Active Drug Substance definition

Active Drug Substance means the compound modafinil having those specifications as set forth on Schedule A hereto.
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Active Drug Substance means [CHEMICAL NAME] having those specifications as set forth on Schedule A hereto.
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Active Drug Substance means (a) [***](known as fasudil), and (b) any of its [***] (c) compounds that are [***] (or as does any other form of it referred to in the foregoing clause (b)), and (d) [***].
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Examples of Active Drug Substance in a sentence

  • Legal title to all Active Drug Substance will remain with CEPHALON, provided however, that CIRCA shall reimburse CEPHALON for the replacement cost of any Active Drug Substance that is lost, contaminated, or destroyed while in the possession of CIRCA.

  • In addition, CIRCA will maintain at all times sufficient property casualty insurance to cover the total quantity of Active Drug Substance and Product on hand at its full cost of replacement.

  • CIRCA will maintain a sample of each ----------------------------- chemical component (including Active Drug Substance) as required by applicable regulatory standards or as otherwise mutually agreed by CEPHALON and CIRCA.

  • If CEPHALON fails to provide such Active Drug Substance and Compressil within such period, CATALYTICA's lead time for the delivery of Product under the affected purchase order shall be extended for a period of two (2) days for each day of delay in the supply of Active Drug Substance and Compressil.

  • In any event, CIRCA shall not be liable for reimbursing CEPHALON its cost of Active Drug Substance used in formulating such non-conforming Product, provided however, that nothing herein shall be construed to limit CIRCA's obligations established in Section 6.1 hereof.

  • Xxxxxxxx ------------------------------------ -18- SCHEDULE A ---------- ACTIVE DRUG SUBSTANCE AND STARTING MATERIAL SPECIFICATIONS; TRADEMARKS ---------------------------------------------------------------------- The parties have agreed upon all those applicable specifications for the Active Drug Substance and Starting Materials as set forth in the following documents.

  • CATALYTICA will maintain a sample of each chemical component (including Active Drug Substance) as required by applicable regulatory standards or as otherwise mutually agreed by CEPHALON and CATALYTICA.

  • Upon termination under this Article XVIII, [MANUFACTURER] shall, at PURCHASER’s expense, return promptly to PURCHASER all Product, Active Drug Substance, Commodities, Components and in process materials in its possession on the effective date of termination.

  • Notwithstanding the above, if the yield loss over any given twelve month period during the term hereof exceeds five percent (5%), then CIRCA will reimburse CEPHALON for its costs for that amount of Active Drug Substance lost that exceeds the aforementioned five percent (5%) maximum threshold.

  • In addition, CATALYTICA will maintain at all times sufficient property casualty insurance to cover the total quantity of Active Drug Substance and Product on hand at its full cost of replacement.


More Definitions of Active Drug Substance

Active Drug Substance means the compound N-(4, 4-di (3-methyl-2-thienyl) but-3-en-1-yl) nipecotic acid, which is more commonly known as tiagabine having those specifications as set forth on Schedule A hereto.
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Active Drug Substance means either the Exendin-4 Compound (currently marketed by Amylin as Byetta(R)) or, if the parties agree to a Substitute Compound as provided in Section 3.1(c), the Substitute Compound then being developed, in each case prior to its combination with any other excipient or molecule (whether such molecule is therapeutically active or has no therapeutic activity) or any molecule used to enable permeation of a drug across membranes.
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Related to Active 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.

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

  • 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;

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • 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 Ingredient means the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

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

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

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

  • Manufacturing Process means any process for—

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

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

  • 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.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • 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.

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

  • 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.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • API means American Petroleum Institute.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;