Cost of Recall. In the event that any Product, Tablet or Packaged Tablet Manufactured or Packaged hereunder is quarantined or recalled, or is subject to field alert, product withdrawal or stop-sale action, whether voluntary or by governmental action (collectively, a “Recall”), it is agreed and understood that any expenses, including 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 the Company unless it is determined that the sole cause necessitating such a Recall is that either (i) the Products at issue are non-compliant with the Product Specifications at the time that such Products are released by Manufacturer, except to the extent that such non-compliance should reasonably have been detected in connection with the bulk tablet release testing, or (ii) the Packaged Tablets at issue are non- compliant with the Packaging Specifications at the time that such Packaged Tablets are released by Manufacturer and such non-compliance is not due to the negligence or intentional malfeasance of any party other than the Manufacturer, in which case Manufacturer shall be liable for up to the limits set forth in Section 13.1 hereof.
Cost of Recall. In the event that any Licensed Product supplied hereunder is recalled or quarantined, or is subject to stop-sale action, whether voluntary or by governmental action, it is agreed and understood that any expenses of such action, including administrative costs, reasonable fees of any experts or attorneys that may be utilized by either Party, and any government fines or penalties related to such recall, quarantine or stop-sale (“Recall Expenses”) will be borne by the Party upon whose act or omission is the cause of the recall, quarantine or stop-sale action.
Cost of Recall. In the event that any 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 Duramed unless it is determined that the reason for the quarantine, recall or stop-sale action is the result of the breach by Shire 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 Product subject to such recall.
Cost of Recall. If a Recall is initiated because of a breach of HD’s warranty obligations, HD will promptly repair (if practical) or replace the defective Products at no charge to LiveWire, and will be responsible for the following out-of-pocket expenses incurred by LiveWire or by HD as a result of such Recall (directly or through LiveWire’s warranty reimbursements to its dealers and distributors) to correct the defective Product: diagnosis, removal, round-trip shipping, installation, testing and, if applicable, retail profit margin. If a Recall is initiated for any other reason (“LiveWire’s Recall Obligations”), LiveWire will be responsible for all expenses incurred by HD as a result of such Recall, and compensate all damages and losses suffered by HD as a result of such Recall. If a Recall is initiated both because of a breach of HD’s warranty obligations and because of LiveWire’s Recall Obligations, then each Party shall be responsible for a pro rata share of the total expenses incurred in connection with such Recall in proportion to each Party’s respective responsibility for the circumstances giving rise to the Recall as determined in good faith by the Operational Committee.
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.
Cost of Recall. If a Recall is initiated due to a defect in workmanship or a non-conformity to the Specifications of a Product and later determined to be due to a breach of KYMCO’s Section 4.1 warranty obligations even after the expiration of the Warranty Period, (i) in the event where such non-conforming Products have already been sold and delivered to any third-party by LiveWire LiveWire will either repair or replace, at its sole option, the non-conforming Products for such third-party, and KYMCO will reimburse LiveWire for any costs (including any shipping or delivery costs in connection with a repair or replacement) reasonably incurred relating to such repair or replacement; and (ii) other than the circumstances described in the preceding Section 6.3(i), each Party will use commercially reasonable efforts to cooperate with the other Party and to take any actions reasonably requested by the other Party with respect to the remediation of any such non-conforming Products at KYMCO’s cost (including any shipping or delivery costs in connection with a repair or replacement), and will be responsible for the following out-of-pocket expenses incurred by LiveWire or by KYMCO as a result of such Recall (directly or through LiveWire’s warranty reimbursements to its dealers and distributors) to correct the defective Product: diagnosis, removal, round-trip shipping, installation, testing, and [***]. The Parties agree that, should there be any disputes regarding the compensation amount, the Parties shall first offer an opportunity to resolve such dispute through amicable discussion between the Parties. If a Recall is initiated for any other reason (“LiveWire’s Recall Obligations”), LiveWire will be responsible for all expenses incurred by KYMCO as a result of such Recall, and compensate all damages and losses suffered by KYMCO as a result of such Recall. If a Recall is initiated both because of a breach of KYMCO’s warranty obligations and because of LiveWire’s Recall Obligations, then each Party shall be responsible for a pro rata share of the total expenses incurred in connection with such Recall in proportion to each Party’s respective responsibility for the circumstances giving rise to the Recall as determined in good faith by the Parties.
Cost of Recall. DSM shall bear the cost of a recall, market withdrawal or corrective action in the event and to the extent that the recall, market withdrawal or corrective action is as a result of (i) any failure of DSM or the Product to comply with CGMP Requirements, the Specifications or any warranty or other requirement under this Supply Agreement or (ii) any failure of DSM to comply in all material respects with applicable Law; otherwise AAI shall bear the costs of a recall, market withdrawal or corrective action.
Cost of Recall. (i) In the event that the principal reason for the recall under this Clause 9.5 of the Product in question is Ligand's negligence or willful misconduct, its failure to supply Products conforming to the specifications therefor, or Ligand's failure to comply with applicable laws or regulations, then *** *** In the event that the principal reason for the recall under this Clause 9.5 is Elan's negligence or willful misconduct, its failure to handle or store Products in conformity with the specifications therefor, or Elan's failure to comply with applicable laws or regulations, *** *** ***
Cost of Recall. In the event that any Finished US Goods are quarantined or recalled, or are subject to stop-sale or other corrective action, whether voluntary or by Governmental Entity action, then any expenses (including reasonable fees of any experts or attorneys that may be utilized by either party and Governmental Entity fines or penalties related to such recall, quarantine or stop-sale or other corrective action) shall be borne by Buyer, except to the extent such quarantine, recall, stop-sale order or other corrective action is demonstrated to be due to failure of Finished US Goods to be manufactured by Manufacturer hereunder in accordance with applicable cGMP Requirements and Specifications, in which case the expenses (including reasonable fees of any experts or attorneys that may be utilized by either party and Governmental Entity fines or penalties related to such recall, quarantine, stop-sale or other corrective action) shall be borne by Manufacturer.
Cost of Recall. Manufacturer shall bear the cost of a recall, market withdrawal or corrective action only in the event that the recall, market withdrawal or corrective action is required by (i) any failure of Manufacturer or the Product to comply with CGMP Requirements, the Specifications or any warranty or other requirement under this Supply Agreement or (ii) any failure of Manufacturer to comply in all material respects with applicable Law.
