Example ContractsClausesMedical Affairs Plan
Medical Affairs Plan
Medical Affairs Plan contract clause examples

Medical Affairs Plan. Ji Xing shall conduct all Medical Affairs Activities for the Product in the Field in the Territory pursuant to a written Medical Affairs Activities plan that set forth the timeline and details of all Medical Affairs Activities to be conducted by or on behalf of Ji Xing for the Product in the Field in the Territory (the “Medical Affairs Plan”), which plan shall, ​. No later than ​ before the planned initiation of the first Clinical Trial of the Product in the Field in the Territory, Ji Xing ​. Thereafter, from time to time, but at least ​, Ji Xing shall prepare updates or amendments to the Medical Affairs Plan ​.

Medical Affairs Activities. In the event the Parties agree to conduct Activities relating to medical affairs activities for the QIAGEN IVD, such Activities shall be outlined in a Schedule.

Medical Affairs Activities Reports. Ji Xing shall keep [[Cytokinetics:Organization]] informed of its, its Affiliates’ and sublicensees’ Medical Affairs Activities with respect to the Product. Without limiting the foregoing, at each regularly scheduled JDC meeting, Ji Xing shall provide the JDC with a reasonably detailed report summarizing the Medical Affairs Activities performed by or on behalf of Ji Xing for the Product in the Field in the Territory. In addition, Ji Xing shall make available to [[Cytokinetics:Organization]] such additional information about its Medical Affairs Activities as may be reasonably requested by [[Cytokinetics:Organization]] from time to time.

Medical Affairs Plan. Ji Xing shall conduct all Medical Affairs Activities for the Product in the Field in the Territory pursuant to a written Medical Affairs Activities plan that set forth the timeline and details of all Medical Affairs Activities to be conducted by or on behalf of Ji Xing for the Product in the Field in the Territory (the “Medical Affairs Plan”), which plan shall, ​. No later than ​ before the planned initiation of the first Clinical Trial of the Product in the Field in the Territory, Ji Xing ​. Thereafter, from time to time, but at least ​, Ji Xing shall prepare updates or amendments to the Medical Affairs Plan ​.

Medical Affairs Plan. The Parties shall coordinate with respect to the strategy and implementation of the Medical Affairs Activities with respect to each Collaboration Product in each Indication [ * ] for such Indication, and such coordination will be set forth in the Medical Affairs Plan. No later than [ * ] Collaboration Product, Astellas shall prepare and provide to the JMAC for review and discussion a written plan for the Medical Affairs Activities for such Collaboration Product (the “Medical Affairs Plan”), subject to Section 10.5 below. The Medical Affairs Plan shall include a reasonably detailed description of and anticipated timeline

Medical Affairs. AcelRx shall provide medical and scientific support for the Products in the Territory. AcelRx shall, subject to Applicable Laws, comply with Aguettant’s policies on engaging and sponsoring healthcare providers.

Medical Affairs. With respect to a given [[Unknown Identifier]] Co-Co Product, approximately ​ before the anticipated submission of the first MAA filing seeking Regulatory Approval for such [[Unknown Identifier]] Co-Co Product in the Territory, the applicable [[Unknown Identifier]] Co-Commercialization Plan shall be updated to include a plan for conducting Medical Affairs with respect to such [[Unknown Identifier]] Co-Co Product in the Territory. The Parties acknowledge and agree that Commercialization and Medical Affairs activities are separate activities and are subject to different Applicable Laws, regulatory requirements and obligations in various jurisdictions throughout the Territory, and that the Parties intend to comply with such Applicable Laws, regulatory requirements and obligations, as applicable.

Medical Affairs Plan. No less than ​ prior to the reasonably anticipated date for a First Commercial Sale of a Product in the Territory, [[Forty Seven:Organization]] shall prepare and present at a JSC meeting for discussion a strategy containing the worldwide strategy, activities and timeline with respect to the Medical Affairs Activities in support of the Products in the Field (such strategy, and any amendments thereto, the “Global Medical Affairs Strategy”). No less than ​ prior to the reasonably anticipated date for a First Commercial Sale of a Product in its respective Territory, each Party shall prepare and present at a JSC meeting a plan containing the strategy, activities and timeline with respect to the Medical Affairs Activities in support of the Products in the Field in its respective Territory (each, “Medical Affairs Plan”) that shall, to the extent reasonably practicable, be aligned with the Global Medical Affairs Strategy. The JSC will review and discuss such Medical Affairs Plan and its amendments under which the Parties shall review, discuss, and coordinate the Parties’ scientific presentation and publication strategy relating to the Products in the Field in each Party’s Territory. Each Party may propose to the other Party the conduct of any Phase 4 Clinical Study (i.e. Clinical Study, epidemiological study and post-marketing surveillance, which is commenced after receipt of the Regulatory Approval, but excluding any Phase 3b trial) in its respective Territory, following which the Parties shall discuss to determine whether to jointly conduct such Phase 4 Clinical Study as a Global Study pursuant to the terms and conditions set forth in Section 4.3.

Medical Affairs. Zai shall be solely responsible, at its sole cost and expense, for conducting medical affairs activities with respect to the Products in the Territory, including communications with key opinion leaders, medical education, symposia, advisory boards (to the extent related to medical affairs or clinical guidance), publications, congress presentations and posters, published manuscripts, activities performed in connection with patient registries and post-approval trials, and other medical programs and communications, including educational grants, research grants (including conducting investigator-initiated studies), and charitable donations to the extent related to medical affairs and not to other activities that do not involve the promotion, marketing, sale, or other Commercialization of the Products, all of which shall be conducted in accordance with Applicable Law.

Medical Affairs Materials. GSK shall prepare and produce all Medical Affairs Materials for the Licensed Products in the Territory in accordance with the Global Strategic Launch Plan and the Joint Commercialization Plan, which Medical Affairs Materials GSK will share with ITEOS for ITEOS’s review and comment, which comments GSK will consider in good faith. GSK will be solely responsible for legal and regulatory review of such Medical Affairs Materials through its normal internal review process, and submission of Medical Affairs Content to applicable Regulatory Authorities for comments or approval as required. GSK shall own all rights, title and interests in and to any and all such Medical Affairs Materials. Neither Party shall use any materials other than the Medical Affairs Materials that have undergone GSK’s internal review and approval process for use in connection with the conduct of Medical Affairs activities related to the Licensed Products under this Agreement; provided that, ITEOS will not be required to use any Medical Affairs Materials that ITEOS’s compliance team has not also approved. GSK shall be responsible for providing and shipping to ITEOS all Medical Affairs Materials in quantities necessary for ITEOS to perform its activities under the Joint Commercialization Plan.

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