Biologic License Application definition

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.
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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.
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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
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Examples of Biologic License Application in a sentence

  • Cx601 has been filed for regulatory approval in Europe and a global Phase III trial intended to support a future U.S. Biologic License Application (BLA) started in 2017.

  • Seeking the benefits of the subsection (k) pathway, Hospira submitted its Biologic License Application (“BLA”) No. 125545 (“the Hospira BLA”) to the FDA, requesting that its biological product (“the Hospira Epoetin Biosimilar Product”) be licensed by relying on Amgen’s demonstration of the safety and efficacy of EPOGEN® (epoetin alfa).

  • Cx601 has been filed for regulatory approval in Europe and a global Phase III trial intended to support a future U.S. Biologic License Application (BLA) is expected to start in 2017.

  • Amgen, through the conduct described herein, and in violation of its statutory obligations, has obstructed Genentech’s ability to perform an infringement analysis of its patent portfolio by withholding “confidential information” highly relevant to that analysis and by unreasonably withholding its permission for any of Genentech’s expert consultants to review the limited information (i.e., the Abbreviated Biologic License Application, or “aBLA”) Amgen has provided.

  • These meetings typically include the following: reviewing the transcript, graduation requirements, and senior year course selection; developing an appropriate standardized test schedule; and discussing college and career goals.

  • In August 2016, Coherus filed an abbreviated Biologic License Application (“aBLA”) seeking FDA approval to market a biosimilar version of Amgen’s pegfilgrastim prod- uct Neulasta.

  • The FDA does require manufacturers to report the amount of overfill as part of the Biologic License Application (“BLA”) process for a drug and to provide the rationale for that amount.

  • Additionally, the FDA’s Rare Pediatric Disease Priority Review Voucher Program states that a sponsor with a Rare Pediatric Disease designation who receives a New Drug Application (NDA) or Biologic License Application (BLA) approval for a rare pediatric disease may be eligible for a voucher that can be redeemed to obtain priority review for any subsequent marketing application.

  • HGS has expended substantial resources researching and developing Benlysta®, including filing a Biologic License Application (“BLA”) with the United States Food and Drug Administration (“FDA”).

  • In a press release dated February 16, 2021, Sesen announced that the U.S. Food and Drug Administration (the “FDA”) has accepted for filing Sesen’s Biologic License Application (“BLA”) for Vicineum.


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.
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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.
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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
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Related to Biologic License Application

  • Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.

  • Specific license means a license, under requirements prescribed by the department by rule, to possess, use, manufac- ture, produce, transfer or acquire radioactive material or devices or equipment utilizing radioactive material.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Licensed Product as a drug in a regulatory jurisdiction.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

  • Mobile Application means a specialized software program downloaded onto a wireless communication device.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Software Application means a digital product or service as defined in Article 2, point 13, of Regulation (EU) …/… [on contestable and fair markets in the digital sector (Digital Markets Act)];

  • Sub-License means the sub-licensing of any space in the Station Development Assets and Project Utilities in the Station Development Project, by the Station Facility Manager to any licensee, in accordance with the Station Facility Management Agreement;

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. § 601.2, or any equivalent or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the United States.

  • Planning Application means the application for [outline/full] planning permission dated [ ] bearing the Council’s reference number [ ];

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • ANDA means an abbreviated new drug application filed with the FDA, pursuant to its rules and regulations (or any equivalent or replacement mechanism).

  • Generation Licence means an electricity generation licence granted or treated as granted pursuant to section 6(1)(a) of the EA 1989 that authorises a person to generate electricity;

  • Copyleft License means any license that requires, as a condition of use, modification and/or distribution of software subject to such license, that such software subject to such license, or other software incorporated into, derived from, or used or distributed with such software subject to such license (i) in the case of software, be made available or distributed in a form other than binary (e.g., source code form), (ii) be licensed for the purpose of preparing derivative works, (iii) be licensed under terms that allow the Company’s or any Subsidiary of the Company’s products or portions thereof or interfaces therefor to be reverse engineered, reverse assembled or disassembled (other than by operation of Law) or (iv) be redistributable at no license fee. Copyleft Licenses include the GNU General Public License, the GNU Lesser General Public License, the Mozilla Public License, the Common Development and Distribution License, the Eclipse Public License and all Creative Commons “sharealike” licenses.

  • Patent Application means an application for patent protection for an Invention with any domestic or foreign patent-issuing authority.