Phase IV Studies Sample Clauses
The 'Phase IV Studies' clause defines the requirements and obligations related to post-marketing clinical studies conducted after a product has received regulatory approval. Typically, this clause outlines the sponsor's responsibility to initiate and manage additional research to monitor long-term safety, effectiveness, or to fulfill regulatory commitments. For example, it may specify timelines for study initiation, reporting requirements, or collaboration with regulatory authorities. The core function of this clause is to ensure ongoing evaluation of the product in real-world settings, addressing any emerging safety concerns and supporting continued regulatory compliance.
Phase IV Studies. AbbVie shall have the right to conduct, at its own cost and expense, Phase IV clinical studies for the Product in the Territory; provided, however, that AbbVie shall provide Kadmon with a copy of such study reports as result from Phase IV clinical studies for which the primary objective is studying the Product (and not, for instance, studies regarding Hepatitis C virus in general) for Kadmon’s use; provided, further, that, such study reports shall be AbbVie’s Confidential Information and shall be handled by Kadmon in accordance with the terms and conditions of Article 9.
Phase IV Studies. 26 Section 11.04. Assistance..............................................26 Section 11.05. Compliance..............................................27
Phase IV Studies. In the event a Governmental Authority requires Atrix to conduct a Phase IV study, Atrix shall develop, design and implement such Phase IV study and the costs shall be borne [ ]** shall pay [ ]** of the costs of any Phase IV study conducted solely for marketing purposes; [ ]** In exchange for [ ]** Upon completion of such Phase IV seeding study, [ ]** in such Phase IV seeding study [ ]** to conduct such Phase IV seeding study, [ ]** The costs of any Phase IV study [ ]**
Phase IV Studies. In the event a Governmental Authority requires Atrix to conduct a Phase IV study, Atrix shall develop, design and implement such Phase IV study and the costs shall be borne 100% by Atrix. CollaGenex shall pay 100% of the costs of any Phase IV study conducted solely for marketing purposes; provided, however, that Atrix shall supply to CollaGenex up to [**] to conduct a Phase IV seeding study, [**] (other than shipping costs) to CollaGenex. In exchange for providing [**] to be used in such Phase IV seeding study, Atrix shall have the rights to use the results of such Phase Iv seeding study outside of the Territory. Upon completion of such Phase IV seeding study, CollaGenex shall provide Atrix with a detailed list of the number of [**] used by CollaGenex in such Phase IV seeding study in the next Royalty Statement. If CollaGenex used its existing inventory of [**] to conduct such Phase IV seeding study, CollaGenex may offset the cost to CollaGenex for [**] excluding shipping and handling costs, from future payments to Atrix. The costs of any Phase IV study conducted solely for marketing purposes shall be included in CollaGenex's aggregate A&S expenditures for purposes of Section 14.04.