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

  • 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 --------------------------------------------- initial U.S. Development Plan for all Development activities for the POI Product, which the Parties hereby approve, is attached to this Agreement as Schedule 1.146.

  • Unless otherwise agreed to by the Joint Development Committee, all Development Expenses for the POI Product for Commercialization in the United States shall be incurred by Adolor, subject to reimbursement as provided for herein.

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

  • 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.

  • Unless otherwise agreed to by the Joint Marketing Committee, all ------ Marketing Expenses for the POI Product shall be incurred by Adolor, subject to reimbursement as provided for herein.

  • 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.

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

  • If the Parties agree to ------------------------------------------ Develop the OBD Acute Product, or any Additional Product that becomes an Adolor Product, the Adolor Product Promotion Term shall be extended until the sooner to occur of (a) ** (**) years following the First Commercial Sale in the United States of the OBD Acute Product or such Additional Product that is designated an Adolor Product, or (b) ** (**) years after the First Commercial Sale of the POI Product in the United States.

  • In the United States, the total daily dose of Compound (in milligrams) in either the IBS Product or the Constipation Product shall be less than ** percent (**%) of the average total daily dose of Compound (in milligrams) recommended in the FDA approved label in the POI Product.

Related to POI Product

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

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • 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.

  • 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

  • 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 any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • 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 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.

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

  • 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.

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

  • 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.

  • Hemp products means all products made from industrial hemp,