POI Product definition

POI Product means a Product for the prevention, treatment or ----------- management of post-operative ileus or post-operative bowel dysfunction.
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Examples of POI Product in a sentence

  • To the extent Adolor reasonably believes any such action is likely to adversely affect the POI Product in the United States, Adolor shall notify GSK and GSK shall not take any action without the prior written consent of Adolor unless otherwise required by Law.

  • In the event that a Collaboration Product other than the POI Product receives the first Marketing Authorization Approval in the United States, then such percentage limitation on dose of Compound shall be redefined by the Parties.

  • The Parties acknowledge and agree that the Agreement, as amended, shall supplement the terms and conditions of the Supply Agreement between Adolor and GSK, dated of even date herewith, (including, without limitation, with respect to the supply of POI Product in the ROW, information required to be shared by the Parties, and indemnification by the Parties).

  • GSK shall, in accordance with the requirements of the E.A.S.E.™ Program, introduce, educate and cause all parties that seek to order the POI Product in the ROW to first apply for registration in the E.A.S.E.™ Program.

  • Each --------------------------------------------------- Party shall offer incentive compensation to its Sales Representatives with respect to the sale of the POI Product in the United States for each Calendar Year during the Adolor Product Promotion Term.

  • GSK shall not ship the POI Product to any party other than a Registered Entity.

  • For the avoidance of doubt, GSK’s deployment of its personnel in the ROW shall have no effect on the calculation of its Sales Representative FTE Requirements for the POI Product in the United States under the Agreement.

  • For the purposes of this Amendment No. 5, the “E.A.S.E.™ Program” means the then-current ENTEREG Access Support and Education (E.A.S.E.™) Program implemented by the Parties as part of the Risk Evaluation and Mitigation Strategy approved by the FDA for the POI Product.

  • The Parties acknowledge that Adolor is in the process of conducting clinical studies on the POI Product necessary to file the NDA.

  • It ------------------------- is understood that Adolor has submitted to the FDA for consideration the trademarks "Entereg" and "Alvanop" for possible use with the POI Product.

Related to POI 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.

  • 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.

  • 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.”

  • 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.

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

  • Royalty Product means, either (a) an Alnylam Royalty Product, or (b) an Inex Royalty 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, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • 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.

  • 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.

  • 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.

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

  • 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;

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

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

  • 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

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

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Vapor product means any:

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

  • Recycled product means a product containing recovered material, or post-consumer recovered material, or both.

  • 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.

  • 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.