definiens: means, with respect to Product or any Product Component supplied by or on behalf of [COMPANY] hereunder ( whether in bulk form, as unmarked or in final packaging, a s applicable ): ( a)in the case of Product or any Product Component manufactured by a Third Party, payments made to such Third Party for such Product or Product Component, plus reasonable and documente d internal and external costs and expenses incurred b y [COMPANY] for quality assurance, quality control, r elease testing, stability testing, labeling, packaging, warehousing and transportation of such Product or Product Comp onent, in each case, determined in accordance with Accounting Standards ; and - 4 - ( b)in the case of Product or any Product Component manufactured by [COMPANY] or its Affiliate, the actua l fully - allocated cost of manufacturing such Product or Pro duct Component ( in accordance with cGMP, if applica ble ), determined in accordance with Accounting Standards, consistently applied, which includes, without limi tation, the direct and indirect cost of any raw materials, pack aging materials and labor ( including benefits ) util ized in such manufacturing ( including formulation, filling, fini shing, quality assurance, quality control, stabilit y testing, release testing, labeling and packaging, as applicable ), an d reasonable and documented internal and external c osts and expenses incurred by [COMPANY] for warehousing and tr ansportation, plus an appropriate share of all fact ory overhead, both fixed and variable, allocated to the applicable Product or Product Component being manu factured, in accordance with the normal accounting practices for all other products manufactured in the applicab le facility