Clinical Study definition

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

Clinical Study means a Xxxxx 0 Xxxxx, Xxxxx 1/2 Study, Phase 2 Study, Phase 2/3 Study or a Phase 3 Study, or other study (including a non-interventional study) in humans to obtain information regarding a product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product.

Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 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

• As partial consideration for the License and other rights granted by Passage to Gemma herein, and in exchange for Passage’s supply of product for the conduct of a Clinical Study for a Licensed Product by Xxxxx or its designee, Gemma shall pay to Passage (a) [*], and (b) [*].

• If Penn (in its sole discretion) is willing and able to conduct a Clinical Study for a Licensed Product developed under the Research Program, the Parties and Penn will negotiate a separate clinical trial agreement and a separate clinical trial budget prior to initiation of such Clinical Study; provided that any such study shall be at Xxxxx’s cost and expense.

• If Penn (in its sole discretion) is willing and able to conduct a Clinical Study for a Licensed Product developed under the Research Program, the Parties and Penn will negotiate a separate clinical trial agreement and ​ ​ ​ a separate clinical trial budget prior to initiation of such Clinical Study; provided that any such study shall be at Xxxxx’s cost and expense.

More Definitions of Clinical Study

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

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 study in which human subjects are dosed or treated with a drug or biological product, whether approved or investigational.

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 investigation in relation to humans intended:

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

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