COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT Project Title: Radiation, Cell Cycle and Protein Kinase C
EXHIBIT
10.1
COOPERATIVE
RESEARCH
AND
DEVELOPMENT AGREEMENT
Project
Title: Radiation, Cell Cycle and Protein Kinase C
This
Cooperative Research and Development Agreement (CRADA), takes effect as of
the
last dated signature, is entered into by and between Inhibetex Therapeutics,
Inc., hereinafter referred to as IT, Inc., and the VA Medical Center, Tampa,
FL,
a laboratory of Department of Veterans Affairs, hereinafter referred to as
VA.
A.
Whereas,
the
Congress in enacting the Federal Technology Transfer Act (FTTA) of 1986, Pub.
L.
No. 99-502, October 20, 1986, which was amended by ▇▇▇.▇.▇▇. 104-113, March
7,
1996, and Pub.L. No. 106-404, November 1, 2000, has found that Federal
laboratories' developments and expertise should be made accessible to private
industry, State and local governments, has declared that one of the purposes
of
such Act is to improve the economic, environmental and social well being of
the
United States by stimulating the utilization of Federally-funded technology
developments by such parties;
B.
Whereas,
the
FTTA, among other technology transfer improvements, has provided each Federal
agency with the authority to permit the directors of Government-operated Federal
laboratories to enter into CRADAs with Federal or non-Federal entities,
including private firms and organizations for the purposes of providing to
or
obtaining from collaborating parties, those resources, e.g., personnel,
services, property, facilities, equipment and funds, (except that funds may
only
be obtained from collaborating parties and may not be provided to such
collaborating parties) necessary to the conduct of specified research and
development efforts, and may include the disposition of patent rights in
inventions resulting from such collaboration;
C.
Whereas,
Mr.
▇▇▇▇▇ ▇▇▇▇ from Inhibetex Therapeutics, Inc. has a Masters degree in Business
Administration and the ability to market a PKC-iota inhibitor and Kit for
detecting PKC-iota in malignant tumors to pharmaceutical companies. For
more
than 25 years ▇▇. ▇▇▇▇ has been involved in the formation of, and early stage
development of, numerous small-cap and mid-cap companies including those
involved in biotech activities. During that time ▇▇. ▇▇▇▇ was involved either
directly, or indirectly, in raising more than $500 million in
capital.
From
1959
to 1982 ▇▇. ▇▇▇▇ served in various accounting, finance and budgeting positions
with the Department of the Air Force. During the period from 1972 to 1981 he
was
assigned to senior supervisory positions at the Department of the Air Force
headquarters in the Pentagon. In 1978, he was selected to participate in the
Federal Executive Development Program and in 1981, he was appointed to the
Senior Executive Service. In 1970 and 1971, he attended the ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
School, Princeton University and was a Princeton Fellow in Public Affairs.
▇▇.
▇▇▇▇ received the Air Force Meritorious Civilian Service Award in 1982. ▇▇.
▇▇▇▇
is a certified public accountant. In March 1994, ▇▇. ▇▇▇▇ was one of twelve
CEOs
selected as Silver Award winners in FINANCIAL WORLD magazine's corporate
American "Dream Team."
D.
Whereas,
VA
possesses certain advanced scientific skills, facilities, special information,
and know-how pertaining to the Technology. This includes the knowledge and
preliminary data to support the concept that in brain cancer cells (glioma),
two
isozymes of PKC (PKC-beta II and PKC-iota) directly or indirectly activates
the
enzyme CAK (cyclin dependent kinase activating kinase), one of the primary
enzymes that regulates the cell cycle; ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇-▇▇▇▇▇▇ has performed
substantial research and development of a model involving brain cancer cells
(glioma) proliferation and has shown that two isozymes of protein kinase C
(PKC;
PKC-beta II and PKC-iota) directly or indirectly activates the enzyme CAK
(cyclin dependent kinase activating kinase), one of the primary enzymes that
regulates the cell cycle, ▇▇. ▇▇▇▇▇▇▇-▇▇▇▇▇▇ has the knowledge to model
PKC-ι’s structure
inorder to establish target inhibition sites, develop PKC-ι inhibitors
for their antiproliferative effects on brain cancer cells and has substantial
expertise in the generation and characterization of efficacy and safety
hereinafter referred to as "the Technology";
E.
Whereas,
VA
desires to pursue the development of the Technology with the final objective
of
developing therapeutic reagents consisting of a PKC-iota inhibitor to inhibit
cancer cell proliferation. The immediate objective of this CRADA is to first
develop a mechanism to establish how PKC-beta II and PKC-iota directly or
indirectly activates the enzyme CAK.
F.
Whereas,
the VA
is interested in the further development of the Technology and its utilization
by veterans and others.
G.
Whereas,
IT, Inc
desires to provide resources for VA's further development of the Technology
and
subsequently, upon the successful completion of development, carry out a plan
for marketing, on a commercial availability basis, [a PKC-iota inhibitor and
a
brain cancer PKC-beta II and/or PKC-iota marker diagnosis test];
H.
Whereas,
VA
views its collaboration with IT, Inc to develop the Technology and the
commitment of IT, Inc. to fund
the commercial development and ultimately develop
and
undertake its marketing plan and make the Technology available for use, to
be in
the furtherance of the public interest.
Now,
therefore, the parties hereto agree as follows:
ARTICLE
I. DEFINITIONS
As
used
in this Agreement, the following terms shall have the following meanings and
such meanings should be equally applicable to both the singular and plural
forms
of the terms defined:
1.1
CRADA
(Cooperative Research and Development Agreement)
means
this agreement as used herein.
1.2
Invention
means
any invention or discovery which is or may be patented or otherwise protected
under title 35 of the United States Code or any novel variety of plant which
is
or may be protected under the Plant Variety Protection Act (7 U.S.C. 2371 et
seq.).
1.3
Laboratory
Director
means
the director of the VA medical center that is a party to this
Agreement.
1.4
Made
in
relation to any invention means the conception or first actual reduction to
practice of such invention.
1.5
Principal
Investigator(s)
means
those persons designated under Article 2.3 hereof, and by name or position
in
the Statement of Work (SOW) by the Parties to this CRADA who will be responsible
for the scientific and technical conduct of the research under this
CRADA.
1.6
Proprietary/Confidential
Information
means
information which embodies trade secrets developed at private expense or which
is confidential science, business or financial information provided that such
information:
1.6.1
Is
not publicly known or available from other sources that are not under a
confidentiality obligation to the source of the information;
1.6.2
Has
not been made available by the owners to others without a confidentiality
obligation;
1.6.3
Is
not already available to the Government without a confidentiality obligation;
or,
1.6.4
Is
not related to potential hazards or cautionary warnings associated with the
production, handling or use of the subject matter of this CRADA.
1.7
Statement
of Work
identifies the main research goals to be achieved under this CRADA, together
with time estimates, methodology, individuals and facilities responsible in
attempting to achieve the research goals under this CRADA.
1.8
Subject
Data
means
all recorded information first produced in the performance of this CRADA by
the
parties.
1.9
Subject
Invention
means
any invention of the parties, conceived or first actually reduced to practice
in
the performance of work under this CRADA.
|
1.10
|
Pre-existing
Inventions
that are directly related and basic to the work to be accomplished
under
this CRADA is co-owned by the VA and the University of South Florida
VA
Invention Disclosure 04-121 'Association of PKC-iota with CAK in
Malignant
Cells'.
|
|
1.11
|
VA
Employee includes any employee who has a VA appointment
|
ARTICLE
II. COOPERATIVE RESEARCH
2.1
Statement of Work.
2.1.1
Cooperative research performed under this CRADA shall be performed in accordance
with the Statement of Work (SOW) attached hereto as Appendix
A, Statement of Work
to
CRADA. Such SOW will include time estimates for completion of each phase of the
SOW; as well as a time estimate for completion of the research project being
performed under this CRADA.
2.1.2
Consistent with the SOW, VA agrees to perform the cooperative research and
to
utilize such personnel, resources, facilities, equipment, skills, know-how
and
information as it considers necessary, consistent with
its
own
policies, missions and requirements. IT, Inc. agrees to provide personnel,
resources, etc., and funds as set forth in Article 4.
2.1.3
Recommendations
for modification(s) to the SOW shall be submitted jointly by the Principal
Investigators (PI) to the signatories of this CRADA. Changes in the SOW shall
be
made consistent with the requirements for amendment(s) set forth under Paragraph
13.6.
2.2
Review
of Work.
Periodic conferences shall be held between VA (▇▇. ▇▇▇▇▇▇▇-▇▇▇▇▇▇) and IT,
Inc.
personnel for the purpose of reviewing the progress of work; however, VA shall
have exclusive control and supervision over the conduct of all cooperative
research. It is understood that the nature of this cooperative research is
such
that completion within the period of performance specified, or within the limits
of financial support allocated, cannot be guaranteed. Accordingly, it is agreed
that all cooperative research is to be performed on a "best efforts"
basis.
2.3
Principal
Investigation.
The
work will be performed under the primary supervision of ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇-▇▇▇▇▇▇,
who as VA’s principal investigator has the responsibility for the scientific and
technical conduct of this project. The principal investigator for IT, Inc.
is
▇▇▇▇▇ ▇▇▇▇ or designee.
ARTICLE
III. REPORTS
3.1
Semi-Annual
Reports.
Commencing 6 months after the effective date, ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇-▇▇▇▇▇▇ shall
submit to each party semi-annual written reports during the term of this
Agreement on the progress of its work and the results being obtained and shall
make available, to the extent reasonably requested, other project information
in
sufficient detail to explain the progress of the work. Monthly reports or
reports as needed may be submitted to IT, Inc.
3.2
Final
Reports.
VA
shall submit a final report of its results within 4 months after completing
the
SOW, or the termination of this CRADA.
ARTICLE
IV. FINANCIAL AND STAFFING OBLIGATIONS
4.1
Advance
Payment.
The
performance of research by VA under this CRADA is conditioned on the provision
of funds from IT, Inc. to be distributed by amount in the timeframe established
in the SOW Appendix A
4.2
Deposit
Account.
IT,
Inc. may, at its discretion, provide additional future funding to VA for the
research being performed under this CRADA; however, IT, Inc ’s contribution, at
this time, is limited to $313,685 per year for 3 years. The amount and timeframe
for distribution of funds is established in the SOW Appendix A.
4.2.1
IT,
Inc.’s provision of funding for the research being performed under this CRADA
will be administered by the Affiliated Research Foundation in accordance with
the VHA Handbook on Research Business Operations. Funds must be sent per the
distribution schedule in Appendix A. to ▇▇▇▇ ▇▇▇▇ Executive Director ▇▇▇▇▇
▇.
▇▇▇▇▇ Veterans Research & Education Foundation (JAHVREF)
13000BruceB.DownsBlvd
VAR151-J,
Room 208C, ▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇
Office
▇▇▇-▇▇▇-▇▇▇▇ ▇▇▇ ▇▇▇▇
4.2.2
Responsibility for all costs associated with the maintenance and transportation
of capital and other equipment used under this CRADA will remain with the party
having title to such equipment.
4.2.3
VA
shall not be obligated to perform any of the research specified herein or to
take any other action required by this CRADA if the agreed-to funds are not
deposited as required by this Article and in accordance with the distribution
schedule in Appendix A. All required payments by IT, INC. to VA shall be paid
in
U.S. dollars by check or bank draft drawn on a US bank and sent as directed
in
4.2.1. The first page of this CRADA must accompany each check.
4.3
Insufficient
and Excess Funds.
VA
shall not be required to continue its research and development activities under
this CRADA if its funding is insufficient. Should IT, Inc. provide funds to
cover all or part of VA's costs, such IT, Inc. funds that are not expended
shall
be returned to JAHVREF, Inc. upon VA's submission of a final fiscal report
to
IT, Inc., except for staffing support pursuant to Article 10.3. Notwithstanding
any other provision of this CRADA, IT, Inc. acknowledges that the U.S.
Government will have the authority to retain and expend any excess funds for
up
to one (1) year subsequent to the expiration or termination of the CRADA to
cover any costs incurred during the term of the CRADA in undertaking the work
set forth in the SOW.
4.4
Accounting
Records.
JAHVREF
shall maintain separate and distinct current accounts, records, and other
evidence supporting all its expenditures under this CRADA. VA shall provide
IT,
Inc. with a report within three (3) months after completing the SOW or ending
its research activities under this CRADA. Those accounts and records of IT,
Inc.’s funds shall be available for reasonable inspection and copying by IT,
Inc. and its authorized representative.
ARTICLE
V. TITLE TO PROPERTY
5.1
Capital
Equipment
5.1.1
All
capital equipment acquired under this CRADA and all Government Furnished
Equipment (GFE), if any, shall be the property of VA, except that title to
items
of equipment purchased by IT, Inc., provided to VA by IT, Inc., or acquired
by
VA with funds supplied by IT, Inc. shall remain or vest in IT, Inc. Co-developed
equipment shall follow the rules set in section VI. Any GFE shall be used solely
for the performance of the effort contemplated by this CRADA. [list
equipment]
5.1.2
Upon completion of the research by VA, and in accordance with the provisions
of
Article 4.2.2, IT, Inc. shall be responsible for all costs attendant to the
maintenance, removal, storage and shipping of identified capital
equipment.
ARTICLE
VI. PATENT RIGHTS, COPYRIGHTS & TRADEMARKS
6.1
Reporting.
VA
shall promptly report to IT, Inc. each Subject Invention reported to VA by
its
employees. IT, Inc. shall promptly report to VA each Subject Invention reported
to IT, Inc. by any of its employees. Such reports shall be treated as
"Proprietary/Confidential Information" in accordance with the provisions of
Article 8.3.
6.2
Employee
Inventions.
VA, on
behalf of the U.S. Government, agrees that IT, Inc. shall have right, title
and
interest to any subject invention made solely by IT, Inc. employees. However,
VA
shall retain, as consideration for its contribution towards development of
a
subject invention, a nonexclusive, nontransferable, irrevocable, paid-up license
to practice or have practiced the invention throughout the world by or on behalf
of the Government. Should IT, Inc. elect not to retain right, title and interest
to subject invention, under this agreement, it agrees to assign right, title
and
interest to the subject invention to the VA.
6.3.
VA
Employee Inventions.
As
appropriate, VA shall retain right, title and interest to any subject invention
made solely by a VA employee. VA agrees to timely file patent applications
on
such subject invention at its own expense. Should VA elect not to retain right,
title and interest to a subject invention under this paragraph, it agrees,
to
assign right, title and interest to IT, Inc. subject to the provisions of
paragraph 6.7 and the reservation by the Government of a nonexclusive,
nontransferable, irrevocable, paid-up license to practice or have practiced
the
invention throughout the world by or on behalf of the Government.
6.4
Joint
Inventions.
The VA
and IT, Inc. will be co- owners to each subject invention made jointly IT,
Inc.
Corporation and one or more VA employees.
6.5
Filing
of Patent Applications.
If IT,
Inc. elects not to file a patent application on a subject invention; it so
must
advise the VA within 90 days from the date it reports the subject invention.
Thereafter, VA may elect to file patent applications on such subject invention.
In the event neither of the parties to this agreement elects to file a patent
application on a subject invention, either or both (if a joint invention) may
release the right to file to the inventor(s) with a nonexclusive,
nontransferable, irrevocable, paid-up license in each party for research,
education or US Government purposes (see
e.g., 37 C.F.R. § 501.6 and 38 C.F.R. § 1.655)
6.6
Patent
Expenses.
The
expenses attendant to the filing of patent applications as specified in
paragraph 6.5, shall be borne by the party filing the patent application. Each
party shall provide the other party with copies of the patent applications
it
files on any subject invention along with the power to inspect and make copies
of all documents retained in the official patent application files by the
applicable patent office.
6.7
Payments
of Royalties.
Corporation shall distribute royalty payments in accordance with the terms
defined in the license or other such agreement at the time of election and
execution. Such license agreement will adhere to the provisions of Article
VII.
6.8
Copyrights:
6.8.1
Work under this CRADA may generate
intellectual property that can be copyrighted by
the
non-government partner, to include software (17 USC 106).
6.8.2
IT, Inc. grants to the US Government a nonexclusive, irrevocable, paid-up,
license in such copyrighted works resulting from the work accomplished under
this CRADA.
6.8.3
Company shall include the following statement on any copyrighted work(s) created
in the performance of this CRADA:
“
The
US Government has a copyright license in this work pursuant to a Cooperative
Research and Development Agreement with the U.S. Department of Veterans
Affairs.”
6.9
Trademarks and Service Marks:
6.9.1
Ownership of Trademarks and Service Marks. The Party first establishing a
trademark or service ▇▇▇▇ for goods or services with which the ▇▇▇▇ is used
shall be considered the owner of the ▇▇▇▇.
6.9.2
Obligation of Employees to Report Trademarks and Service Marks. Employees of
both Parties shall report the adoption of a trademark or service ▇▇▇▇ associated
with the CRADA to their employer within thirty (30) days of the first use of
the
▇▇▇▇. Use includes internal use of any product or service of the
CRADA.
6.9.3
Obligation of Parties to Notify Each Other. Each Party shall notify the other
Party within thirty (30) days of their employee’s report of the first use of a
trademark or service ▇▇▇▇.
6.9.4
Responsibility for Filing an Application for Trademark or Service ▇▇▇▇. The
Party owning a trademark or service ▇▇▇▇ shall establish the use of the ▇▇▇▇
in
intra- and interstate commerce and shall be responsible for filing all
applications for trademark or service ▇▇▇▇ registration as
appropriate.
6.9.5
License to Use Trademark or Service ▇▇▇▇. The Party owning the trademark or
service ▇▇▇▇ shall grant a paid-up, irrevocable, nonexclusive license to the
other Party for use of the trademark or service ▇▇▇▇ on the goods or services
for which the ▇▇▇▇ is intended to be used.
ARTICLE
VII. LICENSING
7.1
License
for VA Employee Inventions and Joint Inventions.
In the
exercise of licenses provided pursuant to Articles 6.3 and 6.4, the Government
shall not publicly disclose trade secrets or commercial financial information
that is privileged or confidential within the meaning of 5 U.S.C. § 552(b)(4) or
which would be considered as such if it had been obtained from a non-Federal
party. Such disclosures will be consistent with the requirements Articles 8.3
and 8.4.2.
7.1.1
For VA employee or co-owned patents, VA grants to IT, Inc. an exclusive option
to elect an exclusive, or partially exclusive license to commercialize any
subject invention valid for 60 days from the date of patent filing. If IT,
Inc.
elects to license the inventions within this time period, this license will
substantially follow the VA model on the web site - ▇▇▇▇://▇▇▇.▇▇▇▇.▇▇▇/▇▇▇/▇▇▇▇/▇▇▇▇.▇▇▇▇;
VA and IT, Inc. will negotiate for a period of 6 months. If no agreement is
reached within that time period, IT, Inc. may elect to extend this time period
for a fee, to be negotiated by the parties. If an agreement is still not
reached, then VA will be free to pursue other options.
7.1.2
For preexisting inventions, in particular the pre-existing
Inventions
that are
directly related and basic to the work to be accomplished under this CRADA
is
co-owned by the VA and the University of South Florida (USF) VA Invention
Disclosure 04-121 'Association of PKC-iota with CAK in Malignant Cells'.
7.1.3
If, and only if, an exclusive license is granted, IT, Inc. shall be responsible
for all VA past and future out-of-pocket expenses in connection with the
preparation, filing, prosecution and maintenance of subject patent. If a
partially exclusive, or non-exclusive license is granted to IT, Inc., then
a
percent of the patent costs will be the responsibility of IT, Inc. to be
negotiated at the time of executing the license.
7.2
Third
Party License.
Pursuant to 15 U.S.C. § 3710a (b)(1)(B), if VA assigns title or grants an
exclusive license to a subject invention made wholly by VA employees or jointly
with IT, Inc. under this CRADA, pursuant to Articles 6.3 and 6.4, the Government
shall retain the right to require
IT, Inc.
to grant
to a responsible applicant a nonexclusive, partially exclusive, or exclusive
license to use the invention in the applicant’s licensed field of use on terms
that are reasonable under the circumstances; or, if IT,
Inc. fails
to
grant such a license, to grant the license itself. The Government may exercise
its rights retained herein only in exceptional circumstances and only if the
Government determines that (i) the action is necessary to meet health or safety
needs that are not reasonably satisfied by IT,
Inc.,
(ii)
the action is necessary to meet requirements for public use specified by Federal
regulations, and such requirements are not reasonably satisfied by IT,
Inc.;
or,
(iii) IT,
Inc. has
failed to comply with an agreement containing provisions described in 15 U.S.C.
§ 3710a(c)(4)(B). The determination made by the Government under this Article
is
subject to administrative appeal and judicial review under 35 U.S.C. § 203(2).
7.3
Joint
Inventions Not Exclusively Licensed.
In the
event that IT, Inc. does not acquire an exclusive commercialized license to
intellectual property rights in all fields that involve the joint subject
inventions described in Article 6.4, then each Party shall have the right to
use
such joint subject inventions and to license their use to others in all fields
not exclusively licensed to IT, Inc. The Parties may agree to a joint licensing
approach for such intellectual property rights.
7.4
Enforcement.
A
collaborating party in an exclusive license in any invention made under this
CRADA shall have the right of enforcement under chapter 29 of title 35, United
States Code.
ARTICLE
VIII. DATA AND PUBLICATION
8.1
Rights.
VA and
IT, Inc. agree to exchange all subject data produced in the course of research
under this CRADA, whether developed by VA (except to the extent that such
subject data is subject to a claim of confidence or privilege by a third party),
by IT, Inc., or jointly by VA and IT, Inc. The Parties to the CRADA will share
research materials equally unless other disposition is agreed to by the Parties.
All Parties to this CRADA will be free to use the subject data and research
materials for their own purposes, consistent with their obligations under this
CRADA.
8.2
Ownership
of Subject Data and Research Materials.
Subject
to the sharing requirements of Article 8.1, the producing Party will retain
ownership of and title to all subject data and all research materials produced
solely by their investigators. Jointly developed subject data and research
materials will be jointly owned.
8.3
Proprietary
Information.
IT,
Inc. shall place a proprietary notice on all information it delivers to VA
under
this CRADA, which it asserts is proprietary. VA agrees that any information
designated as proprietary, which is furnished by IT, Inc. to VA under this
CRADA, or in contemplation of this CRADA, shall be used
by
VA
only for the purpose of carrying out this CRADA. Information designated as
proprietary shall not be disclosed, copied, reproduced or otherwise made
available in any form whatsoever to any other person, firm, corporation,
partnership, association or other entity without the consent of [the Company]
except as such information may be subject to disclosure under the Freedom of
Information Act (FOIA) (5 U.S.C. § 552). VA agrees to use its best efforts to
protect information designated as proprietary from unauthorized disclosure.
IT,
Inc. agrees that VA is not liable for the disclosure of information designated
as proprietary which, after notice to and consultation with IT, Inc., VA
determines may not lawfully be withheld or which a court of competent
jurisdiction requires to be disclosed.
8.4
Release
Restrictions.
VA
shall have the right to use all subject data for any governmental purpose,
but
shall not release such subject data publicly except:
8.4.1
VA,
when reporting on the results of sponsored research, may publish Subject Data,
subject to the provisions of paragraph 8.5, and provided IT,
Inc.
is given
a 90-day opportunity to review the manuscript and provide suggestions before
publication; and
8.4.2
VA
may release such subject data where such release is required pursuant to a
request under FOIA (5 U.S.C. § 552); provided, however, and consistent with
FOIA, such data shall not be released to the public if a patent application
is
to be filed (35 U.S.C. § 205) until the party having the right to file has had a
reasonable time to file.
8.5
Publication.
VA and
IT, Inc. agree to confer and consult prior to the publication of subject data
to
assure that no proprietary information is released and that patent rights are
not jeopardized. If no such review is made, each party shall be offered an
ample
opportunity to review such proposed publication and to file patent applications
in a timely manner, if it is so entitled under this CRADA.
ARTICLE
IX. REPRESENTATIONS AND WARRANTIES
9.1
Representations
and Warranties of VA.
VA
hereby represents and warrants to IT, Inc. as follows:
9.1.1
Organization.
The VA
Medical Center, Tampa, FL, is a Federal laboratory of VA, is wholly owned by
the
Government of the United States, and a substantial purpose of the medical center
is the performance of research, development, evaluation, or engineering by
employees of said Government;
9.1.2
Mission.
The
performance of the activities specified by this CRADA is consistent with the
mission of VA.
9.1.3
Authority.
The VA
official executing this CRADA has the requisite authority to do so. The Office
of General Counsel (OGC) (024), VA Central Office, retains the right to modify
or reject this CRADA within 30 days of receipt of the CRADA. Any rejection
or
modification will be accompanied by a written explanation to the laboratory
head
and IT, Inc.
9.1.4
Statutory
Compliance.
The
laboratory head, prior to entering into this CRADA, has given special
consideration to entering into CRADAs with small business firms and consortia
involving small business firms.
9.2
Representations
and Warranties of
IT, Inc.
hereby represents and warrants to VA as follows:
9.2.1
Corporate
Organization. IT, Inc.,
as of
the date hereof, is a corporation duly organized, validly existing and in good
standing under the laws of the State of Colorado NEEDS TO BE COMPLETED BY IT,
INC., in the USA. It is/ is not classified as a small business in the
US.
9.2.2
Power
and Authority.
IT,
Inc. has the requisite power and authority to enter into this CRADA and to
perform according to the terms thereof.
9.2.3
Due
Authorization.
The
Board of Directors and stockholders of IT, Inc. have taken all actions required
to be taken by law, IT, Inc.’s Certificate or Articles of Incorporation, its
bylaws or otherwise, to authorize the execution and delivery of this
CRADA.
9.2.4
No
Violation.
The
execution and delivery of this CRADA does not contravene any material provision
of, or constitute a material default under any material agreement binding on
IT,
Inc. or any valid order of any court, or any regulatory agency or other body
having authority to which IT, Inc. is subject.
9.2.5
IT,
Inc. certifies
that they are in good standing to do business with the federal government
regarding debarment, suspension, proposed debarment or other matters rendering
them ineligible
ARTICLE
X. TERMINATION
10.1
Termination
by Mutual Consent.
IT,
Inc. and VA may elect to terminate this CRADA, or portions thereof, at any
time
by mutual consent in writing. In such event the Parties shall specify the
disposition of all property, patents and other results of work accomplished
or
in progress, arising from or performed under this CRADA. Upon a termination
by
mutual consent which has been reduced to writing, VA shall not make any new
commitments and shall, to the extent feasible, cancel all outstanding
commitments that relate to this CRADA or portions thereof mutually terminated
by
the termination date, or as soon thereafter as feasible.
10.2
Termination
by Unilateral Action.
10.2.1
Written
Notice.
Either
Party may unilaterally terminate this entire CRADA at any time by giving the
other Party written notice, not less than 30 days prior to the desired
termination date.
10.2.2
New
Commitments.
Neither
VA nor IT,
Inc. shall
make any new commitments after receipt of a written termination notice from
either party to this CRADA and shall, to the extent feasible, cancel all
outstanding commitments and contracts by the termination date.
10.3
Staffing.
If this
CRADA is mutually or unilaterally terminated prior to its expiration, funds
will
nevertheless remain available to VA for continuing any staffing commitment
made
by IT, Inc. pursuant to Article 4.3 above, if applicable, for a period of six
(6) months after such termination. If there are insufficient funds to cover
this
expense, IT, Inc. agrees to pay the difference.
10.4
Termination
Costs.
Within
90 days following termination of this CRADA, VA shall submit a statement of
all
costs incurred prior to the date of termination and for all termination costs
for removal of abandoned property. Any unspent funds provided to VA by IT,
Inc.
shall be used to fund termination costs.
In
the
event such funds are insufficient to cover all the termination costs, IT, Inc.
agrees to promptly meet with VA to reach a settlement agreement regarding the
payment of the remaining termination costs.
ARTICLE
XI. DISPUTES
11.1
Settlement.
Any
dispute arising under this CRADA which is not disposed of by agreement shall
be
submitted jointly to the signatories of this CRADA. A joint decision of the
signatories or their designees shall be the disposition of such dispute. Nothing
in this Article shall prevent any Party from pursuing any additional
administrative remedies that may be available and, after exhaustion of such
administrative remedies, pursuing all available judicial remedies.
11.2
VA
policy is to try to resolve all issues arising from or related to a Cooperative
Research and Development Agreement by mutual agreement. VA and IT, Inc. are
therefore encouraged to use Alternative
Dispute Resolution (ADR)
procedures to the maximum extent practicable. ADR procedures are any voluntary
means used to resolve issues in controversy without resorting to formal
administrative appeals or to litigation. The ADR procedures or techniques to
be
used may either be agreed upon by VA and IT, Inc. in advance or may be agreed
upon at the time the parties elect to use ADR procedures. If VA and IT, Inc.
are
not able to resolve an issue through unassisted negotiations, the VA signatory
shall encourage IT, Inc. to enter into ADR procedures. Nothing in this section
is intended to limit a recipient’s right to any remedy under the
law.
11.3
Continuation
of Work.
Pending
the resolution of any dispute or claim pursuant to this Article, the Parties
agree that performance of all obligations shall be pursued diligently in
accordance with the direction of the VA signatory named in Article
2.3.
ARTICLE
XII. LIMITATION OF LIABILITY
12.1
Property.
The
U.S. Government shall not be responsible for damages to any of IT, Inc.’s
property provided to VA, where IT, Inc. retains title to the property, or any
property acquired by IT, Inc. for its own use pursuant to this CRADA.
12.2
No
Warranty.
Except
as specifically stated in Article 9, VA makes no express or implied warranty
as
to any matter whatsoever, including the conditions of the research or any
invention or product, whether tangible or intangible, made or developed under
this CRADA, or the ownership, merchantability, or fitness for a particular
purpose of the research or any invention or product.
12.3
Force
Majeure.
Neither
Party shall be liable for any unforeseeable event beyond its reasonable control
not caused by the fault or negligence of such Party, which causes such Party
to
be unable to perform its obligations under this CRADA (and which it has been
unable to overcome by the exercise of due diligence), including, but not limited
to, flood, drought, earthquake, storm, fire, pestilence, lightning and other
natural catastrophes, epidemic, war, riot, civic disturbance or disobedience,
strikes, labor dispute, or failure, threat of failure, or sabotage of the VA
facilities, or any order or injunction made by a court or public agency. In
the
event of the occurrence of such a force majeure event, the Party unable to
perform shall promptly notify the other Party. It shall suspend performance
only
for such period of time as is necessary as a result of the force majeure
event.
ARTICLE
XIII. MISCELLANEOUS
13.1
Governing
Law.
The
construction validity, performance and effort of this CRADA for all purposes
shall be governed by Federal law, as applied by the Federal Courts in the
District of Columbia. Federal law and applicable regulations will preempt any
conflicting or inconsistent provisions in this CRADA.
13.2
Entire
Agreement.
This
CRADA constitutes the entire agreement between the Parties concerning the
subject matter hereof and supersedes any prior understanding or written or
oral
agreement relative to said matter.
13.3
Headings.
Titles
and headings of the articles and subarticles of this CRADA are for convenient
reference only, and do not form a part of this CRADA and shall in no way affect
the interpretation thereof.
13.4
Waivers.
None of
the provisions of this CRADA shall be considered waived by any Party hereto
unless such waiver is given in writing to all other Parties. The failure of
any
Party to insist upon strict performance of any of the terms and conditions
hereof, or failure or delay to exercise any rights provided herein or by law,
shall not be deemed a waiver of any rights of any Party hereto.
13.5
Severability.
The
illegality or invalidity of any provisions of this CRADA shall not impair,
affect or invalidate any of the other provisions of this CRADA.
13.6
Amendments.
If any
Party desires a modification in this CRADA, the Parties shall, upon reasonable
notice of the proposed modification by the Party desiring the change, confer
in
good faith to determine the desirability of such modification. Such modification
shall not be effective until a written amendment is signed by all the
signatories hereto, or by their representatives duly authorized to execute
such
amendment.
13.7
Assignment.
Neither
this CRADA nor any rights or obligations of any Party hereunder shall be
assigned or otherwise transferred by any Party without the prior written consent
of the other Party or Parties.
13.8
Notices.
All
notices pertaining to or required by this CRADA shall be in writing and shall
be
signed by an authorized representative and shall be delivered by hand or sent
by
certified mail, return receipt requested, with postage prepaid, addressed as
follows:
13.8.1
If
to
[IT, Inc.]:
Inhibetex
Therapeutics Corporation, Inc.
▇▇▇
▇.
▇▇▇▇▇▇▇▇▇▇ ▇▇▇. # ▇▇▇
▇▇▇▇
▇▇▇▇
▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Attn:
Mr.
▇▇▇▇▇ ▇▇▇▇
13.8.2
If
to VA: Director
VA
Medical Center
▇▇▇▇▇
▇▇▇▇▇ ▇. ▇▇▇▇▇ ▇▇▇▇.
▇▇▇▇▇,
▇▇. ▇▇▇▇▇
_________________
Attn:
▇▇▇▇▇▇▇ ▇. ▇▇▇▇
13.8.3
Any Party may change such address by notice given to the other Party or Parties
in the manner set forth in Article 13.6.
13.8.4
Notices regarding the exercise of license options shall be made pursuant to
Article XII
13.9
Independent
Contractors.
The
relationship of the Parties to this CRADA is that of independent contractors
and
not as agents of each other or joint venturers or partners. VA shall maintain
sole and exclusive control over its personnel and operations.
13.10
Use
of Endorsements and Credits.
By
entering into this CRADA, VA neither directly, nor indirectly, endorses any
products or services provided, or to be provided, whether directly or indirectly
related either to this CRADA, or to any patent or other intellectual property
license or agreement which implements this CRADA. IT, Inc. shall not in any
way
state or imply that this CRADA is an endorsement of any such products or
services by the U. S. Government or any of its organizational units or
employees.
13.10.1
The VA must receive credit for sponsorship of the R&D in all commercial
literature, brochures, and other promotional media; and the US government shall
receive preferential pricing on the resultant commercial product.
13.10.2
IT, Inc. issued press releases that reference or rely on the work of VA under
this CRADA shall be provide to VA at least seven (7) days prior to publication
for review and comment.
13.11
Reasonable
Consent.
Whenever a Party’s consent or permission is required under this CRADA, such
consent or permission shall not be unreasonably withheld.
ARTICLE
XIV. DURATION OF CRADA AND EFFECTIVE DATE
14.1
Duration
of CRADA.
It is
mutually recognized that the duration of this project cannot be rigidly defined
in advance, and that the contemplated time periods applicable to each phase
of
the project are only good faith guidelines subject to adjustment by mutual
agreement to fit the circumstances as the project proceeds. In no case will
the
term of this CRADA extend beyond the term indicated in the SOW for completion
of
the research project under this CRADA, unless such completion date is amended
in
accordance with the provisions of Article 13.6. The work to be accomplished
in
this CRADA is projected to be completed by June 1, 2007.
14.2
Effective
Date.
This
CRADA is effective as of the date of the last signature of the
Parties.
IN
WITNESS WHEREOF, the Parties have caused this CRADA to be executed by their
duly
authorized representatives as follows:
For
[Corporation]:
Inhibetex
Therapeutics Corporation, Inc.
▇▇▇
▇.
▇▇▇▇▇▇▇▇▇▇ ▇▇▇. # 625
West
Palm
Beach, FL. 33401-6223
Attn:
Mr.
▇▇▇▇▇ ▇▇▇▇
9/30/04
Date
/s/
▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇
▇▇▇▇
For
the
Department of Veterans Affairs:
▇▇▇▇▇▇▇
▇. ▇▇▇▇
VA
Medical Center
▇▇▇▇▇
▇▇▇▇▇ ▇. ▇▇▇▇▇ ▇▇▇▇.
▇▇▇▇▇,
▇▇. ▇▇▇▇▇
Sept.
30,
2004
Date
/s/
▇▇▇▇▇▇▇ ▇. ▇▇▇▇
▇▇▇▇▇▇▇
▇. ▇▇▇▇
Appendix
A, Statement of Work: