Exhibit 10.46
 
TRANSITION SERVICES AGREEMENT
 
by and among
 
GENZYME CORPORATION
 
and
 
AASTROM BIOSCIENCES, INC.
 
Dated as of May 30, 2014
 

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TABLE OF CONTENTS
 
ARTICLE 1 DEFINITIONS
1
 
 
ARTICLE 2 SERVICES
2
 
 
ARTICLE 3 GOVERNANCE
4
 
 
ARTICLE 4 TERM AND TERMINATION
5
 
 
ARTICLE 5 PAYMENT TERMS
6
 
 
ARTICLE 6 TRANSITION SERVICE RESPONSIBILITIES
6
 
 
ARTICLE 7 INTELLECTUAL PROPERTY
7
 
 
ARTICLE 8 RELATIONSHIP BETWEEN THE PARTIES
7
 
 
ARTICLE 9 AFFILIATE PERFORMANCE
9
 
 
ARTICLE 10 INDEMNIFICATION
9
 
 
ARTICLE 11 LIMITATION OF LIABILITY, DISCLAIMER OF CONSEQUENTIAL DAMAGES AND CAP
ON LIABILITY
10
 
 
ARTICLE 12 FORCE MAJEURE
11
 
 
ARTICLE 13 MISCELLANEOUS
11

 
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SCHEDULES
 
Schedule 1
 
Transition Services Schedule
Schedule 2
 
Restricted Information Systems of the Service Provider
Schedule 3
 
Acknowledgment and Waiver

 
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TRANSITION SERVICES AGREEMENT
 
This Transition Services Agreement is dated as of May 30, 2014 (the “Execution
Date”), by and between Aastrom Biosciences, Inc., a Michigan corporation
(“Service Recipient”), and Genzyme Corporation, a Massachusetts corporation
(“Service Provider”). Service Recipient and Service Provider are referred to in
this Agreement each as a “Party” and collectively as the “Parties.”
 
RECITALS
 
WHEREAS, Service Recipient and Sanofi, a French Societe anonyme (“Sanofi”) have
entered into an Asset Purchase Agreement dated as of April 19, 2014 (the “Asset
Purchase Agreement”) pursuant to which Service Recipient acquired the
Transferred Assets from Sanofi and its Retained Affiliates;
 
WHEREAS, in connection with the transactions contemplated by the Asset Purchase
Agreement, the Parties contemplate that during the Term, Service Provider will
provide certain transitional services to Service Recipient in accordance with
the terms and conditions set forth herein.
 
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency
of which is hereby acknowledged, the Parties agree as follows:
 
ARTICLE 1
DEFINITIONS
 
For the purpose of this Agreement, the following capitalized terms have the
following meanings. Capitalized terms which are used but not defined herein have
the meanings ascribed to such terms in the Asset Purchase Agreement.
 
“Additional Services” is defined in Section 2.6.
 
“Agreement” means this Transition Services Agreement and includes all Transition
Service Schedules, whether attached hereto or added subsequently pursuant to the
terms of this Agreement.
 
“Asset Purchase Agreement” is defined in the recitals to this Agreement.
 
“Claim” is defined in Section 10.2.
 
“Cleared Service Recipient Personnel” is defined in Section 8.3.
 
“Data” is defined in Section 7.4.
 
“Dispute” is defined in Section 3.3.
 
“Effective Date” means the Closing Date.
 
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“Execution Date” is defined in the introduction to this Agreement.
 
“Expenses” is defined in Section 5.2.
 
“Losses” is defined in Section 10.1.
 
“Party” and “Parties” are defined in the introduction to this Agreement.
 
“SDEA” is defined in Section 13.3.
 
“Services” means all services to be provided by Service Provider to Service
Recipient as described on any Transition Service Schedule, including any
Additional Services.
 
“Service Provider” is defined in the introduction to this Agreement.
 
“Service Provider Manager” is defined in Section 3.1.
 
“Service Provider Personnel” is defined in Section 8.2
 
“Service Provider Representative” is defined in Section 3.1.
 
“Service Recipient” is defined in the introduction to this Agreement.
 
“Service Recipient Manager” is defined in Section 3.1.
 
“Service Recipient Personnel” is defined in Section 8.2.
 
“Service Recipient Representative” is defined in Section 3.1.
 
“Service Term” is defined in Section 2.3.2.
 
“Term” is defined in Section 4.1.
 
“Transition Service Schedule” is defined in Section 2.1.
 
ARTICLE 2
SERVICES
 
2.1.                            Schedules and Precedence. This Agreement governs
the provision of transitional Services described in the schedules attached to
and made a part of this Agreement (each individual schedule, a “Transition
Service Schedule”). Such Transition Service Schedules may be amended in writing
from time to time by the Parties. If there is any inconsistency between the
terms of any Transition Service Schedule and the terms of this Agreement, the
terms of such Transition Service Schedule shall govern.
 
2.2.                            Performance of Services. Service Provider will
perform the Services set forth in the Transition Service Schedules and all
Additional Services.
 
2.3.                            Information. Each Transition Service Schedule
sets forth, among other things:
 
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2.3.1.                  a description of the Services to be provided;
 
2.3.2.                  the term during which each Service will be provided (the
“Service Term”);
 
2.3.3.                  the location(s) where Services are to be provided;
 
2.3.4.                  the Service Provider and Service Recipient
Representative(s) for such Service;
 
2.3.5.                  the maximum percentage of the applicable Service
Provider Representative’s working time to be allocated to the Services, based
upon a normal 40-hour work week; provided that such maximum will not limit
Service Provider’s obligation to allocate resources necessary for the
performance of any Service in accordance with this Agreement;
 
2.3.6.                  the monthly fees due to Service Provider, if any, for
each Service; and
 
2.3.7.                  any other terms applicable thereto on the Transition
Service Schedule.
 
2.4.                            Service Levels. Service Provider will perform
the Services in a manner consistent with the terms and conditions contained
herein and in accordance with applicable Legal Requirements. In addition, in
performing the Services, Service Provider will use a degree of care and
diligence that is not materially less than the care and diligence exercised by
Service Provider and its Affiliates when engaged in similar services or
activities during the twelve (12) month period preceding the Execution Date with
respect to the Business, and will use commercially reasonable efforts to deliver
the Services in a manner consistent with Service Provider’s and its Affiliates’
past practices. Service Provider will use qualified Service Provider
Representatives to perform the Services.
 
2.5.                            Additional Resources. Except as provided in a
Transition Service Schedule for a specific Service, in providing the Services,
Service Provider will not be obligated to:
 
2.5.1.                  hire any additional employees;
 
2.5.2.                  maintain the employment of any specific employee;
 
2.5.3.                  purchase, lease or license any additional equipment or
software; or
 
2.5.4.                  pay any costs related to the transfer or conversion of
Service Recipient’s data to Service Recipient or any alternate supplier of
Services.
 
2.6.                            Additional Services. During the Term, the
Parties may identify additional services that Service Provider will provide to
Service Recipient in accordance with the terms of this Agreement (the
“Additional Services”). Upon mutual agreement of the Parties, the Parties will
execute additional written Transition Service Schedules for such Additional
Services.  Service Provider will have no obligation to execute any additional
Transition Service Schedules; provided, that with respect to any Additional
Service that has historically been provided by Service Provider or its
Affiliates to the Business, Service
 
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Provider will not unreasonably withhold, condition or delay the execution of a
Transition Service Schedule relating to such Additional Service to the extent
generally consistent with this Agreement, including the Transition Service
Schedules.
 
2.7.                            Change Order Process. Any change in the scope or
duration of any Service described in or other amendment to a Transition Service
Schedule must be in writing and signed by the Parties.
 
2.8.                            Third-Party Consents. If any consent or waiver
from any Third Party is needed in connection with Service Provider’s provision
of the Services, Service Provider will be excused from performing such Service
until such consent or waiver is obtained and will use commercially reasonable
efforts to cooperate with Service Recipient to obtain such licenses or
approvals, provided that any payments to Third Parties in connection with
obtaining any such consent or waiver will be paid by Service Recipient.
 
ARTICLE 3
GOVERNANCE
 
3.1.                            Service Provider Manager and Service Provider
Representatives. Service Provider will appoint one individual to have primary
responsibility and oversight for the provision of all of the Services by Service
Provider and to be Service Recipient’s primary point of contact (the “Service
Provider Manager”). The initial Service Provider Manager will be Geary
MacQuiddy. In addition, Service Provider will identify on the applicable
Transition Service Schedule one representative (the “Service Provider
Representative”) for each Service to have primary responsibility and oversight
for the provision or coordination of such Service. Service Provider may appoint
a new Service Provider Manager or a new Service Provider Representative for any
Service by providing Service Recipient with written notice thereof.
 
3.2.                            Service Recipient Manager and Service Recipient
Representatives. Service Recipient will appoint one individual to have primary
responsibility and oversight for the receipt of all of the Services by Service
Recipient and to be Service Provider’s primary point of contact (the “Service
Recipient Manager”). The initial Service Recipient Manager will be Ross Turbo.
In addition, Service Recipient will identify on the applicable Transition
Service Schedule one representative (the “Service Recipient Representative”) for
each Service to have primary responsibility and oversight for the provision or
coordination of such Service. Service Recipient may appoint a new Service
Recipient Manager or a new Service Recipient Representative for any Service by
providing Service Provider with written notice thereof.
 
3.3.                            Dispute Resolution. Any dispute regarding a
Party’s performance under this Agreement (a “Dispute”) will be initially
referred to the Service Provider Manager and the Service Recipient Manager. The
Service Provider Manager and the Service Recipient Manager will meet at a
mutually acceptable time and place (or by teleconference) promptly after the
Dispute has been referred to them, and thereafter as often as they reasonably
deem necessary, to exchange relevant information and to attempt to resolve the
Dispute. If the Service Provider Manager and the Service Recipient Manager are
not
 
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able to resolve the Dispute within thirty (30) days after the Dispute has been
referred to them, then either Party may thereafter submit such Dispute to any
court as permitted by Section 13.9.
 
ARTICLE 4
TERM AND TERMINATION
 
4.1.                            Term. This Agreement will commence on the
Effective Date and remain in effect until the last day that any Service Term in
any Transition Service Schedule remains in effect (the “Term”), unless earlier
terminated under this ARTICLE 4. With respect to each Service, such Service will
begin upon the applicable start date set forth in the Transition Services
Schedule (or the Effective Date if no start date is identified) and will
continue for the longest duration, or until the end date, for such Services set
forth in the Transition Services Schedule, unless earlier terminated under this
ARTICLE 4. This Agreement may be extended by the Parties in writing, either in
whole or with respect to one or more of the Services.
 
4.2.                            Termination.
 
4.2.1.                  Service Recipient may terminate this Agreement, either
with respect to all or with respect to any one or more of the Services (or a
portion thereof) provided to Service Recipient hereunder, for any reason or for
no reason, at any time upon at least thirty (30) days (or such shorter period to
which Service Provider agrees in writing) prior written notice to Service
Provider, unless the specific Transition Service Schedule provides otherwise.
 
4.2.2.                  Subject to the provisions of ARTICLE 12 below, either
Party may terminate this Agreement in its entirety or with respect to affected
Services if the other Party materially breaches a material provision with regard
to those Services and does not cure such breach, or does not take reasonable
steps required under the circumstances to cure such breach going forward, within
thirty (30) days (or ten (10) days in the event of a payment breach) after
receiving notice of the breach.
 
4.2.3.                  Any provision which by its nature or express terms
should survive, including the provisions of Section 4.2.4, ARTICLE 5,
ARTICLE 10, ARTICLE 11 and ARTICLE 13, will survive the expiration or
termination of this Agreement.
 
4.2.4.                  Upon any expiration or termination of this Agreement in
whole or in part and for any reason (a) each Party will use commercially
reasonable efforts to cooperate with the other Party as reasonably necessary to
avoid disruption of the ordinary course of the other Party’s business and
(b) Service Provider will deliver the Data to Service Recipient in accordance
with Section 7.4 and will deliver other assets of Service Recipient in the
possession of Service Provider. Each Party will promptly return to the other
Party or destroy any and all Confidential
 
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Information or other proprietary information of such other Party in its or its
Affiliates’ possession upon expiration or termination of this Agreement.
 
ARTICLE 5
PAYMENT TERMS
 
5.1.                            Charges for Services. Service Recipient will pay
Service Provider the charges, if any, set forth on the applicable Transition
Service Schedule for each Service listed therein as adjusted, from time to time,
in accordance with Section 5.3.
 
5.2.                            Expenses. Service Recipient will, for each
Service performed, reimburse Service Provider for any reasonable documented
out-of-pocket expenses payable to Third Parties which are incurred by Service
Provider or its Affiliates in connection with Service Provider’s provision of
such Service (“Expenses”); provided that the Expenses will not include the
allocation of any corporate overhead or similar expenses incurred by Service
Provider or its Affiliates in connection with the performance of the Services.
Within ten (10) days after the end of each calendar month during the Term,
Service Provider will provide Service Recipient with a report detailing the
Expenses for such previous month. In addition, Service Provider will provide
Service Recipient with advance written notice of any single Expense or series of
related Expenses expected to be in excess of $25,000.
 
5.3.                            Payment Terms. Service Provider will bill
Service Recipient quarterly for all charges pursuant to this Agreement for the
previous calendar quarter. Such invoices will contain reasonable detail of the
Services provided and the charge therefor. Service Recipient will pay Service
Provider for all undisputed amounts due for Services provided hereunder within
thirty (30) days from receipt of an invoice therefor. Late payments will bear
interest at the lesser of twelve percent (12%) per annum or the maximum rate
allowed by law. The Parties acknowledge and agree that failure to pay undisputed
amounts due hereunder pursuant to the terms of this Agreement is a material
breach and Service Provider may terminate this Agreement under Section 4.2.
 
5.4.                            Disputed Amounts. Amounts due hereunder will not
be offset by amounts due under any other agreement. Disputes related to any
other agreement will not serve as grounds to delay obligations under this
Agreement. In particular, Service Recipient will not, and will cause its
Affiliates to not, offset amounts owed to Service Provider or any Affiliate
under this Agreement against amounts owed or allegedly owed by Service Provider
or any Affiliate to Service Recipient or any Affiliate under any circumstances,
and Service Recipient hereby irrevocably waives any such right on its own behalf
and on behalf of each of its Affiliates.
 
ARTICLE 6
TRANSITION SERVICE RESPONSIBILITIES
 
6.1.                            Cooperation; Facilities; Access to Information.
The Parties will use good faith efforts to cooperate with each other in all
matters relating to the provision and receipt of Services. Such cooperation will
include exchanging information relevant to the provision of Services hereunder,
good faith efforts to mitigate problems with the work environment
 
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interfering with the Services, and each Party requiring its personnel to obey
any security regulations and other published policies of the other Party while
on the other Party’s premises. In addition, Service Recipient will provide
Service Provider with access to its facilities as is reasonably necessary for
Service Provider to perform the Services it is obligated to provide hereunder,
provide Service Provider with information and documentation reasonably necessary
for Service Provider to perform the Services it is obligated to provide
hereunder, and make available, as reasonably requested by Service Provider,
reasonable access to resources and provide timely decisions in order that
Service Provider may perform its obligations hereunder.
 
6.2.                            Savings Clause. To the extent Service
Recipient’s failure to discharge its obligations set forth in Section 6.1 or
elsewhere in this Agreement impedes Service Provider’s ability to provide any
Service or Additional Service hereunder, Service Provider will be excused from
its obligation to provide such Services or Additional Services hereunder,
provided, that Service Provider provides Service Recipient with notice of
Service Recipient’s failure to meet such obligation promptly after Service
Provider becomes aware of such failure.
 
ARTICLE 7
INTELLECTUAL PROPERTY
 
7.1.                            Existing Ownership Rights Unaffected. Except as
expressly set out in this ARTICLE 7, neither Party will gain, by virtue of this
Agreement, any rights of ownership or use of Copyrights, Patents, Trade Secrets,
Trademarks or any other Intellectual Property owned by the other Party.
 
7.2.                            Trademarks. Neither Party is granted hereunder
any ownership in or license to the Trademarks of the other Party.
 
7.3.                            Removal of Marks. Neither Party will remove any
Copyright notices, proprietary markings, Trademarks or other indicia of
ownership of the other Party from any materials of the other Party.
 
7.4.                            Ownership of Data and Intellectual Property.
Service Recipient will own all data and records created by Service Recipient or
any of its Affiliates related exclusively to the Business and generated in
connection with the performance of the Services (the “Data”). Service Provider
will and hereby does, without further consideration, assign (and will cause its
Affiliates to assign) to Service Recipient any and all right, title or interest
that Service Provider or its Affiliates may possess in or to the Data. Upon
Service Recipient’s request, Service Provider will provide Service Recipient
with copies of the Data in the format in which such Data is generated.
 
ARTICLE 8
RELATIONSHIP BETWEEN THE PARTIES
 
8.1.                            The Parties to this Agreement are and will
remain independent contractors and neither Party is an employee, agent, partner,
franchisee or joint venturer of or with the other. Each Party will be solely
responsible for any employment-related taxes, insurance
 
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premiums or other employment benefits respecting its employees. Neither Party
will hold itself out as an agent of the other and neither Party will have the
authority to bind the other. (A) No Service Recipient employees, agents or
representatives (including the Service Recipient Personnel) shall be eligible to
participate in any benefit programs or sales or other bonuses offered by Service
Provider to its employees, or in any retirement plans, profit sharing plans,
insurance plans, separation plans or any other employee welfare or benefit plans
offered from time to time by Service Provider to its employees.  Service
Recipient acknowledges that none of its employees, agents or representatives
(including the Service Recipient Personnel) shall be eligible to participate in,
and Service Provider does not and will not maintain or procure for or on such
personnel’s behalf, any worker’s compensation or unemployment compensation
insurance. (B) No Service Provider employees, agents or representatives
(including the Service Provider Personnel) shall be eligible to participate in
any benefit programs or sales or other bonuses offered by Service Recipient to
its employees, or in any retirement plans, profit sharing plans, insurance
plans, separation plans or any other employee welfare or benefit plans offered
from time to time by Service Recipient to its employees.  Service Provider
acknowledges that none of its employees, agents or representatives (including
the Service Provider Personnel) shall be eligible to participate in, and Service
Recipient does not and will not maintain or procure for or on such personnel’s
behalf, any worker’s compensation or unemployment compensation insurance.
 
8.2.                            (A) Neither the execution of this Agreement, nor
performance of Services by the Service Provider and/or any of its Affiliates
shall cause the Service Recipient and/or any of its Affiliates or any person or
entity employed or engaged by the Service Recipient and/or any of its
Affiliates, including the Transferred Employees (collectively “Service Recipient
Personnel”) to be or to be construed to be an agent, employee or legal
representative of the Service Provider and/or any of its Affiliates for any
purpose whatsoever.  The Service Recipient Personnel shall not be considered to
be employees of the Service Provider and/or any of its Affiliates for any
purpose (including Section 8.1), and neither the Service Provider nor any of its
Affiliates shall be or be deemed to be an employer or joint employer of the
Service Recipient Personnel. (B) Neither the execution of this Agreement, nor
performance of Services by the Service Provider and/or any of its Affiliates
shall cause the Service Provider and/or any of its Affiliates or any person or
entity employed or engaged by the Service Provider and/or any of its Affiliates,
(collectively “Service Provider Personnel”) to be or to be construed to be an
agent, employee or legal representative of the Service Recipient and/or any of
its Affiliates for any purpose whatsoever.  The Service Provider Personnel shall
not be considered to be employees of the Service Recipient and/or any of its
Affiliates for any purpose (including Section 8.1), and neither the Service
Recipient nor any of its Affiliates shall be or be deemed to be an employer or
joint employer of the Service Provider Personnel.
 
8.3.                            Notwithstanding anything else in this Agreement
and/or the Transition Services Schedule, only members of the Service Recipient
Personnel (the “Cleared Service Recipient Personnel”) who executed and delivered
to the Service Provider an acknowledgment and waiver in the form attached hereto
as Schedule 3 may receive, or benefit from, Services that involve access to the
information services systems and applications of the Service Provider listed in
Schedule 2, and the Service Provider is
 
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under no obligation to provide any such Services to the extent any Service
Recipient Personnel other than the Cleared Service Recipient Personnel would
receive, or benefit from, such Services.
 
ARTICLE 9
AFFILIATE PERFORMANCE
 
Service Provider may engage one or more Affiliates to perform all or any portion
of Service Provider’s duties under this Agreement; provided that Service
Provider remains liable for the performance of such Affiliates.
 
ARTICLE 10
INDEMNIFICATION
 
10.1.                     Service Recipient will indemnify, defend and hold
harmless Service Provider and its officers, directors, agents, employees and
Affiliates, from and against any and all Damages, including reasonable
attorneys’ fees (collectively, “Losses”) arising out of, relating to or
resulting from (a) Service Recipient’s material breach of this Agreement,
(b) Service Recipient’s gross negligence or willful misconduct in connection
with its receipt of Services or Additional Services pursuant to this Agreement,
(c) Service Recipient Personnel’s misuse of any of Service Provider’s systems or
Services, (d) Service Recipient Personnel’s willful misconduct in connection
with the use of Service Provider’s systems or Services, or (e) Service
Provider’s provision of Services or Additional Services pursuant to and in
accordance with this Agreement, except for those Losses for which Service
Provider is obligated to indemnify, defend and hold harmless Service Recipient
and its officers, directors, agents, employees and Affiliates pursuant to
Section 10.1.  Service Recipient will further indemnify, defend and hold
harmless Service Provider and its officers, directors, agents, employees and
Affiliates, from and against any and all Losses arising out of, relating to or
resulting from any Service Recipient Personnel being classified as, or
determined to be, co-employed by, or a common-law employee of, the Service
Provider and/or any of its Affiliates.
 
10.2.                     Service Provider will indemnify, defend and hold
harmless Service Recipient and its officers, directors, agents, employees and
Affiliates from and against any and all Losses arising out of, relating to or
resulting from (a) Service Provider’s material breach of this Agreement,
(b) Service Provider’s gross negligence or willful misconduct in the provision
of Services or Additional Services pursuant to this Agreement, (c) any Service
Provider Personnel’s willful misconduct in connection with providing the
Services or Additional Services pursuant to this Agreement, or (d) any Service
Provider Personnel’s disclosure or misuse of the Service Recipient’s
Confidential Information.  Service Provider will further indemnify, defend and
hold harmless Service Recipient and its officers, directors, agents, employees
and Affiliates, from and against any and all Losses arising out of, relating to
or resulting from any Service Provider Personnel being classified as, or
determined to be, co-employed by, or a common-law employee of, the Service
Recipient and/or any of its Affiliates.
 
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10.3.                     An indemnifying Party’s indemnification obligations
hereunder will be conditioned upon (a) the indemnified Party providing the
indemnifying Party with written notice describing such indemnification claim
(“Claim”) in reasonable detail in light of the circumstances then known and then
providing the indemnifying Party with further notices to keep it reasonably
informed with respect thereto; provided however, that failure of the indemnified
Party to provide such notice or keep the indemnifying Party reasonably informed
as provided herein will not relieve the indemnifying Party of its obligations
hereunder except to the extent, if any, that the indemnified Party is materially
prejudiced thereby, (b) the indemnifying Party being entitled to participate in
such Claim and assume the defense thereof with counsel reasonably satisfactory
to the indemnified Party, at the indemnifying Party’s sole expense, and (c) the
indemnified Party reasonably cooperating with the indemnifying Party, at the
indemnifying Party’s sole cost and expense, in the defense of any Claim. The
indemnifying Party will not accept any settlement that places restrictions on
any indemnified Party or requires any payment by any indemnified Party and,
further, will not accept any settlement unless the settlement includes as an
unconditional term thereof the giving by the claimant or the plaintiff of a full
and unconditional release of the indemnified Parties, from all liability with
respect to the matters that are subject to such Claim, without the indemnified
Party’s prior written consent, which consent will not be unreasonably withheld,
delayed or conditioned. The indemnified Party may participate in the defense of
any claim with counsel reasonably acceptable to the indemnifying Party, at the
indemnified Party’s own expense.
 
10.4.                     With the exception of any claims of fraud which are
proven and upon which a judgment entered in the involved proceeding will be
expressly based, the Parties acknowledge and agree that the provisions of
ARTICLE 10 will be the exclusive remedy for all claims relating to this
Agreement, including the negotiation or performance hereof.
 
10.5.                     EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT,
SERVICE PROVIDER MAKES NO WARRANTY OR REPRESENTATION WHATSOEVER, EXPRESS OR
IMPLIED, INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE OR AGAINST INFRINGEMENT.
 
ARTICLE 11
LIMITATION OF LIABILITY, DISCLAIMER OF CONSEQUENTIAL DAMAGES AND CAP ON
LIABILITY
 
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LEGAL REQUIREMENTS, AND EXCEPT FOR
CLAIMS PURSUANT TO ARTICLE 10 AND IN CIRCUMSTANCES WHERE AWARDED TO A THIRD
PARTY, (A) NEITHER PARTY WILL BE LIABLE TO THE OTHER FOR ANY LOST PROFITS OR
OTHER SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE OR CONSEQUENTIAL DAMAGES, HOWEVER
CAUSED, UNDER ANY THEORY OF LIABILITY, ARISING FROM THE PERFORMANCE OF, OR
RELATING TO, THIS AGREEMENT REGARDLESS OF WHETHER SUCH PARTY HAS BEEN NOTIFIED
OF THE POSSIBILITY OF, OR THE FORESEEABILITY OF, SUCH DAMAGES; AND (B) EACH
PARTY’S LIABILITY FOR DAMAGES IN CONNECTION WITH THIS AGREEMENT OR THE
PERFORMANCE OR NEGOTIATION HEREOF WILL
 
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NOT EXCEED THE AMOUNT OF THE FEES PAID (OR PAYABLE) BY SERVICE RECIPIENT TO
SERVICE PROVIDER UNDER THE APPLICABLE TRANSITION SERVICES SCHEDULE FROM WHICH
SUCH CLAIM ARISES.
 
ARTICLE 12
FORCE MAJEURE
 
Each Party will be excused for any failure or delay in performing any of its
obligations under this Agreement, other than the obligations of Service
Recipient to make payments to Service Provider for Services already rendered, if
such failure or delay is caused by any act of God, any accident, explosion,
fire, act of terrorism, storm, earthquake, flood or any other circumstance or
event outside of such Party’s reasonable control.
 
ARTICLE 13
MISCELLANEOUS
 
13.1.                     Records. Service Provider shall maintain accurate
records arising from or related to any Services provided hereunder, including
accounting records and documentation produced in connection with the rendering
of any Service, substantially consistent with Service Provider’s past practices
for similar services provided for its own account.
 
13.2.                     Inspection Rights. During the Term and for ninety (90)
days thereafter, Service Provider shall, upon reasonable prior written notice
from Service Recipient, permit Service Recipient, or its designated
representatives, to inspect and audit Service Provider’s records relating to the
Services during regular business hours, with the right to make any copies, for
the sole purpose of verifying the amount charged by Service Provider for
provision of the Services; provided, that Service Recipient shall comply with
Service Provider’s reasonable security and safety procedures as such procedures
are communicated to Service Recipient.
 
13.3.                     SDEA.  Within 30 days after the Execution Date but in
no event later than the day on which the first Business Permit (i.e., relevant
product registration) in respect of any Product will be effectively transferred
from the relevant Selling Person to Purchaser in accordance with the Asset
Purchase Agreement, the Service Provider (or its relevant Affiliate) and the
Service Recipient shall in good faith negotiate and agree in writing a Safety
Data and Exchange Agreement (“SDEA”).  Such SDEA shall be on terms and
conditions customary for similar transactions, and shall govern the transition
of pharmacovigilance activities from the relevant Selling Person (and/or its
Affiliates) to the Purchaser and the transfer of the safety database at a
mutually agreed date.  The SDEA shall enable worldwide safety surveillance and
risk management and allow each Party to comply with its legal and regulatory
obligations as legal manufacturer or holder of the relevant Business Permit
(i.e., relevant product registration).  The SDEA will be signed by authorized
departments of the Parties and shall be considered part of this Agreement,
provided however that it can be amended separately without the need to amend
this Agreement as a whole.
 
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13.4.                     Interpretation. Except as otherwise explicitly
specified to the contrary, (a) references to a section, exhibit or schedule
means a section of, or schedule or exhibit to this Agreement, unless another
agreement is specified, (b) the word “including” (in its various forms) means
“including without limitation,” (c) references to a particular statute or
regulation include all rules and regulations thereunder and any predecessor or
successor statute, rules or regulation, in each case as amended or otherwise
modified from time to time, (d) words in the singular or plural form include the
plural and singular form, respectively, (e) references to a particular Person
include such Person’s successors and assigns to the extent not prohibited by
this Agreement, (f) unless otherwise specified “$” is in reference to United
States dollars, and (g) the headings contained in this Agreement, in any exhibit
or schedule to this Agreement and in the table of contents to this Agreement are
for reference purposes only and will not affect in any way the meaning or
interpretation of this Agreement.
 
13.5.                     Entire Agreement. This Agreement together with the
Asset Purchase Agreement and the other Ancillary Agreements, constitutes the
entire agreement between and among the Parties with regard to the subject matter
of this Agreement, and supersedes all prior agreements and understandings with
regard to such subject matter. Except for the Confidentiality Agreement, there
are now no agreements, representations or warranties between or among the
Parties other than those set forth in the Agreement, the Asset Purchase
Agreement or the Ancillary Agreements.
 
13.6.                     Amendment, Waivers and Consents. This Agreement may
not be changed or modified, in whole or in part, except by supplemental
agreement or amendment signed by the Parties. Any Party may waive compliance by
any other Party with any of the covenants or conditions of this Agreement, but
no waiver will be binding unless executed in writing by the Party making the
waiver. No waiver of any provision of this Agreement will be deemed, or will
constitute, a waiver of any other provision, whether or not similar, nor will
any waiver constitute a continuing waiver. Any consent under this Agreement must
be in writing and will be effective only to the extent specifically set forth in
such writing.
 
13.7.                     Successors and Assigns. This Agreement will bind and
inure to the benefit of the Parties and their respective successors and
permitted assigns, provided, however, that no Party may assign any right or
obligation hereunder without the prior written consent of all other Parties.
 
13.8.                     Governing Law. The rights and obligations of the
Parties will be governed by, and this Agreement will be interpreted, construed
and enforced in accordance with, the laws of the State of New York, excluding
its conflict of laws rules to the extent such rules would apply the law of
another jurisdiction.
 
13.9.                     Jurisdiction; Waiver of Jury Trial.
 
13.9.1.           Any judicial proceeding brought against any Party or any
dispute arising out of this Agreement or related to this Agreement, or the
negotiation or performance hereof, must be brought in the courts of the State of
New York, or in
 
12

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

 
the U.S. District Court for the State of New York, and, by execution and
delivery of this Agreement, each of the Parties accepts the exclusive
jurisdiction of such courts, and irrevocably agrees to be bound by any judgment
rendered thereby in connection with this Agreement and waives any claim and will
not assert that venue should properly lie in any other location within the
selected jurisdiction.  The consents to jurisdiction in this Section 13.9.1 will
not constitute general consents to service of process in the State of New York
for any purpose except as provided in this Section 13.9.1 and will not be deemed
to confer rights on any Person other than the Parties. Service of any process,
summons, notice or document by U.S. mail to a Party’s address for notice
provided in or in accordance with Section 13.12 will be effective service of
process for any action, suit or proceeding in the State of New York with respect
to any matters for which it has submitted to jurisdiction pursuant to this
Section 13.9.1.
 
13.9.2.           TO THE EXTENT NOT PROHIBITED BY APPLICABLE LAW THAT CANNOT BE
WAIVED, THE PARTIES HEREBY WAIVE, AND COVENANT THAT THEY WILL NOT ASSERT
(WHETHER AS PLAINTIFF, DEFENDANT OR OTHERWISE), ANY RIGHT TO TRIAL BY JURY IN
ANY ACTION ARISING IN WHOLE OR IN PART UNDER OR IN CONNECTION WITH THIS
AGREEMENT, WHETHER NOW EXISTING OR HEREAFTER ARISING, AND WHETHER SOUNDING IN
CONTRACT, TORT OR OTHERWISE. THE PARTIES AGREE THAT ANY OF THEM MAY FILE A COPY
OF THIS PARAGRAPH WITH ANY COURT AS WRITTEN EVIDENCE OF THE KNOWING, VOLUNTARY
AND BARGAINED-FOR AGREEMENT AMONG THE PARTIES IRREVOCABLY TO WAIVE ITS RIGHT TO
TRIAL BY JURY IN ANY PROCEEDING WHATSOEVER BETWEEN THEM RELATING TO THIS
AGREEMENT AND SUCH PROCEEDINGS WILL INSTEAD BE TRIED IN A COURT OF COMPETENT
JURISDICTION BY A JUDGE SITTING WITHOUT A JURY.
 
13.10.    Rules of Construction. The Parties acknowledge that each Party has
read and negotiated the language used in this Agreement. Because all Parties
participated in negotiating and drafting this Agreement, no rule of construction
will apply to this Agreement which construes ambiguous language in favor of or
against any Party by reason of that Party’s role in drafting this Agreement.
 
13.11.    Severability. If any provision of this Agreement, as applied to either
Party or to any circumstance, is declared by a court of competent jurisdiction
to be illegal, unenforceable or void, this Agreement will continue in full force
and effect without said provision.
 
13.12.    Notices. Any notice required or permitted to be given hereunder must
be provided in writing and (a) delivered in person or by express delivery or
courier service, (b) sent by facsimile, or (c) deposited in the mail registered
or certified first class, postage prepaid and return receipt requested (provided
that any notice given pursuant to subsection (b) of this Section 13.12 is also
confirmed by the means described in subsections (a) or (c) of this
Section 13.12) to such address or facsimile of the Party set forth in this
Section 13.12
 
13

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

 
or to such other place or places as such Party from time to time may designate
in writing in compliance with the terms of this Section 13.12. Each notice will
be deemed given when so delivered personally, or sent by facsimile transmission,
or, if sent by express delivery or courier service, one Business Day after being
sent, or if mailed, five Business Days after the date of deposit in the mail. A
notice of change of address or facsimile number will be effective only when done
in accordance with this Section 13.12.
 

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

 
(i)
To Service Recipient at:
 
 
 
 
 
Aastrom Biosciences, Inc.
 
 
Domino’s Farms, Lobby K
 
 
24 Frank Lloyd Wright Drive
 
 
Ann Arbor, MI 48105
 
 
 
 
 
 
Attention:
Nick Colangelo
 
 
Fax:
1-734-665-0485
 
 
Phone:
1-734-418-4400
 
 
 
 
 
 
with a copy to:
 
 
 
 
 
 
Goodwin Procter LLP
 
 
 
53 State Street
 
 
 
Exchange Place
 
 
 
Boston, MA 02109
 
 
 
 
 
 
 
Attention:
Mitchell S. Bloom, Esq.
 
 
 
 
Danielle Lauzon, Esq.
 
 
 
Fax:
1-617-523-1231
 
 
 
Phone:
1-617-570-1000
 
 
 
 
 
(ii)
To Service Provider at:
 
 
 
 
 
Genzyme Corporation
 
 
55 Cambridge Parkway
 
 
Cambridge, MA 02142
 
 
 
 
 
 
Attention:
Head of Biosurgery Global GSU
 
 
Facsimile:
1-617-761-8918
 
 
 
 
 
 
with a copy to:
 
 
 
 
 
 
Sanofi
 
 
 
54, rue la Boétie
 
 
 
75008 Paris
 
 
 
France
 
 
 
 
 
 
 
Attention:
General Counsel

 
14

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

 
 
 
 
Facsimile:
33-1-5377-4303
 
 
 
 
 
 
 
 
and
 
 
 
 
 
 
 
Ropes & Gray LLP
 
 
 
Prudential Tower
 
 
 
800 Boylston Street
 
 
 
Boston, MA 02199-3600
 
 
 
 
 
 
 
 
Attention:
Christopher Comeau
 
 
 
Facsimile:
1-617-235-0566

 
13.13.    Rights of Parties. Nothing in this Agreement, whether express or
implied, is intended to confer any rights or remedies under or by reason of this
Agreement on any Persons other than the Parties to it and their respective
successors and permitted assigns, nor is anything in this Agreement intended to
relieve or discharge the obligation or liability of any Third Party to any
Party, nor will any provision give any Third Party any right of subrogation or
action over or against any Party.
 
13.14.    Counterparts. This Agreement may be signed in any number of
counterparts, including by facsimile copies or by electronic scan copies
delivered by email, each of which will be deemed an original, with the same
effect as if the signatures were upon the same instrument.
 
13.15.    Confidentiality.
 
13.15.1.    Neither Party shall possess any interest, title, lien or right in
any Confidential Information of the other Party that is exchanged pursuant to or
in connection with the terms of this Agreement.  Each Party agrees not to
(i) disclose the Confidential Information of the other Party to any third party
or (ii) use the Confidential Information of the other Party except as necessary
to perform its obligations under this Agreement, in either case without the
express prior written consent of the other Party, and each Party shall be
responsible for any breaches of this Section 13.15 by its directors, officers,
employees, representatives (including financial advisors, attorneys and
accountants) or agents (collectively, the “Representatives”).
 
13.15.2.    The term “Confidential Information” will not, however, include
information which (i) is or becomes publicly available other than as a result of
a disclosure by the Party or such Party’s Representatives receiving the
Confidential Information in violation of this Agreement; (ii) is or becomes
available on a non-confidential basis from a third-party source (other than the
party providing, directly or indirectly, its Confidential Information), which,
to the best of the knowledge of the Party receiving Confidential Information
after due inquiry, is not prohibited from disclosing such information to it by a
legal, contractual or fiduciary obligation to the party providing the
Confidential Information; or (iii) was independently developed or learned by a
party without the use or reference to the other Party’s Confidential
Information.
 
15

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

 
13.15.3.    Upon or after the termination or expiration of this Agreement
pursuant to Section 4.1 and upon the relevant disclosing Party’s written
request, the applicable receiving Party shall within thirty (30) business days
of such request destroy all copies of such disclosing Party’s Confidential
Information in its possession or in the possession of any of its
Representatives. Notwithstanding the foregoing, the receiving Party of such
Confidential Information shall be permitted, subject to its continued compliance
with the confidentiality and restricted-use obligations specified in this
Agreement, (i) to retain all or any portion of such Confidential Information to
the extent necessary for the purposes of maintaning its legal file and using the
same to defend against any claims or actions threatened or instituted involving
such Confidential Information, and (ii) entitled to retain copies of any
computer records and files containing such Confidential Information which have
been created pursuant to its automatic electronic archiving and back up
procedures. If so requested by the relevant disclosing Party, the receiving
Party shall confirm in writing that its undertakings relating to the destruction
of any such Confidential Information have been complied with.
 
13.15.4.    Notwithstanding the other provisions of this Section 13.15 either
Party may disclose any Confidential Information of the other Party to the extent
required by applicable Legal Requirements, The Nasdaq Stock Market, GAAP or IFRS
or any disclosure made in connection with the enforcement of any right or remedy
relating to this Agreement or the Services; provided that any Party that is
requested pursuant to, or required by, applicable Legal Requirements, The Nasdaq
Stock Market, GAAP or IFRS to disclose any Confidential Information, shall
provide the other Party with reasonable prior written notice of such requests or
requirement and a reasonable opportunity is afforded to contest the same.
 
13.15.5.    This Section 13.15, and all rights and obligations hereunder, shall
expire three (3) years following the later of (i) the expiration or termination
of this Agreement in accordance with its terms and (ii) the delivery to Aastrom
by Sanofi, Service Provider or any of their Affiliates of historical safety data
and applicable research and development data.  Nothing in this Section 13.15
shall be deemed to limit any rights of Sanofi or Aastrom set forth in the Asset
Purchase Agreement.
 
(The remainder of this page has been intentionally left blank.)
 
16

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

 
IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed
on its behalf by their respective officers thereunto duly authorized all as of
the Execution Date.
 
 
AASTROM BIOSCIENCES, INC.
 
 
 
 
 
By:
/s/ Dominick C. Colangelo
 
Name:
Dominick C. Colangelo
 
Title:
President and CEO
 
 
 
 
 
GENZYME CORPORATION
 
 
 
 
 
By:
/s/ Jerome Delpech
 
Name:
Jerome Delpech
 
Title:
Attorney-in-Fact

 
Signature Page to Transition Services Agreement
 

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

FIRST AMENDMENT TO TRANSITION SERVICES AGREEMENT
This first Amendment effective as of the date last signed by both parties
(“First Amendment”) by and between Genzyme Corporation, a Massachusetts
corporation (“Services Provider”), and Aastrom Biosciences Inc., a Michigan
corporation (“Service Recipient”).
WHEREAS, effective as of May 30, 2014, Service Provider and Service Recipient
entered into a Transition Services Agreement (the “Agreement”) relative to
certain services to be performed by Service Provider.
NOW, THEREFORE, in consideration of the above-recitals, the mutual benefits to
be derived by the parties, and other good and valuable consideration, the
receipt and satisfaction of which are acknowledged, Service Provider and Service
Recipient agree to amend the Agreement as follows:
(1)
The Service description in Line item #4, Section 6 (Commercial) of Schedule 1 of
the Agreement is deleted and replaced with the following

Services
Service Provider will provide Service Recipient support for ASP reporting as
follows:
n    Service Recipient shall provide the wholesale acquisition cost for Carticel
in effect during the quarter.
n    Service Recipient shall provide any changes to the Carticel NDC.
n    Service Recipient shall provide all relevant data required for the
calculation of ASP no fewer than fifteen (15) business days prior to the ASP
quarterly submission deadline established by CMS. The relevant data must be
accurate and complete, may be provided in electronic format, and shall include,
but is not limited to, gross units, gross sales, on invoice discounts and all
price concessions such as off invoice discounts, rebates, volume rebates, market
share rebates, bundled sales, prompt pay discounts, free goods that are
contingent on any purchase requirement, and fees for data or services that do
not meet the definition of bona fide service fees and have been paid during the
quarter. This data shall also include customer name, amount of payment, date
paid, class of trade, description of price concessions and any other reasonable
information that Service Provider would need in calculating the ASP. Service
Recipient shall respond to any questions from Service Provider about the data
within one (1) business day and shall provide additional information as
requested in a timely manner.
n    Based on data provided by Service Recipient and/or made available to
Service Provider by Service Recipient as described above, Service Provider will
calculate the ASP prices for Carticel and provide Service Recipient the ASP
calculations no fewer than six (6) business days prior to the ASP quarterly
submission deadline.
n    Service Recipient will promptly review, validate, sign and provide
appropriate certification for the report. Service Recipient shall submit the
quarterly report to CMS prior to the CMS established deadline for each quarter.
n    Service Provider will provide general advice on reporting requirements and
process as necessary to assist Service Recipient in fulfilling the task
specified in the above mentioned bullets.

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

This First Amendment will terminate in accordance with the terms set forth in
the Agreement.
Except as set forth in this First Amendment, the terms of the Agreement shall
remain in full force and effect; provided however, that in the event of a
conflict between a term contained in this First Amendment and a term contained
in the Agreement, the term contained in this First Amendment shall prevail.
IN WITNESS WHEREOF, Service Provider and Service Recipient have caused this
First Amendment to the Agreement to be executed by their duly authorized
representatives as of the date first above written.
GENZYME CORPORATION
 
AASTROM BIOSERVICES, INC
 
 
 
Signature: /s/ Steve Couldwell
 
Signature: /s/ Daniel R. Orlando
 
 
 
Name: Steve Couldwell
 
Name:  Daniel R. Orlando
 
 
 
Title: VP / GM
 
Title:COO
 
 
 
Date: July 30, 2009
 
Date:7.29.14

2

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

SECOND AMENDMENT TO TRANSITION SERVICES AGREEMENT
This second Amendment effective as of the date last signed by both parties
(“Second Amendment”) is by and between Genzyme Corporation, a Massachusetts
corporation (“Services Provider”), and Aastrom Biosciences Inc., a Michigan
corporation (“Service Recipient”), (collectively, the “Parties”).
WHEREAS, effective as of May 30, 2014, Service Provider and Service Recipient
entered into a Transition Services Agreement (the “Agreement”) which described
transition services that Service Provider agreed to provide to Service Recipient
in support of the sale of three (3) products (Carticel, Epicel and Matrix
Applied Characterized Autologous Cultured Chondrocytes [MACI]) to Service
Recipient (the terms of the sale are memorialized in a separate Asset Purchase
Agreement).
WHEREAS, the Agreement described certain services related to MACI which Service
Provider agreed to provide until the transfer date of the MACI European
centralized Marketing Authorization (the “MA”) (originally anticipated to occur
no later than November 30, 2014).
WHEREAS, Service Recipient subsequently made a business decision to no longer
manufacture MACI from the Kastrup manufacturing site in Denmark as of August 22,
2014 (“Site Closure Date”).
WHEREAS, the Parties have been informed by the European Medicines Agency (EMA)
that (i) the manufacturing site closure will result in a suspension of the MA
once the EMA is notified of the closure and (ii) Service Provider will not be
able to transfer the MA to Service Recipient while the license is in a suspended
status.
WHEREAS, the EMA has informed the Parties that if the MA transfer application
can be completed and submitted to the agency by August 11, 2014, the agency will
expedite the review and approval of the transfer application to facilitate a
transfer of the marketing authorization on or prior to the Site Closure Date and
the corresponding suspension.
WHEREAS, in light of the EMA’s notification, the Parties agree that it is in
their best interests to accelerate the marketing authorization transfer for MACI
and complete such transfer prior to the Site Closure Date.
WHEREAS, Service Recipient lacks certain capabilities to allow Service Recipient
to fulfill all the regulatory responsibilities of a holder of a suspended
European centralized marketing authorization and for that purpose, has asked
Service Provider to provide certain services beyond the MACI marketing
authorization transfer date in order to provide Service Recipient an additional
time period to contract with a third party vendor (CRO) to assume these
functions (anticipated to occur by November 30, 2014).
WHEREAS, Service Provider has agreed to provide these services, subject to
certain dependencies and limitations specified in this Second Amendment.
NOW, THEREFORE, in consideration of the above-recitals, the mutual benefits to
be derived by the parties, and other good and valuable consideration, the
receipt and satisfaction of which are acknowledged, Service Provider and Service
Recipient agree to amend the Agreement as follows:

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

(1)
Unless otherwise specified herein, the scope of the activities and services
outlined in this Second Amendment are limited to MACI only,

(2)
Section 1 of Schedule 1 entitled “Regulatory and Pharmacovigilance” shall be
renamed “Regulatory and Pharmacovigilance Activities for Epicel and Carticel”

(3)
Row #7 and Row #8 of Section 1 of Schedule 1 shall be deleted

(4)
A new Section 1A is hereby created as follows:

Section 1A
REGULATORY and PHARMACOVIGILANCE ACTIVITIES FOR MACI
Provided the European marketing authorization transfer for MACI is completed
prior to the license suspension, and except as otherwise noted below, Service
Provider shall perform the following services up until November 30, 2014. For
the avoidance of doubt and except as otherwise noted below, the provision of
services by Service Provider after November 30, 2014 is subject to the execution
of a separate amendment hereto.
#
Function
Region
Title
TSA Scope
Duration (Months)
Billing/ Fee
1
Regulatory
EU
Label Support
Without prejudice to section 7.14 of the Asset Purchase Agreement, Service
Provider will provide labeling support and provide labels until Service
Recipient becomes the MA holder for MACI. Once Service Recipient becomes the MA
holder for MACI, all labels will be in Service Recipient’s name and no labeling
support will be provided
Until Service Recipient becomes marketing authorization holder
 
2
Regulatory
EU
EMA Point of Contact
Service Provider will remain point of contact until Service Recipient becomes
the MA holder for MACI. Thereafter, Service Recipient will assume the obligation
of providing a point of contact to the EMA
Until Service Recipient becomes marketing authorization holder
 
3
Regulatory
EU
Submission to the Health Authorities
Except with respect to the aggregate and individual case report submissions
which are detailed in row #5 below, Service Provider, working with Service
Recipient, will make all EMA and EU national health authorities’ submissions
relating to the MA for MACI until Service Recipient becomes the MA holder.
Thereafter, Service Recipient will take on this responsibility.
Until Service Recipient becomes marketing authorization holder
 
4
Regulatory / Safety
EU
QPPV Role
Service Provider will provide a qualified person to act as QPPV for MACI until
the earlier of (i) the date Service Recipient has a qualified QPPV in place or
(ii) November 30, 2014
See TSA Scope
 

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

5
Regulatory / Safety
EU
Safety Requirements
Service Provider will provide the following support to Service Recipient until
the earlier of (i) the date Service Recipient acquires the capability to support
these activities or (ii) November 30, 2014 (unless otherwise specified below):
n Maintaining oversight on the product safety which includes ongoing medical
assessment and monitoring of cumulative product safety data (all sources),
signal detection on single case and aggregate data level, support to Service
Recipient on their signal management responsibilities and the following tasks:
o Safety monitoring of ongoing safety study (SUMMIT Extension Trial only) for as
long as Service Provider or its affiliate remains the sponsor of the study
o Preparation of DSURs for as long as Service Provider or its affiliate remains
the sponsor of the study, and (iii) Semi-annual safety report up through data
lock (December 27, 2014)
o Collection and documentation of Pharmacovigliance (PV) data
   ■ Scientific and medical literature screening
   ■ Reconciliation of exchange of cases in collaboration with Service Recipient
o Maintenance of the Global PV Database which includes individual case safety
report processing in this database
n Providing advice to Service Recipient to assist it in its management of
emerging safety issues, alerts, crises, or regulatory actions for safety reasons
n Providing advice to Service Recipient with respect to its pharmacovigilance
related
 
 

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

 
 
 
 
     responses to health authority request
n Submitting individual case safety reports to the competent health authorities,
as appropriate
n Preparing and submitting safety reports (PBRER), for the reference period
covering 28Dec2013 through 27Jun2014, (due date 05Sep2014)
n Monitoring compliance with expedited and periodic reporting to the competent
health authorities
n Assisting Service Recipient with proposed updates to the risk management plan
as needed for Service Recipient’s submission to the competent authorities
n Operating and maintaining Service Provider’s Pharmacovigilance Systems in
support of Service Recipient’s marketing authorization until the earlier of (i)
the date when Service Recipient acquires and implements a PV system capable of
fulfilling this role or (ii) November 30, 2014.
n Providing Service Provider’s Summary PHARMACOVIGILANCE SYSTEM MASTER FILE
(Summary PSMF), to competent authorities, upon the authorities’ request, to
document the pharmacovigilance system supporting MACI until November 30, 2014 at
the latest
n Providing pharmacovigilance Source Document Retention a Supporting Service
Recipient with the management of issues related to any pharmacovigilance
inspection by competent health authorities
n Assisting Service Recipient with covering the relevant Post Approval
Commitments under the MACI RMP
n Assisting Service Recipient with the transfer of pharmacovigilance related
information, including the safety database transfer, to the CRO who will take
over the PV activities. The Parties agree to negotiate in good faith a Safety
Data Exchange Agreement (SDEA) consistent with the relevant elements described
in Sections 1 and 1A of the Agreement, (5) Section 2 of Schedule 1 entitled
“Medical Affairs and Medical Information” is deleted and replaced with the
following

 
 

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

(5) Section 2 of Schedule 1 entitled “Medical Affairs and Medical Information”
is deleted and replaced with the following
SECTION 2
MEDICAL AFFAIRS AND MEDICAL INFORMATION
#
Function
Region
Title
Service
Term Months
Billing/ Fee
1
Clinical/ Med Affairs
EU
Pediatric Investigation Study (PIP)
Service Provider will collaborate with Service Recipient in completing the PIP
change of ownership document
Until the earlier of Service Recipient becoming MAH for MACI or November 30,
2014.
 
2
Medical Affairs
Global
Medical writing and publication management
Service Provider will continue to provide publication monitoring and
surveillance activities in support of periodic safety reports with Service
Recipient’s vendor of choice provided Service Recipient ensures such vendor
reasonably cooperates with Service Provider
6
 
3
Medical Affairs
US
Promotional material review ERC/ePML/ 4M
Service Provider will have final approval authority of promotional materials and
medical communications following Service Recipient review until license transfer
Until the earlier of Service Recipient becoming MAH for Carticel and Epicel or
November 30, 2014.
 
4
Medical Affairs
EU
EU Promotional material review ERC/ePME/4 M
Service Provider will have final approval authority of promotional materials and
medical communications related to MACI following Service Recipient review
Until the earlier of Service Recipient becoming MAH for MACI or November 30,
2014
 
5
Clinical, Medical Affairs, Program Management
US
SUMMIT Extension Trial
Service Provider will continue to support SUMMIT Extension trials until final (5
year) database lock
12
 
6
Clinical, Medical Affairs, Program Management
EU
EU SUMMIT
Extension
Trial
Service Provider will continue to meet obligations as sponsor (including
associated expenses) of the SUMMIT Extension Trials until final database lock
12
(Projected Date June 2015)
 
7
Medical Affairs
Global/ US
Publication Compliance
Service Provider will continue to provide support for all publication compliance
review through the CLEAR system
6
 
8
Medical Affairs
EU
Publication Compliance
Service Provider shall continue to provide support for all publication
compliance review through the CLEAR system
Until the earlier of Service Recipient becoming MATI for MACI or November 30,
2014
 

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

9
Medical Affairs & Market Access
EU
MTA support
Service Provider will provide guidance on the process and data needed for the
submission from personnel not transferring to Service Recipient.
Service Recipient (or designated vendor) will develop and approve the full
submission for NICE
Note: MACI is to be included in a Multiple Technology Assessment (MTA) on
Autologous chondrocyte implantation being performed by NICE
3
 
10
Medical Affairs
Global
Scientific Review Committee
Service Provider will continue to review and approve all post-marketing clinical
trials according to current SOPs. Service Recipient will approve and fund or
reject the Service Provider approved post-marketing clinical trials.
Until the earlier of Service Recipient becoming MAH for MACI or until November
30, 2014
 
11
Medical Affairs
Global/ US
Medical and Educational Grants and IITs
Service Provider may be asked to provide input for background or advice.
Service Recipient will review and decide on all grant and I1T requests received
alter the closure with advice or input from Service Provider as needed.
3
 
12
Medical Affairs
US
Medical Information Services support
Service Provider to provide Medical Information Services (MIS) support to
Service Recipient

Service Provider to provide U.S. standard response documents and top inquiries
training to Service Recipient

Service Provider will assist Service Recipient with Voice Services in modifying
telephony issues and transfer capabilities
6
 
13
Clinical and Medical Affairs
US
Medical Support
Service Provider shall, upon request, provide expert medical opinion and
consultation regarding Carticel and Epicel; such expert opinion will only be
informative and without any liability on the Service Provider’s or Service
Provider Personnel’s side.
12
 
14
Medical Affairs
US/EU
Medical Affairs Point of Contact
Service Provider will make available to Service Recipient a point of contact to
facilitate the provision of services described in this Section 2. Unless and
until Service Provider indicates otherwise, the medical point of contact will be
Richard Toselli.
6
 
15
Clinical and Medical Affairs
EU
Medical Support
Service Provider shall, upon request, provide medical opinion and consultation
regarding MACI. Such expert opinion will only be informative and without any
liability on the Service Provider or Service Provider’s personnel
Up until November 30, 2014
 

*     *     *

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

The rights and obligations of the Parties or any dispute arising out of this
Second Amendment will be interpreted, construed and enforced in accordance with
the laws of the State of New York, excluding its conflict of laws rules to the
extent such rules would apply the law of another jurisdiction.
This Second Amendment will terminate in accordance with the terms set forth in
the Agreement.
Except as set forth in this Second Amendment, the terms of the Agreement
(including but not limited to the Sections of Schedule 1 which are not amended
in this Second Amendment) shall remain in full force and effect; provided
however, that in the event of a conflict between a term contained in this Second
Amendment and a term contained in the Agreement, the term contained in this
Second Amendment shall prevail.
IN WITNESS WHEREOF, Service Provider and Service Recipient have caused this
Second Amendment to the Agreement to be executed by their duly authorized
representatives as of the date first above written.
GENZYME CORPORATION
 
AASTROM BIOSERVICES, INC
 
 
 
Signature: /s/ Steve Couldwell
 
Signature: /s/ Daniel Orlando
 
 
 
Name: Steve Couldwell 
 
Name: Daniel Orlando
 
 
 
Title: GM Biosurgery
 
Title: COO
 
 
 
Date: Aug - 6 - 2014 
 
Date: Aug - 6 - 2014 

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THIRD AMENDMENT TO TRANSITION SERVICES AGREEMENT
This third Amendment effective as of the date last signed by both parties
(“Third Amendment”) is by and between Genzyme Corporation, a Massachusetts
corporation (“Service Provider”), and Vericel Corporation, formerly known as
Aastrom Biosciences Inc., a Michigan corporation (“Service Recipient”),
(collectively, the “Parties”).
WHEREAS, effective as of May 30, 2014, Service Provider and Service Recipient
entered into that certain Transition Services Agreement, as amended from time to
time (collectively, the “Agreement”) which described transition services that
Service Provider agreed to provide to Service Recipient in support of the sale
of three (3) products (Carticel, Epicel and Matrix Applied Characterized
Autologous Cultured Chondrocytes (MACI)) to Service Recipient (the terms of the
sale are memorialized in a separate Asset Purchase Agreement), including without
limitation Service Provider’s agreement to remain the named sponsor for the
matrix applied characterized autologous cultured chondrocytes) clinical study
entitled SUMMIT Extension Trial (Extension Study for Participants of Previous
Study (MACI00206) of MACI Implant for the Treatment of Symptomatic Articular
Cartilage Defects of the Femoral Condyle (MACI00809) (the “MACI00809 Study”);
WHEREAS, as sponsor of the MACI00809 Study, Service Provider has certain legal
and regulatory obligations regarding the conduct of the MACI00809 Study, and
Service Provider has the obligation under the Agreement to continue to support
the MACI00809 Study trials until final (5 year) database lock;
WHEREAS, Service Recipient, as the sole owner of the MACI product, is
responsible for the conduct and oversight of the MACI0809 Publication Steering
Committee comprised of three of the MACI0809 Investigators, and the validity and
completion of the MACI00809 Study Clinical Study Report; and
WHEREAS, the Parties agree that Service Recipient should be provided a limited
right to observe Service Provider’s conduct of the MACI00809 Study in advance of
its undertaking the MACI00809 Study Clinical Study Report at the conclusion of
the study;
NOW, THEREFORE, in consideration of the above-recitals, the mutual benefits to
be derived by the parties, and other good and valuable consideration, the
receipt and satisfaction of which are acknowledged, Service Provider and Service
Recipient agree to amend the Agreement as follows:
1.
Observational Seat. Service Provider hereby invites Service Recipient’s
employee, Ann Remmers, Ph.D., Senior Clinical Scientist (the “Observer”), to
attend, strictly in an observer role, the clinical study team status meetings
for MACI00809 Study, as well as investigator meetings for MACI00809 Study.
Service Recipient expressly agrees that the Observer will only observe at any
meeting which the Observer attends, and will not disrupt such meetings, and that

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

any information learned at such meetings will be kept confidential (“Observed
Information”). Service Recipient hereby agrees to enforce Observer’s obligations
hereunder.
2.
Service Provider Contact and Support. Service Provider hereby designates Geary
MacQuiddy, Associate Director, Program Management (the “Service Provider
Contact”) to address the Observer’s reasonable questions in a commercially
reasonable timely manner. Service Recipient hereby agrees to direct its
reasonable questions regarding the MACI00809 Study to Service Provider Contact.
Additionally, Service Provider hereby agrees to share with Service Recipient
certain clinical study oversight documents for the MACI00809 Study including:
Monitoring plan, Safety/Medical Monitoring plan, Sponsor Oversight plan, Data
management plan, Quality plan/ Internal audit plan (including related
certificates), Trial Master File plan, Operational Procedural Manual, Debarment
statement and Publication Policy (collectively, the “Study Oversight Documents”)

3.
Confidentiality. Service Recipient agrees that the Study Oversight Documents and
Observed Information constitute Service Provider Confidential Information,
provided, however, that after the database lock of the MACI00809 Study, Study
Oversight Documents and any Observed Information that is reduced to records
transferred to Service Recipient upon the end of the MACI00809 Study shall no
longer be Service Provider Confidential Information, and shall constitute
Service Recipient Confidential Information.

*    *    *

The rights and obligations of the Parties or any dispute arising out of this
Third Amendment will be interpreted, construed and enforced in accordance with
the laws of the State of New York, excluding its conflict of laws rules to the
extent such rules would apply the law of another jurisdiction.
This Third Amendment will terminate in accordance with the terms set forth in
the Agreement.
Except as set forth in this Third Amendment, the terms of the Agreement
(including but not limited to the Sections of Schedule 1 which are not amended
in this Third Amendment) shall remain in full force and effect; provided
however, that in the event of a conflict between a term contained in this Third
Amendment and a term contained in the Agreement, the term contained in this
Third Amendment shall prevail.
[Signature Page Immediately Follows.]

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IN WITNESS WHEREOF, Service Provider and Service Recipient have caused this
Third Amendment to the Agreement to be executed by their duly authorized
representatives as of the date first above written.
GENZYME CORPORATION
 
VERICEL CORPORATION
 
 
 
Signature: /s/ Steve Couldwell
 
Signature:
 
 
 
Name: Steve Couldwell
 
Name: Dominick Colangelo
 
 
 
Title: General Manager Biosurgery
 
Title: Chief Executive Officer
 
 
 
Date: 1 - Mar - 2015 
 
Date: 2/23/2015

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FOURTH AMENDMENT TO TRANSITION SERVICES AGREEMENT
This fourth Amendment (the “Fourth Amendment”), effective as of the date last
signed by both parties (the “Effective Date”) is by and between Genzyme
Corporation, a Massachusetts corporation (“Service Provider”), and Vericel
Corporation, formerly known as Aastrom Biosciences Inc., a Michigan corporation
(“Service Recipient”), (collectively, the “Parties”).
WHEREAS, effective as of May 30, 2014, Service Provider and Service Recipient
entered into that certain Transition Services Agreement, as amended from time to
time (collectively, the “Agreement”) which described transition services that
Service Provider agreed to provide to Service Recipient in support of the sale
of three (3) products (Carticel, Epicel and Matrix Applied Characterized
Autologous Cultured Chondrocytes [MACI]) to Service Recipient (the terms of the
sale are memorialized in a separate Asset Purchase Agreement);
WHEREAS, Service Recipient may contract out certain tasks in order to receive
Services by Service Provider, including but not limited to the transfer of data
from Service Provider to Service Recipient, and, on occasion, those contractors
may assign certain responsibilities to subcontractors;
WHEREAS, the Parties acknowledge that certain of the Services require access to
Service Provider systems and Service Provider Confidential Information; and
WHEREAS, the Parties wish to clarify the Parties’ obligations regarding
Confidential Information and to extend Service Recipient’s indemnification
obligation to include subcontractors;
NOW, THEREFORE, in consideration of the above-recitals, the mutual benefits to
be derived by the parties, and other good and valuable consideration, the
receipt and satisfaction of which are acknowledged, Service Provider and Service
Recipient agree to amend the Agreement as follows:
1.
Section 8.2. The first sentence of Section 8.2 is hereby stricken and replaced
in its entirety by the following sentence:

“(A) Neither the execution of this Agreement, nor performance of Services by the
Service Provider and/or any of its Affiliates shall cause the Service Recipient
and/or any of its Affiliates or any person or entity employed by the Service
Recipient and/or any of its Affiliates or engaged by the Service Recipient
and/or any of its Affiliates (a “Contractor”), or any person or entity
subcontracted to by any Contractor, including Transferred Employees
(collectively “Service Recipient Personnel”) to be or to be construed to be an
agent, employee or legal representative of the Service Provider and/or any of
its Affiliates for any purpose whatsoever.”
2.
Section 10.1. The first sentence of Section 10.1 is hereby stricken and replaced
in its entirety by the following sentence:

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“Service Recipient will indemnify, defend and hold harmless Service Provider and
its officers, directors, agents, employees and Affiliates, from and against any
and all Damages, including reasonable attorney’s fees (collectively, “Losses”)
arising out of, relating to or resulting from (a) Service Recipient’s material
breach of this Agreement, (b) Service Recipient’s gross negligence or willful
misconduct in connection with its receipt of the Services or Additional Services
pursuant to this Agreement, (c) Service Recipient Personnel’s misuse of any of
Service Provider’s systems or Services, (d) Service Recipient Personnel’s
disclosure or misuse of any of Service Provider’s Confidential Information, (e)
Service Recipient Personnel’s willful misconduct in connection with the use of
Service Provider’s systems or Services or Confidential Information, or (f)
Service Provider’s provision of Services or Additional Services pursuant to and
in accordance with this Agreement, except for those Losses for which Service
Provider is obligated to indemnify, defend and hold harmless Service Recipient
and its officers, directors, agents, employees and Affiliates pursuant to
Section 10.2.”
3.
Section 10.4. The following phrase is hereby appended to the end of the only
sentence in this Section:

“provided, however, that without prejudice to any rights to relief it may
otherwise have, a Party may be entitled to seek equitable relief including
injunction, without having to post a bond, in the event of any misuse or
disclosure (except as permitted as set forth in Section 13.15) of the Party’s
Confidential Information by the other Party or its (as it respectively applies
to the Party) Service Recipient Personnel or Service Provider Personnel.”
4.
Section 13.15.1. The following sentence is hereby appended to the end of
Section 13.15.1:

“For purposes of clarity, without limitation, Representatives also include any
Contractors and any subcontractors of Contractors, representatives, and/or
agents.”
*    *    *
The rights and obligations of the Parties or any dispute arising out of this
Fourth Amendment will be interpreted, construed and enforced in accordance with
the laws of the State of New York, excluding its conflict of laws rules to the
extent such rules would apply the law of another jurisdiction.
This Fourth Amendment will terminate in accordance with the terms set forth in
the Agreement.
Except as set forth in this Fourth Amendment, the terms of the Agreement shall
remain in full force and effect; provided however, that in the event of a
conflict between a term contained in this Fourth Amendment and a term contained
in the Agreement, the term contained in this Fourth Amendment shall prevail.

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

IN WITNESS WHEREOF, Service Provider and Service Recipient have caused this
Fourth Amendment to the Agreement to be executed by their duly authorized
representatives as of the Effective Date.
GENZYME CORPORATION
 
VERICEL CORPORATION
 
 
 
Signature: /s/ Steve Couldwell
 
Signature: /s/ Dominick Colangelo
 
 
 
Name: Steve Couldwell
 
Name: Dominick Colangelo
 
 
 
Title: VP Biosurgery
 
Title: Chief Executive Officer
 
 
 
Date: 4 - May - 2015 
 
Date: 4/27/15

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FIFTH AMENDMENT TO TRANSITION SERVICES AGREEMENT

This Fifth Amendment (the “Fifth Amendment”), effective as of the date last
signed by both parties (the “Amendment Effective Date”) is by and between
Genzyme Corporation, a Massachusetts corporation (“Service Provider”), and
Vericel Corporation, formerly known as Aastrom Biosciences Inc., a Michigan
corporation (“Service Recipient” or “Vericel”) (collectively, the “Parties”).

WHEREAS, effective as of May 30, 2014, Service Provider and Service Recipient
entered into that certain Transition Services Agreement, as amended from time to
time (collectively, the “Agreement”) which described transition services that
Service Provider agreed to provide to Service Recipient in support of the sale
of three (3) products (Carticel®, Epicel® and Matrix Applied Characterized
Autologous Cultured Chondrocytes (“MACI®”), and collectively the “Products”) to
Service Recipient (the terms of the sale are memorialized in a separate Asset
Purchase Agreement between Sanofi, a French Société anonyme and Service Provider
Affiliate (“Sanofi”) and Vericel, dated as of April 19, 2014 (the “Asset
Purchase Agreement”));

WHEREAS, the Agreement expired May 29, 2015;

WHEREAS, certain of the services provided by Service Provider to Service
Recipient under the Agreement, including without limitation,
1)
IT services related to data transfer,

2)
Service Provider’s agreement to remain the named sponsor until Database Lock for
the MACI clinical study entitled SUMMIT Extension Trial (Extension Study for
Participants of Previous Study (MACI00206) of MACI Implant for the Treatment of
Symptomatic Articular Cartilage Defects of the Femoral Condyle (MACI00809) (the
“MACI00809 Study”), and

3)
Service Provider’s continued support as United States BLA license holder for
Carticel until the time that the BLA license transfer to Service Recipient with
respect thereto is approved,

require additional time and support for wind-down activities;

WHEREAS, Service Provider has agreed to provide these wind-down activities
services, subject to certain dependencies and limitations specified in this
Fifth Amendment; and

WHEREAS, the Parties wish to clarify certain other Services and transfers of
software.
    
NOW, THEREFORE, in consideration of the above-recitals, the mutual benefits to
be derived by the Parties, and other good and valuable consideration, the
receipt and satisfaction of which are acknowledged, Service Provider and Service
Recipient agree to amend the Agreement as follows:

1.
All capitalized terms not defined herein shall have the same meaning as set
forth in the Agreement. For purposes of clarity, the Agreement in certain
instances relies on definitions as set forth in the Asset Purchase Agreement,
and all capitalized terms defined in neither this Fifth Amendment nor the
Agreement shall have the same meaning as set forth in the Asset Purchase
Agreement.

2.
The Parties hereby agree that all Services performed between May 29, 2015, and
the Amendment Effective Date shall be construed to have been performed pursuant
to the terms and conditions of the Agreement.

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

3.
Section 2.9, Data Hosting Services. The Parties hereby agree that the following
Section 2.9, hereby appended to the Agreement, is effective retroactive to the
Closing Date as defined in the Asset Purchase Agreement, and that Service
Recipient’s obligations of indemnification under the Agreement apply
retroactively to that date.

“2.9. Data Hosting Services. As further set forth in Schedule 1, Service
Provider, from time to time, may provide data hosting services to Service
Recipient, consistent with the following terms:
2.9.1. Definitions. Intentionally consistent with their meanings under EU
Directive 95/46/EC - The Data Protection Directive (the “EU Data Directive”),
but applicable across all data covered under this Agreement, the following are
defined terms:

a)
“Data Controller” shall mean the entity which alone or jointly with others
determines the purposes and means of the Processing of Personal Data.

b)
“Data Processor” shall mean an entity which Processes Personal Data on behalf of
the Data Controller.

c)
“Personal Data” shall mean all individually directly or indirectly identifiable
information created, collected or received pursuant to the Services (as defined
in this Agreement) concerning notably research subjects, patients, caregivers,
and health care professionals.

d)
“Processing” shall mean any operation or set of operations which is performed
upon Personal Data or Other Data, whether or not by automatic means, such as
collection, recording, organization, storage, adaptation or alteration,
retrieval, consultation, use, disclosure by transmission, dissemination or
otherwise making available, alignment or combination, blocking, erasure or
destruction.

e)
“Other Data” shall mean all data not governed by the EU Data Directive.

2.9.2    Identification of Parties.

2.9.2.1
EU Data Directive-Governed Information. With respect to such data that is
governed by the EU Data Directive, the Parties agree that upon the transfer of
the EU marketing authorisation for Matrix Applied Characterized Autologous
Cultured Chondrocytes (“MACI”) to Service Recipient on August 26, 2014, as it
relates to MACI data,

a)
Service Recipient is the Data Controller under this Agreement; and

b)
Service Provider is a Data Processor under this Agreement.

Service Recipient hereby warrants and represents that there were no Epicel
patients subject to the EU Data Directive after the Closing Date.

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

2.9.2.2
Other Data. The Parties hereby acknowledge that Other Data is not subject to the
EU Data Directive, but use terms herein consistent with the EU Data Directive
for ease of administration in identifying roles and responsibilities. With
respect to Other Data as of the Closing Date, the Parties hereby agree that,

a)
Service Recipient is the Data Controller under this Agreement; and

b)
Service Provider is a Data Processor under this Agreement.

2.9.3    Compliance with Applicable Data Protection Laws

a)
Service Recipient agrees to comply with all applicable data protection laws and
covenants not to place Service Provider in violation of applicable data
protection laws. In relation to data stored on Service Provider servers since
Service Recipient became Data Controller in the applicable jurisdiction, Service
Recipient warrants and represents that it has and will apply the applicable data
protection laws, and to Service Recipient’s knowledge (in this instance, defined
as known or should have known), it has not placed Service Provider in violation
of applicable data protection laws.

b)
Service Provider shall act only on instructions of Service Recipient with regard
to the Processing of Personal Data or Other Data in accordance with the
Agreement.

2.9.4    No use for unrelated purposes
Service Provider agrees that it will use Personal Data and Other Data stored by
Service Recipient on Service Provider systems or servers solely for the purposes
of this Agreement. Service Provider shall not duplicate or incorporate Personal
Data or Other Data into its own records or databases except for purposes of
performing the Processing Services under this Agreement or, in the case of
Personal Data and Other Data generated prior to the Closing Date, in compliance
with Service Provider’s own policies related to data retention. Service Provider
represents and warrants that Personal Data and Other Data has been stored and
will be stored consistent with the standard by which Service Provider stores its
own data.

2.9.5
WAIVER OF LIMITATION OF LIABILITY. WITH RESPECT TO THE OBLIGATIONS OF SERVICE
RECIPIENT AS DATA CONTROLLER, EACH PARTY HEREBY WAIVES THE LIMITATION OF
LIABILITY SET FORTH IN ARTICLE 11 OF THE AGREEMENT.”

4.
Section 4.1, Term. Section 4.1 is hereby stricken and replaced in its entirety
by the following:

“4.1. Term. This Agreement will commence on the Effective Date and remain in
effect until December 31, 2015 (the “Term”), unless earlier terminated under
this ARTICLE 4.

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

With respect to each Service, such Service will begin upon the applicable start
date set forth in the Transition Services Schedule, unless earlier terminated
under this ARTICLE 4. This Agreement may be extended by the Parties in writing,
either in whole or with respect to one or more of the Services.”

5.
Section 7.5, Crystal Reports. The following Section 7.5 is hereby appended to
the end of Article 7 of the Agreement:

“Section 7.5. Crystal Reports. Service Recipient is responsible for obtaining
and maintaining all relevant SAP software licenses required for its lawful use
of the Crystal Reports.

7.5.1. Standard Crystal Reports. Under, and subject to, the terms of the Asset
Purchase Agreement, three (3) standard Crystal Reports were transferred from
Sanofi to Service Recipient, as Standalone Use licenses further subject to the
SAP OEM Software Use Rights enGLOBAL.v.7-2015 EULA or its most current form (the
“SAP OEM EULA”) pursuant to Section 1.3.2, incorporated herein by reference. For
purposes of administration only, the SAP OEM EULA as of the Amendment Effective
Date may be found at http://www.sap.com.

7.5.2 Custom Crystal Reports. Service Recipient has requested access to, and
Service Provider has agreed to provide such access to, six (6) customized
Crystal Report IT Assets that were excluded from Transferred Assets under
Section 2.1.3 of the Asset Purchase Agreement (the “Custom Crystal Reports”), as
the Custom Crystal Reports were not used or held for use exclusively in the
Business. As the Custom Crystal Reports were created by Service Provider for use
across Service Provider’s and its Affiliates’ businesses, and Service Provider
is not in the business of creating such Custom Crystal Reports, Service Provider
hereby grants to Service Recipient a nonexclusive, revocable, nontransferable,
perpetual, royalty-free, fully paid-up, worldwide license to use, reproduce, and
prepare derivative works of the Custom Crystal Reports to Service Recipient
subject to the SAP OEM EULA as a Standalone Use license under Section 1.3.2, and
subject to the following conditions:

7.5.2.1. No Warranty. SERVICE PROVIDER MAKES NO WARRANTY OR REPRESENTATION
WHATSOEVER, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR AGAINST INFRINGEMENT.

7.5.2.2. Removal of Marks. Service Recipient is not hereby granted rights to use
Service Provider’s or its Affiliate’s Marks, including its company name.
Therefore, Service Recipient hereby agrees to remove any and all Service
Provider and/or Service Provider Affiliate marks from the Custom Crystal Reports
prior to their use.

7.5.2.3. Revocability. This license grant is revocable in the instance where
license transfer is not permitted under the SAP OEM EULA in its current form.
Further, this license grant is revocable at the request of SAP or the

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

then-current Crystal Reports owner, or Sparta Systems, the OEM license provider
to Service Provider.

6.
Schedule 1. Transition Services Schedule. As of the Amendment Effective Date,
all Services set forth in the Transition Services Schedule in Sections 1 through
8 shall terminate, and those Services set forth in Section 9, Wind-Down
Activities Services, attached hereto and incorporated herein by reference as
Attachment 1, shall commence.

7.
Financial Responsibilities. The Parties acknowledge that certain financial
obligations related to the Products may arise while Service Provider continues
to provide Services pursuant to this Fifth Amendment. Service Recipient hereby
agrees that all financial responsibilities related to the Products, except for
those specifically excluded by the Agreement or the Asset Purchase Agreement,
vest with Service Recipient. For purposes of example, without limitation, the
2015 PDUFA fee for Carticel is the responsibility of Service Recipient, even if
the BLA license with respect thereto still rests with Service Provider at the
time it is due. Notwithstanding the foregoing, Service Recipient’s requirement
to pay for Services pursuant to the Agreement shall extend solely to the
payments set forth on Schedule 1 hereto under the heading “Billing/Fee”, such
payment obligations beginning effective May 30, 2015.

8.
Data Extraction Cost Offset, IT Cost Offset, and 2014-2015 Assumed Liability
PDUFA Fee Cost Offset.

a.
Offset to Ease Administrative Burden: To ease the administrative burden of
cross-charging between the Parties, the Parties hereby agree to the following
offsets, and will therefore not seek collection from the other Party as further
described below (the “Offsets”):

i.
Data Extraction Costs.

A.
The Parties acknowledge that, pursuant to the Asset Purchase Agreement, costs
related solely to the extraction of data related to the Assets, and specifically
excluding any conversion of data and any extraction of any new data placed by
Vericel on Sanofi servers or computers (“Data”), are costs to be borne by Sanofi
or its Affiliates (“Data Extraction Costs”). In order to facilitate Data
extraction, Service Recipient, at Service Provider’s suggestion, undertook to
contract with a third party vendor(s) (the “Data Extraction Vendor Agreements”),
and further, Service Recipient has borne Data Extraction Costs under the Data
Extraction Vendor Agreements. Service Recipient will pay for all Data Extraction
Costs associated with the Data Extraction Vendor Agreements up to the amount of
Two Hundred Thousand United States Dollars ($200,000.00) (the “Cap”), which is
the value of the Offsets set forth in 6(a)(ii) and 6(a)(iii), below. If Data
Extraction Costs under the Data Extraction Vendor Agreements should exceed the
Cap, then Service Provider will reimburse Service Recipient for the Data
Extraction Costs above the Cap.

 
B.
Notwithstanding the foregoing, Service Provider will reimburse Service Recipient
up to Fifty Thousand United States Dollars ($50,000.00), for Data Extraction
Costs incurred (the “Reimbursement”). Such Reimbursement is applicable to any
Data Extraction Costs incurred, and will run alongside the Cap, so that, at
most, Service Recipient will be responsible for covering

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

One Hundred Fifty Thousand United States Dollars ($150,000.00) of the Data
Extraction Costs Offset.

ii.
IT Costs. Service Provider, while permitted under the terms of the Agreement to
charge for Services, hereby agrees to waive all fees associated with the
activities set forth in Schedule 9.1.

iii.
2014-2015 Assumed Liability PDUFA Fee Costs. The Parties acknowledge that,
pursuant to the Asset Purchase Agreement, all Assumed Liabilities are costs to
be borne by Service Recipient, and further that the 2014-2015 PDUFA Fees for the
Products and portions attributed thereof for their establishment locations
(collectively, the “2014-2015 PDUFA Fees”), due in October 2014, are Assumed
Liabilities. Service Provider paid the 2014-2015 PDUFA Fees, and hereby agrees
not to seek reimbursement due under the Asset Purchase Agreement from Service
Recipient.

b.
No Admission of Liability. The Parties acknowledge that the Offsets are agreed
upon to ease administrative burden only, and that the Offsets are not, and may
not be construed as, an admission of liability by either Party or their
respective Affiliates and is not to be construed as an admission that either
Party or their respective Affiliates engaged in any wrongful, tortious or
unlawful activity. The Parties specifically disclaim and deny (a) any liability
to the other Party or their respective Affiliates and (b) engaging in any
wrongful, tortious or unlawful activity

9.
Miscellaneous. The Parties acknowledge that, as set forth in Section 7.22 of the
Asset Purchase Agreement, all transition services were to end by May 29, 2015.
Service Provider hereby confirms that Service Provider has received approval
from its Affiliate to continue certain transition services beyond May 29, 2015.
The Parties hereby agree that, notwithstanding the term limit to the transition
services set forth in Section 7.22 of the Asset Purchase Agreement, the Services
will be extended as set forth in this Fifth Amendment.

*    *    *
The rights and obligations of the Parties or any dispute arising out of this
Fifth Amendment will be interpreted, construed and enforced in accordance with
the laws of the State of New York, excluding its conflict of laws rules to the
extent such rules would apply the law of another jurisdiction.

This Fifth Amendment will terminate in accordance with the terms set forth in
the Agreement.

Except as set forth in this Fifth Amendment, the terms of the Agreement shall
remain in full force and effect; provided however, that in the event of a
conflict between a term contained in this Fifth Amendment and a term contained
in the Agreement, the term contained in this Fifth Amendment shall prevail. The
Agreement, as amended, together with the Asset Purchase Agreement and the other
Ancillary Agreements, constitutes the entire agreement between and among the
Parties with regard to the subject matter of this Agreement, and supersedes all
prior agreements and understandings with regard to such subject matter. Except
for the Confidentiality Agreement, there are now no agreements, representations
or warranties between or among the Parties other than those set forth in the
Agreement, the Asset Purchase Agreement or the Ancillary Agreements.

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

IN WITNESS WHEREOF, Service Provider and Service Recipient have caused this
Fifth Amendment to the Agreement to be executed by their duly authorized
representatives as of the Amendment Effective Date.

GENZYME CORPORATION                    VERICEL CORPORATION

Signature:                            Signature:                

Name:                                Name:                    

Title:                                Title:                    

Date:                                Date:                    

        

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Attachment 1

SCHEDULE 1

Transition Services Schedule

Section 9: Wind-Down Activities Services

Section 9.1
IT Services and Systems Access

1    Without prejudice to Section 8.3 of this Agreement, the Service Provider
will provide to the Service Recipient support only with respect to the
Transferred Employees and new employees that are replacing Transferred Employees
or who otherwise require support as reasonably requested by Service Recipient.
Exception: Local Network Connectivity, global network connectivity, and internet
connectivity will be provided to employees of the Service Recipient who require
such access.

2    The Service Provider has the responsibility to provide the Service
Recipient with administrative access to Service Recipient-owned IT assets
(computers, servers, laptops, desktops, etc.), or infrastructure (firewalls,
routers, switches, etc.) only if they are physically located within one of the
transferred offices and are dedicated to the exclusive use by the Business,
provided however that while any such computers and/or infrastructure are still
connected to the Service Provider’s network and until they are segregated in
full, any changes to workstation and/or infrastructure configuration must be
reviewed and approved in advance by the appropriate Service Provider personnel.

3    Administrative access will not be provided to any shared (i.e., only
partially dedicated to the use by the Business) servers, infrastructure, or any
other devices, which are not Transferred Assets (this includes, without
limitation, routers, shared file and print servers, etc.).

4    Service Provider reserves the right to upgrade, replace, or discontinue
individual services as part of Service Provider’s ongoing and regular business
operations. Service Recipient will be provided notice of Service Provider’s
intent to change or discontinue any IT service as soon as practicable once such
plans are revealed to the Service Provider Manager. In any event, commercially
reasonable efforts will be made to avoid or minimize impact to Service
Recipient’s ongoing business operations and Service Provider will provide
Service Recipient with reasonable notice of any changes.

5    Without prejudice to section 8.3 of this Agreement, nothing in this
Transition Services Schedule shall oblige the Service Provider to provide access
to the Service Recipient and/or any of the Service Recipient Personnel to any
information services systems and/or applications other than those listed in
Schedule 9.1.

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9.1.1 Services

#

Function

Region

Title
                                         Services

Term Date

Billing/ Fee

1

IT: GIS

US/

GIS General
Services
Service Provider to provide the following to Service
Recipient:

• Core Security Service – monitor and assist in resolving any Security threats
and risks (perimeter, virus, spam)

December 31, 2015
N/A

2

IT: GIS

US/

GIS Network
Services
Service Provider to provide the following services to Service
Recipient:

• Global Network Connectivity (WAN) – maintain WAN circuit operations, escalate
circuit issues to Telco and troubleshoot to resolution. Monitor WAN availability
and performance.
   Local Network Connectivity (LAN) – monitor and troubleshoot to ensure
availability and performance.
• Remote Access Service – maintain operation of WebVPN
or other applicable user remote access solutions.
• Internet Connectivity – maintain operation of common Internet access for
business needs of Cell Therapy users during service transition to Service
Recipient’s infrastructure.
i) Cambridge Site

December 31, 2015

N/A

3

IT: GIS

US/

GIS Server Operations Services
Service Provider to provide the following services to Service
Recipient at sites other than the transferred sites:

•    Housing Service (Data Center operations): monitoring of DC environment,
availability and adequate performance.
•    Server Service – For existing servers: monitor for availability and
performance, apply critical OS patches and fixes. Note, no additional servers
will be provided by this service during the TSA period.

December 31, 2015
N/A

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

#

Function

Region

Title
                                         Services

Term
(Months)

Billing/ Fee

4

IT: GIS

US/

GIS User
Services
Service Provider will provide the following services to Service
Recipient:

•    Enterprise Computer service, Electronic Software Distribution – apply
critical desktop OS patches and fixes as appropriate, maintain operation of
desktop anti-virus infrastructure.
•    Service Desk – provide end user support, liaise with other Service Provider
and/or Service Recipient support groups to assist in resolving user issues.
•    Enterprise Directory Service, Network Access Service (User Account
Operations) – maintain operation of Active Directory infrastructure and provide
support for end-user accounts (setup, troubleshoot, administer) for former
Service Provider personnel.
•    Workspace Solution service (File & Print Services) – maintain operation of
general File Share and common Printing infrastructure, including setup,
troubleshooting, and administration, for former Service Provider personnel
•    The Parties will use commercially reasonable efforts to transfer or
otherwise resolve PC leases

December 31, 2015

N/A

5
IT
EU/US
MFGPro, NEXTs, Catalyst and SAP
Service Provider will provide the following services to Service
Recipient – AS PER SPECIFICALLY IDENTIFIED IN SECTION 9.1.2 below• Enable users
to access MFGPro, Catalyst, Next and SAP application/s (includes WQR Reflections
– terminal emulation), by setting up users accounts, and enabling connectivity.

 See 9.1.2 below

N/A

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

6

IT

EU/US

Application
Service Provider will provide the following services to Service
Recipient AS PER SECTION 9.1.2 below

• If Service Recipient employees (not former Service Provider employees) require
access to the systems they will be granted access as contractors, and Service
Recipient will be responsible for formal background checks and any training
required Service Recipient

See 9.1.2 below

N/A

7

IT

US & EU

Promotional material review eRC

Service Provider will facilitate necessary interactions with the process-related
applications on behalf of Service Recipient.

See 9.3, #1 below
N/A

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

9.1.2 Systems Access
#
Department
System
Employees that need continued access after
June 1, 2015
Term Date
Rationale
Billing/Fee
1
Quality Assurance
Trackwise
All Sidney Street users
December 31, 2015
Complete transfer of all CTRM data and workflows from Sanofi to Vericel
 N/A

2
Quality Assurance
ROBAR
Philip Carpenter
Amanda Lambirth
Elizabeth Foley
David Futterer
Gen AppRem Test26
GenzymeAppTest10
James George
Kyle Giroux
Jesus Guerrero
Elmer Lemus
Joan Lessor
Lan Luong
Laurie McQueen
Josephine Johansen
Lauren Ann Peterson
ROBAR Default User
Ezequiel Soc
Melissa Sukernick
Adrian Todor
Chad Worthley
Yan Ming Yuan
Carmen Zvinca
December 31, 2015
Ongoing need to print labels until ROBAR system can be transferred and validated
 N/A

3
Quality Assurance
BarTender (Seagull Scientific) - linked with ROBAR
(See above list)
December 31, 2015
Linked with ROBAR
 N/A

4
Finance
Catalyst
Harvey Maki
December 31, 2015
Ongoing analysis of vendor payments for Vericel business
 N/A

5
Finance
NEXTs
Harvey Maki
December 31, 2015
Ongoing analysis of vendor payments for Vericel business
 N/A

6
Finance
MFG\PRO and SAP
Harvey Maki
December 31, 2015
Ongoing analysis of customer billing and cash receipts. Some customers have 90
day payment terms and will likely remit cash to a Genzyme lockbox for May
invoices through July of this year.
 N/A

7
Manufacturing
SQL Epicel Patient Information Database
Melvin Posada
December 31, 2015
Ongoing use of Epicel Patient Information Database until system can be
transferred and validated
 N/A

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

8
Engineering
Continuum BMS
Joe Romano
Tom Harmon
December 31, 2015
Ongoing need for BMS until system transfer and validation is complete
 N/A

9
Materials Management
MFG\PRO and SAP
Brian Dunderdale
Kristen Appleman
Alex Erneste
Sze Chen
Nancy Minghella
Melvin Pasata
David Conrad
Abdell Omalek
Fernando Davalos
December 31, 2015
Open POs and Raw Material Receipts and Transfers
 N/A

10
Quality Assurance
Quality Control
MFG\PRO and SAP
Marianne Pongratz
Melissa Sukernick
Kyle Giroux
Chad Worthley
James George
Carmen Zvinca
Lauren Peterson
Elizabeth Foley
Josephine Johansen
Adrian Todor
Ed Fasano
Matt Stevens
Rob Manzella
Sam Prinzi
Jason Greenberg
December 31, 2015
Used on daily basis to release product - one person from each shift requires
access
 N/A

11
Customer Care
SAP
Tim McKeen
Jennifer Fisher
James Bonasoro
Chad Matthes
Connie Correia
Sydney Laguerre
December 31, 2015
Open Sales Orders and Credits
 N/A

12
Quality Assurance
Catsweb
Cindy Entstrasser
Melissa Sukernick
Alex Ernesti
December 31, 2015
Complete CTRM Adverse Event data transfers
 N/A

13
Network
VPN: 64 - AA
All Sidney Street users
December 31, 2015
Maintain VPN connectivity between 64 Sidney St and AA
 N/A

14
Quality Assurance
Clinical
LiveLink
Josh Hodgson
Ann Remmers
December 31, 2015
Extract remaining necessary data
N/A

9.1.3 Email Services

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

Service Provider will continue to provide email services for to Service
Recipient employees identified above in Section 9.1.2 solely for notifications
for essential applications, including Trackwise (Line #1) and Catalyst (Line
#4). The email services will terminate, respectively, on the system termination
dates listed in Section 9.1.2.

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

Section 9.2

REGULATORY and PHARMACOVIGILANCE ACTIVITIES FOR MACI00809 STUDY

The Parties hereby agree that time is of the essence to transfer sponsorship of
the MACI00809 Study from Service Provider to Service Recipient, with an
effective transfer date of August 24, 2015, as declared in the submission to the
relevant Competent Authorities/ Ethics Committees) (the “Target Transfer Date”).

Service Provider and Service Recipient will make best efforts to maintain this
Target Transfer Date by anticipating submissions to CA/EC. In the event that the
Target Transfer Date transfer is not achieved, Service Provider, at is sole
discretion after consultation with Service Recipient, will inform the Competent
Authorities/Ethics Committees of a new target transfer date, and Service
Provider and Service Recipient will use best efforts to achieve the new target
transfer date.

Service Provider agrees to perform limited wind-down activities as set forth
below.

#
Function
Region
Title
TSA Scope
Termination Date
Billing/Fee
1
Regulatory
EU
Submission to the Health Authorities to change Sponsorship of MACI00809 Study
Service Provider (but in the case of Poland and the Czech Republic, Service
Recipient) will make appropriate submissions to the competent authorities and
ethics committees in the affected jurisdictions to transfer sponsorship of the
MACI00809 Study from Service Provider to Service Recipient.

Service Recipient will comply with Service Provider’s reasonable requests for
assistance in a timely manner.
Until the earlier of Service Recipient becoming sponsor of the MACI00809 Study
in each affected jurisdiction or November 1, 2015.
Service Recipient and Service Provider will each pay for half of any fees
associated with these submissions.

Notwithstanding the foregoing Service Recipient will compensate Service Provider
for all costs incurred by Service Provider, including personnel costs, for such
Services after September 15, 2015.

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

2
Regulatory / Safety
EU
QPPV Role for MACI00809 STUDY
Service Provider will provide a qualified person to act as QPPV for the
MACI00809 Study
Until the earlier of Service Recipient becoming sponsor of the MACI00809 Study
in each affected jurisdiction or November 1, 2015.
Service Recipient will pay for QPPV for the MACI00809 Study

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

3
Regulatory / Safety
EU
Safety Requirements
Service Provider will provide the following support to Service Recipient, with
Service Recipient’s assistance as noted below:

•    Service Provider will provide Safety monitoring of MACI00809 Study for as
long as Service Provider or its affiliates remains the sponsor of the study
including: submitting individual case safety reports to the competent health
authorities, as appropriate
•    Service Recipient will prepare the 2015 DSUR for submission in a timely
manner. Service Provider will provide any supportive data not previously
transferred for the authoring / compilation of the Development Safety Update
Report and / or Semi-Annual Safety Report (due for submission August 26, 2015
and July 27, 2015, respectively) to Service Recipient (patient exposure, actions
taken for safety reasons, significant safety findings, listings of deaths,
etc.).
o    In the event that sponsorship does not transfer from Service Provider to
Service Recipient by the time the DSUR must be submitted, Service Provider will
submit the DSUR that Service Recipient has prepared. Accordingly, during the
preparation of the DSUR, Service Provider will be given opportunity as further
set forth in the agreed upon DSUR Submission Timeline document, incorporated
herein by reference, to review and comment on the DSUR and such comments shall
be duly considered for inclusion in the report.
o    In the event that the Target Transfer Date is not achieved and therefore
Service Provider must submit the DSUR that Service Recipient has prepared, the
Service Provider must approve the final DSUR prior to submission. The Parties
agree to collaborate together to ensure that this report is submitted to
appropriate Health Authorities on or before August 26, 2015.
•    Service Provider will provide pharmacovigilance Source Document Retention
Until the earlier of Service Recipient becoming sponsor of the MACI00809 Study
in each affected jurisdiction or November 1, 2015.
Notwithstanding anything to the contrary in this Agreement, Service Recipient,
as party responsible for drafting the 2015 DSUR, will pay for all costs
associated with drafting such DSUR.

Service Recipient will pay for all reasonable and documented filing fees
incurred by Service Provider to submit the 2015 DSUR in the event that Service
Provider must submit the DSUR due to timing constraints re: sponsorship transfer
vs DSUR submission due date (26Aug2015)

Notwithstanding the foregoing, Service Recipient will compensate Service
Provider for all costs incurred by Service Provider, including personnel costs,
for such Services after September 15, 2015.

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

4
Regulatory / Safety
EU
Residual Documentation
•    Service Provider will and will cause its affiliates to provide residual
documentation related to the MACI00809 Study or its transfer, if any, including,
without limitation, documentation for the trial master file to Service
Recipient.
Upon the Service Recipient becoming sponsor of the MACI00809 Study in each
affected jurisdiction
N/A

SECTION 9.3
MEDICAL AFFAIRS AND MEDICAL INFORMATION ACTIVITIES FOR MACI00809 STUDY and US
CARTICEL PROMOTIONAL REVIEW

The Parties hereby agree that time is of the essence to transfer sponsorship of
the MACI00809 Study from Service Provider to Service Recipient, with an
effective transfer date as of the Target Transfer Date and as further described
on Schedule 9.2.

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

#
Function
Region
Title
Services
Termination Date
Billing/
Fee
1
Promotional Review Process
US
Promotional material review ERC/ePME/ 4M
Service Provider will have final approval authority of promotional materials and
medical communications following Service Recipient review until license transfer

Upon Service Recipient becoming BLA license holder with respect thereto for
Carticel
N/A
2
Clinical, Medical Affairs, Program Management
US and EU
MACI00809 Study
The Parties will use best efforts to effect the transfer of sponsorship in each
affected jurisdiction from Service Provider to Service Recipient in a timely
manner. Both Parties will take appropriate action regarding the sponsorship
change, including, without limitation, for purposes of example only, Service
Recipient is responsible for contacting the competent health authority in Poland
regarding Service Recipient’s assumption of sponsorship for the MACI00809 Study.

Service Provider or its affiliates will remain the sponsor for all site Clinical
Trial Agreements and vendor contracts in support of the MACI00809 Study, until
effective and legal assignment of such contracts has been made to Service
Recipient, which Service Provider shall undertake upon request of Service
Recipient on a case-by-case basis (the “Assignment”), provided, however, that
the CRO agreement with Covance will not be assigned to Service Recipient,
Service Provider shall use its commercially reasonable efforts to effect such
Assignment. If the Parties agree that no assignment is necessary in the case of
a contract, then Service Provider’s obligation to remain sponsor for purposes of
that contract shall terminate upon the transfer of sponsorship to Service
Recipient.

Service Provider hereby agrees to oversee site closure activities.

Service Recipient will accept in a timely manner, according to mutually agreed
upon, reasonable contractual terms, to the assignment of any agreement necessary
to effect the transfer of sponsorship.

Service Recipient and Service Provider will use commercially reasonable efforts
to ensure the timely transfer of the TMF by the Target Transfer Date.
Until the earlier of Service Recipient becoming sponsor of the MACI00809 Study
in each affected jurisdiction or November 1, 2015.
Service Provider will pay final site closure payments and the cost of site
closure activities
Submission fees will be paid as set forth in Section 9.2 (1)

Notwithstanding the foregoing, Service Recipient will compensate Service
Provider for all costs incurred by Service Provider, including personnel costs,
for such Services after September 15, 2015.

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

SIXTH AMENDMENT TO TRANSITION SERVICES AGREEMENT

This Sixth Amendment (the “Sixth Amendment”), effective as of the date last
signed by both parties (the “Amendment Effective Date”) is by and between
Genzyme Corporation, a Massachusetts corporation (“Service Provider”), and
Vericel Corporation, formerly known as Aastrom Biosciences Inc., a Michigan
corporation (“Service Recipient” or “Vericel”) (collectively, the “Parties”).

WHEREAS, effective as of May 30, 2014, Service Provider and Service Recipient
entered into that certain Transition Services Agreement, as amended from time to
time (collectively, the “Agreement”) which described transition services that
Service Provider agreed to provide to Service Recipient in support of the sale
of three (3) products (Carticel®, Epicel® and Matrix Applied Characterized
Autologous Cultured Chondrocytes (“MACI®”), and collectively the “Products”) to
Service Recipient (the terms of the sale are memorialized in a separate Asset
Purchase Agreement between Sanofi, a French Société anonyme and Service Provider
Affiliate (“Sanofi”) and Vericel, dated as of April 19, 2014 (the “Asset
Purchase Agreement”));

WHEREAS, the Agreement will expire on December 31, 2015;

WHEREAS, certain of the services provided by Service Provider to Service
Recipient under the Agreement, including without limitation,
1)
IT services related to data transfer,

2)
Data Controller and data hosting services until such time as data controller
responsibility may be legally transferred, and

3)
Transferred Intellectual Property missing residual documentation,

require additional time and support for wind-down activities; and

WHEREAS, Service Provider has agreed to provide these wind-down activities
services, subject to certain dependencies and limitations specified in this
Sixth Amendment; and

        
NOW, THEREFORE, in consideration of the above-recitals, the mutual benefits to
be derived by the Parties, and other good and valuable consideration, the
receipt and satisfaction of which are acknowledged, Service Provider and Service
Recipient agree to amend the Agreement as follows:

1.
All capitalized terms not defined herein shall have the same meaning as set
forth in the Agreement. For purposes of clarity, the Agreement in certain
instances relies on definitions as set forth in the Asset Purchase Agreement,
and all capitalized terms defined in neither this Sixth Amendment nor the
Agreement shall have the same meaning as set forth in the Asset Purchase
Agreement.

2.
Section 2.9, Data Hosting Services. Sections 2.9.2 and 2.9.3 of the Agreement
are hereby stricken and replaced by the following Sections 2.9.2 and 2.9.3:

“
1.Identification of Parties.

EU Data Directive-Governed Information. With respect to such data that is
governed by the EU Data Directive, the Parties agree:
that upon the transfer of the EU marketing authorisation for Matrix Applied
Characterized Autologous Cultured

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

Chondrocytes (“MACI”) to Service Recipient on August 26, 2014 (“MAH Transfer
Date”), as it relates to MACI data, subject to clause 2.9.2.1.2 below,

a)
Service Recipient is the Data Controller under this Agreement for data generated
on or after the MAH Transfer Date (the “Post-MAH Transfer Data”); and

b)
Service Provider is a Data Processor under this Agreement for the Post-MAH
Transfer Data.

Service Recipient hereby warrants and represents that there were no Epicel
patients subject to the EU Data Directive after the Closing Date.
For all data generated before the MAH Transfer Date, Service Provider or its
Affiliate is and shall remain the Data Controller until such time as it may
legally transfer Data Controller status to Service Recipient.

Other Data. The Parties hereby acknowledge that Other Data is not subject to the
EU Data Directive, but use terms herein consistent with the EU Data Directive
for ease of administration in identifying roles and responsibilities. With
respect to Other Data as of the Closing Date, the Parties hereby agree that,

a)
Service Recipient is the Data Controller under this Agreement; and

b)
Service Provider is a Data Processor under this Agreement.

2.Compliance with Applicable Data Protection Laws

a)
Service Recipient agrees to comply with all applicable data protection laws and
covenants not to place Service Provider in violation of applicable data
protection laws. In relation to data stored on Service Provider servers since
Service Recipient became Data Controller in the applicable jurisdiction, Service
Recipient warrants and represents that it has and will apply the applicable data
protection laws, and to Service Recipient’s knowledge (in this instance, defined
as known or reasonably should have known), it has not placed Service Provider in
violation of applicable data protection laws.

b)
With respect to the data for which Service Provider is the Data Processor,
Service Provider shall act only on instructions of Service Recipient with regard
to the Processing of Personal Data or Other Data in accordance with the
Agreement. Service Provider shall cause its Affiliates to act only on such
instructions from Service Provider (after it has received such instructions from
Service Recipient) and/or directly from Service Recipient.

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

c)
With respect to the data for which Service Provider or its Affiliate is the Data
Controller, Service Provider or its Affiliate will use commercially reasonable
efforts to seek the transfer of Data Controller status to Service Recipient. The
Parties hereby acknowledge and agree that transfer of Data Controller status may
occur on a rolling basis, depending on the nature of the information that is the
subject of the transfer.

d)
At the time of transfer of Data Controller status for particular controlled
information, Service Provider will become the Data Processor for such
transferred information until the expiration or termination of this Agreement.

e)
The Parties hereby agree that if the Parties or, in the case of Service
Provider, its Affiliate, enter into a European Commission “Commission Decision
C(2010)593 Standard Contractual Clauses (processors)” agreement for the transfer
of data (hereinafter, a “Data Export Agreement”), then in the event of any
conflict between the provisions set forth in Section 2.9 of this Agreement and
the provisions of the Data Export Agreement, the provisions of the Data Export
Agreement shall control, provided however that Subsection 2.9.5 of this
Agreement shall control with respect to issues concerning limitation of
liability.”

3.
Section 4.1, Term. Section 4.1 is hereby stricken and replaced in its entirety
by the following:

“4.1. Term. This Agreement will commence on the Effective Date and remain in
effect until June 30, 2016 (the “Term”), unless earlier terminated under this
ARTICLE 4. With respect to each Service, such Service will begin upon the
applicable start date set forth in the Transition Services Schedule, unless
earlier terminated under this ARTICLE 4. This Agreement may be extended by the
Parties in writing, either in whole or with respect to one or more of the
Services.”

4.
Section 13.2, Inspection Rights. The following is hereby appended to the end of
Section 13.2:

“Notwithstanding the foregoing, during the Term, with respect to the data for
which Service Provider or its Affiliate is Data Controller at the time of the
request, upon notice, Service Provider agrees to allow Service Recipient to view
such data to fulfil regulatory reporting or audit obligations; provided, that
Service Recipient shall comply with Service Provider's reasonable security and
safety procedures as such procedures are communicated to Service Recipient and
that Service Provider has the right to attend and control the scope of the audit
to ensure the audit is limited to data for which Service Provider or its
Affiliate is Data Controller.”

5.
Schedule 1. Transition Services Schedule. As of the Amendment Effective Date,
all Services set forth in the Transition Services Schedule in Section 9 shall
terminate, and those Services set forth in Section 10, Wind-Down Activities
Services, attached hereto and incorporated herein by reference as Attachment 1,
shall commence.

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

6.
Miscellaneous. The Parties acknowledge that, as set forth in Section 7.22 of the
Asset Purchase Agreement, all transition services were to end by May 29, 2015.
Service Provider hereby confirms that Service Provider has received approval
from its Affiliate to continue certain transition services beyond May 29, 2015.
The Parties hereby agree that, notwithstanding the term limit to the transition
services set forth in Section 7.22 of the Asset Purchase Agreement, the Services
will be extended as set forth in this Sixth Amendment.

*    *    *
The rights and obligations of the Parties or any dispute arising out of this
Sixth Amendment will be interpreted, construed and enforced in accordance with
the laws of the State of New York, excluding its conflict of laws rules to the
extent such rules would apply the law of another jurisdiction.

This Sixth Amendment will terminate in accordance with the terms set forth in
the Agreement.

Except as set forth in this Sixth Amendment, the terms of the Agreement shall
remain in full force and effect; provided however, that in the event of a
conflict between a term contained in this Sixth Amendment and a term contained
in the Agreement, the term contained in this Sixth Amendment shall prevail. The
Agreement, as amended, together with the Asset Purchase Agreement and the other
Ancillary Agreements, constitutes the entire agreement between and among the
Parties with regard to the subject matter of this Agreement, and supersedes all
prior agreements and understandings with regard to such subject matter. Except
for the Confidentiality Agreement and SDEA, there are now no agreements,
representations or warranties between or among the Parties other than those set
forth in the Agreement, the Asset Purchase Agreement or the Ancillary
Agreements.

IN WITNESS WHEREOF, Service Provider and Service Recipient have caused this
Sixth Amendment to the Agreement to be executed by their duly authorized
representatives as of the Amendment Effective Date.

GENZYME CORPORATION                    VERICEL CORPORATION

Signature:                            Signature:                

Name:                                Name:                    

Title:                                Title:                    

Date:                                Date:                    

        
9

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

Attachment 1

SCHEDULE 1

Transition Services Schedule

Section 10: Wind-Down Activities Services

Section 10.1
IT Services and Systems Access

1
Without prejudice to Section 8.3 of this Agreement, the Service Provider will
provide to the Service Recipient support only with respect to the Transferred
Employees and new employees that are replacing Transferred Employees or who
otherwise require support as reasonably requested by Service Recipient.
Exception: Local Network Connectivity, global network connectivity, and internet
connectivity will be provided to employees of the Service Recipient who require
such access.

2
The Service Provider has the responsibility to provide the Service Recipient
with administrative access to Service Recipient-owned IT assets (computers,
servers, laptops, desktops, etc.), or infrastructure (firewalls, routers,
switches, etc.) only if they are physically located within one of the
transferred offices and are dedicated to the exclusive use by the Business,
provided however that while any such computers and/or infrastructure are still
connected to the Service Provider’s network and until they are segregated in
full, any changes to workstation and/or infrastructure configuration must be
reviewed and approved in advance by the appropriate Service Provider personnel.

3
Administrative access will not be provided to any shared (i.e., only partially
dedicated to the use by the Business) servers, infrastructure, or any other
devices, which are not Transferred Assets (this includes, without limitation,
routers, shared file and print servers, etc.).

4
Service Provider reserves the right to upgrade, replace, or discontinue
individual services as part of Service Provider’s ongoing and regular business
operations. Service Recipient will be provided notice of Service Provider’s
intent to change or discontinue any IT service as soon as practicable once such
plans are revealed to the Service Provider Manager. In any event, commercially
reasonable efforts will be made to avoid or minimize impact to Service
Recipient’s ongoing business operations and Service Provider will provide
Service Recipient with reasonable notice of any changes.

5
Without prejudice to section 8.3 of this Agreement, nothing in this Transition
Services Schedule shall oblige the Service Provider to provide access to the
Service Recipient and/or any of the Service Recipient Personnel to any
information services systems and/or applications other than those listed in
Schedule 10.1.

6
The term date for each of the Services and Systems Access set forth in this
Schedule 10.1 is the earlier of the end of need for the Services as controlled
by Service Providers’ ability to legally transfer data related to a specific
system or June 30, 2016. In the event that such data cannot be transferred to
Service Recipient, Service Provider and Service Recipient will agree to extend
this Agreement as it relates to the Data Hosting Services set forth in Section
2.9 and

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

companion IT requirements set forth in this Schedule 10.1, and determine a
process for Service Recipient to continue to have access to such data.

7
There are no charges associated with the Services or Systems Access set forth in
this Schedule 10.1.

10.1.1 Services

#
Function
Region
Title
Services
1
IT: GIS
US/

GIS General
Services
Service Provider to provide the following to Service
Recipient:

Core Security Service - monitor and assist in resolving any Security threats and
risks (perimeter, virus, spam)
2
IT: GIS
US/

GIS Network
Services
Service Provider to provide the following services to Service
Recipient:

Global Network Connectivity (WAN) - maintain WAN circuit operations, escalate
circuit issues to Telco and troubleshoot to resolution. Monitor WAN availability
and performance.
Local Network Connectivity (LAN) - monitor and troubleshoot to ensure
availability and performance.
Remote Access Service - maintain operation of WebVPN
or other applicable user remote access solutions.
Internet Connectivity - maintain operation of common Internet access for
business needs of Cell Therapy users during service transition to Service
Recipient’s infrastructure.
i)Cambridge Site

3
IT: GIS
US/
GIS Server Operations Services
Service Provider to provide the following services to Service
Recipient at sites other than the transferred sites:

Housing Service (Data Center operations): monitoring of DC environment,
availability and adequate performance.
Server Service - For existing servers: monitor for availability and performance,
apply critical OS patches and fixes. Note, no additional servers will be
provided by this service during the TSA period.

[Continued next page]

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

#
Function
Region
Title
Services
4
IT: GIS
US/

GIS User
Services
Service Provider will provide the following services to Service
Recipient:

Enterprise Computer service, Electronic Software Distribution - apply critical
desktop OS patches and fixes as appropriate, maintain operation of desktop
anti-virus infrastructure.
Service Desk - provide end user support, liaise with other Service Provider
and/or Service Recipient support groups to assist in resolving user issues.
Enterprise Directory Service, Network Access Service (User Account Operations) -
maintain operation of Active Directory infrastructure and provide support for
end-user accounts (setup, troubleshoot, administer) for former Service Provider
personnel.
Workspace Solution service (File & Print Services) - maintain operation of
general File Share and common Printing infrastructure, including setup,
troubleshooting, and administration, for former Service Provider personnel
The Parties will use commercially reasonable efforts to transfer or otherwise
resolve PC leases
5
IT
EU/US
Application
Service Provider will provide the following services to Service
Recipient AS PER SECTION 10.1.2 below

If Service Recipient employees (not former Service Provider employees) require
access to the systems they will be granted access as contractors, and Service
Recipient will be responsible for formal background checks and any training
required Service Recipient

10.1.2 Systems Access

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

#
Department
System
Employees that need continued access after
June 1, 2015
Rationale
1
Quality Assurance
Trackwise
All Sidney Street users
Complete transfer of all CTRM data and workflows from Sanofi to Vericel
2
Manufacturing
SQL Epicel Patient Information Database
Melvin Posada
Ongoing use of Epicel Patient Information Database until system can be
transferred and validated
3
Engineering
Continuum BMS
Joe Romano
Tom Harmon
Ongoing need for BMS until system transfer and validation is complete
4
Materials Management
MFG\PRO and SAP
Brian Dunderdale
Kristen Appleman
Alex Ernesti
Sze Chan
Nancy Minghella
Melvin Posada
David Conrad
Abdell Omalek
Fernando Davalos
Open POs and Raw Material Receipts and Transfers
5
Quality Assurance
Quality Control
MFG\PRO and SAP

Melissa Sukernick
Kyle Giroux
Chad Worthley
James George
Carmen Zvinca
Lauren Peterson
Elizabeth Foley
Josephine Johansen
Adrian Todor
Ed Fasano
Matt Stevens
Rob Manzella
Sam Prinzi
Jason Greenberg
Used on daily basis to release product - one person from each shift requires
access
6
Customer Care
SAP
Tim McKeen
Jennifer Fisher
James Bonasoro
Chad Matthes
Connie Correia
Sydney Laguerre
Open Sales Orders and Credits
7
Quality Assurance
Catsweb
Cindy Entstrasser
Melissa Sukernick
Alex Ernesti
Complete CTRM Adverse Event data transfers
8
Network
VPN: 64 - AA
All Sidney Street users
Maintain VPN connectivity between 64 Sidney St and AA
9
Quality Assurance
Clinical
LiveLink
Josh Hodgson
Ann Remmers
Extract remaining necessary data

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

10.1.3 Email Services

Service Provider will continue to provide email services for to Service
Recipient employees identified above in Section 10.1.2 solely for notifications
for essential applications, including Trackwise (Line #1). The email services
will terminate on the system termination.

Section 10.2

REGULATORY and PHARMACOVIGILANCE ACTIVITIES

Subject to Section 2.8 of this Agreement, Service Provider will use commercially
reasonable efforts to facilitate the timely provision of Transferred
Intellectual Property residual documentation (“Residual Documentation”), as
further set forth below:

#
Function
Region
Title
TSA Scope
Termination Date
Billing/Fee
1
Regulatory / Safety
EU
Residual Documentation
Upon notification of missing Residual Documentation by Service Recipient, the
prerequisite for such notice being Service Recipient’s own due diligence in
reviewing the data and files to which Service Recipient has access at the time
of the request, Service Provider will coordinate the provision of Residual
Documentation to Service Recipient related to: the MACI00809 and MACI00206
Studies or their transfer, if any, including, without limitation, documentation
for the trial master files; and MACI nonclinical studies, including, without
limitation, the nonclinical pharmacology study GENZ 06-0239 (6 month horse study
of MACI).
 June 30, 2016
N/A