Cost of Recall. In the event that any Shire Product is quarantined or recalled, or is subject to a stop-sale action, whether voluntary or by the action of any Governmental Authority, or as a result of the revocation or expiration of any Regulatory Approval, any expenses, including any out-of-pocket administrative costs and reasonable fees of any experts or attorneys that may be utilized by either Party, government fines or penalties, related to such recall, quarantine or stop-sale, shall be borne by Shire unless it is determined that the reason for the quarantine, recall or stop-sale action is the result of the breach by Duramed of its obligations under this Agreement, and in such case such expenses shall be shared according to the relative responsibility of each Party. Such determination may be made by the Governmental Authority involved, or by mutual agreement of the Parties following examination and review of all records pertinent to the manufacture of the Shire Product subject to such recall.
Appears in 2 contracts
Sources: Product Development and License Agreement (Shire PLC), Product Development and License Agreement (Barr Pharmaceuticals Inc)