definiens: means a product ( i ) that contains the same chemical entity as a Product that has receivedRegulatory Approval to be marketed by ASTELLAS, its Affiliates or sub licensees or ( ii ) would be deemed tobe a generic medicinal product under the terms of Article 10 of Directive 2001/83 / EC or any equivalentlegislation in a country in the Territory in relation to the Product that has received Regulatory Approval to bemarketed by ASTELLAS, its Affiliates or sub licensees or ( iii ) that contains the same chemical 5 [ * * * ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HASBEEN REQUESTED . ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES ANDEXCHANGE COMMISSION PURSUANT TO 17 C.F.R. SECTIONS 200.80(B)(4 ) AND 240.24B-2