definiens: means, on a country - by - country basis in the Terri tory, ( a ) the Reference Product, ( b ) a therapeutic product other than the Product that contains the active pharmaceutical ingredient of the Reference Product ( including the Drug Substance or a modified or derivative version thereof ) as its sole active pharmaceutical ingredient or ( c ) any revised formulation, strength, presentation or delivery method of any product described in ( a ) or ( b ), where the Regulatory Mater ials with respect thereto reference or would be required to reference the Reference Produc t, in the case of ( c ), to the extent such product is labeled for use for the same indication as the Reference Product as of the Effective Date . For clarity, Competing Product excl udes any [ * * * ] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both ( i ) not material and ( ii ) would be competitively harmful if publicly disclosed