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

  • If such recall is initiated because of any failure of the Product to conform to the warranties set forth in this Section 6.05, Pfizer shall promptly reimburse Customer the Purchase Price paid by Customer with respect to the recalled API Bulk Drug Substance.

  • Customer further represents, warrants and covenants to Pfizer that Customer shall adhere to all applicable laws relating to the handling, storage, use, disposal, sale, advertising and marketing of all API Bulk Drug Substance and product containing such API Bulk Drug Substance while such API Bulk Drug Substance or such product is in Customer’s possession and/or control.

  • If the foregoing discussions do not resolve the disagreement in a reasonable time (which will not exceed [***], a sample of Pfizer’s USFDA retained sample and a sample of the API Bulk Drug Substance in question will be submitted for retesting by Pfizer and Customer on a side-by-side basis for final determination of whether such API Bulk Drug Substance conforms to the Specifications.

  • 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”).

  • 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.

  • 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.

  • 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.

  • Pfizer shall give Customer written instructions as to how Customer should lawfully dispose of such nonconforming or noncomplying API Bulk Drug Substance, and Customer shall provide Pfizer with written certification of such destruction.

  • Notwithstanding Sections 6.01 and 6.02, Customer shall indemnify and hold harmless the Pfizer Indemnified Parties from, against and in respect of any and all Losses involving a Third Party products liability claim or action incurred or suffered by the Pfizer Indemnified Parties or any of them directly or indirectly or relating to API Bulk Drug Substance or any product formulated using API Bulk Drug Substance supplied hereunder by Pfizer to Customer.

  • 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.


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 any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • 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 the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • 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, 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.

  • 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 all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

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

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • 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):

  • Petroleum product means crude oil, petroleum, refined petroleum products, byproducts and intermediate feed stocks, and other energy-related commodities, including, without limitation, blend components commonly used in the petroleum industry to improve characteristics of, or meet governmental or customer specifications for, petroleum or refined petroleum products.