definiens: D250 D260 D350 D360 D500 D510 Facility Substantially Lost or Rejected " shall mean that with respect to a lot of Product, the loss or rejection of [ forty percent ( 40 % ) or more of the mean average batch yield of forty - eight thousand ( 48,000 ) ] * vials -[assuming an input of thirteen ( 13 ) bags of Bulk Drug per batch . I,, ] * Manufacturing Campaign " shall mean the manufacture of Product by Hospira where there is no break in between the manufacturing of two ( 2 ) or more lots of Product ( e.g. no other products are manufactured by Hospira in between such lots of Product).1.19 shall mean any corporation or non - corporate business entity which controls, is controlled by, or is under common control with a party to this Agreement ; a corporation or non - corporate business entity shall be regarded as in control of another corporation or non - corporate business entity if it owns, or directly or indirectly controls, in excess of fifty percent ( 50 % ) of the voting stock of the other corporation, or ( a ) in the absence of the ownership of in excess of fifty percent ( 50 % ) of the voting stock of a corporation or ( b ) in the case of a non - corporate business entity, if it possesses, directly or indirectly, the power to direct or cause the direction of the management of such other corporation or entity . " 3 . Liscate, Italy Facilitv . The parties agree to delete, render null and void and of no further effect all provisions in the Second Amendment to the Agreement, dated June 26, 2008 ( the ), related to the validation of Hospira 's facility in Liscate, Italy and manufacture of Product at such site . Accordingly, the following provisions of the Second Amendment ( and any amendments to [ Except for D500E ( Europe ), where the mean average batch yield is twenty - five thousand ( 25,000 ) vials, with an input of seven ( 7 ) bags of Bulk Drug per batch . ] * Page 2 of 19 * Confidential Treatment Requested . Omitted portions filed with the Commission