clinical stage definition

clinical stage means any company with a product or product candidate that has been tested in humans in a clinical setting;
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clinical stage means, for a given sublicense agreement (or option thereto), that an IND has been filed to study the safety and/or efficacy of at least one Licensed Product that is the subject of such sublicense agreement (or option thereto) in a clinical trial in humans anywhere in the world, at the time Licensee enters into such sublicense agreement (or option thereto). For the sake of clarity, to qualify as “Clinical Stage,” the aforesaid IND must [***].” 10. The following Section 1.22 is hereby added to Article 1 (“Definitions”):
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Related to clinical stage

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

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

  • Clinical staff means persons who work in a hospital whose duties include the personal care or medical treatment of patients. “Clinical staff” includes, but is not limited to, credentialed physicians, physicians’ assistants, nurses, nursing aides, medical technicians, therapists, and other individuals involved in the personal care or medical treatment of patients.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]