definiens: means : ( i ) the development of a final fonnulation of the Product \vith acceptable phannacokinetic and safety properties, in particular, 10\v inter­patient variability and a profile indicating bioequlvalence to ACTIQ@ ( generally determined by ( A ) meeting the FDA 's requirement for showing bioequivalence ( i.e., 801 % to 125 % ofCmax and AUC ) and ( 8) showing no greater inter patient variability compared to Actiq by measurement of Cmax and AUC ) ; ( ii ) the Company shall have delivered to the FDA and [COMPANY] ( A ) a report confirming acceptability of the synthesis steps, physicochemical characteristics and impurity profile for each API selected by the Company, and ( 8) complete CMC documentation describing changes in the Product fOlIDulation and scientific justification for such changes in the fonnulation components selected by the Company for its Phase III studies ; ( iii ) the initiation ( first patient treated ) of a Phase III Clinical Trial by the Company on or prior to February 28, 2006 ; ( iv ) the Company shall have ( A ) obtained a binding and enforceable license to any Patents and other related Know - How o\vned, Controlled by or licensed by any third party which may { OI)()()O()25.f)(X·.l.1 - 3 -***CO ~ FJDENTIAL TREATI\IENT REQlJESTED * * * ] \jote : The portions hereof for which confidential tr ~ atmeot are being requested are denoted with bold and douhle - underlined lallguag~ impact the method of rna king, use or sale of the Product . the tenus and condition of which license ( including the scope, tenn and consideration with respect to such license ) shall be in a form and substance satisfactory to [COMPANY] in its sale and absolute discretion ; or ( B ) entered into a binding and enforc·cablc agreement which would preclude any third party from enforcing Patents against the Company or its successors, assigns and sublicensees in connection with the use, manufacture and sale of Product ; ( v ) the Company shall have entered into supply agreements for hath clinical and commercial supply of the Product, pursuant to terms and conditions \vhich shall be satisfactory in both form and substance to [COMPANY], in its sole and absolute discretion, and ( vi ) the Company and Subsidiary shall have entered into a Security Agreement substantially in the form attached hereto as Schedule 1.18, and [COMPANY] shall have obtained a valid and enforceable first priority lien on all assets related to the Product, and all third parties shall have released any and all liens on assets related to the Product ( provided, however, that the hens in favor of Laurus Master Fund, Ltd. shall only be required to be subordinated to the lien of [COMPANY] rather than released ) in accordance with terms and conditions satisfactory to [COMPANY], and [COMPANY] shall have obtained a legal opinion from Company counsel to such effect