definiens: means, with respect to a Licensed Product supplied to [COMPANY] pursu ant to this Agreement, and without duplication : ( a ) Esperion ’s or its Affiliate ’s internal costs for the Manufacture and supply of such Licensed Product, including, without limitation : ( i ) direct material costs ( the actual costs incurred in Manufacturing o r purchasing materials for Manufacture, including freight -in costs, sales and excise taxes imposed thereon ( provided that Esperion and its Affiliate will use Commercially Reasonable Efforts to avoid or minimize such taxes ) and customs duty and charges levi ed by government authorities, and all costs of packaging components ), ( ii ) direct labor costs ( the actual cost of employees engaged in direct Manufacturing activities ), ( iii ) costs of quality assurance and quality control activities ( including the actual c ost of employees -3- [ * * * ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED . ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b -2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED engaged in such activities ), ( iv ) storage, packaging and shipping costs, and ( v ) indirect charges and overhead that are reasonably allocable to such Manufacturing, including applicable FTEs, all of the foregoing determined in accordance with IFRS or U.S. Generally Accepted Accounting Principles consistently applied ; and ( b ) the actual Out -of - Pocket Costs paid by Esperion to a CMO or other Third Party Manufacturer for the Manufacture and supply of Licensed Product s without mark -up