BLA Filing definition

BLA Filing means the acceptance by the FDA of the filing of a BLA for the applicable Product in the U.S.

BLA Filing means the date on which the first BLA for Product in any country of the Territory has been submitted which BLA has been accepted (but not yet approved) by the applicable Regulatory Authority.

BLA Filing means the filing of a BLA for the Product in the US.

Examples of BLA Filing in a sentence

• As soon as practicable after the BLA Filing Date, and consistent with the transition plan adopted by the PDC and contained in the initial Clinical Development Plan, the Company shall transition such clinical and other studies ongoing with respect to the Products which have been identified in such Clinical Development Plan as being transferred to ERS in such transition plan from the Company's sole control to the control of the Party(ies) set forth in the initial Clinical Development Plan.

• Therefore, until the Initial Regulatory Filing is made (the "BLA Filing Date"), the Company shall be primarily responsible for conducting the clinical studies and all other regulatory matters, manufacturing matters and/or pre-clinical studies necessary to support, prepare and file the Initial Regulatory Filing until the BLA Filing Date, and the Company shall use all commercially reasonable efforts necessary to make the Initial Regulatory Filing.

• In preparing and updating the Commercialization Plan, Commercialization Budget, each Post BLA Filing Plan and each Post BLA Filing Budget, ELAN will take into consideration factors such as market conditions, regulatory issues and competition.

• Pursuant to the Development Plan, (a) Lannett shall (i) be the sponsor for and design all Clinical Trials for the Product for the US commenced prior to the submission of the BLA Filing and (ii) be responsible for preparing the BLA Filing and (b) HEC shall be responsible for submitting the BLA Filing to the FDA.

• The Post BLA Filing Budget shall be based on and shall supersede the relevant Commercialization Budget.

More Definitions of BLA Filing

BLA Filing means the complete submission and acceptance by the applicable Regulatory Authority of a BLA for filing; provided that such Regulatory Authority has not issued a refusal to file letter or a letter identifying deficiencies for which the Regulatory Authority will suspend its review following submission of such filing.

BLA Filing means a Biologics Licensing Application or New Drug Application filed with the FDA, or the equivalent application to the equivalent agency in any other country, the filing of which is necessary to market and sell a Target Product, including all amendments and supplements to any of the foregoing.

BLA Filing means a Biologics License Application (“BLA”) with respect to RP1 that was submitted by Borrower to

BLA Filing means a Biologics License Application (“BLA”) with respect to RP1 that was submitted by Borrower to the FDA.

BLA Filing means (i) the filing of a BLA for the Product in the Field in the U.S. or (ii) the acceptance of the equivalent application by the equivalent agency in any other regulatory jurisdiction, the filing of which is necessary to obtain Product Approval for the Product in the Field in such jurisdiction, including acceptance of an MAA by the EMEA (or acceptance by the applicable Regulatory Authority in a given country in Europe to the extent mutual recognition or other national approval procedure is utilized) and acceptance of a *** by the ***.

BLA Filing means a Biologics License Application (“BLA”) with respect to RP1 that was submitted by Borrower to the FDA. “Blocked Person” means any Person: (a) listed in the annex to, or is otherwise subject to the provisions of, Executive Order No. 13224, (b) a Person owned or controlled by, or acting for or on behalf of, any Person that is listed in the annex to, or is otherwise subject to the provisions of, Executive Order No. 13224, (c) a Person with which any Lender is prohibited from dealing or otherwise engaging in any transaction by any Anti Terrorism Law, (d) a Person that commits, threatens or conspires to commit or supports “terrorism” as defined in Executive Order No. 13224, or (e) a Person that is named a “specially designated national” or “blocked person” on the most current list published by OFAC or other similar list. “Board of Directors” means the board of directors or comparable governing body of such Person, or any subcommittee thereof, as applicable. “Borrower Products” means all products, software, service offerings, technical data or technology currently being designed, manufactured or sold by Borrower or which Borrower intends to sell, license, or distribute in the future including any products or service offerings under development, collectively, together with all products, software, service offerings, technical data or technology that have been sold, licensed or distributed by Borrower since its incorporation and remain material to its business. “Borrower’s Books” means Borrower’s or any of its Subsidiaries’ books and records including ledgers, federal, state, local and foreign tax returns, records regarding Borrower’s or its Subsidiaries’ assets or liabilities, the Collateral, business operations or financial condition, and all computer programs or storage or any equipment containing such information. “Business Day” means any day other than Saturday, Sunday and any other day on which banking institutions in the State of California are closed for business.

BLA Filing means the Biologics License Application with respect to Teplizumab that was submitted by PRVB to the FDA.