Common use of Diligent Commercialization Clause in Contracts

Diligent Commercialization. Licensee by itself or through its Affiliates and Sublicensees will use commercially reasonable efforts to make a Licensed Product commercially available in the Field within the Territory. Without limiting the foregoing, Licensee will (a) maintain a bona fide, funded, ongoing and active research, development, manufacturing, regulatory, marketing or sales program (all as commercially reasonable) to make a Licensed Product commercially available to the public as soon as commercially practicable, and (b) fulfill the following milestone events by the deadlines indicated: [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] If the obligations under this Section 2.7 are not fulfilled, Licensor may treat such failure as a breach in accordance with Section 7.3(b). For the avoidance of doubt, initiation of a clinical trial means the dosing of the first patient in said clinical trial. Notwithstanding the foregoing, if Licensee believes that, despite using commercially reasonably efforts, it will not achieve any Diligence Milestone Event set forth in this Section 2.7 by the relevant deadline, it may notify Licensor in writing thereof in advance of the deadline. Licensee shall include with such notice a reasonable explanation of the reasons for such failure. If Licensee so notifies Licensor and such explanation is acceptable to Licensor (in its reasonable discretion), or, in any event, if such failure to meet the Diligence Milestone Event is due to circumstances beyond Licensee’s reasonable control (such as patent infringement or regulatory issues), then the Parties shall negotiate in good faith an initial extension of the deadlines for said Diligence Milestone Event and all later Diligence Milestone Events (the “Initial Extended Milestones”) so that Licensee shall not be deemed to be in breach of achieving said Diligence Milestone Event by its deadline. In the event that Licensee believes that, despite using commercially reasonable efforts, it will not achieve one or more such Initial Extended Milestones, then Licensee may notify Licensor in writing thereof in advance of the relevant deadline and the Parties shall negotiate in good faith a second extension of deadlines for said Diligence Milestone Event and all later Diligence Milestone Events (the “Second Extended Milestones”) so that Licensee shall not be deemed to be in breach of achieving said Diligence Milestone Event by its deadline. Upon agreement of the Parties with respect to the deadlines for such Second Extended Milestones, Licensee shall make a non-creditable payment of one-half of the Milestone Fee of the Milestone Event corresponding to said Diligence Milestone Event.

Appears in 2 contracts

Sources: Patent and Technology License Agreement (LogicBio Therapeutics, Inc.), Patent and Technology License Agreement (LogicBio Therapeutics, Inc.)

Diligent Commercialization. Licensee by itself or through its Affiliates and Sublicensees will use commercially reasonable efforts Commercially Reasonable Efforts to make a research, develop and commercialize at least one Licensed Product commercially available in the Field within in the Territory. Without limiting the foregoing, Licensee willwill fulfill the milestone events specified in Section 2.4 of the Patent License Agreement by the deadlines indicated therein and use diligent and commercially reasonable efforts to perform and complete the plans described in the annual report submitted pursuant to Section 4.2 (Annual Written Progress Report). Licensor hereby agrees that the efforts of Sublicensees, Affiliates, and any third party contractors shall be deemed the acts of Licensee for purposes of satisfying this Section 2.4, and for the purposes of fees due under Section 3.l(b) of the Patent License Agreement. [***]. 4. Section 7.5(a) of the Terms and Conditions set forth on Exhibit A of the Patent License Agreement shall be deleted in its entirety and replaced with the following: (a) maintain If a bona fideSublicensee is in good standing under its Sublicense Agreement without any uncured defaults that would otherwise have entitled the Licensee to terminate such Sublicense Agreement, fundedthen at Sublicensee’s request, ongoing Licensor shall automatically grant a direct license to the Sublicensee on comparable terms and active researchconditions as those in such Sublicense Agreement (a “Direct License”) without any further consent or negotiation with Licensor being required. Such Direct License shall be subject to the same terms and conditions as those in such Sublicense Agreement at such time, developmentincluding but not limited to scope, manufacturinglicensed territory, regulatoryduration of license grant, marketing and diligence obligations, in each case to the extent that such terms and conditions are not in conflict with the terms of this Patent License Agreement immediately prior to its termination or sales program (all as commercially reasonableapplicable federal, state or local laws or regulations; provided, however, that under the Direct License, Sublicensee shall be required to make the same monetary payment(s) to Licensor that, had this Patent License Agreement not terminated, Licensee would have been required to make a Licensed Product commercially available to Licensor hereunder to the public as soon as commercially practicable, and (bextent any such monetary payment(s) fulfill the following milestone events by the deadlines indicated: [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] If the obligations under this Section 2.7 are not fulfilled, Licensor may treat such failure arises as a breach in accordance with Section 7.3(b). For the avoidance of doubt, initiation of a clinical trial means the dosing result of the first patient in said clinical trialactivities of Sublicensee, its Affiliates or its further sublicensees. Notwithstanding the foregoing, if In no event shall Licensor have any obligations to Sublicensee other than Licensor’s obligations to Licensee believes that, despite using commercially reasonably efforts, it will not achieve any Diligence Milestone Event as set forth in this Section 2.7 by Patent License Agreement immediately prior to its termination. Promptly, and as soon as practicable following such termination, Licensor and Sublicensee shall execute a written license agreement memorializing the relevant deadline, it may notify Licensor in writing thereof in advance terms of the deadline. Licensee Direct License, which written agreement shall include be fully consistent with such notice a reasonable explanation of the reasons for such failure. If Licensee so notifies Licensor and such explanation is acceptable to Licensor (in its reasonable discretion), or, in any event, if such failure to meet the Diligence Milestone Event is due to circumstances beyond Licensee’s reasonable control (such as patent infringement or regulatory issues), then the Parties shall negotiate in good faith an initial extension of the deadlines for said Diligence Milestone Event and all later Diligence Milestone Events (the “Initial Extended Milestones”this Section 7.5(a) so that Licensee shall not be deemed to be in breach of achieving said Diligence Milestone Event by its deadline. In the event that Licensee believes that, despite using commercially reasonable efforts, it will not achieve one or more such Initial Extended Milestones, then Licensee may notify Licensor in writing thereof in advance of the relevant deadline and the Parties shall negotiate in good faith a second extension of deadlines for said Diligence Milestone Event and all later Diligence Milestone Events (the “Second Extended Milestones”) so that Licensee shall not be deemed to be in breach of achieving said Diligence Milestone Event by its deadline. Upon agreement of the Parties with respect to the deadlines for such Second Extended Milestones, Licensee shall make a non-creditable payment of one-half of the Milestone Fee of the Milestone Event corresponding to said Diligence Milestone Event.applicable Sublicense Agreement;

Appears in 1 contract

Sources: Patent License Agreement (Ikena Oncology, Inc.)

Diligent Commercialization. Licensee by itself or through its Affiliates and Sublicensees will use diligent and commercially reasonable efforts to make a commercialize Licensed Product commercially available Products and/or Licensed Processes in the Field of Use within the Territory. Without limiting the foregoing, Licensee will : (a) maintain a bona fide, funded, ongoing and active research, development, manufacturing, regulatorymarketing, marketing or and sales program (all as commercially reasonable) to make a diligently make, have made, use, sell, and have sold Licensed Product Products and/or Licensed Processes that are commercially available to the public as soon as commercially practicable, and and (b) fulfill the following milestone events specified in Section 2.4 of the PTLA by the deadlines indicated: [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] indicated therein. If the obligations under this Section 2.7 2.4 are not fulfilled, Licensor may treat such failure as a breach in accordance with Section 7.3(b). For the avoidance of doubt; provided, initiation of a clinical trial means the dosing of the first patient in said clinical trial. Notwithstanding the foregoinghowever, that if Licensee believes thatanticipates missing a milestone date and it has used and is using diligent and commercially reasonable efforts to commercialize Licensed Products and/or Licensed Processes in the Field of Use within the Territory, despite using commercially reasonably efforts, it will not achieve any Diligence Milestone Event set forth in this Section 2.7 by the relevant deadline, it may notify Licensor in writing thereof in advance of the deadline. Licensee shall include with such notice a reasonable explanation of the reasons for such failure. If Licensee so notifies Licensor and such explanation is acceptable to Licensor (in its reasonable discretion), or, in any event, if such failure to meet the Diligence Milestone Event is due to circumstances beyond Licensee’s reasonable control (such as patent infringement or regulatory issues), then the Parties parties shall negotiate in good faith an initial extension of reasonably appropriate extensions or other accommodations to the deadlines for said Diligence Milestone Event and all later Diligence Milestone Events (the “Initial Extended Milestones”) so that applicable milestone to enable Licensee shall not be deemed to be achieve such milestone, taking into consideration, Licensee’s active engagement in breach of achieving said Diligence Milestone Event by its deadline. In the event that Licensee believes that, despite using commercially reasonable efforts, it will not achieve one or more such Initial Extended Milestones, then Licensee may notify Licensor in writing thereof in advance of the relevant deadline and the Parties shall negotiate in good faith a second extension of deadlines for said Diligence Milestone Event and all later Diligence Milestone Events (the “Second Extended Milestones”) so that Licensee shall not be deemed to be in breach of achieving said Diligence Milestone Event by its deadline. Upon agreement of the Parties assessing drugability with respect to the deadlines a Licensed Product and, after IND filing for such Second Extended Milestonesa Licensed Product, Licensee Licensee’s ongoing engagement of pre-clinical and clinical development for Licensed Products which shall make a non-creditable payment of one-half be evidenced by conducting at least one of the Milestone Fee following activities in each year starting from the date of IND filing: {00258124-1}Licensee: Arno Therapeutics, Inc. CONFIDENTIAL Exclusive License (Non-Equity) Licensor: Ohio State Innovation Foundation EXHIBIT A INFORMATION MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. (i) having expended at least five hundred thousand dollars ($500,000) for development of a Licensed Product; (ii) having manufactured a Licensed Product suitable for clinical trials under an approved IND; (iii) having responded in full to all regulatory requests/issues relating to a Phase I, II or III Clinical Trial of a Licensed Product; (iv) having prepared documents for NDA filing with respect to a Licensed Product; (v) having filed an NDA for a Licensed Product; (vi) following NDA filing, having actively pursued NDA approval for a Licensed Product; (vii) following NDA approval of Licensed Product, having launched or sold a Licensed Product in the Milestone Event corresponding to said Diligence Milestone EventUnited States or another major market country.

Appears in 1 contract

Sources: License Agreement (Arno Therapeutics, Inc)

Diligent Commercialization. Licensee Licensee, by itself or through its Affiliates and Sublicensees will or Sublicensees, shall use commercially reasonable efforts to make a commercialize Licensed Product commercially available Products in the Field of Use within the Territory. Without limiting the foregoing, Licensee will shall, at a minimum: (a) use commercially reasonable efforts to maintain a bona fide, funded, ongoing and active research, development, manufacturing, regulatorymarketing, marketing or sales program (all as commercially reasonable) to make a make, offer for sale and sell Licensed Product Products so that Licensed Products are commercially available to the public as soon as commercially practicable, and ; and (b) fulfill the following milestone events by stated below (the deadlines indicated: “Diligence Milestones”): Re-qualify existing drug substance and/or drug product within the Assigned Assets or manufacture sufficient GMP material of Licensed Product to initiate a Clinical Trial. Within [***] of the Effective Date Initiate or reinitiate a Clinical Trial. Such trial shall be deemed to have been initiated or reinitiated, as applicable, when such Licensed Product is first administered to any patient enrolled in such clinical trial Within [***] of the Effective Date Initiate a subsequent Clinical Trial. Such trial shall be deemed to have been initiated when such Licensed Product is first administered to any patient enrolled in such clinical trial. Within [***] of the completion of the Clinical Trial in the previous Diligence Milestone Licensee will have the right to extend the dates set forth above by making a payment of [***] per [***] extension. Licensee will have the right to make up to [***] [***] [***] [***] [***] If such extensions. In the event of any such extension, any later occurring diligence milestones dates will be similarly extended without any payment by Licensee. Without limiting the foregoing, if any of the obligations under this Section 2.7 2.4 are not fulfilled, Licensor ▇▇▇▇ may treat such failure as a breach in accordance with Section 7.3(b8.3(b). For the avoidance of doubt, initiation of a clinical trial means the dosing of the first patient in said clinical trial. Notwithstanding the foregoing, if Licensee believes that, despite using commercially reasonably efforts, it will not achieve any Diligence Milestone Event set forth in this Section 2.7 by the relevant deadline, it may notify Licensor in writing thereof in advance of the deadline. Licensee shall include with such notice a reasonable explanation provide written notification of the reasons for such failure. If Licensee so notifies Licensor and such explanation is acceptable to Licensor (in its reasonable discretion), or, in any event, if such failure to meet the completion of each Diligence Milestone Event is due to circumstances beyond Licensee’s reasonable control ▇▇▇▇ within thirty (such as patent infringement or regulatory issues), then the Parties shall negotiate in good faith an initial extension 30) days of the deadlines for said Diligence Milestone Event and all later Diligence Milestone Events (the “Initial Extended Milestones”) so that Licensee shall not be deemed to be in breach of achieving said Diligence Milestone Event by its deadline. In the event that Licensee believes that, despite using commercially reasonable efforts, it will not achieve one or more such Initial Extended Milestones, then Licensee may notify Licensor in writing thereof in advance of the relevant deadline and the Parties shall negotiate in good faith a second extension of deadlines for said Diligence Milestone Event and all later Diligence Milestone Events (the “Second Extended Milestones”) so that Licensee shall not be deemed to be in breach of achieving said Diligence Milestone Event by its deadline. Upon agreement of the Parties with respect to the deadlines for such Second Extended Milestones, Licensee shall make a non-creditable payment of one-half of the Milestone Fee of the Milestone Event corresponding to said Diligence Milestone Eventcompletion.

Appears in 1 contract

Sources: Exclusive License Agreement (Recursion Pharmaceuticals, Inc.)