Fully Burdened Costs. (a) in the case where [**] Manufactures QS-21 for supply to [**] hereunder, the total cost to Manufacture by [**] and/or its Affiliates hereunder, which total cost shall include direct and indirect labor costs, direct material costs (including without limitation, raw materials, lab supplies and other materials used directly in Manufacturing QS-21) and indirect material costs (including without limitation shipping materials (driven by shipments not batches), stability materials, batch record... materials, sundry supplies to support QS-21 Manufacture, record keeping, stationary, incidental supplies etc.) calculated in accordance with Generally Accepted Accounting Principles ("GAAP"), and Other Overhead Costs calculated in accordance with GAAP [**]; or (b) in the case where [**] engages a Third Party to Manufacture QS-21 on its behalf for supply to [**] hereunder, the actual cost to [**] to have QS-21 Manufactured and supplied by such Third Party, including without limitation, direct and indirect costs borne by [**] for any internal quality assurance, quality control, fill/finish, packaging, shipping, and/or delivery, in each case as duly documented by [**]. In the case [**] is [**]of the [**] (both [**] and [**]) to meet it supply obligations under this Agreement, the [**] of the [**] shall be added to the [**]to [**] and/or the [**]by [**] as appropriate, however, in no event shall any [**] be included as part of the Fully Burdened Costs. [**] In the event that [**] Manufactures QS-21 for [**] and/or other customers of [**] during this period, [**] and these other customers will bear their appropriate proportionate share of the [**]. For the avoidance of doubt, in no event shall any of the cost components exclusive of the Manufacturing direct labor and direct material costs exceed [**]. For either (a) or (b) above, Fully Burdened Costs shall also include direct and indirect costs incurred by [**] as a result of [**] fulfilling its Manufacturing and supply obligations pursuant to this Agreement, but shall specifically exclude any costs or expenses otherwise payable or reimbursable by [**] hereunder, if applicable. Upon [**] by [**] to [**],[**] estimated Fully Burdened Cost details shall be updated annually (or semi-annually upon the request of Customer) by Supplier and shall be [**].View More
