Recalled Product. If a Recall or return results from, or arises out of, a failure by Patheon to perform the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will be responsible for the documented out-of-pocket expenses of the Recall or return and will use its commercially reasonable efforts to replace the Recalled or returned Products with new Products, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in Recalled Product will be captured and calculated in the Active Materials Yield under Section 2.
Recalled Product. Recalled products may be sent to Vendor as part of a regular return. Vendor will identify recalled product at the time of processing and apply for necessary return authorization.
Recalled Product. In the event (I) any government authority issues a request, directive or administrative order that Product be recalled, or (ii) a court of competent jurisdiction orders a Product recall, or (iii) the COMPANY reasonably determines that the Product should be recalled, the parties shall take all appropriate corrective actions which are reasonable under the circumstances. In the event that such recall results solely from the breach of DPT’s warranties under this Agreement, DPT shall be responsible for the administrative expenses of the recall in any case not to exceed […***…] per recall incident as well as for the cost of replacing the recalled Product. In the event the recall results from the breach of COMPANY’s warranties under this Agreement, COMPANY shall be responsible for all of the expenses of the recall. For the purposes of this Agreement, administrative expenses of the recall shall be the expenses of notification, destruction or return of the recalled Product; including any reasonable out-of-pocket costs incurred by the parties in connection with any corrective action.
Recalled Product. If a Recall or return results from, or arises out of, a failure by Patheon to perform the Manufacturing Services in accordance with the Manufacturing Requirements, Patheon will be responsible for the documented out-of-pocket expenses of the Recall or return and will promptly, at Client’s election, either: (i) refund the invoice price for the Recalled or returned Product, (ii) offset the amount paid by Client for the Recalled or returned Product against other amounts due to Patheon hereunder; or (iii) replace the Recalled or returned Product with new Product without Client being liable for payment therefore under Section 3.1, contingent upon the receipt from Client of all Active Materials required for the manufacture of the replacement Product. For greater certainty, Patheon’s responsibility for any loss of Active Materials in Recalled Product will be captured and calculated in the yield calculations under Section 2.2. In all other circumstances, Recalls, returns, or other corrective actions will be made at Client’s cost and expense.
Recalled Product. If a Recall or return of Products results from, or arises out of, a failure by Patheon to perform the Manufacturing Services in accordance with the terms of this Agreement, including the warranties set forth in Sections 9.3 and 9.4 or other negligence or willful misconduct of Patheon, Patheon will be responsible for the documented costs and out-of-pocket expenses of the Recall or return and will promptly, at the election of Client, either: (i) refund the amount paid for the Recalled or returned Products and the cost incurred by Client for the Xxxx Back Items and Client-Supplied Components used in the Products; (ii) offset the amount paid for the Recalled or returned Products and the cost incurred by Client for the Xxxx Back Items and Client-Supplied Components used in the Products, against other amounts due to Patheon hereunder; or (iii) replace the Recalled or returned Products with conforming Products, at Patheon’s sole expense (excluding expense to incur replacement Active Materials, but including the expense to obtain replacement Xxxx Back Items and Client-Supplied Components), as promptly as practical without Client being liable for payment therefor under Section 3.1, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in Recalled Product will be captured and calculated in the Active Materials Yield under Section 2.2. In all other circumstances, Recalls, returns, or other corrective actions will be made at Client’s cost and expense. For clarification, any refund of the amount paid by Client for the Recall or return of Products that is paid by Patheon subject to this Section 6.3(b) will not be considered a liability under, and therefore will not be subject to, Section 10.2(a).
Recalled Product. To the extent that a Recall results from, or arises from Deficient Product, Patheon will be responsible for the reasonable documented out-of-pocket expenses of conducting the Recall and will use its commercially reasonable efforts to replace (at its sole cost) the Deficient Product with replacement Products as per Section 10. In all other circumstances, Recalls, returns, or other corrective actions will be made at Client's cost and expense. Patheon’s only liability for API loss is set out in Appendix 3.
Recalled Product. If a Recall or return results from, or arises out of, a failure by Patheon to perform the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will be responsible for the documented out-of-pocket expenses of the Recall or return and will promptly, at Client’s election, either: (i) refund the invoice price for such Recalled or returned Products; (ii) offset such Recalled Product Credit Amount against other amounts due to Patheon hereunder; or (iii) use its commercially reasonable efforts to replace such Recalled or returned Products with conforming Products using the next available manufacturing slot without the Client being liable for payment therefore, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Products. In all other circumstances, Recalls, returns, or other corrective actions will be made at Client's direction, cost and expense. Patheon’s responsibility for any loss of Active Materials in Recalled Product will be captured and calculated in the Active Materials Yield under Section 2.2.
Recalled Product. AstraZeneca, in its sole and absolute discretion, shall determine whether to recall any Co-Promoted Product or withdraw any Co-Promoted Product from the market, any such recall or withdrawal to be at AstraZeneca’s expense, except to the extent such recall resulted from any breach by Targacept of its obligations under the Master Agreement or under the Co-Promotion Agreement or Targacept’s or any of its Affiliates’ negligence or willful misconduct, in which case Targacept shall bear all expenses of such recall, provided that Targacept shall not be deemed to be negligent or in breach solely for complying with the training provided by AstraZeneca under the applicable Co-Promotion Agreement, with AstraZeneca’s standard operating procedures as may be provided under the applicable Co-Promotion Agreement or otherwise with direction from AstraZeneca if the activities required by such training, procedures or other direction would themselves constitute negligence or breach. At AstraZeneca’s request, Targacept shall assist AstraZeneca in obtaining any Co-Promoted Product, including all samples thereof, that has been recalled or withdrawn from the market.
Recalled Product. If a Recall, return or other corrective action for the Products results from, or arises out of, a failure by Patheon to perform the Manufacturing Services in accordance with the Specifications, cGMPs, Applicable Laws, or other warranties or requirements set forth herein, Patheon will (i) be responsible for all documented out-of-pocket expenses (including attorneys’ fees and amounts paid to Authorities) of Client and customers of Client of the Recall, return or other corrective action, and (ii) promptly, at Client’s election: (A) refund the invoice price for the Products that are subject to the Recall, return or other corrective action; (B) offset the amount paid for the Products that are subject to the Recall, return or other corrective action against other amounts due to Patheon hereunder; or (C) replace the Products that are subject to the Recall, return or other corrective action with conforming Products without Client being liable for payment therefor, contingent upon Patheon’s receipt from Client of all Active Materials required for the manufacture of the replacement Products. Patheon’s responsibility for any loss of Active Materials in Products that are subject to a Recall, return or other corrective action will be captured and calculated in the Active Materials Yield under Section 2.2. In all circumstances other than those addressed in this Section 6.3(b), Recalls, returns, or other corrective actions will be made at Client’s cost and expense.
Recalled Product. The cost of any Recall, return or corrective action shall be borne by Acorda, and Acorda shall reimburse Manufacturer for expenses incurred in connection with any Recall, in each case except to the extent such Recall is caused solely by Manufacturer’s [*****], in which case Manufacturer shall bear the cost of any Recall and shall reimburse Acorda for expenses incurred in connection with any such Recall as described below (such Supplied Product or Marketed Product so subject to a Recall, a “Recalled Product”), then Manufacturer will (i) be responsible for all documented out-of-pocket expenses (including reasonable attorneys’ fees and amounts paid to Authorities) of Acorda and its Affiliates of the Recall, return or other corrective action (including any out-of-pocket costs incurred by Acorda in respect of affected Marketed Product or its manufacturing, distribution or sale), and (ii) the returned Supplied Product shall be reimbursed to Acorda in line with Section 6.1.
