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Note 5 - U.S. Department of Defense Contract
12 Months Ended
Dec. 31, 2017
Notes to Financial Statements  
Long-term Contracts or Programs Disclosure [Text Block]
5.
U.S. Department of Defense Funding
 
On
May 11, 2015,
the Company entered into an award contract (referred to as the DoD Contract) supported by
the Clinical and Rehabilitative Medicine Research Program, or CRMRP, of the United States Army Medical Research and Materiel Command, or the USAMRMC, within the U.S. Department of Defense, or the DoD, in which the DoD
agreed to provide up to
$17.0
million to the Company in order to support the development of
DSUVIA (sufentanil sublingual tablet,
30
mcg), a proprietary,
non-invasive, single-use tablet in a disposable, pre-filled single-dose applicator, or SDA, for the treatment of moderate-to-severe acute pain.
Under the terms of the DoD Contract, the DoD has reimbursed the Company for costs incurred for development, manufacturing, regulatory and clinical costs outlined in the DoD Contract, including reimbursement for certain personnel and overhead expenses. The period of performance under the
DoD Contract began on
May 11, 2015.
The
DoD Contract gives the DoD the option to extend the term of the
DoD Contract and provide additional funding for the research.
On
March 2, 2016,
the DoD Contract was amended
to approve enrollment of additional patients in the
SAP302
study, approve the addition of the
SAP303
study, and extend the DoD Contract period of performance by
four
months from
November 10, 2016
to
March 9, 2017,
to accommodate the increased
SAP302
patient enrollment and the
SAP303
study. The costs for these changes were included within the current DoD Contract value. On
March 9, 2017,
the DoD Contract was amended to incorporate additional activities including the development and testing of packaging changes; additional stability testing; and preparation for any FDA advisory committee meeting for DSUVIA. The amendment also extends the DoD Contract period of performance by
11
months through
February 28, 2018
to accommodate these additional activities. At
December 31, 2017,
the additional activities as outlined under the DoD Contract through
February 28, 2018
were substantially complete. On
February 28, 2018,
the DoD contract was amended to incorporate additional services in the amount of
$0.5
million and to extend the contract period by
twelve
months through
February 28, 2019.
If
DSUVIA is approved by the FDA, the DoD has the option to purchase a certain number of units of commercial product pursuant to the terms of the
DoD Contract.
 
Revenue is recognized based on expenses incurred by the Company in conducting research and development activities, including overhead, as set forth in the agreement.
Revenue attributable to the work performed under the DoD Contract, recorded as Contract and other revenue in the Consolidated Statements of Comprehensive Loss, was
$0.9
million,
$10.9
million and
$4.4
million for the years ended
December 31, 2017,
2016
and
2015,
respectively.