Phase III Trial definition

Phase III Trial means a human Clinical Trial of the Licensed Product, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use; (b) to define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) consistent with 21 CFR § 312.21(c).

Phase III Trial means a human clinical trial of a Product on a sufficient number of subjects that is designated to establish that such Product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such Product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval, including tests and studies that are required by the FDA, as described in 21 C.F.R. 312.21(c), as amended from time to time.

Phase III Trial means a clinical trial of a Licensed Product in human patients, which is designated as a Phase III Trial or a pivotal trial and is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use; (b) to define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) to be, either by itself or together with one or more other clinical trials having a comparable design and size, the final human clinical trial in support of Regulatory Approval of the Licensed Product, and (d) consistent with 21 CFR § 312.21(c) (as hereafter modified or amended) and any of its foreign equivalents.

Examples of Phase III Trial in a sentence

• Molecular Heterogeneity and Response to Neoadjuvant Human Epidermal Growth Factor Receptor 2 Targeting in CALGB 40601, a Randomized Phase III Trial of Paclitaxel Plus Trastuzumab With or Without Lapatinib.

• Milestone Event Milestone Payment First dosing of any Product to a subject in a Phase III Trial Fifteen million dollars ($15,000,000) [*] [*] million dollars ($[*]) [*] [*] million dollars ($[*]) [*] [*] million dollars ($[*]) [*] [*] million dollars ($[*]) [*] [*] million dollars ($[*]) [*] [*] million [*] thousand dollars ($[*]) [*] Confidential treatment requested; certain information omitted and filed separately with the SEC.

• Prior to the first Phase III Trial for any Licensed Product, Nanobiotix will provide the initial Global Development Plan to the JSC for its review, discussion, and [***] regarding activities to be conducted in the Territory, approval.

• Biogen Idec will prepare and present to PTI a draft Co-Commercialization Plan for each Co-Developed Licensed Product within [***] after the date of receipt of the final report for the first Phase III Trial for such Co-Developed Licensed Product that is designed to support Regulatory Approval in the United States.

• In the event that the Phase II Pancreatic Cancer Trial is not Positive as determined pursuant to the foregoing and Merck has not yet paid such Phase II Pancreas Milestone, but Merck nonetheless decides to initiate a Phase III Trial in pancreatic cancer, the Phase III Pancreas Milestone payment shall be increased to [* * *].

More Definitions of Phase III Trial

Phase III Trial means that portion of the clinical development program that provides for the pivotal human clinical trials of a Product, which trial(s) is/are designed to (a) establish that such 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; (c) be a pivotal study for submission of a NDA; and (d) be generally consistent with 21 CFR §312.21(c).

Phase III Trial means a human clinical trial that satisfies the requirements for a Phase 3 study as defined in 21 C.F.R. Part 312.21(c) (or its successor regulation).

Phase III Trial means a pivotal clinical trial designed to be used to establish safety and efficacy of a CAR Product as a basis for obtaining Regulatory Approval in the applicable country where such clinical trial takes place, or a trial that would otherwise satisfy the requirements defined in 21 C.F.R. 312.21(c), or other comparable regulation imposed by the FDA, the EMA or their foreign counterparts for an equivalent clinical trial in the applicable country where such clinical trial takes place.

Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

Phase III Trial shall not include a Phase IIIb Trial.

Phase III Trial means the third phase of a clinical study involving expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling, to support registration for a product or compound with the FDA and any FDA counterpart, and that provides data capable of meeting statutory standards for marketing approval. Phase III Trials usually include several hundred to several thousand subjects. For example, in the United States, “Phase III Trial” includes a human clinical study that satisfies the requirements of 21 C.F.R. § 312.21(c) in the United States, or an equivalent or counterpart of the foregoing in any other country or jurisdiction. For clarity, “Phase III Trial” includes both Phase IIIa and Phase IIIb trials.

Phase III Trial means that portion of the clinical development program that provides for the pivotal human clinical trials of a Licensed Product, which trial(s) is/are designed to (a) establish that such Licensed Product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; (c) be a pivotal study for submission of an NDA, and (d) be generally consistent with 21 CFR §312.21(c), or its successor regulation, or the equivalent in any foreign country.