definiens: , Phase m " shall mean Phase I ( or Phase If II ), Phase II ( or Phase II / ill ), and Phase ill clinical trials, respectively, in each case as prescribed by applicable FDA lND Regulations, or any corresponding foreign statutes, rules or regulations . : ; : l 1.37 shall mean any product containing a Collaboration Compoun : 5 5 : : ! Products shall not include Excluded Products or products containing an Other Library = - ; ; : ; : Compound . ~ I, --4 c= 1.38 Of duct D ve ida Compound!or : : a.~ Chemokine Com oun which ( a ) merits initiation of expanded animal toxicology studie, a : : : : ! ata 0 whi ~ h are required'to be submitted to FDA for an IND, including, without : : ; : ; ~ limitation : ( i ) formulation / stability studies ; ( ii ) pharmacokinetic studies ; ( iii ) drug ~ ..