Costs of Recall. Supplier shall reimburse Purchaser for all reasonable costs incurred by Purchaser in implementing a Recall of a Licensed Product resulting from (i) the failure of any Licensed Adjuvant to meet Adjuvant Specifications at the time of delivery of Licensed Adjuvant by Supplier or (ii) Supplier’s failure to manufacture any Licensed Adjuvant in accordance with cGMP and all other Applicable Laws. Purchaser shall be responsible for the costs incurred in implementing any other Recall. Any dispute between the Parties as to which Party is responsible for the costs of a Recall will be governed by the dispute resolution mechanism in Section 10.1 below.
Costs of Recall. Emergent shall reimburse Aptevo for all reasonable costs incurred by Aptevo in implementing a recall or withdrawal of Product resulting from the Delivery of Non-Conforming Product where such non-conformance was caused by Emergent’s negligence, willful misconduct, failure to follow the Master Batch Record or failure to follow cGMP. If the recall or withdrawal is required for any reason not specified in the preceding sentence, then all costs of the Parties incurred in implementing the recall or withdrawal of Product shall be borne by Aptevo. Any dispute between the Parties as to which Party is responsible for the costs of a recall or withdrawal will be governed by the laboratory investigation procedures set forth in Section 3.8 and the dispute resolution mechanism set forth in ARTICLE XI.
Costs of Recall. All Out-Of-Pocket Expenses and FTE Costs (each as defined in the Financial Appendix) incurred by a Party for the execution of any recall or withdrawal of the Product (“Recall Costs”) pursuant to Section 16.4(a) above shall be included in the calculation of Profit/Loss pursuant to the Financial Appendix; except to the extent that [****]:
(i) [****];
(ii) [****].
Costs of Recall. All actual direct and documented out-of-pocket expenses for the execution of any recall or withdrawal of the Product (including the cost of any investigation leading to the decision to recall) (“Recall Costs”) pursuant to Section 17.4(a), above, shall initially be shared equally between the Parties; provided that, in each case, responsibility for the Recall Costs shall be subject to the final allocation between the Parties as set out in paragraphs (i) to (iii) below. For clarity, Recall Costs do not include any lost or refunded sales. In the event that it is finally determined, or agreed between the Parties, that such recall or withdrawal is caused by:
(i) breach of Sepracor’s representations, warranties or covenants as set forth in this Agreement, including failure to supply Bulk Tablets conforming to the standards set forth in the Supply Agreement or Quality Agreement, or the gross negligence or willful misconduct of Sepracor or Sepracor’s failure to comply with applicable laws and regulations including cGMP (to be defined in the Quality Agreement) (collectively, the “Fault of Sepracor”), Sepracor shall be responsible for all Recall Costs;
(ii) failure of GSK, or its Affiliates or Sublicensees, to handle, store, package, transport, distribute or use the Bulk Tablets supplied by Sepracor or Product in accordance with applicable laws and regulations or the terms of the applicable Marketing Approval, the Supply Agreement, the Quality Agreement or the gross negligence or willful misconduct of GSK, its Affiliates or Sublicensees, (collectively, “Fault of GSK”), GSK shall be responsible for all Recall Costs; and
(iii) in all other cases, the Recall Costs shall be borne equally by Sepracor and GSK.
Costs of Recall. To the extent and in the proportion to which the cause or reason of any such Recall or Product Action of Final Product is directly attributable to activities performed by DRL, DRL shall be responsible for the Recall Costs and replacement of the applicable Final Product (at its own cost). To the extent and in the proportion to which the cause or reason of any such Recall or Product Action of Final Product is directly attributable to activities performed by Coya with respect to Final Product, Coya shall be responsible for the Recall Costs and replacement of the applicable Final Product (at its own cost). If the cause of any Recall or Product Action of Final Product cannot be determined, the Parties shall equally share the Recall Costs and replacement of the Final Product
Costs of Recall. Emergent shall reimburse Aptevo for all reasonable costs incurred by Aptevo in implementing a recall or withdrawal of Product resulting from the Delivery of Non-Conforming Product where such non-conformance was caused by Emergent’s negligence, willful misconduct, failure to follow the Master Batch Record or failure to follow
Costs of Recall. All actual direct and documented out-of-pocket expenses for the execution of any recall or withdrawal of a Licensed Product supplied to SEPRACOR by BIAL ("Recall Costs") pursuant to Section 15.6(a) above, will initially be shared equally between the Parties, provided that (i) in each case, responsibility for the Recall Costs will be subject to the final allocation between the Parties as set out in paragraphs (i) and (ii) below, and (ii) BIAL will reimburse SEPRACOR for all amounts paid by SEPRACOR for the recalled products in excess of BIAL's Fully Burdened Manufacturing Costs. For clarity, Recall Costs do not include any lost or refunded sales. In the event that it is finally determined, or agreed between the Parties, that such recall or withdrawal:
(i) is caused by breach of BIAL's representations or warranties as set forth in this Agreement or the Supply Agreement, including failure to supply Licensed Product conforming to the specifications set forth in the Supply Agreement or Quality Agreement, or the gross negligence or willful misconduct of BIAL or BIAL's failure to comply with applicable laws and regulations including cGMP (to be defined in the Quality Agreement) (collectively, the "Fault of BIAL"), BIAL will be responsible for all Recall Costs; and
(ii) is caused by breach of SEPRACOR's representations or warranties as set forth in this Agreement or the Supply Agreement, including failure of SEPRACOR, or its Affiliates, its sublicensee or contractors, to handle, store, transport, market, promote, distribute, sell or use the Licensed Product in accordance with applicable laws and regulations or the terms of the applicable Approval, the Supply Agreement, the Quality Agreement or the gross negligence or willful misconduct of SEPRACOR, its Affiliates, sublicensee or contractors (collectively, "Fault of SEPRACOR"), SEPRACOR will be responsible for all Recall Costs.
Costs of Recall. In the event that King is required to recall, withdraw, or undertake a field correction of any King Supplied Product in accordance with the provisions of this Section 3.3(e), in such event, King shall bear the actual cost of conducting such action or withdrawal, including costs imposed by the applicable Governmental Authority(ies) such as costs for detention and inspection, in accordance with the recall guidelines of the applicable Governmental Authority(ies) or standard U.S. medical device industry practices; and, at the sole election of VSI, King shall either:
(i) in the case of Product supplied under a King Device Forecast or a VSI Device Forecast, supply Product, without charge to VSI, in an amount sufficient to replace the amount of the Product recalled, withdrawn, or subjected to field correction; or
(ii) in the case of Product supplied under a VSI Device Forecast, refund to VSI, or give credit to VSI against outstanding receivables due from VSI against the VSI Device Purchase Price for shipments of the Product to be delivered to VSI in the future, in amounts equal to the VSI Device Purchase Price paid by VSI to King for Product so recalled, withdrawn, or subjected to field correction, plus the reasonable transportation costs incurred by VSI and not recovered by VSI in respect of such Product recalled, withdrawn, or subjected to field correction.
Costs of Recall. The costs of any recall shall be borne consistent with the indemnification in Sections 13.1-2.
Costs of Recall. To the extent and in the proportion the cause or reason of any such recall, withdrawal, field correction or seizure of Product is directly attributable to activities performed by Supplier in the manufacture of the Product, Mikah shall be responsible for the Recall Costs and replacement of the Product (at its own cost). To the extent and in the proportion the cause or reason of any such recall, withdrawal, field correction or seizure of Product is directly attributable to activities performed by DRL with respect to distribution of the Product, DRL shall be responsible for the Recall Costs and replacement of the Product (at its own cost). To the extent the cause or reason of any such recall, withdrawal, field correction or seizure of Product cannot be determined, the Parties shall be responsible for the recall expenses and replacement of the Product in the ratio of their profit sharing percentage.
