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 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

• During the term of this Agreement, the Project Sponsor shall have the exclusive authority to schedule events and functions at the Facility.

• If a question of grievability or Arbitrability is not resolved by either Party, the issue will be referred to the arbitrator as a threshold issue in the arbitration hearing based on the merits of the grievance.

• 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.

• Seller has provided to Buyer true and complete copies of the BLA Approval Letter and any other material communications between Seller or any of its Affiliates and the FDA regarding the Priority Review Voucher.

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

More Definitions of BLA Approval

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 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 approval by the FDA for marketing and sale of a Product in the United States, including any applicable final labelling 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 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 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 notification from a regulatory authority in a country that all approvals for the marketing of Licensed Product, including pricing approvals, have been granted.