What changed in this filing

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Item 1. Business

2021-03-04 compared with 2020-03-05 · 314 added, 171 removed, 483 unchanged (50% of the section changed)

SIGA Technologies, Inc.

is referred to throughout this report as “SIGA,” “the Company,” “we” or “us.”

We are a commercial-stage pharmaceutical company focused on the health security and infectious disease markets.

Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness.

Our lead product is an oral formulation of TPOXX® (“oral TPOXX®”), an antiviral drug for the treatment of human smallpox disease caused by variola virus.

BARDA Contracts-TPOXX®

19C BARDA Contract (2018 BARDA Contract)

On September 10, 2018, the Company entered into a contract with BARDA pursuant to which SIGA agreed to deliver up to 1,488,000 courses of oral TPOXX® to the 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 February 18, 2020, the contract with BARDA (as amended, modified,

or supplemented from time to time, the "19C BARDA Contract" or “2018 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 $25.8 million of payments are related to exercised options and up to approximately $525.0 million of payments are currently specified as unexercised options.

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®

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.

On May 20, 2019, an option for the manufacture and delivery of 363,070 courses of oral TPOXX® was modified to divide it into four procurement-related options.

One of the four modified procurement-related options provides for the payment of $11.2 million for the procurement of raw materials to be used in the manufacture of at least 363,070 courses of oral TPOXX®.

This option was exercised simultaneously with the aforementioned modification.

Each of the other three options individually specifies the delivery of approximately 121,000 courses of oral TPOXX® for consideration of approximately $33.8 million .

In total, the four options under the May 2019 modification provide for the purchase of raw material for and the manufacture and delivery of 363,070 courses of oral TPOXX® for consideration of approximately $112.5 million .

The option modification did not change the overall total potential value of the 19C BARDA Contract, nor did it change the total amount to be paid in connection with the manufacture and delivery of oral TPOXX® courses.

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®;

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, 2019, the Company had received $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 $4.7 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, 2019 and 2018;

such amount is expected to be recognized as revenue when IV TPOXX containing the BDS is delivered to the National Stockpile or placed in vendor-managed inventory.

The options that have been exercised to date provide for additional potential payments up to approximately $25.8 million .

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®;

and, payments of up to $14.6 million for funding of post-marketing activities for oral TPOXX®, of which, $2.3 million had been received as of December 31, 2019.

Unexercised options specify potential payments up to approximately $525.0 million in total (if all options are exercised).

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 $439.0 million for the delivery of up to approximately 1,452,000 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®;

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”).

The options related to IV TPOXX®

are divided into two primary manufacturing steps.

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 make independent exercise decisions.

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;

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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.

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, 2019, $459.8 million had been received by the Company for the manufacture and delivery of 1.7 million courses of oral TPOXX® and $44.9 million had been received for certain reimbursements in connection with development and supportive activities.

Approximately $3.7 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 U.S.

Food & Drug Adinistration ("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 was no difference between the approved product and courses in the Strategic Stockpile.

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.

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 84-month expiry for oral TPOXX® for which the Company was paid $50.0 million in August 2018.

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 would be 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.

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 minimal.

The 2011 BARDA Contract expires in September 2020.

International Promotion Agreement for Oral TPOXX®

On June 3, 2019, the Company entered into an international promotion agreement with Meridian Medical Technologies, Inc.

(“Meridian”), a Pfizer company (the “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 and South Korea (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 and South Korean markets, 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 International Promotion Agreement did not provide for any cash payments at signing, and each party is responsible for the costs and expenses associated with its activities.

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.

The International Promotion Agreement provides for an initial term of five years, and automatic renewals for successive three-year terms unless (i) either party provides the other party with written notice of non-renewal prior to the end of the initial term or any renewal term or (ii) the International Promotion Agreement is earlier terminated in accordance with its terms.

Either party may terminate the agreement immediately by written notice in connection with certain customary events.

Either party shall have the right to terminate the agreement (overall and on a country-by-country basis) in the event of an uncured material breach.

The Company shall have the right to terminate the agreement (i) as to certain countries on a country-by-country basis in the event Meridian does not promote oral TPOXX® in the subject country for a period of time, or (ii) in certain other limited circumstances.

Meridian shall have the right to terminate the Agreement (overall or on a country-by-country basis) without cause subject to a prior written notice period.

The International Promotion Agreement also contains customary representations, warranties and covenants, including provisions related to regulatory matters, reporting obligations, indemnity, limitation of liability, confidentiality and other matters.

On December 5, 2019 SIGA announced that the Canadian Department of National Defence ("CDND") issued an advanced contract award notice ("ACAN"), indicating that the CDND intends to purchase up to 15,235 courses of oral TPOXX® over four years as specified in the ACAN, with an initial purchase of 2,500 courses.

As with any international sale of TPOXX® pursuant to the agreement, Meridian would be the counterparty of any contract award issued by the Canadian government and SIGA would be responsible for the manufacture, regulatory obligations and delivery of product.

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.

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®

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%.

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®

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.

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 has reached concurrence with the FDA that no further clinical studies are required.

Such concurrence will permit the Company to file a new drug application ("NDA") for IV TPOXX®.

The Company believes such NDA can be filed as early as the second half of 2020.

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.

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 planning to seek regulatory approval of oral TPOXX® in Europe and Canada as well.

Based on conversations with regulatory authorities, the Company is currently planning to submit applications for regulatory approval of oral TPOXX® in Europe and Canada during the next twelve months and to seek an expanded indications to cover treatment of orthopox infections.

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.

For the manufacture of oral TPOXX®, the Company uses the following CMOs:

Albemarle Corporation (“Albemarle”);

Powdersize, LLC (“Powdersize”);

Catalent Pharma Solutions LLC (“Catalent”);

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®.

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").

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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.

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 API kilograms 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.

(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”

(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;

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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.

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.

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;

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.

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:

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”);

Roquette provides an excipient to be used in the manufacturing of the intravenous formulation of TPOXX®.

(“Roquette”);

Patheon Manufacturing Services LLC (“Patheon”);

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 the intravenous formulation of TPOXX®.

SIGA agreed that Patheon will be entitled to manufacture at least 80% of the intravenous formulation of TPOXX® offered for sale by SIGA during the first three years of the agreement, provided Patheon adheres to reasonable manufacturing standards.

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 the intravenous formulation of 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 the intravenous formulation of TPOXX®.

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 though its development and commercial activities, which include (i) delivering medical counter measures to governments and/or non-governmental organizations ("NGOs") so that governments 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 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.

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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.

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.

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 addition to the U.S.

government, we believe that potential additional markets for the sale of biodefense countermeasures include:

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;

non-governmental organizations and multinational companies, including transportation and security companies

NGOs and multinational companies, including transportation and security companies

healthcare providers, including hospitals and clinics;

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.

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 were made in the U.S.

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 on December 30, 2020.

As of December 31, 2019 , the IV Formulation R&D Contract provides for future aggregate research and development funding of approximately $3.1 million .

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 an initial award 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").

The term of the initial award is five years.

As of December 31, 2019 the PEP Label Expansion R&D Contract provides for future aggregate research and development funding under the initial award of approximately $12.2 million .

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.

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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.

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.

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Government with respect to biodefense products.

Human Resources and Research Facilities

As of February 18, 2020, we had 41 full-time employees.

None of our employees are covered by a collective bargaining agreement, and we consider our employee relations to be satisfactory.

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.

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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.

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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 candidate TPOXX® (also known as ST-246, tecovirimat).

As of January 30, 2020, the TPOXX® patent portfolio has seven patent families consisting of 23 U.S.

utility patents, 70 issued foreign patents, six U.S.

utility patent applications, and 38 foreign patent applications.

The principal and material issued patents covering TPOXX® are described in the table below.

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

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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

August 14, 2033

US 10716759

United States

Rehydration of micronized Tecovirimat monohydrate

July 21, 2020

November 14, 2034

Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs

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ST-246 liquid formulations and methods

September 19, 2019

August 2, 2031

ST-246 liquid formulations and methods

August 2, 2031

Therapeutic agent for treating orthopoxvirus including ST-246, pharmaceutical composition of matter for the ST-246 compound and method of manufacturing ST-246

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November 14, 2034

BR 112012023743-8

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

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August 14, 2033

CN 2017103075357

Methods of preparing Tecovirimat

March 6, 2020

August 14, 2033

CN 2014800653387

Rehydration of micronized Tecovirimat monohydrate

February 7, 2020

November 14, 2034

Use of ST-246 to treat orthopoxvirus infection, pharmaceutical compositions containing ST-246 and composition of matter for the ST-246 compound

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August 2, 2031

Use of ST-246 to treat orthopoxvirus infections

August 25, 2020

April 23, 2027

Methods of preparing Tecovirimat

October 20, 2020

August 14, 2033

Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs

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November 14, 2034

AU 2018201499

Methods of preparing Tecovirimat

August 14, 2033

AU 2019208252

Rehydration of micronized Tecovirimat monohydrate

November 14, 2034

ARIPO*/Africa

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August 14, 2033

Methods of preparing intermediate in the preparation of Tecovirimat

February 1, 2020

April 23, 2027

Liquid Pharmaceutical formulations containing ST-246

December 27, 2019

August 2, 2031

Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases

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August 2, 2031

Methods of preparing Tecovirimat

February 12, 2020

August 14, 2033

Amorphous Tecovirimat preparation

August 27, 2020

July 11, 2034

Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases

25 unchanged sentences

August 2, 2031

Methods of preparing Tecovirimat

February 12, 2020

August 14, 2033

Amorphous Tecovirimat preparation

August 27, 2020

July 11, 2034

United Kingdom

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August 2, 2031

United Kingdom

Methods of preparing Tecovirimat

February 12, 2020

August 14, 2033

United Kingdom

Amorphous Tecovirimat preparation

August 27, 2020

July 11, 2034

Certain polymorphs of ST-246, method of preparation of the polymorphs and pharmaceutical compositions containing the polymorphs

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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 44 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 2024 and 2037.

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.

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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 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.

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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, record keeping and marketing of such products.

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 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.

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.

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.

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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.

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.”

Product approvals may be withdrawn if compliance with regulatory standards is not maintained.

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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.

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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.

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.

Under Project BioShield, the Secretary of HHS, with the concurrence of the Secretary of the U.S.

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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.

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.

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.

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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 Health 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.

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.

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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.

The public may obtain information on the operation of the Public Reference Room by calling the SEC at (800) SEC-0330.

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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:

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;

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Conflict of Interest Policy.

To review these documents, access www.siga.com and click on “Investor Relations” and “Corporate Governance.”

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.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business