Under the terms of the Distribution Agreement Uman is responsible for all formulation, analytical, and manufacturing and development activities required for obtaining and maintaining required FDA regulatory approvals for commercial sale of the Licensed Product in the U.S. Uman plans to file an Abbreviated New Drug Application (ANDA) for the Licensed Product with the U.S. Food and Drug Administration (FDA) later this year. Subject to the terms of the Distribution Agreement, which requires the Company to make certain milestone and royalty payments and meet certain minimum sales requirements, the Company will have exclusive rights to commercialize gemcitabine manufactured by Uman in the U.S. for seven years from the date of the first commercial sale of gemcitabine by the Company.