Examples of Major EU Country in a sentence
Milestone payments for the achievement of Milestone Events with respect to the EU shall be payable following the achievement of the applicable Milestone Event in any Major EU Country or, in the case of a centralized EU filing or approval, with respect to the EMEA.
Without limiting the obligation set forth in the immediately preceding sentence, Licensee shall initiate Commercialization activities within each of the Major EU Countries within three (3) months following [***] for the Product in the applicable Major EU Country.
The earlier to occur of (a) Initiation by or on behalf of EPIZYME, its Affiliates or Sublicensees of a first Phase 3 Clinical Trial of any Licensed Product for any Indication and in any specific patient population, and (b) the first submission by or on behalf of EPIZYME, its Affiliates or Sublicensees in the United States or a Major EU Country (or to the EMA through the centralized approval procedure) of an NDA for any Licensed Product for any Indication and in any specific patient population.
P&G shall notify, and shall use Commercially Reasonable Efforts to consult with, ARYx prior to initiating a recall or withdrawal of a Licensed Product in the U.S., Japan, or a Major EU Country; provided, however, that the final decision as to whether to recall or withdraw a Licensed Product in the Field in the Territory shall be made by P&G in its sole discretion.
Prior to the anticipated Launch of the first Product in the United States or a Major EU Country, GSK shall prepare the Marketing Plan, which shall include without limitation the Marketing Strategy, and shall provide such Marketing Plan to the Joint Steering Committee.