Registration Application

Registration Application. Shall mean any filing(s) made with the Regulatory Authorities including, without limitation, a new drug submission filed with the TPD, for regulatory approval of the marketing, manufacture and sale (and pricing, as applicable) of the Products, the Method or the DUSA Product in the Territory.

Registration Application. Shall mean a NDA or a comparable filing for Registration in a country , in each case with respect to a Product for application in the Field.

Registration Application. Shall mean any filing(s) made with the Regulatory Authority in any country in the Territory for regulatory approval of the manufacture and sale of the Product in such country.

Registration Application. A New Drug Application under the United States Federal Food, Drug and Cosmetics Act and the regulations promulgated thereunder, or a comparable filing for Registration in a country, in each case with respect to the Product for application in the Field in the Territory