Global Clinical Study definition

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 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.

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.

• Biogen, Press Release: Lecanemab Confirmatory Phase 3 Clarity AD Study Met Primary Endpoint, Showing Highly Statistically Significant Reduction of Clinical Decline in Large Global Clinical Study of 1,795 Participants with Early Alzheimer’s Disease (Sept.

• This document outlines the detailed statistical methods to be implemented for the data collected within the scope of the Medtronic Vascular SPYRAL PIVOTAL – SPYRAL HTN-OFF MED Study: Global Clinical Study of Renal Denervation with the Symplicity Spyral™ Multi-Electrode Renal Denervation System in Patients with Uncontrolled Hypertension in the Absence of Antihypertensive Medications.

• But working with a single CRO—something sponsors have traditionally done for decades—doesn’t necessarily deliver on those crisscrossing needs of the current moment, emphasizes Erika Vento-Gaudens, Director, Global Clinical Study Operations at Guardant Health.

• Until the expiration of the Japan Option or if KKC exercises the Japan Option, then thereafter, if AEVI plans to conduct a Global Clinical Study in various countries in the Territory (including Japan) or a clinical study of the Licensed Product in Japan, at KKC’s request AEVI will in good faith discuss with KKC including sites in Japan for such Global Clinical Study in order for KKC to consider exercising the Japan Option and join such Global Clinical Study or other clinical study in Japan.

More Definitions of Global Clinical Study

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

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, a Phase III Study or a Phase IV post-approval study, of a Licensed Product in the Field which includes sufficient clinical sites and/or patients to achieve Regulatory Approval in both the Antengene Territory and the Karyopharm Territory for the Indication associated with such Clinical Study.

Global Clinical Study means the multi-regional Clinical Study with respect to a Licensed Product that is intended to support regulatory approval of such Licensed Product both within and outside of the Territory for nHCM and is conducted in multiple countries, regions, territories and medical institutions.

Global Clinical Study. 3.2.3 “ICC” 12.2.2(a) “Indemnitee” 11.10.3

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