definiens: means a Product to which, under Applicable Law, data exclusivity protection and / ormarket exclusivity protection has been afforded and is in effect, including : ( a)Market exclusivity respecting introduction of a new chemical entity ( NCE ) to the market, as provided underthe US Hatch - Waxman Act ( 1984 ) as amended ; ( b)Market exclusivity respecting introduction of an orphan drug to the market, as provided under the US OrphanDrug Act ( 1983 ) as amended ; ( c)Market exclusivity respecting introduction of a pediatric drug to the market, as provided under the US BestPharmaceuticals for Children Act ( 2002 ) as amended ; [ † ] DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUESTFOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION 8 ( d)Data exclusivity and/or market exclusivity for a new drug, including any extensions thereto, each pursuant tothe EU Data Exclusivity Regulation ( EC ) No . 726/2004 as amended ; ( e)Market exclusivity respecting introduction of an orphan drug to the market pursuant to the EU Orphan DrugRegulation ( EC ) No 141/2000 as amended ; and ( f)Market exclusivity respecting introduction of a pediatric drug to the market pursuant to the EU Regulation(EC ) No 1901/2006 ( Paediatric Regulation ), including data exclusivity and/or marketing exclusivity under thePaediatric Use Marketing Authorization ( PUMA),and any other similar legislation or regulations to the above, and any successor legislation or regulations relatingthereto, in any jurisdiction in the Territory