Territory-Specific Development Plan. Lian (directly, or through its Affiliates, Sublicensees, and Third Party subcontractors) shall use Commercially Reasonable Efforts to Develop the Licensed Product in the Field in the Territory. Lian will conduct the Development for the Licensed Product in the Field in the Territory in accordance with a development and regulatory plan and regulatory strategy for Development and Regulatory Approval of the Licensed Products solely in the Field in the Territory (the “Territory-Specific Development Plan”, as set forth in Exhibit A). Lian will update the Territory-Specific Development Plan not less than once per Calendar Year, and either Party may propose modifications to the Territory-Specific Development Plan at any time, subject in each case to approval by the JSC. Once approved by the JSC, each update to the Territory-Specific Development Plan will become effective and supersede the then-current Territory-Specific Development Plan. In the event of any proposed change to the Territory-Specific Development Plan as a result of any interaction with any Regulatory Authority, the JSC will meet as promptly as practicable to review and discuss any such proposed changes and determine an appropriate revision (if any) to the Territory-Specific Development Plan. If Lian is delayed in performing (or fails to perform) an obligation assigned to Lian in the Territory-Specific Development Plan as a result of Nanobiotix’s failure to timely perform any of its obligations under this Agreement, then the timelines for the performance of Lian’s obligations under the Territory-Specific Development Plan will be extended commensurate with the delay caused by Nanobiotix. Except as expressly provided for otherwise herein, each Party will be responsible for its costs and expenses incurred in performing Development activities pursuant to the Territory-Specific Development Plan.
Appears in 4 contracts
Samples: License, Development and Commercialization Agreement (Nanobiotix S.A.), License, Development and Commercialization Agreement (Nanobiotix S.A.), License, Development and Commercialization Agreement (LianBio)
Territory-Specific Development Plan. Lian (directly, or through its Affiliates, Sublicensees, and Third Party subcontractors) shall use Commercially Reasonable Efforts to Develop the Licensed Product in the Field in the Territory. Lian will conduct the Development Except for the activities allocated to Lian under a Global Development Plan, all Development of Compounds and Licensed Product in the Field Products in the Territory in accordance with will be conducted pursuant to a development and regulatory written a plan and regulatory strategy for Development and Regulatory Approval of the Licensed Products solely in the Field in the Territory (the “Territory-Specific Development Plan”), as set forth the initial draft of which will be prepared by Lian and submitted to the JSC [***]. The Territory-Specific Development Plan will contain in Exhibit A)reasonable detail (i) [***], (ii) [***], and (iii) [***]. Lian will update the Territory-Specific Development Plan not less than once per Calendar Year[***], and either Party may propose modifications to the Territory-Specific Development Plan at any time, subject in each case to approval by the JSC[***]. Once approved by the JSC[***], each update to the Territory-Specific Development Plan will become effective and supersede the then-current Territory-Specific Development Plan. In the event of any proposed change to the Territory-Specific Development Plan as a result of any interaction with any Regulatory Authority, the JSC will meet as promptly as practicable to review and discuss any such proposed changes and determine an appropriate revision (if any) to the Territory-Specific Development Plan. If Lian is delayed in performing (or fails to perform) an obligation assigned to Lian in the Territory-Specific Development Plan as a result of Nanobiotix’s Landos’ failure to timely perform any of its obligations under this AgreementAgreement or the Development Plan, then the timelines for the performance of Lian’s obligations under the Territory-Specific Development Plan will be extended commensurate with the delay caused by Nanobiotix. Except as expressly provided for otherwise herein, each Party will be responsible for its costs and expenses incurred in performing Development activities pursuant to the Territory-Specific Development PlanLandos.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Landos Biopharma, Inc.), License and Collaboration Agreement (LianBio)
Territory-Specific Development Plan. Lian (directly, or through its Affiliates, Sublicensees, and Third Party subcontractors) shall use Commercially Reasonable Efforts to Develop All Development of the Licensed Product in the Field in the Territory. Lian Territory will conduct the Development for the Licensed Product in the Field in the Territory in accordance with be conducted pursuant to a development and regulatory written a plan and regulatory strategy for Development and Regulatory Approval of the Licensed Products solely in the Field in the Territory (the “Territory-Specific Development Plan”), as set forth the initial draft of which will be prepared by Lian and submitted to the JSC within [***] after the Effective Date [***]. The Territory-Specific Development Plan will contain in Exhibit A)reasonable detail (i) [***], (ii) [***], and (iii) [***]. Lian will update the Territory-Specific Development Plan not less than once per Calendar Year[***], and either Party may propose modifications to the Territory-Specific Development Plan at any time, including with respect to the inclusion of any additional Indication (subject to Section 3.2(b) (Development in the Territory)), subject in each case to approval by the JSC[***]. Once approved by the JSC[***], each update to the Territory-Specific Development Plan will become effective and supersede the then-current Territory-Specific Development Plan. In the event of any proposed change to the Territory-Specific Development Plan as a result of any interaction with any Regulatory Authority, the JSC will meet as promptly as practicable to review and discuss any such proposed changes and determine an appropriate revision (if any) to the Territory-Specific Development Plan. If Lian is delayed in performing (or fails to perform) an obligation assigned to Lian in the Territory-Specific Development Plan as a result of NanobiotixLyra’s failure to timely perform any of its obligations under this Agreement, then the timelines for the performance of Lian’s obligations under the Territory-Specific Development Plan will be extended commensurate with the delay caused by Nanobiotix. Except as expressly provided for otherwise herein, each Party will be responsible for its costs and expenses incurred in performing Development activities pursuant to the Territory-Specific Development PlanLyra.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Lyra Therapeutics, Inc.), License and Collaboration Agreement (LianBio)
Territory-Specific Development Plan. Lian (directlyExcept for the activities allocated to Licensee under a Global Development Plan, or through its Affiliates, Sublicensees, and Third Party subcontractors) shall use Commercially Reasonable Efforts to Develop the all Development of Licensed Product Products in the Field in the Territory. Lian will conduct the Development for the Licensed Product in the Field use in the Territory in accordance with will be conducted pursuant to a written a development and regulatory plan and regulatory strategy for Development and Regulatory Approval of the Licensed Products solely in the Field in the Territory (the “Territory-Specific Development Plan”, as set forth in Exhibit A). Lian The Territory-Specific Development Plan shall be approved by the JSC and will contain in reasonable detail (i) all major Development activities for the Licensed Products (including all non-clinical studies, pre-clinical studies and Clinical Trials to be conducted in the Territory and the trial design thereof) to be conducted in furtherance of obtaining Regulatory Approval of Licensed Products in the Territory (and not outside of the Territory) and (ii) the estimated timelines for achieving such activities. Licensee will update the Territory-Specific Development Plan not regularly as appropriate to track activity thereunder (but in no event less than once per Calendar Year), and either Party may propose modifications to the Territory-Specific Development Plan at any time, subject in each case to approval by the JSCJSC pursuant to Section 3.3. Once approved by the JSCJSC (subject Section 3.4 with respect to final decision-making), each update to the Territory-Specific Development Plan will become effective and supersede the then-current Territory-Specific Development Plan. In the event of any proposed change to the Territory-Specific Development Plan as a result of any interaction with any Regulatory Authority, the JSC will meet as promptly as practicable to review and discuss any such proposed changes and determine an appropriate revision (if any) to the Territory-Specific Development Plan. If Lian is delayed in performing (or fails to perform) an obligation assigned to Lian in the Territory-Specific Development Plan as a result of Nanobiotix’s failure to timely perform any of its obligations under this Agreement, then the timelines for the performance of Lian’s obligations under the Territory-Specific Development Plan will be extended commensurate with the delay caused by Nanobiotix. Except as expressly provided for otherwise herein, each Party will be responsible for its costs and expenses incurred in performing Development activities pursuant to the Territory-Specific Development Plan.
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