definiens: means, with respect to an Optioned Product, ( a ) a ll Phase 3 Clinical Trials required for ( i ) the submission of an NDA with the FDA, and ( ii ) the equivalent filings with the appli cable Regulatory Authorities in each of the Major Europea n Countries and Japan, and ( b ) all Phase 4 Clinical Trials ( other than Voluntary Phase 4 Clinical Trials ), in each case ( ( a ) and ( b ) ) for the initial Indication described in the briefing package delivered to the FDA for the End - o f - Phase 2 Meeting described in Section 5.6 of the Agreement and giving rise to the Exercise Notice ( p rovided that, for purposes of this definition, [ * ] will be treated as one Indication ) and the next Indication pursued by Sanofi ( if and to the extent so conducte d by Sanofi )