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 the approval, registration, license, permit, or authorization issued by the appropriate competent authorities necessary or desirable to market and commercialize a pharmaceutical or biological product in a country or jurisdiction.

Examples of BLA Approval in a sentence

• Seller has made available to Buyer copies of material complaints and notices of alleged defect or adverse reaction with respect to the Product that have been received in writing by Seller and its Affiliates since the BLA Approval Date.

• The payment pertaining to each Development and Regulatory Milestone, other than the BLA Approval Milestone Payment which shall be governed in accordance with Section 3.2(a), shall be made by Buyer to Seller within ninety (90) days after the achievement of the corresponding Development and Regulatory Milestone.

• Current strategies to minimize disturbance and siltation are being developed and are planned for implementation.

• Kolltan may terminate any given Project if Kolltan elects not to continue pursuing the pre-clinical development, clinical development and/or regulatory approval of the Product where Kolltan believes, in good faith, that the Product will not be able to get approved by the FDA under a Biologics License Application (“BLA Approval”) or by the foreign equivalent of the FDA under the foreign equivalent of a BLA Approval, based on the actual or expected clinical merits of the Product.

• 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 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 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 for the applicable Licensed Product (whether alone for as part of a Combination Product or combination therapy).

BLA Approval means the approval by the FDA of a Biologics License Application as more fully defined in 21 C.F.R. Part 600 (including a New Drug Application defined in 21 C.F.R. Part 300 filed with the FDA), or the European Medicines Agency pursuant to the centralized approval procedure or by the applicable regulatory authority of a country in Europe with respect to the mutual recognition or any other national approval procedure for a biologic product (or combination product incorporating a biologic product).

BLA Approval means notification from a regulatory authority in a country that all approvals for the marketing of Licensed Product, including pricing approvals, have been granted.

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 has the meaning set out in the LDA.