Exhibit 10.28

 

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 PPD DEVELOPMENT, LP,
a Texas limited partnership, with its principal executive offices located at 929
North Front Street, Wilmington, North Carolina 28401 (“PPD”) 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, PPD 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 PPD 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, PPD 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 PPD.  PPD 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”).  PPD 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) PPD’s standard operating procedures (“SOPs”),
which have been approved by Sponsor, and (v) all applicable laws, rules and
regulations.  Sponsor agrees that PPD 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, PPD and
Sponsor shall execute a Project Addendum evidencing such Services.  Sponsor
agrees that the Project Addendum shall be executed by both parties before PPD
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 PPD 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 PPD’s provision
of such Out of Scope Services.  The Out of Scope Agreement shall constitute an
amendment to the applicable Project

 

PPD Universal MSA 14July06

 

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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.

 

1.4          Sponsor Cooperation.  Sponsor will cooperate with PPD in providing
information to PPD, 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 PPD’s performance under this Agreement is
dependant on Sponsor’s timely and effective cooperation with PPD and performance
of its obligations in accordance with the applicable Project Addendum. 
Accordingly, Sponsor acknowledges that any delay by Sponsor may result in PPD
being released from an obligation or schedule deadline or in Sponsor having to
pay extra fees in order for PPD 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 PPD 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 PPD is
authorized to commence work, which are beyond the control of PPD, and where
Sponsor desires for PPD to keep PPD 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 PPD 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 PPD on a monthly basis, and
shall be due and payable by Sponsor within 30 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 PPD perform services which require PPD 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 PPD 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 PPD shall not be liable for such
Protocol.

 

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6.             COMPENSATION AND PAYMENT.

 

6.1          Charges for Services.  Sponsor shall pay PPD 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 PPD for all out-of-pocket expenses 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, PPD 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 PPD. 
Sponsor shall pay each monthly invoice within thirty (30) days of receipt of
said invoice to the extent consistent with the applicable budget and/or payment
schedule.  PPD 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 PPD has received
payment of such Pass Through Costs from Sponsor.  In connection with any
contract between PPD 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 PPD 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.  PPD 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, PPD 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 PPD
all Direct Fees and Pass Through Costs for all Services performed through the
termination date.  In addition, Sponsor shall reimburse PPD 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 PPD 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 PPD require greater utilization of
resources at the outset such that compensation for such services based on a
percentage of milestones completed prior to PPD fully completing the milestone
would work to the detriment of PPD.  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 PPD 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 PPD
shall be compensated on a time and materials basis for Services performed in
accordance with the PPD Proposal for Services which formed the basis of the
award of the Project to PPD.

 

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

 

If made by check, payment mailed to:

PPD Development, LP

 

12937 Collections Center Drive

 

Chicago, Illinois 60693

 

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Tax ID# 74-2325267

 

 

If made by wire transfer, payment wired to:

Bank of America

 

Acct: 000696217456

 

ABA: 026009593

 

Acct Name: PPD Development, LP

 

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) PPD’s receipt of all Direct Fees, Pass Through Costs, and any other
payments due to PPD 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.  PPD 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, PPD shall cooperate with Sponsor to provide for an orderly wind-down
of the Services provided by PPD 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 PPD under the direction of the person identified as the
Project Manager in the applicable Project Addendum or such other person
acceptable to Sponsor as PPD may from time to time designate as the

 

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Project Manager, such Sponsor acceptance of the designated Project Manager not
to be unreasonably withheld or delayed in all instances.

 

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

 

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

 

9.3          Use of Sponsor Confidential Information and PPD 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

 

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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 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, PPD hereby assigns
to Sponsor all rights PPD 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 PPD’s
provision of the Services or (ii) specifically sets forth as a deliverable under
a Project Addendum, and PPD shall assist Sponsor, at Sponsor’s sole cost and
expense, in obtaining or extending protection therefor.  PPD warrants that it
has and will continue to have agreements with its Agents to effect the terms of
this Section 10.2.

 

10.3        PPD Property.  PPD 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, “PPD Property”).  For avoidance
of doubt, methods of conducting and administering preclinical and clinical
research that are proprietary to PPD are intended to be and shall be included
within the PPD Property.  Sponsor and PPD agree that any PPD Property or
revisions, improvements or enhancements thereto shall be the sole and exclusive
property of PPD, and Sponsor shall have no rights, title and interest to such
PPD Property.

 

11.          INDEMNIFICATION.

 

11.1        Sponsor Indemnity.  Sponsor shall indemnify, defend, and hold
harmless PPD 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 PPD 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 PPD hereunder, including but not
limited to, Project related services provided by PPD 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 PPD
or its Agents or a breach of this Agreement by PPD or its Agents.

 

11.2        PPD Indemnity.  PPD 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

 

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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 PPD or its Agents.

 

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, PPD shall maintain all materials and all other data obtained or
generated by PPD in the course of providing the Services hereunder, including
all computerized records and files.  PPD 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 PPD 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 PPD, (ii) retained by PPD 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 PPD under applicable law.  If PPD 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 PPD for its maintenance and storage costs. In no event shall PPD
dispose of Records without first giving Sponsor sixty (60) days prior written
notice of its intent to dispose of the Records.  PPD 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.

 

PPD 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 PPD 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, PPD
shall immediately notify Sponsor of same.  The debarment of PPD or any of its
Agents (which are providing services to Sponsor on a Project under this
Agreement) that remains in place for a

 

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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, PPD is able to 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 PPD 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 PPD incurs Pass Through Costs in a
currency other than the Contract Currency, PPD 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.  PPD shall pay investigator fees in the currency
specified in the investigator agreements.  For Sponsor invoicing and payment
purposes, PPD 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.  PPD 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 PPD 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

 

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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 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 PPD:

PPD Development, LP

 

3151 South 17th Street

 

Wilmington, North Carolina 28412

 

Attention: CEO

 

Tel: (910) 251-0081

 

Fax: (910) 762-5820

 

 

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 State of North Carolina 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

 

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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.

 

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) PPD may assign this Agreement or a Project Addendum or
subcontract all or part of the Services to be performed hereunder to an
Affiliate of PPD.  “Affiliate of PPD” shall mean an entity which can provide the
Services and which controls, is controlled by or is under common control with
PPD or PPD’s parent company Pharmaceutical Product Development, Inc.  In the
event the Services shall be performed by an Affiliate of PPD, such Affiliate of
PPD 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 PPD employee or other PPD 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 PPD 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 PPD 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.

 

PPD DEVELOPMENT, LP

 

By:

PPD GP, LLC

 

Its:

General Partner

Aastrom Biosciences, Inc.

 

 

 

By:

/s/ Brent Conway

 

By:

/s/ Tim M. Mayleben

 

 

 

 

 

Name:

Brent Conway

 

Name:

Tim M. Mayleben

 

 

 

 

 

Title:

VP, Business Development PPD, Inc.

 

Title:

President & CEO

 

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