definiens: shall mean, except as provided below, a Person that, directly or indirectly, through one or more interme diaries, controls, is controlled by or is under common control with [COMPANY] or [COMPANY] . For purposes of this definition, shall mean the posses sion, direct or indirect, of the power to cause the direction of the management and policies of a Person, whether through ownership of fifty percent ( 50 % ) or more of the voting securities of such Person, by contract or otherwise . Affiliate [ * * * ] shall [ * * * ] 1.3 shall mean the following information : ( 1 ) information disclosed in the BLA for Infergen as of the Effecti ve Date, ( 2 ) information disclosed as of the Effective Date in any BLA suppl ements for Infergen, ( 3 ) all [COMPANY] - sponsored investigator - driven clinical trial results, and the results of the Ongoing Clinical Trials, ( subject to any contra ctual confidentiality obligations of [COMPANY] to Third Parties regarding suc h results ) ; ( 4 ) Infergen sales and marketing training materials ; ( 5 ) any reg ulatory data which [COMPANY] provides to [COMPANY] pursuant to Section 4.3 ; ( 6 ) [ * * * ] ; ( 7 ) the safety and clinical database referenced in Section 4.8 ; and ( 8 ) Formulating Know - How ( as defined in Section 12.1 of Exhibit F )