Examples of Major European Countries in a sentence
In the event that following and as a result of the pre-submission meeting with the EMEA, the parties mutually agree that it is not possible or commercially viable under the prevailing circumstances to obtain Registration for the Product in the Major European Countries, the parties may agree to terminate this Agreement, and such termination shall be subject to the terms of Article 14.
If a Regulatory Authority in the Major European Countries requires a change to the specifications, the manufacturing process, the Facility or any other aspects with respect to the Bulk Drug Product (“Territory Change Request”), Orion shall submit to Indevus in writing and in English details of the requested change.
Following the selection of a Candidate Drug in accordance with Section 2.5.2 above, AZ shall be responsible for undertaking a development program to obtain regulatory approval in the Field for one or more Licensed Products incorporating such Candidate Drug in the Major European Countries, Japan and the USA and [ * ].
Licensee shall submit to Lilly, every twelve (12) months after First Commercial Sale of a Licensed Product, a written report in reasonably sufficient detail describing the general commercialization progress of Licensee or a Related Party for Licensed Compounds and/or Licensed Products during the previous twelve (12) month period, including a list all ongoing Commercialization Studies and the status of such studies in the United States, the Major European Countries and Japan.
AVROBIO will use Commercially Reasonable Efforts to Develop and Commercialize one or more Licensed Products in the United States and in the Major European Countries.