DMF

DMF. Means a Drug Master File for Captisol, as filed as of the Effective Date, or as hereafter updated from time to time during the Term, by CyDex with the FDA.

DMF. A Drug Master File filed with the FDA, EMA, MHLW or another foreign equivalent

DMF. Shall mean the Drug Master File or modifications to such corresponding files in other countries of the Territory developed and filed by EURAND which relate to the Product.

DMF. Shall mean the Drug Master File (together with all subsequent submissions, supplements and amendments thereto, and any materials, documents or information referred to or relied upon thereby) in the United States and any similar files in other countries of the Territory that relate to the Product.

DMF. Means the Drug Master File, as defined in the 21 C.F.R., Section 314.420 and/or its equivalent in the other countries of the Territory, which Elan (or an Affiliate) may file in respect of the Elan Technology and the application of the Elan Technology as regards the Product.

DMF. Means the Drug Master File developed and filed with the FDA by EURAND which relates to and describes the composition and manufacture of the Product (including all manufacturing batch records, stability information, quality control and assurance assays and procedures for the Product that are reasonably necessary for the chemistry and manufacturing controls section of an NDA.

DMF. Means a drug master file to be maintained with the applicable regulatory authorities in each country of the Territory.

DMF. Means the open and closed portions of the Drug Master File required to manufacture, market and sell Drug Substance in bulk form in the United States, filed with the FDA and to be maintained by Reddy with the FDA.

DMF. Means a Drug Master File for CAPTISOL, as currently filed, or as hereafter updated from time to time, by CyDex with the FDA.

DMF. The drug master file, confidential or otherwise, covering the manufacture and analysis of an API with respect to a Product in the Territory.