definiens: shall mean ( i ) any and all know -how owned or controlled by CYDEX that relates to the use of the Product, and ( ii ) any and all patents own ed or controlled by CYDEX that claims the Product or use thereof . means a pharmaceutical composition comprising as the active pharmaceutical ingredient the compound identified in Exhibit A -3 ( as such Exhibit A -3 may be amended from time to time in writing by the Parties ) prepared or combined with or formulated using the Product . For avoidance of doubt : because only CYDEX -supplied material is such a composition which is prepared or combined with or formulated using non -CYDEX -supplied cyclodextrin material is not a Similarly, a pharmaceutical composition comprising as an active pharmaceutical ingredient a compound not identified in Exhibit A -3 ( as such Exhibit A -3 may be amended from time to time in writing by the Parties ) prepared or combined with or formulated using the ( CYDEX -supplied ) Product is not a ( G)DMF Reference Fee . [COMPANY] shall pay CYDEX a one -time DMF Reference Fee of [ * * * ] in exchange for the right of [COMPANY] and its Affiliates t o reference, in its regulatory filings for and to the extent regarding Licensed Products, CYDEX ’s Type III, IV and V Drug Master Files ( DMF ) for the Product . CYDEX shall invoice this amount within 15 days after the Effective Date . For avoidance of doubt, G ilead shall not be obligated to pay any royalties or other milestones other than the one -time DMF Reference Fee payment