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SEC Company Response from SIGA TECHNOLOGIES (SIGA) — Aug 13, 2014

SIGA TECHNOLOGIES INC
Date: Aug. 13, 2014 · CIK: 0001010086 · Accession: 0001010086-14-000018

AI Filing Summary & Sentiment

File numbers found in text: 000-23047

Date
August 13, 2014
Author
Assistant Director
Form
CORRESP
Company
SIGA TECHNOLOGIES INC

Letter

VIA EDGAR Securities and Exchange Commission Division of Corporation Finance SIGA Technologies, Inc. Form 10-K for the Fiscal Year Ended December 31, 2013 Filed March 10, 2014 File No. 000-23047

Dear Mr. Riedler:

SIGA Technologies, Inc. (the “Company” or “SIGA”) submits this letter in response to the comment letter (the “Comment Letter”), dated July 31, 2014, from the Staff of the Securities and Exchange Commissions (the “Commission”) with respect to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013 (the “Annual Report”).

For ease of reference, set forth in bold below, are the comments to the Annual Report, as reflected in the Comment Letter. The Company’s responses are set forth below each comment.

Item 1. Business

Lead Product- Arestvyr™, page 2

1. We note that in 2013 you received $109.7 million from BARDA for the delivery of 725,000 courses of Arestvyr™ under the BARDA Contract and that you have deferred all revenue except certain amounts related to BARDA’s reimbursement of research and development costs. As disclosed on page 32, the BARDA Contract is a multiple deliverable arrangement and you have not satisfied all obligations necessary to recognize revenue attributable to these delivered courses. Please expand your discussion of the BARDA Contract in the Business section to disclose all material terms. These terms would include all material rights and obligations, including all material deliverables. Discuss the progress made to date towards meeting the obligations necessary for recognition of this revenue. Also disclose the terms of the agreement related to BARDA’s obligation to make payments. These would include milestone payments, reimbursements, and any other payment obligations.

Response:

In response to the Commission’s comment, below is revised draft (marked to show changes from what SIGA disclosed in its Annual Report). The Company advises the Commission that the BARDA Contract was filed in 2011 as part of an 8-K filing and that selected portions of the contract are redacted in accordance with confidential treatment as granted by the Securities and Exchange Commission (“SEC”).

As set forth below in the Section entitled “General” the Company proposes that the below revised disclosure be provided in a future filing with the SEC.

Item 1. Business

BARDA Contract - Arestvyr™ also known as ST-246®

On May 13, 2011, SIGA signed the BARDA Contract pursuant to which SIGA agreed to deliver two million courses of Arestvyr to the U.S. Strategic National Stockpile (“Strategic Stockpile”). The BARDA Contract is worth approximately $463 million, including $409.8 million for the manufacture and delivery of 1.7 million courses of Arestvyr and $54 million of potential reimbursements related to development and supportive activities (the “Base Contract”). In addition to the Base Contract, the BARDA Contract also contains various options that are exercisable at BARDA’s discretion. The BARDA Contract expires in September 2020.

Under the Base Contract with BARDA, BARDA has agreed to buy from SIGA 1.7 million courses of Arestvyr. Additionally, SIGA will contribute to BARDA 300,000 courses manufactured primarily using federal funds provided by the U.S. Department of Health and Human Services (“HHS”) under prior development contracts.

The Base Contract with BARDA includes $409.8 million of payments, inclusive of upfront payments and milestone payments, that can be received by the Company for the manufacture and delivery of 1.7 million courses of Arestvyr that are to be purchased by BARDA and physically delivered to the Strategic Stockpile. The timing and amount of specific payments to the Company are based on sub-payment tranches provided for in the Base Contract. As of December 31, 2013, the Company has received $157.6 million under the Base Contract related to the manufacture and physical delivery of courses of Arestvyr. Included in this amount are: a $41 million advance payment for the completion of certain planning and preparatory activities related to the Base Contract; a $12.3 million milestone payment for the completion of the product labeling strategy for Arestvyr; a $8.2 million milestone payment for the completion of the commercial validation campaign for Arestvyr; and $96.1 million of payments following physical deliveries of 725,000 courses of Arestvyr to the Strategic Stockpile.

The Company is eligible to receive an additional $252.2 million under the Base Contract for the manufacture, delivery and purchase of courses of Arestvyr. Included in this amount are: $129.2 million of payments following additional future physical deliveries of 975,000 courses of Arestvyr to the Strategic Stockpile; a $20.5 million milestone payment for successful submission to the U.S. Food and Drug Administration (“FDA”) of a complete application for Arestvyr regulatory approval; and a $102.5 million holdback payment, which represents a 25% holdback on the $409.8 million of total payments tied to the manufacture and delivery of 1.7 million courses of Arestvyr that are to be purchased by BARDA. The $102.5 million holdback payment would be triggered by FDA approval of Arestvyr, as long as the Company does not have, as described below, a continuing product replacement obligation to BARDA.

The Base Contract with BARDA also includes $54 million of potential reimbursement for development and supportive activities. These activities are reimbursed primarily on a cost-plus basis after each individual activity is authorized by BARDA and after costs are incurred. As of December 31, 2013, the Company received $5.4 million of reimbursement payments under the Base Contract for development and supportive activities.

In addition to the Base Contract, which is worth approximately $463 million, the BARDA Contract also separately contains $178.4 million of options that, if exercised by BARDA: would fund development and supportive activities such as work on pediatric and geriatric formulations of the drug as well as use of Arestvyr for smallpox prophylaxis; would result in a $50 million payment to the Company for FDA approval for extension to 84-month expiry for Arestvyr (from 38 month expiry as required in the Base Contract); and/or would fund production-related activities such as

warm-base manufacturing. As of December 31, 2013, BARDA has not exercised any options and may not exercise any options in the future. These options are exercisable by BARDA in its sole discretion.

For courses of Arestvyr that are physically delivered to the Strategic Stockpile, the Company has replacement obligations, at no cost to BARDA, in the event that: the final FDA approved version of Arestvyr is different from any course of Arestvyr that has been delivered to the Strategic Stockpile; or Arestvyr does not meet any specified label claims, fails release testing or does not meet 38 month expiry period (from time of delivery to the Strategic Stockpile); or Arestvyr is recalled or deemed to be recalled for any reason.

As noted above, the Company is eligible for a $102.5 million holdback payment from BARDA if the FDA approves Arestvyr, either in the currently delivered form or in a different form. If the approved version of Arestvyr is different from those delivered to the Strategic Stockpile, then the Company is obligated to replace the previously delivered courses, at no additional cost, to BARDA. If the final approved version of Arestvyr differs from those delivered, the $102.5 million holdback payment would not be paid until the obligation to replace the previously delivered product at no additional cost is satisfied.

The Company has been actively pursuing FDA approval of Arestvyr, both for purposes of receiving the $102.5 million holdback payment as well as for strategic purposes. The Company is pursuing FDA approval under the “animal rule”. As such, the Company has completed multiple monkeypox and variola efficacy studies in non-human primates and is coordinating and conducting rabbitpox efficacy studies in rabbits. In addition to coordinating and conducting efficacy studies in rabbits, the Company is also planning protocols for an expanded clinical safety trial that could support a future New Drug Application (“NDA”) filing with the FDA.

On May 13, 2011, we signed the BARDA Contract pursuant to which we agreed to deliver two million courses of Arestvyr to the U.S. Strategic National Stockpile (“Strategic Stockpile”). The base contract, worth approximately $463 million, includes $54 million related to development and supportive activities and contains various options to be exercised at BARDA’s discretion. The period of performance for development and supportive activities runs until 2020. As originally issued, the BARDA Contract included an option for the purchase of up to 12 million additional courses of Arestvyr; however, following a protest by a competitor of the Company, BARDA issued a contract modification on June 24, 2011 pursuant to which it deleted the option to purchase theadditional courses. Under the BARDA Contract as modified, BARDA has agreed to buy from SIGA 1.7 million courses of Arestvyr. Additionally, SIGA will contribute to BARDA 300,000 courses manufactured primarily using federal funds provided by the U.S. Department of Health and Human Services (“HHS”) under prior development contracts. The BARDA Contract as modified also contains options that will permit SIGA to continue its work on pediatric and geriatric formulations of the drug as well as use of Arestvyr for smallpox prophylaxis. As discussed in Item 3, “Legal Proceedings,” the amount of profits we will retain pursuant to the BARDA Contract may be adversely affected by the outcome of PharmAthene’s action against SIGA.

As discussed in Item 3, “Legal Proceedings,” the amount of cash inflows we SIGA will retain pursuant to the BARDA Contract may be adversely affected by the outcome of PharmAthene’s action against SIGA.

Lead Product - Arestvyr

We SIGA believes that Arestvyr is among the first new small-molecule drugs delivered to the Strategic Stockpile under the Project BioShield Act of 2004 (“Project BioShield”). Arestvyr is an investigational product that is not currently approved by the U.S. Food and Drug Administration (“FDA”) as a treatment of smallpox or any other indication. Nevertheless, the FDA has designated

Arestvyr for “fast-track” status, creating a path for expedited FDA review and eventual regulatory approval. Arestvyr is a novel, patented drug that is easy to store, transport and administer. There could be several uses for an effective smallpox antiviral drug: to reduce mortality and morbidity in those infected with the smallpox virus, to protect the non-immune who risk developing smallpox following virus exposure, and as an adjunct to the smallpox vaccine in order to reduce the frequency of serious adverse events due to the live virus used for vaccination.

Arestvyr’s regulatory path, and SIGA’s development activities related to Arestvyr, are materially guided by the results of an FDA Advisory Committee meeting that was convened in December 2011 (the “Advisory Committee”). The Advisory Committee was convened to consider proposals for using a surrogate orthopoxvirus model and to determine what elements of the “animal rule” constitute “enough” evidence for approval of a drug for the treatment of smallpox. The Advisory Committee’s recommendation confirmed that the monkeypox, rabbitpox and ectromelia models, especially in combination, could suitably provide appropriate evidence of efficacy for treatment of smallpox. Subsequent to the Advisory Committee, SIGA has had substantive meetings and communications with the FDA regarding the regulatory path of Arestvyr. Development activities for Arestvyr are based on the Advisory Committee’s recommendation, and take into account meetings and communications with the FDA.

The regulatory status of Arestvyr follows: Arestvyr has Orphan Drug designation for both the treatment and prevention of smallpox, and in late 2010, Arestvyr received Orphan Drug designation for the broader indication of treatment of orthopoxvirus infections (vaccinia, variola, monkeypox and cowpox). Also in 2010, a final study report was completed and provided to the FDA for a Phase II multiple dose clinical trial to evaluate the safety, tolerability and pharmacokinetics of Arestvyr when administered as a single, daily oral dose for fourteen days. A clinical study to test the palatability of Arestvyr on various food items was initiated in January 2014, the purpose of which is to support dosage for humans who may have difficulty swallowing capsules including children and the elderly. Protocols for an expanded clinical safety trial to support a New Drug Application (“NDA”) filing and a clinical mass balance (absorption, metabolism and excretion) study to inform on any potential drug to drug interactions are under development. Rabbitpox efficacy studies in rabbits, and supporting studies, are being conducted and planned. An Investigational New Drug (“IND”) application for an intravenous (IV) formulation of Arestvyr was filed with FDA in September 2012 and we SIGA received a safe to proceed letter from FDA in November 2012 along with a letter granting fast-track status. Formulation work has commenced on an oral suspension formulation of Arestvyr which would support dosing for pediatrics and the elderly.

Manufacturing, page 3

2. We note that in 2013 you received approximately $109.7 million from BARDA for the delivery of approximately 725,000 courses of Arestvyr™. We also note that you depend on contract manufacturers to provide this product. Please amend your disclosure to identify the manufacturer(s) and disclose the materials terms of your agreement(s) related to the manufacture of Arestvyr™. Please file these agreements as exhibits to your 10-K. Alternatively, please provide your analysis as to why you are not required to file these manufacturing agreements as exhibits to your 10-K.

Response:

The Company has agreements with three contract manufacturing organizations (“CMOs): Albemarle Corporation (“Albemarle”); Powdersize, Inc. (“Powdersize”); and Catalent Pharma Solutions LLC (“Catalent”). Albemarle receives more than 80% of payments to CMOs and is contractually responsible for the sourcing of raw materials and the synthesis of the active pharmaceutical ingredient (“API”) within Arestvyr. Given the relative importance of Albemarle within the manufacturing process and the large share of payments it receives (in relation to other CMOs), the Company respectfully acknowledges the Commission’s comment and advises the Commission, as further requested by the section entitled “General” below, that the Company agrees to disclose the nature and terms of its relationship with Albemarle in future filings and agrees to file the agreement with Albemarle as an exhibit to such future filings with the SEC.

Powdersize is contractually responsible for micronizing Arestvyr API and Catalent is contractually responsible for granulating, encapsulating and packaging Arestvyr. Since the receipt of technical services are in the ordinary course of business for the Company, and given that the combined payments to Catalent and Powdersize are less than 20% of total payments to CMOs, the Company respectfully advises the Commission that while the Company agrees to disclose the nature and terms of its relationship with Powdersize and Catalent in future filings, the Company does not plan to file the Catalent and Powdersize agreements as exhibits because such agreements are customary in nature and since such agreements are for technical services that are provided in the ordinary course of business.

In response to the Commissions comment, b

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CORRESP
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filename1.htm

		ResponsetoSECcommentletter-aug10

August 13, 2014

VIA EDGAR

Jeffrey Riedler

Assistant Director

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

Re:

 SIGA Technologies, Inc.

 Form 10-K for the Fiscal Year Ended December 31, 2013

 Filed March 10, 2014

 File No. 000-23047

Dear Mr. Riedler:

SIGA Technologies, Inc. (the “Company” or “SIGA”) submits this letter in response to the comment letter (the “Comment Letter”), dated July 31, 2014, from the Staff of the Securities and Exchange Commissions (the “Commission”) with respect to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013 (the “Annual Report”).

For ease of reference, set forth in bold below, are the comments to the Annual Report, as reflected in the Comment Letter.  The Company’s responses are set forth below each comment.

Item 1. Business

Lead Product- Arestvyr™, page 2

1. We note that in 2013 you received $109.7 million from BARDA for the delivery of 725,000 courses of Arestvyr™ under the BARDA Contract and that you have deferred all revenue except certain amounts related to BARDA’s reimbursement of research and development costs. As disclosed on page 32, the BARDA Contract is a multiple deliverable arrangement and you have not satisfied all obligations necessary to recognize revenue attributable to these delivered courses. Please expand your discussion of the BARDA Contract in the Business section to disclose all material terms. These terms would include all material rights and obligations, including all material deliverables. Discuss the progress made to date towards meeting the obligations necessary for recognition of this revenue. Also disclose the terms of the agreement related to BARDA’s obligation to make payments. These would include milestone payments, reimbursements, and any other payment obligations.

Response:

In response to the Commission’s comment, below is revised draft (marked to show changes from what SIGA disclosed in its Annual Report). The Company advises the Commission that the BARDA Contract was filed in 2011 as part of an 8-K filing and that selected portions of the contract are redacted in accordance with confidential treatment as granted by the Securities and Exchange Commission (“SEC”).

As set forth below in the Section entitled “General” the Company proposes that the below revised disclosure be provided in a future filing with the SEC.

Item 1. Business

BARDA Contract - Arestvyr™ also known as ST-246®

On May 13, 2011, SIGA signed the BARDA Contract pursuant to which SIGA agreed to deliver two million courses of Arestvyr to the U.S. Strategic National Stockpile (“Strategic Stockpile”). The BARDA Contract is worth approximately $463 million, including $409.8 million for the manufacture and delivery of 1.7 million courses of Arestvyr and $54 million of potential reimbursements related to development and supportive activities (the “Base Contract”). In addition to the Base Contract, the BARDA Contract also contains various options that are exercisable at BARDA’s discretion. The BARDA Contract expires in September 2020.

Under the Base Contract with BARDA, BARDA has agreed to buy from SIGA 1.7 million courses of Arestvyr. Additionally, SIGA will contribute to BARDA 300,000 courses manufactured primarily using federal funds provided by the U.S. Department of Health and Human Services (“HHS”) under prior development contracts.

The Base Contract with BARDA includes $409.8 million of payments, inclusive of upfront payments and milestone payments, that can be received by the Company for the manufacture and delivery of 1.7 million courses of Arestvyr that are to be purchased by BARDA and physically delivered to the Strategic Stockpile.  The timing and amount of specific payments to the Company are based on sub-payment tranches provided for in the Base Contract.  As of December 31, 2013, the Company has received $157.6 million under the Base Contract related to the manufacture and physical delivery of courses of Arestvyr.  Included in this amount are: a $41 million advance payment for the completion of certain planning and preparatory activities related to the Base Contract; a $12.3 million milestone payment for the completion of the product labeling strategy for Arestvyr; a $8.2 million milestone payment for the completion of the commercial validation campaign for Arestvyr; and $96.1 million of payments following physical deliveries of 725,000 courses of Arestvyr to the Strategic Stockpile.

The Company is eligible to receive an additional $252.2 million under the Base Contract for the manufacture, delivery and purchase of courses of Arestvyr. Included in this amount are: $129.2 million of payments following additional future physical deliveries of 975,000 courses of Arestvyr to the Strategic Stockpile; a $20.5 million milestone payment for successful submission to the U.S. Food and Drug Administration (“FDA”) of a complete application for Arestvyr regulatory approval; and a $102.5 million holdback payment, which represents a 25% holdback on the $409.8 million of total payments tied to the manufacture and delivery of 1.7 million courses of Arestvyr that are to be purchased by BARDA.  The $102.5 million holdback payment would be triggered by FDA approval of Arestvyr, as long as the Company does not have, as described below, a continuing product replacement obligation to BARDA.

The Base Contract with BARDA also includes $54 million of potential reimbursement for development and supportive activities.  These activities are reimbursed primarily on a cost-plus basis after each individual activity is authorized by BARDA and after costs are incurred.  As of December 31, 2013, the Company received $5.4 million of reimbursement payments under the Base Contract for development and supportive activities.

In addition to the Base Contract, which is worth approximately $463 million, the BARDA Contract also separately contains $178.4 million of options that, if exercised by BARDA: would fund development and supportive activities such as work on pediatric and geriatric formulations of the drug as well as use of Arestvyr for smallpox prophylaxis; would result in a $50 million payment to the Company for FDA approval for extension to 84-month expiry for Arestvyr (from 38 month expiry as required in the Base Contract); and/or would fund production-related activities such as

warm-base manufacturing.  As of December 31, 2013, BARDA has not exercised any options and may not exercise any options in the future.  These options are exercisable by BARDA in its sole discretion.

For courses of Arestvyr that are physically delivered to the Strategic Stockpile, the Company has replacement obligations, at no cost to BARDA, in the event that: the final FDA approved version of Arestvyr is different from any course of Arestvyr that has been delivered to the Strategic Stockpile; or Arestvyr does not meet any specified label claims, fails release testing or does not meet 38 month expiry period (from time of delivery to the Strategic Stockpile); or Arestvyr is recalled or deemed to be recalled for any reason.

As noted above, the Company is eligible for a $102.5 million holdback payment from BARDA if the FDA approves Arestvyr, either in the currently delivered form or in a different form.  If the approved version of Arestvyr is different from those delivered to the Strategic Stockpile, then the Company is obligated to replace the previously delivered courses, at no additional cost, to BARDA.  If the final approved version of Arestvyr differs from those delivered, the $102.5 million holdback payment would not be paid until the obligation to replace the previously delivered product at no additional cost is satisfied.

The Company has been actively pursuing FDA approval of Arestvyr, both for purposes of receiving the $102.5 million holdback payment as well as for strategic purposes.  The Company is pursuing FDA approval under the “animal rule”.  As such, the Company has completed multiple monkeypox and variola efficacy studies in non-human primates and is coordinating and conducting rabbitpox efficacy studies in rabbits.  In addition to coordinating and conducting efficacy studies in rabbits, the Company is also planning protocols for an expanded clinical safety trial that could support a future New Drug Application (“NDA”) filing with the FDA.

On May 13, 2011, we signed the BARDA Contract pursuant to which we agreed to deliver two million courses of Arestvyr to the U.S. Strategic National Stockpile (“Strategic Stockpile”). The base contract, worth approximately $463 million, includes $54 million related to development and supportive activities and contains various options to be exercised at BARDA’s discretion. The period of performance for development and supportive activities runs until 2020. As originally issued, the BARDA Contract included an option for the purchase of up to 12 million additional courses of Arestvyr; however, following a protest by a competitor of the Company, BARDA issued a contract modification on June 24, 2011 pursuant to which it deleted the option to purchase theadditional courses. Under the BARDA Contract as modified, BARDA has agreed to buy from SIGA 1.7 million courses of Arestvyr. Additionally, SIGA will contribute to BARDA 300,000 courses manufactured primarily using federal funds provided by the U.S. Department of Health and Human Services (“HHS”) under prior development contracts. The BARDA Contract as modified also contains options that will permit SIGA to continue its work on pediatric and geriatric formulations of the drug as well as use of Arestvyr for smallpox prophylaxis. As discussed in Item 3, “Legal Proceedings,” the amount of profits we will retain pursuant to the BARDA Contract may be adversely affected by the outcome of PharmAthene’s action against SIGA.

As discussed in Item 3, “Legal Proceedings,” the amount of cash inflows we SIGA will retain pursuant to the BARDA Contract may be adversely affected by the outcome of PharmAthene’s action against SIGA.

Lead Product - Arestvyr

We SIGA believes that Arestvyr is among the first new small-molecule drugs delivered to the Strategic Stockpile under the Project BioShield Act of 2004 (“Project BioShield”). Arestvyr is an investigational product that is not currently approved by the U.S. Food and Drug Administration (“FDA”) as a treatment of smallpox or any other indication. Nevertheless, the FDA has designated

Arestvyr for “fast-track” status, creating a path for expedited FDA review and eventual regulatory approval. Arestvyr is a novel, patented drug that is easy to store, transport and administer. There could be several uses for an effective smallpox antiviral drug: to reduce mortality and morbidity in those infected with the smallpox virus, to protect the non-immune who risk developing smallpox following virus exposure, and as an adjunct to the smallpox vaccine in order to reduce the frequency of serious adverse events due to the live virus used for vaccination.

Arestvyr’s regulatory path, and SIGA’s development activities related to Arestvyr, are materially guided by the results of an FDA Advisory Committee meeting that was convened in December 2011 (the “Advisory Committee”). The Advisory Committee was convened to consider proposals for using a surrogate orthopoxvirus model and to determine what elements of the “animal rule” constitute “enough” evidence for approval of a drug for the treatment of smallpox. The Advisory Committee’s recommendation confirmed that the monkeypox, rabbitpox and ectromelia models, especially in combination, could suitably provide appropriate evidence of efficacy for treatment of smallpox. Subsequent to the Advisory Committee, SIGA has had substantive meetings and communications with the FDA regarding the regulatory path of Arestvyr. Development activities for Arestvyr are based on the Advisory Committee’s recommendation, and take into account meetings and communications with the FDA.

The regulatory status of Arestvyr follows: Arestvyr has Orphan Drug designation for both the treatment and prevention of smallpox, and in late 2010, Arestvyr received Orphan Drug designation for the broader indication of treatment of orthopoxvirus infections (vaccinia, variola, monkeypox and cowpox). Also in 2010, a final study report was completed and provided to the FDA for a Phase II multiple dose clinical trial to evaluate the safety, tolerability and pharmacokinetics of Arestvyr when administered as a single, daily oral dose for fourteen days. A clinical study to test the palatability of Arestvyr on various food items was initiated in January 2014, the purpose of which is to support dosage for humans who may have difficulty swallowing capsules including children and the elderly. Protocols for an expanded clinical safety trial to support a New Drug Application (“NDA”) filing and a clinical mass balance (absorption, metabolism and excretion) study to inform on any potential drug to drug interactions are under development. Rabbitpox efficacy studies in rabbits, and supporting studies, are being conducted and planned. An Investigational New Drug (“IND”) application for an intravenous (IV) formulation of Arestvyr was filed with FDA in September 2012 and we SIGA received a safe to proceed letter from FDA in November 2012 along with a letter granting fast-track status. Formulation work has commenced on an oral suspension formulation of Arestvyr which would support dosing for pediatrics and the elderly.

Manufacturing, page 3

2. We note that in 2013 you received approximately $109.7 million from BARDA for the delivery of approximately 725,000 courses of Arestvyr™. We also note that you depend on contract manufacturers to provide this product. Please amend your disclosure to identify the manufacturer(s) and disclose the materials terms of your agreement(s) related to the manufacture of Arestvyr™. Please file these agreements as exhibits to your 10-K. Alternatively, please provide your analysis as to why you are not required to file these manufacturing agreements as exhibits to your 10-K.

Response:

The Company has agreements with three contract manufacturing organizations (“CMOs): Albemarle Corporation (“Albemarle”); Powdersize, Inc. (“Powdersize”); and Catalent Pharma Solutions LLC (“Catalent”).  Albemarle receives more than 80% of payments to CMOs and is contractually responsible for the sourcing of raw materials and the synthesis of the active pharmaceutical ingredient (“API”) within Arestvyr.  Given the relative importance of Albemarle within the manufacturing process and the large share of payments it receives (in relation to other CMOs), the Company respectfully acknowledges the Commission’s comment and advises the Commission, as further requested by the section entitled “General” below, that the Company agrees to disclose the nature and terms of its relationship with Albemarle in future filings  and agrees to file the agreement with Albemarle as an exhibit to such future filings with the SEC.

Powdersize is contractually responsible for micronizing Arestvyr API and Catalent is contractually responsible for granulating, encapsulating and packaging Arestvyr.  Since the receipt of technical services are in the ordinary course of business for the Company, and given that the combined payments to Catalent and Powdersize are less than 20% of total payments to CMOs, the Company respectfully advises the Commission that while the Company agrees to disclose the nature and terms of its relationship with Powdersize and Catalent in future filings, the Company does not plan to file the Catalent and Powdersize agreements as exhibits because such agreements are customary in nature and since such agreements are for technical services that are provided in the ordinary course of business.

In response to the Commissions comment, b