Phase III Clinical Trial definition

Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

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Phase III Clinical Trial means a controlled study in humans of the efficacy and safety of a product, which is prospectively designed to demonstrate statistically whether such product is effective and safe for use in a particular indication in a manner sufficient to file for Marketing Authorization, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(c) or its foreign equivalents.

Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), 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.

Examples of Phase III Clinical Trial in a sentence

• For any Sublicensing and Assignment Revenue received by or on behalf Visara or its Affiliate during its sponsored Phase III Clinical Trial but before the completion of the Phase III Clinical Trial from a Product Deal outside the Territory, Visara shall share [***] of that Sublicensing and Assignment Revenue with Licensor.

• Within [***]days after the Parties agree that Licensor will supply to AffaMed the Licensed Antibodies and Licensed Products for Phase III Clinical Trial or Commercialization purposes, the Parties will enter into such Phase III and Commercial Manufacturing and Supply Agreement.

• If, despite Licensor’s best efforts, such CMO is unable to provide sufficient supply of Licensed Product to satisfy AffaMed’s Phase III and Commercialization requirements in the Territory, then Licensor will complete a Manufacturing Technology Transfer for Phase III Clinical Trial and Commercial supply of the Licensed Products to a CMO designated by AffaMed.

• For any Sublicensing and Assignment Revenue received by or on behalf Visara or its Affiliate during its sponsored Phase III Clinical Trial but before the completion of the Phase III Clinical Trial from a Product Deal in the Territory, Visara shall share [***] of that Sublicensing and Assignment Revenue with Licensor.

• At any time during the Term, if requested by Visara, and if agreed by the Parties, the Parties may negotiate and enter into a service agreement, pursuant to which Licensor may provide the agreed technical support service in connection with Phase III Clinical Trial or Commercialization supply.

More Definitions of Phase III Clinical Trial

Phase III Clinical Trial means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(c).

Phase III Clinical Trial means a human clinical trial in any country, the results of which could be used to establish safety and efficacy of a Product as a basis for an NDA or would otherwise satisfy requirements of (US) 21 C.F.R. 312.21(c), or its foreign equivalent in Canada, the EU or elsewhere.

Phase III Clinical Trial means a Clinical Trial defined in 21 C.F.R. 312.21(c), as may be amended from time to time, or any equivalent thereto in any jurisdiction.

Phase III Clinical Trial means a human clinical trial of a compound or product for an indication on a sufficient number of subjects that is designed to establish that the compound or product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with the compound or product in the dosage range to be prescribed, and to support Regulatory Approval of the compound or product for such indication or label expansion of the compound or product. For clarity, the term “Phase III Clinical Trials” includes early access and compassionate use programs.

Phase III Clinical Trial means a pivotal Clinical Trial (whether or not denominated a “Phase III”) of a product in human patients or subjects with a defined dose or a set of defined doses designed to ascertain efficacy and safety of such product for the purpose of enabling the preparation and submission of MAA to the competent Regulatory Authorities, as further defined in 21 C.F.R. 312.21(c), as amended from time to time, or the corresponding foreign regulations.

Phase III Clinical Trial means one or more clinical trials on sufficient numbers of patients, which trial(s) are designed to (a) establish that a drug is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed; and (c) support Regulatory Approval of such drug.

Phase III Clinical Trial means that portion of a clinical drug development program which provides an expanded trial of a Product on sufficient numbers of patients to establish the safety and efficacy of a Product and generate pharmaco-economic/benefit-risk data to support Regulatory Approval in the proposed therapeutic indication or provide an adequate basis for physician labeling, as more fully defined in 21 C.F.R. § 312.21(c), or its successor regulation, or the equivalent in any foreign country.