Common use of Phase I Clinical Trial Clause in Contracts

Phase I Clinical Trial. The term “Phase I Clinical Trial” shall mean a human clinical trial that is intended to initially evaluate the safety, tolerance or pharmacological or antigenic effects of a product in human subjects, or that is otherwise described in 21 CFR 312.21(a) as amended (or its successor regulation or comparable Laws in countries outside the United States).

Phase I Clinical Trial. The term “Phase I Clinical Trial” shall mean a human clinical trial that is intended Clinical Trial conducted on sufficient numbers of healthy human volunteers with the endpoint of determining initial tolerance, safety and/or pharmacokinetic information in single dose, single ascending dose, multiple dose and/or multiple ascending dose regimens, and to initially evaluate the safety, tolerance or pharmacological or antigenic effects of a product support its continued testing in human subjects, or that is otherwise described in 21 CFR 312.21(a) as amended (or its successor regulation or comparable Laws in countries outside the United States)Phase II Clinical Trials.

Phase I Clinical Trial. The term “"Phase I Clinical Trial” " shall mean a human clinical trial that is intended to initially evaluate the safety, tolerance or pharmacological or antigenic effects those further and lawful studies of a product Product conducted anywhere in the Territory that the applicable Regulatory Authority requires to be performed on a sufficient number of healthy human subjectspatients to generate sufficient data to establish the safety and biological activity of that Product, or that is otherwise described in 21 CFR 312.21(a) as amended (or its successor regulation or comparable Laws in countries outside the United States)and to permit commencement of a Phase II Clinical Trial.

Phase I Clinical Trial. The term “Phase I Clinical Trial” shall mean means a human clinical trial that is intended to initially evaluate in any country which generally provides for the safety, tolerance or pharmacological or antigenic effects initial introduction into humans of a product in human subjectsProduct with the primary purpose of determining its metabolism and pharmacokinetic properties and pharmacology, or that is could otherwise described in meet the definition of 21 CFR 312.21(a) as amended (312.21 or its successor regulation or comparable Laws in countries outside foreign equivalent. * CONFIDENTIAL TREATMENT REQUESTED — This language has been omitted and filed separately with the United States)Securities and Exchange Commission.