Licensed Product NDA definition

Licensed Product NDA means the NOVARTIS Voltaren® Gel NDA #22-122 as approved by the FDA on October 17, 2007, and any subsequent supplements or amendments related to the maintenance thereof.
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Licensed Product NDA means the NOVARTIS AG Voltaren® Gel NDA #22-122 as approved by the FDA on October 17, 2007, and any subsequent supplements or amendments related to the maintenance thereof.
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Licensed Product NDA means the first NDA filed for the Licensed Product in the Initial Indication to the FDA in the U.S. pursuant to the NDA regulatory pathway, as set forth in the Manufacturing, Development and Regulatory Plan.
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Examples of Licensed Product NDA in a sentence

  • ENDO acknowledges and agrees that, notwithstanding the license grant in Section 2.1, neither NOVARTIS nor any Affiliate thereof shall be under any obligation to disclose to ENDO any NOVARTIS Know-How, including the Licensed Product NDA or any data therein, all of which shall constitute NOVARTIS Confidential Information.

  • All Licensed Product supplied by NOVARTIS to ENDO hereunder shall, at the time it is delivered to the carrier by NOVARTIS at the NOVARTIS Warehouse (as defined in Section 5.5(b) below), (a) comply with the Specifications, (b) be consistent, as applicable, with the Licensed Product NDA, and (c) have been manufactured in a facility and in a manner compliant with GMP Requirements and all applicable Laws.

  • If NOVARTIS timely objects to a Notice of Rejection, an independent laboratory which is acceptable to both Parties will test the Rejected Products in dispute (the “Disputed Product”) using the validated and compendial test methods set forth in the Licensed Product NDA and any other applicable GMP test method used by NOVARTIS at the time the Disputed Product was manufactured, all of which test methods will be validated.

  • Within twenty (20) days following delivery of Licensed Product to the Delivery Location in accordance with Section 5.5(c) above, ENDO may perform or cause to be performed such samplings and tests using validated and compendial test methods described in the Licensed Product NDA to determine whether Licensed Product meets the Specifications and the Licensed Product Warranties.

  • Further, no Promotional Materials to be submitted to DDMAC under the Licensed Product NDA shall be used if NOVARTIS reasonably objects based on legal, medical or regulatory grounds.

  • Notwithstanding any other provision of this Agreement, NOVARTIS shall retain exclusive authority and responsibility for all interactions with Governmental Authorities and other Persons with regard to all regulatory matters relating to the Licensed Product, including obtaining, maintaining and updating the Licensed Product NDA and product labeling as required by applicable Law.

  • Subject to the final sentence of this Section 9.1, NOVARTIS and/or its Affiliates shall have the exclusive right, at its sole discretion, to effect a switch of the Licensed Product from an Rx Product to an OTC Product in the Territory (an “OTC Switch”) by filing an amendment or supplement to the Licensed Product NDA or taking any other action necessary or advisable in connection therewith to effect the OTC Switch, and thereafter to Commercialize such OTC Product.

  • Until the Licensed Product NDA is transferred to ASTELLAS in accordance with Section 8.02(a), THERAVANCE shall be primarily responsible for communicating with the FDA regarding the Initial Indications but will give ASTELLAS the opportunity to have a representative present at any meeting with or material conversation with the FDA (with no less than reasonable (under the circumstances) advance notice of the meeting and in any event no less than twenty-four (24) hours notice).

  • If SANDOZ timely objects to a Notice of Rejection, an independent laboratory which is acceptable to both Parties will test the Rejected Products in dispute (the “Disputed Product”) using the validated and compendial test methods set forth in the Licensed Product NDA and any other applicable GMP test method used by SANDOZ at the time the Disputed Product was manufactured, all of which test methods will be validated.

  • The sealed offers should be addressed to the Registrar Jiwaji University Gwalior, and to be submitted on or before 15-03-2012 Till 01:30 P.M.

Related to Licensed Product NDA

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Licensed producer means a person or entity licensed to produce medical cannabis.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Licensed Compound means [***].

  • Licensed Territory means worldwide.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Generic Product means any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • 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;

  • Licensed Field means all fields of use.

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Hemp products means all products made from industrial hemp,

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • processed products means goods placed under a processing procedure which have undergone processing operations;

  • Licensed Programs means, collectively, NeoSystems’ and any Third Party Vendor computer software programs to be provided to Client for use on certain hardware on Client’s premises or a third party’s premises as set forth in an Agreement. The Licensed Programs shall include any fixes, work-arounds, updates, revisions, modifications, enhancements and any derivative works that are provided to Client by NeoSystems under an Agreement.

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Nicotine product means a product that contains nicotine and is not any of the following: