Common use of Exchange of Drug Safety Information Clause in Contracts

Exchange of Drug Safety Information. (a) Clinigen shall be responsible for recording, investigating, summarizing, notifying, reporting and reviewing all Adverse Drug Experiences in the Territory in accordance with applicable Laws and shall require that its Affiliates, sublicensees and subcontractors (i) adhere to all requirements of applicable Laws that relate to the reporting and investigation of Adverse Drug Experiences in the Territory, and (ii) inform the Joint Steering Committee promptly of such matters arising therefrom. (b) Theravance shall notify Clinigen as soon as practicable of all “adverse reactions”, “serious adverse reactions” and “unexpected adverse reactions” as such terms are defined in Directive 2001/83/EC and all “adverse events,” “adverse experiences” and “adverse drug reactions” as such terms are defined in ICH E2A that occur outside the Territory to enable Clinigen to comply with the Guideline on good pharmacovigilance practices (GVP) Module VI — Management and reporting of adverse reactions to medicinal products.