definiens: shall mean, with respect to a Party, any recall or withdrawal that ( a ) is caused by oneor more of the following : ( i ) such Party ’s ( or its Affiliate ’s or subcontractors ’ ) negligence, gross negligence or willful misconduct oromission, ( ii ) safety issues with respect to such Party ’s APIs, ( iii ) breach by such Party ( or its Affiliate or subcontractor ) of this Agreementor any Ancillary Agreement, ( iv ) any event occurring while the applicable Territory Combination Product is under the control of such Party(or its Affiliate ) hereunder, including under the [COMPANY] Distributor Agreement, or ( v ) such Party ’s determination to withdraw a TerritoryCombination Product from the market in one or more countries in the Territory pursuant to Section 13.2.3 ; and ( b ) is not caused by any ofthe following : ( i ) the other Party ’s ( or its Affiliate ’s or subcontractor ’s ) negligence, gross negligence or willful misconduct or omission,(ii ) safety issues with respect to the other Party ’s APIs, ( iii ) the breach by the other Party ( or its Affiliate or subcontractor ) of this Agreementor any Ancillary Agreement, or ( iv ) any event occurring while such Territory Combination Product is under the control of the other Party ( orits Affiliate ) hereunder, including under the [COMPANY] Distributor Agreement