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.
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.
Adjustments Due to Technical Changes. For changes to the Specifications or manufacturing processes that are required by applicable Laws ("Required Manufacturing Changes"), Patheon and the Client shall cooperate in making such changes and use commercially reasonable efforts to implement such changes promptly in a manner that minimizes any effect on the supply hereunder to the Client of Product meeting Specifications. All costs associated with Required Manufacturing Changes directly related to the [ * ] shall be borne by [ * ]. All other costs associated with Required Manufacturing Changes under this Agreement, including, without limitation, obsolete Components, Regulatory Filings, work in process, equipment and Product shall be borne by [ * ]. Amendments to the Specifications or the Quality Agreement requested by the Client that are not Required Manufacturing Changes ("Client Requested Changes") will only be implemented following [ * ] necessitated by any such amendment. Amendments to the Specifications, the Quality Agreement or the Manufacturing Site requested by Patheon that are not Required Manufacturing Changes ("Patheon Requested Changes") will only be implemented following the approval of Client, [ * ], and the costs of the Patheon Requested Changes will be borne by [ * ]. 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 the Product that are manufactured in accordance with the revised Specifications. In addition, with respect to the [ * ] Requested Changes, the [ * ] agrees to purchase, at [ * ] (including all costs incurred by [ * ] in connection with the purchase and handling of such [ * ]), all [ * ] utilized under the [ * ] 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 [ * ] can [ * ] under the revised Specifications. Open purchase orders for [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Components no longer required under any revised Specifications that were placed by Patheon in accordance with this Agreement 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 cancell...
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. Amendments to Cephalon's Technical Information or the Technical Agreement requested by Cephalon will only be implemented following a technical and cost review by Patheon and are subject to Cephalon and Patheon reaching agreement as to revisions, if any, to the fees specified in Schedules A or B necessitated by any such amendment. If Cephalon accepts a proposed fee change, the proposed change in Cephalon'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 Cephalon's Technical Information. In addition, Cephalon agrees to purchase, at Patheon's cost, all Inventory utilized under the "old" 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 Cephalon's Technical Information. Open purchase orders for Components no longer required under any revised 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 Cephalon.
Adjustments Due to Technical Changes. Amendments to the Manufacturing Requirements requested by Zogenix [***]:
Adjustments Due to Technical Changes. 12 4.5 MULTI-COUNTRY MANUFACTURING AND PACKAGING REQUIREMENTS. ........ 12 ARTICLE 5.................................................................. 12
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. Amendments to the Manufacturing Requirements requested by Zogenix will only be implemented following a technical and cost review by both Parties and are subject to Zogenix and Patheon reaching agreement as to:
Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by Somaxon will only be implemented following a technical and cost review by Mylan and are subject to Somaxon and Mylan reaching agreement as to revisions, if any, to the fees specified in Schedule C necessitated by any such amendment. If Somaxon accepts a proposed fee change based on such a requested amendment, the fee change shall become effective only with respect to those orders of Products that are manufactured in accordance with the amended Specifications or Quality Agreement.
