Clinical Study definition

Clinical Study means a clinical study (including a Post-Marketing Study or Phase IV Clinical Study) in humans the purpose of which is to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product, as applicable.

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

Clinical Study or “Clinical Studies” means a Phase ▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇ Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

Examples of Clinical Study in a sentence

For costs incurred pursuant to this Section, Vicore shall have the right to invoice NS on a quarterly basis for such costs incurred by Vicore with respect to the Global Clinical Study, and NS shall pay the amount invoiced within [***] of receipt of any such invoice.
In the event that, subject to NS’s final decision-making authority above, the JSC determines to include the Territory in a Global Clinical Study, the Parties shall consult with the applicable Regulatory Authorities for advice, as needed, and then the JSC shall determine the number (or proportion) of participants to seek to enroll from the Territory in such a Global Clinical Study.
For a Global Clinical Study that NS has agreed to participate in under this Section, consistent with NS’s obligation to ensure its Development Plan is consistent with Vicore’s plan for global Development of the Licensed Product, NS shall use Commercially Reasonable Efforts to initiate enrollment of participants in the Territory in any Global Clinical Study within [***] of Vicore doing so in ROW.
For avoidance of doubt, any [***] of the Licensed Product shall not be considered a Global Clinical Study and NS shall not be required to participate in such Clinical Studies.
Subject to Section 4.2.2, if Vicore plans to conduct a global clinical study (the “Global Clinical Study”), the JSC shall discuss and agree upon whether such Global Clinical Study should include the Territory; [***], NS shall use Commercially Reasonable Efforts to participate in a Global Clinical Study for an indication in the Licensed Field as described in Section 4.2.2 in order to meet its obligation to use Commercially Reasonable Efforts to Develop and Commercialize the Product in the Territory).

More Definitions of Clinical Study

Clinical Study means a Phase I Study, Phase II Study (including a Phase II(a) and Phase II(b) Study), Phase III Study or Post-Approval Studies, as applicable.

Clinical Study means any human clinical trial of a Product Candidate.

Clinical Study means a study in which human subjects or patients are dosed with a drug, whether approved or investigational.

Clinical Study means a Phase I Clinical Study, Phase II Clinical Study, Phase III Clinical Study or any other study in which human subjects or patients are dosed with a drug, whether approved or investigational.

Clinical Study means any investigation in relation to humans intended:

Clinical Study means the investigation as defined in the cadre above, (also) to be conducted at the Study Site in accordance with the Protocol;

Clinical Study means any and all tests and studies in human subjects that are required by Applicable Law, or otherwise requested or recommended by the Regulatory Authorities, to obtain, maintain or expand Regulatory Approvals for a Collaboration Product for an Indication, including Post-Approval Commitments, safety / efficacy studies, and pharmacoeconomic studies or Marketing Studies.