Common use of Adjustments Due to Technical Changes Clause in Contracts

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by the Client will only be implemented following a technical and cost review by Patheon and are subject to the Client and Patheon reaching agreement as to revisions, if any, to the Fees specified in Schedules B or C necessitated by any such amendment. If the Client accepts a proposed fee change, the proposed change in the Specifications shall be implemented, and the fee change shall become effective only with respect to those orders of Drug Product that are manufactured in accordance with the revised Specifications. In addition, the Client agrees to purchase, at Patheon’s cost therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Inventory), all Inventory utilized under the “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with Section 5.3, to the extent that such Inventory can no longer be utilized 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 in accordance with Section 5.3 shall be cancelled where possible, and where such orders are not subject to cancellation without penalty, shall be assigned to and satisfied by the Client. [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by the Client will only be implemented following a technical and cost review by Patheon and are subject to the Client and Patheon reaching agreement as to revisions, if any, on Price changes required because of the amendment. Amendments to the Fees specified in Schedules B Specifications, the Quality Agreement, or C necessitated the Manufacturing Site requested by any such amendmentPatheon will only be implemented following the written approval of Client, the approval not to be unreasonably withheld. If the Client accepts a proposed fee Price change, the proposed change in the Specifications shall will be implemented, and the fee Price change shall will become effective effective, only with respect to for those orders of Drug Product Products that are manufactured in accordance with under the revised Specifications. In addition, the Client agrees to purchase, at Patheon’s cost therefor (including all costs incurred by Patheon in connection with for the purchase and handling of such the Inventory), all Inventory utilized used under the “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with under Section 5.35.2, to if the extent that such Inventory can no longer be utilized 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 in accordance with under Section 5.3 shall 5.2 will be cancelled where possible, and where such if the orders are may not subject to cancellation be cancelled without penalty, shall will be assigned to and satisfied by the Client. [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by the Client will only be implemented following a technical and cost review by Patheon and are subject to the Client and Patheon reaching agreement as to revisions, if any, to the Fees specified in Schedules B or C necessitated by any such amendment. If the Client accepts a proposed fee change, the proposed change in the Specifications shall be implemented, and the fee change shall become effective only with respect to those orders of Drug Product that are manufactured in accordance with the revised Specifications. In addition, the Client agrees to purchase, at [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Patheon’s cost therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Inventory), all Inventory utilized under the “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with Section 5.3, to the extent that such Inventory can no longer be utilized 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 in accordance with Section 5.3 shall be cancelled where possible, and where such orders are not subject to cancellation without penalty, shall be assigned to and satisfied by the Client. [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by the Client, other than those mandated by the FDA or other government regulatory agency (for which Client shall accept reasonable revision of the fees necessitated by such amendment), will only be implemented following a technical and cost review by Patheon and are subject to the Client and Patheon reaching agreement as to revisions, if any, to the Fees fees specified in Schedules B or C necessitated by any such amendment. If the Client accepts a proposed fee change, the proposed change in the Specifications shall be implemented, and the fee change shall become effective only with respect to those orders of Drug Product Products that are manufactured in accordance with the revised Specifications. In addition, the Client agrees to purchase, at Patheon’s 's cost therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Inventory), all Inventory utilized under the “"old” " Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with Section 5.35.2, to the extent that such Inventory can no longer be utilized 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 in accordance with Section 5.3 5.2 shall be cancelled where possible, and where such orders are not subject to cancellation without penalty, shall be assigned to and satisfied by the Client and, at Client's option, Client shall take possession of the material in any such orders. [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect At Client's expense, Patheon shall deliver such Components to the omitted portionsa destination provided by Client.

Adjustments Due to Technical Changes. Amendments to the Specifications Sepracor’s Technical Information or the Quality Agreement requested by the Client Sepracor will only be implemented following a technical and cost review by Patheon and are subject to the Client Sepracor and Patheon reaching agreement as to revisions, if any, to the Fees fees specified in Schedules Schedule B or C necessitated by any such amendment. If the Client Sepracor accepts a proposed fee change, the proposed change in the Specifications Sepracor’s Technical Information shall be implemented, and the fee change shall become effective only with respect to those orders of Drug Product Products that are manufactured in accordance with the revised SpecificationsSepracor’s Technical Information. In addition, the Client Sepracor agrees to purchase, at Patheon’s cost therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Inventory)actual out-of-pocket cost, all Inventory utilized under the “old” Specifications Sepracor Technical Information and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with Section 5.3, to the extent that such Inventory can no longer be utilized under the revised SpecificationsSepracor Technical Information. Open purchase orders for Components no longer required under any revised Specifications Sepracor Technical Information that were placed by Patheon with suppliers in order to fill Firm Orders or in accordance with Section 5.3 shall be cancelled canceled where possible, and where such orders are not subject to cancellation without penalty, shall be assigned to and satisfied by the Client. [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portionsSepracor.

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by the Client, other than those mandated by the FDA or other government regulatory agency (for which Client shall accept reasonable revision of the fees necessitated by such amendment), will only be implemented following a technical and cost review by Patheon and are subject to the Client and Patheon reaching agreement as to revisions, if any, to the Fees fees specified in Schedules B or C necessitated by any such amendment. If the Client accepts a proposed fee change, the proposed change in the Specifications shall be implemented, and the fee change shall become effective only with respect to those orders of Drug Product Products that are manufactured in accordance with the revised Specifications. In addition, the Client agrees to purchase, at Patheon’s 's cost therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Inventory), all Inventory utilized under the “"old” " Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with Section 5.35.2, to the extent that such Inventory can no longer be utilized 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 in accordance with Section 5.3 5.2 shall be cancelled where possible, and where such orders are not subject to cancellation without penalty, shall be assigned to and satisfied by the Client and, at Client's option, Client shall take possession of the material in any such orders. At Client's expense, Patheon shall deliver such Components to a destination provided by Client. [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.4.5

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by the Client Customer will only be implemented following a technical and cost review by Patheon and are subject to the Client Customer and Patheon reaching agreement as to revisions, if any, to the Fees Prices specified in Schedules B or C necessitated by any such amendment. Amendments to the Specifications or the Quality Agreement by Patheon will only be implemented following the approval of Customer, such approval not to be unreasonably withheld. If the Client Customer accepts a proposed fee Price change, the proposed change in the Specifications shall be implemented, and the fee Price change shall become effective only with respect to those orders of Drug Product Products that are manufactured in accordance with the revised Specifications. In addition, the Client Customer agrees to purchase, at Patheon’s 's external cost therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Inventory)therefore, all Inventory utilized under the “"old” " Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with Section 5.35.2, to the extent that such Inventory can no longer be utilized 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 in accordance with Section 5.3 5.2 shall be cancelled where possible, and where such orders are not subject to cancellation without penalty, shall be assigned to and satisfied by the Client. [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portionsCustomer.

Adjustments Due to Technical Changes. Amendments to the Specifications Sepracor's Technical Information or the any Quality Agreement requested by the Client Sepracor will only be implemented following a technical and cost review by Patheon and are subject to Sepracor and the Client and Patheon reaching agreement as to revisions, if any, to the Fees fees specified in Schedules Schedule B or C necessitated by any such amendment. If the Client Sepracor accepts a proposed fee change, the proposed change in the Specifications Sepracor's Technical Information shall be implemented, and the fee change shall become effective only with respect to those orders of Drug Product Products that are manufactured in accordance with the revised SpecificationsSepracor's Technical Information. In addition, the Client Sepracor agrees to purchase, at Patheon’s cost therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Inventory)'s actual out-of-pocket cost, all Inventory utilized under the “"old” Specifications " Sepracor Technical Information and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with Section 5.3, to the extent that such Inventory can no longer be utilized under the revised SpecificationsSepracor Technical Information. Open purchase orders for Components no longer required under any revised Specifications Sepracor Technical Information that were placed by Patheon with suppliers in order to fill Firm Orders or in accordance with Section 5.3 shall be cancelled where possible, and where such orders are not subject to cancellation without penalty, shall be assigned to and satisfied by the Client. [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portionsSepracor.

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by the Client will only be implemented following a good faith technical and cost review by Patheon and are subject to the Client and Patheon reaching agreement in writing as to revisions, if any, to the Fees fees specified in Schedules B or C necessitated by any such amendment. Amendments to the Specifications, the Quality Agreement or the Manufacturing Site or any material deviations from the assumptions specified in Schedule B requested by Patheon will only be implemented following the written approval of Client, such approval not to be unreasonably withheld. If the Client accepts a the proposed fee changechange (if any), the proposed change in the Specifications or the Quality Agreement requested by Client shall be implemented, and the fee change shall become effective only with respect to those orders of Drug Product Products that are manufactured in accordance with the revised SpecificationsSpecifications or Quality Agreement. In addition, the Client agrees ****. If the parties are unable to purchase, at Patheon’s cost therefor (including all agree on what costs incurred by Patheon in connection with are reasonable, then the purchase and handling of parties shall resolve such Inventory), all Inventory utilized under the “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or issue in accordance with Section 5.3, to the extent that such Inventory can no longer be utilized under the revised Specifications. 12.1 Open purchase orders for Components and Xxxx Back Items no longer required under any revised Specifications or Quality Agreement that were placed by Patheon with suppliers in order to fill Firm Orders or in accordance with Section 5.3 5.2 shall be cancelled or used in connection with other Patheon services where possible, and where such orders are not subject to cancellation without penaltypenalty or cannot be used in connection with other Patheon services, Client shall be assigned pay to and satisfied by the Client. [Patheon ***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions*.

Adjustments Due to Technical Changes. Amendments to the Specifications Cephalon's Technical Information or the Quality Technical Agreement requested by the Client Cephalon will only be implemented following a technical and cost review by Patheon and are subject to the Client Cephalon and Patheon reaching agreement as to revisions, if any, to the Fees fees specified in Schedules A or B or C necessitated by any such amendment. If the Client Cephalon accepts a proposed fee change, the proposed change in the Specifications Cephalon's Technical Information shall be implemented, and the fee change shall become effective only with respect to those orders of Drug Product Products that are manufactured in accordance with the revised SpecificationsCephalon's Technical Information. In addition, the Client Cephalon agrees to purchase, at Patheon’s cost therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Inventory)'s cost, all Inventory utilized under the “"old” Specifications " Cephalon's Technical Information and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with Section 5.3, to the extent that such Inventory can no longer be utilized under the revised SpecificationsCephalon's Technical Information. Open purchase orders for Components no longer required under any revised Specifications Client's Technical Information that were placed by Patheon with suppliers in order to fill Firm Orders or in accordance with Section 5.3 shall be cancelled where possible, and where such orders are not subject to cancellation without penalty, shall be assigned to and satisfied by the Client. [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portionsCephalon.

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by the Client will only be implemented following a technical and cost review by Patheon and are subject to the Client and Patheon reaching agreement as to revisions, if any, to the Fees fees specified in Schedules B or C Schedule A necessitated by any such amendment. If the Client accepts a proposed fee change, the proposed change in the Specifications shall be implemented, and the fee change shall become effective only with respect to those orders of Drug Product that are manufactured in accordance with the revised Specifications. In addition, the Client agrees to purchase, at Patheon’s cost therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Inventory)cost, all Inventory utilized under the “old” previous Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with Section 5.35.2, to the extent that such Inventory can no longer be utilized 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 in accordance with Section 5.3 5.2 shall be cancelled where possible, and where such orders are not subject to cancellation without penalty, shall be assigned to and satisfied by the Client. [***]Any amendments or additions to cGMPs or to applicable laws which necessitate: Certain information on this page has been omitted (a) resulting changes to Product Specification or Manufacturing Requirements shall be conducted at the expense of the Client; and filed separately with the Commission. Confidential treatment has been requested with respect (b) resulting changes to the omitted portionsFacility shall be borne by Patheon.

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by the Client will only be implemented following a good faith technical and cost review by Patheon and are subject to the Client and Patheon reaching agreement in writing as to revisions, if any, to the Fees fees specified in Schedules B or C necessitated by any such amendment. Amendments to the Specifications, the Quality Agreement or the Manufacturing Site or any material deviations from the assumptions specified in Schedule B requested by Patheon will only be implemented following the written approval of Client, such approval not to be unreasonably withheld. If the Client accepts a the proposed fee changechange (if any), the proposed change in the Specifications or the Quality Agreement requested by Client shall be implemented, and the fee change shall become effective only with respect to those orders of Drug Product Products that are manufactured in accordance with the revised SpecificationsSpecifications or Quality Agreement. In addition, the Client agrees to purchase, at Patheon’s cost therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Inventory), all Inventory utilized under the “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with Section 5.3, to the extent that such Inventory can no longer be utilized under the revised Specifications****. Open purchase orders for Components no longer required under ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. CONFIDENTIAL TREATMENT REQUESTED any revised Specifications or Quality Agreement that were placed by Patheon with suppliers in order to fill Firm Orders or in accordance with Section 5.3 5.2 shall be cancelled or used in connection with other Patheon services where possible, and where such orders are not subject to cancellation without penaltypenalty or cannot be used in connection with other Patheon services, Client shall be assigned pay to and satisfied by the Client. [Patheon ***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions*.

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by the Client will only be implemented following a technical and cost review by Patheon and are subject to the Client and Patheon reaching agreement as to revisions, if any, to the Fees fees specified in Schedules B C or C D necessitated by any such amendment. If the Client accepts a proposed fee change, the proposed change in the Specifications shall be implemented, and the fee change shall become effective only with respect to those orders of Drug Product Products that are manufactured in accordance with the revised Specifications. In addition, the Client agrees to purchase, at Patheon’s cost therefor (including all costs incurred by Patheon in connection with the purchase and handling of such Inventory), all Inventory utilized under the “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with Section 5.35.2, to the extent that such Inventory can no longer be utilized 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 in accordance with Section 5.3 5.2 shall be cancelled where possible, and where such orders are not subject to cancellation without penalty, shall be assigned to and satisfied by the Client. [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.