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.