iom/cirm contract

8/6/2019 IOM/CIRM Contract

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Agreement No. CIRM _2267 _CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINEINDEPENDENT CONSULTANT AGREEMENT

THIS AGREEMENT to fumish certain consultant services is made by and between the CaliforniaIstitute for Regenerative Medicine hereinafter called (CIRM), and National Academy of Sciences(Consultant).r. NATURE AND PLACE(S) OF SERVTCE

A. The Consultant shall fumish to CIRM the following described services including a timeschedule by which the Consultnt is to produce or provde specified materials or performcertain consulting services as well as reports onthe progress of the services:i. See attachment A.B. If the Consultant is an entity other than an individuI, CIRM requires that staffbe assignedaccording to Attachment A to perform the work set forth herein. No reassignment of work toindividuals other than those described in Attachment A may be made without the writtenapproval of CIRM.C. Place(s) of performance of such services shall be:

Consultant's location: CIRM's location:[500 5 Steet, NWWashington, DC 20001 I 210 King Steett I San Francisco,C[94lDT

D. CIRM will provide working space, equipment, fumiture, utilities, and services, as follows:NoneII. TERMOFAGREEMENTA. The term of this Agreement shall be from July 1, 2011 through November 30,2012.B. CIRM reserves the rght to terminate this Agreement subject to 30 days written notice tothe Consultant. Consultant may submit a written notice to termnate this Agreementonly if CIRM should substantially fail to perform its responsibilities as provided herein.In addition, CIRM may tenninate this Agreement immediately for cause. The term "forcause" shall mean that the Consultant fails to meet the terms, conditions, and/orresponsibilities of this AgreemenL In ttris instance, the termination shall be effectve asofthe date indicated on CIRM's notification to the Consultant.C. The term of this Agreement may be extended by the mutual, written consent of bothparties.


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m, COMPENSATION AND E)GENSESA. CIRM shall pay the Consultant for services performed on the following basis:1, Professional Fees:*MAXIMUM TO BE PAID UNDERTHIS AGREEMENTs699.247+Consultant shall be responsible for covering the costs of all expenses it incurs inperforming the services contemplated by this Agreement, including the costs of tavel for the Consultant'semployees, members, and others whom Consultant invites to participate in performing such services.B. Payments shall be made in four installments of $174,811.75 eact upon the Consultanfssubmission of invoices indicating the Agreement Number. Consultant shall invoiceCIRM for the first tlree instllments on July 1, 2011, January l,2Ol2, and July l,20lZ.The invoice for the final payment shall be submitted upon oompletion of the servicesspecified herein. Consultant must submit a completed Payee Data Record (StateStandard Form 204) before CIRM will issue pyment. Each invoice shall include theConsultanfs tayer identification number (Social Secur or employer identificationnumber). Invoices shall be submitted to:

California Institute for Regenerative MedcineFinance Officer210 King StreetSan Francisco,CA 94107Payment wll be made in accordance witt and within the time specified in, Government Code Chapter 4.5,commencing with Seion'927.IV. REPORTING

In perforrning consulting services under this Agreemen! the Consultant shall be accountable toCIRM and shall provide progress reports to CIRM upon CIRM,s request.V, NOTIFICATIONNotices conceming this Agreement shall be addressed as follows:

CIRM:California Institute for Regenerative MedicineGeneral Counsel210 King StreetSanFrancisco,CA 94107

TO CONSULTANT:National Academy of SciencesOffice of Confacts and Grants500 5th Sreeq NWWashington, DC 20001

VI. TA)GSThe compensation stated in Article III ncludes all applcable taxes and will not be changedhereafter as the result of Consultant's failure to include any applicable tax or as the result of anychange in the Consultanfs tax liabilities. The Consultant acknowledges that compensdion payablehereunder may be subject to wittrholding of state and federal income ta:


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Vtr. INDEPENDENT CONTRACTOR STATUSA. Both parties agree that in the performance of this Agreement the Consultant shall not be anagent or employee of CIRM, shall not be covered by the State's Worker's CompensationInsurance or Unemployment Insurance, shall not be eligible to participt in State employeeretirement programs, and shall not be entitled to any other Cmlvt .tnploy". benefits,B. The Consultant shall be solely responsble for the conduct and control of the work to beprformed by the Consultant under this Agreement, except that the Consultant is accountableto CIRM for the results of such work. The Consultant's services for CIRM shall be performedin accordance with currently approved methods and ethical standads applicable to theConsultanf s professional capacity.C. California Stte Conact Code 10515 (a) states: No person, firm, or subsidiary thereof whohas been awarded a consulting services contact may submit a bid for, nor be awarded acontract on or after July l, 2003, for the provision ofservices, procurement ofgoods orsupplies, or any other related action that is required, suggested, or othen'ise deemedappropriate in the end product of the consulting services contact.ASSIGNMENT OR SUB CONTRACTINGThe Consultant may not assign or transfer this Agreement, or any interest or claim, or subcontactany portion of the work, without the prior written approval of CIRM. The witbholding or grantingof such approval is totally discretionary with CIRM. If CIRM consents to such assignment ortansfer, the terms and conditions ofthis Agreement shall be binding upon any assignee ortrrsferee.PROPERTY RIGTilS, INCLUDING PATENTS AND COPYRIGHTSAll written and other tangible material ("Material") produced pursuant to this Agreement by theConsultant shall be the property of the Consultant. The Consultant shall give CIRM a non-exclusive, irrevocable and paid up license to use the Material..CONSULTANS LIABILITY AND INSURANCE REQUIREMENTSA. The Consultant agrees to defend and, at CIRM's electiorq indemni$ and hold haffilessCIRM, its officers, agents, and employees from its actual liabil, including reasonablecosts and expenses to which they may be subject to, resulting from injuries or damagessustained by any person or persons or propefy by virtue of performance of thisAgreement, but only to the extent arising from the negligence, wrongful act or wrongfulomission of the Consultant, or any subcontractor, ttrer employees and agents.B. The Consultant shall furnish a Certificate of Insurance or sttement of self-insurance(contractual liabl included) showing minimum coverage as follows:1. General Liability: Comprehensive or Commercial Form (Minimum Limits)

( General Aggregate (BI, PD)* $2,000,000(i Products,CompletedOperationsAggregate $2,000,000(ii Personal and Advertising Injury $1,000,000(iv) Each Occurrence $1,000,000* (not applicable to comprehensive form)

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CIRM Contacting Policy Appendix I (approved 8119/2010) Page 3


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However, if such insurance is written on a claims-made form followingtermination of this Agreemen! coverage shall survive for a period no lss thanthree y,ears. coverage must include a primary and Non-contibutory provisionand a severability oflnterest provision. coverage shall also provide for aretroactive date of placement coinciding with the effective date orthisAgreement.Business Auto Liability: (Minimum Limits) for Owned, Scheduled, Non-owned, or Hired Automobiles with a combined single limit of no less than$1,000,000 per occrence. [Alternative: Business o Liabil is waivedbecause consultant will not drive in the course of performing services forcrRM.lWorkers' Compensation; as required under Califomia State Law.Professional Liability Insurance: (Minimum Limits)

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(1) Each occrurence(2) ProjeAggregat $2,000,000$2,000,000If this insurance is written on a claims-made form, it shall continue for threeyears following termination ofths Agreement. The insurance shall have aretroactive date of placement prior to or coinciding with the effective date of thisAgreemenl The insurance must include Contractual Liability Coverage andDefense and Indemnification of CIRM by the contracting party.5. Other insurance in amounts as from time to time may reasonably be required bythe mutual consent of CIRM and the Consultant against such other insurablehazards relating to perfonnance.6. Certificate(s) of Insurance shall name CIRM as an additional insured under 1,2and 4 above, obligate the insurer to notiff CIRM at least thirty (30) days prior tocancellation of or changes in any of the required insurance and include a -provision that the coverage will be primary and will not participate with nor beexcess to any valid and collectible insurance program ofself-insurance carriedor maintained by CIRM. Premiums on all insurance policies shall be paiddirectly by the ConsultanL

RECORDS ABOI.IT INDWIDUALSA. The Consultant will not create or maintain any records under this Agreement onindividuals to accomplish a CIRM firnction, as contemplated by the Information practicesAt, Cvil Code section 1798.19.B. The Consultant shall not use recording devices in discussions with CIRM's employees

witJrout notifying all parties to the discussion that the discussion is being recorded.EXAMINATION OF RECORDSThe Consultant agrees t}rat CIRM and its authorized agents shall have the right to review and copyany rcords and supporting documentation pertaining to the performance of this Agreement,however, said records shall be limited to financial records conceming this Agreemnt and projectrecords that are available in the Public Access File. Consultant agrees to mintain such recordsfor a minimum of three (3) years after final payment, unless a longer period of records retention isstipulated' Consultant agrees to allow CIRM and ts authorized agent's access to such records

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CIRM Contacting Policy Appendix I (approved S/l9l0l0) page 4


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during normal business hours. Further, Consultant agrees to include a similar right of access inany subcontract related to the performance of this Agreement.In accordance with state law, the Consulant agrees that CIRM, its authorizpd agents, the StateConoller's Office, and the Bweau of State Audits (collectively, the ..Auditors;) snff have theright in connection with an audt, to review and copy *y t"*ids and supporting documentationpertaining to the performance ofthis Agreement inciuding,all financial umerits, records andfinancial workpapers concerning this Agreement whether obtained or copied from CIRM odeveloped by the-Consultant. Cnsultant agrees to maintain such records for possiOie auait for aminimum ofthree.(3) years after final paymen! unless a longer period of recods retention isstlated. Consultant agrees to allow the Auditors access to suh records during normal businesshours and to allow interviews of any employees who might reasonably have infmation related tosuch records. Further, Consultant agrees to include a similar right of the Auditors to audit rccordsand interview staff in any subcontract related o the performanc of this Agreement.Notwithstnding the foregoing, minutes and working papers from the Committee meetings inclosed (deliberative) sessions ae considered proprietary by the Consultant and will not beavailable for review by CIRM or provided to CIRM.

XIII. CONFLICT OF INTERESTThe consultant will not hire any officer or employee of CIRM to perform any servicecovered by this Agreement. If the work is to be perfonned in connection with a federalor state confract or gant, the consultrnt will not hire any employee of the governmentagency concerned to perforrr any service covered by this Agreement.The Consultant afTirms that to ttre best of his/her knowledge there exists no actual orpotential conflict between the Consultanfs family, business or financial interest and theservices provided under this Agreement, and in the event of change in eitJrer privateinterests or service under this Agreement, any question regarding possible conflict ofinterest which may arise as a result of such change wilr be raised with ciRM.The Consultant shall not be in a reporting relationship to a CIRM employee who is a nearrelative, nor shall the near relative be in a decision-making position with respect to theConsultant.

D- the Consultant may be required to execute a Form 700 Statement of Economic Interestsas published by the Fair Political Practices Commission. Sktements of EconomicInterests are public documents, More information about Form 700 is available atwww,fupc.ca.gov.XIV. AFFIRMATIVE ACTIONThe Consultant recogaizes that as a state govemment contractor or subcontactor, the Consultant isobligated to comply with all state laws and regulations regarding equal opportunity and affmativeaction in government contracts. When applicable, the Consultant agrees that all sch hws and theirimplementing regulations are incorporated herein as though set forth in full. These laws include thenondiscrimination requirements of Government Code sections 12990 and 11135, and thenondiscrimination program and clause required by Title 2, Division 4, Chapter 5 ofthe CaliforniaCode of Regulations.XV. CONFIDENTIALITY

The Consultant will not provide o CIRM or receive from CIRM any confidential information under thisCIRM Contraing Policy Appendix I (approved Sllgllt}) page 5

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AgreementXVI. APPLICABLELAW

The laws of the state of carifornia shall govern this AgreementXV[. TERMS TO BE EXCLUSIVEThis Ageement constitutes the entire understanding between the parties regarding the subject matterhereof and superuedes any prior understanding beteen the parties, oral or lritte ,"g*ding the samesubject matter.XVItrI. WAIVER OR MODIFICATION OF TERMS

No waiver, amendment or other modifications of the terms ofthis Agreement shall be bind.ing uponeither party unless expressed in wrting and sed by both paxties hereto.)ilX. STANDARDFORPERFORMANCE

The parties acknowledge that CIRM, in selecting the Consultant to perform the services hereunder, isrelying upon the Consultant's reputation for excllence in_ the performance of the services requiredhereunder. The Consultant shall perfonn the services in the m'anner of one who isa re"ognizeaspecialist in the tJpes of services to be performed. All deadlines set forth in the agreemJnt *" uinaingand may be modified only by subsequent written agreement of the parties. the Cosultant shall devotesuch time to performance of its, her, or his dulr undeq this Agreement as is reasonably necessary forthe satisfactory performance of such duties within the deadline-s set forth herein. Noifri"t in tn"foregoing shall be consiued to alter the requirement that time is of the "rr"*" io ttti, irr.*rnt.xx. ExcLUsIoN.Independent Consultant warrants that it is not excluded from participation in any governmentalsponsored progmm: inc,luding, without limitation, the Medicare, Meiicaid, ot Ctr*pur pogx*,(http://exclusions'oig'hhs.gov/search.aspx) and the Federal procurement and NonprocurmentPrograms (ht:/iwww.epls.gov/epls/search.do). This Agreement shall be subject immediatetermination in the event that the Independent Consultant ii excluded from panrcipation in-any federalhealthcae or procurement prograrn.)Oil RESOLUTION OF DISPUTESIf the consultant d-sput any action by CIRM arising under or out ofthe perforrnance ofthis.contract,the Consultant shall noti& CIRM of the dispute in writing and request a claims decison. CIRM shallissue a decision within 30 days of the Consultant's notice. If the onsultant disagrees witll CIRM,sclaims decision, the Consultnt shalt submit a formal claim to the presidenr "M: iil" rri tvthe President of CIRM shall be fnal and conclusive on the claim unless the decision is arbinary,capricious or gross erroneous or ifany determination offact is unsupported by substantial evidence.The decision may encompass facts, interpretation of the conhact an etemrin"io* ;;cations oflaw. The decision shall be in writing foliowing an opportunity for the consultaniio t;"; oral ordocumentary evidence and arguments in support of the claim. Consultant shall continue with theresponsibilities under this Agreement during any dispute.)O SURVIVAL.

The following sections survive the expiraton or early termination ofthis Agreement: IX, X, XI, XJ,xv, xvl, xxl.CIRM Contracting Policy Appendix I (approved g/tglz}l}) page 6


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INSTITUTE OF MEDCINEOt 7HF MI,OML AW'I1IESJudlth A. Salerno, M.D., M.S.Exeqw Diructor

November 22,2010Re: NAS ProposalNo. l0-IOM-377-Al

MelissaKingExecutive Director, ICOCCalifomia Institute for Regenerive Medicine210 King Steet, Third FloorSanFrancisoo,CA 94107Robert KleinChainnar, Goveming BoardCalifomia Institute for Regenerative Medicine210 King Ste,et" Third FloorSanFrancisco, CA 94107Dear Ms. King and Mr, Klein:

We are pleased to submit the enclosed proposal, prepared by oru Board on Heatth SciencsPolic requesting support of the Review of the Califonria Insttute for Regenerative Medicine. Thetotl estimated cost of tbis project is $728,967 for the period from June t, 0t I to November 30,20L2. We are requesting that the Clifornia Irstitrte for Regenerative Medicine provide srryport inthe aiount of 8728,967.The responsible staffofficer for this study is Cafharyn Liverman, Study Dircstor, Board onHeafth Sciences Policy. She may be sontactd a1202-334-3986 regarding pnrgram matters.Business negotiations are the responsibility of Lnd Kilro Contact lvfanager, Office of Contractsand Grants. She may be reached t202-334-2428.

'We appreciafe your considemtion of this mattr.

Enclosures

Sincerely, a9L >''-/4* .. salerno, M.D., M.s.500 Ffih Strce[ t'{WWaefihgton, DC 20001n tln Nfnn n *nr,, @neung

Phor; 20293'21T1Fac 2t233494E+nall [email protected]


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THE NATIONAL ACADEMIESAdusus o the NAan on Sdence, kgiawtng, and llee

INSTITUTE OF MEDICINEHeolth Sciences Policy BoordProposol No. i GIOM-377-O1

Review of the California Institute for Regenerative MedicineNOVEMBER 20]O

Notionol Acodemy of SciencesTelephone : l22l 334-22 4E-moil: [email protected]

AndrewM. Pope, Ph.D.DireclorBoord on Heqlth Sciences Policylnstitute of MedicineTelepho ne : l021 33+1 7 39E-moil:' [email protected]

The Nolionql Acodemies coruisls of four orgonEotlons: the Nolionol Acodemy of Sciences, lhe Nolionql Acodemy ofEngineering, lhe lnstitute of Medlcfne, ond the Notionol Reseorch Councll. The Notionql Reseorch Councilis fhe principoloprofing gency of lhe Notionol Acodemy of Sciences qnd the Nolionol Acodemy of Englneering. Thl proorol hubmllled by fh NATIONAI ACADEIITIY OF SCIENCES (NAS), whlch slrume lull technlcsl ond legol respondblllly under lls.t of Incotporsllon for lc work to be corled out under ony retullunt ogieement We qre o nonprofit publicly supporlEdorgonizolion exempl from federsl income tox under lnternol Revenue Servlce Code section 501fCll3l, The Tqxpoyerldenilftcotion Number is 53-019932. DUNS Number is 01?-4057. Aword reaulllng rom lhl proporol hould be lsucd loNATIONATACA9EMY OF SCIENCES ond poymentdhectd lo:Ncillonol Acqdenry d SclencesAccountlng Offi'ceATIN: Cosh Monogement Section500 Flfth Street, NW, Room T 433CWshlngton DC 20001Telephone: 20234-3351 or 202-3.3/-.1476 (rev.2127lO?l

NANONL ACADEIIY OF SCTENCES * NAIONAL ACAOEMY OF EilCINEERN T NSTITUTE OF MDICINE * iIATIOT.IAL RESEARCI COUNCIL

,frGronts


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Institute of MedicineReview of the Caltfomia Institutefor Regenerative Medicine

A. SurnmaryThe Califomi Instie for Regenerative Medcine (CIRM) bas requested tbt the Institute ofMedicine (IOM) pvide an inependent assessment of CIRM's prgrams, oprations, sfrafegies,and performance since its inception in 2005.B. BacroundThe California Institut for Regenerative Medicine (CIRM) is a state agency whose mission is tosupport and advance stem cell research and regenerative medicine underthe highest ethical andmedioal standanls for the discnvery and development of cures, tlrerapies, diagnostics andresearch technologies to relieVe hrman suffering frorir chonic dsease and injury. Established in2005 following the passage of the California Stem Cell Research rd Cures Initiative, theinstinte mekes grants and provides loans for stem cell rcseacho researoh facilities, and otherresearch opportunities. To date, the CIRM goveming board has warded 328 grants worth morethan $1 billion in 15 rounds of funding. Now in its sixfh year of openition, CIRM is seeking arcview its programs, initiatives, and model of ftrding medical reseach.CIRM is the first agency in the counry created by voters to invest state monies into basic andapplied medical research. CIRM has programs to support investigator-initiated research; yormginvestigators, the training of postdoctoral fellows, graduate and undergraduate studen, and thecreation of an instructionl corrse in stem cell science and ohnology. CIRMs fi:nding modelnvolves selling sta,te bonds that provide the funds for CIRM's operations and grant programs. Tocompensate the State and its oitizens for their inveshe,nt in ClRM-sponsored researoh, therevenues generated by intellectual property arising from Institule-finded projects are sharedbetween tle nventors, the non-profit organization, and the State of California according to aprescribed fonnula.C, PIau of ActionStatenent ofTaskThe Califomia Institr for Rege,lrerafiv Medioine (CIRM) has requested that the Institute ofMedioine (IOM) provide an indepe,nde,nt assessment of CIRM's programs, opermtions, sfiafegies,d performance since its inception in 2005.Specifically, the IOM committee will review and addess re following questions:


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3. CIRMts initiel processes - What can be leamed from tlre history and process of buildingconsensus in thr public and scientific coronnnities to support the inception and work ofCIRM?r CfRMts progremmtic and scientfre scope - Does CIRM have the portfolio ofprojects and grant opportunties necessary to meet its scientific goals? How csn CIRM' improve upon its existing array of pnograms? What additional programs and initiativesare recommended to meet its goals? What impacts have been sen om intenratioualaSee'lne,lrts? Does CIRM's scie,ntific strategic plan address the range of relevant issues inregenerative medioine within CIRM's mandated soope of work?c CIRIVI's organizational and managenent systemc - Are the internal organizational andmanage,ment systems (in particular the board and working group stuctrus andorations, the peer review system, the conflist of interest guidelines, and the grantsrBanagement syste,m) effective in working towad the institu's scientific goals? Are thesyste'ms that are inplace scientfically and ethically valid and rigorous? Do they achieve

the level of tansparency and the lwel of stkeholder and ssientific commwityinvolvement needed to meet the institute's public responsibilities and scientific goals? CIRM's funding model - IIas tbe fiding model for CIRM had an impact ou the workof the institute? What e tlie advantages of CIRM's model for covering long-term costsof medical reseach? Could aspetts of this funding model serve as a paradip for othersttes or counties? What hs been the economic impact of CIRM's researoh and facilties' awads d grants?r CIRM's intellechral properfy policiec - Tffbat are the shmgths and weaknesses ofCIRM's policy for shming revenrrc generated by intellectual property? How does thismodel compar to the model governing federally-supported research?The principal objective of this review is to e,nsure that all aspects of CIRM's operations arernotioning at peak performance. The committe is asked to provide recomme,lrdations regardingshort-, mediunr-, and long-term actons that corrld improve the performance of CIRM.ExpertiseA commttee of approxirnately 14 members will bo appointed with CIrpertise in stenr cellresearch, developmental biology, bioethics and law, reseach adrninstration, progtanx evaluation,finance, business administration, and inllectual property. Committee nominations will besolioited ftom a variety of sources, including the meinbershiF of the National Academies,elevant organizations and associations, federal agencies, and other experts in the eas to beaddressedin the study.


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4WorlanA study committee of approximately 14 mmbers will be assembled to review data, hold publicworkshops, develop findings and recomnendations, and prepare a re,port. The committee willconve,ne 4 times over the course of 18 months. Two public workshops will be planned andconvened in California in conjunction with the committee's meetings to gather data and ensuretht the commttee heas the perspectives of rlevant stakeholders.The first committe neeting will be largely organizational and will include the qured bias andconflist of interest discusson, provide an oven'iew of the study requrements, and discussavailable soufi)es of information The sponsor will be asked to provide the charge to thecommitt and provide backgrormd and context for the study. ln addition, the committee willorganize its fnst workshop and identify potential speakers. It is anticipated that the second andthird meetings will be held in conjunction wth public workshops and will also include time forthe committee to dissuss the outcomes of the workshop andtask in closed se,ssion. Thecommittee will spend time betveen meetings reviewing documentation and processes and willhold discussious uiththe sponsor.and with grantees and other relevant stakeholders. The fourthmeeting will provide time for thc full committee to continue its deliberatons and finalize there,port and its recommendations. The report wll then go through the National Reseach Counoil'speer review proc,ess ard be subject to appropriate institrtional review procedures. Aprepublication oopy of the report will be delivered to the sponsors afrer 15 months with booksdelivered after 18 months. The prepublication copy will be delivered to the sponsors within 10days before the public release of the rportDrafttimeline:Months Actionv2 Seek commitee nominations, assemble committee, begin baokground researth;contapt skeholdrrs; initial dissussions with sponsors4 Hold first committee meeting hold bias and conflict of inteest discussior discussohrge to.the commiec and context for the srdy, plan wor}shops - identifr topiosand potential speakers; identify inforrrtion needs; dovelop plans for receivingstakeholde,r inpu disouss commissioned ppers ad consuhang and identiff opics

+9 Hold secoud and third committee meetings with workshops; develop report outlineand worlan; hold working group conferonco calls; sek and receive input fromstakeholdffs20-l Hold fourth coryrmfes meeting; draft and.revise the rporg draft recommendtions

13-14 Report review and rcsponse to rerriew; finalize roportl5 Deliver prepublication (uucorrected proof) to the sponsorc; public release of thereporS post report onlinel6-18 Prepare report for publication and send to publishers; deliver published books to thesponsors


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PersorueThe shrdy will be conducted ruder the IOM Board on Health Sciences Policy, which is drectedby_-fut&ew Pope, Ph.D. The study team would consist of a senior program offi"o, progamofficer, associate pogram officer, and p'rogram associate, with zupport from a fina;piatassociate, board ednrinisfrsfiye assistant, and edtorial assistant. uricuta vita for Andrerr M,Pope, Ph.D., Director, Board on Health Sciences Policy, is attached.D. Period of PerfomanceThe period ofperfonnance is June 7,20L1to November 30,2012.E. Estimate of CoshThe total estimated cost of this project is $728,967 frr the period from Jrme l, 20l l to November30,2012 (see attached cost estimate). IVe ae requesting that the Califomi Institute forRegnerative Medioine provide support in the amormt of $728,967 for this period.F. Deliverables and llissemlnation PlanThe primary product ofthis shrdy will be atechnical reporl eviewed in accordance withNational Research Council OIRC) proceres. Sponsors, Congressional members and stagovernmeut agencies, and other relevant organiztions will be brefed by committee members onthe conclusions and recommendations contained v/ithin the final'report. Re,ports resulting omthis effort will be prepared in sufficient quantity to ensure their distribution to the spousor and toother relevant parties, in accordance with Academy policy. The National Academies Press willpublish the fingl repo4 and will assst in broader dissemintion by makng the report availableon fhe Intemet" thrcugh the National Academies Press (wwwnap.edu). Commissioned paperswill also be prepared and disfributed in accordance rvith NRc procedures.G. Federal Advisory Committee Act @ACA)The Academy bas dweed irterim polioies aud pmcedrrres o mplemre,lrt Sec.tion 15 of theFederal Advisory CornmitteeAct,5 U.S.C. App.$ 15. Sec.tion 15 includescertainrequircmentsregar{ing public access and conflicts of interest tbat ae appliceble to agreements rmd"r whichtlre Academy, using a commiffee, provides advice or recommendations to a Fedeial agency. Inaccordanc with Section 15 of FACA, the Academy shall submitto the govemment qponso{s)following delivery of each applicable re,port a certification that the policies and procedure. oi-tU"Academy that implement Sestion 15 of FACA bave been subshatally complied with in theperfonnance of the conaclgranlcooperative agreement with respect to the applicable reporL' IilIS Acquisitiou Regulations require the posed electonic copy to comply wir.section 508 of the RshabiltgtionAcr of r9?3 (29U .S.C.7 94d).


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IL Public Infomatiou about I' e ProjectIn order to afford the public greater knowledge of Aoademy activities and an opportrrnity toprovide comments on those activities, the Academy may post on its website(http//qww.national-acade,mies.org) the following informaton as appropriate rnder itsprocedurss: (l) notices of meetings opento the publio; (2) brief descriptions of projects; (3)committe appointnents, if any (inoluding biographies of committee members); (4) reportinformation; and (5) any other pertinent informationI. Experience nd QualificationsOrgani zational Exp er i enc eTheNational Academy of Sciencos (NAS) was established by an Act of Congress and signed byPresident Lincoln in March 1863 to "investigateo examine, experiment, and report upon any'zubject of scienoe or t....whenevr called r:pon by any deptrreirt of the Governurent." TheNational Research Council was cstablished by execr.ive order undr President Wilson n 1916,exparding the operational capac of the National Academy of Sciences. The Institute ofMedicine was chartered in 1970 by the Nationl Academy of Sciences, under the te,ms of theI 863 Congrcssional charter.One central purpose of the NAS, NRC, and IOM is to advise the government on issues ofscience, medicine, and technology. The Academy and i afElited organizations are privafe,indepeirdent, nonprofit institutions that jointly possess a unique statw as congressionallycbartered advisers to the govemerit. Every yer many studics are requested of the Academyand its sister organiztions. kr addition to federal sorlrces, requests for studies ae also rec,eivedfrom fondstions and otherprivate sestor organizations. A small number of studies receiveinternal support.The NRC an lOi have a long tadition of providing policy advice from a national perspeotive.This tadition res on the ability of the NAS/IOM to oonvene committees of experts who aecharged to deliberate important issues of health and health care policy in an objective andindepe,ndent e,nvironment that assutes rigorous analysis. IOM can serve an important finction bybringing rqxesentatives frbm diverse groups together to achieve conserrsus on complex iszues,The NRC/IOM is also able to convene experts atwotkshops to disctus important science andhealth-rlated topics. The workshop swnmary highlights the key issues raised by presenters andby workshop attendees-in ways that he to inform experts and the gelreral pnblic alike.Facl ities ar EqulpmentThe meeting facilities of the Institrte of Medicine e available to the constituent organizationsof the Academy complex. These nclude the National Academy of Sciences }dain Buitding,2l0I


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constitution Av,nue, N.w., rashingt'oa o.c. s!! Fifth stest, N.w. washington, D.c.; TtreAmold and l\{abel Beckman Ceuterin lrvine, California; and the J. Erik Jonsson Woods HoleCenter in rfoods Hole,lvfassachusetts. Thse facilities are used to conduct hundeds ofsommittee meetings eachyeor. Thus, theNational Academyof Sciences *ilf de fr"ititi*and equipment required for the proposed projecq for both committee *"*b"r, and staf.


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CunisulumVitseAI{DREW n[cPmRSON POPE, pb.

August 2008Institute of MedisineThe National Acade,nries500 Fiff Stret,N.lV.Washington" D.C.20001Telephone: (202) 334- I 8EBOIIALIT'ICATIONS

Home Address:10446 OwenBrown RoadColumbiq Maryland 2t044(30i) s964313

' Twenty years of experienoe in develo'ping atirecting and. managing scientifio prcjects and perconnolin addressing contemporarybealth policy iszues. Experienco and skills include:r Evaluating soidntific, technical and policy-related ssues and informationr lVriting and editing scientfic and polcy documents' . Conoeptualizing, dweloping, and waluatingpmjectproposalso Supervising and managingtechnisal staffr Diresting and managing orpert commiees in writing p,reparing,std disseminating soientic reportsr Consensus-building with oert cornmitteese Orgpnizing, coordnating, ard conduoting national andinternational symposia and wodcshops Procuring managing and monitoring program firnding and annual budgetsPROFESSIOIy4,IT EXPERIENCE1998- Directorr Board on Eealth Sciences Policy, Institut ofMedicine, National Academy of Sciences.Major Responsibility: direoting the astivty of the Board on Health Scienoes Policy. The Board'sactivities seek to foster an environment conducive to productive rcserch; consider t impact ofsoientifis advances on society, inoluding social and ethical issues that accompany basie science andtechnological advances; and ensure the continuous vigor ofthe basic biomedical envronmental, andclinicl research enterprises as they relte to ensuring and improving the health of the public.Responsibilities inslude qultty control of studies n the progrzrn, directly supervsing the shrdydirectors, direofing and/or writing sections of program reports, and servjng as snor iOM sbaffforliaison with ottrerNRC unts.1988'97 Senior Progmm Offier and Study Director. ivisions of Health Sciences Pol and HealthPnonotion and Disease Prwention, Institte of vted.ioine National Academy of Scences.. Major Responsbility: deveing and directing projects in heatth sciencs polioy and healttrpomotio:r and disease preve,lrtion with emphasis in occupational and environmentt issues, primaryresponsibilities include oonceptualzing.and developing project proposals, managing and direotingexpert oommitees *i {"f, rebrt vniting and preparation, managing annual program budges, ad

dissemination and public relations. Subjeot areas have included oral ontraceitives and breastoaflceq early detecton and prwention of skin oanseg disabilitypreventon; inioor allergens;informatiou technolory and clinioal medicine; occupational and environmental mediciuJ in medicaland nursing curricula; priority setting at fhe Nationl Institutes of Health; and orgr procure,ment andansplantation.


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Andrew M. Pope,PhJ).19S6-8S Senior Progem Ofrrcer and Study llirecto. Boad on Envirunmental Studies andToxicolory, National Academy oT sciencov.lational Researeh council.Major Responsibility: oversight and cooidination of sciectific, financial, andadminisbative operations, with major responsibilities in planning managemen anddirecton oftoxicology and epide,miolory programs; rupervirioof prossionj statr,rittrcommittees comprising 85 scientists in a variety of discplines and an annual budget ofapproximaely $1.2 million.1984-t6Pugram Oflicen Board on Environmental Studies and Toxicolory, National AcademyofSciences/l.Iational Research Council.I\d4ior Responsibility: coordination and drestion of committee report preparationactivities coucephralization and development of project proposals, walution of data mdprepaation of wricen materials n areas thst included physiIory, toxioolory, reproduction,and rqiury confrol,

POSTDOCTORAL ELLOWSHIPS1982-E3 Natlonel Reesrch Council Fellow. Board on Environmental Studies and Toxicolory,National Academy of Scierices/ National Research Council.Reriel' of behavioral and bochemical sting methodologies in the development of astudy on lateff shronic and delayd neurptoxic effects; evduation of the deoision-makingprocsses used by the Cornmitee on Toxicity Dafa Elemonts in reviowing toxio substaf,cesfottle report entitled 'Toxicity Testin Stategias to Detemrine Needs and Prioritias;'complion of the NAS study entitled "Scie,nce and Creationism: A View ftom the NationalAcademy of Sciences;" dwelop'rrent of a study proposal which received Academy approval' entitled "Ocoupatonal and Environmental'Ilazards to Reproduotion;" dwelopmet f"srdy proposal which receved Aoademy ap'proval entitled "Chemioal Toxic and Agng."1980-82 Senior Staff FeIIow. Pharmacolory andToxicoloryBranch, Division ofVeterinary

Medical Research, FDA, Beltwille, MD.Research emphasis forsed on tbe effecb of organophosphates oir bottr the reproductiveandnervous systems. Research projec included: Organophosphafe induced deyednourotoxioity in sheep; effects of aryl esonse on naiure and severity ofneurohistopafhological lesions and ciroulatingplasma gonadohopins; organophosphafenduced cerebellar hpoplasia and seasonal variation of acefyl-cholinestrsiactivity inpregnant and non-prcgnant ewes; induced bovine pyomeba as a modol for conbolled studiesof therapeutic agents; effects of cold gess on acetyloholinesterase activity; effecs oforganophosphates on dnrg metabolizing enymes in sheep and dogs. I also provided aconsultative rwiew for a New fuiimat Drug Application ior prostagliurdin. 'EDUCATION1980 Ph.D. University of Maryland.1975 M.S. Univers of lt4aryland.1973 B.S. Universiff of lvfarylmd.

Reproductive PhysioloryPhysiolory and BiochemistyT.oolog

Paige2


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Andren'M. Pope, Ph. page 3- AI}DITIONAL EDIICATIgN AND TRII|IINGVious mafiagement coues. l99B -pre.sent,Managing in a Technical Environment. National Academy of Scences. Ma1, l9g7.Supsrvisory Training. National Academy of Sciences. October lggd-Mach 1992,Public Policy and the Environment, Univers of Maryland Gradute School. School of public Affairs, Spring1994.Science and Policy of Global Environmental Problems. University ofMarytand Graduate School. Sohool ofPublic Affairs. Fall 1993.Ocoupational Health Risk Assossment Directions for the 90's. The Harvard Schoot of pubtic Health,Occupational Health Bostoq lvIA. May 1992.Health Risk Assessment and Health Risk Communication. Agency for Toxic Substancqs and DiseaseRegistry. Atlantq GA. Jauuary 1992Clues o Unraveling the Association Between Illness and Environmentol E:rposure. Agency for ToxicSubstances and Disesse Regishy/American Public Halth.Assooetion. Wastrington, Dt. ovomber 1991.Rsgulatory Toxicolory. New England Epidemiologr hstitu. Houston, Texas, October 1991.Prinoiples of Epidemiolory. New England Epiderniolory Institute. Houston, Texas. Ocroberr I 991 .Toxicolory Update. The Johns Hopkins Medical Center. June 1989.General Principles in Toxicolory and Toxicological Patholory. Bosfon University School of Medicine.August 1985.Meshanisms of Neurotoxicrty, The Johns Hopkins School of Hygiene and Publc Helth, November 1983.Intemational Symposium on Biomechanics of Trauma. hrstitrte for Medical Education and Research, San

. Diego. Ocobr 1983.Environmental Toxicolory. NIH Graduatp School (FAES), Spring 1983.' Essentials of Toxicologr. NIHGraduate School (FAES), Spring 1983.Reprodtrction: TheNew Frontier in Ocoupational and Environmental Heatth Resarh. Workshop sponsored Roc Mounain Cenr for Occupational and Bnvironmentl Health. April 1983.Delayed Neurotoxic t/orkshop. University of lllinois. June 1g82.Biometrics. FDd Bweau of Dnrgs, Rockville, MD. Spring 1982,Basics of Toxicolory. FDA, Bureau ofVeterinaryMedicine, Rockville, MD. Spring 19E2.statstical Analysis sysems (sAs). usDA, Beltsville, MD. November 1929.Basic Rdiation Protection and conol. university ofMaryland. January 1979.


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Andrewl\fi. Pope, Ph.D. Page 5fnnovation and Invenon tn Medical Devices. Wor}chop Summary. 2001. Roundtable on Ressarch andDvelopment of rugs, Biologics, and Medicl Devices. National Academy press, Washington, D.C.Organ Procurement and Transptentation Assryng Curent Polleies rnd the potentiel Impact of the' IIHHS I'lnal Rule. 1999. Committee on Orgian Procurement and Transplantation fotic5,. NEHonal AcademyPress, Washington, D.C.tr'luid Resuscltrtion: Stste of the Art for lreatng Combat Csuales and Civitinn Injurier. 1999,Committee on Fluid Resuscitation for Combat Casualtes. National Acsdemy press, Washington, D.C.Toward Envlronmentat Justice: Research, Educetion, nd Health Poticy Needs, lggg. commitree onEnvironmental lustice. National Academy press, Washington, D.C.Sclendfic Opportuirities and Publc Noeds: fmproving Priority Setting snd Public Input at the NatonalInstitutes of Health, 1998. Comrnittee on NIH priority:Setting procesi. Nationat Academy presqWashington, D.C.Ilalcion: An IndependentAssescment of Sefety and Efficaca llt. 1997. Comrnittee on 1lalcion: AnAssessmerit of Data Adeqlacy and Condence. National Academy Press, Washingo4 D.C.Enabling Amerlca: Ase*gl1g tbe Rote of Rehabilittion Scence and Enginering. 19g2.E. Brurdt and A. Pope (ediors). National Academy press, washingon, D.c.Conference on Human Health and Global Climate Change: Summaiy of the Proceedings. 1996.v. setlow and A. Pope (ediors). Nationat Academy press, lvashington, D.c.Nursing, Eealth, and the Environment: Strengthening the Relatonship to Improve the public's Healf.1995. A. Popg M' Snyder, and L. Mood (edtors). Committee on Enhancing Environnental Healttr Contentin Nursing Practioe. National Acadeny Prass,'Washington, D.C.Envircnmontel Medicine: htegrating a Misslng-Element lnto Medical Eduction" lgg5. A, pope and D,

Rall (editors). Commite on Curiculum Development in Environmental Medicine. National acaaenyPrcss, Washington, D,C.Environmental Medicine and the Medical School Curriculun- Iterlm Reporh 1993. Commitree onCurriculum Development in Environmental Medicine. National Academy Pross, lVashington, D.C.Indoor Allergens: Assessing and Controlling Adverse Heslth Effects, 1993, A. Po,pe, R patferson, and H,Bruge (oditors). Committee on the Health EffF,Gts oflndoorAeroallergens. National Acadeny press,l/ashington, D,C,Evlronmental Neurntoxicology. 1992. Committee on Neurobxicolory and Models for Assessing Rislc. Nationl Academy Press,'lVashington, D.C.Orl Conftaceptives and BsastCneer. 1991. Committee on theRelationship Between Oral Conaceptivesand Breast Cancer. Natonal Academy Press, lVashinglon, DCDisabilty lu America: A National Agenda for Prcvendon. 1991. A. Pope and A. Tarloy (editors).Committee on aNatonal Agenda for the Prevention of Disabitities. Natibnal Academy hess, Washington,D.C.


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AndrewM, PopqPh.D. PageTPope, A, J. Heavnern I. Guarnieri and C. Knobloch. 1986. Trichlorfon induced congentel cerebellarhypoplasia in pigs. JAVMA 189: Z8t-283.canpbell, D. L., A. M., Pope, N. K., Das, and t. J., Abramson, 19g4. A Model for the study ofBovineometra. Proceedings of S,mposium on Dptemnination ofDoses of Verinary phannaceuticals,

published by Ohio State UniversitSr Press, ColumbiA Ohio.Heatmr, J.B. and A'M', Pope. 1984. FDA Updates: Toxicity of Orgmophosphorous Comrounds. JAVMA184:30-32.Jortner,8.S., A.M. loPe and J.E. Heavner. 1983. Neuropathological aspeots of llaloxon-inducerl delayedneurotoxicity in E1sA+ and EsA- sheep. Neuotoxicolory {: 241A46.roqe-, eaM. and J.E Heavner. 1983. Actylcholinesterase activity in pregnant and non-pregnant ewes. Am. J,Ve Res. Mz 1731731. :Pope, 4.M., H'D. Guthrie, J.P. McCall and B.H. Stoud. 1983. Relese of luteal progesterone andProstaglandin F in vito during fluprostenol induced luolysis in the mare. Thriogenolo g [g:,a423,Pope, 4.M., D.L' Campbell and J.P. Davidson. 1978. Uterine histolory of posartum marps neated withprogpsterone and GnRH. J. Reprod. Fert., Suppl, ZZ:587-5g1.Pope, A.M' 1978' Foal HeatBreeding. Ir VirginiaHorse ludustyYoarbook, Vol. 3 (virginiaHorue Counoil,Mddleburg VA) pp. 70-73,CO}.GRESSIO-I--LTESTIUOTY"*{ National Agenda for tlie Prevontion and Control of Skin Cncer," Ad Hoo Subcomnrittpe on Consumr andEnvironmental Issues, commitrco on Governmertal Affairs, u.s. Senate, June 5, 1992."Disability in Amerca: Toward a National Agenda for Prevention," Subcommitee on Health and the. Environmenf Commttee on Enerry and Commerce, U.S. House of Representativeq September lg,lggj,,


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NAIIOML ACAEMY OF SCIENCSINSITUIE OF MOONE

IHE NAIONAT ACADEMIES

INSTIIUTE OF MEDICINEBOARD ON HEALTH SCIENCES POLICY

Proposol No. 10.1OM.377-01 - REVISED

XNONAL ACADEMY OF ENGINEEING\lAoNAL RS5CH COUNCTL

EVATUAION OI THE CATIFORNIA INSTITUTE OF REGENERANVE MEDICINE

7 11 111CIRM Summory of Costs

lo 111112

SoloriesProgrom Dkection, Manogemnt, ond Spoce CoslsTrovelReporlsTechnology/Com municofionMeeting ExpenseOther Cosfs

Generol Adminislrotion Cosls

Amount Requesfed From CIRM

Subtolol:

Tolol:

AMOUNT$21,sl 6$r35,346$r 03,964

$r 0.500$rs.4o4$21,10s26.425

$577,765st21 .182

$699,247

Page I

iom/cirm contract

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