definiens: shBIl mean II Licmscd Produ ~ t that is protected ( ll ) by -Orphan Drug " status under the U.S. Orphan DN & ACI, ( b ) by a Supplementary ProtCCl1on Ccrtificale, as JU<;b tem\ i~ defined in CoWle;J RrauJation ( EU ) No . 1768J92, or ( e ) by a similar 1\.a11lS jp'aIlted under sirmlar Jlatutory provisions or another jurisdiclion 4 I 1 I J I J J J J ' J 1 : J ~I ' J : J • J • J I J J 1.28 . ~ht .,'1 t Rigtll::S~ sl'lall mean any WId & II ( a ) pakllUl, ( b ) pendinl pat<:nl applications, indudi " " withou . limitation, all provisionpJ applicatiuns . < ; oounuaUolI$, continuations - in - pan, divisioos, ~ renewals, and all ~ gnlJllm thereon, and ( el all pamlls - of - addition, rUssue paten!$, rcelUll!IinatiOllll and exll'Mi<;ms or = lonItioos by existing or future ntensioo . or reswralion mechanisms, including . without limitation, supplementary protection cmificates or ! be equivalelll therrof