EXHIBIT 10.1
RESEARCH AGREEMENT
EXHIBIT 10.1
RESEARCH AGREEMENT
WHEREAS: This contract is entered into between Xpention Genetics, Inc., a
company organized under the laws of Nevada, having its business office at 00000
Xxxxxxxxx Xxxxx, Xxxxxxx, XX. 00000 ("XPENTION") and The University of Texas
Health Science Center at San Antonio ("UTHSCSA"), 0000 Xxxxx Xxxx Xxxxx, Xxx
Xxxxxxx XX 00000-0000, a component of The University of Texas System ("System").
THEREFORE: In consideration of the foregoing and the mutual promises, covenants
and agreements herein set forth, XPENTION and UTHSCSA agree as follows:
1. Scope of Work
UTHSCSA agrees to perform for XPENTION the research activities for the
project entitled "Development of the p65 Immunological Test" described in
Attachment A hereto.
2. Contract Period
This contract shall become effective on December 1, 2005, and shall be
completed on June 30, 2006 unless subsequent time extension, supplement,
addition, continuation or renewal is mutually agreed upon in writing
between the parties.
3. Standard of Performance
UTHSCSA shall perform the Work in a manner consistent with the highest
standards of scientific and professional skill and in accordance with the
terms and conditions of this Agreement. Xxxxxxxx Xxxxxxxx, Ph.D. ,
UTHSCSA's designated Principal Investigator for the project (the "PI"),
shall monitor UTHSCSA's performance hereunder and shall notify XPENTION of
UTHSCSA's failure to comply with the terms of this Agreement within a
reasonable time after UTHSCSA learns of such failure.
4. Assignment
Neither party shall assign or transfer any interest in this agreement, nor
assign any claims for money due or to become due under this agreement
without the prior written approval of the other party.
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5. Payments to Subcontractor
The cost for UTHSCSA's completion of the Work, including indirect charges,
is $64,306. Payments by XPENTION to UTHSCSA shall be made in accordance
with the following schedule:
a. Signature: $34,306
b. 4 month xxxx: $20,000
c. Final report submission: $10,000
Payments will be effected within 45 days of receipt of invoice.
6. Indemnification
XPENTION agrees to indemnify and hold The University of Texas System
("System"), UTHSCSA, their Regents, officers, agents and employees
harmless from any liability, loss or damage they may suffer as a result of
claims, demands, costs or judgments against them arising out of the
activities to be carried out pursuant to the obligations of this
Agreement, including, but not limited to, the use by XPENTION of the
results obtained from the activities performed by UTHSCSA under this
Agreement; provided, however, that any such liability, loss or damage
resulting from the following subsections is excluded from this Agreement
to indemnify and hold harmless:
a. the negligent failure of UTHSCSA to substantially comply with any
applicable FDA or other governmental requirements; or
b. the negligence or willful malfeasance of any Regent, officer, agent
or employee of UTHSCSA or System.
7. Publications
UTHSCSA shall be sited in all research reports and other publications
relating to the work under this Agreement.
9. Law
This Agreement is entered into pursuant to and under the authority granted
by the laws of the state of Texas and any applicable federal laws. The
provisions of this Agreement shall be construed to conform to those laws.
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10. Termination
This Agreement may be terminated by either of the parties hereto upon
written notice delivered to the other party at least thirty (30) days
prior to intended date of termination. By such termination, neither party
may nullify obligations already incurred for performance or failure to
perform prior to the date of termination.
11. Changes and Amendments
This contract constitutes the entire agreement between the parties. All
amendments and /or changes shall be by written instrument executed by the
parties hereto.
12. Intellectual Property
The parties acknowledge that portions of this research may utilize
intellectual property addressed by the following US patents which are
licensed to XPENTION by the Board of Regents of The University of Texas
System:
o US Patent # 5,310,653 (May, 1994)
o US Patent # 5,411,868 (May, 1995)
o US Patent # 5,773,215 (June, 1998)
All additional intellectual property, if any, which is developed through
this research, shall be governed by The Rules and Regulations of the Board
of Regents of The University of Texas System for the Government of The
University of Texas System, and according to US patent law.
IN WITNESS WHEREOF, the parties hereto have caused this contract to be executed
as of the date set forth herein by their duly authorized representatives.
THE UNIVERSITY OF TEXAS HEALTH XPENTION GENETICS, INC.
SCIENCE CENTER AT SAN ANTONIO
/s/ Xxxx X. Xxxxxxxx 12/12/05 /s/ Xxxxx Xxxxxxxx 12/20/05
------------------------------------------ ----------------------------------------
Xxxx X. Xxxxxxxx Date Xxxxx Xxxxxxxx Date
Assistant Vice President for Research President and CEO
I have read this agreement and understand
my obligations hereunder.
/s/ Xxxxxxxx Xxxxxxxx 12/12/05
------------------------------------------
Xxxxxxxx Xxxxxxxx, Ph.D. Date
Principal Investigator
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ATTACHMENT A
SCOPE OF WORK
THE P65 ONCOFETAL PROTEIN AS A NOVEL TUMOR MARKER IN DETECTION OF BREAST,
PROSTATE AND OTHER CANCERS
Xxxxxxxx Xxxxxxxx, Ph.D., Principal Investigator
The University of Texas Health Science Center at San Antonio
Xxxxx Xxxxxxxx, CEO
Xpention Genetics Inc
Xxxxxxx, XX 00000
The proposed research will focus on a novel oncofetal protein with a molecular
weight of 65 kDa (p65). The development of intermediate biomarkers of cancer
risk and or cancer presence and the evaluation of efficacy of individual
biological or molecular markers is an important avenue in cancer research. The
protein we are studying (p65) appears to have all the characteristics of such a
marker. Our ultimate goal is to prove usefulness of p65 in early detection and
management of different human cancers, including breast and prostate cancer. The
p65 gene is a novel member of the steroid receptor super-family of genes. The
overall objective is to identify the cellular origin of p65 and elucidate the
mechanisms of its expression in rodent and or mammalian (i.e. canine) liver,
skin, colon, prostate, and mammary gland carcinogenesis as well as in the
development of lymphomas and leukemias, and combine these basic studies with the
translational research to provide better understanding of the role of this novel
tumor marker in cancer development.
Malignant tumors appear to universally produce the oncofetal protein, p65. In
addition, p65 is expressed very early during the carcinogenesis process. It is a
shedding antigen and can be found in the blood (plasma/serum) of tumor-bearing
animals, as well as in the plasma/serum of cancer patients. This fact suggests
that p65 antibodies may be useful in human cancer screening, carcinogenesis
studies and studies on cancer risk assessment. The most striking observation
made during development of monoclonal antibodies and establishing ELISA for p65,
was that the monoclonal antibodies directed against p65, detect with a great
accuracy human cancers such as breast, prostate and colon cancer. We have now
identified the p65 gene as a novel member of the super-family of genes that
encode nuclear receptors for various hydrophobic ligands such as steroids,
vitamin D, retinoic acid, and thyroid hormones. These receptors are composed of
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several domains important in hormone binding, DNA binding, dimerization, and
transcription activation. The human p65 cDNA was recently cloned, revealing at
its C-terminal end regulatory elements typical of this super-family of genes.
Using ELISA, p65 was shown to be a promising marker for diagnosis and prognosis
of breast cancer.
Cancer is commonly encountered in pet animal practices and is one of the leading
causes of pet death. While the pet's prognosis is dependent upon various factors
including tumor type and stage at diagnosis, for the vast majority of cancers,
early detection and treatment are extremely important in successful cancer
therapy. Although various tumor markers have been shown to be useful diagnostic
and prognostic indicators in human oncology, their application to companion
animal medicine has barely been explored. The ideal tumor marker would be
produced only by malignant cells, be detectable early after the onset of tumor
formation, and have levels that directly correlate with tumor burden. Our
preliminary studies with a 65-kD tumor-associated protein (p65), in spontaneous
canine lymphosarcoma cases and experimentally induced malignancies in rodent
models indicate that this tumor marker possesses these ideal characteristics and
has great potential utility in companion animal cancer medicine. We have
developed a test for veterinary application in the differential diagnosis of
malignancy, in assessing patient response to cancer therapy, and in monitoring
clinical remission to enable the prompt detection of cancer recurrence using
double sandwich ELISA with monoclonal and polyclonal antibodies to p65.
This study will focus on the characterization, detection method development, and
clinical analysis of a unique 65-kD tumor-associated tumor marker in canine cell
line products and in stored plasma collected from different canine cancer cases.
The project's overall objective will be the development of a quantitative assay
for the p65 tumor marker in the dog. In order to attain our overall objective we
will first obtain p65-specific peptides. Purified p65 peptides will then be used
as source material to obtain monoclonal antibodies and or monospecific
antibodies to detect cancer in dogs. Carefully designed molecular biology and
human studies will then follow.
The following milestones are planned:
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1. We will design synthesis of 15-18 amino acids (2 sets one from NH2 end
and one from C-terminus end) that will serve as primers for monoclonal
and monospecific antibodies. Since the primers are relatively short, it
will be necessary to conjugate them with KLH (keyhole limpet hemocyanin
[KLH] protein) to increase the size of the antigen and its
immunogenicity before injecting mice.
2. We have selected New England Peptide Co. to make both sets of anti-
bodies. The time frame for this work is 3-6 months. The company will
synthesize peptides, conjugate them with KLH, inject mice, as
routinely is done for such projects, and provide us with sera contain
-ing anti-p65 antibodies.
3. When we receive sera plus peptides as standards, we will start work on
the characterization of the antibodies and designing ELISA work. This
step will require 2-3 months.
4. We will receive blood specimens from different canine cancer subjects
from Dr Xxxxx Xxxx, Colorado State University at Fort Xxxxxxx, Animal
Cancer Center. These samples will be taken prior to any cancer
treatment and will include a variety of cancer types and a small number
of normal dogs. Once the antibodies are available the blood samples
will be tested.
This will constitute the first phase of this project. Future work may
entail collection of more specific samples such as post treatment or at the
time of disease progression.
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