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t丨' syncardia Quallty-546 rev 006 e d a-n NNN独家d i s t ri b ut o r协议6。2 .1 S y n Cardia和D i str i b u tor may ar r ange for a qualified and trained surgeon e experienced in the S u r gical implant of the Products io attend the i m p l a n t pro c eurect con d u cted at an eligible H os p i tal n the Ter r i tory（“Proctorin g”）。A ll Proctor jn g应通过SynCardia US i n g a SynCardia approved sur g eon进行管道输送。根据Exhi b i t H. 6.2.26.3 c u stomer s upport中的规定，SY n C a rd ia ai，d d i stribut o r作为相互a g r eed由S y n C a r d i a和d i stri b u t o r承担的T h e费用和相关差旅费将由S y n C a rd ia ai，d d i stribut o r承担。In ord e r to discover a n d d.iss e mi n ate best practices and faci l i tate com m u n icat i on with person ne l from e ligi b l e hospitals，SynCardia w i ll m aintain a customer s u p port rel a tions h i p w i t h a l l e l e i g i b l e hospitals and may spon o r user groups，c u s tomer event s，m e d ical advisory bo a r d s，M e d ia event s，traini ng oppor t u nities and other i n teracti o n s w i th eligible h o s p i tal pe r sonnel。1.到ext e n t p os s i ble，SynCardia将包括e、infonn和co o p erate与Di s t r i butor都通过annu a l营销p l a n s a n d i nfotma l y，在所有t b ese r e l a ti o n s h ip a c ti v i t i es中实现t h e highe s t l. evel的客户支持。2.Di s tr i b u t o r wijJ work w i t h the s a l es，marketing，c e r tificatio n，and clinic a l support deprutme n ts of SynCardia·i n suppo r t of cu s tomer servic e。6.4同步a r d i a s uppoii。D u ring t h e term of this agre e men t，S y n cardia shal l：6.4.1 p u blish distributor's name a nd a d ress in its. l ist of a u th o r i zed clist r i b u t or s _，if s u ch d i r ectory is e sta b l ishe d；from time to tim e，根据将由SynC a r d i a和Dist r i buto r共同商定的ar u 1 ual营销计划，a n d as opportunit i es present themesetve s，支持Dist r·i butor的m营销，方法是i nvolving D istribut o r在任何a d v e 1 t i s i ng a n d dire c t m a i l activiti e s或其他s u ch a c celebrities appropri a te from time to time e e e，pro v i de d i st r i b ut o r训练和ce 1 ti：fic a ti o n to t r ain on the technic a l deta i l s and applic a t i o n of the p ro d u cts thr o u gh the o p p ortuni t y to att e n d而part i cipate i n the fo u r p h ases o f start-u p ce r t ification or o t h e r fi e ld-deliver e d trai n. mg；fur n i sh di s t r i b u t o r，up o n d i st r i butor's r eque s t，r easona b l e technica l informa t ion r e specting ap p l i c a t i o n s of t h e product t s；transmit prom p t ly t o di s tributor a ll sales leads f o r potent i al elig i b l e hospitals i n the terri t ory for the purpose of i n i t i ating t h e qualification proc e s s对于SynCardia授予cert i fic a ti o n p e r the a n n u a l marke t i ng p l a n，a n d在T erritory中提供合理的m a r k et i n g和s a l es s u p po r t，u s ing q u a. lified p e r so n n e l。SynCardia may p rovide such support r e mote l y or，a t its opti o n，in p e r s o n in t h e t e n itory。6.4.2 6.4.3 6.4.4 6.4 .5 6.4 .66.5 T r aining exp. enses for emp l o yees a nd re p r ese n t ativ e s。每一方sha l l lbear i ts o w n e xpens e s for i ts e m ploye e s，re p r entatives，consultants r u 1 d a g e nts（e. g。，salar y，travel and per d i em expenses）i ncurred i n co n n ection w i t h p r o v i d i n g and recei v i ng su c h training。Syn C ardia首字母：_

SY n Car d i a Qu a tity-546 Rev 006 PAG EDA-NN NN EXCLUS IVE DI S TRIBUTOR Agreement6.6 d i s t r i bu t or c o n tact l nf o n ation。DIS t r ibutor SH a ll prov i d e SynCard ia wi t h分销商的contact i u formation for i n terest e d parti e s将添加到SynCardfa databa s e for company updat es和pr o vide customer e r s c o n t act information for r appropriate r e s o urce acc e ss。7 .Trad e marks；packaging a nd Lab e line 7。1 s y a card i a will s uppJy product w i t h t h e r e l. evant docum e n ts as part of l a b eling su c h. as‘’not a ht instrumnctions for us e " required by r e g ul a t ory approval ia official documents并通过SynCard的validati o n. i a t r ansl a t i o n of official documents as des crib e d in secti o n 5（transl a t i on）of th i s a g rne m en t。Distribu t或acknow ] edge and understand s that th e p r oducts may o n l y be used in t h e m a n n e r p r escribed by and described in the syncard：ia r. egulatory a proval current v e r s ion oflabe l i ng‘SynCardia Systems，LLC temporarily Tot a l Artificial Heati（TAH-t）Instruc t i o n s for use " or use r’s Manua l s for other p roducts，nd分销商wi l l不推广或s u ggest t h e将产品t s用于任何其他e r p u r pose或以n y o t b e r方式。D i s t ributor s hal l n o t ma k e any warr a n ties or representations w i th respect to products on behalf o f sync a r dia beyond what is r presented i n l ab e l s，labeli n g and t r aining m a teri a l s by syncardj a。D i strib u tor shall indemn i fy a n d hold SydCardfa harmless from a ll claims and damag e s，including i n g reasonable att o r n ey s‘fees，resulting from d i stributto r’s vi o la t ion of t h is agreem e n t。D i s t ributor agrees t h at it will not se e ll any products for the ex p i ration da t e is p a s e d or i f such sale will r esult in t b. e product’s use after t h e xpiration date or in c o n travention of applicable law。Distribu t或s h all not remove e，cover or ob l i terate a n y markin g s o r inf o r m ation placed on produc t s or t h e packaging th e r eof as s u p p l i ed. by syncard-ia without the expr e ss w r it t en permi s s i on of syncardia。1.所有标签m u s t均符合S y n卡ia R e g ulator y批准要求n ts。2.任何l abeling of products to co m p l y w i th loc a l l aws s hall be und ertaken by Syn C a r d ia with the a dvice and s u p p m t o f d i stri b u t o r. SynCardia auth o r izes distributor to us se，in connection with the s ale，re n ta l，promotion. and adver t is i n g of e r o duc t s，此类t r a d标记和商品名称可能是u s e d b y sync a r dia i n the advertisin g，promo t i on a n d s a le of P r oducts only with t h e pre-authoriza t i on o f SynCardia。7 .2 7 .3 7.4 7 .5 7 .6 7 .6 .1 ALI re q u est for s t 1 c b ap p r o vals made by D i stri b u tor s hall shall with an electronic copy，b ard copy，photo o r other representatat i on of t h e i t em to be approved。Dist r i but o r sh a ll has no right or int e r est in or claims to a n y such marks or n a me s，shajl not u se the same i n.任何可能倾向于击败o r d min i sh t h em and s h all的方式，我都会在S y nCardi a的要求下间接否认i n ue the us se，并且，在任何情况下，在t e rm i nati o n of this agreem e nt。AU U S es by Dist r i but o r in its adv e 1 tising o r els e where of synca r d i a ' s name or a t 1 y t r adem a r k or trade n a me（o any mark or n a me closely similar to l ing t h e s a me）现在或以后拥有或l icens e d b y synca r d i. a（o r any o f its affilia t e s）s h all be s u bject to tbe p r i o r written approval of t h e Co m pa n y。U p o n rec e ipt o f such written approva l，d i s tribu t or s hall has a l i m i ted，n o n e x c l usual license und e r SynCardi a的trndemark权利和其中体现的使用SynCardi a的nam e，tr a demark a n d 7的商誉。6.2 7.6 .3 SynC a rd i a init i a l s：d i distributor ini t ials：-

SY n Car d i a SyaCardia首字母：_第13页，共42页Qu a l ity-546 R e v 006 ED A-N N NN EXC L USIVE DISTRI B U TOR协议商品名称s o l e l y为p e r f o r m i n g Distri b u t o r的mr u·k e ting ob i i ga t i oL 1 s下。Goodw ill resul t i ng from s u ch use s b a lJ ac c r u e t o t h e ben e f i t of and b e owned by syncar d i a。Dist r i bu t or i s n ot au t h o r i z e d to us se Sync a r d ia‘s name o r any su c h商标或t rade n a me o u t s i d e d i s tri b t t o r’s t erxitory或作为d i s tributor's tr a d e style o r corporate n am e的一部分。D i s t ributor may u se i ts own m ark or l ogo in c o m 1 ection with its s s a l e，promo t ion和a d v e r t isi n g o f p r o d u ct；b u t its ma r k 01·l ogo s h a l l be no l arger than synca r di a的商标an d sh a ll not so d i s p l ayed as to cov e r，o b li t er a t e o r减损syncard i a的商标k s。SynCar d i a s h all have t he perpetual，free royalty r i g ht to use and to lice n se o others to u til i ze in the pr o d u ctio n，packag i 11 g，pr omoti o n and s a le of product s，all ljr o c hur e s，po i n t of sa l e materi a l s，catalogu e s，and o t h e r advertisin g，promoti on a l and sales materia l s d e v e l o p ed by. or for distributor fo r use in c o n n ec t i o n with the adv e r tising，promot i o n or sale o f prod u cts。根据SynCa r d i a > s请求，Dist r i b t rtor s hall exec u t e any和所有docu m e n t s that m a y be r e q u i r e d以完成前述pro v i s io n s的t h e p ur p os e s。D i s tr i butor sh a ll n otify SynC a r d fa if i t wants to have SY n Cardia a p p l y f o r a n y reg i strati o n s of trademarks w i th respect t o produ c ts in the juri s d i ctions i：t 1 wh：i c J 1 produ cts are t o resold by di s tt " ibutor。I f Syn。Cardia批准tr a d e m a r k的f i l ing o f任何应用程序。u c b r egistrat离子，i t s h都进行d o s o和SynCardia s hal。L coop e r eat wi t h distri b u tor的e ff 011 s。D i str i b utor shall n o ti f y syn c a r dia firmly on L e ami n g of any i nfringement of the intellectual property a s. so c i a ted witliprod u ct s。1.SynC a rdia s h all not be o b ligated to take any action with r espe c t t o s uch infr i n ge m e n t s。2.D i s t r ibutor s h all coop e r ate fully i n i n i ve t i ga t i n g any s u ch i n stance a n d，o. n sync a rd i a ' s requ e s t，sh a ll a s ist a nd parti c i p ate in any action which syncard i a c h o oses to ta k e w i t h r e spect to there。3.A ll expenses of any su c h ac t i on shall be paid b y syncar d i a；a ll r ecov e r i es obta i ned from t he prose c u t i on. of any such ac t i on shall be retained b y s yn c a r d la。7 .7 7 .8 7 .9 7.i o 8。regul a t ory requirements；G o v e rnment reports & F ilin g s 8。1个R egu l atory s tatus。SynC A：r di a rec e于2004年获得F DA对tl，e美国70 CC TA H t系统的s a le的批准。SynCard i a h as r e c e i ved s i m ilar a p pr o vals from Health C a nada f o r th e sale 70 c c c and 50 cc TA h-t syst e m s（“Canadian Li c e nses”）。S y n Cardia h as received the CE mark（C e r tificate # 93783）f o r the c o m m er c i al d i s tri b u t ion of th e 70 cc a n d 50 cc TA H.-t sy s t em s，70 cc and S o cc s u rg i cal sp a r es kits and pneuma t i c dri v ers（collec t i v e ly，“T AH Dev i ce s”）for pla c ing on the market w i t hin the European Economic A r ea and i n cotmtr i es t hat recognize t h e CE mark。R e gu l atory complianc e。D i s tribu t o r sh a ll co m p ly with ap p l icable laws，incl u d i n g，wi t h o ut l i mitation，those a ppl i c a b l e to the r eceipt，st o r a g e，d i s t ributio n，sale and ser v i ce of m e d i cal devi c es。Governm e n t reports a nd f il ings 8。3 .1 EA C H方同意向H gov e rn m e n t al ag e n c i.es req u i red b y a pplicab l e law s，rules and r egu lations and to u s e i t s b est effo r t s t o obta i n ail approvals，licenses，p ermits and p e rm missions w i t l 1 response to its or th e ir oper a tions p u rsua n t to t h i s agreem e n t。8 .2 8 .3

SY n Car di a SyuCardia init i als：d i s tr i butor首字母：__，_，…，…_ Qua Lity-546 Rev 006第14页，共42页E D A NNNN E X C LUSIVE DI S TRIB U TOR协议8.3。2 T he par t i es sh a ll在提交或r ec e i i pt时立即交换此类文件和批准。分销商应承担（i）rep o 1 i s的f i lings的制备n d making和（ii）领土内任何政府要求的o b tai n i ng批准s、l icens e s、p ennits和p e 1 missio n s的al l费用，但以o 1 y r equ i r em e n ts s u ch作为CE标志的任何与全球r e g u l有关的费用除外。SynCardia应承担（i）t h e prepari ng a nd making rep o 1 t和（i i。）The obtaiJ 1 ing t h e approval s，li c e n se s，permits a n d permi s sions r e quired b y a n y government a l authorities o u tside o f t h e territory。每一方sha l l在作出su c h filin g s和r e p o 1 t s以及获得s u ch批准s、l i cense s、permit s、pe n n i ssi o u s和c e 1 tif i ca t i ons方面相互合作。8.3 .3 8 .3.4 8.3 .58.4分销商SH a ll维护appli c able l oca l，n ation a l和i JJtern a ti o nal government或r e g u l at o r y registrations and s hall provide s u c h r e g i stration numbers or certificates to sync m·d ia u p o n r e quest。分销商s haJ I inform S y n C a rdia with i n twen ty-fo u r（24）hours of any n a tional o r intematjooal r e gulatory agency inspect i on r elated. to SynCardia product or inspection th a t may o t h erwise impact product qualit y，regulatory comp lia n c e，distribut i on of prod u ct or general business practice。Di s tribtttor SH a ll rep o 1 t to Synca r cl. ia via email any regul a tory agency observati o n s，n otice s，findings or officiaJ regulatory action again s t d i s t r i b ut o r that may involve S y n cardia product or my other im p act product quality，r egulatory complianc e，d i s tributi o n of product or g e ner a·1 busin ess practice with i n 20-fo ur（24）hours to become aware of s uch findings。D i分销商s ha l l mainta：in a q ua l i ty systen and esta b l ished proced u r es adequate f o r th e fr o p erati o n，iJJ according to wi t h sectio n s o f 21 c f r prut 820 and i so 13485，a s applicable to di s tributors。8.5 8.6 8.7 8 .7.1Di s tributor sha l l a l ow s y n c a rcli a，or its authorized representative tiv e，to perfonn audit s. of the distributor's facili t i e s，s ystems，docume n tatio n，r u 1 d o t h e r requ irements related to this agreement and to t h e product。Distributor s hall在r e·quest上向SynCardia u p提供质量体系程序和其他r el a ted文件的副本，作为上述程序被e s tablished的证据，或满足合同要求h er e in的证据。这类文件可能是。re d act of information consid e r e d by DistribLRtor to be intellectual property o r trade secret，w h e r e app l icable。8.7.28.7.38.8分销商应在包括或r e fer to the L ocati o n of：8.8.l 8的r ecord s的适当i dentific a tio n、storag e、p r o te c ti o n、检索、保留li m e和d isposit i o.n的程序中维护a。8.2 8.8.3 8.8 .4 8.8 .5初始收货人的名称和地址；标识a n d数量的设备shippp e d；t he d a te s h i pped；和任何contro l，lot o r ser i al num b e r（s）use d；a n y appl i c a b l e test sheets o r check-out f o r m s。

SY n C ar d i a SynCardiainitials：Distri b u tor [ niti a l s：_，-Qua l ity-546 Rev 006 Page 15 of 42 EDA-NNNN Exclusive DI ST RIBUTOR Agreement8。8 .6记录s h au be peunanently s tored in a man n e r that p r ev e 11 t s dama g e or degrada t i on the recor d s。1 n add itio n，the r e c o r d s hall is controlled in a ma n n er that allows the records to be easily loca t ed and not l ost d u e to l ack o f organization。D i s t ribu t or shall comply with the r e qu i r em e 1jts of regul a t i on（EU）2017/745 Article J4. and all rel a ted d i st r. i b u tor oblig a ti o n s，inc l uding but n ot l i mited to t he followin g：8.98.9。1 W母鸡在市场t、Distri b u tor s h au上制作a d e vice availa b l e验证符合以下要求：8。9 .1. d e vice有b e e n c e标记并拟定d e vice bas的EU de c l aration符合性。i mp o r t e r has com p lied w i th the requirements set in Article 13（3）o f regula t i on（EU）2017/745。The d evice i s l abel l ed in accordance，v i tb 2017/745 Ann e x（第23节）并附有i11 fo m1 at i o n to be suppl i. ed by man u facturer according to w i t h Article 10（11）in an offic i al u nio n l angua g e（s）det e r m i ned by t he m ember state where the de v i ce is made ava i l a b l e to the user或pat i e n t t t h e particu l ars of t h e lab e l s l 1 all be indeU b je，eas i l y l eg i ble and clearly comprehensi b l e to the intended user or patient。W h ere applic；a. b le，a u 1 ii q u e de v i. ce ide n t i fier（UDJ）已被m anufa c tu r e r指派。8 .9.1.2 8 .9.1.3 8 .9.1.4 8 .9.2 Di s t r i butor可以应用l y a s a mpling方法，以满足第8节中提到的req u i rements。9 .1 .8 .9.3 Distri but o r shaU，upon requ e s t b y competent au t h o r i ty and/or syncar d i a，向其提供所有i nfo r m a tion和docLtmentation th a t i s a t their d i s p osal，并且是demon s trate符合装置所必需的。8 .9.4 W l 1 ere the D istributor cons i ders or bas reason to believe t h at t h e d e vice pr e s e nts a s e rio u s r i sk o r i s a f a l s i fied devic e，i t s ha will inform SynCardia in w r iting，and wh e r e app l i cable SynCardi a's a u f b orized representative e，以及在w h i c h中的i m p o 11 er a n d competent a u thority of t h e memb e r state in w h i c h。it is est a b lished。8. l O Distri b u tor sh a ll esta b l i s h并维持程序，以在SynCardia的d. irection处或r e m oval t o the i. nitia l c o n si g 11 ee处进行correc t i，并根据w i th SynC a r dia召回策略，包括在q u arantine和traceabi l i ty下保持返回产品的integr ity，并将任何r eturned产品的traceabi l i ty保持到初始c onsigne e。8 .1 0 .1 ff SynCardia or any governme n t a l agency o r ot her proper authority orders a product reca。U或就任何PR o管道发布产品咨询，Di的贡献者应与SynCA r di a在：8。10.l.l在任何此类咨询或reca l l s的T e r r i tory中及时联系此类P r oducts的执行人，迅速向此类客户传达诸如SynCai：d i a may de s i re被传送给t h e m，r emoving all such recalled produ c ts fr o m its.inv e ntory a n d 8等信息或i n s t ructs。I 0。1 .2 8.10.1 .3

SynCar d i a SynCar d i a ini t i a l s：_ quali i y-546 rev 006 e. d a-n n n n n ex c lusive d ISTRIB U TOR a greement 1。. 4 Rett u·ning o f s uch根据a n ce w i t h SynCardi a的.instruction s召回e d Pro d ucts至SynCr u·dla。2.D i stri b utor sh a l l prov i de periodic statu s. r eport s.或根据tb. e Syncantia召回s b·ategy对SynCardia的b ehalf进行有效性检查。8 .10 .3 SynCard i a sh a ll reimb u rse d i str i butor for a。LI r easeable就s u ch Pro d u ct a d v i s o r ies a n d recall s相关的费用jn c ur r e d by distributor，除非t h e咨询或recall i s du e，i n w ho l e或。部分是由于distributor或其re p r esenta t i ves的过错。Di s tr i butor shall ma i n tain bu ildings of suita b l e de s i g n and c o n trun足够的空间来执行必要的操作s，防止m i x-ups，as s u r e ord e r l y h a n dling of s y u cardia prod u ct s。Di s tributor s hal l mai n tain b ui l d i n gs to prev e n t contamination of SynCardia prnducts by substr u 1 ces that co u l d r很容易被认为会对产品qua l i t y产生不利影响，包括来自污物和害虫的污染。8 .12. l其中spe c. i al en v i ronm e n t al con d it i ons have been spe c i fied by sy n c a r d i a，distributor sh a ll e s tabl i sh and m a i ntain procedures t o ade q u a t e l y contr o l these enviromne o tal con d i ti o n s，i n cloud ing periodically i nspecting to ver i fy that these sy s t ems are ade q u ate and fu n ctioning p roperly。D i s t ribu t or sha l l off e r sy n cardia produ cts f o r sale a nd u s e o n jy for a pur p ose for wh i ch s u ch p rod u cts are approved i n syncard i a l ab e lin g，adv e r tising，o r i n stru c t i ons for use。8 .13 .1 If Distribut o r becomes aware t h a t any of its e m p l oyees has markete d，or any of its customers are using a n y synca r dia prod u c t o u t s i d e of the approved l ab e l i n g，Dis t rib u tor sh a U inform synca r d ia immediately in wr iti n g。No c han g e s th a t co u ld i m pact t t h e qualit y，prod u ct design sha l be m a d e by the d i sb'ib u t o r without sy n c ar d ia i nput and pdor w r itten approv a l。Distri b ut o r和SynCardia SH a ll c o l l aborate to ev a J uate a ll rep a i r and service reque s ts as to w h ether they are c o m plai：uts that are to be repotted to SynCardia as described in the f o l. l owing paragraph。Co m p l aint proc e d ures。D i s t ribu t o r sha l l l establishment and ma i nta i n procedur e s f o r receiving c o m p lints from c u st o m ers。S u c h pr o程序sh a ll确保：1。所有投诉均以统一方式处理，并代表o 1 i ed to syncard i a in a t i m e ly m ann e r i 2。0：ral c o m p l aints记录在rec e i pt上；3。CompJ a i n ts c an be ev a l uated to determ i n e wh e t h e r they are requ i r ed to be reported t o r egul a t o r y aLL f b o r i tie s；a nd 4。Sin c e time is of the ess e n ce in meeting s t a t u t ory reporting time period s，Di s tri b u t o r s h all repott co m p l runts to S y n cr u·dia w i thin twenty-fow-（24）h o u rs of the t i m e distributor first b ecomes aware of th e m。ASS e ssm e n t o f操作。Di s t r i b u t o r s h all a g r ee to an ass s m e n t of its opera t ions by sy i 1 c a r d i a at reas o nab l e times of o perat i o n。SynC a r di a，in t u m，shaU give distributor reasonable n otice of i ts desire to a s sess and provide an assessment plan t o di s tributor。Distr i bu tor repot i in g。D i分销商s h a ll prompt l y and accurat e l y provide s y n car d ia wi t h a ll r e p o rt s and inf o n：na t i ou n eeded t o com p l y wi t h report ing r e q u iremen t s to 8.1 18.12 8。1 3 8.14 8.15 8.16 8.17 8 .18

SY n Car d i a s y n c a r d i a i n i tia l s：_ Page 17 of 42 Quality-546 R ev 006 ED A-n n n n n e x CLU s IVE DI S T RIBUTOR Agreement Sync a rd ia and a. SSoc i t e d timi n g set for t h as 附件 k，由SynC a rdia（“D i s t tibutor re p o rtin g”）从t i me更新为t i r n e。9.停产prod u c t s fe x盗版产品9。1 S y n c a r d：i a r es e r ves the r i g h t o modi f y or d i scontinue the sale o r r enta l of any products at any time with l 10 u t inc u r r i ng any lia b il i ty thereby o r any o b l igat i o n t o r ep u r chase或修改P io d u cts先前s o l d b y syncard i a to d i s t r ibut o r。Sync a rd i a sh a ll g i ve d ist r i b u t o r n o t ice of d isconti n ua n ce of prod u ct n ot l ess than sixty（60）days p r i or to the discontinuation of a n y p r o d u ct。SynC a rd i a may rotate [ n v oic e d pr o d u ct to m ore a c tive c l i n i c al c e n t ers. in aa e：ff o 11：to u s e them befo r e t h ey e x pir e。9.29.2.1T h e r e l eased i n voic e d products s halJ be m p laced r u 1 d p ro v i ded to d i distributor at sy 11 card ia exp e n se w i t h in thir t y（30）days unless Distrib u tor d emonstrat e s. a n e m e r g e n cy n e e d for r e p l acem e nt earlier。S ur g ical SP a r e s kits a r e not r o t a t e d and need to b e r e p l ac e d at Distribu t o r e x pense wh e n e x pi r e d。S y n c a rdia s hall also pro v i d e r e placem e n t d r ivel i 11 e s，b a tteries and other p r o d u cts t h at e x pire，除非分销商i s在d v ance中通知s u c h p r o d u cts不会被r e p l aced。9 .2 .2 9.2 .3 1 0.Confidentialitv 10.1 Conf i dential l n f o rm a t i。0 11 .D i s t r i butor a c knowledge es a nd a g r ees tha t，in the c o t irse of p erfo i mi n g i t s duties and obligations u nder th is agreemen t，c e 1 tain inf o rmation that is confidential o r proprietary to SynCardia（“Confidential Information i o n”）wilJ be fm：nished b y syn _ card ia o r s y n c a r di a ' s repr e sentatives。1.D i s t ribu t or agrees t ha any conf i d e n t i al information furnished b y sync a rd ia o r syncard i a ' s repr e sent a tive w ill not be used by it or i ts repr e senta t ives e x cept in c o nne c t i o n w i th，and f o r the p u r p o ses o f，the prom o t i o n，mark e ting，d istri b u tion和s a l e or。P r o d u c t s在此Agre e m e n t an d下，除非提供了h e r ein，否则wi将不会是d i s c l os e d b y i t或其r e p r e n tatives w i t h o u t the pr i o r w r i tten同意SynC a rd i a。2.Du r i n g the term o f this a g reem e n t and any renewal t h ereof and for a p e r i o d of t l u·ee（3）ye a r s after t he t e rination or ex p ir a t i on o f th i s agreemen t，d i s t i-ibu tor and al l of its o winners，d i r e c t o r s，代理商和员工s h all safe g uard and t r eat as c o n fidenti a l the tenns of this Agreement，i n c l ud i n g a ll r ef e r e 11 ced document s，and a lJ training，m a r k e t 1 ng plan s，pr i ce l i s ts a nd q u o tati o ns，技术信息a nd part i c u l a r s and ot h er i n：fo n nat i on由S y u c a rd i a提供。3.D i s t ribu t o r sha II n o t d i sclose a n y c o nfi d e n tial infor m a t i on t o any third p a r ty or person exc e pt in i t s provision of training and s u pport t o eligible h o s pita l s。Excep t i ons t h e c o n fiden t i a lity o b l i ga t离子的Distr i b u tor unde r第10节。1 do not e x tend to a n y conf i d ential 1 n formation furnish e d by syncardia or syncardia ' s represent a tive that：1。I s o r b e c o m es usually availabJe to the publ i c o t h e r than as a r e s ult of a d i s c l osure by d i stri b utor or or its repr e s e n t at i v e s；2。W as a vaila b. l e t o di s trib u t o r o r i t s re p r ese ntati v es o n a non-c o nfi d en t i al b a s is p 1-ior to its d isclosure th. e r eto b y synca r d i a o r sync a rd i a ' s r eprese n t a t i v e s；a 11 d 10。2

t ' > s y n car d i a distributor titials，f！Syncard i a首字母：__ i page { a of 42 qua l i t y-546 rev 006 EDA-N NNN独家D i STRIB U T O R协议10。2 .3成为ava i l a b l e to distributor or i ts r e p r entatives on a n o n confidential ba s j s from a source o t h er than SynCardia or SynCardi a ' s repres e n t a t i ves；p r ovide d，howeve r，th a t s u ch s o u r ce is n ot bound by a confidenti a l i ty agre e ment with S y o C a：rdia o r SynCardi a's. representatives。CompeUed Discl o Sure 1。如果要求分销商或iTS r present a tives或b ecome le g alJy compel l ed（by o r a l que s tion s，i. n t e 1 t og a tori e s，r eque s t s for i n fo n na t i on or docu m ent. s u b poena，ci v il inve s tigative demand or sim i l ar p rocess）to dis c lose any confid. e n t i i l information fumi s b ed b y syncar d i a o r s y n cardia的r e pr e sentatives o r the fact that such conf i d ential informat i on b as be e 11 made avai l able to i t，di s tributor agrees that it or its represententa：tive s，as the case m a y b e，wi 11 p rnv i d e synca r d i a with p r ompt w r itten notice of s uch r e q u e st（s）so tl m t synCardia may seek a protective order or o t h e r appropriate remedication and/or waive compliance w i th the provisions o f this agreem e n t。2.如果su c h protective ord e r或其他re m e d y i is not o b t a in e d，或Syncard ia放弃compli a n ce with tbe provisions qf this agreemen t，Di s tributor agre e s. th a t i t will fa m ish o n l y that por t i on of such confiden t ial inform a tion th a t is l egal 1 y r equir e d and w iD exercise its b e. st effo r t s to obtain r eliable as s urance that confidential t r eatment will be acc o r d tothat p o r ti o n of s u ch conf i den t i al information and other i n formation b eing d i sc l osed。10.3升。任期和终止11. l任期11。1. l本协议SH a l l的初始期限自e生效日起开始，并在续约五（5）年后生效，ltnless终止Earl i e r ll 11 1 der the provisions of t h i s Section 11。11.1.2本协议可在五（5）年后由m utual wr i tten agreem e n t续签e d。由S Y11卡i a11终止。2 .1 SynCA r d ia m ay te r minate this Agreement in i ts s o l e discret i o n for cause at any time up o n s i xty（60）d a ys'w rit t t en n o t ice to d i s t 1·ibtitor i f分销商：l l.2 i 1。2.1.1 d ming t h i s initial ter m，d oes not c o mplete al i regul a tory f i.i i ng s，a ll TA i { pro d u ct appro v als and i ntro d u ction of T AH p r oducts i nto the r e l evant market（s）。在协议生效日期起两（2）年内未能在o r y filin g s和/或批准r e g u l的prov i de e v i d e n c e和/或批准。Fails to estab l i sh au experi e n ced clinica l team for TAH implant s u p p ort and a hospital training program w i t bin two years from effective d a te of t h e agreement。1 1 .2.1 .2 1 1.2.1 .3 2.此Agre e m ent m a y be t e rminated by SynCard i a if dis t r i b u t o r i s adjudged bank r u p t，making a n assignment for the benefit of cred i tor s，has a certain a p p ointed，files or bas filed against it a pe t i tion in b. ankruptcy o r in i tiates r eorganization proceedin g s。3.SynCardia可以在其s o l e discre t ion中终止此agreem e nt for cause a t随时up o n ten（。10）day ' wrjtten通知分销商upo n：

SY n Car d i a rn，TDBUTOR JNIT；AL：-1.。SynCardia i n i tials：_。/p年龄19 of 42 Qua l ity-546 Rev 006 EDA-N NNN独家DIS T RI B UT O R A G REEM E NT 11.2。3. 1任何企图tra n sf e r或thi s的受让人同意m e nt或本协议项下的任何权利或义务或任何出售、tr a nsfe r、放弃、voluL 1自愿或非自愿、通过操作o f法律或o t h erwis e、直接或indi r ect所有权、contr o l或积极管理Dist r iboto r的任何i利益，未经SynC a. rd i a事先书面批准。1 1 .2.3.2任何di s pute，d i s a greemen t，或controv e r sy be t ween or among principal s，p a rt n e r s，manage r s，officers or stockh o l ders of distributor which in the op i n i on of SynCard ia，may adversely affect t he ownership，operatio n，managemen t，b u s in e ss or i n tere s t of distributor o r S y n c a rdi a。1 1 .2.3.3 T I 1 e由分销商执行i on on a s mission f o r the b e nefit of cred i tors；SynCard IA的定罪o f分销商或任何PR i ncipal官员或任何cri：m e s wh i c h i n·tbe意见可能对Distiibutor o r Company的ownershi p、operation、management、b u s in e s o r i nterest产生不利影响。1 l.2.3.4如果D i str i butor i是合资企业e、prutnership、str a. tegic联盟或类似关系（c o l l ectivel y，“实体y”），i 11 tbe的aoy事件如下：（i）t h e退出o r终止参与任何membe r，o w n e r，s tockholder ot p a 1 ticjp a nt of the entit y，（ii）任何ttempt e-d转让或转让第i s协议where e r给m e mbe r、拥有e r、s t ockholder或实体的所有者，（i i i）discon t inu a nce of the entity operations，（iv）t he membe r s hi p、ownership、stockh o l d ers或pa：rtki pants of the entt i t y的任何变更，o r（v）实体或其雇员、高级职员的任何行动，dire c tor s，member s，o w ners OT a g ents that，in the opinion of S y n cania，m ay advers e l y affect the own e rship，op e r a t i o 1：i，，manage m ent，b u s i ness or interest of Di s tributor or s：yn c arclia。11.3终止F ai l ure to pay 11。3 .1在事件D i的出押人fai i s根据t e m 1 s和th i s agr e emellt的条件向Syncardia付款时，Sync a rdia s hall有权在书面通知的t h irty（30）天内终止本协议unl e s全额付款。Tenninaj，ion b y either pqrty 11。4. l t h i s协议可随时因cau s e或i f在履行本协议的任何事项i aJ条款时的其他pa 1 ty d e过失而由eith e r par t y终止，并在通知u 1 writs u 1 g of them后的三十（30）da y s期间终止。For avo i d ance of doub t，. If a breach i s cured within such thi 1 ty（30）day p erio d，then the agreem e nt wijJ not be term i. nated。经双方协议终止。T H E双方可在相互wri t ten a g，i-e e e.ment后终止本协议。Ch a n g e in contr o l tennination 11。6 .1 In t b. e e vent of a C han g e in Con t r o l（' C I C "）of SynCardia，SynCard ia SBAU has the right to term i nate this agreement with。Di s tributo r，according to w i t h the f o l l o w i ng terms：] 1.41 1。5 i 1。6

t，sy n car d i a qu a l ity-546 r ev 006 pa。EDA-NNNN EXCL U S IVE D I S TRIBU T O R协议E N T 11。6 .1. 1 S y 11 Cardia shall p rovide di s tdbutor w i th a write e n n n n o t i ce of t e r m i nation of th. is agreeme n t（the“CIC Notic e”），to become e effec t ive n inety（90）days from t h e date of the n o t i ce（the“Notice peri o d”）。一旦tenni nation p u r s u ant生效中投通知，SynC a r d i a w will accept t t h e return of ally u nused p r oducts，i n i ts 0 1 i. g in a l p acka g i ng w i th a t l east a o n e year sh e l f-l i fe r e m a i n i n g，f o r cred i t at t he o r igina l pri c e由分销商为此类产品c ts支付；prov i ed，h o \-vever，Syncard ia's o b l i gation提供此类c redit i s subject t o分销商的c o m plement of all the follo w i ng precond itions to s u ch repayment or compensat i on：11。6.1.2（a）（b）完成as i g n ments re q u ir e d b y t h i s agr e em e n t；Co m p lete the ret u r n t o Sync a r dia of a ll d r iv e r s，d r iver system components，Con s igned P 1·oducts and training mate r i als under D i s t r i buto r的control；T ransf e r a ll data and records g ath e r ed b y di s t r. ibutor i n the d i s c h arge o f i ts dut i es to provide r eport i ng to SynCard i a；并且N按照SynC a r d i a的指示通知所有HOS p i tals serv e d b y dist r i b u tor to m ake future p ayments and t o return a l l d r i ve r s a 11 d con s i gned produ c ts as directed by SynC a r d a。（c）（d）l i. 6. l. 3分销商ackno w l edge that the CIC not i c e，the good-will amo w 1 t des c r ibed in 11。6 .1 .5、接受任何u n u sed pi-oducts的返还是SynCar d i a的o l e义务与re p ect to a. termina t i on by SynCar d i a in connection i on w i t h a CIC。D i s t r ib u t o r同意co m p ly with all l egal req u i rements in each c o u n t r y throu g h out the territory necess a r y to make any sale to SynCardia here u n der v a l i d a n d bindin g。SynCA r d i a will pay t o distributor a good-will s u m e q u ivalent to the amo u n t alre a dy i n v o i c e d to d i s t r ib utor from SYUCardia（commis s i ons earned）for the p revious 24 mo L 1 ths with-jn 120 days of the change in C o n tr o l。In addi t i on synca r d ia will p ay a ll costs of t h e d i stribut o r related to t r aining of e m ployees and m ark e t i ng ac t i vities which h have been d o n e to p romote the product。1 1 .6.1 .4 11.6 .1.5 11 .7 Tennination的影响1 l。7 .1.1 Exc e p t as h e r einafter pr o vide d，在本协议终止时，Distrib t1 tor应终止prod u. ct s的d ist r i b u tion和s a l e。Distri b u. tot SH a ll r eturn to SynCar d i a a ll Pro d 11 cts not p u rchased by d i s t r i b u t o r，but in t h e contr o l of distri b u tor w i thin 15 d ays of te r m i nation w i t h freight and any d u ties and lmport Co s ts to b e paid by syncard'ia。Di s tributor shall b e s olely r e spon s i ble for all commitment nts incurred or assumed by it d u ring t b e t erm of this agreem e n t or t h ereaft e r，a n d syncar d i a sh a ll n ot be held responsible in a n y mane r t h erefore，iR r e spe c tive of any sugg e stion or r ecommenda t i on with r espe c t thereto by S y n c a r d ia or any i t s employee e s or r epres e n ta t ives u n l e ss s y n c a r d i a has expre s sly agreed in writing to as s u me the r espo n sibi l i ty。11.7.1.2 1 1 .7 .1.3 SynCardia首字母·：DIS T Tibut o r首字母：--，. <-n-

SynCar d i a第21页，共42页质量-546版006 EDA-NNNN EX C LUSIVE D I STRIBU T O R协议l l。7 .i. 4购买O ption。根据t h i s agreem e n t的t e rmi n a tion o r expirati o n，SynCar d i a shall h a ve the ob l i gation，向Distdbutu r采购，以及所有未使用的产品，在i t s o r i ginal包装中与at le a st one（l）year保质期r emai ni n g，that Disttibutor owns aod has in stock for c r edit at the o r i g inal price paid by distributor f o r s uch produ ct s，plll s freight and duty thereo n；pr o vided，h.owevei；，SynCardi a‘s obli g a tion to provide such credit is subject to t o distributor’s com p l etion of all the f o l lowing precondit i ons to such r e i mbursem e nt or compensation：（a）（b）完成本协议要求的a s签署；完成所有driver s，driver syst e m compon e n t s，product s，托运的Produ cts和培训材料LLNder D i的分配者的contro l；在其duti e s的放电中转移所有数据和记录GA t h ered由分销商提供给SynCardi a的再补充；以及N o tify由分销商服务的aU hos p jtals进行未来的付款a s directed by SynCard ia a n d以返回所有驱动程序和托运产品as d i rected by SynCardi a。（c）（d）11。7 .1 .5 Op t i. on for D i s tributor to S e U remaining p roduct. lf S y n c a rd i a t e rmi n a ted thi. s根据SEC t ion l 1的协议。6 and Distributor has r e ma i ning ltllused Products that Distributor owns and has in i nventory at the time of ter m i nat i on and that SynCard ia d i d not e l e ct to p urchase according to Section I 1。7 .1 .4、分销商可在相当于此类产品s的rem a ining s helf-life的一段时间内向s e ll prod u cts th a t distrib t 1 tot bas i n库存；提供d，h owev e r.尽管在th i s agreeme n t上的termina t i，本协议应适用于CONEC T I O N的PA1 iies的r i ghts和o b l igations与t h e distribution和su c h products的s ale以及分销商o f sub products sha ll c om p p l y的ll销售，以符合本协议下的要求a nd obli g ations。在此类货架到期时，如果在ex p：ir y的s u c h时间未使用此类产品的l i fe，Di s tributor sha l l return al. i库存过期产品、Driv e 1·s、Driver Systems和Dr i ver system组件到SynCard IA。12.SvnCard IA的赔偿12.1 i ndemnifica t i. on。分销商应在d e m nify a n d hold harmle s s s y nCard i a for the amount of any and all liabilities，l osses，dama g e s，claim s，costs a nd exp e n se s，inter e s t，award s，judgments and penalties（i n cludin g，without lim i t a tio n，合理的律师费）s u ffer e d或由synca.rd ia因d ist r ibu t违反t h e或因（i）Distrib u tor故意condu c t或（ii）因分销商疏忽而引起的分销商违反本协议的任何其他e r而发生的本协议的任何条款o f本协议e n t whi c jj h而招致。1. D i分销商的h ldemn认证。SynCardia s halJ i n d emnify and b o l.d h a rm l ess distributor for the amount of any and all liability s，loss e s，damage s，cl a i m s，costs and expense s，inter e s t，award s，ju dgment s. and penalti es（including g，without l imitatio n，合理的律师• FEE s）因SynC a rd i a违反任何prNVision o f th i s协议而遭受或招致分销商的r esult，该协议已发生为（i）SynCar d i a的任何故意行为或（ii）SynCardia whicb aris e s out of S y n Card i a的gro s n e gligence 2的其他违反本协议的行为。如一方（t h e“indem n iedied Part y”）应收到任何ny t hiTD方的任何cla i m s通知，其中a r e su b j e c t另一方提供的赔偿（t h e“赔偿Part y”）规定SY.nCardia首字母：_ Distr i but o，首字母：-英镑-

SynCar d i a qua l i ty-546 Rev 006 ED A-n n n n n exclusive DI S T RIBUTOR A G R E E M E N T在本条第12款（“第三方索赔s”）中，被赔偿方应向赔偿方发wri t ten notice of s uch third party claim w ithin t e n（10）da y s of the repensed party receiving su c h notice。赔偿方可随后r、在接到第1被赔偿部分y的通知后，承担并控制sub th i rd party C la i m在其c h oice的ln d emnif ying p art y's e xpense和t h r o u gh counseJ的辩护。被赔方应协同p erat e，并应使用i ts comm e r c i a lly r easonabl. e eff o rts促使i ts offic e r s、董事s、雇员和代理人协同e，与被赔方i fying party u 1 such defense并向被赔方提供赔偿部分y的费用，所有wi t n esse s，相关记录s，t b e受偿的part y的po session（或在受偿的patty的o ffic e-s、董事s、雇员和代理人的p o s session）或根据lndemnifi. ed part y的c o n tr o l（或und e r the contr o l of t b e受偿的pru t y的offi c er s，d irector s，雇员e s a nd agents）按赔偿方的合理要求。No s uch t h ird party claim m a y be settled by the ldern. n ified party w ithout the ludem 11 i ify party的事先书面同意。Not w i thstanding t he foreg o mg，lhe reminded party retains the right to retai n co u n sel of its own choosin g，at t he ndemn i fied party ' s e xpense，to fend the Ind e m nifi ed PR u·ty against tliird party cl a i m s。3.除R E S PECT to SE C TLON 10（保密性）和S E CT I on 12（indemnIFTCATTON）o F本协议T外，在任何情况下均不得向其当事人就d l RECT damages re l. \ t ING to ' i HFS协议支付超过发行人根据本协议支付给SYNCARDIA的A m ounts PA m或付款。就第10条第I款（保密性）而言的EX C EPT，在任何情况下，任何一方均不得对与本G REEMEN T相关的任何间接T、SPECIA L、后果性或PUN L TIVE DAMAGES，即使已告知该方其可能性或F such d AMAGES。4.M anufac t urer的责任。Notwithstand i ng any o t b er provi s ion set f o 1 t h in this agreemen t，the c o mpany的liabi l ity for r u 1 y product d e faul t t s，in p a rticular but not l i mited to，with r e g a rd to the eur o p e an product liabi l i ty law，s ba l l不受限制并且分销商s hall有完整的r e dress against the co _ mpany。S u c h r e dr e ss for product d e faults sha l l mc l ude any d isadv a ntage incu 1 Ted by the d i s tributor in connection w i th co m p ensa t i. on obliga t i o n s vis a v i s第三方。1 3 .杂项规定13。1 .1 n otices。任何notic e、request或other documents required or conspectat e d by th is a g r eement shall be i n writin g，de l ivered in personal，by internat i on a l ov e rn i g h t c o urier or by internationa l air mail，created to the patties at their address h ere i naf t er set f o 1 t h，或在m a y等其他地址不时被par l y c ha n ging发送的书面通知取代there e fo r bynotice，其地址a nd sh a ll be e effective u p o n r eceipt of the par l y c ha n ging is effective u p o n r eceipt of the party of it is addressed to。Notices to SynCA r di a：SynCardia S y stems，LLC ATTN：President & Chi e f Comme r c ial Officer 1992 East S iJ v e rla k e Road Tucson，AZ，85713，U. S.A. Notices to D istributor：Neucom e d GmbH l > onau-City-Stra6e 7/2/26 S y nC a rdia in i t i a l s：_

SynCar d i a ED a-NNNN Exclusive D I S TRIBUTOR Agreement DC TOwe）·，a-1220 Wien FN 462559 i，Handelsgericbt Wien ATU71703123 13。2争议R e解决方案。T H i s协议应由gov e r n ed by and con s tmed根据wi t h the laws o f the st a t e of d e l a ware。，US. S. A.（w it h o u t reg a rd to conf l i ct of laws dictions）。pa t t ies s厅行使其b e st eff o r ts，以a m i电缆方式a n y d isp u t e在m s e lv e s之间设置t le，其中m a y产生了o f或i。n与t h i s a g r eement的连接。双方同意，任何d i sp u t e，con t r oversy o r c laim产生于或r elat i ng to a g r eement sh a ll b e set t l ed by b i nding a r b·i t r ati o n admini s t e r e d by the R 1，1 Jes of Conciliati o n a n a n d a r b itrat i. on of the l nternation a l c h amb e r of Commerce then in effect（the“Arbi t ration RLLle s”）（as m o d ified by t h i s Section 13。2），and j u d g ment on a ward re s u l t i n g from a rbi t ration may b e entered in any c o u rt i n t h e state of Ariz o n a having j u risdiction of them。PA r ties a g r ee that（i）a single arb i trator teas o na b ly knowled geable about t h e me d. i cal device i nd u stry，app o inted according to w i th s a ch rule s，wilJ make bis or her deterer. mioa t ion according to w i t h such rule s，（i）t h e p l ace of arbitration s h aji be tu c son，Ari. zon U. S. a.（u n l ess other site i s agreed b y the partie s），（i i i）a r bitration sh a ll b e e e n glish的语言，（iv）任何仲裁员的费用o n，i n c l u d i n g the i：easonable a ttorney fee of the previous Part y，s厅由当事人认为e d在f a ult或按比例bas i s承担，如果在findi n g中的ar b itration c o n c lu d e有相互过错和（v）t h e a r b i tr a l award s h all b e r以书面形式结束，s厅说明t h e aw a rd的r e. a s o n s，t h e partie s and ar b it r at o r s h all u se all hard efforts to complete s u c h arbitration w ithin t h i rty（30）days of a p p p oi n t m e nt of the arbitor。AJI a r bitration process ings h e reu n d e r s hall b e confi. den t iaJ和arb i trator s h a ll issue approp r i ate protective o r ders to safe g u ard confidential i n format i on。Notwi t h s tandiDg前述，P a 1 ty均不得遵循所描述的disp u t e resohltion过程i n t h为SE c t ion with r e spect to any d i s pute或c o nt r ove r sy r e l a t i ng to Section 10（C onf i d entiality）of this Agreement对于whi c h interim e q ui t a b l e reli e f from a cou，t i s neces a r y to prev e n t se r io u s and ir r epara b l e hurt to a party。If SynCardia terminates t his agreement w ith d i s t ributo r，and th. e partie s are in disputes r es o l. ut i on u n d er th i s section of t h e agreemen t，during the time period of the di s pute resolution process，S y n c a rcl i a sh a ll have the right.；but n ot t h e obligation，指定临时经销商向Eligi B L E医院提供产品，以减轻患者和患者的负担。如果SynCardia确实指定了临时分配给r，则第th e n t h e仲裁员w will be notified aud may take th. is into consider a tion w h en dec i d i ng on a ll a r bi t ral裁决。在这种情况下，Syn C arclia p ay to D istribut o r the av e r age margin whi c h wo u l d b e calcu l ated from o r i ginal co n tract p u r cha s i n g price to market price u n til d i s pute is s o l ved。整个协议1 i t。Th i s agre e m en t，i. ucl L 1 d n g任何经当事人签署的书面修正案n t s或增编s，ev i d ences t h e e e n t i r e agreement of the。缔约方a n d s u p e r sedes和c a n c els就betw e en t h e pr u t ies，w r i tten，ora l o r im p l ied的s u bje ct事项进行的所有事先讨论s、协议和un d e r stan d i n gs wi t h。A s si g n m e nt。Th i s a g r e e m ent may d 01. be as s i g n ed by either part y‘s w r itten conse n t except w i th the other part y’s w r itten conse n t；provide d，howeve r，t h at syncr u·d i a may assign this agreem e nt（i）to any of its affi l. iates，or（ii）in the event of a m e rger，re o r ganization，r ecapit a l i zation or s a le of a U or substantia l l y a ll of syncr u·dia ' s stock o r a s e t s。本协议s hall be b. i ndin g up o n page 23 of 42 qual i ty-546 rev 00613.31 3.4 sync a rd i a initia l s：__

SynCar d i a p年龄24 of 42 quality-546 rev 00。6 EDA-N N N E X C L USIVE DI S TRIBUTOR Agreement a n d i nure t o tJ 1 e benefit of the Partie s h e r eto and the i r respec t i ve s u c cess o r s and p e r mitted a ssignee s。非豁免；A m e n dm e n t；inter p 1·etatio n。e i other party fails to enforce or take adv a n tage of any provision here of s hall not c o n s t itute a waiver o f the right subs e q u e n t l y t o enforce or take advantage o f such prov i s ion。是协议或任何t h e t e r m s o r条款t h e r eof m a y n o t被更改或修改或放弃，i：o a ny way w hatsoeve r，e xcept by written agreement exe c uted by t h e Pat t i e s。标题o f节和p aragraphs为i n s e r t ed for conveni e n ce和sh a l i not affect any interpretation of thjs Agreement。The Part t i es hereto a g 1·ee that th i s agreem e n t bas been nego t i ated b e tween umelated parties that a j·e sop h i s ticated and knowledgeable i n t he m att e r s cont a ined in th i s agreement a nd that h a ve act i n their o w n sel f-interest。在a d d i tion中，每一方h as represented t ed b y legal c o u n s e l或有opp 01 tunity to r etain s uch couns e l。The provisions of th i s agre e m ent s hau b e i n t e r preted in a reasonable manner to effect the p u r p oses of t h e partie s，和t h i s协议sh a将不会被解释o r constru e d对抗任何p a t ty to t h i s协议bec a u se that party o r any attorney or repr e s e native for th a t party drafted t h i s agreement或part i c i p a ted i n the d. raftjng of this agr e ement。此分配i s refl e c ted i n t h e ec o n o m i c本协议的条款和i s an ess e ntial e l ement of the basis o f t h e bargain between t h e par t i e s。F o r ce Ma. j eur e. ff either PR u ty i s cannot ca r r y out its obli g ation u u d er this agreement，e i ther wh o l l y or in par t，foi " a p e r i od of ten consecutive d a ys as a r e sult of acts o f Go d，strike s，locko u ts，or o t h er indu s t r i al d i sturbance s，war s，封锁s，e m bargo s，i n s ur r e c tion s，riot s，act s，or orders of g overnmen t，e xplosi o n s，fires，floods，peri l s of t h e sea，or any other cause not within the t h e con t r o l of the PA1 ty clai m i ng rel ief from any of the requ i r e m ents of t l ris agreem e n t，以及通过行使尽职调查s a i d party i s u n a b le to p r ev e n t o t t overcom e，t b e patty so fail i n g s h all g i ve w r i t e d notice and. fuli par t i cu l ars of s uob cause or causes to the other party as so o n as p o s ible after the oc c c u u e n ce o f a：ny such cau s. e，and then s uch obligat i ons shall be suspe n ded during the continuation of s uch hindranc e，whi c h，howeve r，s hall be r emedied with all p o ssible d i spac h，a nd the obliga t i ons，t enns a nd con d i tions of t h i s ag r eem e nt sh. a il b e e a 1 ended for su c h period as m a y be n ecessary f o t t h e purpose of making g ood any s u s pension so c a u sed。I f su c b hindrance shall l 35 t fo r t h ree（3）consective，tive months o r mor e，eith e r pr u 1 y，by n o t i ce iD writing to t h e othe r，may ter m i. n a te this agr e ement。费用支出。除另有规定外，t l 1中的pro v i d ed为a g r eement，ea c h方应承担l。i co s t s and e xpenses associate d w i t b t b e performance of such par t y's o bl i gati o ns under this a g r eem e nt。13.5 1 3 .6 1 3 .7【本页剩余部分i s inten t i only l eft blank】SynCardia首字母s：

SY n Car d i a第25页，共42页Qua l i ty-546 Rev 006 ED A-NNNN EX C LU S IVE分销商协议s I GNATURE Page to Exclusive DISTRI B UT O R Agreement [ n WITNESS WI-LEREO F，t h is Agreement bas been e xe c uted as of t h e effe c ti v e date。SynCard i a：SYNCARDIA SY S TEM S，LLC BY：------------分销商：NE U COMED GmbH by：Erw i n MUELLER Nam e：ER w in M UELLER tit l e：Geschaftsf i ihrer i C EO SynCa rd ia initi a l s：_

Syn C ar di a Page 26 of 42 Qu A.Lity-546 Rev 006 EDA-NNNN E X CLUSIVE D I S TRIBUTOR A GREMENT Exhibit A-D EFIN I TLONS L. " Affil i a te‘’means，w i t h relative to ei t h er Synca r d i a o r d i s t r i bu t o r，any corporati o n，c o m p an y，partnership，联合通风口u r e和/或fi r m which c o n tr o l s，i s controlled by or is under common control with SynCardia or Distributo r，a s the case m ay b e。A s用于Aff i l i ate的t he d e finition，“con t r o l”是指（a）in t b e c a se of corporate en t i t ie s，d i re c t or i ndire c t o w n er s h i p of m o re than f i fty %（50%）of the stock o r s h are s having the rig h t to vote for the e l ection of d irectors（or such l esser p ercentage that is the maximum a l l owed to be owed by a foreign corp o r ation i n a JJar t i cuJar juri s diction），a n d（b）in the ca s e of non-corporate enti t i e s，the dir e ct o r ind i r e ct power to m anag e，direct or c a u se the direction of the management a nd p o l i c i e s o f t b e non-corporate entity or th e power to elect m ore tban 50%（50%）of the m e mbers of the governing body of su c h n o n-corpor a te en t i ty。" a greement‘’h a s the mea 11 ing set f o r t b in tbe pronember of tbis agreement。tbjs协议第4.10节中规定的“a t 1 t i-bribery policie s”li a s t he meaning。“适用L AWS”在t h i s a g reement的S ection 1.3中具有为t h设置的tbe含义。“AR b i tration R ul e s”has t h e m ea：n i n g set for t h i n section L 3。2 of this A g r e e m ent。“c a n adian l i cense s”b作为本协议第8.1节中的m e aning set f01th。“C atalog”b a s t h e m e a ni n g载于SE c tion 1.4.3 o f t his agreement。“C I C”在l L.上有m e a n i n g集f o 1th i l 1 8ect i。6.1.1这个Agre e m e n t.“C I C No t i c e”有S e ct i于11.6提出的me a 11 ing。1.1of lh i s a g r e e m ent。“Confide n tia l i nformatio n”在t b i s agr e em e n t的第10.1节中有t h e的含义s e t f o 1 i h。“C o nsigned produc t”11 a s secti <；> n2中提出的m eaning。1 .一、本协议。“d istribu t o r”has the meaning s e t forth i n t h e p r eamble of t b i s agreement for avoiding doubt，tbe d istributor i s n atu r al o r l e gal p e r son or en t i ty in the supply c h a i n wh o，o. n d. i s t ributor's o w jl behal f，f u r thers the avail a bil i ty of a m e d _ i c a l device to t h e end user。“D iDistributor Cer t i Fi c a t e”是指证明d 1 e distributor为t h e ex c l u s i ve d i distributor of SynCard i a produ c ts b，the TED " itory pu r s u a nt to Section 1的文件。4 .本协议4。“Distributor Rep 0 1 t ing”有第8节中规定的m e a ni n g。18 o f th i s协议。" Driver‘’是指SynC a rdi a制造的fo l l owns p n eUmatic drive r s：（d c o m p a n i on 2 h ospital Driver通过医院的患者r ecovery向i m plant的SynCardia temp o rary t a h-t提供p n e um a t i c pow e 1·和（ii）一旦i ca l y sta b l e中的p a ti e n t i s c l，h e或s h e可以是s w i tched to t h e s maller，li g h t er f r e e dom®端口a b le dri v er t o pro v i d e such p n eUmatic power。“e effective Da. t e”bas the me a ni n g set in the pre a m ble of this a g r eeme n t。“E ligible H o s p i t a l”mea n s a ho s pital that has experience both herut t r a n s p l a n t procedur e s and MCS devices or e x perience w ith m cs d e vices a nd a formal an-an g ement to s e nd transplant-e l i gible patients t o an exper i ened transplant ce n t er。“e ntitv”有第1节1中阐述的含义。2 .2 .t h的5是协议。“E x pedited purch a se o rder”在第2节中具有均值i ng s e t f o 1 th。2 .2 o f this a g r e e m e n t。“F O B”h作为第2节中的m e a n ing set fortb。1 .6 of th i s a g reement。“F D A”m eans the U n i ted S tates food a n d drug a dm i nitration，a nd any suc c essor a g ency has st i b s tantia l ly the same f u nc t ions。2.3.4.5.6.7.8.9.1 0.1 1.1 2.13.14.1 5 .1 6 .17.18.1 9'.20.21.SY1 1 Card i a initials：_ distributo，initials，（j7 i

SY n Car d i a Quality-546 Rev 006 EDA-NNNN E X C LUSI V E DI S TRIBUT O R协议22。23.«政府批准s " has t he meaning s e t forth iu Section 4。7 of th i s agreeme n t。“Implant Rea d y”是指a n e l i gible h os p ital i n the tenito r y t h at has com p l eted ph a se u of the s t a rt u p c e r tification或正在进行n e m ergency ph a se i-ill traini n g and ha s t he synca r d i a t a h-t kit a n d a ll a p p rop r i ate approved Drive r s和Accesso R ies。“已获弥偿部分y”h为第12条第i款所载的涵义。1 .2 of th i s a g re e m ent。" tndemnify i 11g p arty‘’具有本协议12.l. 2上的均值i n g s e t forth i n se c t i。“Ini ti al Orde r”mea n s the products required f o t a new hospital and the finan c ial a rt an g ement for later ord e rs of Freedom d i s c har g e k.hs for appropriate pati e n ts and replacement TAH Kit s。‘’i nvoiced PR o d u ct " has t h e meaning set fo r th i n section 2.1.1.本协议。“J oi n d er”has t he meaning stated in Sec t i on l. 5 of t h j s a g r eem e nt。“MCS D e v i ces”是指机械循环支持装置。“N otice PE r i o d”has the meaning set in S ection 11.6。1 .1 of t h i s agre e m ent。“正式文件s”具有美国证券交易委员会（SEC）5日提出的含义。1 of this Agre e·m ent。“Offi c ials”具有iu第4节所述的含义。9 of th. is a g r eement。SynC m·dia和distributor（a nd统称，tbe“p a rtie s”）的“part y”mea n s each of synC m·dia和distributor（a nd统称，tbe“p a rtie s”）。“P a ym e n t”有t h e的意思set f o 1 th i n section i on 4。9 of t h i s agr e ement。“permanentl y”是指perpetu aJ；ev e r l是t i ng。打算在最后一个SynCard i a medical dev i ce的m a n u facture的t h e日期之后，对15（15）ye a r s的m i n i mum进行无变化的存在。《Proctoring》has. The me a ning set out i n sec t i o n 6。2 .1 of th i s agreement。“P roduct s”would u 1 c lud e the SyoCar d i a products in Catalog（附件 e）t h at a r e avru i ab l e from time 24。25.26.2 7 .28.29.30.3 1 .32.33.34.3 5 .3 6 .37.to time fo r s a l e by to d i s tributor with th i s agreem e nt（ex c l u d ing driver s）。“P urch a s e o r de r”b as the meaning s e t forth i n section 2.2. l of t h i s agreem e nt。" re g ul at o.1y approval s，，has the mean i ng set f o ttb i：n section 1.4.2 of thls agreement。‘’r e quired C o ntact Informatio n " has t he m e aning set for t h i n section 1.4.7of th i s agreement。“Shipping Container s”具有t h i s协议第2.5.3节中规定的m e a ni n g。“Su b-Di s tribato r”h为mea. o i 11 g set fotth in SE c t i on 1.5 of this agreeme n t.“s y nCardi a”h为mean n g s et f o r th in the p r eam b l e of th i s agreement。" T AR Devic e sn h a s the m e aning in S ect i on 8.1 of t h i s Agreement。‘’不是一个H-t '具有本AGR E E M E 11t的t h e序言中提出的均值i n g。“TAH-T S vstem”has t h e mean i ng set out i n the promise of this AG r e e m ent。“Ter r i to r y '”m e ans the co u n t r y or geograph i cal area。d e scribed i J 1 ex h ibit B to th i s a g r eement。“Thi r d Party C lai m s”h as t h e meanin. g set fmth in Section 12. l。第i条协议的第2条。3 8 .3 9 .40.41.42.43.44.45.4 6 .4 7.48.[本页R e m ai n d er.is ini e n tional l y l e ft空白] SynCardia initia l s：_

t ' > SY n Car d i a第28页，共4页2 Qua l l l ty-546 Rev 006 E D A-NNN N EX C LU S IVE D I S TRIBUTOR Agreement Exiibit B-T E R RIT O RY 1。格尔曼2号。澳大利亚T RIA 3。SWITZE R LAND SynCar dia initials：_ Distributor initials：_ J _

EDA-NNNN

独家分销商协议

展品C –报价和初始股票订单

[省略]

SynCardia首字母：	分销商首字母：

质量-546修订版006		页2942个

Syn C ar di a Qual l t y-546 Rev 006第31页，共42页E D A-N NNN EX C LUSIVE DI S TRI B UTOR Agreement Exhibit D-REGUL A T ORY A P Provals Following i ng r egulat o ry approv a l docu m e n t s accompany th i s agreement（in PDF packet）and wiU be updated b y S y nCA n：lia t h r ou g hout th e term of th i s agreement as nee d ed。1.向Foreign Government提供PMA批准的产品c ts 2的证书。50CC T A H-T（：未获P MA批准）3的Expo r tabil i ty证书。D e c l arati o n of conf o nnity for th e following devices a. 50cc a nd 70cc t a h-t b. Freedom dr i ver system c. C o mpanion 2 dri v e r s y s tem 4。BSI CE1tificates a. EC D e s i gn examination in a tion certificate-CE665479 b. EC CE1tificat e-Fu l l qual i ty a ssura n ce-CE665477 c. certific a te of registration-ISO 13485：2003-MDSAP 65377 Syncardia initials：___ d；stdbro，lnitfa l s：l

Syn C ar d i a e d a-n NNN独家DI S t RIBUTOR协议e XHIBIT E-S Y N C ARDIA C ATALOG部件号Name Qucil i ty-546 Rev 006 p年龄32 of 42500101 TA H-t K i t 70cc 570500--001t AH-t K i t 5QCC 500177备件套件for TA H-t 70cc 55017 7-001备件K i tFor TAH-T 50cc DDR001 Freedom Dr i ver Month l y Rental CER001 4-Phase C e r tification 395102-001 New Center Star t-up K i t Package CER001 R e-cert i ficati on fee FEE001 Proctor F e es C400700-001 Tra i n i ng Center w/Patient S i mu l ator Mock Tank 397600-001 Compan i on 2 Handpump 295513-001 Freedom Permahent Center Tool K i t 395103-001 Freedom Battery Char g er K it适用于H o s p i tal使用定制订单患者S i mulator模拟箱升级397002-001伴侣2 Dr i ver*Companioh推车医院*397003-001 397001-001伴侣球童*197053-001Compan i on 2 Lock i ng电源线*293001-001 Compan i on Battery*Compan i on Dr i ve li nes*193002-001197306---001Com p；m i on F i lters*397600--001 Compan i on 2 Handpump*595510-001自由待命司机*Freedom车载电池*295025-00129504-001F re e dom Battery C Harger*295600-001F re e dom AC p·ower supply ly w/cord-hom e*295400-001F re e dom AC Power suppl y w/cord-hosp i tal*295053-001F re e dom Car C h arger*自由袋-配件*195129-001295502-001F r eedom包-backp ac k*295501-001自由袋-Sho u l d e r*295595-QOL Freedom Fil t e r5*395101-001Freedom Tool K i t-患者/临床医生T ool试剂盒*演示TAH-t*0400101-001600260--001设备检索K i t SynC a rdia ini t i a ls：_

SY n Car d i a Qu al ty-546 Rey 006第33页，共42页E D A-N N NN专属分销商协议附件F--，D I STRIBUTOR CERTIF I CATE将在最终协议t后添加。S y n c a rdia init i a l s：___

SY n Car d ia Qua l it y-546 Rev 006 EO A-N N N N EXCLU S IVE DISTRI B U T或协议展览g-模板JOIN D ER to EXCL U SIVed I S T RIBUTION Agreement JOIN D E R to Exclusive D I STRI B U TION Agreement this J oinder to Exclusrve DLSTRL B UTION Agreement（“J o i nde r”）i s made as of！ST Ma Y，2020（“J oind e r Effect v e i d a t e”）by a nd a m o n g（i）S y nCard ia Systems，LL C，a limi t ed l i a b ili t y c o m p any organized un d er tbe l aws of the State of D e l aware wi t h a prin c i pal pla c c e of business at 1992 East Silve r l ake roa d，tucso n，a z，8571.3，美国（“S Y n Car di a”），（ii）Neucomed G m b b，a c o r p o rat i on o rgan i z e d under the l a w s of a u s t ria w ith pr i ncipa l pl a ce of b u s i n ess at Donau-ci t y-stra s e 7/2/26，DC t ow e r，a-1220 w i en，奥地利独奏会：A. SynCar d ia a n d d i s t r i bu t o r 1，a v e entered i n to an exc l u s i ve d i stribut i on a g r e e e m ent dated·1 5th a ug u s t，2020（“a greement”）。B. Di s tributor wi s bes委任S ub-D i distributor服务As a s ub-d i stri b u t o r under the Agreement nt f o r t b e f o ljowing t e rrito r y o r t e ritori e s：a. g e r m any：n e u c o m e d d euts c h l a nd g m bh b. SW i t zerland：neuc o m ed Schweiz G mbH C. u n d e r the terms of the agr e em e n t，Sub-Dist r ibutor m ust同意受Ag r ee m e nt的r e l eva n t prov i s i. o n s的约束，作为a c o nd i t i o n to S y n c a rd ia cons e nti n g to the appointment of Sub Di s tributo r，which h provisions are contained i n the atta c h m ent l o this J oind e r。现在，因此，考虑到前提和covena nt s提出了he r ein，并打算被le g a l l y bound。hereb y，t h e Part i es he r e t o a g r ee a s fouows：i.当事人同意t. U p o n t h e execution a n d d e l i very of th i s joinde r，S u b-D i s t r ibutor正在成为一个P a 1 ty t o the agr e e e m ent。Sub-D i stri b utor ag r ees l o be bound b y t h e r elev a n t terms and provision s of the Agreement，atta c h e d h eret o。2.Joinder的效果。每个o f syncardi a，distributor a n d su b-d i st ribu t o r承认并同意，所有th e e r ms，prov i s ion s，covena i 1ts和c o nd i ti o n s of t h e agreement s hall h ereafter continue i n full force and e effect i n acc o rda n ce with terms t h ereof，除了t o t h e程度e x pr e ssly集f o 1 t h h e r ein 3。同行。T H i s Joinder may b e exe c u l ed on separate counterparts s，each of w h i ch i s d e e m e d to be an o r i g i n a l and b oth of which took t ogether s hall c o n stitute one and t h e same agreement。[ R em a i nd e r of this pa g e i s intent离线留白] Sync a r d ia initials：___

SynCar d ia ED A-NNNN EXCLU S IVEDIS T RIBU T或作为证人的协议whereo f，本协议各方已exe c u ted this Join d e r as the Join d er e effective da t e。S ynCardia：d分销商：SYN C ARDJA SYSTEMS，LLC by：___ Nam e：T it l e：SynCardia i n iti a l s：_ Distr；bu t o，lnif i als，{ f；7 page-35 of 42 Qualit y-546 Rev 006

t‘丨’syn C ar di a e d a-n n n n n ex c lusive DIS t ribut o r a g reement exhi b it h-terms and c o nd i tions for DIS t ributor 2。Comment m e nt d a t e and ini t i al t e r m this contract s hall sta r t（« c om m encement dat e "）o n i：he effective d a te here r ef e m，d as 15th a u g u st and w i ll h a ve an initial term（section 1 1.l a nd sub.）截至2025年8月31日151日。3.1nitial股票订单a。A product s upp l y pri ce l. i st（“q u ot a t i o n”）h a s has been attached to th e-agre e m e n t（ex h i b i t c）b. U pon sig n ing t h i s agreem e nt，t h e d is t r i but o r wUI purchase the f o l l l owing produ c ts from synca r d i a（“initial orde r”）。1.O n e（1）70 CC TA H-t套件i i。一（1）70ce Surgica l Spare Kit ru。一（1）50 cc t A H-t Kits 1 v.一（1）50cc s u r gic al s pares kit c. la case of c o n tract t t e r m in a t i o n f o r any r eas o n 12 mon t h s after p l acin g the imtial o r der，购买的初始订单的no n-u s ed p r o d u ct将是r e p u r c ha s e d b y synca r d a at t h e invoiced p rice d。Lnitial Order w iU not b e s up p l ied to the distributor un til aft e r SynC a r di a ha s received p a y m ent f o r the in i t ial o r der and the payment f 1 m d s cleared in t o syn c r o·d ia b a n k acc o u nt。4 .M a intenance of fn v entory L e ve l s：a. d i s o·i bu tor m u st maintains a min i m um of the f o ll o wing Co n si g n e d pr o duc t s：t. o n e（1）70 cc tah-t ki t s i。一（1）70 c c s u r gical s par e s k i t m。一（1）SOCC TAH-T K i t s iv。一（1）50cc surgi c al sp a r e s k i t v. s uch other pr o d u ct由mu t 1 1al协议betw e e e n n di s tribu t o r和sy n c a r d i a. v 1确定。D istr ibut or will r e i mbu r se synca r dia f o r the costs of s h i pment/tra n s p orta t i on f o r s uch pr o d u cts.into a n d o u t of the territory. b. S ynCardia拥有U nits：d i str i bu t o r must m a i nt a i n a miL1i m u m of the following c o n s i gn e d product s s：1。T hree（3）C2 dri v e r syst e m s 11。三（3）F r eedom dri v er systems i i i i。D i s tr i b u tol'wiU r e imbu r se syqcardia f o r the costs of shipping/transportation f o r s uch consigned prod u cts into and out the territory. c. Di s tributor m u s t ma i tain an adequ a te s upply of s urg i cal sp a r e s kits c u stomer bas e，As mutu a l l y d et e ani n ed by S y n CA r d i a and distributor。5.PR i cin g（f erms：a. SynCardia t e r ms t o Distributor is as set fo rth in SynCardia ' quote t h at is mutual l y a g r eed b y sy u cardia and d i s t ribu t o r. b.逾期发票w will be ch a r g e d interest at t he l ow e r of（i）l.5 % per m o n th or（i i）t h e highest rate allowed b y applicable law。SynCar d i a initia l s：_ d ist r ibutor jnit i alsc i z quality-546 rev 006第36页，共42页

SY n C ar d i a Q u ality-546 Rev 006 p年龄37 of 42 EDA-NNNN Exclusive DISTRIB U T O R Agreement6。报告：a. Dist r i butor将根据E x h i b i t k b提供该地区产品的任何和所有植入物/外植体的报告。Dist n butor将向SynCardia提供（i）第4节（a ditional distributor responsibilities）、（ii）第8节（regulatory requires e m e nts；government reports and filing）和（iii）e x h ibit k. c.分销商将向S y nCardia提供季度预计销售预测，不迟于提供S uch foreca s t的季度收盘后十（10）天提交。7.S ales和Ma r keting P lan：D分销商应在本协议生效的每一年的15日或之前，以及在任何新产品推出之前的六十（60）天，提供详细的销售和M arketing P l an。此类销售a n d mar k eting plan s hall至少包含有关以下方面的详细信息：a. b US i ness和战术计划b. Custo m er en g agement c.最终用户定价d.达到和频率e.合格H ospit a l s i n teITitory f.领土8的潜在合格H ospitals。培训；监理：a. D i stiib u t或分配给SynCardia Products的人员mu s t p：arti c ipate i n批准了由SynCar d ia开展的培训项目。在销售代表：tative i s被授权详细介绍任何SynCardia产品之前，需要Successf u l co m完成SynCardia培训计划s hall的文件。医院人员的费用和培训，费用由SynCardia和分销商平均分摊。SynCardia将承担首次认证认证和培训的费用。SynCA r d ia应承担在符合条件的新医院进行首次4（fou r）p roctoring的费用。此后，这些费用和开支将由Di的贡献者全权负责（i. e。，100%由Distr i butor支付）。这将适用于所有T e r r itory b. c. d. e. 9。S ervices：分销商应协助Sync a rdia i n遵守（i）美国FD A、（ii）欧盟（CE标志）或（iii）经不时修订的分销商原产国（i e s）内的监管管理机构详述的AP p可许可质量体系要求。10.T e chnical支持；vigi l ance和post-mark e t s监视。经销商同意，作为产品与客户和/或终端用户技术支持的第一联系点负责。分销商将根据《欧盟委员会关于医疗器械警戒系统的指导方针》，在vig i l ance和上市后监测（早期预警）事项中提供一条通信线路t o SynCardia dire c tly。" D分销商将进一步向基于SynCardia的Information Suppl i ed的定制e-RS提供产品使用方面的技术支持。Custo MER反馈（包括客户投诉nts事件和近-事件的发生）将由分销商w i thin（3）b _ business days直接向SynCardi a报告。If the matter invol ves regulatory information that may r e quire r e porting to the regulatory authoritie s，for such events such as a d v e r se incidents or product recal l，then d i s t r ibutor shall also no t·syn c ard.ia initials：___

Syn C ar d i a oa l i ty-546 Rev 006第38页，共42页EDA-NNNN独家DIS T RIBUTOR协议SynCarclia。对于在欧盟分销的产品d i，分销商报告s应遵循欧洲C ommi s sion《医疗器械e s警戒系统指南》。"对于以其他r e g离子分销的产品，分销商将协助SynCardia遵守产品被放置在Commerica I分销的主题国家的特定卫生当局监管r e quire m ents。11.D i distributi on record s。D i str i butor同意在收到SynCardia和/或监管机构auth o 1 ities的r e请求时维护并提供分销商按产品批号或按其他要求销售的所有产品c ts的分销记录。分销商承认，这些信息是foll产品可追溯性所必需的，并在p ro d u ct字段corre c tion或recaU或其他向health autho r ities报告的义务的情况下将风险降至最低。1 2.M iscellan eous：a.分销商应根据SynCardia的合理要求，提供足够的证明以证明满足库存的足够财务能力需要m en t s ancl SynCardia pay：m nt t t erms；b. Distrib u tor may no t，tmder any c ircumstance s，issue any press releases or distribute a n y sales and/or marketing mater i als w i thout p r ior writt e n approval of SynCardia SynCardia initials：_ distributo，initials，g i

EDA-NNNN

独家分销商协议

展览I –每年销售配额

[省略]

SynCardia首字母：	分销商首字母：

质量-546修订版006		页3942个

EDA-NNNN

独家分销商协议

附件J –缔约方的联系信息

及属地合资格医院

[省略]

SynCardia首字母：	分销商首字母：

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t，syncar d i a ED a-NNNN E X C LUSIVE DISTIUBUTOR Agreem e NT Eligible H o Spital s：Di s tributor w i will provide SynCardla the following information（and any additional information reasonably requested by SynCardia）011 any and all eligible hospitals. in the T erritory。主体法定名称：Principal E x ECUTE Office r s：---------------工商注册：-----P r n c pal Office：-------Principa ]联系人：----------------------------------------------------------------------------------------------------------------------------------_ D i分发，首字母：t. _ Q u a l i ty-5 46 Rev 006第41页，共42页

质量-546 Rev 006 PA42 of 42 SY n Car d i a EDA-N N N N Exclusive D I STRIBUTOR Agreement EXHIB I T K-D I STRIBUTOR向S YNCARDIA和相关T I Ming SYUCardia首字母的报告要求：_ d是k ibuto，lnirials，4完成I on & RETUR N TIMEFrame文档标题设备跟踪表单-植入物-表单90 1004-000 W i thin 3 d ays from m tmn l ant 3 days from outcome device tracking表单-outcome-表单901004-000 within. in 24 hours from driver checkout或患者开关伴侣2d r iver系统检查表格-F orm C2-900005在司机结账后24小时内o r p a tient开关fr e edom driver s ystem test p rotocol-表格F-900013-en