Phase III Studies definition

Phase III Studies means large, adequate and well-controlled clinical studies that are conducted in human patients, after successful completion of the first Phase II Study, designed to evaluate safety and therapeutic efficacy of the Product and that are needed to obtain regulatory approval(s) and product labeling, with respect to (i) the United States, as more fully defined in 21 C.F.R. § 312.21(c), as may be amended; or (ii) the equivalent of such a clinical study for submission to the EMEA; or (iii) equivalent submission in such other country or jurisdiction.

Phase III Studies means that portion of the clinical U.S. ----------------- Development Plan, ROW Development Plan or Development relating to each Collaboration Product which provides for large scale, pivotal, clinical studies conducted in a sufficient number of patients and whose primary objective is to obtain a definitive evaluation of the therapeutic efficacy and safety of the Collaboration Product in patients for the particular indication in question that is needed to evaluate the overall risk-benefit relationship of Collaboration Product and to provide adequate basis for obtaining requisite regulatory approval(s) and product labeling, as more fully defined in 21 C.F.R. (S) 312.21(c).

Phase III Studies means that portion of the Development Plan or Development relating to each Alliance Product which provides for large scale, pivotal, clinical studies conducted in a sufficient number of patients and whose primary objective is to obtain a definitive evaluation of the therapeutic efficacy and safety of the Alliance Product in patients for the particular indication in question that is needed to evaluate the overall risk-benefit profile of the Alliance Product and to provide adequate basis for obtaining requisite regulatory approval(s) and product labeling.

Examples of Phase III Studies in a sentence

• The Differential Efficacy of Pemetrexed According to NSCLC Histology: A Review of Two Phase III Studies.

• If Vitae exercises its Co-Development Option, it shall reimburse BI for Vitae’s specified share of any reasonable Development costs actually incurred by BI in performing such Phase III Studies from the Initiation of such Phase III Studies until the submission of an NDA with the FDA or the EMEA.

• Vitae shall have the right, but not the obligation, to co-fund the global Development of one (1) Product by sharing between ten percent (10%) to twenty percent (20%) of all costs of the Phase III Studies for such Product in return for an increased royalty in accordance with Section 9.6.5(b) (the “Co-Development Option”).

• To exercise its Co-Development Option, Vitae shall notify BI in writing at least thirty (30) days prior to the Initiation of Phase III Studies that it is exercising its Co-Development Option; such written notice shall also specify the percentage of expenses that Vitae will be co-funding.

• At least six (6) months prior to Initiation of Phase III Studies for each Product, BI shall provide Vitae with a budget for the estimated Development costs for such Phase III Studies.

More Definitions of Phase III Studies

Phase III Studies means large scale clinical studies conducted in a sufficient number of patients to establish the Product clinical efficacy in the Field and its safety.

Phase III Studies means the human clinical trials of the Product described in the Development Plan that are designed to ascertain efficacy and safety of the Product, for the purpose of enabling the preparation and submission of a NDA or a foreign equivalent thereof in the Territory.

Phase III Studies means a series of controlled pivotal clinical trials, after completion of preliminary efficacy and dose-ranging studies and after adequate safety data has been established for a Product, that are necessary to obtain sufficient confirmatory efficacy and safety data for the preparation and submission of an NDA for such Product for the human therapeutic indication being investigated by the trials, and which are planned to involve a sufficient number of patients who suffer from the condition for which the NDA is to be submitted for submission of such NDA.

Phase III Studies means that portion of the clinical development program which provides for large scale clinical studies conducted in a sufficient number of patients to establish Product clinical efficacy for one or more indications and its safety, as more fully defined in 21 C.F.R. § 312.21(c).

Phase III Studies means large, adequate and well controlled clinical studies that are conducted in human patients designed to demonstrate definitive information about safety and efficacy of the Licensed Product that is needed to evaluate the overall benefit-risk relationship with the primary objective being to obtain regulatory approval(s) and product labeling, as described in 21 C.F.R. § 312.12(c), or a similar clinical study prescribed by the Regulatory Authorities in a country other than the United States. These studies and the approach are generally discussed with applicable Regulatory Authorities prior to initiation, but Regulatory Authority approval is not required prior to initiation of such studies.

Phase III Studies means Phase III clinical studies conducted by or on behalf of Licensee showing additional therapeutic benefits of the Product as indicated with data on the labels and/or required for a Regulatory Approval Application.

Phase III Studies means a program of clinical studies approved by the FDA or other equivalent national or supranational regulatory agencies outside of the United States which, if successfully completed to the satisfaction of the FDA or equivalent agencies outside of the United States, is intended to enable the sponsor of the studies to file an NDA and/or other equivalent applications for Regulatory Approval (as defined below).