["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
EXHIBIT 10.14
AMENDED AND RESTATED
COLLABORATION AGREEMENT
AMONG
AMERICAN NATIONAL RED CROSS,
NEW YORK BLOOD CENTER, INC.
AND
V.I. TECHNOLOGIES, INC.
THIS AMENDED AND RESTATED COLLABORATION AGREEMENT (the "Restated
Agreement") entered into this 15th day of December, 1997, (the "Effective Date")
by and between the American National Red Cross, a congressionally chartered not
for profit corporation, with its headquarters at 0000 Xxxxxxxxx Xxxx, Xxxxx
Xxxxxx, Xxxxxxxx 00000 (the "ANRC"), New York Blood Center, Inc., a New York
not-for-profit corporation, with its headquarters at 000 Xxxx 00xx Xxxxxx, Xxx
Xxxx, Xxx Xxxx 00000 (the "NYBC"), and V.I. Technologies, Inc., a Delaware for-
profit corporation, with its headquarters at 000 Xxxxxx Xxxx, Xxxxxxxx, Xxx Xxxx
00000 (formerly known as Melville Biologics, Inc., "VITEX").
WHEREAS, the ANRC and the NYBC entered into that certain Collaboration
Agreement dated February 22, 1991 (the "Original Agreement"); and.
WHEREAS, the ANRC, the NYBC and VITEX have entered into a First Amendment
and Restatement of the Original Agreement on July 22, 1996 (the "First Restated
Agreement"); and
WHEREAS, with the consent of the NYBC, the ANRC and VITEX have
contemporaneously entered into a Supply, Manufacturing, and Distribution
Collaboration Agreement
(the "Distribution Agreement") providing for (a) VITEX's processing of Input (as
hereinafter defined) provided by the ANRC and manufacturing of the Product (as
hereinafter defined) by VITEX, and (b) VITEX's granting the ANRC certain
distribution rights to the Product; and
WHEREAS, the mission of the ANRC is to fulfill the needs of the American
people for the safest, most reliable and most cost-effective blood, plasma and
tissue services through voluntary donations; and
WHEREAS, the ANRC entered into the Original Agreement, the First Restated
Agreement, the Distribution Agreement and this Restated Agreement so as to
materially enhance the safety of the Input (as hereinafter defined) to aid and
assist in advancing the health and well-being of as many people as possible and
thereby furthering the charitable mission of the ANRC.
NOW, THEREFORE, the NYBC, the ANRC and VITEX agree to amend and restate the
First Restated Agreement in its entirety by agreeing to the following:
ARTICLE I
---------
DEFINITIONS
2
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
1.1 "ANRC Know-How" shall mean all proprietary technical information,
including processes, formulae, designs and data, owned or possessed in whole or
in party by the ANRC relating to the manufacture or use of the Product.
1.2 "Expansion" shall mean the expansion (i.e., facility and equipment)
of the Melville Plant to accommodate the processing of up to ******************
*******************.
1.3 "Input" shall mean human blood plasma provided to VITEX by the ANRC
pursuant to the terms of the Distribution Agreement which plasma meets the
specifications set forth in the Distribution Agreement.
1.4 "FDA" shall mean the U.S. Food and Drug Administration or any
successor agency.
1.5 "Know-How" shall mean VITEX Know-How and ANRC Know-How.
1.6 "Melville Plant" shall mean the manufacturing facility licensed by
the FDA, located in Melville, New York, and occupied and controlled by VITEX.
1.7 "PLA" shall mean a Product License Application submitted to and for
approval by the FDA. "S/D Plasma PLA" shall mean the PLA for solvent/detergent-
treated human blood plasma for transfusion submitted by the NYBC for filing with
the FDA on February 28, 1993, as revised on July 11, 1994. Pursuant to the
Amended and Restated Asset Transfer Agreement between the NYBC
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and VITEX, dated February 7, 1995 (the "Asset Transfer Agreement"), the S/D
Plasma PLA was transferred from the NYBC to VITEX.
1.8 "Product" shall mean the product referenced in the S/D Plasma PLA,
which product is a human blood plasma, pooled and treated to inactivate virus
and intended for transfusion as such or following minor changes in composition.
Purified plasma derivatives, such as coagulation factor concentrates,
fibrinogen, or immunoglobulin, prepared from virus-inactivated plasma, are not
covered by this Agreement and the Distribution Agreement. The Product is also
known under the names VIPLAS/SD, Plas Plus or S/D Plasma and conforms to the
specifications set forth in the Distribution Agreement.
1.9 "Units(s)" shall mean two hundred (200) milliliters of frozen liquid
Product, prepared within VITEX's manufacturing specifications and intended for
use in patients.
1.10 "VITEX Know-How" shall mean all proprietary technical information,
including processes, formulae, designs and data, owned or possessed in whole or
in part by the NYBC and/or VITEX relating to the manufacture or use of the
Product.
4
["****" indicates material omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.]
ARTICLE II
----------
PAYMENTS
2.(a) As of the Effective Date, the ANRC has loaned VITEX three million
dollars ($3,000,000) (the "Expansion Fee") for the Expansion. Such Expansion Fee
is a loan that shall be repaid by VITEX to the ANRC in accordance with Sections
2(b) and 2(c).
2.(b) VITEX shall amortize the Expansion Fee at the rate of fifteen
percent (15%) per year for five (5) years following approval of the S/D Plasma
PLA, provided, however, that during Period One (as defined in the Distribution
Agreement), the ANRC shall provide ******* units of Input, and further provided,
that during Period Two (as defined in the Distribution Agreement) and every
Subsequent Period(s) (as defined in the Distribution Agreement), the ANRC shall
provide ******* units of Input, all in accordance with the Distribution
Agreement. The balance of the Expansion Fee will be payable in the fifth
anniversary of the approval of the S/D Plasma PLA.
2.(c) If in any year the ANRC fails to provide the Input as set forth in
Section 2(b), the amortization of the Expansion Fee for such year shall be
prorated accordingly.
5
ARTICLE III
-----------
CONFIDENTIALITY
3.1 Each party agrees not to disclose any Know-How or other proprietary
information provided to it pursuant to the Restated Agreement. This obligation
shall not apply to any such information which:
(a) Is or subsequently becomes known to the public through no
fault of the disclosing party.
(b) Was in the possession of the disclosing party prior to
disclosure hereunder as established by documentation within thirty
(30) days of disclosure.
(c) Is obtained from a third party who or which has the right to
disclose same.
(d) Is disclosed to governmental, authorities in response to a
lawful order or demand for disclosure or in order to obtain required
consents, permits, licenses or other approvals relating to the
processing, use or sale of Product.
3.2 Each party agrees to treat as confidential the terms and conditions
of the Restated Agreement.
3.3 The provisions of this Article shall survive termination,
cancellation or expiration of the Restated Agreement.
6
3.4 To the extent there are any inconsistencies with respect to
confidentiality between the Restated Agreement and the Distribution Agreement,
the Distribution Agreement shall control.
ARTICLE IV
----------
TERM
The Restated Agreement shall terminate upon repayment of the Expansion Fee
to the ANRC. Termination of the Restated Agreement shall not affect Article
III, which shall survive such termination.
ARTICLE V
---------
NOTICES
Any notice, report or other communication required or permitted to be given
or made under the Restated Agreement by one of the parties to the other shall be
in writing and shall be deemed to have been sufficiently given or made for all
purposes if mailed by certified mail, postage prepaid, or by facsimile,
confirmed forthwith in written dispatch as described herein, addressed to such
other party at its respective address as follows:
7
If to the NYBC: New York Blood Center, Inc.
000 Xxxx 00xx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: Xxxxxx Xxxxxxx, Esq.
If to VITEX: V.I. Technologies, Inc.
000 Xxxxxx Xxxx
Xxxxxxxx, Xxx Xxxx 00000
Attention: President
Facsimile: (000) 000-0000
with a copy to: Crummy, Del Deo, Dolan, Griffinger & Xxxxxxxxx
Xxx Xxxxx Xxxxx Xxxxx
Xxxxxx, Xxx Xxxxxx 00000
Attention: Xxxxx Xxxxxxxx, Xx.
Facsimile: (000) 000-0000
If to the ANRC: American National Red Cross
0000 Xxxx Xxxx Xxxxx, 00xx Xxxxx
Xxxxxxx, Xxxxxxxx 00000-0000
Attention: Xxxxxxxxxxx Xxxx, Esq.
with a copy to: Office of General Counsel
0000 Xxxx Xxxx Xxxxx, 00xx Xxxxx
Xxxxxxx, Xxxxxxxx 0000-0000
Facsimile: (000) 000-0000
ARTICLE VI
----------
RELATIONSHIP WITH THE NEW YORK BLOOD CENTER
The ANRC and the NYBC agree to negotiate in good faith an agreement under
which the ANRC will provide the NYBC with the opportunity to purchase the
Product at reasonable cost and, subject to equitable allocation required in the
event of unavailability of the Product, in
8
quantities that the NYBC deems sufficient for its needs. The agreement between
the ANRC and the NYBC will insure that the ANRC will supply the Product on terms
which are commercially reasonable and no less favorable than those granted to
any other purchaser of the Product.
ARTICLE VII
-----------
GOVERNING LAW
The Restated Agreement shall be construed and the rights of the parties
governed in accordance with the laws of the State of New York, without regard to
principles of conflicts of law, including matters of validity, construction,
performance and remedy.
ARTICLE VIII
------------
ENTIRE AGREEMENT; AMENDMENT
The Restated Agreement, and the Distribution Agreement set forth the entire
understanding and agreement of the parties with respect to the subject matter
contained herein and may not be modified or amended except as expressly stated
herein or by a written agreement duly executed by all parties hereto.
9
ARTICLE IX
----------
DISTRIBUTION AGREEMENT
To the extent the Distribution Agreement may be deemed an amendment to the
First Restated Agreement, the NYBC consents to such amendment, but such consent
shall not be deemed a consent to the terms and conditions of the Distribution
Agreement to which it is not a party.
10
IN WITNESS WHEREOF, the parties hereto have caused the Restated Agreement to be
executed in triplicate by their duly authorized representatives.
AMERICAN NATIONAL RED CROSS NEW YORK BLOOD CENTER, INC.
SIGNATURE: SIGNATURE:
NAME: NAME:
TITLE: TITLE:
DATE: DATE:
V.I. TECHNOLOGIES, INC.
SIGNATURE:
NAME:
TITLE:
DATE:
11
