Phase III Clinical Trial

Phase III Clinical Trial. As to a particular product for a particular indication, the large scale human clinical trials conducted in humans of the safety and efficacy of such product for such indication, which is prospectively designed to demonstrate statistically whether such product is safe and effective for use in such indication in order to file an application for regulatory approval with respect to such product for such indication.

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)

Phase III Clinical Trial. The term "Phase III Clinical Trial" shall mean a pivotal random clinical trial having a sufficient number of patients to provide statistically significant results regarding safety and efficacy of a particular Licensed Product in the treatment of prostate cancer. The Phase III Clinical Trial shall be conducted pursuant to the requirements of the Federal Drug, Food and Cosmetic Act, as amended [Title 21, United States Code] and regulations promulgated thereunder, and shall commence on the first... day the first patient is treated under the protocol of such Phase III Clinical Trial. View More

Phase III Clinical Trial. Shall mean PN's currently on-going controlled studies in humans testing the efficacy and safety of the Product for use in the Field in a manner sufficient to obtain FDA Registration of such Product, a summary and description of which are set forth in the General Development Plan.

Phase III Clinical Trial. Means a pivotal human clinical trial the results of which may be used to establish safety and efficacy of a product as a basis for a NDA.

Phase III Clinical Trial. Shall mean the Phase III clinical trial for NUMAX ongoing as of the EFFECTIVE DATE (designated by MEDIMMUNE as of the EFFECTIVE DATE as STUDY #MI-CP110).

Phase III Clinical Trial. Means, with respect to the United States, large-scale, pivotal, clinical trials conducted in a sufficient number of human patients whose primary objective is to obtain a definitive evaluation of the therapeutic efficacy and safety of a Licensed Product in patients for the particular indication in question that is needed to evaluate the overall risk-benefit profile of such Licensed Product and to provide an adequate basis for obtaining requisite regulatory approval(s) and product labeling, as... more fully defined in 21 C.F.R. § 312.21(c), as may be amended, and, with respect to any other country or jurisdiction, the equivalent of such a clinical trial in such other country or jurisdiction. View More

Phase III Clinical Trial. Means a pivotal efficacy trial whose primary objective is to obtain a definitive evaluation of the therapeutic efficacy and safety of a Licensed Product in patients for the particular indication in question that is needed to evaluate the overall risk-benefit profile of a Licensed Product and to provide adequate basis for obtaining requisite Marketing Approval(s) and product labeling, as more fully defined in 21 C.F.R. 312.21(c).

Phase III Clinical Trial. Means, with respect to a clinical trial conducted pursuant to an IND, any controlled human clinical trial conducted in the United States as required under and pursuant to 21 C.F.R. §312.21(c) and subject to the general oversight of the FDA, or, with respect to a jurisdiction other than the United States, a similar clinical study subject to the general oversight of the applicable Regulatory Authority.

Phase III Clinical Trial. Any investigational use of a Licensed Product in humans that triggers a payment by Procept to Penn under Section 4.8.3 of the Penn License Agreement.