definiens: means any phannaccutical product that consists o[(a ) a Licensed Product and ( b ) one or more active ingredients that are not Licensed Products or a delivery device ( whether such clements arc combined in a single tonnulatiol1 andlor package, as applicable, or [ onnulated andlor packaged separately but sold together for a single price ), Section 1.56 . Ongoing Clinical Studies means ( a ) the Phase II Clinical Study known as PEP0208 sponsored by EEl which is desclibed 011 Exhibit B~ 1 ; ( b ) the Phase I Clinical Study sponsored by N;:lJiQn ~ lH ~ ill.th . Rs;~Gk!rch In§titute~, Taiwan, known as PIST - CRC - OI which is described on Exhibit B-2 ; and ( c ) the Phase II Clinical Study sponsored by Groupe COQPcratcur Multidisciplinaire en OncolQgi~.cGERCQR ' ) known as PJ;J ~ CQL which is described on Exhibit B-3, All statements regarding the status of the Ongoing Clinical Studies in such Exhibits reflect such status as of the Effective Datc only