Recro Product definition

Recro Product has the meaning attributed to it in the License Agreement.
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Recro Product means a pharmaceutical product in a Licensed Dosage Form developed by or on behalf of Licensee, containing Dexmedetomidine as a therapeutically active ingredient, which product is licensed, sold and/or marketed for use in the Field.
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Examples of Recro Product in a sentence

  • Supplier shall first obtain Customer’s prior written consent to any such change (other than a change required by a Regulatory Authority) that would affect Customer’s then pending Regulatory Filing(s) or in-process pre-marketing clinical trial for a Recro Product.

  • All regulatory authority contacts and coordination of any Recall activities relating to Recro Product will be initiated by, and will be the sole responsibility of, Customer, and all regulatory authority contacts and coordination of any Recall activities relating to API will be initiated by, and will be the sole responsibility of, Supplier.

  • Should the Customer be able to sell or otherwise utilize for Commercialization any quantity of Recro Product manufactured using Developmental Quantities of API, title and interest in and to all API Product Developments and all rights to Intellectual Property arising therefrom.

  • In consideration of Customer’s undertakings with respect to the Development of the Recro Product under and in accordance with the terms of the License Agreement, Supplier shall supply the Developmental Quantities required a) for purposes identified under the headers “Part—I” and “Part—II” of Schedule 2.1, and b) for production of the first (1st) production scale batch (referred to on Schedule 2.1 as “NDA Batch”) of each Recro Product at no charge.

  • The initial term of this Agreement (“Initial Term”) shall begin on the Effective Date and, unless earlier terminated in accordance with this Section 10, shall expire, with respect to each country in the Recro Territory, upon the later of: fifteen (15) years from the First Commercial Sale of the Recro Product in such Recro Territory; or (b) fifteen (15) years after the Effective Date.

  • If Customer should elect or be required to initiate a recall, withdrawal, stock recovery or field correction (each, or collectively, a “Recall”) of Recro Product containing API because of supply by Supplier of API that does not conform to the Specifications and warranties set forth in this Agreement, subject in any case to Section 9.1 hereunder, Customer will notify Supplier as required by Regulatory Requirements and provide Supplier a copy of its recall letter prior to initiation of the recall.

  • After receipt of Regulatory Approval of a Recro Product, Customer agrees to maintain throughout the Term a safety stock of API.

  • The Customer shall have the burden of proof to establish such use Should the Development of a Recro Product be terminated, the Customer shall not without the Supplier’s written consent have the right to utilize the Developmental Quantities of API supplied for such Recro Product for the Development of any other Recro Product(s) but shall, upon the Supplier’s request, return such Developmental Quantities to the Supplier.

Related to Recro Product

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

  • 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.

  • 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.

  • 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.

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

  • 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.”

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

  • 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.

  • 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:

  • 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.

  • Hemp products means all products made from industrial hemp,

  • 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 Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • 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.

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

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

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

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

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

  • 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.

  • 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.

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

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • 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.