Neos NDA definition

Neos NDA means NDA 204326, and any amendment or supplement thereto.
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Neos NDA means New Drug Application No. 205489. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Neos NDA means New Drug Application No. 204326.
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Examples of Neos NDA in a sentence

  • Subject to Actavis’s compliance, neither shall Neos nor any of its Affiliates Officially Discontinue the products described in the Neos NDA prior to the expiration of the Licensed Patents, unless required, requested, or recommended to do so by the FDA or other governmental authority or applicable law.

  • Subject to Teva’s compliance, neither shall Neos nor any of its Affiliates Officially Discontinue the products described in the Neos NDA prior to the expiration of the Licensed Patents, unless required, requested, or recommended to do so by the FDA or other governmental authority or applicable law.

  • Notwithstanding the above, Neos shall be permitted to disclose to the FDA the existence of this Agreement and the fact that the Licensed Patents are licensed for purposes of obtaining Regulatory Approval of the Neos NDA.

Related to Neos NDA

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

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

  • ONYX means Onyx Acceptance Corporation, and its successors.

  • Pfizer shall have the meaning set forth in the preamble.

  • Novartis shall have the meaning set forth in the Preamble.

  • BMS means the Company, all related companies, affiliates, subsidiaries, parents, successors, assigns and all organizations acquired by the foregoing.

  • Elan means Elan Corp and its Affiliates.

  • Sublicense Agreement means any agreement or arrangement pursuant to which Licensee (or an Affiliate or Sublicensee) grants to any third party any of the license rights granted to the Licensee under the Agreement.

  • 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.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

  • Manufacturing Agreement has the meaning set forth in Section 2.6.

  • ISIS means the department’s individualized services information system.

  • Collaboration Technology means all Collaboration Patents and Collaboration Know-How.

  • Merck has the meaning set forth in the preamble.

  • GSK will have the meaning set forth in the Preamble.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • GTC means General Terms & Conditions of Contract.

  • BLS means Basic Life Support.

  • Company License Agreements means any license agreements granting any right to use or practice any rights under any Intellectual Property (except for such agreements for off-the-shelf products that are generally available for less than $25,000), and any written settlements relating to any Intellectual Property, to which the Company is a party or otherwise bound; and the term “Software” means any and all computer programs, including any and all software implementations of algorithms, models and methodologies, whether in source code or object code.

  • License Agreement means the agreement between SAP (or an SAP SE Affiliate, or an authorized reseller) under which Customer procured the rights to use SAP Software or a Cloud Service.

  • Lilly has the meaning set forth in the Preamble.

  • Technology License Agreement means the Technology License Agreement dated as of the date hereof between Allergan and ASTI.

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • GTCs means these AVEVA General Terms and Conditions, which includes those terms and conditions set forth in the main body of the GTCs, and all of the various exhibits, addenda, and other documents incorporated into the GTCs.

  • Soil scientist means an individual duly qualified in accordance with standards set by the Federal Office of Personnel Management.