definiens: means all reasonable out of pocket Third Party expenses incurred for North Americaby [COMPANY] related to a Phase IV Trial for any Product in North America, including expenses arising from : ( a ) theactivities related to the performance of the Phase IV Trial ; ( b ) Manufacturing Expenses for Product used in connectionwith such Phase IV Trial ; ( c ) preparation, filing, and maintenance of Regulatory Documentation ; and ( d ) any ProductLiabilities relating to a Product being used in the course of such Phase IV Trial ; provided, however, any ProductLiabilities that are the result of a Party ’s negligence, gross negligence, illegal conduct, willful misconduct or breach ofsuch Party ’s representations or warranties are expressly excluded from the definition of Phase IV Trial Expenses, andshall be treated as the sole and exclusive responsibility of the Party whose actions or omissions gave rise to suchlosses, damages, fees, costs and other Liabilities