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  1. Use of Patented Products for International Humanitarian Purposes Regulations - SOR/2005-143 (SCHEDULE)
    Use of Patented Products for International Humanitarian Purposes Regulations

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    • 2 The pharmaceutical product that the undersigned intends to manufacture and sell for export under the authorization is

      • (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

        (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or

      • (b) if the pharmaceutical product is a medical device:

        (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of theMedical Devices Regulations).

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    • 4 For each patented invention to which the application relates, the name(s) of the patentee(s) of the invention, the name(s) and postal address(es) of the representative(s) of the patentee(s) or, if no representative has been appointed, the postal address(es) of the patentee(s), and the patent number(s) issued in respect of the invention are as follows:

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    • 6 The name, postal address and telephone number of the person or entity referred to in paragraph 21.04(2)(f) of the Act, to which the pharmaceutical product is to be sold, are as follows:

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    • 8 The name, postal address and telephone number of the undersigned are as follows:

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    In the matter of an application by

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    (name of country or WTO Member) of the following pharmaceutical product:

    • (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

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      (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or

    • (b) if the pharmaceutical product is a medical device:

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      (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of theMedical Devices Regulations);

    • 1 The undersigned (name of applicant) hereby declares, in accordance with paragraph 21.04(3)(c) of the Act, that on (date), being at least 30 days before the date of filing of the application for an authorization under section 21.04 of the Act, the undersigned

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      • (b) provided the patentee, or each of the patentees, as the case may be, by certified or registered mail, in the written request for a licence, with the information that is in all material respects identical to the information required under paragraphs 21.04(2)(a) to (g) of the Act.

    • 2 The name, postal address and telephone number of the undersigned are as follows:

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    In the matter of an application by

    (name of applicant) for export to (name of WTO Member) of the following pharmaceutical product:

    • (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

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      (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or

    • (b) if the pharmaceutical product is a medical device:

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      (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

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    • 2 The name, postal address and telephone number of the undersigned are as follows:

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    In the matter of an application by

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    (name of WTO Member) of the following pharmaceutical product:

    • (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

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      (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or

    • (b) if the pharmaceutical product is a medical device:

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      (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

    • [...]

    • 2 The name, postal address and telephone number of the undersigned are as follows:

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    In the matter of an application by

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    (name of country) of the following pharmaceutical product:

    • (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

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      (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or

    • (b) if the pharmaceutical product is a medical device:

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      (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

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    • 2 The name, postal address and telephone number of the undersigned are as follows:

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    In the matter of an application by

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    (name of country) of the following pharmaceutical product:

    • (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

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      (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or

    • (b) if the pharmaceutical product is a medical device:

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      (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

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    • 2 The name, postal address and telephone number of the undersigned are as follows:

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    In the matter of an application by

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    (name of country or WTO Member) of the following pharmaceutical product:

    • (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

      [...]

      (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or

    • (b) if the pharmaceutical product is a medical device:

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      (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

    • 1 The undersigned (name of applicant) hereby declares, in accordance with clause 21.04(3)(d)(iii)(A), (iv)(A) or (v)(A) of the Act, as the case may be, that the pharmaceutical product to which the application relates is not patented in the country or WTO Member.

    • 2 The name, postal address and telephone number of the undersigned are as follows:

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    In the matter of authorization number granted on (date) to (name of holder of authorization) for export to (name of country or WTO Member) of the following pharmaceutical product:

    • (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

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      (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or

    • (b) if the pharmaceutical product is a medical device:

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      (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

    • 1 The undersigned (name of holder of authorization) hereby declares, in accordance with paragraph 21.16(1)(b) of the Act, that

      • (a) the total monetary value of the agreement, expressed in Canadian currency, as it relates to the pharmaceutical product authorized to be manufactured and sold is $ ; and

    • 2 The name, postal address and telephone number of the undersigned are as follows:

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    In the matter of application for authorization number by (name of applicant) for export to (name of country or WTO Member) of the following pharmaceutical product:

    • (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

      [...]

      (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or

    • (b) if the pharmaceutical product is a medical device:

      [...]

      (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

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    In the matter of an application for renewal of authorization by (name of applicant) for export to (name of country or WTO Member) of the following pharmaceutical product:

    • (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

      (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or

    • (b) if the pharmaceutical product is a medical device:

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      (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

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    • 2 For each patented invention to which the application for renewal relates, the name(s) of the patentee(s) of the invention, the name(s) and postal address(es) of the representative(s) of the patentee(s) or, if no representative has been appointed, the postal address(es) of the patentee(s), and the patent number(s) issued in respect of the invention are as follows:

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    In the matter of an application for a renewal of an authorization by (name of applicant) for export to (name of country or WTO Member) of the following pharmaceutical product:

    • (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act:

      [...]

      (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or

    • (b) if the pharmaceutical product is a medical device:

      [...]

      (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations);

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  2. Use of Patented Products for International Humanitarian Purposes Regulations - SOR/2005-143 (Section 8)
    Use of Patented Products for International Humanitarian Purposes Regulations

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    • (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

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    • (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

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    • (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

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      • (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,

    • (6) If the name of the country or WTO Member to which an authorization relates does not appear 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

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  3. Use of Patented Products for International Humanitarian Purposes Regulations - SOR/2005-143 (Section 7)
    Use of Patented Products for International Humanitarian Purposes Regulations

    7 For the purpose of section 21.06 of the Act, the website of the holder of an authorization shall disclose the following information:

    • (a) if the pharmaceutical product named in the application is a drug as defined in section 2 of the Food and Drugs Act, the name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product, or if the pharmaceutical product is a medical device, the name of the medical device;

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    • (e) the distinguishing features of the pharmaceutical product — including its colour if applicable — and of its label and packaging, as required by regulations made under the Food and Drugs Act;

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    • (g) if the consignee in the importing country or WTO Member is a person or entity other than the country or WTO Member referred to in paragraph (b), or the person or entity referred to in paragraph (c), as the case may be, the name and postal address of the consignee;


  4. Use of Patented Products for International Humanitarian Purposes Regulations - SOR/2005-143 (Section 11)
    Use of Patented Products for International Humanitarian Purposes Regulations

    11 For the purpose of paragraph (b) of the definition average price in subsection 21.17(6) of the Act, the publications reporting the prices in Canada of pharmaceutical products sold by or with the consent of the patentee that are equivalent to the pharmaceutical product to which an authorization under section 21.04 of the Act relates are the following:

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    • (b) the list of insured medications set out in Schedule 1 to the Regulation respecting the List of medications covered by the basic prescription drug insurance plan, CQLR, c. A-29.01, r. 3, as is published under the title “List of Medications” on the website of the Régie de l’assurance maladie du Québec; and

    • (c) the PPS Buyers Guide published by ProActive Pharma Solutions (PPS) or the parts of its website known as PPS Centrus where those prices are set out.

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