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. (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 activiti...
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. 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. Licensee shall be solely responsible, at its own costs and expense, for the Development of the Products in the Field in the Licensee Territory. Licensee shall use Commercially Reasonable Efforts to (i) Develop each Product in the Field in the Licensee Territory in accordance with the Development Plan (including the timeline set forth therein); (ii) perform the Development activities in compliance with Applicable Law, including GCP and cGMP; and (iii) obtain and maintain Regulatory Approvals for the Products in each jurisdiction in the Licensee Territory. Failure to use Commercially Reasonable Efforts to meet the foregoing obligations shall constitute a material breach of Licensee, which shall entitle Allogene to terminate this Agreement with respect to the applicable Product in accordance with and subject to the provisions of Section 12.2(a). Licensee will notify the JSC if it reasonably determines that, notwithstanding its Commercially Reasonable Efforts, any milestone or other requirement under the then current Development Plan will unlikely be achieved by Licensee in connection with Developing the Products, whether because of changes in scientific, business, market, or other conditions, in each case outside of its reasonable control. After such notice, the JSC shall promptly meet, discuss and consider in good faith appropriate modifications to the Development Plan in light of the changed circumstances.
Overview; Diligence. The Parties shall discuss the regulatory strategy for the Products in their respective Territories through the JSC in order to identify any material risk, value and impact on regulatory assessment and labeling, in markets throughout the world. Forty Seven shall prepare and present at a JSC meeting for discussion a global registration strategy for such Product for consistency of content and labeling, and optimal filing timelines (parallel and staggered) for markets throughout the world (such strategy, and any amendments thereto, the “Global Registration Strategy”). Each Party’s registration plan for its respective Territory (such plan, and any amendments thereto, the “Registration Plan”) shall, to the extent reasonably practicable and subject to Section 3.3.2, be aligned with the Global Registration Strategy. Each Party will deliver to the JSC an update of the relevant sections of its Registration Plan no less frequently than twice per Calendar Year during the Term. Ono will be solely responsible for all decisions regarding the day-to-day conduct of registration activities within the Ono Territory. Forty Seven will be solely responsible for all decisions regarding the day-to-day conduct of registration activities within the Forty Seven Territory.
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 or after Next Generation Option Exercise, the Next Generation ADC Licensed Product 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 such Original ADC Licensed Products or Next Generation 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 or Next Generation 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 [***] in [***]. For the avoidance of doubt, Licensee shall have fulfilled its diligence obligation under this Section 7.1 if it has used Commercially Reasonable Efforts to launch either the Original ADC Licensed Products or the Next Generation ADC Licensed Product in [***].
Overview; Diligence. Subject to the terms and conditions of this Agreement (including the diligence obligations set forth below), Licensee (itself and through its Affiliates and Sublicensees, as applicable) shall be solely responsible for all aspects of the Commercialization of the Products (including, for clarity, any CDx) in the Field in the Licensee Territory. Licensee shall bear all of the costs and expenses incurred in connection with Commercialization activities. Licensee shall [*] (a) [*]. In the event that a Product is for sale as part of a bundle or group sale with other products not covered by this Agreement, including without limitation, [*], and discounts, allowances or rebates are provided to Third Parties for the sale of such bundled or group products based on the total invoiced price, then such discounts, allowances or rebates shall be allocated pro rata to such Product based on the sale prices of such Product and all such other products.
