definiens: For the purposes of the definition of, in the definition of Affiliate shall mean direct orindirect beneficial ownership of 35 % or greater interest in the income of a Person or such other relationshipas, in fact, constitutes actual control ; ( w ) shall mean : ( i)any issued patent or patent application, ( ii)all continuations and continuations - in - part applications to the issued patent or patent application setout in Paragraph ( i ) ( solely to the extent such continuations - in - part applications contain subject matteron which claims issuing obtain the benefit of a priority date of any patent or patent application set outin Paragraph ( i ) ), ( iii)all divisions, patents of addition, reissues, renewals and extensions of any of the patent, patentapplication, continuations and continuations - in - part applications set out in Paragraphs ( i ) and ( ii ), and ( iv)all foreign counterparts of any of the foregoing ( including, without limitation, European SupplementaryProtection Certificates or its equivalent ) ; ( x ) shall mean and include any individual, corporation, partnership, firm, joint venture, syndicate, association, trust, government body and any other form of entity or organization ; ( y ) shall mean that portion of the FDA submission and approval process which provides for the initialtrials of a Licensed Compound and/or Licensed Product on a limited number of patients for the purposes ofdetermining dose and evaluating safety and efficacy in the proposed therapeutic indication as more fullydefined in 21 C.F.R. § 312.21(b ), and such equivalent regulations or standards of countries outside the UnitedStates as may be applicable to activities conducted hereunder ; ( z ) shall mean that portion of the FDA submission and approval process which provides for continuedtrials of a Licensed Compound and/or Licensed Product on sufficient numbers of patients to establish thesafety and efficacy of a Licensed Compound and/or Licensed Product and generate, if required, pharmacoeconomics data to support regulatory approval in the proposed therapeutic indication as more fullydefined in 21 C.F.R. § 312.21(c ), and such equivalent regulations or standards of countries outside the UnitedStates as may be applicable to activities conducted hereunder ; ( aa ) shall mean the rate of interest that the Royal Bank of Canada has announced as the prime rateas the reference rate to determine interest payable on commercial loans to its most creditworthy customerson the last Business Day of the calendar quarter immediately preceding the date of the amount due under theAgreement ; ( bb ) shall mean : - 4 - ( i)any action to recover possession of any Licensed Product shipped to Third Parties ( for this purpose, the definition of Third Parties shall not include any Affiliate, where in the definition of Affiliateshall mean direct or indirect beneficial ownership of 35 % or greater interest in the income of a Personor such other relationship as, in fact, constitutes actual control ) ; or ( ii)any action by the FDA or any other applicable governmental or regulatory agency in any jurisdiction, to detain or destroy quantities of any Licensed Product intended for commercial sale or distribution ofsuch Licensed Product or to prevent release of such Licensed Product for commercial sale ordistribution