OBD Chronic Product definition

OBD Chronic Product means a Product for the management of ------------------- patients with bowel dysfunction caused by the ** administration of opioids.
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Examples of OBD Chronic Product in a sentence

  • The Parties acknowledge that Adolor is in the process of conducting clinical studies on the OBD Chronic Product necessary to file the NDA and such activities **.

  • The Parties shall ---------------------------------- plan and implement periodic joint sales and marketing meeting, including a national launch meeting, for each Adolor Product, and the OBD Chronic Product and each other GI Product where Adolor has elected to fund Development Expenses under Section 4.6.5 and where Adolor has not made a Royalty Conversion Election, in the United States.

  • GSK shall have the overall responsibility ------------------- for the performance of all Development activities, including regulatory filings, of the OBD Chronic Product that is required to obtain Marketing Authorization for the OBD Chronic Product in the United States and, in furtherance thereof, the Parties shall perform Development activities, all in accordance with the applicable U.S. Development Plan, for the OBD Chronic Product.

  • Thereafter, Marketing Expenses for the OBD Chronic Product shall be shared in accordance with the sharing of the GI Product Marketing Contribution for such OBD Chronic Product as adjusted pursuant to Section 6.3.4. Notwithstanding the foregoing, upon notice by Adolor to GSK of a Royalty Conversion Election, GSK shall be solely responsible and pay for all Marketing Expenses relating to periods after such notice for the OBD Chronic Product for which the Royalty Conversion Election was made.

  • To the extent such transfer is not timely made, the time period of any delay in transfer shall toll the timeline for Development of the OBD Chronic Product as set forth in the applicable U.S. Development Plan.

  • Streets in a subdivision which provides an approved alternate pedestrian circulation system shall have a right-of- way that will provide a minimum parkway width of at least eight feet.

  • GSK shall be solely responsible for the ----------------- performance of all Development activities, including regulatory filings, for each GI Product (other than the OBD Chronic Product covered in Section 4.1.2) that is required to obtain Marketing Authorization in the United States for such GI Products in accordance with the applicable U.S. Development Plan for such GI Products.

  • For the avoidance of doubt, the termination right pursuant to this Section 16.7.3 shall not be available for the OBD Chronic Product.

  • For the avoidance of doubt, the termination right pursuant to this Section 16.7.2 shall not be available for the OBD Chronic Product.

  • For the avoidance of doubt, the termination right pursuant to this Section 16.7.1 shall not be available for the OBD Chronic Product.

Related to OBD Chronic Product

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

  • cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epi­ dermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

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

  • 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.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • 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.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • 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.

  • 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.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • 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;

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

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

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

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • 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.”

  • Licensed Compound means [***].

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

  • Non-Microsoft Product means any third-party-branded software, data, service, website or product, unless incorporated by Microsoft in a Product.

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

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

  • Clinical Trial means any human clinical trial of a Product.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Licensed Programs means, collectively, NeoSystems’ and any Third Party Vendor computer software programs to be provided to Client for use on certain hardware on Client’s premises or a third party’s premises as set forth in an Agreement. The Licensed Programs shall include any fixes, work-arounds, updates, revisions, modifications, enhancements and any derivative works that are provided to Client by NeoSystems under an Agreement.