BLA

BLA. Shall mean a Biologics License Application made according to regulations of the United States Food and Drug Administration ("FDA") or an equivalent application submitted to a corresponding foreign or international regulatory agency.

BLA. Shall mean a Biologics License Application, as defined by the regulations promulgated under the FD&C Act and the United States Public Health Services Act, and any supplements thereunder, as amended from time to time, with respect to Labeled Drug.

BLA. Means a Biologics License Application (or any successor application) filed with the FDA with respect to the Next Generation ******, or any comparable filing made with a regulatory authority outside the United States.

BLA. The approved biologics license application for Regulatory Approval of the Product in the United States of America, as amended;

BLA. The FDA required Biologic License Application or a corresponding license required by a Regulatory Authority.

BLA. A Biologics License Application.

BLA. The term "BLA" or "Biologics License Application" shall mean a request to the FDA for permission to introduce, or deliver for introduction, a biologic product into interstate commerce under 21 CFR § 601.2 or its foreign equivalent.

BLA. A Biologics License Application, or similar application for marketing approval of a Licensed Product for use in the Field submitted to the FDA, or a foreign equivalent of the FDA.

BLA. Means a biologicals license application, as defined in the FD&C Act, or any equivalent document filed with the FDA and necessary for the commercial distribution of a biologicals product for humans or any application or other documentation filed with any Regulatory Authority of a country other than the U.S. required for commercial distribution of any biologicals product for humans in that country.

BLA. Means, with respect to a Licensed Product and a jurisdiction, approval or authorization from the relevant governmental authority to market and sell such Licensed Product in the Field in such jurisdiction.