definiens: means, with respect to [COMPANY] ’s suppl y of Product and/or provision of Services hereunder, [COMPANY] ’s reasonable, documented costs, including b ut not limited to such costs of all raw materials, intermediates, reagents, solvents, excipients, comp arators, packaging and labeling supplies, shipping expenses, and externally contracted materials or services and labor used or consumed in provision of Services, i ncluding all overhead amounts reasonably allocable to such Produ cts and/or Services hereunder, provided that ( i ) al l of the foregoing shall be calculated in accordance with U. S. GAAP and ( ii ) such costs shall not include any c osts for lot failures, batch failures, or other quality control, production, or performance failures to the extent such failures result from any factors reasonably within [COMPANY] ’s ( or its Affiliates ’ or third party contractors ’ ) c ontrol or any negligence, intentional misconduct, or breach of th is Agreement by [COMPANY], any Affiliate thereof, or any employees, agents, contractors, directors, officers, or other representatives of any of the foregoing