Recalled or Returned Product. To the extent that a Recall or return results from, or arises out of, a failure by Patheon to perform the Manufacturing Services in accordance with the Specifications, cGMP, or Applicable Laws, Patheon will be responsible for Client’s documented expenses of the Recall or return and Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the Recalled or returned Product; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Product with conforming Product (if Patheon is able to manufacture the replacement Product at the same Manufacturing Site as that of the rejected Product), without Client being liable for payment therefor under Section 3.1, and contingent upon the receipt from Client of all Active Materials and Client-Supplied Components 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 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. If Client and Patheon fail to agree whether Patheon failed to perform the Manufacturing Services in accordance with the Specifications, cGMP, or Applicable Laws, with respect to any Recall, such disagreement shall be considered a technical dispute subject to Section 12.2 and Exhibit A. For clarity, any appointed expert will determine questions relating only to compliance with technical aspects of Patheon’s obligations within the expert’s field of expertise.
Recalled or Returned 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 Client’s documented expenses of the Recall or return and Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the defective Products; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Recalled or returned Products with conforming Products, provided that Patheon is able to manufacture replacement Product at the same Manufacturing Site as that of the Recalled or returned Products, without Client being liable for payment therefor under Section 3.1, and contingent upon the receipt from Client of all Active Materials and Client-Supplied Components (the cost of which shall be subject to reimbursement by Patheon under the yield calculation and subject to the Maximum Credit Value) 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. Notwithstanding anything to the contrary in this Agreement, Patheon will only be required to replace or refund any batch or portion of a batch of recalled Product and will only be liable for Active Material contained therein to the extent the Product is unsold, returned, destroyed or otherwise disposed of by Client in accordance with the terms of this Agreement. The quantity of API contained in this Product will be included in the Quantity Dispensed but not in the Quantity Converted for purposes of calculating the Shortfall in Section 2.2(b).
