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.
Appears in 3 contracts
Sources: Manufacturing Agreement (PTC Therapeutics, Inc.), Manufacturing Agreement (Corcept Therapeutics Inc), Manufacturing Agreement (Corcept Therapeutics Inc)