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.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc), Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc)
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 a technical and cost review [ * ] necessitated 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 amendmentsamendment. Amendments to the Specifications, the Quality Agreement, Agreement or the Manufacturing Site requested by Patheon that are not Required Manufacturing Changes ("Patheon Requested Changes") will only be implemented following the written approval of Client, [ * ], and the approval not to costs of the Patheon Requested Changes will be unreasonably withheldborne by [ * ]. If the Client accepts a proposed Price change relating to a proposed Specifications 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 the Product that are manufactured under in accordance with the revised Specifications. In addition, Client with respect to the [ * ] Requested Changes, the [ * ] agrees to purchase, at Patheon’s cost [ * ] (including all reasonable costs incurred by Patheon for [ * ] in connection with the purchase and handling of the Inventorysuch [ * ]), 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 Inventory extent that such [ * ] can no longer be used [ * ] 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 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 Client[ * ].
Appears in 2 contracts
Samples: Manufacturing Services and Supply Agreement (Jazz Pharmaceuticals Inc), Manufacturing Services and Supply Agreement (Jazz Pharmaceuticals Inc)
Adjustments Due to Technical Changes. Amendments to the Specifications or Specifications, to any manufacturing/packaging requirements (including the analytical methods) and/or to the Quality Agreement requested by Client will only be implemented following a technical and cost review by Patheon review, and are subject to Client and Patheon reaching agreement on Price changes required because of the amendment through amendment. The parties shall use good faith negotiations. Amendments efforts to the Specifications required by the FDA agree upon any such increase or any other Regulatory Authority will be implemented by Patheon, and the parties will subsequently negotiate any change decrease in the Price that is required because and the date for implementation of any such amendmentsamendment. Amendments to the Specifications, to any manufacturing/packaging requirements, the Quality Agreement, or and/or to the Manufacturing Site requested by Patheon will Patheon, shall only be implemented implemented: (i) following the written approval of Client, the approval not to be unreasonably withheld; and (ii) utilizing appropriate change control procedures as identified in the Quality Agreement. If Client accepts a proposed Price change relating (i.e. in respect of an amendment implemented pursuant to a proposed Specifications changethis Section 2.3, requested by Client), 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 Product Products that are manufactured manufactured/packaged under the revised Specifications. In addition, in respect of Inventory or Components subject to an amendment requested by Client, (a) 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 5.21(d) of Schedule D, if provided that the Inventory can no longer be used under the revised Specifications. Open , or used by Patheon in the manufacture of product for Patheon’s other customers; and (b) 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 1(d) of Schedule D 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
Samples: Manufacturing Services Agreement, Manufacturing Services Agreement (Aptevo 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 that Patheon will perform at Client’s cost, and are subject to Client and Patheon reaching agreement on any 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 amendmentsamendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Client. Upon receiving notice of a request by Client for any such amendments, Patheon will promptly advise Client in writing of any scheduling adjustments, any cost increases or decreases or other changes that may result from the approval not change, and (a) will use its best efforts to be unreasonably withheldmake any change identified in the Client request that is in response to a regulatory or safety issue pertaining to the Product, and (b) will use commercially reasonable efforts to implement any other change identified in a Client request by the date requested by Client, or as soon thereafter as it is commercially reasonable. 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 Products that are manufactured under the revised Specifications. In addition, Client agrees to purchase, at Patheon’s 's actual 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 but only to the extent 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 will, at Client’s sole discretion, be assigned to and satisfied by Client.Client or cancelled by Patheon and Client will reimburse Patheon for any penalty it incurs due to the cancellation. ***Confidential Treatment Requested Master Manufacturing Services Agreement
Appears in 1 contract
Adjustments Due to Technical Changes. Amendments to the Specifications or for a given Drug Product, the Quality Agreement relating to Processing or the minimum order quantities for each Drug Product requested by Client Gilead will only be implemented following a technical and cost review by Patheon and are subject to Client Gilead and Patheon reaching agreement on Price changes required because as to revisions, if any, to the fees specified in Exhibit C of the amendment through good faith negotiations. Amendments to the Specifications required corresponding Product-Specific Appendix or otherwise necessitated 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 withheldamendment. If Client Gilead accepts a proposed Price change relating to a proposed Specifications fee change, the proposed change in the Specifications will Specifications, Quality Agreement or minimum order quantities shall be implemented, and the Price fee change will shall become effective, effective only for with respect to those orders of such Drug Product that are manufactured under Processed in accordance with such revision(s). The Parties acknowledge in Sections 2.2, 2.6 and 2.8 the potential need to refine or modify the Specifications, Quality Agreement or minimum order quantities for Drug Products, respectively. Accordingly, the Parties will negotiate in good faith to modify the applicable Specifications, Quality Agreement or minimum order quantities from time to time if requested by Gilead. Patheon will facilitate appropriate changes to the Exhibits, and shall implement any changes to the Specifications and/or Quality Agreement that are required by applicable legal requirements; provided that Gilead bears the costs of such changes to the extent relating solely to the Drug Product(s) or the Parties reach written agreement as to a different allocation of such increased costs. The Parties agree to allocate on an equitable basis any special costs of developing and implementing revised Specificationsprocedures, meaning that the cost of implementing any revised procedures shall be borne in full by Gilead in such cases where the changes are made solely for the benefit of Gilead, and the costs of other changes shall be allocated between the Parties on the basis of the extent to which such Party will be benefited by such change relative to the extent to which the other Party will be benefited by such change. In additionany event, Client Gilead agrees to purchase, at Patheon’s cost (including all reasonable costs incurred by Patheon for the purchase and handling of the Inventory)cost, all Inventory used for the relevant Drug Product utilized under any of the “old” Specifications and/or Quality Agreement and purchased or maintained by Patheon in order to fill Firm Orders for such Drug Product or under in accordance with Section 5.22.5, if to the extent that such Inventory can no longer be used utilized under the revised SpecificationsSpecifications and/or Quality Agreement. Open purchase orders for Components Materials no longer required under any such revised Specifications and/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 2.5 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 ClientGilead.
Appears in 1 contract
Samples: Master Clinical and Commercial Supply Agreement (Gilead Sciences 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 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 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 amendmentsamendment. 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 implementedimplemented at Client's cost, and the Price change will become effective, only for those orders of Product Products that are manufactured under the revised Specifications. In addition, Client agrees to purchase, at Patheon’s '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. 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
Samples: Product Agreement (Horizon Therapeutics Public LTD Co)
Adjustments Due to Technical Changes. Amendments Patheon shall implement Client’s written amendments to the Specifications or and/or the Quality Agreement requested by Client will only Agreement(s), provided that the fees specified in Schedules B or C shall 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 revised as mutually agreed by the FDA Parties in writing to reflect the increase or decrease in Patheon’s costs necessitated by 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 amendmentsamendment. Amendments to the Specifications, the Quality Agreement, Agreement(s) or the Manufacturing Site or the Secondary Manufacturing Site requested by Patheon will only be implemented following the written approval of Client, the approval not which shall be in Client’s sole discretion. Fee changes made pursuant to be unreasonably withheld. If Client accepts a proposed Price change relating this Section 5.4 shall become effective only with respect 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 Products that are manufactured under in accordance with the revised Specifications. In addition, subject to Section 3.7(c), the Client agrees to purchase, at Patheon’s cost (including all reasonable out-of-pocket costs incurred by Patheon for the purchase and handling of the Inventory)therefor, all Inventory used 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 under and in accordance with Section 5.23.7(b), if to the extent that such Inventory can no longer be used under utilized 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 under and in accordance with Section 5.2 will 3.7(b) shall be promptly cancelled where possible, and if the . Where such orders may are not be cancelled subject to cancellation without penalty, will be assigned Patheon shall promptly provide Client notice of such orders and the amount of such penalty and, at Clients option, Client shall reimburse Patheon the amount of such penalty or, subject to Section 3.7(c), purchase such Components from Patheon. [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and satisfied by Clienthave 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 Client Éclat will only be implemented following a technical and cost review by Patheon and are subject to Client Éclat and Patheon reaching agreement on Price changes required because of as to revisions, if any, to the amendment through good faith negotiationsPrices specified in Schedules B or C to a Product Agreement necessitated by any such amendment. 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 Agreement requested by Patheon will only be implemented following the written approval of ClientÉclat, the such approval not to be unreasonably withheld. If Client Éclat accepts a proposed Price change relating to a proposed Specifications 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 Product Products that are manufactured under in accordance with the revised Specifications. In addition, Client Xxxxx agrees to purchase, at Patheon’s cost therefor (including all reasonable 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 5.2, 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 ClientÉclat.
Appears in 1 contract
Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by Client Supernus will only be implemented following a technical and good faith cost review by Patheon Supplier and are subject to Client Supernus and Patheon Supplier 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 amendmentsamendment. Amendments to the Specifications, the Quality Agreement, Agreement or the Manufacturing Site Facility requested by Patheon Supplier will only be implemented following the written approval of ClientSupernus, the approval not to be unreasonably withheld. If Client Supernus 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 Products that are manufactured under the revised Specifications. In addition, Client Supernus agrees to purchase, at PatheonSupplier’s cost (including all reasonable costs incurred by Patheon Supplier for the purchase and handling of the Inventory), (i) all Inventory of Materials used under the “old” Specifications and purchased or maintained by Supplier in order to fill firm Purchase Orders or under Section 6.3, if such Inventory can no longer be used under the revised Specifications, and (ii) all other Inventory used under the “old” Specifications and purchased or maintained by Patheon Supplier in order to fill Firm Orders Commitments or under Section 5.26.3, if the such Inventory can no longer neither be used under the revised Specifications nor, within four (4) months of implementation of the proposed change in the Specifications, in any third party products manufactured by Supplier (whether the reason such Inventory cannot be used in third party products within said timeline is that the Inventory is not suitable for such products or has expired). Open purchase orders for Components Materials no longer required under any revised Specifications that were placed by Patheon Supplier with suppliers in order to fill Firm Orders Commitments or under Section 5.2 6.3 will be cancelled where possible, and if the orders may not be cancelled without penalty, will be assigned to and satisfied by ClientSupernus.
Appears in 1 contract
Samples: Commercial Supply Agreement (Supernus Pharmaceuticals Inc)
Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by an Authority or by Client (including, without limitation, amendments requested during or resulting from the completion of the Services performed by Patheon pursuant to the Clinical Trial Agreement) will only be implemented following a technical and cost review by Patheon and are subject to Client and Patheon reaching written agreement on changes to the Product Price, Stability Price changes and/or Validation Price (as appropriate) 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 amendmentsamendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon (including, without limitation, amendments requested during or resulting from the completion of the Services performed by Patheon pursuant to the Clinical Trial Agreement) will only be implemented following the written approval of Client, the approval not to be unreasonably withheld. Client may reasonably withhold approval due to adverse changes in any price or inventory obsolescence. If Client accepts a proposed Price change relating to a proposed Specifications change, the proposed change in the Specifications Specifications, Quality Agreement or Manufacturing Site, as applicable, the associated change in Product Price (if any) will be implemented, and the Product Price change will become effective, only for those orders of Product Products that are manufactured under the revised Specifications. In addition, if the changes to the Specifications or Quality Agreement are requested by Client, Client agrees to purchase, at Patheon’s 's cost (including all reasonable costs incurred by Patheon for the purchase and handling of the Inventory)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. But the work-in-process portion of Inventory will not exceed the quantities provided for in the first 90 days of Client’s then current forecast. 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. Patheon will use reasonable efforts to use the Inventory with other clients or otherwise minimize the obsolescence costs.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Acura 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 NPI and CUSTOMER, and are subject to Client CUSTOMER and Patheon NPI reaching agreement on Price changes required because of the amendment through good faith negotiations. Amendments as to any applicable revisions, up or down, to the Specifications required Prices specified in Schedules B or C that are necessitated 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 amendmentsamendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site manufacturing site requested by Patheon CUSTOMER will only be implemented unless NPI notifies CUSTOMER that NPI cannot implement such changes due to pre-existing commitments to Third Parties, facilities or personnel limitations, Applicable Laws, government orders or regulations, or similar commitments, limitations or restrictions. Amendments to the Specifications, the Quality Agreement, or the manufacturing site requested by NPI will be implemented only following the written approval of ClientCUSTOMER, the such approval not to be unreasonably withheld. If Client CUSTOMER accepts a proposed Price change relating to a proposed Specifications change, the such proposed change in the Specifications will be implemented, and the Price change will become effective, effective only for those orders of Product Products that are manufactured under the revised Specifications. In addition, Client CUSTOMER agrees to purchasepurchase all Inventory (at the actual cost incurred by NPI, at Patheon’s cost (including all reasonable costs incurred by Patheon for in connection with the purchase and handling of the Inventory), all Inventory used ) utilized under the “old” Specifications and purchased or maintained by Patheon NPI in order to fill Firm Orders or under in accordance with 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 NPI 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 ClientCUSTOMER. For avoidance of doubt, the cost of any changes to the manufacturing site that are required for NPI to remain compliant with regulations that are generally applicable to manufacturers of pharmaceutical products shall not be passed through to CUSTOMER. * Confidential material redacted and filed separately with the Commission.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Keryx Biopharmaceuticals 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 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 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 amendmentsamendment. 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 implementedimplemented at Client’s cost, and the Price change will become effective, only for those orders of Product Products 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.. 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. ***Confidential Treatment Requested Master Manufacturing Services Agreement
Appears in 1 contract
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 Client either party will only be implemented following a technical and cost review by Patheon and are subject to Client Depomed and Patheon reaching agreement on Price Production Fees changes required because of the amendment through good faith negotiationsamendment. 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 any change of the Manufacturing Site Patheon Facility (including without limitation the location thereof) requested by Patheon will only be implemented following the written approval of ClientDepomed, the such approval not to be unreasonably withheld. Any change in the manufacturing process by Patheon (such as changes in Materials testing, quality controls, equipment, facilities, or manufacture and/or packaging methods) shall be subject to Depomed’s prior written approval. If Client Depomed accepts a proposed Price change relating to a proposed Specifications Production Fees change, the proposed change in the Specifications will be implemented, and the Price Production Fees change will become effective, effective only for those orders of Product that are manufactured under the revised Specifications. In addition, Client Depomed agrees to purchase, at Patheon’s cost (including all reasonable costs incurred by Patheon for the purchase and handling of the Inventory), all Inventory 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 under Section 5.2, 3.4 if the Inventory can no longer be 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 under Section 5.2 3.4 will be cancelled where possible, and if the orders may not be cancelled without penalty, will be assigned to and satisfied by ClientDepomed.
Appears in 1 contract
Samples: Commercial Manufacturing Services Agreement (Depomed 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 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 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 amendmentsamendment. 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 implementedimplemented at Client’s cost, and the Price change will become effective, only for those orders of Product Products 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.. 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. *** Confidential Treatment Requested Master Manufacturing Services Agreement
Appears in 1 contract
Adjustments Due to Technical Changes. Amendments to the Specifications or the Quality Agreement requested by Client Avanir will only be implemented following a technical and cost review by Patheon and are subject to Client Avanir and Patheon reaching agreement on Price changes required because of the amendment through good faith negotiations. Amendments as to revisions, if any, to the Specifications required fees specified in Schedules B or C necessitated 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 amendmentsamendment. Amendments to the Specifications, the Quality Agreement, Agreement or the Manufacturing Site requested by Patheon will only be implemented following the written approval of ClientAvanir, the such approval not to be unreasonably withheld. If Client Avanir accepts a proposed Price change relating to a proposed Specifications 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 Product Products that are manufactured under in accordance with the revised Specifications. In addition, Client Avanir agrees to purchase, at Patheon’s cost therefor (including all reasonable 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 5.2, if to the extent that such Inventory can no longer be used utilized under the revised Specifications. Open purchase orders for Components and Packaging Materials no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders Orders, or under in accordance with Section 5.2 will shall be cancelled by Patheon, where possible. Patheon shall also use commercially reasonable efforts to return, where possible, Components and if Packaging Materials utilized under the orders may not “old” Specifications and purchased by Patheon in order to fill Firm Orders or in accordance with Section 5.2. Where the cancellation of an open purchase order or the return of Components or Packaging Materials is subject to a cancellation penalty or restocking charge, Patheon shall initially pay such cancellation penalty or restocking charge and be cancelled without penalty, will be assigned to and satisfied reimbursed for such costs by ClientAvanir.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Avanir Pharmaceuticals)
Adjustments Due to Technical Changes. Amendments Material 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 (if any) 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 amendmentsamendment. 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. Upon receiving notice of a request by Client for any such amendments, Patheon shall promptly advise Client in writing of any scheduling adjustments, any cost increases or decreases or other changes that may result from such change, and (a) will use its best efforts to make any change identified in such Client request that is in response to a regulatory or safety issue pertaining to the approval not Product, and (b) will use commercially reasonable efforts to be unreasonably withheldimplement any other change identified in a Client request by the date requested by Client, or as soon thereafter as it is commercially reasonable. If Client accepts a proposed Price change relating (if any) in response to a such Client-proposed Specifications changematerial amendment, the proposed change in the Specifications or the Quality Agreement will be implemented, and the Price change (if any) will become effective, only for those orders of Product Products that are manufactured under the revised SpecificationsSpecifications or revised Quality Agreement. In addition, Client agrees to purchase, at Patheon’s actual 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 and necessary in order to fill Firm Orders or under Section 5.2, if solely to the extent the Inventory can no longer be used under the revised SpecificationsSpecifications or be returned to the vendor for a refund or credit. Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers and necessary 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 be, at Client’s sole discretion, either (i) assigned to and satisfied by Client., or (ii) cancelled by Patheon, and Client will reimburse Patheon for the penalty it incurs as a result of such cancellation. *** Confidential Treatment Requested
Appears in 1 contract
Samples: Manufacturing Services Agreement (Optimer 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 changes, if any, 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 amendmentsrequested 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 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 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 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 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. [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
Appears in 1 contract
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 any 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 amendmentsamendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Client. Upon receiving notice of a request by Client for any such amendments, Patheon will promptly advise Client in writing of any scheduling adjustments, any cost increases or decreases or other changes that may result from the approval not change, and (a) will use its best efforts to be unreasonably withheldmake any change identified in the Client request that is in response to a regulatory or safety issue pertaining to the Product, and (b) will use commercially reasonable efforts to implement any other change identified in a Client request by the date requested by Client, or as soon thereafter as it is commercially reasonable. 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 Products that are manufactured under the revised Specifications. In addition, Client agrees to purchase, at Patheon’s 's actual 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 but only to the Master Manufacturing Services Agreement extent 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 will, at Client’s sole discretion, be assigned to and satisfied by ClientClient or cancelled by Patheon and Client will reimburse Patheon for any penalty it incurs due to the cancellation.
Appears in 1 contract
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 any 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 amendmentsamendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Client. Upon receiving notice of a request by Client for any such amendments, Patheon will promptly advise Client in writing of any scheduling adjustments, any cost increases or decreases or other changes that may result from the approval not change, and (a) will use its best efforts to be unreasonably withheldmake any change identified in the Client request that is in response to a regulatory or safety issue pertaining to the Product, and (b) will use commercially reasonable efforts to implement any other change identified in a Client request by the date requested by Client, or as soon thereafter as it is commercially reasonable. 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 Products that are manufactured under the revised Specifications. In addition, Client agrees to purchase, at Patheon’s actual 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 but only to the ***Confidential Treatment Requested Master Manufacturing Services Agreement extent 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 will, at Client’s sole discretion, be assigned to and satisfied by ClientClient or cancelled by Patheon and Client will reimburse Patheon for any penalty it incurs due to the cancellation.
Appears in 1 contract