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Purchase Commitments
9 Months Ended
Sep. 30, 2017
Commitments And Contingencies Disclosure [Abstract]  
Purchase Commitments

6. Purchase Commitments

Commercial Supply Agreement

In 2016, we entered into an Amended Restated Commercial Supply Agreement (“aCSA”) with CMC ICOS Biologics, Inc. (“CMC”), a subsidiary of AGC Asahi Glass, that amends and restates the terms of the original Commercial Supply Agreement. Under the aCSA, CMC will continue to manufacture bulk drug substance for andexanet alfa under our first generation manufacturing process and will support other regulatory and manufacturing activities. We have made firm orders to manufacture 20 batches in 2017 and are required to make a non-refundable manufacturing reservation payment of $2.5 million for ten batches to be manufactured in 2018 contingent upon CMC’s successful delivery of services related to our BLA re-submission to the FDA.

Pursuant to the terms of the aCSA, we received a $33.7 million credit, which may be applied to either satisfy or partially offset specified amounts owed to CMC for services rendered under the aCSA, existing obligations/payables to CMC as of the execution date and future services to be rendered through December 31, 2017. For the three and nine months ended September 30, 2017, the Company utilized $2.0 million and $7.3 million of these credits as a reduction of R&D expense to settle accounts payable and accrued liabilities related to specified services rendered by CMC.

 

Under the consolidation guidance, we determined that CMC is a VIE and we are not the primary beneficiary and therefore consolidation of CMC is not required. As of September 30, 2017, we have not provided financial or other support to CMC that was not previously contractually required. We have recorded $0.5 million of accounts payable and $0.5 million of prepaid manufacturing services in our condensed consolidated balance sheet as of September 30, 2017. Our agreement with CMC does not require us to fund operations at CMC and therefore, we quantify our maximum exposure to loss as the aggregate value of prepaid manufacturing services as of September 30, 2017. Further, we believe that our total exposure to losses associated with the fixed pricing terms of this agreement is de minimis given the cost per batch, number of batches and time frame over which the batches will be manufactured, pursuant to the amended agreement.         

Betrixaban Manufacturing Agreement

 

In 2016 we entered into a Manufacturing Agreement, as amended, with Hovione, Limited, (“Hovione”), pursuant to which Hovione will manufacture active pharmaceutical ingredient for betrixaban at commercial scale and perform process validation during the term of the agreement. As of September 30, 2017, we have recorded $2.7 million in prepaid expenses and other current assets and $9.6 million in prepaid and other long-term under the agreement, and will make up to $12.9 million of additional cancellable and non-cancellable payments throughout the term of the Hovione Agreement, ending June 2018.