OBD Acute Product definition

OBD Acute Product means a Product for the management of opioid ----------------- induced bowel dysfunction in hospitalized patients or patients discharged from a hospital for whom prescriptions or **.
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Examples of OBD Acute Product in a sentence

  • The total daily dose of ---------------------------- Compound (in milligrams) in the OBD Acute Product Commercialized in the ROW shall be ** the total daily dose of Compound (in milligrams) in the label approved by the relevant Governmental Authority for the GI Products Commercialized in the ROW.

  • With respect to the OBD Acute Product, Adolor shall be solely responsible for (and such expenses shall not be deemed Development Expenses) expenses related to the Development of the OBD Acute Product incurred prior to the determination to proceed with the Development of the OBD Acute Product in accordance with Section 4.4.4 other than those expenses associated with clinical study 14CL306 which are set forth in Schedule 1.146.

  • 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.

  • 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) eight (8) 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) twelve (12) years after the First Commercial Sale of the POI Product in the United States.

Related to OBD Acute Product

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

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

  • 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.

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

  • 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.

  • 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.

  • 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.

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

  • Runtime Product means the version specific files and application program interfaces (APIs) specified in the RUNTIME.TXT file provided with SAP Crystal Reports 2008, SAP Crystal Reports for Eclipse 2.0, and SAP Crystal Reports for Visual Studio 2010.

  • Combination Product means a product (a) containing a Licensed Product together with one or more other active ingredients, or (b) with one or more products, devices, pieces of equipment or components, but sold for an integrated price (e.g., with the purchase of one product the customer gets a coupon for the other) or for a single price.

  • 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.

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).