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 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 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.
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 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.
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. […***…] 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 the Components cannot be used by other Patheon customers.
Adjustments Due to Technical Changes. In the event that there are changes in laws or regulations, cGMPs, the Specifications or the Quality Agreement in a manner that increases or decreases, in the aggregate, the manufacturing cost on a per lot basis by more than [***] of the per unit price to DEPOMED, the entire corresponding change on a per unit price to DEPOMED shall be made to the Production Fees set forth in Schedule B, any other relevant document and the related schedules shall be revised. Any changes subject to this Section 5.5 shall be implemented after a technical review and prior approval by the Parties.
Adjustments Due to Technical Changes. 12 4.5 MULTI-COUNTRY MANUFACTURING AND PACKAGING REQUIREMENTS. ........ 12 ARTICLE 5.................................................................. 12 ORDERS, DELIVERY, INVOICING, PAYMENT, PRODUCT DEFICIENCIES................. 12 5.1
Adjustments Due to Technical Changes. Amendments to the Manufacturing Requirements requested by Zogenix [***]:
Adjustments Due to Technical Changes. Amendments to the Specifications or the GMP Technical Agreement as requested by SciClone will only be implemented following a technical and cost review by Patheon and are subject to SciClone and Patheon reaching agreement as to such revisions, including the prices specified in Schedule B necessitated by any such amendment. If SciClone and Patheon agree to such revisions including the prices, the proposed change in Specifications shall be implemented, and the price change shall become effective only with respect to those orders of Products that are manufactured in accordance with the revised Specifications. [****]. Should a change in the Specifications or Manufacturing Requirements become necessary in order to allow Patheon to guarantee the performance of the activities in a state of the art way or to comply with new provisions or orders of the Public Authorities, the above provisions of this Section 5.3 shall apply. -------------------- * 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. (a) In the event that New River requests an amendment to the Specifications or the Quality Agreement, Patheon shall conduct a technical and cost review of the proposed amendment. If requested by Patheon, Patheon and New River shall negotiate in good faith an equitable revision to the fees specified in Schedule B or C to reflect changes in costs that would result from such amendment. Any cost increases asserted by Patheon shall be consistent with then-prevailing market standards, and Patheon will provide New River with documentation reasonably sufficient to demonstrate that a fee adjustment is justified, provided that Patheon shall have no obligation to provide any supporting documents to the extent such documents are subject to obligations of confidentiality between Patheon and its suppliers. If the Parties agree on a proposed fee change, the proposed change in the Specifications and/or Quality Agreement 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 and/or revised Quality Agreement. In addition [***], all Inventory utilized under the “old” Specifications and purchased or maintained by Patheon necessary 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 New River.
Adjustments Due to Technical Changes. (a) During any Year of the Term, including the first Year, 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 prices specified in Schedule C necessitated by any such amendment.
