definiens: means with respect to either one of the parties, any person, firm, trust, corporation orother entity or combination thereof which directly or indirectly ( a ) controls saidparty, ( b ) is controlled by said party, or ( c ) is under common control with said party;the terms and meaning ownership of fifty percent ( 50 % ) ormore, including ownership by trusts with substantially the same beneficial interests, ofthe voting and equity rights of such person, firm, trust, corporation or other entity orcombination thereof or the power to direct the management of such person, firm, trust, corporation or other entity or combination thereof ; means a calendar quarter ending on 31st March, 30th June, 30th September and 31stDecember in any Calendar Year ; means the twelve ( 12 ) month period from January 1st to December 3l ; means the date of execution of this Agreement ; means the level of resources, effort and urgency to market and sell the Product in theTerritory applied by the Distributor that is consistent with the Distributor ’s practicesin actively pursuing the marketing and sales of its other pharmaceutical products at asimilar stage of product life to the Product and of similar market potential and profitpotential based on conditions then prevailing, taking into account, without limitation, competing products, market demand, proprietary position, safety, regulatory statusand pricing, medical or scientific developments, in the Indication, any adversegovernmental interventions and any potential legal liability or other legal issues ; 2st means, with respect to any material, information, or intellectual property right, thata party owns or has a license to such material, information, or Intellectual Propertyright and has the ability to grant to the other party access, a license, or a sublicense(as applicable ) to such material, information, or Intellectual Property right on theterms and conditions set forth herein without violating the terms of any agreementor other arrangement with any Third Party existing at the time such party would befirst required hereunder to grant to the other party such access, license, orsublicense ; means the Development and License Agreement dated 20 August 2004 entered intobetween Jagotec AG ( ), SkyePharma AG ( ) and thePrincipal and all amendments thereto ; means exclusive to the Distributor and its Associates and excluding the Principaland all others ; means the treatment of inflammatory diseases in humans ; means any act, event, non - occurrence, omission or accident beyond the reasonablecontrol of the parties including ( without limitation ) strikes, lock - outs or otherindustrial action ; civil commotion, riot, invasion, terrorist attack or threat ofterrorist attack, war ( whether declared or not ) or threat or preparation for war ; orfire, explosion, storm, flood, earthquake, subsidence, epidemic or other naturaldisaster ; 3 means any improvement, modification or enhancement ( including newpresentation(s ) ) of or to modified release formulation of prednisone 1 mg, 2 mg, 5 mg orany of its components or constituent parts and any related Principal IntellectualProperty ( as defined above ) which shall include all dosage strengths and lineextensions to the Product and any improvement thereof ; means an independent Third Party with significant expertise and experience in thestrategic marketing, pricing and reimbursement of pharmaceutical products similar tothe Product in the Field in the Territory ; means the treatment of moderate to severe active rheumatoid arthritis in adultsparticularly when accompanied by morning stiffness ; means fifteen ( 15 ) years from the date the Product is first Launched ( as defined inClause 5.8 ) in a country within the Territory ; means the European Federation of Pharmaceutical Industries and Associations(LFPIA ) ; means patents, divisional patents, patent continuations in whole and in part, supplementary protection certificates, designs, trademarks, domain names, servicemarks, logos, trade names, copyright, utility models, data, rights in know - how andother intellectual property rights, in each case whether registered or unregistered andincluding applications for registration, and all rights or forms of protection havingequivalent or similar effect anywhere in the world ; 4 means all necessary regulatory and governmental approvals by a national, supra - national, regional, state or local regulatory agency or other governmental bodyrequired to develop, market, sell or have sold the Product in the Indication in aparticular country but excluding any Pricing Approval ; means each event identified in Schedule 3 ; means each amount specified in Schedule 3, the payment of which by the Distributorto the Principal is triggered by a Milestone Event ; the gross amount invoiced by Distributor, its Associates or sub - licensees for sales ofthe Product in a particular country within the Territory, less deductions for : ( a ) quantity and cash discounts and sales rebates actually given ; ( b ) freight, shipping insurance and other transportation expenses ; ( c ) sales, value - added, excise taxes, tariffs and duties, and other taxes directlyrelated to the sale ; all to the extent that items ( a ), ( b ) and ( c ) are included in the gross invoice price andspecified on the invoice ( but not including taxes assessed against the income derivedfrom such sale ) ; ( d ) returns ( including withdrawals and recalls ) other than returns by third partiesto Distributor on account of lack of sufficient remaining shelf life ; and 5 ( e ) amounts repaid, discounted or credited by reason of ( i ) retroactive pricereductions, discounts and rebates, which are, in any case, imposed onDistributor or its Associates or sub - licensees by any governmental or non - governmental body with the authority to impose such price reductions, discounts or rebates, all to the extent reasonably demonstrated by Distributorby written records, or ( ii ) retroactive price reductions, discounts or rebates(not specified in an invoice ) granted to a third party without the authority toimpose such price reductions, discounts or rebates to the extent these areeither pre - agreed with Principal or do not exceed [ … * * * … ] % of the grossinvoice price