definiens: has the meaning specified in Section 2.4 ; means : ( a ) a business entity which owns, directly or indirectly, a controlling interest in a party ; or ( b ) a business entity which is controlled by a party, either directly or indirectly ; or ( c ) a business entity, the controlling interest of which is directly or indirectly common to the majority ownership of a party ; For this definition, means the lawful right to determine ( by ownership of shares or otherwise ) the election of the majority of directors ( or equivalent managers ) of a business entity ; means the active m aterial Tenapanor ( references to or in this Agreement will mean ) ; means the value of the API on an actual cost per [ * * * ] basis ( [ * * * ] ) ; means ( i ) [ * * * ] ; and ( i i ) [ * * * ] ; means any governmental or regulatory authority, department, securities exchange, body or agency or any court, tribunal, bureau, commission or other similar body, whether foreign, federal, state, provincial, county or municipal, with c ompetent jurisdiction over a party, the Manufacturing Services, or the Product ( or its use ) ; means a day other than a Saturday, Sunday or a day that is a statutory holiday in [COMPANY] ’s resident jurisdiction, Client ’s resident jurisdiction, o r the jurisdiction where the Manufacturing Site is located ; means, as applicable, current good manufacturing practices as described in : ( a ) Parts 210 and 211 of Title 21 of the United States ' Code of Federal Regulations ; ( b ) Commission Directiv e ( EU ) 2017/1572 ( art . 2 ) ; and ( c ) Division 2 of Part C of the Food and Drug Regulations ( Canada ) ; together with current final industry -accepted Health Canada, FDA and EMA guidance documents pertaining to manufacturing and quality control practice, all a s updated, amended and revised from time to time ; May 18, 2020 Manufacturing Services Agreement between [COMPANY] and [COMPANY], Inc