definiens: means : ( a ) a business entity which owns, directly or indirectl y, a controlling interest in a party to this Agreement, by stock ownership or otherwise ; or ( b ) a business entity which is controlled by a party to this Agreement, either directly or indirectly, by stock ownership or otherwise ; or ( c ) a business entity, the controlling interest of whic h is directly or indirectly common to the majority ownership of a party to this Agreement ; ( d ) For the purposes of this definition, mean s the ownership of shares carrying at least a majority of the votes in respect of the election of the directors of a corporation ; shall have the meaning ascribed thereto in the pr eamble ; means all Laws to the extent applicable to the su bject matter of, or the performance by the parties of their respective obligations under, this Agreement, including, but not limited to, ( i ) with respect to [COMPANY], the Act and any other Laws of all jurisdictions where the Products are manufactured and packaged, and ( ii ) with respect to [COMPANY], the Law s of all jurisdictions where the Products are distributed and marketed ; means the annual report as described in 21 CFR, Se ction 314.81(b)(2 ) ; means the annual product review report as describ ed in 21 CFR, Section 211.180(e ) ; means any governmental or regulatory authority, d epartment, body or agency or any court, tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or muni cipal, including, but not limited to, the FDA ; means a day other than a Saturday, Sunday or a da y that is a statutory holiday in the State of West Virginia or the State of California ; means current good manufacturing practices as des cribed in Parts 210 and 211 of Title 21 of the United States ’ Code of Federal Regulations, togethe r with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time, including, but not limited to, the FDA ’s Guidance f or Industry, Manufacturing, Processing or Holding Active Pharmaceutical Ingredients ; shall have the meaning ascribed thereto in Sectio n 7.9(d ) ; means the certificate of analysis confirming the identity, strength, quality and purity of each batch of finished Product to which i t pertains ; means, collectively, all raw materials and ingred ients ( including Packaging components, labels, product inserts and other labeling for the Products ), required to be used in order to produce the Products in accordance with the Specifications, inc luding the Active Materials ; shall have the meaning ascribed thereto in Sectio n 11.1 ; shall have the meaning ascribed thereto in Sectio n 6.1(a ) ; shall have the meaning ascribed thereto in Sectio n 11.1 ; means free carrier, as that term is defined in IN COTERMS 2010 published by the International Chamber of Commerce ; means the United States government agency known a s the United States Food and Drug Administration, and any successor thereto ; has the meaning specified in Section 5.1(b ) ; shall have the meaning ascribed thereto in Sectio n 13.7 ; shall have the meaning ascribed thereto in Sectio n 10.4(a ) ; shall have the meaning ascribed thereto in Sectio n 10.4(a ) ; means Producer Price Index, Industry : Pharmaceuti cal Preparations, Series ID : pcu325412325412, as published by the U.S. Departmen t of Labor, Bureau of Labor Statistics