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CONFIDENTIAL CT1-05168APPENDIX B - CIRM RFA 10-03: Targeted
Clinical Development Awards
California Institute for Regenerative MedicineGrant Number:
CT1-0S168 Budget Period: Annual as of 8/1/2011Grantee Name: Geron
CorporationGrantee ID: PR-Y0009A-SF Project Period Start:
8/1/2011Principal Investigator: Dr. Jane Lebkowski Project Period
End: 7/31/2014Project Title: Evaluation of Safety and Preliminary
Efficacy of Escalating Doses of GRNOPC 1 in SubacuteSpinal Cord
InjuryMilestone achievement is an important indtc9!q_rof progress
and is a major factor in review of progress reports.The milestones
summarized below replace the milestones proposed in the original
Application. "ProgressMilestones" identify activities or outcomes
to.be completed by a specified date. They will be used as a basis
forreview of progress reports and at progress evaluation meetings.
"No Go Milestones" state conditions that permitCIRM to suspend or
permanently cease disbursements under this Award. Milestones may
only be modified withPrior Approval from GJ8M. ,- -
I _
Progress Milestones Comments and.potenttel.actlvity
modifications
Year _JUY 2012
1. leteenrollrnen.t_of_pkt~2. Developafetypackagewithdatato30
days~nt f~lIIients,_ by.-
3.
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CONFIDENTIAL CT1-05168
Progress Milestones Comments and potential activity
modifications
, r
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CONFIDENTIAL CT1-05168
Year 1:MiilUIY 2012
Progress Milestones Comments and potential activity
modifications
10.Obtain IRB clearance atll-- -- -
Year 1:May 2011o July 2012Manufacturing Process
iProgress MHestones Comments and potential activity
rnodlflcatlons11.Manufacture at leastll vials
(net of release testing andretains) of GMP material iiSSing
IiiiiiiliinSbY
Year 2:AIliliiliJUIY 2013
Progress Milestones Comments and potential activity
modifications1.
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CONFIDENTIAL CT1-05168
2.
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L
L .
I _
, r
t I
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CONFIDENTIAL CT1-05168
Comments and potential activity modifications
Year 2:AliiiiliJUY013Progress Milestones
3. Obtain IRSclearanceatllclinical sites by_.
I4. Completeenrollmentof at least 3_tsin ~ Y I I
5. lete atIeastpatisafety LI
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CONFIDENTIAL CT1-05168
Year 2: August 2012 to July 2013Manufacturing Process
Progress Milestones Comments and potential activity
modifications7. Manufacture total of at least_
vials (net of release testing a~retains) of GMP mate~ __
s_I'
Year 3: AililiiiiJUIY 2014
Progress Milestones,
Comments andpotentlillacUvitY moaificatfons1.
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CONFIDENTIAL CT1-05168
Progress Milestones Comments and potential activity
modifications2.
3.
4.
Year 3:AliliiliJUY 2014IProgress Milestones I Comments and
potential activity modifications
5. Obtain IRB clearance a t l lby 2H 2013.6. I
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CONFIDENTIAL CT1-05168
Year 3: August 2013 to July 2014Manufacturing ProcessProgress
Milestones Comments and potential activity modifications
7. Manufacture total of at least_vials (net of release testing
a~retains) of GMP material passin.g__i.ons during I -
, -
FDA communicationsPeriod.4. FDA communications suggest5. Serious
safety issues otrseuzen
