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. (b) Without limiting the foregoing, Licensee shall use Commercially Reasonable Efforts to (i) make all regulatory submissions to the applicable Regulatory Authorities within the Territory in respect of the Original ADC Licensed Product; and (ii) obtain Regulatory Approval for Original ADC Licensed Products in the Territory, in each case of (i) and (ii) in accordance with the Development Plan. (c) Without limiting Sections 4.3 and 4.4, where responsibility for conducting any Development activities (falling within the scope of this Agreement) is designated by Licensee to Duality or its Affiliates and subcontractors, Duality, its Affiliates and subcontractors shall perform the Development activities assigned to it under the Development Plan(s), in compliance with Applicable Laws (including GCP).
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Overview; Diligence. (a) Except as expressly provided herein with respect to the Ongoing Planned Trials, Licensee Original ADC Added Trials (as applicable) and or after Next Generation Option Exercise, the preparatory activities for the HER2-Low BC Phase III Global Trial as set forth in Section 4.6(b)Next Generation Added Trials, 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 or after the Next Generation Option Exercise, Next Generation ADC Licensed Product in the Field in the Territory under the oversight of JSC. Without limiting the generality of the foregoing, Licensee shall, subject to in accordance with 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 GCPGXPs); , with reasonable due care and (iii) in conformity with current generally accepted industry standards and procedures. Licensee shall use Commercially Reasonable Efforts to dose adhere to the first patient timelines set forth in the Development Plan. For the avoidance of doubt, Licensee shall have fulfilled its diligence obligation under Section 4.1(a) (i) if it has used Commercially Reasonable Efforts to develop and seek Regulatory Approval for either the Original ADC Licensed Products or a Registrational Trial within Next Generation ADC Licensed Product in [***] months ]. Licensee is not obliged to develop and/or seek Regulatory Approval for both the Original ADC Licensed Products and the Next Generation ADC Licensed Product. For the avoidance of doubt, as regards the Clinical Trials in the Retained Territory, unless otherwise agreed under this Agreement, Duality shall be solely responsible at is own expenses, for the applicable HER2-low breast cancer Indication or EC Indication after Successful Completion of each Development 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 Original ADC Licensed Products and the Licensee shall consider Next Generation ADC Licensed Product in good faith and reasonably address Duality’s input and comments with respect theretothe Retained Territory.
(b) Without limiting the foregoing, Licensee shall use Commercially Reasonable Efforts to (i) make all regulatory submissions to the applicable Regulatory Authorities within the Territory in respect of the Original ADC Licensed Product, or after Next Generation Option Exercise, the Next Generation ADC Licensed Product; and (ii) obtain Regulatory Approval for Original ADC Licensed Products Products, or after Next Generation Option Exercise, the Next Generation ADC Licensed Product; in the Territory, in each case of (i) and (ii) in accordance with the Development Plan.
(c) Without limiting Sections 4.3 and 4.4, where responsibility for conducting any Development activities (falling within the scope of this Agreement) is designated by Licensee to Duality or its Affiliates and subcontractors, Duality, its Affiliates and subcontractors shall perform the Development activities assigned to it under the Development Plan(s), in compliance with Applicable Laws (including GCP).
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