ࡱ> {}z] 'bjbjZ!Z! IF8K4\8K4\ o::&&&&&&&&8&TR',&aC~'~''''( ( (BBBBBBB$ EG(C&a*((a*a*C&&''4C111a*^&'&'B1a*B11?DA'0T*j?B1C0aC?^H)+*H4DA,H&pA\(>$),1P)$t)(((CCS/(((aCa*a*a*a*H(((((((((:> x%: MEDICINES AUSTRALIA FORM OF INDEMNITY FOR CLINICAL TRIALS STANDARD For use where the Indemnified Party is providing premises for the conduct of the Study and HREC Review, OR is providing premises only. NOTE there is a different Form of Indemnity for use where the Indemnified Party is providing HREC Review ONLY of the study [The HREC Review ONLY Form of Indemnity]; This Form has been developed by Medicines Australia and is an adaptation of the form used by The Association of the British Pharmaceutical Industry (ABPI), for use in Australia. It is to be regarded as the basis for agreements between pharmaceutical companies sponsoring clinical studies and the institution that hosts the study to be conducted. Non-members of Medicines Australia are encouraged to use this Form of Indemnity. To: Murdoch Childrens Research Institute (ABN 21 006 566 972) of The Royal Childrens Hospital, 50 Flemington Road, Parkville VIC 3052 AUSTRALIA ("the Indemnified Party") From: [Name, registered address and Australian Business Number of sponsoring company] ("the Sponsor") Re: Clinical Study No. [ ], [protocol title including name of product] The Indemnified Party agrees to participate in the above sponsored study ("the Study") involving [{patients of the Indemnified Party} {non-patient volunteers}] ("the Participants") to be conducted by [name of investigator(s)] ("the Investigator") in accordance with the above referenced protocol, as amended in writing from time to time with the agreement of the Sponsor and the Indemnified Party ("the Protocol"). The Sponsor confirms that it is a term of its agreement with the Indemnified Party that the Investigator shall obtain all necessary approvals from a relevant and appropriate Human Research Ethics Committee (HREC) and the Indemnified Party, where appropriate. The Indemnified Party agrees to participate by allowing the Study to be undertaken on its premises or as otherwise agreed, utilising such facilities, personnel and equipment as may reasonably be required for the Study. In consideration of such participation by the Indemnified Party, subject to paragraph 4, the Sponsor indemnifies and holds harmless the Indemnified Party and its employees, agents (which for the avoidance of doubt includes The Royal Childrens Hospital (ABN 35 655 720 546)),and if the HREC is the ethics committee of the Indemnified Party, the members of and advisors to its HREC (collectively the Indemnified), in respect of and against all claims and proceedings (including any settlements or ex gratia payments made with the consent of the parties hereto and reasonable legal and expert costs and expenses) made or brought (whether successfully or otherwise) by or on behalf of Participants (including their dependants and children injured in utero through the participation of the childs mother or father in the Study) against any of the Indemnified for personal injury (including death) to Participants (and children injured in utero through the participation of the child's mother or father in the Study) arising out of or relating to the administration and/or use of the product(s) under investigation or any clinical intervention or procedure provided for or required by the Protocol to which the Participants would not have been exposed but for the participation of the Participants in the Study. The above indemnity by the Sponsor will not apply to any such claim or proceeding referred to in paragraph 3: (1) to the extent that such personal injury (including death) is caused by the negligent or wrongful acts or omissions or breach of statutory duty of the Indemnified; (2) to the extent that such personal injury (including death) is caused by the failure of the Indemnified Party, its employees, or agents to conduct the Study strictly in accordance with the Protocol; (3) unless as soon as reasonably practicable following receipt of notice of such claim or proceeding, the Indemnified Party notifies it to the Sponsor in writing and at the Sponsor's request, and cost, has permitted the Sponsor to have full care and control of the claim or proceeding using legal representation of its own choosing; or (4) if any of the Indemnified have made any admission in respect of any such claim or proceeding or taken any action relating to any such claim or proceeding prejudicial to the defence of any such claim or proceeding without the written consent of the Sponsor. Such consent will not be unreasonably withheld. This condition will not be treated as breached by any statement properly made by any of the Indemnified in connection with the operation of the Indemnified Party's internal complaint procedures, accident reporting and quality assurance procedures or disciplinary procedures or where such statement is required by law. The Sponsor will keep the Indemnified Party and its legal advisers fully informed of the progress of any such claim or proceeding, consult fully with the Indemnified Party on the nature of any defence to be advanced and not settle any such claim or proceeding without the written approval of the Indemnified Party which approval is not to be unreasonably withheld. Without prejudice to the provisions of paragraphs 4(3) and 4(4), the Indemnified Party will use reasonable endeavors to inform the Sponsor promptly of any circumstances of which it has knowledge and which may reasonably be thought likely to give rise to any such claim or proceeding and will keep the Sponsor informed of developments in relation to any such circumstances even where the Indemnified Party decides not to claim indemnity from the Sponsor. Likewise, the Sponsor will use reasonable endeavors to inform the Indemnified Party of any such circumstances and will keep the Indemnified Party informed of developments in relation to any such claim or proceeding made or brought against the Sponsor alone. The Sponsor and the Indemnified Party will each give to the other such help as may reasonably be required for the efficient conduct and prompt handling of any claim or proceeding by or on behalf of Participants (including their dependants and children injured in utero through the participation of the childs mother or father in the Study). Without prejudice to the foregoing, if injury is suffered by a Participant while participating in the Study, the Sponsor agrees to adhere to the Guidelines for Compensation for Injury Resulting From Participation in a Company-sponsored Clinical Trial published by Medicines Australia and will request the Investigator to make clear to the Participants that the Study is being conducted subject to those Guidelines. For the purpose of this indemnity, the expression "agents" is deemed to include, but is not limited to: (1) any person carrying out activities for the Indemnified Party under a contract connected with such of the Indemnified Party's facilities and equipment as are made available for the Study under paragraph 2; and (2) any health professional providing services to the Indemnified Party under a contract for services or otherwise. This indemnity will be governed by and construed in accordance with the laws applicable in the State or Territory in which the Indemnified Party is established. DATED the day of in the year . SIGNED by a duly authorised representative of the Sponsor who certifies that they have authority to sign on behalf of the Sponsor ...................................................................... (Signature) ...................................................................... (Name) ...................................................................... (Position) SIGNED by the Chief Executive or a duly authorised representative of the Indemnified Party ...................................................................... (Signature) ...................................................................... (Name) ...................................................................... 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v2 oGcMurdoch Childrens Research Institute (ABN 21 006 566 972) of The Royal                  2 cChildren     2 c a2 9cs Hospital, 50 Flemington Road, Parkville VIC 3052 AUSTRA               2 cLIA    2 c   12 c("the Indemnified Party")      2 [c   2 qcFrom:    2 c  2 c[Name    2 c,  2 c  2  cregistered     2 1caddress    :2 mcand Australian Business Number         2 Vcof sponsoring      /2 ccompany] ("the Sponsor")       2 fc   2 qcRe:   2 c " ,2 cClinical Study No. [ ]       2 >c,  2 Bc  (2 Fc[protocol title inc       2 cluding    #2 cname of product]       2 ec  @"Arial------ 2 qc1.---  2 }c 2--- 2 OcThe Indemnified Party agrees to participate in the above sponsored study ("the    c'' d2 ;cStudy") involving [{patients of the Indemnified Party} {non     2 !c- +2 &cpatient volunteers}]  c'' 2 ,c("the  2 , cParticipant  72 ,cs") to be conducted by [name   22 ,cof investigator(s)] ("the  c'' D2 ?&cInvestigator") in accordance with the   %2 ?cabove referenced  /2 ?cprotocol, as amended in   c'' q2 SDcwriting from time to time with the agreement of the Sponsor and the        2 Sh cIndemnified   c'' 2 fcParty  %2 fc("the Protocol").   2 f<c   2 f@c  _2 fD8cThe Sponsor confirms that it is a term of its agreement      c'' 2 z cwith the  2 zcIndemni  2 z cfied Party   U2 z\1cthat the Investigator shall obtain all necessary  c'' "2 capprovals from   22 ca relevant and appropriate  2 c  "2 cHuman Research    %2 :cEthics Committee    c'' 2  c(HREC)   2 cand the  (2 %cIndemnified Party,    %2 cwhere appropriate   2 c.  2 c  c''--- 2 qc2.---  2 }c 2--- P2 .cThe Indemnified Party agrees to participate by     2 c  )2 callowing the Study t   2 ^co be  c'' 2 Ncundertaken on its premises or as otherwise agreed, utilising such facilities,    c'' p2 Ccpersonnel and equipment as may reasonably be required for the Study     2 yc.  2 }c  c''--- 2 qc3.---  2 }c /--- 2 cIn  2  cconsideration  2 c  d2 ;cof such participation by the Indemnified Party, subject to    c'' 2 ! cparagraph   2 !c4 %2 !c, the Sponsor ind  52 !lcemnifies and holds harmless    ,2 !,cthe Indemnified Party    c'' 12 5cand its employees, agents   2 5Yc   2 5^c( Y2 5c4cwhich for the avoidance of doubt includes The Royal    c'' G2 H(cChildrens Hospital (ABN 35 655 720 546)    2 Hc), 2 Hcand  2 Hc  22 Hcif the HREC is the ethics   c'' G2 \(ccommittee of the Indemnified Party, the     82 \cmembers of and advisors to its    2 \zc  2 \~cHREC   2 \c  c'' =2 o!c(collectively the Indemnified),   2 otc  F2 oz'cin respect of and against all claims an  2 oocd  c'' F2 'cproceedings (including any settlements   2 cor  2  cex gratia  .2 cpayments made with the     c'' w2 Hcconsent of the parties hereto and reasonable legal and expert costs and  c'' 2 Qcexpenses) made or brought (whether successfully or otherwise) by or on behalf of     c''--- 2  cParticipant  2 cs ( 2  cincluding  2 Ccth  2 Oceir dependants  2 c  2  cand children  2 cinjured --- 2 8cin utero---  2 ic  2 m cthrough the  c'' A2 $cparticipation of the childs mother   2  cor father  2 cin the  2 cStudy  2  c) against  2 Ncany of  2 zcthe  c'' 2  cIndemnified   2 c  I2 )cfor personal injury (including death) to  2  cParticipant  2 >cs   2 Ic( 2 Ncand  2 fc  2 k cchildren  c''--- 2 cinjured --- 2 cin utero---  2 c  .2 cthrough the participati 12 con of the child's mother   2 = cor father  2 wcin the  c'' 2 cStudy)  82 carising out of or relating to  (2 cthe administration   2  cand/or use  &2 Mcof the product(s)  c'' 2 Ncunder investigation or any clinical intervention or procedure provided for or  c''"Systemw@ \_wdwF,\--ccbbaab*0՜.+,D՜.+,T hp  Deacons8 &FORM OF INDEMNITY FOR CLINICAL TRIALS Title@[Document Footer MAIL_MSG_ID1 MAIL_MSG_ID2RESPONSE_SENDER_NAMEEMAIL_OWNER_ADDRESS 1350940 \ 99999999 \ LINDENSUFAA9qelww5tp41vEt9kiqEkb2yOs9cgdb/IGPxG5bC1+vAnY/Y8pLkwVY7e2X/Vlu+cSY+UAOdjgwqv u9jaJoV5Evd1lq6cTx8BcvzhccRZrEvh59HEKG2TjHo/Jd0dmAvmrxm8TiNov7opg8oVrpXWgghe z2K98WntOAIM5jG1IM0a5WNT8LFAblbETTAJej9g7apfZG0Ze1IvHfB5Hk3IDmP8tkRZnZsdN4I2 Kt5NCRSK8U6ba/O80\BDOLKEfmiZYQcCcFpE+5a7l0YzG4nCwcv7CRc7AkzV30b9eOPY9xcXyBO0h uc4OoB/83Q34aXkzeiMo+tRqBqA=4sAAAb0xRtPDW5UuuDCC9G/TznPMNR1V9Ntt1tre12nySMHs=HABAAv4tRYjpfjUsj0YSSU0IYb6pt98FIoeieFPegkQ2LRFwcIPEoodlAGXztO5Rd80Lp  !"#%&'()*+,-./0123456789:;<=>?@ABCDEFGHJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqstuvwxy|Root Entry F T~1Table$IWordDocumentIFSummaryInformation(IQDocumentSummaryInformation8rCompObjr  F Microsoft Word 97-2003 Document MSWordDocWord.Document.89q