Post-Approval Commitments definition

Post-Approval Commitments means all clinical studies (including pediatric studies and Post-Marketing Studies) conducted after Regulatory Approval for the Licensed Product that are requested by a Regulatory Authority or that are necessary to fulfill commitments made to any Regulatory Authority as a condition for the receipt or maintenance of such Regulatory Approval in any country.
Post-Approval Commitments means a study or data collection effort mandated by the applicable Regulatory Authority as a condition of Regulatory Approval in the US or the EU.
Post-Approval Commitments means all clinical studies (including pediatric studies) conducted after receipt of a Marketing Approval for the Licensed Product that are requested by Regulatory Authorities or that are necessary to fulfill commitments made to the Regulatory Authority as a condition for the receipt and/or maintenance of such Marketing Approval in any country.

Examples of Post-Approval Commitments in a sentence

  • For any Additional Agreed Activity that is [**] by the Parties, including any US/EU Post-Approval Commitments, the Party that is responsible for obtaining data and preparing analyses and reports concerning such data shall, in addition to providing the top-line results, make available to the other Party in a reasonable format the full data and any analyses and additional reports relating thereto.

  • Any data and other Information arising from an Additional Agreed Activity (whether commenced before or after Opt-In for the relevant Product) that is [**] will trigger access to the full data and analyses and additional reports, then such other agreed ratio) by the Parties or any US/EU Post-Approval Commitments shall be deemed to be Jointly-Owned Know-How, and the provisions of Section 7.2(b) shall apply thereto.

  • 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.

  • Subject to the exclusions set forth in Section 1.61, all data and information derived from Post-Approval Commitments and Development activities of VeroScience relating to the Product or Additional Products shall be deemed to be Proprietary Information of VeroScience for all purposes hereunder; provided, however, that Santarus may use such data and information, in the exercise of, and to the extent of, its rights hereunder.

  • Except as otherwise set forth herein, the JSC shall provide strategic input and serve as a forum for monitoring the Post-Approval Commitments and Development and Commercialization.


More Definitions of Post-Approval Commitments

Post-Approval Commitments means a human clinical study for a Collaboration Product Conducted after Marketing Authorization of such Collaboration Product has been obtained from an appropriate Regulatory Authority due to a request or requirement of such Regulatory Authority.
Post-Approval Commitments means any human clinical study or other test or study, including a Phase 4 Trial that is required or other obligation, including an obligation to develop a risk evaluation and mitigation strategy or similar safety program, that is imposed with respect to an Initial Product by a Regulatory Authority as a condition of obtaining or maintaining NDA Approval for such Initial Product for an indication, to be performed following NDA Approval of such Licensed Product for such indication.
Post-Approval Commitments has the meaning set forth in Section 2.5(a).
Post-Approval Commitments means the post approval commitments regarding clinical studies EpiCept agreed to undertake, as set out in the grant of the Marketing Authorisation, dated 24 July 2008.
Post-Approval Commitments means any post-approval commitments, including any non-clinical study or Clinical Study of a Licensed Product, required by a Regulatory Authority in a country or territory in connection with the Regulatory Approval for such Licensed Product in such country or jurisdiction.
Post-Approval Commitments means any human clinical study or other test or study or other obligation with respect to a Licensed Product that is required by the FDA as a condition of obtaining NDA Approval for such Licensed Product for an indication, to be performed following NDA Approval of such Licensed Product for such indication.
Post-Approval Commitments means the clinical studies agreed by EpiCept as part of the marketing authorization under exceptional circumstances as granted by the European Commission for Ceplene, which are detailed in Exhibit B.