definiens: Indication " : means any indication for which ( a ) a Product is developedpursuant to an IND or CTA ( or if no such filing is required, pursuant to the applicable clinical trial protocol ), ( b ) an NDA for aProduct is submitted, or ( c ) an NDA for a Product is approved bya Regulatory Authority . Any distinct Indication must include newclinical trial data . Any change in tumor type is considered as anew Indication . For instance, the passage from ovarian cancer tobreast cancer is considered as a new Indication . However achange in the line of treatment or a passage from metastatic toadjuvant setting within the same tumor type will not beconsidered as a new Indication . For instance, the indicationmetastatic Colo - Rectal Cancer ( CRC ) replacing second linemetastatic CRC is not a new Indication . Also the addition ofadjuvant treatment of CRC is not considered as a new Indicationin this example . Variations such as change in regimen orcombination with other anticancer drugs or change in formulationwithin the same tumor type are also not considered as a newIndication