Exhibit 10.17
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 000 Xxxxxxxxx Xxxxxx,
0xx Xxxxx, Xxxxxx, Xxxxxxxxxxxxx 00000, 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 00 Xxxxxxxx Xxxxxx, Xxxxx
000, Xxxxxxxxxx, Xxx Xxxxxx 00000.
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.
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 [*], 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. [*]
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.
AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
3. [*]
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, [*]
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.
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.
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, [*]
8. TERM; TERMINATION
1. The term of this Agreement shall be from the Effective Date
through [*].
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.
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.
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.
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.
AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
IN WITNESS THEREOF, the parties have hereunto set their hands and seals.
FOR VIACORD:
/s/ Xxxxxx X. Xxxxxxxxxx 12/7/01
------------------------------------- -------------------------------
Xxxxxx X. Xxxxxxxxxx Date
Vice President, Operations
ViaCell, Inc.
FOR PCT:
/s/ Xxxxxx X. Xxxxxxxxxx 12/11/01
------------------------------------- -------------------------------
Xxxxxx X. Xxxxxxxxxx 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.
AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
ATTACHMENT I. SCHEDULES OF SERVICES, FEES AND FORECASTED QUANTITIES
[*]
2 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.
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.
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.
AGREEMENT
FOR
HUMAN UMBILICAL CORD BLOOD PROCESSING SERVICES
ATTACHMENT IV. PCT-VIACORD QUALITY AGREEMENT
11 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.
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.
