definiens: means : ( a ) in the case where [ * * ] Manufactures QS-21 for supply to [ * * ] hereunder, thetotal cost to Manufacture by [ * * ] and/or its Affiliates hereunder, which total cost shall include direct and indirect laborcosts, direct material costs ( including without limitation, raw materials, lab supplies and other materials used directly inManufacturing QS-21 ) and indirect material costs ( including without limitation shipping materials ( driven by shipmentsnot 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 ( ), and Other Overhead Costs calculated in accordance with GAAP [ * * ] ; or ( b ) in the case where [ * * ] engages a Third Partyto Manufacture QS-21 on its behalf for supply to [ * * ] hereunder, the actual cost to [ * * ] to have QS-21 Manufactured andsupplied by such Third Party, including without limitation, direct and indirect costs borne by [ * * ] for any internal qualityassurance, quality control, fill / finish, packaging, shipping, and/or delivery, in each case as duly documented by [ * * ] . Inthe 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 [ * * ] beincluded as part of the Fully Burdened Costs . [ * * ] In the event that [ * * ] Manufactures QS-21 for [ * * ] and/or othercustomers 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 directlabor and direct material costs exceed [ * * ]