Clinical Batch definition

Clinical Batch means a Batch produced from a Clinical Run.
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Clinical Batch means a Batch produced by SAFC under cGMP conditions and intended for use by Company for investigational purposes.
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Clinical Batch means the first batch of Product, manufactured by or on behalf of PEGA 1, suitable to be used for Clinical Studies according to specifications accepted by Regulatory Authorities.
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Examples of Clinical Batch in a sentence

  • Each Party shall act in good faith and shall cooperate with the other Party, with any qualified independent Third-Party laboratory in connection with an investigation, and with the arbitrator, as to the existence of or source of nonconformity with respect to a Clinical Batch supplied under this Agreement.

  • If PROTEON issues a notice of rejection of a Clinical Batch pursuant to Section 10.1 or revokes its acceptance of a Clinical Batch pursuant to * CONFIDENTIAL TREATMENT REQUESTED.

  • LONZA shall pay for the fees associated with any dispute regarding a Clinical Batch that is determined to be Nonconforming Drug Substance.

  • If PROTEON issues a notice of rejection of a Clinical Batch pursuant to Section 10.1 or revokes its acceptance of a Clinical Batch pursuant to Section 10.1 and the Parties or a qualified and independent arbitrator selected using the procedure specified in Section 102 determine that such Batch is Non-Conforming Drug Substance, then LONZA shall, as soon as it is commercially practicable to do so, replace such Non-Conforming Drug Substance with Conforming Drug Substance (the “Replacement Drug Substance”).

  • Notwithstanding anything to the contrary contained in this Agreement, in no event shall LONZA be required to store any Clinical Batch for more than twenty (20) calendar days after PROTEON’s acceptance of such Batch pursuant to Article 10.

  • PROTEON shall arrange for shipment and take delivery of such Batch from LONZA’s Facility via the Designated Carrier, at PROTEON’s expense, within five (5) Business Days after PROTEON’s acceptance of a Clinical Batch pursuant to Article 10, or pay applicable storage costs.

  • 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.

  • LONZA will deliver each Clinical Batch EXW LONZA’s Visp Facility to the Designated Carrier in accordance with the Shipping Guidelines; provided that risk of loss in and title to the Clinical Batch shall pass to PROTEON when the Clinical Batch is placed upon the Designated Carrier’s vehicle.

  • LONZA shall provide storage for such Clinical Batch in accordance with the Storage Guidelines at [*] during such forty-five (45) day period; provided, that any additional storage beyond such forty-five (45) day period will be charged to Client [*] in accordance with the Project Rates.

  • If a Clinical Batch is not picked-up by GenSight or its appointed carrier within [**] days of the Notice of Delivery, NOVASEP shall charge to GenSight a storage fee of [**] (€) Euros, VAT excluded, per Clinical Batch and per week (complete or partial) of storage beyond the [**] days weeks period after the Notice of Delivery.


More Definitions of Clinical Batch

Clinical Batch means the fermentation of a strain of Escherichia coli (hereafter referred to as the "Strain") expressing the compound Pro- Apolipoprotein Al (hereinafter referred to as the "Product") and the purification of the Product in EUROGENTEC's pharmaceutical Production Unit, as hereinafter defined, applying Current Pharmaceutical Guidelines, with the intention to use the Product for research, preclinical research (phamacokinetics, toxicology, stability, scale-up processes, production consistency, etc.), and clinical development.
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Clinical Batch means a production batch of the Product intended to have uniform character and quality that is Processed by I3 in accordance with the terms and conditions of this Agreement. [ * ]
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Related to Clinical Batch

  • 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.

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

  • 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.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

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

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • 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.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

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

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Manufacturing Process means any process for—

  • Manufacturing Site means a location where a manufacturing

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • API means American Petroleum Institute.

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.