definiens: means the centralized EU marketing authorization held by Seller ’s wholly - owned subsidiary, ASK Pharmaceutica ls GmbH Heimeranstraße 35, D-80339 München, Deutschland, relating to the product named ( previously Cholic Acid FGK ) for the therapeutic a reas of and therapeutic indicat ion of the treatment of inborn errors in primary bi le acid synthesis due to Sterol 27 - hydroxylase ( presenting as cerebrotendinous xanthomatosis, CTX ) deficiency, 2- ( or a- ) methylacyl - CoA racemase ( AMACR ) deficiency or Cho lesterol 7a - hydroxylase ( CYP7A1 ) deficiency in infa nts, children and adolescents aged 1 month to 18 years a nd adults, with agency product number EMEA / H / C/0020 81 -T/0004 and the date of issue of marketing authoriza tion valid throughout the European Union : 04/04/20 14