Day-to-Day Responsibility. Each Party shall be responsible for day-to-day implementation of the Development, Manufacturing and Commercialization activities for which it (or its Affiliate) has been, or otherwise is, assigned responsibility under this Agreement or the applicable Development Plan or Commercialization Plan and shall keep the other Party reasonably informed as to the progress of such activities, as determined by the JDC and JCC.
Day-to-Day Responsibility. Each Party shall be responsible for day-to-day implementation of the Commercialization activities with respect to the Products for which it has or otherwise is assigned responsibility under this Agreement or the U.S. Commercialization Plan and shall keep the other Party reasonably informed as to the progress of such activities, as determined by the USCC.
Day-to-Day Responsibility. Each Party shall be responsible for day-to-day implementation of the Commercialization activities with respect to the Products for which it has or otherwise is assigned responsibility under this Agreement or the U.S. Commercialization Plan and shall keep the other Party reasonably informed as to the progress of such activities, as determined by the JCC. Each of the Parties may appoint a single U.S. Commercialization alliance manager to be responsible for the day-to-day coordination of the Commercialization activities in the United States contemplated by this Agreement and the U.S. Commercialization Plan.
Day-to-Day Responsibility. Each U.S. Party shall be responsible for day-to-day implementation of the Commercialization activities in the U.S. Territory for which it is assigned responsibility under the U.S. Commercialization Plan or this Agreement and shall have the right to make operational and administrative decisions with respect to how to implement such Commercialization activities (e.g., if a U.S. Party is responsible for providing sales representatives in the U.S. Territory, such U.S. Party shall be responsible for hiring, training, deploying and managing such sales representatives but shall coordinate such efforts with the other U.S. Party); provided that such decisions shall not conflict with the U.S. Commercialization Plan or any decision of the JCC or JSC with respect to such Commercialization activity. Each U.S. Party shall keep the other U.S. Party and the JCC reasonably informed on the progress of its Commercialization activities in the U.S. Territory.
Day-to-Day Responsibility. Xxxxxxx will be responsible for day-to-day implementation of the Development activities with respect to the Licensed Products and will have the right to make operational and administrative decisions with respect to how to implement such Development activities (e.g., with respect to a Clinical Study, Xxxxxxx will have the right to select and engage clinical trial sites), as long as such decisions do not conflict with the GDP or any decision of the JDC with respect to such Development activity.
Day-to-Day Responsibility. Each Party shall be responsible for day-to-day implementation of the Development activities for which it is assigned responsibility under the -39- GDP or this Agreement and shall have the right to make operational and administrative decisions with respect to how to implement such Development activities (e.g., with respect to a Clinical Trial, the responsible Party shall have the right to select and engage clinical trial sites); provided that such decisions shall not conflict with the GDP (including the Development Budget) or any decision of the JDC or JSC with respect to such Development activity. Each Party shall keep the other Party reasonably informed on the progress of its Development activities.
Day-to-Day Responsibility. Each Party shall be responsible for day-to-day implementation of the Development activities for which it (or any of its Affiliates) is assigned responsibility under this Agreement or the GDP and shall keep the other Party reasonably informed as to the progress of such activities. In addition, notwithstanding anything to the contrary in this Agreement:
(a) The Party who is the regulatory sponsor of any Clinical Study of a Licensed Compound or Product or the Party conducting such Clinical Study may terminate or suspend such Clinical Study, without the approval or consent of a Committee or the other Party, if (A) a Regulatory Authority, institutional review board or safety data review board for such Clinical Study has required or recommended such termination or suspension or (B) such Party believes in good faith that such termination or suspension is warranted because of observed safety risks to the study subjects or patients. In either case, the Party making the decision shall promptly notify the other Party of such termination or suspension, and shall use Diligent Efforts to notify and consult with such other Party prior to taking such action; and
(b) If the Party who is not conducting and who is not the regulatory sponsor of any Clinical Study of a Licensed Compound or Product (the “Non-Sponsor) believes in good faith that termination or suspension of such Clinical Study is warranted because of safety risks to the study subjects or patients, then the Non-Sponsor shall so notify the other Party (the “Sponsor”), and the JDC shall discuss the Non-Sponsor’s concerns in good faith to determine whether to terminate, suspend, modify or continue such Clinical Study. If the JDC and, if applicable following escalation, JSC and Executive Officers are unable to reach agreement with respect to whether to terminate, suspend, modify or continue such Clinical Study, and the Sponsor wants to continue such Clinical Study, the Sponsor shall have the right to do so, provided that the Sponsor shall indemnify and hold harmless the Non-Sponsor from and against any Losses to the extent resulting from any Product Liability Action alleged to be caused by the safety risks raised by the Non-Sponsor and in fact occurring during the conduct of such Clinical Study from and after the date that the Non-Sponsor first notified the Sponsor in accordance with this Section 4.3.2(b) of such safety risks and proposed terminating or suspending such Clinical Study.
Day-to-Day Responsibility. Xxxxxxx (and Fate, if Fate exercises the U.S. Commercialization Option for any Profit Share Product) shall be responsible for day-to-day implementation of the Commercialization activities with respect to the Profit Share Products in the U.S. for which it is assigned responsibility under the U.S. Commercialization Plans or this Exhibit and shall have the right to make operational and administrative decisions with respect to how to implement such Commercialization activities, provided that such decisions shall not conflict with the U.S. Commercialization Plans or any decision of the USJCC or JSC with respect to such Commercialization activity. For example purposes only (and such example shall have no impact on the allocation of U.S. Commercialization responsibilities under Section 5.1.3), with respect to sales representatives, if a Party is responsible under the U.S. Commercialization Plan for providing [***] percent ([***]%) of the sales representatives in the U.S. and the U.S. Commercialization Plan provides for a total of [***] sales representatives in the U.S., such Party shall be responsible for hiring, training, deploying and managing [***] sales representatives, but shall coordinate such efforts with the other Party.
Day-to-Day Responsibility. Each Party shall be responsible for day-to-day implementation of its Co-Promotion activities for which it (or with respect to Xxxxxxx only, its Affiliate) has or otherwise is assigned responsibility under the US Promotional Plan and shall keep the JMC and the other Party reasonably informed as to the progress of such activities.
Day-to-Day Responsibility. Each Party will be responsible for routine, non-strategic, operational- level decisions relating to the Research and Development activities for which it is assigned responsibility under the COVID-19 Research and Development Plan, provided that such decisions will not conflict with the COVID-19 Research and Development Plan, or any decision of the JRDC or JSC with respect to such activity, or be a matter for which such Party does not have authority to take such decision per Article 9 (Governance), or is otherwise inconsistent with Section 3.4 (Research and Development Diligence).
