Overview; Diligence. Subject to the terms and conditions of this Agreement (including the diligence obligations set forth below), Advaccine shall have the sole right and responsibility for and have operational control over all aspects of the Commercialization of the Products in the Field in the Advaccine Territory, including: (a) developing and executing a commercial launch and pre-launch plan, (b) negotiating with applicable Governmental Authorities regarding the price and reimbursement status of the Products; (c) marketing, advertising and promotion; (d) booking sales and distribution and performance of related services; (e) handling all aspects of order processing, invoicing and collection, inventory and receivables; (f) providing customer support, including handling medical queries, and performing other related functions; and (g) conforming its practices and procedures to applicable Laws relating to the marketing, detailing and promotion of the Products in the Field in the Advaccine Territory. Advaccine shall bear all of the costs and expenses incurred in connection with such Commercialization activities. Advaccine shall use Commercially Reasonable Efforts to Commercialize the Products in the Advaccine Territory and to actively market and sell the Products in the Advaccine Territory and to expand annual Net Sales of the Products in the Advaccine Territory. Without limiting the generality of the foregoing, Advaccine shall use Commercially Reasonable Efforts to conduct its Commercialization activities under and in accordance with the Commercialization Plan.
Overview; Diligence. Following expiration of the applicable Research Term with respect to a License-Only Program, as between the Parties, Zai shall be solely responsible for the Development of License-Only Molecules and License-Only Products for such License-Only Program in the Field in the License-Only Territory and be the sole owner of all data (including Clinical Data) generated or arising from any License-Only Program after the Research Term. Zai shall use Commercially Reasonable Efforts to Develop License-Only Molecules and License-Only Products in the Field in the License-Only Territory.
Overview; Diligence. Subject to the terms and conditions of this Agreement, Licensee shall be solely responsible, at its sole cost and effort, for the Development of Product(s) in the Field in the Territory. Licensee shall use Commercially Reasonable Efforts to (a) [***]; and (b) [***].
Overview; Diligence. (a) Except as expressly provided herein with respect to the Ongoing Trials, Licensee Added Trials (as applicable) and the preparatory activities for the HER2-Low BC Phase III Global Trial as set forth in Section 4.6(b), Licensee (itself and through its Affiliates and their respective Sublicensees) shall be responsible, at its own expense, for the Development of the Original ADC Licensed Products in the Field in the Territory under the oversight of JSC. Without limiting the generality of the foregoing, Licensee shall, subject to the Development Plan (i) use Commercially Reasonable Efforts to Develop and seek Regulatory Approval for [***] in the Field in each of [***], and (ii) use Commercially Reasonable Efforts to perform the Development activities assigned to it under the Development Plan(s) and in compliance with Applicable Laws (including GCP); and (iii) use Commercially Reasonable Efforts to dose the first patient in a Registrational Trial within [***] months for the applicable HER2-low breast cancer Indication or EC Indication after Successful Completion of each of the HER2-Low BC Expansion Trial and EC Expansion Trial conducted by or on behalf of Duality, taking into account the timelines and interactions with Regulatory Authorities. Licensee’s (including its Affiliates’ and Sublicensees’, as appliable) failure to dose the first patient in a Registrational Trial within such [***] months period shall not be a breach of this provision if the delay is caused by any safety issues, a requirement or decision from a Regulatory Authority, Force Majeure Events, or any other events that are outside the reasonable control of Licensee, its Affiliates or Sublicensees. If such a delay happens, Licensee shall promptly notify Duality (within [***] Days) and shall provide detailed explanations for such delay. The Parties shall engage in good faith discussions and the Licensee shall consider in good faith and reasonably address Duality’s input and comments with respect thereto.
Overview; Diligence. Subject to the terms and conditions of this Agreement (including the diligence obligations set forth below), Licensee (itself or through its Affiliates or Sublicensees, as applicable) shall be solely responsible for Commercialization of the Original ADC Licensed Products in the Field in the Territory, including: (i) developing and executing a commercial launch and pre-launch plan, (ii) developing the global pricing strategy and negotiating with applicable Governmental Authorities regarding price and reimbursement of the Original ADC Licensed Products; (iii) marketing, advertising and promotion; (iv) booking sales; (v) distribution and handling all aspects of order processing, invoicing and collection, inventory and receivables; (vi) providing customer support, and performing other related functions; (vii) conforming its practices and procedures to Applicable Laws relating to the marketing, detailing and promotion of the Original ADC Licensed Products in the Field; and (viii) developing and implementing the global and local Medical Affairs Activities and medical information infrastructure required in the Field in the Territory. Licensee shall bear all of the costs and expenses incurred in connection with such Commercialization activities in the Territory. Licensee shall use Commercially Reasonable Efforts to launch the [***] in [***].
Overview; Diligence. Subject to the terms and conditions of this Agreement (including the diligence obligations set forth below), 3D Medicines shall be solely responsible for the Development of Licensed Products in the Field in the 3D Medicines Territory, at its own cost and expense (except as otherwise expressly set forth herein), including (except as set forth in Section 4.6) all non-clinical and clinical studies and collection of CMC Information, as necessary to obtain Regulatory Approval for Licensed Products in any Region in the 3D Medicines Territory. 3D Medicines shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for Licensed Products in the Field in each Region in the 3D Medicines Territory, provided that 3D Medicines shall not be liable for any delays in any Development activities that are caused by any force majeure event as specified in Section 15.2 or Aravive’s failure to provide to 3D Medicines Product Materials that are necessary for the performance of such Development activities, except to the extent Aravive’s failure to provide such Product Materials is caused by 3D Medicines’ action or inaction. Without limiting the generality of the foregoing, 3D Medicines shall use Commercially Reasonable Efforts to conduct its Development activities under and in accordance with the Development Plan, as well as Manufacturing activities related to such Development, as set forth in the Initial Development Plan. In addition to the foregoing, 3D Medicines shall: (i) [***], (ii) [***], and (iii) [***]. For clarity, [***].
Overview; Diligence. Subject to the terms and conditions of this Agreement (including the diligence obligations set forth below), 3D Medicines shall have the sole right and responsibility for and have operational control over all aspects of the Commercialization of Licensed Products in the Field in the 3D Medicines Territory, including: (a) developing and executing a commercial launch and pre-launch plan, (b) negotiating with applicable Governmental Authorities regarding the price and reimbursement status of Licensed Products; (c) marketing, advertising and promotion; (d) booking sales and distribution and performance of related services; (e) handling all aspects of order processing, invoicing and collection, inventory and receivables; (f) providing customer support, including handling medical queries, and performing other related functions; and (g) conforming its practices and procedures to applicable Laws relating to the marketing, detailing and promotion of Licensed Products in the Field in the 3D Medicines Territory. 3D Medicines shall bear all of the costs and expenses incurred in connection with such Commercialization activities. 3D Medicines shall use Commercially Reasonable Efforts to Commercialize the Licensed Products in the 3D Medicines Territory and to actively market and sell the Licensed Products in the 3D Medicines Territory and to expand annual Net Sales of the Licensed Products in the 3D Medicines Territory. Without limiting the generality of the foregoing, 3D Medicines shall use Commercially Reasonable Efforts to conduct its Commercialization activities under and in accordance with the Commercialization Plan.
Overview; Diligence. (a) Kaken Obligations Subject to the terms and conditions of this Agreement and to Spruce performing its Development obligations with respect to Licensed Products set forth in the Territory Development Plan, Kaken shall be solely responsible for the Development of Licensed Products in the Field in the Kaken Territory, at its own cost and expense (except as otherwise expressly set forth herein), including (except as set forth in Section 4.6) all non-clinical studies, and Clinical Trials and collection of CMC Information, as necessary to obtain Kaken Territory Regulatory Approval for Licensed Products in the Field. Kaken shall use Commercially Reasonable Efforts to Develop Licensed Products and obtain Kaken Territory Regulatory Approval for Licensed Products in the Field, provided that Kaken shall not be liable for any delays in any Development activities that are caused by any force majeure event as specified in Section 15.2, Spruce’s failure to timely perform its Development activities set forth in the Development Plan, Spruce’s failure to timely provide Licensed Product in accordance with the Clinical Supply Agreement or Spruce’s failure to provide to Kaken Product Materials that are necessary for the performance of such Development activities, except to the extent Spruce’s failure to provide such Product Materials is caused by Kaken’s action or inaction. Without limiting the generality of the foregoing, Kaken shall use Commercially Reasonable Efforts to conduct its Development activities under and in accordance with the Territory Development Plan. A breach of Kaken’s obligation to use Commercially Reasonable Efforts to conduct its Development activities under and in accordance with the Territory Development Plan shall constitute a material breach of this Agreement.
Overview; Diligence. Subject to the terms and conditions of this Agreement (including the diligence obligations set forth below), Kaken shall have the sole right and responsibility for and have operational control over all aspects of the Commercialization of Licensed Products in the Field in the Kaken Territory, including: (a) developing and executing a commercial launch and pre-launch plan, (b) negotiating with applicable Governmental Authorities regarding the price and reimbursement status of Licensed Products and obtaining pricing and reimbursement approvals for Licensed Products; (c) marketing, advertising and promotion; (d) booking sales and distribution and performance of related services; (e) handling all aspects of order processing, invoicing and collection, inventory and receivables; (f) providing customer support, including handling medical queries, and performing other related functions; and (g) conforming its practices and procedures to applicable Laws relating to the marketing, detailing and promotion of Licensed Products in the Field in the Kaken Territory. Kaken shall bear all of the costs and expenses incurred in connection with such Commercialization activities. Kaken shall use Commercially Reasonable Efforts to Commercialize the Licensed Products in the Field in the Kaken Territory and to actively market and sell the Licensed Products in the Kaken Territory and to expand annual Net Sales of the Licensed Products in the Kaken Territory. Without limiting the generality of the foregoing, Kaken shall use Commercially Reasonable Efforts to conduct its Commercialization activities under and in accordance with the Commercialization Plan.
Overview; Diligence. Subject to the terms and conditions of this Agreement (including the diligence obligations set forth below), Terns shall be solely responsible for the Development of Licensed Products in the Field in the Terns Territory, at its own cost and expense (except as otherwise expressly set forth herein), including (except as set forth in Section 4.6) all non-clinical and clinical studies and collection of CMC Information, as necessary to obtain Regulatory Approval for Licensed Products in any Region in the Terns Territory. Terns shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for Licensed Products in the Field in each Region in the Terns Territory, provided that Terns shall not be liable for any delays in any Development activities that are caused by Genfit’s failure to provide to Terns Product Materials that are necessary for the performance of such Development activities, except to the extent Genfit’s failure to provide such Product Materials is caused by Terns’ action or inaction. Without limiting the generality of the foregoing, Terns shall use Commercially Reasonable Efforts to conduct its Development activities under and in accordance with the Development Plan, as well as Manufacturing activities related to such Development, as set forth in the Initial Development Plan.
