definiens: means the actual invoiced price paid by [COMPANY] to any Third Party for acquiring any raw materials, packaging components and intermediates used exclusively in the manufacture of the Product under this Agreement, including [ direct out - of - pocket shipping and handling costs and cust ~ ms duties incurred and paid by [COMPANY] ] in connection with the acquisition of such materials, packaging components and intermediates . 1.2 means, with respect to any Party, any other corporation or business entity that directly, or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Party . For purposes of this definition, the term means direct or indirect ownership of fifty percent ( 50 % ) or more of the securities or other ownership interests representing the equity voting stock or general partnership or membership interest of such entity or the power to direct or cause the direction of the management or policies of such entity, whether through the ownership of voting securities, by contract, resolution or otherwise . Notwithstanding the foregoing, Roche shall not be considered an Affiliate of [COMPANY]