Common use of Diligence Clause in Contracts

Diligence. 6.1. Licensee, upon execution of this Agreement, will diligently proceed with the development, manufacture, and Sale of Licensed Products, Licensed Services, and Licensed Methods, and will diligently market them in quantities sufficient to meet the market demand. 6.2. In addition to its obligations under Paragraph 6.1, Licensee specifically commits to achieving the following milestones (either itself, or through its Sublicensees) in its activities under this Agreement: (a) Milestone #1: Greenhouse Proof of Concept — on or before […*…]; (b) Milestone #2: Field Proof of Concept — on or before […*…]; (c) Milestone #3: Regulatory Submission — on or before […*…]; (d) Milestone #4: Regulatory Approval — on or before […*…]; and (e) Milestone #5: Commercial Launch of a Licensed Product — on or before […*…]. 6.3. If The Regents believes that Licensee has failed to meet any milestone set forth in Paragraphs 6.1 and 6.2 by the date set forth therein (if applicable), The Regents will provide written notice to Licensee of the same within a reasonable time. License will have one hundred and twenty (120) days from the date of such written notice (“Cure Period”) to complete the stated milestone or otherwise fulfill the stated diligence obligations. If Licensee is unable to complete the stated milestone or otherwise fulfill the stated diligence obligations within the Cure Period, Licensee may extend the completion date of such milestone or diligence obligation for a period of six (6) months from the expiration of the Cure Period upon the payment of […*…], due within ten (10) days of expiration of the Cure Period. Licensee may further extend the completion date of any milestone or diligence obligation for an additional six (6) months upon payment of an additional […*…]. Additional extensions may be granted only by mutual written agreement of the Parties. All such payments to extend deadlines are in addition to the annual License Maintenance Fee payment specified in Paragraph 4.2. Should Licensee opt not to pay to extend the completion date or if Licensee should fail to complete the stated milestone or otherwise fulfill the stated diligence obligations by any extended target date, then The Regents may provide written notice to Licensee that the license granted in Paragraph 2.1 has been converted to a non-exclusive license, effective as of the date of expiration of the Cure Period or any extended target date, whichever is later. (a) Unless earlier terminated in accordance with other provisions of this Agreement, the non-exclusive license will remain in effect for one (1) year from the date of conversion under this Paragraph 6.

Appears in 3 contracts

Samples: Exclusive License Agreement (Arcadia Biosciences, Inc.), Exclusive License Agreement (Arcadia Biosciences, Inc.), Exclusive License Agreement (Arcadia Biosciences, Inc.)

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Diligence. 6.1. Licensee7.1 LICENSEE will use commercially reasonable and diligent efforts to research, upon execution 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 diligently proceed 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 development, manufacture, amount of research and Sale of development monies related to Licensed Products, Products and/or Licensed Services, Services and Licensed Methods, and will diligently market them in quantities sufficient to meet the market demandexpended during that time period. 6.2. In addition 7.4 Without limiting the foregoing, in the event that LICENSEE Is unable to its obligations under Paragraph 6.1, Licensee specifically commits to achieving complete the following milestones (either itself, or through its Sublicensees) in its activities under this Agreement: (a) Milestone #1: Greenhouse Proof of Concept — on or before […*…]; (b) Milestone #2: Field Proof of Concept — on or before […*…]; (c) Milestone #3: Regulatory Submission — on or before […*…]; (d) Milestone #4: Regulatory Approval — on or before […*…]; and (e) Milestone #5: Commercial Launch of a Licensed Product — on or before […*…]. 6.3. If The Regents believes that Licensee has failed to meet any milestone and diligence requirements set forth in Paragraphs 6.1 7.1 and 6.2 by 7.2, despite using its diligent efforts to do so, due to delays which are out of the date set forth therein reasonable control of LICENSEE (if applicablee.g., changes to the regulatory pathways or other regulatory delays, problems with clinical trial protocols or designs or adverse events and the like), The Regents will provide written notice LICENSORS agree to Licensee grant reasonable extensions of the same within a reasonable timetimeline for the applicable diligence milestones. License will have one hundred and twenty (120) days from Subject to the date foregoing, failure by LICENSEE to achieve any of such written notice (“Cure Period”) to complete the stated milestone or otherwise fulfill the stated diligence obligations. If Licensee is unable to complete the stated milestone or otherwise fulfill the stated diligence obligations within under this Article 7 will result in LICENSORS in their sole discretion having the Cure Period, Licensee may extend the completion date option of such milestone or diligence obligation for a period of six (6) months from the expiration terminating all of the Cure Period upon the payment of […*…]exclusive licenses granted under Article 3, due within ten (10) days of expiration of the Cure Period. Licensee may further extend the completion date of any milestone or diligence obligation for an additional six (6) months upon payment of an additional […*…]. Additional extensions may be granted only by mutual written agreement of the Parties. All such payments to extend deadlines are in addition to the annual License Maintenance Fee payment specified in Paragraph 4.2. Should Licensee opt not to pay to extend the completion date or if Licensee should fail to complete the stated milestone or otherwise fulfill the stated diligence obligations by any extended target date, then The Regents may provide written notice to Licensee that the license granted in Paragraph 2.1 has been converted to a non-exclusive license, effective as of the date of expiration of the Cure Period or any extended target date, whichever is later. (a) Unless earlier terminated in accordance with other provisions 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 non-exclusive license will remain in effect for one (1) year from the date of conversion under this Paragraph 6licenses 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. 6.13.1 LICENSEE and its sublicensees shall use commercially reasonable efforts to bring Licensed Products or Licensed Processes to market through a [ * ] exploitation of the Patent Rights. Licensee, upon execution of Non-compliance with this Agreement, will diligently proceed with the development, manufacture, and Sale of Licensed Products, Licensed Services, and Licensed Methods, and will diligently market them in quantities sufficient to meet the market demandSection 3.1 shall be grounds for termination. 6.2. In addition to its obligations under Paragraph 6.13.2 in addition, Licensee specifically commits to achieving LICENSEE and UNIVERSITY shall adhere is the following milestones (either itself, or through its Sublicensees) in its activities under this Agreementfollowing: (a) Milestone #1: Greenhouse Proof LICENSEE shall deliver to UNIVERSITY within [ * ] of Concept — Effective Date of this 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 or before […*…];LICENSEE’s progress on development of the Patent Rights, including projections of activity anticipated for the next reporting year. (b) Milestone #2: Field Proof LICENSEE shall be responsible for diligently and promptly taking all reasonable steps to secure all required and/or necessary governmental approvals to sell, exploit, or market any and all Licensed Products. Subject to the terms and conditions of Concept — on or before […*…]; (c) Milestone #3: Regulatory Submission — on or before […*…]; (d) Milestone #4: Regulatory Approval — on or before […*…]; and (e) Milestone #5: Commercial Launch of a Licensed Product — on or before […*…]. 6.3. If The Regents believes that the Research Agreement, the Licensee has failed to shall meet any milestone the Milestones set forth in Paragraphs 6.1 and 6.2 by the date set forth therein (if applicable), The Regents will provide written notice to below. Licensee can request extension of the same within a reasonable time. License will have one hundred and twenty (120) days from the date of such written notice (“Cure Period”) to complete the stated milestone or otherwise fulfill the stated diligence obligations. If Licensee is unable to complete the stated milestone or otherwise fulfill the stated diligence obligations within the Cure Period, Licensee may extend the completion date of such milestone or diligence obligation each Milestone deadline for a period of six (6) months from the expiration of the Cure Period upon the payment of […*…], due within ten (10) days of expiration of the Cure Period. Licensee may further extend the completion date of any milestone or diligence obligation for an additional six (6) months upon payment of an additional […*…]. Additional extensions may be granted only by mutual written agreement of the Parties. All such payments to extend deadlines are in addition to the annual License Maintenance Fee payment specified in Paragraph 4.2. Should Licensee opt not to pay to extend the completion date or if Licensee should fail to complete the stated milestone or otherwise fulfill the stated diligence obligations by any extended target date, then The Regents may provide written notice to Licensee that the license granted in Paragraph 2.1 has been converted to a non-exclusive license, effective as of the date of expiration of the Cure Period or any extended target date, whichever is later. (a) Unless earlier terminated in accordance with other provisions of this Agreement, the non-exclusive license will remain in effect for one (1) year from upon payment of a fee of [ * ] for each extension requested (“Extended Deadline”). (i) If Licensee fails to [ * ], or within the date 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 conversion the University that there is a valid cause for delaying the [ * ]. (ii) If Licensee fails to [ * ], or 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 the University that there is a valid cause for delaying the [ * ]. (c) UNIVERSITY agrees to provide existing back-up data and documentation as may be required by regulatory agencies for purposes of supporting applications under this Paragraph 6government review. (d) LICENSEE shall advise UNIVERSITY, through [ * ] reports to be provided [ * ] pursuant to Section 5.2 below, of its program of development for and status of obtaining said approvals.

Appears in 2 contracts

Samples: Exclusive License Agreement (Quark Pharmaceuticals Inc), Exclusive License Agreement (Quark Pharmaceuticals Inc)

Diligence. 6.1. Licensee, upon execution of 5.1 As an inducement to STANFORD to enter into this Agreement, will diligently LICENSEE agrees to use commercially reasonable efforts and diligence to proceed with the development, manufacture, offering for sale, and Sale sale or lease of Licensed Products and to diligently develop markets for the Licensed Products. 5.2 LICENSEE shall provide a development plan for each Licensed Antibody by *****. In the event that LICENSEE does not provide a development plan for ***** Licensed Antibodies, the license rights granted hereunder with respect to such Licensed ServicesAntibody(ies) only shall become nonexclusive upon ***** notice from STANFORD. 5.3 If LICENSEE or its sublicensees have not made substantial progress on or completed preclinical studies that serve as a basis for LICENSEE’s development plan with respect to the Licensed Antibody *****, LICENSEE agrees that the license rights granted hereunder with respect to ***** only shall become nonexclusive upon ***** notice from STANFORD. If LICENSEE or its sublicensees have not made substantial progress on or completed preclinical studies that serve as a basis for LICENSEE’s development plan with respect to any other Licensed Antibody by *****, LICENSEE agrees that the license rights granted hereunder with respect to such Licensed Antibody only shall become nonexclusive upon ***** notice from STANFORD. 5.4 If LICENSEE or its sublicensees have not initiated *****, LICENSEE agrees that the license rights granted hereunder with respect to ***** only shall become nonexclusive upon ***** notice from STANFORD. If LICENSEE or its sublicensees have not initiated *****, LICENSEE agrees that the license rights granted hereunder with respect to such Licensed Antibody only shall become nonexclusive upon ***** notice from Stanford. 5.5 If LICENSEE or its sublicensees have not initiated *****, LICENSEE agrees that the license rights granted hereunder with respect to ***** only shall become nonexclusive upon ***** notice from STANFORD. If LICENSEE or its sublicensees have not initiated *****, LICENSEE agrees that the license rights granted hereunder with respect to such Licensed Antibody only shall become nonexclusive upon ***** notice from Stanford. 5.6 LICENSEE and Licensed Methods, and will diligently market them in quantities sufficient STANFORD agree to meet *****, to discuss and agree upon further diligence milestones, including the market demand. 6.2. In addition to its obligations under Paragraph 6.1, Licensee specifically commits to achieving the following milestones (either itself, or through its Sublicensees) in its activities under this Agreement: (a) Milestone #1: Greenhouse Proof of Concept — on or before […*…]; (b) Milestone #2: Field Proof of Concept — on or before […*…]; (c) Milestone #3: Regulatory Submission — on or before […*…]; (d) Milestone #4: Regulatory Approval — on or before […*…]; and (e) Milestone #5: Commercial Launch of date by which a Licensed Product — on or before […*…]will first be available for commercial sale. 6.3. 5.7 If The Regents believes that Licensee neither LICENSEE nor any of its sublicensees has failed to meet any milestone set forth in Paragraphs 6.1 and 6.2 by the date set forth therein (if applicable), The Regents will provide written notice to Licensee of the same within sold a reasonable time. License will have one hundred and twenty (120) days from the date of such written notice (“Cure Period”) to complete the stated milestone or otherwise fulfill the stated diligence obligations. If Licensee is unable to complete the stated milestone or otherwise fulfill the stated diligence obligations within the Cure Period, Licensee may extend the completion date of such milestone or diligence obligation Licensed Product for a period of six (6) months ***** after such Licensed Product is first offered for commercial sale, the license rights granted hereunder with respect to such Licensed Product shall become nonexclusive upon ***** notice from STANFORD. 5.8 Progress Report - ***** until LICENSEE markets a Licensed Product, LICENSEE shall make a written ***** report to STANFORD covering *****, regarding the expiration progress of LICENSEE toward commercial use of Licensed Products. Such report shall include, as a minimum, information sufficient to enable STANFORD to satisfy reporting requirements of the Cure Period upon U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the payment of […*…], due within ten (10) days of expiration of the Cure Period. Licensee may further extend the completion date of any milestone or diligence obligation for an additional six (6) months upon payment of an additional […*…]. Additional extensions may be granted only by mutual written agreement of the Parties. All such payments to extend deadlines are in addition to the annual License Maintenance Fee payment specified in Paragraph 4.2. Should Licensee opt not to pay to extend the completion date or if Licensee should fail to complete the stated milestone or otherwise fulfill the stated diligence obligations by any extended target date, then The Regents may provide written notice to Licensee that the license granted in Paragraph 2.1 has been converted to a non-exclusive license, effective as of the date of expiration of the Cure Period or any extended target date, whichever is later. (a) Unless earlier terminated in accordance with other provisions requirements of this Agreement, the non-exclusive license will remain in effect for one (1) year from the date of conversion under this Paragraph 6Article 5.

Appears in 2 contracts

Samples: License Agreement (XTL Biopharmaceuticals LTD), License Agreement (XTL Biopharmaceuticals LTD)

Diligence. 6.1. Licensee4.1 Licensee will use commercially reasonable efforts to develop, upon execution of this Agreementcommercialize, will diligently proceed with the developmentmarket, manufacturepromote, and Sale sell Licensed Products in each of Licensed Productsthe XLMTM Field and the Pompe Field. Commercially reasonable efforts means efforts equivalent to those utilized by ****. Without limiting the foregoing, Licensed Services, and Licensed Methods, and Licensee will diligently market them in quantities sufficient to meet the market demand. 6.2. In addition to its obligations under Paragraph 6.1, Licensee specifically commits to achieving the following milestones (either itself, or through its Sublicensees) in its activities under this Agreementfollowing: (a) Milestone #1: Greenhouse Proof Acceptance by the FDA of Concept — on or before […an Investigational New Drug application for a Licensed Product in the XLMTM Field by no later than *…];***; and (b) Milestone #2: Field Proof Acceptance by the FDA of Concept — on or before […*…]; (c) Milestone #3: Regulatory Submission — on or before […*…]; (d) Milestone #4: Regulatory Approval — on or before […*…]; and (e) Milestone #5: Commercial Launch of an Investigational New Drug application for a Licensed Product — on or before […in the Pompe Field by no later than *…]. 6.3***. If The Regents Licensee will notify Licensor in writing as soon as Licensee believes in good faith that Licensee has failed will not be able to meet any achieve either milestone set forth in Paragraphs 6.1 and 6.2 Section 4.1(a) or (b) by the date set forth therein (if applicable)relevant deadline date, The Regents will provide written notice to Licensee of the same within a reasonable time. License will have one hundred and twenty (120) days from the date of such written notice (“Cure Period”) to complete the stated milestone or otherwise fulfill the stated diligence obligations. If Licensee is unable to complete the stated milestone or otherwise fulfill the stated diligence obligations within the Cure Periodand, Licensee may extend the completion date of such milestone or diligence obligation for a period of six (6) months from the expiration of the Cure Period upon the payment to Licensor of […*…], due *** within ten (10) days of expiration **** of the Cure Periodoriginal deadline date, the deadline date for such milestone set forth in Section 4.1(a) or (b), as applicable, will be extended for **** from the original deadline date; provided that Licensee will only be entitled to **** for the XLMTM Field and **** for the Pompe Field, each of which extensions will require a payment of **** as provided in this Section 4.1. 4.2 Within **** after the Effective Date and within **** of each December 1 thereafter, Licensee shall provide Licensor with written progress reports, setting forth in such detail as Licensor may reasonably request, the progress of the development, evaluation, testing, and commercialization of each Licensed Product. Licensee may further extend the completion date of any milestone or diligence obligation for an additional six (6) months upon payment of an additional […will also notify Licensor within *…]. Additional extensions may be granted only by mutual written agreement *** of the Partiesfirst commercial sale by Licensee, its Affiliates, or any Sublicensees of each Licensed Product. All Such a report (“Development Progress Report”), setting forth the current stage of development of Licensed Products, shall include: 4.2.1 Date of Development Progress Report and time covered by such payments to extend deadlines are in addition report; 4.2.2 Major activities and accomplishments completed by Licensee, its Affiliates, and any Sublicensees relating directly to the annual License Maintenance Fee payment specified in Paragraph 4.2Licensed Product since the last Development Progress Report; ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. Should Licensee opt not to pay to extend the completion date or if Licensee should fail to complete the stated milestone or otherwise fulfill the stated diligence obligations by any extended target date, then The Regents may provide written notice to Licensee that the license granted in Paragraph 2.1 has been converted to a non-exclusive license, effective as of the date of expiration of the Cure Period or any extended target date, whichever is laterCONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. (a) Unless earlier terminated in accordance with other provisions of this Agreement, the non-exclusive license will remain in effect for one (1) year from the date of conversion under this Paragraph 6.

Appears in 2 contracts

Samples: License Agreement (REGENXBIO Inc.), License Agreement (REGENXBIO Inc.)

Diligence. 6.1. Licensee, upon execution of this Agreement, 6.1 Licensee will diligently proceed with the development, manufacture, marketing, and Sale of Licensed Products, Licensed Services, and Licensed Methods, and will diligently market them and/or Licensed Services in quantities sufficient to meet the market demand. 6.2. 6.2 In addition to its Licensee’s obligations under Paragraph 6.1, Licensee specifically commits to achieving will accomplish the following milestones (either itself, or through its Sublicensees) in its Licensee’s activities under this Agreement: (a) Milestone #1: Greenhouse Proof of Concept — on or before [*…]; (b) Milestone #2: Field Proof of Concept — on or before […*…]; (c) Milestone #3: Regulatory Submission — on or before […*…]; (d) Milestone #4: Regulatory Approval — on or before […*…]; and (eb) Milestone #5: Commercial Launch of a Licensed Product — on or before [***]. 6.3. 6.3 If The Regents believes that Licensee has failed is unable to meet any milestone of its diligence obligations set forth in Paragraphs 6.1 and 6.2 by the date set forth therein (if applicable)6.2, then The Regents will provide written notice to 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 same within a reasonable time. License will have one hundred right and twenty (120) days from option to extend the target date of any such written notice (“Cure Period”) to complete the stated milestone or otherwise fulfill the stated diligence obligations. If Licensee is unable to complete the stated milestone or otherwise fulfill the stated diligence obligations within the Cure Period, Licensee may extend the completion date of such milestone or diligence obligation for a period of six (6) months from the expiration of the Cure Period [***] upon the payment of [***] dollars ($[***]) within the thirty (30)-day period prior to the date to be extended, due within ten (10) days of expiration of the Cure Periodfor each such extension option exercised by Licensee. Licensee may further extend the completion target date of any milestone or diligence obligation for an additional six (6) months [***] upon payment of an additional [***] dollars ($[***]). Additional extensions may be granted only by mutual written agreement of the Parties. All such These payments to extend deadlines are in addition to the annual License Maintenance Fee payment specified in Paragraph 4.2any other payments owed under this Agreement. Should Licensee opt not to pay to extend the completion date obligation or if Licensee should fail to complete meet the stated milestone or otherwise fulfill obligation by the stated diligence obligations by any extended target date, then The Regents may provide written notice will have the right and option either to Licensee that terminate this Agreement 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 granted in Paragraph 2.1 has been converted to a non-exclusive licenselicense for lack of diligence under Paragraph 6.1 or 6.2, effective as The Regents will give Licensee written notice of the date of expiration deficiency. Licensee thereafter will have sixty (60) days to cure the deficiency. If The Regents has not received satisfactory written evidence that the deficiency has been cured by the end of the Cure Period sixty (60)-day period, then The Regents may, at its option, either terminate the Agreement or any extended target date, whichever is later. (a) Unless earlier terminated in accordance with other provisions of this Agreement, the reduce Licensee’s exclusive license to a non-exclusive license by giving written notice to Licensee. These notices will remain in effect for one be subject to Article 22 (1) year from the date of conversion under this Paragraph 6Notices).

Appears in 2 contracts

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

Diligence. 6.14.1 LICENSEE accepts that commercialization of the Licensed Product or Licensed Services is of utmost importance to MSK. LicenseeLICENSEE 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 execution 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: [*] 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, will diligently proceed with 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 sale of Licensed ProductsProducts and performance of Licensed Services (“Regulatory Approval”). LICENSEE shall advise MSK, Licensed Servicesthrough annual reports described in Section 4.1(c) above, and Licensed Methods, and will diligently market them in quantities sufficient to meet the market demandof its program of development for obtaining said Regulatory Approvals. 6.2. In addition to its obligations under Paragraph 6.1, Licensee specifically commits to achieving the following milestones (either itself, or through its Sublicensees) in its activities under this Agreement: (a) Milestone #1: Greenhouse Proof of Concept — on or before […*…]; (b) Milestone #2: Field Proof of Concept — on or before […*…]; (c) Milestone #3: Regulatory Submission — on or before […*…]; (d) Milestone #4: Regulatory Approval — on or before […*…]; and (e) Milestone #5: Commercial Launch 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. 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 a Licensed Product — on or before […*…]. 6.3this Agreement. If The Regents believes results of the Feasibility Study do not indicate that Licensee has failed to meet any milestone set forth in Paragraphs 6.1 and 6.2 by the date set forth therein (if applicable)[*], The Regents will provide LICENSEE can terminate this Agreement upon [*] prior written notice to Licensee MSK. At the end of the same within Feasibility Study, LICENSEE shall notify MSK in writing whether or not it will exercise its rights to 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 reasonable time. License will have one hundred and twenty demand, notice, inquiry, or inspection report by a governmental authority or certification agency in relation to any Licensed Product or Licensed Service that (120i) days from the date by its terms directs or contemplates, or may reasonably be expected to require or relate to, suspension or cessation of such written notice manufacturing, sale, development, or marketing of Licensed Products or Licensed Services efforts, (“Cure Period”ii) concerns a recall or potential recall of Licensed Products or Licensed Services, (iii) concerns a loss of life or material issue of safety, or (iv) may reasonably be expected to complete the stated milestone or otherwise fulfill the stated prevent LICENSEE’s compliance with its diligence obligations. If Licensee is unable to complete the stated milestone or otherwise fulfill the stated diligence obligations within the Cure Period, Licensee may extend the completion date of such milestone or diligence obligation for a period of six (6) months from the expiration of the Cure Period upon the payment of […*…], due within ten (10) days of expiration of the Cure Period. Licensee may further extend the completion date of any milestone or diligence obligation for an additional six (6) months upon payment of an additional […*…]. Additional extensions may be granted only by mutual written agreement of the Parties. All such payments to extend deadlines are in addition to the annual License Maintenance Fee payment specified in Paragraph 4.2. Should Licensee opt not to pay to extend the completion date or if Licensee should fail to complete the stated milestone or otherwise fulfill the stated diligence obligations by any extended target date, then The Regents may LICENSEE shall provide written notice a copy to Licensee that the license granted in Paragraph 2.1 has been converted to a non-exclusive license, effective as MSK without delay and keep MSK reasonably apprized of the date of expiration of the Cure Period or any extended target date, whichever is laterits response. (a) Unless earlier terminated in accordance with other provisions of this Agreement, the non-exclusive license will remain in effect for one (1) year from the date of conversion under this Paragraph 6.

Appears in 1 contract

Samples: Exclusive License Agreement (Abpro Corp)

Diligence. 6.1. Licensee8.1 Licensee and/or its Sublicensees, promptly upon execution of this Agreement, will shall diligently proceed with with, or engage others to proceed with, the research, development, manufacture, and Sale 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 Services, Products commercially available as rapidly as reasonably possible and Licensed Methods, and will diligently market them in quantities sufficient to meet market demands. For the market demandavoidance 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. 6.28.2 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. In addition 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 obligations under Paragraph 6.1intent to terminate this Agreement. If Licensee fails to commence or otherwise conduct or have conducted substantive research, Licensee specifically commits development, manufacture, marketing and/or sale of Licensed Technology within sixty (60) days after receipt of The Regents' notice of intent to achieving 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 milestones shall be sufficient (either itself, but not necessary) to satisfy Licensee's or through its Sublicensees) in its activities ' diligence obligations under this Agreement: (a) Milestone #1: Greenhouse Proof of Concept — on Continuing to fund the Sponsored Research Agreement and any extensions, amendments or before […*…];renewals thereof; or (b) Milestone #2: Field Proof Licensee and/or its Sublicensees spending at least $2,400,000 in the aggregate over a period of Concept — 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 before […*…];its Sublicensees, provided that the aggregate total amount spent by License and/or its Sublicensees meets the Minimum Spending Requirement. (c) Milestone #3: Regulatory Submission — on If Licensee or before […*…]; 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 (d) Milestone #4: Regulatory Approval — on or before […*…]; and (e) Milestone #5: Commercial Launch of a Licensed Product — on or before […*…]. 6.3. If The Regents believes that Licensee has failed to meet any milestone 8) year period set forth in Paragraphs 6.1 and 6.2 by the date set forth therein (if applicableSection 8.3(b), Licensee and/or its Sublicensees shall report to The Regents will provide 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 the same within a reasonable time. License will have one hundred and twenty (120) days from the date of such written notice (“Cure Period”) its intent to complete the stated milestone or otherwise fulfill the stated diligence obligations. If Licensee is unable to complete the stated milestone or otherwise fulfill the stated diligence obligations within the Cure Period, Licensee may extend the completion date of such milestone or diligence obligation for a period of six (6) months from the expiration of the Cure Period upon the payment of […*…], due within ten (10) days of expiration of the Cure Period. Licensee may further extend the completion date of any milestone or diligence obligation for an additional six (6) months upon payment of an additional […*…]. Additional extensions may be granted only by mutual written agreement of the Parties. All such payments to extend deadlines are in addition to the annual License Maintenance Fee payment specified in Paragraph 4.2. Should Licensee opt not to pay to extend the completion date or if Licensee should fail to complete the stated milestone or otherwise fulfill the stated diligence obligations by any extended target date, then The Regents may provide written notice to Licensee that the reduce Licensee's exclusive license granted in Paragraph 2.1 has been converted to a non-exclusive license. Upon receipt of such written notice, effective as 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 date of expiration Spending Shortfall plus the amount of the Cure Period 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 any extended target dateif, whichever is laterwithin 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. (a) Unless earlier terminated 8.4 Licensee shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of the Licensed Technology, when appropriate given the stage of Licensee's efforts to research, develop, manufacture, market and/or sell Licensed Technology but in accordance with other provisions any event prior to the first Final Sale, and shall use substantive efforts to fill the market demand for Licensed Technology following commencement of marketing at any time during the exclusive period of this Agreement, the non-exclusive license will remain in effect for one (1) year from the date of conversion under this Paragraph 6.

Appears in 1 contract

Samples: Exclusive License Agreement (Biotime Inc)

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Diligence. 6.1. Licensee, upon 6.1 Upon the execution of this Agreement, will Licensee must diligently proceed with the development, manufacture, manufacture and Sale sale (“Commercialization”) of Licensed Products, Licensed Services, Products and Licensed Methods, must earnestly and will diligently endeavor to market them within a reasonable time after execution of this Agreement and in quantities sufficient to meet the market demanddemands for them. 6.2. In addition 6.2 Licensee must endeavor to its obligations under 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 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 specifically commits fails to achieving perform any of the following milestones (either itself, or through its Sublicensees) in its activities under this Agreement: (a) Milestone #1: Greenhouse Proof of Concept — on or before […*…]; (b) Milestone #2: Field Proof of Concept — on or before […*…]; (c) Milestone #3: Regulatory Submission — on or before […*…]; (d) Milestone #4: Regulatory Approval — on or before […*…]; and (e) Milestone #5: Commercial Launch of a Licensed Product — on or before […*…]. 6.3. If The Regents believes that Licensee has failed to meet any milestone set forth terms in Paragraphs 6.1 and 6.2 by the date set forth therein (if applicable)6.3a through 6.3h, The Regents will provide 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 same within 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 reasonable time. License will have one hundred Notice of Default and twenty 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 (12060) days from the date of such advance written notice (“Cure Period”) to complete thereof. In each of the stated milestone or otherwise fulfill the stated diligence obligations. If Licensee is unable to complete the stated milestone or otherwise fulfill the stated diligence obligations within the Cure Periodcases above, Licensee may extend the completion date of use such milestone or diligence obligation for a 60-day advance written notice period of six (6) months from the expiration of the Cure Period upon the payment of […*…], due within ten (10) days of expiration of the Cure Period. Licensee may further extend the completion date of any milestone or diligence obligation for an additional six (6) months upon payment of an additional […*…]. Additional extensions may be granted only by mutual written agreement of the Parties. All such payments to extend deadlines are in addition to the annual License Maintenance Fee payment specified in Paragraph 4.2. Should Licensee opt not to pay to extend the completion date or if Licensee should fail to complete the stated milestone or otherwise fulfill the stated diligence obligations by any extended target date, then confer with The Regents may provide written notice to Licensee that demonstrate Licensee’s diligent efforts to meet such Development Milestone and Licensee’s anticipated timelines for achieving the license 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 Paragraph 2.1 has been converted Article 2 (GRANT). With respect to a non-exclusive license, effective as of pegylated Licensed Product or Licensed Method covered by the date of expiration of Regents’ Patent Rights other than the Cure Period or any extended target date, whichever is later. (a) Unless earlier terminated in accordance with other provisions of this Agreement, the non-exclusive license will remain in effect for one (1) year from the date of conversion under this Paragraph 6.Newly Added Patent Rights:

Appears in 1 contract

Samples: Exclusive License Agreement (Bone Biologics Corp)

Diligence. 6.1. Licensee, upon execution of this Agreement, will diligently proceed with the development, manufacture, and Sale of Licensed Products, Licensed Services, and Licensed Methods, and will diligently market them in quantities sufficient to meet the market demand. 6.2. In addition to its obligations under Paragraph 6.1, Licensee specifically commits to achieving the following milestones a. Company (either itself, itself or through its Affiliates or Sublicensees) shall use commercially reasonable efforts to research, discover, develop and market at least one (1) Tianeptine Product and at least one (1) Mitragynine Product for commercial sale and distribution in its activities under this Agreement: (a) Milestone #1: Greenhouse Proof of Concept — on or before […*…]; (b) Milestone #2: Field Proof of Concept — on or before […*…]; (c) Milestone #3: Regulatory Submission — on or before […*…]; (d) Milestone #4: Regulatory Approval — on or before […*…]; and (e) Milestone #5: Commercial Launch of a Licensed Product — on or before […*…]. 6.3the Territory. If The Regents believes that Licensee has failed Company shall be deemed to meet any milestone such “commercially reasonable efforts” in the event it achieves all of the due diligence milestones set forth in Paragraphs 6.1 this Article 6. Company shall achieve the following due diligence milestones (“Milestones”) for at least one Tianeptine Product and 6.2 at least one Mitragynine Product by the date dates (“Achievement Dates”) as set forth therein (if applicable), The Regents will provide written notice to Licensee of below: i. Due Diligence Milestones for the same within a reasonable timeTianeptine Products: ii. License will have one hundred and twenty (120) days from Due Diligence Milestones for the date of such written notice (“Cure Period”) to complete Mitragynine Products: b. In the stated milestone or otherwise fulfill the stated diligence obligations. If Licensee event that Company is unable to complete achieve the stated milestone or otherwise fulfill the stated diligence obligations within the Cure Periodmilestones in Section 6a(i), Licensee Columbia may extend the completion date of such milestone or diligence obligation for a period of six (6) months from the expiration of the Cure Period upon the payment of […*…], due within ten (10) days of expiration of the Cure Period. Licensee may further extend the completion date of any milestone or diligence obligation for an additional six (6) months upon payment of an additional […*…]. Additional extensions may be granted only by mutual written agreement of the Parties. All such payments to extend deadlines are in addition to the annual License Maintenance Fee payment specified in Paragraph 4.2. Should Licensee opt not to pay to extend the completion date or if Licensee should fail to complete the stated milestone or otherwise fulfill the stated diligence obligations by any extended target date, then The Regents may provide written notice to Licensee that the license granted in Paragraph 2.1 has been converted to a non-exclusive license, effective as of the date of expiration of the Cure Period or any extended target date, whichever is later. (a) Unless earlier terminated 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 license will remain in effect for one 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 (112) year from months after the Effective Date of this Agreement until the date of conversion under the first bona fide commercial sale of a Product, Company shall report in writing to Columbia on progress made toward the diligence objectives set forth above, using Exhibit D to this Paragraph 6Agreement or an equivalent to Exhibit D to make the report.

Appears in 1 contract

Samples: Exclusive License Agreement (ATAI Life Sciences B.V.)

Diligence. 6.14.1 LICENSEE accepts that commercialization of the Licensed Product or Licensed Services is of utmost importance to MSK. LicenseeLICENSEE 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 execution 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 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, will diligently proceed with 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 sale of Licensed ProductsProducts and performance of Licensed Services (“Regulatory Approval”). LICENSEE shall advise MSK, Licensed Servicesthrough annual reports described in Section 4.1(c) above, and Licensed Methods, and will diligently market them in quantities sufficient to meet the market demandof its program of development for obtaining said Regulatory Approvals. 6.2. In addition to its obligations under Paragraph 6.1, Licensee specifically commits to achieving the following milestones (either itself, or through its Sublicensees) in its activities under this Agreement: (a) Milestone #1: Greenhouse Proof of Concept — on or before […*…]; (b) Milestone #2: Field Proof of Concept — on or before […*…]; (c) Milestone #3: Regulatory Submission — on or before […*…]; (d) Milestone #4: Regulatory Approval — on or before […*…]; and (e) Milestone #5: Commercial Launch 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. 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 a Licensed Product — on or before […*…]. 6.3this Agreement. If The Regents believes results of the Feasibility Study do not indicate that Licensee has failed to meet any milestone set forth in Paragraphs 6.1 and 6.2 by the date set forth therein (if applicable)[*], The Regents will provide LICENSEE can terminate this Agreement upon [*] prior written notice to Licensee MSK. At the end of the same within Feasibility Study, LICENSEE shall notify MSK in writing whether or not it will exercise its rights to 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 reasonable time. License will have one hundred and twenty demand, notice, inquiry, or inspection report by a governmental authority or certification agency in relation to any Licensed Product or Licensed Service that (120i) days from the date by its terms directs or contemplates, or may reasonably be expected to require or relate to, suspension or cessation of such written notice manufacturing, sale, development, or marketing of Licensed Products or Licensed Services efforts, (“Cure Period”ii) concerns a recall or potential recall of Licensed Products or Licensed Services, (iii) concerns a loss of life or material issue of safety, or (iv) may reasonably be expected to complete the stated milestone or otherwise fulfill the stated prevent LICENSEE’s compliance with its diligence obligations. If Licensee is unable to complete the stated milestone or otherwise fulfill the stated diligence obligations within the Cure Period, Licensee may extend the completion date of such milestone or diligence obligation for a period of six (6) months from the expiration of the Cure Period upon the payment of […*…], due within ten (10) days of expiration of the Cure Period. Licensee may further extend the completion date of any milestone or diligence obligation for an additional six (6) months upon payment of an additional […*…]. Additional extensions may be granted only by mutual written agreement of the Parties. All such payments to extend deadlines are in addition to the annual License Maintenance Fee payment specified in Paragraph 4.2. Should Licensee opt not to pay to extend the completion date or if Licensee should fail to complete the stated milestone or otherwise fulfill the stated diligence obligations by any extended target date, then The Regents may LICENSEE shall provide written notice a copy to Licensee that the license granted in Paragraph 2.1 has been converted to a non-exclusive license, effective as MSK without delay and keep MSK reasonably apprized of the date of expiration of the Cure Period or any extended target date, whichever is laterits response. (a) Unless earlier terminated in accordance with other provisions of this Agreement, the non-exclusive license will remain in effect for one (1) year from the date of conversion under this Paragraph 6.

Appears in 1 contract

Samples: Exclusive License Agreement (Abpro Corp)

Diligence. 6.1. Licensee8.1 Licensee and/or its Sublicensees, promptly upon execution of this Agreement, will shall diligently proceed with with, or engage others to proceed with, the research, development, manufacture, and Sale 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 Services, Products commercially available as rapidly as reasonably possible and Licensed Methods, and will diligently market them in quantities sufficient to meet market demands. For the market demandavoidance 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. 6.28.2 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. In addition 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 obligations under Paragraph 6.1intent to terminate this Agreement. If Licensee fails to commence or otherwise conduct or have conducted substantive research, Licensee specifically commits development, manufacture, marketing and/or sale of Licensed Technology within sixty (60) days after receipt of The Regents' notice of intent to achieving 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 milestones shall be sufficient (either itself, but not necessary) to satisfy Licensee's or through its Sublicensees) in its activities ' diligence obligations under this Agreement: (a) Milestone #1: Greenhouse Proof of Concept — on Continuing to fund the Sponsored Research Agreement and any extensions, amendments or before […*…];renewals thereof; or (b) Milestone #2: Field Proof Licensee and/or its Sublicensees spending at least $2,400,000 in the aggregate over a period of Concept — 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 before […*…];its Sublicensees, provided that the aggregate total amount spent by License and/or its Sublicensees meets the Minimum Spending Requirement. (c) Milestone #3: Regulatory Submission — on If Licensee or before […*…]; 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 (d) Milestone #4: Regulatory Approval — on or before […*…]; and (e) Milestone #5: Commercial Launch of a Licensed Product — on or before […*…]. 6.3. If The Regents believes that Licensee has failed to meet any milestone 8) year period set forth in Paragraphs 6.1 and 6.2 by the date set forth therein (if applicableSection 8.3(b), Licensee and/or its Sublicensees shall report to The Regents will provide 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 the same within a reasonable time. License will have one hundred and twenty (120) days from the date of such written notice (“Cure Period”) its intent to complete the stated milestone or otherwise fulfill the stated diligence obligations. If Licensee is unable to complete the stated milestone or otherwise fulfill the stated diligence obligations within the Cure Period, Licensee may extend the completion date of such milestone or diligence obligation for a period of six (6) months from the expiration of the Cure Period upon the payment of […*…], due within ten (10) days of expiration of the Cure Period. Licensee may further extend the completion date of any milestone or diligence obligation for an additional six (6) months upon payment of an additional […*…]. Additional extensions may be granted only by mutual written agreement of the Parties. All such payments to extend deadlines are in addition to the annual License Maintenance Fee payment specified in Paragraph 4.2. Should Licensee opt not to pay to extend the completion date or if Licensee should fail to complete the stated milestone or otherwise fulfill the stated diligence obligations by any extended target date, then The Regents may provide written notice to Licensee that the reduce Licensee's exclusive license granted in Paragraph 2.1 has been converted to a non-exclusive license. Upon receipt of such written notice, effective as 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 date of expiration Spending Shortfall plus the amount of the Cure Period 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 any extended target dateif, whichever is laterwithin 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. (a) Unless earlier terminated 8.4 Licensee shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of the Licensed Technology, when appropriate given the stage of Licensee's efforts to research, develop, manufacture, market and/or sell Licensed Technology but in accordance with other provisions any event prior to the first Final Sale, and shall use substantive efforts to fill the market demand for Licensed Technology following commencement of marketing at any time during the exclusive period of this Agreement, the non-exclusive license will remain in effect for one (1) year from the date of conversion under this Paragraph 6.

Appears in 1 contract

Samples: Exclusive License Agreement (Asterias Biotherapeutics, Inc.)