BLA Definition: 2k Samples

BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

BLA means a Biologics License Application, for which Regulatory Approval by the FDA is required to market a Product in the U.S.

BLA means a biologics license application, or similar application, submitted to a Regulatory Authority.

Examples of BLA in a sentence

If either Party becomes aware of any existing or threatened infringement of the GCLC Core Patents or Joint Patents, or the filing of a BLA by a Third Party for a product that names a Licensed Product as a reference product (or similar filing in a country other than the U.S.), it shall promptly notify the other Party in writing to that effect, and the Parties will consult with each other regarding any actions to be taken with respect to such infringement.
If either Party becomes aware of any existing or threatened infringement of the Product Patents or Additional Joint Patents, or the filing of a BLA by a Third Party for a product that names a Product as a reference product (or similar filing in a country other than the U.S.), it shall promptly notify the other Party in writing to that effect, and the Parties will consult with each other regarding any actions to be taken with respect to such infringement.

BLA means a complete biologics license application as defined in, and containing the content, and in the format, required by 21 C.F.R. § 600 et seq filed with the FDA, or a corresponding application with a Regulatory Authority in a country other than the United States, together with all replacements, additions, deletions, and supplements thereto.

BLA means basic liquidity adjustment which is 0% or 25% as determined by Fitch in accordance with the Fitch Criteria;

BLA means a Biologics License Application to the FDA or an equivalent application to any other Government Authority within the Territory requesting market approval for a new biological product (or a New Drug Application (NDA), or equivalent application, in the event that the FDA or other Government Authority determines that an NDA, rather than a BLA, is the appropriate mechanism for requesting such approval).

BLA means a Biologics License Application submitted to the FDA pursuant to Section 351 of the Public Health Service Act (42 U.S.C. § 262) and the FDA’s implementing regulations at 21 C.F.R. Part 601.

BLA means (i) (x) a biologics license application (as defined in the FD&C Act) to introduce, or deliver for introduction, a biologic product, including vaccines into commerce in the U.S., or any successor application or procedure and (y) any similar application or functional equivalent relating to biologics licensing applicable to or required by any non-U.S. Governmental Authority, and (ii) all supplements and amendments that may be filed with respect to the foregoing.