Device Master File

Device Master File. Means the device master file for Polymer intended to be filed or filed by Tepha with the U.S. Food and Drug Administration. * Denotes confidential information that has been omitted from the exhibit and filed separately, accompanied by a confidential treatment request, with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. 1

Device Master File. Shall mean materials that may be used to provide detailed information to the FDA about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of the Products or Material.