On November 13, 2011, the Los Angeles Times published a story by David Willman on a no-bid contract with the Department of Health and Human Services (DHHS) to supply the government with a drug for smallpox. The LA Times story begins with this:
Over the last year, the Obama administration has aggressively pushed a $433-million plan to buy an experimental smallpox drug, despite uncertainty over whether it is needed or will work.
Senior officials have taken unusual steps to secure the contract for New York-based SIGA Technologies Inc., whose controlling shareholder is billionaire Ronald O. Perelman, one of the world’s richest men and a longtime Democratic Party donor.
When SIGA complained that contracting specialists at the Department of Health and Human Services were resisting the company’s financial demands, senior officials replaced the government’s lead negotiator for the deal, interviews and documents show.
When SIGA was in danger of losing its grip on the contract a year ago, the officials blocked other firms from competing.
SIGA was awarded the final contract in May through a “sole-source” procurement in which it was the only company asked to submit a proposal. The contract calls for SIGA to deliver 1.7 million doses of the drug for the nation’s biodefense stockpile. The price of approximately $255 per dose is well above what the government’s specialists had earlier said was reasonable, according to internal documents and interviews.
The LA Times story focuses on the decision by DHHS to eliminate any competitors for the contract. SIGA itself only had 65 full time employees as of February 15, 2011, and the company initially on a bid for a contract as a small business. But SIGA was eventually disqualified as a small business, because of its affiliations with Perelman’s holding company, MacAndrews & Forbes Holding, Inc. Rather than award the contract to a small business or open the competition to firms of all sizes, DHHS entered into a sole source negotiation with Sega. The LA Times reports:
Officials at the Small Business Administration investigated and quickly agreed, finding that SIGA’s affiliation with MacAndrews & Forbes disqualified it. The Obama administration could have awarded the contract to Chimerix as the only eligible small-business applicant. Or it could have reopened the competition to companies of any size. Instead, the administration moved to block all companies — except SIGA — from bidding on a second offering of the contract. In early December, officials completed a required “justification for other than full and open competition,” which said an antiviral against smallpox was needed within five years and SIGA was the only company able to meet that timetable. The rationale was questioned by some in HHS, including contracting officer Brian K. Goodger, who in an internal email called it “a stretch.”
The entire LA Times story is worth reading. Here are some other quotes from the story:
- Neither the HHS spokeswoman nor the SIGA representatives would disclose the agreed-upon profit margin or the per-treatment price.
- In 2003, Perelman, through his holding company MacAndrews & Forbes Holdings Inc., invested heavily in SIGA and installed a team of executives to run it. The move seemed prescient when Bush, in June 2004, signed Project BioShield, a 10-year, $5.6-billion initiative to fund the development and stockpiling of medications to counter bioterrorism. Two months later, SIGA purchased the rights to what became known as ST-246 from a Pennsylvania company, ViroPharma Inc., for $1 million in cash and 1 million shares of SIGA’s common stock. Over the next three years, the National Institute of Allergy and Infectious Diseases awarded SIGA two research grants and a related contract, worth a total of $23.5 million, to develop the new drug. From the outset, there was only one potential customer: the U.S. government.
- From 2005 through September, the company has paid three lobbying firms $800,000 to represent its interests in Washington, public records show. Disclosures filed by the lobbyists said they focused on Project BioShield and “issues related to homeland security and HHS,” along with “government procurement of vaccines.”
- officials looked at how much government money had already gone into developing ST-246. Public records show $115 million in federal support, not including the stockpile contract.
According to the LA Times story, DHHS has struggled to determine what is a reasonable price for the drug. Here are some notes on the costs of the development of S-246, and the federal subsidies.
Grants and Contracts
The LA Times story reports that the federal government has provided $115 million in federal support.
The SIGA web page provides this list of “government partners:”
http://www.SIGA.com/?ID=14
SIGA’s government partners: Agencies and Activities
- National Institute of Allergy and Infectious Diseases (NIAID) – NIAID has been a major supporter of SIGA antiviral countermeasure development, awarding approximately $47 million in funding since 2006.
- Office of Biodefense Research Affairs (OBRA) – In addition to administering the major contract supporting ST-246® (Tecovirimat) development, OBRA has provided access to animal models and preclinical testing capabilities.
- Department of Defense (DOD) – Several federal appropriations administered by the U.S. Army, the U.S. Air Force and the Defense Threat Reduction Agency have supported SIGA’s programs.
- The Defense Threat Reduction Agency (DTRA) – DTRA has provided essential funding to enable the testing of ST-246 in monkeypox and smallpox infected non-human primates under BSL-3 and BSL-4 conditions, respectively as well as provided support for our broad-spectrum antiviral.
- The United States Army Medical Research Institute for Infectious Diseases (USAMRIID) – SIGA has numerous ongoing projects with scientists at USAMRIID to test viral countermeasures against monkeypox, smallpox, Ebola and Lassa fever.
- Defense Science and Technology Laboratories (DSTL) – At Porton Down in the U.K., SIGA is working with DSTL scientists to test the effectiveness of ST-246 in murine aerosol challenge models.
- Centers for Disease Control and Prevention (CDC) – All of the in vitro and in vivo testing of ST-246 against variola virus has been conducted at the CDC BSL-4 laboratories in Atlanta. In addition, SIGA worked closely with CDC scientists on the treatment of several emergency cases that were conducted under eINDs, which are emergency Investigational New Drug applications.
- Biomedical Advanced Research and Development Authority (BARDA) – Like NIAID, BARDA has also been a major supporter of ST-246 over the last few years. BARDA is responsible for acquiring vaccines and drugs for Project BioShield as well as countermeasures for emerging infectious diseases and supplying them to the Strategic National Stockpile (SNS).
Clinical Trials
According to ClinicalTrials.Gov, there have been three clincial trials involving S-246/Tecovirimat. All three list co-sponsorship and co-funding between SIGA and NIH.
- Phase II. Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
Condition:, Orthopoxviral Disease
Interventions:, Drug: ST-246 400 mg; Drug: ST-246 600 mg; Drug: Placebo
Sponsors:, SIGA Technologies; National Institutes of Health (NIH)
Number Enrolled:, 107
Funded By:, Industry / NIH
Study Type:, Interventional
Start Date:, June 2009
Completion Date:, January 2010 - Phase I Trial of an Investigational Small Pox Medication
Conditions:, Orthopoxviral Disease; Smallpox; Monkey Pox
Interventions:, Other: Days 1 – 3; Other: Days 11 – 13
Sponsors:, SIGA Technologies; National Institutes of Health (NIH)
Number Enrolled:, 12
Funded By:, Industry / NIH
Study Type:, Interventional
Start Date:, August 2008
Completion Date:, October 2008 - Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers
Condition:, Healthy
Interventions:, Drug: ST-246; Drug: Placebo
Sponsors:, SIGA Technologies; National Institute of Allergy and Infectious Diseases (NIAID)
Number Enrolled:, 30
Funded By:, Industry / NIH
Study Type:, Interventional
Start Date:, February 2007
Completion Date:, February 2008
Patents
SIGA is involved in R&D projects related to other diseases and other drugs. The USPTO lists 19 patents assigned to SIGA. 12 of the 19 patents disclose U.S. government rights. However, the SIGA 10-K report, published in March 2011, claimed SIGA was the “exclusive owner” of fewer patents:
We are exclusive owner of 2 U.S. patents. We are also exclusive owner of 4 U.S. provisional patent applications, 15 U.S. utility patent applications, 3 international PCT patent applications and 105 foreign patent applications.
SIGA is seeking patent protection around the world, including South Africa, and the two leading regional Africa patent offices, ARIPO and OAPI. From the SIGA 2010 10-K report:
SIGA patent positions as of December 31, 2010:
ISSUED PATENTS
Jurisdiction, Number Owned by SIGA, Patent Expiration Dates
U.S. 2 2024 (1), 2027 (1)
South Africa 2, 2027 (2)
OAPI (African Intellectual Property Organization) 2 2027 (2)PATENT APPLICATIONS
Jurisdiction, Number
U.S. applications 15
U.S. provisionals 4
PCT 3
Australia 8
Canada 13
Europe 13
Japan 12
Mexico 6
South Africa 6
ARIPO (African Regional Intellectual Property Organization) 8
OAPI, 6
All Other Jurisdictions, 33
USPTO results for patents assigned to SIGA, with government rights in patents
AN/SIGA AND GOVT/government
- 8,039,504 — Chemicals, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases. This invention was made with U.S. government support under Contract No. HHSN266200600014C awarded by the National Institute of Health (NIH). The U.S. Government has certain rights in the invention.
- 7,994,221 — Sulfonyl semicarbazides, carbonyl semicarbazides, semicarbazides and ureas, pharmaceutical compositions thereof, and methods for treating hemorrhagic fever viruses, including infections associated with arenaviruses. This invention was made with U.S. government support under Grant No. R43 AI056525-01, Grant No. R43 AI056525-02, and Grant No. R44 AI056525-04 awarded by the National Institute of Health (NIH). The U.S. Government has certain rights in the invention.
- 7,977,365 — Antiviral drugs for treatment of arenavirus infection. This invention was made with U.S. government support under Grant No. 7R4 3AI056525 and Grant No. R44 AI056525 awarded by the National Institute of Health (NIH). The U.S. Government has certain rights in the invention.
- 7,956,197 — Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases. This invention was made with U.S. government support under Grant No. 7R43AI056409 and Contract No. HHSN266200600014C awarded by the National Institute of Health (NIH). The U.S. Government has certain rights in the invention.
- 7,872,037 — Antiviral drugs for treatment of arenavirus infection. The research described herein was supported in part by funds from the U.S. Government (Grant no. 7R43AI056525) and the U.S. Government may therefore have certain rights in the invention.
- 7,067,248 — Screening method for orthopoxvirus antivirals. The present invention was developed in part with funding from the United States Government, NIH Grant number AI-48486-02.
- 6,962,791 — Treatment or prophylaxis of diseases caused by pilus-forming bacteria. This invention was made with US government support under grant number R01AI29549 (S.J.H.) and training grant AI07172, both awarded by NIH. The US government has certain rights in the invention.
- 6,872,542 — Treatment or prophylaxis of diseases caused by pilus-forming bacteria. This invention was made with US government support under grant number R01AI29549 (S.J.H.) and training grant AI07172, both awarded by NIH. The US government has certain rights in the invention.
- 6,596,504 — Treatment of prophylaxis of diseases caused by pilus-forming bacteria. This invention was made with US government support under grant number R01AI29549 (S. J. H.) and training grant AI07172, both awarded by NIH. The US government has certain rights in the invention.
- 6,548,265 — Treatment or prophylaxis of diseases caused by pilus-forming bacteria. This invention was made with US government support under grant number R01AI29549 (S. J. H.) and training grant AI07172, both awarded by NIH. The US government has certain rights in the invention.
- 6,420,127 — Compounds and pharmaceutical compositions for the treatment and prophylaxis of bacterial infections. This invention was made with US government support under grant number R01AI29549 (S.J.H.) and training grant AI07172, both awarded by NIH. The US government has certain rights in the invention.
- 6,153,396 — Treatment or prophylaxis of diseases caused by pilus-forming bacteria. This invention was made with US government support under grant number R01AI29549 (S.J.H.) and training grant AI07172, both awarded by NIH. The US government has certain rights in the invention.
Seven of the 19th patents do not disclose federal rights.
Patents assigned to SIGA, without government rights in patents
AN/SIGA ANDNOT GOVT/government
- 7,737,168 — Compounds, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
- 7,687,641 — Chemicals, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
- 7,025,971 — Treatment or prophylaxis of diseases caused by pilus-forming bacteria
- 6,312,955 — Streptococcus gordonii strains resistant to fluorodeoxyuridine
- 6,306,619 — DegP periplasmic protease a new anti-infective target and an in vitro assay for DegP protease function
- 5,976,792 — Regulation of exoprotein in staphylococcus aureus
- 5,821,088 — Use of gram-positive bacteria to express recombinant proteins
Orphan Drug Status
Tecovirimat has received Orphan Drug Designations in both Europe and the United States. The European Commission granted an orphan designation on October 1, 2010 (EU/3/10/799) to SIGA Pharmaceuticals (Europe) Ltd, United Kingdom, for tecovirimat (also known as ST-246) for the treatment of cowpox infection. The USFDA has granted three Orphan Drug Product Designations
- Tecovirimat 09-29-2010 Treatment of orthopoxvirus infections.
- Tecovirimat 12-27-2006 Treatment of smallpox.
- Tecovirimat 12-18-2006 post exposure prophylaxis against smallpox
Under U.S. law, SIGA be able to claim tax credits for 50 percent of the non-federally funded costs of clinical trials. To the extent that SIGA actually financed any of the trials with its own money, it would earn the generous 50 percent tax credits. These credits care be carried forward, to be used to offset profits in future years, and are an asset in acquisitions. In recent SEC filings, SIGA says it expects to use the tax credits when it earns large profits from the new supply contract for the smallpox drug.
SIGA Financials
According to various SEC filings, most of SIGA’s “revenues” are from federal grants and contracts, and most of the R&D outlays were financed by the federal government.
SIGA financials for 2010-2006: Source: 10K
(in thousands)
| 2010 | 2009 | 2008 | 2007 | 2006 | |
| Revenues | $ 19,216 | $ 13,812 | $ 8,066 | $ 6,699 | $ 7,258 |
| Selling, general and administrative | 8,130 | 7,533 | 4,608 | 3,704 | 4,624 |
| Research and development | 22,659 | 17,423 | 11,613 | 9,943 | 9,149 |
| Patent preparation fees | 1,149 | 734 | 582 | 515 | 295 |
From the 2010 10-K report
Collaborative Research Agreements
We have entered into the following collaborative research arrangements and contracts:
National Institutes of Health . We have been awarded the following grants and contracts by the NIH which were still active for 2010:
Smallpox antiviral drug development: In 2006, SIGA was awarded grants and contracts from the NIH totaling approximately $21 million for the continued development of ST-246®. In 2008, SIGA was awarded a $55 million contract from the NIH to support the development of additional formulations and orthopox-related indications for ST-246®. In 2008, SIGA was also awarded $20 million from the NIH in supplemental funding to the Company’s existing $16.5 million contract. In September 2009, SIGA received a three-year, $3.0 million Phase II grant from the NIH to fund the continued development of ST-246® treatment of smallpox vaccine-related adverse events. As of December 31, 2010, approximately $63 million is available to the Company under these funding opportunities.
Anti-arenavirus drug development: In 2006, SIGA received a three-year grant of $6.0 million from the NIH to support the development of antiviral drugs for Lassa fever virus. As of December 31, 2010, there are no remaining funds available for the development of the drug.
Dengue antiviral drug development: In 2008, SIGA was awarded a $1.0 million, two-year grant from the NIH to support lead optimization and animal efficacy for our Dengue antiviral program. As of December 31, 2010, there are no remaining funds available for the development of the drug.
Broad spectrum antiviral drug development: In September 2009, the Company was awarded a two-year, $1.7 million grant from the NIAID to support the development of broad spectrum, small-molecule inhibitors of bunyaviruses. The grant was awarded under the American Recovery and Reinvestment Act of 2009 (“the Recovery Act”). As of December 31, 2010, approximately $0.9 million is still available to the Company under this grant.
Defense Threat Reduction Agency . In February 2010, the Company was awarded a $2.9 million contract with options for up to $9.9 million from DTRA to support the pre-clinical development and IND filing of a broad spectrum antiviral drug candidate. During the year ended December 31, 2010, we recognized revenue of $2.3 million from our contract with DTRA. As of December 31, 2010, approximately $0.6 million is still available to the Company from this contract.
SIGA receives cash payments from the NIH under its grants on monthly and semi-monthly bases, and under its NIH and DTRA contracts on a monthly basis, as the work is performed and the related revenue is recognized. SIGA’s current grants and contracts do not include milestone payments. The agreements can be cancelled for non-performance and if cancelled, the Company will not receive funds for additional future work under the agreements.
From an earlier Form 10-K, for the fiscal year ended December 31, 2005:
Collaborative Research and Licenses
We have entered into the following license agreements, collaborative
research arrangements and contracts:National Institutes of Health. In August 2004, we were awarded two Phase I
and two Phase II Small Business Innovation Research (SBIR) grants totaling
approximately $11.1 million to support our work on Smallpox and Arenaviruses.
The grants were acquired as part of our acquisition of certain assets from
ViroPharma6
Incorporated (“Viropharma”). For the years ending December 31, 2005, 2004 and,
2003, we have recognized revenue from the SBIR grants of $6,596,000, $1,415,000,
and $388,000 respectively.Prior to 2003, we received grants amounting to approximately $1.1 million
to support our antibiotic and vaccine development programs including a Phase II
SBIR grant for approximately $865,000 that began in 2002 and was completed in
May 2004.As part of our operational strategy we routinely submit grants to the NIH.
However, there is no assurance that we will receive additional grants.United States Army Medical Research and Material Command. In September
2005, we entered into a $3.2 million, one year contract with the United States
Army Medical Research and Material Command (USAMRMC). The agreement, for the
rapid identification and treatment of anti-viral diseases, is funded through the
United States Air Force (USAF). It is anticipated that our efforts will aid the
USAF Special Operations Command in its use of computational biology to design
and develop specific countermeasures against biological threat agents Smallpox
and Adenovirus. In 2005, we recognized revenue of $653,000 from this contract.United States Army Medical Research Acquisition Activity. In December
2002, we entered into a four year contract with the U.S. Army Medical Research
Acquisition Activity (USAMRAA) to develop a drug to treat Smallpox. The contract
start date was January 1, 2003 for the total amount of $1.6 million. Annual
payments over the term of the agreement will be approximately $400,000. In the
years ended December 31, 2005, 2004 and 2003 we recognized revenue of $427,000,
$425,000, and $315,000 respectively.Saint Louis University. On September 1, 2005, we entered into an agreement
with Saint Louis University for the continued development of one of our Smallpox
drugs. The agreement is funded through the NIH. Under the agreement, SIGA will
receive approximately $1.0 million during the term of September 1, 2005 to
February 28, 2006. Revenues are recognized as services are performed. In 2005,
we recognized revenues of $775,000 from the agreement.Oregon State University. Oregon State University (OSU) is also a party to
our license agreement with Rockefeller (discussed below), whereby we have
obtained the right and license to make, use and sell products for the therapy,
prevention and diagnosis of diseases caused by streptococcus. Pursuant to a
separate research support agreement with OSU, we provided funding for sponsored
research through December 31, 1999, with exclusive license rights to all
inventions and discoveries resulting from this research. At this time, no
additional funding is contemplated under this agreement, however, we retain the
exclusive licensing rights to the inventions and discoveries that may arise from
this collaboration. The term of the agreement is for the duration of the patents
licensed. As we do not currently know when any patents pending or future patents
will expire, we cannot at this time determine the term of this agreement. The
agreement can be terminated earlier if we are in breach of the provisions of the
agreement and do not cure the breach in the allowed cure period. We are
compliant in all our obligations under the agreement.In September 2000, we entered into a subcontract with OSU. The contract is
for a project which is targeted towards developing novel antiviral drugs capable
of preventing disease and pathology for Smallpox in the event this pathogen were
to be used as an agent of bioterrorism. The project is being funded by a grant
from the NIH. The basic virology aspects of the project will be conducted at OSU
and the drug development will be performed by us under the subcontract. The
budget for the subcontract work was negotiated on a year by year basis with OSU
and depended on the progress of the program and funding available. In the year
ended December 31, 2001 we recognized revenue of $15,000. On October 5, 2001 the
agreement was extended through August 31, 2002. For the period ended December
31, 2002 we recognized $75,000 in revenue. The agreement was extended again
through August 31, 2003 and is now subject to renewal on a year to year basis.
Through December 31, 2003, we received a total of $130,000 under the agreement.
During the year ended December 31, 2003 work under the subcontract was
completed.Regents of the University of California. In December 2000, we entered into
an exclusive license agreement and a sponsored research agreement with the
Regents of the University of California (“Regents”). Under the license agreement
we obtained rights for the exclusive commercial development, use and sale of
products related7
to certain inventions in exchange for a non-refundable license issuance fee of
$15,000 and an annual maintenance fee of $10,000. As of December 31, 2005 we
have made payments of approximately $101,000 under the license. In the event
that we sub-license the license, we must pay Regents 15% of all royalty payments
made to SIGA. We have currently met all our obligations under this agreement.Rockefeller University. In accordance with an exclusive worldwide license
agreement with Rockefeller, we have obtained the right and license to make, use
and sell mucosal vaccines based on gram-positive organisms and products for the
therapy, prevention and diagnosis of diseases caused by streptococcus,
staphylococcus and other organisms. The license covers eight issued U.S. patents
and three issued European patents, as well as one pending U.S. patent
application and one pending European application. The issued United States
patents expire in 2008, 2014 (4), 2015 (2), and 2016, respectively. The
agreement generally requires us to pay royalties on sales of products developed
from the licensed technologies, and fees on revenues from sub-licensees, where
applicable, and we are responsible for the costs of filing and prosecuting
patent applications. Under the agreement, we paid Rockefeller approximately
$850,000 to support research at Rockefeller. The agreement to fund research has
ended and no payments have been made to the university since the year ended
December 31, 1999. Under the agreement we are obligated to pay Rockefeller a
royalty on net sales by SIGA at rates between 2.5% and 5% depending on product
and amount of sales. On sales by any sub-licensee, we will pay Rockefeller a
royalty of 15% of anything we receive. The term of the agreement is for the
duration of the patents licensed. As we do not currently know when any patents
pending or future patents will expire, we cannot at this time determine the term
of this agreement. At the end of that term of the agreement, we have the right
to continue to practice the then existing technical information as a fully paid,
perpetual license. The agreement can be terminated earlier if we are in breach
of the provisions of the agreement and do not cure the breach in the allowed
cure period. We are compliant in all our obligations under the agreement.TransTech Pharma, Inc. In October 2002, we entered into a drug discovery
collaboration agreement with TransTech Pharma, Inc., a related party (“TransTech
Pharma”). Under the agreement, SIGA and TransTech Pharma collaborate on the
discovery, optimization and development of lead compounds to certain therapeutic
agents. The costs of development are shared. SIGA and TransTech Pharma would
share revenues generated from licensing and profits from any commercialized
product sales. The agreement will be in effect until terminated by the parties
or upon cessation of research or sales of all products developed under the
agreement. If the agreement is terminated, relinquished or expires for any
reason certain rights and benefits will survive the termination. Obligations not
expressly indicated to survive the agreement will terminate with the agreement.
No revenues were recognized in 2005, 2004 and 2003 from this collaboration.
In its 2005 10-K Report, SIGA noted that “Substantially all of our revenues for the years ended December 31, 2005, 2004 and 2003, respectively, were derived from revenues related to grants, contracts and license agreements.”
Until and unless we successfully make a product, our ability to generate
revenues will largely depend on our ability to enter into additional
collaborative agreements, strategic alliances, research grants, contracts and
license agreements with third parties and maintain the agreements we currently
have in place. Substantially all of our revenues for the years ended December
31, 2005, 2004 and 2003, respectively, were derived from revenues related to
grants, contracts and license agreements. Our current revenue is derived from
contract work being performed for the NIH under two major grants which are
scheduled to expire in September 2006 and contracts with the U.S. Army which
expire in September 2006 and December 2007. These agreements are for specific
work to be performed under the agreements and could only be canceled by the
other party thereto for non-performance. We may not earn significant milestone
payments under our existing collaborative agreements until our collaborators
have advanced products into clinical testing, which may not occur for many
years, if at all.We have material agreements with the following collaborators:
o National Institutes of Health. Under our collaborative agreement
with the NIH we have received SBIR Grants totaling approximately
$11.1 million in 2004. The term of these grants expire in September
2006. We are paid as the work is performed and the agreement can be
cancelled for non-performance. We also have an agreement whereby the
NIH is required to conduct and pay for the clinical trials of our
strep vaccine product through phase II human trials. The NIH can
terminate the agreement on 60 days written notice. If terminated, we
receive copies of all data, reports and other information related to
the trials. If terminated, we would have to find another source of
funds to continue to conduct the trials. We are current in all our
obligations under our agreements.13
o United States Army Medical Research and Material Command. In
September 2005 we entered into a $3.2 million, one year contract
with the USAMRMC. The agreement, for the rapid identification and
treatment of anti-viral diseases, is funded through the USAF. It is
anticipated that our efforts will aid the USAF Special Operations
Command in its use of computational biology to design and develop
specific countermeasures against biological threat agents Smallpox
and Adenovirus. We are current in all our obligations under our
agreement.o Saint Louis University. On September 1, 2005, we entered into an
agreement with Saint Louis University for the continued development
of one of our Smallpox drugs. The agreement is funded through the
NIH. Under the agreement, SIGA will receive approximately $1.0
million during the term of September 1, 2005 to February 28, 2006.
We are current in all our obligations under our agreement.o United States Army Medical Research Acquisition Activity. In
December 2002, we entered into a four year contract with USAMRAA to
develop a drug to treat Smallpox. We are current in all our
obligations under our agreement.o Rockefeller University. The term of our agreement with Rockefeller
is for the duration of the patents and a number of pending patents.
As we do not currently know when any patents pending or future
patents will expire, we cannot at this time definitively determine
the term of this agreement. The agreement can be terminated earlier
if we are in breach of the provisions of the agreement and do not
cure the breach in the allowed cure period. We are current in all
obligations under the contract.o Oregon State University. OSU is a signatory of our agreement with
Rockefeller. The term of this agreement is for the duration of the
patents and a number of pending patents. As we do not currently know
when any patents pending or future patents will expire, we cannot at
this time definitively determine the term of this agreement. The
agreement can be terminated earlier if we are in breach of the
provisions of the agreement and do not cure the breach in the
allowed cure period. We are current in all obligations under the
contract. We have also entered into a subcontract agreement with OSU
for us to perform work under a grant OSU has from the NIH. The
subcontract agreement was renewable annually and the current terms
expired on August 31, 2003. Work on this agreement was completed in
2003.o Washington University. We have licensed certain technology from
Washington under a non-exclusive license agreement. The term of our
agreement with Washington is for the duration of the patents and a
number of pending patents. As we do not currently know when any
patents pending or future patents will expire, we cannot at this
time definitively determine the term of this agreement. The
agreement cannot be terminated unless we fail to pay our share of
the joint patent costs for the technology licensed. We have
currently met all our obligations under this agreement.o Regents of the University of California. We have licensed certain
technology from Regents under an exclusive license agreement. We are
required to pay minimum royalties under this agreement. We have
currently met all our obligations under this agreement.o TransTech Pharma, Inc. Under our collaborative agreement with
TransTech Pharma, a related party, TransTech Pharma is collaborating
with us on the discovery, optimization and development of lead
compounds to certain therapeutic agents. We and TransTech Pharma
have agreed to share the costs of development and revenues generated
from licensing and profits from any commercialized products sales.
The agreement will be in effect until terminated by the parties or
upon cessation of research or sales of all products developed under
the agreement. We are current in all obligations under this
agreement.