Regulatory Application

Regulatory Application. Means any regulatory application or any other application for marketing approval for the Product, which NitroMed may file in the Territory, including any supplements or amendments thereto which NitroMed may file.

Regulatory Application. The new drug application or other submission made by Customer to the FDA, or any equivalent regulatory agency in the Territory, seeking allowance to market, distribute, and sell the Product in the United States and/or elsewhere in the Territory, as such application may be amended or supplemented.