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 [****]:
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:
Costs of Recall. The costs of any recall shall be borne consistent with the indemnification in Sections 13.1-2.
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:
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. 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:
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.
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
