definiens: means, with respect to each Cell Therapy Product, all of the external and internal costs andexpenses ( including applicable overhead costs and expenses, including applicable general and administrative expenses, but excluding any Clinical Development Costs and Commercial Manufacturing Costs ) incurred or paid by [COMPANY] andits Affiliates in connection with the commercialization of Cell Therapy Products, including, without limitation, thefollowing costs to the extent such costs are actually incurred by a Party, accounted for in accordance with U.S. GAAP asconsistently applied by such Party and attributable to the promotion, marketing, advertising, sale, or distribution of theCell Therapy Product and preparing and conducting Phase IV Studies : ( a ) All direct costs of promoting, marketing, advertising and selling the Cell Therapy Product, including salescommissions, product labels, marketing brochures, graphic and media design, website modification and license fees ( ifany ) ; ( b ) All Third Party Payments ; and ( c ) A reasonable allocation of indirect costs associated with the foregoing ; provided that any costs described above incurred or paid by [COMPANY] and its Affiliates in connection with thepreparation for commercialization of a Clinical Development Candidate that [COMPANY] reasonably believes willobtain Regulatory Approval for at least one Cardiovascular Indication ( and thereby become a hereunder ) shall also be deemed to be