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Exhibit 10.8
 
 

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March, 28 2012
 
 
Stephanie McSwain
Vice President, Manufacturing
Aeolus Pharmaceuticals, Inc.
26361 Crown Valley Parkway
Mission Viejo, CA 92681
 
 
Dear Stephanie,
 
 
Thank you for your continued interest in Johnson Matthey Pharma Services
(JMPS).  As a follow-up to your recent request, we are pleased to provide Aeolus
Pharmaceuticals (Aeolus) with this proposal for Aldehyde Development and non-GMP
Manufacture.
 
Please contact me if I can provide additional information or be of additional
service.  We appreciate the opportunity to support your chemistry service needs
and look forward to your feedback on this proposal.
 

All the Best,
 
/s/ Todd Stark
Todd Stark, Ph.D.
 
Manager, Business Development
Johnson Matthey Pharma Services
 
978-496-7088
tstark@jmusa.com
 
 
 
 

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Proposal for Aldehyde Development and non-GMP Manufacture
 
Appendix 6 to the Research and Manufacturing Agreement Dated:  February 16, 2011
 
Proposal Date:  March, 28 2012
 
Johnson Matthey Pharma Services (JMPS) is pleased to provide Aeolus
Pharmaceuticals (Aeolus) with this proposal for Aldehyde Development and non-GMP
Manufacture.  JMPS will use commercially reasonable efforts to meet all
milestones for the estimated fees as outlined in this proposal.  This proposal
is based on technical information provided by Aeolus and other available
technical information within the public literature and available at JMPS.
 
Summary
 
Proposal No:  AEO-111129-1084
Stage #
Description
Service Fee*
Estimated Timeline
1
Scale-up Aldehyde Development
$[…***…]
[…***…]
       
2
Non-GMP Aldehyde Manufacture ([…***…] target)
$[…***…]
[…***…]
         
Total
$[…***…]
[…***…]

*Includes […***…].
 
JMPS will use commercially reasonable efforts to achieve the deliverables as
outlined in this proposal.  This estimate is based on a specific scope of work
that was developed using technical information provided by Aeolus.  Project
objectives or technical details may differ from those assumed in this
estimate.  If a significant difference occurs from the originally proposed scope
of work or with the actual technical details from those assumed, JMPS will
assess the impact of such a change and inform Aeolus.  JMPS and Aeolus will
promptly and in good faith develop and agree to a modified project plan to
ensure that project delays are avoided or minimized.  If these changes result in
additional cost, Aeolus must authorize the additional cost in writing prior to
implementation.
 
JMPS will schedule resources and order materials upon acceptance of this
proposal.  Scheduling is contingent on prevailing staff commitments, raw
material, and equipment availability.  Aeolus will be notified of the expected
start date as soon as is practical.  JMPS will appoint a project leader to
oversee the work and serve as the primary technical liaison with
Aeolus.  Project updates will be submitted weekly and conference calls will be
arranged on a frequency agreed upon by both parties.
 
JMPS offers to perform this work on a Fixed Fee basis.  Notwithstanding anything
to the contrary, upon acceptance of this proposal, Aeolus will be invoiced a
deposit of […***…]% in the amount of $[…***…].  Deposits will be credited
proportionally against the final invoice for each Stage.  Invoices for fixed fee
work are issued upon completion of stage deliverables.  Invoices are payable
within thirty (30) days from the date of issuance.  Materials will be shipped
from JMPS’s facility F.C.A (Incoterm 2010) within 30 days of project completion.
 
 

 
 
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All work specified in this proposal is subject to the Research and Manufacturing
Agreement between Johnson Matthey Pharma Materials dba Johnson Matthey Pharma
Services and Aeolus Pharmaceuticals dated February 16, 2011.  This proposal is
valid for thirty (30) days from the preparation date.
 
Stage 1:  Scale-up Development
 
JMPS will perform scale-up process development activities prior to the non-GMP
manufacture.
 
1.  
Further develop the preparation of 1-ethyl-1H-imidazole-2-carbaldehyde (Aeolus
aldehyde) using sub-stoichiometric amounts of hexyllithium

[…***…]
2.  
Develop an IPC Analytical Method

[…***…]
3.  
Fifty gram scale demo-run using the aldehyde/N-ethylimidazole mixture as the
starting material.

[…***…]

Stage 2:  Non-GMP Manufacture
 
JMPS will use commercially reasonable efforts to demonstrate a plant-scale
manufacture under non-GMP of approximately […***…] of Aeolus aldehyde.
 
1.  
Write non-GMP batch record

2.  
Prepare Certificate of Testing for prepared material.

Deliverables:
 
·  
A brief (1 -2 page) report summarizing the process and yield.

·  
Copies of executed non-GMP batch records.

·  
COT for lots manufactured.

JMPS offers to perform this work on a Fixed Fee basis.
 
 
 
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AUTHORIZATION
 
Appendix 6 to the Research and Manufacturing Agreement Dated:  February 16, 2011
 
Aldehyde Development and non-GMP Manufacture
 
AEO-111129-1084
 
 
This proposal, including all work and material provided by JMPS hereunder, shall
be governed by the Research and Manufacturing Agreement between Johnson Matthey
Pharma Materials dba Johnson Matthey Pharma Services and Aeolus
Pharmaceuticals.  By its signature below, Aeolus Pharmaceuticals hereby
authorizes Johnson Matthey Pharma Services to perform the work detailed in this
proposal subject to the Research and Manufacturing Agreement dated February 16,
2011.
 
 
For:  Aeolus Pharmaceuticals
 
/s/ John L.
McManus                                                               
Date:  4/30/12                                                              
Signature
     
John L.
McManus                                                                    
 
Printed Name
         

 
For:  Johnson Matthey Pharmaceutical Materials, Inc. d/b/a Johnson Matthey
Pharma Services
 

 
Date:  April 30, 2012                                                     
/s/ Jayachandra Reddy                                                           
Jayachandra Reddy, Ph.D.
General Manager
 

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