DMF

DMF. Shall mean the drug master files covering the analysis and manufacturing of API, comprising any and all technical information, including analytical methods, stability and pharmaceutical data and manufacturing processes with respect to API.

DMF. A Drug Master File (or similar dossier filed with an equivalent regulatory body in another country) 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 (or equivalent regulatory body in another country)

DMF. A drug master file as more fully defined in 21 C.F.R §314.420 in the United States, or similar documents filed with a Regulatory Authority in another jurisdiction.

DMF. Shall mean Drug Master File

DMF. Means a Drug Master File as described in 21 CFR 14.420.

DMF. Shall mean the drug master file covering the analysis and manufacturing of the API which was filed with the FDA by XIANJU (DMF Number 23934), comprising any and all technical information, including, without limitation, analytical methods, stability and pharmaceutical data and manufacturing processes with respect to the API in the possession of XIANJU.

DMF. Means a Drug Master File for Captisol, as on file as of the Effective Date, and as hereafter updated from time to time during the Term, by CyDex with the FDA or an equivalent filing made outside the United States.

DMF. Any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions covering Product.