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臺灣臺北地方法院104年度金重訴字第13號

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      10413              Inopha AG    Okle Andreas Willi     104 3378104947010410939 1.20082 2.200911 3.2012 4.2012FK 5. Inopha AG 1.21,513,495.8320177J&J 2.FK1,382,000 3.13Inopha AG101CaelyxEXHIBIT A 3-13TTY BIOPHARM COMPANY LIMITED,TTY49 877219092783103610312 1510162099128101222101222103331 905 171123Denis OpitzDenis9269492006ZugInopha AG10Baarerstrass 1126302 Zug91Caminada Treuhand AG Zug201013000 DenisInopha AGOkle Andreas Willi OkleInopha AG DenisOkleDenisDenisInopha AGDenis 103331 9410Denis Chief RepresentativeDenis 82171123 Denis9497 Taxtere98 IrinotecanDenis 使Denis Denis Denis Denis DenisDenisDenisDenisDenis 984 52.949912 10012 101620Inopha AG103331 Denis Denis Denis Inopha AG979813 Inopha AG Inopha AG Denis2006918256 Inopha AGInopha AGDenisInopha AGDenisDenisInopha AGDenis2008Inopha AGInopha AG"I am the investor of Inopha", "in behalf of Inopha ","I setup the companyInopha in Switzerland"Denis Inopha AG Denis使Denis Inopha AGDenis Doxorubicin使 DNAtopoisomerase liposomeJ&J Liposomal Doxorubicin Doxil /Caelyx 84FDAJ&JCaelyx Caelyx20使 8611Lipo-Dox8789J&JCaelyx Lipo-Dox041037Lipo-Dox Caelyx Lipo-Dox使J&J Lipo-DoxCaelyx 9497Lipo-DoxCaelyxLipo-DoxCaelyx Lipo-Dox Liposomal Amphoteracin BBLIPO-ABGilead Sciences,Inc.Nexstar Pharmaceuticals,Inc.39109 86Lipo-DoxLipo-AB Lipo-ABCaelyx86 8797 Risperidone DepotJ& J109仿Risperidone pilot BE Leuprorelin TAPLeuprolide 仿Leuprorelin prototype 2009Inopha AG Irinotecan2005Docetaxel2006 Gemcitabine2006Voriconazole Zoledronic Acid BendamustineCapecitabineNaltrexonePemetrexed4 131Inoph AG 166-168 2008CaelyxLipo-AB Lipo-DoxDenisCaelyx CaelyxInophaAG Caelyx2008315 Caelyx500 CTD Inopha AGCaelyx Inopha AGDenisCaelyx Lipo-AB Inopha AGDenisDenisInopha AG Inopha AGDue Diligence DenisInopha AGDenis973Inopha AG 稿Denis 200859Inopha AG DenisInopha AGInopha AGDenisInopha AG Inopha AG "Exclusivity & Territory" Denis Denis DenisDenisInopha AGDenisInopha AGInopha AG InophaAGCaelyxInopha AG 20% 20%使 InophaAGInopha AG5% 使CMC CMC 500 使 1792329 4 1.1 5,000,001 210,000,001 100098415 CRO 1 CaelyxLipo-AB 2005CaelyxLipo-AB200810%Inopha AG2008 2010CaelyxCMC Inopha AG Inopha AGAlfred E.TiefenbacherGmbH & Co.KGAETCRO3S100MoldovaCaelyx98415 4.1.8 200820012007Caelyx84,647,708200840,481074Lipo-AB2001200760,560,545200821,862,045使Inopha AG 2008CMC Inopha AG 1000 DenisInopha AGInopha AG Denis Inopha AGDenisDenis Denis 2008Inopha AG6 97 Inopha AG2008623Denis CaelyxLipo-ABInopha AG20084114 CaelyxInopha AG 使使使Inopha AG use使offer for sale selldevelopmanufacturehave manufactured the PRODUCTS sublicense2. Inopha AG 4.2 1.1.13 2.11.1 2. 20081230Inopha AGknow how 4.1 Inopha AG使 4.2Inopha AG使4.5 InophaAGCaelyx4.3 Inopha AG5%Caelyx10% Lipo-ABInopha AG6.1 13.5 滿使know how 9798CaelyxLDIA0999CaelyxCMC Inopha AGInopha AGAETDevelopment Cooperation AgreementCRO3S100MoldovaCaelyx20113BE 20117 3201272420135 Inopha AGAET1200 Lipo-AB5% Inopha AG10%100 12Inopha AGAETPiolet Batch800 Lipo-AB 101 Lipo-AB Lipo- AB103 49 2Inopha AG Inopha AG10 Inopha AGAETAET Inopha AG AET42Inopha AG2012J&JFK AET Caelyx2001200784,647, 708200840,481,074 Lipo-AB2001200760,560,5452008 21,862,045 2009340 200911 2009Denis Denis 11313DenisInopha AG使使119898 Risperidone Depot25mg 37.5mg50mg per vial lyophilized depot injection, further formulations to be determined Leuprorelin7.5mg/22.5mg per vial lypophilized further formulations to be determinedVoriconazole200mg per vial lyophilized, further formulations to be determined Zoledronic Acid4mg/5ml per vial lyophilized, further formulations to be determined Pemetrexed500mg per vial lyophilized, further formulations to be mutually determined Irinotecan40mg100mg per vial lyophilized,further formulations to be mutually determined Docetaxel40mg100mg per vial lyophilized, further formulations to be mutually determinedPCT/CN2007/071274 Capecitabine150mg500mg per vial lyophilized , further formulations to be mutually determined Bendamustinefoumulation to be mutually determined NaltrexoneSR injection, formulatons to be mutually decided Gemcitabine200mg and 1g, further formulation to be mutually determined 1.Inopha AG200946 2009715200811 2. 1.17 Inopha AG 使使使Inopha AG使 1530%2 使Inopha AG 3.1 Inopha AG Inopha AG 使3.2 使Inopha AG使 Inopha AG 2001/83/EC104.1 Inopha AG使 4.3 3.13.24.160Inopha AGInopha AG 4.4 Inopha AG 4.6 Inopha AG Inopha AG Inopha AG / Inopha AG 5.1 Inopha AG Inopha AGInopha AG5.2 Inopha AG/使5.3 Inopha AG Inopha AG使 Inopha AG5.4 Inopha AG630%6.2 Inopha AG使 調使150 Inopha AG使 7.3 12.1滿使12.212.3 3.13.2使InophaAG3.1 Inopha AG Inopha AG使 3.2 CMC 11InophaAGInopha AG 200111CapecitabineBendamustine Naltrexone20012004131 Pemetrexed2009Inopha AG 2011352,014 CRO Inopha AG Inopha AG 使Inopha AG 10621813227 CaelyxJ&J100J&J J&JCaelyx/Doxil 1005Caelyx7J&J J&JDenisDenisDenis Inopha AGCaelyx J&JJ&JCaelyxDenis Denis 20111017J&J non-binding term sheetJ&JCaelyx/Doxil J&J J&J / J&J 使PLD Caelyx/DoxilLipo-doxJ&J :J&JJ&J退 300151300 EMA200FDA200100EMA200 2001004300 :J&J J&J J&J J&J J&J AJ&J20mg50mg 1. 2.J&J 3.J&J J&JInopha AGDenisDenisInopha AG J&J J&J J&J J&JCaelyx Inopha AGInopha AGInopha AGInopha AG10139412License, Manufacturing and Supply AgreementDenis J&JInopha AGDenisDenisInophaAGDenisJ&J Inopha AG J&JDenisCaelyxJ&J J&J J&J J&JCaelyx J&J TTYTTYCaelxyJJJ&J 2.1.1 JJJ&J TTY JJJ&J TTYJ&J J&JCaelyx DenisInopha AG Inopha AG8.1.18.3.18.48.1.2.8.3.3 J&J J&J 2008 Inopha AG2008 10J&J 12Inopha2008J&J 2012382008Amendment to Licensing Agreement 退2008 1.1015 2."only to Products"1.8 使使使 3. 4.A2 201238Side Agreement to the Amendment of the Licensing AgreementFKFKInopha退 J&J Denis J&Ja ProductTTY5.1.15.2.1 5.3.15.3.25.5.1 J&JJ&J9.1.19.2.49.2.5 J&J 9.4.19.4.5 9.5.19.5.2 9.10.19.10.2 14.2.3 J&J J&J 20129TTY105J&J8.1.18.3.18.4.1 2.1.11使J&J 8.1.28.3.32.1.11使JJ/ 2.1.11 DenisDenisInopha AG InophaAGJ&J Denis Inopha AG2008 14506,826,599.3120177J&J15075 Inopha AG563,103.48 21,513,495.8320177J&J Inopha AG 使TTY 使 2011428 2.26.16.2 2011428 Denis 101 201254J&JUS DoxilLiposomal DoxorubicinInophaLicense 2012 FK Fresenius Kabi Deutschland GMBHFK 100Caelyx FKCaelyx100 FKMat Henriksson CaelyxFKDDCaelyxFK1009221115CaelyxFK稿Denis DenisFK DenisDenis10011 302008CaelyxInopha AGInopha AGFKCaelyxFKInopha AG FKFKMarc-Alexander.Mahl Denis Inopha AGInopha AGCaelyxDenisDenisFKInopha AG GMP Inopha AGDenisInophaAGInopha AG Inopha AG FKDeclarationFKCaelyx Inopha AGFK 使Inopha AGFK 361 101224Caelyx Inopha AGInopha AGFKCaelyx101316Inopha AG FKFKPhamaceutical Dossier License AgreementFKInopha AG300600使Inopha AG FKInophaFK361 FK Inopha AG201235FK201231620111230Inopha AG Caelyx201271Inopha AG GPLDCaelyx/DoxilGPLD使FK使Inopha AG FK3 1.西 2.西 3.西 Inopha AG5FK使使使2.1.2 Inopha AG 使使1.16 使Generic UseJ&J使使1.22 Inopha AG FKInopha AG 2.1.1 FK滿2.2.5 FKFK2.3.1 Inopha AGFK 2.1.3 FKInopha/ GPLDFKFK3.2.1 FK/ 3.3.1 Inopha AG GPLDCMC 3.3.2 FK3.3.3 FKInopha AG900 300100100 5050 600 1.150 2.150 3.100 4.100 5.50 6.505.1.1 InophaInophaTTY SMPC's6.1 InophaInopha2011FKCMCCMCFK6.3 CDP21020151230滿7.1 FK1.3DCP 7.1滿 滿FK使Inopha AG 使FK5.1 7.5 InophaInophaFKInophaTTY 3.5.1 滿J&J90%J&J Inopha AG FKFK 2008Inopha AG Caelyx6 Inopha AG CMCCMCInopha AG Inopha AGInopha AGAET CRO 20114 CMC InophaAG5%Inopha AG Inopha AG 6.1 Inopha AG10 AET J&JCaelxy J&J J&J J&JTTYTTY Inopha AG FKFKFKFKFKInopha AG Inopha AG FK35% 20mg3550mg85Inopha AG 5%Inopha AG 20083.3.2Inopha AGCMC GPLD2008Inopha AG FK300 600 FKInopha AG FK201212Inopha AG300175 20135FK201312 稿Inopha AG FKdossierdocumentationinformation Inopha AG200Inopha AG Inopha AG10112272 184,000368,000Inopha AG1,382,000FK3002368,000Inopha AG125 Inopha AG1 使調 1.1051Inopha AG 6170-177 2.52210-213 PLM 32105 117 15942 3.THOMSON REUTERS CORTELLISLIPO-AB1043378187-195LIPO-AB 4.10275057992 調103-106 Lipo-AB 5.AETDieter 205-207 調102293899 6410 6.2014103TonyLuc103 12393133J&J 1501300 Inopha AG 2032061 208120812061206 159512 調 25%20052005 3%GDP 使2008GMPCTDDMF 2008使Lipo-dox 2008Lipo-doxLipo-ABBecan,Sandoz , Teva,BBrown,Midas,Radiopharm, Hospira dossier dossier退 Lipo-AB TTY19982008 BEKuhnil Caelyx10153 5Inopha/AET 1,0001,0005 51,000BE Inopha2008TTYCaelyxLipo-ABTTYTTYTTYTTYTTY 使2008TTY TTY+5%+20% 2008Inopha13 1.3 1InophaAETFKInophaTTY 2.TTYin-house TTY TTY 2012+ 1.J&JTTYTTYLipo-dox 8006,000TTYInopha CaelyxMoldova67 J&JJ&J2 TTY20%4050% 2TTYTTY使J&JTTY 2.TTYJ&J使JJ J&JTTYJ&J DenisCaelyxJ&JTTYInopha AGJ&JFK TTYTTY DenisJ&J稿TTY J&J TTY 3.TTY2008 2011MoldovaBE J&J2011 4023使TTYInopha CaelyxJ&JTTY/Inopha2008 2017Lipo-AB Inopha 2010TTY AET 201020113 J&JOkle 30% 70%Inopha20141Inopha30% 1.2008CaelyxLipo -AB2009Risperidone Leuprorelin Caelyx2Inopha AGOkleDenis Caelyx5%Lipo-AB 10% 2.2012J&J CaelyxDenis Inopha AG 1015 3.2012J&J J&JInopha AG 4.FKFKDenis FK 5.InophaAG30% DenisDenis 1.2009Caelyx2 91963 Inopha AG 5 % 2.J&J 30 3.J&J J&J 4.FKFK2008CMCInophaInopha AGFKInophaFKFK 5.30% 使 2008CaelyxLipo-AB 1.20022008 2.InophaInopha 3.Inopha AG 使滿使InophaKnow-howLipo-AB Caelyx5%Lipo-AB5% 10InophaInopha使know-how 4.2008CaelyxLipo-AB5%10%Inopha AG 200911 1.Inopha2007Docetaxel Inopha2008InophaInopha 2.InophaInopha 3.稿Denis Inopha AG Inopha使30150Inopha AG2 使Inopha AG 4.2009111111使11 2012 1.J&J20117J&J 45J&J20%J&J 2012 2.J&JJ&J使J& J 3.J&J調 InophaInopha AGseller ManufacturerInopha AG 4.Moldova 117Term Sheet 5.Moldova CaelyxCMC 20082012CMCInopha AGMoldova J&JCMCCMC J&J J&J 6.使InophaJ&J InophaInopha 2012FK 1.InophaJ&JFK TTYTTY2008InophaDenis FKInophaDenis InophaInophaFK 2.InophaFKCaelyx 3.FKdossierJ&J使Denis20111231FKDavid使FK使FKFK 2.1.2...an exclusive licence for the Generic UseJ&JTTYFK 2012 1.J&JInopha 2008 2.Inopha2008CaelyxInophaAETMoldovaJJJ&J 使調調Inopha2008J&J 使 106724 102 17684712 Caelyx2Liposomal Doxorubicin259,7822,000 LIPO-ABRisperidoneLeuprorelin34 4956,116302778,116 20083312012229-J&JCaelyxCaelyxCaelyx4.7Caelyx 2012201687.5%Gaelyx Lipo-Dox100%Caelyx1.31 2.20082012 3.2008Inopha AG2012 4.87.5% 20082013J&J 1.(95)Caelyx102 2,909,760 3888 Caelyx 2.Lipo-DoxCaelyxCaelyxLipo-DoxCaelyxCaelyxLDIA09200990 3.Lipo ABRisperdoneLeuprolide RisperdoneLipo-AB 稿 20082009Inopha AG 1.10% 1398CaelyxKPI 200 2.1320082009 Liposomal DoxurobicinLipo ABRisperidoneLeuprorelin DocetaxelIrinotecanGemcitabin InophaVoriconazoleZoledronic Acid PemetrexedCapecitabineBendamustine Naltrexone 3.2012FKInopha AG 調2008 20%5% 106724 Denis InophaAGLipo-doxDenisInopha AG Inopha AG 2010122014 Inopha AG Inopha AGInopha AG30%)Inopha AGInopha AGInopha AGCOO3 Inopha AG 1.DenisMr. Lin, as far as I believed,had no idea about the "beneficial ownershipof Inopha. Denis 2.OkleJung-chin Lin ...Jung-chin LinTTY Biopharm...Denis...LinInopha AG...Opitz Inopha AG Inopha AG.. 79-81Inopha AGInopha AGUBSCommerzbank 3.200820-22DenisInopha AG 4.20111214Denis Inopha AG Inopha AG 5.2014428Denis10611610627106410 6.2011Inopha AG Inopha AG 30%Inopha AG70%2011119DenisInopha AGInopha AG 369-2369-3 7.Inopha AG 100%Inopha30% Inopha AG Inopha AG 便Inopha AG30%20141.128 347.25 Inopha AGFK FK200FK+J&J1067 TTY=1,267AET 25%=317950x30%=2851.141.1283,50412.24%429 FK150 1450FK3001900 0000-0000 13%9880FK Inopha AG 3.672%2,790(106724Inopha AG TTYInopha AG 20122011729201392011J&J Denis+CaelyxJ&J8J&JDenisCaelyx200063826J&JDenis 64923DenisJ&J65J& J9281500Moldova 201212Denis 2008TTY /InophaInopha10%8%33稿2012227DenisFK2008FKInopha AG 201222337DenisAAInophaTTY 3489InophaA FK2008調A Inopha2012Denis Denis201212 27Inopha AG37 20131215DenisInopha 20082014320 2008201220% 5%J&J 2012FKTTYInopha AG2008MoldovaJ&J使2008使106724TTY&Inopha 稿 1.Denis2008114202008328 920082009 6264Inoph 2014Inopha AG 2.2008911Denis212008Inopha2011FKInopha AG Inopha AG 3.201116Denis2Jimmy ChangAET20131017151Inopha 2012Inopha AGInopha 4.2013326 2015/1/8134 1.108 108 2.161Intial contact 3.224394,000Caelyx106724 2008Generic Caelyx 使21Caelyx使know-how使know-how Caelyx (Formulation) (Formula) know-how1.7BTTY-KHOW-HOW2008Caelyx 1.21Inopharelating only to Products Inopha使 2. 1.使CaelyxInophaAETInopha 2.Caelyx使InophaInophaInopha 2.1.1iJJ FormulationiiFormulation 2.7.1TTY Formulation2.1.1iii9.5.12.7.1Inopha AG Inopha AG 20122008J&J J&J Inopha J&J 使J&JJ&J J&J J&J 1.TTY Formulation J&J J&J 2.J&J J&J Caelyx使TTY FormulationJ&J調J&J 2013111Inopha AGCaelyx使J&J 3.J&JTTY FormulationJJ Formulation 2012J&J J&JJ&JJ&J J&J 使J&J 8.1.1 8.3.18.4.12.12.79.13J&J J&J201359 24 8.3.3 InophaDenis 稿InophaInophaJ&J 8.3.3 Inopha 73J&J FK TTY Formulation使(generic use of Dossier)FK 使2.1.2 2008Inopha AGFK 2.7.1J&JInophaTTY Formulation FKInophaFKDossier使 FK1.22使J&J 使J&JDossier使FK使FKFKInophaJ&JInopha J&JFK 10658 10666106522106629 Inopha AG FKTTYAET便106522 J&JCaelyx InophaJ&J InophaInopha2008 1.Inopha使J&J 2.15Inopha20081012使J&J 3.InophaInopha2008J&JInopha2008 使 4.AJ&JA 5.InophaJ&J 調使InophaJ&J Inopha2013211 701,103.48FK184,000333,103.48201426230,000J&J 20146J&J1,610,000 使Caelyx200810667 Inopha Denis20032004 200420082012Denis eusiaeusiaInopha2008Denis Denis Inopha2022DenisInopha DenisInopha Denis Denis Denis InophaDenis InophaInopha20123Inopha 201259148 30%Inopha DenisInopha InophaInopha 10666 Inopha2008 1.2008Denis 2.CaelyxInopha InophaAETInopha InophaCaelyxLipo-DoxLipo-DoxCaelyx 3.InophaInophaInopha使 4.4.12008 1230InophaAET20102011 InophaAET J&J 使J&J 使FKCaelyxInopha10667 5.InophaAET CaelyxInopha AETAET1000Caelyx II 200810667 8310361031215 99128101222 101222103331調64-88 Denis 2006Inopha AG 10Baarerstrass 112,6302 Zug 1,000 Caminada Treuhand AG Zug201013000 Denis DenisOkle Denis OkleDenisDenisInopha AG 1.Denis"I am the chairman of Aimpharma Limited,... and also the beneficial owner of Inopha AG","I founded Inopha in 2006... I chose to make a trust agreement and management agreement with Mr. Andreas Okle " 1421Inopha AGOkle 2.Okle2015529Zug調Denis Opitz Opitz ZugCaminad a Treuhand AGInopha AG2006822ZugCaminada Treuhand AGOpitz DenisOpitz UBS AGInopha AG OpitzOpitzOpitzInopha AGInopha AG 79-80Okle951031 UBS 130136205 3.Inopha AG1031239331 83Caminada77134 1352032041051 Inopha AG6170-177Inopha AG99 4.Denis103331 調Okle調Aimpharma Inc.Inopha AG,Zug2014 Aimpharma Inc. Kathleen TarngDenis Optiz Aimpharma Inc.Inopha AG OpitzAimpharma Inc. 81 Denis 1.Denis926949 Contractual Employer Agreementbase salary per year32,500payment per month7bonus compensationbenefitsDenis941010312Contract about the performance of services6-15141-154 Denis 1Denis OptizDenis TTYDenis使1042445101Chief Representative Europe and North AmericaDenis 2.Denis Denis1011.1 Denis TTYDenis1041130104()11003718-202102155-159Denis 9679712 21514-18Denis0346 Denis 宿Denis Denis Denis 3.Denis94 952DenisDenisbusiness cardgeneral manager EurpoeChief Representive Eurpoe DenisTTY Biopharm Eurpoegeneral manager EurpoeDenis Denis 199158Denis 2006124DenisChu-Lan Tseng ...business cardDenis OptizGeneral Manager EuropeTTY Biopharm Eurpoe ON-Zentrum... Roy Chang200623DenisDenis Chu-Lan ......使 4.Denis KPIkey performance indicator 340 Denis Denis 1066135758Denis 103160-167 Denis 便 2008923 Denis11KPIDenis198157 5.Denis使denis@tty.com.tw 95-105Denis 6.Denis13Inopha AG97 6TTZ000000000197 144 -156214574103132161190219248277306335Denis82 Denis948Eusia Business Consultancy Ltd, Denis Eusia Contract about the performance of services19178 23-33104168-169DenisDenis Denis9497 Taxtere98 IrinotecanDenis 使Denis調480調Denis1041 7調47DenisDenis Denis DenisDenisDenis DenisDenisDenisCEO104 Inopha AGDenisDenis DenisDenis 1.36Denis 2.18 3.Denis 10Denis DenisDenisDenis Denis DenisDenisDenis FKFKInopha AG FKDenisDenisDenis FKInopha AGDenisInopha AGDenis 使Denis 10082J&JEHasethl10312393280 198Denis...J&JDenis 23223 106 562 32 2091 Denis Denis Inopha AG9798 CaelyxLipo-AB13 Inopha AG Inopha AG 984 991210012 調72-81230-23563475 DenisDenisInopha AG 2 Denis2006918256 Addition note meeting outcome EuropeInopha AGInopha 調20069 18959DenisJust go ahead 87257-258Denis95InophaAGDenisInopha AGDenis Denis Inopha AG 2008Denis Inopha AG 1.200814916 "Generic Caelyx development"20179 CaelyxCaeyx 便Inopha InophaLipo-DoxInophaInopha 2.200891197Denis21181 ... InophaInopha 3.2008113959Denis 22183 InophaInopha便Inopha...Inopha OkleInopha Denis DenisInopha AGDenis Denis InophaAGInoph AGDenis Denis Denis4Denis InophaAG Doxorubicin使 DNAtopoisomerase liposome3 105 1024113 1011088 Liposomal Doxorubicin Doxil/Caelyx84J&JCaelyx Caelyx20使104337876 Lipo-Dox8789J&JCaelyx Lipo-DoxLipo-DoxCaelyxLipo-Dox使J&J Lipo-DoxCaelyx104337876 1041213 1051031771051019588611190 調89-919551524 -29Lipo-Dox 調92 9497Lipo-DoxCaelyxLipo-DoxCaelyxLipo-Dox104337876104427 104126156 1051024122 125 1051018 19105101959 105102412210510 31610105117 169 Medicines and Healthcare products Regulatory AgencyMHRA978188181-18287-88 Liposomal Amphoteracin BLIPO-AB Gilead Sciences,Inc.Nexstar Pharmaceuticals,Inc. 3 8109THOMSON REUTERS CORTELLISLIPO-AB1043378187-1951051024 119123105117168 86Lipo-DoxLipo-ABLipo-ABCaelyx868797105 117172173 2008CaelyxLipo-AB Lipo-DoxDenisCaelyx CaelyxInopha AG Caelyx20083515Caelyx500 CTD 2008315148LIPO- DOXCaelyx 1051024116117128 437 14257-58Inopha AGCaelyxInopha AGDenisDenisInopha AG Inopha AG Due Diligence DenisDenis973Inopha AG稿Denis 200859DenisInopha AGInopha AGDenisInopha AG milestone Inopha AG Exclusivity & TerritoryLAIA98 52210-213 10511732調Inopha AG 1031226調16 Inopha AG Denis Opitz Inopha AGOkle Inopha AG 21Inopha AG Inopha AG 22 Inopha AG Inopha AGOkleInopha AGDenisDenisDenis DenisDenisInopha AGDenisInopha AG Inopha AG 56-2189735 9734稿2008315 2008422 1043378233-235110-112 2008328DenisREGeneric Caelyx 1.After talking to Dr.Hu and Meihui2.We concern about Inopha AG may use the "know how"free of chargeafter agreement expiry(Please see the 11.2)... no any milestone payment and no quantity promise... oursuggestion is that possible delete manufacturing rights in the agreement 2Inopha AG使Know how11.2...... 2.DENIS OPITZ DENIS OPITZInopha AGKNOW HOWKNOW HOW2561042212.4Inopha AG KNOW HOW257 3.3 Inopha AG 105103114 200842Denis104 3378235 1.Inopha20 2.Denis2InophaAG20Point 2 2008430410Denis 234111 1.DenisWe still cannot agree the revisedsentence. From TTY's point of view , this case seemslike technical transfer case.However, TTY will not receive any upfront payment or milestone payment andmay lose our core technology without any compensation, because we are not sure when we can receive the royalty and 10 years later Inopha can have this technology.210Inopha AG Therefore, we suggest, 1. Delete 11.2.We don't agree they can use our technology after agreement expired. 2. If theydon't agree to delete 11.2, please ask them to agree that TTY also can use their "Know-How" 3. Or your idea. 11.2使11.2使 Know how 2.DenisInopha AG20% 11.2滿滿InophaAG使11.2Inopha AGKnow-how Inopha AG2008623CaelyxLICENSING AGREEMENTLipo-AB263-270104244517-31104337833-38 Denis Caelyx197 14414520084114 CaelyxLipo-AB Inopha AG 使使使 Inopha AGuse使offer for saleselldevelop manufacturehave manufactured the PRODUCTSsublicense20% 20%2. Inopha AG 4.2 1.1.13 2.11.1 2. 20081230Inopha AGknow how 4.1 Inopha AG使 4.2 Inopha AG 使4.5 Inopha AGCaelyx4.3 Inopha AG5%Caelyx10% Lipo-ABInopha AG6.1 滿使know how12.212.3 13.5 Inopha AG CaelyxInopha AG 20% 20%使 InophaAG6.1Inopha AG使5%Caelyx10% Lipo-AB 調917 LIPSOME-TECH12%Lipo-Dox8%Lipo-ABCaelyxInopha AG Inopha AG Inopha AG5% CMC CMC 500 2008 1.1769204 55 2.96621 1239314-17575510001 3.14463-673.6 98415.4 CRO 36111 1150015.1150011 4.92329 114 A.1 5,000,001 B.10,000,00142167 1 退2008CaelyxLipo-AB know-how"Inopha desires to obtain from TTY an exclusive license of the FORMULATIONS which are developed or formulated undersuch PATENTS and KNOW-HOW to use...", FORMULATIONSKnow-how1.51.7 1.82Inopha AG 使10197 J&JFKFK CaelyxLipo-AB 20051192013227120 2005181444CaelyxLipo-AB 10% CaelyxLipo-AB 200810% Inopha AG2008 99CaelyxIICMC Inopha AGInopha AGAETCRO3S100MoldovaCaelyxII98415 4.1.8 200820012007 CaelyxII84,647,708200840,481,074Lipo-AB20012007 60,560,545200821,862,045106 21813225-227使Inopha AG2008CMCInopha AG 1000 DenisInopha AGInopha AGInopha AGDenis Inopha AGDenisDenis 2008Inopha AG 1.1 2003301 105 103156 2.Caelyx85LIPO-DOXCaelyx20081000 200720082 西0.520020086 4 LIPO-DOXLIPO-DOXLIPO-DOX3LIPO-DOX 3 LIPO-DOXInopha AG 701105103157 3.20131217J&J 5620082012J&J Caelyx105103157 Inopha AG Inopha AGInopha AG Inopha AG Milestone PaymentsRoyalty Inopha AGAETInopha AGAETInopha AG Inopha AGAETAndreas OkleAET2008 Inopha AG 2008西Inopha AG J&J RoyaltyMilestone Payments1 RoyaltyMilestone Payments西Inopha AG Attachment西西105103161 Inopha AG 1.202 142 3 940927166 6 1030813 1815171007713 1362()641 23 2.24 3.DenisInopha AG2008CaelyxLipo-ABInopha AGDenis CaelyxLipo-AB Inopha AGInopha AGInopha AG 500 CaelyxLipo-AB 9797135 97CaelyxLDIA0999CaelyxIICMC Inopha AG Inopha AGAETCRO3S100MoldovaCaelyx 20113BE 20117 320127241Inopha AGAET2008 581-91 20135 105 117172175 1051024 127100101 Caelyx3SInvoice1043378181-184 Inopha AGAET1200AETDeiter201524 206 Lipo-AB5% Inopha AG 10%LAIA98 200859MHMeiHuiLipo-ABTLC5%royalty 10%52212 10012Inopha AGAET Piolet Batch 800Lipo-AB101 Lipo-ABLipo-AB103 491051024 123124 10511717317410275 057992Lipo-AB調103-106 2Inopha AGInopha AG 使 Inopha AG10 Inopha AGAETAET Inopha AG AET42 Inopha2012J&JFK AETInopha AG 1.CaelyxAETAETInopha AGInopha AGDenis Optiz Inopha AG10510241172008Caelyx AET Caelyx.. .Denis Opitz Denis Opitz Denis OpitzAETAET30AETAET123Inopha AGAETAET Inopha AG 128Caelyx LIPO-ABcmc使AETDenis Opitzcmc 調1051025 136 Inopha AG Inopha AG AETAETmoldova moldova moldova 調moldova Inopha AG Inopha AG143 2.AETDieter201524 DieterTTY InophaDenis TTY Inopha...AETInophaTTYInopha 調Denis TTYTTYTTYInophaInopha ......Inpha InophaInopha......TTY...InophaTTY Inopha CEO TTY CEO 205-207 3.OkleZUG調Inopha AGInopha AGInopha AG79 4.Inopha AG 2013227CEO20052008Suffer2005181814414 2 10% 3/42119119Lipo-DoxLipo-AB20052007 2 20082 1020081231223,160.45115 8,055.70116 447.15116 46,894.99117 1.200811200833127.3212.9266,525.39136 2.200841200863027.3312.6266,540.10137 3.200871200893027.6313.6166,544.86137 4.20081012008123127.64 13.6166,568.89138 Denis 104 163163283284285287288294Denis 1.Ausnutria Hyproca B.V.Neolac NutritionB.V. 2.Hyproca Nutrition East Limited 3.Hyproca Nutrition Canada Inc. 4.Neolac NutritionHong KongCo.,Ltd. 5.Hyproca NutritionHong KongCo.,Ltd. 6.Hyproca Nutrition USA Inc. 103111130 10312121044 DenisCEO稿DenisCEO16449Denis 使 2008121DenisInopha稿1.24Inopha3.5.4Inopha 4. 7.3使150 15311502009 112009112008Caelyx20081.8 pharmaceutical formTTY使 2008328Denis....2. Inopha AG使know howliposomal doxorubicin & liposomal Amphoteracin B10Inpoha AG 西3.Inopha AG 使liposomal doxorubicin923 2 Inpoha AG使使 Inopharelated only to Product 10621813225-227 Caelyx2001200784,647, 708200840,481,074 Lipo-AB2001200760,560,5452008 21,862,045 2009340 Caelyx200 2009101454372009200 5101051025140 CaelyxCMC 3538CaelyxCMC2010CMCInopha AG 40CMC Caelyx 使使使使使使使InophaInopha5%CaelyxLiposomal Doxorubicin 259,7822,0009 Caelyx 1.97331578099104 1093959J&JCaelyx108,92651Caelyx 469,17355 2.1012292419322115J&JCaelyx548,456103Caelyx1,870,866109 974110138 J&JFK 259,7822,000118 1.J&JCaelyx 548,456103Caelyx1,870,866109178,500 2.J&J7503FK3001212,750432,750 3.2,165,0722,597,822432,750,000 1.Caelyx2012Caelyx2016Caelyx485499108 87.5% Caelyx Nature Biotechnology578 Caelyx2011201220135 201687.5% 20122016 Caelyx II 10619 1512015 2015 Caelyx152 Inopha AGmoldova20131051212 42 2.2008Caelyx2012沿87.51041093911311410 3.Caelyx CaelyxΠCaelyxCaelyx51102 J&JCaelyx Caelyx 200911 2009Denis Denis 313 11Inopha AG 使使1198160 3.13.2使InophaAG3.1 Inopha AG Inopha AG使 3.2 CMC 11Inopha AG Inopha AG 200111CapecitabineBendamustineNaltrexone20012004Pemetrexed2009Inopha AG 2011 352,014 CRO Inopha AG Inopha AG 使Inopha AG 200810241471.17 InophaInopha 11Denis197DenisInopha AG 97Inoph AG11姿Inoph AGLeuprorelinRisperidone15%30%Inoph AG使Inoph AGInoph AG Inopha AGDenisCMC InophaAET Inopha AG Inopha AGAETDenisAETInopha AG AETDieter Inopha AG 60Inopha AG Inopha AG Inopha AG Denis Inopha AG Inopha AG AET J&JCaelyx 10621813225-227 J&J CaelyxJ&J100J&J J&JCaelyx/Doxil 1005Caelyx7J&JJ&JLee Dong-Ho10411510312393213-215Lee DongHo10052862710312393170-17610312393223-226 J&JDenisDenisDenis Inopha AGCaelyx J&JJ&JCaelyxDenisDenis100818100819J&J Lee Dong-Ho103 12393277-27810082 J&JMs. HasethDenis198 DenisDenisDenisDenis....DenisJ&J 20111017J&J non-binding term sheet117 108-11674-81 J&J / J&J 使PLD Caelyx/DoxilLipo-doxJ&J :J&JJ&J退 300151300 EMA200FDA200100EMA200 2001004300 :J&J J&J J&J J&J J&J AJ&J20mg50mg 1. 2.J&J 3.J&J Term sheetJ&J Inopha AGJ&JJ&J3001300J&J 150J&J Inopha AG20084.5Inopha AG 使使Inopha AG J&J J&JJ&J3001300 J&JInopha AGDenisInopha AGJ&J J&J J&J J&JCaelyxInopha AGInopha AG InophaAGInopha AG Denis J&JInopha AG DenisDenisInopha AG DenisJ&JInopha AG J&JDenisJ&J J&J J&JJ&JCaelyxJ&J TTYTTYCaelxyJ&J J&J 2.1.1 JJJ&J TTY JJJ&J TTYJ&J J&J Inopha AG Inopha AGJ&J J&J DenisInopha AGInopha AG 8.1.18.3.18.4 8.1.2. 8.3.3 J&J J&J 2008 200810J&J 12Inopha2008J&J201238 20081031239361-621043378 117 -118Caelyx Inopha1015退2008 1.1015 2."only to Products"1.8 使使使 3. 4.A2 9293 Lipo-DoxInopha AG J&J 使 36247-248FK 2008FKInophaFK退13.5退 FKInophaJJFK1000 J&J Denis J&Ja ProductJ&JCaelyx TTY 1.5.1.1TTY使使 2.5.2.1 3.5.3.1 4.5.3.2 5.5.5.1 J&JJ&J 1.9.1.1 使TTY TTY 2.9.2.4 9.1.1 滿 3.9.2.5 20% 90% 90% J&J 1.9.4.1 2.9.4.5 使使使 9.5.19.8.3 9.5.2 滿100 使 9.10.150005000使 9.10.2 50001000 14.2.3 1.2. 3. 4.EMATTYJJTTYJJ 5.6 TTY 9.3.32012531FK201271使PLD EMACaelyx MAA Inopha AGInopha AGTTYInopha AGJ&J Inopha AG TTY EMAJ&JInopha AG TTYJ&JTTY...... 使TTY 5.1.2TTYJJ J&J J&JTTYJ&J 2.1.11J&J J&J 9.10.150009.10.2使 J&J J&J J&J 1572252012147183J&J 20129TTY105J&J2012108J&JLucDenis77231720121212CMC157201336158227 CMC159233 Doxil 使Doxil 使Doxil使 Doxil 2.1.11使a.JJPLD/b.8.1.18.3.18.4.1 2.1.11使J&J 8.1.28.3.32.1.11使JJ/ 2.1.11DenisDenisInopha AG Inopha AG 使TTY使 5 J&J Caelyx2013919 205201J&J Caelyx147 J&J 20122BE201334 FK100%InophaInopha85% 100%Inopha AG Inopha AG CaelyxJ&JTTYJ&JTTYJ&J Inopha AG2008 2012退Inopha AG 2011428 18496 18392 2.2 6.1 使 6.2 6.2.1 A. B.調 C. D.使 E.使 F. G. H.使 I.... 6.2.2 A. B. C. D.... 2011428 1.2012372033Denis J&JJ&JInophaJ&J J&J OkleJ&JJ&J稿便FKFKJ&J 133381 2.20123864Denis 133381 3 Denis201239 J&J J InophaJJ149 96 10652222123 101 101 201254316 201254332 18444 37JJUSDoxilLiposomal DoxorubicinInophaLicense 18084 201235183-265 J&J J&J J&J 10.1.110.2.310.2.2J&J 2.1.12J&JCaelyx 2.1.12使TTY PLDJ&JCaelyx使J&JJJ 2.1.11J&J J&J使 CaelyxJ&J J&JJ&JJ&J J&J 117 2.1.1 J&J J&J J&J 1450201359J&J Luc RuenlensDenis TTYJanssen44841 2.1.112.1.12.75Inopha AGJ&JInopha AG2.1.1 2.7TTYJJPLD J&J Inopha AG J&J BEJ&J J&J117J&J J&JJ&J 150 J&J BEJ&J Luc TTYJ&J使BEJ&J 使BE J&J J&J使 使J&J 1450 aba EMA b aba BE1450150 Inopha AGJ&J Inopha AGJ& J150J&J使 2008Inopha AG2012 使Inopha AG Inopha AG2.1.11 使J&J J&J BEJ&J DenisJ&JJ&JInopha AGBE J&JJ&JBECMC DenisInopha AG DenisDenisInopha AG J&J Non-Binding Term SheetDenis Inopha AG Inopha AG Inopha AG Inopha AG Denis DenisInopha AGInopha AG Denis 2008DenisJ&J101379Denis Denis J&J 退1215 Inopha AG 2.1.112.1.11 2.1.11Inopha AG J&J使 JJPLD 使Inopha AG J&J Inopha AG2012531 2012108J&JLucDenis9.3.32012531TTY TTY2012 512 使J&JDoxil/Caelyx 20129TTY105J&JRueien,LucDenis 235.2 J&J Buyer shall not be obligated to Deveolop mor than one Product in the territory.J&J J&J J&J 20135 5060BE使J&J Doxil/ Caelyx20129 TTY105J&J J&J Caelyx2013919205199 BEbio-waiverJ&JCaelyxJ&J Inopha AG 20136BE 1.1.63Product(s)JJJJPLDGMP 1.1.6Assembled Product(s) JJJJPLD GMP 1.1.73 SELLER and MANUFACTURER Intellectual Property Rights使1.1.38JJTTY PLD 1.1.77SELLER andMANUFACTURER TechnologyTTYTTY 使 1.1.63JJJJPLDGMP1.1.731.1.77JJPLDJJ PLD2.1.11 TTYJJTTYTTY JJTTY TTY 2.1.11 J&J 5.2 J&J 2.1.12TTY JJPLD J&JCaelyx J&J 8.4.3 J&J9.13.2 F調25%2.1.11J&J J&J 2.7.2TTYPLD2.7.1 TTY/ 2.1.11J&JJ&JFKCaelyxCMC J&J FKFK2.7.2 2.1.132.7TTY2.1.11 JJBEBE Inopha AG BEJ&JBE BE2.1.11J&J J&J J&J BE 5.1.1Inopha AGTTY JJJ&J BEJ&J 150150bJ&J3 Inopha AG TTY2008 使31501450 Inopha AGAET20126Inopha AGDenisInopha AGDenis Inopha AG AET Inopha AG AET Inopha AGAET20119Inopha AGAET AET 使Generic useInopha AGJ&J 16001501450 Inopha AGInopha AGAETJ&J使Generic useAETAETInopha AGInopha AG 2.1.11JJAET Inopha AG 5.1.1 Inopha AGTTY......AET TTY 2.1.112.1.132.7 J&JTTYTTY AETDieter Inopha AG AET J&JInopha AG2008Caaelyx Inopha AG Inopha AGAET J&J AETInopha AG 使J&JAETJ&J BE 2.1.132.7TTYJ&JLUC201359TTYJ&J使BE8.1.18.3.18.4.1 5.1.1 14508.1.18.3.18.4.1 J&J LUC201210 8J&JJ&J 14.2.35J&JTTY JJJ&J 2012531 JJJ&J Inopha AG DenisInopha AGJ&J Denis Inopha AG 100%Inopha AGInopha AGOkleDenis Denis Inopha AG Denis 2008200815Inopha AG Inopha AG 2008Inopha AG 退15Inopha AG J&J 2008Inopha AG Inopha AG Inopha AG8%10%Inopha AG Inopha AG 2.1.118106717 FKTTYJJ 1.1.731.1.77PLD J&J J&J Denis Denis Inopha AG2008 Inopha AG 8% 1.15075 2.1300 3. 4.Inopha AG75Inopha AG 150 Inopha AGJ&JBEInopha AG Inopha AG563,103.48 1.333,103.48 Inopha AG 2013211701,103.48101122710312393105103 12393112 150Denis 362,0698%333,103.48 2.201326230,000 Inopha AG 10312393112118 2014.10.03:TonyLuc103 12393133103103J&J 750150600 Inopha AGJ&J Inopha AGInopha AGcredit suisse 120J&J106331 9,879,868.31500 1076 6,826,599.31106724143 J&J75+1300+201766, 826,599.31 20177J&J+150Inopha AGJ&JInopha AG 563,103.4821,513, 495.8320177J&J FK FK FK100Caelyx Caelyx100 FKMat HenrikssonCaelyxIIFKDDCaelyx121051018 5 FK1009221115 CaelyxFK稿Denis DenisFKFK 100922Denis稿Letter of Intent on Pegylated Liposomal Doxorubicin 稿FK and TTY Phamaceutial Dossier PurchaseAgreement104244532-3435-411001125 DD161236Denis Denis10011302008CaelyxInopha AG Inopha AGFKCaelyx FKInopha AGDenis1001130FK David DasbergFKCaelyx 104244553-63 FKDenisInopha AGInopha AG CaelyxII219 DenisDenisFKInopha AGGMP Inopha AGDenisInopha AGInopha AGInopha AGFK Marc-Alexander.MahlDenis1001125 28104244542-43201163-167 FK "Declaration "FKCaelyxIIInopha AGFK 使Inopha AGFK 101224CaelyxInopha AGInopha AGFK Caelyx20088.38.3使101316Inopha AGFKFK FKInopha AG300使InophaAG 1.Denis104244593-96 2.Denis2012224FKInopha2Side letterJJ74220 3.Denis2012322FKside letterPDF200 159-162 4.DenisFK201163-167 FKCaelxyDossier 2008Inopha AG Caelxy6Inopha AG1.8 pharmacertical form TTY使使 EMA 201237J&J 2008Caelyx FK使Inopha/FK CaelyxCMCInopha AGCMC Inopha AGInopha AG使2008CMCInopha AGDenisInopha AGInopha AGFK Inopha AG300 600FK1.11 InophaFK FK113 9-35 2008Inopha AG Caelyx6 Inopha AGCMCCMCInopha AGInopha AG Inopha AGAETCRO20114CMC Inopha AG 5%Inopha AGInopha AG 6.1 Inopha AG10 AET J&JCaelxy J&J J&J J&JTTYTTY Inopha AG FKFKFKFKFKInopha AG Inopha AG FK35% 20mg3550mg85Inopha AG 5%Inopha AG 3.3.2Inopha AGCMCGPLD 2008Inopha AG FK300 600 FKInopha AG 20135FK201312 稿Inopha AG FKdossierdocumentationinformation Inopha AG200Inopha AG FK TTY J&JInopha AGFKJ&JFK CaelyxFK2.1.1132.7J&JTTYJ&J 1.2.7.2TTYPLD2.7.1TTY / 2.7.2TTYFK2.7.22.7.1使TTY使 PLDFK2.1.2使使 J&JFK Caelyx FK1.16Inopha AG使 使FK1.22使 J&J使使 any use and commercial explotation other than any use by the Originator 2.12.4.1Inopha AGJ&JTTY 3.5.2 4.5.3.1 5.5.3.2 Buyer shall own all Marketing Authorization,and the content of all registration filings, including all data, and the rights associated with such ownership, including but limit to the rights associated with any regulatory exclusivity. FKJ&JFKInopha AGJ&JFK TTY 90% 12.4.1FKCMCJ&JInopha AG Inopha AG J&J FKJ&JFK FKCaelyxJ&J 2.7.2 FK12.4.1Inopha AGInopha AGJ&JJ&JFK FK90%J&J10% FKFK1.22使J&J使使J&JFKJ&J FK1.16Inopha AG使 使Inopha AG FK Inopha AG FK 1.16 Inopha AG 1.22J&J1.16 FK使J&J J&JFK 90%FK 10%J&JFK12.4.1J&J 使FK使FKJ&J J&J Inopha AGFK 300600J&J 10% FK FK1011FKFK105 101810447調 6-7 20111125FKMarcInophaTTYLipodoxMarcInopha AG Denis使Inopha AGAETDieter MarcInopha AG GMPCTD1042445 42-43 2012211DenisFK6FK 5Inopha AGFKMarc201227DenisFK ..........Denis稿 8 It is my ultimate goal to fulfill both parties's requests. I have instructed Denis, with our position , to find an acceptable approach and I'm certain it can be developed.95120FK FKDossior CMC FKInophaFK FKMatsJ&JLee DongHo2011528FKDenis Inopha AGDenisInopha AG J&JFK DeclarationFK 161 361 111 ...... 3 55 3 1.2.3. 6 70207 DeclarationFK 1.CaelyxInopha AG 2.Inopha AGFKFK 3 6 FKInopha AG FKInopha AGFK 使FK使FKInopha FK CMCCMCInopha AGAETFK2008退Inopha AG2008 Inopha AG 30010010050 50505050Inopha AG 175Inopha AG 125退 FKInopha AGInopha AG 1011214FK104244597201312Inopha AGFK 175Inopha AG101 12272184,0001042445699Inopha AG10112 27701,103.4810312393 105 1.5020%40 50%208% 2.ROW,Rest of world5020%4050%20 8% 368,000 Inopha AG300175Inopha AG368,000 1,382,000 2008Inopha AG 20102CaelyxCMCInopha AGInopha AGAET 3S20114 2 3 TTY Caelyx使1 2 S 24AB1228127 ABA B 242 2011J&J AET 使使使使使2 2012352 2012342012102424退 encapsulatednon-encapsulated3 AET3S 192Caelyx 24trement cycleJJ27 J&J 246 201282565692 2012102312576 3S5264 20121211185818121252645060 18J&J24 55J&J Inopha AGAETMoldova201354105117172 Inopha AGAETAETInopha AGInopha AGAETDenisAETAETInopha AGAET Dieter 1.9044AET10031Inopha AG20115AET 2.Denis1001227FKDavid AET Inopha AG 172-179 3.Inopha AG 20126Denis4 Inopha AG Denis Opitz 4Liposomal DoxorubicinLIPO-ABRisperidoneLeuprorelinInopha AG 105 117165... 166AETAET Liposomal DoxorubicinLIPO-ABAET cmc AET 167 西176Caelyx 5 AET3S3S 3SAET BSLLiposomal DoxorubicinCaelyxIILIPO-AB Liposomal Doxorubicin 3CROCRO-AAET3SMONIPOL104420 153154105117 172-175 4.20126 Inopha AG Inopha AGAimPharmaInopha AG AimPharma Denis Opitz Denis Opitz CaelyxLIPO-ABLeuprorelin Risperidone201256 25 10611623101116service agreement -Inopha-aimpharma (track-change)0000000 124110 5.AETInopha AG2012101 Framework Development Cooperation Agreement 601141.15(c)Dossier Inopha AG75%AET25%50%Inopha AG75%AET 25% Chief operation office,TAP123 6.DenisInopha InophaAET InophaAETInopha InophaAET InophaAET InophaDenis 82.8Denis 4 7.102326AETDieter AET124AET 使DieterAET CDT Dossier Dieter2013321 326Dieter AET 211273-279FKInopha AG FKFKInopha AG 8.AETDieter10424DieterInophaDenis InophaInophaInpohaInopha 2.1.11FK 9.10.2 5.1.1TTY 使 使 5.1.2TTYEMAJJ TTYTTY使TTY 使TTY 1.1.73...... (pertains to Product or component thereof or it's manufacture or use in the FieldJJTTYPLDTTYJJ 1.1.77TTY TTY 使pertains to Product or component thereof or it's manufactureor use in the Field 1.1.63JJ JJPLDcGMP 1.1.731.1.77 使JJ 1.1.731.1.77 JJ 117J&J J&J150使J&J BEJ&JJ&JBE J&JBEBE BE BE 1450 2.1.11 1.1.731.1.77JJ PLD 2.1.13TTY1.63JJ TTYJJTTYJJ 2.1.13 2.1.11 使 BE TTYJJ AET 1.50mg/m2225 2.30mg/m2750 3.47 4.200300 Inopha AGJ&JJ&J 15020141192013912Inopha AGTTYJ&JCaelyxJ&J15064169-176 12TTYJ&JJJJ&JJJ 1501504 8.3.4 1 8.3.31J&JInopha AG1 1011021 6J&JJ&J3JJ 150JJ InophaInopha AG Inopha AG 201395DenisDenisJJ187104 2013917DenisJ&JDOK188105 201310171031... JJ 1.workflow3 3 2. 3.2Inopha&JJ 10/18 !65177-183 FKCaelyx2008J&J Inopha AG 10152 1501450 2.1.11Inopha AG Inopha AG 2 Inopha退FKInopha AG 200813.520122.1.132.7FK 13.5 Denis Inopha AGJ&J150FK 300 Denis Inopha200813.5 201289Inopha AGJ&JFKDenisDenisInopha AG Denis Denis10%1051122161 201210Inopha2008InophaInopha8% Inopha AG J&J J&JBE Denis Inopha8% Inopha AGJ&JInopha AG2008 Inopha AG J&J 2.1.1 1.1.731.1.771.2.使pertains to Product or component thereof or it's manufacture or use in the Field1.63 JJJJPLDGMPJJJJ2.1.11PLD 1.1.73JJPLD 1.1.77JJPLD 1.1.771.1.73Product1.1.63 JJJJPLD1.1.77 1.1.77JJJJJ&J JJPLD 1.1.77TTYJJ JJ2.1.11 使101Inopha AG8820121225201312Calculation JJ and Fresenius Amounts 54-57 1.20121225921DenisJJFK FK 5020%40 50%2020 Inpoha10%18 5020%40 50%2020 Inpoha10%18 5020%4040 Inpoha10%36 5020%4040 Inpoha10%36 JJ 150362,069Inpoha10%325,826.1 100100Inpoha10%90 100100Inpoha10%90 15075Inpoha 10%675,000 15075Inpoha 10%675,000 DenisNo share for TTY in the agreement, but to be fair and compensate the CaelyxIII investment I would propose payment like that. 退Denis Inpoa AGInpoa Inpoha AG 退15Inpoha AGInpoha AG5J&JInopha AG 1.1.731.1.77PLD Inpoha AG Denis J&J 使InophaAG2008Inopa AG使2008Inopha AG 2.20121225450Denis FK 5020%40 50%2020 Inpoha8%184000 5020%40 50%2020 Inpoha8%184000 5020%4040 Inpoha8%368 5020%4040 Inpoha8%368 JJ 150362,069Inpoha8%333,103.48 100100Inpoha8%92 100100Inpoha8%92 15075Inpoha 8%69 15075Inpoha 8%69 3.20121225745Denis Denis..... 4.20121226346Denis Denis 701,103.48184,000 +184,000+333,103.48 5.101122710%685,862.1Denis201312701,103.48 201312 Denis 201270196 6.10112271021231 701,103.483871230,000 39Inopha AG 102211103211Inopha AG 931,103.488958-60 7 Denis 92Inopha23 Inopha AG2013211701,10320132623J&JInopha AGInopha AG 931,103.48102129KathleenKathleen21031301:05 4110312393115 InophaCaelyx/Inopha 6 Inopha/ Inopha10InophaJJFK6 8%InophaJJ便3 InophaJJFK便70JJFK 201210退FKDenis 8%10%20121225調 8%13.5 1.20131225Denis....2012JJ TTY Caelyx 2008TTY 使...71 199 2.2014115Denis72200 1.20082. 3.InophaFKFK西西西 FK 4.20085% Inopha2008 InophaInopha8% 2012121049 Denis 201212166-2 20121210Denis Inopha189 106 20121222Denis 使滿186103FKJJDenis1FK2J&J 2012122520121225Denis 201212 2 6-1 40165 6.1.115 6.1.290 20%Risk ofPay BackUpfront Gross8% Filing ShareInopha AG 6.1.3Inopha AGUpfront Gross InophaAG8%Inopha AG 6.1.490 Inopha AG20%Filing Share Filing Share8% 6.1.590 Inopha AG20%Obtaining Share Obtaining Share8% 2008 Inopha AGInopha 退 Inopha 201412812925Denis Inopha稿190107 J&J Inopha AG5DenisInopha AGFK 2008Inopha AG 2008 relating only to Productsrelating to Products使only Inopha AGInopha AG 20082 sublicenses relating only to Products 97121DenisTTY is the sole supplier of sublicense for the product111 971120210 1.(product) Inopha AG Inopha AG 2.2c2.1.13b)2.7J&JCaelyx2008 8.3.12.12.7 8.3.2 8.3 JJTTY JJTTY1J&J 使JJTTY 8.3.1 2.1.11Inpoha AGJJ / Inopha AG 9.1.1 使 2.1.119.1.1 8 5 Inopha AG 2.1.12.7J&JJJ /J&JInpoha AG J&J1.1.73 1.1.77PLD Inopha AG TTYJJ 2.1.1 2.7Inpoha AGJ&JInopha AG2.1.132.7 2.1.112.1.11the right of access PLD access Inopha AG Inopha AGInopha AG 2008( 1.150 MoldovaPLDEMA Caelyx Inopha AGMoldova使TTY)JJ 2.200 Inopha AGJ&JMAA EMA 3.200 Inopha AGJ&JMAA FDA 4.100 Inopha AGJ&JMAA 5.200 EMA 6.200 FDA 7.100 8.150 西 9.150 Moldova EMA Inopha AG)MAAJ&JEMAFDA西 Inopha AG Inopha AG? JJTTY1J&J J&J Inopha AGInopha AGInopha AGInpoha AG使J&J J&J Inopha AG MAAJ&JJ&J Inpoha AG J&J J&J J&J LUCthe collaboration is set-uparound TTY Moldova study along with the opton that Jassen can develop our own product through feferringto the Moldova study or doing our own BE study. LucJ&J使orJ&J J&J TTY便 J&JBE LUCJ&JBE J&J Inopha AG 2.1.11J&JLUC2.1.111.1.731.1.77J&J 2.1.132.7 J&J2.1.132.72.1.11 Inopha AG5.1.1J&J 2.1.132.7 J&JBE Inopha AGJ&JJ&J Inopha AGLUC552013111LucDenis 25J&JLuc Ruelens20121119201317J&J J&JBE J&J J&JInpoha AG5060BEJ&JInopha AG Receipt of Acceptance of a MAA filing and Regulatory Dossior by EMA for Productsuppled to Buy or by Seller.CMC BECMC Inopha AG BEJ&J J&J 201343J&J 退2.1.11JJ2.1.11117J&JJ&J 2.1.11J&J使 Doxil使 Doxil使 Doxi1...J&JJ&J使8.1.18.3.18.4.1 Denis 使Inopha AG Inopha AGDenis20118J& JCaelyx J&J使 2000100822631001218.3.3 Inopha AG Denis稿Inopha AGJ&JJ&J2013InophaAG73125 Inopha AGJ&J 8.3.38.31 1 1 Inopha AG8.3.3使1 J&J J&J DenisJ&JDenis FKAET 調便AET AET J&JFK AET)調 AETFK FKJ&JFK AETFK J&J Denis Inopha AG J&J 2.1.1 J&J J&J DenisInopha AG2008Inpoha AG Denis ) CaelyxJ&J J&J 退J&J FK退Inopha AGInopha AG退 Denis Denis J&J 10% (8%)Inopha AG FK2008 Inopha AG J&JInopha AG Denis Denis 17112 使 Inopha AG 2.1.11J&J(FK J&J2008 調J&J Denis652011923Denis Herwig Janssen65Denis J&J 2.1.11Inopha AG J&J FK200813.5FK10.12.1.1 2.1.1 1 Inopha AG JJ Herwig JanssenMichael AtkinsLuc Ruelens David DasbergFK Inopha AG 39-42 Inopha AG Denis Denis J&J FK調 200817112 1 2 2255223 Denis 200911Inopha AG 17112111225511112 2 3 Denis 2012Inopha AG 11712131Caelyx2255Denis 2008Lipoaomal Doxorubicin Lipoaomal Doxorubicin2008Caelyx 369571J&J2000 20122008 2012FK171113Inopha AG Inopha AG10 361 51FK2008Lipoaomal Doxorubicin Lipoaomal Doxorubicin 2008CaelyxFKDenis 151 105103 DenisInopha AGInopha AG 97CaelyxLipo-AB Inopha AG9811 101J&JFKDenisInopha AGInopha AGFK 使 Inopha AG 1.1041220 10571211381 13 2.103104121710552710571 10571 調2 3.103210571 171713 4.381232412 38113 Inopha AGDenis 1.972011Caelyx 2.Inopha AG200911 3.J&JInopha AG751,450 J&J1076 6,826,599.3120177J&J 500106724 143 563,103.4821,513,495.83 20177J&J 4.FKInopha AG300175Inopha AG125Inopha AG368,000Inopha AGFK1,382,0003,000,0001,250,000 368,0001,382,000 5.38121 3 1055273091519 4021 CaelyxLIPO-AB RisperidoneLeuprorelin4 Inopha AG Denis Inopha AGInopha AG1003Denis ()Inopha AGDenisInopha AG () 1015961Inopha AGOkleShare Purchase Capital Increase Agreement1014 30100%Inopha AG Inopha AG25(17)Inopha AG20%30% 101622175,000Inopha AGBank nameUBS AG, Business Banking, Bank address: Postfach 000 0000 Zug, , Account name: Inopha AG, Account Number: 000-000000.70A IBAN CZ000000000000000000A Inopha AG20 1011391013Inopha AG1016175 5,479Inopha AGLiposomal DoxorubicinLIPO-ABRisperidoneLeuprorelin4 Inopha AG Inopha AG Inopha AG 100 30175000101917Inopha AG1021223 103110Andreas OkleInopha AG Share Purchase Agreement 102320Inopha AG103331583100 Denis DenisInopha AGInopha AG 退Inopha AG 10381 9,6755001 175Inopha AG1039109,675 1031215 30% Denis Liposomal DoxorubicinLIPO-ABRisperidone Leuprorelin4 Inopha AGInopha AGInopha AG 4 1061123820126Denis4Inopha AGTTY J&J Inopha AG Inopha AGCaelyxLipo-ABRisperidone Leuprorelin 102 Inopha AG100% Inopha AGInopha AG85% 30%Inopha AGInopha AGInopha AGInopha AG4 28"AimPharma Inc.""Inopha"10151410717310158 101528106171-17212557103 12393236237 Denis Opitz 2526106116 1.Liposomal Doxorubicin 2.Liposomal Amphoteracin B 3.Risperidone Depot injection 4.Leuprolide Depot injection 8640 -46 4 Inopoha AGInopha AG 1061124 41Liposomal Doxorubicin 3 使4 2 2 216 215 104121051 Caminada Treuhand AG Zug10512 9105121910413194199 1.1041210450,000 2.104122515,313 3.1021230450,030 4.1041231400,030 5.10515400,030 1.105122400,000 2.10522400,030 Landeshauptstand Dresden 3.10523196,796 Landeshauptstand Dresden 4.105219109,264Denis 5.105219215,030Denis 1046Caminada Treuhand AG ZugInopha AGInopha AGOkleCaminada Treuhand AG ZugDenis Opitz 10631356J&J 35104 116256,516,0007786Inopha AGInopha AGOkle104101Denis Denis 37 2991171 112322211 285551538123 106 9 1 10滿20 106 9 6 171 3 10 1 2 20 1 2 155 1 2 157 1 1 2 使 5 1 7 2 5 5 1 3 5 336 342 1 3 1 2 1 3 165 1 165 2 20 1 2 155 1 2 157 1 1 2 1 1 2 1 2 3 2 7