Pivotal Trial definition

Pivotal Trial means a clinical trial on a sufficient number of patients that is designed to establish that a drug is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed, and to support Regulatory Approval of such drug or label expansion of such drug.
View Source
Pivotal Trial means (a) a Phase 2 Clinical Trial, or a combination Phase 2 Clinical Trial and Phase 3 Clinical Trial, that (taken together with any other trials completed prior to or concurrently with such trial) is intended to support Marketing Approval for a Product by the relevant Regulatory Authority in the indication under study, or (b) a Phase 3 Clinical Trial.
View Source
Pivotal Trial means a human clinical trial that (a) if the defined endpoints for such trial are met, is intended to be a pivotal trial for purposes of obtaining Regulatory Approvals and (b) satisfies the requirements of 21 C.F.R. 312.21(c) (or its successor regulation), or its equivalent in any other jurisdiction.
View Source

Examples of Pivotal Trial in a sentence

  • Following completion of the POC Trial with respect to a Licensed GT Product, Bayer, itself or through one or more Affiliates or Sublicensees, shall use Commercially Reasonable Efforts to conduct a Pivotal Trial and such other clinical development activities as are required to obtain Regulatory Approval in the U.S. and at least […***…] Major Market Countr[…***…] in the Territory for the Licensed GT Product.

  • Without prejudice to Section 3.1(c) Nanobiotix will notify Lian reasonably in advance of the initiation of a Pivotal Trial for the Licensed Product (each, a “Global Registrational Study”) and may propose to Lian to participate in any such Global Registrational Study (such notice, a “Global Registrational Study Notice”).

  • In the event that Lian intends to conduct a Pivotal Trial for the Licensed Product in the Field in the Territory (each, a “Local Registrational Study”), Lian will notify Nanobiotix reasonably in advance of the initiation of such Local Registrational Study and provide Nanobiotix with the study design, study protocol, study budget, and anticipated study initiation date (such notice, a “Local Registrational Study Notice”).

  • Pfizer may [**] the Pivotal Trial Development Plan [**], provided that any such [**] with Pfizer’s exercise of its required Commercially Reasonable Efforts, and shall promptly provide to Spark with such [**] Pivotal Trial Development Plan.

  • Pfizer shall ensure that the Pivotal Trial Development Plan and [**] submitted to Spark shall be the same as or substantially consistent with the corresponding plan used by Pfizer for internal planning and management purposes.


More Definitions of Pivotal Trial

Pivotal Trial means any pivotal or registration study or equivalent thereof for the purpose of obtaining regulatory approval or clearance in any jurisdiction as determined or confirmed by the applicable regulatory authority to market, sell and use a LICENSED T CELL PRODUCT within the FIELD.
View Source
Pivotal Trial means, as to a specific Licensed Product, the first of either a Phase II Clinical Study or Phase III Clinical Study that is intended to be sufficient for obtaining Regulatory Approval for such Licensed Product in any jurisdiction.
View Source
Pivotal Trial means a controlled human clinical trial to evaluate the safety and efficacy of a PATENT PRODUCT in which data are sufficient to form the basis for the filing of an NDA. A PIVOTAL TRIAL may not necessarily be a PHASE III CLINICAL TRIAL.
View Source
Pivotal Trial means a controlled human clinical trial to evaluate the safety and efficacy of a LICENSED PRODUCT in which data are sufficient to form the basis for the filing of an NDA. A PIVOTAL TRIAL may not necessarily be a PHASE III CLINICAL TRIAL,
View Source
Pivotal Trial means a series of controlled, multi-center clinical trials, involving patients with the disease or condition of interest to obtain sufficient efficacy and safety data to support regulatory submissions and labeling for marketing of a candidate drug or other product.
View Source
Pivotal Trial means a Clinical Study intended to provide the basis for Regulatory Approval. For clarity, a Pivotal Trial shall include a Phase III Study, a Phase I/II Study or a later Clinical Study where the evidence from such Clinical Study is intended to be used as the basis for Regulatory Approval.
View Source
Pivotal Trial means a controlled clinical trial to evaluate the safety and/or efficacy of a given PRODUCT IN CLASS and/or a given LICENSED METHOD in humans. Each such clinical trial should show safety and efficacy to a statistical significance and suffice as demonstration of such PRODUCT IN CLASS’s or such LICENSED METHOD’s safety and efficacy such that the results of said trial are the basis for the filing of an NDA for such a PRODUCT IN CLASS and/or such a LICENSED METHOD.
View Source