Registrational Clinical Trial definition

Registrational Clinical Trial means any one of a Phase III clinical trial or pivotal Phase II clinical trial conducted in furtherance of Regulatory Approvals.

Registrational Clinical Trial means a human clinical trial of a Licensed Product that: (a) would satisfy the requirements of 21 C.F.R. § 312.21(c) or corresponding foreign regulations; or (b) that if successful would provide sufficient efficacy data to support the filing of an MAA for such Licensed Product in such country.

Registrational Clinical Trial means, with respect to a Licensed Product, either (a) a Phase III Clinical Trial for such Licensed Product or (b) a pivotal Phase II Clinical Trial, in each case that, at the time of commencement, is expected to provide an adequate basis for the preparation and submission of a BLA or NDA to obtain Marketing Approval of such Licensed Product in a Major Market.

Examples of Registrational Clinical Trial in a sentence

• Without limiting the foregoing, the Development Plan will include projected timelines for the achievement of material development milestones, including the following material development milestones: (a) submission by Betta of the first IND for a Licensed Product in China; (b) initiation of the first clinical trial in China for a Licensed Product; (c) initiation of the first Registrational Clinical Trial in China for a Licensed Product; and (d) the submission of an NDA for a Licensed Product to the NMPA.

• ATHX may terminate this Agreement immediately by notice to CHUGAI in the event that after completion of a Pivotal Registrational Clinical Trial in the Territory CHUGAI fails to pay any of the remaining amounts due under Sections 7 and 8 and fails to rectify such breach within sixty (60) days of written notice of such breach from ATHX, but not for any other material breach (for which all remedies other than termination remain available).

• For clarity, if Betta elects not to participate in the Global Trial but conducts its own Registrational Clinical Trial for the Licensed Product in the Territory for the same indication, EyePoint will still provide Betta all the data, results and documents generated through the Global Trial to support the clinical, commercial development and the regulatory approval of the Licensed Product in the Territory for such indication as provided in this Agreement.

• Prior to conducting any Registrational Clinical Trial intended to show Clinical Superiority, the Parties must mutually agree in writing upon the [...***...] and must mutually agree in writing upon any amendments thereto once initially approved.

• Without limiting the foregoing, any Clinical Data arising from the Initial Global Studies (other than the Novartis-Initiated Trials) and any New Registrational Clinical Trial and New Other Clinical Trial for which BeiGene is the Sponsoring Party and for which Novartis has provided a Novartis Study Design Agreement Notice (the “BeiGene Clinical Trial Data”) shall be owned by BeiGene and included in BeiGene Know-How and the Product Licenses granted to Novartis pursuant to Section 9.3.

More Definitions of Registrational Clinical Trial

Registrational Clinical Trial means, with respect to a given Product, either: (a) a Phase III Clinical Trial with such Product; or (b) a Phase IIb Clinical Trial that, at the time of commencement, is expected to be the basis for initial Regulatory Approval of such Product.

Registrational Clinical Trial means any a clinical trial, or arm thereof, in human subjects that has been approved by an institutional review board or ethics committee, as applicable, of any product that would satisfy the requirements of 21 C.F.R. § 312.21(c) or corresponding foreign regulations, regardless of whether such trial is referred to as a “Phase III Clinical Trial”, that is intended (as of the time such clinical trial is initiated) to obtain data and results necessary 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).

Registrational Clinical Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to (a) establish that a drug is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed; and (c) support Regulatory Approval of such drug, in each case as described in 21 C.F.R. § 3I2.12(c). For purposes of this Agreement, “initiation of a Registrational Clinical Trial” for a Product means the first dosing of a human in the Registrational Clinical Trial involving administration of such Product.

Registrational Clinical Trial means, in respect of a Product, either (a) a Phase 3 Clinical Trial for such Product or (b) a registration trial sufficient for filing an MAA for such Product with the FDA or the EMA as evidenced by (i) an agreement with, or statement from, the FDA or the EMA on a special protocol assessment or its equivalent, or (ii) other guidance or minutes issued by the FDA or EMA, for such registration trial.

Registrational Clinical Trial means, with respect to a Licensed Product, a clinical trial that is expected, based on guidance from the FDA or other applicable Regulatory Authority, to provide the basis for submitting an application for Regulatory Approval for such Licensed Product (whether it be for the first Regulatory Approval for that Licensed Product or expansion of that Regulatory Approval to include an additional indication for such Licensed Product). For avoidance of doubt, a clinical trial or portion thereof may be a Registrational Clinical Trial regardless of whether the protocol for such clinical trial describes it as a “Phase 1,” “Phase 2,” or “Phase 3” clinical trial, or any variation thereof.

Registrational Clinical Trial means: (a) a human clinical trial of a compound or product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(c) or corresponding foreign regulations or (b) a human clinical trial of a compound or product that is intended to: (i) establish that the compound or product is safe and efficacious for its intended use; (ii) define contraindications, warnings, precautions, and adverse reactions that are associated with the compound or product in the dosage range to be prescribed; and (iii) support Regulatory Approval for such compound or product (whether conditional or final), but may not include the data that may be necessary to support the Pricing and Reimbursement Approvals; or (c) a human clinical trial similar to a human clinical trial described in sub-clause (a) prescribed by the relevant Regulatory Authorities in a country other than the United States.

Registrational Clinical Trial means a Clinical Trial that is prospectively designed to support an MAA without a further Clinical Trial being required. Notwithstanding the foregoing, [...***...].