Exhibit 10.1

 

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

Confidential Treatment Requested

 

MASTER SERVICES AGREEMENT

 

THIS MASTER SERVICES AGREEMENT (the “Agreement”) is made and entered into as of
September 23rd, 2011 (the “Effective Date”) by and between [ * * * ] and Aastrom
Biosciences, Inc., a Michigan Corporation, with its principal executive offices
located at 24 Frank Lloyd Wright Drive, Lobby K, Ann Arbor Michigan 48105
(“Sponsor”).

 

WHEREAS, Sponsor is engaged in the development, manufacture, distribution and
sale of pharmaceutical products; and

 

WHEREAS, [ * * * ] is a clinical research organization engaged in the business
of managing clinical research programs and providing clinical development and
other related services; and

 

WHEREAS, Sponsor may wish to retain the services of [ * * * ] from time to time
to perform clinical development services in connection with certain clinical
research programs Sponsor is conducting (individually, a “Project”), in which
case the terms and conditions for each such Project shall be set forth in a
project addendum to be attached to this Agreement and incorporated herein by
reference (individually, a “Project Addendum” and collectively, the “Project
Addenda”); and

 

WHEREAS, [ * * * ] is willing to provide such services to Sponsor in accordance
with the terms and conditions of this Agreement and the attached Project
Addenda.

 

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.

 

1.1                                 Services to be Provided by [ * * * ].  [ * *
* ] hereby agrees to provide to Sponsor the services identified and described in
the Services section of each Project Addendum attached to this Agreement (the
“Services”).  [ * * * ] shall perform the Services for each Project set forth in
the applicable Project Addendum in compliance with (i) the protocol for the
Project (“Protocol”), which shall be attached to and made a part of the
applicable Project Addendum, (ii) the terms and conditions of this Agreement,
(iii) the terms and conditions of the applicable Project Addendum, (iv) [ * * *
]’s standard operating procedures (“SOPs”), which have been approved by Sponsor,
and (v) all applicable laws, rules and regulations.  Sponsor agrees that [ * * *
] is responsible only for those Services set forth on a properly executed
Project Addendum.

 

1.2                                 Project Addendum.  In the event that the
parties hereto shall reach agreement with respect to the provision of Services
for a Project, [ * * * ] and Sponsor shall execute a Project Addendum evidencing
such Services.  Sponsor agrees that the Project Addendum shall be executed by
both parties before [ * * * ] commences work under the Project Addendum, unless
the parties otherwise agree in writing.  Each Project Addendum shall be attached
to this Agreement and incorporated into and made a part of this Agreement by
reference, and each such Project Addendum and this Agreement shall constitute
the entire agreement for the applicable Project.  To the extent any terms set
forth in a Project Addendum conflict with the terms set forth in this Agreement,
the terms of this Agreement shall control unless otherwise specifically set
forth in the Project Addendum.

 

1.3                                 Out of Scope.  In the event that [ * * * ]
is requested or required to perform services for a Project that are not
specifically provided for in the applicable Project Addendum (the “Out of Scope
Services”), such Out of Scope Services and a compensation schedule therefor (the
“Out of Scope Agreement”) must be mutually agreed upon by the parties in writing
prior to [ * * * ]’s provision of such Out of Scope Services.  The Out of Scope
Agreement shall constitute an amendment to the applicable Project Addendum and
the Out of Scope Services set forth therein shall be deemed to be Services as
that term is used in this Agreement and the applicable Project Addendum.

 

[ * * * ] Universal MSA 14July06

 

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[ * * * ] Master Services Agreement

 

1.4                                 Sponsor Cooperation.  Sponsor will cooperate
with [ * * * ] in providing information to [ * * * ], taking action and
executing documents, as set forth in the applicable Project Addendum, to achieve
the objectives of this Agreement.  Sponsor acknowledges and agrees that [ * * *
]’s performance under this Agreement is dependant on Sponsor’s timely and
effective cooperation with [ * * * ] and performance of its obligations in
accordance with the applicable Project Addendum.  Accordingly, Sponsor
acknowledges that any delay by Sponsor may result in [ * * * ] being released
from an obligation or schedule deadline or in Sponsor having to pay extra fees
in order for [ * * * ] to meet a specific obligation or deadline despite the
delay.  Sponsor shall comply with all applicable laws, rules and regulations
governing the performance of its obligations hereunder and the subject matter of
this Agreement, including without limitation, Sponsor’s Property (as defined
below).

 

1.5                                 Serious Adverse Event and Medical Management
Plan.  Notwithstanding anything to the contrary herein, in the event [ * * * ]
and Sponsor agree upon a serious adverse event and medical management plan
relating to a specific Project (“SMMP”), the parties shall comply with the terms
and conditions of any such SMMP.  In the event of any conflict between the terms
and conditions of the SMMP and the relevant Project Addendum, the terms and
conditions of the SMMP shall control.  Sponsor shall be responsible for any
additional costs associated with compliance with the SMMP as set forth therein
or as set forth in the applicable Out of Scope Agreement pursuant to Section 1.3
herein.

 

2.                                      PERSONNEL RETENTION.

 

In the event of delays in the performance of the Study, i.e., after [ * * * ] is
authorized to commence work, which are beyond the control of [ * * * ], and
where Sponsor desires for [ * * * ] to keep [ * * * ] Study personnel assigned
to the Study, the parties shall execute an Out of Scope Agreement pursuant to
Section 1.3 herein providing for such personnel retention, and, in addition to
any other sums payable to [ * * * ] hereunder, Sponsor agrees that Sponsor shall
pay a personnel fee calculated on an FTE-day basis as set forth in the
applicable Out of Scope Agreement. Said personnel fees shall be invoiced by [ *
* * ] on a monthly basis, and shall be due and payable by Sponsor within [ * * *
] days of receipt of invoice.

 

3.                                      MEDDRA AND WHODRUG DICTIONARY LICENSE.

 

The parties acknowledge that MedDRA and Uppsala Monitoring Centre product
licenses are required by all parties who wish to distribute or receive MedDRA or
WHODrug dictionary terminology.  Each party represents and warrants that it
possesses a current MedDRA and/or Uppsala Monitoring Centre product license.  In
the event Sponsor requests that [ * * * ] perform services which require [ * * *
] to distribute MedDRA terminology or WHODrug dictionary to third parties,
Sponsor shall be responsible for ensuring that all such third parties possess
the necessary MedDRA and/or Uppsala Monitoring Centre product licenses.

 

4.                                      ENROLLMENT DISCLAIMER.

 

Except as may otherwise be provided in a Project Addendum, enrollment numbers
are good faith estimates and [ * * * ] shall exercise all reasonable diligence
to meet such enrollment estimates.

 

5.                                      FINAL PROTOCOL.

 

The parties agree that Sponsor shall be solely responsible for the final review,
approval and adoption of the Protocol and [ * * * ] shall not be liable for such
Protocol.

 

6.                                      COMPENSATION AND PAYMENT.

 

6.1                                 Charges for Services.  Sponsor shall pay [ *
* * ] for all Services performed under this Agreement and any Project Addendum
(“Direct Fees”) in accordance with the rates for such Services set forth in such
Project Addendum.  Sponsor shall also reimburse [ * * * ] for all out-of-pocket
expenses

 

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

Confidential Treatment Requested

 

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[ * * * ] Master Services Agreement

 

incurred in connection with the performance of the Services with respect to a
Project, including, without limitation, investigator grants and fees, travel
expenses, shipping and postage costs, copying and printing fees, copyright fees,
third party drug storage and distribution fees, required Institutional Review
Board or similar board or committee fees, and other “pass through” expenses
incurred in accordance with the budget for the Services and included in the
applicable Project Addendum (collectively, the “Pass Through Costs”).  Except as
otherwise expressly provided in a Project Addendum, [ * * * ] shall submit to
Sponsor for each Project a monthly invoice describing the Services performed on
such Project, the Direct Fees due for such Services, and all Pass Through Costs
paid by [ * * * ].  Sponsor shall pay each monthly invoice within [ * * * ] days
of receipt of said invoice to the extent consistent with the applicable budget
and/or payment schedule.  [ * * * ] shall have no obligation to pay
subcontractor costs or investigator grant payments to any subcontractor or
investigator site (the “Site”) for conduct of services related to a Project
until [ * * * ] has received payment of such Pass Through Costs from Sponsor. 
In connection with any contract between [ * * * ] and a third party that will
perform Services as contemplated herein, provided that Sponsor has reviewed and
approved the execution and delivery of such contract, then, it is the parties’
express intent that such third party shall be a third party beneficiary to this
Agreement to the extent necessary to enforce payment by Sponsor of any monies
owed by [ * * * ] to the Site or Subcontractor for Services under such reviewed
and approved contract.  Notwithstanding anything to the contrary contained
herein, Sponsor acknowledges and agrees that certain vendor and subcontractor
contracts, including without limitation, contracts for investigator meetings and
patient recruitment services, must be advanced and paid up front by Sponsor as
provided in the applicable budget.  [ * * * ] shall be under no obligation to
incur any such vendor or subcontractor fees until such fees are received by
Sponsor.  In addition, in certain circumstances, [ * * * ] may require
investigator grants to be advanced by Sponsor at the timeframes mutually agreed
upon by the parties.

 

6.2                                 Payment after Termination.  Upon termination
of any Project Addendum or this Agreement pursuant to Section 7 below, Sponsor
shall pay [ * * * ] all Direct Fees and Pass Through Costs for all Services
performed through the termination date.  In addition, Sponsor shall reimburse
[ * * * ] for all reasonable, non-cancelable obligations to third parties (where
such obligations were created as a result of a Project being authorized by the
Sponsor) that were incurred or to be incurred as provided in the applicable
Project Addendum, otherwise as approved by Sponsor, or as reasonably required to
ensure access to persons or assets required to perform the Services as described
in the applicable Project Addendum; provided that the total amount payable under
this Section 6.2 upon such a termination shall in no event exceed the amounts
that would have been payable if the termination has not occurred and the
Services had been performed in full.  Any funds held by [ * * * ] which shall be
shown by Sponsor to be unearned at the date of termination shall be returned to
Sponsor within forty-five (45) days of after the termination date of the Project
Addendum or this Agreement, whichever is applicable.  Certain Services of [ * *
* ] require greater utilization of resources at the outset such that
compensation for such services based on a percentage of milestones completed
prior to [ * * * ] fully completing the milestone would work to the detriment of
[ * * * ].  Accordingly, the parties agree that in the event of early
termination, compensation for partially completed milestones shall be made on a
time and materials basis.

 

6.3                                 Pre-Execution Services.  In the event
Sponsor requests [ * * * ] to begin providing the Services for a Project prior
to the execution by Sponsor of a Project Addendum or other mutually agreed upon
writing, Sponsor agrees that [ * * * ] shall be compensated on a time and
materials basis for Services performed in accordance with the [ * * * ] Proposal
for Services which formed the basis of the award of the Project to [ * * * ].

 

6.4                                 Payments.  Unless otherwise set forth in a
Project Addendum, all payments to [ * * * ] under this Agreement or any Project
Addendum shall be made as follows:

 

If made by check, payment mailed to:                                           
[ * * * ]

 

If made by wire transfer, payment wired to:              [ * * * ]

 

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

Confidential Treatment Requested

 

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[ * * * ] Master Services Agreement

 

 

7.                                      TERM AND TERMINATION.

 

7.1                                 Term.  The term of this Agreement shall
commence on the Effective Date and shall continue for a period of three
(3) years unless extended by mutual written agreement by the parties.  Each
Project Addendum shall be effective upon the date signed by the last signatory
thereto and shall terminate upon (i) the completion of the Services to be
provided thereunder, and (ii) [ * * * ]’s receipt of all Direct Fees, Pass
Through Costs, and any other payments due to [ * * * ] related to the Services
provided thereunder, unless earlier terminated in accordance with this
Section 7.

 

7.2                                 Early Termination.  This Agreement and any
Project Addendum may be terminated with or without cause by Sponsor upon thirty
(30) days prior written notice.  [ * * * ] may terminate this Agreement with or
without cause upon thirty (30) days prior written notice at any time during
which no Project Addendums are then in effect.  Either Party may terminate this
Agreement upon the uncured material breach of a material provision of this
Agreement (including any Project Addendum) that is not cured within thirty (30)
days after notice of breach sent by the non-breaching Party to the breaching
Party.

 

7.3                                 Insolvency.  Either party hereto may
terminate this Agreement immediately upon the occurrence of an “Insolvency
Event” with respect to the other party.  For purposes of this Agreement,
“Insolvency Event” shall mean (1) a party or any of its subsidiaries shall
commence a voluntary proceeding seeking liquidation, reorganization or other
relief with respect to itself or its debts under any bankruptcy, insolvency or
other similar law or seeking the appointment of a trustee, receiver, liquidator,
custodian or other similar official of it or any substantial part of its
property, or shall consent to any such relief or to the appointment of or taking
possession by any such official in an involuntary case or other proceeding
commenced against it, or shall make a general assignment for the benefit of
creditors, or shall fail generally to pay its debts as they become due, or shall
take any action to authorize any of the foregoing; (2) an involuntary case or
other proceeding shall be commenced against a party or any of its subsidiaries
seeking liquidation, reorganization or other relief with respect to it or its
debts under bankruptcy, insolvency or other similar law or seeking the
appointment of a trustee, receiver, liquidator, custodian or other similar
official of it or any substantial part of its property, and such involuntary
case or other proceeding shall remain undismissed and unstayed for a period of
sixty (60) days; or (3) an order for relief shall be entered against a party or
any of its subsidiaries under the federal bankruptcy laws now or hereafter in
effect.

 

7.4                                 Effect of Termination.  The termination of
this Agreement by either party shall automatically terminate all Project
Addenda, unless otherwise agreed in writing.

 

7.5                                 Wind Down.  Upon the termination of this
Agreement or a Project Addendum, [ * * * ] shall cooperate with Sponsor to
provide for an orderly wind-down of the Services provided by [ * * * ]
hereunder.

 

7.6                                 Provisions Surviving Termination.  The
obligations of the parties contained in Sections 6, 7.4, 7.5, 7.6, 9, 10, 11,
12, 13.2, 16.2, 16.3, 16.6, 16.7, 16.8, 16.11, 16.12 and 16.13 hereof and herein
shall survive termination of this Agreement.

 

8.                                      PERSONNEL.

 

8.1                                 Project Management.  The Services with
respect to each Project shall be performed by [ * * * ] under the direction of
the person identified as the Project Manager in the applicable Project Addendum
or such other person acceptable to Sponsor as [ * * * ] may from time to time
designate as the Project Manager, such Sponsor acceptance of the designated
Project Manager not to be unreasonably withheld or delayed in all instances.

 

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

Confidential Treatment Requested

 

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[ * * * ] Master Services Agreement

 

8.2                                 Covenant Not to Interfere.  During the
period in which a particular Project is being conducted, neither party shall
recruit, hire or employ any personnel of the other party who is material to the
performance of such Project without the prior written consent of such other
party.

 

9.                                      CONFIDENTIALITY.

 

9.1                                 Sponsor Confidential Information.  [ * * * ]
shall treat all information obtained from Sponsor or developed by [ * * * ] for
Sponsor in connection with the performance of the Services (“Sponsor
Confidential Information”) as the confidential and exclusive property of
Sponsor.

 

9.2                                 [ * * * ] Confidential Information.  Sponsor
shall treat all information obtained from [ * * * ] including, without
limitation, any [ * * * ] bids or proposals, standard operating procedures,
personnel information, all [ * * * ] Property (as defined below) and any
revisions, improvements or enhancements thereto (“[ * * * ] Confidential
Information”) as the confidential and exclusive property of [ * * * ].

 

9.3                                 Use of Sponsor Confidential Information and
[ * * * ] Confidential Information.  Each party shall use the other’s
Confidential Information solely for the purposes contemplated by this Agreement
and for no other purpose without the prior written consent of the other party. 
Neither party shall publish, disseminate or otherwise disclose Confidential
Information of the other to any third party without first obtaining the written
consent of such other party.  Each party shall restrict the dissemination of the
other’s Confidential Information with its organization to only those persons who
have a need to know, and shall ensure that all of its directors, officers,
employees, agents, representatives and advisors (collectively, “Agents”) are
aware of this Agreement and bound by the terms of confidentiality stated herein.

 

9.4                                 Exceptions to Confidential Information.  The
above provisions of confidentiality shall not apply to that part of disclosing
party’s Confidential Information which the receiving party is able to
demonstrate by documentary evidence: (i) was in the receiving party’s possession
prior to receipt from the disclosing party or is independently developed by the
receiving party by persons who have not had access to the disclosing party’s
Confidential Information; (ii) was in the public domain at the time of receipt
from disclosing party; (iii) subsequently becomes a part of the public domain
through no fault of the receiving party or its Agents; and (iv) is lawfully
received by the receiving party from a third party having a right of further
disclosure.

 

9.5                                 Disclosure Required by Law.  The
non-disclosure obligations pursuant to this Agreement shall not apply to
Confidential Information that a receiving party is required to disclose pursuant
to any judicial action, order of the court or other governmental agency;
provided, however, that the receiving party shall make all reasonable efforts to
notify the disclosing party prior to the disclosure of Confidential Information
and allow the disclosing party the opportunity to contest and avoid such
disclosure, and further provided that the receiving party shall disclose only
that portion of such Confidential Information that it is legally required to
disclose.

 

9.6                                 Return of Information.  Upon termination or
expiration of this Agreement or at the disclosing party’s earlier written
request, the receiving party shall return, and shall cause its Agents to return,
all documentary, electronic or other tangible forms of Confidential Information
provided by the disclosing party including, without limitation, any and all
copies thereof, or, at the disclosing party’s request, destroy all or such parts
of the disclosing party’s Confidential Information as the disclosing party shall
direct.  Notwithstanding the foregoing, the receiving party may retain copies of
such of the disclosing party’s Confidential Information as is reasonably
necessary for regulatory and business archival purposes, subject to the ongoing
obligation to maintain the confidentiality of such information.

 

9.7                                 Remedy.  Each party agrees that its
obligations hereunder are necessary and reasonable in order to protect the other
party and the other party’s business, and expressly agrees that monetary damages
would be inadequate to compensate the other party for any breach of the terms of
this Agreement.  Accordingly, each party agrees and acknowledges that any such
violation or threatened violation will cause irreparable injury to the other
party, and that, in addition to any other remedies that may be available, in
law, in equity or otherwise, the other party shall be entitled to obtain
injunctive relief

 

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

Confidential Treatment Requested

 

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[ * * * ] Master Services Agreement

 

against the threatened breach of this Agreement or a Project Addendum or the
continuation of any such breach, without the necessity of proving actual
damages.

 

9.8                                 Privacy Laws.  All information containing
personal data shall be handled in accordance with all applicable privacy laws,
rules and regulations, including, without limitation, the European Data
Protection Directive [EC/95/46] and Health Insurance Portability Accountability
Act (HIPAA).

 

10.                               INTELLECTUAL PROPERTY.

 

10.1                           No License.  Neither anything contained herein,
nor shall the delivery of any information to a party hereto, be deemed to grant
the receiving party any right or license under any patent or patent application
or to any know-how, technology or invention of the disclosing party.

 

10.2                           Sponsor Property.  Subject to Section 10.3 below,
[ * * * ] hereby assigns to Sponsor all rights [ * * * ] or its Agents may have
in any invention, technology, know-how or other intellectual property directly
relating to the use or composition of a Project drug or Protocol and which
(i) results from [ * * * ]’s provision of the Services or (ii) specifically sets
forth as a deliverable under a Project Addendum, and [ * * * ] shall assist
Sponsor, at Sponsor’s sole cost and expense, in obtaining or extending
protection therefor.  [ * * * ] warrants that it has and will continue to have
agreements with its Agents to effect the terms of this Section 10.2.

 

10.3                           [ * * * ] Property.  [ * * * ] possesses certain
inventions, processes, technology, know-how, trade secrets, improvements, other
intellectual property and assets, including, without limitation, those related
to business or product plans or proposals, marketing strategies, standard
operating procedures, data, composition of matter, research, experimental
results, personnel data, financial information and conditions, pricing
information, customer information, supplier/vendor information, raw materials,
data collection and data management processes, laboratory analyses, analytical,
biotechnology and clinical methods, procedures and techniques, computer
technical expertise and software (including code) which have been independently
developed without the benefit of any information provided by Sponsor
(collectively, “[ * * * ] Property”).  For avoidance of doubt, methods of
conducting and administering preclinical and clinical research that are
proprietary to [ * * * ] are intended to be and shall be included within the
[ * * * ] Property.  Sponsor and [ * * * ] agree that any [ * * * ] Property or
revisions, improvements or enhancements thereto shall be the sole and exclusive
property of [ * * * ], and Sponsor shall have no rights, title and interest to
such [ * * * ] Property.

 

11.                               INDEMNIFICATION.

 

11.1                           Sponsor Indemnity.  Sponsor shall indemnify,
defend, and hold harmless [ * * * ] and its Agents from and against any and all
damages, liabilities, losses, fines, penalties, settlement amounts, costs and
expenses of any kind or nature whatsoever, including, without limitation,
reasonable attorneys’ fees, expert witness fees, court costs, and amounts
incurred by [ * * * ] under indemnity obligations imposed upon it by a third
party provided to a Project where such third party provider has been approved by
Sponsor and such obligations arise under an agreement that was reviewed and
approved by Sponsor, incurred in connection with any claim, demand, action,
proceeding, investigation or hearing (collectively, a “Claim”) directly or
indirectly relating to or arising from this Agreement or any Services provided
by [ * * * ] hereunder, including but not limited to, Project related services
provided by [ * * * ] at the request of Sponsor yet prior to finalization of the
relevant Project Addendum; provided however, that Sponsor shall have no
obligation of indemnity hereunder with respect to any Claim arising from the
negligence or intentional misconduct on the part of [ * * * ] or its Agents or a
breach of this Agreement by [ * * * ] or its Agents.

 

11.2                           [ * * * ] Indemnity.  [ * * * ] shall indemnify,
defend and hold harmless Sponsor and its Agents from and against any and all
damages, liabilities, losses, fines, penalties, settlement amounts, cost and
expenses of any kind or nature whatsoever, including, without limitation,
reasonable attorney’s fees, expert witnesses and court costs, incurred in
connection with any Claim to the extent arising from the negligence or
intentional misconduct of [ * * * ] or its Agents.

 

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

Confidential Treatment Requested

 

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11.3                           Indemnification Procedure.  Each indemnified
party shall give the indemnifying party prompt notice of any Claim for which
indemnification is sought hereunder.  The indemnifying party shall have the
right to control the defense and settlement of a Claim, provided the
indemnifying party shall act reasonably and in good faith with respect to all
matters relating to the settlement or disposition of the Claim, and the
indemnified party shall reasonably cooperate in the investigation, defense and
settlement of such Claim.  Any indemnified party shall have the right to
participate in, but not control, the defense and settlement of a Claim and to
employ separate legal counsel of its own choice; provided, however, that such
employment shall be at the indemnified party’s own expense, unless (i) the
employment thereof has been specifically authorized by the indemnifying party,
or (ii) the indemnifying party has failed to assume the defense and employ
counsel (in which case the indemnified party shall control the defense and
settlement of such Claim).  The costs and expenses, including reasonable fees
and disbursements of counsel, incurred by any indemnified party in connection
with any Claim shall be reimbursed on a monthly basis by the indemnifying party
subject to refund in the event the indemnifying party is ultimately held not to
be obligated to indemnify the indemnified party.

 

12.                               LIMITATION OF LIABILITY.

 

WITH THE EXCEPTION OF A PARTY’S INDEMNIFICATION OBLIGATIONS, NEITHER PARTY SHALL
BE LIABLE TO THE OTHER PARTY FOR ANY INCIDENTAL, INDIRECT, SPECIAL OR
CONSEQUENTIAL LOSSES OR DAMAGES, WHETHER IN CONTRACT OR TORT.

 

13.                               RECORD STORAGE.

 

13.1                           Record Maintenance during Project.  During the
term of this Agreement, [ * * * ] shall maintain all materials and all other
data obtained or generated by [ * * * ] in the course of providing the Services
hereunder, including all computerized records and files.  [ * * * ] shall
cooperate with any reasonable internal review or audit by Sponsor and make
available to Sponsor for examination and duplication, during normal business
hours and at mutually agreeable times, all documentation, data and information
relating to a Project.

 

13.2                           Record Maintenance after Expiration or
Termination.  Upon the expiration or termination of this Agreement other than
for Sponsor’s breach of required payment hereunder, all materials and all other
data and information obtained or generated by [ * * * ] in the course of
providing the Services hereunder (collectively, the “Records”) shall, at
Sponsor’s option, be (i) delivered to Sponsor at its expense and risk to its
offices identified herein in such form as is then currently in the possession of
[ * * * ], (ii) retained by [ * * * ] for Sponsor for a period of three
(3) years, or (iii) disposed of at Sponsor’s expense, as directed by written
request of Sponsor, unless the Records are otherwise required to be stored or
maintained by [ * * * ] under applicable law.  If [ * * * ] is required or
requested to maintain and/or store the Records for a period beyond three
(3) years after the termination or expiration of this Agreement, Sponsor shall
reimburse [ * * * ] for its maintenance and storage costs. In no event shall
[ * * * ] dispose of Records without first giving Sponsor sixty (60) days prior
written notice of its intent to dispose of the Records.  [ * * * ] shall be
entitled at its expense to retain copies of the Records reasonably necessary for
regulatory purposes or to demonstrate the satisfaction of its obligations
hereunder, all subject to the confidentiality obligations set forth in Section 9
above.

 

14.                               DEBARMENT.

 

[ * * * ] hereby certifies that it has not been debarred, and has not been
convicted of a crime which could lead to debarment, under the Generic Drug
Enforcement Act of 1992.  If [ * * * ] or any of its Agents who perform Services
for a Project is debarred or receives notice of an action or threat of action of
debarment, [ * * * ] shall immediately notify Sponsor of same. The debarment of
[ * * * ] or any of its Agents (which are providing services to Sponsor on a
Project under this Agreement) that remains in place for a period of at least
thirty (30) days shall be deemed to be a material breach of this Agreement,
unless, with respect to the debarment of an Agent which is providing services to
Sponsor hereunder, [ * * * ] is able to

 

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

Confidential Treatment Requested

 

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replace the Agent within such 30-day period, in which case the debarment of the
replaced Agent shall not be a material breach of this Agreement.

 

15.                               CURRENCY MANAGEMENT.

 

15.1                           Direct Fees.  All Direct Fees owed to [ * * * ]
for Services performed under this Agreement or any Project Addendum shall
generally be invoiced to and paid by Sponsor in the “Contract Currency”, which
shall be defined as the currency or currencies designated in any budget or
payment schedule set forth in a Project Addendum.  However, any Services
performed outside the United States shall be invoiced to and paid by Sponsor in
the local currency where such Services are performed with any Services performed
in Europe being invoiced to and paid by Sponsor in British pounds or Euros.

 

15.2                           Pass Through Costs.  Where [ * * * ] incurs Pass
Through Costs in a currency other than the Contract Currency, [ * * * ] shall,
for Sponsor invoicing and payment purposes, convert such costs to the Contract
Currency based on the average of the daily exchange rates as published in the
Wall Street Journal between the local currency and the Contract Currency for the
month in which such costs were incurred.

 

15.3                           Investigator Fees.  [ * * * ] shall pay
investigator fees in the currency specified in the investigator agreements.  For
Sponsor invoicing and payment purposes, [ * * * ] shall convert all investigator
fees that are to be paid in a currency other than the Contract Currency to the
Contract Currency.  The conversion to the Contract Currency shall be based on
the monthly average of the daily exchange rates as published in the Wall Street
Journal between the currency specified in an investigator agreement and the
Contract Currency for the month prior to the month the Sponsor invoice is
raised.  All amounts invoiced to Sponsor will be based upon an accrual of costs
owed to investigators.  At the end of the project a ‘true up’ will be completed
between the estimated exchange rate used for the purposes of billing on the
basis of the accrued costs versus the exchange rate when the actual payment is
made to the sites and any variation billed or credited to the Sponsor as
applicable.

 

16.                               MISCELLANEOUS.

 

16.1                           Independent Contractor Relationship.  The parties
hereto are independent contractors, and nothing contained in this Agreement is
intended, and shall not be construed, to place the parties in the relationship
of partners, principal and agent, employer/employee or joint venturer.  Neither
party shall have any right, power or authority to bind or obligate the other,
nor shall either hold itself out as having such right, power or authority.

 

16.2                           Publicity.  Neither party shall mention or
otherwise use the name, insignia, symbol, trademark, trade name or logotype of
the other party (or any abbreviation or adaptation thereof) in any publication,
press release, promotional material or other form of publicity without the prior
written approval of the other party in each instance.  The restrictions imposed
by this Section shall not prohibit a party from making any disclosure
identifying the other party that is required by any applicable law, rule or
regulation.

 

16.3                           Publication.  [ * * * ] may not publish any
articles or make any presentations relating to the Services provided to Sponsor
hereunder with respect to a Project or referring to data, information or
materials generated as part of the Services without the prior written consent of
Sponsor.

 

16.4                           Insurance.  Sponsor and [ * * * ] each will
maintain insurance in types and amounts reasonably adequate to cover any
liabilities arising out of its obligations hereunder, and, upon request, each
party will provide to the other party a certificate of insurance showing that
such insurance is in place, which certificate shall demonstrate the amounts,
exclusions and deductibles of such insurance coverage.

 

16.5                           Force Majeure.  If either party shall be delayed,
hindered, or prevented from the performance of any act required hereunder by
reason of strike, lockouts, labor troubles, restrictive governmental or judicial
orders or decrees, riots, insurrection, war, acts of God, inclement weather, or
other cause beyond such party’s reasonable control (each, a “Disability”), then
performance of such act

 

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

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shall be excused for the length of time necessary to cure such Disability and
resume performance.  A party shall not be liable for any delays resulting from a
Disability, and any affected timelines shall be extended for a period at least
equal to that of the Disability and each Project budget shall be adjusted to
reflect any cost increases resulting from such Disability.  The party incurring
the Disability shall provide notice to the other of the commencement and
termination of the Disability.

 

16.6                           Notices. Any notice required or permitted to be
given hereunder by either party hereto shall be in writing and shall be deemed
given on the date delivered if delivered (i) personally, (ii) on the first
business day after the date sent if sent by recognized overnight courier,
(iii) on the date transmitted if sent via facsimile (with confirmation of
receipt generated by the transmitting machine), or (iv) on the second business
day after the date deposited if mailed by certified mail, return receipt
requested, postage prepaid. All notices to each party shall be sent to the
address for said party set forth in the applicable Project Addendum.  If no
address is provided in the Project Addendum, then notices shall be sent to the
following address:

 

If to [ * * * ]

 

 

 

 

 

If to Sponsor:

 

Aastrom Biosciences, Inc.

 

 

24 Frank Lloyd Wright Drive

 

 

Lobby K

 

 

Ann Arbor, MI 48105

 

 

Attention: Tim Mayleben, CEO and President

 

 

Tel: (734) 418-4410

 

 

Fax: (734) 665-0485

 

Either party may change its notice address by notice to the other party hereto
in the form and manner provided in this Section 16.6.

 

16.7                           Governing Law.  This Agreement and the rights and
obligations of the parties hereunder shall be governed by and construed in
accordance with the laws of the [ * * * ] without reference to its conflicts of
laws provisions.

 

16.8                           Severability.  If any provision of this Agreement
or any Project Addendum is held to be illegal, invalid or unenforceable under
any present or future law, and if the rights or obligations of any party hereto
under this Agreement or such Project Addendum will not be materially or
adversely affected thereby, (a) such provision will be fully severable, (b) this
Agreement or such Project Addendum will be construed and enforced as if such
illegal, invalid or unenforceable provision had never compromised a part hereof,
(c) the remaining provisions of this Agreement or such Project Addendum will
remain in full force and effect and will not be affected by the illegal, invalid
or unenforceable provision or by its severance herefrom, and (d) in lieu of such
illegal, invalid or unenforceable provision, there will be added automatically
as a party of this Agreement or such Project Addendum, a legal, valid and
enforceable provision as similar in terms as to such illegal, invalid or
unenforceable provision as may be possible and reasonably acceptable to the
parties herein.

 

16.9                           Waiver.  Any term or condition of this Agreement
or a Project Addendum may be waived at any time by the party that is entitled to
the benefit thereof, but no such waiver shall be effective unless set forth in a
written instrument duly executed by or on behalf of the party waiving such term
or condition.  No waiver by any party hereto of any term or condition of this
Agreement or a Project Addendum, in any one or more instances, shall be deemed
to be or construed as a waiver of the same or any other term or condition of
this Agreement or such Project Addendum on any future occasion.

 

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

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16.10                     Amendments.  No amendment, change or modification to
this Agreement or any Project Addendum shall be effective unless in writing and
executed by the parties hereto.

 

16.11                     Assignment and Subcontracting.  This Agreement and any
Project Addendum may not be assigned by either party without the prior written
consent of the other party; provided, however, that (i) a party hereto may
assign this Agreement or a Project Addendum hereunder to a successor-in-interest
to the party’s business and (ii) [ * * * ] may assign this Agreement or a
Project Addendum or subcontract all or part of the Services to be performed
hereunder to an Affiliate of [ * * * ].  “Affiliate of [ * * * ]” shall mean an
entity which can provide the Services and which controls, is controlled by or is
under common control with [ * * * ] or [ * * * ].  In the event the Services
shall be performed by an Affiliate of [ * * * ], such Affiliate of [ * * * ] may
be the contracting party to any Project Addendum for the Services.

 

16.12                     Construction.  Except where the context otherwise
requires, wherever used the singular shall include the plural, the plural the
singular, the use of any gender shall be applicable to all genders and the word
“or” is used in the inclusive sense.  The captions of this Agreement are for
convenience of reference only and in no way define, describe, extend or limit
the scope or intent of this Agreement or the intent of any provision contained
in this Agreement.  The language of this Agreement shall be deemed to be the
language mutually chosen by the parties and no rule of strict construction shall
be applied against either party hereto.

 

16.13                     Counterparts and Facsimile Signatures.  This
Agreement, and any subsequent amendment(s), may be executed in counterparts and
the counterparts, together, shall constitute a single agreement.  A facsimile
transmission of this signed Agreement bearing a signature on behalf of a party
shall be legal and binding on such party.

 

16.14                     Representative - Sponsor represents and warrants that
it shall not name any [ * * * ] employee or other [ * * * ] representative on
Line 15 of Form FDA 1571 or as the Senior Medical Officer in Canada on Line 87
of Form HC/SC 3011 or in any similar capacity for clinical trials conducted in
other countries.  Sponsor acknowledges and understands that if Sponsor desires
[ * * * ] to be responsible for review and evaluation of information relevant to
the safety of the drug, Sponsor will have to enter into a separate contract with
[ * * * ] for the provision of these services.

 

16.15                     Entire Agreement. This Agreement constitutes the
entire agreement between the parties and supersedes all prior negotiations,
representations or agreements, either written or oral, with respect to the
subject matter hereof.

 

IN WITNESS WHEREOF, this Agreement has been executed and delivered by the
parties hereto by their duly authorized officers as of the date first above
written.

 

 

[ * * * ]

 

 

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

 

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