definiens: shall mean all Regulatory Documentation that is ( a ) specificallyapplicable to a Combination Product or the Combination Product Development Activities and ( b ) developed by or on behalf of a Party, orany of its Affiliates, Third Party distributors or Sublicensees, pursuant to, and during the term of, this Agreement or any AncillaryAgreement, but excluding ( i ) any Regulatory Documentation developed, owned, or generated by any Generic Licensee, ( ii ) anyRegulatory Documentation resulting from Development Activities relating specifically to RPV ( or any RPV Product ), including the EdurantDevelopment Activities, ( iii ) any Regulatory Documentation resulting from Development Activities relating specifically to one or more ofTDF, TAF or FTC ( or one or more of the [COMPANY] Compound Products ), and ( iv ) any INDs that a Party that is not the MA Holder withrespect to a given country is permitted to hold pursuant to Section 4.4.2