Clinical Studies definition

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.

Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

Clinical Studies means all Clinical Phase I Studies, Clinical Phase II Studies and Clinical Phase III Studies, including pivotal studies.

Examples of Clinical Studies in a sentence

• Kissei shall have a right to Develop the Companion Diagnostic in the Kissei Territory, including the conduct of all Clinical Studies to obtain and maintain Regulatory Approval of the Companion Diagnostic in the Kissei Territory in cooperation with a Third Party (the “CDx Company”).

• Within ** after the effective date of termination, Kissei shall transfer and assign to Rigel, ** all Regulatory Filings and Regulatory Approvals for the Product, Data from all preclinical, non-clinical, and Clinical Studies of the Product conducted by or on behalf of Kissei, its Affiliates, or Sublicensees, and all pharmacovigilance data (including all adverse event data) on the Product.

• Each Party shall document all non-clinical studies and Clinical Studies in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH guidelines, GCP, GLP, and GMP).

• For clarity, such Clinical Studies include but are not limited to Clinical Studies of the Product in the Initial Indication.

• Kissei shall either, as directed by Xxxxx, (i) wind-down any ongoing Development activities (including any Clinical Studies) of Kissei or its Affiliates and Sublicensees with respect to any Product in the Kissei Territory in an orderly fashion at Kissei’s cost or (ii) promptly transfer such Development activities to Rigel or its designee, ** in each case in compliance with all Applicable Laws.

More Definitions of Clinical Studies

Clinical Studies means Phase I, Phase II, Phase III, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise conducted or recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the approved indications for such Licensed Product.

Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

Clinical Studies means any human clinical study or clinical trial of a Licensed Product.

Clinical Studies means a research study in humans that is (a) conducted in accordance with international ethical and scientific quality standards for designing, conducting, recording and reporting research studies involving investigational medicinal products for human use and that involve the participation of human subjects, which standards are established through Laws, and (b) designed to generate clinical data and results regarding a chemical compound or biological molecule in support of Marketing Approval, including any translational research studies. Clinical Studies include any Phase 1 Clinical Study(ies), any Phase 2 Clinical Study(ies), any Phase 3 Clinical Study(ies) or any Phase 4 Clinical Study(ies).

Clinical Studies means any study in which human subjects are dosed with a drug, whether approved or investigational, including any Phase 1, 2, 3 or 4 clinical study.

Clinical Studies means Phase 0, Phase I, Phase II, Phase III, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more Indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such Indication.