Registration Study definition

Registration 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 application for Regulatory Approval (but may not include the data that may be necessary to support the pricing and/or reimbursement approvals).

Registration Study means a human clinical trial, the principal purpose of which is to establish safety and efficacy in patients with the disease being studied, as further described in 21 C.F.R. §312.21(c) (including, any such clinical study in any country other than the United States), which is designed and intended to be of a size and statistical power sufficient to serve as a pivotal study to support the filing of an MAA for the indication being studied.

Registration Study means any Clinical Trial of a Licensed Product for which [***].

Examples of Registration Study in a sentence

• The Contractor shall coordinate his work with the following Campus Calendar, and No Utility shutdowns will be permitted during Registration, Study Periods, Exam Periods, or Commencement.

• Age-specific Incidence and Prevalence of Keratoconus: A Nationwide Registration Study.

• Thrombolysis with 0.6 mg/kg intravenous alteplase for acute ischemic stroke in routine clinical practice: the Japan post-Marketing Alteplase Registration Study (J-MARS).

• In the event that Xxxxxxx conducts an Independent Development Activity that requires a regulatory filing to conduct such activity in Greater China, or completes a Registration Study as an Independent Development Activity and desires to file a Drug Approval Application related to such study in Greater China, Legend shall make such filing on Xxxxxxx’x behalf at Xxxxxxx’x request and, with respect to any such Drug Approval Application, shall use Diligent Efforts to obtain Commercialization Approval.

• The “‘consensual relationship’ analysis under Montana resembles the [federal courts’] Due Process Clause analysis for purposes of personal jurisdiction,” the touchstone of which is “‘whether the defendant purposefully established minimum contacts’” in the forum jurisdiction.

More Definitions of Registration Study

Registration Study means a Phase 2/3 Clinical Study or Phase 3 Clinical Study. For purposes of Section 7.2, if a Clinical Study becomes a Phase 2/3 Clinical Study after the dosing of the fifth (5th) patient, the applicable Milestone Event shall be deemed to occur on the date that the Party conducting such Clinical Study receives the evidence described in clause (b) of the definition of Phase 2/3 Clinical Study from the applicable Regulatory Authority or, if earlier, on filing of a Drug Approval Application based on the results of such Clinical Study.

Registration Study means a Clinical Trial of a Licensed Product which is sufficiently powered to demonstrate the efficacy and safety of such Licensed Product for purposes of obtaining a Product Approval of such Licensed Product in the U.S. or EU.

Registration Study means a Clinical Study in humans that is intended to obtain the data sufficient to support the filing of an NDA for a product with any applicable Regulatory Authority. Registration Studies include any Clinical Studies designed as a pivotal study to confirm with statistical significance the efficacy and safety of a product with respect to a given indication (whether structured as a superiority, equivalence or non-inferiority study), which study is performed for purposes of filing an NDA to obtain Regulatory Approval for such product or such indication from the applicable Regulatory Authority (regardless of whether such Clinical Study is identified as a Phase 3 Clinical Study on XxxxxxxxXxxxxx.xxx), including a Clinical Study as described under 21 C.F.R. §312.21(c) with respect to the United States (or, with respect to a jurisdiction other than the United States, a similar Clinical Study).

Registration Study means a Pivotal Clinical Trial or a Converted Clinical Trial.

Registration Study means, with respect to a Licensed Product, (a) a human clinical trial (whether or not designated a phase 3 clinical trial) for such Licensed Product, the results of which, together with prior data and information concerning such Licensed Product, would (if such human clinical trial meets its primary endpoints) be sufficient to support the filing of a BLA for such Licensed Product in the United States or (b) a foreign clinical trial that is equivalent to the one described in the preceding clause (a), in each case ((a) and (b)), as acknowledged by the applicable Regulatory Authority. For clarity, a human clinical trial that does not meet the foregoing criteria when it is Initiated, but later meets the foregoing criteria or its data are otherwise included as a registration study in the BLA filing that is accepted by the applicable Regulatory Authority, shall constitute a Registration Study for purposes of this Agreement only at the time the applicable Regulatory Authority acknowledges that such human clinical trial meets such criteria or accepts such BLA filing, and, for purposes of Section 10.3.1, such Registration Study shall be deemed to be Initiated as of the date such criteria are met or such data are included.

Registration Study means a clinical study that would satisfy the requirements of 21 C.F.R. § 312.21(c) (or analogous statutory requirements outside of the United States).

Registration Study means, with respect to a given Licensed Product, any pivotal Clinical Trial of such Licensed Product designed to establish safety and efficacy of such Licensed Product in patients with the disease or condition being studied for purposes of filing a BLA with the FDA or, with respect to a jurisdiction other than the United States, a similar clinical trial for the purpose of enabling the filing of a Marketing Approval Application equivalent to a BLA with the applicable Regulatory Authority(ies) in such jurisdiction.