definiens: means all pa yments received by Parent, Arius, or any Affiliate of either of the foregoing from any Third Party fol lowing the Effective Date but prior to the initial approval by FDA of an NDA submitted with respect to the Royalty Product, as consideration for the grant of a licen se by Parent, Arius, or any Affiliate of either of 4 the foregoing to such Third Party to commercialize the Royalty Product, and paid with respect to ( i ) a ny events occurring prior to the initial approval by FDA of a n NDA with respect to the Royalty Product or ( ii ) t he approval by FDA of the initial such NDA, provided that Non - R oyalty Sublicensing Revenue shall specifically excl ude ( i ) Sublicensing Royalties, ( ii ) purchases of equit y or debt of Arius, Parent, or any Affiliate of eit her of the foregoing, ( iii ) payments made in connection with r esearch and development agreements, joint ventures, partnerships or collaboration agreements where Ariu s, Parent, or an Affiliate of either of the foregoi ng is obligated to perform research and development of an y Royalty Product(s ), and ( iv ) other payments made by a sublicensee as consideration for Arius ’, Parent ’s, or any of their Affiliate ’s performance of services or provision of goods including clinical trial materials and pro duct placebos, but other than providing Royalty Pro duct for commercial sale without a charge of any nature . For clarification, Sublicensing Royalties are excluded from Non - Royalty Sublicensing Revenue . For further clari fication, any payment received by BDSI that is in l ieu of future commercial sales or provides for the recaptu re or repayment of such payment based on future com mercial sales of Royalty Products will be considered part o f Sublicensing Royalties