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Procurement Contract and Research Agreements
6 Months Ended
Jun. 30, 2018
Research and Development [Abstract]  
Procurement Contract and Research Agreements
Procurement Contract and Research Agreements
On May 13, 2011, the Company signed a contract with BARDA pursuant to which SIGA agreed to deliver two million courses of oral TPOXX® to the Strategic Stockpile. The contract with BARDA (as amended, modified, or supplemented from time to time, the “BARDA Contract”) includes a base contract (“Base Contract”) as well as options (described below). The Base Contract contemplates approximately $472.3 million of payments, of which $409.8 million is consideration for the manufacture and delivery of 1.7 million courses of oral TPOXX® and $62.5 million is available for certain development and supportive activities.

Under the Base Contract, 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 delivery of 2.0 million courses of oral TPOXX® to the Strategic Stockpile was required in order for the Company to receive a $41 million hold back payment (see description of hold back payment below).

For courses of oral TPOXX® that have been physically delivered to the Strategic Stockpile, the Company has a product replacement obligation, at no cost to BARDA, in the event that the final version of oral TPOXX® approved by the FDA is different from any courses of oral TPOXX® that have been delivered to the Strategic Stockpile or if oral TPOXX® does not meet any specified label claims, fails release testing or does not meet the 38-month expiry period (from time of delivery to the Strategic Stockpile), or if oral TPOXX® is recalled or deemed to be recalled for any reason (the “Replacement Obligation”).

As of June 30, 2018, the Company has cumulatively delivered 2.0 million courses of oral TPOXX® to the Strategic Stockpile and received $368.9 million under the Base Contract in connection with the manufacture and delivery of courses of oral TPOXX®. Such receipts were received in the following manner; a $41.0 million advance payment in 2011 for the completion of certain planning and preparatory activities related to the Base Contract; a $12.3 million milestone payment in 2012 for the completion of the product labeling strategy for oral TPOXX®; an $8.2 million milestone payment in 2013 for the completion of the commercial validation campaign for oral TPOXX®; a $20.5 million payment in 2016 for submission of documentation to BARDA indicating that data covering the first 100 subjects enrolled in the phase III pivotal safety study had been submitted to and reviewed by a Data Safety and Monitoring Board (“DSMB”) and that such DSMB had recommended continuation of the safety study, as well as submission of the final pivotal rabbit efficacy study report to the FDA; and $286.9 million of payments for physical deliveries of oral TPOXX® to the Strategic Stockpile beginning in 2013.

On July13, 2018, the FDA approved oral TPOXX® for the treatment of smallpox. There is no difference between the approved product and courses already delivered to the strategic stockpile. As such, pursuant to the terms of the BARDA Contract the Company received $41 million that previously had been held back; the hold back payment represented an approximate 10% hold back on the $409.8 million of total payments related to the manufacture and delivery of 1.7 million courses of oral TPOXX® under the Base Contract.

In addition to the Base Contract, the BARDA Contract also includes options. On July 30, 2018, the BARDA Contract was modified and BARDA exercised its option relating to FDA approval of 84-month expiry for oral TPOXX®, for which the Company has invoiced BARDA for $50.0 million and payment is due August 2018. The other 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 smallpox prophylaxis 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 BARDA Contract expires in September 2020.

As described in Note 2, cash inflows related to delivery of courses under the BARDA Contract have been recorded as deferred revenue due to the constraint on the consideration received. As of June 30, 2018, the Company recorded $375.5 million of deferred revenue in connection with the BARDA contract (of which $368.9 million relates to the manufacture and delivery of 1.7 million courses of oral TPOXX® and the remainder relates to supportive activities). In addition, direct costs incurred by the Company to fulfill the delivery of courses also have been deferred. As of June 30, 2018 and December 31, 2017, deferred direct costs under the BARDA Contract were approximately $94.4 million and $96.5 million, respectively. The Company expects this deferred revenue and related deferred costs to be recognized as revenue and expense on the income statement in the third quarter of 2018 since the constraint on consideration was resolved with the FDA approval of oral TPOXX® on July 13, 2018.

Research Agreements and Grants
The Company has an R&D program for IV TPOXX®. This program is funded by a development contract with BARDA (“IV Formulation R&D Contract”). This contract has a period of performance that terminates on December 30, 2020.

Contracts and grants include, among other things, options that may or may not be exercised at BARDA’s discretion. Moreover, contracts and grants contain customary terms and conditions including BARDA’s right to terminate or restructure a contract or grant for convenience at any time. As such, we may not be able to utilize all available funds.