Biologic License Application definition

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Biologic License Application or “BLA” 5.1.1 “Breaching Party” 13.2 “BTC” 1.10 “CDS” 5.1.1 “CHMP” 5.2.1(a) “CMC” 1.80 “Commercialization Payments 8.3.1

Biologic License Application means a biologics license application filed with the FDA pursuant to 21 C.F.R. § 601.2 et seq., or any foreign equivalent filed with the Regulatory Authorities in a country or territory to obtain authorization to market A1PI IV Product in such country or territory.

Examples of Biologic License Application in a sentence

Auxilium shall, as soon as reasonably practicable after it becomes available, provide Pfizer with a copy of the Biologic License Application (“BLA”) for submission for the Product in the Field in the U.S. The foregoing shall be provided in an electronic format with a content and specification in such form as such other Party may reasonably request including formatting such that each clinical study report is merged with bookmarks applied to the table of contents as a PDF document.
There are no options, warrants, rights, calls, commitments or agreements of any character to which the Company is a party or by which it is bound calling for the issuance of shares of capital stock of the Company or any securities convertible into or exercisable or exchangeable for, or representing the right to purchase or otherwise receive, any such capital stock, or other arrangement to acquire, at any time or under any circumstance, capital stock of the Company or any such other securities.
Employee shall be paid a cash bonus of $139,024 as of the date the Company files a Biologic License Application for its PolyHeme blood substitute product with the United States Food and Drug Administration.
In November of 2016, the United States Food and Drug Administration (the “FDA”) granted Fast Track designation for AG013, and we believe it may be eligible for Biologic License Application (“BLA”) exclusivity as well.
In accordance to the 21 CFR 601.12, Changes to an Approved Application, and as agreed upon by both parties, BAXTER will supply documentation to support the Zevalin Biologic License Application (BLA).
Employee shall be paid a cash bonus of $116,479 as of the date the Company files a Biologic License Application for its PolyHeme blood substitute product with the United States Food and Drug Administration.
Fujifilm may not make any Modifications without the prior written consent of Sponsor, other than a Modification required by a Regulatory Authority that would not affect the Product’s Biologic License Application (or foreign equivalent) or Product validation.
In consideration for Lonza carrying out the Services as detailed in Schedule 2 (Stages and 20) the Customer shall pay Lonza as follows: Stage 19 Preparation of a Biologic License Application (BLA) to support the Customer's Regulatory Filing to the US FDA of the Product.
If such a Modification required by a Regulatory Authority would affect the Product’s Biologic License Application or Product validation, the Parties shall discuss such proposed Modification in good faith and such Modification shall require Sponsor’s prior written consent, which consent shall not be unreasonably withheld or delayed.
NPS is also developing Natpara® (rhPTH[1-84]) for the treatment of adult hypoparathyroidism and expects to submit its Biologic License Application (BLA) to the FDA in 2013.

More Definitions of Biologic License Application

Biologic License Application or "BLA" shall mean a Biologic License Application filed with the FDA in accordance with applicable regulations and requirements of the FDA in effect from time-to-time.

Biologic License Application or “BLA” means a Biologic License Application in the United States as described in Section 351(a) of the United States Public Health Service Act (“PHS Act”) or an abbreviated Biologic License Application as described in Section 351(k) of the PHS Act.

Biologic License Application means (a) an application requesting permission from the FDA to introduce, or deliver for introduction, a biopharmaceutical product into interstate commerce, or (b) any similar application or submission for Marketing Approval of a biopharmaceutical product filed with a Regulatory Authority in a country or group of countries. 1.9 “Business Day” means a day other than a Saturday, Sunday or a bank or other public holiday in California or New York. 1.10 “Calendar Quarter” means a period of three consecutive calendar months ending on March 31, June 30, September 30 or December 31. 1.11 “Calendar Year” means any twelve (12) month period beginning on January 1 and ending on the first December 31 thereafter. 1.12 “Change of Control” means, with respect to a Party, (a) a merger, reorganization, combination or consolidation of such Party with a Third Party that results in holders of beneficial ownership (other than by virtue of obtaining irrevocable proxies) of the voting securities or other voting interests of such Party (or, if applicable, the ultimate parent of such Party) immediately prior to such merger, reorganization, combination or consolidation ceasing to hold beneficial ownership of at least fifty percent (50%) of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger, reorganization, combination or consolidation, (b) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the beneficial owner (other than by virtue of obtaining irrevocable proxies) of fifty percent (50%) or more of the combined voting power of the outstanding securities or other voting interest of such Party, or (c) the sale, lease, exchange, contribution or other transfer (in one transaction or a series of related transactions) to a Third Party of all or substantially all of such Party’s assets to which this Agreement relates, other than a sale or disposition of such assets to an Affiliate of such Party or (d) the approval of any plan or proposal for the liquidation or