definiens: means the sum of the following costs incurred by Generex to the extent allocable to Products and components thereof sold to [COMPANY] : Generex 's cost of direct materials, direct labor and manufacturing overhead . For avoidance of any doubt, notwithstanding anything to the contrary in this Agreement, lrex 's Fully Burdened Manufacturing Cost shall specifically exclude ( i ) capacity costs not allocable to Products ; ( ii ) any cost associated with reimb g [COMPANY] with respect to Wasted Compound ; ( iii ) any royalties and/or indemnification that Generex is obligated to pay under this Agreement ( e.g., Sections 6.3(c ), 6.3(d ), 11.2 and 13.3 ) ; ( iv ) any costs incurred by Generex in connection with improvements and changes to the Standard Device as described in Section 3.1(a ) of this Agreement ; ( v ) any item that Generex is financially responsible for under this Agreement ( except direct depreciation associated with manufacturing as allowed for in Section 7.1 ( f)(2 ) ) ; or ( vi ) any item that Generex has already been compensated for by [COMPANY] under this Agreeme ~ Generex 's Fully Burdened Manufacturing Cost shall be calculated in a manner sistent with Generally Accepted Accounting Principles ( ) consistently applied . Furthermore, the methodology to be used in making the allocations referred to above shall be disclosed by Generex to [COMPANY] and shall be consistent with Generex 's methodology for other products and shall be consistent from year - to - year