Use of Patented Products for International Humanitarian Purposes Regulations — 8
8 (1) In this section, Index means the Human Development Index developed and maintained by the United Nations Development Programme. (2) For the purpose of subsection 21.08(1) of the Act, the events on the occurrence of which a royalty is required to be paid, and the manner of determining the royalty, are as follows: (a) if the total quantity of the pharmaceutical product that is authorized to be manufactured and exported is exported in a single shipment, the amount of the royalty determined in accordance with subsection (4) or (6), as the circumstances require, shall be paid in full within 45 days after the date of the export notice provided under section 21.07 of the Act; and (b) if the quantity of the pharmaceutical product that is authorized to be manufactured and exported is exported in a series of shipments, a royalty shall be paid within 45 days after the date of the export notice provided under section 21.07 of the Act in an amount for a shipment that is the same proportion of the full amount of the royalty determined in accordance with subsection (4) or (6), as the circumstances require, as the quantity of the pharmaceutical product exported in the shipment is of the quantity of the pharmaceutical product that has been authorized to be manufactured and exported. (3) If the name of the country or WTO Member to which an authorization relates appears on the Index, the rate for calculating the royalty that is required to be paid to the patentee or to each of the patentees, as the case may be, in respect of the authorization shall be determined by (a) adding 1 to the total number of countries listed on the Index; (b) subtracting from the sum determined under paragraph (a) the numerical rank on the Index of the country or WTO Member to which the pharmaceutical product is to be exported; (c) dividing the difference determined under paragraph (b) by the total number of countries listed on the Index; and (d) multiplying the quotient determined under paragraph (c) by 0.04. (4) If the name of the country or WTO Member to which an authorization relates appears on the Index, the amount of royalty payable to the patentee or to each of the patentees, as the case may be, shall be determined (a) when there is only one patentee, by multiplying the total monetary value, expressed in Canadian currency, of the agreement pertaining to the pharmaceutical product to be manufactured, sold and exported under the authorization by the royalty rate determined in accordance with subsection (3); and (b) when there is more than one patentee, by dividing the amount determined under paragraph (a) by the number of patentees. (5) If the name of the country or WTO Member to which an authorization relates does not appear on the Index, the rate for calculating the royalty that is required to be paid to the patentee or to each of the patentees, as the case may be, in respect of the applicable authorization shall be determined by (a) adding 1 to the total number of countries listed on the Index; (b) subtracting from the sum determined under paragraph (a) the average (i) in the case of a country or WTO Member to which the pharmaceutical product is to be exported and whose name appears in Schedule 2 or 3 to the Act, of the numerical ranks on the Index of all of the countries and WTO Members whose names appear both on the Index and in the same Schedule to the Act as the country or WTO Member to which the pharmaceutical product is to be exported, (ii) in the case of a country — other than a WTO Member — to which the pharmaceutical product is to be exported and whose name appears in Schedule 4 to the Act, of the numerical ranks on the Index of all of the WTO Members whose names appear both on the Index and in Schedule 3 to the Act, and (iii) in the case of a WTO Member to which the pharmaceutical product is to be exported and whose name appears in Schedule 4 to the Act, of the numerical ranks on the Index of all of the WTO Members whose names appear both on the I