Master Files definition

Master Files means all drug master files and device master files relating to Product filed or that may be filed with any Regulatory Authority in any country or jurisdiction in the Territory.

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Master Files means submissions made to the FDA in order to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more veterinary drugs, and includes both the master files maintained by the FDA Center for Drug Evaluation and Research (generally referred to as “Drug Master File(s)” or “DMF(s)”) and those maintained by the FDA Center for Veterinary Medicine (generally referred to as “Veterinary Master File(s)” or “VMF(s)”).

Master Files means submissions made to the FDA in order to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more veterinary drugs, and includes both master files maintained by the FDA Center for Drug Evaluation and Research (generally referred to as drug master files) and those maintained by the FDA Center for Veterinary Medicine (generally referred to as veterinary master files).

Examples of Master Files in a sentence

• Licensee shall make certain data generated during the research and development of Testim accessible to Licensor through the preparation and filing of one or more Drug Master Files (“DMF”).

• Except as otherwise provided herein, nothing in this Agreement shall, during or after the Term hereof, give Reliant any of Novartis’ rights in or to the Product, including, but not limited to, Novartis’ rights in or to trademarks, copyrights, the NDAs, ANDAs, Drug Master Files, patent rights, preclinical or clinical data, manufacturing rights relating to the Product, or any supply of the Product or the active ingredient thereof.

• Licensor shall grant to Licensee (and the agreed upon provider) access to various SPE marketing sites containing available metadata for the Picture Master Files.

• Miltenyi has established, or may from time to time establish, Master Files for one or more Miltenyi Products with one or more Regulatory Authorities in the Territory.

• The SSA records are from the Earnings Recording and Self-Employment Income System, SSA/OEEAS 09–60–0059 and Master Files of Social Security Number Holders and SSN Applications, SSA/OEEAS, 60–0058, (referred to as ‘‘the Numident’’).

• If needed, 3M will provide for regulatory review by right of reference to Drug Master Files.

• Miltenyi shall solely own and retain all rights, title and interest in and to the Master File(s) (and any pertaining regulatory documentation).

• Master Files of SSN Holders and SSN Applications, 60-0058, last fully published at 87 Fed.

• Catalent expressly agrees that Xencor shall have the right to reference any and all Drug Master Files relating to any Product or Technology covered by this Agreement insofar as such information is necessary or desirable in the prosecution of any submission to the FDA and/or other regulatory agencies.

• SSA’s SOR applicable to the verification process is the Master Files of SSN Holders and SSN Applications (Enumeration System), 60-0058, as published at 75 FR 82121 (December 29, 2010), as amended at 78 FR 40542 (July 5, 2013) and 79 FR 8780 (February 13, 2014).

More Definitions of Master Files

Master Files means all carbon product protocol master files and carbon measurement device master files relating to Product filed or that may be filed with any relevant carbon entity in any country or jurisdiction in the Territory.

Master Files shall have the meaning set forth in the Supply Agreement.