Multi-Region Trial definition

Multi-Region Trial means a clinical trial in which each Party participates in its respective Territory in accordance with a Multi-Region Development Plan that is designed to obtain data to be used to support filing for and obtaining Regulatory Approval of a Collaboration Product in the Field in both (a) one or more countries in the LGC Territory and (b) one or more countries in the Cue Territory.
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Multi-Region Trial means a Clinical Trial for a Product sponsored by ▇▇▇▇▇ or its Affiliate for which clinical sites are located both in and outside the Territory. Section 1. 103 “NDA” means a new drug application or marketing authorization application filed with the applicable Regulatory Authority in a country or Region, which application is required for Marketing Approval for a Product in the Field in such country or Region.
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Examples of Multi-Region Trial in a sentence

  • Within [***] days of the JSC’s review of the Cue Territory Development Plan for a Program, LGC shall prepare a plan for the Development (including all clinical trials) of all Collaboration Products for such Program in the Field in the LGC Territory, which plan shall be materially consistent with [***], and shall be reasonable in scope and detail (the “LGC Territory Development Plan”), provided that, for avoidance of doubt, neither Party is required to agree to a Multi-Region Trial.

  • The Parties shall share all Development Costs incurred by either Party in performing the Multi-Region Trials for Collaboration Compounds in accordance with Section 7.3 as follows: Multi-Region Trial Territorial Costs shall be apportioned as follows: [***].

  • Without limiting the foregoing, LGC shall, and shall cause its Affiliates and Sublicensees to, use Commercially Reasonable Efforts to conduct its activities under and in accordance with the Research Plans and the applicable Development Plans, including with respect to the CUE-101 Program, the CUE-102 Program and the CUE-103 Program, and to perform any Multi-Region Trial under and in accordance with the applicable Multi-Region Development Plan.

  • With respect to any Development Costs for a Multi-Region Trial, the actual Development Costs for any activity performed in accordance with a Multi-Region Development Plan associated with such Multi-Region Trial shall not exceed [***] of the budgeted amount for such activity as set forth in the applicable Multi-Region Development Budget for such Plan.

  • On a Calendar Quarter basis during the conduct of any Multi-Region Trial, ▇▇▇▇▇ shall invoice Everest for its share of such indirect costs and any Territory-specific direct costs for such Multi-Region Trial that are incurred by ▇▇▇▇▇ (if any), and Everest shall pay each such invoice within [***] after confirmation in accordance with Section 5.3.6 (Confirmation) thereof.

  • Everest shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory, including the decision to commence such Remedial Action and the control over such Remedial Action; provided, that ▇▇▇▇▇ shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Multi-Region Trial.

  • As between the Parties, Genelux shall be responsible for all regulatory activities relating to the Licensed Products and Derived Products outside the Territory, including those related to the NSCLC Multi-Region Trial, and Newsoara shall reasonably cooperate with and assist Genelux in connection with such regulatory activities.

  • For clarity, Data generated in connection with a Multi-Region Trial will be owned by ▇▇▇▇▇ and deemed ▇▇▇▇▇ Data.

  • Everest shall prepare an initial version of the Development Plan, which is attached hereto as Exhibit D and includes the participation of Everest in the Multi-Region Trial (Protocol ID KZR-616-202) for the Product sponsored by ▇▇▇▇▇ in Lupus Nephritis (the “Palizade Trial”).

  • If Everest declines to exercise its option to participate in any Multi-Region Trial, then (a) Everest shall have the right to use the Data resulting from such trial solely as necessary to comply with applicable Law, and (b) if Everest includes any such Data in a Regulatory Filing (including an NDA) for approval of the applicable Product, then Everest shall pay to ▇▇▇▇▇, within [***] after confirmation in accordance with Section 5.3.6 (Confirmation) of an invoice therefor from ▇▇▇▇▇, [***].

Related to Multi-Region Trial

  • Phase IV Clinical Trial means a post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.