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 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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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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Examples of Product License Application in a sentence

  • Licensee shall issue to Licensor 25,000 shares of common stock of Licensee upon the submission of a Product License Application ("PLA") for the first indication of Product.

  • CBC shall cooperate with and assist Progenies in the preparation and filing of information with respect to the Adjuvant for use in any Investigational New Drug application, Product License Application or any other regulatory filings throughout the Licensed Territory with respect to any Licensed Product.

  • The license granted to PMC under this Section 2.1 shall not include (i) the right to use CORIXA Technology for any commercial purpose whatsoever, (ii) the right to grant sublicenses thereto to any Affiliate or Third-Party, (iii) the right to file a Product License Application in any country, or (iv) the right to make, have made, use or sell a Product or Material for any purpose other than the foregoing evaluation, including for any commercial purpose.

  • The fractionation procedure will be performed according to Current Good Manufacturing Practices and in accordance with the NewCo Biologics License Application (formerly known as the Establishment License and the Product License Application) for Plasma Protein Fraction (Human).

  • From a performance standpoint, successful completion of Phase III trials is defined as the Product having the necessary safety and efficacy profile to submit a Product License Application / New Drug Application.

  • The fractionation procedure will be performed according to Current Good Manufacturing Practices and in accordance with the NewCo Biologics License Application (formerly known as the Establishment License and the Product License Application) for Albumin (Human).

  • The Company must submit a Product License Application ("PLA") and Establishment License Application ("ELA").

  • Such New Product License shall remain exclusive for eighteen months after the date UK Licensee's New Product License Application has been accepted (New Product Initial Exclusive Term"), upon which acceptance, Licensee can sell such New Product in the Territory.

  • Seller further represents that none of its officers, directors or employees been convicted of a felony under federal law for conduct relating to the development or approval of any drug product, new drug application (NDA), abbreviated new drug application (ANDA), Product License Application (PLA), Establishment License Application (ELA), or Biologics License Application (BLA).

  • In addition, for the first Licensed Product in the Field formulated as an injectable product for which Cyanamid submits a Product License Application, Cyanamid will pay $2.5 million at the time of such submission.


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 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 shall have the same meaning as understood in the MIT Agreement;
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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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Product License Application means a product license application made under the NHPR regulations;
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Related to Product 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.

  • Patent License means any written agreement granting any right with respect to any invention on which a Patent is in existence or a Patent application is pending, in which agreement Borrower now holds or hereafter acquires any interest.

  • Patent License Agreement means the Patent License Agreement by and between Buyer and Seller substantially in the form attached hereto as Exhibit F.

  • 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.