definiens: means a pharmaceutical preparation which meets all of the following criteria : ( a ) itincludes dendritic cells intentionally generated, induced, differentiated, obtained or derived from monocytesextracted from the individual human subject for whom the product is manufactured ; ( b ) such dendritic cellsare generated by the culture at least with GM - CSF, IL-4, IL-10, and TGF - ß and presenting antigen(s)intentionally loaded ; and ( c ) it involves the patent application under listed inExhibit C. As long as a product is comparable with the above definition, such product is also regarded as . A product is deemed comparable to Regulatory DC Product if the product isapproved for commercial sale without a requirement by the FDA ( or a comparable regulatory body ) toconduct any additional scientific or clinical studies ( beyond those required for approval of Regulatory DCProduct in the formulation used in the first human clinical trial ) other than a study 5 demonstrating that the new product is bioequivalent to the first Regulatory DC Product tested in humans