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Development and License Agreements | 9 Months Ended
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Sep. 30, 2014
Development and License Agreements | Note 12. Development and License Agreements The Company has certain agreements with Fresenius which require the Company to pay royalties on INTERCEPT Blood System product sales at royalty rates that vary by product: 10% of product sales for the platelet system and 3% of product sales for the plasma system which it records as a liability in accounts payable on the Company’s unaudited condensed consolidated balance sheet. During the three months ended September 30, 2014 and 2013, the Company made royalty payments to Fresenius of $0.6 million and $0.8 million, respectively. During the nine months ended September 30, 2014 and 2013, the Company made royalty payments to Fresenius of $1.9 million and $2.3 million, respectively. At September 30, 2014 and December 31, 2013, accrued royalties due to Fresenius were $0.6 million and $0.7 million, respectively. The Company also paid Fresenius certain costs associated with the amended manufacturing and supply agreement the Company executed with Fresenius in December 2008 (the “Original Supply Agreement”), for the manufacture of INTERCEPT finished disposable kits for the Company’s platelet and plasma systems through December 31, 2013. Under the Original Supply Agreement, the Company paid Fresenius a set price per disposable kit, which was established annually, plus a fixed surcharge per disposable kit. In addition, volume driven manufacturing overhead was paid or refunded if actual manufacturing volumes were higher or lower than the annually estimated production volumes. In November 2013, the Company amended the Original Supply Agreement with Fresenius, with the new terms effective January 1, 2014 (the “2013 Amendment”). Under the 2013 Amendment, Fresenius is obligated to sell, and the Company is obligated to purchase, up to a certain specified annual volume of finished disposable kits for the platelet and plasma systems from Fresenius for both clinical and commercial use. Once the specified annual volume of disposable kits is purchased from Fresenius, the Company is able to purchase additional quantities of disposable kits from other third-party manufacturers. The 2013 Amendment also provides for fixed pricing for finished kits with successive decreases in pricing at certain annual production volumes. In addition, the 2013 Amendment requires the Company to purchase additional specified annual volumes of sets per annum if and when an additional Fresenius manufacturing site is identified and qualified to make INTERCEPT disposable kits subject to mutual agreement on pricing for disposable kits manufactured at the additional site. Fresenius is also obligated to purchase and maintain specified inventory levels of the Company’s proprietary inactivation compounds and adsorption media from the Company at fixed prices. The Company sold such components to Fresenius in an aggregate amount of $2.2 million during the three months ended September 30, 2014, and $6.0 million during the nine months ended September 30, 2014. The Company maintains the amounts due from the components sold to Fresenius as a current asset on its accompanying unaudited condensed consolidated balance sheets until such time as the Company purchases finished disposable kits using those components. The term of the 2013 Amendment extends through December 31, 2018, subject to termination by either party upon thirty months prior written notice, in the case of Fresenius, or twenty-four months prior written notice, in the Company’s case. The Company and Fresenius each have normal and customary termination rights, including termination for material breach. The Company made payments to Fresenius of $4.3 million and $4.2 million relating to the manufacturing of the Company products during the three months ended September 30, 2014 and 2013, respectively and $13.9 million and $11.8 million during the nine months ended September 30, 2014 and 2013, respectively. At September 30, 2014 and December 31, 2013, accrued amounts due to Fresenius were $4.1 million and $4.3 million, respectively, for INTERCEPT disposable kits manufactured. At September 30, 2014 and December 31, 2013, amounts due from Fresenius were $2.0 million and zero, respectively.

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