Global Trial definition

Global Trial means a Clinical Trial designed to obtain Regulatory Approvals for a Licensed Product in multiple countries through the conduct of a Clinical Trial in multiple countries, regions and/or medical institutions and conducted as part of one (1) unified Clinical Trial or separately but concurrently in accordance with a common Clinical Trial protocol.

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Global Trial means a clinical trial designed to obtain data to be used to support filing for and obtaining Regulatory Approval of a Product in the Field in both (a) Japan and either (b) the U.S. or EU. For the avoidance of doubt, a Global Trial does not include the HD Trial.

Global Trial means Development activities related to a Clinical Trial for a Licensed Product that are (a) conducted outside the Territory, or both inside and outside the Territory, and (b) are intended to support Regulatory Filings both inside and outside the Territory.

Examples of Global Trial in a sentence

• Payments due by Lian according to Section 3.1(c)(i) or 3.2(b)(i) shall be invoiced by Nanobiotix after the completion of the respective Global Trial and Lian will pay the undisputed invoiced amounts within [***] days after the date of such invoice.

• For each Global Trial (excluding [***]) meeting the Enrollment Commitment, the Royalty Rates shall be reduced by [***], provided that in no event will the applicable Royalty Rate be less than [***] (the “Development Plan Incentive”).

• Except as set forth in Section 3.3 (Global Trial Preparation) and this Section 3.5 (Development Costs), each Party will bear 100% of the costs and expenses it incurs in connection with the Development activities conducted under the Development Plans.

• Landos will determine the study design and study protocol for any Global Phase III Trial or Other Global Trial, and Lian will have the right to determine which patient types to enroll in the Territory for such Global Phase III Trial or Other Global Trial.

• Notwithstanding the foregoing, in the event Licensee is required by the Regulatory Authority in the Territory to provide such Clinical Data for such Global Trial in support of Licensee’s other Development or Commercialization activities for an indication for which Licensee has borne such share of costs, then, [***].

More Definitions of Global Trial

Global Trial has the meaning set forth in Section 3.3(a) (Global Phase III Trial Participation).

Global Trial would mean a (i) Trial, other than a MorphoSys Trial, that is required to obtain and/or maintain Regulatory Approvals in at least the Co-Commercialization Territory and possibly also other country(ies) within the COMPANY Territory, or (ii) an investigator initiated Trial, which is conducted in at least the Co-Commercialization Territory and possibly also other country(ies) within the COMPANY Territory or (iii) an Early Access Program based on a MorphoSys Trial or a Trial under (i) above, which is conducted in at least the Co-Commercialization Territory and possibly also other country(ies) within the COMPANY Territory. If any activity under each of (i), (ii) and (iii) above is a Non-NDA Study, such activity to be subject to approval under Section 9.2(e).

Global Trial means a Clinical Trial for a Royalty Product that [ * ].

Global Trial means a multi-regional clinical trial for a Licensed Product conducted by either Party or both Parties in at least one country or region in the ArriVent Territory and at least one country or region in the Lepu Territory.

Global Trial means [*].

Global Trial means any clinical trial (excluding any Phase 1 Trial) of a Product, which is described in the Global Development Plan, including, without limitation, the Trius 113 Trial.

Global Trial means a Clinical Trial of a Cost Share Product intended to support Regulatory Approval of such Cost Share Product in at least the United States amongst other jurisdictions and that may include Clinical Trial sites both in the United States and outside of the United States.