BLA Approval definition

BLA Approval means, with respect to a Product, receipt of Regulatory Approval of a BLA by the FDA for such Product in the U.S.

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 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.

Examples of BLA Approval in a sentence

• If the Borrower has not received the Final BLA Approval on or prior to December 31, 2021, the Subsequent Convertible Loan Commitments shall immediately and automatically terminate on such date without any action or notice by any Person.

• 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.

• 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.

• No later than the first Business Day following the date on which the Borrower receives the Final BLA Approval (but in no event prior to the time at which the Final BLA Approval is Publicly Disclosed as required by Section 6.17(b)), the Borrower shall deliver to the Agent a fully executed Disbursement Request, together with reasonable evidence thereof to each of the Lenders (and thereafter promptly respond to any request for additional supporting documentation and/or other evidence from any of the Lenders).

More Definitions of BLA Approval

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.

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 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 has the meaning set forth in Section 3.2.

BLA Approval means receipt of a biologics license from the FDA to market a biological product in the United States pursuant to 21 C.F.R. § 601.20.