Exhibit 10.2

 

CONFIDENTIAL AND PROPRIETARY TO [ * * * ]

 

*** Text Omitted and Filed Separately with the Secretary of the Commission

Confidential Treatment Requested

 

PROJECT ADDENDUM

 

THIS PROJECT ADDENDUM (the “Project Addendum”) is made and entered into as of
November 16, 2011 (the “Effective Date”) by and between [ * * * ] and AASTROM
BIOSCIENCES, INC., with its principal executive offices located at 24 Frank
Lloyd Wright Drive, Lobby K, Ann Arbor Michigan 48105 (“Sponsor”).

 

WHEREAS, [ * * * ] and Sponsor entered into a certain Master Services Agreement
(“Agreement”) dated September 23, 2011; and

 

WHEREAS, pursuant to Section 1.2 of the Agreement, the parties now wish to enter
into this Project Addendum for the purposes of setting forth the
responsibilities and obligations of the parties in regards to conducting a
certain clinical research program entitled “A Multicenter, Randomized,
Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy,
Safety and Tolerability of Autologous Tissue Repair Cells in Patients with
Critical Limb Ischemia” (“Study”) under Sponsor’s protocol # 55-1009-1
(“Protocol”), which Protocol is incorporated herein by reference.

 

NOW, THEREFORE, for good and valuable consideration contained herein, the
exchange, receipt and sufficiency of which are acknowledged, the parties agree
as follows:

 

1.                                      Services.

 

[ * * * ] shall perform those certain services set forth in the proposal
submitted to Sponsor by [ * * * ], which proposal is attached hereto as
Exhibit A and incorporated herein by reference (“Services”).

 

2.                                      Compensation and Payment.

 

2.1 - Compensation - For its performance of Services under this Project
Addendum, [ * * * ] shall receive a total sum anticipated not to exceed $[ * * *
] of which $[ * * * ] shall be direct costs, and of which $[ * * * ] shall be
handled as indirect reimbursable costs.  Should a change in any of the key Study
parameters, e.g., countries included, number or country distribution of sites,
number of patients, number of CRF pages, number of statistical tables or
listings, study timeline or protocol design result in an increase or decrease in
the Study budget (attached hereto as Exhibit B), such financial implications
will be summarized in writing and approved by Sponsor.

 

The indirect reimbursable costs are estimated and may vary as circumstances
require.

 

2.2 - Payment - Payment for the direct costs and indirect reimbursable costs
will be made according to the Unitized Budget  set forth in Exhibit B attached
hereto and incorporated herein by reference. Upon execution of this Project
Addendum Sponsor will pay $[ * * * ] as an advance payment towards the direct
fees. This payment is in addition to the $[ * * * ] already invoiced under the
previously executed Letter of Authorization (“LOA”) for preliminary/start-up
Services. The $[ * * * ] advance payment will be held in reserve and used to pay
for units associated with the final data cleaning activities. Sponsor will be
invoiced monthly for units achieved pursuant to the Budget (Exhibit B) and
indirect reimbursable costs as incurred. All payments made under the LOA will be
applied to the monthly unit invoices until depleted.

 

In addition to the above referenced advance payment for direct fees, Sponsor
shall pay upon execution of this Project Addendum $[ * * * ] as an advance for
investigator grants, and [ * * * ] will invoice Sponsor monthly as needed for
additional investigator grants. [ * * * ] will not release payment for any
3rd party vendor cost including investigator meeting costs until Sponsor has
remitted the applicable amount.

 

1

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CONFIDENTIAL AND PROPRIETARY TO [ * * * ]

 

2.3 — Payments to [ * * * ] shall be made to:

 

[ * * * ]

 

Or, if wired to:     [ * * * ]

 

3.                                      Standard Operating Procedure

 

[ * * * ] shall conduct the Study according to [ * * * ]’s Standard Operating
Procedures  (“SOPs”).  These SOPs are subject to revision by [ * * * ] in which
case [ * * * ] shall notify Sponsor of revision.  If any such SOP revision can
be reasonably expected to affect the budget or timelines for the Study, [ * * *
] shall submit to Sponsor revised cost estimates or timelines for the relevant
Services which will become a part of this Project Addendum upon written approval
by Sponsor.  The current SOPs for conducting and monitoring clinical trials are
available for review upon request by Sponsor.

 

Upon mutual agreement in writing, the parties may conduct the Study under
Sponsor’s standard operating procedures. In such case, Sponsor shall provide
prompt and reasonable training to any [ * * * ] personnel subject to such SOPs
at Sponsor’s expense.

 

4.                                      Term and Termination.

 

The term of this Project Addendum shall commence on the Effective Date and end
upon the completion of Services unless otherwise terminated in accordance with
the Agreement.

 

5.                                      Incorporation by Reference/Conflict of
Terms.

 

The terms and conditions of this Project Addendum and Exhibits hereto are hereby
incorporated into and made a part of the Agreement.  To the extent any terms
contained in an Exhibit hereto conflict with this Project Addendum, the terms of
this Project Addendum shall govern and control.  In the event of any
inconsistency between the Agreement, the Project Addendum, and the Protocol, the
terms of the Protocol shall govern first, followed by the Project Addendum, and
then by the Agreement unless otherwise specified.

 

6.                                      Modifications.

 

Any changes to this Project Addendum or its Exhibits shall be documented by
written Amendments executed by both parties and shall be attached hereto.

 

7.                                      Notices.

 

Each Party represents that its respective contact person set forth below shall
have the authority to make all executive decisions regarding this Project
Addendum.  Any notice required or permitted to be given hereunder by either
party hereunder shall be in writing and shall be deemed given on the date
received if delivered personally or by fax or five (5) days after the date
postmarked if sent by registered or certified U.S. mail, return receipt
requested, postage prepaid to the following address:

 

If to [ * * * ]

 

*** Text Omitted and Filed Separately with the Secretary of the Commission

Confidential Treatment Requested

 

2

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CONFIDENTIAL AND PROPRIETARY TO [ * * * ]

 

If to Sponsor:

 

Aastrom Biosciences, Inc.

 

 

24 Lloyd Wright Drive

 

 

Lobby K

 

 

Ann Arbor, MI 48105

 

 

Attn: Tim Mayleben, CEO and President

 

 

Tel: (734) 418-4410

 

 

Fax: (734) 665-0485

 

8.                                      Counterparts and Facsimiles.

 

This Project Addendum may be executed in counterparts and the counterparts,
together, shall constitute a single agreement.  A facsimile transmission of this
signed Project Addendum bearing a signature on behalf of a party shall be legal
and binding on such party.

 

IN WITNESS WHEREOF, this Project Addendum has been executed and delivered by the
parties hereto by their duly authorized officers as of the Effective Date.

 

 

[ * * * ]

AASTROM BIOSCIENCES, INC.

 

 

 

 

 

By:

/s/ Tim M. Mayleben

 

 

 

 

Name:

Tim M. Mayleben

 

 

 

 

Title:

President & CEO

 

*** Text Omitted and Filed Separately with the Secretary of the Commission

Confidential Treatment Requested

 

3

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Exhibit A

 

Proposal

 

[See attached pages]

 

4

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[ * * * ]

 

Page 1 of 22

 

*** Text Omitted and Filed Separately with the Secretary of the Commission

Confidential Treatment Requested

 

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APPENDIX 1: SPECIFICATIONS AND ASSUMPTIONS

[***]

 

Number of Randomized Patients

 

594

[ * * *]

 

 

Participating Countries (Sites)

 

United States (80)

Estimated Enrollment Rate (Patents/Site/Month)

 

0.35

[ * * *]

 

 

Maximum Duration of Patient Participation in Months

 

18.50

[ * * *]

 

 

Number of Active Sites

 

80

 

Page 2 of 22

 

*** Text Omitted and Filed Separately with the Secretary of the Commission

Confidential Treatment Requested

 

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[***]

Pages 3 through 22 of Exhibit A have been redacted in their entirety

and have been filed separately with the Secretary of the Commission.

Confidential Treament Requested

 

[ * * * ]

 

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CONFIDENTIAL AND PROPRIETARY TO [ * * * ]

 

Exhibit B

 

Budget

 

[ * * * ]

 

The remainder of the text on the two pages of Exhibit B have been redacted
entirely and have been filed

separately with the Secretary of the Commission.

Confidential Treatment Request

 

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