Clinical Trial definition

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.
Clinical Trial means a clinical trial in human subjects that has been approved by a Regulatory Authority and Institutional Review Board or Ethics Committee, and is designed to measure the safety and/or efficacy of Product. Clinical Trials shall include Phase I Clinical Trials, Phase II Clinical Trials, Phase III Clinical Trials and Phase IV Clinical Trials.
Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial.

Examples of Clinical Trial in a sentence

  • Bambusa will use commercially reasonable efforts to include substantially similar audit rights as set forth in this Section 5.5 (Clinical Trial Audit Right) in any sublicense agreement and any applicable subcontract agreement; provided, however, that any such agreement may provide that such audit would be conducted by an independent, qualified, and reputable auditor engaged by Bambusa or one of its Affiliates instead of an independent, qualified, and reputable auditor engaged by Biotheus.

  • Upon reasonable written notice, Biotheus may engage an independent, qualified, and reputable auditor to conduct an audit of Bambusa and its Affiliates to determine whether any Clinical Trial for a Licensed Product conducted by Bambusa or such Affiliate is being conducted in compliance with the terms of this Agreement, GLP, GMP, and GCP (as applicable), and all Applicable Law.

  • Bambusa will have the right to subcontract the performance of its obligations under this Agreement to one or more Affiliates or Third Party subcontractors engaged on a fee-for-service basis (such as contract research organizations, contract manufacturing organizations, Clinical Trial sites, distributors, wholesalers, and contract sales organizations), without first obtaining Biotheus’ prior written consent.

  • No amount of Revenue Sharing shall be payable to Bambusa in the event Biotheus grants a License to a Third Party after end of Phase II Clinical Trial (as evidenced by completion of the End-of-Phase II Meeting).

  • Initiation of the first Phase I Clinical Trial for the first Aspen CT Product in a country in the Territory for the treatment of any [***], whichever comes earlier.


More Definitions of Clinical Trial

Clinical Trial means any human clinical trial of a Licensed Product.
Clinical Trial means any human clinical study of a pharmaceutical product.
Clinical Trial means any human clinical trial of a Product.
Clinical Trial means a human clinical study conducted on sufficient numbers of human subjects that is designed to (a) establish that a pharmaceutical product is reasonably safe for continued testing, (b) investigate the safety and efficacy of the pharmaceutical product for its intended use, and to define warnings, precautions and adverse reactions that may be associated with the pharmaceutical product in the dosage range to be prescribed or (c) support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product.
Clinical Trial means a study in humans that is conducted in accordance with GCP and is designed to generate data in support of an NDA.
Clinical Trial means an investigation in human subjects and/or patients intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of a Licensed Product, and/or to identify any adverse reactions to a Licensed Product, and/or to study absorption, distribution, metabolism, and/or excretion of a Licensed Product with the objective of ascertaining its safety, activity and/or efficacy.
Clinical Trial means the investigation to be conducted at the Trial Site in accordance with the Protocol numbered […insert identification number…].