Dare' Single Dose PK Study in Sheep

The following Scope of Work defines the "Research Program": University will perform sheep studies to define local (ectocervical tissue and vaginal fluid) and systemic (plasma) concentrations of lopinavir and ritonavir after a single vaginal dose of the Material. Naive vaginal biopsies will be obtained for pharmacokinetic (PK) method development and then three timepoints per sheep will be collected in six sheep at two, four, six, eight, and twenty-four hours post dosing. Plasma, vaginal fluid, and ectocervical tissue collected from six sheep will be processed, stored, and shipped to Sponsor for analysis. Administering the Material to two sheep and collecting biopsies from those two sheep shall constitute mid-completion of the Research Program.