DEED OF VARIATION between COMMONWEALTH OF AUSTRALIA acting through and represented by the National Blood Authority, a Commonwealth agency established under the National Blood Authority Act 2003 (NBA) and AUSTRALIAN RED CROSS SOCIETY (ARCS) a body corporate established by Royal Charter dated 28 June 1941, acting through that part of its operations known as the Australian Red Cross Blood Service (Blood Service) Recitals A. The Parties entered into a Deed of Agreement (Principal Deed) dated 21 August 2006. B. Clause 17.1 provides that no variation to the Principal Deed will be binding unless agreed in writing between the Parties. C. The Parties varied the Principal Deed on 30 June 2009 and 30 June 2010. D. The Parties now wish to vary the Principal Deed (as varied to date) in accordance with this Deed of Variation. Operative Provisions Part A: Interpretation and operation of this Deed of Variation 1. This Deed of Variation operates from the date it is executed by the Parties, and operates in respect of the 2011-2012 financial year until 15 December 2011. 2. The parties may further extend this Deed of Variation from 15 December 2011 until 30 June 2012, operating in respect of the 2011-2012 financial year by agreement in writing by way of an exchange of letters signed by both parties before 15 December 2011. 3. Unless the contrary intention appears, in and for the purposes of this Deed of Variation: 3.1 words or phrases in the Principal Deed have the same defined meaning, except that the term ‘the Blood Service’ rather than the term ‘ARCBS’ is used to refer to the Australian Red Cross Blood Service; 3.2 the rules of interpretation set out in Schedule 2 of the Principal Deed apply; 3.3 ‘Output Based Funding Model’ means the document at Annex 1 to this Deed of Variation; Blood Service – NBA Deed of Variation 1 3.4 the phrase ‘Product Price’ or ‘PP’ in the Output Based Funding Model or Part C of this Deed of Variation will be taken to be within the meaning of the phrase ‘Product Unit Payment’ or ‘PUP’ in the Principal Deed; and 3.5 the phrase ‘Capital Funding Payment’ in the Output Based Funding Model or Part C of this Deed of Variation will be taken to be within the meaning of the phrase ‘Capital Payment’ in the Principal Deed. 4. A reference in the Principal Deed to Schedule 6 of the Principal Deed will be taken to include a reference to Part C of this Deed of Variation and to the Output Based Funding Model. 5. The laws of the Australian Capital Territory apply to this Deed of Variation. Part B Extension and amendment of the Principal Deed 6. In clause S1-2.1 of the Principal Deed, replace ‘30 June 2011’ with ’15 December 2011’, and in the event that the parties extend this Deed of Variation in accordance with clause 2, with ’30 June 2012’. 7. In relation to the operation of clauses 29.10 to 29.12 and Schedule 6 Items 7.1 to 7.5 of the Principal Deed dealing with Change Program Funding Pool Payments: 7.1 the Blood Service may continue to invoice, hold and use; and 7.2 NBA may continue to pay in response to a correctly rendered invoice, Change Program Funding Pool Payments after 30 June 2010, in accordance with the Principal Deed, to the extent that such Payments are in respect of a specific initiative agreed by the Parties under Schedule 6 Items 7.2 and 7.3 on or before 30 June 2010. Part C Determination of Payments for 2011-12 financial year until 15 December 2011 8. The following provisions in the Principal Deed do not operate in respect of the 20112012 financial year up to 15 December 2011: 8.1 Schedule 6 Part A (Basis for Payments) Items 2, 3, 4, 5 and 6; and 8.2 Schedule 6 Part B (Invoicing and Payment) Items 11.1, 11.2, 11.4 and 11.6. 9. Subject to this Deed of Variation, the Parties agree to apply the principles set out in the Output Based Funding Model in respect of Payments for the 2011-2012 financial year, except that the parties agree, consistent with previously agreed arrangements for the purposes of item 6.4 of the Output Based Funding Model, that $4.75 million will be returned to the jurisdictions in 2011-12 by way of lower product prices, which is reflected in the agreed Product Price for each Product for 2011-12 as specified in Annex 2. 10. In giving effect to clause 8 of this Deed of Variation, the Parties have: Blood Service – NBA Deed of Variation 2 11. 10.1 agreed the Product Price for each Product (including the Tier 1, Tier 2 and Non Tier Product Prices) to be applied for 2011-12 as specified in Annex 2 (GST exclusive) ; 10.2 agreed the following amounts to be applied from 1 July 2011: 10.2.1 the amount of the Capital Funding Payments for 2011-12 is $45,692,940 (GST exclusive) and has been included in the Product Prices specified in Annex 2; 10.2.2 the amount of the Research and Development Payments for 201112 including capital is $7,773,447 (GST exclusive) to be paid as an Other Payment under the Principal Deed; 10.2.3 the amount of, and conditions applying to, Payments in respect of the Blood Service NSW and ACT Principal Site for 2011-12 is $9,023,924(GST exclusive) to be paid as an Other Payment under the Principal Deed; 10.2.4 the amount of, and conditions applying to, Payments in respect of the Blood Service VIC and TAS Principal Site for 2011-12 is $3,892,378 (GST exclusive) to be paid as an Other Payment under the Principal Deed; 10.3 negotiate the principles relating to Product substitution under Item 4.1 of the Output Based Funding Model with a view to agreeing those principles by 15 December 2011, or the event that the parties extend this Deed of Variation in accordance with clause 2, by 30 June 2012; and 10.4 comply with obligations under the Principal Deed in relation to Payments in accordance with: 10.4.1 the elements agreed under clauses 10.1, 10.2 and 10.3 of this Deed of Variation; 10.4.2 the Output Based Funding Model; and 10.4.3 this Deed of Variation. In giving effect to clause 9 of this Deed of Variation, the Parties acknowledge and agree that: 11.1 notwithstanding that this Deed of Variation extends the Principal Deed until at least 15 December 2011, the 2011-2012 financial year is intended to operate as part of a three year planning and funding cycle as contemplated in the Output Based Funding Model, with the part of the second and all of the third financial year of the cycle to be implemented through further agreement of the Parties; 11.2 despite Items 3.1 and 3.2 of the Output Based Funding Model, for the 20112012 financial year the basis for planning of Product volumes between the Parties must be Annual Supply Estimates in accordance with Schedule 3 Part L of the Principal Deed; Blood Service – NBA Deed of Variation 3 11.3 despite Item 4.1 of the Output Based Funding Model, for the 2011-2012 financial year, requirements in relation to the list of Products, frequency of deliveries and inventory levels must be determined in accordance with Schedule 3 of the Principal Deed; 11.4 clause 25 of the Principal Deed will apply to any activities of the Blood Service referred to in Item 4.2 of the Output Based Funding Model; 11.5 Items 168 and 174 to 178 of Schedule 4 Table B of the Principal Deed are deleted; 11.6 Items 160 to 163, 165, 167, 182, 184 and 192 of Schedule 4 Table B of the Principal Deed are amended as set out in Annex 3 to this Deed of Variation; and 11.7 other than the cash advances provided for in Item 6.1 of the Output Based Funding Model, invoicing and payment must be in arrears in accordance with Item 5.2 of the Output Based Funding Model and, except to the extent of any inconsistency with Items 5.2 and 6.1 of the Output Based Funding Model, in accordance with clauses 16.8 to 16.12 of Schedule 11 of the Principal Deed. Part D Treatment of financial outcome of 2010-2011 financial year 12. Items 16.4.1 to 16.4.3 of Schedule 11 of the Principal Deed do not operate in respect of the 2010-2011 financial year. 13. Within 40 Business Days after the end of the 2010-11 financial year, the Parties must undertake and agree a reconciliation of total actual costs incurred by the Blood Service for the financial year (‘total actual costs’) against the total amount of Payments made in respect of that financial year (‘total Payments’). 14. If the reconciliation referred to in clause 13 of this Deed of Variation identifies a deficit of total Payments against total actual costs, the Parties must agree any appropriate treatment of the deficit in accordance with Item 6.2 of the Output Based Funding Model. Blood Service – NBA Deed of Variation 4 Executed as a Deed SIGNED SEALED AND DELIVERED for and on behalf of the COMMONWEALTH OF AUSTRALIA acting through the NATIONAL BLOOD AUTHORITY on: ______________________________ Date by: ____________________________ Name of signatory _____________________________ Position of signatory in the presence of: ____________________________ Name of witness ) ) ) ) ) ) ) ) ) ) ) ) _______________________________ ) Signature ) ) ) ) ) ) _______________________________ ) Signature of witness Signed on behalf of the Australian Red Cross Society in accordance with its Rules: ____________________________ Full Name of ARC Board Member or other Authorised Representative ____________________________ ___________________________ Signature ___________________________ Position Full Name of ARC Board Member or other Authorised Representative ____________________________ Signature ___________________________ Position Dated this ___________________________ day of __________________________ 2011 Blood Service – NBA Deed of Variation 5 Annex 1 – OBFM Principles OUTPUT BASED FUNDING MODEL for 2010-11 to 2012-13 Key Principles All Australian Governments have agreed to continue to meet the fair and reasonable costs of the management and operation of the Australian Red Cross Blood Service (Blood Service), including necessary investments in capital infrastructure. This commitment is limited to the cost of products and services provided in accordance with arrangements established under the National Blood Agreement and consistent with policy determined by governments. Australian Governments also require adequate accountability and transparency in the application of funding provided to the Blood Service and that the Blood Service appropriately manage its affairs and associated financial risks within the resources provided by governments. This funding model is to be read in conjunction with the Deed of Agreement dated 21 August 2006 which takes precedence over this agreement if in conflict. The existing indemnities provided to the Blood Service by the NBA continue to apply (Clause 57). Component Item OBFM Principles 1. Product Costing 1.1 Costs for products reflect the actual cost of production o o Corporate overheads and indirect costs will be attributed to products and services as outlined in 2 below. Costs may not necessarily reflect the scarcity and difficulty of obtaining particular products. 1.2 Payment for services reflects the actual cost of providing that service. 1.3 Non-Deed services will not be cross subsidised by Deed funds. 1.4 Transfusion Medicine Services (TMS) will be funded under the existing process for 2010-11. Funding for 2011-12 onwards will be on the basis of a new 3 tiered funding model which may include; grant, fee for service and a Product Price (PP) component and will be adjusted annually by indexation (net of efficiency dividend) and 10% Capital. The PP component will grow in line with activity. The grant and the fee for service component will be adjusted for activity growth where justified and agreed by JBC. Research and Development will be grant funded based on the 2009-10 budget and will be adjusted annually by indexation (net of Blood Service – NBA Deed of Variation 6 Component Item OBFM Principles efficiency dividend) and 10% Capital. The grant will be indexed by the activity growth where justified and agreed by JBC. 1.5 Product costs will be fixed in each financial year of the cycle and not changed, other than in response to a major change in government policy, a regulatory change, or other extraordinary reason which has been agreed by governments. Any JBC approved extraordinary items will be grant funded for at least the term of the funding cycle at which time the interim grant funding where appropriate will be incorporated into the PP. 1.6 Product costs will be indexed annually at 4.1% which is net of a 1% efficiency dividend. All other grants and payments will also be indexed at 4.1% annually. This net indexation factor is in accordance with advice from the Commonwealth Department of Finance and Deregulation as stated in the Forward Estimates. A higher indexation rate may be approved by governments on presentation of evidence that business critical costs have risen well in excess of 4.1% and the additional costs could not be recovered by other savings. 1.7 Product costs will facilitate international comparison and benchmarking where relevant and practical. 1.8 For items not funded through grant payments, an annual Capital Funding Payment will be made based on 10% of total annual estimated revenue. Grant items mentioned in 1.4 and 1.13 are excluded from this capital payment as capital payments for these items are separately defined and provided for. While this funding will be incorporated in the PP it may be cash flowed within the year in advance of the PP payments subject to cash being available with the NBA. At the beginning of the year the monthly cash flow is provided by the Blood service as part of the Annual Capital Plan. Capital advances will be made quarterly in advance and reconciled/acquitted quarterly with the monthly PP invoices, contingent on cash being available. If cash is not available then a monthly advance will be provided and reconciled/acquitted quarterly with the monthly PP invoices. 1.9 At the cost agreement stage, the overall cost to governments of the products and services in 2010-11 cannot increase on the funding that would have been provided based on 2009-10 costs (other than Indexation net of efficiency dividend), activity increases based on the Blood Service – NBA Deed of Variation 7 Component Item OBFM Principles agreed supply plan, other extraordinary items and changes in government/regulatory policy. 1.10 The costs of the following products will be constructed to reflect a two tiered costing structure to ensure recovery of 100% of fixed costs when 90% of supply has been delivered. They are - 2b Whole blood red cells – leucodepleted 4b Clinical fresh frozen plasma 4d Apheresis Clinical FFP 3b Whole blood platelets – leucodepleted 3d Apheresis platelets – leucodepleted The tier one base cost will be fully costed to reflect recovery of 100% of fixed costs at 90% of delivered supply. Deliveries after 90% of the supply plan are costed at variable cost. 100% of the Annual Capital Funding Payment as defined in 1.8 will be added to tier one product costs and plasma for fractionation. Variable Costs are: All consumables; 5% of operating unit overhead less rent and rates; and 3% of collection centres salary and statutory on costs. All other costs are Fixed costs. 1.11 The Blood Service will be a participant in the policy development of prices paid by jurisdictions. 1.12 Governments will provide reasonable notice to the Blood Service of their intention to increase or reduce services that are funded on a fixed grant basis. Governments may be required to fund reasonable increased or exit costs. 1.13 Victoria/Tasmania Principal Site (VTPS) and New South Wales/Act Principal Site (NAPS) net additional expenses (fit out, rent, outgoings etc) are to be separately funded on a grant basis and not included in the PP. Blood Service – NBA Deed of Variation 8 Component Item OBFM Principles 2. Attribution Rules 2.1 For costing attribution the principal purpose of the Blood Service is to provide a fresh blood service. The collection of plasma for fractionation for costing purposes, is a non principal activity, and so only bears direct operating unit costs and excludes corporate and operating unit management overhead. This approach will assist in: 2.2 providing internationally comparable fresh blood costs; and keeping plasma costs lower to support domestic collection and governments policy to promote national self sufficiency. Product costing outcomes are aimed at minimising risk to Blood Service from changes in volume and product mix (i.e. minimise cross subsidisation and use of subjective drivers) by using supportable cost allocation methodologies and tier pricing that means fixed costs and capital payments are not put at risk. Costs which cannot be directly associated with an individual product eg donor services, donor recruitment, collection and testing, are allocated on a collection based driver. Direct Operating Costs that are absorbed by all products are all direct operating unit costs of Production, Distribution, product specific Testing, or Product Enhancements involved in the production and processing of the separate product. Separate product costs will not be established for value added activities such as irradiated red blood cells unless the cost of the value added activity is material for the Blood Service. Direct Operating costs Includes: o o o o o o o Donor Centre Costs - Labour - Consumables - Donor Centre Overheads Testing (including those provided by the NTS within the Deed) Production Marketing & related activities (Operating Units only) Principal Site Overheads (where not separately funded) Medical Services Direct Product and Collection Support Distribution of fresh blood products and plasma for fractionation Blood Service – NBA Deed of Variation 9 Component Item OBFM Principles But excludes: o 2.3 2.4 2.5 Corporate Overheads ie - Finance - Human Resources - Information Systems - Quality - Corporate - Corporate Strategy and Performance o Medical Services Management and Support o National Operations Management o National Transplantation Service (Excluding Testing done for the blood supply) o Research and Development o Operations unit management overheads o Distribution costs of non fresh products Distribution costs will be allocated to products on the basis of units issued. Distribution costs include o Labour, Consumables and Overheads (other than Transport), o Fresh, fractionated and recombinant product transport, o Plasma to CSL (Transport) Corporate and Operating Unit Management Overhead will be allocated to fresh products excluding plasma for fractionation. These overheads will be a standard charge for every adult equivalent product unit issued to eliminate the financial risks to the Blood Service of product substitution. Fresh Product and Clinical Focus: Plateletpheresis direct operating unit costs should be allocated to the platelets only, not to the plasma for fractionation derived through this collection (100% primary product). 3. Volumes 3.1 Rolling three year supply forecasts will be provided by the NBA and jointly reviewed on an annual basis 3.2 The three year supply estimates prior to the commencement of the three year funding cycle are used to set the fixed cost recovery levels for those products that have tiered costing structure. Blood Service – NBA Deed of Variation 10 Component 4. Products and Services 5. Payment Process Item OBFM Principles 3.3 During the year both NBA and the Blood Service will work together to best inform up to date trends on supply and demand. 4.1 There will be an agreed National Service Standards. Refer to this document for issues relating to Product List, frequency of deliveries, inventory levels and principles relating to product substitution. 4.2 The Blood Service may provide services outside the deed to jurisdictions or other organisations at a Fee for Service. These services must be fully cost recovered and do not impact on the Blood Service ability to meet deed obligations. 5.1 Payment is made for those products that are ordered and issued, and within defined and agreed substitution rules. Payment on products received is the optimum goal (which ensures formal receipt verification), with payment on product issued acceptable until a system allows (ie an inventory and receipting system implemented). 6. Risk Treatment of Cash Advance, Surplus or Loss 5.2 Invoicing occurs at the end of the month and payment is on agreed terms of 10 business days from receipt of a correctly rendered invoice based on issues to Approved Health Providers. 5.3 After the first year of the model, NBA and the Blood Service will review the model and the Blood Service financial performance to ensure appropriateness and to inform the costs/model for the remainder of the funding cycle. 6.1 The NBA will provide a cash advance to cover the initial 55 days operation, excluding capital, to be reconciled at the end of each year. o 6.2 The advance will be split into two advances made at the beginning of July (30 days) and August (25 Days) and reconciled/acquitted annually with the monthly PP invoice. The Blood Service can approach the NBA within each year should there be events that require additional funding such as extraordinary circumstances and government regulatory or policy changes. The Blood Service can also approach the NBA in the event of a material change (as defined below) from forecast to actual supply to meet demand (and/or year on year forecast) if the Blood Service needs to recoup costs associated with responding to those changes and the overall costing structure does not accommodate it. This Includes changes in product mix that cause changes in cost structure or changes in product cost or value added costs. Blood Service – NBA Deed of Variation 11 Component Item OBFM Principles Materiality for one year result where a loss incurred is equivalent to $1.5M The triggering of this clause will be at the discretion of the Blood Service, and the funds available and the level of financial risk that they are prepared to manage before they seek reimbursement. 6.3 The Blood Service will be expected to manage losses annually (subject to 6.2) and within the 3 year funding cycle subject to materiality. The Blood Service can approach the NBA at the conclusion of the 3 year funding cycle should a material loss (as defined below) be evident and seek to be reimbursed for the deficit. Note: In the event of a claim for loss at the end of the funding cycle, the Blood Service will be subject to a full disclosure audit. In this event, and subject to no impropriety, governments agree to maintain their existing commitment to meet the fair and reasonable costs of the Blood Service. As agreed by AHMC in July 2008 (refer to the introduction statement above). Materiality for three year result where losses incurred is equivalent to, $4.5M. The triggering of this clause will be at the discretion of the Blood Service, and the funds available; and the level of financial risk that they are prepared to manage before they seek reimbursement. 6.4 - The Blood Service will be allowed to retain the 2009-10 operational efficiencies (surplus) to allow one off reinvestment in line with government policy including; o to comply with regulatory changes o to improve the safety and security of the blood supply o for strategies to achieve efficiencies in the blood service o to further achieve national consistencies o to reduce the product cost o to provide for a management reserve (risk pool) Subject to any resultant ongoing costs being absorbed within the agreed 2010-11 product prices. 6.5 - Future Surplus - The Blood Service will be able to reinvest operational efficiencies (surplus) up to $5 million in any year to allow reinvestment in line with government policy including; o to comply with regulatory changes o to improve the safety and security of the blood supply Blood Service – NBA Deed of Variation 12 Component Item OBFM Principles o o o o for strategies to achieve efficiencies in the blood service to further achieve national consistencies to reduce the product cost to provide for a management reserve (risk pool) Subject to any resultant ongoing costs being absorbed. It is intended that the first call on surplus funds will be any regulatory or government policy changes and new Business Cases approved by JBC provided any on-going costs can be absorbed in existing funding. If the annual surplus is more than $5 million in any year then the use of the surplus over the $5 million will need to be agreed between the Blood Service and the NBA. 7. Business Cases 7.1 The Blood Service will have the opportunity to present business cases for projects/initiatives greater than $2m that cannot be funded within price and services funding or surplus reinvestment, noting that this needs to align with government timeframes for new funding, i.e. 2 years out. Acronyms: NBA National Blood Authority Blood Service Australian Red Cross Blood Service JBC Jurisdictional Blood Committee TMS Transfusion Medicine Services PP Product Price FFP Fresh Frozen Plasma VTPS Victoria/Tasmania Principal Site NAPS New South Wales/Act Principal Site NTS National Transplantation Service Blood Service – NBA Deed of Variation 13 Blood Service – NBA Deed of Variation 14 Annex 3 – Amendments to Schedule 4 Table B of the Principal Deed Process key: A – Blood Service Strategic Planning B – Blood Service Annual Business Planning Research & Development C Supply Plan Review for 2010-11 By 31 Aug 11 161 C Supply Trend Analysis for 2010-11 By 31 Aug 11 C Consultation on ASEs for 2012-13 (All Product Groups) and consultation with NBA on Supply Plan scenarios taking into account proposed PP and business case proposals, if any 1 Jul 11 to 31 Oct 11 D Consultation with NBA on proposed PP scenarios for 2012-13 taking into account Blood Service business case proposals, if any 1 July 11 to 31Oct 11 C End of year reconciliation of planned v. actual supply for the purposes of clause 13 of the Deed of Variation 1 Aug 11 to 30 Sept 11 163 165 Quarterly CEO Meeting 167 182 184 D - - Year in Review 2010-11 - Review Qtr 4 (April-June 2011) Agree final PPs for 2012-13 Quarterly CEO Meeting -- Review Qtr 1 (July-September 2011) Blood Service – NBA Deed of Variation 2006-17 2015-16 2014-15 D – Blood Service Financial Planning & Review E – Blood Service SCIP and Annual Capital Plan Development F Blood Service Performance C – Supply Planning G– 160 162 2013-14 2012-13 2011-12 2010-11 Activity Date 2008-09 Activity 2009-10 Process Financial Year that Activity Relates to By 31 Aug 11 By 31 Dec 11 By 7 Dec 11 15