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 Client will only be implemented following a technical and cost review by Patheon 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 will be implemented, 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 Patheon’s cost (including all costs incurred by Patheon for the purchase and handling of the Inventory), 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.

Appears in 2 contracts

Sources: Manufacturing Services Agreement (Santarus Inc), Manufacturing Services Agreement (Santarus Inc)

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented following a technical and cost review by Patheon and are subject to Client and Patheon reaching agreement on Price changes required because of the amendmentamendment through good faith negotiations. Amendments to the Specifications required by the FDA or any other Regulatory Authority will be implemented by Patheon, and the parties will subsequently negotiate any change in the Price that is required because of such amendments. 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 relating to a proposed Specifications change, the proposed change in the Specifications will be implemented, 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 reasonable costs incurred by Patheon for the purchase and handling of the Inventory), 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.

Appears in 2 contracts

Sources: Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc), Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc)

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 on Price changes required because of as to revisions, if any, to the Fees specified in Schedules B or C necessitated by any such amendment. Amendments to If 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 fee change, the proposed change in the Specifications will shall be implemented, and the Price fee change will shall become effective, effective only for with respect to those orders of Products Drug Product that are manufactured under in accordance with the revised Specifications. In addition, the Client agrees to purchase, at Patheon’s cost therefor (including all costs incurred by Patheon for in connection with the purchase and handling of the such Inventory), all Inventory used utilized under the “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under in accordance with Section 5.25.3, if to the extent that such 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 with suppliers in order to fill Firm Orders or under in accordance with Section 5.2 will 5.3 shall be cancelled where possible, and if the where such orders may are not be cancelled subject to cancellation without penalty, will 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.

Appears in 2 contracts

Sources: Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented following a technical and cost review by Patheon and are subject to Client and Patheon reaching agreement on Price changes required because of the amendment. Amendments to the Specifications, the Quality Agreement, 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 will be implemented, 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 Patheon’s 's cost (including all costs incurred by Patheon for the purchase and handling of the Inventory), 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 If the orders may not be cancelled without penalty, will be assigned to and satisfied by Client.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Egalet Corp)

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented following a technical and cost review by Patheon and are subject to Client and Patheon reaching agreement on Price changes required because of the amendment. Amendments to the Specifications, the Quality Agreement, Agreement or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Client, the such approval not to be unreasonably withheld. If Client accepts a proposed Price change, the proposed change in the Specifications will be implemented, 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 's cost therefor (including all costs incurred by Patheon for in connection with the purchase and handling of the such Inventory), all Inventory used utilized 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 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 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.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Acorda Therapeutics Inc)

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by Client Customer will only be implemented following a technical and cost review by Patheon and are subject to Client Customer and Patheon reaching agreement on Price changes required because of as to revisions, if any, to the Prices specified in Schedules B or C necessitated by any such amendment. Amendments to the Specifications, Specifications or the Quality Agreement, or the Manufacturing Site requested Agreement by Patheon will only be implemented following the written approval of ClientCustomer, the such approval not to be unreasonably withheld. If Client Customer accepts a proposed Price change, the proposed change in the Specifications will shall be implemented, and the Price change will shall become effective, effective only for with respect to those orders of Products that are manufactured under in accordance with the revised Specifications. In addition, Client Customer agrees to purchase, at Patheon’s 's external cost (including all costs incurred by Patheon for the purchase and handling of the Inventory)therefore, all Inventory used utilized 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 such 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 with suppliers in order to fill Firm Orders or under in accordance with Section 5.2 will shall be cancelled where possible, and if the where such orders may are not be cancelled subject to cancellation without penalty, will shall be assigned to and satisfied by ClientCustomer.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Gentium S.p.A.)

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by Client PGx will only be implemented following a technical and cost review by Patheon and are subject to Client PGx 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 withheldPGx. If Client PGx accepts a proposed Price change, the proposed change in the Specifications will be implemented, and the Price change will become effective, only for those orders of Products that are manufactured under the revised Specifications. In addition, Client PGx agrees to purchase, at Patheon’s cost (including all costs incurred by Patheon for the purchase and handling of the Inventory), 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 ClientPGx.

Appears in 1 contract

Sources: Commercial Manufacturing Services Agreement (Clinical Data Inc)

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented following a technical and cost review by Patheon 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 will be implemented, 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 Patheon’s cost (including all costs incurred by Patheon for the purchase and handling of the Inventory), 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 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 possible5.2, and if the orders may not be cancelled without penalty, will be assigned to and satisfied by Client.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Orexigen Therapeutics, Inc.)

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented following a technical and cost review by Patheon 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 will be implemented, 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 Patheon’s cost (limited to reasonable, documented, direct out-of-pocket costs for Components consumed in such batch, including all costs incurred by Patheon for the purchase and handling of the Inventory), 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 [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. 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. Patheon shall use commercially reasonable efforts to cancel such orders. Amendments to the Specifications, the Quality Agreement or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Client, such approval not to be unreasonably withheld.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Chelsea Therapeutics International, Ltd.)

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented following a technical and cost review by Patheon and are subject to Client and Patheon reaching agreement on Price changes changes, if any, required because of the requested 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. The Client will not be deemed to have unreasonably withheld consent if approval of the changes requested by Patheon will increase the Price or result in delays in the delivery of the Products. If Client accepts a proposed Price change, the proposed change in the Specifications will be implemented, and the Price change will become effective, only for those orders of Products that are manufactured under the revised Specifications. In addition, if the amendment to the Specifications has been requested by Client, Client agrees to purchase, at Patheon’s 's cost (including all costs incurred by Patheon for the purchase and handling of the Inventory), 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 to the extent (i) the Inventory can no longer be used under the revised Specifications, (ii) cannot be utilized by Patheon on behalf of another client, or (iii) cannot be returned to the supplier for a credit or refund. Open purchase orders for Components unique to the Manufacture of the Products and 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 cannot be cancelled without penalty, will be assigned to and satisfied by Client.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Pozen Inc /Nc)

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented following a technical and cost review by 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 will be implementedimplemented 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 Patheon’s 's cost (including all costs incurred by Patheon for the purchase and handling of the Inventory), 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. If an amendment to the Specifications or the Quality Agreement becomes necessary as the result of changes to a compendia, the Parties will discuss the necessary changes and Client will be solely responsible for the costs associated with these changes.

Appears in 1 contract

Sources: Master Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co)

Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by Client Penwest will only be implemented following a technical and cost review by Patheon and are subject to Client Penwest 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 withheldPenwest. If Client Penwest accepts a proposed Price change, the proposed change in the Specifications will be implemented, and the Price change will become effective, only for those orders of Products that are manufactured under the revised Specifications. In addition, Client Penwest agrees to purchase, at Patheon’s cost (including all costs incurred by Patheon for the purchase and handling of the Inventory), all Inventory used under the “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 5.2Orders, 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 ClientPenwest. Patheon agrees to use commercially reasonable efforts to minimize Penwest’s costs under this Section 4.4.

Appears in 1 contract

Sources: Manufacturing Services Agreement (Penwest Pharmaceuticals Co)