For API. Cost of Raw Materials The purchase unit cost of raw materials multiplied by [**] including [**] and any [**]. Direct Labor and Allocable Overhead Costs The cost of direct labor and manufacturing overhead resources consumed in the production process. Costs will include any efficiency, activity and spending variances from standards as well as any underabsorbed overhead expenses incurred during the startup of the biologic operation for the Product or caused by subsequent evolution of the Product's volumes sold in North America or Japan, as the case may be, including, without limitation, process development, process improvement, scale-up, recovery, and qualification lots costs. Manufacturing overhead includes the following costs: Normal depreciation of building, machinery and equipment Plant management Plant services and utilities Plant maintenance Quality control at all stages Freight and storage costs at all stages Confidential treatment requested by Xxxxxxx-Xxxxx Squibb Company, Xxxxxxx-Xxxxx Squibb Biologics Company and ImClone Systems Incorporated. Cost accounting and data processing services Any taxes and duties other than VAT and income tax
For API. Executive Director, Center for ORshore Safety Date
For API. Except as expressly set forth in Section 5.6, under no circumstances will Patheon be responsible for any loss or damage to API. Patheon’s maximum responsibility for loss or damage to API will not exceed the Maximum Credit Value set forth in Schedule E
For API. Cost of Raw Materials The purchase unit cost of raw materials multiplied by [**] including [**] and any [**]. Direct Labor and Allocable Overhead Costs The cost of direct labor and manufacturing overhead resources consumed in the production process. Costs will include any efficiency, activity and spending variances from standards as well as any underabsorbed overhead expenses incurred during the startup of the biologic operation for the Product or caused by subsequent evolution of the Product's volumes sold in North America or Japan, as the case may be, including, without limitation, process development, process improvement, scale-up, recovery, and qualification lots costs. Manufacturing overhead includes the following costs: Normal depreciation of building, machinery and equipment Plant management Plant services and utilities Plant maintenance Quality control at all stages Freight and storage costs at all stages Cost accounting and data processing services Any taxes and duties other than VAT and income tax
For API. ImClone shall be required to bid on the supply of all API required under this Agreement for use in the manufacture of Cetuximab and Final Product for use and/or sale in Japan at a price not greater than its Fully Burdened Manufacturing Cost. Any bid by Merck to supply such API requirements (if it elects to do so) must be at a price not greater than its Fully Burdened Manufacturing Cost. For clarification, no Party, any of its Affiliates, nor any Third Party shall be entitled to bid for such API supply if, where a license or other right is needed to so manufacture and supply API for use in making Cetuximab and Final Product for use and sale in Japan, it does not have such a license or other right, it being understood that no such right or license is granted in this Agreement. The Parties shall use commercially reasonable efforts to effect a smooth transition of API manufacturing responsibilities (and associated contractual relationships and responsibilities) as and when a change in API supplier is determined by the JJMC and approved by the SCJ.
For API. Executive Director, Center for Offshore Safety Date
