Exhibit 10.16
AGREEMENT BETWEEN
VIACORD, INC.
AND
THE UNIVERSITY OF CINCINNATI ON BEHALF OF
XXXXXXXX BLOOD CENTER
AGREEMENT entered into effective as of December 30, 1994 (the "Effective Date")
by and between VIACORD, INC., (hereafter "Viacord"), a Delaware corporation, and
THE UNIVERSITY OF CINCINNATI on behalf of XXXXXXXX BLOOD CENTER (hereafter
"Hoxworth"). Hoxworth and Viacord are sometimes referred to herein individually
as a "Party" and collectively as the "Parties".
Hoxworth and Viacord desire to enter into an agreement pursuant to which Viacord
will contract Hoxworth to provide the service of pick up, transport, delivery,
testing, processing, cryopreservation, long term storage, retrieval,
distribution, record keeping, and other services relating to umbilical cord and
placental blood (hereafter referred to as "Cord Blood Banking"). All blood or
blood components derived from the umbilical cord and/or placenta are hereafter
referred to as "Cord Blood".
ACCORDINGLY, for and in consideration of the mutual agreements contained herein,
the Parties, intending to be legally bound, hereby mutually agree as follows:
I. EXCLUSIVITY
1.1 Hoxworth agrees that all Cord Blood Banking (as defined above) for
commercial and clinical use and for research related to the performance of this
agreement shall be exclusively provided to Viacord for so long as this Agreement
remains in effect.
1.2 Viacord agrees that Hoxworth shall exclusively be its contract service
provider for all Cord Blood Banking services contracted within the geographic
region defined as the states of Ohio, Indiana, and Kentucky (the "Geographic
Region") for so long as this Agreement remains in effect.
1.3 Viacord may engage any other contract lab for the purpose of
conducting research, validation studies, or commercial and clinical Cord Blood
Banking outside the Geographic Region for which Hoxworth has exclusive rights
under Section 1.2 hereof.
1.4 Both Parties agree that Hoxworth is currently in the business of
providing blood banking services and that none of the terms of this Agreement
shall prevent Hoxworth from continuing or expanding in its current blood banking
businesses (other than Cord Blood Banking); provided, however, that Hoxworth
shall not copy the marketing formulas or strategies of Viacord in order to
perform Cord Blood Banking and/or Cord Blood related services or components for
itself or others. Hoxworth shall not copy or implement the Standard Operating
CONFIDENTIAL--TRADE SECRET
* 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.
VIACORD, INC./XXXXXXXX BLOOD CENTER
AGREEMENT
Procedures (as defined below), or any improvements or modifications to the
Standard Operating Procedures made after the Effective Date in order to perform
Cord Blood Banking and/or Cord Blood related services or components for itself
or others. The "Standard Operating Procedures" of this Agreement are those
protocols provided by Viacord and mutually agreed upon by both Parties used to
systemize pick up, transport, delivery, testing, processing, cryopreservation,
long term storage, retrieval, distribution, record keeping and other services
relating to umbilical cord and placental blood. Viacord will provide input from
other centers regarding procedures, practices, and regulatory measures in
conjunction with Xxxxxxxx'x current protocols to determine the said Standard
Operating Procedures.
1.5 All Cord Blood, Cord Blood Banking, or Cord Blood related services or
components shall be produced and performed for the sole benefit of Viacord and
used for no other purpose for the term of this Agreement.
II. SCOPE OF THE AGREEMENT
2.1 Hoxworth shall secure and maintain and pay for all permits, licenses,
approvals and the like required for bone marrow, stem cell processing, somatic
cell processing, and Cord Blood Banking by all federal, state or local agencies.
If such agencies require permits, licenses, and approvals unique and only unique
to Cord Blood Banking, such costs will be borne by Viacord if approved in
writing by Viacord prior to the costs being incurred.
2.2 Hoxworth shall validate the Standard Operating Procedures used for
Cord Blood Banking at its facility according to specifications in Schedule B,
Viacord Validation Program.
2.3 Viacord will use Xxxxxxxx'x current storage and controlled rate
Freezers (collectively the "Freezers") if these Freezers meet Viacord's
operating and security standards, which standards Viacord may in its reasonable
discretion change from time to time. Hoxworth will operate and maintain the
Freezers. The Parties anticipate that Viacord will eventually purchase its own
Freezers (the "Viacord Freezers"). Hoxworth will provide the space and will
operate and maintain these Viacord Freezers, continuing to charge Viacord the
prices set forth in Schedule X. Xxxxxxxx may, with written permission of
Viacord, use the Viacord Freezers for its own purposes if Freezer space is
available. Reasonable charges to Hoxworth for such use will be negotiated. [*]
2.4 Hoxworth shall operate and maintain equipment used for Cord Blood
Banking, and shall contract liquid nitrogen (LN2) services in support of Cord
Blood Banking. Cost of operation and maintenance of the Freezers will be borne
initially by Hoxworth and reimbursed by Viacord according to Schedule A.
2.5 Hoxworth shall conduct Cord Blood Banking operations using the
materials and according to Standard Operating Procedures specified by Viacord.
Viacord, in its sole discretion, shall have the right to change materials and/or
procedures provided. Any significant revision to materials and/or Standard
Operating Procedures shall be reviewed by Viacord's Medical Advisory Board prior
to implementation. Viacord's Medical Advisory Board shall consist of scientific
staff and medical doctors including Hoxworth representatives. Changes in
materials pricing shall be adjusted per Schedule A, section (d).
CONFIDENTIAL--TRADE SECRET
* 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.
VIACORD, INC./XXXXXXXX BLOOD CENTER
AGREEMENT
2.6 The Parties will conduct all studies and operations in accordance with
applicable federal, state, and local laws including, but not limited to the
Federal Food, Drug, and Cosmetics Act, the Biological Products Sections of the
Public Health Service Act, AABB, CLIA, and the regulations issued thereunder.
Both Parties will notify the other of any actual, or pending, regulatory action
from any federal, state, local, or other licensing agencies promptly and in any
event [*] relating to this agreement or the services provided hereunder.
2.7 The results of any research or validation study made by Hoxworth under
this Agreement will be reported on the appropriate forms provided by Viacord, or
on forms supplied by Hoxworth approved in writing by Viacord, on a weekly basis,
and within seven (7) business days after the completion of the study. The
reports and forms of the research and validation studies shall be mutually
agreed upon as defined in the Standard Operating Procedures.
2.8 Hoxworth will provide a monthly summary report to Viacord by the
fifteenth (15th) day of the following month consisting of hard copy records of
all units processed [*] The monthly summary reports and forms shall be mutually
agreed upon as defined in the Standard Operating Procedures.
2.9 Hoxworth shall maintain strict security in processing areas including
limited access to storage locations in accordance with reasonable standards
provided by Viacord per the Standard Operating Procedures. Viacord will pay
reasonable charges for build out and systems required by virtue of Viacord's
security requirements.
2.10 Viacord shall develop and administer a cGMP audit program covering
all aspects of Cord Blood Banking operations at Hoxworth. Hoxworth shall make
its facilities and records available to Viacord for inspection and auditing
purposes. Such cGMP audits and inspections will be scheduled at such frequency
to assure compliance with Standard Operating Procedures and at reasonable times
to accommodate both Parties' staffing requirements. Inspection and audit of
facilities and records will be made available following a twenty-four (24) hour
notice from Viacord. Record retention will be in accordance with applicable
published standards. Review of records will normally be within the past twelve
months and requests for other time periods will not be unreasonably denied.
III. MANNER OF PAYMENT
3.1 Viacord agrees to pay Hoxworth on a fee for services basis per
Schedule A.
IV. TERM
4.1 The term of this Agreement shall be seven (7) years beginning on the
Effective Date and may be renewed by mutual agreement of the Parties for
successive one year periods thereafter.
V. TERMINATION
5.1 Should Hoxworth be unable to process Cord Blood by reason of labor
dispute, governmental action, act of God or the like, Viacord reserves the right
to contract other parties to meet its obligation, until such time as Hoxworth is
fully able to perform its obligations under this Agreement. Hoxworth agrees to
use best efforts to regain its ability to perform Cord Blood Banking should such
a situation arise. In the event that Hoxworth is unable to meet its obligations
under this Agreement for a period of sixty (60) days, Viacord reserves the right
to terminate this Agreement and enter a long term agreement with another blood
center.
CONFIDENTIAL--TRADE SECRET
* 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.
VIACORD, INC./XXXXXXXX BLOOD CENTER
AGREEMENT
5.2 Viacord may terminate this Agreement effective immediately upon
written notice if Hoxworth is in material default of any of its obligations to
perform Cord Blood Banking which default continues for sixty (60) days following
receipt by Hoxworth of written notice from Viacord regarding such default.
Viacord reserves the right to contract other parties to meet its obligation
until such time as Hoxworth is able to cure the default. Hoxworth agrees to use
best efforts to cure the default. Hoxworth may terminate this Agreement
effective immediately upon written notice if Viacord is in material default of
its financial obligations to Hoxworth which default continues for a period of
sixty (60) days following receipt by Viacord of written notice from Hoxworth
regarding such default. Hoxworth reserves the right to contract other parties to
meet its obligation until such time as Viacord is able to cure the default.
5.3 This Agreement may be terminated by either Party, upon giving
written notice to the other Party, in the event that the other Party shall
become insolvent or be declared bankrupt by a court of competent jurisdiction
or shall be the subject of any reorganization (other than a corporate
reorganization effected in the ordinary course of business and not arising out
of any insolvency) or winding-up, receivership or dissolution, bankruptcy or
liquidating proceeding, or any proceeding or action similar to one or more of
the above, in which termination shall be effective upon written notice. In the
event that this Agreement is terminated due to happening of any of the above
with respect to Viacord, Hoxworth shall have the right to purchase Viacord's
contracts for Cord Blood Banking services and shall be entitled to purchase the
contracts at a mutually agreeable price and Viacord Freezers for the then net
book value of such Viacord Freezers.
5.4 Upon termination of this Agreement, the provisions of Sections 1.5,
6.3, 6.4, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, and 7.8, shall remain in effect.
VI. AGENCY AND INDEMNIFICATION.
6.1 Neither Party is by virtue of this Agreement, an agent, employee,
partner, or joint venturer of/for the other.
6.2 Neither Party has any right or authority to assume or create any
obligation or responsibility, express or implied, for or on behalf of or in the
name of the other, or to bind the other in any manner whatsoever.
6.3 Viacord shall indemnify and hold harmless Hoxworth from and against
any and all claims, expenses, causes of action or liability to the extent that
damages are caused by the independent conduct of Viacord, including and not
limited to ownership, sibling and/or parental rights with respect to any and all
cells processed and/or preserved and stored by Hoxworth. Hoxworth is further
indemnified and held harmless from any and all claims arising from allegations
that Cord Blood Banking provided by Hoxworth could be construed to be insurance
as defined by the laws of the state of Ohio.
6.4 Hoxworth shall, to the extent permitted by Ohio law, indemnify and
hold harmless Viacord from and against any and all claims, expenses, causes of
action or liability to the extent that damages are caused by the independent
conduct of relating Hoxworth to Cord Blood Banking, including without limitation
storage and processing of Cord Blood under this Agreement.
6.5 Hoxworth shall maintain professional and general liability insurance
coverage in the respective amount of [*] relating to products and/or components
produced and/or services performed by Hoxworth for Viacord. At such time as
Viacord begins to provide commercial or
CONFIDENTIAL--TRADE SECRET
* 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.
VIACORD, INC./XXXXXXXX BLOOD CENTER
AGREEMENT
therapeutic services beyond those under the auspices of Institutional Review
Boards at the hospitals where the cord blood will be collected, Viacord shall
maintain comprehensive general liability insurance of [*] and product liability
insurance covering exposures with minimum liability limits of [*]
6.6 Viacord agrees to indemnify and hold harmless Hoxworth for any costs
and damages resulting from patent infringement claims and litigation filed
against Hoxworth based upon [*] limited to activities Hoxworth is engaged in
specifically for Viacord under this Agreement, providing:
(i) Viacord is provided with prompt written notice of any threat and/or filing
of such a lawsuit against Hoxworth.
(ii) To the extent permitted by Ohio law, Viacord is given total control of the
handling of such suit, including any defenses, to be made and settlements
thereof. To the extent the University of Cincinnati or any party on behalf
of Hoxworth handles or controls such defense, the University will cover
all its costs of such defense and damages assessed against Hoxworth.
(iii) Hoxworth has complied with and is currently in compliance with all of its
material obligations to Viacord pursuant to this Agreement.
VII. CONFIDENTIALITY AND NON COMPETITION
7.1 Discoveries and inventions jointly made by employees of both Parties
to this Agreement as a direct result of work performed under this Agreement, and
any patent applications and patents issuing thereon, [*] Inventions made by
employees of only one Party to this Agreement, as a direct result of work
performed under this Agreement, and any patent applications and patents issuing
thereon shall be owned [*]. Inventorship shall be determined under patent law.
Future projects between the parties will be negotiated separately.
7.2 Hoxworth hereby grants to Viacord, its successors and assigns, as
described in Section 8.1, a royalty free, fully paid, non-exclusive, perpetual
and irrevocable license, including the right to make or use, sell or otherwise
distribute components or services, or practice methods comprising any
discoveries, inventions, patents or improvements made under this Agreement.
7.3 Hoxworth hereby grants to Viacord a [*] from Hoxworth an exclusive,
perpetual and irrevocable, except for cause, transferable license, including the
right to sub license, to make, use, or sell or otherwise distribute components
or services, or practice methods comprising any discoveries, inventions,
patents, or improvements made under this Agreement. [*]
7.4 Both Parties agree that during the term of this Agreement, and
thereafter, that they, and all of their employees, will hold in strictest
confidence and will not disclose, use, lecture upon or publish any of the other
Party's Trade Secrets (as defined below) except as such
CONFIDENTIAL--TRADE SECRET
* 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.
VIACORD, INC./XXXXXXXX BLOOD CENTER
AGREEMENT
disclosure, use or publication may be required in connection with their work
under this Agreement; provided, however, Hoxworth and its employees may lecture
and publish on the results of their own research if Hoxworth and/or any such
employee provide Viacord with written notice, where such notice is return
receipt requested, of such intended lecture or publication, including outlines,
manuscripts, proofs and any other materials relating to such lecture or
publication, and Viacord gives written consent, such consent not to be
unreasonably withheld, within 60 days after receipt of such notice from Hoxworth
and/or such employee, return receipt requested. If, after 60 days, Viacord has
not responded, Hoxworth may proceed with such lecture or publication. For
purposes of this Agreement, the term "Trade Secrets" shall mean information,
including the whole or any portion of phase of any scientific or technical
information, design, process, procedure, formula, pattern, compilation, program,
device, method, technique, or improvement, or any business information or plans,
financial information, or listing of names, addresses, or telephone numbers,
that satisfies both of the following: (1) it derives independent economic value,
actual or potential from not being generally known to, and not being readily
ascertainable by proper means by, other persons who can obtain economic value
from its disclosure or use, and (2) it is the subject of efforts that are
reasonable under the circumstances to maintain its secrecy. Hoxworth
acknowledges that Viacord considers its Standard Operating Procedures to be
Trade Secret information, and are to be treated accordingly. Neither party shall
consider information its Trade Secret which: (1) is now common knowledge or
subsequently becomes such through no breach of this Agreement; (2) is rightfully
in the receiving party's possession prior to the receiving party's disclosure as
shown by written records; (3) is disclosed to the receiving party by an
independent third party who is not under an obligation of confidentially with
respect to such Information; or (4) is independently developed by or for the
receiving party without benefit of confidential information received from the
disclosing party.
7.5 Hoxworth for itself (or for any of its Affiliates) or on behalf of any
unaffiliated entity or individual will not at any time provide Cord Blood
Banking services other than pursuant to this Agreement for so long as this
Agreement remains in effect and for a period of [*] after termination of this
Agreement without the express written permission of Viacord, provided if this
Agreement is terminated by Hoxworth or if this Agreement is terminated by
Viacord due to a material breach by Hoxworth. For purposes of this Agreement,
the term "Affiliate" shall mean any person controlled by, under common control
with, or in control of such person, and the term "control" shall mean the
possession (directly or indirectly) of the power to direct or cause the
direction of the management or policies of such person.
7.6 During the term of this Agreement, [*] provided this Agreement is
terminated by Hoxworth or if this Agreement is terminated by Viacord due to a
material breach by Hoxworth, Hoxworth shall not directly, or indirectly, (i)
engage in, (ii) own an interest in, (iii) be employed by or consulting in any
way in, any activity which competes with Viacord's Cord Blood Banking
CONFIDENTIAL--TRADE SECRET
* 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.
VIACORD, INC./XXXXXXXX BLOOD CENTER
AGREEMENT
service, the business or any proposed Cord Blood related businesses of Viacord.
The term of this restriction shall be extended by any period of violation.
7.7 Hoxworth agrees that during the term of this Agreement no employee of,
or consultant to, Hoxworth, will without Viacord's express written consent
engage in any employment or business activity relating to Cord Blood Banking
other than for Viacord. All employees and consultants to Hoxworth working on
this project shall sign a non-disclosure agreement and [*] agreement not to
compete with Viacord substantially in the form of Exhibit 1 hereto, provided,
however, if this Agreement is terminated by Viacord for reasons other than due
to a material breach by Hoxworth, then such employees and consultants shall be
free to perform services while in the employment of Hoxworth as specified in
sections 7.5 and 7.6.
7.8 If disclosure of Trade Secrets of the non-disclosing Party is required
to comply with applicable law, court or order of governmental regulation, such
disclosure shall not constitute a breach of this Agreement if the disclosing
Party provides the non-disclosing Party sufficient advance notice of such
disclosure to permit the non-disclosing Party to seek to obtain a court order
prohibiting the same but any such Trade Secrets shall still be deemed
confidential under this Agreement.
VIII. SUCCESSORS AND ASSIGNS
8.1 This Agreement shall be binding upon and inure to the benefit of the
successors and assigns of the Parties, but shall not be assigned by either
Party other than to an Affiliate or successor in interest by merger or
otherwise, without the prior written consent of the other Party, which consent
will not be unreasonably withheld. Assignment of this Agreement shall not
relieve the assigning Party of its financial obligation hereunder, including
its indemnification obligations hereunder.
IX. TRADEMARKS
9.1 Hoxworth acknowledges that no trademark or trade name rights in
"Viacord, Inc.", "Viacord", "Life Through The Cord. . .", "Life From The Cord",
"The Family Cord Blood Bank", "Cord Blood Banking Service", "The Community Cord
Blood Bank", "The Foundation For Cord Blood Banking" and any other trademarks,
trade names, service marks, or logos owned by Viacord (collectively, the
"Trademarks") are granted by this Agreement and Hoxworth agrees not to use or
adopt any confusingly similar or colorable imitations of such marks or any marks
subsequently adopted by Viacord.
X. NOTICES
10.1 All notices required herein shall be given personally by confirmed
facsimile, by a reputable, established courier service that guarantees next day
delivery or by registered airmail, return receipt requested, to the following
addresses (unless change thereof has previously been given to the Party giving
the notice) and shall be deemed effective when received:
If to Viacord: with a copy to:
Xxxxxxx X. Xxxxxx, President, CEO Xxxxxx Xxxxxxxx, Esq.
Viacord, Inc. Xxxxxxx, Xxxx, & Xxxxx
000 Xxxxxxxxxxxx Xxxxxx, Xxxxx 0 000 Xxxxxxx Xxxxxx
Xxxxxx, XX 00000 Xxxxxx, XX 00000
If to Hoxworth: with a copy to:
Xxxxxx X. Xxxx, MD., L.L.B., Director Xxxxx X. Xxxxxxxxxx
Xxxxxxxx Blood Center Deputy Director, Administration
The University of Cincinnati Medical Center Xxxxxxxx Blood Center
0000 Xxxxxxxx Xxxxxx, XX0000 The University of Xxxxxxxxxx
Xxxxxxxxxx, XX 00000-0000 0000 Xxxxxxxx Xxxxxx, XX0000
Xxxxxxxxxx, XX 00000-0000
CONFIDENTIAL--TRADE SECRET
* 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.
VIACORD, INC./XXXXXXXX BLOOD CENTER
AGREEMENT
XI. EXECUTION IN COUNTERPARTS
11.1 This Agreement may be executed in one or more counterparts each of
which shall be deemed to be an original but all of which shall constitute one
and the same document.
XII. AMENDMENTS
12.1 No amendment, change or modification of any of the terms, provisions,
or conditions of this Agreement shall be effective unless made in writing and
signed on behalf of the Parties hereto by their duly authorized representatives.
XIII. GOVERNING LAW
13.1 The agreement shall be interpreted and construed in accordance with
the laws of the State of Ohio.
XIV. AUTHORITY
14.1 Each of the Parties hereto represents and warrants that it has full
power and authority to execute and deliver this Agreement and to consummate the
transactions contemplated herein and that this Agreement and the provisions
hereof constitute valid and legally binding obligations of each such Party and
do not violate the terms of any agreement to which such Party is a party.
XV. ENTIRE AGREEMENT
15.1 This Agreement constitutes the entire agreement between the Parties
and supersedes all prior agreements and understandings whether written or oral,
relating to the subject matter of this Agreement.
CONFIDENTIAL--TRADE SECRET
* 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.
VIACORD, INC./XXXXXXXX BLOOD CENTER
AGREEMENT
XVI. SEVERABILITY
16.1 In the event that any provision of this Agreement is held by a court
of competent jurisdiction to be unenforceable to any extent, the validity of the
remaining provisions shall not be affected, and the rights and obligations of
the Parties shall be construed and enforced to the extent, if any, that the
unenforceable provisions are held to be enforceable.
XVII. FURTHER ASSURANCES
17.1 Each of the Parties agrees to execute and/or deliver such further and
other documents and other assurances that may be required or reasonably
requested by the other Party from time to time in order to give effect to the
provisions of this Agreement.
XVIII. HEADINGS AND COUNTERPARTS
18.1 The headings and captions of sections are for convenience of
reference only and shall not define or limit the provisions of this Agreement.
This Agreement may be executed in any number of counterparts, which may be
separately executed by the Parties hereto, each of which shall be an original
but all of which taken together will constitute to one and the same instrument.
In making proof of this Agreement, it shall be necessary to produce or account
for only one such counterpart signed by or on behalf of the Party sought to be
charged therewith.
CONFIDENTIAL--TRADE SECRET
* 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.
VIACORD, INC./XXXXXXXX BLOOD CENTER
AGREEMENT
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
by their respective authorized officers as of the day, month and year as stated
in the first paragraph of this Agreement.
The University of Cincinnati Viacord, Inc. by:
on behalf of
Xxxxxxxx Blood Center
/s/ Xxxxx Xxxxxx /s/ Xxxxxxx X. Xxxxxx 12/16/94
----------------------------------- --------------------------------------
Xxxxx X. Xxxxxx Xxxxxxx X. Xxxxxx
As Contracting Offer Officer President, Chief Executive Officer
CONFIDENTIAL--TRADE SECRET
* 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.
VIACORD, INC./XXXXXXXX BLOOD CENTER
AGREEMENT
Exhibit 1
PROPRIETARY INFORMATION, NON-COMPETITION AND INVENTIONS AGREEMENT
I understand that I will be participating in a joint project relating to
Cord Blood Banking between Xxxxxxxx Blood Center (the "Company") and Viacord,
Inc. ("Viacord") (the "Viacord Project"). In consideration of my employment or
continued employment by the Company, and the compensation now and hereafter paid
to me, I hereby agree as follows:
1. RECOGNITION OF VIACORD'S RIGHTS; NONDISCLOSURE. At all times during
the term of my employment and thereafter, I will hold in strictest confidence
and will not disclose, use, lecture upon or publish any of the Company's or
Viacord's Proprietary Information (defined below), relating to Cord Blood
Banking except as such disclosure, use or publication may be required in
connection with my work on the Viacord Project, or unless I provide Viacord
with written notice of such intended lecture or publication, and Viacord gives
written consent to such lecture or publication with sixty (60) days after
receipt of such notice.
The term "Proprietary Information" shall mean trade secrets, confidential
knowledge, data or any other proprietary information of the Company or Viacord.
By way of illustration but not limitation, "Proprietary Information" includes
(a) inventions, mask words, trade secrets, ideas, processes, formulas, source
and object codes, data, programs, other works of authorship (including the
Standard Operating Procedures), know-how, improvements, discoveries,
developments, designs and techniques (hereinafter collectively referred to as
"Inventions"); and (b) information regarding plans for research, development,
new products, regulatory matters, marketing and selling, business plans, budgets
and unpublished financial statements, licenses, prices and costs, suppliers and
customers; and information regarding the skills and compensation of employees of
the Company and Viacord.
2. THIRD PARTY INFORMATION. I understand, in addition, that the Company
has received, and in the future will receive, from third parties, including
Viacord pursuant to the Viacord Project, confidential or proprietary ("Third
Party Information") subject to a duty on the Company's part to maintain the
confidentiality of such information and to use it only for certain limited
purposes. During the term of my employment and thereafter, I will hold Third
Party Information in the strictest confidence and will not disclose to anyone
(except in connection with my work for the Company and on the Viacord Project),
unless expressly authorized by an officer of the Company in writing.
3. ENFORCEMENT OF PROPRIETARY RIGHTS. From time to time, I will assist
the Company and Viacord in every proper way to obtain and enforce United States
and foreign Proprietary Rights relating to Inventions made pursuant to the
Viacord Project in any and all countries. My obligation to assist the Company
and Viacord with respect to Proprietary Rights relating to such Inventions in
any and all countries shall continue beyond the termination of my employment.
4. RESTRICTIVE COVENANTS. I agree that during the period of my employment
by the Company and for a period of one year thereafter I will not engage in any
employment or business activity relating to Cord Blood Banking other than for
Viacord with the exception of Cord Blood Banking for research where such
research is not in competition with Viacord's businesses. During the term of my
employment with the Company and for a period of one year thereafter, I also
shall not solicit, or arrange to have any other person or entity solicit, any
person or entity engaged by Viacord as an employee, customer, supplier, or
consultant or advisor to, Viacord to terminate such party's relationship with
Viacord. The time periods provided for in this Section 4 shall be extended for a
period of time equal to any period of time in which I shall be in violation of
any provision of this Section 4.
5. RETURN OF DOCUMENTS. When I leave the employ of the Company or cease
to work on the Viacord Project, I will deliver to the Company and/or Viacord
any and all drawings, notes, memoranda, specifications, devices, formulas,
molecules, cells, storage media, including software, documents and computer
printouts, together with all copies thereof, and any other material containing
or disclosing any Inventions, Third Party Information, or Proprietary
Information relating to the Viacord Project.
6. LEGAL AND EQUITABLE REMEDIES. Because my services are personal and
unique and because I may have access to and may become acquainted with the
Proprietary Information of the Company and Viacord, the Company and Viacord
shall have the right to enforce this Agreement and any of its provisions by
injunction, specific performance or other equitable relief, without bond,
without prejudice to any other rights and remedies that the Company or Viacord
may have for a breach of this Agreement, and I waive the claim or defense that
the Company or Viacord has an adequate remedy at law. I shall not, in any action
or proceeding to enforce any of the provisions of this Agreement, assert the
claim or defense that such an adequate remedy at law exists.
7. NOTICES. Any notices required or permitted hereunder shall be given
to me at the address specified below or at such other address as I shall
specify in writing. Such notice shall be deemed given upon personal delivery to
the appropriate address or if sent by certified or registered mail, three days
after the date of mailing.
8. GENERAL PROVISIONS.
8.1 SEVERABILITY. If one or more of the provisions in this Agreement
are deemed unenforceable by law, then the remaining provisions will continue in
full force and effect.
8.2 SURVIVAL. The provisions of this Agreement survive the termination
of my employment and the assignment of this Agreement by the Company or Viacord
to any successor in interest or other assignee.
8.3 WAIVER. No waiver by the Company or Viacord of any breach of this
Agreement shall be a waiver of any preceding or succeeding breach. No waiver by
the Company or Viacord of any right under this Agreement shall be construed as
a waiver of any other right. Neither the Company nor Viacord shall be required
to give notice to enforce strict adherence to all terms of this Agreement.
8.4 COUNTERPARTS. This Agreement may be executed in counterparts, all
of which together shall for purposes constitute one Agreement, binding on each
of the parties hereto notwithstanding that each such party shall not have signed
the same counterpart,
This Agreement shall be effective as of December 30, 1994.
I UNDERSTAND THAT THIS AGREEMENT AFFECTS MY RIGHTS TO INVENTIONS I MAKE
DURING MY EMPLOYMENT, AND RESTRICTS MY RIGHTS TO DISCLOSE OR USE THE COMPANY'S
OR VIACORD'S CONFIDENTIAL INFORMATION OR TO COMPETE WITH THE COMPANY OR VIACORD
DURING OR SUBSEQUENT TO MY EMPLOYMENT.
I HAVE READ THIS AGREEMENT CAREFULLY AND UNDERSTAND ITS TERMS.
Dated:____________, 19__.
Signature ______________________
________________________________
Name of Employee
Address: ________________________________
________________________________
________________________________
CONFIDENTIAL--TRADE SECRET
* 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.
SCHEDULE A: PRICING AND PAYMENT DETAILS
[*]
7 pages omitted pursuant to a request for confidential treatment.
CONFIDENTIAL--TRADE SECRET
* 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.
SCHEDULE B
VIACORD VALIDATION PROGRAM
Validation is a long-standing principle by which organizations within FDA
regulated industry document their activities. The FDA defines validation as
establishing documented evidence which provides a high degree of assurance that
a specific process will consistently produce a product meeting its
pre-determined specifications and quality attributes.
Process validation is a requirement of the Current Good Manufacturing Practices
(cGMP) Regulations, 21 CFR Parts 210 and 211. The FDA has stated that blood and
blood components are defined as drugs in the FD&C Act, and that the Current
Good Manufacturing Practices in 21 CFR, Parts 210 and 211, are applicable.
The documentation and evaluation of evidence to provide a high degree of
assurance, as required of a validation program, applies to a process, equipment,
lab method, system, or facility. Required elements of a validation program, as
defined in the FDA Guideline on General Principles of Process Validation,
include (but are not limited to):
INSTALLATION QUALIFICATIONS - establishing confidence that process equipment and
ancillary systems are capable of consistently operating within established
limits and tolerance.
PROCESS PERFORMANCE QUALIFICATION - establishing confidence that the process
is effective and reproducible.
PRODUCT PERFORMANCE QUALIFICATION - establishing confidence through
appropriate testing that the finished product produced by a specified process
meets all release requirements for functionality and safety.
VALIDATION PROTOCOL - a written plan stating how validation will be conducted,
including test parameters, product characteristics, production equipment, and
decision points on what constitutes acceptable results.
Validation requirements to support Cord Blood Banking are consistent with the
above requirements. Validation studies, as mentioned in Section 2.2 of The
Agreement, are intended to meet these requirements. The validation process
will be governed by Viacord Standard Operating Procedures (SOPs). Any change to
a process, equipment, or method must be reviewed in advance of implementation
to adjudicate the impact of the proposed change on the safety and purity of the
product being produced.
A general goal of the validation program is to document that by collecting,
processing, and storing cord blood, according to applicable procedures
supplied by Viacord, the end product will be pure and safe. Control measures to
be monitored include pre/post sterility, cell counts (mononuclear, CD34+, CFU
assay), and cell viability. An annual revalidation of all major processes,
methods, or systems will be required.
All processes, equipment, and analytical methods used in the processing of cord
blood are required to be validated. Any validations that have been conducted by
Hoxworth, for the purpose of supporting its existing products or services, can
be reviewed in conjunction with Viacord to prevent redundant testing. For those
processes not yet validated, we will perform installation qualification (IQ),
production equipment review, operational qualification (OQ), and performance
qualification (PQ).
REFERENCES:
1. Draft Guideline for the Validation of Blood Establishment Computer Systems
(docket No. 93N-0394), CBER, 1993
2. Guideline on General Principles of Process Validation, CBER, CDER, CDRH,
1987
3. 21CFR, Parts 210, 211, 640
CONFIDENTIAL--TRADE SECRET
* 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.
VIACELL, INC.
December 21, 2001
Xxxxx Xxxxxxxx, Esq.
Xxxxxxxx Blood Center
The University of Cincinnati
0000 Xxxxxxxx Xxxxxx, XX0000
Xxxxxxxxxx, XX 00000-0000
Re: Extension of December 30, 1994 Agreement between ViaCord, Inc. and The
University of Cincinnati on behalf of Xxxxxxxx Blood Center
Dear Xxxxx:
In furtherance of our discussions regarding an amendment and extension of
the Agreement (the "Agreement") dated December 30, 1994 between ViaCell, Inc.,
successor in interest to ViaCord, Inc. ("ViaCell") and The University of
Cincinnati on behalf of Xxxxxxxx Blood Center ("Hoxworth") (ViaCell and Hoxworth
to be collectively referred to as the "Parties"), I memorialize in this letter
agreement our agreement to a short-term extension of the term of the Agreement
in order to provide time for the Parties to consummate the negotiation and
execution of a more detailed amendment and extension of the Agreement (an
"Amendment and Extension").
By the signatures below of their authorized representatives, the Parties
hereby extend the term of the Agreement, with all terms and conditions
thereunder remaining in full force and effect, until January 14, 2002, prior to
which time ViaCell and Hoxworth will negotiate in good faith and execute an
Amendment and Extension. The terms and conditions of the Amendment and Extension
shall be retroactive to December 30, 2001. If the Parties cannot agree to an
Amendment and Extension, then the terms and conditions of the original
Agreement, as amended by this letter agreement, shall remain in full force and
effect; provided, however that ViaCell shall remove the Freezers (as defined in
the Agreement) within [*] of December 30, 2001.
Yours truly,
/s/ Xxxxxx Xxxxxxxxxx
AGREED TO AND ACCEPTED this 21st day of December, 2001.
The University of Cincinnati on behalf
ViaCell, Inc. of Xxxxxxxx Blood Center
By: /s/ Xxxxxx Xxxxxxxxxx By: /s/ Xxxxx X. Xxxxxxxx
--------------------------- ------------------------------
(Name) (Name)
Per: Vice President, Operation Per: Associate General Counsel
-------------------------- -----------------------------
(Position) (Position) 12/21/01
* 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.
EXECUTION COPY
AMENDMENT TO
AGREEMENT BETWEEN UNIVERSITY OF CINCINNATI ON BEHALF OF
XXXXXXXX BLOOD CENTER
AND
VIACELL, INC.
THIS AMENDMENT (the "Amendment") to the Agreement is effective as of
December 30, 2001 (the "Amendment Effective Date"), by and between the
University of Cincinnati on behalf of Xxxxxxxx Blood Center hereinafter referred
to as "Hoxworth", and ViaCell, Inc., successor in interest to Viacord, Inc.
("Viacord"), hereinafter both ViaCell, Inc. and Viacord shall be collectively
referred to as "ViaCell".
WHEREAS, Hoxworth and Viacord, Inc. ("Viacord") entered into an Agreement
which was effective as of December 30, 1994 for the testing, processing,
cryopreservation, long term storage, and other services related to Cord Blood
Banking, hereinafter, the "Agreement", and
WHEREAS, ViaCell acquired Viacord in an Agreement and Plan of Merger dated
April 11, 2000 by and among ViaCell, Inc. (f/k/a t.Breeders, Inc.), ViaCell
Acquisition Corporation, a wholly owned subsidiary of ViaCell and Viacord
providing for the merger of ViaCell Acquisition Corporation with and into
Viacord (the "Acquisition");
WHEREAS, pursuant to the Acquisition, ViaCell became a successor in
interest to Viacord, and ViaCell, with Xxxxxxxx'x consent, has freely assumed
all the duties, responsibilities, obligations, and rights under the Agreement as
Viacord's assignee, and has continued to carry out the terms, conditions, and
obligations of the Agreement;
WHEREAS, on December 21, 2001, Hoxworth and ViaCell entered into a letter
agreement pursuant to which the parties agreed to a short term extension of the
term of the Agreement until January 14, 2002 (the "Short Term Extension"); and
WHEREAS, the parties hereto have agreed upon an extension and certain
other changes to the Agreement, which shall be effective as of the Amendment
Effective Date.
NOW, THEREFORE, for and in consideration of the mutual promises, covenants
and agreements herein contained, the parties hereto agree to amend and
supplement the Agreement in the following respects and in those respects only.
All other terms and conditions of the original Agreement will remain in full
force and effect.
1. Capitalized terms used herein and not otherwise defined shall have the
meanings given to them in the Agreement. All capitalized terms defined in
this Amendment shall have the meanings given herein for the purposes of
both this Amendment and the Agreement.
2. ViaCell agrees to interview and consider for employment the following
three Hoxworth employees: [*] and any offers of employment were made as of
[*]
3. Up to and including [*] Hoxworth shall provide work space (e.g., a desk or
a cubicle) in Xxxxxxxx'x space at 0000 Xxxxxxxx Xxxxxx in Cincinnati, Ohio
and a working phone
* 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.
EXECUTION COPY
line and e-mail access (with any related e-mail access fees to be paid by
ViaCell) for [*] ViaCell employees. In exchange for this provision of work
space and phone and e-mail access, ViaCell shall pay to Hoxworth a
one-time fee of [*]
4. Prior to [*] ViaCell shall remove from Hoxworth space, at ViaCell's sole
cost, all patient files related to the Cord Blood units stored by
Hoxworth.
5. All references to "Viacord" in the Agreement are hereby replaced by
"ViaCell".
6. Sections 1.1, 1.2 and 1.3 of the Agreement are hereby deleted in their
entirety.
7. Section 1.4 of the Agreement is hereby renumbered as Section 1.1 and, in
addition, the parenthetical language in this Section, "(other than Cord
Blood Banking)" is hereby deleted from the new Section 1.1.
8. Section 2.3 of the Agreement is hereby amended and restated in its
entirety as follows:
(a) Subject to Section (a)(iii) of Schedule A hereto, Hoxworth shall
provide for ViaCell, in accordance with the Standard Operating
Procedures, the Cord Blood testing, processing and cryopreservation
services (collectively "Processing Services") for each Cord Blood
unit delivered to Hoxworth by ViaCell on or before February 15,
2002.
(b) Hoxworth shall provide for ViaCell, in accordance with the
Standard Operating Procedures, the long term storage, retrieval,
distribution, record keeping and other services for all Cord Blood
units until September 30, 2002, unless ViaCell, at its sole
discretion, removes all Cord Blood units and all freezers containing
Cord Blood units ("Freezers") from Hoxworth space prior to September
30, 2002 upon thirty (30) days written notice to Hoxworth.
Beginning in January 2002, ViaCell shall pay Hoxworth fifteen
thousand dollars ($15,000.00) for each full or partial month in
which Hoxworth provides the storage services described in this
Section 2.3(b). As between ViaCell and Hoxworth, ViaCell shall pay
all costs for the retrieval, preparation and shipment of Cord Blood
units that are needed for potential transplants. The parties
understand and agree that the costs to ViaCell per Cord Blood unit
for such retrieval, preparation and shipment is estimated to be
approximately two thousand dollars ($2,000.00).
(c) All responsibility for the removal of the Freezers and Cord
Blood units from Hoxworth space shall be ViaCell's, and any
liability which arises from such removal shall be assumed by
ViaCell, except to the extent such liability is based on the gross
negligence or willful misconduct of Hoxworth, or breach of
Xxxxxxxx'x warranties or obligations under this Agreement.
9. Section 3.1 of the Agreement is hereby amended and restated in its
entirety, as follows:
ViaCell agrees to pay Hoxworth the amounts detailed in Section
2.3(b) and in Schedule A pursuant to the terms of Section (d) of
Schedule A.
10. Sections (a), (d) and (e) of Schedule A to the Agreement are hereby
deleted in their entirety.
11. Section (b)(i) of Schedule A of the Agreement is hereby amended and
restated in its entirety as a new Section (a)(i) as follows:
[*]
12. Section (b)(ii) of Schedule A of the Agreement is hereby renumbered as
Section (a)(ii), and shall be amended to remove the [*]
* 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.
EXECUTION COPY
13. The Agreement is hereby amended to insert new Section (a)(iii) to Schedule
A thereof, as follows:
ViaCell shall, at its cost, provide sufficient personnel to Hoxworth
to process the number of Cord Blood units that Hoxworth processes
under this Agreement beginning on [*] Hoxworth shall process only
those number of Cord Blood units for which ViaCell so provides
personnel, and [*]
14. The Agreement is hereby amended to insert new Section (a)(iv) to Schedule
A thereof, as follows:
ViaCell shall pay Hoxworth at the following prices for [*] units,
which units shall be so tested as ViaCell directs at its sole
discretion:
[*]
15. The Agreement is hereby amended to insert new Section (a)(v) to Schedule A
thereof, as follows:
If, for Processing Services performed under this Agreement between
[*] the amount due from ViaCell to Hoxworth does not equal or exceed
[*] ViaCell shall pay to Hoxworth, the difference between [*] and
the amount otherwise due from ViaCell to Hoxworth for such services.
Hoxworth shall invoice ViaCell for the amount of such difference
after [*] and ViaCell shall pay such invoice within fifteen (15)
days of ViaCell's receipt of the invoice and will not alter the
amount without Hoxworth concurrence.
16. Section (c)(i) of Schedule A of the Agreement is hereby renumbered as
Section (b)(i) and, in addition, is hereby amended and restated in its
entirety as follows:
Materials, reagents, and supplies used in the Processing Services
and storage of Cord Blood will be purchased directly by Hoxworth and
the associated costs are included in the payments made by ViaCell
hereunder for the Processing Services and storage of Cord Blood. If
Hoxworth has any excess materials, reagents and supplies
(collectively "Excess Supplies") related to the Processing Services
after February 15, 2002 Hoxworth may offer to sell any or all of the
Excess Supplies to ViaCell, and ViaCell shall purchase such Excess
Supplies at Xxxxxxxx'x [*]
17. Section (g) of Schedule A of the Agreement is hereby renumbered as Section
(d) and, in addition, is hereby amended and restated in its entirety as
follows:
Except as otherwise provided in this Schedule A, Hoxworth shall
invoice ViaCell for amounts due under this Agreement at the end of
each month, and ViaCell shall remit payment within fifteen (15) days
of ViaCell's receipt of the invoice and will not alter the amount
without Hoxworth concurrence.
18. Section 4.1 of the Agreement is hereby amended and restated in its
entirety as follows:
* 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.
EXECUTION COPY
The term of the Agreement shall commence on the Effective Date and
continue until the earlier of [*] (b) the earlier date that ViaCell
removes all of the Cord Blood units and Freezers from Hoxworth space
pursuant to Section 2.3(b), above; or (c) or the date that the
Agreement is earlier terminated pursuant to Article V, below, unless
the Agreement is later extended by mutual agreement of the Parties
(the "Term").
19. Section 5.4 of the Agreement is hereby amended and restated in its
entirety as follows:
Upon termination of this Agreement, the provisions of Article VII
and Sections 2.3(c), 5.4, 6.3, 6.4 and 6.6 shall remain in effect.
20. The Agreement is hereby amended to insert a new Section 5.5 as follows:
ViaCell may terminate this Agreement by giving Hoxworth seven (7)
days prior written notice.
21. Section 6.4 of the Agreement is hereby amended to add at the end of such
Section:
, but only to the extent such conduct was performed on or before
December 29, 2001.
22. Sections 7.5, 7.6, and 7.7 of the Agreement are hereby deleted in their
entirety.
23. Section 10.1 of the Agreement shall be amended to remove the Viacord
address information, and to replace such information with the following:
ViaCell, Inc. With a copy to:
Xxxxxx X. Xxxxxxxxxx Xxxx Xxxxxxxx, Esq
Vice President of Operations Xxxxxx & Dodge LLP
000 Xxxxxxxxx Xxxxxx, 0xx Xxxxx 000 Xxxxxxxxxx Xxxxxx xx
Xxxxxx, Xxxxxxxxxxxxx 00000-0000 Prudential Center
Xxxxxx, XX 00000-0000
24. All other Sections of the Agreement and any internal references to other
Sections of the Agreement shall be renumbered in accordance with the above
changes to the Agreement made pursuant to this Amendment.
25. This Amendment supersedes any provisions in the Short Term Extension. Any
conflicts between the original Agreement and this Amendment shall be
resolved in favor of this Amendment.
26. This Amendment may be executed in one or more counterparts each of which
shall be deemed to be an original but all of which shall constitute one
and the same document.
27. This Amendment shall be interpreted and enforced in accordance with the
laws in the state and federal courts of the State of Ohio without regard
to conflict of laws principles.
* 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.
EXECUTION COPY
IN WITNESS HEREOF, the parties have executed this Agreement as of the date
of their signatures below.
University of Cincinnati ViaCell, Inc.
On behalf of
Xxxxxxxx Blood Center
By: /s/ Xxxxx X. Xxxxxxxx By: /s/ Xxxx Beer
------------------------------- -------------------------------
Title: Associate General Counsel Title: Xxxx Beer, CEO
----------------------------- -----------------------------
Date: 1/14/02 Date: 1/14/02
------------------------------ ------------------------------
* 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.
