Finished Bulk Product definition

Finished Bulk Product means budesonide MMX 9 mg tablets manufactured in bulk in accordance with the Specifications.

Examples of Finished Bulk Product in a sentence

  • Supplier shall, or shall cause Manufacturer to, purchase, at its cost and expense, all raw materials and other ingredients, including API, excipients and components for the manufacture and shipment of the Finished Bulk Product (collectively, “Raw Materials”).

  • Prior to shipping (or temporarily storing, if requested by Santarus) any order, Supplier shall have Manufacturer test each batch of Finished Bulk Product manufactured under this Agreement, and Raw Materials used for such batch, for conformity with the Specifications (“Supplier Release Testing”).

  • If any process event or deviation occurs during the manufacturing of any Finished Bulk Product, which event is likely to affect the safety, efficacy or regulatory status of the Finished Bulk Product or Finished Commercial Product, then Supplier shall promptly notify Santarus in writing no later than [***] hours after first discovery by Supplier or Manufacturer.

  • Supplier shall have Manufacturer retain sufficient quantities of all shipped Finished Bulk Product and Raw Materials to perform at least full duplicate quality control testing.

  • Santarus shall pay the Base Supply Price and the Additional Supply Price (each as defined below, and collectively referred to herein as the “Price”) for the Finished Bulk Product, which Price shall constitute payment in full for such Finished Bulk Product and shall include the cost of all Raw Materials.

  • If longitudinal crowning is proposed for use on high speed roads, the prior approval of Transport Infrastructure Ireland shall be sought via the Departures Application procedure.

  • It also allows an employer to repurchase more of an employee’s shares for tax withholding purposes without triggering liability accounting and to make a policy election to account for forfeitures as they occur rather than apply an estimate for expense recognition.

  • If materials are used in several lots of Finished Bulk Product, retained repository samples shall be maintained as set forth above until [***] after expiry of the last Finished Bulk Product lot in which such material was incorporated, or such longer period as may be required by Applicable Laws.

  • Santarus shall have no obligation to receive any quantity of Finished Bulk Product in excess of that ordered.

  • If Santarus and Supplier fail to agree within [***] days after Santarus’ receipt of Supplier’s notice as to whether any Finished Bulk Product identified in the Deficiency Notice deviates from the Supplier Manufacturing Responsibilities, then the Parties shall mutually select an independent laboratory to evaluate if the Finished Bulk Product deviates from the Supplier Manufacturing Responsibilities.

Related to Finished Bulk Product

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

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

  • 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:

  • 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.

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

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

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

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

  • API means the American Petroleum Institute.

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

  • 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.

  • Finished Goods means completed goods which require no additional processing or manufacturing to be sold to third party customers by the Loan Parties in the ordinary course of business.

  • 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.”

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

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • 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.

  • Product Specifications means those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

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

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • 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.

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

  • Bulk plant means a motor fuel storage and distribution facility that is not a terminal and from

  • Raw Materials means all raw materials, supplies, components and packaging necessary to manufacture and ship the Product in accordance with the Specifications, as provided in Exhibit A, but not including the API.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

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