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 clarity, Eikon shall have the right to utilize the data and results generated by Impact, including from Impact’s performance of the first-in-human Clinical Study or the global Clinical Studies in the Impact Territory, for its Drug Approval Applications in Eikon Territory.

• Promptly after the Effective Date, Impact shall deliver to Eikon or Eikon’s designee Licensed Product or Licensed Compound to enable Eikon’s commencement of a first Eikon Clinical Study of the first Licensed Product, including, without limitation, certificates and other documentation regarding the properties of such Licensed Product or Licensed Compound.

• If Parties agree in writing that Eikon will not Develop the Licensed Compound or Licensed Product with respect to an indication under a Global Clinical Study, then, subject to JSC approval, Impact shall have the right to Develop the Licensed Compound or Licensed Product with respect to such indication in the Impact Territory under the Impact Development Plan approved by the JSC.

• For the avoidance of doubt, except for the Impact [***] IND submission work outlined in 4.1.1(i)(C), all clinical development of [***] and [***] shall be treated the same as provided for a Global Clinical Study with respect to roles and responsibilities of the parties and the bearing of costs and expenses.

• Parties will discuss in good faith the subsequent supply arrangement during the Term, and with respect to any global Clinical Study, the Parties shall use the same Licensed Compound or Licensed Product Manufactured by on behalf of the same Party unless otherwise agreed by the JSC; provided that in the event that Impact uses alternatively-Manufactured Licensed Compound or Licensed Product, Impact is responsible for performing any and all applicable equivalence studies at Impact’s sole cost and expense.

More Definitions of Clinical Study

Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

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.