definiens: shall mean:(i)any product for delivering transgenes, in a lentiviral - based vector, which transgenesencode proteins having the enzymatic or cofactor activities of any one or two or three ofthe following : AADC ( aromatic L - amino acid decarboxylase ), TH ( tyrosine hydroxylase),or CH1 ( GTP cyclohydrolase 1 ), in each case either alone or in combination with othertherapeutic moieties, but excluding a BioMedica Reserved Product, and(ii)any product for delivering transgenes, in a lentiviral - based vector, which transgenesencode proteins having the enzymatic or cofactor activities of all three ( 3 ) of the following : AADC ( aromatic L - amino acid decarboxylase ), TH ( tyrosine hydroxylase ), and CH1(GTP cyclohydrolase 1 ), and any other therapeutic moiety where the therapeutic effect ofsuch product is the increased production of dopamine