definiens: means a pharmacokinetic profile for Product WhiCh ~ i ) has been reproducibly generated, with intra - patient variability of < 30 % and inter - patient variability of < 50 % and ( ii ) uses a commercially acceptable oral tablet formulation comprising up to 2.4 g of amoxicillin and a Beta Lactamase Inhibitor in not more than two tablets when administered to human subjects . Such profile, when administered in an adjusted Woodnutt Berry Infection Model against two ( 2 ) strains of S. pneumonia ( minimum inhibitory concentrations of 8/4 mcg / ml ) and two ( 2 ) strains of H flu ( minimum inhibitory concentrations of 4/2 mcg / ml ) must produce a statistically significant three ( 3 ) log decrease in bacterial counts as compared to the non - treated controls ] 3 Confidential 1.14 Final Execution Copy means the Food and Drug Administration of the United States Department of Health and Human Services, or any successor agency(ies ) thereof performing similar functions