definiens: means a human clinical trial in IIny country that provides for mndomizcd controlled trials of a product on a sufficient number ofpalienls 10 establish the safety find efficacy of .. produci tlnd gcnerllle, if required, datA to support regulatory approval in the proposed therapeutic indications as more fully defined in 21 C.F.R. ( S ) 3l2.21(c ) or equivalent in a foreign country . For clarity, each time a milestone is achieved with respect to a Licensed Product, and then any otJler milestone payments with rcspe<:t to carlier milestones tbat have not yet been paid for said Licenscd Product wjl ! be dlle and payable togethcr with the milestone payment for the milestone that is actually achieved . For additional clarity, milestones are due and payable on Licensed Products and on products that, upon FDA tlpproval, would become Licensed Products