Common use of Adjustments Due to Technical Changes Clause in Contracts

Adjustments Due to Technical Changes. For changes to the Specifications or manufacturing processes that are required by applicable Laws ("Required Manufacturing Changes"), Patheon and the Client shall cooperate in making such changes and use commercially reasonable efforts to implement such changes promptly in a manner that minimizes any effect on the supply hereunder to the Client of Product meeting Specifications. All costs associated with Required Manufacturing Changes directly related to the [ * ] shall be borne by [ * ]. All other costs associated with Required Manufacturing Changes under this Agreement, including, without limitation, obsolete Components, Regulatory Filings, work in process, equipment and Product shall be borne by [ * ]. Amendments to the Specifications or the Quality Agreement requested by the Client that are not Required Manufacturing Changes ("Client Requested Changes") will only be implemented following [ * ] necessitated by any such amendment. Amendments to the Specifications, the Quality Agreement or the Manufacturing Site requested by Patheon that are not Required Manufacturing Changes ("Patheon Requested Changes") will only be implemented following the approval of Client, [ * ], and the costs of the Patheon Requested Changes will be borne by [ * ]. If the Client accepts a proposed fee change, the proposed change in the Specifications shall be implemented, and the fee change shall become effective only with respect to those orders of the Product that are manufactured in accordance with the revised Specifications. In addition, with respect to the [ * ] Requested Changes, the [ * ] agrees to purchase, at [ * ] (including all costs incurred by [ * ] in connection with the purchase and handling of such [ * ]), all [ * ] utilized under the [ * ] Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with Section 5.2, to the extent that such [ * ] can [ * ] under the revised Specifications. Open purchase orders for [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Components no longer required under any revised Specifications that were placed by Patheon in accordance with this Agreement with suppliers in order to fill Firm Orders or in accordance with Section 5.2 shall be cancelled where possible, and where such orders are not subject to cancellation without penalty, shall be [ * ].

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 by NPI and CUSTOMER, and are subject to CUSTOMER and NPI reaching agreement as to any applicable revisions, up or down, to the Prices specified in Schedules B or C that are necessitated by any such the amendment. Amendments to the Specifications, the Quality Agreement Agreement, or the Manufacturing Site manufacturing site requested by Patheon that are not Required Manufacturing Changes ("Patheon Requested Changes") 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, [ * ], and the costs of the Patheon Requested Changes will such approval not to be borne by [ * ]unreasonably withheld. If the Client CUSTOMER accepts a proposed fee Price change, the such proposed change in the Specifications shall will be implemented, and the fee Price change shall will become effective only with respect to for those orders of the Product Products that are manufactured in accordance with under the revised Specifications. In addition, with respect to the [ * ] Requested Changes, the [ * ] CUSTOMER agrees to purchasepurchase all Inventory (at the actual cost incurred by NPI, at [ * ] (including all costs incurred by [ * ] in connection with the purchase and handling of such [ * ]), all [ * ] the Inventory) utilized under the [ * ] “old” Specifications and purchased or maintained by Patheon NPI in order to fill Firm Orders or in accordance with Section 5.2, to if the extent that such [ * ] Inventory can [ * ] no longer be utilized 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 NPI with suppliers in order to fill Firm Orders or in accordance with under Section 5.2 shall will be cancelled where possible, and where such if the orders are cannot subject to cancellation be cancelled without penalty, will be assigned to and satisfied by CUSTOMER. 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. For changes to the Specifications or manufacturing processes that are required by applicable Laws ("Required Manufacturing Changes"), Patheon and the Client shall cooperate in making such changes and use commercially reasonable efforts to implement such changes promptly in a manner that minimizes any effect on the supply hereunder to the Client of Product meeting Specifications. All costs associated with Required Manufacturing Changes directly related to the [ * ] shall be borne by [ * ]. All other costs associated with Required Manufacturing Changes under this Agreement, including, without limitation, obsolete Components, Regulatory Filings, work in process, equipment and Product shall be borne by [ * ]. Amendments to the Specifications or the Quality Agreement requested by the Client that are not Required Manufacturing Changes ("Client Requested Changes") will only be implemented following [ * ] necessitated a technical and cost review by any such Patheon and are subject to Client and Patheon reaching agreement on Price changes, if any, required because of the requested amendment. 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 costs 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 Requested Changes will be borne by [ * ]increase the Price or result in delays in the delivery of the Products. If the Client accepts a proposed fee Price change, the proposed change in the Specifications shall will be implemented, and the fee Price change shall will become effective effective, only with respect to for those orders of the Product Products that are manufactured in accordance with under the revised Specifications. In addition, with respect if the amendment to the [ * ] Requested ChangesSpecifications has been requested by Client, the [ * ] Client agrees to purchase, at [ * ] Patheon's cost (including all costs incurred by [ * ] in connection with Patheon for the purchase and handling of such [ * ]the Inventory), all [ * ] utilized Inventory used under the [ * ] "old" Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with under Section 5.2, to the extent that such [ * ] (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 [ * ] = 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 unique to the Manufacture of the Products and no longer required under any revised Specifications that were placed by Patheon in accordance with this Agreement with suppliers in order to fill Firm Orders or in accordance with under Section 5.2 shall will be cancelled where possible, and where such if the orders are cannot subject to cancellation be cancelled without penalty, shall 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.].

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 Specifications, to any manufacturing/packaging requirements (including the analytical methods) and/or to the Quality Agreement requested by the Client that are not Required Manufacturing Changes ("Client Requested Changes") will only be implemented following [ * ] necessitated by 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 or Agreement, and/or to the Manufacturing Site requested by Patheon that are not Required Manufacturing Changes ("Patheon Requested Changes") 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 costs of the Patheon Requested Changes will be borne by [ * ]Quality Agreement. If the Client accepts a proposed fee changePrice change (i.e. in respect of an amendment implemented pursuant to this Section 2.3, requested by Client), the proposed change in the Specifications shall will be implementedimplemented at Client’s cost, and the fee Price change shall will become effective effective, only with respect to for those orders of the Product Products that are manufactured in accordance with manufactured/packaged under the revised Specifications. In addition, with in respect of Inventory or Components subject to the [ * ] Requested Changesan amendment requested by Client, the [ * ] (a) Client agrees to purchase, at [ * ] Patheon’s cost (including all reasonable costs incurred by [ * ] in connection with Patheon for the purchase and handling of such [ * ]the Inventory), all [ * ] utilized Inventory used under the [ * ] “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with under Section 5.21(d) of Schedule D, to provided that the extent that such [ * ] 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 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Components no longer required under any revised Specifications that were placed by Patheon in accordance with this Agreement with suppliers in order to fill Firm Orders or in accordance with under Section 5.2 shall 1(d) of Schedule D will be cancelled where possible, and where such if the orders are may not subject to cancellation be cancelled without penalty, shall will be [ * ]assigned to and satisfied by Client.

Adjustments Due to Technical Changes. For changes to the Specifications or manufacturing processes that are required by applicable Laws ("Required Manufacturing Changes"), Patheon and the Client shall cooperate in making such changes and use commercially reasonable efforts to implement such changes promptly in a manner that minimizes any effect on the supply hereunder to the Client of Product meeting Specifications. All costs associated with Required Manufacturing Changes directly related to the [ * ] shall be borne by [ * ]. All other costs associated with Required Manufacturing Changes under this Agreement, including, without limitation, obsolete Components, Regulatory Filings, work in process, equipment and Product shall be borne by [ * ]. Amendments Material amendments to the Specifications or the Quality Agreement requested by the Client that are not Required Manufacturing Changes ("Client Requested Changes") will only be implemented following [ * ] necessitated a technical and cost review by any such Patheon and are subject to Client and Patheon reaching agreement on Price changes (if any) required because of the amendment. Amendments to the Specifications, the Quality Agreement or the Manufacturing Site requested by Patheon that are not Required Manufacturing Changes ("Patheon Requested Changes") will only be implemented following the 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 costs of Product, and (b) will use commercially reasonable efforts to implement any other change identified in a Client request by the Patheon Requested Changes will be borne date requested by [ * ]Client, or as soon thereafter as it is commercially reasonable. If the Client accepts a proposed fee changePrice change (if any) in response to such Client-proposed material amendment, the proposed change in the Specifications shall or the Quality Agreement will be implemented, and the fee Price change shall (if any) will become effective effective, only with respect to for those orders of the Product Products that are manufactured in accordance with under the revised SpecificationsSpecifications or revised Quality Agreement. In addition, with respect to the [ * ] Requested Changes, the [ * ] Client agrees to purchase, at [ * ] Patheon’s actual cost (including all reasonable costs incurred by [ * ] in connection with Patheon for the purchase and handling of such [ * ]the Inventory), all [ * ] utilized Inventory used under the [ * ] “old” Specifications and purchased or maintained by Patheon and necessary in order to fill Firm Orders or in accordance with under Section 5.2, solely to the extent that such [ * ] 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 [ * ] = 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 and necessary in order to fill Firm Orders or in accordance with under Section 5.2 shall will be cancelled where possible, and where such if the orders are may not subject to cancellation be cancelled without penalty, shall be [ will 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

Adjustments Due to Technical Changes. For changes to the Specifications or manufacturing processes that are required by applicable Laws ("Required Manufacturing Changes"), Patheon and the Client shall cooperate in making such changes and use commercially reasonable efforts to implement such changes promptly in a manner that minimizes any effect on the supply hereunder to the Client of Product meeting Specifications. All costs associated with Required Manufacturing Changes directly related to the [ * ] shall be borne by [ * ]. All other costs associated with Required Manufacturing Changes under this Agreement, including, without limitation, obsolete Components, Regulatory Filings, work in process, equipment and Product shall be borne by [ * ]. Amendments to the Specifications or the Quality Agreement requested by the Client that are not Required Manufacturing Changes ("Client Requested Changes") will only be implemented following [ * ] necessitated by a technical and cost review that Patheon will perform at Client’s cost, and are subject to Client and Patheon reaching agreement on any such Price changes required because of the amendment. 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. 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 change, and (a) will use its best efforts to make any change identified in the costs of Client request that is in response to a regulatory or safety issue pertaining to the Patheon Requested Changes Product, and (b) will be borne 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 the Client accepts a proposed fee Price change, the proposed change in the Specifications shall will be implemented, and the fee Price change shall will become effective effective, only with respect to for those orders of the Product Products that are manufactured in accordance with under the revised Specifications. In addition, with respect to the [ * ] Requested Changes, the [ * ] Client agrees to purchase, at [ * ] Patheon's actual cost (including all reasonable costs incurred by [ * ] in connection with Patheon for the purchase and handling of such [ * ]the Inventory), all [ * ] utilized Inventory used under the [ * ] "old" Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with under Section 5.2, but only to the extent that such [ * ] the Inventory 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 in accordance with under Section 5.2 shall will be cancelled where possible, and where such if the orders are may not subject to cancellation be cancelled without penalty, shall will, at Client’s sole discretion, be [ * ].assigned to and satisfied by 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

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 for a given Drug Product, the Quality Agreement relating to Processing or the minimum order quantities for each Drug Product requested by the Client that are not Required Manufacturing Changes ("Client Requested Changes") Gilead will only be implemented following [ * ] a technical and cost review by Patheon and are subject to Gilead and Patheon reaching agreement as to revisions, if any, to the fees specified in Exhibit C of the corresponding Product-Specific Appendix or otherwise necessitated by any such amendment. Amendments to the Specifications, the Quality Agreement or the Manufacturing Site requested by Patheon that are not Required Manufacturing Changes ("Patheon Requested Changes") will only be implemented following the approval of Client, [ * ], and the costs of the Patheon Requested Changes will be borne by [ * ]. If the Client Gilead accepts a proposed fee change, the proposed change in the Specifications Specifications, Quality Agreement or minimum order quantities shall be implemented, and the fee change shall become effective only with respect to those orders of the such Drug Product that are manufactured 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, with respect to the [ * ] Requested Changes, the [ * ] Gilead agrees to purchase, at [ * ] (including all costs incurred by [ * ] in connection with the purchase and handling of such [ * ])Patheon’s cost, all [ * ] Inventory 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 in accordance with Section 5.22.5, to the extent that such [ * ] Inventory can [ * ] no longer be utilized under the revised SpecificationsSpecifications and/or Quality Agreement. 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 Materials no longer required under any such revised Specifications and/or Quality Agreement that were placed by Patheon in accordance with this Agreement with suppliers in order to fill Firm Orders or in accordance with Section 5.2 2.5 shall be cancelled where possible, and where such orders are not subject to cancellation without penalty, shall be [ * ]assigned to and satisfied by Gilead.

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") Avanir will only be implemented following [ * ] a technical and cost review by Patheon and are subject to Avanir and Patheon reaching agreement as to revisions, if any, to the fees specified in Schedules B or C necessitated by any such amendment. Amendments to the Specifications, the Quality Agreement or the Manufacturing Site requested by Patheon that are not Required Manufacturing Changes ("Patheon Requested Changes") will only be implemented following the approval of ClientAvanir, [ * ], and the costs of the Patheon Requested Changes will such approval not to be borne by [ * ]unreasonably withheld. If the Client Avanir accepts a proposed fee change, the proposed change in the Specifications shall be implemented, and the fee change shall become effective only with respect to those orders of the Product Products that are manufactured in accordance with the revised Specifications. In addition, with respect to the [ * ] Requested Changes, the [ * ] Avanir agrees to purchase, at [ * ] Patheon’s cost therefor (including all costs incurred by [ * ] Patheon in connection with the purchase and handling of such [ * ]Inventory), all [ * ] Inventory utilized under the [ * ] “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with Section 5.2, to the extent that such [ * ] Inventory can [ * ] no longer be utilized under the revised Specifications. Open purchase orders for [ * ] = 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 and Packaging Materials no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders, or in accordance with this Agreement with suppliers Section 5.2 shall be cancelled by Patheon, where possible. Patheon shall also use commercially reasonable efforts to return, where possible, Components and Packaging Materials utilized under the “old” Specifications and purchased by Patheon in order to fill Firm Orders or in accordance with Section 5.2 shall be cancelled where possible, and where such orders are not 5.2. Where the cancellation of an open purchase order or the return of Components or Packaging Materials is subject to a cancellation without penaltypenalty or restocking charge, Patheon shall initially pay such cancellation penalty or restocking charge and be [ * ]reimbursed for such costs by Avanir.

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 an Authority or by Client (including, without limitation, amendments requested during or resulting from the Client that are not Required Manufacturing Changes ("Client Requested Changes"completion of the Services performed by Patheon pursuant to the Clinical Trial Agreement) will only be implemented following [ * ] necessitated a technical and cost review by any such Patheon and are subject to Client and Patheon reaching written agreement on changes to the Product Price, Stability Price and/or Validation Price (as appropriate) required because of the amendment. Amendments to the Specifications, the Quality Agreement Agreement, or the Manufacturing Site requested by Patheon that are not Required Manufacturing Changes ("including, without limitation, amendments requested during or resulting from the completion of the Services performed by Patheon Requested Changes"pursuant to the Clinical Trial Agreement) will only be implemented following the written approval of Client, [ * ], and the costs of the Patheon Requested Changes will approval not to be borne by [ * ]unreasonably withheld. Client may reasonably withhold approval due to adverse changes in any price or inventory obsolescence. If the Client accepts a proposed fee change, the proposed change in the Specifications shall Specifications, Quality Agreement or Manufacturing Site, as applicable, the associated change in Product Price (if any) will be implemented, and the fee Product Price change shall will become effective effective, only with respect to for those orders of the Product Products that are manufactured in accordance with under the revised Specifications. In addition, with respect if the changes to the [ * ] Requested ChangesSpecifications or Quality Agreement are requested by Client, the [ * ] Client agrees to purchase, at [ * ] Patheon's cost (including all costs incurred by [ * ] in connection with Patheon for the purchase and handling of such [ * the Inventory [***]), all [ * ] utilized Inventory used under the [ * ] "old" Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with under Section 5.2, to if the extent that such [ * ] 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 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Components no longer required under any revised Specifications that were placed by Patheon in accordance with this Agreement with suppliers in order to fill Firm Orders or in accordance with under Section 5.2 shall will be cancelled where possible, and where such if the orders are may not subject to cancellation be cancelled without penalty, shall will be [ * ]assigned to and satisfied by Client. Patheon will use reasonable efforts to use the Inventory with other clients or otherwise minimize the obsolescence costs.

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") Supernus will only be implemented following [ * ] necessitated a technical and good faith cost review by any such Supplier and are subject to Supernus and Supplier reaching agreement on Price changes required because of the amendment. Amendments to the Specifications, the Quality Agreement or the Manufacturing Site Facility requested by Patheon that are not Required Manufacturing Changes ("Patheon Requested Changes") Supplier will only be implemented following the written approval of ClientSupernus, [ * ], and the costs of the Patheon Requested Changes will approval not to be borne by [ * ]unreasonably withheld. If the Client Supernus accepts a proposed fee Price change, the proposed change in the Specifications shall will be implemented, and the fee Price change shall will become effective effective, only with respect to for those orders of the Product Products that are manufactured in accordance with under the revised Specifications. In addition, with respect to the [ * ] Requested Changes, the [ * ] Supernus agrees to purchase, at [ * ] Supplier’s cost (including all costs incurred by [ * ] in connection with Supplier for the purchase and handling of such [ * ]the Inventory), (i) all [ * ] utilized Inventory of Materials used under the [ * ] “old” Specifications and purchased or maintained by Patheon 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 Supplier in order to fill Firm Orders Commitments or in accordance with under Section 5.26.3, to the extent that if such [ * ] Inventory can [ * ] 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 [ * ] = 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 Materials no longer required under any revised Specifications that were placed by Patheon in accordance with this Agreement Supplier with suppliers in order to fill Firm Orders Commitments or in accordance with under Section 5.2 shall 6.3 will be cancelled where possible, and where such if the orders are may not subject to cancellation be cancelled without penalty, shall will be [ * ]assigned to and satisfied by Supernus.

Adjustments Due to Technical Changes. For changes to the Specifications or manufacturing processes that are required by applicable Laws ("Required Manufacturing Changes"), Patheon and the Client shall cooperate in making such changes and use commercially reasonable efforts to implement such changes promptly in a manner that minimizes any effect on the supply hereunder to the Client of Product meeting Specifications. All costs associated with Required Manufacturing Changes directly related to the [ * ] shall be borne by [ * ]. All other costs associated with Required Manufacturing Changes under this Agreement, including, without limitation, obsolete Components, Regulatory Filings, work in process, equipment and Product shall be borne by [ * ]. Amendments to the Specifications or the Quality Agreement requested by the Client that are not Required Manufacturing Changes ("Client Requested Changes") will only be implemented following [ * ] necessitated by a technical and cost review that Patheon will perform at Client’s cost, and are subject to Client and Patheon reaching agreement on any such Price changes required because of the amendment. 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. 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 change, and (a) will use its best efforts to make any change identified in the costs of Client request that is in response to a regulatory or safety issue pertaining to the Patheon Requested Changes Product, and (b) will be borne 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 the Client accepts a proposed fee Price change, the proposed change in the Specifications shall will be implemented, and the fee Price change shall will become effective effective, only with respect to for those orders of the Product Products that are manufactured in accordance with under the revised Specifications. In addition, with respect to the [ * ] Requested Changes, the [ * ] Client agrees to purchase, at [ * ] Patheon's actual cost (including all reasonable costs incurred by [ * ] in connection with Patheon for the purchase and handling of such [ * ]the Inventory), all [ * ] utilized Inventory used under the [ * ] "old" Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with under Section 5.2, but only to the Master Manufacturing Services Agreement extent that such [ * ] the Inventory 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 in accordance with under Section 5.2 shall will be cancelled where possible, and where such if the orders are may not subject to cancellation be cancelled without penalty, shall will, at Client’s sole discretion, be [ * ]assigned to and satisfied by Client 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 or the Quality Agreement requested by the Client that are not Required Manufacturing Changes ("Client Requested Changes") will only be implemented following [ * ] necessitated by a technical and cost review that Patheon will perform at Client’s cost, and are subject to Client and Patheon reaching agreement on any such Price changes required because of the amendment. 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. 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 change, and (a) will use its best efforts to make any change identified in the costs of Client request that is in response to a regulatory or safety issue pertaining to the Patheon Requested Changes Product, and (b) will be borne 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 the Client accepts a proposed fee Price change, the proposed change in the Specifications shall will be implemented, and the fee Price change shall will become effective effective, only with respect to for those orders of the Product Products that are manufactured in accordance with under the revised Specifications. In addition, with respect to the [ * ] Requested Changes, the [ * ] Client agrees to purchase, at [ * ] Patheon’s actual cost (including all reasonable costs incurred by [ * ] in connection with Patheon for the purchase and handling of such [ * ]the Inventory), all [ * ] utilized Inventory used under the [ * ] “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or in accordance with under Section 5.2, but only to the ***Confidential Treatment Requested Master Manufacturing Services Agreement extent that such [ * ] the Inventory 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 in accordance with under Section 5.2 shall will be cancelled where possible, and where such if the orders are may not subject to cancellation be cancelled without penalty, shall will, at Client’s sole discretion, be [ * ]assigned to and satisfied by Client or cancelled by Patheon and Client will reimburse Patheon for any penalty it incurs due to the cancellation.