MEDICAL AFFAIRS, PHARMACOVIGILANCE AND OTHER REGULATORY MATTERS Sample Clauses
The "Medical Affairs, Pharmacovigilance and Other Regulatory Matters" clause defines the parties' responsibilities regarding compliance with medical, safety, and regulatory requirements related to a product or service. It typically outlines obligations for reporting adverse events, managing product safety information, and ensuring that all promotional and scientific communications meet applicable legal and regulatory standards. This clause ensures that both parties coordinate effectively to maintain regulatory compliance, protect patient safety, and avoid legal or reputational risks associated with non-compliance.
MEDICAL AFFAIRS, PHARMACOVIGILANCE AND OTHER REGULATORY MATTERS. 9.1 During the Term, each Party whether acting directly or through its Affiliates, shall, at its own cost and expense except as set forth in Section 7.7 with respect to the UCB Commercialisation Costs Deductions, undertake and perform Medical Affairs activities for the Product in the Promotion Territory for the Promotion Indication and, if applicable, the Development Indication in accordance with the Medical Affairs Plan and the provisions of this Section 9. All Medical Affairs activities for the Product for the Promotion Indication and, if applicable, the Development Indication in the Promotion Territory shall be coordinated through the JDT and subject to the oversight of the JDC. For the avoidance of doubt, UCB shall be responsible for all Medical Affairs activities for the Product in the Promotion Indication and, if applicable, the Development Indication, in each case in the Reserved Territory, which activities shall not be subject to the oversight of the JSC or the terms of this Agreement.
9.2 In accordance with Section 7.4, as part of the Commercialisation Plan Dermira shall prepare for the JDT’s review and JDC’s recommendation for JSC approval, a Medical Affairs Plan for each Calendar Year including budget thereof, provided that Dermira shall have the final decision making authority for its level of activities under and the budget under such Medical Affairs Plans as set forth in and in accordance with Section 4.11(b). Each Medical Affairs Plan shall be consistent with UCB Medical Affairs and MSL activity related SOPs and include: (i) Medical Affairs programs, including professional symposia and other educational activities, grants, and guidelines and budgets for the support of investigator initiated interventional or observational (prospective and retrospective) clinical or health economics/outcomes studies and (ii) any post-approval Clinical Studies (other than Post-Approval Studies) in the Promotion Indication and Development Indication. The Medical Affairs Plan will include an agreed budget for the current Calendar Year, as well as outline of the projected plan and an estimated budget for the next Calendar Year (“Medical Affairs Budget”). The initial Medical Affairs Plan for the Product in the Development Indication and the Promotion Indication will be prepared by Dermira and submitted to the JDC for recommendation for approval by the JSC at least [*] before the anticipated first Launch of the Product in the Development Indication in the Promotion...