NDA Products definition

NDA Products means the products that are the subject of the Xtampza® ER NDA.
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NDA Products means the extended-release orally disintegrating tablets containing 8.6 mg, 17.3 mg, or 25.9 mg of methylphenidate Marketed under the Trademark in the Territory that contain the Compound as the sole active ingredient and that are approved for Marketing in the Territory pursuant to the Neos NDA, as defined below.
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NDA Products means the NDA Syringe Products and the NDA Vial Product,
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Examples of NDA Products in a sentence

  • Zhang Tr. at 100; Pinal Tr. at 246; Mohapatra Tr. at 325; PTX-95 at 1) Hence, the total amount of l-epinephrine delivered to a patient is the same for both the Belcher and Hospira NDA Products: approximately 1 mg.

  • Multiteam systems are thus a hybrid organisational form that is larger than an individual team, but smaller than an organisation, potentially spanning across boundaries to other organisations (Rico et al., 2017; Shuffler et al., 2015).

  • On information and belief, if NDA No. 209653 is approved, Defendants’ NDA Products would, among other things, be marketed and distributed in Delaware, and/or prescribed by physicians practicing and dispensed by pharmacies located within Delaware, all of which would have a substantial effect on Delaware.

  • On information and belief, Defendants have been aware of the existence of the ’109 patent and have no reasonable basis for believing that Defendants’ NDA Products will not infringe the ’109 patent, thus rendering the case “exceptional,” as that term is used in 35 U.S.C. § 285.

  • As mentioned before (see section 1), this direct link between pro-business behavior and fiscal revenue has constituted during the first period of the reform an effective proxy for a formal protection of property rights on the firms’ assets.

  • Defendants’ NDA Products constitute a material part of the inventions covered by the claims of the ’060 patent.

  • If approved by the FDA, Defendants’ commercial manufacture, use, importation, sale, and/or offer for sale of Defendants’ NDA Products will infringe, contribute to the infringement of, and/or induce the infringement of one or more claims of the ’109 patent under 35 U.S.C. § 271(a)-(c).

  • Pursuant to 35 U.S.C. § 271(e)(2), Defendants’ submission of NDA No. 209653 to the FDA seeking approval of Defendants’ NDA Products was an act of infringement of the ’391 patent by Defendants.

  • If approved by the FDA, Defendants’ importation, offer for sale, sale, and/or use of the oxycodone HCl API in Defendants’ NDA Products will infringe one or more claims of the ’434 patent under 35 U.S.C. § 271(g).

  • Defendants’ NDA Products, or the use or manufacture thereof, are covered by one or more claims of the ’060 patent, including but not limited to independent claim 1, which recites, inter alia, an abuse-proofed, thermoformed dosage form comprising an active ingredient with abuse potential, and at least one polymer having a molecular weight of at least 0.5 million, wherein the dosage form has a breaking strength of at least 500 N, and various claims dependent therefrom, and various claims dependent therefrom.

Related to NDA Products

  • Hemp products means all products made from industrial hemp,

  • SAP Products means Software, Documentation, SAP Materials, Services, Subscription Services, Cloud Services and Maintenance Services. “SAP SDK” means SAP software development kit that includes tools such as APIs, source code, redistributable files and instructions. “Services” means SAP’s then-current services offered under and described in detail in the applicable SAP PartnerEdge Model.

  • 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.

  • New Products means any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.

  • Tobacco products means cigars, cigarettes, cheroots, stogies, periques, granulated, plug cut, crimp cut, ready rubbed, and other smoking tobacco, snuff, snuff flour, moist snuff, cavendish, ping and twist tobacco, fine-cut and other chewing tobaccos, shorts, refuse scraps, clippings, cuttings and sweepings of tobacco, and other kinds and forms of tobacco, prepared in such manner as to be suitable for chewing or smoking in a pipe or otherwise, or both for chewing and smoking.

  • 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.

  • 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.”

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

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

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • 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;

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

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

  • Cannabis products 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.

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

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

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

  • Steel Products means products rolled, formed, shaped, drawn, extruded, forged, cast, fabricated or otherwise similarly processed, or processed by a combination of two or more or such operations, from steel made by the open heath, basic oxygen, electric furnace, Bessemer or other steel making process.

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

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

  • 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.

  • End Products as used in this clause, means those articles, materials, and supplies to be acquired for public use under this contract.

  • 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.

  • the Products means all products and associated documentation to be supplied under this Contract;

  • Products means information resources technologies that are, or are related to, EIR.