EXHIBIT 10(n)
[RESEARCH AGREEMENT BETWEEN THE COMPANY AND
THE RESEARCH FOUNDATION OF STATE UNIVERSITY OF NEW YORK]
RESEARCH AGREEMENT
BETWEEN
SIGA PHARMACEUTICALS, INC.
AND
THE RESEARCH FOUNDATION OF STATE UNIVERSITY
OF NEW YORK
THIS AGREEMENT entered into this 1st day of July, 1997 is by and between
SIGA PHARMACEUTICALS, INC., a for-profit corporation existing under the laws of
the State of Delaware, with its principal offices located at 000 Xxxxx Xxxxxx,
00xx Xxxxx, Xxx Xxxx, XX 00000, hereinafter referred to as "Sponsor" and THE
RESEARCH FOUNDATION OF STATE UNIVERSITY OF NEW YORK, a nonprofit, educational
corporation existing under the laws of the State of New York, with its principal
offices located at Xxxxx Xxxxxxxxxx Xxxxx, Xxxxxxxx xxx Xxxxx Xxxxxx, Xxxxxx,
Xxx Xxxx 00000 (Mailing Address: The UB Commons, Suite 211, 520 Xxx Entrance,
Amherst, New York 14228), hereinafter referred to as "Foundation".
WITNESSETH:
WHEREAS, Sponsor desires to have Foundation undertake a research program in
"P. gingivalis Fimbrillin Expression in S. gordonii"; and
WHEREAS, Foundation has available personnel and facilities needed to
conduct such studies; and
WHEREAS, the Foundation desires to enter into an agreement with Sponsor for
the conduct of the aforementioned research program,
NOW, THEREFORE, in consideration of the premises and the mutual covenants
hereinafter contained, the parties agree as follows:
1. SCOPE OF WORK
The Foundation agrees to conduct and carry out in a professional and
competent manner all the work and services set forth in Exhibit A, which is
attached to and made a part of this Agreement.
2. KEY PERSONNEL
The research will be conducted at the State University of New York at
Buffalo under the direction of Xx. Xxxxxx X. Xxxxx and Dr. Xxxx Xxxxx. Xx.
Xxxxxx X. Xxxxx shall act as technical representative of Sponsor.
3. COMPENSATION
Sponsor shall pay the Foundation ***** for the work performed in accordance
with the terms of this Agreement. The cost of the research is mutually agreed
upon and will not be exceeded by Foundation without prior specific written
authorization from Sponsor. This sum shall be paid in ***** equal quarterly
installments of ***** commencing on July 1, 1997.
4. TERM
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This Agreement shall commence on July 1, 1997 and shall terminate on (i)
the later of June 30, 1998, or 90 days following the completion of the research
and presentation of a written report to the Sponsor, or (ii) thirty (30) days
after notice of termination has been given by either one of the parties hereto,
unless extended by mutual agreement of the parties hereto expressed in writing
in the manner provided in Article 10 of this Agreement. In the event of
termination, Sponsor shall reimburse Foundation for the costs of all obligations
which Foundation entered into prior to cancellation that cannot be cancelled.
5. PROPRIETARY INFORMATION
It is understood that in the course of carrying out the purposes of this
Agreement Sponsor may wish to provide the Foundation with information
proprietary to Sponsor. The Foundation agrees not to disclose such information
which is clearly marked as proprietary to other than its employees and shall use
its best efforts to prevent unauthorized disclosure of such proprietary
information.
6. USE OF NAME
Sponsor agrees not use the name of The Research Foundation of State
University of New York of the State University of New York or the State of New
York or the name of any member of the respective organization in sales promotion
or advertising or in any other form of publicity without the express written
permission of the respective organization and, if appropriate, the individual
whose name is to be used.
7. PUBLICATION
The Foundation will be free to publish papers consistent with protection of
any patentable rights and proprietary information dealing with results of
research under this Agreement after giving a copy of material intended for
publication to Sponsor. Title to and the right to determine the disposition of
any copyrightable material, first produced or composed in performance of this
research, shall remain with the Foundation, provided that the Foundation shall
grant to Sponsor an irrevocable, royalty-free, nonexclusive right to reproduce,
translate, and use all such copyrighted material for its own purposes.
8. PATENTS
The parties to this Agreement recognize that inventions may result from the
investigations which are pursued by the Foundation during the performance of
this Agreement. Title to any invention or discovery made or conceived in the
performance of this research shall be determined in the following manner:
(a) In the event that a patentable invention is, or inventions are
conceived or reduced to practice under this Agreement utilizing University
or Foundation owned or controlled facilities at any of the State-operated
institutions of the State University of New York, the Foundation may, at
its option, file or cause to have filed and prosecute domestic and foreign
patent applications covering such invention or inventions, and the
Foundation shall have title to any such inventions, and the patent
applications or patents maturing therefrom.
(b) In the event that a patentable invention or inventions are conceived or
reduced to practice under this Agreement by one or more employees of the
project team employed by Sponsor not utilizing University or Foundation
owned or controlled facilities at any of the State-operated institutions of
the State University of New York, Sponsor may, at its option, file or cause
to have filed and prosecute domestic and foreign patent covering such
invention or inventions, and Sponsor shall have title to any inventions,
patent applications or patents
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maturing therefrom. Sponsor shall provide a nonexclusive, royalty-free
license to Foundation for research purposes.
(c) In the event one or more employees of the project team of the
State University of New York and one or more employees of Sponsor conceive
or reduce to practice under this Agreement an invention or inventions
utilizing University or Foundation owned or controlled facilities at any of
the State-operated institutions of the State University of New York, the
Foundation shall have title to any inventions, patent applications or
patents maturing therefrom.
9. OPTION FOR LICENSE
Sponsor shall have an exclusive option to negotiate an exclusive license to
commercialize any invention or discovery made or conceived in the performance of
this research. Such option shall include an exclusive option to an exclusive
license to technology described in U.S. Patent Number 5,536,497 (Fimbrial
polypeptids useful in the prevention of periodontitis, Xxxxx et. al., July 16,
1996) and any foreign counterparts. The royalty rate shall be negotiated at the
time the option is exercised by Sponsor. Sponsor must exercise its option
within three (3) months of the termination of the Research Agreement.
10. NOTICES
All notices, demands and other communications hereunder, except exchanges
of technical information, shall be delivered personally to the party hereto to
which it is addressed or mailed to such party by registered or certified mail,
return receipt requested, with postage hereon fully prepaid at the following
addresses, unless otherwise subsequently modified by change of address in
writing:
If to the SPONSOR:
SIGA PHARMACEUTICALS, INC.
000 Xxxxx Xxxxxx, 00/xx/ Xxxxx
Xxx Xxxx, XX 00000
Attn: Xxxxx X. xx Xxxxx, President and CEO
If to the FOUNDATION:
Xxxxxxx X. XxXxxxx
Office of Sponsored Programs Administration
The Research Foundation of State University
of New York
The UB Commons - Suite 211
000 Xxx Xxxxxxxx
Xxxxxxx, Xxx Xxxx 00000
Any notices, demands and other communications delivered personally shall be
deemed to have been received by addressee at the time and date of its delivery.
Any notices, demands and other communications so mailed shall be deemed to have
been received by the addressee seven (7) days after the time and date of its
being so mailed.
11. WAIVERS
No waiver of any term, provision or condition of this Agreement whether by
conduct or otherwise in any one or more instances shall be deemed to be or
construed as a further or continuing waiver of any such term, provision or
condition or of any other term, provision or condition of the Agreement.
12. INTEGRATION
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This Agreement represents and embodies all the agreements and negotiations
between the parties hereto and no oral agreements of correspondence prior to the
date of execution of this Agreement shall be held to vary the provision hereof.
13. MODIFICATIONS AND CHANGES
This Agreement may be changed, amended, modified, extended or terminated by
mutual consent provided that such consent shall be in writing and executed by
the parties hereto prior to the time such change shall take effect.
14. SITUS
Regardless of the place of physical execution, this Agreement shall be
construed according to the laws of the State of New York.
15. ORDER OF PRECEDENCE
In the event of any inconsistency between Clauses 1 through 12 of this
Agreement, and the attached Exhibit A, the inconsistency should be resolved by
giving precedence to Clauses 1 through 13.
IN WITNESS WHEREOF, this Agreement has been duly executed by and the
parties hereto as of the date hereinabove first written.
THE RESEARCH FOUNDATION OF STATE UNIVERSITY OF NEW YORK
By /s/ Xxxxxxx Xxxxx July 1, 1997
------------------ ------------
Xxxxxxx Xxxxx Date
Assistant Vice President
SIGA PHARMACEUTICALS, INC.
By /s/ Xxxxx xx Xxxxx June 25, 1997
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Xxxxx xx Xxxxx Date
President and CEO
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EXHIBIT A
P. GINGIVALIS FIMBRILLIN EXPRESSION IN S. GORDONII
SIGA PROJECT- GNOTOBIOTIC RAT
Purpose: This project will measure the effect of using S. gordonii
recombinants expressing Fim A from P. gingivalis in preventing or
modifying P. gingivalis-induced alveolar bone destruction in the
rat model of periodontal disease.
Recombinant: Two strains of S. gordonii provided by Siga Pharmaceutical
Inc. will be constructed to express the carboxy portion of
P. gingivalis strain 381 fimbriae. Modified strain I will
express the peptide anchored to the cell at the carboxyl
terminal end. Modified strain II will secrete the peptide.
Animal Model: A rat model based on the Xxxxx et al. finding that gnotobiotic
rats can be infected with P. gingivalis resulting in alveloar
bone loss. It is known that as a result of the P. gingivalis
strain 381 infection in rats that hose-derived MMP are found in
gingival tissue presumably derived from macrophages. It may be
postulated that FimA expression could induce protective
antibodies or low levels of expression could block receptors on
machrophages preventing induction of MMP.
Experimental: Preliminary study. Nine animals infected by the intranasal route
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with S. gordonii WT will be examined for bone loss as a result of
infection with WT only. It is anticipated that no bone loss will
be evident. Colonization by S. gordonii will be monitored by
culture.
Challenge study. Four groups of 12 animals each (total 48
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animals) of Xxxxxxx-Xxxxxx gnotobiotic rats obtained from Taconic
Farms will be maintained in barriers. No pre-treatment with
antibiotics prior to infection with P. gingivalis is required.
The following groups will be used: (1) negative controls which
receive a sham infection; (2) an untreated positive control which
is infected with P. gingivalis only (3)an experimental group
which receives the S. gordonii with the anchored peptide
(modified Sg strain I); and (4) an experimental group which
receives the S. gordonii secreting Fim A (modified Xx xxxxxx XX).
Animal numbers used in each group are based on previously
performed studies which determined the optimal group size to
obtain the desired sensitivity.
Outcomes: Periodontal disease will be estimated by alveolar bone loss
measurements using the horizontal bone loss method. Infection
will be monitored for S. gordonii and P. gingivalis infection by
culture. Antibody production in serum and saliva by PCFIA.
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