BLA Approval definition

BLA Approval means the final approval of a BLA for a given indication by the FDA for the applicable Licensed Product in the U.S.; provided, that, for milestone payment purposes, BLA Approval shall in any event be deemed achieved upon First Commercial Sale in the U.S. for such indication.

BLA Approval shall be achieved upon receiving Regulatory Approval of a BLA by the FDA for the applicable Product in the U.S.

BLA Approval means approval from the United States Food and Drug Administration (or its equivalent in a Major Market Country outside the United States) of a BLA filed by or on behalf of Introgen, to market a Licensed Product. For such purposes a "BLA" means a Biological License Application, as defined in the United States Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or an equivalent foreign application for marketing approval in Major Market Country outside the United States.

Examples of BLA Approval in a sentence

• The BLA Approval Letter for COMIRNATY® states that, “[t]he final formulated product will be manufactured, filled, labeled and packaged .

• See SOPP 8408.1: Development of Laboratory Quality Product Testing Plans and Release of Lots as Part of the BLA Approval Process.

• FDA website Research into Orphan Drugs approved by the FDA was carried out using the FDA website: www.fda.gov and the links ‘Drugs’, ‘Drug and Biologic Approval and IND Activity Reports’, ‘NDA and BLA Approval Reports’ and ‘Rare Disease and Orphan Drug Designated Approvals’.

• The term “First BLA Approval” as used above, with respect to the US, means the initial BLA Approval for the applicable Licensed Product or Licensed Product combination therapy in the US.

• There is no term or condition imposed by the FDA on the Priority Review Voucher that is not set forth in the BLA Approval Letter or Section 529 of the FDC Act.

More Definitions of BLA Approval

BLA Approval means an approval of a biologics license application for Commercialization of a Consumable made to the FDA under the provisions of the Public Health Service Act in the USA or its equivalent in any other country, which Consumable is in accordance with the Specification and the Requirements.

BLA Approval means the approval of a BLA by the FDA or other applicable Regulatory Authority for a Product containing a Biologic Collaboration Compound in the United States or any other country in the Territory, respectively.

BLA Approval means the Marketing Approval of a BLA by the FDA for a Collaboration Product in the United States, or a foreign equivalent of the FDA for a Collaboration Product in the applicable jurisdiction.

BLA Approval means approval by the FDA for marketing and sale of a Product in the United States, including any applicable final labelling approval.

BLA Approval means the grant by the FDA under 21 C.F.R. §601.20 or §601.40 of the right to market commercially and distribute a Licensed Product(s) within the United States after completion of a Phase III Clinical Trial.

BLA Approval is Lenders’ receipt of evidence satisfactory to Lenders that Borrower has received FDA approval of Borrower’s BLA for its product candidate, TOCA 511, to the FDA.

BLA Approval means the Marketing Approval of a BLA by the FDA for a Collaboration Product in the United States, or a foreign equivalent of the FDA for a Collaboration Product in the applicable jurisdiction. * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission.