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. 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.

Phase III Clinical Trial. A pivotal human clinical trial conducted in any country that satisfies the requirements of 21 CFR 312.21(c) or its foreign equivalent, which trial is designed to (a) establish that a pharmaceutical product is safe and efficacious for its intended use, (b) define warnings, precautions, and adverse reactions that are associated with the product in the dosage range to be prescribed; and (c) support Marketing Authorization of such product.

Phase III Clinical Trial. A human clinical trial in any country, the results of which could be used to establish of a product as a basis for a marketing approval application submitted to the FDA or that would otherwise satisfy the requirements of 21 CFR 312.21(c) or its foreign equivalent

Phase III Clinical Trial. A clinical trial as defined in 21 C.F.R. 312.21(c), as may be amended from time to time, or any foreign equivalent thereto. A Phase III Clinical Trial shall be deemed to have been initiated when the first patient is dosed in such Phase III Clinical Trial

Phase III Clinical Trial. Any human clinical trial to confirm with statistical significance the efficacy and safety of a Licensed Product, as described under 21 C.F.R. §312.21(c) (as hereafter modified or amended) and any of its foreign equivalents. For avoidance of doubt: any pivotal trial shall be deemed to be a Phase III Clinical Trial

Phase III Clinical Trial. The term "Phase III Clinical Trial" shall mean those controlled and lawful studies of a Product conducted anywhere in the Territory on sufficient numbers of patients with the condition treated by the Product that are prospectively designed, using predetermined endpoints, to demonstrate clinically and statistically the efficacy and safety of that Product for one or more indications as a pivotal study intended to lead to regulatory approval of such Product for such indication or indications.

Phase III Clinical Trial. Means a human clinical trial of a Licensed Product that satisfies the requirements of 21 CFR 312.21(c).

Phase III Clinical Trial. A human clinical study on sufficient numbers of patients that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed, and to support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product, as described in 21 C.F.R. § 312.21(c), as amended, or a similar... clinical study prescribed by the Regulatory Authorities in a foreign country View More

Phase III Clinical Trial. The term "Phase III Clinical Trial" means a clinical trial in an extended human patient population designed to obtain data determining efficacy and safety of any Product to support regulatory approvals in the proposed therapeutic indication, as more fully defined in 21 C.F.R. §312.21(c), or its successor regulation, or the equivalent in any foreign country.