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.

Split View

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Get StartedSchedule a Demo

BLA Filing means acceptance of the filing of a BLA 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.

• If in any year of a Post BLA Filing Plan the aggregate expenses incurred by the Parties are in excess of [***] of the amounts set out in the Post BLA Filing Budget for that year (a "Post BLA Excess Year") then each Party shall charge to its R&D Account [***] of such [***] and, in addition, ELAN shall charge to its R&D Account any amounts in excess of such [***] (the "Post BLA Excess Charge").

• 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.

• If CAT's liability hereunder in any year does exceed [***] of [***] of the relevant Post BLA Filing Budget then this Section shall apply mutatis mutandis thereto.

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 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 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 (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.

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

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