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EXHIBIT 10.1
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UNITED STATES DEPARTMENT OF AGRICULTURE
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TYPE OF
RESEARCH AGREEMENT
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RESEARCH
AGREEMENT
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Cooperative Research and
Development Agreement
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AGREEMENT
NO.
58-3K95-3-967
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TYPE OF
ACTION
NEW
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AGENCY
(Name and Address)
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Agricultural Research Service
1400 Independence Avenue SW
Washington DC 20250-0302
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PERIOD
OF AGREEMENT
11/1/02 through 10/31/04
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FEDERAL
OBLIGATION
$ -0-
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CHANGE IN
FEDERAL OBLIGATION
N/A
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CRIS
NO.
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AUTHORITY
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PERFORMING ORGANIZATION (Name and Address)
Zeta Corporation
1025 - 11811 N. Tatum Blvd.
Phoenix, AZ 85028-1699
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1265-31000-087-01T
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15 USC 3710a, et seq.
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OBLIGATION DISTRIBUTION
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Accounting Code
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$Amount
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X91-1265-356
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$292,727.00
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PRINCIPAL INVESTIGATOR (Name and Address)
Harmel Rayat
(Same as Above)
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FINANCE OFFICE (Complete Mailing Address)
USDA, ARS, BA, Budget and Fiscal Office
10300 Baltimore Ave.
Bldg. 003, Rm. 206, BARC-West
Beltsville, MD 20705-2350
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TITLE
OF PROJECT
Development
and Application of an In Vitro Model
of the Pig
Liver
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AUTHORIZED
DEPARTMENTAL OFFICER'S DESIGNATED REPRESENTATIVE (Name and
Address)
Neil C. Talbot
USDA, ARS, BA, ANRI, GEML
10300 Baltimore Ave.
Bldg. 200, Rm. 13A, BARC-E
Beltsville, MD 20705-2350
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LOG
#22659
Incorporated into this
Agreement are the following:
1.
General Provisions.
2.
Schedule 1 - Certifications.
3.
Schedule 2 - Statement of Work.
4.
Schedule 3 - Estimated Budget.
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FOR THE UNITED STATES DEPARTMENT OF AGRICULTURE
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AUTHORIZED DEPARTMENTAL OFFICER
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TYPED
NAME
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DATE
October 22, 2002
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/s/ Richard Brenner
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RICHARD J. BRENNER
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FOR THE PERFORMING ORGANIZATION
(Signature of person authorized by the governing body of
the performing organization to incur contractual obligations.)
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SIGNATURE
/s/ Harmel S. Rayat
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TYPED NAME
AND TITLE
Harmel Rayat
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DATE
November 1, 2002
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SIGNATURE
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TYPED NAME
AND TITLE
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DATE
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GENERAL PROVISIONS
1.
Definitions
ARS means the United States Department
of Agriculture = s
Agricultural Research Service.
Zeta means Zeta Corporation
Agreement means this Cooperative
Research and Development Agreement.
Confidential Information means trade
secrets or commercial or financial information that is privileged
or confidential, under the meaning of 5 USC 552(b)(4).
Subject Inventions means any invention
or other intellectual property conceived or first reduced to
practice under this Agreement which is patentable or otherwise
protectable under Title 35 of the United States Code, under 7 USC
2321, et seq., or under the patent laws of a foreign
country. Specifically not included in the definition of
Subject Inventions are inventions made outside The Scope of
Agreement or prior to the execution of this Agreement .
Scope of Agreement means those
activities set forth in Schedule 2, Statement of Work.
2.
Publications
a.
Subject to the
requirements of confidentiality and preservation of rights in
Subject Inventions, either party may publish the results of this
Agreement, PROVIDED:
(1)
The other party is
allowed to review the manuscript at least sixty (60) days prior to
submission for publication.
(2)
The publication shall
acknowledge this Agreement and the contributions of each party's
personnel.
b.
The final decision as to
the publication content rests with the party that writes the
publication.
c.
Publication and/or other
disclosure of the results of this Agreement shall be delayed as
necessary to preserve both United States of America and foreign
patent rights in a Subject Invention.
(1)
Such a delay will only be
granted if requested in writing; and
(2)
The requesting party
demonstrates promptness and diligence in seeking patent protection
on the Subject Invention.
3.
Meetings, Reports and
Records
a.
Frequent and effective
communication is essential to the successful accomplishment of the
objectives of this Agreement. To this end, the scientific
representatives of ARS and Zeta shall meet at least once every six
(6) months to exchange results, perform critiques, and make plans
and recommendations. Written progress reports shall be
supplied by each party to the other at least fifteen (15) calendar
days prior to each semiannual meeting.
b.
Any such plan or
recommendation that is outside the Scope of Agreement shall be
reduced to writing and referred to the management of each party for
appropriate action. Any such plan or recommendation so
referred shall not be binding upon either party unless incorporated
into this Agreement by amendment.
c.
Each party shall keep
complete records relating to this research. All such records
shall be available for inspection by either party at reasonable
times. The records, or true copies of them, shall be
delivered to either party upon request.
d.
The results of this
Agreement and research data which are collected, compiled, and
evaluated under this Agreement shall be shared and mutually
interchanged by Zeta and ARS.
e.
A final report summarizing
all data shall be submitted by each party to the other within sixty
(60) days of the completion of this Agreement.
4.
Confidentiality
a.
Confidential Information
which is owned by one party to this Agreement and given to the
other shall not be disclosed by the recipient without the written
permission of the owner.
b.
Confidential Information
given by one party to the other under this Agreement shall be
labeled "CONFIDENTIAL" by the submitter.
c.
To the extent either party
orally submits its Confidential Information to the other party, the
submitting party will prepare a document marked "CONFIDENTIAL"
embodying or identifying in reasonable detail such orally submitted
Confidential Information and provide the document to the other
party.
d.
Any Confidential
Information created under this Agreement which normally would be
included in scientific publications describing the results under
this Agreement may be included in such publications after an one
(1) year delay after creation of the information unless Zeta waives
delay.
(1)
Such publications may be
delayed an additional year upon justifiable request from the
non-publishing party; and
(2)
The preparation and
filing of a patent application on a Subject Invention is sufficient
justification.
e.
Neither party shall be
bound by confidentiality if the Confidential Information received
from the other party:
(1)
Already is available to
the public or known to the recipient;
(2)
Becomes available to the
public through no fault of the recipient; or
(3)
Is nonconfidentially
received from another party legally entitled to it.
5.
Research
Exclusion
a.
The results of this
Agreement owned or co-owned by the US Government may be made
available to others by ARS for bona fide noncommercial research
purposes if:
(1)
Confidentiality is not
breached; or
(2)
Patent or Plant Variety
Protection Certificate rights are not compromised.
b.
Plants and animals, their
genetic materials or information relating thereto, or reproducing
parts thereof, covered by Plant Variety Protection Certificates,
Plant Patents, or Utility Patents, owned or co-owned by ARS, may be
made available by ARS to third parties for bona fide research
purposes including the development of new animals or plants.
6.
Ownership of
Inventions
a.
All rights, title, and
interest in any Subject Invention made solely by employee(s) of ARS
shall be owned by ARS.
b.
All rights, title, and
interest in any Subject Invention made jointly by at least one (1)
employee of ARS and at least one (1) employee of Zeta shall be
jointly owned by ARS and Zeta.
c.
All rights, title, and
interest in any Subject Invention made solely by employees of Zeta
shall be owned by Zeta.
7.
Subject Invention
Licenses
a.
Zeta is granted an option
to negotiate an exclusive license in each Subject Invention owned
or co-owned by ARS for one or more field(s) of use encompassed by
the Scope of Agreement. This license shall be consistent with
the requirements of 35 USC 209(a), 209(b), and 209(f) and other
such terms and conditions as may be reasonable under the
circumstances, as agreed upon through good faith negotiations
between Zeta and ARS.
b.
The option shall terminate
whenever Zeta fails to:
(1)
Submit a complete
application for an exclusive license within sixty (60) days of
being notified by ARS of an Inventions availability for licensing;
or
(2)
Submit a good faith
written response to a written proposal of licensing terms within
forty five (45) days of such proposal.
c.
Zeta grants ARS, on behalf
of the US Government, a royalty free, nonexclusive, worldwide,
irrevocable, nontransferable license for any Zeta solely owned
Subject Invention. The purpose of this license shall be to
practice the Subject Invention or have it practiced, by or on
behalf of the US Government, for research or other US Government
purposes. 15 USC 3710a(b)(2).
8.
Subject Invention
Information
a.
The Authorized Agents or
designees of each party shall promptly make written disclosure to
each other of each Subject Invention.
b.
This information shall be
treated in confidence by the receiving party, EXCEPT: it may be
shared with those having a need to know.
c.
Each party shall provide,
when requested by the other, all information in its possession, or
true copies thereof, pertaining to a Subject Invention which may be
necessary or useful in the preparation, filing, and prosecution of
patent or Plant Variety Protection Certificate applications
covering the Subject Invention.
9.
Intellectual Property
Protection Applications
a.
ARS and Zeta agree to
cooperate with the other in the preparation, filing, and
prosecution of Patent or Plant Variety Protection Certificate
applications on Subject Inventions in the United States of America
and any other country.
b.
The Authorized Agents of
each party or their designees shall provide the other party with a
copy of any such application on a Subject Invention within fourteen
(14) calendar days after filing.
c.
ARS shall have the first
option to prepare and prosecute patent or Plant Variety Protection
Certificate applications on Subject Inventions that are owned or
co-owned by the U.S. Government, which option may be waived in
whole or in part.
10.
Copyrights
a.
Any work copyrightable
under 17 USC 101, et seq. , produced in whole or in part by
Zeta's employees under this Agreement shall be owned by Zeta.
b.
Zeta shall mark any such
works with a copyright notice showing Zeta as an owner and shall
have the option to register the copyright at Zeta's expense.
c.
Zeta hereby grants in
advance to the U.S. Government, as represented by ARS, a worldwide,
royalty-free, and nonexclusive license to use such copyrightable
work for U.S. Governmental purposes.
d.
Examples of Governmental
purposes are:
(1)
The right to reproduce
the work in copies, phonograph or electronic records;
(2)
The right to perform or
display the work publicly;
(3)
The right to prepare
derivative works based on the work; and
(4)
The right to have others
do so for U.S. Governmental purposes.
e.
Zeta will prominently mark
each such copyrighted work subject to the U.S. Government purpose
license with the words:
"This work was created in the performance of
a Cooperative Research and Development Agreement with the U.S.
Department of Agriculture. The Government of the United
States has a royalty-free government purpose license to use,
duplicate or disclose the work, in whole or in part and in any
manner, and to have or permit others to do so, for government
purposes."
f.
Zeta
shall furnish to ARS, at no cost to ARS, three (3) copies of each
such work created in whole or in part by Zeta under this
Agreement.
11.
Use of Name or Endorsements
Zeta
shall not in any way state or imply that this Agreement or the
results of this Agreement is an endorsement of its organizational
units, employees, products, or services except to the extent
permission is specifically granted by ARS' Authorized Agent
(Authorized Departmental Officer).
12.
Regulatory Approvals
a.
Zeta is responsible for obtaining appropriate opinions, permits, or
licenses from Federal or State agencies which regulate research
materials orcommercial products that may arise from the research
work performed within the Scope of Agreement.
b.
In carrying out its responsibilities under this clause, Zeta
shall:
(1)
Consult and coordinate regulatory approval actions with ARS;
and
(2)
Give ARS = Authorized
Agent or designee a copy of any applications and opinions, permits,
or licenses issued.
13.
Indemnity and Liability
a.
Zeta
agrees to indemnify and hold harmless ARS from any liability
arising from the negligent acts or omissions of an employee, agent,
or officer of Zeta, EXCEPT: to the extent aforesaid liability
arises from the negligent acts or omissions of ARS, its employees,
agents, or contractors and employees or agents of the
contractor.
b.
ARS will hold Zeta
harmless from any liability arising from the negligent act or
omission of a Federal Government officer or employee acting within
the scope of his or her employment, EXCEPT: to the extent
afore
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