Sandoz ANDA Product definition

Sandoz ANDA Product means the Argatroban 50mg/50m1 product that is the subject of ANDA (as defined in 21 U.S.C. 355(j) et seq., and the regulations promulgated thereunder) No. 203743, and any amendments or supplements thereto.
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Examples of Sandoz ANDA Product in a sentence

  • The limited License conferred under the terms of this agreement expressly and specifically excludes conferring any and all rights, license, sublicense, or approval to the use of any device(s), pump(s), or equipment that may be used with the Sandoz ANDA Product.

  • Sandoz covenants and agrees never in any way to assist voluntarily, appear voluntarily, testify voluntarily, voluntarily offer evidence, or attempt to obtain or produce discovery in any judicial, administrative, or arbitral proceeding, in the Territory, relating in any way to the Licensed Patents solely with respect to the Sandoz ANDA Product, except as otherwise permitted in this Agreement.

  • Sandoz has committed an act of infringement in this Judicial District by filing ANDA No. 216236 with the intent to make, use, sell, offer for sale, and/or import the Sandoz ANDA Product in or into this Judicial District, prior to the expiration of the patent-in-suit.

  • Each of these activities would have a substantial effect within New Jersey and would constitute infringement of the patent-in-suit in the event that the Sandoz ANDA Product is approved before the patent-in-suit expires.

  • In the Sandoz Notice Letter, Sandoz stated that the Sandoz ANDA Product contains neratinib as the active ingredient.

  • On information and belief, upon FDA approval of Sandoz’s ANDA, Sandoz will, through its own actions or through the actions of its agents, affiliates, and subsidiaries, market and/or distribute the Sandoz ANDA Product to resellers, pharmacies, hospitals, clinics, healthcare professionals, and other end users.

  • On information and belief, the Sandoz ANDA relies upon the Nerlynx® NDA and, according to Sandoz, contains the required data with respect to the bioavailability or bioequivalence of the Sandoz ANDA Product to Nerlynx®.

  • On information and belief, Sandoz will knowingly and intentionally accompany the Sandoz ANDA Product with a product label or product insert that will include instructions for using or administering the Sandoz ANDA Product, which are substantially similar to the instructions in the prescribing information for Nerlynx®.

  • Sandoz seeks FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Sandoz ANDA Product in or into the United States, including in New Jersey, prior to the expiration of the ’865 patent.

  • The commercial manufacture, use, sale, offer for sale, or importation of the Sandoz ANDA Product in or into the United States would infringe one or more claims of the ’865 patent.

Related to Sandoz ANDA Product

  • 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.

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

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

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • 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 Compound means [***].

  • 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.

  • 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.”

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

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

  • 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.

  • Hemp products means all products made from industrial hemp,

  • 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.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

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

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

  • 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;

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

  • 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.

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

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

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

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Spray buff product means a product designed to restore a worn floor finish in conjunction with a floor buffing machine and special pad.