Post-Approval Studies Sample Clauses
The Post-Approval Studies clause requires that certain studies or research activities be conducted after a product, such as a drug or medical device, has received regulatory approval. Typically, this clause outlines the obligations of the manufacturer or sponsor to carry out additional clinical trials or data collection to monitor long-term safety, effectiveness, or other outcomes in real-world use. By mandating these follow-up studies, the clause ensures ongoing oversight and helps address any uncertainties or risks that may not have been fully resolved during the initial approval process.
Post-Approval Studies. (a) UCB agrees to [*] for the Product in the Development Indication from the FDA so that the FDA [*] the Product in the Development Indication [*] of the Product for use in the Development Indication. To the extent the FDA requires a Paediatric Plan to be undertaken as a condition for the Regulatory Approval of the Product in the Development Indication, such Paediatric Plan shall be included within the Development Plan.
(b) If the EMA requires a Paediatric Plan to be undertaken as a condition for Regulatory Approval of the Product for the Development Indication by the EMA, such Paediatric Plan shall be included within the Development Plan.
(c) If the Development activities to be conducted under the Development Plan to satisfy the requirements of the FDA and EMA for the Regulatory Approval of the Product in the Development Indication, including any Paediatric Plan and/or other Post-Approval Studies, are not sufficient to satisfy the requirements of Health Canada for the Regulatory Approval of the Product in the Development Indication (the “Health Canada Additional Requirement”), Dermira shall have the right to terminate its rights and obligations under this Agreement with respect to Canada by providing written notification to UCB within sixty (60) Business Days after learning about such Health Canada Additional Requirement, whereupon: (A) Canada shall no longer be included in the Promotion Territory, (B) all of Dermira’s obligations with respect to the Product in Canada shall terminate, and (C) any costs and expenses incurred in connection with any Development activities to be conducted by or on behalf of UCB thereafter for the purpose of obtaining Regulatory Approval from Health Canada shall be solely borne by UCB. In the event there exists no Health Canada Additional Requirement, or if Dermira does not provide UCB with such written notification of termination as set forth in the preceding sentence, then: (X) Canada shall remain included in the Promotion Territory, (Y) to the extent there exists any Health Canada Additional Requirement, the Development Plan (together with the JDC-Approved Development Budget therein) shall be modified to include the Development activities that would satisfy such Health Canada Additional Requirement; and (Z) the Development Costs in connection therewith shall be deemed to be included in the FDA/EMA Development Costs, provided that Dermira’s share of such Development Costs, as incurred, shall be counted towards the Cap.
(d) T...
Post-Approval Studies. ▇▇▇▇▇▇ shall be responsible for, and shall bear all expenses related to, any post-Marketing Approval studies (including Phase 4 Clinical Trials) required by individual countries in the Licensed Territory for the Licensed Product. ▇▇▇▇▇▇ shall bear all costs and expenses related to the establishment of any safety registry mandated as part of Marketing Approvals in the Licensed Territory.
Post-Approval Studies. Licensee shall be responsible for conducting any post-Regulatory Approval studies of Product (i) that are required by the FDA in the Licensee Territory (“FDA-Required Studies”) or (ii) that Licensee determines to conduct with respect to the Product in the Field in the Licensee Territory. Any and all such post-Regulatory Approval studies shall be conducted by Licensee as its sole expense. Licensee shall not be under any obligation to conduct any such additional post-Regulatory Approval studies of Product (other than the FDA-Required Studies).
Post-Approval Studies. VIVUS shall be responsible for conducting any post-Regulatory Approval studies of Product that are required by the FDA in the Auxilium Territory (“FDA-Required Studies”). The costs of conducting any FDA-Required Studies shall be borne by the Parties equally, up to a maximum aggregate payment by Auxilium of [**], and once this maximum is reached, VIVUS shall be solely responsible for the remainder of such costs. VIVUS shall conduct such studies using Commercially Reasonable Efforts. Any additional post-Regulatory Approval studies of Product that Auxilium determines to conduct with respect to the Product in the Field in the Auxilium Territory shall be conducted by Auxilium as its sole expense. Auxilium shall not be under any obligation to conduct any such additional post-Regulatory Approval studies of Product.
Post-Approval Studies. Post-Approval Studies shall mean those studies and activities subsequent to the granting of a Regulatory Approval that are required or necessary for the maintenance of such Regulatory Approval.
Post-Approval Studies. Where requirements to conduct post-Regulatory Approval studies are imposed by a Regulatory Authority in the Menarini Territory (including the Post-Marketing Requirements, but excluding the QT Study), whether imposed on VIVUS as the initial holder of the Product Marketing Authorization or on Menarini as the subsequent holder of the Product Marketing Authorization, Menarini shall be responsible for conducting such post-Regulatory Approval studies of Product. VIVUS shall pay for *** percent (***%) of the costs of conducting any such post-Regulatory Approval studies. Notwithstanding the foregoing, if and when VIVUS’s actual aggregate payments under the preceding sentence exceed *** Euros (€***), VIVUS shall have the right to forego any further ***, in which case Menarini shall be solely responsible for any further costs of conducting such post-Regulatory Approval studies, subject to its termination right described in the following sentence. For clarity, if the EMA or the European Commission requires any post-Regulatory Approval studies under the Existing MAA that were not included in the opinion adopted by the EMA’s Committee for Medicinal Products for Human Use and the Product Marketing Authorization or if the QT Study results into any change of the SmPC of Product which would reasonably have a negative impact on the Commercialization of the Product in the Territory, Menarini shall have the right to terminate this Agreement at its sole discretion pursuant to Section 12.2(c).
Post-Approval Studies. After the POCD EIR Product receives Initial U.S. Marketing Approval, Alfa shall transfer the IND back to Salix, and Salix shall manage and control (at its sole cost and expense) any post-approval marketing studies, as agreed and directed by the Steering Committee.
Post-Approval Studies. Sanofi shall be responsible, at Sanofi’s sole expense, for conducting any clinical or non-clinical studies of Product that are required by any of the individual countries in the Sanofi Territory, whether such studies are conducted prior to or after receipt of the Sanofi Territory Approvals. Sanofi shall conduct such studies using Commercially Reasonable Efforts.
Post-Approval Studies. In the event the FDA requires a Phase IV study, BPA shall conduct such study but shall only be responsible for XXX% of the fully burdened cost and expense of any Phase IV commitment up to a maximum of $XXXXXX, with Company responsible for the excess. BPA shall from time to time invoice Company for Company’s share of such costs and expenses, and Company shall pay such invoices within thirty (30) days of receipt.