definiens: means the filing by or on behalf of [COMPANY], or an Affiliate or permittedsublicensee of [COMPANY], of a Supplemental FDA Application with the FDA ( or an equivalent filing with anotherequivalent regulatory agency ) which Supplemental FDA Application seeks approval of an indication for use of anOragenics Product for a use other than the current regulatory - approved indication for the respective OragenicsProduct . Notwithstanding the foregoing and in order to incentivize [COMPANY] to pursue new indications for the productAG013 in parallel with the existing indication ( as such existing indication is described in Investigational DrugApplication no . 13995 ) for product AG013, the New Indication Milestone Event will be deemed not to have occurred ifthe filed regulatory package under the prior sentence relies upon one or more human clinical trials for the specific newindication, which clinical trial(s ) were conducted simultaneously and in parallel with human clinical trials underpinningthe first - approved indication for AG013 . For the avoidance of doubt and clarification purposes, any occurrence of theNew Indication Milestone Event shall not also be deemed the occurrence of the New Product Milestone Event or viceversa