Common use of Manufacturing Services Clause in Contracts

Manufacturing Services. Patheon will perform the Manufacturing Services for the Territory for the fees specified in a Product Agreement in Schedules B and C. Schedule B to a Product Agreement sets forth a list of cost items that are included or not included in the unit Price for Products; all cost items that are not included in the Price are subject to additional fees to be paid by the Client as agreed by the Parties. Patheon may amend the fees set out in Schedules B and C to a Product Agreement as set forth and in accordance with Article 4. Patheon will perform the Manufacturing Services in strict compliance with the established Specifications, cGMP and Applicable Laws. Patheon may not change the Specifications or the Manufacturing Site (including facility modifications) or any other aspect of the manufacturing process used to perform the Manufacturing Services with respect to the Products except with the prior written consent of Client, this consent not to be unreasonably withheld. Unless otherwise agreed in a Product Master Manufacturing Services Agreement Agreement or in this Agreement, and for so long as Patheon remains in material compliance with its obligations under this Agreement and the applicable Product Agreement, Patheon will manufacture at least […***…] % (“Annual Minimum”) of Products manufactured by or on Client’s behalf for sale by Client in the Territory in a particular Year. If Patheon does not remain in material compliance, the Annual Minimum will no longer apply in addition to any other remedies the Client may have under this Agreement. In performing the Manufacturing Services, Patheon and Client agree that:

Manufacturing Services. Patheon will perform the Manufacturing Services for the Territory for the fees specified in a Product Agreement in Schedules B and C. C in order to manufacture Product for Client. The parties acknowledge and agree that all Product manufactured by Patheon for commercial distribution after January 22, 2010, through the Effective Date is also subject to the terms and conditions of this Agreement and the Quality Agreement. Client and Patheon acknowledge that this Agreement will be utilized for the manufacture and supply of Product outside the US through Client’s licensee, Biogen Idec. Client and Patheon agree to work together in good faith and negotiate an amendment to this Agreement for such manufacture and supply. Additionally, Patheon acknowledges and agrees that requirements outside the US may require quality agreement(s) for ex-US quality-related matters, and Client and Patheon agree to work together in good faith to negotiate any such quality agreement(s) for ex-US quality-related matters. Schedule B to a Product Agreement sets forth a list of cost items that are included or not included in the unit Price for Products; all cost items that are not included in the aforementioned list are excluded from the Price and are subject to additional fees to be paid by the Client. Patheon may change the Manufacturing Site for the Product only with the prior written consent of Client as agreed by this consent not to be unreasonably withheld. If Manufacturing Services have not started within 12 months of the Parties. Effective Date of this Agreement Patheon may amend the fees set out in Schedules B and C and submit to a Product Agreement as set forth Client for Client’s review and in accordance with Article 4consideration. Patheon will perform acknowledges that Patheon is not the Manufacturing Services in strict compliance with the established Specifications, cGMP and Applicable Laws. Patheon may not change the Specifications or the Manufacturing Site (including facility modifications) or any other aspect exclusive manufacturer of the manufacturing process used to perform the Manufacturing Services with respect to the Products except with the prior written consent of Client, this consent not to be unreasonably withheld. Unless otherwise agreed in a Product Master Manufacturing Services Agreement Agreement or in this Agreement, and for so long as Patheon remains in material compliance with its obligations under this Agreement and the applicable Product Agreement, Patheon will manufacture at least […***…] % (“Annual Minimum”) of Products manufactured by or on Client’s behalf for sale by Client in the Territory in a particular Year. If Patheon does not remain in material compliance, the Annual Minimum will no longer apply in addition to any other remedies the Client may have under this AgreementProduct. In performing providing the Manufacturing Services, Patheon and Client agree that:

Manufacturing Services. Patheon will perform the Manufacturing Services for the Territory for the fees specified in a Product Agreement in Schedules B and C. C and any additional countries outside the Territory subject to Section 4.5 for the fees specified in applicable amendments entered into by the parties. Schedule B to a Product Agreement sets forth a list of cost items that are included or not included in the unit Price for Products; all cost items . Patheon shall not perform any Manufacturing Services at any location other than at the Manufacturing Site located at 0000 Xxxxxx Xxxxx, Xxxxxxxxxxx, Xxxxxxx, Xxxxxx X0X 0X0 without the express written consent of Client, except that are not included in the Price are subject to additional fees to be paid by the Client Patheon may perform certain analytical release and stability testing activities as agreed by the PartiesParties at the Manufacturing Site located at 000 Xxxxxxx Xxxxx, Xxxxxxxxxx, Xxxxxxx, Xxxxxx X0X 0X0. Patheon may amend the fees set out in Schedules B and C to a Product Agreement as set forth and in accordance with Article 4. Patheon will shall perform the Manufacturing Services in strict compliance with this Agreement, the established Specifications, the Quality Agreement, cGMP and Applicable Laws. , Patheon may not change the Specifications or the Specifications, Manufacturing Site (including facility modifications) modification), site of stability testing or any other aspect of the manufacturing process used to perform the Manufacturing Services with respect to the Products except with without the prior written consent of Client, this consent not to be unreasonably withheld. Unless otherwise agreed in a Product Master If Manufacturing Services Agreement Agreement or in this Agreement, and for so long as Patheon remains in material compliance with its obligations under have not started within 12 months of the date of execution of this Agreement and the applicable Product Agreement(other than as a result of Patheon’s acts or omissions or a Force Majeure Event), Patheon will may propose an amendment of the fees set out in Schedules B and C, which shall be subject to Client’s approval. Patheon’s right to manufacture Products offered for sale by Client in the Territory shall be non-exclusive. However, Client shall procure at least […***…] % percent (“Annual Minimum”[…***…] %) of Products manufactured by or on Client’s behalf its annual Product requirements for sale by Client in the Territory in a particular Year. If from Patheon does not remain in material compliance, the Annual Minimum will no longer apply in addition to any other remedies the Client may have under this Agreementor its Affiliates. In performing the Manufacturing Services, Patheon and Client agree that:

Manufacturing Services. Patheon will perform the Manufacturing Services for the Territory for the fees Price specified in a Product Agreement in Schedules B and C. C to manufacture Products for Client. Schedule B to a Product Agreement sets forth a list of cost items that are included or not included in the unit Price for Products; . Patheon will use commercially reasonable efforts to ensure that all applicable cost items that are not included in each Schedule B, as applicable, and if either Patheon or Client detects that a cost item is missing, Patheon will submit a reasonable offer to Client to fulfill the Price are subject to additional fees to be paid by the Client as agreed by the Partiesmissing cost item. Patheon may amend the fees set out in Schedules B and C to a Product Agreement as set forth and in accordance with Article 4. Patheon will perform the Manufacturing Services in strict compliance with the established Specifications, cGMP and Applicable Laws. Patheon may not change the Specifications or the Manufacturing Site (including facility modifications) or any other aspect of the manufacturing process used to perform the Manufacturing Services with respect to the Products except for a Product only with the prior written consent of Client, this consent not to be unreasonably withheldwithheld (it being acknowledged that it will not be unreasonable for Client to condition approval upon qualification of the new Manufacturing Site for the manufacture of the Product and Patheon obtaining all other approvals, licenses, consents and satisfying all other similar requirements from any applicable Regulatory Authority). Unless otherwise agreed in a Product Master Manufacturing Services Agreement Agreement or in this Agreement, and for so long as Patheon remains in material compliance with its obligations under this Agreement and the applicable Product Agreement, Patheon will manufacture at least have the right and the obligation, to […***…] % ]. [***], Patheon, Client and Client Licensees will, in accordance with Section 7.1 (“Annual Minimum”) of Products manufactured by or on Client’s behalf for sale by Client in the Territory in a particular YearQuarterly Review), [***]. If Patheon does not remain in material compliance, the Annual Minimum will no longer apply in addition be entitled to any other remedies applicable manufacturing tax credits that arise from performing the Client may have Manufacturing Services under this Agreement. In performing the Manufacturing Services, Patheon and Client agree that: