3364 NEW ZEALAND GAZETTE, No. 116 20 SEPTEMBER 2012

Product: Thalomid
Active Ingredient: Thalidomide 150mg
Dosage Form: Capsule
New Zealand Sponsor: Celgene Limited
Manufacturers: Institute of Drug Technology (Aust) Limited, Boronia, Australia
Penn Pharmaceutical Services Limited, Gwent, United Kingdom
Celgene International Sarl, Boudry, Switzerland

Note: This consent is given subject to the following conditions:

1. Thalidomide may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope and practice of internal medicine.

2. Celgene Limited will manage the risk management programme relating to the distribution and use of Thalomid.

Note: This renewed consent is valid for two years from 25 November 2012.

Product: Thalomid
Active Ingredient: Thalidomide 200mg
Dosage Form: Capsule
New Zealand Sponsor: Celgene Limited
Manufacturers: Institute of Drug Technology (Aust) Limited, Boronia, Australia
Penn Pharmaceutical Services Limited, Gwent, United Kingdom
Celgene International Sarl, Boudry, Switzerland

Note: This consent is given subject to the following conditions:

1. Thalidomide may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope and practice of internal medicine.

2. Celgene Limited will manage the risk management programme relating to the distribution and use of Thalomid.

Note: This renewed consent is valid for two years from 25 November 2012.

Dated this 13th day of September 2012.

DR STEWART JESSAMINE, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Inland Revenue

Tax Administration Act 1994

Special Determination S22: Application of the Financial Arrangements Rules to a Public-private Partnership

This determination may be cited as Special Determination S22: Application of the Financial Arrangements Rules to a Public-private Partnership.

1. Explanation (which does not form part of the determination)

(1) This determination relates to an arrangement (the “Project”) involving the design, construction and ongoing provision of operation and maintenance services in respect of a prison by a certain company (the “Company”) under a public-private partnership agreement (the “Project Agreement”) with the Crown. The Company is a wholly-owned subsidiary of Holdings. The Company and Holdings are members of a consolidated group.

(2) The Project Agreement comprises three basic components:

• A construction phase under which the Company agrees to design and construct the prison for the Crown in consideration for a fixed lump-sum payment (the “Construction Phase”);
• the lease of the completed prison by the Crown to the Company in consideration for a rental prepayment (the “Lease”); and
• a services phase under which the Company will provide operation and maintenance services to the Crown over a 25-year term in consideration for monthly payments (the “Services Phase”).

(3) The Company will enter into:

• a Construction Agreement with a contractor (the “Contractor”), under which the Contractor will design and construct the prison in consideration for capped monthly payments;
• an Operation and Maintenance Contract with a service provider (the “Service Provider”), under which the Service Provider will provide the ongoing operation and maintenance (and other) services in consideration for monthly payments; and
• an Asset Management Agreement with the Service Provider, under which the Service Provider will provide management and administrative services to the Company and Holdings in consideration for periodic payments.