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).

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Registration Study means (i) a Phase III Clinical Trial or (ii) any other human clinical trial of a Licensed Product or Lilly Product that is intended to support the submission of a Regulatory Application without conduct of any subsequent Phase I Clinical Trial, Phase II Clinical Trial, or Phase III Clinical Trial.

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.

Examples of Registration Study in a sentence

• If Lilly exercises its Option, L▇▇▇▇ shall use Commercially Reasonable Efforts to conduct a Registration Study of the Lilly Product for use by patients that have been screened using the Companion Diagnostic.

• If Lilly exercises its Option and no human subject or patient has qualified for acceptance or enrollment into a Registration Study of the Lilly Product for use by patients that have been screened using the Companion Diagnostic by the second (2nd) anniversary of the date Lilly exercises its Option, Telix shall be entitled to terminate this Agreement on [**] notice given within [**] of such anniversary.

• In the event that ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇’▇ behalf at ▇▇▇▇▇▇▇’▇ request and, with respect to any such Drug Approval Application, shall use Diligent Efforts to obtain Commercialization Approval.

• Without limiting the foregoing, Zai shall use Commercially Reasonable Efforts to (a) promptly conduct all clinical activities as described in the Development Plan, including the Pivotal Study in the Territory or a Registration Study in the Territory, following approval of a CTA from the CDFA to conduct such Clinical Trial and (b) seek Regulatory Approval for a Licensed Product in the Field in the Territory in at least [*] ([*]) countries or regions [*] within [*] after Regulatory Approval by the CFDA.

• Orion shall have the right to make all decisions with respect to such Registration Studies, except that if Indevus reasonably believes a proposed Registration Study would have an impact on Licensed Product outside the Initial Indication or outside the Territory, Indevus shall have the right to make all decisions with respect to such Registration Study, subject to the provisions of Section 1.60(d).

More Definitions of Registration Study

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 [***].

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 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 ▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇), 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 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 any Clinical Study which, at the time of Initiation thereof, is intended for use as a basis for obtaining Regulatory Approval of an Indication with respect to a Collaboration Product.

Registration Study means, with respect to a given Licensed Product, any pivotal clinical study of such Licensed Product for the purpose of establishing safety and efficacy of such Licensed Product in patients with the disease or condition being studied for purposes of filing an NDA with the FDA, 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 for the purpose of enabling the filing of a Marketing Approval Application equivalent to an NDA with the applicable Regulatory Authority(ies) in such jurisdiction. For the avoidance of doubt, Registration Study includes an adaptive study only at such time and to the extent such adaptive study meets the criteria of a pivotal study sufficient for registration.