SIGA TECHNOLOGIES INC 10-K

Item 1. Business   Overview   SIGA Technologies, Inc. is referred to throughout this report as “SIGA,” “the Company,” “we” or “us.”   We are a commercial-stage pharmaceutical company. Our lead product, TPOXX® (“oral TPOXX®”), is a U.S. Food & Drug Administration ("FDA")-approved oral formulation antiviral drug for the treatment of human smallpox disease caused by variola virus.    BARDA Contracts-TPOXX®   19C BARDA Contract   On September 10, 2018, the Company entered into a contract with the U.S. Biomedical Advanced Research and Development Authority ("BARDA") pursuant to which SIGA agreed to deliver up to 1,488,000 courses of oral TPOXX® to the U.S. Strategic National Stockpile ("Strategic Stockpile"), and to manufacture and deliver to the Strategic Stockpile, or store as vendor-managed inventory, up to 212,000 courses of the intravenous (IV) formulation of TPOXX® (“IV TPOXX®”). Additionally, the contract includes funding from BARDA for advanced development of IV TPOXX®, post-marketing activities for oral and IV TPOXX®, and procurement activities. As of December 31, 2020, the contract with BARDA (as amended, modified, or supplemented from time to time, the "19C BARDA Contract") contemplates up to approximately $602.5 million of payments, of which approximately $51.7 million of payments are included within the base period of performance of five years, approximately $127.1 million of payments are related to exercised options and up to approximately $423.7 million of payments are currently specified as unexercised options. BARDA may choose in its sole discretion when, or whether, to exercise any of the unexercised options. The period of performance for options is up to ten years from the date of entry into the 19C BARDA Contract and such options could be exercised at any time during the contract term, including during the base period of performance.    2 Table of Contents   The base period of performance specifies potential payments of approximately $51.7 million for the following activities: payments of approximately $11.1 million for the delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile; payments of $8.0 million for the manufacture of 20,000 courses of final drug product of IV TPOXX® ("IV FDP"), of which $3.2 million of payments are related to the manufacture of bulk drug substance ("IV BDS") to be used in the manufacture of IV FDP; payments of approximately $32.0 million to fund advanced development of IV TPOXX®; and payments of approximately $0.6 million for supportive procurement activities. As of December 31, 2020, the Company had received or billed for $11.1 million for the successful delivery of approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile, $3.2 million for the manufacture of IV BDS and $9.7 million for other base period activities. IV BDS is expected to be used for the manufacture of 20,000 courses of IV FDP. The $3.2 million received for the manufacture of IV BDS has been recorded as deferred revenue as of December 31, 2020 and December 31, 2019; such amount is expected to be recognized as revenue when IV TPOXX® containing such IV BDS is delivered to the Strategic Stockpile or placed in vendor-managed inventory.   The options that have been exercised to date provide for payments up to approximately $127.1 million. There are exercised options for the following activities: payments up to $11.2 million for the procurement of raw materials to be used in the manufacture of at least 363,070 courses of oral TPOXX®, payments up to $101.3 million for the delivery of up to 363,070 courses of oral TPOXX®; and, payments of up to $14.6 million for funding of post-marketing activities for oral TPOXX®. As of December 31, 2020, the Company has received the following payments in connection with exercised options: $11.2 million was received for the procurement of raw materials and such amount was initially recorded as deferred revenue and was recognized as revenue during the year ended December 31, 2020, with deliveries of approximately 363,000 courses, in the aggregate, of oral TPOXX®; $101.3 million was received in connection with the June, September and October deliveries, in total, of approximately 363,000 courses of oral TPOXX®; and $5.4 million has been received or billed for in connection with post-marketing activities for oral TPOXX®.   Unexercised options specify potential payments up to approximately $423.7 million in total (if all such options are exercised). There are options for the following activities: payments of up to $337.7 million for the delivery of up to approximately 1,089,000 courses of oral TPOXX® to the Strategic Stockpile; payments of up to $76.8 million for the manufacture of up to 192,000 courses of IV FDP, of which up to $30.7 million of payments would be paid upon the manufacture of IV BDS to be used in the manufacture of IV FDP; payments of up to approximately $3.6 million to fund post-marketing activities for IV TPOXX®; and payments of up to approximately $5.6 million for supportive procurement activities.   The options related to IV TPOXX® are divided into two primary manufacturing steps. There are options related to the manufacture of bulk drug substance (“IV BDS Options”), and there are corresponding options (for the same number of IV courses) for the manufacture of final drug product (“IV FDP Options”). BARDA may choose to exercise any, all, or none of these options in its sole discretion. The 19C BARDA Contract includes: three separate IV BDS Options, each providing for the bulk drug substance equivalent of 64,000 courses of IV TPOXX®; and three separate IV FDP Options, each providing for 64,000 courses of final drug product of IV TPOXX®. BARDA has the sole discretion as to whether to simultaneously exercise IV BDS Options and IV FDP Options, or whether to exercise options at different points in time (or alternatively, to only exercise the IV BDS Option but not the IV FDP Option). If BARDA decides to only exercise IV BDS Options, then the Company would receive payments up to $30.7 million; alternatively, if BARDA decides to exercise both IV BDS Options and IV FDP Options, then the Company would receive payments up to $76.8 million. For each set of options relating to a specific group of courses (for instance, the IV BDS and IV FDP options that reference the same 64,000 courses), BARDA has the option to independently purchase IV BDS or IV FDP. The Company estimates that sales of the IV formulation under this contract (under current terms), assuming the IV FDP Options were exercised, would have a gross margin (sales less cost of sales, as a percentage of sales) that is less than 40%.   Under the terms of this contract, exercise of procurement options are at the sole discretion of BARDA. The request for proposal that preceded the award of the 19C BARDA Contract indicated that the expected purpose of the contract was to maintain the level of smallpox antiviral preparedness in the Strategic Stockpile. Based on prior product delivery activity, and current FDA-approved shelf life of oral TPOXX®, the Company estimates that approximately one million courses of smallpox antiviral treatment would need to be delivered to the U.S. Government between 2021 and 2023 in order to maintain stockpile levels of unexpired smallpox antiviral treatment during this period.          2 011 BARDA Contract   On May 13, 2011, the Company signed a contract with BARDA pursuant to which BARDA agreed to buy from the Company 1.7 million courses of oral TPOXX®. Additionally, the Company agreed to contribute to BARDA 300,000 courses at no additional cost to BARDA.   3 Table of Contents   The contract with BARDA (as amended, modified, or supplemented from time to time the "2011 BARDA Contract”) includes a base contract, as modified, (“2011 Base Contract”) as well as options. The 2011 Base Contract specifies approximately $508.4 million of payments (including exercised options), of which, as of December 31, 2020, $459.8 million has been received by the Company for the manufacture and delivery of 1.7 million courses of oral TPOXX® and $45.6 million has been received for certain reimbursements in connection with development and supportive activities. Approximately $3.0 million remains eligible to be received in the future for reimbursements of development and supportive activities.   For courses of oral TPOXX® that have been physically delivered to the Strategic Stockpile under the 2011 BARDA Contract, there are product replacement obligations, including: (i) a product replacement obligation in the event that the final version of oral TPOXX® approved by the FDA was different from any courses of oral TPOXX® that had been delivered to the Strategic Stockpile (the "FDA Approval Replacement Obligation"); (ii) a product replacement obligation, at no cost to BARDA, in the event that oral TPOXX® is recalled or deemed to be recalled for any reason; and (iii) a product replacement obligation in the event that oral TPOXX® does not meet any specified label claims. On July 13, 2018, the FDA approved oral TPOXX® for the treatment of smallpox and there is no difference between the approved product and courses in the Strategic Stockpile. As such, the possibility of the FDA Approval Replacement Obligation resulting in any future replacements of product within the Strategic Stockpile is remote.   The 2011 BARDA Contract includes options. On July 30, 2018, the 2011 BARDA Contract was modified and BARDA exercised its option relating to FDA approval of the aforementioned 84-month expiry for oral TPOXX® for which the Company was paid $50.0 million in August 2018. With the option exercise, the 2011 BARDA Contract was modified so that the 2011 Base Contract increased by $50.0 million. Remaining options, if all were exercised by BARDA, would result in aggregate payments to the Company of $72.7 million, including up to $58.3 million of funding for development and supportive activities such as work on a post-exposure prophylaxis ("PEP") indication for TPOXX® and/or $14.4 million of funding for production-related activities related to warm base manufacturing. BARDA may choose, in its sole discretion not to exercise any or all of the unexercised options. In 2015, BARDA exercised two options related to extending the indication of the drug to the geriatric and pediatric populations. The stated value of those exercises was immaterial.   The 2011 BARDA Contract expires in December 2024.   International Procurement Contracts   Contract with Public Health Agency of Canada   On January 13, 2021, the Public Health Agency of Canada ("PHAC") awarded a contract to Meridian Medical Technologies, Inc. (“Meridian,” a Pfizer Company) (the “Contract”) for the purchase of up to approximately $33 million of oral TPOXX® (tecovirimat) within five years. The Contract specifies firm commitments for the purchase of approximately $3.4 million of oral TPOXX® to occur by March 31, 2021 and a cumulative purchase of approximately $17 million of oral TPOXX® by March 31, 2023; the remaining courses under the Contract are targeted for delivery after March 31, 2023 and are subject to option exercise by PHAC. To date, SIGA has not finalized any deliveries yet in connection with this contract. The contract award was coordinated between SIGA and Meridian under an international promotion agreement, as amended (the "International Promotion Agreement") that was entered into by the parties on June 3, 2019. As such, Meridian is the PHAC's counterparty under the Contract, and SIGA is responsible for manufacture and delivery of any oral TPOXX® purchased thereunder.    Canadian Military Contract   On April 3, 2020, the Company announced that the Canadian Department of National Defence (“CDND”) awarded a contract (the "Canadian Military Contract") to Meridian, pursuant to which the CDND will purchase up to approximately $14 million of oral TPOXX® over four years.  In the second quarter 2020, CDND purchased $2.3 million of oral TPOXX®.  The remaining purchases are at the option of the CDND, and are expected to occur after regulatory approval of oral TPOXX® in Canada. Meridian is the CDND's counterparty under the Canadian Military Contract, and SIGA is responsible for manufacture and delivery of any oral TPOXX® purchased thereunder.    International Promotion Agreement   Under the terms of the International Promotion Agreement, Meridian was granted exclusive rights to market, advertise, promote, offer for sale, or sell oral TPOXX® in a field of use specified in the International Promotion Agreement in all geographic regions except for the United States (the “Territory”), and Meridian has agreed not to commercialize any competing product, as defined in the International Promotion Agreement, in the specified field of use in the Territory. SIGA will retain ownership, intellectual property, distribution and supply rights and regulatory responsibilities in connection with TPOXX®, and, in the United States market, will also retain sales and marketing rights with respect to oral TPOXX®. SIGA’s consent shall be required for the entry into any sales arrangement pursuant to the International Promotion Agreement.   The fee Meridian retains pursuant to the International Promotion Agreement will be a specified percentage of the collected proceeds of sales of oral TPOXX® net of certain expenses, for years in which customer invoiced amounts net of such expenses are less than or equal to a specified threshold, and a higher specified percentage of such collected net proceeds for years in which such net invoiced amounts exceed the specified threshold.  Taking into account Meridian’s fee and manufacturing costs of oral TPOXX®, it is currently estimated by the Company that international sales of oral TPOXX® will have a contribution margin (as expressed as a percentage of product sales, and before any consideration of expenses not directly related to manufacturing or Meridian activities) of between approximately 65% and 80%.   4 Table of Contents   Lead Product-TPOXX®   SIGA believes that TPOXX® is among the first new small-molecule drugs delivered to the Strategic Stockpile under Project BioShield. Oral TPOXX® is a novel, patented drug that is easy to store, transport and administer. On July 13, 2018, the FDA approved oral TPOXX® for the treatment of smallpox. Oral TPOXX® labeling, approved by the FDA, limits sales of oral TPOXX® in the U.S. to those for the Strategic Stockpile. Under the 2011 BARDA Contract, 1.7 million courses of oral TPOXX® were sold to BARDA and delivered to the Strategic Stockpile between 2013 and 2017. Courses delivered under the 2011 BARDA Contract have an FDA-approved shelf life of seven years. Under the 19C BARDA Contract, SIGA can deliver up to 1.7 million courses of TPOXX® (of which 1,488,000 courses would be oral TPOXX® and 212,000 courses would be IV TPOXX®) to the Strategic Stockpile, at the option of BARDA.   For IV TPOXX®, SIGA expects to file a new drug application ("NDA") for IV TPOXX® as early as during the second quarter of 2021. Based on its review of the NDA, the FDA will decide whether to approve IV TPOXX® and whether to impose any marketing restrictions or require additional post-approval clinical studies. This review process will typically take ten months. There can be no assurance that any approval will be granted on a timely basis, if at all.   As noted above, the FDA approved oral TPOXX® for the treatment of smallpox. The Company is currently seeking regulatory approval of oral TPOXX® in Europe and Canada as well. In July 2020, the Company filed a Marketing Authorisation Application ("MAA") with the European Medicines Agency ("EMA") for oral tecovirimat, the same formulation that was approved by the FDA in July 2018 under the name TPOXX®.  The MAA was filed under the centralized application process, which, upon approval, will enable sales and marketing of oral tecovirimat in all EU member states, as well as Norway, Iceland, and Liechtenstein.  SIGA has filed its application for oral tecovirimat seeking a broader label indication covering the treatment of smallpox, monkeypox, cowpox, and complications from Vaccinia infection.   In December, 2020, the Company filed an application for marketing authorization in Canada for oral tecovirimat, using the same formulation approved by the FDA.   Manufacturing   SIGA does not have a manufacturing infrastructure and does not intend to develop one for the manufacture of TPOXX®. SIGA relies on and uses third parties known as Contract Manufacturing Organizations (“CMOs”) to procure commercial raw materials and supplies, and to manufacture TPOXX®. SIGA's CMOs apply methods and controls in facilities that are used for manufacturing, processing, packaging, testing, analyzing and holding pharmaceuticals which conform to current good manufacturing practices (“cGMP”), the standard set by the FDA for manufacture and storage of pharmaceuticals intended for human use.   Oral TPOXX®:   For the manufacture of oral TPOXX®, the Company uses the following CMOs: Albemarle Corporation (“Albemarle”); Powdersize, LLC (“Powdersize”); Catalent Pharma Solutions LLC (“Catalent”); and Packaging Coordinators, LLC ("PCI").   In August 2011, SIGA entered into an agreement with Albemarle. Such agreement was amended in April 2015 and expired in April 2018. On October 1, 2018, SIGA entered into a new agreement with Albemarle pursuant to which Albemarle manufactures, tests and supplies active pharmaceutical ingredient (“API”) for use in TPOXX®. The agreement provides that, during the term of the new agreement, SIGA will purchase 100% of its internal and external API requirements for TPOXX® from Albemarle until the later of (i) September 30, 2021 and (ii) such time as SIGA has purchased twelve metric tons of API from Albemarle under the new agreement. From and after the later of: (i) September 30, 2021, or (ii) such time as SIGA has purchased twelve metric tons of API from Albemarle, SIGA will purchase at least 70% of its internal and external API requirements for TPOXX® from Albemarle until the end of the term of the new agreement (as described below), unless the Company receives an offer to purchase API at a price that Albemarle is unable to match, in which event SIGA will purchase at least 30% of its internal and external API requirements for TPOXX® from Albemarle until September 30, 2023. There is no minimum amount of kilograms of API that must be used or acquired by SIGA. The following events are excluded from the “100% API” requirement: (i) if a contract entered into by SIGA for the sale of final drug product (“FDP”) requires that the product used as the API for such FDP be manufactured outside the U.S. and Albemarle is unwilling or unable to subcontract such manufacture to a party or parties that meet the terms of the agreement; (ii) if a contract entered into by SIGA for the sale of FDP in an intravenous formulation requires different specifications than those provided for under the agreement and the parties are not able to reach agreement on the necessary changes to the specifications or on pricing; or (iii) if Albemarle fails to perform any of its obligations under the agreement and does not cure such failure within 30 days of written notice from SIGA. SIGA is required to pay Albemarle within 45 days of its invoice date. Pricing for API is at a fixed price per kilogram, subject to adjustment for increases in raw material costs and/or general manufacturing costs. Albemarle is required to deliver API that conforms to specifications outlined in the agreement; the Company is not required to pay for API that does not meet specifications. The Company has 120 days to reject any shipments that do not meet such specifications or are damaged. In addition to receiving payments for API deliveries, Albemarle is also paid for related services, such as stability testing. The Company’s agreement with Albemarle is currently scheduled to expire upon the earlier of: (i) September 30, 2023, or (ii) the fulfillment of delivery obligations under the 19C BARDA Contract. Thereafter, the agreement shall renew for successive one-year renewal terms until either the Company or Albemarle provides notice of non-renewal at least 90 days prior to the expiration date of a term.   5 Table of Contents   Powdersize, a Lonza Group company, micronizes and tests API for use in oral TPOXX®. The Company’s agreement with Powdersize was amended on January 11, 2019. The amended term ends on the tenth anniversary of the amendment date.   Catalent granulates, encapsulates, and tests oral TPOXX®. In addition, Catalent provides services related to commercial stability testing of drug product and preparation for tabulated stability and trend analysis for each time point. The Company’s agreement with Catalent has an initial term that ends on June 28, 2021. Thereafter, this agreement automatically renews for three years unless either party provides six months' notice of its desire to terminate the agreement prior to the expiration of the term; as of the filing date, the Company has not provided nor received notice of termination. During the term of the agreement, SIGA will purchase all of its requirements for bulk product under the 19C BARDA contract from Catalent.   PCI provides packaging services in connection with oral TPOXX®. Additionally, PCI has contracted with the Company to provide packaging services in connection with the intravenous formulation of TPOXX®. The Company’s agreement with PCI has an initial term that ends on March 1, 2022. Thereafter, this agreement automatically renews for successive one-year periods unless either party provides 120 days' notice of its desire to terminate the agreement prior to the expiration of the term. The agreement can be terminated earlier than March 1, 2022 under certain conditions.   Intravenous (IV) formulation of TPOXX®:   For the manufacture of IV TPOXX® under the BARDA Contracts, the Company has agreed to use the following CMOs: Roquette America, Inc. (“Roquette”); Patheon Manufacturing Services LLC (“Patheon”); and PCI.   Roquette provides an excipient to be used in the manufacturing of IV TPOXX®. The Company's agreement with Roquette has no minimum amount of manufacturing services that must be used. The Company’s agreement with Roquette has an initial term that ends on December 31, 2023. Thereafter, this agreement automatically renews on a year-by-year basis unless either party provides four months’ notice of its desire to terminate the agreement prior to the expiration of the term.   Patheon manufactures, tests and packages IV TPOXX®. SIGA agreed that Patheon will be entitled to manufacture at least 80% of IV TPOXX® offered for sale by SIGA during the first three years of the agreement, provided Patheon adheres to reasonable manufacturing standards. Thereafter, the manufacturing percentage will be as mutually agreed upon by the parties. The Company’s agreement with Patheon has an initial term that ends on the later of: December 31, 2022 or, such date as all government contracts related to IV TPOXX® are terminated. Thereafter, this agreement automatically renews for two-year increments unless either party provides twelve months’ notice of its desire to terminate the agreement prior to the expiration of the term.   As noted above, PCI is expected to provide packaging services for IV TPOXX®.   Corporate Responsibility and Sustainability   SIGA focuses on the health security market and seeks to advance global health while promoting a sustainable environment.   SIGA seeks to advance global public health through its development and commercial activities, which include (i) delivering medical countermeasures to governments and/or non-governmental organizations ("NGOs") so that governments and/or NGOs can cost-effectively stockpile treatments for potential public health emergencies and (ii) donating therapies to NGOs to treat patients with serious infectious diseases in developing countries or those who are being treated on a compassionate basis and/or within clinical trials.   SIGA seeks to promote a sustainable environment by tracking the involvement of its manufacturing supply chain in initiatives and organizations that prioritize a sustainable environment. All manufacturers within SIGA’s supply chain, including Albemarle, Powdersize, Catalent, PCI, Patheon and Roquette maintain corporate social responsibility and/or sustainability programs and publicly report on those programs.   SIGA also pursues such policies within its own corporate environment, although the scale is too small to report separately their impact.   6 Table of Contents   Market for Biological Defense Programs   The market for biodefense countermeasures reflects continued awareness of the threat of global terror and biowarfare activity. The U.S. Government is the largest source of development and procurement funding for academic institutions and biopharmaceutical companies conducting biodefense research or developing vaccines, anti-infectives and immunotherapies directed at potential agents of bioterror or biowarfare. U.S. Government spending on biodefense programs includes development funding awarded by the National Institute of Allergy and Infectious Diseases, BARDA and the Department of Defense (“DoD”), and procurement of countermeasures by BARDA, the Strategic Stockpile and the DoD. For the fiscal year ending September 30, 2021, the budget for the U.S. Department of Health and Human Services provides an annual appropriation of approximately $2.0 billion for activities related to advanced development and procurement of medical countermeasures for biological and other threats to civilian populations.   In response to the COVID-19 pandemic, Congress has appropriated over $45 billion over the past year across four supplemental appropriations for the purposes of developing necessary countermeasures and vaccines, prioritizing platform-based technologies with U.S.-based manufacturing capabilities, the purchase of vaccines, therapeutics, diagnostics, necessary medical supplies, as well as medical surge capacity, and other preparedness and response activities. While the focus of such appropriations is to support a broad-based response to the COVID-19 pandemic, funds from these appropriations could, depending on the COVID-19 response, be available to support biodefense activities related to the development of new medical countermeasures, building and upgrading of facilities, improvement in surge capacity, and procurement of ancillary medical supplies.   We believe that potential markets for the sale of biodefense countermeasures in addition to the U.S. Government include:     • foreign governments, including both defense and public health agencies;   • NGOs and multinational companies, including transportation and security companies   • healthcare providers, including hospitals and clinics; and   • state and local governments, which may be interested in these products to protect, among others, emergency responders, such as police, fire and emergency medical personnel.   At present, oral TPOXX® is not approved for sale in the U.S. beyond sales to the U.S. Government for the purpose of stockpiling and/or usage by the Strategic Stockpile. The Company would need to meet additional regulatory requirements before sales could be made in the U.S. beyond the U.S Government.   Research Agreements and Grants   The Company has an R&D program for IV TPOXX®. This program is funded by the 19C BARDA Contract and a separate development contract with BARDA ("IV Formulation R&D Contract"). The IV Formulation R&D Contract has a period of performance that terminates in February 2024. As of December 31, 2020, the IV Formulation R&D Contract provides for future aggregate research and development funding of up to approximately $2.1 million. See Note 3 to the consolidated financial statements regarding the 19C BARDA Contract.   In July 2019, the Company was awarded a multi-year research contract valued at a total of $19.5 million, with initial available funding of $12.4 million, from the DoD to support work in pursuit of a potential label expansion for oral TPOXX® that would include post-exposure prophylaxis ("PEP") of smallpox (such work known as the "PEP Label Expansion Program" and the contract referred to as the "PEP Label Expansion R&D Contract"). In May 2020, the DoD increased the scope and the contract value to a total of $26 million with current available funding of $23 million. As of December 31, 2020, the PEP Label Expansion R&D Contract provides for future aggregate research and development funding under the award, as modified, of up to approximately $22.4 million. The period of performance for this contract, as modified, terminates on July 31, 2025.   Contracts and grants include, among other things, options that may or may not be exercised at the U.S. Government’s discretion. Moreover, contracts and grants contain customary terms and conditions including the U.S. Government’s right to terminate or restructure a contract or grant for convenience at any time. As such, we may not be eligible to receive all available funds.   7 Table of Contents   General   We receive cash payments from BARDA on a monthly basis, as services are performed or goods are purchased. Amounts under contract and grant agreements are not guaranteed and can be canceled at any time for reasons such as non-performance or convenience of the U.S. Government and, if canceled, we will not receive funds for additional work under the agreements.   Competition   The biotechnology and pharmaceutical industries are characterized by rapidly evolving technology and intense competition. Our competitors include many major pharmaceutical companies, each of which has financial, technical and marketing resources significantly greater than ours. Biotechnology and other pharmaceutical competitors in the biodefense space include, but are not limited to, Emergent BioSolutions Inc., Bavarian Nordic AS, and Chimerix Inc. Academic institutions, governmental agencies and other public and private research organizations are also conducting research activities and seeking patent protection and may commercialize products on their own or through joint ventures.   TPOXX® faces significant competition for government funding for both development and procurement of medical countermeasures for biological, chemical, radiological and nuclear threats, diagnostic testing systems, and other emergency preparedness countermeasures.   Our commercial opportunities could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer side effects, are more convenient or are less expensive than products that we may develop. In addition, we may not be able to compete effectively if our product candidates do not satisfy governmental procurement requirements, particularly requirements of the U.S. Government with respect to biodefense products.   Human Capital Resources and Research Facilities   As of February 16, 2021, we had 42   full-time employees. None of our employees are covered by a collective bargaining agreement, and we consider our employee relations to be satisfactory.  Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants with the overall goal of having an employee base that embraces teamwork and shares a focus for using each person’s individual skills, experience and expertise in order to develop and maximize the value of corporate assets, and achieve long-term revenue and earnings growth.   Our research and development facilities are located in Corvallis, Oregon, where we lease approximately 10,276 square feet under a lease agreement that commenced on January 1, 2018 and which expires in December 2021. This lease has one remaining renewal option for an additional three years.   Intellectual Property and Proprietary Rights   SIGA’s commercial success will depend in part on its ability to obtain and maintain patent and other intellectual property protection in the U.S. and the rest of the world for its proprietary technologies, drug targets, and potential products and to preserve its trade secrets. Because of the substantial length of time and expense associated with bringing potential products through the development and regulatory clearance processes to reach the marketplace, the pharmaceutical industry places considerable importance on obtaining patent and trade secret protection. The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions. No consistent policy regarding the breadth of claims allowed in biotechnology patents across various jurisdictions has emerged to date. Accordingly, SIGA cannot predict the type and extent of claims that will be allowed in pending patent applications.   SIGA also relies upon trade secret protection for its confidential and proprietary information. No assurance can be given that other companies will not independently develop substantially equivalent proprietary information and techniques or otherwise gain access to SIGA’s trade secrets or that SIGA can meaningfully protect its trade secrets.   SIGA exclusively owns its key patent portfolios, which relate to its leading drug product, TPOXX® (also known as ST-246, tecovirimat). As of January 12, 2021, the TPOXX® patent portfolio has seven patent families consisting of 27 U.S. utility patents, 86 issued foreign patents, three U.S. utility patent applications, and 30 foreign patent applications.   The principal and material issued patents covering TPOXX® are described in the table below.   Patent Number Country Protection Conferred Issue Date Expiration Date US 7737168 United States Method of treating orthopoxvirus infection with ST-246 June 15, 2010 May 3, 2027^ US 8039504 United States Pharmaceutical compositions and unit dosage forms containing ST-246 October 18, 2011 July 23, 2027 US 7687641 United States Method of manufacturing ST-246 March 30, 2010 September 27, 2024 US 8124643 United States Composition of matter for the ST-246 compound and Pharmaceutical compositions containing ST-246 February 28, 2012 June 18, 2024^ US 7956197 United States Method of manufacturing ST-246 June 7, 2011 June 18, 2024 US 8530509 United States Pharmaceutical compositions containing a mixture of compounds including ST-246 September 10, 2013 June 18, 2024   8 Table of Contents   US 8802714 United States Method of treating orthopoxvirus infection with a mixture of compounds including ST-246 August 12, 2014 June 18, 2024 US 9045418 United States Method of manufacturing ST-246 June 2, 2015 June 18, 2024 US 9233097 United States Liquid Pharmaceutical formulations containing ST-246 January 12, 2016 August 2, 2031 US 9339466 United States Certain polymorph of ST-246, method of preparation of the polymorph and pharmaceutical compositions containing the polymorph May 17, 2016 March 23, 2031 US 9546137 United States Methods of preparing ST-246 January 17, 2017 August 14, 2033 US 9744154 United States Polymorphic forms of ST-246 and methods of preparation August 29, 2017 March 23, 2031 US 9862683 United States Methods of preparing Tecovirimat January 9, 2018 August 14, 2033 US 9670158 United States Amorphous Tecovirimat preparation June 6, 2017 July 11, 2034 US 9889119 United States Amorphous Tecovirimat preparation February 13, 2018 July 11, 2034 US 9907859 United States ST-246 liquid formulations and methods March 6, 2018 August 2, 2031 US 10029985 United States Methods of preparing Tecovirimat July 24, 2018 August 14, 2033 US 10045963 United States Amorphous Tecovirimat preparation August 14, 2018 July 11, 2034 US 10045964 United States Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs August 14, 2018 March 23, 2031 US 10124071 United States ST-246 liquid formulations and methods November 13, 2018 August 2, 2031 US 10155723 United States Methods of preparing Tecovirimat December 18, 2018 August 14, 2033 US 10406137 United States Certain polymorphs of ST-246 and pharmaceutical compositions containing the polymorphs September 10, 2019 March 23, 2031 US 10406103 United States Rehydration of micronized Tecovirimat monohydrate September 10, 2019 November 14, 2034 US 10576165 United States Liquid Pharmaceutical formulations containing ST-246 March 3, 2020 August 2, 2031 US 10864282 United States Methods of preparing liquid formulations containing ST-246 December 15, 2020 August 2, 2031 US 10662155 United States Methods of preparing Tecovirimat May 26, 2020 August 14, 2033 US 10716759 United States Rehydration of micronized Tecovirimat monohydrate July 21, 2020 November 14, 2034 SG 184201 Singapore Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs June 22, 2015 March 23, 2031 RU 2578606 Russia Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus March 27, 2016 March 23, 2031 OA 16109 OAPI/Africa Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus October 31, 2013 March 23, 2031 NZ 602578 New Zealand Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus December 2, 2014 March 23, 2031 MX 326231 Mexico Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246 December 11, 2014 April 23, 2027 MX 348481 Mexico Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases June 15, 2017 April 23, 2027 MX 347795 Mexico ST-246 liquid formulations and methods May 15, 2017 August 2, 2031 MX 361428 Mexico Polymorphic forms of ST-246 and methods of preparation December 6, 2018 March 23, 2031 MX 363189 Mexico Use of pharmaceutical compositions containing ST-246 March 14, 2019 April 23, 2027 MX 368106 Mexico ST-246 liquid formulations and methods September 19, 2019 August 2, 2031 KR 101868117 Korea ST-246 liquid formulations and methods June 8, 2018 August 2, 2031 JP 4884216 Japan Therapeutic agent for treating orthopoxvirus including ST-246, pharmaceutical composition of matter for the ST-246 compound and method of manufacturing ST-246 December 16, 2011 June 18, 2024 JP 5657489 Japan Method of manufacturing ST-246 December 5, 2014 June 18, 2024 JP 5898196 Japan Liquid Pharmaceutical formulations containing ST-246 March 11, 2016 August 2, 2031 JP 6018041 Japan Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs October 7, 2016 March 23, 2031 JP 6188802 Japan Methods of preparing Tecovirimat August 10, 2017 August 14, 2033 JP 6444460 Japan Methods of preparing Tecovirimat December 7, 2018 August 14, 2033 JP 6564514 Japan Methods of preparing Tecovirimat August 2, 2019 August 14, 2033   9 Table of Contents   JP 6594303 Japan Rehydration of micronized Tecovirimat monohydrate October 4, 2019 November 14, 2034 BR 112012023743-8 Brazil Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs February 18, 2020 March 23, 2031 CN 2011800245893 China Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs August 26, 2015 March 23, 2031 CN 2013800429237 China Methods of preparing Tecovirimat June 20, 2017 August 14, 2033 CN 2017103075357 China Methods of preparing Tecovirimat March 6, 2020 August 14, 2033 CN 2014800653387 China Rehydration of micronized Tecovirimat monohydrate February 7, 2020 November 14, 2034 CA 2529761 Canada Use of ST-246 to treat orthopoxvirus infection, pharmaceutical compositions containing ST-246 and composition of matter for the ST-246 compound August 13, 2013 June 18, 2024 CA 2685153 Canada Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246 December 16, 2014 April 23, 2027 CA 2866037 Canada Chemicals, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases May 16, 2017 April 23, 2027 CA 2807528 Canada Liquid Pharmaceutical formulations containing ST-246 September 25, 2018 August 2, 2031 CA 2966466 Canada Use of ST-246 to treat orthopoxvirus infections August 25, 2020 April 23, 2027 CA 2882506 Canada Methods of preparing Tecovirimat October 20, 2020 August 14, 2033 CA 2793533 Canada Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs February 26, 2019 March 23, 2031 AU 2004249250 Australia Method of treating orthopoxvirus infection, pharmaceutical composition containing ST-246 and composition of matter for the ST-246 compound March 29, 2012 June 18, 2024 AU 2007351866 Australia Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246 January 10, 2013 June 18, 2024 AU 2011232551 Australia Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus February 26, 2015 March 23, 2031 AU 2011285871 Australia Liquid Pharmaceutical formulations containing ST-246 August 6, 2015 August 2, 2031 AU 2013302764 Australia Methods of preparing Tecovirimat April 5, 2018 August 14, 2033 AU 2012268859 Australia Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246 August 18, 2016 June 18, 2024 AU 2014290333 Australia Amorphous Tecovirimat preparation February 21, 2019 July 11, 2034 AU 2014353235 Australia Rehydration of micronized Tecovirimat monohydrate August 22, 2019 November 14, 2034 AU 2018201499 Australia Methods of preparing Tecovirimat May 21, 2020 August 14, 2033 AU 2019208252 Australia Rehydration of micronized Tecovirimat monohydrate July 2, 2020 November 14, 2034 AP 3221 ARIPO*/Africa Certain polymorphs of ST-246, method of preparation of the polymorphs and their use in treating orthopoxvirus April 3, 2015 March 23, 2031 ZA 2012/07141 South Africa Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs June 29, 2016 March 23, 2031 ZA 2013/00930 South Africa Liquid Pharmaceutical formulations containing ST-246 November 25, 2015 August 2, 2031 IL 201736 Israel Pharmaceutical compositions containing ST-246 and one or more additional ingredients and dosage unit forms containing ST-246 October 1, 2016 April 23, 2027 IL 236944 Israel Methods of preparing Tecovirimat February 1, 2017 August 14, 2033 IL 242665 Israel Methods of preparing intermediate in the preparation of Tecovirimat February 1, 2020 April 23, 2027 IL 224430 Israel Liquid Pharmaceutical formulations containing ST-246 December 27, 2019 August 2, 2031 IL 242666 Israel Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases December 1, 2018 April 23, 2027 IL 221991 Israel Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs October 1, 2019 March 23, 2031   10 Table of Contents   AT 1638938 Austria Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 BE 1638938 Belgium Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 BE 2549871 Belgium Polymorphic forms of ST-246 August 22, 2018 March 23, 2031 BE 2600715 Belgium Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 CH 1638938 Switzerland Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 CH 2549871 Switzerland Polymorphic forms of ST-246 August 22, 2018 March 23, 2031 CH 2600715 Switzerland Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 DE 1638938 Germany Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 DE 2549871 Germany Polymorphic forms of ST-246 August 22, 2018 March 23, 2031 DE 2887938 Germany Methods of preparing Tecovirimat January 10, 2018 August 14, 2033 DE 2600715 Germany Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 DE 3321253 Germany Methods of preparing Tecovirimat February 12, 2020 August 14, 2033 DE 3021836 Germany Amorphous Tecovirimat preparation August 27, 2020 July 11, 2034 DK 1638938 Denmark Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 DK 2549871 Denmark Polymorphic forms of ST-246 August 22, 2018 March 23, 2031 DK 2600715 Denmark Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 ES 1638938 Spain Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 FI 1638938 Finland Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 FR 1638938 France Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 FR 2887938 France Methods of preparing Tecovirimat January 10, 2018 August 14, 2033 FR 2549871 France Polymorphic forms of ST-246 August 22, 2018 March 23, 2031 FR 2600715 France Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031 FR 3321253 France Methods of preparing Tecovirimat February 12, 2020 August 14, 2033 FR 3021836 France Amorphous Tecovirimat preparation August 27, 2020 July 11, 2034 GB 1638938 United Kingdom Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024 GB 2887938 United Kingdom Methods of preparing Tecovirimat January 10, 2018 August 14, 2033 GB 2549871 United Kingdom Polymorphic forms of ST-246 August 22, 2018 March 23, 2031 GB 2600715 United Kingdom Liquid Pharmaceutical formulations containing ST-246 December 11, 2019 August 2, 2031   11 Table of Contents   GB 3321253 United Kingdom Methods of preparing Tecovirimat February 12, 2020 August 14, 2033   GB 3021836 United Kingdom Amorphous Tecovirimat preparation August 27, 2020 July 11, 2034   HK 1179824 Hong Kong Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs June 21, 2019 March 23, 2031   IE 1638938 Ireland Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024   IT 502017000078377 Italy Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024   NL 1638938 Netherlands Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024   PL 1638938 Poland Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024   SE 1638938 Sweden Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases April 12, 2017 June 18, 2024     ^ A Patent Term Extension Application is pending for US 7737168, which would change the expiration date from May 3, 2027 to September 4, 2031. A Patent Term Extension Application is also pending for US 8124643, which would change the expiration date from June 18, 2024 to December 13, 2027. In the event that both US 7737168 and US 8124643 are found to be eligible for a patent term extension, SIGA would only be able to elect one of the two patents for which the extension is sought and would elect to extend US 7737168.   * ARIPO has 19 member African States as follows: Botswana, The Gambia, Ghana, Kenya, Lesotho, Malawi, Mozambique, Namibia, Sierra Leone, Liberia, Rwanda, Sao Tome and Principe, Somalia, Sudan, Swaziland, Tanzania, Uganda, Zambia and Zimbabwe.   In addition to the patents listed in the above chart, the principal and material patent applications covering TPOXX® include patent filings in multiple jurisdictions, including the United States, Europe, Asia, Australia, and other commercially significant markets. We hold 33 patent applications currently pending with respect to various compositions of TPOXX®, methods of manufacturing, methods of treatment, and dosage forms. Expiration dates for pending patent applications, if granted, will fall between 2027 and 2037.   FDA regulations require that patented drugs be sold under brand names that comply with various regulations. SIGA must develop and make efforts to protect these brand names for each of its products in order to avoid product piracy and to secure exclusive rights to these brand names. SIGA may expend substantial funds in developing and securing rights to adequate brand names for our products. SIGA currently has proprietary trademark rights in SIGA®, TPOXX® and other brands used by us in the United States and certain foreign countries, but we may have to develop additional trademark rights in order to comply with regulatory requirements. SIGA may need to pursue different names and trademarks ex-U.S. in light of native language and other jurisdictional considerations. SIGA considers securing adequate trademark rights to be important to its business.   Government Regulation   Regulatory Approval Process   Regulation by governmental authorities in the United States and other countries is a significant factor in the manufacture and marketing of any biopharmaceutical product that we may develop. The nature and the extent to which such regulations may apply to us will vary depending on the nature of any particular product. Virtually all of our potential pharmaceutical products will require regulatory approval by governmental agencies prior to non-governmental commercialization. In particular, human therapeutic products are subject to rigorous pre-clinical and clinical testing and other approval procedures by the FDA and similar health authorities in foreign countries. Various federal statutes and regulations also govern or regulate the manufacturing, safety, labeling, storage, recordkeeping and marketing of such products. The process of obtaining these approvals and the subsequent compliance with appropriate federal and foreign statutes and regulations is complex and requires expertise and the expenditure of substantial resources.   In order to test clinically, and to manufacture and market products for diagnostic or therapeutic use, a company must comply with mandatory procedures and safety standards established by the FDA and comparable agencies in foreign countries. Before beginning human clinical testing of a potential new drug in the United States, a company must file an Investigational New Drug ("IND") application and receive clearance from the FDA. An IND application is a summary of the pre-clinical studies that were conducted to characterize the drug, including toxicity and safety studies, information on the drug’s composition and the manufacturing and quality control procedures used to produce the drug, as well as a discussion of the human clinical studies that are being proposed to evaluate the safety and efficacy of the product.   12 Table of Contents   The pre-marketing clinical program required for approval by the FDA for a new drug typically involves a time-consuming and costly three-phase process. In Phase I, trials are conducted with a small number of healthy subjects to determine the early safety profile, the pattern of drug distribution, metabolism and elimination. In Phase II, trials are conducted with small groups of patients afflicted with a target disease in order to determine preliminary efficacy, optimal dosages and expanded evidence of safety. In Phase III, large scale, multi-center comparative trials, which may include both controlled and uncontrolled studies, are conducted with patients afflicted with a target disease in order to provide enough data for statistical proof of efficacy and safety required by the FDA and other authorities. Additional trials may be required to evaluate how a new drug interacts with other drugs as well as if the drug has any impact on cardio-vascular or other potential risks.   The FDA closely monitors the progress of each of the three phases of clinical testing and may, in its discretion, reevaluate, alter, suspend or terminate the testing based on the data that have been accumulated to that point and its assessment of the risk/benefit ratio to the patients involved in the testing. Estimates of the total time typically required for carrying out such clinical testing vary between two and 10 years. Upon completion of such clinical testing, a company typically submits an NDA to the FDA that summarizes the results and observations of the drug during the clinical testing. Based on its review of the NDA, the FDA will decide whether to approve the drug and whether to impose any marketing restrictions or require additional post-approval clinical studies. This review process can be quite lengthy, and approval for the production and marketing of a new pharmaceutical product can require a number of years and substantial funding. There can be no assurance that any approval will be granted on a timely basis, if at all. In some circumstances, a new formulation of an approved product may be reviewed through a supplemental NDA process which relies in part on the prior approval of the initial formulation.   The FDA amended its regulations, effective June 30, 2002, to include the “Animal Rule” in circumstances that would permit the typical clinical testing regime to approve certain new drug and biological products used to reduce or prevent the toxicity of chemical, biological, radiological, or nuclear agents not otherwise naturally present for use in humans based on evidence of safety in healthy subjects and evidence of effectiveness derived only from appropriate animal studies and any additional supporting data. The FDA has indicated that approval for therapeutic use of TPOXX® was determined under the “Animal Rule.”   Once the product is approved for sale, FDA regulations govern the manufacturing and marketing activities, and a post-marketing testing and surveillance program may be required to monitor a product’s usage and effects. Product approvals may be withdrawn if compliance with regulatory standards is not maintained. Many other countries in which products developed by us may be marketed impose similar regulatory processes.   FDA regulations also make available an alternative regulatory mechanism that may lead to use of the product under limited circumstances. The Emergency Use Authorization (“EUA”) authority allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological and nuclear agents that may be used to attack the American people or the U.S. armed forces. Under this authority, the FDA Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions caused by such agents when appropriate findings are made concerning the nature of the emergency, the availability of adequate and approved alternatives, and the quality of available data concerning the drug candidate under consideration for emergency use.   Legislation and Regulation Related to Bioterrorism Counteragents and Pandemic Preparedness   Because our drug candidates are intended for the treatment of diseases that may result from acts of bioterrorism or biowarfare or for pandemic preparedness, they may be subject to the specific legislation and regulation described below and elsewhere in this Annual Report on Form 10-K.   Project BioShield   Project BioShield and related 2006 federal legislation provide procedures for biodefense-related procurement and awarding of research grants, making it easier for the U.S. Department of Health and Human Services (“HHS”) to commit funds to countermeasure projects. Project BioShield provides alternative procedures under the Federal Acquisition Regulation, the general rubric for acquisition of goods and services by the U.S. Government, for procuring property or services used in performing, administering or supporting biomedical countermeasure research and development. In addition, if the Secretary of HHS deems that there is a pressing need, Project BioShield authorizes the Secretary of HHS to use an expedited award process, rather than the normal peer review process, for grants, contracts and cooperative agreements related to biomedical countermeasure research and development activity.   13 Table of Contents   Under Project BioShield, the Secretary of HHS, with the concurrence of the Secretary of the U.S. Department of Homeland Security and upon the approval of the President, can contract to purchase unapproved countermeasures for the Strategic Stockpile in specified circumstances. The U.S. Congress is notified of a recommendation for a Strategic Stockpile purchase after Presidential approval. Project BioShield specifies that a company supplying the countermeasure to the Strategic Stockpile is paid on delivery of a substantial portion of the countermeasure. To be eligible for purchase under these provisions, the Secretary of HHS must determine that there are sufficient and satisfactory clinical results or research data, including data, if available, from pre-clinical and clinical trials, to support a reasonable conclusion that the countermeasure will qualify for approval or licensing within eight years. Project BioShield also allows the Secretary of HHS to authorize the emergency use of medical products that have not yet been approved by the FDA. To exercise this authority, the Secretary of HHS must conclude that:     • the agent for which the countermeasure is designed can cause serious or life-threatening disease;         • the product may reasonably be believed to be effective in detecting, diagnosing, treating or preventing the disease;         • the known and potential benefits of the product outweigh its known and potential risks; and         • there is no adequate alternative to a product that is approved and available.   Although this provision permits the Secretary of HHS to circumvent FDA approval (entirely, or in part) for procurement and use, its use in this manner would likely be limited to rare circumstances. Prior to the award of the BARDA Contract in May 2011, the Secretary of HHS concluded that TPOXX® would qualify within eight years for approval by the FDA for therapeutic use against smallpox.   Public Readiness and Emergency Preparedness Act   The Public Readiness and Emergency Preparedness Act (the "PREP Act") provides immunity for manufacturers from claims under state or federal law for “loss” arising out of the administration or use of a “covered countermeasure” in the United States. However, injured persons may still bring a suit for “willful misconduct” against the manufacturer under some circumstances. “Covered countermeasures” include security countermeasures and “qualified pandemic or epidemic products,” including products intended to diagnose or treat pandemic or epidemic disease, as well as treatments intended to address conditions caused by such products. For these immunities to apply, the Secretary of HHS must issue a declaration in cases of public health emergency or “credible risk” of a future public health emergency. Since 2007, the Secretary of HHS has issued eight declarations under the PREP Act to protect from liability countermeasures that are necessary to prepare the nation for potential pandemics or epidemics, including a declaration on October 10, 2008 that provides immunity from tort liability as it relates to smallpox. The PREP Act was amended in 2015 to extend protection for smallpox and other countermeasures from December 31, 2015 to December 31, 2022.   Foreign Regulation   As noted above, in addition to regulations in the United States, we might be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our drug candidates. Regardless of any FDA approval of a product, we may have to obtain approval of that product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The actual time required to obtain clearance to market a product in a particular foreign jurisdiction varies substantially, based upon the type, complexity and novelty of the pharmaceutical drug candidate, the specific requirements of that jurisdiction, and in some countries whether the FDA has previously approved the drug for marketing. The requirements governing the conduct of clinical trials, marketing authorization, pricing and reimbursement vary from country to country. Certain foreign jurisdictions, including the European Union and Canada, have adopted certain biodefense-specific regulations akin to that available in the United States such as a procedure similar to the “Animal Rule” promulgated by the FDA for review and potential approval of biodefense products.   Regulations Regarding Government Contracting   The status of an organization as a government contractor in the United States and elsewhere means that the organization is also subject to various statutes and regulations, including the Federal Acquisition Regulation, which governs the procurement of goods and services by agencies of the United States. These governing statutes and regulations can impose stricter penalties than those normally applicable to commercial contracts, such as criminal and civil damages liability and suspension and debarment from future government contracting. In addition, pursuant to various statutes and regulations, government contracts can be subject to unilateral termination or modification by the government for convenience in the United States and elsewhere, detailed auditing requirements, statutorily controlled pricing, sourcing and subcontracting restrictions and statutorily mandated processes for adjudicating contract disputes.   14 Table of Contents   Availability of Reports and Other Information   We file annual, quarterly, and current reports, proxy statements, and other documents with the SEC under the Securities Exchange Act of 1934. The public may read and copy any material that we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, D.C. 20549. The public may obtain information on the operation of the Public Reference Room by calling the SEC at (800) SEC-0330. Also, the SEC maintains an Internet website that contains reports, proxy and information statements, and other information regarding issuers, including us, that file electronically with the SEC. The public can obtain any document that we file with or furnish to the SEC at www.sec.gov .   In addition, our website can be found on the internet at www.siga.com. The website contains information about us and our operations. Copies of each of our filings with the SEC on Form 10-K, Form 10-Q, and Form 8-K, and all amendments to those reports, can be viewed and downloaded free of charge as soon as reasonably practicable after the reports and amendments are electronically filed with or furnished to the SEC. To view the reports, access www.siga.com, click on “Investor Relations” and “Financial Information.”    The following corporate governance related documents are also available on our website:     • Audit Committee Charter;         • Compensation Committee Charter;         • Nominating and Corporate Governance Committee Charter;         • Code of Ethics and Business Conduct;     • Procedure for Sending Communications to the Board of Directors;         • Procedures for Security Holder Submission of Nominating Recommendations;         • Policy on Confidentiality of Information and Securities Trading; and     • Conflict of Interest Policy.   To review these documents, access www.siga.com and click on “Investor Relations” and “Corporate Governance.”   Any of the above documents can also be obtained in print by any shareholder upon request to the Secretary, SIGA Technologies, Inc., 31 E 62nd Street, 5th floor, New York, New York 10065.   15 Table of Contents