ADC Drug Reagent definition

ADC Drug Reagent means [**].
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ADC Drug Reagent means a Drug Moiety conjugated to an Antibody by a Linker, wherein the Antibody Specifically Binds the Target or the Replacement Target if elected pursuant to this Agreement.
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Examples of ADC Drug Reagent in a sentence

  • If at the end of the applicable evaluation period the Evaluation License for an Approved Target is not converted into a Commercial License, or the Approved Target of any Commercial License is replaced (each such Target a “Rejected Target”), ADCT shall no longer be licensed under this Agreement with respect to such Rejected Target or any ADC Drug Reagent or Non-ADC Reagent against such Target.

  • For the avoidance of doubt, in the event Licensee develops an ADC Drug Reagent and a Non-ADC Drug Reagent against the same Approved Target, such Approved Target will be counted as both an Approved ADC Target and an Approved Non-ADC Target.

  • In such instance, Kolltan shall no longer be licensed under this Agreement with respect to an ADC Drug Reagent having an Antibody that Specifically Binds KIT but thereafter shall be licensed under this Agreement with respect to an ADC Drug Reagent that has an Antibody that Specifically Binds the Replacement Target, and Kolltan agrees, in such circumstance, not to pursue work on an ADC Drug Reagent having an Antibody that Specifically Binds KIT utilizing materials provided by Spirogen.

Related to ADC Drug Reagent

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

  • 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.

  • 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;

  • 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.

  • Reagent means any product other than fuel that is stored on-board the vehicle and is provided to the exhaust after-treatment system upon request of the emission control system.

  • New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. § 601.2, or any equivalent or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the United States.

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

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

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • 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.

  • API means American Petroleum Institute.

  • Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.

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

  • 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.

  • 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.

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

  • Generic Drug means any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.

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

  • Manufacturing Process means any process for—

  • 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: