a short two-to-three day treatment regimen

EX-10.19 19 f32419orexv10w19.htm EXHIBIT 10.19 exv10w19
 

Exhibit 10.19
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
 
  GPO Box 9839
 
  BRISBANE QLD 4001
 
   
The Grantee
   
 
   
- ABN
  Peplin Operations Pty Ltd
- ACN
  69093317367
- postal address
  093 317 367
 
  PO Box 346
 
  FORTITUDE VALLEY QLD 4006
 
   
- business address
  Ground Floor, South Tower
 
  527 Gregory Terrace
 
  BOWEN HILLS QLD 4006
         
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 Act 1986 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
    )          
 
               
SIGNED for and on behalf of the
    )          
COMMONWEALTH OF AUSTRALIA by
    )          
Paul Flynn a delegate of the INDUSTRY
    )          
RESEARCH AND DEVELOPMENT
    )          
BOARD in the presence of:
    )          
 
               
 
    )          
/s/ Bruce Dawson
    )          
 
               
Signature of witness
    )          
 
    )          
 
    )          
Bruce Dawson
    )          
 
               
Name of witness (block letters)
    )     /s/ [ILLEGIBLE]    
 
    )    
 
   
 
    )          
 
    )          
 
               
Grantee
The terms and conditions pursuant to which the Grant is made are hereby accepted by the Grantee.
   
THE COMMON SEAL of
    )          
Peplin Operations Pty Ltd
    )          
is affixed in the presence of:
    )          
 
    )          
/s/ Garry Llewellyn Redlich
    )     /s/ David Legh Craig    
 
               
Signature of director
    )     Signature of secretary    
 
    )          
 
    )          
 
    )          
GARRY LLEWELLYN REDLICH
    )     DAVID LEGH CRAIG    
                 
Name of director (block letters)
    )     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
         
        Expected Achievement
    Major Milestone   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        
             
            Audit
            Report
Review Type   Due Date   Report Period   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 Box 9839, BRISBANE Qld 4001
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:
Peplin Operations Pty Ltd
Mr Garry Redlich
CEO and Managing Director
PO Box 346
FORTITUDE VALLEY QLD 4006
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