definiens: means all reasonable out of pocket Third Party expenses incurred for the Territory byTakeda related to each Phase III Trial which [COMPANY], at the initiation of such Phase III Trial, reasonably intends willbe used in support of a Regulatory Approval Application in North America for any Product in the Territory and, unlessotherwise agreed by both Parties in writing at the JSC, includes at least one clinical site located in North America, including expenses arising from : ( a ) the activities related to the performance of such Phase III Trial ; ( b ) ManufacturingExpenses for Product used in connection with such Phase III Trial ; ( c ) preparation, filing, and maintenance ofRegulatory Documentation ; and ( d ) any Product Liabilities arising from the conduct of such Phase III Trial relating to aProduct being used in such Phase III Trial ; provided, however, any Product Liabilities that are the result of a Party’snegligence, gross negligence, illegal conduct, willful misconduct or breach of such Party ’s representations orwarranties are expressly excluded from the definition of Phase III Trial Expenses, and shall be treated as the sole andexclusive responsibility of the Party whose actions or omissions gave rise to such Product Liabilities . Phase III TrialExpenses shall not include any costs to conduct stability trials, bridging trials, national registration trials, or otheractivity to the extent such activity is intended to obtain Regulatory Approval solely in a jurisdiction other than NorthAmerica, regardless if such clinical trial occurs concomitantly with a Phase III Trial . For the avoidance of doubt, eitherParty ’s Internal Expenses related to the Development of a Compound or a Product shall not be a Phase III TrialExpense