definiens: means, with respect to a particular Licensed Olig o or Licensed Product : ( a ) if such Licensed Oligo or Licensed Product is manuf actured by a Third Party manufacturer, ( i ) Miragen or [COMPANY] ’s actual Third Party cost ( e xpressed on a per unit manufactured basis ) of manuf acturing, processing, testing, filling, finishing, packaging and labeling such Licensed Oligo or Licensed Produc t, and ( ii ) any costs incurred by Miragen or [COMPANY] for m anufacturing oversight and quality assurance with r espect to such Licensed Oligo or Licensed Product, [ * ] ; ( b ) if such Licensed Oligo or Licensed Product is manuf actured by Miragen or [COMPANY], the actual, fully - burdened cost of manufacturing, processing, t esting, filling, finishing, packaging and labeling such Licensed Oligo or Licensed Product, including witho ut limitation raw materials, direct labor and benef its, and the proportionate share of indirect manufacturing c osts . For clarity, such fully - burdened cost shall b e calculated ( i ) on a theoretical full - capacity basis ( with reas onable changeover and maintenance downtime ) with th e percentage allocable to Cost of Goods representing the number of units or runs of Licensed Oligo or Li censed Product produced or performed as a percentage of th e total number of units or runs, including those of other products, that could be manufactured in such facili ty during a calendar year and ( ii ) in accordance wi th IFRS or GAAP, whichever such manufacturing Party uses throu ghout its organization at the time in question, consistently applied with allocations by Miragen or [COMPANY] calculated in accordance with a methodolog y unanimously approved by the JSC ( which methodology shall be consistent with IFRS or GAAP, as applicabl e ) and based upon all similar activities conducted by Miragen or [COMPANY] ( i.e., not to disproportionately allocate costs to manufacturing of Licensed Oligo or License d Products when compared to similar costs for other manufacturing activities of Miragen or [COMPANY] ) . Co sts that can not be identified to a specific activit y supporting product manufacturing, such as charges for central corporate overhead that are not controllable by the manufacturing plant, shall not be included in the d etermination of Cost of Goods