Product Placebo definition

Product Placebo means the placebo supplied by UCB for use in the Clinical Studies that is manufactured in accordance with the same manufacturing process as the Product and used in the same Clinical Studies, except that the Product Placebo does not contain Cimzia® as an active ingredient.
Product Placebo means a form of the Product intended for human use and manufactured fully in accordance with the Product Specifications, but without the inclusion of the API. For purposes of this Agreement, the terms “Product” and “Products” shall include Product Placebo unless the context specifically requires otherwise.

Examples of Product Placebo in a sentence

  • UCB acknowledges that Institutions may require Dermira to include in Clinical Site Agreements representations and warranties regarding Product and/or Product Placebo supplied to Institutions or Investigators for use in a Phase 3 Study, or any Post-Approval Study in the Development Indication, and will require Dermira to include in such Clinical Site Agreements standard indemnities regarding the Product and/or Product Placebo.

  • On request, UCB shall provide Dermira with copies of certificates of analysis for the Product and Product Placebo supplied by UCB for use in connection with the Development activities under the Development Plan.

  • Clinical Product Placebo Product 45/49 Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 406 of the Securities Act of 1933, as amended.

  • Over the last two decades, policy makers, regulators, experts and academicians realized the need to outline and implement a special set of rules to enable SMEs access to capital markets, making them available to a wide range of investors.

  • The procedures are included in the sections on Study Product Placebo and Drug Dispensing in Pharmacy Guidelines and Instructions for DAIDS Clinical Trials Networks.

  • Except as provided below, such arbitration shall be Designs' and the Partnership's exclusive formal means of resolving any such Controversy.

Related to Product Placebo

  • product placement means any form of audiovisual commercial communication consisting of the inclusion of or reference to a product, a service or the trade mark thereof so that it is featured within a programme, in return for payment or for similar consideration;

  • 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.”

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

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

  • Manufacturing Process means any process for—

  • 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:

  • 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;

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

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

  • 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.

  • 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.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • 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.

  • API means the American Petroleum Institute.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

  • Spray buff product means a product designed to restore a worn floor finish in conjunction with a floor buffing machine and special pad.

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

  • Active Ingredient means the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

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

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Replacement Product means electric generating capacity, capacity-related benefits, environmental attributes, Energy or other electric products from a generation resource other than the Facility that are provided or delivered to replace or substitute for Contract Capacity or Storage Capacity (or any Capacity-Related Benefit, Environmental Attribute, Other Electric Product, Contract Energy, or Storage Energy associated therewith), in each case, in whole or in part, pursuant to Section 4.6.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Combination Product means any product that comprises a Licensed Compound or Licensed Product sold in conjunction with another active component so as to be a combination product (whether packaged together or in the same therapeutic formulation).

  • 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.