Post-Approval Commitments Clause Samples
The Post-Approval Commitments clause outlines the obligations that a party must fulfill after a product or project has received regulatory or formal approval. Typically, this clause requires ongoing actions such as additional studies, monitoring, or reporting to regulatory authorities to ensure continued compliance and safety. For example, a pharmaceutical company may need to conduct post-marketing surveillance or submit periodic safety updates. The core function of this clause is to ensure that all necessary follow-up actions are clearly defined and undertaken, thereby maintaining regulatory compliance and managing potential risks after approval.
Post-Approval Commitments. Jazz shall be solely responsible for conducting, at its sole expense, any post-approval commitment or requirement studies or Clinical Trials (collectively, “Post-Approval Commitments”) that are requested or required by any Regulatory Authority in the Territory with respect to any Regulatory Approval of a Licensed Product based on the Zymeworks Ongoing Studies. Zymeworks shall (i) upon Jazz’s request and expense, reasonably cooperate with Jazz to prepare a Clinical Trial design, protocol and schedule that satisfies the applicable Regulatory Authority’s requests or requirements with respect to the Post-Approval Commitments and (ii) supply Licensed Antibody and Licensed Product to Jazz for use in such Post-Approval Commitments, in accordance with Article 7.
Post-Approval Commitments. (i) Grünenthal shall use Commercially Reasonable Efforts to conduct (at its cost) development activities for Territory-specific Post Approval Commitments for the Licensed Product in the Field that are not also required by the FDA in the U.S. for the Licensed Product in the Field. Grünenthal shall not be required to obtain AcelRx’s consent to conduct such development activities but shall provide, through the JSC, reasonable detail regarding these Post Approval Commitments. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(ii) AcelRx shall use Commercially Reasonable Efforts to conduct development activities for all Post Approval Commitments in the U.S., including such Post Approval Commitments required by the FDA and any Regulatory Authorities in the Territory that overlap in whole or in parts. AcelRx shall bear all costs for Post Approval Commitments required by the FDA [ * ]. In the event that AcelRx is required to expand its development activities for Post Approval Commitments beyond FDA requirements and in order to meet additional requirements by Regulatory Authorities in the Territory, then Grünenthal shall bear any incremental costs beyond those costs for such FDA-required Post Approval Commitments, provided that the development activities applicable to the Territory and allocation of related costs shall be discussed and agreed by the JSC prior to their initiation.
Post-Approval Commitments. Cell Genesys agrees to provide Takeda technical assistance in the form of personnel to support the conduct of studies in regards to the manufacturing, nonclinical or clinical area that may be required to meet post-approval commitments in the Shared Territory. Takeda shall bear the cost incurred by either Party in connection with the performance and conduct of post-approval commitments, including any Internal FTE Costs, Out-of-Pocket Cost and Clinical Supply Costs for such studies.
Post-Approval Commitments. In the event that the FDA shall require any Post-Approval Commitment in connection with the Initial Approval of the Existing Licensed Product, the Parties shall mutually agree which Party shall conduct such Post-Approval Commitment. In the event that Licensor is conducting any Post-Approval Commitment, the JCC shall establish a budget with respect to such Post-Approval Commitment (each such budget, a "POST-APPROVAL BUDGET"). Each Post-Approval Budget shall include line item estimates of expenses with respect to such Post-Approval Commitments broken down on a Calendar Year basis, which costs and expenses shall include only external, out-of-pocket costs and expenses (such costs and expenses collectively, the "POST-APPROVAL COSTS"). Licensee shall bear [REDACTED] [Exclusion of confidential information relating to cost-sharing] of the actual Post-Approval Costs incurred by Licensor, to the extent that such expenses do not exceed in the aggregate [REDACTED] [Exclusion of confidential information relating to cost-sharing] of the applicable Post-Approval Budget. All Post-Approval Commitments shall be conducted under the oversight of the JCC.
Post-Approval Commitments. Following NDA Approval, in the event that the FDA requires any Post-Approval Commitments, Licensee shall, subject to the provisions of this Section 2.2, use Commercially Reasonable Efforts to conduct such Post-Approval Commitments. Licensee and POZEN shall [* * *] any out-of-pocket expenses incurred in connection with such Post-Approval Commitments up to an aggregate amount of US$[* * *]. POZEN’s share of the expenses incurred in connection with such Post-Approval Commitments, which, for the avoidance of doubt, shall not in any case [* * *], shall be [* * *]; provided, that [* * *]; provided, further, [* * *]. If Licensee reasonably determines that the expenses of such Post-Approval Commitments will [* * *] then Licensee shall, within sixty (60) days of NDA Approval of the Initial Products either (a) terminate this Agreement pursuant to Section 13.7 hereof or (b) agree to pay when due all such expenses that are [* * *] in respect of such Post-Approval Commitment. Notwithstanding the foregoing, if Licensee cannot reasonably determine whether the costs of such Post-Approval Commitments will [* * *] at the time of receipt of the NDA Approval for the Initial Products, then Licensee will request a meeting with the FDA within thirty (30) days after NDA Approval of the Initial Products to finalize the scope, timing and extent of the Post-Approval Commitments (the “Post-Approval Meeting”), and Licensee’s right to terminate this Agreement under this Section 2.2 shall be extended until the earlier of (x) ten (10) days following the Post Approval Meeting, or (y) one hundred twenty (120) days following Licensee’s request to the FDA for the Post-Approval Meeting; provided if Licensee does not request a Post-Approval Meeting with the FDA within thirty (30) days of the NDA Approval for the Initial Products, then Licensee’s right to terminate this Agreement shall expire sixty (60) days following NDA Approval for the Initial Products. If Licensee does not make an election within sixty (60) days of the NDA Approval of the Initial Products, or if applicable, pursuant to the preceding sentence following the Post-Approval Meeting, Licensee shall be deemed to have elected to pay all such expenses [* * *] in expenses incurred in respect of such Post-Approval Commitment pursuant to clause (b). Licensee shall provide POZEN with quarterly updates on the status of such out-of-pocket expenses until such time as an aggregate amount of US$[* * *] of such expenses are incurred in connec...
Post-Approval Commitments