the functions and responsibilities of the NBA under the National Blood Authority Act 2003 (Cth). The Parties agree to establish the terms of reference for the Process Migration Governance Committee by Formal Notice agreed between them. The Process Migration Governance Committee will: comprise the chief executives of each Party (or any deputy nominated by each chief executive) and any other representatives nominated by each Party; meet on a basis agreed between the Parties. Starting Plasma and Plasma Material Provision of Starting Plasma CSL acknowledges that the Starting Plasma provided to it for the purposes of this Deed is funded by Australian Governments through the National Blood Arrangements. The Parties acknowledge that: CSL has informed the NBA that the size and technology of CSL’s Broadmeadows plasma fractionation facility means that CSL’s ability to achieve economies of scale and to provide internationally competitive pricing for Australian plasma products is facilitated through a throughput of plasma for fractionation in the order of 500 tonnes per year; at the Commencement Date, Australia is the primary customer of CSL’s Broadmeadows facility, while overseas customers also contribute to annual throughput; and [Not disclosed – this clause provides for the availability of a minimum volume of Starting Plasma for each financial year of the Agreement.] Despite clause 13.2, the NBA does not warrant or guarantee the quality, fitness for purpose or suitability of the Starting Plasma, or the quantity of Starting Plasma to be provided to CSL at any time or over any period. The NBA acknowledges that CSL relies on the Starting Plasma Provider holding a current TGA licence for blood collection, and having conducted such tests and procedures in relation to the Starting Plasma as are required to have been undertaken by that provider to meet TGA requirements, prior to delivery to CSL (subject to any requirements of CSL applying under the TG Act in relation to Starting Plasma). CSL and the NBA may agree by Formal Notice on a specification to apply for Starting Plasma suitable for particular Products under this Deed. CSL’s obligations to produce and supply Products under this Deed are subject to: circumstances affecting the timely provision of adequate Starting Plasma, which is available for production, to CSL; and circumstances in relation to safety concerns, latent defects, contaminants or donor issues which prevent or limit the effective use of Starting Plasma; in accordance with clause 43, where these circumstances are beyond the reasonable control of CSL, and are not able to be reasonably mitigated by CSL.
an Insolvency Event occurs in respect of CSL; CSL commits a material breach of the Deed which is not capable of remedy; or CSL fails to take action to remedy a breach of another obligation under the Deed and does not commence to remedy the breach within 5 Working Days after being given Formal Notice by the NBA requiring CSL to remedy the breach or fails to remedy the breach within 20 Working Days (or such longer period as consented to by the NBA) after being given that Formal Notice. A Party may terminate the Deed as expressly permitted under clauses 34.8, 43.7.2, 43.8 or 44.8. Nothing in this Deed affects any right CSL may have at common law or under any statute to terminate the Deed. If the Deed is terminated under this clause 68, clause 69 or any other provision of this Deed, subject to the Deed: the Parties are relieved from future performance (to the extent of the termination if a partial termination occurs), without prejudice to any right of action that has accrued at the date of termination; the NBA's rights to recover damages are not affected, provided that termination as permitted under clause 44 does not, of itself, give rise to a right to recover damages; CSL must take all reasonable steps to protect, and otherwise must comply with all obligations in the Deed relating to, Commonwealth Material and Contract Material, Personal Information, Confidential Information and Intellectual Property; CSL must at its cost deliver any Commonwealth Material, Contract Material or other NBA Confidential Information held by it to the NBA, except that CSL may retain a copy of Contract Material for the purpose of compliance with Laws, maintaining a record of its performance of the Deed or, where Contract Material is of general application, its ongoing business activities; and CSL must continue to provide Products and Services in accordance with this Deed until the effective date of the notice of termination. Termination for Change in Policy Notice of termination The NBA may, at any time by Formal Notice to CSL, terminate the Deed following any change in government policy where the NBA is requested by Australian Governments under the National Blood Arrangements to terminate the Deed, or which, in the NBA’s reasonable opinion, makes continuation of the Deed inconsistent with that changed policy. The NBA will provide: not less than 24 months’ notice of an exercise of the NBA's rights under this clause, but may provide less notice where the remaining period of the Term is less than 24 months; or
Schedules List of Schedules Schedule 1 – NBA contacts Schedule 2 – CSL contacts Schedule 3 – Deed management meetings Schedule 4 - Product Specifications Schedule 5 – Shelf Life and expiry of Products Schedule 6 – Ordering and delivery requirements Schedule 7 - Minimum Inventory Requirements Schedule 8 – National CSL Reserve Schedule 9 – Required Reports Schedule 10 – Key Performance Indicators Schedule 11 – Prices and fees Schedule 12 – Plasma Volume Payments Schedule 13 – Required guarantees and undertakings Schedule 14 – Confidential Information of CSL Schedule 15 – Home Delivery Schedule 1 NBA contacts Process for updates of schedule Formal Notice from NBA to CSL Version number 1 Version issue date Commencement Date Version date of effect Commencement Date NBA General Manager
Product Concentration Each vial nominally contains 2g of human albumin in 50mL of electrolyte solution Kit Items (if applicable) - ARTG Number AUST R 59154 Approved Indications Hypovolaemia/shock, priming the cardiopulmonary bypass pump and plasma exchange. Shelf Life (months) 48 Storage Conditions Store below 30ºC. (Do not freeze) Protect from light. Planned Product Changes [Not disclosed – specifies planned product changes ] Ability for a Party to remove the Product from supply under the Deed [Not disclosed – specifies when products may be removed from supply under the Deed] Ability for a Party to add the Product to supply under the Deed [Not disclosed – specifies when products may be added to supply under the Deed] CSL Product Number 34500170 Product Name ALBUMEX 4 500mL Product Description Human Albumin 4%, solution for intravenous infusion Product Concentration Each vial nominally contains 20g of human albumin in 500mL of electrolyte solution Kit Items (if applicable) - ARTG Number AUST R 59155 Approved Indications Hypovolaemia/shock, priming the cardiopulmonary bypass pump and plasma exchange. Shelf Life (months) 48 Storage Conditions Store below 30ºC. (Do not freeze.) Protect from light. Planned Product Changes [Not disclosed – specifies planned product changes ] Ability for a Party to remove the Product from supply [Not disclosed – specifies when products may be removed from
Storage Conditions Store at 2° - 8°C (Refrigerate. Do not freeze). Once removed from refrigeration, store below 25°C and use within 3 months. Protect from light. Planned Product Changes [Not disclosed – specifies planned product changes ] Ability for a Party to remove the Product from supply under the Deed [Not disclosed – specifies when products may be removed from supply under the Deed] Ability for a Party to add the Product to supply under the Deed [Not disclosed – specifies when products may be added to supply under the Deed] CSL Product Number 37900155 Product Name INTRAGAM 10 100ml Product Description Human Normal Immunoglobulin solution for intravenous injection Product Concentration Each vial nominally contains 10g of IgG Kit Items (if applicable) - ARTG Number AUST R 162488 Approved Indications Intragam 10 is indicated for replacement IgG therapy in: Primary Immunodeficiency Diseases (PID) Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. Intragam 10 is indicated for immunomodulatory therapy in: Idiopathic Thrombocytopenic Purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count Kawasaki disease Guillain-Barré Syndrome (GBS) Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Multifocal Motor Neuropathy (MMN) Myasthenia Gravis (MG) in acute exacerbation (myasthenic crisis) or prior to surgery and/or thymectomy; as maintenance therapy for moderate to severe MG when other treatments have been ineffective or caused
Approved Indications Management of congenital and acquired forms of primary hypogammaglobulinaemia, in treating secondary forms of this disorder, and in susceptible contacts of hepatitis A, measles and poliomyelitis. Shelf Life (months) 36 Storage Conditions Store at 2° - 8°C (Refrigerate. Do not freeze). Protect from light. Planned Product Changes [Not disclosed – specifies planned product changes ] Ability for a Party to remove the Product from supply under the Deed [Not disclosed – specifies when products may be removed from supply under the Deed] Ability for a Party to add the Product to supply under the Deed [Not disclosed – specifies when products may be added to supply under the Deed] CSL Product Number 36900185 Product Name Rh (D) Immunoglobulin-VF 250IU Product Description Human Anti-D Rho Immunoglobulin, solution for intramuscular injection Product Concentration Vial nominally contains 250IU Rh (D) antibody Kit Items (if applicable) - ARTG Number AUST R 76643 Planned Indications Prevention of Rh sensitisation in Rh (D) negative females at or below child bearing age. Anticipated Shelf Life (months) 24 Anticipated Storage Conditions Store at 2° - 8°C (Refrigerate. Do not freeze). Protect from light. Planned Product Changes [Not disclosed – specifies planned product changes ] Ability for a Party to remove the Product from supply under the Deed [Not disclosed – specifies when products may be removed from supply under the Deed]
accordance with arrangements established under the National Blood Agreement in order for the Product improvement to be able to be supplied under arrangements funded by the NBA; and the Parties agreeing an implementation plan for the introduction of the Product improvement. Packaging and Labelling All components required for the reconstitution and administration of Products delivered to Approved Home Delivery Recipients must be provided at the time of supply of the Product under this Deed. Alternative or additional components, including but not limited to a suitable syringe for pooling of doses, must be supplied free of charge with the Product. Reporting [Not disclosed – this clause outlines reporting by CSL for home delivery purposes under the Deed.] Templates List of Templates Template 1 – Notification of Notifiable Event Template 2 – Formal Notice Template 3 - Variation proposal Template 4 – Financial Undertaking Template 5 – Performance Guarantee Template 6 – Reports Template 1 Notification of Notifiable Event Process for updates of template Formal Notice from NBA to CSL