Clinical Manufacture definition

Clinical Manufacture means the Manufacture of any Compound or any Product (including the Manufacturing of any Compound contained in any Product) or acquisition of any Compound or any Product from a CMO, in each case, for use in Clinical Trials.
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Clinical Manufacture has the meaning set forth in the MDSA
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Clinical Manufacture means the Manufacture of a Licensed Product (including Manufacturing the Licensed Compound contained in such Licensed Product) or the acquisition of such Licensed Compound and Licensed Product from a CMO, in each case, for use in Clinical Trials.
Sample 1

Examples of Clinical Manufacture in a sentence

  • Pursuant to the terms and conditions of the Development and Clinical Manufacture Agreement of (the “Master Agreement”), SIEGFRIED has agreed to perform certain services in accordance with written Scopes of Work, such as this one, entered into from time-to-time.

  • This document constitutes a “Statement of Work” under the Development and Clinical Manufacture Agreement, and this Statement of Work and the work contemplated herein are subject to the terms and provisions of the Development and Clinical Manufacture Agreement.

  • Level 1 being the standard, the customer is able to perform additional checks and have access to a broader inspection by selecting levels 2 or 3.Before presenting each set of activities, general guidelines are presented in order to establish rules that enable the customer to timely and properly prepare for the inspection and also to avoid any impact in the production schedule.

  • Pursuant to the terms and conditions of the Development and Clinical Manufacture Agreement of Patheon has agreed to perform certain services in accordance with written Scopes of Work, such as this one, entered into from time-to-time.

  • The effect of any termination of a Process Development Program as a result of a Change in Control and, subject to Sections 7.14 and 16.3.1, the right to terminate a Process Development Program for breach and the effects thereof shall be addressed in the Process Science and Clinical Manufacture Agreement.

  • During a transitional period until the earlier of (i) [***] or (ii) [***], BioNTech shall perform Clinical Manufacture and supply the quantities of Collaboration Products for Clinical Studies contemplated by the GDP (as amended until the Opt-Out Commencement Date) or for Genentech Studies pursuant to the patient demand forecasting provisions of the MDSA.

  • For clarity, notwithstanding the negotiation of the Commercial Supply Agreement prior to initiation of the Phase III Clinical Trial for the Covered Product, any Clearside Devices Manufactured and supplied for use in the Phase III Clinical Trial or any Phase IV Clinical Trial will be Manufactured and supplied pursuant to Section 4.2 (Preclinical and Clinical Manufacture and Supply of Clearside Devices), not the Commercial Supply Agreement.

  • NeoRx agrees to pay ABC [*] as full compensation for services rendered and expenses incurred on behalf of NeoRx but beyond the scope of the Clinical Manufacture and Supply Agreement dated September 1, 2000.

  • Without limiting the foregoing, with respect to (a) Vir-2482, following GSK’s exercise of the Option, and (b) any Additional Pathogen Product that is a Program mAb Controlled by Vir and for which the JSC determines that GSK will be responsible for Clinical Manufacture for the pre-clinical studies, Phase I Clinical Studies and Phase II Clinical Studies, [***], in each case ((a) and (b)), [***], Vir shall [***].


More Definitions of Clinical Manufacture

Clinical Manufacture means Manufacture for clinical use in Clinical Studies, including (a) reservation of Manufacturing capacity for use in Manufacture for clinical use; (b) selection and use of contract manufacturers; (c) selection of the Clinical Facilities; and (d) subject to the terms of any existing Third Party agreements and as applicable, technology transfer of the then-current Manufacturing process for Collaboration Product to Clinical Facilities.
Sample 1

Related to Clinical Manufacture

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • 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.

  • Manufacturing Process means any process for—

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

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

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

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • 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.

  • Third Party Manufacturer means any person, firm or company which carries out the reproduction of Work and/or manufactures and/or prints the Licensed Publication on behalf of the Licensee;

  • 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;

  • Hemp products means all products made from industrial hemp,

  • 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.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • 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.

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

  • API means the American Petroleum Institute.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.