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, 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 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 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 5.2, 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 5.2 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.

Appears in 2 contracts

Samples: Manufacturing Services Agreement (Critical Therapeutics Inc), Manufacturing Services Agreement (Critical Therapeutics Inc)

AutoNDA by SimpleDocs

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 Products 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 ’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 5.25.3, 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 5.2 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 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.

Appears in 2 contracts

Samples: 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 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 Products Drug Product 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 5.25.3, 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 5.2 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 and, at Client's option, Client shall take possession of . [***]: Certain information on this page has been omitted and filed separately with the material in any such ordersCommission. At Client's expense, Patheon shall deliver such Components Confidential treatment has been requested with respect to a destination provided by Clientthe omitted portions.

Appears in 2 contracts

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

Adjustments Due to Technical Changes. Amendments Patheon shall implement Client’s written amendments to the Specifications or and/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 amendmentAgreement(s), 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 provided that the fees specified in Schedules B or C shall be revised as mutually agreed by the Parties in writing to reflect the increase or decrease in Patheon’s costs necessitated by any such amendment. If Amendments to the Client accepts a proposed fee changeSpecifications, the proposed change in Quality Agreement(s) or the Specifications Manufacturing Site or the Secondary Manufacturing Site requested by Patheon will only be implemented following the written approval of Client, which shall be implemented, and the fee change in Client’s sole discretion. Fee changes made pursuant to this Section 5.4 shall become effective only with respect to those orders of Products that are manufactured in accordance with the revised Specifications. In addition, subject to Section 3.7(c), the Client agrees to purchase, at Patheon's cost therefor (including all ’s out-of-pocket costs incurred by Patheon in connection with the purchase and handling of such Inventory)therefor, all Inventory utilized under the "old" Specifications and purchased or and maintained by Patheon in accordance with this Agreement and the Specifications, in order to fill Firm Orders or and in accordance with Section 5.23.7(b), to the extent that such Inventory can no longer be utilized under due to the revised revisions in the 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 and in accordance with Section 5.2 3.7(b) shall be promptly cancelled where possible, and where . Where such orders are not subject to cancellation without penalty, Patheon shall be assigned to promptly provide Client notice of such orders and satisfied by the Client amount of such penalty and, at Client's Clients option, Client shall take possession reimburse Patheon the amount of the material in any such orders. At Client's expensepenalty or, Patheon shall deliver subject to Section 3.7(c), purchase such Components to a destination provided by Clientfrom Patheon. [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Transcept Pharmaceuticals Inc)

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 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 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 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 5.2, 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 5.2 shall be cancelled or used in connection with other Patheon services where possible, and where such orders are not subject to cancellation without penalty, shall penalty or cannot be assigned to and satisfied by the Client and, at Client's optionused in connection with other Patheon services, Client shall take possession of the material in any such orders. At Client's expense, pay to Patheon shall deliver such Components to a destination provided by Client****.

Appears in 1 contract

Samples: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)

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), Éclat will only be implemented following a technical and cost review by Patheon and are subject to the Client Éclat and Patheon reaching agreement as to revisions, if any, to the fees Prices specified in Schedules B or C to a Product Agreement necessitated by any such amendment. Amendments to the Specifications and the Quality Agreement requested by Patheon will only be implemented following the approval of Éclat, such approval not to be unreasonably withheld. If the Client Éclat 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 Products that are manufactured in accordance with the revised Specifications. In addition, the Client Xxxxx 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 5.2, 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 5.2 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 ClientÉclat.

Appears in 1 contract

Samples: Product Agreement (Avadel Pharmaceuticals PLC)

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 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 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 5.2, 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 5.2 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.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Somaxon Pharmaceuticals, Inc.)

AutoNDA by SimpleDocs

Adjustments Due to Technical Changes. Amendments to the Specifications Specifications, the Quality Agreement, or the Quality Agreement Product manufacturing process, 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)either Party, will only be implemented following a technical and cost review by Patheon and are subject to MDCO and Patheon’s approval. Once agreement is reached between the Client and Patheon reaching agreement Parties as to revisions, the proposed charges, if any, will be implemented to the fees Prices specified in Schedules B or C necessitated by any such amendment. Such approval not to be unreasonably withheld. If the Client MDCO accepts a proposed fee Price change, the proposed change in the Specifications Specifications, the Quality Agreement or the Product manufacturing process shall be implemented, and the fee Price change shall become effective only with respect to those orders of Products that are manufactured in accordance with the revised Specifications, the Quality Agreement or Product manufacturing process. In addition, the 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 in accordance with Section 5.2, 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 in accordance with Section 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 ClientMDCO.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Medicines Co /De)

Adjustments Due to Technical Changes. Depomed will inform Patheon in writing of any changes required to the Specifications. 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), either party will only be implemented following a technical and cost review by Patheon and are subject to the Client Depomed and Patheon reaching agreement as to revisions, if any, on Production Fees changes required because of the amendment. Amendments to the fees specified Specifications or Quality Agreement, or any change of the Patheon Facility (including without limitation the location thereof) requested by Patheon will only be implemented following the written approval of Depomed, such approval not to be unreasonably withheld. Any change in Schedules B the manufacturing process by Patheon (such as changes in Materials testing, quality controls, equipment, facilities, or C necessitated by any such amendmentmanufacture and/or packaging methods) shall be subject to Depomed’s prior written approval. If the Client Depomed accepts a proposed fee Production Fees change, the proposed change in the Specifications shall will be implemented, and the fee Production Fees change shall will become effective only with respect to for those orders of Products that are Product manufactured in accordance with under the revised Specifications. In addition, the Client Depomed 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 to be used for manufacturing Product under the "old" formerly applicable Specifications and purchased or maintained by Patheon in order to fill Firm Purchase Orders or in accordance with under Section 5.2, to 3.4 if the extent that such Inventory can no longer be utilized used under the revised SpecificationsSpecification. Open purchase orders for Components Materials no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Purchase Orders or in accordance with under Section 5.2 shall 3.4 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 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 ClientDepomed.

Appears in 1 contract

Samples: Commercial Manufacturing Services Agreement (Depomed Inc)

Adjustments Due to Technical Changes. Amendments to the Specifications Sepracor's Technical Information or the any 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), 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 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 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 5.25.3, 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 5.2 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 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 ClientSepracor.

Appears in 1 contract

Samples: Quality Agreement (Sepracor Inc /De/)

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 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 Products 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)’s 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 5.2, 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 5.2 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, Client. Any amendments or additions to cGMPs or to applicable laws which necessitate: (a) resulting changes to Product Specification or Manufacturing Requirements shall be conducted at Client's option, Client shall take possession the expense of the material in any such orders. At Client's expense, Patheon ; and (b) resulting changes to the Facility shall deliver such Components to a destination provided be borne by ClientPatheon.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Axcan Intermediate Holdings Inc.)

Time is Money Join Law Insider Premium to draft better contracts faster.