Both supplemental NDAs received priority review designations from the NMPA in July 2020. In November 2018, we extended our partnership with KBI until December 31, 2023. Any legal and regulatory changes may impact our operations in the future. An IND must become effective before U.S. clinical trials may begin. The CCPA and the CPRA may increase our compliance costs and potential liability. We believe we have good relations with our employees. We completed the initial public offering of our common stock in November 2014. We continue to be dependent on the ability to raise funding. As of December 31, 2020, we had 317 employees. CROs may also generate higher costs than anticipated. On October 11, 2019, we filed a Motion for Attorneys' Fees with the District Court. Third parties may request an IPR of our patents in the USPTO. 6.Simultaneous Exchange of Patents. We currently do not have any approved products, other than UDENYCA®. The BPCIA established this abbreviated pathway under section 351(k) of the PHSA. Moreover, market acceptance of biosimilar products in the United States is unclear. In addition, there may be other efforts to challenge, repeal or replace the ACA.
