Common use of Adjustments Due to Technical Changes or Regulatory Authority Requirements Clause in Contracts

Adjustments Due to Technical Changes or Regulatory Authority Requirements. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented following a technical and cost review that Patheon will perform at Client’s cost and are subject to Client and Patheon reaching agreement on Price changes required because of the amendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Client, the approval not to be unreasonably withheld. If Client accepts a proposed Price change, the proposed change in the Specifications and the associated scope of work will be implemented at Client’s cost, and the Price change will become effective, only for those orders of Products that are manufactured under the revised Specifications. In addition, Client agrees to purchase, at [***] all Inventory used under the “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 5.2, if the Inventory can no longer be used under the revised Specifications. Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders or under Section 5.2 will be cancelled where possible, and if the orders may not be cancelled without penalty, will be assigned to and satisfied by Client. Additional payments or price increases may also be required to compensate Patheon for fees and other expenses incurred by Patheon to comply with Regulatory Authority requirements which apply to the Manufacturing Services.

Adjustments Due to Technical Changes or Regulatory Authority Requirements. Amendments (a) Technical Changes to the Specifications or the Quality Agreement Requirements. Technical changes requested by Client will only be implemented following a technical and cost review that Patheon will perform at Client’s cost and are subject to Client and Patheon reaching agreement on Price changes required because of the amendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site Technical changes requested by Patheon will only be implemented following an assessment by Patheon and the Client regarding the technical changes that may have an effect on certain areas including, but not limited to Regulatory filings, fees, etc. All technical changes requested by Patheon require the written approval of Client, the approval not to be unreasonably withheld. If Client accepts a proposed Price change, the proposed change in the Specifications and the associated scope of work will be implemented at Client’s cost. All costs relating to the technical changes, including re-validations of the process, or stability program shall be determined by the parties after good faith discussions, and the Price change will become effective, effective only for those orders of Products that are manufactured under the revised Specifications. In addition, Client agrees to purchase, at [***] Patheon's cost (including all costs incurred by Patheon for the purchase and handling of the Inventory), all Inventory for Firm Orders used under the “"old” " Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 5.2, if the Inventory can no longer be used under the revised Specifications. Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders or under Section 5.2 will be cancelled where possible, and if the orders may not be cancelled without penalty, will be assigned to and satisfied by Client. Additional payments or price increases may also be required to compensate Patheon for fees and other expenses incurred by Patheon to comply with Regulatory Authority requirements which apply to the Manufacturing Services.

Adjustments Due to Technical Changes or Regulatory Authority Requirements. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented only following a technical and cost review that Patheon will perform at Client’s cost and are subject to Client and Patheon reaching agreement on Price changes required because of the amendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Client, the approval not to be unreasonably withheld, conditioned or delayed. If Client accepts a proposed Price change, the proposed change in the Specifications or the Quality Agreement and the associated scope of work will be implemented at Client’s cost, and the Price change will become effective, only for those orders of Products Product that are manufactured under the revised Specifications. In addition, Client agrees to purchase, at [***] the price paid by Patheon (including all costs incurred by Patheon for the purchase, handling and transport of the Inventory), all Inventory used held under the “"old” " Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 5.2, if the Inventory can no longer be used under the revised Specifications. Open Patheon will use commercially reasonable efforts to cancel any open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders or under Section 5.2 will be cancelled where possible, and if the orders may not be cancelled without penalty, will be assigned to and satisfied paid for by Client. Additional payments or price increases may also be required to compensate Patheon for fees and other expenses incurred by Patheon to comply with additional Regulatory Authority requirements which apply to the Manufacturing Services.

Adjustments Due to Technical Changes or Regulatory Authority Requirements. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented only following a technical and cost review that Patheon will perform at Client’s cost and are subject to Client and Patheon reaching agreement on Price changes required because of the amendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Client, the approval not to be unreasonably withheld, conditioned or delayed. If Client accepts a proposed Price change, the proposed change in the Specifications or the Quality Agreement and the associated scope of work will be implemented at Client’s costwith the costs to be allocated between the parties as mutually agreed in writing, and the Price change will become effective, only for those orders of Products Product that are manufactured under the revised Specifications; provided that the parties agree that if such changes are implemented due to a regulatory requirement that applies generally to the Product as well as to other products manufactured by Patheon for itself or for third parties, then Client shall pay a pro rata amount of the reasonable cost of such regulatory changes. In addition, Client agrees to purchase, at [***] the price paid by Patheon (including all costs incurred by Patheon for the purchase, handling and transport of the Inventory), all Inventory used held under the “"old” " Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 5.2, if the Inventory can no longer be used under the revised Specifications; provided that Patheon shall use reasonable efforts to mitigate such costs. Open Patheon shall, where possible, cancel open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders or under Section 5.2 will be cancelled where possible5.2, and but if the orders may not be cancelled without penalty, will be assigned to and satisfied by ClientClient shall pay the lesser of the price for such order or such penalty. Additional payments or price increases may also be required agreed to by the parties to compensate Patheon for fees and other expenses incurred by Patheon to comply with Regulatory Authority requirements which apply to the Manufacturing Services.

Adjustments Due to Technical Changes or Regulatory Authority Requirements. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented only following a technical and cost review that Patheon will perform at Client’s cost and are subject to Client and Patheon reaching agreement on Price changes required because of the amendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Client, the approval not to be unreasonably withheld, conditioned or delayed, and subject to any necessary approvals by Regulatory Authorities. If Client accepts a proposed Price change, the proposed change in the Specifications and the associated scope of work will be implemented at Client’s cost, and the Price change will become effective, effective only for those orders of Products Product that are manufactured under the revised Specifications. In addition, Client agrees to purchase, at [***] Patheon’s cost (including all costs incurred by Patheon for the purchase and handling of the Inventory), all Inventory used held under the “old” previous Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 5.2, if the Inventory can no longer be used under the revised Specifications. Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders or under Section 5.2 will be cancelled where possible, and if the orders may not be cancelled without penalty, will be assigned to and satisfied by Client. Additional payments or price increases may also be required to compensate Patheon for fees and other expenses incurred by Patheon to comply with Regulatory Authority requirements which apply to the Manufacturing Services.under

Adjustments Due to Technical Changes or Regulatory Authority Requirements. Amendments to the Specifications or the Quality Agreement requested by Client Indivior will only be implemented only following a technical and cost review that Patheon will perform at ClientIndivior’s cost and are subject to Client Indivior and Patheon reaching agreement on Price changes required because of the amendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of ClientIndivior, the approval not to be unreasonably withheld, conditioned or delayed. If Client Indivior accepts a proposed Price change, the proposed change in the Specifications or the Quality Agreement and the associated scope of work will be implemented at ClientIndivior’s cost, and the Price change will become effective, only for those orders of Products Product that are manufactured under the revised Specifications. In addition, Client Xxxxxxxx agrees to purchase, at [***] the price paid by Patheon (including all reasonable costs incurred by Patheon for the purchase, handling, and transport of the Inventory), all Inventory used held under the “"old” " Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 5.25.1, if the Inventory can no longer be used under the revised Specifications. Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders or under Section 5.2 5.1 will be cancelled where possible, and but if the orders may not be cancelled without penalty, they will be assigned to and satisfied paid for by ClientIndivior. Additional payments or price increases may also be required to compensate Patheon for fees and other expenses incurred by Patheon to comply with Regulatory Authority requirements or changes in Applicable Laws which apply to the Manufacturing Services.

Adjustments Due to Technical Changes or Regulatory Authority Requirements. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented only following a technical and cost review that Patheon will perform at Client’s cost and are subject to Client and Patheon reaching agreement on Price changes increases or decreases required because of the amendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Client, the approval not to be unreasonably withheld, conditioned or delayed. If Client accepts a proposed Price change, the proposed change in the Specifications or the Quality Agreement and the associated scope of work will be implemented at Client’s cost, and the Price change will become effective, only for those orders of Products Product that are manufactured under the revised Specifications. In addition, Client agrees to purchase, at [***] the price paid by Patheon (including all costs incurred by Patheon for the purchase, handling, and transport of the Inventory), all Inventory used held under the “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 5.2, if the Inventory can no longer be used under the revised Specifications. Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders or under Section 5.2 will be cancelled where possible, and but if the orders may not be cancelled without penalty, they will be assigned to and satisfied paid for by Client. Additional payments or price increases may also be required to compensate Patheon for fees and other expenses incurred by Patheon to comply with Regulatory Authority requirements which apply to the Manufacturing Services[***].

Adjustments Due to Technical Changes or Regulatory Authority Requirements. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented only following a technical and cost review that Patheon will perform at Client’s cost and are subject to Client and Patheon reaching agreement on Price changes required because of the amendmentSection 6.10. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Client, the approval not Client subject to be unreasonably withheldSection 6.10. If Client accepts a proposed Price change, the proposed change in the Specifications or the Quality Agreement and the associated scope of work will be implemented at Client’s cost, and the Price change will become effective, only for those orders of Products Product that are manufactured under the revised Specifications. In addition, Client agrees to purchase, at [***] the price paid by Patheon (including all costs incurred by Patheon for the purchase, handling, and transport of the Inventory), all Inventory used held under the “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 5.2, if the Inventory can no longer be used under the revised Specifications. Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders or under Section 5.2 will be cancelled where possible, and but if the orders may not be cancelled without penalty, they will be assigned to and satisfied paid for by Client. Additional *** Confidential Treatment Requested payments or price increases may also be required to compensate Patheon for fees and other expenses incurred by Patheon to comply with Regulatory Authority requirements or changes in Applicable Laws which apply solely to the Manufacturing ServicesServices provided herein.

Adjustments Due to Technical Changes or Regulatory Authority Requirements. For changes to the Specifications or manufacturing processes that are required by Applicable Laws ("Required Manufacturing Changes"), Patheon and Client will cooperate in making these changes and use commercially reasonable efforts to implement the changes promptly in a manner that minimizes any effect on the supply hereunder to Client of Product meeting Specifications. All costs associated with Required Manufacturing Changes directly related to the Manufacturing Site will be borne by Patheon. All other costs associated with Required Manufacturing Changes under this Agreement, including, without limitation, obsolete Components, Regulatory Filings, work in process, equipment and Product will be borne by Client. Amendments to the Specifications or the Quality Agreement requested by the Client that are not Required Manufacturing Changes ("Client Requested Changes") will only be implemented following a technical and cost review that by Patheon will perform at Client’s cost and are subject to Client and Patheon reaching agreement on Price changes required because as to revisions, if any, to the fees specified in Schedules B or C of the Product Agreement necessitated by the amendment. Amendments to the Specifications, the Quality Agreement, Agreement or the Manufacturing Site requested by Patheon that are not Required Manufacturing Changes ("Patheon Requested Changes") will only be implemented following the written approval of Client, the this approval not to be unreasonably withheld, and the costs of the Patheon Requested Changes will be borne by Patheon. If Client accepts a proposed Price fee change, the proposed change in the Specifications and the associated scope of work will be implemented at Client’s costimplemented, and the Price fee change will become effective, effective only for those orders of Products the Product that are manufactured under in accordance with the revised Specifications. In addition, for Client Requested Changes, Client agrees to purchase, at [***] Patheon's cost (including all costs incurred by Patheon in connection with the purchase and handling of the Inventory), all Inventory used held under the “"old” " Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under in accordance with Section 5.2, if to the extent that the Inventory can no longer be used utilized under the revised Specifications. Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon in accordance with this Agreement with suppliers in order to fill Firm Orders or under in accordance with Section 5.2 will be cancelled where possible, and if where the orders may are not be cancelled subject to cancellation without penalty, will be assigned to and satisfied by Client. Additional payments or price increases may also be required [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to compensate Patheon for fees and other expenses incurred by Patheon to comply with Regulatory Authority requirements which apply to Rule 24b-2 of the Manufacturing ServicesSecurities Exchange Act of 1934, as amended.

Adjustments Due to Technical Changes or Regulatory Authority Requirements. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented only following a technical and cost review that Patheon will perform at Client’s cost and are subject to Client and Patheon reaching agreement on Price changes required because of the amendment. Amendments to the Specifications, Specifications or the Quality Agreement, or the Manufacturing Site Agreement requested by Patheon will only be implemented following the written approval of Client, the approval not to be unreasonably withheld. If Client accepts a proposed Price change, the proposed change in the Specifications or the Quality Agreement and the associated scope of work will be implemented at Client’s costcost (subject to the last sentence of this Section 4.4), and the Price change will become effective, only for those orders of Products Product that are manufactured under the revised Specifications. In addition, Client agrees to purchase, at [***] the price paid by Patheon (including all costs incurred by Patheon for the purchase, handling, and transport of the Inventory), all Inventory used held under the “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 5.2, if the Inventory can no longer be used under the revised Specifications. Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders or under Section 5.2 will be cancelled where possible, and but if the orders may not be cancelled without penalty, they will be assigned to and satisfied paid for by Client. Additional Subject to the last sentence of this Section 4.4, additional payments or price increases may also be required to compensate Patheon for fees and other expenses incurred by Patheon to comply with Regulatory Authority requirements or changes in Applicable Laws which apply to the Manufacturing Services. The Parties agree that Client’s obligation to bear cost increases in this Section 4.4 will be limited to those cost increases that relate to a change in scope for the Product; costs for other changes relating to cGMP compliance or affecting other products generally will be discussed and agreed in good faith between the parties.

Adjustments Due to Technical Changes or Regulatory Authority Requirements. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented only following a technical and cost review that Patheon will perform at Client’s cost and are subject to Client and Patheon reaching agreement on Price changes required because of the amendmentamendments. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following a technical and cost review that Patheon will perform at Patheon’s cost and are subject to the written approval of Client, the approval not to be unreasonably withheld, conditioned or delayed, and subject to any necessary approvals by Regulatory Authorities. If Client accepts a proposed Price change, the proposed change in the Specifications or the Quality Agreement and the associated scope of work will be implemented at Client’s cost, and the Price change will become effective, only for those orders of Products Product that are manufactured under the revised Specifications. In addition, Client agrees to purchase, at [***] Patheon's cost (including all costs incurred by Patheon for the purchase and handling of the Inventory), all Inventory used held under the “old” previous Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 5.2, if the Inventory can no longer be used under the revised Specifications. Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders or under Section 5.2 will be cancelled where possible, and but if the orders may not be cancelled without penalty, they will be assigned to and satisfied paid for by Client. Additional payments or price increases may also be required to compensate Patheon for fees and other expenses incurred by Patheon to comply with Regulatory Authority requirements which apply to the Manufacturing ServicesServices specific to Client Products, with such additional payments or price increases to be implemented only upon written approval of Client, which shall not be unreasonably withheld, conditioned or delayed.

Adjustments Due to Technical Changes or Regulatory Authority Requirements. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented only following a technical and cost review that Patheon will perform at Client’s reasonable cost and are subject to Client and Patheon reaching agreement on Price changes required because of the amendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of ClientClient and in accordance with the terms of this Agreement, the approval not to be unreasonably withheld, conditioned or delayed. If Client accepts a proposed Price change, the proposed change in the Specifications or the Quality Agreement and the associated scope of work will be implemented at Client’s reasonable cost, and the Price change will become effective, only for those orders of Products Product that are manufactured Manufactured under the revised SpecificationsSpecifications or Quality Agreement, as applicable. In addition, Client agrees to purchase, at [***] the price paid by Patheon (including all costs incurred by Patheon for the purchase, handling, and transport of the Inventory), all Product specific Inventory used held under the “old” ’ Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 5.2, if the Inventory can no longer be used under the revised Specifications. Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders or under Section 5.2 will be cancelled where possible, and but if the orders may not be cancelled without penalty, they will be assigned to and satisfied paid for by Client. Additional payments or price increases may also be required to compensate Patheon for fees and other expenses incurred by Patheon to comply with Regulatory Authority requirements or changes in Applicable Laws which apply to the Manufacturing Services. The Parties recognize that as a contract Manufacturer, some of the changes required by Regulatory Authorities or other authorities will benefit Patheon and all clients. These costs will be borne by Patheon and factored into the next year’s cost estimates. Parties agree to work in good faith to identify and notify Client of changes which may result in the current process not being adequate to create commercially viable Product as early as possible and also agree to work in good faith to minimize the risk of obsolete Product.

Adjustments Due to Technical Changes or Regulatory Authority Requirements. For changes to the Specifications or manufacturing processes that are required by Applicable Laws ("Required Manufacturing Changes"), Patheon and Client will cooperate in making these changes and use commercially reasonable efforts to implement the changes promptly in a manner that minimizes any effect on the supply hereunder to Client of Product meeting Specifications. All costs associated with Required Manufacturing Changes directly related to the Manufacturing Site will be borne by Patheon. All other costs associated with Required Manufacturing Changes under this Agreement, including, without limitation, obsolete Components, Regulatory Filings, work in process, equipment and Product will be borne by Client. Amendments to the Specifications or the Quality Agreement requested by the Client that are not Required Manufacturing Changes ("Client Requested Changes") will only be implemented following a technical and cost review that by Patheon will perform at Client’s cost and are subject to Client and Patheon reaching agreement on Price changes required because as to revisions, if any, to the fees specified in Schedules B or C of the Product Agreement necessitated by the amendment. Amendments to the Specifications, the Quality Agreement, Agreement or the Manufacturing Site requested by Patheon that are not Required Manufacturing Changes ("Patheon Requested Changes") will only be implemented following the written approval of Client, the this approval not to be unreasonably withheld, and the costs of the Patheon Requested Changes will be borne by Patheon. If Client accepts a proposed Price fee change, the proposed change in the Specifications and the associated scope of work will be implemented at Client’s costimplemented, and the Price fee change will become effective, effective only for those orders of Products the Product that are manufactured under in accordance with the revised Specifications. In addition, for Client Requested Changes, Client agrees to purchase, at [***] Patheon's cost (including all costs incurred by Patheon in connection with the purchase and handling of the Inventory), all Inventory used held under the “"old” " Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under in accordance with Section 5.2, if to the extent that the Inventory can no longer be used utilized under the revised Specifications. Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon in accordance with this Agreement with suppliers in order to fill Firm Orders or under in accordance with Section 5.2 will be cancelled where possible, and if where the orders may are not be cancelled subject to cancellation without penalty, will be assigned to and satisfied by Client. Additional payments or price increases may also be required to compensate Patheon for fees and other expenses incurred by Patheon to comply with Regulatory Authority requirements which apply to the Manufacturing Services.