Common use of Safety Databases Clause in Contracts

Safety Databases. Upon NDA Assignment, Collegium (or its agent) will maintain a pharmacovigilance database for each Licensed Product in the Territory (or each country thereof, if/as applicable). The database(s) will include all ADE reports from spontaneous sources, scientific literature, and PMS reports (serious) and SAE reports from clinical studies coming into the actual knowledge of Collegium, its Affiliates, or any Sublicensee (or any agent of the foregoing). Spontaneous cases will include reports received from both healthcare professionals and consumers. AE data will be coded to the latest version of MedDRA. Report handling and classifying will be carried out in accordance with Collegium’s (or its agent’s) SOPs (as defined below). All reasonable assistance and access requested by either Party in responding to safety inquiries will be provided upon request. Information in Collegium’s safety databases will be used by Collegium to compile PSURs (as defined below) to the FDA (providing a waiver of the requirement to submit postmarketing periodic safety reports in the format described in the regulations has been granted) and other Competent Authorities in the Territory and prepare safety-related supplemental applications for changes in the package insert(s)/labelling for Licensed Products in the Territory.