NDA

NDA. The Confidentially and Non-Disclosure Agreement between Seller and ASK dated January 25, 2018.

NDA. Is defined in paragraph 10.c

NDA. A New Drug Application or Biologic License Application filed with the U.S. Food and Drug Administration for marketing approval of a pharmaceutical product or any successor applications or procedures, and all supplements and amendments that may be filed with respect to the foregoing. The term "NDA" shall not include applications for pricing or reimbursement approval.

NDA. (a) (i) a New Drug Application submitted to the FDA, or any successor application or procedure, as more fully defined in 21 C.F.R. § 314.50 et seq., or (ii) any non-United States counterpart of such a New Drug Application, and (b) all supplements and amendments, including supplemental New Drug Applications (and any non-United States counterparts) that may be filed with respect to the foregoing

NDA. Means each of the Company NDA and the IFID NDA

NDA. A new drug application (or any successor form or application having substantially the same effect with respect to the approval of a drug for marketing and sale)

NDA. Shall mean a United States New Drug Application.

NDA. A New Drug Application (as described in 21 C.F.R. § 314) that is submitted to the U.S. Food and Drug Administration ("FDA") to propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.

NDA. Means a New Drug Application, or the equivalent submission, submitted to the applicable Regulatory Agency.

NDA. A New Drug Application as submitted to the FDA for marketing approval in the United States, or similar marketing license applications in other countries.