licensed Products, and shall earnestly and diligently endeavor to market the same within a reasonable period of time after execution of this Agreement, with the goal of making Licensed Products commercially available as rapidly as reasonably possible and in quantities sufficient to meet market demands. For the avoidance of doubt, research and development of the Licensed Technology conducted on Licensee's or its Sublicensee's behalf under appropriate research or other agreements, or pursuant to such agreements (including, without limitation, the Sponsored Research Agreement and any extensions, amendments or renewals thereof), shall satisfy the diligence obligation under this Agreement.
8.2 If Licensee ceases to conduct or have conducted activities that satisfy the diligence obligations set forth in Section 8.1 above for a period of more than two(2) consecutive years, then The Regents shall have the right and option to give written notice to Licensee of its intent to reduce Licensee's exclusive license under this Agreement to a nonexclusive license. If Licensee fails to commence or otherwise conduct or have conducted research, development, manufacture, marketing and/or sale of Licensed Technology within sixty (60) days after receipt of The Regents' notice of intent to reduce Licensee's exclusive rights to non-exclusive pursuant to the preceding sentence, The Regents may reduce the exclusive license granted to Licensee to a nonexclusive license, subject to Article 25 (Non-Binding Dispute Resolution). This right, if exercised by The Regents, supersedes the rights granted in Article 2 (Life of Patent Exclusive Grant). If Licensee fails to commence or otherwise conduct or have conducted research, development, manufacture, marketing and/or sale of the Licensed Technology for a period of more than three (3) consecutive years after the effective date of any such reduction of Licensee's exclusive license rights to non-exclusive, then The Regents shall have the right and option to give written notice to Licensee of its intent to terminate this Agreement. If Licensee fails to commence or otherwise conduct or have conducted substantive research, development, manufacture, marketing and/or sale of Licensed Technology within sixty (60) days after receipt of The Regents' notice of intent to terminate pursuant to the preceding sentence, The Regents may terminate this Agreement pursuant to Article 12 (Termination By The Regents), and subject to Article 25 (Non- Binding Dispute Resolution).
8.3 Notwithstanding the foregoing Sections 8.1 or 8.2, either of the following shall be sufficient (but not necessary) to satisfy Licensee's or its Sublicensees' diligence obligations under this Agreement:
(a) Continuing to fund the Sponsored Research Agreement and any extensions, amendments or renewals thereof; or
(b) Licensee and/or its Sublicensees spending at least $2,400,000 in the aggregate over a period of eight (8) years ("Minimum Spending Requirement") for research, development, manufacture, marketing and/or sale of Licensed Products (including, without limitation, direct and indirect expenditures on development and/or implementation of methods for making, qualifying, and scaling up undifferentiated human embryonic stem cells as source material for Licensed Products). Decision-making with respect to any amounts to be spent on a year-to-year basis shall be at the sole discretion of Licensee or its Sublicensees, provided that the aggregate total amount spent by License and/or its Sublicensees meets the Minimum Spending Requirement.
(c) If Licensee or its Sublicensees choose to rely upon Section 8.3(b) to satisfy the diligence obligations set forth under this Article 8, then upon expiration of the eight (8) year period set forth in Section 8.3(b), Licensee and/or its Sublicensees shall report to The Regents whether the Minimum Spending Requirement has been met. If the Minimum Spending Requirement has not been met, Licensee or its Sublicensees shall report to The Regents the amount by which Licensee's and/or its Sublicensees' spending fell below the Minimum Spending Requirement (the "Spending Shortfall"), and The Regents shall have the right and option to give written notice to Licensee of its intent to reduce Licensee's exclusive license to a non-exclusive license. Upon receipt of such written notice, Licensee and/or its Sublicensees shall have the right, for a period of sixty (60) days thereafter, to submit to The Regents a detailed development plan demonstrating Licensee's and/or its Sublicensees' intent to commence or otherwise conduct or have conducted research, development, manufacture, marketing and/or sale of Licensed Technology at a spending rate equal to the sum of the Spending Shortfall plus the amount of the Minimum Spending Requirement allocated evenly, from year-to-year, over the next eight (8) year period (the "Annual Spending Minimum"). If Licensee and/or its Sublicensees fail to submit such a development plan, or if, within twelve (12) months after providing such development plan to The Regents, Licensee and/or its Sublicensees have not met the Annual Spending Minimum, the Regents will be entitled, upon prior written notice to Licensee, to reduce the exclusive rights granted to Licensee to a non-exclusive license. If, for a period of an additional twelve (12) months after reduction of Licensee's rights to non-exclusive pursuant to the preceding sentence, Licensee and/or its Sublicensees have not met the Annual Spending Minimum, The Regents may terminate this Agreement pursuant to Article 12.
8.4 Licensee shall endeavor to obtain all necessary governmental approvals for the manufacture, use commercially reasonable and diligent sale of the Licensed Technology, when appropriate given the stage of Licensee's efforts to research, develop and develop, manufacture, market and/or sell Licensed Products and or Licensed Services for commercial sale and distribution throughout Technology but in any event prior to the Licensed Territoryfirst Final Sale, and shall use substantive efforts to such end, such efforts will include fill the following:
7.1.1 Within [***] after market demand for Licensed Technology following commencement of marketing at any time during the Effective Date exclusive period of this Agreement, LICENSEE will provide an updated financing and business plan for the research, development and marketing of Licensed Products and Licensed Services reasonably acceptable to REGENTS.
7.2 In addition, LICENSEE, an Affiliate of LICENSEE or a Sublicensee will meet the following milestones: [***]
7.3 No less than [***] after the Effective Date of this Agreement, LICENSEE will submit to REGENTS a written report on progress made toward the diligence objectives set forth above, including updated business plans, together with the amount of research and development monies related to Licensed Products and/or Licensed Services and expended during that time period.
7.4 Without limiting the foregoing, in the event that LICENSEE Is unable to complete the milestones and diligence requirements set forth in Paragraphs 7.1 and 7.2, despite using its diligent efforts to do so, due to delays which are out of the reasonable control of LICENSEE (e.g., changes to the regulatory pathways or other regulatory delays, problems with clinical trial protocols or designs or adverse events and the like), LICENSORS agree to grant reasonable extensions of the timeline for the applicable diligence milestones. Subject to the foregoing, failure by LICENSEE to achieve any of the diligence obligations under this Article 7 will result in LICENSORS in their sole discretion having the option of terminating all of the exclusive licenses granted under Article 3, in accordance with Article 18 of this Agreement, or converting any or all of such exclusive licenses to nonexclusive licenses; provided that prior to any such termination, LICENSORS, at LICENSEE’s request, shall negotiate in good faith for at least [***] days regarding amendment of this Agreement and maintaining the exclusive licenses granted to LICENSEE.
Appears in 1 contract
Samples: Exclusive License Agreement (Asterias Biotherapeutics, Inc.)
Diligence. 7.1 4.1 LICENSEE will accepts that commercialization of the Licensed Product or Licensed Services is of utmost importance to MSK. LICENSEE shall use commercially reasonable and diligent efforts to research, develop and market achieve all Milestone Activities for the first Licensed Products and Product or Licensed Services for commercial sale and distribution throughout Service on or prior to the Licensed TerritoryExpected Completion Date listed below. If LICENSEE is unable to meet such milestones, it shall notify MSK as far in advance as practical of the likely inability, and the Parties shall discuss in good-faith modification of the schedule; if technical, scientific, or regulatory (but not economic or financial) impediments beyond the control of LICENSEE were the substantial cause of the delay, MSK will agree to such enda reasonable modification. Further, such efforts will include LICENSEE shall have the following:
7.1.1 Within option of unilaterally extending any of the following milestones by [*] upon payment to MSK of [*], plus an additional [*] after upon payment to MSK of an additional [*], but no more than [*] in total for each milestone, e.g., the first milestone could be extended at LICENSEE’s option to within [*] of the Effective Date and then again to within [*] by making such payments, but not beyond that date. Without limiting the generality of this Agreementthe foregoing, it shall be inconsistent with the exercise of commercially reasonable efforts for LICENSEE will [*]. [*] if LICENSEE cannot provide an updated financing proof of its commercially reasonable efforts towards the development of a Licensed Product or Licensed Service or fails to achieve a Development Milestone Activity associated with the development of said Licensed Product or Licensed Service on or prior to the Expected Completion Date. Development Milestone Activities may be modified and business plan Expected Completion Dates extended with MSK’s written approval and, upon LICENSEE’s request, the Parties shall discuss and negotiate in good faith any reasonable extensions of the applicable Expected Completion Dates that may be necessary despite LICENSEE’s use of its commercially reasonable efforts towards the development of a Licensed Product or Licensed Service.
(a) LICENSEE shall use commercially reasonable efforts to (i) bring at least one (1) Licensed Product or Licensed Service to market through a thorough, vigorous and diligent program for exploitation of the researchLicensed Rights, development and (ii) following the first commercial sale of a Licensed Product or Licensed Service in any country of the Territory, continue active, diligent marketing efforts for such Licensed Product or Licensed Service and make continuing sales of such Licensed Products Product and Licensed Services reasonably acceptable to REGENTS.
7.2 In additionService in such country throughout the Term. Without limiting the foregoing, LICENSEE, an Affiliate of LICENSEE or a Sublicensee will meet such commercially reasonable efforts shall include achieving the following milestones: [***]
7.3 No less than ] Within [*] of Effective Date [*] Within [*] of Effective Date [*] Within [*] of Effective Date [*] Within [*] of Effective Date [*] Within [*] of Effective Date
(b) LICENSEE shall give MSK written notice and evidence within [*] of the achievement of each of the above specific diligence obligations. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(c) LICENSEE’s detailed business plan for the development of the Licensed Rights, including, for example, relevant schedules of capital investments needed to implement the plan, financial, equipment, facility plans, number and kind of personnel and time planned for each phase of development of the Licensed Rights for a [*] period, to the extent formed by LICENSEE, will be provided by LICENSEE within [*] of the Effective Date and will be annexed hereto and made part of this Agreement. LICENSEE shall provide similar reports to MSK annually to relay update and status information on LICENSEE’s business, research and development progress, including projections of activity anticipated for the next reporting year.
(d) LICENSEE shall be solely responsible, at its sole cost and expense, for securing any necessary governmental or regulatory approvals for development, manufacture, and sale of Licensed Products and performance of Licensed Services (“Regulatory Approval”). LICENSEE shall advise MSK, through annual reports described in Section 4.1(c) above, of its program of development for obtaining said Regulatory Approvals.
(e) LICENSEE shall perform the Feasibility Study diligently and at its sole cost and expense. LICENSEE shall conclude the Feasibility Study as promptly as possible and in all events within [*] after the Effective Date Date. During the Feasibility Study, LICENSEE shall regularly share any data generated with MSK. Should any data be generated by MSK under Exhibit D funded by LICENSEE, MSK will likewise regularly share such data with LICENSEE. The recipient shall treat such data as confidential in accordance with Section 9 of this Agreement. If results of the Feasibility Study do not indicate that [*], LICENSEE can terminate this Agreement upon [*] prior written notice to MSK. At the end of the Feasibility Study, LICENSEE shall notify MSK in writing whether or not it will submit exercise its rights to REGENTS terminate this Agreement pursuant to the foregoing sentence. Without limitation to Section 16.8, termination under this Section 4.1 (e) shall not relieve LICENSEE from obligations (x) that have already been accrued prior to the termination date and/or (y) in respect of costs and/or commitments that cannot be cancelled.
4.2 If LICENSEE is the subject of a written demand, notice, inquiry, or inspection report on progress made toward the diligence objectives set forth aboveby a governmental authority or certification agency in relation to any Licensed Product or Licensed Service that (i) by its terms directs or contemplates, including updated business plansor may reasonably be expected to require or relate to, together with the amount suspension or cessation of research and development monies related to manufacturing, sale, development, or marketing of Licensed Products and/or or Licensed Services and expended during that time period.
7.4 Without limiting the foregoingefforts, in the event that LICENSEE Is unable to complete the milestones and diligence requirements set forth in Paragraphs 7.1 and 7.2(ii) concerns a recall or potential recall of Licensed Products or Licensed Services, despite using its diligent efforts to do so, due to delays which are out (iii) concerns a loss of the reasonable control life or material issue of LICENSEE (e.g., changes to the regulatory pathways or other regulatory delays, problems with clinical trial protocols or designs or adverse events and the like), LICENSORS agree to grant reasonable extensions of the timeline for the applicable diligence milestones. Subject to the foregoing, failure by LICENSEE to achieve any of the diligence obligations under this Article 7 will result in LICENSORS in their sole discretion having the option of terminating all of the exclusive licenses granted under Article 3, in accordance with Article 18 of this Agreementsafety, or converting any or all of such exclusive licenses (iv) may reasonably be expected to nonexclusive licenses; provided that prior to any such termination, LICENSORS, at prevent LICENSEE’s requestcompliance with its diligence obligations, then LICENSEE shall negotiate in good faith for at least [***] days regarding amendment provide a copy to MSK without delay and keep MSK reasonably apprized of this Agreement and maintaining the exclusive licenses granted to LICENSEEits response.
Appears in 1 contract
Diligence. 7.1 LICENSEE will a. Company (itself or through its Affiliates or Sublicensees) shall use commercially reasonable and diligent efforts to research, discover, develop and market Licensed Products at least one (1) Tianeptine Product and or Licensed Services at least one (1) Mitragynine Product for commercial sale and distribution throughout in the Licensed Territory, . Company shall be deemed to meet such “commercially reasonable efforts” in the event it achieves all of the due diligence milestones set forth in this Article 6. Company shall achieve the following due diligence milestones (“Milestones”) for at least one Tianeptine Product and to such end, such efforts will include at least one Mitragynine Product by the followingdates (“Achievement Dates”) as set forth below:
7.1.1 Within [***] i. Due Diligence Milestones for the Tianeptine Products:
ii. Due Diligence Milestones for the Mitragynine Products:
b. In the event that Company is unable to achieve the diligence milestones in Section 6a(i), Columbia may exercise its right in accordance with Section 15 solely to terminate the license under the Tianeptine Patents and Tianeptine Technical Information granted to Company in Section 2, but not under the Mitragynine Patents or Mitragynine Technical Information. In the event that Company is unable to achieve the diligence milestones in Section 6a(ii), Columbia may exercise its right in accordance with Section 15 solely to terminate the license under Mitragynine Patents and Mitragynine Technical Information granted to Company in Section 2, but not under the Tianeptine Patents or Tianeptine Technical Information. Notwithstanding any other provisions of this Agreement, if Company does not achieve any of Company’s diligence obligations under this Section, Columbia may terminate all of the licenses granted under Section 2 in accordance with Section 16 of this Agreement, or Columbia may convert any or all of such exclusive licenses to non-exclusive licenses with no right to sublicense and no right to initiate legal proceedings under Section 11; provided that Company may first request a reasonable extension to the performance period of the above milestones and Columbia shall reasonably grant such extension if Company has exercised commercially reasonable efforts to achieve the target completion date and has a plan to achieve it within the extension period.
c. No less often than every twelve (12) months after the Effective Date of this AgreementAgreement until the date of the first bona fide commercial sale of a Product, LICENSEE will provide an updated financing and business plan for the research, development and marketing of Licensed Products and Licensed Services reasonably acceptable Company shall report in writing to REGENTS.
7.2 In addition, LICENSEE, an Affiliate of LICENSEE or a Sublicensee will meet the following milestones: [***]
7.3 No less than [***] after the Effective Date of this Agreement, LICENSEE will submit to REGENTS a written report Columbia on progress made toward the diligence objectives set forth above, including updated business plans, together with the amount of research and development monies related using Exhibit D to Licensed Products and/or Licensed Services and expended during that time period.
7.4 Without limiting the foregoing, in the event that LICENSEE Is unable to complete the milestones and diligence requirements set forth in Paragraphs 7.1 and 7.2, despite using its diligent efforts to do so, due to delays which are out of the reasonable control of LICENSEE (e.g., changes to the regulatory pathways or other regulatory delays, problems with clinical trial protocols or designs or adverse events and the like), LICENSORS agree to grant reasonable extensions of the timeline for the applicable diligence milestones. Subject to the foregoing, failure by LICENSEE to achieve any of the diligence obligations under this Article 7 will result in LICENSORS in their sole discretion having the option of terminating all of the exclusive licenses granted under Article 3, in accordance with Article 18 of this Agreement, or converting any or all of such exclusive licenses to nonexclusive licenses; provided that prior to any such termination, LICENSORS, at LICENSEE’s request, shall negotiate in good faith for at least [***] days regarding amendment of this Agreement and maintaining or an equivalent to Exhibit D to make the exclusive licenses granted to LICENSEEreport.
Appears in 1 contract
Samples: Exclusive License Agreement (ATAI Life Sciences B.V.)
Diligence. 7.1 LICENSEE 8.1 Licensee and/or its Sublicensees, promptly upon execution of this Agreement, shall diligently proceed with, or engage others to proceed with, the research, development, manufacture, marketing and/or sale of Licensed Products, and shall earnestly and diligently endeavor to market the same within a reasonable period of time after execution of this Agreement, with the goal of making Licensed Products commercially available as rapidly as reasonably possible and in quantities sufficient to meet market demands. For the avoidance of doubt, research and development of the Licensed Technology conducted on Licensee's or its Sublicensee's behalf under appropriate research or other agreements, or pursuant to such agreements (including, without limitation, the Sponsored Research Agreement and any extensions, amendments or renewals thereof), shall satisfy the diligence obligation under this Agreement.
8.2 If Licensee ceases to conduct or have conducted activities that satisfy the diligence obligations set forth in Section 8.1 above for a period of more than two (2) consecutive years, then The Regents shall have the right and option to give written notice to Licensee of its intent to reduce Licensee's exclusive license under this Agreement to a nonexclusive license. If Licensee fails to commence or otherwise conduct or have conducted research, development, manufacture, marketing and/or sale of Licensed Technology within sixty (60) days after receipt of The Regents' notice of intent to reduce Licensee's exclusive rights to non-exclusive pursuant to the preceding sentence, The Regents may reduce the exclusive license granted to Licensee to a nonexclusive license, subject to Article 25 (Non-Binding Dispute Resolution). This right, if exercised by The Regents, supersedes the rights granted in Article 2 (Life of Patent Exclusive Grant). If Licensee fails to commence or otherwise conduct or have conducted research, development, manufacture, marketing and/or sale of the Licensed Technology for a period of more than three (3) consecutive years after the effective date of any such reduction of Licensee's exclusive license rights to non-exclusive, then The Regents shall have the right and option to give written notice to Licensee of its intent to terminate this Agreement. If Licensee fails to commence or otherwise conduct or have conducted substantive research, development, manufacture, marketing and/or sale of Licensed Technology within sixty (60) days after receipt of The Regents' notice of intent to terminate pursuant to the preceding sentence, The Regents may terminate this Agreement pursuant to Article 12 (Termination By The Regents), and subject to Article 25 (Non- Binding Dispute Resolution).
8.3 Notwithstanding the foregoing Sections 8.1 or 8.2, either of the following shall be sufficient (but not necessary) to satisfy Licensee's or its Sublicensees' diligence obligations under this Agreement:
(a) Continuing to fund the Sponsored Research Agreement and any extensions, amendments or renewals thereof; or
(b) Licensee and/or its Sublicensees spending at least $2,400,000 in the aggregate over a period of eight (8) years ("Minimum Spending Requirement") for research, development, manufacture, marketing and/or sale of Licensed Products (including, without limitation, direct and indirect expenditures on development and/or implementation of methods for making, qualifying, and scaling up undifferentiated human embryonic stem cells as source material for Licensed Products). Decision-making with respect to any amounts to be spent on a year-to-year basis shall be at the sole discretion of Licensee or its Sublicensees, provided that the aggregate total amount spent by License and/or its Sublicensees meets the Minimum Spending Requirement.
(c) If Licensee or its Sublicensees choose to rely upon Section 8.3(b) to satisfy the diligence obligations set forth under this Article 8, then upon expiration of the eight (8) year period set forth in Section 8.3(b), Licensee and/or its Sublicensees shall report to The Regents whether the Minimum Spending Requirement has been met. If the Minimum Spending Requirement has not been met, Licensee or its Sublicensees shall report to The Regents the amount by which Licensee's and/or its Sublicensees' spending fell below the Minimum Spending Requirement (the "Spending Shortfall"), and The Regents shall have the right and option to give written notice to Licensee of its intent to reduce Licensee's exclusive license to a non-exclusive license. Upon receipt of such written notice, Licensee and/or its Sublicensees shall have the right, for a period of sixty (60) days thereafter, to submit to The Regents a detailed development plan demonstrating Licensee's and/or its Sublicensees' intent to commence or otherwise conduct or have conducted research, development, manufacture, marketing and/or sale of Licensed Technology at a spending rate equal to the sum of the Spending Shortfall plus the amount of the Minimum Spending Requirement allocated evenly, from year-to-year, over the next eight (8) year period (the "Annual Spending Minimum"). If Licensee and/or its Sublicensees fail to submit such a development plan, or if, within twelve (12) months after providing such development plan to The Regents, Licensee and/or its Sublicensees have not met the Annual Spending Minimum, the Regents will be entitled, upon prior written notice to Licensee, to reduce the exclusive rights granted to Licensee to a non-exclusive license. If, for a period of an additional twelve (12) months after reduction of Licensee's rights to non-exclusive pursuant to the preceding sentence, Licensee and/or its Sublicensees have not met the Annual Spending Minimum, The Regents may terminate this Agreement pursuant to Article 12.
8.4 Licensee shall endeavor to obtain all necessary governmental approvals for the manufacture, use commercially reasonable and diligent sale of the Licensed Technology, when appropriate given the stage of Licensee's efforts to research, develop and develop, manufacture, market and/or sell Licensed Products and or Licensed Services for commercial sale and distribution throughout Technology but in any event prior to the Licensed Territoryfirst Final Sale, and shall use substantive efforts to such end, such efforts will include fill the following:
7.1.1 Within [***] after market demand for Licensed Technology following commencement of marketing at any time during the Effective Date exclusive period of this Agreement, LICENSEE will provide an updated financing and business plan for the research, development and marketing of Licensed Products and Licensed Services reasonably acceptable to REGENTS.
7.2 In addition, LICENSEE, an Affiliate of LICENSEE or a Sublicensee will meet the following milestones: [***]
7.3 No less than [***] after the Effective Date of this Agreement, LICENSEE will submit to REGENTS a written report on progress made toward the diligence objectives set forth above, including updated business plans, together with the amount of research and development monies related to Licensed Products and/or Licensed Services and expended during that time period.
7.4 Without limiting the foregoing, in the event that LICENSEE Is unable to complete the milestones and diligence requirements set forth in Paragraphs 7.1 and 7.2, despite using its diligent efforts to do so, due to delays which are out of the reasonable control of LICENSEE (e.g., changes to the regulatory pathways or other regulatory delays, problems with clinical trial protocols or designs or adverse events and the like), LICENSORS agree to grant reasonable extensions of the timeline for the applicable diligence milestones. Subject to the foregoing, failure by LICENSEE to achieve any of the diligence obligations under this Article 7 will result in LICENSORS in their sole discretion having the option of terminating all of the exclusive licenses granted under Article 3, in accordance with Article 18 of this Agreement, or converting any or all of such exclusive licenses to nonexclusive licenses; provided that prior to any such termination, LICENSORS, at LICENSEE’s request, shall negotiate in good faith for at least [***] days regarding amendment of this Agreement and maintaining the exclusive licenses granted to LICENSEE.
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Diligence. 7.1 4.1 LICENSEE will accepts that commercialization of the Licensed Product or Licensed Services is of utmost importance to MSK. LICENSEE shall use commercially reasonable efforts to achieve all Milestone Activities for the first Licensed Product or Licensed Service on or prior to the Expected Completion Date listed below. If LICENSEE is unable to meet such milestones, it shall notify MSK as far in advance as practical of the likely inability, and the Parties shall discuss in good-faith modification of the schedule; if technical, scientific, or regulatory (but not economic or financial) impediments beyond the control of LICENSEE were the substantial cause of the delay, MSK will agree to a reasonable modification. Further, LICENSEE shall have the option of unilaterally extending any of the following milestones by [*] upon payment to MSK of [*], plus an additional [*] upon payment to MSK of an additional [*], but no more than [*] in total for each milestone, e.g., the first milestone could be extended at LICENSEE’s option to within [*] of the Effective Date and then again to within [*] by making such payments, but not beyond that date. Without limiting the generality of the foregoing, it shall be inconsistent with the exercise of commercially reasonable efforts for LICENSEE [*]. [*] if LICENSEE cannot provide proof of its commercially reasonable efforts towards the development of a Licensed Product or Licensed Service or fails to achieve a Development Milestone Activity associated with the development of said Licensed Product or Licensed Service on or prior to the Expected Completion Date. Development Milestone Activities may be modified and Expected Completion Dates extended with MSK’s written approval and, upon LICENSEE’s request, the Parties shall discuss and negotiate in good faith any reasonable extensions of the applicable Expected Completion Dates that may be necessary despite LICENSEE’s use of its commercially reasonable efforts towards the development of a Licensed Product or Licensed Service.
(a) LICENSEE shall use commercially reasonable efforts to (i) bring at least one (1) Licensed Product or Licensed Service to market through a thorough, vigorous and diligent program for exploitation of the Licensed Rights, and (ii) following the first commercial sale of a Licensed Product or Licensed Service in any country of the Territory, continue active, diligent marketing efforts for such Licensed Product or Licensed Service and make continuing sales of such Licensed Product and Licensed Service in such country throughout the Term. Without limiting the foregoing, such commercially reasonable efforts shall include achieving the following milestones: IND Filing Within [*] of Effective Date Completed accrual of first Phase 1 clinical trial Within [*] of Effective Date Completed accrual of first Phase 2 clinical trial Within [*] of Effective Date Completed accrual of first Phase 3 clinical trial Within [*] of Effective Date FDA approval of first Licensed Product Within [*] of Effective Date
(b) LICENSEE shall give MSK written notice and evidence within [*] of the achievement of each of the above specific diligence obligations. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to researchRule 406 of the Securities Act of 1933, develop as amended.
(c) LICENSEE’s detailed business plan for the development of the Licensed Rights, including, for example, relevant schedules of capital investments needed to implement the plan, financial, equipment, facility plans, number and market kind of personnel and time planned for each phase of development of the Licensed Rights for a [*] period, to the extent formed by LICENSEE, will be provided by LICENSEE within [*] of the Effective Date and will be annexed hereto and made part of this Agreement. LICENSEE shall provide similar reports to MSK annually to relay update and status information on LICENSEE’s business, research and development progress, including projections of activity anticipated for the next reporting year.
(d) LICENSEE shall be solely responsible, at its sole cost and expense, for securing any necessary governmental or regulatory approvals for development, manufacture, and sale of Licensed Products and or performance of Licensed Services (“Regulatory Approval”). LICENSEE shall advise MSK, through annual reports described in Section 4.1(c) above, of its program of development for commercial sale obtaining said Regulatory Approvals.
(e) LICENSEE shall perform the Feasibility Study diligently and distribution throughout at its sole cost and expense. LICENSEE shall conclude the Licensed Territory, Feasibility Study as promptly as possible and to such end, such efforts will include the following:
7.1.1 Within in all events within [***] after the Effective Date Date. During the Feasibility Study, LICENSEE shall regularly share any data generated with MSK. Should any data be generated by MSK under Exhibit D funded by LICENSEE, MSK will likewise regularly share such data with LICENSEE. The recipient shall treat such data as confidential in accordance with Section 9 of this Agreement. If results of the Feasibility Study do not indicate that [*], LICENSEE can terminate this Agreement upon [*] prior written notice to MSK. At the end of the Feasibility Study, LICENSEE shall notify MSK in writing whether or not it will provide an updated financing and business plan for exercise its rights to terminate this Agreement pursuant to the researchforegoing sentence. Without limitation to Section 16.8, development and termination under this Section 4.1 (e) shall not relieve LICENSEE from obligations (x) that have already been accrued prior to the termination date and/or (y) in respect of costs and/or commitments that cannot be cancelled.
4.2 If LICENSEE is the subject of a demand, notice, inquiry, or inspection report by a governmental authority or certification agency in relation to any Licensed Product or Licensed Service that (i) by its terms directs or contemplates, or may reasonably be expected to require or relate to, suspension or cessation of manufacturing, sale, development, or marketing of Licensed Products and or Licensed Services reasonably acceptable to REGENTS.
7.2 In additionefforts, LICENSEE, an Affiliate (ii) concerns a recall or potential recall of LICENSEE or a Sublicensee will meet the following milestones: [***]
7.3 No less than [***] after the Effective Date of this Agreement, LICENSEE will submit to REGENTS a written report on progress made toward the diligence objectives set forth above, including updated business plans, together with the amount of research and development monies related to Licensed Products and/or or Licensed Services and expended during that time period.
7.4 Without limiting the foregoingServices, in the event that LICENSEE Is unable to complete the milestones and diligence requirements set forth in Paragraphs 7.1 and 7.2, despite using its diligent efforts to do so, due to delays which are out (iii) concerns a loss of the reasonable control life or material issue of LICENSEE (e.g., changes to the regulatory pathways or other regulatory delays, problems with clinical trial protocols or designs or adverse events and the like), LICENSORS agree to grant reasonable extensions of the timeline for the applicable diligence milestones. Subject to the foregoing, failure by LICENSEE to achieve any of the diligence obligations under this Article 7 will result in LICENSORS in their sole discretion having the option of terminating all of the exclusive licenses granted under Article 3, in accordance with Article 18 of this Agreementsafety, or converting any or all of such exclusive licenses (iv) may reasonably be expected to nonexclusive licenses; provided that prior to any such termination, LICENSORS, at prevent LICENSEE’s requestcompliance with its diligence obligations, then LICENSEE shall negotiate in good faith for at least [***] days regarding amendment provide a copy to MSK without delay and keep MSK reasonably apprized of this Agreement and maintaining the exclusive licenses granted to LICENSEEits response.
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Diligence. 7.1 LICENSEE will use commercially reasonable and diligent efforts to research, develop and market Licensed Products and or Licensed Services for commercial sale and distribution throughout 6.1 Upon the Licensed Territory, and to such end, such efforts will include the following:
7.1.1 Within [***] after the Effective Date execution of this Agreement, LICENSEE will provide an updated financing Licensee must diligently proceed with the development, manufacture and business plan for the research, development and marketing sale (“Commercialization”) of Licensed Products and Licensed Services reasonably acceptable must earnestly and diligently endeavor to REGENTS.
7.2 In addition, LICENSEE, an Affiliate of LICENSEE or market them within a Sublicensee will meet the following milestones: [***]
7.3 No less than [***] reasonable time after the Effective Date of this Agreement, LICENSEE will submit to REGENTS a written report on progress made toward the diligence objectives set forth above, including updated business plans, together with the amount of research and development monies related to Licensed Products and/or Licensed Services and expended during that time period.
7.4 Without limiting the foregoing, in the event that LICENSEE Is unable to complete the milestones and diligence requirements set forth in Paragraphs 7.1 and 7.2, despite using its diligent efforts to do so, due to delays which are out of the reasonable control of LICENSEE (e.g., changes to the regulatory pathways or other regulatory delays, problems with clinical trial protocols or designs or adverse events and the like), LICENSORS agree to grant reasonable extensions of the timeline for the applicable diligence milestones. Subject to the foregoing, failure by LICENSEE to achieve any of the diligence obligations under this Article 7 will result in LICENSORS in their sole discretion having the option of terminating all of the exclusive licenses granted under Article 3, in accordance with Article 18 of this Agreement, or converting any or all of such exclusive licenses to nonexclusive licenses; provided that prior to any such termination, LICENSORS, at LICENSEE’s request, shall negotiate in good faith for at least [***] days regarding amendment execution of this Agreement and maintaining in quantities sufficient to meet the market demands for them.
6.2 Licensee must endeavor to obtain all necessary governmental approvals for the Commercialization of Licensed Products.
6.3 The Regents has the right and option to either terminate this Agreement or reduce Licensee’s exclusive licenses license to a nonexclusive license if Licensee fails to perform any of the terms in Paragraph 6.1. With respect to the Regents’ Patent Rights other than the Newly Added Patent Rights, if Licensee fails to perform any of the terms in Paragraphs 6.3a through 6.3h, The Regents shall have the right and option to either terminate the License to such Regents’ Patent Rights other than the Newly Added Patent Rights by delivering a Notice of Default and Notice of Termination to Licensee in accordance with Paragraph 12, or to reduce Licensee’s exclusive license to such Regents’ Patent Rights other than the Newly Added Patent Rights to a nonexclusive license by providing Licensee sixty (60) days advance written notice thereof. With respect to the Newly Added Patent Rights, if Licensee fails to perform any of the terms in Paragraphs 6.3i through 6.3r, The Regents shall have the right and option to either terminate the License to such Newly Added Patent Rights by delivering a Notice of Default and Notice of Termination in accordance with Paragraph 12, or to reduce Licensee’s exclusive license to such Newly Added Patent Rights to a nonexclusive license upon providing Licensee sixty (60) days advance written notice thereof. In each of the cases above, Licensee may use such 60-day advance written notice period to confer with The Regents to demonstrate Licensee’s diligent efforts to meet such Development Milestone and Licensee’s anticipated timelines for achieving the Development Milestones, which The Regents will consider when determining whether to take such action. The foregoing rights, if exercised by The Regents, supersede the applicable rights granted in Article 2 (GRANT). With respect to LICENSEE.a non-pegylated Licensed Product or Licensed Method covered by the Regents’ Patent Rights other than the Newly Added Patent Rights:
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