Post Approval Support Clause Samples

Post Approval Support. (a) 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. (b) Manufacturing. Zymeworks shall be responsible [***] for correcting all CMC or other manufacturing deficiencies with respect to Licensed Antibody and Licensed Product manufactured by or on behalf of Zymeworks for Jazz, as required by any Regulatory Authority in the Territory after Regulatory Approval but prior to the Manufacturing Transition Date, and shall correct such deficiencies.