Post-Marketing Commitments Clause Samples
Post-Marketing Commitments. If the FDA or other Competent Authority requires a Post Marketing Commitment for the Product, then Strata shall use Commercially Reasonable Efforts to implement such Post Marketing Commitment at Strata’s expense.
Post-Marketing Commitments. Each Party shall perform all activities necessary to satisfy any post-marketing requirements imposed by a Regulatory Authority with respect to a Single Agent Product in such Party’s Field, in accordance with the timelines established by such Regulatory Authority.
Post-Marketing Commitments. The Parties acknowledge that Fresenius’ rights and responsibilities hereunder in respect of Commercialization of the Distribution Product in the Field in the Territory, including under Section 9.1.1 and Section 9.1.2.1, include such rights and responsibilities in respect of the design and conduct of (a) Post-Marketing Commitments in respect of the Distribution Product in the Field and (b) other post-approval Clinical Studies in respect of the Distribution Product in the Field not required to obtain, support, or maintain Regulatory Approval (other than Pricing Approval) for the Distribution Product, and agree that the design and conduct of any corresponding Clinical Study will be determined [***] if such Clinical Study is in the Field. However, Fresenius will not conduct any such Clinical Study outside of the Field without obtaining Humacyte’s prior written consent.
Post-Marketing Commitments. If the FDA or other Competent Authority requires any post-approval commitments for the Licensed Product, then the Company shall use commercially reasonable efforts to implement such post marketing commitment(s) at the Company’s expense.
Post-Marketing Commitments. Within 90 days after the Effective Date, Daiichi shall post or make available information on its company website about post-marketing commitments (PMCs). The Daiichi website or links included therein shall provide access to general information about the PMC process, descriptions of ongoing Daiichi studies related to PMCs, and information about the nature and status of FDA PMCs. Daiichi shall continue to post or make available the above-described information about PMCs on its website or links included therein throughout the term of this CIA.
Post-Marketing Commitments. Within 30 days after the first date when Shire engages in any FDA post-marketing commitment (PMC), Shire shall post or make available information on its company website about PMCs. The Shire website or links included therein shall provide access to general information about the PMC process, descriptions of ongoing Shire studies, and information about the nature and status of FDA post-marketing commitments. Shire shall continue to post or make available the above-described information about PMCs on its website or links included therein throughout the term of this CIA.
Post-Marketing Commitments. In the case where both Parties have sought a labeled indication based on the Combined Therapy, if post-marketing commitments are required by a Regulatory Authority (e.g.: US post-marketing commitments and post marketing requirements, EU post approval commitments etc), the Parties shall negotiate in good faith.
Post-Marketing Commitments. Buyer acknowledges that from and after Closing, Buyer shall be, and hereby is, responsible to the FDA and any or all other applicable Governmental Entities for full performance of all the Post-Marketing Commitments. Buyer has the necessary expertise to properly perform all of the Post-Marketing Commitments. Buyer acknowledges, and the Parties agree, that, from and after Closing, Seller will have no further obligations whatsoever for, or in connection with, the Post-Marketing Commitments.
Post-Marketing Commitments. Schedule 4.19 describes all of the post-marketing commitments related to the Products or the Purchased Assets that have been imposed by a Governmental Authority as of the Effective Date.