definiens: shall mean, with respect t o a Party for a given Calendar Year, ( a ) with respe ct to Product in its respective form ( Drug Substance, Drug Produc t, Finished Product ), such Party ’s reasonable best estimate of its Fully Burdened Manufacturing Costs for such Pro duct for such Calendar Year ( without markup ) based on such Party ’s Fully Burdened Manufacturing Costs for the prior Calendar Year for such Product and any antici pated changes in Fully Burdened Manufacturing Costs for s uch Calendar Year ( e.g., manufacturing efficiencies, changes in cost of raw materials ) calculated on a per unit basis ( i.e. kilogram for Drug Substance, and unit f or Drug Product and Finished Product ) and, for Finished Product, on a per Presentation basis, for such Party and with respect to Drug Product and Finished Product, each Party may h ave a different Standard Cost for each Permutation of each applicable Presentation of such Product, in each ca se determined pursuant to Section 4.2 and ( b ) with respect any manufacturing - related services ( e.g., filling, fini shing, packaging and labelling ) that one Party perf orms for the other Party, the cost for such services determined by the Parties based on the Fully Burdened Manufact uring Costs of performing such services ( without mark - up ), in e ach case ( ( a ) and ( b ) ), in accordance with such Par ty ’s Accounting Standards . For clarity, if Finished Prod uct distributed by a Party contains Drug Substance supplied by the other Party or the other Party performed any ma nufacturing services ( e.g., filling, finishing, pac kaging and labelling ) with respect to such Finished Product, t hen such Party would pay the other Party such other Party ’s Standard Costs for such Drug Substance or such serv ices and such Standard Costs shall be included in t he Standard Cost for such Finished Product for such first Party . A Party may have a different Standard Costs for D rug Product or Finished Product that is manufactured entirely b y or on behalf of such Party as well as Drug Produc t or Finished Product that is filled, finished, packaged or label led, or incorporates Drug Substance or Drug Product supplied by or on behalf of the other Party ( each such permutat ion of Drug Product or Finished Product that is man ufactured using a different combination of materials and serv ices provided by or on behalf - 18 - of the Parties, a ) . Notwithstanding the foregoing, a Party may calc ulate and use a blended Standard Cost for use with all Permutations of a Presentatio n of Drug Product or Finished Product as provided i n Section 4.2, in its own discretion