definiens: , in the deﬁnition of Afﬁliate shall mean direct or indirect beneﬁcial ownership of 35 % or greater interest in the income of a Person or such other relationship as, in fact, constitutes actual control ; shall mean : ( i ) any issued patent or patent application, ( ii ) all continuations and continuations - in - part applications to the issued patent or patent application set out in Paragraph ( i ) ( solely to the extent such continuations - impart applications contain subject matter on which claims issuing obtain the beneﬁt of a priority date of any patent or patent application set out in Paragraph ( i ) ), ( iii ) all divisions, patents of addition, reissues, renewals and extensions of any of the patent, patent application, continuations and continuations - impart applications set out in Paragraphs ( i ) and ( ii ), and ( iv ) all foreign counterparts of any of the foregoing ( including, without limitation, European Supplementary Protection Certi ﬁcates or its equivalent ) ; shall mean and include any individual, corporation, partnership, ﬁrm, joint venture, syndicate, association, trust, government body and any other form of entity or organization ; shall mean that portion of the FDA submission and approval process which provides for the initial trials of a Licensed Compound and/or Licensed Product on a limited number of patients for the purposes of determining dose and evaluating safety and efﬁcacy in the proposed therapeutic indication as more ﬁrlly deﬁned in 21 CPR . § 312.21(b ), and such equivalent regulations or standards of countries outside the United States as may be applicable to activities conducted hereunder ; shall mean that portion of the FDA submission and approval process which provides for continued trials of a Licensed Compound and/or Licensed Product on sufﬁcient numbers of patients to establish the safety and efﬁcacy of a Licensed Compound and/or Licensed Product and generate, if required, pharmacoeconomics data to support regulatory approval in the proposed therapeutic mdicatron as more fully deﬁned in 21 CPR . § 312.21(c ), and such equivalent regulations or standards of countries outside the United States as may be applicable to activities conducted hereunder ; shall mean the rate of interest that the Royal Bank of Canada has announced as the prime rate as the reference rate to determine interest payable on commercial loans to its most creditworthy customers on the last Business Day of the calendar quarter immediately preceding the date of the amount due under the Agreement ; shall mean : 2 ] 826B90242\V39.RAC 020404/1 143/097 ( 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 Afﬁliate shall mean direct or indirect beneﬁcial wnership of 35 % or greater interest in the income of a Person or 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 -of such Licensed Product or to prevent release of sucir ‘ ﬁzicensed Product for commercial sale or distribution