definiens: means a new drug application, hea lth regi st rati on, marketing a uthori zati on appli cation, common technical document, regul atory submission, notice of com p li ance or equi valent application ( excluding local and general business li censes and permi ts ) req uired to be approved before commer cial sale or use of the Product as a pharm aceuti ca l or medi c inal product in a Jurisd icti on ( includi ng, w ith respe ct to any Jurisd icti on other than the U.S., an y Prici n g Appr ova ls and/or Reimbur sement Approva ls that are comme rciall y necess ary prior to comm erci a l sal e of such Product in such Juri sd i ction ), together with al l subseq uent submi ssi ons, su pp l ements and am endments thereto, in cludin g an NDA in the U.S. or loca l approva ls i n the Juri sdi cti ons as applicable