Trokendi XR Product definition

Trokendi XR Product means the extended release oral capsule product containing the Compound as its sole active ingredient which is approved for Marketing pursuant to the Supernus NDA and is Marketed in the Territory under the Trokendi XR® trademark (or a successor trademark adopted for such product).
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Examples of Trokendi XR Product in a sentence

  • Further meetings were planned and would be reported at the next Board meeting.

  • Notwithstanding the foregoing, nothing herein shall prohibit Ascent from asserting any and all counterclaims or defenses of invalidity, non-infringement, or unenforceability of the Litigated Patents in any proceeding the subject matter of which is not the Ascent Product or a Generic Equivalent Product or products subject to a Section 505(b)(2) application referencing the Trokendi XR Product as the reference listed drug (and Ascent may file a petition for ex parte reexamination.

  • 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.

  • Nothing herein shall prevent Ascent from filing or maintaining any Paragraph IV Certification with respect to any Litigated Patent or any other patent listed in the Orange Book in connection with any product which is not the Ascent Product or a Generic Equivalent Product or products subject to a Section 505(b)(2) application referencing the Trokendi XR Product as the reference listed drug.

  • Ascent shall have the right to maintain with the FDA any Paragraph IV Certifications filed against the Litigated Patents in connection with the Ascent ANDA and to file Paragraph IV Certifications in connection with the Ascent ANDA against any patents now listed or listed in the future in the Orange Book with respect to the Trokendi XR Product.

  • For any of the Licensed Patents listed in the Orange Book for the Trokendi XR Product, the Covenant Not to Sue will hereby be treated as a non-exclusive license, so that Zydus or its Affiliates may file and maintain with the FDA “Paragraph IV Certifications” under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) and 21 U.S.C. § 355(b)(2)(A)(iv) (as amended or replaced) with respect to Zydus ANDA No. 216167.

  • Inter Partes Review (IPR), and Post Grant Review (PGR) of a Litigated Patent, if such Litigated Patent is asserted against Ascent in any proceeding the subject matter of which is not the Ascent Product or a Generic Equivalent Product or products subject to a Section 505(b)(2) application referencing the Trokendi XR Product as the reference listed drug).

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

Related to Trokendi XR Product

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

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

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

  • 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.

  • 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.

  • Vapor product means any:

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

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

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Royalty Product means, either (a) an Alnylam Royalty Product, or (b) an Inex Royalty Product.

  • 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.

  • Hemp products means all products made from industrial hemp,

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • 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.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

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

  • 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.

  • 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:

  • Other Product means Product which an End User acquired from sources other than Integrator.

  • 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;

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • 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.”

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

  • Commercialized shall have corresponding meanings.