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EXHIBIT 10.2
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UNITED STATES DEPARTMENT OF AGRICULTURE
RESEARCH AGREEMENT
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TYPE OF
RESEARCH AGREEMENT
Cooperative
Research and Development Agreement
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AGREEMENT
NO.
58-3K95-3-0967
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TYPE OF
ACTION
Amendment No. 3
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AGENCY (Name
and Address)
Agricultural Research Service
1400 Independence Avenue SW
Washington, D.C. 20250-0302
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PERIOD OF
AGREEMENT
10/01/02 through 9/30/07
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FEDERAL
OBLIGATION
$ 0
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CHANGE IN
FEDERAL OBLIGATION
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This
Agreement is authorized by the Federal Technology Transfer Act, 15
USC 3710a, et seq., and is governed by its terms.
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Items
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1 Descriptions
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1.
Technology Transfer Coordinator
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Harry D.
Danforth
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2.
Cooperator
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Hepalife
Technologies, Inc.
Suite 216 -
1628 West 1 st Ave,
Vancouver,
BC, V6J 1G1
Tax ID #
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3.
Principal Investigator
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Harmel
Rayat, Director
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4.
USDA Laboratory
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Growth
Biology Laboratory
10300
Baltimore Ave.
Beltsville,
MD 20705-2350
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5.
USDA Researcher (ADODR)
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Neil
Talbott, Thomas Caperna
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6.
National Program Leader & Area
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First &
Last Name of NPL
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7.
Accounting Code
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X91-1265-356
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8.
Amount
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$807,828.00
(total for 5 years)
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9.
Finance Office
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Budget &
Fiscal Office
USDA-ARS-BA
Bldg. 003,
Room 306, BARC-West
Beltsville,
MD 20705-2350
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10.
Cris No.
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1365-31000-087-01T
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11.
Title of Project
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OPTIMIZATION
OF THE ARS-PICM-19 CELL LINE FOR AN IN VITRO MODEL OF PIG LIVER
FUNCTION AND APPLICATION TO AN EXTRACORPOREAL LIVER ASSIST
DEVICE
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12.
Log #
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22659
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This
Agreement is amended, as follows:
The duration of the Agreement is extended for three (3) years
through September 30, 2007. ARS will receive a total of
$807,828.00 in funds of which $153,600.00 has been paid. The
Statement of Work and Clause 9 have been changed and are
incorporated herein. The Title of Project has been changed.
ALL OTHER TERMS AND CONDITIONS REMAIN THE SAME.
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FOR THE UNITED STATES DEPARTEMENT OF
AGRICULTURE
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SIGNATURE
/s/
Richard Brenner
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TYPED
NAME
RICHARD J. BRENNER
Authorized Departmental Officer
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DATE
May 19, 2004
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FOR THE COOPERATOR
(Signature of person(s) authorized by the governing body
of the COOPERATOR to incur contractual obligations)
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SIGNATURE
/s/
Harmel Rayat
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TYPED NAME
AND TITLE
HARMEL
RAYAT
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DATE
May 24,
2004
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Clause 9
9.1
HEPALIFE shall have the
first option to prepare and prosecute patent or Plant Variety
Protection Certificate applications, foreign and domestic, on
Subject Inventions owned or co-owned by the U.S. Government,
subject to the following conditions:
a.
All documents shall be
submitted to ARS sufficiently in advance of filing to allow ARS a
reasonable opportunity to review and make recommendations
thereon;
b.
Copies of all
correspondence from the U.S. Patent and Trademark Office or Plant
Variety Protection Office and foreign equivalent offices shall be
provided promptly to ARS;
c.
The following USDA
personnel shall be given an associate power of attorney or be
listed as an attorney of record:
Patent Advisor
Patent
Attorney
Evelyn Rabin
John
Fado
USDA-ARS-OTT
USDA-OGC Rm. 3311
5601 Sunnyside Avenue
South
Agriculture Bldg.
Beltsville MD
Washington, D.C. 20250-1415
Registration Number
Registration No. 27876
Tel: 301-504-4781
Tel.:
202-720-2421
Fax: 301-504-5060
Fax:
202-720-8706
9.2
The act of preparing
and/or filing documents, per se , shall not entitle HEPALIFE
to any rights in such Inventions or the reimbursement of costs
incident to patent prosecution.
9.3
ARS shall have the right
at any time, at its sole discretion, concerning Inventions solely
owned by the U.S. Government, to: (1) assume responsibility for
prosecuting any such application; and (2) permit any application to
become abandoned or issued patent/certificate to expire, subject to
the provisions of any license agreement relating to the subject
matter.
9.4
ARS agrees to provide
HEPALIFE consultation and advice in the preparation, filing, and
prosecution of patent or Plant Variety Protection Certificate
applications on Subject Inventions.
STATEMENT OF WORK
A.
Introduction/Background
ARS
has developed several in-vitro model systems to investigate various
aspects of hepatic gene expression and metabolic regulation. These
systems encompass both established cell lines and primary liver
cell cultures. One stem-like cell line, derived from porcine
epiblast (embryonic) tissue is the ARS PICM-19 cell line (ARS
patent #5,532,156), has been partially characterized and is a
non-transformed immortal cell line that possesses many
characteristics similar to that of intact liver parenchymal cells.
ARS interests would be greatly enhanced by further characterization
and improvements in the culture technology that would ultimately
result in the cell line not requiring feeder cell support and
growth in a completely serum-free defined medium. These
advancements would facilitate our understanding of regulatory
events in pig liver gene/proteome expression and in regulation of
nutrient metabolism. Further, it has already been demonstrated that
the unique hepatic characteristics of the ARS-PICM-19 cell line
would have potential application for use in the production of a
rescue device for human patients in liver failure (ARS patent #
5,866,420; “Artificial Liver Device”, granted to ARS on
2/2/1999). To date, the cellular components of artificial liver
devices that are being tested by other institutions are based on
freshly isolated porcine hepatocytes, human transformed tumor
cells, or poorly defined stem-like cells prepared from fresh human
adult liver tissue. It is widely recognized that the greatest
hindrance to the development of a completely functional artificial
liver rescue device is the lack of an appropriate defined cell line
that will provide the functions of an intact liver. The primary
interest of Hepalife is to explore the possibility that the ARS
PICM-19 cell line is indeed the most appropriate cell line to use
in such a device.
B.
Objective
The overall objective of the
work is to optimize the patented ARS-PICM-19 cell line as an
in-vitro model of the pig liver. The first objective is to
investigate and discover culture conditions for the ARS-PICM-19
cell line, or modifications of the ARS-PICM-19 cell line technology
itself, that will optimize function, i.e., culture conditions or
cell line modifications that will enable, as closely as possible,
the reproduction of normal pig liver functions in an in-vitro
environment. Directly related to the first objective will be
the second and third objectives. The second objective is
adapting and applying the optimized ARS-PICM-19 cell line
technology to the development of an extracor
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