Clinical Batches definition

Clinical Batches means any cGMP batches that will be used by Company in Clinical Trials.
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Clinical Batches mean such batches of Products manufactured and released by Novasep pursuant to this Agreement for use in clinical trials by and or on behalf of GenSight.
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Clinical Batches means commercial size batches of any product on which the clinical studies and tests necessary to file an Application for Regulatory Approval and for obtaining Regulatory Approval are to be performed.
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Examples of Clinical Batches in a sentence

  • LONZA shall identify and retain certain reserve samples of all Raw Materials and intermediate production samples generated in the production of Clinical Batches as set forth in the applicable Materials Specifications, the applicable standard operating procedures, the Master Production Record or as otherwise agreed in writing by LONZA and PROTEON.

  • In addition to its obligations under Section 10.3 with respect to production and delivery of Replacement Drug Substance, LONZA will, upon PROTEON’s request and at PROTEON’s expense, use Commercially Reasonable Efforts to produce additional Clinical Batches in cases where a Clinical Batch is not Non-Conforming Drug Substance but where such Clinical Batch does not satisfy PROTEON’s requirements.

  • Following TRANSMEDICS acceptance of the Research & Development Report, if FRESENIUS and TRANSMEDICS so agree, FRESENIUS shall produce one or more Clinical Batches of the Products.

  • CBSB shall perform all Clinical Runs required to manufacture Clinical Batches at 1,000L scale in accordance with the Project Scope, the Project Schedule and Budget and the Master Production Record or as otherwise directed by Tercica in writing and mutually agreed to by the Parties.

  • Semnur acknowledges that, except for the Clinical Batches, no other material supplied by Lifecore in connection with the Development Services under this Agreement, may be used in humans, in foods, drugs, medical devices, cosmetics, or for in vitro diagnostic uses.

  • LONZA shall identify and retain certain reserve samples of all Raw Materials and intermediate production samples generated in the production of Clinical Batches as set forth in the applicable Materials Specifications, the applicable standard operating procedures, the Master Production Record or as otherwise agreed in writing by LONZA and Client.

  • CBSB will provide, to Tercica, the cGMP manufacturing services to produce such Clinical Runs and Clinical Batches on a time and materials basis as set forth in Section 8.3 and in accordance with the delivery terms set forth in Section 7.4. Subject to the provisions of Article 13, Tercica shall have no obligation to pay for, and CBSB shall replace, at CBSB’s cost, any Non-Conforming Drug Substance resulting from any Clinical Run.

  • The production facilities will be operated by NOVASEP in compliance with current GMP rules with respect to the Clinical Batches and all applicable laws.

  • The purposes, criteria, procedures, eligibility, and priorities for distribution of these monies to employees in the bargaining unit shall be established by the Labour/ Management Committee.

  • The Supply Agreement shall contain other terms as those provided under this Agreement and the Technical Specifications Agreement, including without limitation representation and warranties, confidentiality, indemnification and termination which shall apply to the Parties with respect to the manufacturing and supply of Clinical Batches.

Related to Clinical Batches

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • 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.

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

  • Finished Product means the final packaged product intended for human consumption;

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