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Development and License Agreements
9 Months Ended
Sep. 30, 2015
Development and License Agreements

Note 13. Development and License Agreements

Agreements with Fresenius

The Company had an agreement with Fresenius that required the Company to pay royalties on future 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. During the three months ended September 30, 2015 and 2014, the Company made royalty payments to Fresenius of $0.7 million and $0.6 million, respectively. During each of the nine months ended September 30, 2015 and 2014, the Company made royalty payments to Fresenius of $1.9 million. At both September 30, 2015 and December 31, 2014, accrued royalties due to Fresenius were $0.7 million.

Through December 31, 2013, the Company and Fresenius operated under a supply agreement (the “Original Supply Agreement”) for the manufacture of the Company’s platelet and plasma systems. Under the Original Supply Agreement, the Company paid Fresenius a set price per kit, which was established annually, plus a fixed surcharge per kit. In addition, volume driven manufacturing overhead was to be paid or refunded if actual manufacturing volumes were lower or higher than the 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 was obligated to sell, and the Company was 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 was purchased from Fresenius, the Company was able to purchase additional quantities of disposable kits from other third-party manufacturers. The 2013 Amendment also provided for fixed pricing for finished kits with successive decreasing pricing tiers at various annual production volumes. In addition, the 2013 Amendment required the Company to purchase additional specified annual volumes of sets per annum if and when an additional Fresenius manufacturing site was identified and qualified to make INTERCEPT disposable kits subject to mutual agreement on pricing for disposable kits manufactured at the additional site. Fresenius was 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. During the three and nine months ended September 30, 2015, the Company sold $0.5 million and $1.5 million, respectively, of such components to Fresenius. During the three and nine months ended September 30, 2014, respectively, the Company sold $2.2 million and $6.0 million of such components to Fresenius. 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. In October 2015, the Company entered into an Amended and Restated Manufacturing and Supply Agreement with Fresenius, which amends and restates the 2013 Amendment and Original Supply Agreement (see Note 15).

The Company made payments to Fresenius of $3.0 million and $4.3 million relating to the manufacturing of the Company’s products during the three months ended September 30, 2015 and 2014, respectively, and $12.5 million and $13.9 million during the nine months ended September 30, 2015 and 2014, respectively. At September 30, 2015 and December 31, 2014, accrued amounts due to Fresenius were $1.8 million and $5.1 million, respectively, for INTERCEPT disposable kits manufactured. At September 30, 2015 and December 31, 2014, amounts due from Fresenius were $0.4 million and $1.3 million, respectively.