definiens: and meaning ownership of fifty percent(50 % ) or more, including ownership by trusts with substantially the samebeneficial interests, of the voting and equity rights of such person, firm, trust, corporation or other entity or combination thereof or the power to direct themanagement of such person, firm, trust, corporation or other entity orcombination thereof ; a calendar quarter ending on 31st March, 30th June, 30th September and 31stDecember in any Calendar Year ; the twelve ( 12 ) month period from January 1st to December 31 ; the date of execution of this Agreement ; 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’spractices in actively pursuing the marketing and sales of its otherpharmaceutical products at a similar stage of product life to the Product and ofsimilar market potential and profit potential, based on conditions thenprevailing, taking into account, without limitation, competing products, market demand, proprietary position, safety, regulatory status, medical orscientific developments in the Indication, any adverse governmentalinterventions and any potential legal liability or other legal issues ; Page 2 of 46stthe Development and Licence Agreement dated 20 August 2004 entered intobetween Jagotec AG ( ), SkyePharma AG ( ) and thePrincipal and all amendments thereto ; the European Economic Area as constituted from time to time ; the decentralised procedure for obtaining marketing authorisation forpharmaceutical products across multiple member states of the European Unionas prescribed by European Directive 2001/83 / EC, as amended by Directive2004/27 / EC ; exclusive to the Distributor and its Associates and excluding the Principal andall others ; the treatment of human diseases ; 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;or fire, explosion, storm, flood, earthquake, subsidence, epidemic or othernatural disaster ; the guiding principles of Drug Regulatory Affairs ( DRA ) activities betweenthe Principal and the Distributor as set out in Schedule 6 ; any improvement, modification or enhancement ( including newpresentation(s ) ) of or to the Product or any of its components or constituentparts and any Page 3 of 46 related Principal Intellectual Property, which shall include ( without limitation)all dosage strengths and line extensions to the Product and any improvementthereof ; an independent third party with significant expertise and experience in thestrategic marketing, pricing and reimbursement of pharmaceutical productssimilar to the Product in the Territory ; the treatment of moderate to severe active rheumatoid arthritis in adultsparticularly when accompanied by morning stiffness as described in thecurrent SMPC documentation of Principal or any subsequent amendmentsthereto ; the European Federation of Pharmaceutical Industries and Associations(EFPIA ) ; fifteen ( 15 ) years from the date the Product is first Launched ( as defined inClause 5.8 ) in a country within the Territory ; patents, registered designs, unregistered rights in designs, trade marks, domainnames, service marks, logos, trade names, copyright, utility models, rights inknow - how and other intellectual property rights, in each case whetherregistered or unregistered and including applications for registration, and allrights or forms of protection having equivalent or similar effect anywhere inthe world ; all necessary regulatory and governmental approvals by a RegulatoryAuthority or other governmental body required to develop, market, sell orotherwise deal in the Page 4 of 46 Product in the Indication in a particular country but excluding any PricingApproval ; each event identified in Schedule 5 which triggers a one - off MilestonePayment ; each one - off payment by the Distributor to the Principal identified inSchedule 5 which is triggered by a Milestone Event ; the gross amount invoiced by Distributor, its Associates or sub - licensees forsales of the Product in a particular country within the Territory, lessdeductions 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 taxesdirectly related to the sale;all to the extent that items ( a ), ( b ) and ( c ) are included in the gross invoiceprice and specified on the invoice ( but not including taxes assessed againstthe income derived from such sale ) ; ( d)returns ( including withdrawals and recalls ) other than returns bythird parties to Distributor on account of lack of sufficientremaining shelf life ; and ( e)amounts repaid, discounted or credited by reason of ( i)retroactive price reductions, discounts and rebates, which are, inany case, imposed on Distributor or its Associates or sub - licensees Page 5 of 46 by any governmental or non - governmental body with theauthority to impose such price reductions, discounts or rebates, all to the extent reasonably demonstrated by Distributor bywritten records, or ( ii ) retroactive price reductions, discounts orrebates ( not specified in an invoice ) granted to a third partywithout the authority to impose such price reductions, discountsor rebates to the extent these are either pre - agreed with Principalor do not exceed [ … * * * … ] of the gross invoice price