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

  • 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 second round of home study materials were eventually printed through the competitive bidding process by three private firms and distributed to both government and private primary and secondary schools in the country successfully.

  • 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.

  • Subject to Section 6.4, the Parties contemplate that upon the earlier of (a) the effective date of either Party’s exercise of its Opt-Out Right, or (b) initiation of the first Phase II Study under the Program, the Parties shall agree to commence discussions to finalize the terms of a supply agreement for clinical and commercial supply of API Bulk Drug Substance, Delivery Compound, Formulated Bulk or Finished Product (as applicable) based on the Supply Agreement Term Sheet (the “Supply Agreement”).

  • The purchase and sale of all API Bulk Drug Substance under this Agreement will be implemented by Customer’s issuance of individual written purchase orders to Pfizer for specific quantities of API Bulk Drug Substance (each a “Purchase Order”), at least [***] before the beginning of each succeeding [***].

  • 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.

  • Alnylam’s Cost of Goods Sold for API Bulk Drug Substance and Finished Product (as applicable) supplied by Alnylam to Cubist pursuant to this Section 6.1 for Development in the Profit-Share Territory shall be included as Development Costs.

  • Pfizer will ensure that all Records of the Manufacture of API Bulk Drug Substance under this Agreement will be retained and archived in accordance with cGMP and applicable law, but in no case for less than a period of five (5) years following completion of the applicable Manufacturing cycle.

  • 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.

  • Pfizer or its designate Affiliate shall use Diligent Efforts to Manufacture, and Customer shall purchase from Pfizer or its designate Affiliate and in accordance with the Initial Supply Forecast and the Rolling Supply Forecast, Customer’s requirements of API Bulk Drug Substance.


More Definitions of API Bulk Drug Substance

API Bulk Drug Substance. API Bulk Drug Substance shall mean the Compound in bulk form manufactured for use as an active pharmaceutical ingredient in the Product; provided [*****].
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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 the 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 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.

  • 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.”

  • cGMPs means current good manufacturing practices as described in Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations together with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;

  • 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.

  • Distillery manufacturing license means a license issued in accordance with

  • 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.

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

  • 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.

  • 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):