definiens: means, with respect to ZIOPHARM Products, the FTE costs ( under a reasonable accounting mechanism to be agreed upon b y the Parties and out - of - pocket costs of a Party or any of its Affiliates incurred in manufacturing such ZIOPH ARM Products, including costs and expenses incurred in connection with ( 1 ) the development or validation o f any manufacturing process, formulations or delive ry systems, or improvements to the foregoing ; ( 2 ) manu facturing scale - up ; ( 3 ) in - process testing, stabili ty testing and release testing ; ( 4 ) quality assurance / quality control development ; ( 5 ) internal and Third Party c osts and expenses incurred in connection with qualification and validation of Third Party contract manufacturer s, including scale up, process and equipment validatio n, and initial manufacturing licenses, approvals an d inspections ; ( 6 ) packaging development and final pa ckaging and labeling ; ( 7 ) shipping configurations a nd shipping studies ; and ( 8) overseeing the conduct of any of the foregoing . shall further include : ( a ) to the extent that any such ZIOPHARM Product is Ma nufactured by a Third Party manufacturer, the out - of - pocket costs incurred by such Party or a ny of its Affiliates to the Third Party for the man ufacture and supply ( including packaging and labeling ) thereof, and any reasonable out - of - pocket costs and direct l abor costs incurred by such Party or any of its Affiliates in managing or overseeing the Third Party relationship determined in accordance with the books and records of such Pa rty or its Affiliates maintained in accordance with US GAAP ; and ( b ) to the extent that any such ZIOPHARM Product is ma nufactured by such Party or any of its Affiliates, direct material and direct labor costs attributable to such ZIOPHARM Product, as well as r easonably allocable overhead expenses, determined in accordan ce with the books and records of such Party or its Affiliates maintained in accordance with US GAAP