Clinical Material definition

Clinical Material shall have the meaning provided in Section 4.2(b).
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Clinical Material means finished, labeled Product (or matched placebo and/or comparator drug, as applicable) suitable for use in human clinical trials, as further described on Exhibit A attached hereto, as amended from time to time to include all future IV and SC formulations thereof.
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Clinical Material shall have the meaning set forth in each Material Transfer Addendum, if applicable to the rights granted thereunder.
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Examples of Clinical Material in a sentence

  • These times conform with Department policy outlined in the Control of Clinical Material procedure, MP-GEN-CLINMCON.

  • The bulk lot of the drug substance was manufactured under cGMP using a stably transfected CHO cell line, purified, and the drug product vials were filled and labeled at the VRC, Vaccine Clinical Material Program operated by Leidos Biomedical Research, Inc., Frederick, MD.

  • Unless and until such time as the Parties have executed the Supply Agreement, the terms of Schedule 4.1 shall govern any supply of Clinical Material and Licensed Compound requested by Unity.

  • Biocon shall keep complete and accurate records related to the manufacture of the Clinical Material and the methods and facilities used by it for such manufacture as necessary to comply with GMP and Applicable Laws and to permit the Clinical Material to be used in humans.

  • Biocon shall be responsible for procuring […***…] all Materials and resources needed for the Manufacture of Clinical Material ordered under this Agreement, including all Materials and resources needed for manufacturing all ITO needed to Manufacture such Clinical Material.

  • Each Batch (or portion of a Batch) of Clinical Material delivered to Equillium hereunder shall be accompanied by (a) a copy of the Batch Records for such Batch, together with written confirmation that such Batch Records have been reviewed and approved by Biocon’s quality assurance unit, (b) a Certificate of Analysis and (c) a Certificate of Compliance.

  • If Equillium does not notify Biocon of its rejection of any Defective Product in a shipment of Clinical Material within such […***…] period, Equillium will be deemed to have accepted the shipment of Clinical Material, except as otherwise provided below with respect to any quantities of Clinical Material containing Latent Defects.

  • Biocon represents and warrants to Equillium that all Clinical Material supplied by Biocon hereunder: (a) will have been Manufactured in compliance with GMP and other Applicable Laws and (b) will, at the time of delivery, conform to the Specifications then in effect (collectively, the “Clinical Material Warranty”).

  • Biocon shall provide all labels and packaging materials for, and shall perform, all packaging and labeling of Clinical Material; provided, however, that Equillium shall be responsible for providing and determining the content of such labels and Equillium shall have the right to approve the final content of such labels.

  • Biocon shall keep (and shall cause its Affiliates to keep) complete and accurate records pertaining to the Manufacture of Clinical Material in sufficient detail to permit Equillium to confirm the accuracy of all Cost of Goods and supply price determinations, for at least […***…] following the end of the calendar year to which they pertain.


More Definitions of Clinical Material

Clinical Material means a composition of matter in Bulk Drug Substance form and which is an active ingredient and intended for use in Clinical Trials.
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Related to Clinical Material

  • Biological Material means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system;

  • Biological Materials means certain tangible biological materials that are necessary for the effective exercise of the Patent Rights, which materials are described on Exhibit A, as well as tangible materials that are routinely produced through use of the original materials, including, for example, any progeny derived from a cell line, monoclonal antibodies produced by hybridoma cells, DNA or RNA replicated from isolated DNA or RNA, recombinant proteins produced through use of isolated DNA or RNA, and substances routinely purified from a source material included in the original materials (such as recombinant proteins isolated from a cell extract or supernatant by non-proprietary affinity purification methods). These Biological Materials shall be listed on Exhibit A, which will be periodically amended to include any additional Biological Materials that Medical School may furnish to Company.

  • 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.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Fill material means material deposited in accordance with these specifications from any of the classes specified in order to build up an earthworks construction to formation level as shown on the Drawings or as ordered by the Project Manager. The Contractor shall obtain the fill material from a source approved by the Project Manager.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

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

  • Input Material means all documents, information, representations, statements and materials provided by Customer or a third party on behalf of Customer, relating to the Services, including computer programs, data, logos, reports and specifications and inventories.

  • 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.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • 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.

  • 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;

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

  • clinical investigation means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device;

  • 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—

  • 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.

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

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Product Know-How means Know-How to the extent related to the properties, manufacture or use of any products.

  • Licensed Material means the artistic or literary work, database, or other material to which the Licensor applied this Public License.

  • Clinical Trial means any human clinical trial of a Product.

  • Third Party Material means software, software development tools, methodologies, ideas, methods, processes, concepts and techniques owned by, or licensed to a third party and used by the Service Provider in the performance of the Services;

  • 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.