SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
----------------------
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15 (d) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): September 14, 2005
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SIGA TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-23047 13-3864870
(State or other jurisdiction of (Commission file number) (I.R.S. employer
incorporation or organization) identification no.)
420 Lexington Avenue, Suite 408 10170
New York, New York (Zip code)
(Address of principal executive offices)
Registrant's telephone number, including area code: (212) 672-9100
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions (see General Instruction A.2. below):
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[ ] Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Item 1.01. Entry into a Material Definitive Agreement.
On September 14, 2005, SIGA Technologies, Inc., a Delaware
corporation ("SIGA"), entered into an agreement with Saint Louis University for
the continued development of SIGA's smallpox drug (SIGA-246). The agreement is
funded through the National Institutes of Health. Under the terms of the
agreement, SIGA will receive approximately $1 million to support specific
aspects of the preclinical development of SIGA's oral anti-smallpox drug
SIGA-246. A copy of the agreement is attached hereto as Exhibit 10.1, which is
incorporated into this Item 1.01 by reference.
On September 20, 2005, SIGA issued a press release announcing that
it had entered into the agreement with Saint Louis University. A copy of the
press release is attached hereto as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
(c) Exhibits
Exhibit No. Description
- ----------- -----------
10.1 Agreement, dated as of September 14, 2005, between Saint Louis
University and SIGA.
99.1 Press Release, dated September 20, 2005.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
SIGA TECHNOLOGIES, INC.
By: /s/ Thomas N. Konatich
----------------------------------
Name: Thomas N. Konatich
Title: Chief Financial Officer
Date: September 20, 2005
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Exhibit 10.1
SUBCONTRACT
between-
SAINT LOUIS UNIVERSITY
and
SIGA Technologies, Inc.
This subcontract, entered into on September 1,2005, by and between Saint Louis
University : (hereinafter referred to as SLU) and SIGA Technologies, Inc.
(hereinafter referred to as Subcontractor), is for the, performance of certain
work/services arid reimbursement of allowable costs.
BACKGROUND
SLU has received from the National Institute of Allergy and Infectious Diseases
(N1AID), (hereinafter referred to as Sponsor) an Award, entitled "Small Animal
Models of Human Infections for Evaluation of Experimental Therapies"
(hereinafter referred to as Award), with an ID number N01-AI-15436.
The Subcontractor has agreed to participate in collaboration with SLU, as
detailed in the Application for the Award agreement attached and part of this
subcontract.
Therefore, the parties agree as follows:
ARTICLES
ARTICLE I - Scope of Work
- -------------------------
The Subcontractor agrees to perform the work outlined in Attachment 1 for the
reason specified in Attachment 4.
ARTICLE II - Period of Performance
- ----------------------------------
The term of this Subcontract shall extend from 9/1/2005 through 2/28/2006.
Unless stated elsewhere in this subcontract, Subcontractor's expenditures
incurred prior to the beginning date or subsequent to the end date are
unallowable. Subcontractor shall notify SLU, as soon as possible, of any reason
that might contribute to the failure to perform within the specified term even
if such reason is beyond the control and without fault or negligence of the
Subcontractor. The performance period may be modified by mutual agreement of the
parties. The term of this Subcontract may be extended by amendment and upon
authorization of the Sponsor to continue the Award with SLU.
ARTICLE HI - Scientific Direction
- ---------------------------------
The Technical Representative for SLU is Mark Buller, Ph.D., ("SLU's Technical
Representative"), who shall coordinate the research efforts of SLU and the
Subcontractor. SLU's Technical Representative shall have final authority with
respect to the performance of the work in relation.to the Award. In the event
that SLU's Technical Representative is no longer able to perform in such
capacity, SLU shall be responsible for appointing a successor Technical
Representative.
ARTICLE IV - Consideration, Records and Billing Instruction
- -----------------------------------------------------------
1. The total compensation to be paid for Subcontractor's activities will not
exceed $1,001,000 based on the budget outlined in Attachment 2. Funding
for additional years is contingent upon additional funding received from
Sponsor for this Award.
2. SLU's payment to Subcontractor shall be based upon the terms and
conditions as specified in this subcontract and the availability and
allocation of Sponsor's funds necessary to finance SLU's performance.
3. The determination of allowable costs for Subcontractor's activities will
be made in accordance with the following applicable Federal Cost
Principles inclusive of all amendments in effect as of the date of this
agreement.
- Institutions of Higher Education (OMB Circular A-21);
- Nonprofit Organizations other than Institutions of Higher
Education and Hospital (OMB Circular A-122); -State and Local
Governments (OMB Circular 87); -For-profit Hospitals
(45 C'FR 74, Appendix E); -For-profit (Commercial)
Organizations (48 CFR 31.2);
4. Subcontractor shall maintain reasonable records incident to the
performance of this subcontract and shall allow SLU access to these
records. If this subcontract is greater than $10,000 and Sponsor is a
Federal agency, Sponsor, the Comptroller General of the United States, or
any of their representatives shall have the right of access to any books,
documents, papers and records of the Subcontractor which are directly
pertinent to a specific program for the purpose of making audits,
examinations, excerpts and transcripts.
5. Payment will be provided upon receipt of invoices (a) identified by the ID
number located on the top of each subcontract page, (b) reflecting the
cost categories as outlined in the budget (Attachment 2), and (c) approved
and signed by the Subcontractor's appropriate administrative official.
Subcontractor shall submit invoices after the incurrence of allowable
costs, but not more frequently than monthly; invoices shall provide a
current and cumulative breakdown of costs and required cost sharing in
separate columns. The appropriate official who requests payment shall send
a signed note that states: "I hereby certify the following: All
expenditures reported (or payments requested) are for appropriate purposes
and in accordance with the agreements set forth in the application and
award documents. Cost sharing is adequately documented." The
Subcontractor's monthly invoices shall constitute the required financial
reports under this Agreement.
6. The Final Invoice shall be clearly identified as "final" and shall be
submitted no later than 30 days after the subcontract's end date.
7. All invoices shall be submitted in triplicate to:
Name: Mr. Douglas Leavell
Director
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Department: Office of Sponsored Programs
Address: Saint Louis University
Salus Center
3545 Lafayette Ave.
St. Louis, MO 63104
Phone: 314-977-3925
FAX: 314-977-1894
email: leavelld@slu.edu
----------------
8. An informational copy of each invoice is to be sent to:
Charlotte Avett
Molecular Microbiology & Immunology
SchwitallaHall)Room412 1402 S. Grand
Blvd Saint Louis University Saint Louis,
MO 63104
ARTICLE V - Facilities and Administrative Costs
- -----------------------------------------------
Federal Awards only:
1. Only facilities and administrative cost rates negotiated and approved by
the Subcontractor's cognizant federal agency at the time of the Award may
be charged for this project. The amount of facilities and administrative
costs charged must be based upon actual direct cost expenditures but is
limited to the amount awarded pursuant to attachment 2, and no additional
funds will be chargeable for facilities and administrative costs incurred
by the Subcontractor.
2. The Subcontractor will provide to SLU one copy of its current memorandum
of negotiation covering all facilities and administrative costs charged
under this Agreement. As new rates are negotiated, the Subcontractor will
forward one copy of the revised memorandum to the SLU.
ARTICLE VI - Designated Representatives
- ---------------------------------------
Technical Representative:
For SLU: For Subcontractor:
Mark Buller, Ph.D. Dennis E. Hruby, Ph.D.
Molecular Microbiology & Immunology Chief Scientific Officer
Saint Louis University SIGA Technologies, Inc.
Schwitalla Hall, Room 432 4575 SW Research Way
1402 S. Grand Blvd.
Saint Louis, MO 63104 Corvallis, OR 97333
Phone: (314) 977-8870 Phone: (541) 753-2000
Fax: (314)977-8717 Fax:(541)753-9999
E-mail: bullemn@slu.edu E-mail: dhruby@sgph.com
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Administrative Representative:
For SLU North Campus Office: For Subcontractor:
Michael Luczak Dennis e. Hruby, Ph.D.
Office of Research Services Chief Scientific Officer
Saint Louis University SIGA Technologies, Inc.
3556 Caroline Mall 4575 SW Research Way
Saint Louis, MO 63104-1085 Corvallis, OR 97333
Phone: (314) 977-7742 Phone: (541) 753-2000
Fax: (314) 977-7730 Fax: (541) 753-9999
E-mail: luczak@slu.edu E-mail: dhruby@sgph.com
The Subcontractor's Technical Representative shall be responsible for the work
earned out on behalf of the Subcontractor with respect to the Award and shall
report to SLU's Technical Representative. The Subcontractor's Technical
Representative shall not be replaced without prior consultation with and the
written approval of SLU's Technical Representative and/or the Sponsor as
appropriate.
ARTICLE VII - Reports
- ---------------------
Subcontractor will submit reports required by SLU's Technical Representative
cited in Article IV. Such reports shall be submitted according to the schedule
and in the format agreed to by the Technical Representative of both parties. The
Final Progress Report must be submitted to SLU's Technical Representative no
later than 90 days [ ] before [ X ] after the project's end date.
ARTICLE VIII - Intellectual Property
- ------------------------------------
Any intellectual property arising out of the activities assisted by this
subcontract shall be promptly and fully reported to SLU's Administrative
Representative. The ownership and manner of disposition of all rights in and to
such intellectual property shall be subject to the regulations issued by the
Sponsor as such regulations appear in the Award between the Sponsor and SLU
(including 37 CFR 401.14 when Sponsor is a Federal agency).
ARTICLE VIX - Proprietary and Confidential Information
- ------------------------------------------------------
SLU and Subcontractor agree to use all reasonable diligence to prevent
disclosure to third parties any confidential information disclosed to it under
this subcontract and marked by either party as confidential for a period of
three (3) years from the date of disclosure. Such information shall be disclosed
in writing and marked "confidential," or if disclosed orally or in other
documentary form shall be reduced to writing and marked "confidential" within
thirty (30) days thereafter. Disclosure of confidential information to
employees, officers, agents, and representatives shall be only on a need-to-know
basis and as necessary for the purposes of this subcontract. This non-disclosure
obligation shall not apply to information:
1. already in or subsequently enters the public domain through no fault of
SLU or Subcontractor;
2. presently known or that becomes known to SLU or Subcontractor from its own
independent sources;
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3. received by SLU or Subcontractor from any third party not under obligation
to keep such information confidential;
4. independently developed by SLU or Subcontractor without use of the other's
confidential information; or
5. required to be disclosed by law.
ARTICLE X - Publications
- ------------------------
Any publications resulting from this subcontract must be coordinated with the
Technical Representative. The Subcontractor must ensure that all publications
bear the proper acknowledgment of the support provided by SLU and the Sponsor.
Three copies of all publications will be forwarded to the Technical
Representative for transmittal to the Sponsor.
ARTICLE XI - Assignments and Subcontracts
- -----------------------------------------
Neither performance nor payment involving the whole or any part of this
subcontract as described under Article 1 may be assigned, subcontracted,
transferred, or otherwise given or imposed on any other party by Subcontractor
without the prior written consent of SLU. Subcontractor shall pass the
appropriate Sponsor information to any Subrecipient. As applicable, this shall
include Sponsor name, Award ID number, Award title, CFDA number and appropriate
flow-down requirements.
ARTICLE XII - Changes and Prior Approval
- ----------------------------------------
Subcontractor is responsible for both notifying SLU and obtaining prior written
approval of SLU with respect to any changes which might materially alter the
terms of this subcontract. Examples include, but are not limited to, changes in
the period of performance, in Subcontractor's Technical Representative,
significant rebudgeting and changes in the scope of work. In the event of
uncertainty as to whether a change is significant enough to require prior
approval refer questions to SLU's Administrative Representative noted in Article
IV.
It is understood that the Subcontractor's budget referred to in Attachment 2 is
an estimate and that there may be a need to depart from such budget to meet
certain unanticipated requirements of Award. The Subcontractor is authorized to
re-budget funds which do not require prior approval from the Sponsor in
accordance with any applicable Grants Policy Statement, with all applicable
addenda, but provided each such re-budgeting action is approved by the
authorized official of the Subcontractor who is designated to grant such
approval.
ARTICLE XIII - Insurance
- ------------------------
Subcontractor shall be solely responsible for any and all third party liability
that might be incurred in the performance of this Subcontract. Therefore,
Subcontractor shall maintain sufficient insurance coverage for Public Liability,
Property Damage, Employer's Liability and Compensation Insurance and Motor
Vehicle Liability (Personal Injury and Property Damage).
ARTICLE XTV - Suspension
- ------------------------
SLU reserves the right to suspend this subcontract at any time by electronic or
telephone notice to
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Subcontractor followed by written notice within 10 days of the initial notice.
Subcontractor will immediately stop performance and will not perform under this
subcontract until receiving a resume performance notice from SLU followed by
written notice within 10 days. SLU will provide Subcontractor with the reason(s)
for suspension and indicate if any remedies are available to Subcontractor. If
SLU and Subcontractor mutually agree the reason(s) for the suspension have been
remedied, SLU will issue a resume performance notice to Subcontractor.
Subcontractor will not be reimbursed or paid for any charges during the
suspension period.
ARTICLE XV - Disputes and Termination
- -------------------------------------
Any dispute or differences arising out of this Agreement, which cannot be
settled amicably between the parties within a reasonable time, shall be finally
settled under the rules of arbitration of the American Arbitration Association
by an arbitrator appointed in accordance with such rules. The arbitration shall
take place in St. Louis. Missouri. The dispute or difference shall be decided by
the arbitrator in accordance with the substantive laws of the State of Missouri,
without regard to the choice of law principles thereof. Further, the parties
agree that any award or final decision rendered pursuant to such arbitration may
be entered for enforcement, and irrevocably consent to the jurisdiction of any
United States court, tribunal or agency in St. Louis, Missouri, for purposes of
enforcement of this Agreement or arbitration decision and award made by the
arbitrator. This provision shall survive if this Agreement is adjudged void or
should be canceled, annulled, or terminated.
SLU reserves the right to terminate this subcontract at any time by giving
Subcontractor written notice at least 30 days prior to the effective date of
termination. The Subcontractor may submit a written request to SLU for
termination at least 30 days prior to the effective date of termination.
In the event of default, either by Subcontractor's failure to substantially
perform its obligations, Subcontractor's violation of other material terms of
this subcontract, or Sponsor's termination of work by SLU on the subject matter
of this Award, then performance by the Subcontractor under this subcontract may
be terminated by SLU at any time by given written notice to the Subcontractor.
Should performance be so terminated, the Subcontractor shall be paid for its
reasonable costs and commitments to the date of termination, but only to the
extent that such costs and commitments are reimbursable to SLU under the terms
of Sponsor's Award. Payment shall be made upon submission to SLU of a final
invoice covering the aforementioned performance and submission of any and all
results achieved to the time of termination and acceptance thereof by SLU.
ARTICLE XVI - General Provisions
- --------------------------------
The following general provisions become operative if the particular subject
relates to activity to be performed under this subcontract.
1. Protection of Human Subjects
----------------------------
Subcontractor agrees that the rights and welfare of human subjects will be
protected in accordance with applicable policies set forth in 45CFR 46 and
21 CFR 50 and 56. Subcontractor shall bear full responsibility for the
proper and safe performance of its work and services involving human
subjects.
SLU's Technical Representative identifies Subcontractor's work as
involving human subjects
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[ ] Yes [ X ] No. If yes, Subcontractor must provide to SLU documentation
that an Institutional Review Board (IRB) has reviewed and approved such
procedures and must provide the IRB's federally assigned assurance number.
SLU's Technical Representative identifies Subcontractor's work as
including a responsibility for the design and conduct of research
involving human subjects, and as being funded by the National Institutes
of Health [ ] Yes [ X ] No. If yes. Subaward Attachment 3 describes the
education completed in the protection of human subjects for each
individual identified as "key personnel" that will be involved in
Subcontractor's work. Furthermore, as required by NIH Notice OD-00-039,
Subcontractor agrees that Attachment 3 was submitted by Subcontractor to
SLU in accordance with Just-in-Time proposal procedures, PHS prior
approval requirements, or as part of a non-competing renewal as
applicable. Subcontractor further agrees to include a description of such
education in their progress reports or scope of work description that will
be incorporated into the non-competing renewal.
The Subcontractor certifies that it is familiar with the requirements of
the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
and its accompanying regulations, and will comply with all applicable
HIPAA requirements in the course of this Agreement.
2. Animal Welfare
--------------
Subcontractor shall comply with all procedures and regulations that ensure
the humane care of animals to include but not limited to the following:
-Animal Welfare Act as amended (7 USC 2131 et seq.)
-PHS Policy on Humane Care of Laboratory Animals by Awardee Institutions
-U.S. Government Principles for the Utilization and Care of Vertebrate
Animals Used in Testing. Research, and Training
-NIH Publication (85-23) Guide for the Care and Use of Laboratory Animals
SLTJ's Technical Representative identifies Subcontractor's work as
involving animals [ X ] Yes [ ] No. If yes, Subcontractor must provide to
SLU documentation that an Institutional Animal Care Use Committee (IACUC)
has reviewed and approved such procedures and must provide the lACUC's
federally assigned assurance number.
3. Recombinant DNA Research
------------------------
Subcontractor must comply with NIH Guidelines for Research Involving
Recombinant DNA Molecules (49 CFR 46266 or latest revision).
4. Small Business, Minority-Owned Business, and Woman-Owned Business
Utilization
-----------------------------------------------------------------
Subcontractor must make positive efforts to use small business concerns,
minority-owned businesses, and woman-owned businesses as sources for
procurement of goods or services, including consultant services.
5. Grant-Related Income
--------------------
If this project is Federally funded, the Subcontractor must report to SLU
any grant related income as covered by OMB Circular A-110, Paragraph 24.
Disposition of such income will be consistent with the terms of the
Sponsor's Award.
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6. Equipment Accountability and Disposition
----------------------------------------
For purposes of this subcontract equipment is defined as those items
costing $5,000 or more, and having a useful life of more than two years.
Except for for-profit firms/organizations, title to all equipment
purchased under this subcontract shall vest in Subcontractor upon
acquisition unless it is determined that to do so is not in furtherance of
the objectives of the Sponsor. subject to the provisions for right to
transfer contained in OMB Circular A-110. Paragraph 34(g)(4).
Administration, internal control and management of equipment shall comply
with the requirements of OMB Circular A-110, Paragraph 34.
Except for a model change for equipment in Subcontractor's proposed
budget, Subcontractor shall request SLU's prior approval for the purchase
of equipment not in Subcontractor's proposed budget, Attachment 2,
7. DHHS
----
If the Award covered in this Agreement is provided by a Federal agency
other than the National Institutes of Health or the National Science
Foundation, the Public Health Service Grants Policy Statement, DHHS
Publication No. (OASH) 94-50,000 (Rev.) April 1, 1994, with all applicable
addenda issued since that date, to the effective date of this Agreement,
are incoiporated by reference and made a part of this Agreement.
ARTICLE XVn - Certifications
- ----------------------------
By accepting this subcontract, Subcontractor certifies compliance with the
following, if applicable:
1. Non-Discrimination
------------------
Subcontractor certifies that it complies with all federal statues relating
to non-discrimination.
These include but are not limited to:
- E.0.11246 "Equal Employment Opportunity," as amended by E.0.11375
"Amending Executive Order 11246 relating to Equal Employment Opportunity"
-Title VI of the Civil Rights Act of 1964 (P.L. 88-352) which prohibits
discrimination based on race, color, or national origin and certifies that
valid Assurances of Compliance (Forms HHS 441 and HHS 641) are on file
with the HHS Office for Civil Rights;
-Rehabilitation Act of 1973 which prohibits discrimination based on
physical and mental handicap;
-Title IX of the Educational Amendments of 1972 which prohibits
discrimination based on sex; and
-Age Discrimination Act of 1975 which prohibits unreasonable
discrimination based on age.
2. Drug-Free Work Place
--------------------
Subcontractor will provide a drug-free workplace in accordance with the
provision of the Drug Free Workplace Act of 1988 (P.L. 100-690, Title V,
Subtitle D) and 45 CFR 76.
3. Smoke-Free Work Place
---------------------
Subcontractor will provide a smoke-free workplace in accordance with the
provisions of the Pro-Children Act of 1994 (P.L. 303-227, Part C -
Environmental Tobacco Smoke, Section 1041-1044).
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4. Misconduct in Science
---------------------
Subcontractor certifies that an acceptable assurance for dealing with
reporting possible misconduct in science is on file with the PHS Office of
Research Integrity and that it is in compliance with 42 CFR 50 Subpart A.
5. Debarment Suspension, Repayment of Federal Debt
-----------------------------------------------
Subcontractor certifies that neither it nor its principal are presently
debarred, suspended, proposed for debarment. declared ineligible, or
voluntarily excluded from participation in this transaction by any federal
department or agency. Furthermore, Subcontractor certifies neither it nor
its principals are delinquent on the repayment of any federal debt.
6. Audit Requirements
------------------
By accepting this subcontract. Subcontractor certifies that it meets the
audit requirements of OMB Circular A-133 or Circular A-128 as appropriate,
and will furnish a copy of such audit report to SLU within 30 days of
completion of said audit, if this Award is $25,000 or more. Subcontractor
further certifies that, in instances of non-compliance with federal laws
and regulations, appropriate corrective action will be taken.
Subcontractor agrees to notify SLU of the corrective action within six
months of furnishing the audit report to SLU. All records and reports
prepared in accord with the requirement of OMB Circular A-133 or Circular
A-128 as appropriate shall be available for inspection by Sponsor's
representatives or the federal government during normal business hours. If
Subcontractor is not subject to OMB Circular A-133 and in the event of
noncompliance which involves a subaward from SLU. Subcontractor agrees to
send its financial audit report to SLU within 30 days of receipt by
Subcontractor's auditors. If Subcontractor must send its A-133 or
financial audit report to SLU, Subcontractor further agrees to notify SLU
of its corrective action taken within six months of furnishing its
applicable audit report to SLU. In accordance with OMB Circular A-133, SLU
will issue a management decision to the Subcontractor within six months.
7. Clean Air and Water Certification
---------------------------------
Subcontractor certifies that any facility to be used in the performance of
this subcontract is not listed on the Environmental Protection Agency
(EPA) list of Violating Facilities. Subcontractor will immediately notify
SLU, before this subcontract, of the receipt of any communication from the
Administrator, or a designee of the EPA, indicating that any facility the
Subcontractor proposes to use for the performance of the contract is under
consideration to be listed on the EPA list of Violating Facilities.
When the total award is in excess of $100,000, the Subcontractor agrees to
comply with all applicable standards, orders or regulations issues
pursuant to the Clean Air Act (42 U.S.C. 7401 et. seq.) and the Federal
Water Pollution Control Act as amended (33 U.S.C. 1251 et. seq.).
8. Conflict of Interest
--------------------
The Subcontractor agrees that it has a conflict of interest policy which
compiles with the Public Health Services and National Science Foundation
policies; namely, the Subcontractor has a conflict of interest policy
which requires disclosure and resolution of all conflicts of interest,
potential and actual, which exist for those involved in the design,
conduct and reporting of research under this agreement prior to acceptance
of funding. The Subcontractor is responsible
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for informing its Technical Representatives and/or other applicable
employees of its conflict of interest policy and procedures, designating
officials to review conflict of interest financial disclosures, managing
conflicts, informing the University and the cognizant federal sponsor(s)
of conflicts and remedying same, certifying in each proposal for funding
that required conflict of interest policies are in place and that no
conflicts exist related to the proposed project, notifying SLU and federal
sponsor(s) of any post-award conflicts and otherwise complying in all
other respects with all applicable federal regulations, including 42 CFR
50, Subpart F.
If a conflict of interest related to the Award exists, the Subcontractor
will furnish SLU with the following information:
1. Nature of conflict
2. Subcontractor's institutional policy for Conflict of Interest
3. Certification from the Subcontractor that appropriate institutional
leadership is aware of Technical Representative's and/or other
applicable employee's conflict and that the Subcontractor's policy
will be followed
4. Technical Representative's and/or other applicable employee's plan
for minimizing or eliminating potential study bias that such an
interest might represent.
9. Certification and Disclosure Regarding Payments to Influence Certain
Federal Transactions If the total Award is greater than $100?000, by
signing this subcontract Subcontractor hereby certifies to the best of his
or her knowledge and belief that on or after December 23, 1989:
No Federal appropriated funds have been paid or will be paid to any person
for influencing or attempting to influence an officer or employee of any
agency, a Member of Congress, an officer or employee of Congress, or an
employee of a Member of Congress on his or her behalf in connection with
the awarding of any Federal contract, the making of any Federal grant, the
making of any Federal loan, the entering into of any cooperative
agreement, and the extension, continuation, renewal, amendment or
modification of any Federal contract, grant, loan, or cooperative
agreement.
If any funds other than Federal appropriated funds (including profit or
fee received under a covered Federal transaction) have been paid, or will
be paid, to any person for influencing or attempting to influence an
officer or employee of any agency, a Member of Congress, an officer or
employee of Congress, or an employee of a Member of Congress on his or her
behalf in connection with this solicitation, Subcontractor shall complete
and submit, with its offer, OMB standard form LLL, Disclosure of Lobbying
Activities, to SLU. Submission of this certification and disclosure is a
prerequisite for making or entering into this subcontract imposed by
section 1352, title 31, United States Code. Any person who makes an
expenditure prohibited under this provision or who fails to file or amend
the disclosure form to be filed or amended by mis provision, shall be
subject to a civil penalty of not less than $10,000, and not more than
$100,000, for each such failure.
10. Terms and Conditions of Prime Award
-----------------------------------
By signing this Subcontract, Subcontractor agrees to all terms and
conditions of the prime award which is hereto attached as Attachment 3.
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ARTICLE XVIII - Indemnification
- -------------------------------
In the performance of the work, duties and obligations contemplated herein, it
is mutually understood and agreed that the Subcontractor and SLU are at all
times acting and performing as independent contractors, each responsible only
for their respective acts or omissions. The Subcontractor shall, during the term
of this Agreement and at all times thereafter, indemnify, defend and hold
harmless SLU. its trustees, directors, officers, employees and agents, from and
against any and all claims, demands, damages, losses and other expenses
(including attorneys' fees) arising in whole or in part out of the negligent
acts or omissions of Subcontractor in the performance of this Agreement. SLU
shall, during the term of this Agreement and at all times thereafter, indemnify,
defend and hold harmless the Subcontractor, its trustees, directors, officers,
employees and agents, from and against any and all claims, demands, damages,
losses and other expenses (including attorneys' fees) arising in whole or in
part out of the negligent acts or omissions of SLU in the performance of this
Agreement.
ARTICLE XIX - Order of Precedence
- ---------------------------------
In the event of any inconsistency among the provisions of this subcontract the
inconsistency shall be resolved by giving precedence as follows: (1) if
attached, any Special Provisions; (2) subcontract's General Provisions and other
documents, exhibits and attachments; and (3) Sponsor's Award. (Attachment 3).
ARTICLE XX - No Employer-Employee Relationship
- ----------------------------------------------
This agreement does not create any agency, employment, joint employer, joint
venture, or partnership between SLU and Subcontractor. Neither party will have
the right, power, or authority to act for the other in any manner whatsoever.
ARTICLE XXI - Entire Subcontract
- --------------------------------
This subcontract is intended by the parties as a final written expression of
their agreement and supersedes and replaces any prior oral or written agreement.
Any terms or conditions proposed by Subcontractor inconsistent with or in
addition to terms and conditions herein contained shall be void and or no effect
unless specifically agreed to by SLU in writing and signed by both parties.
THIS AGREEMENT CONTAINS A BINDING ARBITRATION PROVISION THAT IS ENFORCEABLE
AGAINST THE PARTIES HERETO:
IN WITNESS WHEREOF, the parties hereto have caused their authorized officials to
execute this subcontract as of the date(s) set forth below:
SAINT LOUIS UNIVERSITY SUBCONTRACTOR
- ---------------------- -------------
/s/ Michael G. Luczak 9/8/2005 /s/ Dennis E. Hruby 9/14/2005
- ------------------------ --------- ---------------------- ---------
Authorized Signatory Date Authorized Signatory Date
11
Exhibit 99.1
SIGA
Contact:
Dr. Bernard Kasten
SIGA Technologies, Inc.
CEO
bkasten@siga.com
(212) 672-9100
SIGA ANNOUNCES $ 1 MILLION AGREEMENT WITH SAINT LOUIS UNIVERSITY
FOR SMALLPOX DRUG (SIGA-246) DEVELOPMENT
New York, September 20, 2005 -- SIGA Technologies, Inc. (NASDAQ: SIGA) today
announced that it had entered into an agreement with Saint Louis University for
the continued development of SIGA's smallpox drug (SIGA-246). The agreement is
funded through the National Institutes of Health. Under the terms of the
agreement, SIGA will receive approximately $1 million to support specific
aspects of the preclinical development of SIGA's oral anti-smallpox drug
SIGA-246. SIGA will receive the revenue from the agreement over the next six
months.
"We are delighted to have this opportunity to expand the scope of our relations
with Saint Louis University" said Dennis E. Hruby, Ph.D., Chief Scientific
Officer of SIGA. "Saint Louis University and its scientific team are playing a
central role in helping to advance SIGA-246 through development."
Smallpox is classified as a Category A agent by the Center for Disease Control
(CDC). It is considered one of the most significant threats for use as a
biowarfare agent due to the fact that people in the United States have not been
vaccinated against it since 1972. Smallpox is very easily transmitted from
person to person, and has high mortality rates (30-60%) with 90% morbidity. Mass
immunizations of the general population using the current live vaccine are not
recommended, as there are known complications in certain individuals from
vaccination (including encephalitis, myocarditis, disseminated vaccinia virus
infection, and death). At present there is no approved treatment for smallpox
that can be safely administered to the general population without significant
risk of adverse reactions.
SIGA's CEO Bernard L. Kasten, MD stated "The NIH has been a strong supporter of
our smallpox anti-viral counter measure development program and we are looking
forward to working with the Saint Louis University scientific team to further
expedite the development of our promising smallpox drug SIGA-246."
About SIGA Technologies, Inc.
SIGA Technologies is applying viral and bacterial genomics and sophisticated
computational modeling in the design and development of novel products for the
prevention and treatment of serious infectious diseases, with an emphasis on
products for biological warfare defense. SIGA has the potential to become a
significant force in the discovery of vaccine and pharmaceutical agents to fight
emerging pathogens. SIGA's product development programs emphasize the
increasingly serious problem of drug resistant bacteria and emerging pathogens.
SIGA's vaccine and drug platforms are based on its pioneering research into the
structure, function and processing of bacterial surface proteins. In addition to
smallpox, SIGA also has antiviral programs targeting other Category A pathogens
which cause hemorrhagic fevers. Included are the arenaviruses (Lassa Fever
Virus, Junin, Macupo, Guanarito, and Sabia), Lymphocytic choriomeningitis virus
(LCMV), Dengue, and the filoviruses, Ebola and Marburg. For more information
about SIGA, please visit SIGA's Web site at www.siga.com.
Forward-looking statements
This Press Release contains certain "forward-looking statements'' within the
meaning of the Private Securities Litigation Reform Act of 1995, as amended,
including statements regarding the efficacy of potential products, the timelines
for bringing such products to market and the availability of funding sources for
continued development of such products. Forward-looking statements are based on
management's estimates, assumptions and projections, and are subject to
uncertainties, many of which are beyond the control of SIGA. Actual results may
differ materially from those anticipated in any forward-looking statement.
Factors that may cause such differences include the risks that (a) potential
products that appear promising to SIGA or its collaborators cannot be shown to
be efficacious or safe in subsequent pre-clinical or clinical trials, (b) SIGA
or its collaborators will not obtain appropriate or necessary governmental
approvals to market these or other potential products, (c) SIGA may not be able
to obtain anticipated funding for its development projects or other needed
funding, (d) SIGA may not be able to secure funding from anticipated government
contracts and grants, (e) SIGA may not be able to secure or enforce adequate
legal protection, including patent protection, for its products
and (f) unanticipated internal control deficiencies or weaknesses or ineffective
disclosure controls and procedures. More detailed information about SIGA and
risk factors that may affect the realization of forward-looking statements,
including the forward-looking statements in this Press Release and the above
mentioned presentation, is set forth in SIGA's filings with the Securities and
Exchange Commission, including SIGA's Annual Report on Form 10-K for the fiscal
year ended December 31, 2004, and in other documents that SIGA has filed with
the Commission. SIGA urges investors and security holders to read those
documents free of charge at the Commission's Web site at http://www.sec.gov.
Interested parties may also obtain those documents free of charge from SIGA.
Forward-looking statements speak only as of the date they are made, and except
for our ongoing obligations under the U.S. federal securities laws, we undertake
no obligation to publicly update any forward-looking statements whether as a
result of new information, future events or otherwise.
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