Notification and Approval of Changes. Company shall have sole responsibility for obtaining any and all necessary regulatory approvals from the relevant regulatory agencies in the Territory for changes to the Specifications and the Marketing Authorizations and for reporting any changes to such Specifications and the Marketing Authorizations to the relevant regulatory agencies in the Territory as appropriate. Upon request by Company, AAIPharma shall use commercially reasonable efforts to assist Company in obtaining any such approvals; provided that Company will pay AAIPharma its standard fees and expenses therefor.
Notification and Approval of Changes. Client shall have sole responsibility for obtaining any and all necessary regulatory approvals from the relevant regulatory agencies in the Territory for changes to the Specifications and the Marketing Authorizations and for reporting any changes to such Specifications and the Marketing Authorizations to the relevant regulatory agencies in the Territory as appropriate. Upon request by Client, Company shall use commercially reasonable efforts to assist Client in obtaining any such approvals; provided that Client will pay Company in accordance with the terms of a separate statement of work or similar agreement which is governed by the terms of this Agreement. Client will provide to Company for its files a final copy of the CMC section related to Company activities of any such applications and/or submissions for regulatory approval unless otherwise prohibited by Applicable Law(s).
Notification and Approval of Changes. Purchaser shall have sole responsibility for obtaining any and all necessary regulatory approvals from the FDA for changes to the Specifications and the Marketing Authorizations for the Products other than the Azathioprine Product and for reporting any changes to such Specifications and the Marketing Authorizations to the FDA as appropriate; and AAI DS shall have such responsibility with respect to the Azathioprine Product. Upon request by Purchaser, AAI DS shall use commercially reasonable efforts to assist Purchaser in obtaining any such approvals; provided that Purchaser will pay AAI DS its standard fees and expenses therefor.
Notification and Approval of Changes. 5.3.1. Grantee shall use the grant solely for the Project described in the approved grant proposal attached as Exhibit A.
Notification and Approval of Changes. Grantee will not change the purpose, scope, or budget of the Project without first obtaining the written approval of Client. Grantee will notify Client immediately of any change in its legal or tax status or in the key personnel involved in the Project.
Notification and Approval of Changes. Project Director will not change the purpose, scope, or budget of Project without first obtaining the written approval of Client. Project Director will notify Client immediately of any change in the key personnel involved in the Project.
