Global Clinical Study means, with respect to any Split Territory Licensed Product, a Clinical Study included in the Split Territory Global Development Activities for such Split Territory Licensed Product.

Global Clinical Study means, with respect to Development of Licensed Products, a study with a unique protocol, the results of which are designed to be submitted to Regulatory Authorities of the United States and European Union and other countries as mandatory for obtaining Regulatory Approval of such Licensed Products in the respective countries.

Global Clinical Study. 4.2.4 “ICC” 13.2.2(a) “Indemnitee” 12.10.3 “Infringement Claim” 9.4.1

Examples of Global Clinical Study in a sentence

If Medgenics conducts a Global Clinical Study in the Field in any country in the Territory, at KHK’s request Medgenics will in good faith discuss with KHK including sites in countries outside of the Territory for such Global Clinical Study in order for KHK to join such Global Clinical Study.
The JSC shall review and approve each such Global Clinical Study Proposal.
If the JSC approves a Global Clinical Study Proposal, then within [***] after the date of such approval, Repare shall prepare a Global Development Plan based on such Global Clinical Study Proposal.
From time to time during the Term after the DC Selection Date, either Repare (or its Related Party) or Ono (or its Related Party) may submit to the JSC a proposal for a Global Clinical Study that would support the filing of an NDA for the Licensed Drug Candidate and Licensed Product with Regulatory Authorities in the Major Market Countries of both the Repare Territory and the Ono Territory (a “Global Clinical Study Proposal”).
Ono shall be responsible for bearing all costs and expenses incurred for patients enrolled in such Global Clinical Study in the Ono Territory after the date of JOC’s approval.

More Definitions of Global Clinical Study

Global Clinical Study means, with respect to any Licensed Drug Candidate or Licensed Product, a Clinical Study included in the Global Development Activities for such Licensed Drug Candidate or Licensed Product.

Global Clinical Study means a combined Phase I Study and Phase II Study, a combined Phase II Study and Phase III Study, a Phase II Study or a Phase III Study, of a Licensed Product in the Field which includes sufficient [**] clinical sites and/or [**] patients to achieve Regulatory Approval in both the Ono Territory and the Karyopharm Territory for the Indication associated with such Clinical Study.

Global Clinical Study. 4.2.4 “ICC” 13.2.2(a) “Indemnitee” 12.10.3 ***** Confidential Information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to this omitted information. “Infringement Claim” 9.4.1

Global Clinical Study means, with respect to any Licensed Product, a Clinical Study included in the Esperion Global Development Plan for such Licensed Product. As of the Effective Date, the Global Clinical Studies are listed on Schedule 1.60. Schedule 1.60 shall be amended from time to time at the initiative of Esperion or the reasonable request of DSE to reflect the then-current status of the Global Clinical Studies being planned or executed.

Global Clinical Study has the meaning set forth in Section 2.2.2.5(b) (Oversight of the Global Development Plans).

Global Clinical Study has the meaning set forth in Section 5.5.5 (PJSC Development Responsibilities).

Global Clinical Study means the [**] of the Licensed Product that is conducted [**] under [**] and the relevant guidelines issued by the applicable Regulatory Authorities in Japan.