While the Industrialisation agreement for the Unilife Ready-to-Fill Syringe was signed on June 30, 2009, the actual industrialisation program for the product commenced one year earlier on July 1, 2008 following the signing of the Exclusive Agreement. The program targets the development of production systems capable of supporting the supply of an initial 40 million units of the Unilife Ready-to-Fill Syringe per year. Prior to the start of the industrialisation program, Unilife had already commenced initial pilot production of the product for the supply of samples to sanofi-aventis for evaluation.

Unilife has dedicated significant resources over a six-year period towards ensuring the Unilife Ready-to-Fill Syringe is engineered for high volume production and compatible with the filling and packaging systems of pharmaceutical customers. Areas where innovative design and production strategies have been utilised to de-risk the product commercialisation process include:

+ Glass Barrel

Standard prefilled syringes use glass barrels which require shaping at both ends of the tube (the needle and the flanges used to grip the product).There are only five companies which specialise in the production of glass barrels for standard prefilled syringes. The Unilife glass barrel design requires shaping at only one end, enabling us to enter into supply relationships with any of a multitude of manufacturers of glass cartridges.

+ Materials

Unilife has selected components in the fluid path which use the same materials as standard prefilled syringes or glass vials to facilitate drug compatibility.

The industrialisation program for the Unilife Ready-to-Fill Syringe is running well ahead of schedule, with its expected completion by the end of 2010. As a result, Unilife expects to be in a position to commence the supply of the product to pharmaceutical customers within 18 months.

Unilife Scheduled Annual Production Volumes

Total Projected Growth of Prefilled Markets

Unilife has decided to outsource the development of automated assembly systems to be used in the production of the Unilife Ready-to-Fill Syringe. The extensive scale of Unilife’s production plans makes it prudent to contract the design and development of these assembly systems to a large and well-established industry specialist with proven expertise in key areas such as the high-volume handling of glass barrels and needles. Unilife will, however, utilise its in-house experience in the design, development and operation of automated assembly systems to ensure the appointed supplier fully meets its contract obligations. Following the development of these assembly linesby the contracted supplier, they will be installed and validated at the Pennsylvania facilities of Unilife prior to commencing the supply of the product to pharmaceutical customers. Unilife undertook an exhaustive review of more than 30 global specialists with the industry expertise and operational resources necessary to meet production growth targets. The Company is pleased with the quality of the proposals received, and expects to make anannouncement of the selected supplier for its automated assembly systems during 2009.

As a result of these discussions, Unilife has been able to increase the projected annual capacities for the Ready-to-Fill Syringe to meet anticipated market demand faster and more cost-effectively than originally envisioned. Given the strong level of interest in the Unilife Ready-to-Fill Syringe from a number of pharmaceutical companies, the competitive position of its technology and the rapid transition of international healthcare markets towards the mandatory use of safety syringes, Unilife is confident that it is in a strong position to reach an industrial capacity in excess of 450 million units beyond 2014 and 850 million units beyond 2016.