definiens: , as that term is defined in 21 U.S.C. § 355(j)(5)(B)(iv ) ( II ) ( as amended or replaced ), Markets a Generic Vial Product in the Territory or ( y ) for the [COMPANY] PF S Product, 181 days after any Third Party, who is the, Markets a Generic PFS Pro duct in the Territory, provided that the First Applicant for purposes of ( x ) or ( y ) has not forfei ted, relinquished, or otherwise waived its Hatch - Waxman exclusivity as described in 21 U.S.C. § 355 ( j)(5)(B)(iv)(II)(aa ) ( as amended or replaced ) ( ) ; ( iii ) ( x ) for the [COMPANY] Vial Product, the date on whi ch a Single - dose Vial Authorized Generic is first Marketed in the Territory by a Third Party ( not a F irst Applicant ) or ( y ) for the [COMPANY] PFS Product, the date on which a Single - dose Pre - filled Syringe Authorized Generic is first Marketed in the Territory by a Third Party ( not a First Applicant ) ; Confidential Settlement Agreement Page 9 of 32 ( iv ) ( x ) for the [COMPANY] Vial Product, the date on whic h a Third Party who is not a First Applicant, or who is a First Applicant but has forfeited, relinqu ished or otherwise waived its 180 - day exclusivity, Markets, or is first authorized by Plaintiffs to be gin Marketing, a Generic Vial Product in the Territory or ( y ) for the [COMPANY] PFS Product, the date on which a Third Party who is not a First Applicant, or who is a First Applicant but has forf eited, relinquished or otherwise waived its 180 - day exclusivity, Markets, or is first authorized by Plaintiffs to begin Marketing, a Generic PFS Product in the Territory ; ( v ) the date on which a Final Court Decision is ent ered holding that each of the asserted claims against [COMPANY] in the Lawsuit from the ’ 025, ’ 096, ’ 42 5, ’ 663, ’ 490, ’ 125, and ’ 445 Patents are ( A ) adjudicated invalid, unpatentable, and/or unenforce able or ( B)(1 ) for the [COMPANY] Vial Product, found not infringed ; or ( vi ) the date on which the ’ 025, ’ 096, ’ 425, ’ 663, ’ 490, ’ 125, and ’ 445 Patents have expired, been permanently abandoned, or delisted from the Orange Book . In the event Plaintiffs become aware of the actual date under ( ii ), ( iii ) or ( iv ) above, it shall give [COMPANY] notice of such date and, to the extent practicable, at least 180 days prior to such date . With respect to ( iii ), ( iv ), and ( v ), [COMPANY] ’s is still subject to any First Appli ca nt rights to the extent that the First Applicant has not forfeited, relinquished, or otherwise waive d its Hatch - Waxman exclusivity as described in 21 U.S.C. § 355(j)(5)(B)(iv ) ( as amended or replace d )