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.

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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

• 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.

• Since the BLA Approval Date, neither Seller nor its Affiliates has sought to acquire license rights to any registered intellectual property owned by a Third Party, which license rights are required for Seller and its Affiliates’ use of the Product and conduct of the Product Business since the BLA Approval Date.

• 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.

• On or at any time after the occurrence of a Payment Acceleration Event, Seller may by notice to Buyer declare that all or part of the outstanding BLA Approval Payments, together with accrued interest, and all other amounts accrued or outstanding under this Agreement be due and payable, at which time they shall become due and payable [***].

• 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.

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 approval from the FDA of Borrower’s Biologics License Application with respect to Atacicept for the treatment of IgA nephropathy (“IgAN”), written evidence of which approval is provided, and is in form and content reasonably acceptable, to Collateral Agent.

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.

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 approval of an BLA for the Product by FDA. 1.76 “BLA Approval Date” means date on which Client receives the BLA Approval for the Product. 1.77 Net Profit” means, for any calendar quarter or year (as applicable), Net Sales of the Product in the Territory during such calendar quarter or year, less the [***]. 1.78 “Net Sales” means the gross amounts invoiced by or on behalf of Client and its Affiliates (including by EVERSANA or its Affiliates on behalf of Client) on sales of Product to Third Party purchasers in the Territory, less the following deductions, if not previously deducted from the invoiced amount to the extent attributable to the Product (“Net Sales Deductions”):

BLA Approval means the approval of an BLA for the Product by the FDA. 1.16 “BLA Date” means the date the Client receives the BLA Approval from the FDA. 1.17 “Brand Team” means the leadership team established by EVERSANA to oversee Commercial operations, including, but not limited to the following members: Commercial Lead or Chief Commercial Officer, Project Manager, Market Access Lead, Marketing Lead, Commercial Operations Lead, and Scientific & Medical Affairs Lead. 1.18 “Business Day” means a day other than Saturday or Sunday or other day on which commercial banks in the State of New York are authorized or required by law to close. 1.19 “Change of Control” means, in a single transaction or series of related transactions, any one or more of the following events: (a) the acquisition of Client by a Third Party (including, any merger, consolidation in which the majority of the outstanding shares of Client are exchanged for securities or other consideration issued, or caused to be issued, by the acquiring entity or its subsidiary, but excluding any transaction effected primarily for the purpose of changing Client’s jurisdiction of incorporation), unless Client’s shareholders of record as constituted immediately prior to such transaction or series of related transactions will, immediately after such transaction or series of related transactions