Product License Application definition

Product License Application or "PLA" shall mean a Product License Application, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, and any corresponding foreign application, registration or certification.
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Product License Application means a product license application or biologics license application as described in the laws and regulations of the U.S. Public Health Service Act, 42 U.S.C. Section 262, et. seq.
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Product License Application means an application, filed with the U.S. Food and Drug Administration and accepted by that agency for filing, for the purpose of seeking approval to sell a Genentech Licensed Product in the United States.
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Examples of Product License Application in a sentence

  • After successful completion of Phase III trials, the sponsor of the new drug submits a New Drug Application ("NDA") or Product License Application ("PLA") to the FDA requesting that the product be approved for marketing.

  • After successful completion of Phase III trials, the sponsor of the new drug submits a New Drug Application (“NDA”) or Product License Application (“PLA”) to the FDA requesting that the product be approved for marketing.

  • The Company has not, to date, filed a Product License Application for any therapeutic products.

  • The FDA Modernization Act of 1997 (FDAMA) amended the PHS Act to require a single biological license application (BLA) for a biological product, rather than the two licenses— Establishment License Application (ELA) and Product License Application (PLA)—that had been required between 1944 and 1997.

  • Legacy files and parameter descriptions can be found in other formats, from plain text or .csv files to binary formats.

  • S.GrenzandR.Olson, 20th Century Theology (Downers Grove, IL: InterVarsity, 1992), 74.

  • The FDA Modernization Act of 1997 (FDAMA) amended the PHS Act to require a single biological license application (BLA) for a biological product, rather than the two licenses — Establishment License Application (ELA) and Product License Application (PLA) — that had been required between 1944 and 1997.

  • After successful completion of Phase III clinical trials, the sponsor of the new drug submits a New Drug Application (“NDA”) or Product License Application (“PLA”) to the FDA requesting that the product be approved for marketing.

  • Strakan filed a Product License Application in the United Kingdom with the Medicines Control Agency for Zindaclin TM in December 2000.

  • The Food and Drug Administration requires that an investigator will retain records for a period of two years following the date of the New Drug Application or Product License Application is approved for the drug for the indication for which is being investigated; or, if no application or license is to be filed or, if the application or license is not approved for such indication, until two years after the investigation is discontinued (21 CFR 312.62).


More Definitions of Product License Application

Product License Application means any application seeking Regulatory Approval of the Finished Product filed with a Regulatory Authority by Ascent, Recordati, their Affiliates or their subcontractors or sublicensees anywhere in the Territory. For the purposes of this Agreement a PLA includes an NDA or New Drug Application.
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Product License Application shall have the same meaning as understood in the MIT Agreement;
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Product License Application means a product license application made under the NHPR regulations;
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Product License Application or "PLA" means an application to the FDA or the equivalent agency of the European Union or Japan to commence commercial sale of a biological.
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Product License Application means the application submitted to the appropriate regulatory agency (e.g. US FDA) for approval to market a Licensed Product in the United States.
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Related to Product 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.

  • Patent License means all agreements, whether written or oral, providing for the grant by the Company of any right to manufacture, use or sell any invention covered by a Patent, including, without limitation, any thereof referred to in Schedule B hereto.

  • Patent License Agreement means the Patent License Agreement substantially in the form of Exhibit C.

  • CREFC® Intellectual Property Royalty License Fee With respect to each Mortgage Loan (including any REO Mortgage Loan) and for any Distribution Date, the amount accrued during the related Interest Accrual Period at the CREFC® Intellectual Property Royalty License Fee Rate on, in the case of the initial Distribution Date, the Cut-Off Date Balance of such Mortgage Loan and, in the case of any subsequent Distribution Date, the Stated Principal Balance of such Mortgage Loan as of the close of business on the Distribution Date in the related Interest Accrual Period; provided that such amounts shall be computed for the same period and on the same interest accrual basis respecting which any related interest payment due or deemed due on the related Mortgage Loan is computed and shall be prorated for partial periods. For the avoidance of doubt, the CREFC® Intellectual Property Royalty License Fee shall be payable from the Lower-Tier REMIC.

  • Client Application means an application developed by Customer that a) utilizes the Runtime Product, b) is installed fully on an end user’s machine, with all report processing local to that machine, and c) adds significant and primary functionality to the Runtime Product.

  • Product Patents means any Patent Controlled or owned by Quoin in the Territory that, absent the license in Section 2.1, would be infringed by the importation, sale, or use of the Product in the Territory by a third party.

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • 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.

  • ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

  • Patent Applications means all published and unpublished nonprovisional and provisional patent applications, reexamination proceedings, invention disclosures and records of invention, applications for certificates of invention and priority rights, in any country and regardless of formal name, including without limitation, substitutions, continuations, continuations-in-part, divisions, renewals, revivals, reissues, re-examinations and extensions thereof.

  • 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.

  • New Drug Application means a New Drug Application filed with the FDA in accordance with Applicable Law.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Intellectual Property License Agreement shall have the meaning set forth in Section 6.11.

  • 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.

  • Licensed Application means an Application that (a) meets and complies with all of the Documentation and Program Requirements, and (b) has been selected and digitally signed by Apple for distribution, and includes any additional permitted functionality, content or services provided by You from within an Application using the In-App Purchase API.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Third Party License means licenses from third parties governing third party software embedded or used in the Trading Platform.

  • 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.

  • 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 Licenses means all agreements, whether written or oral, providing for the grant by or to any Grantor of any right to manufacture, use or sell any invention covered in whole or in part by a Patent, including any of the foregoing referred to in Schedule 5.

  • License Key means a unique key-code that enables Licensee to run Software subject to the obtained User Pack.

  • CREFC® Intellectual Property Royalty License Fee Rate With respect to each Mortgage Loan, a rate equal to 0.0005% per annum.

  • 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.