Definition of FDA Documentation

FDA Documentation means, with respect to a Licensed Product, all filings and supporting documents submitted to the FDA relating to such Licensed Product, and all data contained therein, including, without limitation, any INDs, BLAs, investigators brochures, correspondence to and from the FDA, minutes from teleconferences with the FDA, registrations and * This provision is the subject of a Confidential Treatment Request. licenses, regulatory drug lists, advertising and promotion documents shared with the FDA, adverse event files, complaint files and Manufacturing records.

Examples of FDA Documentation in a sentence

For greater certainty, the FDA Documentation shall exclude any information that relates to the business or other products, technology or know-how of QLT other than the Vanadium Technology.
Akesis, hereby, in consideration of the receipt of the FDA Documentation, agrees that it will defend, indemnify and hold QLT, and its directors, officers, employees, and agents harmless from and against any and all third party claims and actions, and losses, liabilities, damages, costs, and expenses (including reasonable attorneys fees) resulting therefrom, based on the use of the FDA Documentation by Akesis or the development or commercialization of the Vanadium Technology by Akesis.
In consideration of the foregoing, UBC and Akesis agree that, except as expressly provided above, they shall not, without the consent of QLT, reproduce the FDA Documentation in any publications or promotional material and shall not use the name of QLT (including the name of Kinetek) in any publications, press releases or other materials.
After termination of the License Agreement, QLT has returned to UBC certain data and documentation and retained other data and documentation developed by Kinetek in connection with its development and commercialization of the Vanadium Technology, including the data and documents described in the attached Appendix A relating to Kineteks Investigational New Drug Application and Phase I clinical trial (the FDA Documentation).