definiens: ) . As used herein, the with respect to an Independent Project shall mean the period beginning upon the date on which the Non - Developing Party elected not to jointly Develop such Label Expansion or New Formulation ( as applicable ) pursuant to Section 6.1.2(a ) and ending on ninety ( 90 ) days after the later of ( x ) first { End of Phase II Meeting}<[***l > for such Independent Project or ( y ) the submission of the protocol to such Institutional Review Board or Ethics Committee for the first Phase III Clinical Trial of such Independent Project, provided, that in the event ( x ) does not occur then upon the dosing of the first patient in the first Phase III Clinical Trial for such Independent [ * * * ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED . ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED