ER Product definition

ER Product. ER Product means a Product containing an extended release formulation of Memantine as its sole active ingredient. For clarity, Namenda shall not constitute an ER Product, but Namenda XR shall constitute an ER Product.
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ER Product means any Product that is identified as “extended release” or “ER” on Appendix A.
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Examples of ER Product in a sentence

  • Notwithstanding the foregoing, nothing herein shall prevent Impax from (a) maintaining the Paragraph IV Certifications contained in the Impax ANDA, (b) amending the Impax Settlement and License Agreement ANDA, such as to include future Opana® ER Product dosages, or a Paragraph IV Certification to any patents that may be listed in the Orange Book for the Opana® ER Product, or (c) challenging the Licensed Patents with respect to any product that is not the subject of the Impax ANDA.

  • Without limiting the foregoing, Forest agrees to conduct any promotion of an ER Product for use in combination with Donepezil in good faith and in a manner that does not intentionally discourage sales of any FDC Product for the primary purpose of benefiting from the differential royalty provisions set forth in Sections 6.4(c)(i) and 6.4(c)(iii).

  • We note your disclosure that you have a contract with Ximedica to prepare your ER Product for FDA 510(k) clearance submission.

  • Endo shall at all times during the term of this Agreement maintain (or otherwise not change the status of) the National Drug Code(s) in respect of the Opana® ER Product until the end of the Exclusivity Period, unless otherwise directed by the FDA.

Related to ER Product

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

  • Vapor product means any:

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • 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 or the active pharmaceutical contained in a Unity Bcl-2 [***] Product, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

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

  • 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.”

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

  • Other Products means all products and services, other than an Advance, Credit Product or Derivative Transaction, offered by the Bank to any Obligor from time to time, including correspondent banking services, mortgage purchase programs and affordable housing and community investment products and services.

  • 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.

  • 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 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.

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.

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

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

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

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

  • 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.

  • 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.

  • 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.

  • Bundled Product means Product sold together with any other product(s) or service(s) at a single unit price, whether packaged together or separately, and which other product(s) or service(s) have material independent value from Product itself.

  • 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.

  • 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.

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

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

  • 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.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.