NDA. “NDA” shall mean (a) (i) a New Drug Application submitted to the FDA, or any successor application or procedure, and (ii) any foreign counterpart of such a New Drug Application, and (b) all supplements and amendments, including supplemental New Drug Applications (and any foreign counterparts) that may be filed with respect to the foregoing.
Appears in 3 contracts
Samples: License Agreement (Discovery Partners International Inc), License Agreement (Infinity Pharmaceuticals, Inc.), License Agreement (Discovery Partners International Inc)
NDA. “NDA” shall mean (a) (i) means a New Drug Application submitted to the FDA, or any successor application or procedure, and (ii) any foreign counterpart of such a and/or an Abbreviated New Drug Application, and (b) all supplements and amendments, including supplemental New Drug Applications (and any foreign counterparts) that may be filed with respect to the foregoingFDA, together with all amendments and supplements thereto.
Appears in 2 contracts
Samples: Three Way Agreement, Three Way Agreement (Nabriva Therapeutics PLC)