Human Umbilical Cord Blood Processing Services Agreement - Viacord Inc. and Progenitor Cell Therapy LLC
AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
This AGREEMENT for Human Umbilical Cord Blood Processing Services (the
"Agreement"), effective December 1, 2001 (the "Effective Date") is by and
between VIACORD, INC. ("VIACORD"), a Delaware corporation and a wholly-owned
subsidiary of ViaCell, Inc., with its principal office at 131 Clarendon Street,
3rd Floor, Boston, Massachusetts 02116, and PROGENITOR CELL THERAPY, L.L.C.
("PCT"), a limited liability company organized and existing under the laws of
the state of New Jersey, with its principal office at 20 Prospect Avenue, Suite
400, Hackensack, New Jersey 07601.
RECITALS
WHEREAS, PCT operates a laboratory that processes human cells for the
treatment of human disease, including, without limitation, cellular therapy
services;
WHEREAS, ViaCord is a private human umbilical cord blood banking company
that engages in the business of private cord blood banking, which includes
collecting blood from a newborn's umbilical cord and/or placenta immediately
after delivery, and the processing and freezing of such blood for long-term
cryogenic storage;
WHEREAS, ViaCord desires to engage PCT to provide the services listed in
Attachment I (the "Services") pursuant to the terms of this Agreement, and PCT
desires to accept such engagement pursuant to the terms of this Agreement; and
NOW, THEREFORE, in consideration of the premises and the mutual covenants
and other good and valuable consideration hereinafter contained, the parties
hereto agree as follows:
1. ENGAGEMENT
1. ViaCord hereby engages PCT, and PCT accepts such engagement,
to provide the Services subject to and upon the terms and
conditions set forth in this Agreement.
2. PCT RESPONSIBILITIES AND REPRESENTATIONS
1. Subject to Section 3.2 hereof, PCT shall be responsible for
scheduling and performing the Services so as to meet ViaCord's
reasonable business and quality requirements.
2. PCT shall be responsible for communicating to ViaCord all
quantitative results generated as part of the Services in a
manner consistent with ViaCord's standard operating procedures
("SOPs").
3. PCT will perform the Services in accordance with:
i. all applicable legal requirements, including, but not
limited to, the laws of the states of New York and New
Jersey;
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
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AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
ii. ViaCord and PCT's SOPs. Where ViaCord procedures are to
be adhered to and where PCT procedures are to be adhered
to is detailed in PCT's SOP Number 01.041A, included
here as Attachment II. Each party agrees to provide the
other party with advance written notice of any material
changes to their respective relevant SOPs.
4. PCT will obtain and maintain licensure from the states of New
York and New Jersey for processing human umbilical cord blood
units ("HUCB' s") prior to processing any units originating in
either of these states.
5. PCT will provide reasonable cooperation for ViaCord to obtain
and maintain AABB accreditation for the Services. ViaCord will
pay all costs associated with obtaining and maintaining such
accreditation.
6. PCT agrees to be audited by ViaCord from time to time. All
audits shall occur at such time and with such frequency as
mutually agreed upon by both parties in advance; provided,
however, that ViaCord shall provide no less than twenty-four
(24) hours prior written notice to PCT prior to conducting an
audit pursuant to this Section 2.6. For the purpose of
conducting such audit, PCT shall make its facilities and
records available to ViaCord.
7. Prior to the commencement of the Services, PCT shall undergo
and pass a Vendor Qualification per ViaCord [*], which is
included here as Attachment III. PCT's approval as a vendor is
not to be unreasonably withheld by ViaCord.
8. PCT shall not provide the Services outside of its [*] without
the written consent of ViaCord.
9. PCT will ensure that all quarantine and long-term storage
freezers are connected to emergency backup power and
environmental monitoring and alarms systems.
10. Upon written request, and at ViaCord's expense, PCT will
prepare HUCBs for transplants in accordance with ViaCord's
Procedures.
3. VIACORD RESPONSIBILITIES AND REPRESENTATIONS
1. ViaCord will be responsible for the collection of cord blood
from patients and transportation of the cord blood to PCT's
laboratory.
2. To assist with daily scheduling, ViaCord will notify PCT as
soon as possible when an HUCB is due to arrive at PCT.
Typically this means notifying PCT once a patient goes into
labor, at which time ViaCord will notify PCT of the estimated
time of arrival of the HUCB at PCT.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
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AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
3. ViaCord will pay all costs associated with obtaining AABB
accreditation in connection with the Services.
4. ViaCord will pay all costs related to the preparation and
transportation of HUCBs for transplant.
5. ViaCord shall provide, at ViaCord's expense, all quarantine
and long-term storage freezers used for the storage of ViaCord
product. These freezers, and the capital equipment described
in Attachment I, shall remain ViaCord property and shall be
removed from PCT prior to the termination of this Agreement.
4. MUTUAL RESPONSIBILITIES AND REPRESENTATIONS OF BOTH PARTIES
1. The Parties agree to the terms of a Quality Agreement
("Quality Agreement"), which is included here as Attachment
IV.
2. The Parties acknowledge and agree that each HUCB shall be the
property of the donor child. The parents of such child shall
have custodial ownership of such HUCB until the donor child
reaches the age of majority at which time the donor child
shall own the HUCB.
3. Prior to the commencement of Services, PCT and ViaCord shall
execute a Technology Transfer Protocol that is mutually
acceptable to both PCT and ViaCord. The Technology Transfer
Protocol shall be included here as Attachment V.
5. SERVICE CHARGES AND BILLING PROCEDURES
1. ViaCord shall compensate PCT for the Services according to the
fee schedule contained in Attachment I.
2. PCT shall invoice ViaCord at the time of service. Payment is
due within thirty (30) days of the date of each such invoice.
With respect to any compensation or portion thereof not paid
within ten (10) days after the date upon which the same are
due, ViaCord shall pay a late charge equal to the lesser of
eighteen percent (18.0%) per annum or the maximum allowable
rate of interest permitted by law. Upon any default by ViaCord
of any term or condition hereunder, with respect to its
obligations hereunder, which has not been cured by the
expiration of the applicable period under Section 8.2, PCT
may, with or without terminating this Agreement, exercise all
rights and remedies afforded by law.
3. The parties agree to negotiate in good faith any pricing
changes resulting from any material change to the Services.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
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AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
6. RELATIONSHIP OF THE PARTIES
1. The relationship between ViaCord and PCT with respect to the
Services shall be that of independent contracting parties. In
this regard, the parties agree that: (i) nothing in this
Agreement shall be construed to create a principal-agent,
employer-employee, or master-servant relationship or that of
partners or joint venturers between the parties; and (ii) each
party shall be liable for its own debts, obligations, acts,
and omissions, including the payment of all required
withholding, social security and other taxes on behalf of its
employees. None of the employees or contractors engaged by
either party shall be deemed employees of the other party.
7. INDEMNIFICATION; INSURANCE; DISCLAIMER
1. ViaCord shall indemnify, defend and hold harmless PCT, its
members, their affiliates, and their respective directors,
officers, and employees, from any and all costs, damages,
injunctions, suits, actions, fines, penalties, liabilities,
losses, settlements, claims, demands and expenses of any kind
(including, but not limited to, legal costs and reasonable
attorneys' fees) made by or on behalf of any party, person, or
governmental entity which result or arise out of any of the
acts or omission of ViaCord, its employees, officers,
directors and agents in connection with its obligations under
this Agreement. This provision shall survive the termination
of this Agreement, regardless of the reason for termination.
2. PCT shall indemnify, defend and hold harmless ViaCord, its
affiliates, directors, officers, and employees, from any and
all costs, damages, injunctions, suits, actions, fines,
penalties, liabilities, losses, settlements, claims, demands
and expenses of any kind (including, but not limited to, legal
costs and reasonable attorneys' fees) made by or on behalf of
any party, person, or governmental entity which result or
arise out of any of the acts or omission of PCT, its
employees, officers, directors and agents in connection with
its obligations under this Agreement. This provision shall
survive the termination of this Agreement, regardless of the
reason for termination.
3. The foregoing indemnification shall be contingent on: (i)
prompt written notice of any claim or proceeding subject to
such indemnity; (ii) cooperation in the defense and settlement
of such claim at the expense of the indemnifying party where
such indemnifying party is not a defendant, in the suit
involving such claim; (iii) prior written approval by
indemnifying party of any settlement, which approval shall not
be
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
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AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
unreasonably withheld. The defense of such claim or assertion
and any action relating thereto shall be within the control of
the indemnifying party; provided, however, that the
indemnifying party's choice of counsel shall be reasonably
satisfactory to the indemnified party.
4. Each party shall maintain and keep in full effect throughout
the term of this Agreement, professional liability insurance
coverage in the amount of not less than [*] in the aggregate
per year for damages arising out of its performance hereunder.
Additionally, each party shall maintain and keep in full force
and effect throughout the term of this Agreement, other
insurances and coverages necessary for the operation of their
respective businesses, consistent with the standards in the
respective communities.
5. The parties acknowledge and agree that the Services are not
deemed to be products. Therefore, ViaCord acknowledges and
agrees that PCT does not in any way warrant the
merchantability or fitness for a particular purpose of the
Services; provided, however, that each party represents and
warrants to the other that its services small be performed in
a professional and workmanlike manner.
8. TERM; TERMINATION
1. The term of this Agreement shall be from the Effective Date
through June 30, 2002.
2. Either party to this Agreement may, at any time at its
election, terminate this Agreement forthwith and shall have no
further obligations hereunder by delivering written notice of
termination to the non-terminating party upon occurrence of
any one or more of the following events: (i) except with
respect to the payment obligations contained in Section 5
hereof, any material breach by either party of any of the
obligations established hereunder or other written agreements
between the parties if such breach continues for thirty (30)
days after receipt by the breaching party of notice specifying
such breach in reasonable detail; (ii) failure to make payment
in accordance with Section 5 hereof within ten (10) days of
the date upon which a payment is due pursuant to Section 5 if
such breach continues for three (3) days after receipt by the
breaching party of a demand for immediate payment; or (iii)
either party voluntarily files a petition in bankruptcy, makes
an assignment for the benefit of creditors, otherwise seeks
relief from its creditors under any federal or state
bankruptcy, insolvency, reorganization, or moratorium statute,
or either party is the subject of an involuntary petition in
bankruptcy which is not set aside within sixty (60) days of
its filing.
3. Upon termination of this Agreement, or upon any written
request from ViaCord, PCT agrees to relinquish to ViaCord any
HUCB(s) (contained in freezers), patient file(s), processing
record(s) and/or any capital equipment (including freezers)
paid for by ViaCord under this Agreement; provided, however,
that ViaCord has paid in full for the Services related to any
such
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
HUCB(s), patient file(s), processing record(s) and/or capital
equipment. PCT shall provide any reasonable accommodations, at
ViaCord's expense, for the transfer of any such HUCB(s),
patient file(s), processing record(s) or capital equipment.
9. CONFIDENTIALITY
1. Confidential Information means any and all data, records,
reports, policies, knowledge, information and materials of a
party, including, without limitation, all data, records,
reports, policies, knowledge, information and materials
relating to this Agreement and/or such party's performance
hereunder. Without limitation of the foregoing, Confidential
Information of a party shall include all (i) technical
knowledge, information and materials of such party, such trade
secrets, data, concepts, ideas, information, processes,
formulae, improvements, inventions, computer programs, source
code, object code, micro code, documentation, diagrams, flow
charts, drawings, and experimental and development work
techniques; (ii) marketing and other business information of
such party, such as customer lists, marketing and business
plans, manuals and personnel records or data; and (iii)
Intellectual Property of such party. For purposes of this
Agreement, the terms and conditions of this Agreement shall be
deemed Confidential Information of each party. Confidential
Information shall not include information which: (1) is or
becomes publicly available without breach of this Agreement by
the party receiving the Confidential Information; (2) released
to the receiving party for disclosure by the disclosing party;
(3) known by the receiving party prior to the disclosure; or
(4) required to be disclosed by law or is compelled to be
disclosed by a court of competent jurisdiction; provided,
however, that notice is given to the other party of such
requirement as soon as possible and reasonable assistance is
rendered to such concerned parties, if requested, to prevent
such requirements becoming effective.
2. Each party shall (i) keep secret and retain in confidence, and
(ii) not use for its own benefit (except as expressly required
by this Agreement in connection with the performance of its
obligations hereunder or except as otherwise expressly
provided in this Agreement) the Confidential Information of
the other party. Upon termination of this Agreement for any
reason, subject only to ViaCord's right to retain patient
files pursuant to Section 8.3 hereof, each party shall
immediately deliver to the other party all Confidential
Information of such other party within its possession and/or
control.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
10. MISCELLANEOUS
1. The parties further agree that PCT shall retain and make
available upon request of ViaCord for a period of [*] years
after the furnishing of the Services, the contract and books,
documents and records which are necessary to certify the
nature and extent of the costs thereof when requested by the
Secretary of Health and Human Services or the Comptroller
General, or any of their duly authorized representatives. The
provision relating to the retention and production of
documents is included because of possible application of
Section 1861 (v) (1) (I) of the Social Security Act to this
Agreement; if this section should be found to be inapplicable,
then this clause shall be deemed to be inoperative and without
force and effect.
2. Any notice required by this Agreement shall be deemed
sufficient if it is in writing and delivered personally or by
certified mail, return receipt requested, or overnight mail by
a nationally-recognized carrier (e.g., Federal Express) or by
facsimile, if followed by a copy sent by one of the
aforementioned methods addressed to the party at its principal
office and to the party or his legal representatives at the
addresses written above or to such other addresses as they may
designate by giving notice pursuant to this Section 10.2.
3. This Agreement shall be governed by and construed in
accordance with the law of the State of New Jersey.
4. This Agreement may not be amended or revised except with the
mutual written consent of the parties hereto.
5. This Agreement may be executed in any number of counterparts,
each of which shall be deemed an original, but all of which
shall constitute one and the same instrument.
6. Not withstanding any other provision in this Agreement, the
parties remain responsible for ensuring that any service
provided hereunder complies with all pertinent provisions of
Federal, State and local statutes, rules and regulations.
7. If any provision of this Agreement is or becomes invalid,
illegal or unenforceable in any respect, the validity,
legality and enforceability of the remaining provision
contained herein shall not be affected thereby, and the
parties acknowledge and agree that each of them shall be
required to
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
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AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
use their best efforts to negotiate a mutually acceptable
modification of provision(s) so as to satisfy applicable law.
8. Waiver, express or implied, of any default by either party of
any provision(s) of the Agreement shall not be deemed to be a
waiver of any other default. Waiver of any default shall not
affect the right of either party to require performance of the
defaulted provision at any further time.
9. No party may assign its rights and obligations under this
Agreement, except that each party has the right to assign its
rights and obligations hereunder to a successor to all or
substantially all of such party's assets related to this
Agreement, which successor agrees in writing to assume all
of such party's obligations hereunder. This Agreement shall
be binding upon and shall insure to the benefit of PCT and
ViaCord and their respective heirs, legal representatives,
successors and permitted assigns.
10. This Agreement represents the full understanding of the
parties regarding the subject matter and supercedes any prior
agreements between the parties on this subject.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
IN WITNESS THEREOF, the parties have hereunto set their hands and seals.
FOR VIACORD:
/s/ Robert A. Koshgarian 12/7/01
------------------------------------- -------------------------------
Robert A. Koshgarian Date
Vice President, Operations
ViaCell, Inc.
FOR PCT:
/s/ George S. Goldberger 12/11/01
------------------------------------- -------------------------------
George S. Goldberger Date
Chief Financial Officer
Progenitor Cell Therapy, L.L.C.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
ATTACHMENT I. SCHEDULES OF SERVICES, FEES AND FORECASTED QUANTITIES
Services performed by PCT for ViaCord include:
- Receipt of cord blood units for processing
- Processing of units per ViaCord's Procedures and PCT's SOP's
- Quarantine storage in [*]
- Long-Term storage in [*]
- Creation of patient files, recording of processing data and [*] into
patient files in accordance with ViaCord's Procedures
- Reporting of results to ViaCord's home office [*] after the
conclusion of processing or the [*].
Fee(s):
- ViaCord shall pay [*] for each cord blood unit processed. This
includes all materials and labor as well as all [*].
- ViaCord shall provide up to [*] for the purchase of capital
equipment. These payments will be due upon receipt of invoice. This
capital equipment shall remain ViaCord property and shall be removed
from PCT prior to the termination of this Agreement.
- Within twelve (12) months of the Effective Date, ViaCord shall
conduct contracted research at PCT totaling up to [*].
- ViaCord shall be responsible for all taxes related to the Services
provided under this Agreement except for taxes on PCT's net income.
- ViaCord shall provide, at ViaCord's expense, all quarantine and
long-term storage freezers. These freezers shall remain ViaCord
property and shall be removed from PCT prior to the termination of
this Agreement.
- ViaCord agrees to cover reasonable costs to secure appropriate
storage space for the freezers used for long-term storage. The parties
agree to negotiate in good faith regarding the size and functional
requirements for any such space.
Forecasted Quantities:
December, 2001: [*] Units
January, 2002: [*] Units
February, 2002: [*] Units
March, 2002: [*] Units
April, 2002: [*] Units
May, 2002: [*] Units
June, 2002: [*] Units
Notes on Forecasted Quantities:
1. All quantities contingent on ViaCord realizing these quantities in
actual deliveries each month.
2. The parties agree to negotiate in good faith regarding quantities
processed at PCT from April 1, 2002 through June 30, 2002 if ViaCord's
own processing facility becomes operational during this period.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
ATTACHMENT II. PCT'S SOP NUMBER [*] ("MATRIX OF SOP'S")
[*]
9 pages omitted pursuant to a request for confidential treatment.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
ATTACHMENT III. VIACORD VENDOR QUALIFICATION SOP
[*]
12 pages omitted pursuant to a request for confidential treatment.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
ATTACHMENT IV. PCT-VIACORD QUALITY AGREEMENT
QUALITY AGREEMENT
BETWEEN
VIACORD
AND
PROGENITOR CELL THERAPY, L.L.C.
Documentation of ViaCell, Inc. is considered proprietary and is made available
for business operations and review by employees of ViaCell and
regulatory agencies. Distribution to third parties
without written permission is prohibited.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
Quality Agreement 07 December 2001
TABLE OF CONTENTS
INTRODUCTION..................................................................3
LIST OF CONTACTS..............................................................3
Viacord...................................................................3
PCT.......................................................................3
MANAGEMENT RESPONSIBILITY.....................................................3
REGULATORY COMPLIANCE.........................................................4
CORD BLOOD PROCUREMENT SERVICES...............................................4
UMBILICAL CORD BLOOD PROCESSING AND STORAGE...................................4
TESTING SERVICES..............................................................4
MEDICAL MANAGEMENT............................................................4
TECHNOLOGY TRANSFER...........................................................5
TRAINING AND COMPETENCY ASSESSMENT............................................5
CHANGE REQUESTS...............................................................5
CORRECTIVE ACTIONS............................................................5
DOCUMENT CONTROL..............................................................6
AUDITS........................................................................6
QUALITY ASSURANCE MEETINGS....................................................7
DISPUTE RESOLUTION............................................................7
SIGNATURES....................................................................7
APPENDIX A LISTING OF SOPS..................................................8
APPENDIX B CHANGE CONTROL FORM..............................................9
Page 2 of 9
Documentation of ViaCell, Inc. is considered proprietary and is made available
for business operations and review by employees of ViaCell and
regulatory agencies. Distribution to third parties
without written permission is prohibited.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
Quality Agreement 07 December 2001
INTRODUCTION
Viacord (a wholly owned subsidiary of ViaCell, Inc.) is a premier provider of
umbilical cord blood (UCB) stem cell preservation services and Progenitor Cell
Therapy, L.L.C. (PCT) has developed substantial expertise in cell processing
technology. Viacord and PCT intend to enter into an agreement whereby PCT
performs processing, testing, and storage of UCB units for Viacord. This quality
agreement specifies the procedures and actions that Viacord and PCT will
undertake to ensure the maximum quality of the UCB units.
LIST OF CONTACTS
The following individuals from Viacord and PCT may be contacted regarding any
quality issues relating to procedures and policies described in this document:
VIACORD
[*], Manager of Quality Assurance, [*]
Bob Koshgarian, Vice President, Operations (617-320-4704,
rkoshgarian@viacellinc.com)
Kurt Gunter, SVP, Clinical & Reg. Affs./Gov. Relations, kgunter@viacellinc.com,
617-603-6164
PCT
Robert A. Preti, Ph.D., President & Chief Scientific Officer,
rpreti@progenitorcell.net, 201.291.2778
[*], QA Director, [*]
[*], National Director of laboratory Operations, [*]
MANAGEMENT RESPONSIBILITY
Both parties agree to define and document the responsibility, authority, and
relationship of personnel who perform, verify, or manage work related to the
product under this Agreement. The responsibility of these personnel is such that
there will be no limit in their efforts to maintain the quality and safety of
the products and services outlined in this Agreement. This will be accomplished
by their commitment to training, providing the best possible resources, internal
assessments and audits, and compliance with the regulations under which each
company operates.
Page 3 of 9
Documentation of ViaCell, Inc. is considered proprietary and is made available
for business operations and review by employees of ViaCell and
regulatory agencies. Distribution to third parties
without written permission is prohibited.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
Quality Agreement 07 December 2001
REGULATORY COMPLIANCE
Both parties agree to establish standard operating procedures (SOPs) consistent
with industry standards and guidelines established by regulatory agencies (i.e.,
FDA, New York state, New Jersey state) and quality standards [i.e. American
Association of Blood Banks (AABB), Foundation for the Accreditation of
Hematopoietic Cell Therapy (FAHCT)]. The responsibility of maintaining
compliance with regulatory agencies is the sole responsibility of each company.
PCT will be responsible for obtaining all necessary licensures and
accreditations as required by local, state and federal laws, including those of
the states of New York and New Jersey. PCT will also, in good faith, work with
Viacord to achieve accreditation with AABB for its UCB processing services.
CORD BLOOD PROCUREMENT SERVICES
Viacord will be responsible for all cord blood procurement services. Viacord
will direct certain cord blood collections to PCT for processing and storage.
Viacord will be responsible for [*].
UMBILICAL CORD BLOOD PROCESSING AND STORAGE
PCT will be responsible for the processing and storage of UCB collections
shipped to PCT' s facilities as directed by Viacord. PCT will utilize reasonable
judgment based on current industry practices, relevant regulations and
scientific expertise to optimally manage all processing and storage services.
TESTING SERVICES
PCT will be responsible for all testing of UCB units stored for Viacord. Such
testing will be in compliance with all applicable local, state and federal
regulations, including those of the states of New York and New Jersey. All
testing will also be in compliance with applicable AABB guidelines. PCT will be
responsible for reporting of the testing results to Viacord in a timely manner.
Prior to initiation of all testing procedures, PCT will allow Viacord's
Department of Quality Assurance to review and approve specific testing methods.
[*]
MEDICAL MANAGEMENT
Viacord will be responsible for the medical management and all medical decisions
regarding the disposition of UCB collections (e.g., quarantine storage).
Viacord's medical director will consult with the director of PCT's laboratory
prior to any significant medical decision regarding the disposition of a
collection or UCB unit that has been processed. Viacord will be responsible for
the coordination of shipping UCB units for transplantation with the transplant
Page 4 of 9
Documentation of ViaCell, Inc. is considered proprietary and is made available
for business operations and review by employees of ViaCell and
regulatory agencies. Distribution to third parties
without written permission is prohibited.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
Quality Agreement 07 December 2001
center. PCT shall be responsible for sample and dry shipper preparations for UCB
units for transplantation. Viacord will also be responsible for collection of
follow up medical data from patients transplanted with Viacord's UCB units.
TECHNOLOGY TRANSFER
Both parties agree to execute a prospectively defined technology transfer
protocol to ensure that all Viacord procedures will be successfully carried out
by PCT personnel and that all appropriate equipment used by PCT in the
processing, testing, and storage of Viacord UCB collections is appropriately
validated. The technology transfer document will be reviewed and approved by
both parties in advance of execution. Following the execution of the technology
transfer protocol, PCT will prepare a report and submit it to Viacord. Viacord
will review the report and recommend any required amendments or additional
experiments. Following approval of the final technology report by Viacord, the
technology will be considered to have been successfully transferred to PCT.
TRAINING AND COMPETENCY ASSESSMENT
All employees directly involved with the processing, testing, and storage of UCB
units must be properly trained and competency assessment must be completed and
documented. Training will be performed and documented by competent peers and/or
managers, utilizing all appropriate SOPs and manuals. Viacord will inspect
training and competency documentation during audits. Continued competency
assessment will be performed and documented at regular intervals. Competency
assessments will be conducted by direct managers, through questions and
observations directly related to the SOPs/manuals utilized in the processing,
testing and storage of UCB units.
CHANGE REQUESTS
Any and all changes made to the UCB processing, testing, and storage must go
through a Change Request process. A Change Control Form, (Appendix B) will be
completed and approved by appropriate individuals at PCT and Viacord. After such
approval, but prior to implementation, training will be conducted and
documented. No changes to the processing, testing, and storage of UCB units may
be implemented prior to PCT and Viacord' s approval of the change and all
appropriate training has been conducted and documented.
CORRECTIVE ACTIONS
PCT and Viacord will establish procedures for identifying, documenting and
implementing corrective actions. This exercise is critical to the adherence to
this Quality Agreement. The procedure will include, but not be limited to,
handling of error and accident reports and/or deviation reports, product
nonconformities, investigations resulting form any customer complaints, and
audits. Upon discovery of a deviation or error and accident, PCT shall notify
Viacord both verbally and in writing [*] of the occurrence. All investigations
will include the participation of both Viacord and PCT to determine the root
cause and corrective action required. All corrective actions will be tracked to
ensure implementation. Should a deviation, customer complaint, audit or other
situation identify a potential corrective action,
Page 5 of 9
Documentation of ViaCell, Inc. is considered proprietary and is made available
for business operations and review by employees of ViaCell and
regulatory agencies. Distribution to third parties
without written permission is prohibited.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
Quality Agreement 07 December 2001
PCT will have [*] to respond to Viacord's recommendation and [*] to complete the
corrective action process.
DOCUMENT CONTROL
PCT agrees to establish and maintain procedures and processes for the
appropriate control of documents. The procedure shall contain guidelines for the
identification, filing, access, storage, maintenance, and disposition of all
documents associated with the processing, testing, and storage of Viacord's UCB
units. Documents shall be maintained to demonstrate that a product conforms to
specified requirements and quality systems. Documents from suppliers directly
concerning the quality and/or specification of any material used in the
processing, testing, and storage of UCB units will be retained as well. All
documents will be legible, retained in a way so as to be easily retrievable, and
stored in such a way as to prevent damage, deterioration, and loss. Documents
will be deemed confidential and shall be stored in such a way as to prevent the
accidental or unauthorized retrieval of this confidential information. All
documents must be maintained for a period of time in accordance with applicable
regulatory standards. This is to include, but not be limited to, documents
referencing facility, processing documents in regard to product trace ability,
testing results, and general documents in regard to corrective actions,
deviations, and error and accident reports. Documents not included in the AABB
Standards shall be retained for a length of time as determined by the business
needs and requirements of PCT and Viacord.
Viacord may have access to all Viacord UCB-related documents upon reasonable
prior notice. Upon request, PCT will provide originals or copies of all
requested documents to Viacord. If Viacord requests transfer of Viacord-related
documents from PCT, PCT will be responsible for the archival, inventory, and
shipment to a site specified by Viacord. The shipment costs and the logistics
surrounding the receipt of this shipment will be the responsibility of Viacord.
Viacord will assume the responsibility for document control for documents stored
off-site, once these documents are in the possession of Viacord. It is
understood that PCT may require copies of certain Viacord-related documents for
business purposes.
AUDITS
PCT and Viacord agree to procedures for external and internal audits. Both
internal and external assessments will be used to determine if the effectiveness
of the quality system in place and if it complies with requirements. Viacord
will perform an initial audit (prior to authorizing processing, testing, and
storage of UCB units), and may elect to perform additional audits throughout the
term of this agreement. Viacord will notify PCT at least 2 business days in
advance prior to an audit. Viacord will make available the written results of
the audit within 30 (thirty) days, post-audit. Furthermore, PCT agrees to
perform internal audits at regular intervals, as determined by, but not limited
to, regulations, trends in deviations, and corrective actions assigned by
Viacord. Records of any and all audits and all associated results shall be
maintained according to the requirements given in the Document Control section
of this document. PCT agrees to cooperate fully with any and all regulatory
inspections. A Viacord representative may be in attendance at PCT for any
regulatory and/or quality agency inspections.
Page 6 of 9
Documentation of ViaCell, Inc. is considered proprietary and is made available
for business operations and review by employees of ViaCell and
regulatory agencies. Distribution to third parties
without written permission is prohibited.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
Quality Agreement 07 December 2001
QUALITY ASSURANCE MEETINGS
Representatives of the Departments of Quality Assurance from PCT and Viacord
will meet on a regular basis to analyze manufacturing deviations, abnormal
testing results for trends, and other quality issues, and recommend
implementation of corrections actions as necessary.
DISPUTE RESOLUTION
Viacord and PCT will make all efforts to resolve disputes amicably. In the event
of an irresolvable dispute, the two parties will select a mutually agreeable
independent arbiter to recommend the most appropriate action.
SIGNATURES
PCT and Viacord agree to follow all the provisions of this Quality Agreement to
the best of our abilities.
/s/ Robert Preti /s/ Kurt Gunter 6 Dec. 01
------------------------------------ ----------------------------------
Robert A. Preti, Ph.D. Kurt C. Gunter, M.D.
President & Chief Scientific Officer Associate Medical Director
Progenitor Cell Therapy, L.L.C. Viacord, Inc.
Page 7 of 9
Documentation of ViaCell, Inc. is considered proprietary and is made available
for business operations and review by employees of ViaCell and
regulatory agencies. Distribution to third parties
without written permission is prohibited.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
Quality Agreement 07 December 2001
APPENDIX A LISTING OF SOPS
PROGENITOR CELL THERAPY STANDARD OPERATING PROCEDURE 01.041A "VIACORD SOP
MATRIX"
Page 8 of 9
Documentation of ViaCell, Inc. is considered proprietary and is made available
for business operations and review by employees of ViaCell and
regulatory agencies. Distribution to third parties
without written permission is prohibited.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
Quality Agreement 07 December 2001
APPENDIX B CHANGE CONTROL FORM
VIACORD CHANGE CONTROL FORM
CHECK ONE: [ ] NEW [ ] REVISION [ ] OBSOLETION
DEPARTMENT:
---------------------------------------------------------------------
SOP/FORM/POLICY:
----------------------------------------------------------------
SOP/FORM/POLICY NO.: REVISION NO.: SUPERCEDES:
------- -------- -------
DESCRIPTION OF CHANGE:
---------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
REASON FOR PROPOSED CHANGE:
-----------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
OTHER DOCUMENTS AFFECTED: [ ] YES [ ] NO (If yes, please list)
INSTRUCTIONS: Please review the attached SOP/Form/Policy. Sign and date this
change control form and as indicated by the X. If revisions are required, DO NOT
sign, but return it immediately to Quality Assurance, stating the required
revisions on the document.
[ ] [ ]
------------------------- -----------------------------
OPERATIONS QUALITY ASSUR./REG. AFFAIRS
[ ] [ ]
------------------------- -----------------------------
MARKETING PATIENT & PHYSICIAN SERVICES
[ ] [ ]
------------------------- -----------------------------
HUMAN RESOURCES VALIDATION
[ ] [ ]
------------------------- -----------------------------
PRESIDENT OTHER
[ ] [ ]
------------------------- -----------------------------
CEO OTHER
REGULATORY AFFAIRS FDA NOTIFICATION REQUIREMENTS:
[ ] FDA Approval required Prior to Implementation
[ ] FDA Notification Required [ ] None
IMPLEMENTATION APPROVAL
EFFECTIVE DATE of NEW (or Revised) Document:
---------------------------------
OBSOLETION or DECLINED DATE:
---------------------------------
APPROVED BY (QA) / DATE:
---------------------------------
Page 9 of 9
Documentation of ViaCell, Inc. is considered proprietary and is made available
for business operations and review by employees of ViaCell and
regulatory agencies. Distribution to third parties
without written permission is prohibited.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.
<PAGE>
AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
ATTACHMENT V. TECHNOLOGY TRANSFER PROTOCOL
[*]
8 pages omitted pursuant to a request for confidential treatment.
* Confidential treatment has been requested with respect to certain portions of
this exhibit. Such portions are marked with a "[*]" in place of the redacted
language. Omitted portions are filed separately with the Securities and Exchange
Commission.