Registrational Study definition

Registrational Study means, with respect to a given product, any clinical study that is intended to be the basis for initial Regulatory Approval of such product.

Registrational Study means, with respect to the United States, a Clinical Study of a product on sufficient numbers of patients that is designed to establish that such product is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with such product in the dosage range to be prescribed, and to support Regulatory Approval of such product or label expansion of such product, as described under 21 C.F.R. §312.21(c), or, with respect to a jurisdiction other than the United States, an equivalent clinical trial.

Registrational Study means (a) in the case of a Clinical Study with respect to which GPC Biotech is the Development Lead, a pivotal Clinical Study for the Licensed Product for the Initial Indication or any Additional Indication that is designed to be sufficient to obtain Initial Regulatory Approval by the FDA of the Licensed Product for such indication or (b) in the case of a Clinical Study with respect to which Licensee is the Development Lead, a pivotal Clinical Study for the Licensed Product for the Initial Indication or any Additional Indication that is designed to be sufficient to obtain Initial Regulatory Approval by the applicable Regulatory Authorities in a given country or countries in the Licensee Territory, or if applicable, the European Union. For the avoidance of doubt, the SPARC Study shall be deemed to constitute a Registrational Study for the Initial Indication.

Examples of Registrational Study in a sentence

• Notwithstanding the foregoing described exclusivity, from and after the initiation of a Registrational Study with respect to a given Product Candidate or Elected Candidate, Merck and/or its Third Party Manufacturer can Manufacture, and Merck may purchase, cGMP Moderna mRNA API for each such Product Candidate or Elected Candidate, in accordance with Section 4.3; provided, that, [***].

• 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”).

• 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”).

• The Parties shall discuss and agree in good faith any Post-Approval Commitment mandated by a Regulatory Authority upon the Regulatory Approval of the Licensed Product in the Territory, including the inclusion of such mandated Post-Approval Commitment in a Global Registrational Study.

• Before the Commencement of the first Registrational Study for any Collaboration Product following the exercise of the Merck Participation Election for the applicable Program, Merck shall provide, and within [***] days after such provision the JCC will review and update for approval by the JSC, a written summary of the global Commercialization strategy for all Collaboration Products included in the Joint Development Plan and Budget for the applicable Program in the Territory.

More Definitions of Registrational Study

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

Registrational 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) or regulatory approval outside the Territory. A Registrational Study includes any Clinical Trial that satisfies at least one of the following criteria: (a) It would, based on interactions with a Regulatory Authority or otherwise prior to the initiation of such trial, satisfy the requirements of 21 CFR 312.21(c) or corresponding foreign regulations; (b) It is designed in a manner to allow for the addition of patient such that it could satisfy the requirements of 21 CFR 312.21(c) or corresponding foreign regulations; or (c) It is otherwise intended, at the time of initiation to support (either alone or together with another Phase 3 Clinical Trial) an application for marketing approval of a new product (or a new indication or intended use for an already approved product).

Registrational Study means a Clinical Trial that is intended to establish that a product is safe and efficacious for its intended use in the target population, and to determine warnings, precautions, and adverse reactions that may be associated with such pharmaceutical product in the dosage range to be prescribed, which clinical trial is a registration trial intended to enable submission of an Approval Application for such product, as and to the extent defined for the United States in 21 C.F.R. § 312.21(c) or 21 C.F.R. Part 314 Subpart H, or its successor regulations, or, with respect to a jurisdiction other than the United States, a similar Clinical Trial.

Registrational Study means a human 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 Drug Approval of a compound or product, which may include a Phase 2b Study or a Phase 3 Study.

Registrational Study means (a) a Phase 3 Clinical Trial or (b) any other human clinical trial of a Product that is intended to support the submission of an NDA or BLA (or any corresponding foreign application in the Territory to seek Regulatory Approval of a Product in any country or multinational jurisdiction) without conduct of any subsequent human clinical trial.

Registrational Study means a clinical trial of an investigational product in human patients that is designed to be sufficient to obtain Regulatory Approval by the applicable Regulatory Authorities in a given country or countries.

Registrational Study means a Clinical Study (regardless of whether or not called a “Phase 3 Study”) for a product the results of which, together with prior data and information concerning such product, are intended to be sufficient to meet the evidentiary standard for demonstrating the safety and efficacy of such active substance of such product established by a Regulatory Authority in any particular jurisdiction and is sufficient for filing of an NDA for such product in patients having the disease or condition being studied.