definiens: means all payments received by Parent, Arius, or any Affiliate of either of theforegoing from any Third Party following the Effective Date but prior to the initial approval by FDA of an NDA submittedwith respect to the Royalty Product, as consideration for the grant of a license by Parent, Arius, or any Affiliate of either of 4the foregoing to such Third Party to commercialize the Royalty Product, and paid with respect to ( i ) any events occurring priorto the initial approval by FDA of an NDA with respect to the Royalty Product or ( ii ) the approval by FDA of the initial suchNDA, provided that Non - Royalty Sublicensing Revenue shall specifically exclude ( i ) Sublicensing Royalties, ( ii ) purchases ofequity or debt of Arius, Parent, or any Affiliate of either of the foregoing, ( iii ) payments made in connection with research anddevelopment agreements, joint ventures, partnerships or collaboration agreements where Arius, Parent, or an Affiliate of eitherof the foregoing is obligated to perform research and development of any Royalty Product(s ), and ( iv ) other payments madeby a sublicensee as consideration for Arius ’, Parent ’s, or any of their Affiliate ’s performance of services or provision of goodsincluding clinical trial materials and product placebos, but other than providing Royalty Product for commercial sale withouta charge of any nature . For clarification, Sublicensing Royalties are excluded from Non - Royalty Sublicensing Revenue . Forfurther clarification, any payment received by BDSI that is in lieu of future commercial sales or provides for the recapture orrepayment of such payment based on future commercial sales of Royalty Products will be considered part of SublicensingRoyalties