R&D Start Program Grant Agreement Particular Conditions
Exhibit 10.19
Project No: GRA02090
R&D Start Program
Grant Agreement
Grant Agreement
Particular Conditions
Parties |
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Commonwealth of Australia acting |
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through the Industry Research and |
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Development Board |
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ABN 51 835 430 479 |
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(Department of Industry, Science and |
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Resources) |
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Postal address |
OLD State Manager | |
Department of Industry, Tourism and Resources | ||
XXX Xxx 0000 | ||
XXXXXXXX XXX 0000 | ||
The Grantee |
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- 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
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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
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2 | |||
Version 6.1 — Release Date July 2001 | ||||
Author: R&D Start Program Management |
Acceptance of terms
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EXECUTED as a deed |
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Date of deed: 19 September 2003 |
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Commonwealth of Australia
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SIGNED for and on behalf of the
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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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Xxxxx Xxxxxx
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Name of witness (block letters)
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Grantee The terms and conditions pursuant to which the Grant is made are hereby accepted by the Grantee. |
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THE COMMON SEAL of
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Xxxxxx Operations Pty Ltd
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is affixed in the presence of:
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/s/
Xxxxx Xxxxxxxxx Xxxxxxx
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Signature of director
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) | Signature of secretary | ||||||
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XXXXX XXXXXXXXX XXXXXXX
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Name of director (block letters)
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R&D
Start Grant Agreement Particular Conditions
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3 | |||
Version 6.1 — Release Date July 2001 | ||||
Author: R&D Start Program Management |
The Schedule
1
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Project Title | New generation anti-cancer drugs. | ||
2
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Project Reference Number | GRA02090 | ||
3
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Project Duration | |||
(a) Commencement Date: | 25 May 2001 | |||
(b) Completion Date: | 31 August 2004 | |||
4
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Grant | A maximum amount of $3,247,950 | ||
5
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Grant Percentage of Eligible Expenditure | 50% | ||
6
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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
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Initial Payment | $621,535 |
R&D
Start Grant Agreement Particular Conditions
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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 |
Expected Achievement | ||||
Major Milestone | Date | |||
1
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Selection of lead compound. | 31 October 2001 | ||
2
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Successful scale up of plant production | 7 December 2001 | ||
3
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Successful scale up of active ingredient extraction. | 4 January 2002 | ||
4
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Acceptable formulation for clinical trials. | 30 September 2002 | ||
5
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Completion of toxiclogy studies for Phase 1 study. | 30 November 2003 | ||
6
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Acceptance of IND submission for Phase 1 Clinical Trial. | 31 December 2003 | ||
7
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Completion of Phase 1 Clinical Trial. | 31 August 2004 | ||
8
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Completion of phase 2 Clinical Trial. | 31 August 2004 |
11
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Retention Amount | $ | 162,400 | |||
12
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Reports |
Audit | ||||||
Report | ||||||
Review Type | Due Date | Report Period | Y/N | |||
Progress
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26 January 2002 | 28 November 2001 to 31 December 2001 | ||||
Progress
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26 April 2002 | 1 January 2002 to 31 March 2002 | ||||
Progress
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28 July 2002 | 1 April 2002 to 30 June 2002 | Y | |||
Progress
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28 October 2002 | 1 July 2002 to 30 September 2002 | ||||
Progress
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28 January 2003 | 1 October 2002 to 31 December 2002 | ||||
Progress
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28 April 2003 | 1 January 2003 to 31 March 2003 | ||||
Progress
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28 July 2003 | 1 April 2003 to 30 June 2003 | Y | |||
Progress
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28 October 2003 | 1 July 2003 to 30 September 2003 | ||||
Progress
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28 January 2004 | 1 October 2003 to 31 December 2003 | ||||
Progress
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28 April 2004 | 1 January 2004 to 31 March 2004 | ||||
Progress
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28 July 2004 | 1 April 2004 to 30 June 2004 | ||||
Final
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28 September 2004 | 1 July 2004 to 31 August 2004 | Y |
R&D
Start Grant Agreement Particular Conditions
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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
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
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
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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; |
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• | 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); |
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• | 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; |
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• | as a result of the commercialisation, Australian residents receive commercial compensation
through royalties, licence fees, equity, dividends or outright sale; and |
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• | 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
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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
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8 | |||
Version 6.1 — Release Date July 2001 | ||||
Author: R&D Start Program Management |