the EMEA definition
Examples of the EMEA in a sentence
In the event that a cause of termination shall relate solely to any country not subject to regulation by the EMEA, then termination of this Agreement shall be limited and applied only to such country or portion of the Territory.
If requested by Vertex, CFFT will arrange for one or more representatives of CFFT to participate in meetings between representatives of Vertex and any of the FDA, the EMEA and Koseisho (MHW Japan), to the extent that Vertex reasonably believes that representatives from CFFT would further the regulatory approval process.
Celltech shall use its Commercially Reasonable Efforts to cause a pre-submission meeting to be held with the EMEA in respect of the cataplexy Licensed Indication within one hundred eighty (180) days of the Effective Date.
Within thirty (30) days of such meeting with the EMEA, Celltech shall report to Orphan Medical about the content of such meeting and advise Orphan Medical as to whether additional data or documentation or additional action is required or deemed reasonably necessary by Celltech to obtain approval from the EMEA to commercially promote and distribute the Product for the cataplexy Licensed Indication.
There are no, and have not been, any inspection reports, warning letters, notices of adverse findings, Section 305 notices or similar written documents received by the Company or, to the knowledge of the Company, by any Company Partner, that assert a lack of compliance with any applicable Laws, Orders, or regulatory requirements that have not been fully resolved to the satisfaction of the FDA, the EMEA or any other Regulatory Authorities, as applicable.
If Vitae exercises its Co-Development Option, it shall reimburse BI for Vitae’s specified share of any reasonable Development costs actually incurred by BI in performing such Phase III Studies from the Initiation of such Phase III Studies until the submission of an NDA with the FDA or the EMEA.
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.
Unless the context specifically requires, the provisions contained in the body of this Agreement and the provisions of the EMEA Asset Sale Agreement shall be interpreted independently and without reference to each other.
All fee and commission income is received from JPMorgan Chase undertakings within the EMEA region.
Nothing herein shall in any way be deemed to limit the ability of the Administrative Agent to serve any such process in any other manner permitted by applicable law or to obtain jurisdiction over the EMEA Borrower in such other jurisdictions, and in such manner, as may be permitted by applicable law.