Definition of FRA Documentation


FRA Documentation means, with respect to a Licensed Product, all filings and supporting documents submitted to an FRA relating to such Licensed Product, and all data contained therein, including, without limitation, any INDs, BLAs, investigators brochures, correspondence to and from that FRA, minutes from teleconferences with that FRA, registrations and licenses, regulatory drug lists, advertising and promotion documents shared with that FRA, adverse event files, complaint files and Manufacturing records.