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

  • 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 be responsible for procuring […***…] all equipment, personnel and other resources needed for the Manufacture of Clinical Material ordered under this Agreement.

  • Biocon shall Manufacture Clinical Material ordered by Equillium in compliance with GMP and all other Applicable Laws.

  • Biocon shall keep complete, accurate and authentic accounts, notes, data and records pertaining to the Manufacture, processing, testing, storage, and distribution of Clinical Material and of the work performed under this Agreement, including, without limitation, all quality control documentation and the Master Batch Records, for the longer of (i) a period of […***…] after delivery of such Clinical Material to Equillium or (ii) the period of time required by Applicable Law.

  • 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.

  • Biocon shall obtain and maintain for the Facility, […***…], all permits, licenses and approvals (including facilities licenses) needed for Biocon to be able to Manufacture and supply all Clinical Material in compliance with GMP and all Applicable Laws (the “Facilities Licenses”), in a timely manner such that Biocon is able to meet is Manufacturing and supply obligations under this Agreement.

  • In any event, Biocon shall use commercially reasonable efforts to address and resolve as soon as possible any issues, concerns or warnings from any Regulatory Authority that might affect Biocon’s ability to Manufacture and supply Clinical Material in accordance with this Agreement.

  • Equillium may reject any Clinical Material delivered under this Agreement that does not conform to the Clinical Material Warranty (a “Defective Product”) by giving written notice to Biocon within […***…] after delivery.

  • Biocon shall be responsible for allocating appropriate space in the Facility, and for obtaining, installing and maintaining in such Facility all capital equipment, as needed to manufacture the quantities of Clinical Material ordered by Equillium in accordance with the terms of this Agreement.

  • Such Forecasts (including the Initial Forecast) represent Equillium’s reasonable estimates of the quantity of Clinical Material it may require during the applicable […***…]-calendar quarter period.


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 any material (including, without limitation, plants, animals, microbes or viruses) of biological origin which contains genetic information capable of reproduction and/or material derived from the same that is collected or produced through the Contract;

  • 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 with respect to the Licensed Product or the Licensed Compound made, collected or otherwise generated under or in connection with pre-clinical, clinical, or the post-Approval studies for the Licensed Compound or Licensed Product, including any data, reports and results with respect to any of the foregoing.