CONFIDENTIAL

CT1-05168

APPENDIX B - CIRM RFA 10-03: Targeted Clinical Development Awards
California Institute for Regenerative Medicine Annual as of 8/1/2011 Grant Number: CT1-0S168 Grantee Name: Geron Corporation Grantee ID: PR-Y0009A-SF Principal Investigator: Dr. Jane Lebkowski Project Title: Evaluation of Safety and Preliminary Efficacy of Spinal Cord Injury Budget Period:

Project Period Start: 8/1/2011 Project Period End: 7/31/2014 Escalating Doses of GRNOPC 1 in Subacute

Milestone 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. "Progress Milestones" identify activities or outcomes to.be completed by a specified date. They will be used as a basis for review of progress reports and at progress evaluation meetings. "No Go Milestones" state conditions that permit CIRM to suspend or permanently cease disbursements under this Award. Milestones may only be modified with Prior Approval from GJ8M. ,- -

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Year _JUlY

2012

Progress Milestones

Comments and.potenttel.actlvity

modifications

1.

leteenrollrnen.t_ of_pkt~

2. Develop safetypackage with data to 30 days~nt f~ lIIients,_ by.3.

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CT1-05168

Progress Milestones

Comments and potential activity modifications

,r

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CT1-05168

Year 1:MiilUIY Progress Milestones

2012

Comments and potential activity modifications

10. Obtain IRB clearance atll--

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Year 1: May 2011 July 2012 to Manufacturing Process iProgress MHestones Comments and potential activity rnodlflcatlons

11. Manufacture at leastll

iiiiiilii

vials (net of release testing and retains) of GMP material iiSSing nSbY

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Year 2:AIliliiliJUIY

2013

Progress Milestones

Comments and potential activity modifications

1.

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CT1-05168

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Year 2: AlliiiiliJUIY 2013

Progress Milestones 3. Obtain IRS clearance atll clinical sites by_. 4. Complete enrollment of at least 3 _tsin 5. lete atIeast pati safety
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Comments and potential activity modifications

~YII

LI<:I\

..

.rvc ..... '"

Year 2: AlliiiiliJUIY 2013 Progress Milestones

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Comments and potential activity modifications

6.

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Year 2: August 2012 to July 2013 Manufacturing Process Progress Milestones 7. Manufacture total of at least_ vials (net of release testing a~ retains) of GMP mate~ Comments and potential activity modifications

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_

s_I'

Year 3: AililiiiiJUIY Progress Milestones

2014

, Comments andpotentlillacUvitY

moaificatfons

1.

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CT1-05168

Progress Milestones

Comments and potential activity modifications

2.

3.

4.

Year 3: AIliliiliJUIY
I

2014

Progress Milestones
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Comments and potential activity modifications

5. Obtain IRB clearance by 2H 2013.

atll

6.

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CT1-05168

Year 3: August 2013 to July 2014 Manufacturing Process Progress 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
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FDA communications Period. 4. FDA communications suggest 5. Serious safety issues otrseuzen <:n,... sorwhich n tead to termination of all clinical studies.

within the Project

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