definiens: shall mean the sum of XOMA US ' Direct Manufacturing Cost and XOMA US ' Fixed Manufacturing Overhead, including, but not limited to, all costs of materials, labor and reaso nable allocations of overhead necessary to perform receiving, manufacturing, assa ying, release testing, packaging, labeling, shipping ( excluding distributi on to customers ), quality assurance and other tasks required for compliance w ith governmental regulations which govern the manufacture of a pharmaceutical pr oduct . Cost of Manufacturing shall also include the full cost associated with qu ality control samples and retention samples and shall not include any fully b urdened costs associated with production failures which cause the actual success ratio for the plant to fall below the lowest point of the expected success rati o range allowed for such plant as determined by the Project Core Team . In th e event that one or more Third Parties manufacture the product ( or any part thereof ), Cost of Manufacturing shall mean the amount paid under the contract arrangement with such Third Parties