definiens: shall mean anyProceeding arising anywhere in the world in which any Party or any of its Indemnified Persons is involved or threatened to be involved tothe extent such Proceedings arise from personal injury or death caused by a Territory Combination Product due to defects or the inherentcharacteristics of such Territory Combination Product, ( a ) where the preponderance of the evidence indicates that such defects orcharacteristics are the direct result of both ( i ) the Supplied RPV and ( ii ) TDF, TAF or FTC or any combination of the foregoing beingincorporated into such Territory Combination Product, ( b ) where it ultimately can not be or is not determined whether such defects orcharacteristics are the direct result of the Supplied RPV, on the one hand, or the TDF, TAF or FTC or any combination of the foregoing, on the other hand, being incorporated into such Territory Combination Product, or ( c ) where such defects or characteristics are the directresult of an aspect of such Territory Combination Product other than any of its APIs, except, in each case ( ( a ), ( b ) and ( c ) ), to the extentsuch Proceeding arises from personal injury or death caused by a Territory Combination Product due to the Label Characteristics, whichProceeding is covered in Section 18.2.2