Pivotal Clinical Study definition

Pivotal Clinical Study means a study in the Field in human patients of a Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purposes of enabling the preparation and submission of applications for Marketing Authorization to the competent Regulatory Authorities in a country of the Territory and that is adequate to satisfy the requirements of 21 C.F.R. § 312.21(c) or its equivalent in that country.

Pivotal Clinical Study means a clinical study of a product that is designed to generate statistically significant evidence of the efficacy of a product for a particular Indication or use (as well as additional safety information) and that is intended to form the primary scientific support for filing a BLA to obtain Marketing Approval to market the product, (or any MAA for the non-United States equivalent thereof).

Pivotal Clinical Study means a human clinical study of the Product in any country on a sufficient number of subjects that is designed to establish that the Product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with the Product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of the Product, as described in 21 C.F.R. § 312.21(c), or equivalent clinical study in a country other than the United States.

Examples of Pivotal Clinical Study in a sentence

• For any Licensed Product, once a milestone is reached, the amounts under all prior milestones shall be due, if not yet paid (for example, if a Pivotal Clinical Study is initiated and the Phase 2a Clinical Study or Phase 1 Clinical Study Expansion Cohorts milestone has not yet been paid, it shall become due and payable at the same time as the Pivotal Clinical Study milestone).

• In addition, failure to achieve the following shall be deemed to be material breaches of this Agreement: (i) within [**] months of the first [**] U.S. FDA approvals obtained by Argos for a Licensed Product, China Company must Initiate Clinical Study of said Licensed Products, and (ii) within [**] months from Initiation of a Pivotal Clinical Study for said Licensed Products, China Company must submit the relevant application(s) for the Regulatory Approval to Commercialize said Licensed Products.

• For each such exclusive option, the Option Notice procedures of Section 4.4.2.2 and [***] shall apply mutatis mutandis, e.g., (i) PIRS shall issue an Option Notice to SGEN for such PIRS Collaboration Product prior to Initiating the first Pivotal Clinical Study therefor, such Option Notice to include an initial CoDev Product Plan and corresponding Joint Development Budget as well as an accounting of Reimbursable [***], and (ii) if SGEN timely exercises such option, [***].

• For any [***] CoDev Product, SGEN shall not Initiate a Pivotal Clinical Study in [***] that would have represented a Development in [***] with respect to the corresponding CoDev Product until the earlier of (i) [***] years after the Initiation of the first Pivotal Clinical Study for the [***] CoDev Product or (ii) termination of the clinical Development of the corresponding CoDev Product in the [***] that would have represented a Development in [***].

• Subject to Section 4.3.6.2, and pursuant to the applicable guidelines set forth in Section 4.4.2.3, for applicable Collaboration Products, SGEN may or shall (depending on the Collaboration Product) issue a written notice (“Option Notice”) triggering a PIRS CoDev Option after Key Data from the Clinical Study preceding the first Pivotal Clinical Study is available and prior to initiating such Pivotal Clinical Study with respect to such Collaboration Product (the “CoDev Decision Point”).

More Definitions of Pivotal Clinical Study

Pivotal Clinical Study means, as to a particular Licensed Product for a particular indication, a controlled and lawful study in humans of the safety and efficacy of such Licensed Product for such indication, which is prospectively designed to demonstrate statistically whether such Licensed Product is safe and effective for use in such indication in a manner sufficient to file a Drug Approval Application to obtain Regulatory Approval to market and sell that Licensed Product in any country in the Territory for the indication under investigation in such study.

Pivotal Clinical Study means a Clinical Trial that is intended (as of the time the Clinical Trial is Initiated) to obtain sufficient data and results to support the filing of an Approval Application.

Pivotal Clinical Study means any human clinical study of a product that, if pre-specified primary endpoints are met, would demonstrate the safety and efficacy of such product as required to support the Regulatory Approval of such product in an applicable country or territory.

Pivotal Clinical Study. Pivotal Clinical Study means a human clinical study, including any Phase III Clinical Study, the results of which, if the pre-defined endpoints are met, are intended to be the data from a pivotal study necessary to support Regulatory Approval for Licensed Product in any country.

Pivotal Clinical Study means, with respect to a product, a Clinical Study for the purpose of establishing any randomized, well-controlled, appropriately powered study of product as described in 21 C.F.R. §312.21(c) that is either a Phase II Clinical Study (including any Phase II Clinical Study as described in 21 C.F.R. §312.84(b)), Phase II/III Clinical Study or any Phase III Clinical Study, the results of which, if the pre-defined primary endpoint(s) is met or where the weight of evidence or totality of data provide sufficient data on safety and effectiveness to support a marketing approval (including any conditional approval) of the relevant product in the Territory.

Pivotal Clinical Study means (a) a Phase III Study, or (b) any other Clinical Study that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, and which Clinical Study is intended to be sufficient for filing an application for a Regulatory Approval for the Product in the U.S.

Pivotal Clinical Study means a Phase III Study or any other Clinical Trial that has been identified by a Regulatory Authority as being sufficient to obtain Regulatory Approval to market a Licensed Product in such indication.