Pivotal Trial definition

Pivotal Trial means a clinical study in humans of the efficacy and safety of a Licensed Product that is prospectively designed to demonstrate with statistical significance that such product is effective and safe for use in a particular indication in a manner sufficient to file for Marketing Approval of such product and would satisfy the requirements of 21 CFR 312.21(c), or a similar clinical study prescribed by the Regulatory Authorities in a country other than the United States.

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.

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 LTC T CELL PRODUCT within the FIELD.

Examples of Pivotal Trial in a sentence

• It is expected that re-hospitalization or device removals will not exceed 6% (upper confidence limit of 12.6%) at the 12-month visit based on the clinical experience from the LINX Pivotal Trial in support of FDA approval, which established this level of risk did not outweigh the benefit of treatment with the LINX device.

• If it is unclear whether or not a study design will be sufficient to support an BLA or MAA filing (other than by virtue of the uncertainty of efficacy data from that trial), the study will be deemed to be a Pivotal Trial on the initiation of activities to support an BLA or MAA filing.

• 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”).

• Initiation of a Phase III clinical trial will be deemed to be initiation of a Pivotal Trial.

• 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”).

More Definitions of Pivotal Trial

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.

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.

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.

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.

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.

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.

Pivotal Trial means a clinical trial that is designed to provide data establishing the safety and efficacy of a Collaboration Product in support of obtaining marketing approval from the MHLW.