Drug Product Intermediate definition

Drug Product Intermediate or “DPI” means ferumoxytol used in the production of Drug Product for supply to the European Union and Canada, and if applicable (that is, if a DPI is used for supply of Drug Product to the following countries), to Switzerland and other countries, in accordance with this Agreement, in each case, including the Specifications.
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Drug Product Intermediate means the PPI-149-*** in powder form.
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Drug Product Intermediate means the intermediate formulated Abarelix used as the raw material in the Production of Product.
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Examples of Drug Product Intermediate in a sentence

  • PRAECIS shall provide BAXTER a Material Safety Data Sheet for Drug Product Intermediate and for each Product.

  • This analysis assumes that unit benefits of avoided paint chip ingestion are realized for five years because paint stabilization should provide approximately five years of protection against significant amounts of deteriorated LBP.

  • The Parties’ obligations with respect to the Primary Supply Chain and the establishment, regulatory approval and maintenance of a DSS (other than the Primary Supply Chain) for each of Drug Substance, Drug Product Intermediate and Drug Product (the “Required Sites”) are set forth in the License Agreement.

  • For spectral responsivity calibrations, a new calibration report format was prepared which now includes detailed uncertainty budgets for various measurement scenarios.

  • SAFC will continue to manufacture Active Pharmaceutical Ingredient and Drug Product Intermediate at T-East Plant in accordance with Section 2.8(a) of this Agreement.

  • If Product is rejected by PRAECIS and such Product's failure to meet the Product Requirements is determined in accordance with Section 7.3.1 to be the result of the failure at the time delivered to XXXXXX of Drug Product Intermediate to meet the Component CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

  • The CHMP recommends continuation of the ongoing stability program for the Drug Product Intermediate over the intended period.

  • No later than ten (10) days after receipt by XXXXXX of a Purchase Order, XXXXXX shall provide a confirmation of receipt of such Purchase Order confirming the Delivery Date of the Product, XXXXXX'x scheduled date of filling for the Product, and the scheduled date for PRAECIS delivery of the Drug Product Intermediate for the Product ordered thereunder.

  • All Inventions (as defined below) and all documents, computer documentation and other tangible materials related thereto, which are conceived, reduced to practice or created by BAXTER in the course of performing its obligations under this Agreement and which relate directly to the Product, Drug Product Intermediate or PRAECIS Supplied Components (the "PRAECIS CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

  • Sigmapharm’s expert Dr. Hollingsworth testified that Sigmapharm’s ANDA Products and Drug Product Intermediate do not infringe Claims 1-3 of the ’684 Patent, Claims 2- 7 of the ’630 Patent, and Claims 4-5 of the ’096 Patent (the “crystalline claims”).

Related to Drug Product Intermediate

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

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

  • Intermediate product means marijuana flower lots or other material lots that have been converted by a marijuana pro­ cessor to a marijuana concentrate or marijuana-infused product that must be further processed prior to retail sale.

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

  • 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.

  • 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.”

  • Hemp products means all products made from industrial hemp,

  • 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.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • 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:

  • API means the American Petroleum Institute.

  • Finished Products means the fully assembled and shrink-wrapped Licensed Products, each including a Game Cartridge, Game Cartridge label and Printed Materials.

  • Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

  • 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.

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

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

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

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

  • Refined Products means gasoline, diesel fuel, jet fuel, asphalt and asphalt products, and other refined products of crude oil.

  • Vapor product means any:

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

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • 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.

  • 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.

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

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