API Bulk Drug Substance definition

API Bulk Drug Substance means the Licensed Compound in bulk form manufactured for use as an API.
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API Bulk Drug Substance means siRNA in bulk form manufactured for use as an active pharmaceutical ingredient.
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API Bulk Drug Substance means a Collaboration Compound in bulk form manufactured for use as an active pharmaceutical ingredient.
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Examples of API Bulk Drug Substance in a sentence

  • This Agreement may be executed in separate counterparts and by each party separately on a separate counterpart, and each such counterpart, when so executed, shall be an original.

  • Each Purchase Order will set forth the quantities of API Bulk Drug Substance desired, the shipping location and dates by which delivery is to be made, said delivery dates to be no earlier than [***] and no later than [***] after delivery of such Purchase Order.

  • Pfizer further represents, warrants and covenants that, at the time of delivery to Customer, the API Bulk Drug Substance manufactured under this Agreement will have been manufactured in accordance with cGMP and all other applicable law, the Quality Agreement, and Specifications.

  • By the last business day of the [***] and each [***] thereafter during the term of this Agreement, Customer shall provide Pfizer with Customer’s good faith estimate of Customer’s updated projected monthly requirements for supply of API Bulk Drug Substance for delivery during the following [***] (each such estimate, a “Rolling Supply Forecast”).

  • Upon execution of this Supply Agreement, Customer will provide Pfizer with Customer’s good faith estimate of Customer’s projected requirements for supply of API Bulk Drug Substance for delivery during the first [***] (such estimate, the “Initial Supply Forecast”).

  • Customer is desirous of purchasing from Pfizer API Bulk Drug Substance and Pfizer is agreeable to supply same under the terms and conditions set out in this Agreement.

  • In addition, for any binding [***] of a Rolling Supply Forecast, the sum of quantities of API Bulk Drug Substance in Purchase Orders must meet the quantity PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [***] DENOTES OMISSIONS.

  • The selection of such API Bulk Drug Substance Supplier and the terms and conditions of the agreement to be entered into with the API Bulk Drug Substance Supplier shall be subject to approval by the MSC.

  • The purchase price of API Bulk Drug Substance sold to Customer under this Agreement is outlined below, based upon quantities of Product purchased during a calendar year: Tier Quantity (annum) Price per kilogram [***] [***] PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [***] DENOTES OMISSIONS.

  • Upon any termination of this Agreement, Customer will promptly return to Pfizer all relevant records, materials or Pfizer Confidential Information relating to the API Bulk Drug Substance in its (or any of its Affiliates’ or contractors’) possession or control.


More Definitions of API Bulk Drug Substance

API Bulk Drug Substance. API Bulk Drug Substance means Fovista in the pegylated form supplied under the Supply Agreement for use as an active pharmaceutical ingredient in a Product.
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Related to API Bulk Drug Substance

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

  • 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.

  • 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.

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

  • API means American Petroleum Institute.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

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

  • 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.

  • Product Specifications means those product, labeling and performance specifications for the Product filed with and approved by the relevant Regulatory Authority, including Product formulae, labeling, and materials required for the manufacture of the Product that is to be purchased and supplied under this Agreement, as such are set forth on Schedule 1.25, which specifications may be amended by the Parties from time to time in accordance with this Agreement.

  • cGMPs means, as applicable, current good manufacturing practices as described in:

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

  • Manufacturing Process means any process for—

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

  • 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;

  • Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

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

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

  • 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.

  • 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.

  • 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: