definiens: means the filing by or on behalf of [COMPANY], or an Affiliate or permittedsublicensee of [COMPANY], of a regulatory package with the FDA or with another equivalent regulatory agency, whichregulatory package seeks approval of, or seeks permission to begin human trials in support of approval of, a subjectOragenics Product that is deemed ( according to relevant FDA guidelines ) to be a different drug product than the firstOragenics Product that was clinically pursued under the Program . For purposes of the New Product Milestone Event, the subject [COMPANY] Product shall be deemed to be a [COMPANY] Product from the first [COMPANY] Product(and thus constitute an occurrence of the New Product Milestone Event ) if regulatory approval of the subjectOragenics Product must be obtained from the FDA under a different FDA New Product Application than the firstOragenics Product . For the avoidance of doubt and clarification purposes, any occurrence of the New ProductMilestone Event shall not also be deemed the occurrence of the New Indication Milestone Event or vice versa