--------------------------------------------------------------------------------

Exhibit 10.61
 
Confidential Materials Omitted and Filed Separately with the Securities and
Exchange Commission Pursuant to a Request for Confidential Treatment under Rule
24b-2 under the Exchange Act of 1934, as amended.  Confidential Portions are
marked: [***]
 
SIGN AND RETURN ALL PAGES TO
CIRM                                                                                                                SP3A-07552

NOTICE OF GRANT AWARD – RFA 13-03A: CIRM Strategic Partnership III Track A
Awards
California Institute for Regenerative Medicine
 
Issue Date: October 16, 2015
 
Grant Number:
SP3A-07552
Project Period Start:
10/01/2014
Grantee Name:
Asterias Biotherapeutics
Project Period End:
09/30/2018
Grantee ID:
PR-Y0035A-SF
   
Principal Investigator:
Jane Stephanie Lebkowski
Total Award Amount:
$14,323,318
Project Title:
A Phase I/IIa Dose Escalation Safety Study of AST-OPC1 in Patients with Cervical
Sensorimotor Complete Spinal Cord Injury

Authorized Organizational Official and Address:
Official and Address to Receive Payments:
Katharine E. Spink
Chief Operating Officer
230 Constitution Drive
Menlo Park, CA 94025
Katharine E. Spink, Ph.D.
230 Constitution Drive
Menlo Park, CA 94025

The California Institute for Regenerative Medicine (CIRM) hereby awards a grant
in the amount of $14,323,318 to be disbursed over a total period of 4 years to
Asterias Biotherapeutics (Grantee ID: PR-Y0035A-SF) in support of the above
referenced project. This award is pursuant to the California Stem Cell Research
and Cures Act (Health and Safety Code section 125290.10 et. seq.) and is subject
to terms and conditions referenced below.  (Capitalized terms are defined in the
CIRM Grants Administration Policy for For-Profit Organizations (GAP), a copy of
which may be found on the CIRM website at:
http://www.cirm.ca.gov/our-funding/chapter-5-grants-administration-policies

In accepting this Grant, the Grantee warrants to CIRM that any funds expended
under the Award will be for the purposes set forth in the approved Application
and agrees to comply with all applicable CIRM regulations and standards.

To accept this Grant, the Principal Investigator and Authorized Organizational
Official must sign and return this Notice of Grant Award (NGA) to CIRM within 45
days of the issue date. Payment will be issued only after the fully signed NGA
is received by CIRM.  Grant funds will be sent to the organization’s address
listed above under Official and Address to Receive Payments unless an updated
address is provided in the box below.  If the Applicant cannot accept the award,
including the legal obligation to perform in accordance with the provisions of
this NGA, it should notify CIRM immediately.

If you have any questions about this award, please contact the CIRM staff
referenced on page 3.
 
 
 
 
Ellen Feigal, M.D.
Senior Vice President, Research & Development
California Institute for Regenerative Medicine
 
Updated Address to Receive Payments:
 
 
 
 

 
AWARD ACCEPTANCE: The Principal Investigator and Authorized Organizational
Official must sign below and return the entire NGA to CIRM to accept the Grant
award.

 
Principal Investigator
Authorized Organizational Official
Name
Jane Stephanie Lebkowski
Katharine E. Spink
Signature
/s/ Jane Stephanie Lebkowski
/s/ Katharine E. Spink
Date
October 16, 2014
October 16, 2014

 
Page 1 of 12

--------------------------------------------------------------------------------

SIGN AND RETURN ALL PAGES TO CIRM     SP3A-07552

TERMS AND CONDITIONS:
 
A.
This award is based on the application submitted to CIRM, and as approved by the
Independent Citizens' Oversight Committee (ICOC) on the above-titled project and
is subject to the terms and conditions incorporated either directly or by
reference in the following:

1. The California Stem Cell Research and Cures Act (Health and Safety Code
Section 125290.10 et. seq.) and regulations adopted by the ICOC.

2. The CIRM Grants Administration Policy for Academic and Non-Profit
Institutions (Title 17, California Code of Regulations, Section 100500), CIRM
Intellectual Property Policy and Revenue Sharing Requirements for Non-Profit and
For-Profit Grantees (Title 17, California Code of Regulations. Sections
100600-100611), the CIRM Medical and Ethical Standards Regulations (Title 17,
California Code of Regulations, Sections 100010-1000120), and any subsequently
adopted applicable regulations.

3. The terms and requirements detailed in RFA 13-03A: CIRM Strategic Partnership
III Track A Awards.

4. The Progress Milestones and Go/No Go Milestones set out in Appendix A to this
NGA.

5. Budget detail for the Principal Investigator set out below.

B. CIRM-funded animal work to be carried out by Asterias Biotherapeutics, which
requires IACUC protocol approval, cannot commence until such IACUC approval is
provided to CIRM.

C. CIRM-funded human subjects work to be carried out under this Award, which
requires IRB protocol approval, cannot commence until such IRB approval is
provided to CIRM.

D. If CIRM determines, in its sole discretion, that Grantee has not satisfied a
Progress Milestone, CIRM may suspend disbursements until such time as Grantee
satisfies the Progress Milestone. Upon suspending disbursements, CIRM may
convene its progress Evaluation Committee and may seek input from Grantee in
order to evaluate the circumstances of the delay, including, but not limited to,
its cause, impact and any mitigating factors; provided, however, that CIRM may
permanently cease disbursements if Grantee does not satisfy the Progress
Milestone within four (4) months of the date that the Progress Milestone was
scheduled to have been satisfied, or if the delay is not addressed to CIRM's
satisfaction, as determined by CIRM in its sole discretion.

E. CIRM may suspend or permanently cease disbursements if CIRM determines, in
its sole discretion, that the Grantee has not satisfied a Go/No Go Milestone (as
defined in Appendix A to this NGA).

F. Of the total award amount of $14,323,318, up to $6,737,865 is available for
process development. The disbursement of these funds shall be contingent upon
the negotiation of Progress and Go/No Go Milestones and a payment schedule
satisfactory to CIRM. Upon CIRM’s approval of Progress and Go/No Go Milestones
and a payment schedule, CIRM shall make disbursements based on the approved
payment schedule. As set forth in Paragraphs C and D, CIRM reserves the right to
suspend or terminate disbursements if CIRM determines, in its sole discretion,
that Grantee has failed to satisfy a Progress or Go/No Go Milestone relating to
process development.

G. Grantee shall conduct CIRM-funded work only on the basis of the milestones
and/or success criteria outlined in Appendix A that have been agreed upon by
Grantee and CIRM.  Throughout the progress of the grant, Grantee and CIRM may
agree upon new or modified milestones, success criteria, or other funding
requirements (identified as “Modified Requirements”). Such Modified Requirements
shall be agreed upon in writing between Grantee and CIRM and will be
incorporated by reference to the milestones document set forth in Appendix A.

H. In the event that Grantee elects to terminate the award or the clinical trial
or other work to be funded by the award, for reasons other than the Grantee’s
failure to meet a Progress or Go/No Go Milestone and/or a decision by the Food
and Drug Administration to place a clinical hold on the trial, Grantee shall
reimburse CIRM for the funds received by Grantee from CIRM under the award, with
interest at a rate per annum equal to the one year LIBOR rate (in effect as of
the last business day of the immediately preceding calendar month) plus 1%, from
the date of receipt of each disbursement to the date of repayment.

 
Page 2 of 12

--------------------------------------------------------------------------------

I. At least one month prior to each Q1 disbursement date (see Reporting Schedule
below), Grantee will demonstrate to CIRM’s reasonable but sole satisfaction that
Grantee has funds available, either in the form of cash, cash equivalents or
securities listed on an automated quotation system which have no resale
restrictions under federal or other applicable securities laws, sufficient to
fund all of Grantee’s budgeted expenses (excluding depreciation, amortization,
and other GAAP expenses which do not affect cash levels, but including overhead
and administrative expenses, taxes, and the costs and expenses detailed in the
Notice of Grant Award), less the costs budgeted to be covered by planned Grant
disbursements, which are anticipated by Grantee to be incurred by Grantee in
connection with the CIRM-Funded Project and its business operations over the
next twelve (12) months, as demonstrated by Grantee’s submission of its most
recent budget forecasts and other financial information reasonably requested by
CIRM.  CIRM reserves the right to suspend or terminate disbursements if CIRM
determines, in its sole discretion, that Grantee has failed to satisfy this
financial requirement.

J. CIRM has the right to attend key FDA meetings regarding the funded project,
including but not limited to any clinical milestone meeting, or clinical hold
meeting (FDA Meetings).  CIRM also has the right to review any data package(s)
or other information, including confidential and/or proprietary information,
provided by Grantee to the FDA in connection with such FDA Meetings, as well as
any FDA Meeting minutes, and to share such information with CIRM’s confidential
advisers.  To facilitate CIRM’s participation in FDA Meetings, Grantee shall
notify CIRM as soon as practicable after it has scheduled an FDA Meeting, and
shall, upon request, provide CIRM a copy of any data package or other
information it intends to provide or has provided to the FDA, as well as any FDA
Meeting minutes.

K. Grantee shall comply with the terms of the Communication Plan, attached
hereto as Appendix B.

L. If CIRM determines, in its sole discretion, that Grantee has not complied
with the terms and conditions of this award, CIRM may suspend or permanently
cease Disbursements, or pursue other remedies as allowed by law.

M. The timing of the distribution of funds pursuant to this Grant shall be
contingent upon the availability of funds in the California Stem Cell Research
and Cures Fund in the State Treasury, as determined by CIRM in its sole
discretion.

Please check the following website for updated policy
documents: http://www.cirm.ca.gov/cirm-operations/Regulations
 
AWARD DETAIL (U.S. Dollars):

   
Year 1
   
Year 2
   
Year 3
   
Year 4
 
Direct Project Costs
               
Personnel
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
Travel
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
Supplies
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
Equipment
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
Consultants/Subcontracts
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
Total Direct Project Costs
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
                                 
Facilities Costs
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
Indirect Costs
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
 
$
[***]
 
                                 
TOTAL BUDGET
 
$
4,211,863
   
$
4,543,518
   
$
4,136,541
   
$
1,431,103
 

QUARTERLY INSTALLMENTS ON GRANT PAYMENTS
Payments will be made in quarterly installments, issued at the beginning of each
quarter. Quarters will be tied to the project start date.  The Year 1 Budget
represents a 15 month period and hence the 1st disbursement issued upon
execution of the agreement represents 6/15ths of the Year 1 Budget to cover
pre-award costs and the 1st 3 months of the project period.

*Any interest accrued by the Grantee from the Grant payments must be used for
the CIRM Strategic Partnership III Track A Awards.
 
Page 3 of 12

--------------------------------------------------------------------------------

Disbursement Schedule:

Payment #:
Type
Schedule Date
 
Amount
 
1
Pre-Award and Year 1 Q1
~10/15/2014
 
$
916,554
 
2
Year 1 Q2
1/1/2015
 
$
458,277
 
3
Year 1 Q3
4/1/2015
 
$
458,277
 
4
Year 1 Q4
7/1/2015
 
$
458,277
 
5
Year 2 Q1
10/1/2015
 
$
541,012
 
6
Year 2 Q2
1/1/2016
 
$
541,012
 
7
Year 2 Q3
4/1/2016
 
$
541,012
 
8
Year 2 Q4
7/1/2016
 
$
541,012
 
9
Year 3 Q1
10/1/2016
 
$
489,786
 
10
Year 3 Q2
1/1/2017
 
$
489,786
 
11
Year 3 Q3
4/1/2017
 
$
489,786
 
12
Year 3 Q4
7/1/2017
 
$
489,786
 
13
Year 4 Q1
10/1/2017
 
$
292,719
 
14
Year 4 Q2
1/1/2018
 
$
292,719
 
15
Year 4 Q3
4/1/2018
 
$
292,719
 
16
Year 4 Q4
7/1/2018
 
$
292,719
 

These disbursements represent the funding for the clinical trial. Disbursements
for the process development activities will be determined upon final negotiation
of milestones for those activities as stated in condition F above.

PROGRESS & FINANCIAL REPORTS SCHEDULE

Requirement Type
Due Date
Notes
Progress Report
01/01/2015
Year 1 Q1
Financial Report
02/01/2015
Year 1 Q1
Progress Report
04/01/2015
Year 1 Q2
Financial Report
05/01/2015
Year 1 Q2
Progress Report
07/01/2015
Year 1 Q3
Financial Report
08/01/2015
Year 1 Q3
Financial Milestone Check
09/01/2015
Year 1
Annual Progress Report
10/01/2015
Year 1
Financial Report
01/01/2016
Year 1
Progress Report
01/01/2016
Year 2 Q1
Financial Report
02/01/2016
Year 2 Q1
Progress Report
04/01/2016
Year 2 Q2
Financial Report
05/01/2016
Year 2 Q2
Progress Report
07/01/2016
Year 2 Q3
Financial Report
08/01/2016
Year 2 Q3
Financial Milestone Check
09/01/2016
Year 2
Annual Progress Report
10/01/2016
Year 2
Financial Report
01/01/2017
Year 2
Progress Report
01/01/2017
Year 3 Q1
Financial Report
02/01/2017
Year 3 Q1
Progress Report
04/01/2017
Year 3 Q2
Financial Report
05/01/2017
Year 3 Q2

 
Page 4 of 12

--------------------------------------------------------------------------------

Progress Report
07/01/2017
Year 3 Q3
Financial Report
08/01/2017
Year 3 Q3
Financial Milestone Check
09/01/2017
Year 3
Annual Progress Report
10/01/2017
Year 3
Financial Report
01/01/2018
Year 3
Progress Report
01/01/2018
Year 4 Q1
Financial Report
02/01/2018
Year 4 Q1
Progress Report
04/01/2018
Year 4 Q2
Financial Report
05/01/2018
Year 4 Q2
Progress Report
07/01/2018
Year 4 Q3
Financial Report
08/01/2018
Year 4 Q3
Annual Progress Report
10/01/2018
Year 4
Financial Report
01/01/2019
Year 4

 
CIRM CONTACTS:
Gabriel Thompson, Grants Management Officer
Phone: 415-396-9274                               Email:
gthompson@cirm.ca.gov             Fax:  (415) 396-9141

Kevin Whittlesey, Science Officer
Phone: 415-396-9311                               Email:
kwhittlesey@cirm.ca.gov             Fax: (415) 396-9141

The CIRM home page is at http://www.cirm.ca.gov

CIRM Mailing Address:
California Institute for Regenerative Medicine
Attn:  Gabriel Thompson, Grants Management Officer
210 King Street
San Francisco, CA 94107
 

Page 5 of 12

--------------------------------------------------------------------------------

APPENDIX A -
Confidential                                                                                    SP3A-07552

NOTICE OF GRANT AWARD – RFA 13-03A: CIRM Strategic Partnership III Track A
Awards
California Institute for Regenerative Medicine

Grant Number:
SP3A-07552
Project Period Start:
10/01/2014
Grantee Name:
Asterias Biotherapeutics
Project Period End:
09/30/2017
Grantee ID:
PR-Y0035A-SF
   
Principal Investigator:
Jane Stephanie Lebkowski
Total Award Amount:
$14,323,318
Project Title:
A Phase I/IIa Dose Escalation Safety Study of AST-OPC1 in Patients with Cervical
Sensorimotor Complete Spinal Cord Injury

 
Milestone achievement is an important indicator of progress and is a major
factor in review of progress reports.  Insufficient progress through Milestones
may result in loss of further funding.  The Milestones summarized below replace
the Milestones proposed in the original Application.   These Milestones will be
used as a basis for review in the progress reports and progress Evaluation
Meetings unless further modified with Prior Approval from CIRM.

Clinical Trial Milestones: Year 1 (Q4 2014-Q3 2015)

 
Milestone
Target
completion
date
Progress
or Go/No
Go
Comments
Clinical/
Regulatory
1.        Execute contracts with [***] and all other contractors necessary to
open all four clinical sites.
Q4 2014
Progress
Applies to contracts with vendors and service providers. Does not apply to
contracts with all four clinical sites, which will likely extend into Q1-2 2015
for completion.
CMC
2.       Complete final release of sufficient cGMP-grade material to supply
proposed clinical plan
 
Success criteria: At least [***] differentiated cells meeting specified release
criteria
Q4 2014
Progress milestone
Clinical/ Regulatory
3.    Open first site
 
Success criteria:  First site open for enrollment, including site initiation,
site agreement signed and IRB approval and imaging CRO contract signed
Q1 2015
 
Progress
 
Based on previous experience, it will likely take 5-6 months to complete IRB
review and site training after obtaining FDA clearance for the trial.
Clinical/ Regulatory
4.    Execute contracts with all clinical sites
Q2 2015
Progress
Agreements signed with all remaining clinical sites and remaining IRB approvals
obtained.

 
Page 6 of 12

--------------------------------------------------------------------------------

Clinical/ Regulatory
5.        Enroll first subject
 
Success criteria:  First subject enrolled in first cohort
Q2 2015
Progress
Enrollment will likely be slow at first, but is expected to accelerate as more
sites open and outreach efforts reach referral centers
Clinical/ Regulatory
6.        Complete site initiation for remaining three  clinical sites
 
Success criteria:  Four clinical sites open for enrollment
Q2 2015
Progress
Currently anticipated sites are Shepherd
 
                 [***];
 
 
however, this is subject to change based on results of final site qualification
visits and other considerations.

Clinical Trial Milestones: Year 2 (Q4 2015-Q3 2016)

 
Milestone
Target
completion
date
Progress
or Go/No
Go
Comments
Clinical/
Regulatory
7.        Complete enrollment, DMC review of 30 day safety data from first
cohort
 
Success criteria:  Enrollment of  3 subjects within 6 months; DMC approves
escalation to second dose cohort
Q4 2015
Go/no go
If safety concerns deemed by DMC serious enough to pose an undue risk to
patients are observed in the first dose cohort, a no go decision will be made.
Clinical/ Regulatory
8.        Enroll first subject in second dose cohort
 
Success criteria:  Enrollment of first subject in second cohort
Q1 2016
 
 
 
 
 
Progress
 
 
 
 
 
Assumes acceptable safety in cohort 1. Target is to enroll first subject within
two months of DMC approval of dose escalation.
 
Clinical/ Regulatory
9.        Complete enrollment, DMC review of safety data from second dose cohort
 
Success criteria:  Enrollment of 5 subjects in second cohort; DMC approves
escalation to third dose cohort
Q3 2016
Go/no go
 
Enrollment should be more rapid in second dose cohort as more sites open,
outreach completed. It is expected to take 4-6 months to enroll 5 patient
cohort.
 
If safety concerns deemed by DMC serious enough to pose an undue risk to
patients are observed in the second dose cohort, a no go decision will be made.

 
Page 7 of 12

--------------------------------------------------------------------------------

Clinical Trial Milestones: Year 3 (Q4 2016-Q3 2017)

 
Milestone
Target
completion
date
Progress
or Go/No
Go
Comments
Clinical/ Regulatory
10.      Enroll first subject in third dose cohort
 
Success criteria:  Enrollment of first subject in the third cohort
Q4 2016
 
Progress
 
 
Assumes acceptable safety in cohort 2. Target is to enroll first subject within
1-2 months of DMC approval of dose escalation.
Clinical/ Regulatory
11.      Initial (6 month) activity readout from second dose cohort
 
Success criteria:  Continued demonstration of safety. If  ≥2 of 5 subjects show
≥2 neurological levels improvement in  motor function, this could be a possible
early sign of efficacy
Q1 2017
Progress
Based on historical controls, anticipated spontaneous frequency of ≥2
neurological level improvement in motor function  is 1 of 5 subjects (21%) at 6
months.  However, given early timepoint, small number of subjects, and dose at
low end of likely efficacious range, data will not be used as a go/no go
decision point.
Clinical/ Regulatory
12.     Complete enrollment of Phase 1/2a dose escalation study
 
Success criteria:  Enrollment of 5 subjects in third dose cohort
Q2 2017
Progress
Target is to enroll 5 subjects in third dose cohort within 4-6 months.

 
Page 8 of 12

--------------------------------------------------------------------------------

Clinical Trial Milestones: Year 4 (Q4 2017-Q3 2018)

 
Milestone
Target
completion
date
Progress
or Go/No
Go
Comments
Clinical/ Regulatory
13.      Initial (6 month) activity readout from third dose cohort
 
Success criteria:  Continued demonstration of safety. If  ≥2 of 5 subjects show
≥2 neurological levels improvement in  motor function, this could be a possible
early sign of efficacy.
 
Q4 2017
 
 
 
 
Progress
 
 
 
 
Based on historical controls, anticipated spontaneous frequency of ≥2
neurological level improvement  in motor function  is 1 of 5 subjects (21%) at 6
months.  If the data show a higher frequency of improvement this could be a
promising early sign of efficacy.  However, subjects will also be followed to 1
year as improvements may take longer than 6 months to manifest.
Clinical/ Regulatory
14.      Complete one year follow-up of Phase 1/2a dose escalation study
Q2-2018
 
Progress
 
 
Clinical/ Regulatory
15.      Complete study report
 
Success criteria:  No major safety concerns identified;  ≥2 of 5 subjects show
two neurological levels of improvement in at least one dose cohort
 
Q3 2018
Go/no go
Go/no go decision point for subsequent clinical trials, primarily from a safety
perspective.  Will also be looking for evidence that are meeting TPP of >40% of
patients achieving 2 neurological levels of improvement as preliminary efficacy
readout for justification of investment in subsequent trials.

Page 9 of 12

--------------------------------------------------------------------------------

APPENDIX B -
Confidential                                                                                    SP3A-07552
 
Communication Plan for CIRM-Funded Clinical Trial

[image00005.jpg]
*Upon notification of an FDA Clinical Hold, Sponsor must inform CIRM within 24
hrs. of receipt of the FDA notice.  In cases where the FDA communicates issues
or seeks information for a potential clinical hold, Sponsor will inform CIRM
concurrent with (i.e. within 24 hrs. of) their response to the FDA
 

I. SAE Reporting

(1) Site Reporting to Sponsor

 
The Investigator must notify the Sponsor by telephone or fax of any serious
adverse event within 24 hours of the Investigator’s knowledge of the event. 
Telephone reports must be followed by a written report within 24 hours. 
Follow-up reports must be submitted in a timely fashion as additional
information becomes available.

(2) Sponsor Reporting to the Food and Drug Administration (FDA)

The trial Sponsor, Asterias Biotherapeutics, will report any suspected adverse
reaction to study treatment that is both serious and unexpected to the FDA in an
IND safety report (21 CFR 312.32(c)(1)(i)).  Each report will be documented
using FDA Form 3500A.  Asterias will submit an IND safety report to FDA and all
participating investigators no later than 15 calendar days after the Sponsor’s
initial receipt of the information and determination that the suspected adverse
reaction or other information qualifies for reporting.  Asterias will report any
unexpected fatal or life-threatening suspected adverse reaction to FDA no later
than 7 calendar days after the Sponsor’s initial receipt of the information (21
CFR 312.32(c)(2)).

Reports will be completed with all available information, including a brief
narrative describing the suspected adverse reaction and any other relevant
information. If applicable, the Sponsor will also include identification of
similar reports and an analysis of the significance of the suspected adverse
reaction.
 
Page 10 of 12

--------------------------------------------------------------------------------

(3) Review of Safety events by the Data Monitoring Committee (DMC)

The Asterias Biotherapeutics DMC is responsible for safeguarding the interests
of study participants and assessing the safety of study procedures and will
manage the overall conduct of study AST-OPC1-01. This committee will provide
recommendations about continuing, and stopping the study. In addition, DP
Clinical will provide the DMC with summary data on adverse events, serious
adverse events, and reports submitted to FDA.

Please refer to the Asterias Biotherapeutics Data Monitoring Committee Charter.

(4) Sponsor Reporting to CIRM

DMC meetings will be conducted on a routine basis. During each meeting, critical
issues, unexpected problems and trends will be identified and discussed.  The
Asterias Clinical Trial Manager (TBD reporting to Edward Wirth) will have
responsibility for reporting any suspected adverse reaction to study treatment
that is both serious and unexpected, and any event of impact to the clinical
project to CIRM within 24 hours.  In addition, Asterias will provide a summary
of safety events, in coordination with the meetings of the DMC.

Asterias Safety Reporting Contacts:

· Edward Wirth III, MD, PhD, Chief Translational Officer

· Naomi Kautz, Associate Director of Regulatory Affairs

CIRM Safety Reporting Contacts:

· Kevin Whittlesey, Ph.D.

· Ellen Feigal, M.D.

 

II. Other Study Related Press Releases and Trial Hold “Crisis Reporting”

The Asterias Project Manager,(Katharine Spink) will have primary responsibility
of communication with CIRM overall project information, including study
decisions and “crisis” issues or other occurrences that may impact the conduct
of the trial and to do so within 24 hours of determination by the DMC.  Upon
notification of an FDA Clinical Hold, Asterias will inform CIRM. CIRM will also
be notified of an announced FDA audit within 7 business days, and other study
related issues at least 5 business days advanced notice.

Any news releases and/or public statements related to this CIRM grant will be
approved by both sides to ensure consistency of message.

Asterias and CIRM agree to provide reasonable advanced notice (at least 5
business days unless otherwise dictated by SEC reporting regulations) of news
releases and/or public statements related to this grant, to the other party, in
order to give the other party an opportunity to review and suggest edits to the
content.  However, both Asterias and CIRM retain the ultimate right of authority
regarding their external communications.  Neither Asterias nor CIRM shall use
the name of the other party in public-facing documents, statements or
presentations without the prior consent of an authorized individual within the
organization.
 
Page 11 of 12

--------------------------------------------------------------------------------

Management and Communications Contacts:
 
For Asterias, the authorized individuals shall be Katharine E Spink and Jane
Lebkowski.

For CIRM, the authorized individuals are the Sr. Director of Public
Communications, Kevin McCormack, and Sr. Vice President of Research and
Development, Dr. Ellen Feigal.

III. Routine Communications

Asterias and CIRM will have a mutual commitment towards maintaining
communication between quarterly reports.

 
Page 12 of 12

--------------------------------------------------------------------------------