Manufacturing Services. Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].
Manufacturing Services. Patheon will perform the Manufacturing Services for Products to be distributed and sold by Client in the Territory for the fees specified in Schedules B and C to the relevant Product Agreement. Schedule B to each Product Agreement sets forth a list of cost items that are included in the Price for Products; all cost items that are not included in this list are excluded from the Price and are subject to additional fees to be paid by Client. Patheon may amend the fees set out in Schedules B and C to a Product Agreement as set forth in Article 4. Patheon will perform the Manufacturing Services solely at the Manufacturing Site, unless otherwise agreed in writing by Client. If the parties agree that Patheon will supply, and Client will purchase, at least a specified minimum percentage of Client’s requirements for a Product under a Product Agreement (the “Required Percentage”), then the applicable Product Agreement will set forth the Required Percentage and the time period during which the obligation will apply (the “Required Period”). But this obligation (if any) will cease to apply to Client with respect to the Product if Patheon fails to remain in material compliance with its obligations under this Agreement or the applicable Product Agreement, or Patheon suspends performance under this Agreement or the applicable Product Agreement in connection with a Force Majeure Event or where Patheon is or will be prevented from supplying the Product as a result of the action of a Regulatory Authority. Subject to its obligation (if any) to purchase the Required Percentage of a Product during the Required Period, Client may, at any time, obtain Product from a third party or may, at any time, qualify a third party to perform Manufacturing Services for the Product. 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 Schedules B and C to manufacture Products for Client. Schedule B sets forth a list of cost items that are included in the Price for Products; all cost items that are not included in this 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 Products only with the prior written consent of Client, this consent not to be unreasonably withheld. If Manufacturing Services have not started within [***] months of the date of execution of this Agreement, Patheon may amend the fees set out in Schedules B and C. Patheon will manufacture at least [***]% of the Products offered for sale by Client in the Territory so long as Patheon is in material compliance with its obligations to Client under this Agreement (including without limitation satisfying all orders placed by Client in accordance with the provisions of this Agreement), the Quality Agreement and the Capital Expenditure and Equipment Agreement and is fully in compliance with all Applicable Laws. In performing the Manufacturing Services, Patheon and Client agree that:
Manufacturing Services. Patheon shall provide the Manufacturing Services for the Territory for the fees specified in Schedules B in order to produce Drug Product for the Client. Subject to Client’s continuing obligation to purchase certain quantities of Packaged Drug Product from Novartis Pharmaceutical Corporation, during the Term and provided that Patheon is not in material default hereunder and is otherwise capable of meeting all of Client’s demand for the Drug Product in accordance with forecasts and Firm Orders set forth in Section 5.2 hereof Client shall purchase all of its other requirements of Drug Product from Patheon. In providing the Manufacturing Services, Patheon shall perform each of the following services:
Manufacturing Services. Patheon will perform the Manufacturing Services for the Territory for the Price specified in a Product Agreement in Schedules B and C to manufacture Products for Client. Schedule B to a Product Agreement sets forth a list of cost items that are included in the Price for Products; all cost items that are not included in the Price are subject to additional fees to be paid by Client, provided, that all such additional fees are subject to Client’s prior written consent. Patheon may amend the fees set out in Schedules B and C to a Product Agreement as set forth in Article 4. Patheon may change the Manufacturing Site for the Products only with the prior written consent of Client, this consent not to be unreasonably withheld, and subject to any necessary approvals by Regulatory Authorities. Unless otherwise agreed in a Product Agreement and subject to Section 2.3 below, during the term of any Product Agreement, Client will purchase from Patheon [***] of its requirements for the Product in the Territory set forth in the applicable Product Agreement. In performing the Manufacturing Services, Patheon and Client agree that, unless otherwise set forth in a Product Agreement:
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. The following terms apply only to the manufacture of commercial quantities of the Product:
Manufacturing Services. Jabil will manufacture the Product in accordance with the Specifications and any applicable Purchase Order. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil for Company. Company shall be solely responsible for the sufficiency and adequacy of the Specifications and shall hold Jabil harmless for any claim arising therefrom pursuant to Section 19.2.
Manufacturing Services. During the term of this Agreement, the price for the Manufacturing Services shall be based upon Mommers' direct cost to manufacture such Product for which such Manufacturing Services are contracted for at Mommers' Echt facility. During the term of this Agreement, Mommers shall submit to North Tyneside a complete breakdown of its direct cost associated with the manufacture of any Product for which Mommers is contracting for Manufacturing Services. The price of such Manufacturing Services shall be increased or decreased, as the case may be and from time to time, to reflect changes in the cost of raw materials, labor rates, utility rates and any other component of direct manufacturing cost at Mommers' Echt facility.
Manufacturing Services. Subject to the terms and conditions set forth in this Agreement, Norrkoping agrees to provide all services related to the manufacturing of the Products (the "Manufacturing Services") and Mommers agrees to accept the Manufacturing Services for Products meeting Mommers' Specifications (as defined), in such quantities as determined under Section 1.2 hereof. For purpose of this Agreement the term "Mommers' Specifications" means and includes any and all designs, drawings, blueprints, formulations, models, specifications, manufacturing data, techniques, processes, procedures, performance data, know-how and other technical information relating to the design, manufacture and/or operation of the Products, which are provided by Mommers to Norrkoping for the purpose of manufacturing Products pursuant to this Agreement.
