definiens: shall mean : ( a ) all research data, pharmacology data, preclinical data and/or clinicaldata for the Compound and/or [COMPANY] Products ; and/or ( b ) all regulatory documentation, information andsubmissions pertaining to, or made in association with, an IND, Marketing Approval Application, Marketing Approvalor the like for the Compound or any [COMPANY] Product ; in each case, that are Controlled by Xanodyne as of theEffective Date and/or during the term of this Agreement . As used herein, shall also include ( i ) allresearch data, pharmacology data, preclinical data and/or clinical data for a Xanodyne Product generated by, or onbehalf of, Xanodyne or its Affiliates ; and ( ii ) all regulatory documentation, information and submissions pertaining to, or made in association with, an IND, MAA, Marketing Approval or the like for a Xanodyne Product ; in each case thatare Controlled by Xanodyne or its Affiliates as of the Effective Date and/or during the term of this Agreement andwhich are relied upon by Xanodyne in association with any IND, MAA or other approval for the Compound or aXenoPort Product in the Territory . Notwithstanding the foregoing, Xanodyne Data shall exclude the Tools