Global Study definition

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

Global Study means a multi-country Phase II Clinical Trial or Phase III Clinical Trial of a Licensed Product that is conducted by Arcus, its Affiliates or a Third Party under authority from Arcus, is joined by TAIHO or any of its Affiliates or Sublicensees with respect to any part of the Clinical Trial conducted in Japan and is designed (a) to satisfy the requirements of the Regulatory Authorities in Japan (including sufficient numbers of Japanese (or other mutually agreed Asian) patients to satisfy such requirements) and (b) (i) if such Clinical Trial is a Phase II Clinical Trial, to be sufficient without a further Clinical Trial, to form the basis for proceeding to a Phase III Clinical Trial (or filing a BLA or NDA in Japan and one or more Major Markets) or (ii) if such Clinical Trial is a Phase III Clinical Trial, to provide an adequate basis to obtain Marketing Approval in Japan and one or more Major Markets. For such purposes, to “join” a Clinical Trial means that TAIHO or any of its Affiliates or Sublicensees (or a combination of them) (A) is the sponsor of such Clinical Trial in Japan, or is primarily responsible for carrying out or overseeing the conduct of such Clinical Trial in Japan, (B) is responsible for no more than its proportionate share of the costs of such Clinical Trial based on the number of patients in Japan (or other mutually agreed Asians) relative to all patients in the Clinical Trial and (C) has mutually agreed with Arcus in a writing specifically referencing this Agreement that it is joining such Clinical Trial. If TAIHO (or its Affiliate or Sublicensee or any combination of them) is “joining” a Global Study, then the parties shall enter into an agreement specifying the parties’ respective roles and responsibilities and describing how costs associated therewith shall be handled.

Global Study means any global clinical studies conducted with the Licensed Compound and Licensed Product to be performed in at least one jurisdiction in the Licensed Territory and one in the Retained Territory but may not be part of the Joint Global Development Plan. For clarity, (a) any clinical study to be performed in the Retained Territory only is not a Joint Global Study even if the data generated from such study will be shared for use in the Licensed Territory and (b) any clinical study to be performed in the Licensed Territory only is not a Joint Global Study even if the data generated from such study will be shared for use in the Retained Territory.

Examples of Global Study in a sentence

• Zenas shall provide Licensee with access to all records and data for the Zenas Global Study promptly (and in no event later than [***] following receipt of the payment made by Licensee pursuant to paragraph (i)(B) of this Section 4.4.7.

• Licensee shall have the right, at reasonable times and upon written request, to review all records maintained by Zenas for the purposes of the [***] and any Joint Global Study.

• Zenas shall have sole discretion with respect to any matters relating to any Remedial Action in the Territory to the extent related to any Global Study; provided that Zenas shall consult with the JSC regarding such matters and reasonably consider the comments of Licensee’s JSC members.

• Each Party shall report to the other Party in writing, within [***] after the end of each Calendar Quarter, the Shared Development Costs incurred by or on behalf of such Party during such Calendar Quarter on a Joint Global Study-by-Joint Global Study basis.

• With respect to each Joint Global Study, following the final patient enrollment for such Joint Global Study, together with the report for the last Calendar Quarter during which the Joint Global Study was conducted, Zenas shall provide Licensee a written notice stating the percentage of patients located in the Territory that were enrolled in such Joint Global Study.

More Definitions of Global Study

Global Study means any global clinical trial to be conducted with any Product that the Parties mutually agree to conduct. For clarity, (a) any clinical study to be performed in the Retained Territory only is not a Global Study even if the data generated from such study will be shared for use in the Licensed Territory and (b) any clinical study to be performed in the Licensed Territory only is not a Global Study even if the data generated from such study will be shared for use in the Retained Territory.

Global Study means, as mutually agreed (in writing) to be conducted by the Parties, the Phase 3 Clinical Trial for HoFH or other Clinical Trials with Gemphire as the sponsor that is designed to include the enrollment of patients in both the Beijing SL Territory and the Gemphire Territory.

Global Study has the meaning provided in Section 4.1(e).

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

Global Study means a global Clinical Study being or to be conducted by or on behalf of Licensor in the Field and within and outside the Territory. “Global Studies” means more than one Global Study.

Global Study means any study that is “used” in both the US Territory and the ROW Territory, with “used” meaning that it will be submitted to the relevant Regulatory Authorities in the United States and the ROW Territory, other than studies submitted solely to meet safety reporting obligations.

Global Study has the meaning set forth in Section 5.5.1.