Common use of Product Vigilance System Clause in Contracts

Product Vigilance System. Wyeth shall be responsible for maintaining medical device vigilance systems, as established for the Products and Extended Products by applicable regulatory requirements, and shall promptly provide Biomatrix with notice of all product related events and complaints, including medical complaints. The parties shall develop a mutually agreed procedure to comply with applicable regulatory requirements and the policies of each party. Biomatrix shall be solely responsible for processing, analyzing and, if necessary, reporting medical complaints to regulatory authorities. Wyeth shall provide all necessary support to Biomatrix for carrying out such activities.

Product Vigilance System. Wyeth shall be responsible for maintaining medical device vigilance systems, as established for the Products and Extended Products by applicable regulatory requirements, and shall promptly provide Biomatrix with notice of all product related events and complaints, including medical complaints. The parties shall develop a mutually agreed procedure to comply with applicable regulatory requirements and the policies of each party. Biomatrix shall be solely responsible for processing, analyzing and, if necessary, reporting medical complaints to regulatory authorities. Wyeth shall provide all necessary support to Biomatrix for carrying out such activities.