Common use of Recalled Product Clause in Contracts

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 this Agreement, the Specifications, cGMPs, or Applicable Laws, Patheon will be responsible for the documented out-of-pocket expenses of the Recall or return, including, without limitation, reasonable documented costs and expenses relating to communications and meetings with all required regulatory agencies, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of Recalled Product from customers and shipment of an equal amount of replacement Product to those same customers. Patheon will use its commercially reasonable efforts to replace the Recalled or returned Products with new Products, contingent upon the receipt from Indivior of all Active Materials and Indivior-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. If Patheon is unable to replace the Recalled or returned Products (except where this inability results from a failure to receive the required Active Materials and Indivior-Supplied Components), then, in addition to any other remedies Indivior may have at law or in equity, at Indivior’ request, Patheon shall reimburse Indivior for the price that Indivior paid to Patheon for Manufacturing Services for the affected Products. In all other circumstances, Recalls, returns, or other corrective actions will be made at Indivior's cost and expense; provided, however, that if a Recall is in part the responsibility of Patheon and in part the responsibility of Indivior, the costs and expenses associated with the Recall shall be allocated in an equitable manner between the parties.

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 this Agreement, the Specifications, cGMPs, or and Applicable Laws, Patheon will be responsible for the documented out-of-pocket expenses of the Recall or returnreturn and will promptly, includingat Client’s election, without limitation, reasonable documented costs and expenses relating to communications and meetings with all required regulatory agencies, expenses of replacement stock, either: (i) refund the cost of notifying customers and costs associated with shipment of invoice price for such Recalled or returned Products (the “ Recalled Product from customers and shipment of an equal amount of replacement Credit Amount “); (ii) offset such Recalled Product Credit Amount against other amounts due to those same customers. Patheon will hereunder; or (iii) use its commercially reasonable efforts to replace the Recalled or returned Products with new Products, contingent upon the receipt from Indivior Client of all Active Materials and Indivior-Supplied Components required for the manufacture of the replacement Products. A recall arising out of Patheon’s gross negligence, intentional misconduct, Patheon’s failure to follow cGMP or ICH guidelines is considered a material breach, and in such an event Client shall have the option to terminate the contract without the Remediation Period described in section 8.2(a). 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. If Patheon is unable to replace the Recalled or returned Products (except where this inability results from a failure to receive the required Active Materials and Indivior-Supplied ComponentsMaterials), then, in addition then Client may request Patheon to any other remedies Indivior may have at law or in equity, at Indivior’ request, Patheon shall reimburse Indivior Client for the price that Indivior Client paid to Patheon for Manufacturing Services for the affected Products. In all other circumstances, Recalls, returns, or other corrective actions will be made at Indivior's Client’s cost and expense; provided, however, that if a Recall is in part the responsibility of Patheon and in part the responsibility of Indivior, the costs and expenses associated with the Recall shall be allocated in an equitable manner between the parties.

Recalled Product. If To the extent that a Recall recall or return results from, or arises out of, a failure by Patheon to perform provide the Manufacturing Services in accordance with this Agreement, the Specifications, cGMPs, or Applicable LawsManufacturing Requirements, Patheon will shall be responsible for the documented out-of-pocket expenses of the Recall such recall or return, including, without limitation, reasonable documented costs return and expenses relating to communications and meetings with all required regulatory agencies, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of Recalled Product from customers and shipment of an equal amount of replacement Product to those same customers. Patheon will shall use its commercially reasonable efforts to replace the Recalled recalled or returned Products with new Products, contingent upon the receipt from Indivior MDCO of all Active Materials and Indivior-Supplied Components required for the manufacture of the such replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in Recalled connection with recalled or returned Product will shall be captured and calculated in the Active Materials Yield under Section 2.210.2. If In the event that Patheon is unable to replace the Recalled recalled or returned Products (except where this such inability results from a failure to receive the required Active Materials and Indivior-Supplied ComponentsMaterials), then, in addition to any other remedies Indivior may have at law or in equity, at Indivior’ upon MDCO’s request, Patheon shall reimburse Indivior MDCO for the price that Indivior MDCO paid to Patheon for Manufacturing Services for in respect of the affected Products. In all other circumstances, Recallsrecalls, returns, returns or other corrective actions will shall be made at Indivior's MDCO’s cost and expense; provided. Except as provided in Sections 6.2(a) and (b) above, howeverPatheon shall not be liable nor have any responsibility for any deficiencies in, that if a Recall or other liabilities associated with, any Product manufactured by it, (collectively, "Product Claims"). For greater certainty, Patheon shall have no obligation for any Product Claims to the extent such Product Claim (i) is in part caused by deficiencies with respect to the responsibility of Patheon and in part the responsibility of IndiviorSpecifications, the costs safety, efficacy or marketability of the Products or any distribution thereof, (ii) results from a defect in a Component that is not reasonably discoverable by Patheon using the test methods set forth in the Specifications, (iii) results from a defect in the Active Materials or Components supplied by MDCO that is not reasonably discoverable by Patheon using the test methods set forth in the Specifications, (iv) is caused by actions of third parties occurring after such Product is shipped by Patheon pursuant to Section 5.4, (v) is due to packaging or labeling defects or omissions for which Patheon has no responsibility, (vi) is due to any unascertainable reason despite Patheon's having met the Manufacturing Requirements, or (vii) is due to any other breach by MDCO of its obligations under this Agreement. Notwithstanding anything in this Agreement to the contrary, the Parties agree that, for the purposes of this Article 6 and expenses associated with Section 10.2, Patheon shall not be liable vis-à-vis MDCO for any vial of Product manufactured for the Recall shall Japanese market and rejected, recalled or returned due to cosmetic defects. For avoidance of doubt, Patheon will be allocated in an equitable manner between entitled to invoice MDCO for the partiesPrice of the Products rejected, recalled or returned due to cosmetic defects.

Recalled Product. If To the extent a Recall or return results from, or arises out of, a failure by Patheon to perform the Manufacturing Services in accordance with this Agreement, the Specifications, cGMPs, or Applicable Laws, Patheon will be responsible for the documented out-of-pocket expenses of the Recall or return, including, without limitation, reasonable documented costs return and expenses relating to communications and meetings with all required regulatory agencies, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of Recalled Product from customers and shipment of an equal amount of replacement Product to those same customers. Patheon will use its commercially reasonable efforts to replace the Recalled or returned Products with new Products, contingent upon the receipt from Indivior Client of all Active Materials and IndiviorClient-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. If Patheon is unable to replace the Recalled or returned Products (except where this inability results from a failure to receive the required Active Materials and IndiviorClient-Supplied ComponentsComponents due to the fault of Client), then, in addition to any other remedies Indivior may have then at law or in equity, at Indivior’ Client’s request, Patheon shall will reimburse Indivior Client for the price that Indivior Client paid to Patheon for Manufacturing Services for the affected Products. Patheon will also be responsible for investigating all Recalls and returns (other than as a result of the -21- [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Master Manufacturing Services Agreement expiration of the Product) resulting from Patheon’s failure to manufacture the Product in accordance with the Specifications, cGMPs, or Applicable Laws, at its own expense and Patheon will promptly report to Client in writing the results of this investigation. In all other circumstances, Recalls, returns, or other corrective actions will be made at IndiviorClient's cost and expense; provided. (c) Except as set forth in Sections 6.3(a) and (b) above, howeverPatheon will not be liable to Client nor have any responsibility to Client for any deficiencies in, that if a Recall or other liabilities associated with, any Product manufactured by it in accordance with this Agreement, (collectively, "Product Claims"). For greater certainty but not limitation, except as set forth in Sections 6.3(a) and (b) above, Patheon will have no obligation for any Product Claims to the extent the Product Claim (i) is caused by deficiencies in part the responsibility of Patheon and in part the responsibility of IndiviorSpecifications, the costs and expenses associated safety, efficacy, or marketability of the Products or any distribution thereof after delivery in accordance with Section 5.4, (ii) results from a defect in a Component that is not reasonably discoverable by Patheon using the test methods set forth in the Specifications prior to use of the applicable Component in the performance of the Manufacturing Services, (iii) results from a defect in the Active Materials, Client-Supplied Components or Components supplied by a Client designated additional source that is not reasonably discoverable by Patheon using the test methods set forth in the Specifications, (iv) is caused by actions of third parties occurring after the Product is shipped by Patheon under Section 5.4, (v) is due to packaging design or labelling defects or omissions for which Patheon has no responsibility, (vi) is due to any unascertainable reason despite Patheon having performed the Manufacturing Services in accordance with the Recall shall be allocated in an equitable manner between the partiesSpecifications, cGMPs, and Applicable Laws, or (vii) is due to any breach by Client of its obligations under this Agreement.