definiens: means ( i ) the Orphan Product Designation from the Department of Health and Human Services, Food and Drug Adminis tration Office of Orphan Products Development for C holic Acid, designated as of 07 - 18 - 2003, under the name as a for the treatment of inborn errors of cholesterol and bile acid synthesis and metabolism under the Orphan Drug Act, as amended, and implementing regulations at 21 C.F.R. Part 316, and ( ii ) the designation of Cholic Acid a s an orphan medicinal product under Regulation ( EC ) No 141/2000 of the European Parliament and of the Council by t he Commission of the European Communities ( EU orphan d esignation number : EU/3/09/683 ) to Seller ’s wholly - owned subsidiary, ASK Pharmaceuticals GmbH Heimeran straße 35, D-80339 München, Deutschland, for the treatment of inborn errors of primary bile acid syn thesis responsive to treatment with Cholic Acid