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 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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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.

  • Return unopened, expired, or unused study drug with the Inventory of Returned Clinical Material form as directed by Genentech.

  • Return unopened, expired, or unused study drug with the Inventory of Returned Clinical Material form as directed by Genentech and Novartis for everolimus.

  • 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.

  • The distribution of such materials is governed by Vapotherm’s Review and External Distribution of Clinical Material policy.Nor does this Policy govern the details of an arrangement for the sale of Vapotherm products.

  • Control of Clinical MaterialDepartmental Policy [ MP-CGEN-004] indicates that information relating to the control of clinical material is detailed in individual Examination Procedure documents, with details inclusive of: identification, collection, indexing, accessing, filing, storage times (including legislated minimum retention times) and disposal of Clinical Material.

  • Such Preclinical and/or Clinical Material supplied by ImmunoGen to Biotest shall have attached with each shipment the respective safety data sheets and instructions for use, waste management, transportation, packaging and labeling.

  • Should it be necessary to expand or reduce the number of days of service for any or all of the facilities, the Town will provide ten (10) days written notice.

  • 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”).


More Definitions of Clinical Material

Clinical Material shall have the meaning set forth in each Material Transfer Addendum, if applicable to the rights granted thereunder.
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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, 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.

  • 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, 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, with respect to a Licensed Product for any particular indication in any particular jurisdiction, regulatory applications and submissions (and any supplements or amendments thereto), and any notifications, communications, correspondence, registrations, drug master files, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority, including BLAs and INDs, as applicable, that relate to such Licensed Product in such jurisdiction. Regulatory Materials also include presentations, responses, and applications for Regulatory Approvals.

  • 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;

  • Investigational Medicinal Product means the study drug or control material as defined 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, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Product Know-How means all the know how, trade secrets, expertise, inventions, discoveries, technical information and other unpatented information related solely and specifically to the Product, that is owned or controlled by Seller or its Affiliates and used in the Territory, including, but not limited to, all information presently used by the Seller to make, have made, use or sell the Product.

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

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • 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;