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

  • 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.

  • Carticel received a Biologic License Application (“BLA”) approval in 1996 with a number of post approval commitments, including a pivotal clinical trial and a registry.MACI was obtained via the acquisition by Genzyme of Verigen AG in 2005.

  • The acquired assets include a pre-Investigational New Drug (IND) package for P3A (SYN-004), Phase I and Phase II clinical data for P1A, manufacturing processes and data, and a portfolio of issued and pending U.S. and international patents intended to support an IND and Biologic License Application (BLA) with the FDA.

  • Carticel received a Biologic License Application ("BLA") approval in 1996 with a number of post approval commitments, including a pivotal clinical trial and a registry.

  • 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.

  • FDA notified Mylan that its application—i.e., its abbreviated Biologic License Application, or “aBLA” No. 761274—for M710 had been accepted for review.

  • Id. Abbvie holds the drug’s Biologic License Application (“BLA”).

  • If the study includes investigational agents, then in addition to the above requirements, records may only be destroyed two years after the New Drug Application (NDA) or Biologic License Application (BLA) has been approved or withdrawn, or the Investigation New Drug (IND) has been withdrawn/closed.

  • 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.

  • The approval process begins when a New Drug Application (NDA), or in the case of a biologic, a Biologic License Application (BLA) contains enough information to permit FDA review.


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 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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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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Related to Biologic License Application

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • 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.

  • Automatic licensure means granting the occupational licensure without an individual having met occupational licensure requirements provided under the Arkansas Code or by other provisions in these Rules.

  • Public library means a library that is lawfully established for free public purposes by 1 or more counties, cities, townships, villages, school districts, or other local governments or a combination thereof, or by a public or local act, the entire interests of which belong to the general public. Public library does not include a special library such as a professional, technical, or school library.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a 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 to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • 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.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epi­ dermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

  • ANDA means Abbreviated New Drug Application.

  • Therapeutic school means a residential group living facility:

  • 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;

  • Alcoholic liquor means that term as defined in section 105 of the Michigan liquor control code of 1998, 1998 PA 58, MCL 436.1105.

  • 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 a CRADA Subject Invention with the United States Patent and Trademark Office (“U.S.P.T.O.”) or the corresponding patent-issuing authority of another nation.

  • Cannabinoid means any of the chemical compounds that are the active constituents of marijuana.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.