R&D Start Program Grant Agreement Particular Conditions

Exhibit 10.21

Project No: GRA02090

R&D Start Program

Grant Agreement

Particular Conditions

Parties
Commonwealth of Australia acting through the Industry Research and Development Board
ABN 51 835 430 479
(Department of Industry, Science and
Resources)
Postal address		OLD State Manager
		Department of Industry, Tourism and Resources
		XXX Xxx 0000
		XXXXXXXX XXX 0000
The Grantee
- ABN		Xxxxxx Operations Pty Ltd
- ACN		69093317367
- postal address		093 317 367
		XX Xxx 000
		XXXXXXXXX XXXXXX XXX 0000
- business address		Ground Floor, South Tower
		000 Xxxxxxx Xxxxxxx
		XXXXX XXXXX XXX 0000

R&D Start Grant Agreement Particular Conditions 1

Version 6.1 — Release Date July 2001

Author: R&D Start Program Management

Operative provisions

1. This Grant is made to the Grantee in respect of the Project by the Industry Research and Development Board on behalf of the Commonwealth to the Grantee under the R&D Start Program.

2. The Grant is made pursuant to the Industry Research and Development Xxx 0000 and the relevant Ministerial Directions issued under sections 19 and 20 of that Act.

3. The Grant is made on the terms and conditions of the Grant Agreement, which comprises the General Conditions (version 6.1) and the Particular Conditions (including the schedule).

4. The Grantee acknowledges that it has received and read a copy of the General Conditions (version 6.1), and agrees that the terms and conditions of the General Conditions form part of the Grant Agreement.

5. Terms defined in the General Conditions (version 6.1) have the same meaning in the Particular Conditions.

6. If there is an inconsistency between the Particular Conditions and the General Conditions (version 6.1), the Particular Conditions prevail to the extent of the inconsistency.

R&D Start Grant Agreement Particular Conditions 2

Version 6.1 — Release Date July 2001

Author: R&D Start Program Management

Acceptance of terms

EXECUTED as a deed

Date of deed: 19 September 2003

Commonwealth of Australia

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SIGNED for and on behalf of the

)

COMMONWEALTH OF AUSTRALIA by

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Xxxx Xxxxx a delegate of the INDUSTRY

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RESEARCH AND DEVELOPMENT

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BOARD in the presence of:

)

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/s/ Xxxxx Xxxxxx

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Signature of witness

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)

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Xxxxx Xxxxxx

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Name of witness (block letters)

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/s/ [ILLEGIBLE]

)

)

)

Grantee The terms and conditions pursuant to which the Grant is made are hereby accepted by the Grantee.

THE COMMON SEAL of

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Xxxxxx Operations Pty Ltd

)

is affixed in the presence of:

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/s/ Xxxxx Xxxxxxxxx Xxxxxxx

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/s/ Xxxxx Xxxx Xxxxx

Signature of director

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Signature of secretary

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XXXXX XXXXXXXXX XXXXXXX

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XXXXX XXXX XXXXX

Name of director (block letters)

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Name of secretary (block letters)

)

)

)

)

R&D Start Grant Agreement Particular Conditions 3

Version 6.1 — Release Date July 2001

Author: R&D Start Program Management

The Schedule

1		Project Title		New generation anti-cancer drugs.
2		Project Reference Number		GRA02090
3		Project Duration
		(a) Commencement Date:		25 May 2001
		(b) Completion Date:		31 August 2004
4		Grant		A maximum amount of $3,247,950
5		Grant Percentage of Eligible Expenditure		50%
6		Interest Rates [5.525%] per annum
7		Project Planned Eligible Expenditure by Financial Year

Head of Expenditure		Estimated Expenditure $								Total $
		2001/02		2002/03		2003/04		2004/05
R&D Salary Expenditure		348,000		351,100		354,300		NIL		1,053,400
Contract Expenditure		1,945,000		1,745,000		1,745,000		NIL		5,435,000
Plant Expenditure		NIL		NIL		NIL		NIL		NIL
Prototype Expenditure		NIL		NIL		NIL		NIL		NIL
Other Expenditure		2,500		2,500		2,500		NIL		7,500
Project Eligible Expenditure		2,295,500		2,098,600		2,101,800		NIL		6,495,900
Annual Cap Amount		1,417,380		827,650		840,520		162,400		3,247,950
8    Initial Payment		$621,535

R&D Start Grant Agreement Particular Conditions 4

Version 6.1 — Release Date July 2001

Author: R&D Start Program Management

9 Project Description and Planned Outcomes

The project will compete the development of the company’s topical drug for the treatment of skin cancer and progress the research and development of intracavitary, intralesional and systemic drugs for solid tumours from the company’s novel proprietary compounds.

10 Performance Milestones and Planned Achievement Dates

		Major Milestone		Expected Achievement Date
1		Selection of lead compound.		31 October 2001
2		Successful scale up of plant production		7 December 2001
3		Successful scale up of active ingredient extraction.		4 January 2002
4		Acceptable formulation for clinical trials.		30 September 2002
5		Completion of toxiclogy studies for Phase 1 study.		30 November 2003
6		Acceptance of IND submission for Phase 1 Clinical Trial.		31 December 2003
7		Completion of Phase 1 Clinical Trial.		31 August 2004
8		Completion of phase 2 Clinical Trial.		31 August 2004

11		Retention Amount		$162,400
12		Reports

Review Type		Due Date		Report Period		Audit Report Y/N
Progress		26 January 2002		28 November 2001 to 31 December 2001
Progress		26 April 2002		1 January 2002 to 31 March 2002
Progress		28 July 2002		1 April 2002 to 30 June 2002		Y
Progress		28 October 2002		1 July 2002 to 30 September 2002
Progress		28 January 2003		1 October 2002 to 31 December 2002
Progress		28 April 2003		1 January 2003 to 31 March 2003
Progress		28 July 2003		1 April 2003 to 30 June 2003		Y
Progress		28 October 2003		1 July 2003 to 30 September 2003
Progress		28 January 2004		1 October 2003 to 31 December 2003
Progress		28 April 2004		1 January 2004 to 31 March 2004
Progress		28 July 2004		1 April 2004 to 30 June 2004
Final		28 September 2004		1 July 2004 to 31 August 2004		Y

R&D Start Grant Agreement Particular Conditions 5

Version 6.1 — Release Date July 2001

Author: R&D Start Program Management

Reports must conform with the requirements in the Project Reporting Guide supplied to the Grantee by the Commonwealth, as varied from time to time by the Commonwealth and notified to the Grantee.

Unless the Grantee is otherwise notified by the Commonwealth, commercialisation reports will be required 1, 3 and 5 years after completion of the Project, in the format supplied by the Commonwealth at those times.

13 Notices

Notices must be addressed as follows:

a) if given to the Commonwealth, addressed and forwarded to the Director, AusIndustry State Office, Department of Industry, Science and Resources for the attention of an AusIndustry Customer Service Manager at the following address:

Address: GPO Xxx 0000, XXXXXXXX Xxx 0000

Facsimile No: 3227 4730

Email address: aiqld@industry

or as otherwise notified in writing by an AusIndustry Customer Service Manager;

and

b) if given by the Commonwealth, signed by an authorised delegate of the Industry Research and Development Board and forwarded to the Grantee at the following address:

Xxxxxx Operations Pty Ltd

Xx Xxxxx Xxxxxxx

CEO and Managing Director

XX Xxx 000

XXXXXXXXX XXXXXX XXX 0000

or as otherwise notified in writing by the Grantee.

14		Special Conditions
		None

R&D Start Grant Agreement Particular Conditions 6

Version 6.1 — Release Date July 2001

Author: R&D Start Program Management

NATIONAL BENEFIT INDICATORS — COMMERCIALISATION

The Industry Research and Development (IR&D) Board understands the increasing global nature of business and the need for innovative companies to respond flexibly to market needs. For example, while the IR&D Board is keen to support projects which involve manufacturing or production in Australia, it accepts that there will be instances where Australian manufacture could limit the commercialisation prospects of intellectual property developed with its grant funding. This does not remove the necessity for the commercialisation of project outcomes to provide national benefits.

Set out below are the indicators by which the IR&D Board will assess the level of national benefit contribution to Australia and the Australian economy from the commercialisation of R&D Start projects where commercialisation will not take place in Australia;

•		the commercialisation plan includes Australia being maintained as the home base for future R&D, manufacture or product development;
•		the ongoing development of the commercial outcomes, (product, process or service), arising from R&D activities involves interactions with other firms and research institutions (both domestic and international);
•		the commercialisation of the products, processes or services arising from R&D activities result in an increase in the number of employees in the company’s operations based in Australia;
•		as a result of the commercialisation, Australian residents receive commercial compensation through royalties, licence fees, equity, dividends or outright sale; and
•		production overseas could be considered reasonable as:

Ø local production is demonstrated to be uneconomic in terms of cost structure; and/or

Ø the production or commercialisation requires close physical interaction with overseas companies, customers, suppliers and competitors.

Where a company is proposing to conduct exploitation overseas due to economic viability in terms of cost structure, the Board will consider:

•		the level of commitment to retaining or enhancing the companies R&D facilities in Australia;
•		the degree of globalisation of the relevant industry sector;
•		the relative input costs to production as identified by the company;
•		the relative transport costs as identified by the company;
•		the relative costs of skilled labour as identified by the company; and
•		legal barriers to entry; or
•		any other factors the Board considers relevant.

R&D Start Grant Agreement Particular Conditions 7

Version 6.1 — Release Date July 2001

Author: R&D Start Program Management

Where the company is proposing to conduct exploitation overseas due to close proximity to customers, suppliers and competitors, the Board will consider:

•		the level of commitment to retaining or enhancing the companies R&D facilities in Australia;
•		the mechanisms established to disseminate knowledge and market intelligence from overseas to the companies operations based in Australia;
•		the industry norms in terms of proximity;
•		the level of competition in the industry sector and the need to innovate quickly;
•		the nature of the products’ inputs which require close contact eg perishables, knowledge, etc; and
•		any other factors the Board considers relevant.

R&D Start Grant Agreement Particular Conditions 8

Version 6.1 — Release Date July 2001

Author: R&D Start Program Management