EXHIBIT 10.41
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
DEVELOPMENT AND SUPPLY AGREEMENT
BETWEEN
V.I. TECHNOLOGIES, INC.
AND
HAEMONETICS CORPORATION
This Development and Supply Agreement entered into as of this 25th day of
January, 2000 (the "Effective Date"), is made by and between V.I. Technologies,
Inc., a corporation having a principal place of business at ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇,
▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇ ("VITEX") and Haemonetics Corporation, a corporation having a
principal place of business at ▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇
("Haemonetics").
WHEREAS, VITEX is developing Viral Inactivation Agent, as hereafter
defined, including associated processes, among them a joint development effort
involving a Haemonetics' Cell Washing System, as hereafter defined; and
WHEREAS, Haemonetics develops and commercializes, among other things,
automated blood processing systems (consisting of equipment and disposables),
including the Equipment, as hereafter defined.
NOW, THEREFORE, in consideration of the terms and conditions herein, the
parties agree as follows:
1. DEFINITIONS.
------------
1.1. The term "Viral Inactivation Agent" shall refer to VITEX's
proprietary materials for pathogen inactivation, including materials designed to
inactivate viruses and other microorganisms, developed or being developed by
VITEX.
1.2. The term "Equipment" shall refer to Haemonetics' automated medical
devices using proprietary centrifugal technology to wash red cells and shall
include the Model 215, the Pivotal Trial 215, the Commercial 215, and the Multi-
Unit Commercial Device, all as more specifically defined herein.
1.3. The term "Disposables" shall refer to single-use disposables for use
with the Equipment.
1.4. The term "Cell Washing System" shall refer to Equipment and
Disposables and does not include leukoreduction, delivery and incubation of the
Viral Inactivation Agent.
1.5. The term "Viral Inactivation System" shall refer to Equipment,
Disposables, Viral Inactivation Agent and other solutions, all used together in
a viral inactivation process using cell washing.
1.6. The term "Model 215" shall refer to Haemonetics' existing red blood
cell washing technology which has not yet been cleared by the Food and Drug
Administration ("FDA") for sale.
1.7. The term "Pivotal Trial 215 Equipment" shall refer to optimized
Model 215 cell washing devices, as more fully described in specifications
attached hereto as Exhibit 1.
1.8. The term "Commercial 215" shall refer to a modified Model 215 that
incorporates bar coding and necessary IT interface for tracking purposes, as
more specifically described in the specifications attached hereto as Exhibit 2.
1.9. The term "Multi-Unit Commercial Device" shall refer to a red blood
cell washing system that would process 6-10 units of red blood cells per
operator on a single device, as more specifically described in the
specifications attached hereto as Exhibit 3.
1
1.10. The term "Cell Washing Technology" shall refer to any process that
allows for the washing of red blood cells incorporating centrifugal separation.
2. SCOPE AND EXCLUSIVITY.
----------------------
For the term of this Agreement, and subject to the terms and conditions
herein, VITEX and Haemonetics shall collaborate to develop a Cell Washing System
that can be utilized with the Viral Inactivation Agent to inactivate pathogens
in red cells and then to remove or neutralize the inactivation agent. The
specifications, development guidelines, pricing, and milestones herein are
applicable to a Cell Washing System and Viral Inactivation System to be marketed
and sold in the United States. In addition, the parties shall work together to
develop a mutually agreed plan, including development guidelines, to obtain
necessary regulatory approvals in countries outside the United States. Unless
specifically limited to the United States market, however, the provisions of
this Agreement are worldwide in scope.
VITEX agrees to purchase Cell Washing Technology for use in viral
inactivation of red blood cell concentrates only from Haemonetics. VITEX shall
have the exclusive worldwide right to buy Haemonetics' Cell Washing Technology
in the field of viral inactivation of red blood cell concentrates, except that
VITEX's rights become nonexclusive: 1) if VITEX, for reasons not due to
Haemonetics, fails to gain FDA approval for viral inactivation of red blood
cells with its Viral Inactivation Agent together with the Cell Washing System by
[*****]; or 2) if VITEX's purchases of Cell Washing Systems from Haemonetics in
calendar year [*****] are less than [*****].
3. EQUIPMENT SPECIFICATIONS.
-------------------------
The specifications for Equipment to be developed for the United States
market pursuant to this Agreement are attached hereto as ▇▇▇▇▇▇▇▇ ▇, ▇ ▇▇▇ ▇
▇▇▇▇▇▇ (▇▇▇ "▇▇▇▇▇▇ ▇▇▇▇▇▇ Specifications"). The parties shall work together to
develop specifications for a Cell Washing System to be marketed outside the
United States.
Any changes to the United States Specifications will be mutually agreed to by
Haemonetics and VITEX.
The parties understand and agree that, prior to commercialization of the Viral
Inactivation System, they shall agree in writing to mutually acceptable
procedures to assure compliance with applicable quality standards and regulatory
requirements, including complaint handling and record keeping.
4. DEVELOPMENT MILESTONES AND INCENTIVE BONUSES.
---------------------------------------------
4.1. COLLABORATION.
--------------
The parties agree that the development process will be a collaborative
effort that will require input from all parties and good faith negotiation by
all parties to resolve issues, concerns and disputes that may arise. Each party
agrees that it shall reasonably collaborate in this process. If the parties
disagree as to the best method for achieving a specification or a process, then
Haemonetics shall make the final decision if the disagreement relates to the
Cell Washing System and VITEX shall make the final decision if the disagreement
relates to the Viral Inactivation Agent.
4.2. MILESTONES.
-----------
Haemonetics shall achieve the following development milestones for the
United States market:
4.2.1. [*****]
----------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
2
4.2.2. [*****]
4.2.3. [*****]
4.2.4. [*****]
Delivery of all above Equipment assumes that all necessary documentation
for that Equipment is available for regulatory submission. FDA approval is not
required for achievement of these milestones. Milestones shall be deemed to be
satisfied if Haemonetics delivers each of the above milestones no later than 90
days after the above dates, unless a delay in delivery is caused by VITEX, in
which case the delivery shall be extended for a period comparable to the period
of delay caused by VITEX. Should Haemonetics fail to deliver the Pivotal Trial
215 equipment within 90 days after September 1, 2000 for reasons not caused by
VITEX, it shall pay to VITEX a lump sum of $100,000.
4.3. INCENTIVE BONUSES.
------------------
VITEX shall pay to Haemonetics the following incentive bonuses if
Haemonetics achieves the milestones in Paragraph 4.2 prior to the completion
dates therein.
4.3.1. [*****]
4.3.2. [*****]
4.3.3. [*****]
4.3.4. [*****]
5. DEVELOPMENT FUNDING.
--------------------
To fund development of the Cell Washing System(s) to be marketed either
within or outside the United States, VITEX shall reimburse Haemonetics within 30
days of invoice for any development, regulatory, manufacturing and associated
costs reasonably and necessarily incurred by Haemonetics to develop the Cell
Washing System(s) ("Development Costs"), including without limitation any
Development Costs to achieve the development milestones set forth above, any
Development Costs occasioned by changes to specifications and any Development
Costs related to the manufacturing of Disposables and Equipment during the
development phase. Haemonetics' labor costs for the development and regulatory
approval of the Cell Washing System are based on anticipated wage rates, fringe
benefit costs and overhead for personnel working on the development program and
will initially be a blended rate of [*****]per hour. Labor costs associated
with manufacture of the Cell Washing System during the development phase shall
be based on anticipated wage rates, fringe benefits costs, and standard labor
minutes per product. All labor costs shall be updated annually.
Materials, travel and other actual expenses will be billed at actual cost.
6. REGULATORY SUBMISSIONS.
-----------------------
VITEX shall be responsible for managing regulatory approval within and
outside the United States of the Viral Inactivation Agent. Haemonetics will
provide information as needed to support regulatory approval. Haemonetics shall
be responsible for managing regulatory approval of the Cell Washing System
within and outside
----------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
3
the United States. VITEX will provide Haemonetics with clinical data as needed
to support complementary 510(k)'s for the Cell Washing System or other 510(k)'s
outside of the area of viral inactivation. Each party shall provide the other
party with those sections of regulatory submissions that relate specifically to
the other party's Cell Washing System or Viral Inactivation Agent in order to
ensure the truth and accuracy of such information and to support the other
party's regulatory filings.
7. PROJECT MANAGER.
----------------
Each party shall appoint an individual to coordinate that company's
implementation of this Agreement (the "Project Manager"). Each may also appoint
outside representatives who are working on the project, subject to the approval
of the other party. During the first eighteen (18) months of the term of this
Agreement, the parties' designated representatives shall meet bi-weekly and
thereafter they shall meet according to a mutually agreeable schedule but no
less than once per quarter.
8. TERM AND TERMINATION.
---------------------
This Agreement shall commence on the Effective Date and shall continue for
a term of ten (10) years unless extended by mutual written agreement.Either
party may terminate this Agreement if the other party breaches any of the terms
of the Agreement and such breach is not cured within ninety (90) days of written
notice by the non-breaching party. In such case, termination shall be effective
on the ninety-fifth (95) day following notice of the breach. Either party may
terminate this Agreement, effective immediately, upon the occurrence of any of
the following events of insolvency: the other party commits or suffers any act
of bankruptcy, comes under the control of a receiver, becomes insolvent, makes
an assignment for the benefit of creditors of all or part of its assets, or
undergoes liquidation or dissolution. Any obligation of either party accrued
prior to termination of this Agreement for any reason shall survive termination.
In addition, Paragraphs 10, 13, 14, 15, 18, 19, 20, and 21 of this Agreement
shall survive termination for any reason.
9. PRICING OF EQUIPMENT AND DISPOSABLES.
-------------------------------------
9.1. PRICING FORMULA.
----------------
Prices for the United States market for Equipment and Disposables,
effective following FDA approval, shall be set by Haemonetics and shall be
based on the following:
9.1.1. Direct labor costs (based upon anticipated wage rates, fringe
benefits costs, and standard labor minutes per product); and
9.1.2. Direct materials (based upon ▇▇▇▇ of materials and most recent
estimates of pricing from vendors); and
9.1.3. Overheads (standard forecasted rates computed as multiples of
labor hours generally applied by Haemonetics to similar manufactured products);
and
9.1.4. An amount that achieves a gross margin of [*****] for
Haemonetics for both Disposables and Equipment.
9.2. INITIAL PRICES.
---------------
Based on current forecasts, Haemonetics anticipates that initial prices to
VITEX for Disposables will not exceed [*****] per Disposable, [*****] per single
wash Equipment unit, and [*****] per monitoring/communications module to be used
with the Multi-Unit Commercial Device and, except in the event of compelling
business reasons, Haemonetics agrees that the initial prices shall not exceed
these amounts. The parties will work together using reasonable efforts to
achieve target prices of [*****] per Disposable, [*****] per single
----------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
4
wash Equipment unit, and [*****] per monitoring/communications module; however,
this provision shall not restrict Haemonetics right to set initial prices
subject to the maximum price provisions above.
9.3. FORECASTS, ORDERING AND DELIVERY.
---------------------------------
VITEX shall provide Haemonetics with rolling 12 month forecasts for
Equipment and Disposables. VITEX shall place fixed orders for Equipment with
[*****] months lead time and fixed orders for Disposables with [*****] months
lead time. Haemonetics will make products to VITEX's orders; therefore, orders
are non-cancelable once placed. Haemonetics will deliver Equipment no more than
[*****] days after receipt of an order and Disposables no more than [*****]
after receipt of an order. In the event that Haemonetics cannot meet the
delivery times set forth herein, Haemonetics shall so advise VITEX as soon as
reasonably possible, at which point the parties shall negotiate in good faith on
an amended delivery schedule, not to exceed the cure period provided in Section
8. If the parties cannot agree on a renegotiated delivery schedule or if
Haemonetics is fails to meet an agreed upon renegotiated delivery schedule, then
Haemonetics will license its Cell Washing Technology to VITEX only for use in
viral inactivation and only for the duration of the delay or failure of
delivery, subject to mutually agreeable terms and conditions, including royalty
or other payments to Haemonetics, to be negotiated in good faith at the time of
such failure or delay. Nothing contained herein shall be construed to limit or
restrict any claim for damages that VITEX may have against Haemonetics in the
event of any breach of delivery obligations herein.
9.4. SHIPPING AND PAYMENT TERMS.
---------------------------
All prices are FOB Braintree. Invoices shall be paid within 30 days.
9.5. PRICE CHANGES.
--------------
The initial prices to VITEX shall be set by Haemonetics, subject to
Paragraph 9.2; shall become effective beginning with the first sale after FDA
approval; and shall remain fixed for the next three years. Thereafter, prices
shall be reviewed every three years. Prices shall be increased or decreased at
the same rate as changes in the Consumer Price Index (CPI) compounded over a
three-year time frame. Any price changes in excess of this calculation shall be
mutually agreed.
10. ROYALTY PAYMENTS FOR NON-PURSUIT OF CELL WASHING.
-------------------------------------------------
If, during the term of this Agreement, VITEX elects not to pursue Cell
Washing Technology and instead elects to proceed with a different removal
technology, then VITEX will pay to Haemonetics as a royalty [*****] of its sales
revenue for the first five (5) years of market sales worldwide using the
different removal technology or for the remainder of the term of this Agreement,
whichever is less. VITEX shall have no obligation to make royalty payments (i)
if Haemonetics' 510(k) for a Cell Washing System is not approved by FDA within
two (2) years of submission, except if the delay or failure to obtain approval
is caused by VITEX, or (ii) if VITEX can demonstrate that Haemonetics could not
make available a Cell Washing System that would be approvable by FDA.
11. MARKETING AND SALE.
-------------------
Haemonetics shall have no obligation for worldwide inventory, marketing,
and sale of the Viral Inactivation System, including the Cell Washing System to
be used with it, though Haemonetics' name shall appear on all Equipment and
Disposables as the manufacturer of those products. All such inventory,
marketing and sales efforts shall be undertaken by VITEX at its sole discretion.
Haemonetics shall retain the worldwide right to install and service the
Equipment, and the parties shall separately negotiate mutually agreeable terms
and conditions for service and installation.
----------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
5
12. BOOKS AND RECORDS.
------------------
Each party shall provide the other party with reasonable access to its
books and records to ensure its compliance with this Agreement. Such access
shall be during regular business hours with reasonable advance notice.
---------------
13. INVENTIONS AND INTELLECTUAL PROPERTY.
-------------------------------------
Each party shall continue to own all right, title and interest to all
inventions and intellectual property owned or developed prior to this Agreement.
All right, title and interest in all clinical data, documents, information and
results prepared and developed in connection with this Agreement and inventions
and intellectual property made during or in connection with this Agreement that
are discovered, made or conceived solely by employees of VITEX or others acting
exclusively on behalf of VITEX shall be owned by VITEX. All right, title and
interest in all inventions and intellectual property made during or in
connection with this Agreement that are discovered, made or conceived solely by
Haemonetics or others acting exclusively on behalf of Haemonetics shall be owned
by Haemonetics. All right, title and interest in all inventions made during or
in connection with this Agreement that are discovered, made, or conceived
jointly by employees of VITEX and Haemonetics or others acting on their joint
behalf shall be jointly owned by VITEX and Haemonetics, except that all right,
title and interest in all inventions made during the term of this Agreement
relating to the Viral Inactivation Agent shall be owned solely by VITEX.
Each party shall promptly disclose to the other party the making, conception or
reduction to practice of inventions, subject to the ownership and
confidentiality provisions in this Agreement. In addition, attached as Exhibit
4 hereto is a list of patent disclosures or applications relating to methods of
removing pathogen inactivation agents from red cells by washing. Each party
represents and warrants to the other party that the list is true and complete to
the best of its knowledge and each further agrees to update this list as
required in the event that any new patent disclosures or applications are made
after the effective date of this Agreement.
14. WARRANTIES AND INDEMNIFICATION.
-------------------------------
VITEX and Haemonetics each warrants and represents to the other that: it
is a corporation duly organized, validly existing, and in good standing under
the laws of the state in which it is incorporated; it has the right to enter
into this Agreement; the execution, delivery, and performance of this Agreement
have been authorized by all necessary corporate action and by all necessary
parties; and the terms of this Agreement are not inconsistent with other
contractual obligations, express or implied, existing or contemplated, which it
may have or expects to have during the term of this Agreement, including any
existing or contemplated contractual obligations by VITEX to Pall Corporation.
VITEX and Haemonetics each further warrants and represents that the development
efforts contemplated by this Agreement are not the subject of any third party
licensing or consulting obligations; that each of its employees participating in
the development efforts has executed an assignment to their respective employer
of any and all right, title and interest such employee may have in any
invention, discovery, or technology he/she, alone or jointly conceives, reduces
to practice, or otherwise develops relating to and in the course of his/her
employment by VITEX or Haemonetics; that it will comply with all applicable
laws, rules and regulations.
The parties agree and understand that the Phase 2/3 trials will involve
human subjects in addition to in vitro research investigations. VITEX will
defend, indemnify and hold Haemonetics, its directors, officers, employees, and
agents harmless from any cost, expense, or liability (including attorneys' fees)
or claims of third parties, including any human subjects, arising out of the use
of the Viral Inactivation Agent or out of any human subject studies during the
development of the Viral Inactivation System, except to the extent caused by the
negligence, gross negligence or willful misconduct of Haemonetics or others
acting on behalf of Haemonetics. Following the sale of the viral inactivation
system, including Haemonetics' Equipment and Disposables, VITEX will defend,
indemnify and hold Haemonetics, its directors, officers, employees, and agents
harmless from any cost, expense, or liability (including attorneys' fees) or
claims of third parties arising out of the use of the Viral Inactivation Agent,
except to the extent caused by the negligence, gross negligence or willful
misconduct of Haemonetics or others acting on behalf of Haemonetics, provided
further that, to the extent the cost, expense, liability or third party claim is
based on injury caused by physical contact with the Viral Inactivation Agent,
then VITEX shall defend, indemnify and hold Haemonetics harmless irrespective of
Haemonetics' negligence.
Except as set forth above, Haemonetics shall defend, indemnify and hold
VITEX, its directors, officers, employees, and agents harmless from any cost,
expense, or liability (including attorneys' fees) or claims of third parties,
including any human subjects, arising out of a defect of the Cell Washing
System, except to the extent caused by the negligence, gross negligence or
willful misconduct of VITEX, the Naval Blood Research Laboratory when acting for
VITEX, or others acting on behalf of VITEX.
EACH PARTY HEREBY DISCLAIMS ALL FURTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT OF THE INTELLECTUAL
6
PROPERTY RIGHTS OF THIRD PARTIES. ANY REMEDIES SET FORTH HEREIN ARE EXCLUSIVE
AND IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR TO ANY PARTY
CLAIMING THROUGH IT FOR CONSEQUENTIAL, SPECIAL, INCIDENTAL, INDIRECT OR PUNITIVE
DAMAGES.
15. PUBLICATIONS AND PUBLICITY.
---------------------------
Subject to the confidentiality provisions in this Agreement, publication of
results of work performed under this Agreement will be by mutual agreement and
with advance written approval of both parties. Authorship of any publication or
presentation based on work performed hereunder will take into account the
scientific contributions of all individuals participating in such work. Neither
party shall use the trade name or trademarks or copyrights or intellectual
property of the other or the existence and terms of this Agreement in any
written or verbal public announcement or disclosure, publicity, or advertising
with respect to the subject matter of this Agreement unless 1) reasonably
necessary to comply with applicable government laws or regulations with
reasonable notice provided to the other party or 2) with the advance written
permission of the other party, which permission shall not be unreasonably
withheld or delayed.
16. NO LICENSE.
-----------
Except as expressly set forth in this Agreement, neither party has granted
or shall grant any right, license or option to the other party under any patent
or other intellectual property right.
17. RELATIONSHIP.
-------------
The parties understand and agree neither party is an agent of the other nor
are the parties to be principals, agents, partners, joint venturers or
otherwise. Each party shall be solely responsible to purchase any required
insurance such as workers compensation insurance and to pay or withhold any
federal, state or local taxes on account of their employees. Neither party has
authority to bind the other by contract or agreement of any kind nor to
undertake any obligation on behalf of the other party and neither shall
represent itself to third parties as having such authority.
18. CONFIDENTIALITY.
----------------
For purposes of this Agreement, the term "Confidential Information" means
all information, reagents, procedures, data, results, conclusions, drawings,
know-how, experience or trade secrets owned by one party (the "Disclosing
Party") and disclosed or provided to the other party (the "Receiving Party"),
including without limitation the testing of Viral Inactivation Agent.
Confidential Information shall include that which is either specifically
designated as confidential or which a reasonable person would understand to be
confidential.
The Receiving Party agrees that it will not use, except as needed for the proper
performance of this Agreement, nor disclose to any third party without the prior
written consent of the Disclosing Party, any Confidential Information of the
Disclosing Party for the entire term of this Agreement and for 5 years
thereafter. The Receiving Party shall have no obligations with respect to any
portion of such Confidential Information which:
(a) is or later becomes generally available to the public by use, publication
or the like, through no fault of the Receiving Party; or
(b) is obtained from a third party who had the legal right to disclose the same
to the Receiving Party; or
(c) the Receiving Party already possesses, as evidenced by its written records
predating receipt thereof from the Disclosing Party; or
(d) is required to be released by law or court order; provided, however, that
in such event, the Receiving Party shall give the Disclosing Party
reasonable advance notice of such disclosure and, save to the extent
necessary in the case of patent applications, shall use reasonable efforts
to secure confidential treatment of Confidential Information prior to its
disclosure (by protective order or otherwise).
19. ARBITRATION.
------------
Except with respect to any disputes relating to the provisions on
confidentiality and intellectual property rights of either party, any claim or
dispute concerning questions of law or fact arising out of, or relating to, this
Agreement or its performance or any alleged breach thereof which is not disposed
of by Agreement of the parties, including without limitation any claim
concerning the interpretation or validity of this Agreement, upon written demand
of one of the parties, shall be determined, solely and exclusively, by a single
arbitrator sitting in accordance
7
with the Rules of Commercial Arbitration of the American Arbitration Association
then in force at its office in Boston, Massachusetts. The decision of the
arbitrator shall be final and binding. The expense of the arbitration shall be
shared equally by the parties and each party shall bear its own attorneys fees,
unless the arbitration award states that the expenses and fees shall be
otherwise assessed. Any such arbitration shall take place in Boston,
Massachusetts. Notwithstanding the foregoing, in the event both parties hereto
are named as defendants by an arms length third party plaintiff asserting a
claim against both parties, then and in such event, either party may seek the
resolution of their respective rights and obligations, arising from such claim
in said proceedings.
Notwithstanding the foregoing, both parties acknowledge that a breach by either
party of its confidentiality obligations or of the provisions governing the
parties' respective intellectual property rights will cause the non-breaching
party irreparable harm for which injunctive relief is the only adequate remedy.
The parties therefore agree that both parties shall have the right to seek
injunctive or other immediate relief from any United States court or tribunal of
competent jurisdiction to prevent or stop any violations by the other party of
those obligations without being required to submit such dispute to arbitration.
20. NOTICE.
-------
Unless otherwise provided in this Agreement, any notice to be given
hereunder shall be deemed effective when sent to the party to be notified.
Notice may be made via overnight courier, registered mail, postage prepaid, and
the like, to the address listed below, or such other person or address as a
party may later specify:
If to VITEX: If to Haemonetics:
V.I. Technologies, Inc. Haemonetics Corporation
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: ▇▇▇▇ ▇▇▇▇ Attn: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
cc: ▇▇▇▇▇▇ ▇. ▇▇▇▇▇, Esq.
21. GOVERNING LAW.
--------------
This Agreement shall be governed as to interpretation, validity, effect,
enforceability and all other substantive or procedural matters by the laws of
the Commonwealth of Massachusetts.
22. ENTIRE AGREEMENT.
-----------------
This Agreement constitutes the entire agreement between the parties
relating to the subject matter herein and supersedes all prior agreements,
proposals, understandings, course of conduct and writings by and between the
parties and relating to the subject matter herein, including without limitation
the "Collaborative Research Agreement between Pentose Pharmaceuticals, Inc. and
Haemonetics Corp." effective February 4, 1999 and the Development Agreement
Between Pentose Pharmaceuticals, Inc. and Haemonetics Corporation, except those
provisions of the prior agreements that expressly survive termination unless the
surviving provisions conflict with the terms of this Agreement in which case
this Agreement shall govern. None of the terms of this Agreement shall be
deemed to be amended unless such amendment is in writing and duly executed by
all parties to this Agreement and such writing specifically states that it is an
amendment to this Agreement.
23. ASSIGNMENT; SUCCESSORS AND ASSIGNS.
-----------------------------------
This Agreement may not be assigned without the advance written consent of
the nonassigning party, which consent shall not be unreasonably withheld,
provided, however, that, without consent of the other party being required, a
party (i) may assign its rights and obligations under this Agreement in
connection with a corporate reorganization, to any affiliate, all or
substantially all of the equity interest of which is owned and controlled by
such party or its direct or indirect parent corporation, and (ii) must assign
its rights and obligations under this Agreement in connection with a merger,
consolidation or sale of substantially all of the assets of such party to which
8
this Agreement relates to an unrelated third party; provided, however, that such
party's rights and obligations under this Agreement shall be assumed by its
successor in interest in any such transaction. Any permitted assignee shall
assume all obligations of its assignor under this Agreement.
This Agreement shall be binding on and inure to the benefit of all
permitted successors and assigns. IN WITNESS WHEREOF a duly authorized
representative of each of the parties executes duplicate originals of this
Agreement, each of which shall be considered one and the same instrument, as of
the effective date above.
V.I. TECHNOLOGIES, INC. HAEMONETICS CORPORATION
BY: /s/ ▇▇▇▇ ▇▇▇▇ BY: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
------------------------- ---------------------------
▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
TITLE: President and CEO TITLE: President and CEO
9
EXHIBIT 1
---------
SPECIFICATIONS FOR PIVOTAL TRIAL 215 EQUIPMENT
----------------------------------------------
1) [*****]
2) [*****]
3) [*****]
4) [*****]
5) [*****]
6) [*****]
7) [*****]
Projected Instrument Requirements: [*****]
[*****]
----------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions
EXHIBIT 2
---------
SPECIFICATIONS FOR COMMERCIAL 215
---------------------------------
1) [*****]
2) [*****]
3) [*****]
4) [*****]
5) [*****]
6) [*****]
----------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions
EXHIBIT 3
---------
MULTI-UNIT COMMERCIAL DEVICE
----------------------------
1) [*****]
2) [*****]
3) "[*****]
4) [*****]
5) [*****].
6) [*****]
7) [*****]
8) [*****]
9) [*****]
10) [*****]
----------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
EXHIBIT 4
---------
VITEX Patents
[*****]
HAEMONETICS PATENTS
[*****]
----------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions