definiens: means, with respect to the Licensed Products, the reasonable FTECosts and Out - of - Pocket Costs of a Party or any of its Affiliates or sublicensees incurred inManufacturing the Licensed Products, excluding Manufacturing Scale - Up Costs, but including:(h ) to the extent that the Licensed Products are manufactured by a Party or any ofits Affiliates or sublicensees, direct material and direct labor costs, plus manufacturing overheadattributable to the Compound and any Products ( including facility start - up costs, all directlyincurred manufacturing variances, and a reasonable allocation of related manufacturingadministrative and facilities costs ( including depreciation ) and a reasonable allocation of thecosts of failed batches to be further described in the applicable supply agreement, to be providedfor the Licensed Products, but excluding costs associated with excess capacity ), all determinedin accordance with the books and records of the applicable Party or its Affiliates or sublicenseesmaintained in accordance with the Accounting Standards, consistently applied ; and(i ) to the extent that the Licensed Products are manufactured by a Third Partymanufacturer, the Out - of - Pocket Costs paid by a Party or any of its Affiliates or sublicensees tothe Third Party for the manufacture, supply, packaging and labeling of the Licensed Products, and any reasonable Out - of - Pocket Costs and direct labor costs actually incurred by such Party orany of its Affiliates or sublicensees in managing or overseeing the Third Party relationship, determined in accordance with the books and records of the applicable Party or its Affiliates orsublicensees maintained in accordance with the Accounting Standards, consistently applied