Common use of Adjustments Due to Technical Changes Clause in Contracts

Adjustments Due to Technical Changes. Amendments to the 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, and are subject to Client and Patheon reaching agreement on Price changes required because of the amendment. The parties shall use good faith efforts to agree upon any such increase or decrease in the Price and the date for implementation of any such amendment. Amendments to the Specifications, to any manufacturing/packaging requirements, the Quality Agreement, and/or to the Manufacturing Site requested by Patheon, shall only be 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 (i.e. in respect of an amendment implemented pursuant to this Section 2.3, requested by Client), the proposed change in the Specifications will be implemented at Client’s cost, and the Price change will become effective, only for those orders of Products that are 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 1(d) of Schedule D, provided that the Inventory can no longer be used under the revised Specifications, 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 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.

Adjustments Due to Technical Changes. Amendments to the Specifications, to any manufacturing/packaging requirements (including the analytical methods) and/or to Specifications or the Quality Agreement requested by Client will only be implemented following a technical and cost reviewreview 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. The parties shall use good faith efforts to agree upon any such increase or decrease in the Price and the date for implementation of any such amendment. Amendments to the Specifications, to any manufacturing/packaging requirements, the Quality Agreement, and/or to or the Manufacturing Site requested by Patheon, shall Patheon will only be implemented: (i) 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 to be unreasonably withheld; change, and (iia) utilizing appropriate will use its best efforts to make any change control procedures as identified in the Quality AgreementClient 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 (i.e. in respect of an amendment implemented pursuant to this Section 2.3, requested by Client)change, the proposed change in the Specifications will be implemented at Client’s costimplemented, and the Price change will become effective, only for those orders of Products that are manufactured/packaged manufactured 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 '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 1(d) of Schedule D5.2, provided that but only to the extent the Inventory can no longer be used under the revised Specifications, or used by Patheon in the manufacture of product for Patheon’s other customers; and (b) open . 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 1(d) of Schedule D 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.

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, to any manufacturing/packaging requirements (including the analytical methods) and/or to 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, and are subject to Client and Patheon reaching agreement on Price changes required because of the amendment. The parties shall use good faith efforts to agree upon any such increase or decrease in the Price and the date for implementation of [ * ] necessitated by any such amendment. Amendments to the Specifications, to any manufacturing/packaging requirements, the Quality Agreement, and/or to Agreement or the Manufacturing Site requested by Patheon, shall Patheon that are not Required Manufacturing Changes ("Patheon Requested Changes") will only be implemented: (i) implemented following the written approval of Client, [ * ], and the approval not to costs of the Patheon Requested Changes will be unreasonably withheld; and (ii) utilizing appropriate change control procedures as identified in the Quality Agreementborne by [ * ]. If the Client accepts a proposed Price change (i.e. in respect of an amendment implemented pursuant to this Section 2.3, requested by Client)fee change, the proposed change in the Specifications will shall be implemented at Client’s costimplemented, and the Price fee change will shall become effective, effective only for with respect to those orders of Products the Product that are manufactured/packaged under manufactured in accordance with the revised Specifications. In addition, in with respect of Inventory or Components subject to an amendment requested by Clientthe [ * ] Requested Changes, (a) Client 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 1(d) of Schedule D5.2, provided to the extent that the Inventory such [ * ] can no longer be used [ * ] under the revised Specifications, or used by Patheon in the manufacture of product for Patheon’s other customers; and (b) open . 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 1(d) of Schedule D will 5.2 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[ * ].

Adjustments Due to Technical Changes. Amendments (a) During any Year of the Term, including the first Year, amendments to the Specifications, to any manufacturing/packaging requirements (including the analytical methods) and/or to Specifications or the Quality Agreement requested by the Client will only be implemented following a technical and cost review, review by Patheon and are subject to the Client and Patheon reaching agreement on Price changes required because of as to revisions, if any, to the amendment. The parties shall use good faith efforts to agree upon any such increase or decrease prices specified in the Price and the date for implementation of Schedule C necessitated by any such amendment. Amendments to . (b) If the Specifications, to any manufacturing/packaging requirements, the Quality Agreement, and/or to the Manufacturing Site requested by Patheon, shall only be 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 (i.e. in respect of an amendment implemented pursuant to this Section 2.3, requested by Client)price change, the proposed change in the Specifications will shall be implemented at Client’s costimplemented, and the Price price change will shall become effective, effective only for with respect to those orders of Products the Product that are manufactured/packaged under manufactured in accordance with the revised Specifications. In addition, in respect of Inventory or Components subject to an amendment requested by Client, (a) the Client agrees to purchase, at Patheon’s cost therefore (including all reasonable reasonable, out-of-pocket 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 1(d) of Schedule D5.2, provided to the extent that the such Inventory can no longer be used utilized under the revised Specifications, or used by Patheon in the manufacture of product for Patheon’s other customers; and (b) open . 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 1(d) of Schedule D will 5.2 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 the Client. (c) If a change in the Specifications becomes necessary in order to allow Patheon to guarantee the performance of the activities in accordance with new cGMPs or to comply with new provisions of applicable laws or orders of Regulatory Authorities and directly impacts the manufacture of the Product, then the above provisions of this Section 4.3.3 shall apply. (d) In connection with a price adjustment request pursuant to this Section 4.3.3, Patheon shall deliver to the Client a revised Schedule C and such budgetary pricing information or other documentation reasonably sufficient to demonstrate that a fee adjustment is justified.

Adjustments Due to Technical Changes. Amendments to the Specifications, to any manufacturing/packaging requirements (including the analytical methods) and/or to 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, 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. The parties shall use good faith efforts to agree upon any such increase or decrease in the Price and the date for implementation of any such amendment. Amendments to the Specifications, to any manufacturing/packaging requirements, the Quality Agreement, and/or to or the Manufacturing Site requested by PatheonPatheon (including, shall 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: (i) implemented following the written approval of Client, the approval not to be unreasonably withheld; and (ii) utilizing appropriate change control procedures as identified . Client may reasonably withhold approval due to adverse changes in the Quality Agreementany price or inventory obsolescence. If Client accepts a proposed Price change (i.e. in respect of an amendment implemented pursuant to this Section 2.3, requested by Client), 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 at Client’s costimplemented, and the Product Price change will become effective, only for those orders of Products that are manufactured/packaged manufactured under the revised Specifications. In addition, in respect of Inventory if the changes to the Specifications or Components subject to an amendment Quality Agreement are requested by Client, (a) 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 1(d) of Schedule D5.2, provided that if the Inventory can no longer be used under the revised Specifications, or used by Patheon . But the work-in-process portion of Inventory will not exceed the quantities provided for in the manufacture first 90 days of product for PatheonClient’s other customers; and (b) open 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 1(d) of Schedule D 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.

Adjustments Due to Technical Changes. Amendments to the SpecificationsSpecifications for a given Drug Product, to any manufacturing/packaging requirements (including the analytical methods) and/or to 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, 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. The parties shall use good faith efforts to agree upon any such increase corresponding Product-Specific Appendix or decrease in the Price and the date for implementation of otherwise necessitated by any such amendment. Amendments to the Specifications, to any manufacturing/packaging requirements, the Quality Agreement, and/or to the Manufacturing Site requested by Patheon, shall only be 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 Gilead accepts a proposed Price change (i.e. in respect of an amendment implemented pursuant to this Section 2.3, requested by Client)fee change, the proposed change in the Specifications will Specifications, Quality Agreement or minimum order quantities shall be implemented at Client’s costimplemented, and the Price fee change will shall become effective, effective only for with respect to those orders of Products such Drug Product that are manufactured/packaged 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, in respect of Inventory or Components subject to an amendment requested by Client, (a) 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 1(d) of Schedule D2.5, provided to the extent that the such Inventory can no longer be used utilized under the revised Specifications, or used by Patheon in the manufacture of product for Patheon’s other customers; and (b) open Specifications 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 1(d) of Schedule D 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.

Adjustments Due to Technical Changes. Amendments Material amendments to the Specifications, to any manufacturing/packaging requirements (including the analytical methods) and/or to Specifications or the Quality Agreement requested by Client will only be implemented following a technical and cost review, review by Patheon and are subject to Client and Patheon reaching agreement on Price changes (if any) required because of the amendment. The parties shall use good faith efforts to agree upon any such increase or decrease in the Price and the date for implementation of any such amendment. Amendments to the Specifications, to any manufacturing/packaging requirements, the Quality Agreement, and/or to Agreement or the Manufacturing Site requested by Patheon, shall Patheon will only be implemented: (i) implemented following the written approval of Client. Upon receiving notice of a request by Client for any such amendments, the approval not to be unreasonably withheld; 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 (iia) utilizing appropriate will use its best efforts to make any change control procedures as identified in such Client request that is in response to a regulatory or safety issue pertaining to the Quality AgreementProduct, 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 (i.e. if any) in respect of an amendment implemented pursuant response to this Section 2.3, requested by such Client)-proposed material amendment, the proposed change in the Specifications or the Quality Agreement will be implemented at Client’s costimplemented, and the Price change (if any) will become effective, only for those orders of Products that are manufactured/packaged manufactured under the revised SpecificationsSpecifications or revised Quality Agreement. In addition, in respect of Inventory or Components subject to an amendment requested by Client, (a) 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 1(d) of Schedule D5.2, provided that solely to the extent the Inventory can no longer be used under the revised Specifications, Specifications or used by Patheon in be returned to the manufacture of product vendor for Patheon’s other customers; and (b) open 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 1(d) of Schedule D 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.

Adjustments Due to Technical Changes. Amendments (a) In the event that New River requests an amendment to the Specifications, to any manufacturing/packaging requirements (including the analytical methods) and/or to Specifications or the Quality Agreement requested by Client will only be implemented following Agreement, Patheon shall conduct a technical and cost review, and are subject to Client and Patheon reaching agreement on Price changes required because review of the proposed amendment. The parties shall use good faith efforts to agree upon any such increase or decrease in the Price and the date for implementation of any such amendment. Amendments to the Specifications, to any manufacturing/packaging requirements, the Quality Agreement, and/or to the Manufacturing Site If requested by Patheon, Patheon and New River shall only 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 implemented: (i) following 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 written approval extent such documents are subject to obligations of Client, the approval not to be unreasonably withheld; confidentiality between Patheon and (ii) utilizing appropriate change control procedures as identified in the Quality Agreementits suppliers. If Client accepts the Parties agree on a proposed Price change (i.e. in respect of an amendment implemented pursuant to this Section 2.3, requested by Client)fee change, the proposed change in the Specifications will and/or Quality Agreement shall be implemented at Client’s costimplemented, and the Price fee change will shall become effective, effective only for with respect to those orders of Products that are manufactured/packaged under manufactured in accordance with the revised SpecificationsSpecifications and/or revised Quality Agreement. 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)addition [***], all Inventory used utilized under the “old” Specifications and purchased or maintained by Patheon in order necessary to fill Firm Orders or under in accordance with Section 1(d) of Schedule D5.2, provided to the extent that the such Inventory can no longer be used utilized under the revised Specifications, or used by Patheon in the manufacture of product for Patheon’s other customers; and (b) open . 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 1(d) of Schedule D will 5.2 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 ClientNew River. (b) Amendments to the Specifications, the Quality Agreement or the Manufacturing Site requested by Patheon will only be implemented following the prior approval of New River, including a technical and cost review by the parties and are subject to New River and Patheon reaching agreement as to revisions, if any, to the fees specified in Schedules B or C necessitated by any such amendment. (c) Patheon and New River may collaborate to identify, target and implement all potential areas of cost reduction relating to the performance of their obligations under this Agreement, including the cost of Components and improvements in processing and Manufacturing Services. Such areas of jointly developed cost reduction shall be discussed at the quarterly meetings of the relationship managers as set forth in Section 7.1. Any benefits of such jointly developed cost reductions or improved efficiencies achieved shall be shared equally between Patheon and New River after the party who incurred any costs associated therewith, if any, has recovered its costs.

Adjustments Due to Technical Changes. Amendments to the Specifications, to any manufacturing/packaging requirements (including the analytical methods) and/or to Specifications or the Quality Agreement requested by Client will only be implemented following a technical and cost reviewreview by NPI and CUSTOMER, and are subject to Client CUSTOMER and Patheon NPI reaching agreement on Price changes required because of as to any applicable revisions, up or down, to the amendment. The parties shall use good faith efforts to agree upon any such increase Prices specified in Schedules B or decrease in C that are necessitated by the Price and the date for implementation of any such amendment. Amendments to the Specifications, the Quality Agreement, or the manufacturing site requested by CUSTOMER will be implemented unless NPI notifies CUSTOMER that NPI cannot implement such changes due to any manufacturing/packaging requirementspre-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, and/or to or the Manufacturing Site manufacturing site requested by Patheon, shall NPI will be implemented only be implemented: (i) following the written approval of ClientCUSTOMER, the such approval not to be unreasonably withheld; and (ii) utilizing appropriate change control procedures as identified in the Quality Agreement. If Client CUSTOMER accepts a proposed Price change (i.e. in respect of an amendment implemented pursuant to this Section 2.3change, requested by Client), the such proposed change in the Specifications will be implemented at Client’s costimplemented, and the Price change will become effective, effective only for those orders of Products that are manufactured/packaged manufactured under the revised Specifications. In addition, in respect of Inventory or Components subject to an amendment requested by Client, (a) 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 1(d) of Schedule D5.2, provided that if the Inventory can no longer be used utilized under the revised Specifications, or used by Patheon in the manufacture of product for Patheon’s other customers; and (b) open . 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 1(d) of Schedule D 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.

Adjustments Due to Technical Changes. Amendments to the Specifications, to any manufacturing/packaging requirements (including the analytical methods) and/or to Specifications or the Quality Agreement requested by Client Avanir will only be implemented following a technical and cost review, review by Patheon and are subject to Client Avanir and Patheon reaching agreement on Price changes required because of as to revisions, if any, to the amendment. The parties shall use good faith efforts to agree upon any such increase fees specified in Schedules B or decrease in the Price and the date for implementation of C necessitated by any such amendment. Amendments to the Specifications, to any manufacturing/packaging requirements, the Quality Agreement, and/or to Agreement or the Manufacturing Site requested by Patheon, shall Patheon will only be implemented: (i) implemented following the written approval of ClientAvanir, the such approval not to be unreasonably withheld; and (ii) utilizing appropriate change control procedures as identified in the Quality Agreement. If Client Avanir accepts a proposed Price change (i.e. in respect of an amendment implemented pursuant to this Section 2.3, requested by Client)fee change, the proposed change in the Specifications will shall be implemented at Client’s costimplemented, and the Price fee change will shall become effective, effective only for with respect to those orders of Products that are manufactured/packaged under manufactured in accordance with the revised Specifications. In addition, in respect of Inventory or Components subject to an amendment requested by Client, (a) 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 1(d) of Schedule D5.2, provided to the extent that the such Inventory can no longer be used utilized under the revised Specifications, or used by Patheon in the manufacture of product for Patheon’s other customers; and (b) open . 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 1(d) of Schedule D will 5.2 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.

Adjustments Due to Technical Changes. Amendments to the Specifications, to any manufacturing/packaging requirements (including the analytical methods) and/or to the Quality Agreement Manufacturing Requirements requested by Client Zogenix will only be implemented following a technical and cost review, review by both Parties and are subject to Client Zogenix and Patheon reaching agreement on Price changes required because of as to: (a) Revisions, if any, to the amendment. The parties shall use good faith efforts to agree upon fees specified in Schedules A or B necessitated by any such increase amendment if such fees are not the result, directly or decrease in indirectly, of Shutdown Activities; (b) The payment by Zogenix of any capital or other one-off costs incurred by Patheon that are necessitated by any such amendment if such fees are not the Price and the date result, directly or indirectly, of Shutdown Activities; (c) Reimbursement by Zogenix to Patheon for implementation any Materials or Product that becomes obsolete as a result of any such amendmentamendment if such obsolescence is not solely as the direct result of Shutdown Activities. Amendments to For the Specificationsavoidance of doubt, to this shall include any manufacturing/packaging requirements, the Quality Agreement, and/or to the Manufacturing Site requested open purchase orders for Materials that can not be cancelled by Patheon, shall only be implemented: penalties incurred by Patheon in cancelling purchase orders for Materials and work in progress for the Product. If the Parties agree to a fee revision, one-off payment or reimbursement for obsolete Materials and Product as set out in (ia), (b) following the written approval of Clientor (c) above, 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 (i.e. in respect of an amendment implemented pursuant to this Section 2.3, requested by Client), the proposed change in the Specifications will or the Quality Agreement shall be implemented at Client’s cost, and implemented. The above provisions shall also apply if a change in the Price change will become effective, only for those orders of Products that are 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 Manufacturing Requirements becomes necessary in order to fill Firm Orders allow Patheon to guarantee the performance of the activities in accordance with the cGMPs or under Section 1(d) to comply with new provisions of Schedule D, provided that the Inventory can no longer be used under the revised Specificationsapplicable laws or orders of relevant regulatory or governmental authorities, or used by Patheon in the manufacture MA if such fees are not the result, directly or indirectly, 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 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 ClientShutdown Activities.

Adjustments Due to Technical Changes. Amendments to the Specifications, to any manufacturing/packaging requirements (including the analytical methods) and/or to Specifications or the Quality Agreement requested by Client will only be implemented following a technical and cost reviewreview 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. The parties shall use good faith efforts to agree upon any such increase or decrease in the Price and the date for implementation of any such amendment. Amendments to the Specifications, to any manufacturing/packaging requirements, the Quality Agreement, and/or to or the Manufacturing Site requested by Patheon, shall Patheon will only be implemented: (i) 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 to be unreasonably withheld; change, and (iia) utilizing appropriate will use its best efforts to make any change control procedures as identified in the Quality AgreementClient 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 (i.e. in respect of an amendment implemented pursuant to this Section 2.3, requested by Client)change, the proposed change in the Specifications will be implemented at Client’s costimplemented, and the Price change will become effective, only for those orders of Products that are manufactured/packaged manufactured 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 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 1(d) of Schedule D5.2, provided that but only to the extent the Inventory can no longer be used under the revised Specifications, or used by Patheon in the manufacture of product for Patheon’s other customers; and (b) open . 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 1(d) of Schedule D 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.

Adjustments Due to Technical Changes. Amendments to the Specifications, to any manufacturing/packaging requirements (including the analytical methods) and/or to Specifications or the Quality Agreement requested by Client Supernus will only be implemented following a technical and good faith cost review, review by Supplier and are subject to Client Supernus and Patheon Supplier reaching agreement on Price changes required because of the amendment. The parties shall use good faith efforts to agree upon any such increase or decrease in the Price and the date for implementation of any such amendment. Amendments to the Specifications, to any manufacturing/packaging requirements, the Quality Agreement, and/or to Agreement or the Manufacturing Site Facility requested by Patheon, shall Supplier will only be implemented: (i) implemented following the written approval of ClientSupernus, the approval not to be unreasonably withheld; and (ii) utilizing appropriate change control procedures as identified in the Quality Agreement. If Client Supernus accepts a proposed Price change (i.e. in respect of an amendment implemented pursuant to this Section 2.3, requested by Client)change, the proposed change in the Specifications will be implemented at Client’s costimplemented, and the Price change will become effective, only for those orders of Products that are manufactured/packaged manufactured under the revised Specifications. In addition, in respect of Inventory or Components subject to an amendment requested by Client, (a) 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 1(d) of Schedule D6.3, provided that the if 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 used by Patheon in the manufacture of product for Patheon’s other customers; and (b) open 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 1(d) of Schedule D 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.

Adjustments Due to Technical Changes. Depomed will inform Patheon in writing of any changes required to the Specifications. Amendments to the Specifications, to any manufacturing/packaging requirements (including the analytical methods) and/or to Specifications or the Quality Agreement requested by Client either party will only be implemented following a technical and cost review, review by Patheon and are subject to Client Depomed and Patheon reaching agreement on Price Production Fees changes required because of the amendment. The parties shall use good faith efforts to agree upon any such increase or decrease in the Price and the date for implementation of any such amendment. Amendments to the Specifications, to any manufacturing/packaging requirements, the Specifications or Quality Agreement, and/or to or any change of the Manufacturing Site Patheon Facility (including without limitation the location thereof) requested by Patheon, shall Patheon will only be implemented: (i) implemented following the written approval of ClientDepomed, the such approval not to be unreasonably withheld; and (ii) utilizing appropriate . Any change control procedures as identified in the Quality Agreementmanufacturing 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 (i.e. in respect of an amendment implemented pursuant to this Section 2.3, requested by Client)Production Fees change, the proposed change in the Specifications will be implemented at Client’s costimplemented, and the Price Production Fees change will become effective, effective only for those orders of Products that are manufactured/packaged Product manufactured under the revised Specifications. In addition, in respect of Inventory or Components subject to an amendment requested by Client, (a) 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 1(d) of Schedule D, provided that 3.4 if the Inventory can no longer be used under the revised Specifications, or used by Patheon in the manufacture of product for Patheon’s other customers; and (b) open purchase Specification. Open 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 1(d) of Schedule D 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.