Supernus NDA definition

Supernus NDA means NDA No. 201635, as amended, or supplemented.
Supernus NDA means NDA No. 201635, as amended or supplemented.
Supernus NDA means Supernus’ NDA No. 201635, as amended, or supplemented, for the Regulatory Approval of the product sold under the Trokendi XR® trademark or any successor trademark thereto.

Examples of Supernus NDA in a sentence

  • Prior to the Ascent License Date, Supernus will provide written notice to Ascent within [**] after each time either (i) Supernus submits a document to FDA seeking a change in the [**] for the Trokendi XR Product, including any specific [**] amendments or supplements to the Supernus NDA or (ii) FDA communicates to Supernus a suggestion or directive to make a change to the [**] for the Trokendi XR Product.

  • Report Cards/Progress ReportsIt is essential for parents/guardians to be kept fully informed of their student's progress in school.

Related to Supernus NDA

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

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

  • Elan means Elan Corp and its Affiliates.

  • ONYX means Onyx Acceptance Corporation, and its successors.

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

  • Merck has the meaning set forth in the preamble.

  • BLS means Basic Life Support.

  • 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.

  • PTC means the tax credit for electricity produced from certain renewable generation resources described in Section 45 of the Internal Revenue Code of 1986, as it may be amended or supplemented from time to time.

  • Shire means Shire of Augusta Margaret River

  • Lilly has the meaning set forth in the Preamble.

  • GSK has the meaning set forth in the preamble.

  • GTC means General Terms & Conditions of Contract.

  • NPS means nominal pipe size.

  • Abbott has the meaning set forth in the Preamble.

  • SPI means the information categories listed at Tex. Bus. & Com. Code § 521.002(a)(2).

  • CTI means CTI Logistics Limited (ABN 69 008 778 925) and/or any Affiliate of CTI Logistics Limited as the case may be, which performs all or any of the Services.

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

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

  • DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • PMDA means Japan’s Pharmaceuticals and Medical Devices Agency and any successor agency(ies) or authority having substantially the same function.

  • Raptor means all birds of the orders Falconiformes and Strigiformes, commonly called falcons,

  • ANDA means Abbreviated New Drug Application.

  • Supplier Background IPR means Intellectual Property Rights owned by the Supplier before the Call Off Commencement Date, for example those subsisting in the Supplier's standard development tools, program components or standard code used in computer programming or in physical or electronic media containing the Supplier's Know-How or generic business methodologies; and/or Intellectual Property Rights created by the Supplier independently of this Call Off Contract,

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, 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.

  • CDC means Centers for Disease Control and Prevention.