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.
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.
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.
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.
Licensee and POZEN shall [* * *] any out-of-pocket expenses incurred in connection with such Post-Approval Commitments up to an aggregate amount of US$[* * *].