Regulatory File

Regulatory File. Any regulatory file at FDA that contains information that can be referenced via a letter of authorization, including but not limited to Drug Master File (DMF), Device Master File (MAF), Investigational New Drug Application (IND), Abbreviated New Drug Application (ANDA), or New Drug Application (NDA), if applicable.

Regulatory File. Means all completed or partially completed (a) data and results provided by LICENSOR according to this Agreement and derived during the Term from or for: (i) the Licensed Orphan Designation; (ii) the Licensed IND or any other new IND application for Licensed Product; (iii) any associated new drug application (NDA), biologic license application (BLA), investigational device exemption (IDE) or other application required to be filed with a Regulatory Authority for a Licensed Product; and (iv) any... preclinical testing for a Licensed Product; and (b) all correspondence with, submissions to, and notices from Regulatory Authorities related to the foregoing. View More