definiens: , or means the materials listed in a Product Agreement on Schedule D ; [ * * * ] ; [ * * * ] ; [ * * * ] ; 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, e ither 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 ; For this definition, means the ownership of shares carrying at least a majority of the votes for the election of the directors of a corporation ; means the annual product review report prepared by [COMPANY] or an Affiliate of [COMPANY] as described in Title 21 of th e United States Code of Federal Regulations, Sectio n 211.180(e ) ; means the annual report to the FDA which is requi red to be prepared and filed by Client regarding the Product as described in Title 21 of the United States Code of Federal Regulations, Section 314.81(b)(2 ) ; [ * * * ] ; means [ * * * ] - 2 - THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT O F A CONFIDENTIAL TREATMENT REQUEST