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Development and License Agreements | 12 Months Ended
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Dec. 31, 2020
Development And License Agreements [Abstract] |
Development and License Agreements | Note 13. Development and License Agreements Agreements with Fresenius Fresenius Kabi AG (“Fresenius”) manufactures and supplies the platelet and plasma systems to the Company under a supply agreement (the “Supply Agreement”). Fresenius is obligated to sell, and the Company is obligated to purchase, finished disposable kits for the Company’s platelet and plasma systems and the Company’s red blood cell system product candidate (the “RBC Sets”). The Supply Agreement permits the Company to purchase platelet and plasma systems and RBC Sets from third parties to the extent necessary to maintain supply qualifications with such third parties or where local or regional manufacturing is needed to obtain product registrations or sales. Pricing terms per unit are initially fixed and decline at specified annual production levels, and are subject to certain adjustments after the initial pricing term. Under the Supply Agreement, the Company maintains the amounts due from the components sold to Fresenius as a current asset on its accompanying consolidated balance sheets until such time as the Company purchases finished disposable kits using those components. The Supply Agreement also required the Company to make certain payments totaling €8.6 million (“Manufacturing and Development Payments”) to Fresenius. In 2016, the Company paid $3.4 million (€3.1 million) to Fresenius. In August 2019, the Company paid the remaining $6.2 million (€5.5 million) to Fresenius. The Supply Agreement also required the Company to make payments to support certain projects Fresenius has and will perform on behalf of the Company related to certain R&D activities and manufacturing efficiency activities for which certain assets have been established in the Company’s consolidated balance sheets. The manufacturing efficiency asset is expensed on a straight-line basis over the life of the Supply Agreement. The prepaid asset related to amounts paid up front for the R&D activities to be conducted by Fresenius on behalf of the Company is expensed over the period which such activities occur. The following table summarizes the amounts of prepaid R&D asset and manufacturing efficiency asset at December 31, 2020 and December 31, 2019 (in thousands).
|  | December 31, 2020 |  |  | December 31, 2019 |
Prepaid R&D asset – current (1) |  | $ | — |  |  | $ | 54 |
Prepaid R&D asset – non-current (2) |  |  | 2,088 |  |  |  | 2,094 |
Manufacturing efficiency asset (2) |  |  | 1,104 |  |  |  | 1,349 |
(1) | Included in “Prepaid and other current assets” in the Company's consolidated balance sheets.
(2) | Included in “Other assets” in the Company's consolidated balance sheets.
The initial term of the Supply Agreement extends through July 1, 2025 (the “Initial Term”) and is automatically renewed thereafter for additional two-year terms (each, a “Renewal Term”), subject to termination by either party upon (i) two years written notice prior to the expiration of the Initial Term or (ii) one year written notice prior to the expiration of any Renewal Term. Under the Supply Agreement, the Company has the right, but not the obligation, to purchase certain assets and assume certain liabilities from Fresenius. The Company made payments to Fresenius of $31.3 million, $29.5 million and $21.3 million relating to the manufacturing of the Company’s products during the years ended December 31, 2020, 2019 and 2018, respectively. The following table summarizes the amounts of the Company’s payables to and receivables from Fresenius at December 31, 2020 and December 31, 2019 (in thousands).
|  | December 31, 2020 |  |  | December 31, 2019 |
Payables to Fresenius (1) |  | $ | 13,838 |  |  | $ | 8,470 |
Receivables from Fresenius (2) |  |  | 2,380 |  |  |  | 1,796 |
(1) | Included in “Accounts Payable” and “Accrued Liabilities” in the Company's consolidated balance sheets.
(2) | Included in “Prepaid and other current assets” in the Company's consolidated balance sheets.
Government contracts In June 2016, the Company entered into an agreement with Biomedical Advanced Research and Development Authority (“BARDA”) to support the Company’s development and implementation of pathogen reduction technology for platelet, plasma, and red blood cells. The agreement with BARDA and its subsequent modifications include a base period (the “Base Period”) and options (each, an “Option Period”). The agreement includes committed funding for clinical development of the INTERCEPT Blood System for red blood cells (the “red blood cell system”). In April 2020, BARDA committed an additional $13.8 million raising the committed funding to up to $116.9 million as of December 31, 2020, and the potential for the exercise by BARDA of subsequent Option Periods that, if exercised by BARDA and completed, would bring the total funding opportunity to $213.9 million through December 31, 2021. If exercised by BARDA, subsequent Option Periods would fund activities related to broader implementation of the platelet and plasma system or the red blood cell system in areas of emerging pathogens, clinical and regulatory development programs in support of the potential licensure of the red blood cell system in the U.S., and development, manufacturing and scale-up activities for the red blood cell system. The Company is responsible for co-investment of $5.0 million and would be responsible for an additional $9.6 million, if certain Option Periods are exercised. Through December 31, 2020, the Company has incurred approximately $2.2 million related to the co-investment. BARDA will make periodic assessments of the Company’s progress and the continuation of the agreement is based on the Company’s success in completing the required tasks under the Base Period and each exercised Option Period. BARDA has rights under certain contract clauses to terminate the agreement, including the ability to terminate the agreement for convenience at any time. As of December 31, 2020 and December 31, 2019, $4.6 million and $4.2 million, respectively, of billed and unbilled amounts were included in accounts receivable on the Company’s consolidated balance sheets related to BARDA. In September 2020, the Company entered into a five-year agreement with the U.S. Food and Drug Administration for the development of next-generation compounds to optimize pathogen reduction treatment of whole blood to reduce the risk of transfusion-transmitted infections. The total potential contract value is $11.1 million. As of December 31, 2020, less than $0.1 million of billed and unbilled amounts were included in accounts receivable on the company’s consolidated balance sheets related to FDA.

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