definiens: means the possession, directly o r indirectly, of the power to direct or cause the direction of the management and policies of such firm, person or company, whether through the ownership of voting securities, by contract or otherwise, or the ownership either directly or indirectly of 50 % or m ore of the voting securities of such firm, person or company ; 1.2 Agreement shall mean this licensing and distribution agreemen t and the appendices hereto ; 1.3 BfArM shall mean Bundesinstitut für Arzneimittel und Medi zinprodukte ( Federal Institute for Drugs and Medical Devices ) in Germany, and any succ essor agency thereto ; 1.4 Business Day shall mean any day other than Saturday or Sunday on which the banks in London are open for business ; 1.5 Clinical Trial Materials shall mean the Product to be used by DESITIN in con nection with the development and registration process in the Territory ; for the avoi dance of doubt Clinical Trial Materials shall exclude all packaging and blinding thereof ; 1.6 Confidential Information shall mean any scientific, technical, formulation, process, manufacturing, clinical, non - clinical, regulatory, marketing, financial or comme rcial information or data relating to the business, projects or products of either Party and provided by one Party to the other by written, oral, electronic or other means in connect ion with this Agreement ; 1.7 cGMP shall mean current good manufacturing practices as set out under the European Directive 2003/94 / EC and promulgated by the International Con ference on Harmonisation, as the same may be modified or amended from time to time ; 1.8 shall mean costs to produce Clinical Trial Material s and/or commercial supplies of Product to the extent that such costs would ordinar ily be included as a Cost of Goods sold in accordance with U.S. generally accepted accounti ng principles, including : ( a ) the amounts paid by ZOGENIX or its Affiliates for ( i ) manufacturing, filling and/or finishing Product, but excluding costs, charges and allocatio ns related to or occasioned by unused manufacturing capacity, ( ii ) transporting, storing and insuring Product, and ( iii ) testing Product, including with respect to the foregoing su bsections ( i ) – ( iii ), all taxes ( other than income taxes ) and customs duty charges imposed by governmental authorities with respect thereto ; ( b ) to the extent not included in subsection ( a ), the direct costs and charges incurred by ZOGENIX or its Affiliates in co nnection with the manufacture, filling, finishing, testing, storing, insuring and transportation of the Product, including direct internal costs with respect thereto ; ( c ) to the extent not included in subsection ( a ), ZOGENIX ’s or its Affiliate ’s intellectual property acquisition and licensing costs ( including royalties ) paid to Third Parties ( i ) dir ectly allocable to the applicable Product to the extent that such intellectual property is re quired for the manufacture of such Product in the country of manufacture and ( ii ) actu ally incurred by ZOGENIX or its Affiliates and not otherwise reimbursed by or paid for by any Third Parties ; and ( d ) to the extent not included in subsection ( a ), allocable de preciation, amortization and facilities costs ( e.g., sewer, water, property taxes ), with an y such allocations made on the basis of theoretical full capacity operation of the relevant facility, adjusted for changeovers in production runs, and excluding costs and charges re lated to or occasioned by ( i ) unused manufacturing capacity not reserved for the product ion of Product ; ( ii ) the manufacture of other products at the manufacturing party ’s faci lities, and ( iii ) allocation of general corporate overhead ; 1.9 Change of Control shall have the meaning as given to it in Clause 2.3 ; 1.10 Committee Members shall have the meaning as given to it in Clause 4.1 ; * * * Certain information on this page has been omitted a nd filed separately with the Commission . Confidenti al treatment has been requested with respect to the om itted portions