BLA definition

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

• The Company will use its reasonable best efforts to resubmit to the FDA prior to February 1, 2024 the BLA for LYMPHIRTM (denileukin diftitox) in accordance with Company’s plan to address the FDA’s complete response letter received by the Company on July 28, 2023, and with any additional guidance provide by the FDA to the Company.

• Seller shall be permitted to make sure reasonable modifications to the proposed boundaries of the Land as may be necessary or required in pursuing the Approvals to ensure legal compliance of all land affected by the BLA Process, as well as committing to reserve or grant such easements as may be required as part of the BLA Process.

• In the event that Opthea fails to use Commercially Reasonable Efforts to so obtain Regulatory Approval for the Product or fails to file a BLA for the Product for the Indication in the U.S. within [***] following achievement of the Phase 3 Success Criteria for the Product, and this failure is not cured as set forth in Section ‎13.4.2, the Required Investors may terminate this Agreement pursuant to Section ‎13.4.2.

• The Company and the Subsidiaries have not failed to submit to the FDA any IND, BLA or NDA necessary to conduct the business of the Company and the Subsidiaries, any such filings that were required to be made were in material compliance with applicable laws when filed, and no material deficiencies have been asserted by the FDA with respect to any such filings or submissions that were made.

• The BLA Process shall be considered “complete” upon completion of the activities in the previous sentence.

More Definitions of BLA

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 with respect to a Licensed Product, a filing serving to apply for Regulatory Approval including, in the United States, a Biologics License Application (as defined in the FDC Act and the regulations promulgated thereunder (21 CFR 600 et seq)), in the European Union, a Marketing Approval Application (MAA), or, in any other jurisdiction, a comparable filing, and, in each case, any amendments 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 Biologic License Application (as more fully described in U.S. 21 C.F.R. Part 601.20 or its successor regulation), as may be amended from time to time, or any analogous application or submission with any Regulatory Authority outside of the United States.

BLA means a biologics license application that is submitted to the FDA for a Licensed Product, pursuant to 21 C.F.R. § 601.2.

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 (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.