(a)    The name of our competitor’s branded product.

(b)   Preclinical testing refers to studies done before initiation of any human studies. Pilot Phase I studies for the NDA products are generally preliminary studies done in healthy human subjects to assess the tolerance/safety and pharmacokinetics (PK) of the product. Additional larger studies in humans will be required prior to submission of this product to the FDA for review. Pilot bioequivalence (BE) studies are initial studies done in humans for generic products and are used to assess the likelihood of achieving bioequivalence for generic products. Larger pivotal bioquivalence studies will be required prior to submission of the product for FDA for review.