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, 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 only for those orders of Products that are manufactured under the revised Specifications. In addition, 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 under Section 5.2, if the 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 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
Samples: Manufacturing Services Agreement (Acorda 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 Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Client, such 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 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 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 under Section 5.2, if the Inventory can no longer be utilized 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.
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Samples: 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, 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 (limited to reasonable, documented, direct out-of-pocket costs for Components consumed in such batch, 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 under Section 5.2, if the Inventory can no longer be utilized used under the revised Specifications. Open purchase orders for [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. Standard Form 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.
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Samples: Manufacturing Services Agreement (Chelsea Therapeutics International, Ltd.)
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 requested by Patheon will only be implemented following the written approval of Client, such 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 effective, only for those orders of Products that are manufactured under the revised Specifications. In addition, Client Penwest agrees to purchase, at Patheon's ’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 under Section 5.2Orders, if the 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 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
Samples: Manufacturing Services Agreement (Penwest Pharmaceuticals Co)
Adjustments Due to Technical Changes. Amendments to the Specifications Specifications, the Quality Agreement, or the Quality Agreement Product manufacturing process, requested by Client either Party, will only be implemented following a technical and cost review by Patheon and are subject to Client MDCO and Patheon reaching Patheon’s approval. Once agreement on Price changes required because of is reached between the Parties as to revisions, the proposed charges, if any, will be implemented to the Prices specified in Schedules B or C necessitated by any such 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, such Such approval not to be unreasonably withheld. If Client MDCO accepts a proposed Price change, the proposed change in the Specifications will Specifications, the Quality Agreement or the Product manufacturing process shall be implemented, and the Price change will shall become effective only for with respect to those orders of Products that are manufactured under in accordance with the revised Specifications, the Quality Agreement or Product manufacturing process. In addition, Client MDCO agrees to purchase, at Patheon's ’s cost therefor therefore (including all costs incurred by Patheon in connection with the purchase and handling of such Inventory), all Inventory utilized under the "“old" ” Specifications or Quality Agreement 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 utilized under the revised SpecificationsSpecifications or Quality Agreement. Open purchase orders for Components no longer required under any revised Specifications or Quality Agreement 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 ClientMDCO.
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Samples: Manufacturing Services Agreement (Medicines Co /De)
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 requested by Patheon will only be implemented following the written approval of Client, such 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 effective, only for those orders of Products that are manufactured under the revised Specifications. In addition, Client PGx agrees to purchase, at Patheon's ’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 under Section 5.2, if the 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 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
Samples: 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, such 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 effective, only for those orders of Products that are manufactured under the revised Specifications. In addition, 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 under Section 5.2, if the 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 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