Phase III Clinical Trial

Phase III Clinical Trial. As to a particular Licensed Product for a particular indication, a controlled and lawful study in humans of the safety and efficacy of such Licensed Product for such indication, which is prospectively designed to demonstrate statistically whether such Licensed Product is safe and effective for use in such indication in a manner sufficient to file a BLA or New Drug Application or its equivalent to obtain regulatory approval to market and sell that Licensed Product in the United States or any... country for the indication under investigation in such study. View More

Phase III Clinical Trial. Means a pivotal human clinical trial in any country conducted by Company or its Affiliate the results of which could be used to establish safety and efficacy of the Licensed Product as a basis for approval of an NDA for such Licensed Product or that would otherwise satisfy the requirements of 21 CFR 312.21(c) or the equivalent laws, rules or regulations in a regulatory jurisdiction outside the United States.

Phase III Clinical Trial. Means a pivotal human clinical trial of a therapeutic that is designed to ascertain efficacy and safety of such therapeutic for the purpose of enabling the preparation and submission of a regulatory approval application to a competent regulatory authority, as further defined in 21 C.F.R. 312.21(c) for the United States, as amended from time to time, or the corresponding foreign regulations.

Phase III Clinical Trial. As to a specific Licensed Product, a study in humans designed to satisfy the requirements of 21 C.F.R. § 312.21(c), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States. A Phase III Clinical Trial shall be deemed initiated upon the first dosing of the first research subject.

Phase III Clinical Trial. A human clinical trial, in any country, that would satisfy the requirements of 21 C.F.R. 312.21(c).

Phase III Clinical Trial. A clinical trial of a LICENSED PRODUCT in human subjects for the purpose of gathering the definitive information about efficacy, dosage and safety in the proposed therapeutic indication that is needed for the FDA or other appropriate regulatory agency to evaluate the overall benefit-risk relationship of the drug prior to granting (or denying) approval to market the drug.

Phase III Clinical Trial. Means a human clinical trial of a compound or product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(c), as amended, and is intended to (a) establish that the compound or product is safe and efficacious for its intended use, (b) define contraindications, warnings, precautions and adverse reactions that are associated with the compound or product in the dosage range to be prescribed, and (c) support Regulatory Approval for such compound or product, or a similar clinical study... prescribed by the relevant Regulatory Authorities in a country other than the United States. View More

Phase III Clinical Trial. A pivotal human clinical trial the results of which could be used to establish safety and efficacy of a product as a basis for an NDA or that would otherwise satisfy requirements of 21 CFR 312.21(c)