definiens: means, with respect to API Bulk Drug Substance, Fin ished Drug Product or placebo, as the case may be, Manufactured under this Agreement, the reason able internal and external costs of a Party or any of its Related Parties incurred in Manufactu ring such API Bulk Drug Substance, Finished Drug Product or placebo, including : ( a ) to the extent th at such API Bulk Drug Substance, Finished Drug Prod uct or pla cebo is Manufactured by a Party or any of its Relat ed Parties, direct material ( including shipping ) and direct labor costs, plus a reasonable allocatio n of Manufacturing plant overhead ( including start- up costs and depreciation ) and a reasonable allocation of the costs of failed batches, to be further descr ibed in the Supply Agreement, but excluding corporate an d administrative overhead and costs associated with excess capacity, all determined in accordance with the books and records of the applicable Party or its Related Party(ies ) maintained in accordance with GA AP, consistently applied and ( b ) to the extent that such API Bulk Drug Substance, Finished Drug Product or placebo is Manufactured by a Third Party manufacturer, the actual fees paid by a Party or an y of its Related Parties to the Third Party for the - 4 - [ * * ] = Portions of this exhibit have been omitted p ursuant to a confidential treatment request