definiens: shall mean an amount equal to ALIMERA ’s and/or its Affiliate ’s costs directlyallocated to the Licensed Products distributed for, as the case may be, test marketing, sampling and promotionaluses, clinical trial purposes, regulatory approval or compliance, compassionate uses, global access programsintended to provide Licensed Product at reduced prices in the developing world, or other similar uses, consisting of:(i ) direct labor, including all resources utilized in support of ALIMERA ’s and/or its Affiliate ’s manufacturing operations;(ii ) materials ; ( iii ) a reasonable allocation of overhead, facilities expense ( including depreciation over the expected lifeof the buildings and equipment ), and administrative costs directly in support of such manufacturing operationscalculated by ALIMERA and/or its Affiliate in accordance with reasonable cost accounting methods consistent withthe way ALIMERA and/or its Affiliate allocates such costs to other products ; and ( iv ) third - party costs . For the sake ofclarity, in no event shall ALIMERA incur an obligation to pay royalties to EMORY for Licensed Products distributed fortest marketing, sampling and promotional uses, clinical trial purposes, regulatory approval or compliance, compassionate uses, global access programs intended to provide Licensed Product at reduced prices in thedeveloping world, or other similar uses, if payment of such royalty would cause ALIMERA to realize a loss ; however, should ALIMERA realize a profit on such distributions, it is the intent of the parties that ALIMERA would incur anobligation to pay royalties to EMORY on such profit