Title of each class
|
Name of each exchange on which registered
|
American Depositary Shares,
each representing sixty Ordinary Shares
|
NASDAQ Capital Market
|
U.S. GAAP
☐
|
International Financial Reporting Standards as issued by the International Accounting Standards Board
☒
|
Other
☐
|
5 | ||
5
|
||
5
|
||
5
|
||
A.
|
Selected Consolidated Financial Data
|
5
|
B.
|
Capitalization and Indebtedness
|
6
|
C.
|
Reasons for the Offer and Use of Proceeds
|
6
|
D.
|
Risk Factors
|
7
|
21
|
||
A.
|
History and Development of the Company
|
21
|
B.
|
Business Overview
|
22
|
C.
|
Organizational Structure
|
37
|
D.
|
Property, Plants and Equipment
|
37
|
37
|
||
37
|
||
A.
|
Operating Results
|
37
|
B.
|
Liquidity and Capital Resources
|
43
|
C.
|
Research and Development, Patents and Licenses
|
46
|
D.
|
Trend Information
|
47
|
E.
|
Off-Balance Sheet Arrangements
|
47
|
F.
|
Tabular Disclosure of Contractual Obligations
|
47
|
48
|
||
A.
|
Directors and Senior Management
|
48
|
B.
|
Compensation
|
50
|
C.
|
Board Practices
|
52
|
D.
|
Employees
|
55
|
E.
|
Share Ownership
|
56
|
59
|
||
A.
|
Major Shareholders
|
59
|
B.
|
Related Party Transactions
|
59
|
C.
|
Interests of Experts and Counsel
|
59
|
60
|
||
A.
|
Financial Statements and Other Financial Information
|
60
|
B.
|
Significant Changes
|
60
|
60
|
||
A.
|
Offer and Listing Details
|
60
|
B.
|
Plan of Distribution
|
62
|
C.
|
Markets
|
62
|
D.
|
Selling Shareholders
|
62
|
E.
|
Dilution
|
62
|
F.
|
Expenses of the Issue
|
62
|
62
|
||
A.
|
Share Capital
|
62
|
B.
|
Memorandum and Articles of Association
|
62
|
C.
|
Material Contracts
|
64
|
D.
|
Exchange Controls
|
65
|
E.
|
Taxation
|
66
|
F.
|
Dividends and Paying Agents
|
72
|
G.
|
Statement by Experts
|
72
|
H.
|
Documents on Display
|
72
|
I.
|
Subsidiary Information
|
73
|
73
|
||
74
|
76 | ||
76
|
||
76
|
||
76
|
||
77
|
||
77
|
||
77
|
||
77
|
||
78
|
||
78
|
||
78
|
||
78
|
||
78
|
||
78
|
||
78
|
||
79
|
||
|
81 |
ITEM 1. | IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS |
ITEM 2. | OFFER STATISTICS AND EXPECTED TIMETABLE |
ITEM 3. | KEY INFORMATION |
A. | Selected Consolidated Financial Data |
Statement of Comprehensive Income:
|
||||||||||||||||
Year Ended June 30,
|
||||||||||||||||
2016
|
2015
|
2014
|
2013
|
|||||||||||||
(in A$, except loss per share and number of shares)
|
||||||||||||||||
Revenue from continuing operations
|
142,657
|
176,842
|
363,775
|
150,867
|
||||||||||||
Other income
|
4,753,697
|
6,317,438
|
7,845,396
|
4,488,526
|
||||||||||||
Research and development expenses
|
(9,585,371
|
)
|
(12,298,167
|
)
|
(14,908,098
|
)
|
(8,203,822
|
)
|
||||||||
General and administration expenses
|
(3,610,551
|
)
|
(4,506,122
|
)
|
(4,925,411
|
)
|
(3,793,235
|
)
|
||||||||
Intellectual property expenses
|
(241,954
|
)
|
(257,299
|
)
|
(477,079
|
)
|
(294,894
|
)
|
||||||||
Other operating expenses
|
(45,276
|
)
|
(39,210
|
)
|
(451,251
|
)
|
(257,769
|
)
|
||||||||
Finance expense – ADDF
|
-
|
-
|
(29,978
|
)
|
(17,676
|
)
|
||||||||||
Other gains and losses
|
857,247
|
4,721,449
|
(746,593
|
)
|
140,761
|
|||||||||||
Net loss
|
(7,729,551
|
)
|
(5,885,069
|
)
|
(13,329,239
|
)
|
(7,787,242
|
)
|
||||||||
Loss per share– basic and diluted
|
(1.45
|
)
|
(1.17
|
)
|
(3.11
|
)
|
(2.30
|
)
|
||||||||
Weighted average number of ordinary shares outstanding - basic and diluted
|
533,891,470
|
502,714,982
|
428,047,123
|
338,700,006
|
Balance Sheet Data
|
||||||||||||||||
As at June 30,
|
||||||||||||||||
2016
|
2015
|
2014
|
2013
|
|||||||||||||
(in A$ )
|
||||||||||||||||
Cash and cash equivalents
|
28,593,538
|
34,909,574
|
34,167,018
|
13,346,760
|
||||||||||||
Working capital
|
31,299,470
|
39,025,487
|
37,597,770
|
13,883,965
|
||||||||||||
Total assets
|
33,725,020
|
41,834,382
|
41,640,855
|
17,073,821
|
||||||||||||
Net assets
|
31,367,213
|
39,113,264
|
37,686,287
|
13,974,713
|
||||||||||||
Issued capital
|
146,879,214
|
146,895,714
|
140,009,415
|
101,379,111
|
||||||||||||
Share based payment reserves
|
9,363,181
|
9,363,181
|
8,937,434
|
10,526,925
|
||||||||||||
Accumulated deficit during development stage
|
(124,875,182
|
)
|
(117,145,631
|
)
|
(111,260,562
|
)
|
(97,931,323
|
)
|
||||||||
Total equity
|
31,367,213
|
39,113,264
|
37,686,287
|
13,974,713
|
Year
Ended June 30,
|
At Period End
|
Average Rate
|
High
|
Low
|
||||||||||||
2012
|
1.0161
|
1.0327
|
1.1080
|
0.9387
|
||||||||||||
2013
|
0.9146
|
1.0273
|
1.0624
|
0.9112
|
||||||||||||
2014
|
0.9439
|
0.9183
|
0.9757
|
0.8659
|
||||||||||||
2015
|
0.7655
|
0.8369
|
0.9457
|
0.7580
|
||||||||||||
2016
|
0.7432
|
0.7289
|
0.7817
|
0.6855
|
Month
|
High
|
Low
|
April 2016
|
0.7817
|
0.7504
|
May 2016
|
0.7641
|
0.7184
|
June 2016
|
0.7598
|
0.7225
|
July 2016
|
0.7632
|
0.7453
|
August 2016
|
0.7717
|
0.7516
|
September 2016 (through September 23)
|
0.7470
|
0.7675
|
B. | Capitalization and Indebtedness |
C. | Reasons for the Offer and Use of Proceeds |
D. | Risk Factors |
· | the continued progress of our research and development programs; |
· | the timing, scope, results and costs of pre-clinical studies and clinical trials; |
· | the cost, timing and outcome of regulatory submissions and approvals; |
· | determinations as to the commercial potential of our product candidates; |
· | our ability to successfully expand our contract manufacturing services; |
· | our ability to establish and maintain collaborative arrangements; and |
· | the status and timing of competitive developments. |
· | government or regulatory delays, including delays in obtaining approvals from applicable hospital ethics committees and internal review boards; |
· | slower than expected patient enrollment; |
· | our inability to manufacture sufficient quantities of our new proprietary compound or our other product candidates or matching controls; |
· | unforeseen safety issues; or |
· | lack of efficacy or unacceptable toxicity during the clinical trials or non-clinical studies. |
· | the receipt and timing of regulatory approvals for the uses that we are studying; |
· | the establishment and demonstration to the medical community of the safety, clinical efficacy or cost-effectiveness of our product candidates and their potential advantages over existing therapeutics and technologies; and |
· | the pricing and reimbursement policies of governments and third-party payors. |
· | obtain and maintain patents to protect our own products and technologies; |
· | obtain orphan designation for our products and technologies; |
· | obtain licenses to the patented technologies of third parties; |
· | operate without infringing on the proprietary rights of third parties; and |
· | protect our trade secrets, know-how and other confidential information. |
· | Others may be able to make products that are similar to ours but that are not covered by the claims of the patents that we own. |
· | Others may independently develop similar or alternative technologies or otherwise circumvent any of our technologies without infringing our intellectual property rights. |
· | We or any of our collaboration partners might not have been the first to conceive and reduce to practice the inventions covered by the patents or patent applications that we own, license or will own or license. |
· | We or any of our collaboration partners might not have been the first to file patent applications covering certain of the patents or patent applications that we or they own or have obtained a license, or will own or will have obtained a license. |
· | It is possible that our pending patent applications will not lead to issued patents. |
· | Issued patents that we own may not provide us with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by our competitors. |
· | Our competitors might conduct research and development activities in countries where we do not have patent rights, or in countries where research and development safe harbor laws exist, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets. |
· | The patents of third parties or pending or future applications of third parties, if issued, may have an adverse effect on our business. |
· | Compulsory licensing provisions of certain governments to patented technologies that are deemed necessary for the government to access. |
· | the results of pre-clinical testing and clinical trials by us and our competitors; |
· | developments concerning research and development, manufacturing, and marketing alliances or collaborations by us and our competitors; |
· | announcements of technological innovations or new commercial products by us and our competitors; |
· | determinations regarding our patent applications, patents and those of others; |
· | publicity regarding actual or potential results relating to medicinal products under development by us and our competitors; |
· | proposed governmental regulations and developments in Australia, the United States and elsewhere; |
· | litigation; |
· | economic and other external factors; and |
· | period-to-period fluctuations in our operating results. |
A. | History and Development of the Company |
B. | Business Overview |
· | The Massachusetts General Hospital, Genetics and Aging Unit in Boston. Massachusetts General Hospital is the largest teaching hospital for Harvard Medical School; |
· | University of California, San Francisco; |
· | The University of Melbourne, Department of Pathology; and |
· | The Florey Institute of Neuroscience and Mental Health in Melbourne. |
v | Preservation of motor function in animal models of Parkinson's disease created by administration of the Parkinsonian toxins (MPTP) and 6-OHDA. |
v | Significantly improved motor function and coordination as tested by the ability of MSA mice to remain on a rotating rod. Indeed this improvement has been sustained for five months and resulted in a reduction in the accumulation of the insoluble forms of α-synuclein. |
v | In TgA53T, a generic model of synucleinopathy, to investigate Dementia with Lewy Bodies, animals treated with PBT434 exhibited significantly increased numbers of s.nigra neurons and a s ignificant reduction in insoluble α-synuclein and incidence of clasping behavior. Cognition evaluated using the Y-Maze is also significantly improved. |
v | In mutant overexpressing tau mice, rTg4510, PBT434 has demonstrated highly significant improvement in the Y-maze cognitive assessment and resulted in a significant reduction in the number of abnormal tau deposits in the hippocampus of 12 month old mice. |
v | Significant reduction in the levels of α-synuclein and tau in the cerebrospinal fluid (CSF) sampled from normal healthy rats within 4 hours and a reduction in α-synuclein (non-significant) in CSF of dogs over a 28-day period. |
1. | A drug to drug interaction study, ‘PBT2-104’. Based on in vitro metabolism studies indicating that PBT2 is both a substrate for, and an inhibitor of, CYP1A2, this study was designed to investigate the potential for drug to drug interactions in healthy volunteers when PBT2 is concurrently administered with other agents metabolized by this CYP450 isozyme. |
2. | A food interaction Study, PBT2-103’. Healthy volunteers were randomized into 2 dosing groups; one which was administered 250mg PBT2 after a 12 hour fast, the other which was administered 250mg PBT2 after a prescribed FDA meal. Blood samples were taken over multiple time points over 24 hours to determine the pharmacokinetic profile of PBT2 and its metabolites. |
3. | Evaluation of the three pharmacokinetic parameters, absorption, metabolism and excretion (ADME) of [C]-PBT2 and to estimate the Absolute Bioavailability of PBT2 in healthy volunteers, ‘PBT2-102’ to understand the passage of the drug in humans after administration. |
(i) | In October 2015, Prana achieved Allowance of patent claims in the USA covering the use of PBT2 for the treatment of Huntington’s disease. These claims provide a second level of protection, in addition to the successfully Granted composition of matter claims to PBT2 in a related application. |
(ii) | In August 2015, Prana filed a second Continuation Application in the USA, with claims seeking coverage of the use of 8-hydroxyquinoline compounds, other than PBT2 for the treatment of Huntington disease. This case is currently in active prosecution with the USPTO. |
(iii) | In September 2015, Prana received Notice of Grant from the United States patent office in relation to the patent family entitled ‘Quinazolinone compounds’, which covers selected novel chemical drug candidates related to PBT434. |
(iv) | In August 2015, Prana filed a Continuation Application, with claims directed to the use of Quinazolinone compounds for the treatment of neurological diseases. This case is also in active prosecution with the USPTO. |
(v) | In December 2015, Prana filed a PCT application directed to 4H-Pyrido(1,2-a) Pyrimidin-4-one compounds, which are novel MPAC compounds for the treatment of neurodegenerative diseases. |
(vi) | In March 2016 Prana re-filed two Australian provisional patent applications directed to novel methods of synthesizing compounds including the candidate PBT434 and compounds of similar structure. These patents are titled ‘A method of the production of 2-substituted-3H-quinazolin-4-ones-I and ‘A method of the production of 2-substituted-3H-quinazolin-4-ones-II’. |
(vii) | The patent family cases entitled ‘Compounds for Therapy and Diagnosis’ continues to be prosecuted Europe, with a case in Canada proceeding to Acceptance. This case includes composition of matter claims to novel non-MPAC metallocomplex compounds that are designed to treat Alzheimer’s disease by binding to the metal binding site of Abeta in the brain. The case also covers the use of these metallocomplexes as imaging agents for Alzheimer’s disease. |
(viii) | An Australian provisional patent application entitled ‘Processes for the preparation of an 8-Hydroxyquinoline derivative’ has been re-filed in January 2016 to cover alternative synthetic routes to selected 8-Hydroxyquinolines . |
PATENT
|
STATUS
|
INVENTION
|
“Beta amyloid peptide inhibitors”
Filed: July 21, 2000
Applicant: Biomolecular Research Institute and University of Melbourne
Assigned to Prana Biotechnology Limited
|
Patents have been granted in the USA, Canada and Australia.
|
The invention encompasses claims to specific classes of metallocomplex agents capable of inhibiting binding of specified metal ions to the N-terminus of beta-amyloid and the use of these agents in the treatment of amyloid related conditions including Alzheimer’s Disease.
|
“Neurotoxic Oligomers”
Filed: June 28, 2000
Applicants: Prana Biotechnology Limited and The General Hospital Corporation
|
Patents have been Granted in Australia, New Zealand, Canada, China and the USA (2). A case has been granted in Europe and has been validated in separate countries.
|
The invention is directed to an immunotherapy strategy using or targeting tyrosine cross-linked protein aggregates. The approach may be used in the treatment of Alzheimer’s Disease and other amyloid related conditions.
|
“8-Hydroxyquinoline Derivatives”
Filed: July 16, 2003
Applicant: Prana Biotechnology Limited
|
Patents in Europe, the USA, New Zealand, Canada, Japan, Russia, Singapore, South Korea, Australia, Israel, China, Mexico and South Africa have been Granted. A patent in Hong Kong has been registered. Applications in India and Brazil are under examination. A Continuation Application in the USA is also under examination.
|
The invention is directed to chemical scaffolds of the 8-Hydroxyquinoline MPAC class and their utility in the treatment of neurological conditions.
|
“Neurologically-Active Compounds”
Filed: October 3, 2003
Applicant: Prana Biotechnology Limited
|
Patents in the USA, New Zealand, Canada, Japan, Mexico, India, Australia, China, South Korea, Japan, Israel, South Africa and Singapore have been granted. A case has been granted in Europe and has been validated in separate countries. An application in Brazil is under examination. A patent in Hong Kong has been registered.
|
The invention is directed to alternative MPAC chemical structures and their utility in the treatment of neurological conditions.
|
“Quinazolinone compounds”
Filed: 24 December 2008
Applicant: Prana Biotechnology Limited
|
Patents have been granted in Japan and the USA. An application in the USA is undergoing prosecution. Cases in Australia and Europe have been Accepted.
|
This invention is directed to novel MPAC compounds and to selected MPAC’s used in the treatment of Parkinson’s Disease.
|
“4H-Pyrido(1,2-a) Pyrimiidin-4-one compounds”
Filed: 2 December 2014 (prov)
Applicant: Prana Biotechnology Limited
|
A PCT patent application has been filed.
|
This invention is directed to novel MPAC compounds for the treatment of neurodegenerative diseases.
|
“A method of the production of 2-substituted-3H-quinazolin-4-ones-I”
Filed: 12 March 2016
Applicant: Prana Biotechnology Limited
|
An Australian provisional application has been refiled.
|
This invention is directed to synthetic routes for quinazolinone compounds.
|
“A method of the production of 2-substituted-3H-quinazolin-4-ones-II”
Filed: 12 March 2016
Applicant: Prana Biotechnology Limited
|
An Australian provisional application has been refiled.
|
This invention is directed to synthetic routes for quinazolinone compounds.
|
C. | Organizational Structure |
D. | Property, Plants and Equipment |
ITEM 5. | OPERATING AND FINANCIAL REVIEW AND PROSPECTS |
A. | Operating Results |
· | the technical feasibility of completing the intangible asset so that it will be available for use or sale; |
· | the intention to complete the intangible asset and use or sell it; |
· | the ability to use or sell the intangible asset; |
· | how the intangible asset will generate probable future economic benefits; |
· | the availability of adequate technical, financial and other resources to complete the development and to use or sell the intangible asset; and |
· | the ability to measure reliably the expenditure attributable to the intangible asset during its development. |
B. | Liquidity and Capital Resources |
· | Core activities, which are experimental activities whose outcome cannot be known or determined in advance, but can only be determined by applying a systematic progression of work; |
· | Core activities conducted for the purpose of generating new knowledge (including new knowledge in the form of new or improved processes and materials); or |
· | Supporting activities that are directly related and designed to support the above). |
Year ended June 30,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
(A$) | ||||||||||||
Net cash used in operating activities
|
(7,418,526
|
)
|
(10,871,074
|
)
|
(13,536,223
|
)
|
||||||
Net cash used in investing activities
|
(833
|
)
|
(182,834
|
)
|
(23,048
|
)
|
||||||
Net cash provided by financing activities
|
-
|
6,843,211
|
34,960,792
|
|||||||||
Net increase (decrease) in cash and cash equivalents
|
(7,419,359
|
)
|
(4,210,697
|
)
|
21,401,521
|
|||||||
Cash and cash equivalents at beginning of period
|
34,909,574
|
34,167,018
|
13,346,760
|
|||||||||
Redemption of security deposit
|
152,603
|
-
|
-
|
|||||||||
Exchange rate adjustments on cash held in foreign currencies
|
950,720
|
4,953,253
|
(581,263
|
)
|
||||||||
Cash and cash equivalents at end of period
|
28,593,538
|
34,909,574
|
34,167,018
|
Contractual Obligations
|
Payments due by period
|
|||||||||||||||||||
|
Total
|
less than 1 year
|
1-3 years
|
3-5
Years
|
more than
5 years |
|||||||||||||||
Operating lease obligations
|
193,940
|
145,610
|
48,330
|
-
|
-
|
|||||||||||||||
Total
|
193,940
|
145,610
|
48,330
|
-
|
-
|
A. | Directors and Senior Management |
Name
|
Age
|
Position
|
||
Geoffrey P. Kempler
|
60
|
Chairman of the Board of Directors and Chief Executive Officer
|
||
Kathryn Andrews
|
48
|
Chief Financial Officer
|
||
Phillip A. Hains
|
55
|
Company Secretary
|
||
Dianne M. Angus
|
55
|
Chief Operating Officer
|
||
Peter A. Marks(1)
|
59
|
Director
|
||
Brian D. Meltzer(1)(2)(3)
|
61
|
Director
|
||
George W. Mihaly(1)(2)(3)
|
62
|
Director
|
||
Lawrence B. Gozlan(3)
|
36
|
Director
|
||
Ira Shoulson
|
69
|
Director
|
B. | Compensation |
Salaries, fees,
commissions, bonuses and other |
Pension, retirement and other similar
benefits |
|||||||
Geoffrey P. Kempler (1)
|
$
|
A486,372
|
--
|
|||||
Dianne M. Angus
|
$
|
A
378,658
|
--
|
|||||
Kathryn Andrews (1)
|
$
|
A
136,429
|
--
|
|||||
Peter A. Marks
|
$
|
A60,000
|
--
|
|||||
Brian D. Meltzer
|
$
|
A85,000
|
--
|
|||||
George W. Mihaly
|
$
|
A75,000
|
--
|
|||||
Lawrence B. Gozlan
|
$
|
A
60,000
|
--
|
|||||
Ira Shoulson (2)
|
$
|
A
303,474
|
--
|
(1) | Base Fee includes movements in annual leave provision for Mr. Kempler, Ms. Angus and Ms. Andrews accrued in accordance with their employment contracts. |
(2) | Prof. Ira Shoulson provides consulting services to our company in a separate capacity to his position as Non-Executive Director. Total cash compensation of $258,474 was paid to Prof. Ira Shoulson during the 2016 fiscal year in his capacity as a consultant to our company. |
· | By our company without cause (as defined in the agreement) or by Mr. Kempler with good reason (as defined in the agreement), he will be entitled to: (i) the sum of A$1 million provided we have sufficient capital requirements to fulfill this obligation within 90 days of termination date; (ii) business expenses that have not been reimbursed and accrued and unused vacation days; and (iii) the acceleration of the vesting of any unvested options to purchase ordinary shares which may be purchased during the remainder of the exercise period of such options. |
· | By our company with cause (as defined in the agreement) or by Mr. Kempler without good reason (as defined in the agreement), he will be entitled to business expenses that have not been reimbursed and accrued and unused vacation days. Mr. Kempler will only be permitted to exercise unvested options to purchase shares that had been granted to him prior to the employment agreement. |
· | Due to death or disability (as defined in the agreement), we shall pay Mr. Kempler or his estate, as applicable, all accrued base salary, pro-rata bonus, business expenses that have not been reimbursed and accrued, unused vacation days (and in the case of disability, less such amounts under any disability policy maintained by our company). Mr. Kempler or his estate, as applicable, will be entitled to exercise vested options for ordinary shares. |
C. | Board Practices |
· | incurred by the person in his or her capacity as an officer of our company or a subsidiary of our company provided that the liability does not arise out of a conduct involving a willful breach of duty in relation to our company or a subsidiary of our company; or |
· | for costs and expenses incurred by that person defending proceedings, whatever their outcome. |
D. | Employees |
A. | Share Ownership |
Name
|
Number of Ordinary Shares Beneficially Owned
(1)
|
Percentage of Ownership
(2)
|
||||||
Geoffrey P. Kempler
(3)
|
22,011,000
|
4.05
|
%
|
|||||
Kathryn Andrews
|
-
|
*
|
||||||
Dianne M. Angus
(4)
|
1,463,947
|
*
|
||||||
Peter A. Marks
(5)
|
1,043,111
|
*
|
||||||
Brian D. Meltzer
(6)
|
1,326,666
|
*
|
||||||
George W. Mihaly
(7)
|
1,226,666
|
*
|
||||||
Lawrence B. Gozlan
(8)
|
1,000,000
|
*
|
||||||
Ira Shoulson
|
-
|
*
|
||||||
All directors and executive officers as a group (9 persons)
|
28,071,390
|
5.17
|
%
|
* | Less than 1% |
1. | Beneficial ownership is determined in accordance with the rules of the Securities and Exchange Commission, and generally includes voting or investment power with respect to securities. Ordinary shares relating to options currently exercisable or exercisable within 60 days of the date of the above table are deemed outstanding for computing the percentage of the person holding such securities but are not deemed outstanding for computing the percentage of any other person. Except as indicated by footnote, and subject to community property laws where applicable, the persons named in the table above have sole voting and investment power with respect to all shares shown as beneficially owned by them. |
2. | The percentages shown are based on 543,209,289 consisting of 533,891,470 ordinary shares and 9,317,819 unlisted options, issued and outstanding as of October 3, 2016. |
3. | Includes options to purchase 4,000,000 ordinary shares that are exercisable for A$0.33 consideration on or before December 13, 2017. Of the 18,011,000 outstanding ordinary shares, 30,000 ordinary shares are held of record by Mr. Kempler, 14,165,000 ordinary shares are held by Baywick Pty Ltd., an Australian corporation owned by Mr. Kempler, 156,000 ordinary shares are held by Sadarajak Pty Ltd., an Australian corporation owned by Mr. Kempler, 90,000 ordinary shares are held of record by Crystal Triangle Pty Ltd., an Australian corporation owned by Mr. Kempler and 2,970,000 ordinary shares are held of record by NRB Developments Pty Ltd., an Australian corporation in which Mr. Kempler holds a 50% interest, 600,000 ordinary shares are held of record by Sandhurst Trustees Ltd. Mr. Kempler may be deemed to be the beneficial owner of the ordinary shares held of record by Baywick Pty Ltd., Crystal Triangle Pty Ltd., NRB Developments Pty Ltd. and Sandhurst Trustees Ltd. |
4. | Includes (i) options to purchase 160,000 ordinary shares that are exercisable for A$0.73 consideration on or before November 3, 2018; (ii) options to purchase 157,819 ordinary shares that are exercisable for A$0.25 consideration on or before March 20, 2017; (iii) options to purchase 1,000,000 ordinary shares that are exercisable for A$0.34 consideration on or before October 2, 2018; and (iv) 146,128 outstanding ordinary shares held of record by Ms. Dianne Angus. |
5. | Includes options to purchase 1,000,000 ordinary shares that are exercisable for A$0.33 consideration on or before December 13, 2017. The 43,111 outstanding ordinary shares are held of record by Lampam Pty Ltd., an Australian corporation owned by Mr. Peter Marks. |
6. | Includes options to purchase 1,000,000 ordinary shares that are exercisable for A$0.33 consideration on or before December 13, 2017. The 326,666 outstanding ordinary shares are held of record by Navigator Australia Ltd., a superannuation fund of Mr. Meltzer. |
7. | Includes options to purchase 1,000,000 ordinary shares that are exercisable for A$0.33 consideration on or before December 13, 2017. Of the 226,666 outstanding ordinary shares, 166,666 ordinary shares are held of record by Dr. Mihaly, 52,000 ordinary shares are held of record by Waide Pty Ltd., an Australian corporation owned by Dr. Mihaly, and 4,000 ordinary shares are held of record by each of Kieren Mihaly and Warwick Mihaly, Dr. Mihaly’s sons. Dr. Mihaly disclaims beneficial ownership of the ordinary shares held by his sons, Kieren Mihaly and Warwick Mihaly. |
8. | Includes options to purchase 1,000,000 ordinary shares that are exercisable for A$0.33 consideration on or before December 13, 2017. |
As of June 30,
|
|||||||||||||||||||||
2016
|
2015
|
2014
|
|||||||||||||||||||
Amount
|
Weighted
average
exercise
price
|
Amount
|
Weighted
average
exercise
price
|
Amount
|
Weighted
average
exercise
price
|
||||||||||||||||
Options outstanding at the beginning of the year…
|
19,395,582
|
16,375,582
|
$
|
0.41
|
17,031,476
|
$
|
0.23
|
||||||||||||||
Granted
|
4,400,000
|
$
|
0.28
|
3,926,490
|
$
|
0.69
|
|||||||||||||||
Exercised
|
(180,000
|
)
|
--
|
(4,582,384
|
)
|
$
|
0.11
|
||||||||||||||
Expired
|
(1,000,000
|
)
|
--
|
--
|
--
|
||||||||||||||||
Lapsed
|
(200,000
|
)
|
--
|
--
|
--
|
||||||||||||||||
Options outstanding at the end of the year
|
19,395,582
|
$
|
0.38
|
16,375,582
|
$
|
0.41
|
|||||||||||||||
Options exercisable at the end of the year
|
19,395,582
|
19,395,582
|
$
|
0.38
|
16,175,582
|
$
|
0.40
|
||||||||||||||
Options that may be granted as of the end of the year
|
15,319,202
|
15,319,202
|
19,629,202
|
A. | Major Shareholders |
B. | Related Party Transactions |
A. | Interests of Experts and Counsel |
A. | Financial Statements and Other Financial Information |
B. | Significant Changes |
ITEM 9. | THE OFFER AND LISTING |
A. | Offer and Listing Details |
Per Ordinary Share (A$)
|
||||||||
High
|
Low
|
|||||||
Fiscal Year Ended June 30,
|
||||||||
2012
|
0.22
|
0.14
|
||||||
2013
|
0.31
|
0.14
|
||||||
2014
|
1.37
|
0.16
|
||||||
2015
|
0.36
|
0.14
|
||||||
2016
|
0.17
|
0.06
|
||||||
Fiscal Year Ended June 30, 2014:
|
||||||||
First Quarter
|
0.74
|
0.24
|
||||||
Second Quarter
|
0.85
|
0.38
|
||||||
Third Quarter
|
1.37
|
0.62
|
||||||
Fourth Quarter
|
0.30
|
0.16
|
||||||
Fiscal Year Ended June 30, 2015:
|
||||||||
First Quarter
|
0.36
|
0.22
|
||||||
Second Quarter
|
0.25
|
0.17
|
||||||
Third Quarter
|
0.22
|
0.14
|
||||||
Fourth Quarter
|
0.26
|
0.14
|
||||||
Fiscal Year Ended June 30, 2016:
|
||||||||
First Quarter
|
0.18
|
0.13
|
||||||
Second Quarter
|
0.14
|
0.10
|
||||||
Third Quarter
|
0.11
|
0.06
|
||||||
Fourth Quarter
|
0.12
|
0.06
|
||||||
Month Ended:
|
||||||||
April 2016
|
0.09
|
0.06
|
||||||
May 2016
|
0.09
|
0.08
|
||||||
June 2016
|
0.12
|
0.08
|
||||||
July 2016
|
0.11
|
0.10
|
||||||
August 2016
|
0.15
|
0.09
|
||||||
September 2016
|
0.12
|
0.09
|
Per ADS (U.S. $)
|
||||||||
High
1
|
Low
1
|
|||||||
Fiscal Year Ended June 30,
|
||||||||
2012
|
13.86
|
8.40
|
||||||
2013
|
18.36
|
9.00
|
||||||
2014
|
79.74
|
8.82
|
||||||
2015
|
17.64
|
6.42
|
||||||
2016
|
7.68
|
2.70
|
||||||
Fiscal Year Ended June 30, 2014:
|
||||||||
First Quarter
|
39.00
|
13.86
|
||||||
Second Quarter
|
47.22
|
21.72
|
||||||
Third Quarter
|
79.74
|
16.68
|
||||||
Fourth Quarter
|
16.26
|
8.82
|
||||||
Fiscal Year Ended June 30, 2015:
|
||||||||
First Quarter
|
17.64
|
11.58
|
||||||
Second Quarter
|
13.74
|
8.40
|
||||||
Third Quarter
|
10.26
|
6.42
|
||||||
Fourth Quarter
|
11.10
|
6.48
|
||||||
Fiscal Year Ended June 30, 2016:
|
||||||||
First Quarter
|
7.68
|
4.20
|
||||||
Second Quarter
|
6.42
|
4.08
|
||||||
Third Quarter
|
4.50
|
2.70
|
||||||
Fourth Quarter
|
5.14
|
2.79
|
||||||
Month Ended:
|
||||||||
April 2016
|
4.01
|
2.79
|
||||||
May 2016
|
3.99
|
3.60
|
||||||
June 2016
|
5.14
|
3.65
|
||||||
July 2016
|
5.04
|
4.25
|
||||||
August 2016
|
6.69
|
4.30
|
||||||
September 2016
|
5.39
|
4.38
|
B. | Plan of Distribution |
C. | Markets |
D. | Selling Shareholders |
E. | Dilution |
F. | Expenses of the Issue |
A. | Share Capital |
B. | Memorandum and Articles of Association |
C. | Material Contracts |
D. | Exchange Controls |
E. | Taxation |
· | Retain access to the full CGT discount for discount capital gains of foreign resident individuals in respect of the increase in the value of a CGT asset that occurred before 9 May 2013; and |
· | Remove the CGT discount for discount capital gains for foreign resident individuals that arise after 8 May 2013. |
· | you will be required to allocate “excess distributions” or gain recognized upon the disposition of ADRs ratably over your holding period for the ADSs. An “excess distribution” is the amount by which distributions during a taxable year in respect of an ADS exceed 125% of the average annual distributions during the three preceding taxable years (or, if shorter, your holding period for the ADSs). |
· | the amount allocated to each year during which we are considered a PFIC, other than the year of the distribution or disposition, will be subject to tax at the highest individual or corporate tax rate, as the case may be, in effect for that year and an interest charge will be imposed with respect to the resulting tax liability allocated to each such year, |
· | the amount allocated to the current taxable year and any taxable year before we became a PFIC will be taxable as ordinary income in the current year, and |
· | you will be required to file an annual return on IRS Form 8621. |
· | a direct or indirect owner of a pass-through entity, including a trust or estate, that is a direct or indirect shareholder of a PFIC, |
· | a shareholder of a PFIC that is a shareholder of another PFIC, or |
· | a 50%-or-more shareholder of a foreign corporation that is not a PFIC and that directly or indirectly owns stock of a PFIC. |
F. | Dividends and Paying Agents |
G. | Statement by Experts |
H. | Documents on Display |
I. | Subsidiary Information |
Persons Depositing or Withdrawing Shares Must Pay:
|
|
For:
|
|
||
• US$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)
|
|
• Issuance of ADSs, including issuances resulting from a distribution of shares or rights or other property
• Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates
|
• US$0.005 (or less) per ADS
|
|
• Any cash distribution to you
|
• A fee equivalent to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance of ADSs
|
|
• Distribution of securities distributed to holders of deposited securities which are distributed by the depositary to ADS holders
|
• US$1.50 (or less) per ADS
|
|
• Transfers,
combination and split-up of ADSs
|
• Expenses of the depositary
|
|
• Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement)
• Converting foreign currency to U.S. dollars
|
• Taxes and other governmental charges the depositary or the custodian have to pay on any ADS or share underlying an ADS, for example, stock transfer taxes, stamp duty or withholding taxes
|
|
• As necessary
|
• Any charges incurred by the depositary or its agents for servicing the deposited securities
|
|
• As necessary
|
ITEM 13. | DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES |
ITEM 14. | MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS |
ITEM 15. | CONTROLS AND PROCEDURES |
· | pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company; |
· | provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and |
· | provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use of disposition of the company’s assets that could have a material effect on the financial statements. |
Year Ended June 30,
|
||||||||
Services Rendered
|
2016
|
2015
|
||||||
Audit (1)
|
$
|
A166,479
|
$
|
A160,158
|
||||
Audit-Related (2)
|
$
|
A38,297
|
$
|
A256,113
|
||||
Other (3)
|
-
|
$
|
A83,640
|
|||||
Total
|
$
|
A204,776
|
$
|
A499,911
|
ITEM 17. | FINANCIAL STATEMENTS |
ITEM 18. | FINANCIAL STATEMENTS |
Page
|
|
Index to Consolidated Financial Statements
|
F-1
|
Report of Independent Registered Public Accounting Firm
|
F-2
|
Consolidated
Statements of Financial Position
|
F-3
|
Consolidated
Statements of Profit or Loss and Other Comprehensive Income
|
F-4
|
Consolidated Cash Flow Statements
|
F-5
|
Consolidated Statements of Changes in Shareholders’ Equity
|
F-6
|
Notes to Consolidated Financial Statements
|
F-7
|
Exhibit
Number
|
|
Exhibit Description
|
|
Incorporated by
Reference |
||||
|
|
Form
|
|
Exhibit
|
|
Filing Date/
Period End
Date
|
||
1
|
|
Constitution of Registrant.
|
|
20-F
|
|
1.1
|
|
6/30/09
|
2.1
|
|
Deposit Agreement dated March 23, 2001, as amended and restated as of December 21, 2007, among the Registrant, the Bank of New York, as Depositary, and owners and holders from time to time of ADRs issued thereunder, including the Form of American Depositary Receipts.
|
|
F-6 POS
|
|
1
|
|
12/21/07
|
4.1
|
License Agreement dated January 1, 2001, between the Registrant and The General Hospital Corporation.
|
20-F
|
5/29/02
|
|||||
4.2
|
|
Variation Agreement dated August 8, 2001, between the Registrant and The General Hospital Corporation, which amends the License Agreement dated January 1, 2001, between the parties.
|
|
20-F
|
|
|
5/29/02
|
|
4.3
|
|
Agreement to Provide Accounting, Administration, Corporate Advice and Company Secretarial Services dated February 23, 2000, between the Registrant and Malvern Administrative Services (now The CFO solution).
|
|
20-F
|
|
|
5/29/02
|
|
4.4
|
|
Second Amendment to Exclusive License Agreement dated January 1, 2001, between the Registrant and The General Hospital Corporation dated March 15, 2004.
|
|
20-F
|
|
4.6
|
|
6/30/04
|
4.5
|
|
Settlement Agreement dated July 28, 2004, among the Registrant, P.N. Gerolymatos S.A, or PNG, Mr. Gerolymatos, GHC, Professor Ashley Bush, Dr. Rudolph Tanzi and Dr. Robert Cherny and the ancillary agreements of even date therewith exhibited thereto, including the Patent Assignment and Settlement Agreement among the Registrant and PNG, Patent Rights Security Agreement among the Registrant and PNG and the Derivatives Agreement among the Registrant and PNG.
|
|
20-F
|
|
4.21
|
|
6/30/04
|
4.6
|
|
Prana Biotechnology Limited, 2004 American Depository Share (ADS) Option Plan.
|
|
6-K
|
|
Annexure A
|
|
11/3/04
|
to Item 1
|
||||||||
4.7
|
Prana Biotechnology Limited, 2004 Employees’, Directors’ and Consultants’ Share and Option Plan.
|
6-K
|
Annexure B
|
11/3/04
|
||||
to Item 1
|
||||||||
4.8
|
Fourth Research Funding and Intellectual Property Assignment Agreement dated December 1, 2009.
|
20-F
|
4.9
|
6/30/12
|
||||
4.9
|
Fifth Research Funding and Intellectual Property Assignment Agreement dated December 1, 2012.
|
20-F
|
4.9
|
6/30/13
|
||||
4.10*
|
Sixth Research Funding and Intellectual Property Assignment Agreement dated November 7, 2014.
|
|||||||
4.11
|
Employment Agreement dated September 21, 2007, among the Registrant and Mr. Kempler.
|
20-F
|
4.19
|
6/30/07
|
4.12
|
Letter Agreements effective as of June 12, 2007 between the Registrant and Ms. Dianne Angus.
|
20-F
|
4.21
|
6/30/07
|
||||
4.13
|
Placement Confirmation Letter dated September 8, 2009, between the Registrant and BAM Capital LLC.
|
20-F
|
4.25
|
6/30/07
|
||||
4.14
|
Manufacturing Services Agreement for PBT2 HCI Supply dated August 19, 2013 between the Registrant and Dr. Reddy’s Laboratories Limited.
|
20-F
|
4.30
|
6/30/13
|
||||
4.15
|
Amendments to Manufacturing Services Agreement for PBT2 HCI Supply dated August 19, 2013 between the Registrant and Dr. Reddy’s Laboratories Limited, as amended: Amendment No. 1 effective September 26, 2013; and Amendment No. 2 effective August 31, 2013.
|
20-F
|
4.35
|
6/30/14
|
||||
4.16
|
Manufacturing Services Agreement for PBT434 API supply dated March 28, 2014
|
20-F
|
4.36
|
6/30/14
|
||||
4.17
|
Master Service Agreement between the Registrant and Certara Portugal dated January 22, 2015
|
20-F
|
4.17
|
6/30/15
|
||||
4.18
|
Master Service Agreement between the Registrant and d3 Medicine LLC dated March 17, 2015
|
20-F
|
4.18
|
6/30/15
|
||||
4.19*
|
Master Service Agreement between the Registrant and Orgapharm S.A.S. dated September 21, 2015.
|
|
||||||
4.20*
|
Master Service Agreement between the Registrant and IDT Australia Limited dated September 1, 2015
|
|
||||||
8.1*
|
|
List of Subsidiaries of the Registrant.
|
|
|
|
|||
12.1*
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act, as amended.
|
|||||||
12.2*
|
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act, as amended.
|
|
|
|
|||
13.1*
|
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|||
13.2*
|
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|||
15.1*
|
|
Consent of PricewaterhouseCoopers.
|
|
|
|
Page Number
|
|
F-2
|
|
F-3
|
|
F-4
|
|
F-5
|
|
F-6
|
|
F-7
|
June 30,
|
||||||||||||
Notes
|
2016
|
2015
|
||||||||||
Assets
|
||||||||||||
Current Assets
|
||||||||||||
Cash and cash equivalents
|
28,593,538
|
34,909,574
|
||||||||||
Trade and other receivables
|
5
|
4,786,765
|
6,521,154
|
|||||||||
Other current assets
|
6
|
276,504
|
313,465
|
|||||||||
Total Current Assets
|
33,656,807
|
41,744,193
|
||||||||||
Non-Current Assets
|
||||||||||||
Property and equipment, net of accumulated depreciation of A$329,541 and $322,342, respectively
|
7
|
24,225
|
44,727
|
|||||||||
Other non-current assets
|
6
|
43,988
|
45,462
|
|||||||||
Total Non-Current Assets
|
68,213
|
90,189
|
||||||||||
Total Assets
|
33,725,020
|
41,834,382
|
||||||||||
Liabilities
|
||||||||||||
Current Liabilities
|
||||||||||||
Trade and other payables
|
8
|
1,748,566
|
2,152,015
|
|||||||||
Other financial liabilities
|
9
|
-
|
12,076
|
|||||||||
Provisions
|
10
|
608,771
|
554,615
|
|||||||||
Total Current Liabilities
|
2,357,337
|
2,718,706
|
||||||||||
Non-Current Liabilities
|
||||||||||||
Provisions
|
10
|
470
|
2,412
|
|||||||||
Total Non-Current Liabilities
|
470
|
2,412
|
||||||||||
Total Liabilities
|
2,357,807
|
2,721,118
|
||||||||||
Net Assets
|
31,367,213
|
39,113,264
|
||||||||||
Equity
|
||||||||||||
Issued capital
2016: 533,891,470 fully paid ordinary shares
Nil options over fully paid ordinary shares
2015: 533,891,470 fully paid ordinary shares
Nil options over fully paid ordinary shares
|
12
|
146,879,214
|
146,895,714
|
|||||||||
Reserves
|
13
|
9,363,181
|
9,363,181
|
|||||||||
Accumulated deficit during the development stage
|
14
|
(124,875,182
|
)
|
(117,145,631
|
)
|
|||||||
Total Equity
|
31,367,213
|
39,113,264
|
Years ended
June 30,
|
||||||||||||||||
Notes
|
2016
|
2015
|
2014
|
|||||||||||||
Revenues from ordinary activities
|
2
|
142,657
|
176,842
|
363,775
|
||||||||||||
Other income
|
2
|
4,753,697
|
6,317,438
|
7,845,396
|
||||||||||||
Intellectual property expenses
|
(241,954
|
)
|
(257,299
|
)
|
(477,079
|
)
|
||||||||||
General and administration expenses
|
3
|
(3,610,551
|
)
|
(4,506,122
|
)
|
(4,925,411
|
)
|
|||||||||
Research and development expenses
|
3
|
(9,585,371
|
)
|
(12,298,167
|
)
|
(14,908,098
|
)
|
|||||||||
Finance expenses
|
-
|
-
|
(29,978
|
)
|
||||||||||||
Other operating expenses
|
(45,276
|
)
|
(39,210
|
)
|
(451,251
|
)
|
||||||||||
Other gains and losses
|
3
|
857,247
|
4,721,449
|
(746,593
|
)
|
|||||||||||
Loss before income tax expense
|
(7,729,551
|
)
|
(5,885,069
|
)
|
(13,329,239
|
)
|
||||||||||
Income tax expense
|
4
|
-
|
-
|
-
|
||||||||||||
Loss for the year
|
(7,729,551
|
)
|
(5,885,069
|
)
|
(13,329,239
|
)
|
||||||||||
Other comprehensive loss
|
-
|
-
|
||||||||||||||
Total comprehensive loss for the year
|
15 (a)
|
(7,729,551
|
)
|
(5,885,069
|
)
|
(13,329,239
|
)
|
|||||||||
Loss per share (basic and diluted - cents per share)
|
19
|
(1.45
|
)
|
(1.17
|
)
|
(3.11
|
)
|
|||||||||
Weighted average number of ordinary shares used in computing basic and diluted net loss per share
|
533,891,470
|
502,714,982
|
428,047,123
|
Years Ended June 30,
|
||||||||||||||||
Notes
|
2016
|
2015
|
2014
|
|||||||||||||
Cash Flows from Operating Activities
|
||||||||||||||||
Payments to suppliers and employees
|
(14,055,879
|
)
|
(18,124,102
|
)
|
(18,011,310
|
)
|
||||||||||
Interest received
|
120,392
|
216,317
|
377,587
|
|||||||||||||
Grants received
|
-
|
228,541
|
2,500
|
|||||||||||||
R&D tax refund
|
6,516,961
|
6,808,170
|
4,095,000
|
|||||||||||||
Net cash flows used in operating activities
|
15(a)
|
(7,418,526
|
)
|
(10,871,074
|
)
|
(13,536,223
|
)
|
|||||||||
Cash Flows from Investing Activities
|
||||||||||||||||
Payment for payroll and rental security deposits
|
1,474
|
(154,077
|
)
|
-
|
||||||||||||
Payments for purchase of plant and equipment
|
(2,307
|
)
|
(28,757
|
)
|
(23,048
|
)
|
||||||||||
Net cash flows used in investing activities
|
(833
|
)
|
(182,834
|
)
|
(23,048
|
)
|
||||||||||
Cash Flows from Financing Activities
|
||||||||||||||||
Proceeds from exercise of options and issue of securities
|
-
|
7,128,142
|
37,110,325
|
|||||||||||||
Payment of share issue costs
|
-
|
(284,931
|
)
|
(1,339,369
|
)
|
|||||||||||
Repayment of borrowings
|
-
|
-
|
(810,164
|
)
|
||||||||||||
Net cash flows provided by financing activities
|
-
|
6,843,211
|
34,960,792
|
|||||||||||||
Net (decrease) increase in cash and cash equivalents
|
(7,419,359
|
)
|
(4,210,697
|
)
|
21,401,521
|
|||||||||||
Opening cash and cash equivalents brought forward
|
34,909,574
|
34,167,018
|
13,346,760
|
|||||||||||||
Redemption of security deposit
|
152,603
|
-
|
-
|
|||||||||||||
Exchange rate adjustments on cash and cash equivalents held in foreign currencies
|
950,720
|
4,953,253
|
(581,263
|
)
|
||||||||||||
Closing cash and cash equivalents carried forward
|
15(b)
|
28,593,538
|
34,909,574
|
34,167,018
|
Notes
|
Number of Shares
|
Issued Capital
|
Reserves
|
Accumulated
Deficit During Development Stage
|
Total Equity
|
|||||||||||||||||||
Balance, June 30, 2013
|
381,610,426
|
101,379,111
|
10,526,925
|
(97,931,323
|
)
|
13,974,713
|
||||||||||||||||||
Transactions with owners in their capacity as owners:
|
||||||||||||||||||||||||
Issuance of shares in connection with At-The-Market facility, net of costs
|
12(b)
|
85,108,500
|
30,818,030
|
-
|
-
|
30,818,030
|
||||||||||||||||||
Issuance of shares in connection with share purchase plan, net of costs
|
12(c)
|
1,000,000
|
276,950
|
-
|
-
|
276,950
|
||||||||||||||||||
Non-cash issuance of options to employees
|
13(b)
|
-
|
-
|
33,824
|
-
|
33,824
|
||||||||||||||||||
Non-cash issuance of options to consultants
|
13(b)
|
-
|
-
|
959,084
|
-
|
959,084
|
||||||||||||||||||
Issuance of shares in connection with exercise of options, net of costs
|
12(b) &(b)(b)
|
20,928,034
|
7,535,324
|
(2,582,399
|
)
|
-
|
4,952,925
|
|||||||||||||||||
107,036,534
|
38,630,304
|
(1,589,491
|
)
|
-
|
37,040,813
|
|||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(13,329,239
|
)
|
(13,329,239
|
)
|
|||||||||||||||||
Total comprehensive loss for the year
|
-
|
-
|
-
|
(13,329,239
|
)
|
(13,329,239
|
)
|
|||||||||||||||||
Balance, June 30, 2014
|
488,646,960
|
140,009,415
|
8,937,434
|
(111,260,562
|
)
|
37,686,287
|
||||||||||||||||||
Transactions with owners in their capacity as owners:
|
||||||||||||||||||||||||
Issuance of shares in connection with At-The-Market facility, net of costs
|
12(b)
|
44,954,510
|
6,844,311
|
-
|
-
|
6,844,311
|
||||||||||||||||||
Issuance of shares in connection with share purchase plan, net of costs
|
12(c)
|
110,000
|
16,500
|
-
|
-
|
16,500
|
||||||||||||||||||
Non-cash issuance of options to employees
|
13(b)
|
|
-
|
-
|
170,397
|
-
|
170,397
|
|||||||||||||||||
Non-cash issuance of options to consultants
|
13(b)
|
|
-
|
-
|
280,838
|
-
|
280,838
|
|||||||||||||||||
Issuance of shares in connection with exercise of options, net of costs
|
12(b) &(b)(b)
|
180,000
|
25,488
|
(25,488
|
)
|
-
|
-
|
|||||||||||||||||
45,244,510
|
6,886,299
|
425,747
|
-
|
7,312,046
|
||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(5,885,069
|
)
|
(5,885,069
|
)
|
|||||||||||||||||
Total comprehensive loss for the year
|
-
|
-
|
-
|
(5,885,069
|
)
|
(5,885,069
|
)
|
|||||||||||||||||
Balance, June 30, 2015
|
533,891,470
|
146,895,714
|
9,363,181
|
(117,145,631
|
)
|
39,113,264
|
||||||||||||||||||
Transactions with owners in their capacity as owners:
|
||||||||||||||||||||||||
Issuance of shares in connection with At-The-Market facility, net of costs
|
12(b)
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||
Issuance of shares in connection with share purchase plan, net of costs
|
12(c)
|
-
|
(16,500
|
)
|
-
|
-
|
(16,500
|
)
|
||||||||||||||||
Non-cash issuance of options to employees
|
13(b)
|
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||
Non-cash issuance of options to consultants
|
13(b)
|
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||
Issuance of shares in connection with exercise of options, net of costs
|
12(b) &(b)(b)
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||
-
|
(16,500
|
)
|
-
|
-
|
(16,500
|
)
|
||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(7,729,551
|
)
|
(7,729,551
|
)
|
|||||||||||||||||
Total comprehensive loss for the year
|
-
|
-
|
-
|
(7,729,551
|
)
|
(7,729,551
|
)
|
|||||||||||||||||
Balance, June 30, 2016
|
533,891,470
|
146,879,214
|
9,363,181
|
(124,875,182
|
)
|
31,367,213
|
· | The Company continues to pursue raising additional funds through alternative funding structures and has a strong history of raising capital. The Company had an "at the market” (ATM) facility through which it could raise additional funds of up to US$44.5 million by the sale of American Depositary Receipts ("ADRs"). This facility, which was established through the filing of a shelf registration statement on Form F-3 with the United States Securities and Exchange Commission in November, 2014 has been a successful source of raising funds. In prior reporting periods, the Company has raised A$46.5 million (US$42.5 million) under this and a previous ATM facility. |
· | The Company has on issue a total of 19.4 million unlisted, unexercised options. The options have exercise prices ranging from A$0.25 to A$1.12. If all unlisted options were exercised, the Company would receive consideration of A$7.5 million in total. Although the exercise of options may be available, it is not in the Company’s control to receive this consideration. |
· | Notwithstanding, in the event that the Company will not have sufficient funds to effect its current plans through the above mentioned methods, the Company has the ability to scale down its operations and prioritize its research and development programs. |
· | assets and liabilities for each balance sheet presented are translated at the closing rate at the date of that balance sheet, and |
· | income and expenses for each income statement are translated at average exchange rates (unless this is not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case income and expenses are translated at the dates of the transactions), and |
· | all resulting exchange differences are recognized as a separate component of equity. |
Years ended
June 30, 2015
|
||||||||||||
Unadjusted
|
Adjustment
|
Adjusted
|
||||||||||
Revenues from ordinary activities
|
176,842
|
176,842
|
||||||||||
Other income
|
6,317,438
|
6,317,438
|
||||||||||
Research and development expenses
|
(12,298,167
|
)
|
(12,298,167
|
)
|
||||||||
Corporate personnel expenses
|
(2,344,337
|
)
|
2,344,337
|
-
|
||||||||
General and administrative expenses
|
-
|
(4,506,122
|
)
|
(4,506,122
|
)
|
|||||||
Intellectual property expenses
|
(257,299
|
)
|
(257,299
|
)
|
||||||||
Auditor and accounting expenses
|
(416,271
|
)
|
416,271
|
-
|
||||||||
Travel expenses
|
(125,532
|
)
|
125,532
|
-
|
||||||||
Public relations and marketing expenses
|
(87,851
|
)
|
87,851
|
-
|
||||||||
Depreciation expenses
|
(31,587
|
)
|
31,587
|
-
|
||||||||
Other expenses
|
(1,626,076
|
)
|
1,626,076
|
-
|
||||||||
Other operating expenses
|
-
|
(39,210
|
)
|
(39,210
|
)
|
|||||||
Other gains & losses
|
-
|
4,721,449
|
4,721,449
|
|||||||||
Foreign exchange gain (loss)
|
4,721,449
|
(4,721,449
|
)
|
-
|
||||||||
Gain (loss) on fair valuation of financial liabilities
|
86,322
|
(86,322
|
)
|
-
|
||||||||
Loss before income tax expense
|
(5,885,069
|
)
|
(5,885,069
|
)
|
||||||||
Income tax expense
|
-
|
-
|
||||||||||
Loss for the year
|
(5,885,069
|
)
|
(5,885,069
|
)
|
||||||||
Other comprehensive loss
|
-
|
-
|
||||||||||
Total comprehensive loss for the year
|
(5,885,069
|
)
|
(5,885,069
|
)
|
||||||||
Loss per share (basic and diluted - cents per share)
|
(1.17
|
)
|
(1.17
|
)
|
||||||||
Weighted average number of ordinary shares used in computing basic and diluted net loss per share
|
502,714,982
|
502,714,982
|
Years ended
June 30, 2014
|
||||||||||||
Unadjusted
|
Adjustment
|
Adjusted
|
||||||||||
Revenues from ordinary activities
|
363,775
|
363,775
|
||||||||||
Other income
|
7,845,396
|
7,845,396
|
||||||||||
Research and development expenses
|
(14,908,098
|
)
|
(14,908,098
|
)
|
||||||||
General and administrative expenses
|
-
|
(4,925,411
|
)
|
(4,925,411
|
)
|
|||||||
Corporate personnel expenses
|
(2,059,642
|
)
|
2,059,642
|
-
|
||||||||
Intellectual property expenses
|
(477,079
|
)
|
(477,079
|
)
|
||||||||
Auditor and accounting expenses
|
(342,609
|
)
|
342,609
|
-
|
||||||||
Travel expenses
|
(421,013
|
)
|
421,013
|
-
|
||||||||
Public relations and marketing expenses
|
(358,597
|
)
|
358,597
|
-
|
||||||||
Depreciation expenses
|
(22,384
|
)
|
22,384
|
-
|
||||||||
Other expenses
|
(2,142,179
|
)
|
2,142,179
|
-
|
||||||||
Finance expenses
|
-
|
(29,978
|
)
|
(29,978
|
)
|
|||||||
Other operating expenses
|
-
|
(451,251
|
)
|
(451,251
|
)
|
|||||||
Other gains & losses
|
-
|
(746,593
|
)
|
(746,593
|
)
|
|||||||
Interest expense - ADDF
|
(29,978
|
)
|
29,978
|
-
|
||||||||
Foreign exchange gain (loss)
|
(746,593
|
)
|
746,593
|
-
|
||||||||
Gain (loss) on fair valuation of financial liabilities
|
(30,238
|
)
|
30,238
|
-
|
||||||||
Loss before income tax expense
|
(13,329,239
|
)
|
(13,329,239
|
)
|
||||||||
Income tax expense
|
-
|
-
|
||||||||||
Loss for the year
|
(13,329,239
|
)
|
(13,329,239
|
)
|
||||||||
|
||||||||||||
Other comprehensive loss
|
-
|
-
|
||||||||||
Total comprehensive loss for the year
|
(13,329,239
|
)
|
(13,329,239
|
)
|
||||||||
Loss per share (basic and diluted - cents per share)
|
(3.11
|
)
|
(3.11
|
)
|
||||||||
Weighted average number of ordinary shares used in computing basic and diluted net loss per share
|
428,047,123
|
428,047,123
|
Pronouncement
|
Title (Issue date)
|
Effective date
|
Impact on financial report
|
IFRS 15
|
Revenue from contracts with customers
|
Annual periods beginning on or after January 1, 2017
Earlier application is permitted.
|
The Company is currently not generating revenue from contracts and thus the impact is expected to be nil.
|
IFRS 9
|
Financial instruments
|
Annual periods beginning on or after January 1, 2018
Earlier application is permitted.
|
Management is in the process of determining the impact of this standard for subsequent reporting periods.
|
IFRS 16
|
Leases
|
Annual periods beginning on or after January 1, 2019
Earlier application is permitted.
|
Management is in the process of determining the impact of this standard for subsequent reporting periods
|
IFRS 2 (Amendments)
|
Classification and Measurement of
Share-based Payment Transactions
|
Annual periods beginning on or after January 1, 2018
Earlier application is permitted.
|
Management is in the process of determining the impact of this standard for subsequent reporting periods.
|
Years Ended June 30,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
2.
REVENUE AND OTHER INCOME FROM CONTINUING OPERATIONS
|
||||||||||||
Other revenue
|
||||||||||||
Interest
|
142,657
|
176,842
|
363,775
|
|||||||||
Total other revenue
|
142,657
|
176,842
|
363,775
|
|||||||||
Other income
|
||||||||||||
R&D Tax Incentive
|
4,753,697
|
6,088,897
|
7,802,947
|
|||||||||
Michael J Fox Foundation Grant
|
-
|
-
|
39,949
|
|||||||||
Other Grants
|
-
|
228,541
|
2,500
|
|||||||||
Total other income
|
4,753,697
|
6,317,438
|
7,845,396
|
|||||||||
Total revenue and other income from continuing operations
|
4,896,354
|
6,494,280
|
8,209,171
|
Years Ended June 30,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
3.
EXPENSES FROM ORDINARY ACTIVITIES
|
||||||||||||
Research and Development Expenses (1)
|
||||||||||||
Employee expenses
|
1,821,717
|
1,866,915
|
1,827,934
|
|||||||||
Other research and development expenses
|
7,763,654
|
10,431,252
|
13,080,164
|
|||||||||
General and Administration Expenses
|
||||||||||||
Depreciation on fixed assets
|
22,810
|
31,587
|
22,384
|
|||||||||
Employee expenses (non R&D related)
|
992,751
|
937,348
|
807,502
|
|||||||||
750,158
|
1,227,731
|
1,212,240
|
||||||||||
Audit, internal control and other assurance expenses
|
204,776
|
499,911
|
420,519
|
|||||||||
Corporate compliance expenses
|
358,096
|
421,958
|
493,362
|
|||||||||
Office rental
|
195,561
|
161,175
|
163,583
|
|||||||||
Other administrative and office expenses
|
1,086,400
|
1,226,412
|
1,805,821
|
|||||||||
Other gains and losses
|
||||||||||||
Foreign exchange (gain)/loss
|
(857,247
|
)
|
(4,721,449
|
)
|
746,593
|
|||||||
Years Ended June 30,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
4.
INCOME TAX
|
||||||||||||
(a)
Income tax expense:
|
||||||||||||
Current tax
|
-
|
-
|
-
|
|||||||||
Adjustment for current tax of prior periods
|
-
|
-
|
-
|
|||||||||
Deferred tax
|
-
|
-
|
-
|
|||||||||
(b)
Numerical reconciliation of income tax expense to prima facie tax payable:
|
||||||||||||
Prima facie tax on net loss before income tax at 30% (2016, 2015 & 2014: 30%)
|
(2,318,865
|
)
|
(1,765,431
|
)
|
(3,998,686
|
)
|
||||||
Effect of lower tax rates of tax on overseas income
|
(11,111
|
)
|
(41
|
)
|
(43
|
)
|
||||||
Add tax effect of:
|
||||||||||||
(Over)/Under provision of income tax in previous year relating to a revision of estimates
|
4,582,839
|
3,071,631
|
2,214,342
|
|||||||||
Equity issued for nil consideration
|
-
|
140,651
|
1,269,857
|
|||||||||
Research and development expenditure (net of tax incentive)
|
1,743,004
|
(2,153,737
|
)
|
(7,180,486
|
)
|
|||||||
Gain/(loss) on fair value of financial liabilities
|
-
|
25,897
|
(30,238
|
)
|
||||||||
Other
|
54,222
|
1,549
|
5,761
|
|||||||||
Deferred tax asset not recognized
|
(4,050,088
|
)
|
679,571
|
7,719,579
|
||||||||
Income tax expense attributable to loss before income tax
|
-
|
-
|
-
|
|||||||||
(c)
Potential deferred tax asset at June 30, 2016, 2015 and 2014 in respect of: tax losses not brought to account is (1):
|
35,687,127
|
38,463,614
|
39,143,186
|
|||||||||
Temporary differences
|
(1,655,223
|
)
|
3,934,146
|
(37,806
|
)
|
|||||||
Years Ended June 30,
|
||||||||
2016
|
2015
|
|||||||
6.
OTHER ASSETS
|
||||||||
Current
|
||||||||
Prepayments
|
276,504
|
159,963
|
||||||
Payroll term deposit
|
-
|
152,603
|
||||||
Other receivables
|
-
|
899
|
||||||
Total
|
276,504
|
313,465
|
||||||
Non-current
|
||||||||
Rental term deposit
|
43,988
|
45,462
|
||||||
Total
|
43,988
|
45,462
|
||||||
Years Ended June 30,
|
||||||||||||
Notes
|
2016
|
2015
|
||||||||||
7.
PROPERTY AND EQUIPMENT
|
||||||||||||
Gross carrying amount
|
||||||||||||
Balance at beginning of year
|
367,069
|
392,795
|
||||||||||
Additions
|
2,799
|
28,757
|
||||||||||
Disposals
|
(16,102
|
)
|
(54,483
|
)
|
||||||||
Balance at end of year
|
353,766
|
367,069
|
||||||||||
Accumulated depreciation
|
||||||||||||
Balance at beginning of year
|
(322,342
|
)
|
(345,238
|
)
|
||||||||
Disposals
|
15,611
|
54,483
|
||||||||||
Depreciation expense
|
3
|
(22,810
|
)
|
(31,587
|
)
|
|||||||
Balance at end of year
|
(329,541
|
)
|
(322,342
|
)
|
||||||||
Net book value at end of year
|
24,225
|
44,727
|
Years Ended June 30,
|
||||||||
2016
|
2015
|
|||||||
Laboratory equipment, at cost
|
112,631
|
112,631
|
||||||
Less accumulated depreciation
|
(111,839
|
)
|
(110,964
|
)
|
||||
Total laboratory equipment
|
792
|
1,667
|
||||||
Computer equipment, at cost
|
127,078
|
140,382
|
||||||
Less accumulated depreciation
|
(107,583
|
)
|
(103,771
|
)
|
||||
Total computer equipment
|
19,495
|
36,611
|
||||||
Furniture and fittings, at cost
|
38,398
|
38,398
|
||||||
Less accumulated depreciation
|
(34,460
|
)
|
(31,949
|
)
|
||||
Total furniture and fittings
|
3,938
|
6,449
|
||||||
Leasehold improvements, at cost
|
75,659
|
75,659
|
||||||
Less accumulated depreciation
|
(75,659
|
)
|
(75,659
|
)
|
||||
Total leasehold improvements
|
-
|
-
|
||||||
Total
|
24,225
|
44,727
|
Years Ended June 30,
|
||||||||
2016
|
2015
|
|||||||
8.
TRADE AND OTHER PAYABLES
|
||||||||
Trade creditors
|
311,719
|
362,493
|
||||||
Accrued research and development expenses
|
1,178,656
|
1,299,492
|
||||||
Accrued intellectual property expenses
|
10,910
|
-
|
||||||
Accrued corporate personnel expenses
|
7,421
|
535
|
||||||
Accrued audit and accounting fees
|
143,776
|
415,911
|
||||||
Accrued travel expenses
|
1,650
|
-
|
||||||
Other accrued expenses
|
94,434
|
73,584
|
||||||
Total
|
1,748,566
|
2,152,015
|
Years Ended June 30,
|
||||||||||||||||
2016
|
2015
|
2016
|
2015
|
|||||||||||||
9.
FINANCIAL LIABILITIES
|
No.
|
No.
|
A$
|
A$
|
||||||||||||
Current
|
||||||||||||||||
Warrants over ordinary shares (a)
|
-
|
612,397
|
-
|
12,076
|
||||||||||||
Total
|
-
|
12,076
|
Years Ended June 30,
|
||||||||
2016
|
2015
|
|||||||
10.
PROVISIONS
|
||||||||
Current
|
||||||||
Annual leave (1)
|
288,122
|
261,823
|
||||||
Long service leave (1)(2)
|
320,649
|
292,792
|
||||||
Total
|
608,771
|
554,615
|
||||||
Non-Current
|
||||||||
Long service leave (2)
|
470
|
2,412
|
Years Ended June 30,
|
||||||||
2016
|
2015
|
|||||||
Annual leave
|
||||||||
Carrying amount at start of year
|
261,823
|
217,646
|
||||||
Charged/(credited) to profit or loss
|
||||||||
-additional provisions recognized
|
165,384
|
199,667
|
||||||
-unused amounts reversed
|
-
|
-
|
||||||
Amounts used during the year
|
(139,085
|
)
|
(155,490
|
)
|
||||
Carrying amount at end of year
|
288,122
|
261,823
|
||||||
Long service leave
|
||||||||
Carrying amount at start of year
|
295,204
|
280,166
|
||||||
Charged/(credited) to profit or loss
|
||||||||
-additional provisions recognized
|
25,915
|
15,038
|
||||||
-unused amounts reversed
|
-
|
-
|
||||||
Amounts used during the year
|
-
|
-
|
||||||
Carrying amount at end of year
|
321,119
|
295,204
|
||||||
TOTAL
|
609,241
|
557,027
|
Years Ended June 30,
|
||||||||
2016
|
2015
|
|||||||
Long service leave obligation expected to be settled after 12 months
|
320,649
|
292,792
|
Years Ended June 30,
|
||||||||||||||||
Notes
|
2016
|
2015
|
2014
|
|||||||||||||
12. ISSUED CAPITAL
|
||||||||||||||||
(a) Issued Capital
|
||||||||||||||||
533,891,470 (2015: 533,891,470) fully paid ordinary shares
|
12(b)
|
144,177,570
|
144,194,070
|
137,307,771
|
||||||||||||
Nil (2015: Nil) options for fully paid ordinary shares
|
12(c)
|
2,701,644
|
2,701,644
|
2,701,644
|
||||||||||||
146,879,214
|
146,895,714
|
140,009,415
|
(b) Movements in Issued Shares
|
June 30,
|
||||||||||||||||||||||||
2016
|
2015
|
2014
|
||||||||||||||||||||||
No.
|
A$
|
No.
|
A$
|
No.
|
A$ | |||||||||||||||||||
Beginning of the year
|
533,891,470
|
144,194,070
|
488,646,960
|
137,307,771
|
381,610,426
|
98,677,467
|
||||||||||||||||||
Movement during the year
|
-
|
(16,500
|
)
|
45,244,510
|
6,886,299
|
107,036,534
|
38,630,304
|
|||||||||||||||||
End of the year
|
533,891,470
|
144,177,570
|
533,891,470
|
144,194,070
|
488,646,960
|
137,307,771
|
Date
|
Details
|
Notes
|
Number
|
Issue Price
|
A$ | |||||||||||
Year ended June 30, 2013
|
83,629,608
|
15,245,034
|
||||||||||||||
August 2, 2013
|
Shares to investors as part of at-the-market facility
|
1,469,780
|
0.40
|
588,216
|
||||||||||||
August 5, 2013
|
Shares to investors as part of at-the-market facility
|
465,980
|
0.38
|
176,592
|
||||||||||||
August 6, 2013
|
Shares to investors as part of at-the-market facility
|
3,601,550
|
0.39
|
1,413,617
|
||||||||||||
August 7, 2013
|
Shares to investors as part of at-the-market facility
|
2,517,590
|
0.38
|
956,832
|
||||||||||||
August 30, 2013
|
Exercise of options – consultants
|
150,000
|
0.35
|
52,140
|
||||||||||||
August 30, 2013
|
Exercise of options – consultants
|
100,000
|
0.12
|
11,700
|
||||||||||||
August 30, 2013
|
Exercise of options – consultants
|
86,625
|
0.14
|
12,266
|
||||||||||||
August 30, 2013
|
Exercise of options – consultants
|
100,000
|
0.12
|
11,700
|
||||||||||||
August 30, 2013
|
Exercise of options – investors
|
10,000,000
|
0.39
|
3,857,143
|
||||||||||||
August 30, 2013
|
Shares to investors as part of at-the-market facility
|
1,167,610
|
0.57
|
662,809
|
||||||||||||
September 9, 2013
|
Shares to investors as part of at-the-market facility
|
2,160,950
|
0.58
|
1,261,265
|
||||||||||||
September 10, 2013
|
Shares to investors as part of at-the-market facility
|
1,395,610
|
0.56
|
786,494
|
||||||||||||
September 11, 2013
|
Shares to investors as part of at-the-market facility
|
523,120
|
0.55
|
288,606
|
||||||||||||
September 12, 2013
|
Shares to investors as part of at-the-market facility
|
2,056,760
|
0.52
|
1,071,557
|
||||||||||||
October 3, 2013
|
Exercise of options – employees
|
97,418
|
0.18
|
17,577
|
||||||||||||
October 3, 2013
|
Exercise of options – employees
|
625,000
|
0.45
|
282,828
|
||||||||||||
October 25, 2013
|
Exercise of options – consultants
|
60,000
|
0.14
|
8,496
|
||||||||||||
October 25, 2013
|
Exercise of options – employees
|
217,478
|
0.14
|
30,795
|
||||||||||||
November 4, 2013
|
Shares to investors as part of at-the-market facility
|
6,745,750
|
0.48
|
3,209,209
|
||||||||||||
November 5, 2013
|
Shares to investors as part of at-the-market facility
|
143,700
|
0.48
|
69,054
|
||||||||||||
November 4, 2013
|
Exercise of options – employees
|
722,419
|
0.42
|
300,405
|
||||||||||||
November 6, 2013
|
Shares to investors as part of at-the-market facility
|
8,380
|
0.49
|
4,070
|
||||||||||||
November 25, 2013
|
Exercise of options – consultants
|
200,000
|
0.40
|
80,786
|
12. ISSUED CAPITAL (continued)
|
Date
|
Details
|
Notes
|
Number
|
Issue Price
|
A$ | ||||||||||
December 13, 2013
|
Exercise of options – employees
|
73,200
|
0.35
|
25,444
|
|||||||||||
December 20, 2013
|
Exercise of options – employees
|
81,750
|
0.14
|
11,576
|
|||||||||||
December 20, 2013
|
Exercise of options – consultants
|
100,000
|
0.40
|
40,393
|
|||||||||||
January 3, 2014
|
Exercise of options – investors
|
1,700,000
|
0.35
|
593,622
|
|||||||||||
January 28, 2014
|
Exercise of options – investors
|
500,000
|
0.35
|
174,595
|
|||||||||||
February 6, 2014
|
Exercise of options – investors
|
3,928,900
|
0.35
|
1,371,931
|
|||||||||||
February 6, 2014
|
Exercise of options – employees
|
50,000
|
0.35
|
17,380
|
|||||||||||
February 21, 2014
|
Exercise of options – employees
|
60,000
|
0.28
|
16,800.00
|
|||||||||||
February 21, 2014
|
Exercise of options – employees
|
146,128
|
0.25
|
36,532
|
|||||||||||
February 21, 2014
|
Exercise of options – employees
|
157,818
|
0.35
|
54,858
|
|||||||||||
February 26, 2014
|
Exercise of options – employees
|
34,220
|
0.51
|
17,298
|
|||||||||||
February 26, 2014
|
Exercise of options – employees
|
47,700
|
0.35
|
16,581
|
|||||||||||
March 11, 2014
|
Exercise of options – consultants
|
200,000
|
0.40
|
80,786
|
|||||||||||
March 11, 2014
|
Exercise of options – employees
|
60,000
|
0.35
|
20,856
|
|||||||||||
March 11, 2014
|
Exercise of options – employees
|
66,500
|
0.28
|
18,620
|
|||||||||||
March 11, 2014
|
Exercise of options – consultants
|
1,000,000
|
0.26
|
260,000
|
|||||||||||
March 11, 2014
|
Exercise of options – employees
|
146,128
|
0.25
|
36,532
|
|||||||||||
March 11, 2014
|
Shares to investors as part of at-the-market facility
|
980,130
|
1.23
|
1,202,928
|
|||||||||||
March 12, 2014
|
Shares to investors as part of at-the-market facility
|
41,760
|
1.18
|
49,339
|
|||||||||||
March 14, 2014
|
Shares to investors as part of at-the-market facility
|
1,594,220
|
1.11
|
1,767,019
|
|||||||||||
March 17, 2014
|
Shares to investors as part of at-the-market facility
|
2,280,750
|
1.05
|
2,405,397
|
|||||||||||
April 3, 2014
|
Exercise of options – investors
|
216,750
|
0.35
|
75,687
|
|||||||||||
April 3, 2014
|
Shares to investors as part of at-the-market facility
|
22,339,170
|
0.31
|
6,963,613
|
|||||||||||
April 4, 2014
|
Shares to investors as part of at-the-market facility
|
17,290,080
|
0.27
|
4,607,964
|
|||||||||||
April 7, 2014
|
Shares to investors as part of at-the-market facility
|
18,325,610
|
0.25
|
4,672,819
|
|||||||||||
April 7, 2014
|
Non cash share issue in consideration for services provided by consultants
|
(i)
|
1,000,000
|
0.25
|
252,750
|
||||||||||
June 30, 2014
|
Non cash share issue in consideration for services provided by consultants
|
-
|
-
|
24,200
|
|||||||||||
Security issuance costs
|
-
|
-
|
(1,339,369
|
)
|
|||||||||||
Year ended June 30, 2014
|
107,036,534
|
38,630,304
|
|||||||||||||
July 1, 2014
|
Reverse proposed issue to a consultant
|
-
|
-
|
(24,200
|
)
|
||||||||||
July 21, 2014
|
Non cash share issue in consideration for services provided by consultants
|
(i)
|
110,000
|
0.23
|
25,300
|
||||||||||
July 21, 2014
|
Exercise of options – employees
|
180,000
|
-
|
25,488
|
|||||||||||
February 23, 2015
|
Shares to investors as part of at-the-market facility
|
35,631,690
|
0.15
|
5,304,319
|
|||||||||||
February 24, 2015
|
Shares to investors as part of at-the-market facility
|
2,538,820
|
0.14
|
357,270
|
|||||||||||
June 2, 2015
|
Shares to investors as part of at-the-market facility
|
6,784,000
|
0.22
|
1,466,553
|
|||||||||||
June 30, 2015
|
Non cash share issue in consideration for services provided by consultants
|
-
|
-
|
16,500
|
|||||||||||
Security issuance costs
|
-
|
-
|
(284,931
|
)
|
|||||||||||
Year ended June 30, 2015
|
45,244,510
|
6,886,299
|
|||||||||||||
July1, 2015
|
Reverse proposed issue to a consultant
|
-
|
(16,500
|
)
|
|||||||||||
Year ended June 30, 2016
|
-
|
(16,500
|
)
|
12. ISSUED CAPITAL (continued)
|
(c) Movements in Options
|
June 30,
|
||||||||||||||||||||||||
2016
|
2015
|
2014
|
||||||||||||||||||||||
Number of Options
|
A$
|
Number of Options
|
A$
|
Number of Options
|
A$ | |||||||||||||||||||
Beginning of the year
|
-
|
2,701,644
|
-
|
2,701,644
|
-
|
2,701,644
|
||||||||||||||||||
End of the year*
|
-
|
2,701,644
|
-
|
2,701,644
|
-
|
2,701,644
|
(d) Terms and Conditions of Issued Capital
|
Ordinary shares
|
Ordinary shares have the right to receive dividends as declared and, in the event of a winding up of the Company, to participate in the proceeds from the sale of all surplus assets in proportion to the number of and amounts paid up on shares held. Ordinary shares entitle their holder to vote, either in person or by proxy, at a meeting of the Company’s shareholders.
|
Options
|
Option holders do not have the right to receive dividends and are not entitled to vote at a meeting of the Company’s shareholders. Options may be exercised at any time from the date they vest to the date of their expiration. Share options convert into ordinary shares on a one for one basis on the date they are exercised.
|
(e) Shares Issued after Reporting Date
|
Years Ended June 30,
|
||||||||||||||||
Notes
|
2016
|
2015
|
2014
|
|||||||||||||
(a)
Share Based Payments
|
||||||||||||||||
19,395,582 (2015: 19,395,582) options for fully paid ordinary shares
|
13(b)
|
7,394,184
|
7,394,184
|
6,968,437
|
||||||||||||
Nil (2015: Nil) options for ADRs
|
13(c)
|
1,515,434
|
1,515,434
|
1,515,434
|
||||||||||||
Nil (2015: 612,397) warrants for ADRs
|
13(d)
|
453,563
|
453,563
|
453,563
|
||||||||||||
9,363,181
|
9,363,181
|
8,937,434
|
Years Ended June 30,
|
||||||||||||||||||||||||
2016
|
2015
|
2014
|
||||||||||||||||||||||
Number of
Options
|
Comp.
Expense (A$)
|
Number of
Options
|
Comp.
Expense (A$)
|
Number of
Options
|
Comp.
Expense (A$)
|
|||||||||||||||||||
Beginning of the year
|
19,395,582
|
7,394,184
|
18,542,577
|
6,968,437
|
35,544,121
|
8,557,928
|
||||||||||||||||||
Issued during the year
|
-
|
-
|
4,400,000
|
451,235
|
3,926,490
|
992,908
|
||||||||||||||||||
Expired during the year
|
-
|
-
|
(3,166,995
|
)
|
-
|
-
|
-
|
|||||||||||||||||
Forfeited during the year
|
-
|
-
|
(200,000
|
)
|
-
|
-
|
-
|
|||||||||||||||||
Exercised during the year
|
-
|
-
|
(180,000
|
)
|
(25,488
|
)
|
(20,928,034
|
)
|
(2,582,399
|
)
|
||||||||||||||
End of the year
|
19,395,582
|
7,394,184
|
19,395,582
|
7,394,184
|
18,542,577
|
6,968,437
|
Years Ended June 30,
|
||||||||||||||||||||||||
2016
|
2015
|
2014
|
||||||||||||||||||||||
Number of Options
|
Comp.
Expense (A$)
|
Number of Options
|
Comp.
Expense (A$)
|
Number of Options
|
Comp.
Expense (A$)
|
|||||||||||||||||||
Beginning of the year
|
-
|
1,515,434
|
-
|
1,515,434
|
-
|
1,515,434
|
||||||||||||||||||
Expiration of options (1)
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||
End of the year
|
-
|
1,515,434
|
-
|
1,515,434
|
-
|
1,515,434
|
Years Ended June 30,
|
||||||||||||||||||||||||
2016
|
2015
|
2014
|
||||||||||||||||||||||
Number of Warrants
|
Comp.
Expense (A$)
|
Number of Warrants
|
Comp.
Expense (A$)
|
Number of Warrants
|
Comp.
Expense (A$)
|
|||||||||||||||||||
Beginning of the year
(1)
|
-
|
453,563
|
-
|
453,563
|
-
|
453,563
|
||||||||||||||||||
Beginning of the year (2)
|
612,397
|
-
|
612,397
|
-
|
612,397
|
-
|
||||||||||||||||||
Expired
|
(612,397
|
)
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||
End of the year
|
-
|
453,563
|
612,397
|
453,563
|
612,397
|
453,563
|
(e) Terms and Conditions of Reserves
|
||||||||
Options and warrants
|
||||||||
Option holders and warrant holders do not have the right to receive dividends and are not entitled to vote at a meeting of the Company’s shareholders. Options and warrants may be exercised at any time from the date they vest to the date of their expiration. Share options are exercisable into ordinary shares on a one for one basis on the date they are exercised. Options granted under the 2004 ADS Plan are exercisable into ADRs, being one option for one ADR, which equals ten ordinary shares, on the date they are exercised.
|
(f) Options and Warrants Issued after Reporting Date
|
Years Ended June 30,
|
||||||||
2016
|
2015
|
|||||||
14.
ACCUMULATED DEFICIT DURING DEVELOPMENT STAGE
|
||||||||
Balance at beginning of year
|
(117,145,631
|
)
|
(111,260,562
|
)
|
||||
Net loss for the year
|
(7,729,551
|
)
|
(5,885,069
|
)
|
||||
Balance at end of year
|
(124,875,182
|
)
|
(117,145,631
|
)
|
Years Ended June 30,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
15.
CASH FLOW INFORMATION
|
||||||||||||
(a) Reconciliation of Net Loss to Net Cash Flows From Operations
|
||||||||||||
Net loss
|
(7,729,551
|
)
|
(5,885,069
|
)
|
(13,329,239
|
)
|
||||||
Non-cash items
|
||||||||||||
Depreciation of property and equipment
|
22,810
|
31,587
|
22,384
|
|||||||||
Non-cash issue of equity in consideration of operating expenses
|
(16,500
|
)
|
468,835
|
1,269,857
|
||||||||
Foreign exchange (gain) loss
|
(950,720
|
)
|
(4,953,253
|
)
|
581,263
|
|||||||
(Gain) loss on fair value of financial liabilities
|
-
|
(86,322
|
)
|
37,473
|
||||||||
Changes in assets and liabilities
|
||||||||||||
Decrease (increase) in trade and other receivables
|
1,734,389
|
764,255
|
(3,761,471
|
)
|
||||||||
Decrease (increase) in other current assets
|
(115,643
|
)
|
(63,979
|
)
|
15,359
|
|||||||
(Decrease) increase in trade and other payables
|
(403,449
|
)
|
(1,206,343
|
)
|
1,582,980
|
|||||||
(Decrease) in other current liabilities
|
(12,076
|
)
|
-
|
(33,332
|
)
|
|||||||
Increase in provision for employee entitlements
|
52,214
|
59,215
|
78,503
|
|||||||||
Net cash flows used in operating activities
|
(7,418,526
|
)
|
(10,871,074
|
)
|
(13,536,223
|
)
|
||||||
(b) Reconciliation of Cash and Cash Equivalents
|
||||||||||||
Cash and cash equivalents balance comprises:
|
||||||||||||
- cash and cash equivalents on hand
|
28,593,538
|
34,909,574
|
34,167,018
|
|||||||||
Closing cash and cash equivalents balance
|
28,593,538
|
34,909,574
|
34,167,018
|
Years Ended June 30,
|
||||||||||||||||||||||||
2016
|
2015
|
2014
|
||||||||||||||||||||||
Number of Options
|
Weighted Average Exercise Price (A$)
|
Number of Options
|
Weighted Average Exercise Price (A$)
|
Number of Options
|
Weighted Average Exercise Price (A$)
|
|||||||||||||||||||
Beginning of the year
|
19,395,582
|
0.38
|
16,375,582
|
0.41
|
17,031,476
|
0.23
|
||||||||||||||||||
Issued during the year
|
-
|
-
|
4,400,000
|
0.28
|
3,926,490
|
0.69
|
||||||||||||||||||
Exercised during the year
|
-
|
-
|
(180,000
|
)
|
-
|
(4,582,384
|
)
|
0.11
|
||||||||||||||||
Expired during the year
|
-
|
-
|
(1,000,000
|
)
|
0.25
|
-
|
-
|
|||||||||||||||||
Lapsed during the year
|
-
|
-
|
(200,000
|
)
|
1.12
|
-
|
-
|
|||||||||||||||||
Forfeited during the year
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||||||||||
Outstanding at year end
|
19,395,582
|
0.38
|
19,395,582
|
0.38
|
16,375,582
|
0.41
|
||||||||||||||||||
Exercisable at year end
|
19,395,582
|
0.38
|
19,395,582
|
0.38
|
16,175,582
|
0.40
|
Series
|
Grant Date
|
Expiry Date
|
Exercise Price
|
Share options
|
Share options
|
|||||||||||
$A
|
|
2016 | 2015 | |||||||||||||
PBTAA
|
October 25, 2013
|
October 24, 2018
|
0.61
|
200,000
|
200,000
|
|||||||||||
PBTAB
|
October 3, 2014
|
October 2, 2018
|
0.34
|
1,000,000
|
1,000,000
|
|||||||||||
PBTAC
|
June 26, 2013
|
June 25, 2018
|
0.37
|
1,649,573
|
1,649,573
|
|||||||||||
PBTAD
|
November 4, 2013
|
November 3, 2018
|
0.73
|
360,000
|
360,000
|
|||||||||||
PBTAE
|
December 13, 2013
|
December 11, 2018
|
1.04
|
1,200,000
|
1,200,000
|
|||||||||||
PBTAF
|
February 7, 2014
|
February 5, 2019
|
1.12
|
100,000
|
100,000
|
|||||||||||
PBTAG
|
April 7, 2014
|
April 6, 2018
|
0.25
|
1,200,000
|
1,200,000
|
|||||||||||
PBTAH
|
February 19, 2015
|
February 18, 2020
|
0.26
|
2,000,000
|
2,000,000
|
|||||||||||
PBTAQ
|
December 12, 2012
|
December 13, 2017
|
0.33
|
8,500,000
|
8,500,000
|
|||||||||||
PBTAR
|
May 27, 2015
|
May 25, 2020
|
0.27
|
1,400,000
|
1,400,000
|
|||||||||||
PBTAW
|
March 21, 2012
|
March 20, 2017
|
0.25
|
1,119,519
|
1,119,519
|
|||||||||||
PBTAY
|
August 5, 2013
|
August 4, 2018
|
0.66
|
306,490
|
306,490
|
|||||||||||
PBTAZ
|
October 2, 2013
|
October 1, 2018
|
0.66
|
360,000
|
360,000
|
|||||||||||
Total
|
19,395,582
|
19,395,582
|
||||||||||||||
Weighted average remaining contractual life of options outstanding at end of period
|
2.04 years
|
3.04 years
|
Series
|
Grant Date
|
Exercise Price per Share
|
Share Price at Grant Date
|
Expected Share Price Volatility
|
Years to Expiry
|
Dividend Yield
|
Risk-free Interest Rate
|
A$
|
A$
|
||||||
PBTAY
|
August 5, 2013
|
0.66
|
0.38
|
62.00%
|
5.00
|
0%
|
3.05%
|
PBTAZ
|
October 2, 2013
|
0.66
|
0.41
|
61.00%
|
5.00
|
0%
|
3.24%
|
PBTAA
|
October 25, 2013
|
0.61
|
0.38
|
63.60%
|
5.00
|
0%
|
3.31%
|
PBTAD
|
November 4, 2013
|
0.73
|
0.44
|
68.80%
|
5.00
|
0%
|
3.46%
|
PBTAE
|
December 13, 2013
|
1.04
|
0.69
|
70.70%
|
5.00
|
0%
|
3.45%
|
PBTAF
|
February 7, 2014
|
1.12
|
1.18
|
58.50%
|
5.00
|
0%
|
3.44%
|
PBTAG
|
April 7, 2014
|
0.25
|
0.23
|
289.40%
|
4.00
|
0%
|
3.02%
|
PBTAB
|
October 3, 2014
|
0.34
|
0.22
|
130.50%
|
4.00
|
0%
|
2.71%
|
PBTAH
|
February 19, 2015
|
0.26
|
0.16
|
74.80%
|
5.00
|
0%
|
2.00%
|
PBTAR
|
May 27, 2015
|
0.27
|
0.17
|
69.40%
|
5.00
|
0%
|
2.25%
|
Years Ended June 30,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
Number of Shares
|
Number of Shares
|
Number of Shares
|
||||||||||
Beginning of the year
|
13,277,715
|
12,987,715
|
7,405,331
|
|||||||||
Issued during the year (1)
|
-
|
290,000
|
5,582,384
|
|||||||||
End of the financial year
|
13,277,715
|
13,277,715
|
12,987,715
|
Years Ended June 30,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
|
||||||||||||
Basic and diluted loss per share (cents per share)
|
(1.45
|
)
|
(1.17
|
)
|
(3.11
|
)
|
||||||
Weighted average number of ordinary shares on issue used in the calculation of basic and diluted loss per share
|
533,891,470
|
502,714,982
|
428,047,123
|
Years Ended June 30,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
Short-term employee benefits
|
1,476,000
|
1,554,843
|
1,139,860
|
|||||||||
Post-employment benefits
|
95,117
|
96,324
|
77,775
|
|||||||||
Long-term benefits
|
13,817
|
2,733
|
17,615
|
|||||||||
Share-based payments
|
-
|
170,397
|
33,824
|
|||||||||
1,584,934
|
1,824,297
|
1,269,074
|
Years Ended June 30,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
|
||||||||||||
- audit and review fees: current year financial reports
|
166,479
|
160,158
|
145,187
|
|||||||||
- audit and review fees: internal controls
|
38,297
|
256,113
|
187,422
|
|||||||||
- audit and review fees: other assurance services
|
-
|
83,640
|
65,000
|
|||||||||
204,776
|
499,911
|
397,609
|
Short Term Benefits
|
Post-Employment
|
Long Term Benefits
|
Equity
|
|||||||||||||||||||||
2016
Directors’ remuneration
|
Base Fee
A$
|
Bonus
A$
|
Superannuation
Contribution
A$
|
Long-service Leave
A$
|
Options
A$
|
Total
A$
|
||||||||||||||||||
Geoffrey Kempler (1)
|
448,617
|
-
|
29,990
|
7,766
|
-
|
486,373
|
||||||||||||||||||
Brian Meltzer
|
50,000
|
-
|
35,000
|
-
|
-
|
85,000
|
||||||||||||||||||
George Mihaly
|
75,000
|
-
|
-
|
-
|
-
|
75,000
|
||||||||||||||||||
Peter Marks
|
60,000
|
-
|
-
|
-
|
-
|
60,000
|
||||||||||||||||||
Lawrence Gozlan
|
60,000
|
-
|
-
|
-
|
-
|
60,000
|
||||||||||||||||||
Ira Shoulson (2)
|
303,474
|
-
|
-
|
-
|
-
|
303,474
|
||||||||||||||||||
997,091
|
-
|
64,990
|
7,766
|
-
|
1,069,847
|
Short Term Benefits
|
Post-Employment
|
Long Term Benefits
|
Equity
|
|||||||||||||||||||||
2015
Directors’ remuneration
|
Base Fee
A$
|
Bonus
A$
|
Superannuation
Contribution
A$
|
Long-service Leave
A$
|
Options
A$
|
Total
A$
|
||||||||||||||||||
Geoffrey Kempler (1)
|
421,689
|
100,000
|
35,000
|
(224
|
)
|
-
|
556,465
|
|||||||||||||||||
Brian Meltzer
|
50,000
|
-
|
35,000
|
-
|
-
|
85,000
|
||||||||||||||||||
George Mihaly
|
75,000
|
-
|
-
|
-
|
-
|
75,000
|
||||||||||||||||||
Peter Marks
|
60,000
|
-
|
-
|
-
|
-
|
60,000
|
||||||||||||||||||
Lawrence Gozlan
|
50,000
|
-
|
-
|
-
|
-
|
50,000
|
||||||||||||||||||
Ira Shoulson (2)
|
250,648
|
-
|
-
|
-
|
-
|
250,648
|
||||||||||||||||||
1,007,337
|
-
|
70,000
|
(224
|
)
|
-
|
1,077,113
|
Short Term Benefits
|
Post-Employment
|
Long Term Benefits
|
Equity
|
|||||||||||||||||||||
2014
Directors’ remuneration
|
Base Fee
A$
|
Bonus
A$
|
Superannuation
Contribution
A$
|
Long-service Leave
A$
|
Options
A$
|
Total
A$
|
||||||||||||||||||
Geoffrey Kempler (1)
|
444,389
|
-
|
25,000
|
8,601
|
-
|
477,990
|
||||||||||||||||||
Brian Meltzer
|
50,000
|
-
|
35,000
|
-
|
-
|
85,000
|
||||||||||||||||||
George Mihaly
|
75,000
|
-
|
-
|
-
|
-
|
75,000
|
||||||||||||||||||
Peter Marks
|
60,000
|
-
|
-
|
-
|
-
|
60,000
|
||||||||||||||||||
Lawrence Gozlan
|
50,000
|
-
|
-
|
-
|
-
|
50,000
|
||||||||||||||||||
Ira Shoulson (2)
|
5,625
|
-
|
-
|
-
|
-
|
5,625
|
||||||||||||||||||
685,014
|
-
|
60,000
|
8,601
|
-
|
753,615
|
Short Term Benefits
|
Post-Employment
|
Long Term Benefits
|
Equity
|
|||||||||||||||||||||
2016
Executives’ Remuneration
|
Base Fee
A$
|
Other
A$
|
Superannuation
Contribution
A$
|
Long-service Leave
A$
|
Options
A$
|
Total
A$
|
||||||||||||||||||
Dianne Angus (1) (2)
|
353,300
|
-
|
19,307
|
6,051
|
-
|
378,658
|
||||||||||||||||||
Kathryn Andrews (1)
|
125,609
|
-
|
10,820
|
-
|
-
|
136,429
|
||||||||||||||||||
478,909
|
-
|
30,127
|
6,051
|
-
|
515,087
|
Short Term Benefits
|
Post-Employment
|
Long Term Benefits
|
Equity
|
|||||||||||||||||||||
2015
Executives’ Remuneration
|
Base Fee
A$
|
Other
A$
|
Superannuation
Contribution
A$
|
Long-service Leave
A$
|
Options
A$
|
Total
A$
|
||||||||||||||||||
Phillip Hains (2)
|
100,000
|
-
|
-
|
-
|
-
|
100,000
|
||||||||||||||||||
Dianne Angus (1)
|
326,346
|
-
|
18,783
|
2,874
|
170,397
|
518,401
|
||||||||||||||||||
Kathryn Andrews (3)
|
81,233
|
-
|
7,541
|
82
|
-
|
88,857
|
||||||||||||||||||
Richard Revelins (4)
|
39,926
|
-
|
-
|
-
|
-
|
39,926
|
||||||||||||||||||
547,506
|
-
|
26,324
|
2,957
|
170,397
|
747,184
|
|||||||||||||||||||
Short Term Benefits
|
Post-Employment
|
Long Term Benefits
|
Equity
|
|||||||||||||||||||||
2014
Executives’ Remuneration
|
Base Fee
A$
|
Other
A$
|
Superannuation
Contribution
A$
|
Long-service Leave
A$
|
Options
A$
|
Total
A$
|
||||||||||||||||||
Richard Revelins
|
80,013
|
-
|
-
|
-
|
-
|
80,013
|
||||||||||||||||||
Dianne Angus (1) (2)
|
324,833
|
-
|
17,775
|
9,015
|
33,824
|
385,447
|
||||||||||||||||||
Phillip Hains (3)
|
50,000
|
-
|
-
|
-
|
-
|
50,000
|
||||||||||||||||||
454,846
|
-
|
17,775
|
9,015
|
33,824
|
515,460
|
Directors
|
Duration
|
Notice Requirements
|
Termination
|
Mr. Geoffrey Kempler
|
Until termination by either party
Signed September 21, 2007
|
For Good Reason Mr. Kempler may terminate with 30 days’ notice
Or
Without Cause the Company may terminate with 90 days’ notice
|
·
Pay Mr. Kempler within ninety (90) days of the termination date A$1,000,000 provided the Company has sufficient capital requirements to fulfill this clause
·
Accrued entitlements including all unreimbursed business expenses
·
Accelerate the vesting of any unvested options
|
Without Good Reason Mr. Kempler may terminate with 90 days’ notice
Or
With Cause the Company may terminate with 30 days’ notice
|
·
Bonus pro-rate only if termination occurs in 1
st
year
|
Key Management Personnel
|
Duration
|
Notice Requirements
|
Termination
|
Ms Dianne Angus
|
Until termination by either party
Signed October 2, 2006
Letter Agreement signed June 12, 2007
|
For Good Reason Ms
.
Angus may terminate with 30 days’ notice
Or
Without Cause the Company may terminate with 120 days’ notice
|
·
Pay remuneration entitlements three months from the time of termination
(less any payout made for the notice period).
The Company can elect to pay such sum as cash, equity in the Company or as
a combination of both cash and equity
·
Accrued entitlements including all unreimbursed business expenses
·
Accelerate the vesting of any unvested options
|
Without Good Reason Ms Angus may terminate with 120 days’ notice
Or
With Cause the Company may terminate without notice
|
·
Permitted to keep and/or exercise options that have vested at the time
of termination
·
Accrued entitlements including all unreimbursed business expenses
|
||
Ms Kathryn Andrews
|
Until termination by either party
Signed November 11, 2014
|
Ms Andrews may terminate with 30 days’ notice
Or
Without Cause the Company may terminate with 30 days’ notice
Or
With Cause the Company may terminate without notice
|
·
Permitted to keep and/or exercise options that have vested at the time
of termination
·
Accrued entitlements including all unreimbursed business expenses
|
Fully Paid Ordinary
Shares of the Company
|
Balance July 1, 2015
|
Received as Remuneration
|
Received on Exercise of Options
|
Net Change Other (1)
|
Balance
June 30, 2016
|
|||||||||||||||
No.
|
No.
|
No.
|
No.
|
No.
|
||||||||||||||||
Geoffrey Kempler
|
18,011,000
|
-
|
-
|
-
|
18,011,000
|
|||||||||||||||
Brian Meltzer
|
326,666
|
-
|
-
|
-
|
326,666
|
|||||||||||||||
George Mihaly
|
226,666
|
-
|
-
|
-
|
226,666
|
|||||||||||||||
Peter Marks
|
43,111
|
-
|
-
|
-
|
43,111
|
|||||||||||||||
Lawrence Gozlan
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Ira Shoulson
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Richard Revelins (5)
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Dianne Angus
|
146,128
|
-
|
-
|
-
|
146,128
|
|||||||||||||||
Phillip Hains (5)
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Kathryn Andrews (6)
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
18,753,571
|
-
|
-
|
-
|
18,753,571
|
||||||||||||||||
Fully Paid Ordinary
Shares of the Company
|
Balance July 1, 2014
|
Received as Remuneration
|
Received on Exercise of Options
|
Net Change Other (1)
|
Balance
June 30, 2015
|
|||||||||||||||
No.
|
No.
|
No.
|
No.
|
No.
|
||||||||||||||||
Geoffrey Kempler
|
17,811,000
|
-
|
-
|
200,000
|
18,011,000
|
|||||||||||||||
Brian Meltzer
|
326,666
|
-
|
-
|
-
|
326,666
|
|||||||||||||||
George Mihaly
|
226,666
|
-
|
-
|
-
|
226,666
|
|||||||||||||||
Peter Marks
|
43,111
|
-
|
-
|
-
|
43,111
|
|||||||||||||||
Lawrence Gozlan
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Ira Shoulson
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Richard Revelins (5)
|
20,308
|
-
|
-
|
(20,308
|
)
|
-
|
||||||||||||||
Dianne Angus
|
146,128
|
-
|
-
|
-
|
146,128
|
|||||||||||||||
Phillip Hains (5)
|
211,800
|
-
|
-
|
(211,800
|
)
|
-
|
||||||||||||||
Kathryn Andrews (6)
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
18,785,679
|
-
|
-
|
(32,108
|
)
|
18,753,571
|
Fully Paid Ordinary
Shares of the Company
|
Balance July 1, 2013
|
Received as Remuneration
|
Received on Exercise of Options
|
Net Change Other (1)
|
Balance
June 30, 2014
|
|||||||||||||||
No.
|
No.
|
No.
|
No.
|
No.
|
||||||||||||||||
Geoffrey Kempler
|
17,811,000
|
-
|
-
|
-
|
17,811,000
|
|||||||||||||||
Brian Meltzer
|
326,666
|
-
|
-
|
-
|
326,666
|
|||||||||||||||
George Mihaly
|
226,666
|
-
|
-
|
-
|
226,666
|
|||||||||||||||
Peter Marks
|
43,111
|
-
|
-
|
-
|
43,111
|
|||||||||||||||
Lawrence Gozlan
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Ira Shoulson (3)
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||
Richard Revelins
|
20,308
|
-
|
500,000
|
(500,000
|
)
|
20,308
|
||||||||||||||
Dianne Angus
|
-
|
-
|
868,547
|
(722,419
|
)
|
146,128
|
||||||||||||||
Phillip Hains (4)
|
211,800
|
-
|
-
|
-
|
211,800
|
|||||||||||||||
18,639,551
|
-
|
1,368,547
|
(1,222,419
|
)
|
18,785,679
|
Share Options of
the Company
|
Balance
July 1, 2015
No.
|
Granted as Remuneration
No.
|
Options Exercised
No.
|
Options Forfeited
No.
|
Net Change Other
|
Options Vested
During 2016 fiscal year
|
Balance
June 30, 2016
No.
|
Total Vested and Exercisable
June 30, 2016
No.
|
Total Unvested June 30, 2016
No.
|
|||||||||||||||||||||||||||
Geoffrey Kempler
|
4,000,000
|
-
|
-
|
-
|
-
|
-
|
4,000,000
|
4,000,000
|
-
|
|||||||||||||||||||||||||||
Brian Meltzer
|
1,000,000
|
-
|
-
|
-
|
-
|
-
|
1,000,000
|
1,000,000
|
-
|
|||||||||||||||||||||||||||
George Mihaly
|
1,000,000
|
-
|
-
|
-
|
-
|
-
|
1,000,000
|
1,000,000
|
-
|
|||||||||||||||||||||||||||
Peter Marks
|
1,000,000
|
-
|
-
|
-
|
-
|
-
|
1,000,000
|
1,000,000
|
-
|
|||||||||||||||||||||||||||
Lawrence Gozlan
|
1,000,000
|
-
|
-
|
-
|
-
|
-
|
1,000,000
|
1,000,000
|
-
|
|||||||||||||||||||||||||||
Ira Shoulson
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||||||||||||
Dianne Angus
|
1,317,819
|
-
|
-
|
-
|
-
|
-
|
1,317,819
|
1,317,819
|
-
|
|||||||||||||||||||||||||||
Kathryn Andrews (6)
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||||||||||||
9,317,819
|
-
|
-
|
-
|
-
|
-
|
9,317,819
|
9,317,819
|
-
|
Share Options of
the Company
|
Balance
July 1, 2014
No.
|
Granted as Remuneration
No.
|
Options Exercised
No.
|
Options Forfeited
No.
|
Net Change Other
|
Options Vested
During 2015 fiscal year
|
Balance
June 30, 2015
No.
|
Total Vested and Exercisable
June 30, 2015
No.
|
Total Unvested June 30, 2015
No.
|
|||||||||||||||||||||||||||
Geoffrey Kempler
|
4,000,000
|
-
|
-
|
-
|
-
|
-
|
4,000,000
|
4,000,000
|
-
|
|||||||||||||||||||||||||||
Brian Meltzer
|
1,000,000
|
-
|
-
|
-
|
-
|
-
|
1,000,000
|
1,000,000
|
-
|
|||||||||||||||||||||||||||
George Mihaly
|
1,000,000
|
-
|
-
|
-
|
-
|
-
|
1,000,000
|
1,000,000
|
-
|
|||||||||||||||||||||||||||
Peter Marks
|
1,000,000
|
-
|
-
|
-
|
-
|
-
|
1,000,000
|
1,000,000
|
-
|
|||||||||||||||||||||||||||
Lawrence Gozlan
|
1,000,000
|
-
|
-
|
-
|
-
|
-
|
1,000,000
|
1,000,000
|
-
|
|||||||||||||||||||||||||||
Ira Shoulson
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||||||||||||
Richard Revelins (5)
|
500,000
|
-
|
-
|
-
|
(500,000
|
)
|
-
|
-
|
-
|
-
|
||||||||||||||||||||||||||
Dianne Angus
|
317,819
|
1,000,000
|
-
|
-
|
-
|
-
|
1,317,819
|
1,317,819
|
-
|
|||||||||||||||||||||||||||
Phillip Hains (5)
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||||||||||||
Kathryn Andrews (6)
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||||||||||||
8,817,819
|
1,000,000
|
-
|
-
|
(500,000
|
)
|
-
|
9,317,819
|
9,317,819
|
-
|
Share Options of
the Company
|
Balance
July 1, 2013
No.
|
Granted as Remuneration
No.
|
Options Exercised
No.
|
Options Forfeited
No.
|
Net Change Other (1)
|
Options Vested
During 2014 fiscal year
|
Balance
June 30, 2014
No.
|
Total Vested and Exercisable
June 30, 2014
No.
|
Total Unvested June 30, 2014
No.
|
|||||||||||||||||||||||||||
Geoffrey Kempler
|
4,000,000
|
-
|
-
|
-
|
-
|
-
|
4,000,000
|
4,000,000
|
-
|
|||||||||||||||||||||||||||
Brian Meltzer
|
1,000,000
|
-
|
-
|
-
|
-
|
-
|
1,000,000
|
1,000,000
|
-
|
|||||||||||||||||||||||||||
George Mihaly
|
1,000,000
|
-
|
-
|
-
|
-
|
-
|
1,000,000
|
1,000,000
|
-
|
|||||||||||||||||||||||||||
Peter Marks
|
1,000,000
|
-
|
-
|
-
|
-
|
-
|
1,000,000
|
1,000,000
|
-
|
|||||||||||||||||||||||||||
Lawrence Gozlan
|
1,000,000
|
-
|
-
|
-
|
-
|
-
|
1,000,000
|
1,000,000
|
-
|
Ira Shoulson (3)
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||||||||||||
Richard Revelins
|
1,000,000
|
-
|
(500,000
|
)
|
-
|
-
|
-
|
500,000
|
500,000
|
-
|
||||||||||||||||||||||||||
Dianne Angus
|
2,052,730
|
160,000
|
(868,547
|
)
|
-
|
(1,026,364
|
)
|
-
|
317,819
|
317,819
|
-
|
|||||||||||||||||||||||||
Phillip Hains (4)
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||||||||||||
11,052,730
|
160,000
|
(1,368,547
|
)
|
-
|
(1,026,364
|
)
|
-
|
8,817,819
|
8,817,819
|
-
|
||||||||||||||||||||||||||
Consolidated Entity
|
||||||||
2016
|
2015
|
|||||||
A$ | A$ | |||||||
Cash and cash equivalents (USD)
|
21,890,509
|
27,100,354
|
||||||
Cash and cash equivalents (€EUR)
|
-
|
-
|
||||||
Cash and cash equivalents (£GBP)
|
-
|
-
|
||||||
Trade and other payables (USD)
|
(36,348
|
)
|
(79,490
|
)
|
||||
Trade and other payables (€EUR)
|
(10,176
|
)
|
(25,617
|
)
|
||||
Trade and other payables (£GBP)
|
(2,437
|
)
|
(4,926
|
)
|
||||
Total exposure
|
21,841,548
|
26,990,321
|
June 30, 2016
|
Floating
Interest Rate
(A$)
|
Fixed Interest
Maturing in
(A$)
|
Non-Interest bearing
(A$)
|
Total
(A$)
|
Average Interest Rate
|
|||||||||||||||||||
1 year
or less |
1-5 years
|
|||||||||||||||||||||||
Financial Assets
|
||||||||||||||||||||||||
Cash and cash equivalents
|
22,440,074
|
6,150,000
|
-
|
3,464
|
28,593,538
|
0.68
|
%
|
|||||||||||||||||
Trade and other receivables
|
-
|
-
|
-
|
4,786,765
|
4,786,765
|
|||||||||||||||||||
Other current assets
|
-
|
-
|
-
|
276,504
|
276,504
|
|||||||||||||||||||
Other non-current assets
|
-
|
-
|
43,988
|
-
|
43,988
|
2.85
|
%
|
|||||||||||||||||
Total Financial Assets
|
22,440,074
|
6,150,000
|
43,988
|
5,066,733
|
33,700,795
|
|||||||||||||||||||
Financial Liabilities
|
||||||||||||||||||||||||
Trade and other payables
|
-
|
-
|
-
|
1,748,566
|
1,748,566
|
|||||||||||||||||||
Total Financial Liabilities
|
-
|
-
|
-
|
1,748,566
|
1,748,566
|
June 30, 2015
|
Floating
Interest Rate
(A$)
|
Fixed Interest
Maturing in
(A$)
|
Non-Interest bearing
(A$)
|
Total
(A$)
|
Average Interest Rate
|
|||||||||||||||||||
1 year
or less |
1-5 years
|
|||||||||||||||||||||||
Financial Assets
|
||||||||||||||||||||||||
Cash and cash equivalents
|
34,906,965
|
2,609
|
34,909,574
|
0.59
|
%
|
|||||||||||||||||||
Trade and other receivables
|
-
|
6,521,154
|
6,521,154
|
|||||||||||||||||||||
Other current assets
|
-
|
152,603
|
160,862
|
313,465
|
2.90
|
%
|
||||||||||||||||||
Other non-current assets
|
-
|
45,462
|
-
|
45,462
|
3.10
|
%
|
||||||||||||||||||
Total Financial Assets
|
34,906,965
|
152,603
|
45,462
|
6,684,625
|
41,789,655
|
|||||||||||||||||||
Financial Liabilities
|
||||||||||||||||||||||||
Trade and other payables
|
-
|
-
|
-
|
2,152,015
|
2,152,015
|
|||||||||||||||||||
Other financial liabilities
|
-
|
-
|
-
|
12,076
|
12,076
|
|||||||||||||||||||
Total Financial Liabilities
|
-
|
-
|
-
|
2,164,091
|
2,164,091
|
|||||||||||||||||||
Maturities of Financial Liabilities
|
||||||||||||||||||||
2016
|
Less than 6 months
|
6-12 months
|
Greater than 12 months and less than 5 years
|
Total contracted cash flows
|
Carrying amounts
|
|||||||||||||||
Trade and other payables
|
1,748,566
|
-
|
-
|
1,748,566
|
1,748,566
|
|||||||||||||||
Total
|
1,748,566
|
-
|
-
|
1,748,566
|
1,748,566
|
2015
|
Less than 6 months
|
6-12 months
|
Greater than 12 months and less than 5 years
|
Total contracted cash flows
|
Carrying amounts
|
|||||||||||||||
Trade and other payables
|
2,152,015
|
-
|
-
|
2,152,015
|
2,152,015
|
|||||||||||||||
Total
|
2,152,015
|
-
|
-
|
2,152,015
|
2,152,015
|
- | quoted prices in active markets for identical assets or liabilities (Level 1); |
- | inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly (as prices) or indirectly (derived from prices) (Level 2); and |
- | inputs for the asset or liability that are not based on observable market data (unobservable inputs) (Level 3). |
|
Prana Biotechnology Limited
|
By: | /s/ Geoffrey P. Kempler |
Geoffrey P. Kempler
Chief Executive Officer
|
Date
|
September, 2015
|
Parties
|
Orgapharm S.A.S.
of Rue du Moulin de la Canne, Pithiviers France 45 300
(
Orgapharm
)
|
Prana Biotechnology Ltd
ACN 080 699 065
of Level 2, 369 Royal Parade, Parkville Victoria Australia 3052
(
Prana
)
(each a
party
and collectively, the
parties
)
|
A | Prana is in the business of developing drug candidates for the treatment of neurodegenerative diseases. |
B | Orgapharm is in the business of manufacturing fine chemicals. |
C | Prana has sought the assistance of Orgapharm to manufacture PBT2 API. There may also be occasions in future where Prana may call on Orgapharm to provide other pharmaceutical manufacturing and related services. |
D | This Agreement contains the terms and conditions upon which Orgapharm will provide services to Prana. |
1 | Definitions and Interpretation |
1.1 | In this Agreement: |
(a) | the Deliverables; and |
(b) | the Results, |
(b) | Prana’s input in pursuance of this Agreement to facilitate the performance of the Services by Orgapharm; and |
(c) | the use of the Agreement IP by Prana for its business purposes. |
(a) | a material breach by Orgapharm of its obligations under this Agreement or the Quality Agreement; |
(b) | receipt by Orgapharm of an FDA Form 483 or Warning Letter or other like document from the EMA or any other regulatory authority; |
(c) | any audit, inspection or product, documentation or information request by the FDA, TGA or other regulatory authority which is specific to Prana’s Compounds. |
(a) | the principles and guidelines of good manufacturing practice stated in Commission Directive 2003/94/EC; and |
(b) | the guidelines published by the European Commission in EudraLex Volume 4, |
(a) | prior to the Commencement Date; or |
(b) | independent of this Agreement and without the use of the other party’s Confidential Information, |
(a) | an application is made to a court for an order that a party be wound-up or that a provisional liquidator be appointed (unless the application is withdrawn, struck out or dismissed within 45 days of it being made); |
(b) | a liquidator is appointed in respect of a party; |
(c) | an administrator, receiver or receiver and manager is appointed in relation to a party or in respect of any of its assets; |
(d) | except to reconstruct or amalgamate while solvent on terms approved by the other party, a party enters into, or resolves to enter into, an arrangement or composition with, or assignment for the benefit of, all or any of its creditors, or it, or anyone on its behalf, proposes a reorganisation, moratorium, deed of company arrangement or other administration involving any of them or the winding up or dissolution of the party; |
(e) | a party is, states that it is or is presumed under any applicable law to be, insolvent; and |
(f) | anything having a substantially similar effect to any of the events specified above happens under the law of any jurisdiction. |
(a) | Proposals; and |
(b) | all: |
(i) | Existing IP of Orgapharm; |
(ii) | information concerning Orgapharm’s affairs, assets or property or any business, property or transaction in which it may be or may have been concerned or interested; |
(iii) | information which, by its nature or by the circumstances of its disclosure, is or could reasonably be expected to be regarded as confidential to Orgapharm, |
(a) | the Compounds; |
(b) | RFPs; |
(c) | Agreement IP; and |
(d) | all: |
(i) | Existing IP of Prana; |
(ii) | data, results, information, analyses, papers, materials, records, notes, documents and reports concerning: |
(A) | the Compounds; |
(B) | the synthesis or commercial manufacture of the Compounds; |
(C) | research, tests, trials and studies planned or conducted in relation to the Compounds; |
(D) | Prana’s dealings with regulatory authorities around the world in relation to any Compound; |
(ii) | information concerning Prana’s affairs, assets or property or any business, property or transaction in which it may be or may have been concerned or interested; |
(iii) | information which, by its nature or by the circumstances of its disclosure, is or could reasonably be expected to be regarded as confidential to Prana, |
(b) | any subsequent project for the delivery of agreed Services by Orgapharm to Prana under this Agreement. |
(a) | information which, at the time of disclosure, was published, known publicly or otherwise in the public domain; |
(b) | information which, after disclosure, is published, becomes known publicly, or otherwise becomes part of the public domain through no fault of the receiving party; |
(c) | information which, prior to the time of disclosure, is known to the receiving party as evidenced by its written records or other tangible evidence; |
(d) | information which is made available to the receiving party in good faith by a third party who is under no obligation of confidence to the disclosing party; |
(e) | information which the receiving party is required to disclose by law, provided the receiving party has given the disclosing party prompt prior notice and assistance in any reasonable effort to obtain confidential treatment with respect to such disclosure; or |
(f) | information which is independently developed by or for the receiving party without use of, reliance upon, or with reference to the disclosing party’s Confidential Information. |
(a) | all results, data, information, processes, procedures, methodologies, techniques, concepts, ideas, compounds, formulations, materials, reports, analyses, documents, items or things; and |
(b) | all discoveries, inventions, developments, modifications, innovations, enhancements or improvements, |
(a) | annexed to a Work Order or incorporated therein by reference; or |
(b) | prepared and agreed by the parties during the course of a Project. |
(a) | proprietary compounds, samples, prototypes, formulations, ideas, knowledge, concepts, methods, techniques, processes, procedures, trade secrets, technology, discoveries, inventions, know-how, data, technical and scientific information, research and development results, development plans, test results, procedures for experiments and tests and manufacturing scale-ups, methods or schemes for synthesising chemicals and compounds, isolation and purification methods, hardware and software; |
(b) | patents, patentable inventions, designs, trade marks, works of copyright and rights in confidential information; |
(c) | all other intellectual property of any kind, whether or not protectable under patent, trade mark, copyright, design or other intellectual property laws. |
1.2
|
In this Agreement, unless the context requires another meaning:
|
(a) | a reference to: |
(ii) | a document (including this Agreement) is a reference to that document (including any Schedules and Annexures) as amended, consolidated, supplemented, novated or replaced; |
(iii) | an item, Recital, clause, Schedule or Annexure is to an item, Recital, clause, Schedule or Annexure of or to this Agreement; |
(iv) | a notice means a notice, approval, demand, request, nomination or other communication given by one party to another under or in connection with this Agreement; |
(v) | a person (including a party) includes an individual, company, other body corporate, association, partnership, firm, joint venture, trust or government agency; and |
(vi) | the words "including" or "includes" means "including, but not limited to", or "includes, without limitation" respectively; |
(b) | where a word or phrase is defined, its other grammatical forms have a corresponding meaning; and |
(c) | headings are for convenience only and do not affect interpretation of this Agreement. |
1.3
|
This Agreement may not be construed adversely to a party only because that party was responsible for preparing it.
|
2 | Term |
2.1
|
This Agreement commences on the Commencement Date and continues for five (5) years or until the completion of any then current Work Order by Orgapharm, unless terminated earlier in accordance with this Agreement. This Agreement may be extended by mutual agreement of the parties in writing.
|
3 | Services and Work Orders |
3.1 | If at any time during the Term Prana wishes to engage Orgapharm to provide Services to it, then subject to the parties entering a Work Order in respect of the Services, Orgapharm agrees to provide the Services on the terms and conditions contained in this Agreement. |
3.2 | Each Work Order: |
(a) | is incorporated herein by reference; |
(b) | shall be in a form similar to the sample Work Order attached to this Agreement as Annexure A; |
(c) | shall include a description of the specific services to be performed by Orgapharm, the deliverables, timelines, protocols, specifications, fees and charges payable by Prana and such other details and terms as are agreed to by the parties; |
(d) | is taken to include the Quality Agreement and all applicable Specifications. |
3.3 | In the event of any conflict between the terms and conditions of a Work Order and a provision of this Agreement, the terms and conditions of this Agreement shall prevail unless the Work Order expressly specifies that the particular term of the Work Order takes precedence. |
3.4 | Any change to a Work Order must be mutually agreed and documented by Orgapharm in a written amendment to the Work Order (a “ Change Order ”). When a signed Change Order is received from Prana, the Change Order shall constitute an amendment to the applicable Work Order and shall be considered part of this Agreement. No changes to a Work Order will take effect and Orgapharm must not commence any new or changed Services unless and until it has received a signed Change Order from Prana. |
4 | Orgapharm’s Obligations and Warranties |
4.1 | Orgapharm will perform each Project and the associated Services: |
(a) | using suitably qualified Representatives; |
(b) | in a timely manner in accordance with the Work Order; |
(c) | with due care and skill and to the best of Orgapharm’s knowledge and expertise; |
(d) | in accordance with relevant local industry standards, best practice and guidelines or where none apply, relevant international industry standards, best practice and guidelines; |
(e) | in accordance with cGMP, the Work Order and all applicable Laws; |
(f) | in accordance with any reasonable direction given by Prana; and |
(g) | otherwise in accordance with the provisions of this Agreement. |
4.2 | Orgapharm represents and warrants that: |
(a) | it has the right to enter into this Agreement; |
(b) | it has and will maintain the requisite licences from the EMA, FDA, TGA and all other applicable governmental, municipal and public agencies, bodies and authorities for the conduct of its business at each of its premises; |
(c) | it has and will maintain all rights, title, licences, interests, property, equipment and resources necessary to fully and lawfully perform each Project and the associated Services; |
(d) | it and its Representatives have the necessary experience, skill, knowledge and competence to perform each Project and the associated Services; |
(e) | each Deliverable will meet the Specification and be: |
(i) | complete, accurate, free from errors and fit for the purpose/s for which it is required by Prana; |
(ii) | compliant with all requirements specified in this Agreement and the relevant Work Order; |
(iii) | cGMP compliant and otherwise compliant with all other applicable Laws; |
(iv) | provided at the time and in the manner and form prescribed in the relevant Work Order. |
4.3 | Orgapharm will: |
(a) | permit all relevant inspections by the EMA, FDA, TGA or other regulatory authorities of its premises, procedures and documentation; |
(b) | notify Prana: |
(i) | within five (5) Business Days of receiving any notice of inspection from the EMA, FDA, TGA or other regulatory authority; |
(ii) | within three (3) Business Days of receiving any request from the EMA, FDA, TGA or other regulatory authority for Prana’s Compounds, products or samples or related batch or other documentation or information; |
(iii) | within one (1) Business Day of receiving any FDA Form 483 or Warning Letter or other like document from the EMA, TGA or any other regulatory authority which relates to Prana’s Compounds or which may impact on Orgapharm’s ability to supply such products (in accordance with a Work Order) or the facilities used to produce, test or package them, |
4.4 | Orgapharm must: |
(a) | take out and maintain during the term of this Agreement and for 12 months thereafter, appropriate public and product liability insurance policies with a reputable insurer which give coverage against all usual risks and for an amount of at least $ €10,000,000 per occurrence. |
(b) | at Prana’s request provide Prana with certificates of currency for those policies. |
5 | Project Obligations |
5.1 | For each Project: |
(a) | Orgapharm will designate a project leader to liaise with Prana in relation to Orgapharm’s performance of the Services and the provision of the Deliverables (the “ Project Leader ”); and |
(b) | Prana will designate a contact who will be the point of contact for the Project Leader (the “ Prana Contac t”). |
5.2 | The parties must agree the Specifications for each Deliverable and Orgapharm must receive written authority from the Prana Contact or Prana’s Chief Operating Officer before commencing any Sub-Project. Without such agreement and authority for a given Sub-Project, Orgapharm must not undertake and may not charge Prana its fee for the Sub-Project or any other amount. If in relation to a given Sub-Project, Prana provides written authority to undertake the Sub-Project after the relevant commencement date specified in the Work Order, then Orgapharm shall commence the Sub-Project as soon as is reasonably practicable thereafter, and in any event, not later than 14 days after Prana provides written authority to undertake the Sub-Project. |
5.3 | Orgapharm must provide the following updates and reports to the Prana Contact for each Project: |
(a) | prompt email notification of any material technical or operational problems or issues encountered by Orgapharm; |
(b) | fortnightly written updates (in a format acceptable to Prana) of the work undertaken and the Results obtained for the fortnight, problems encountered by Orgapharm, the stage of each Project or Sub-Project, as applicable that Orgapharm is up to and any other information that would be relevant to Prana in relation to the Project; and |
(c) | such reports specified in the applicable Work Order for the Project. |
5.4 | Orgapharm must create a separate project folder in the applicable department directory in its computer system: |
(a) | which is dedicated to Prana Projects; and |
(b) | accessible only by those Orgapharm Representatives working on such projects. |
5.5 | Copies of all letters, reports, memos, notes, documents and other written materials created or brought into existence by Orgapharm in relation to each Project shall be saved electronically and stored by Orgapharm on the Prana drive. |
5.6 | All Results arising out of the Project must be recorded in a written format. The results captured in a written format must: |
(a) | be maintained and signed in accordance with best industry practice; and |
(b) | be made available for inspection by Prana upon request by Prana in writing. |
5.7 | If they have not already done so, the parties agree to put a quality agreement in place for the purpose of the Services to be undertaken by Orgapharm under this Agreement. |
5.8 | On 30 days prior written notice, Orgapharm (or such shorter period of notice as may be agreed in good faith by the parties) must allow Prana to undertake an audit of its premises, procedures actions and documentation in relation to Prana’s Projects, Compounds and Agreement IP and Orgapharm’s observance of obligations under this Agreement and the Quality Agreement. Prana audits shall be limited to one audit with a maximum of two (2) auditors for two (2) days (or otherwise as may be negotiated in advance and agreed by the parties) per calendar year except if Prana reasonably believes that a Cause Event has occurred, in which case Prana may conduct an additional audit with 48 hrs prior written notice. |
5.9 | At any time during the conduct of a Project on prior notice by Prana, Orgapharm must allow Prana or any Representative of it to attend any premises at which a Project is being conducted for the purpose of assessing the progress of the Project. |
5.10 | If at any time during or after the termination of this Agreement, Prana requires a third party to perform any work relating to a Compound, including its manufacture, then Orgapharm must, at the request of Prana, co-operate with Prana and the third party and provide such assistance, advice, documentation and information (including the relevant Results) as is necessary to enable the third party to perform the work requested by Prana. Prana agrees to pay all out-of-pocket expenses reasonably incurred by Orgapharm, provided that any anticipated expenses in excess of USD$1,000 are approved by Prana in writing before they are incurred. |
5.11 | It is agreed in relation to any Deliverables supplied by Orgapharm pursuant to this Agreement that Prana shall have fifteen (15) days (“ Testing Period ”) from the date they are delivered to perform acceptance testing on the Deliverables in order to confirm that they comply with the Specifications (“ Acceptance Testing ”). If Prana is satisfied that the Deliverables meet Specification, then it will confirm this in writing to Orgapharm and pay the applicable payment. If Prana finds that any Deliverables supplied by Orgapharm do not meet specification, then Prana will immediately notify Orgapharm in writing of any non-compliance. If the non-compliance relates to: |
(a) | Product supplied to Prana, then Prana may by written notice: |
(i) | require that Orgapharm (at Orgapharm’s cost) manufacture and supply the applicable quantity of Product again based on: |
(A) | a manufacture start as soon as practicable after the date of Prana’s notice, and as agreed in good faith by both parties, given the understanding that delay in delivery of acceptable Product will adversely impact Prana; |
(B) | a manufacturing period less than or equal to the period of time originally allocated for the activity in the Work Order; or |
(ii) | terminate the Project in whole or in part, in which case Prana will not be liable to pay for, and Orgapharm must immediately refund any moneys paid by Prana (if any) on account of, the Project or the terminated part of it; |
(b) | services or documents or Results supplied, then Prana may by written notice: |
(i) | require that Orgapharm (at Orgapharm’s cost) immediately repeat the services or re-write the documents to rectify the non-compliance as soon as practicable thereafter;; or |
(ii) | terminate the Project in whole or in part, in which case Prana will not be liable to pay for, and Orgapharm must immediately refund any moneys paid by Prana (if any) on account of, the Project or the terminated part of it. |
6 | Fees and Charges |
6.1 | Orgapharm shall invoice Prana in a manner consistent with the payment schedule and other terms and conditions set out in the relevant Work Order. Payment of invoices shall be due thirty (30) days after the date of each invoice unless any milestone or Deliverable or Service referable to the invoiced Services has not been satisfied or supplied in accordance with the Work Order or this Agreement in which case payment shall be due on the later of thirty (30) days after the date of the invoice or the date when the milestone is satisfied or the Deliverable or Service is supplied in accordance with the Work Order or this Agreement. |
7 | Risk and Property |
7.1 | Property in any Product produced by Orgapharm pursuant to a Work Order will pass to Prana upon payment for it in full. Risk in the Product will remain with Orgapharm while in storage at Orgapharm’s premises but will otherwise pass to Prana on despatch from its premises to Prana or Prana’s nominee. |
8 | Intellectual Property |
8.1 | The parties acknowledge and agree that all Agreement IP will vest in and be solely owned by Prana. Orgapharm hereby assigns all of Orgapharm’s right, title and interest (if any) in the Agreement IP to Prana with effect from the time it is generated or comes into existence. |
8.2 | Orgapharm and its Representatives must give Prana all assistance and advice and execute all documents as may be required by Prana from time to time in relation to: |
(a) | any assignment that may be required to transfer Agreement IP to Prana; |
(b) | any applications by Prana for patents or other registrable Intellectual Property Rights in respect of the Agreement IP; |
(c) | any applications, submissions or other documents that Prana seeks to file with a regulatory authority or other government department, agency or body to obtain an approval or consent in relation to its proprietary compounds; |
(d) | any other purpose reasonably arising from or incidental to this Agreement. |
8.3 | This Agreement will not affect the ownership of a party’s Existing IP which is, and will continue to be, solely owned by that party. In particular, it is expressly agreed Orgapharm will remain the sole owner of any and all of its Existing IP (including its Existing IP used in connection with any given Project or Work Order). |
8.4 | Orgapharm grants Prana a non-exclusive, perpetual, worldwide, royalty-free licence (with the right to grant sublicences) to use and reproduce its Existing IP to the extent necessary to enable Prana to use the Agreement IP for the sole purpose of manufacturing and marketing PBT2 or any other PBT2 pharmacophore Compound. |
9 | Confidentiality |
9.1 | Each party: |
(a) | acknowledges and agrees that the Confidential Information of the other party will at all times remain the exclusive property of that other party; and |
(b) | undertakes to keep the Confidential Information of the other party secret and to protect and preserve the confidential nature and secrecy of that Confidential Information. |
9.2 | Prana agrees and acknowledges in relation to Orgapharm Confidential Information, and Orgapharm agrees and acknowledges in relation to Prana Confidential Information, that it: |
(a) | may only use or reproduce the other party’s Confidential Information for the Approved Purposes; |
(b) | must not disclose the other party’s Confidential Information to any person except as permitted by this Agreement; |
(c) | must not permit unauthorised persons to have access to the other party’s Confidential Information; |
(d) | must not make, or assist or permit any person (including its Representatives) to make any unauthorised use, disclosure or reproduction of the other Party’s Confidential Information; |
(e) | must ensure that any person who has access to the other party’s Confidential Information does not make any unauthorised use, reproduction or disclosure of that information; |
(f) | must enforce the confidentiality obligations imposed or required to be imposed by this Agreement, including diligently prosecuting at its cost any breach or threatened breach of those confidentiality obligations by a person to whom that party has disclosed the other Party’s Confidential Information and, where appropriate, making applications for interim or interlocutory relief; and |
(g) | must provide assistance reasonably requested by the other party, in relation to any proceedings the other party may take against any person for unauthorised use, copying or disclosure of the other Party’s Confidential Information. |
9.3 | A party may disclose the other party’s Confidential Information to a Representative on a need to know basis but in each case, only to the extent necessary for the Approved Purposes, and provided the Representative is placed under confidentiality obligations no less onerous than those set out in this Agreement. |
9.4 | Each party must: |
(a) | establish and maintain effective security measures to safeguard the other party’s Confidential Information from access or use not authorised under this Agreement; |
(b) | keep the other party’s Confidential Information under its own control; |
(c) | immediately notify the other party of any suspected or actual unauthorised use, copying or disclosure of the other party’s Confidential Information; |
9.5 | Either party may at any time by notice in writing to the other party request the return, deletion or destruction of all Material Forms of its Confidential Information in the possession, power or control of the other party or any of its Representatives (whether or not those Material Forms were created by the other party or its Representatives) and the other party must immediately comply with such request. In the case of Prana Compounds to be returned by Orgapharm, the parties acknowledge and agree that Orgapharm may retain samples of any Compounds manufactured by it so that it may comply with its cGMP obligations. |
9.6 | The return, deletion or destruction, as applicable, of the Material Forms of Confidential Information under clause 9.5 does not release a Party from its obligations under this clause 10. |
9.7 | Each party acknowledges and agrees that: |
(a) | its breach of this Agreement would be harmful to the business interests of the other party; |
(b) | monetary damages alone would not be a sufficient remedy for a breach of this Agreement; and |
(c) | in addition to any other remedy which may be available in law or equity, a party is entitled to interim, interlocutory and permanent injunctions or any of them, to prevent breach of this Agreement and to compel specific performance of it. |
10.1 | Except as expressly provided to the contrary in this Agreement, all terms, conditions, warranties, guarantees, undertakings or representations of any kind made by or on behalf of a party, prescribed by statute or implied in relation to the subject matter of this Agreement are, to the fullest extent permitted by law, excluded. |
10.2 | Subject to clause 10.4 and except to the extent that liability may not be lawfully excluded, Orgapharm’s liability in respect of all and any claims arising under this Agreement in relation to a Work Order, including any breach of this Agreement by Orgapharm or any negligence of Orgapharm or its Representatives, cannot exceed three times the agreed aggregate contract price for all works specified in the Work Order. |
10.3 | Notwithstanding any other provision of this Agreement, neither party shall have any liability to the other for any consequential loss suffered or incurred by the other party, however arising. |
10.4 | Clauses 10.2 and 10.3 shall have no application to any claim arising from a breach by either party of clause 9. |
10.5 | Prana shall indemnify and hold harmless Orgapharm in respect of any and all claims or demands by any third party against Orgapharm alleging loss, damage, personal injury or death arising out of the Deliverables provided by Orgapharm save and except for claims for loss, damage, injury or death arising directly or indirectly from any negligence or recklessness on the part of Orgapharm or any intentionally harmful act or omission by Orgapharm or any Representative of it or any infringement by Orgapharm of the third party’s intellectual property rights. |
11 | Termination |
11.1 | Either party may terminate this Agreement and/or any Work Order by written notice to the other party with immediate effect from the date of the notice or any later date that it may nominate if: |
(a) | the other party materially breaches this Agreement and fails to remedy such breach within 30 days of receipt of notice from the first party specifying the breach and requiring it to be remedied; |
(b) | the other party materially breaches this Agreement and the breach is incapable of remedy; or |
(c) | an Insolvency Event happens to the other party. |
11.2 | Prana may terminate this Agreement and/or or any Work Order (or any part of a Work Order) by giving Orgapharm 30 days written notice. For any incomplete Work Order, Orgapharm must, unless otherwise directed by Prana, cease work immediately and use its commercially reasonable efforts to mitigate any reimbursable expenses or non-cancellable commitments properly incurred in accordance with this Agreement or the applicable Work Order. |
11.3 | Upon the termination of this Agreement or any Work Order pursuant to clauses 11.1, 11.2 or 11.2, Orgapharm may invoice Prana for Services and reimbursable expenses and non-cancellable commitments properly performed or incurred in accordance with this Agreement and the applicable Work Order through to the date of termination ( Final Invoice ). In the absence of any offsetting claim, Prana agrees to immediately pay all outstanding invoices and otherwise pay the Final Invoice (or so much thereof as may be due having regard to any up-front fees already paid) within 30 days of the date of the invoice. If after raising the Final Invoice, Prana’s account is in credit, then Orgapharm shall immediately refund the credit balance. |
11.4 | The expiry or termination of this Agreement will not affect or limit any accrued rights of the parties. |
11.5 | Clauses 1, 4.2, 4.4, 5.10, 7, 8, 9, 10, 11, 14.15 and 14.16 shall survive the termination of this Agreement. |
12 | Force Majeure |
12.1 | If any party to this Agreement is unable to carry out any obligation (other than to pay money), by reason of Force Majeure, then that obligation will be suspended so far as it is affected by the Force Majeure for the duration of the Force Majeure. The party affected must promptly give written notice to the other party of the Force Majeure with full particulars thereof and so far as is known, the probable extent to which that party will be unable to perform or will be delayed in performing the obligation. |
12.2 | If: |
(a) | performance of an obligation is prevented by Force Majeure; or |
(b) | a delay caused by Force Majeure exceeds 90 days, |
13 | Notices |
13.1 | All notices must be: |
(a) | in legible writing and in English; |
(b) | addressed to the recipient at the address or facsimile number set out below or to any other address or facsimile number that a party may notify to the other: |
Address:
|
Rue du Moulin de la Canne,
Pithiviers France 45 300
|
|
Attention:
|
Rabiaâ Berkous
|
|
Facsimile no:
|
33(0)2 38 30 24 2 4
|
|
to Prana:
|
||
Address: | Level 2, 369 Royal Parade | |
Parkville Victoria 3052 | ||
Australia | ||
Attention:
|
Dianne Angus | |
Facsimile no:
|
9348 0377 |
(c) | signed by the party or, where the sender is a company, by an authorised representative of the sender; and |
(d) | sent to the recipient by hand, prepaid post or facsimile. |
13.2 | Without limiting any other means by which a party may be able to prove that a notice has been received by the other party, a notice will be considered to have been received: |
(a) | if sent by hand, when left at the address of the recipient; |
(b) | if sent by prepaid post, 2 days after the date of posting; or |
(c) | if sent by facsimile, on receipt by the sender of an acknowledgment or transmission report generated by the sender's machine indicating that the whole facsimile was sent to the recipient's facsimile number; |
14 | General provisions |
14.1 | This Agreement and any other documents referred to in this Agreement or executed in connection with this Agreement is the entire agreement of the parties about the subject matter of this Agreement and supersedes all other representations, negotiations, arrangements, understandings or agreements and all other communications. No party has entered into this Agreement relying on any representations made by or on behalf of the other, other than those expressly made in this Agreement. |
14.2 | Each party must, at its own expense, whenever reasonably requested by the other party, promptly do or arrange for others to do, everything reasonably necessary or desirable to give full effect to this Agreement and the transactions contemplated by this Agreement. |
14.3 | Each party must pay its own costs in respect of this Agreement and the documents and transactions contemplated by this Agreement. |
14.4 | Orgapharm must not subcontract the Services or assign or otherwise transfer, create any charge, trust or other interest in, or otherwise deal in any other way with any of its rights under this Agreement without the prior written consent of Prana. Orgapharm shall remain responsible for any Services performed by any subcontractors to the same extent as if such Services were being performed by Orgapharm itself. |
14.5 | If a provision of this Agreement is invalid or unenforceable in a jurisdiction: |
(a) | it is to be read down or severed to the extent of the invalidity or unenforceability; and |
(b) | that fact does not affect the validity or enforceability of the remaining provisions. |
14.6 | A waiver by a party of a provision of or of a right under this Agreement is binding on the party granting the waiver only if it is given in writing and is signed by the party or an authorised representative of the party granting the waiver. |
14.7 | A waiver is effective only in the specific instance and for the specific purpose for which it is given. |
14.8 | A single or partial exercise of a right by a party does not preclude another exercise of that right or the exercise of another right. |
14.9 | Failure by a party to exercise or delay in exercising a right does not prevent its exercise or operate as a waiver. |
14.10 | This Agreement may be amended only by a document signed by all parties. |
14.11 | This Agreement may be signed in counterparts, both of which shall be deemed to be an original but when taken together shall constitute one and the same agreement and shall become effective when a counterpart has been signed by each of the parties hereto and delivered to the other (by facsimile, pdf or otherwise). |
14.12 | The rights, remedies and powers of the parties under this Agreement are cumulative and do not exclude any other rights, remedies or powers. |
14.13 | A party may give its approval or consent conditionally or unconditionally or withhold its approval or consent in its absolute discretion unless this Agreement expressly provides otherwise. |
14.14 | This Agreement is binding on, and has effect for the benefit of, the parties and their respective successors and permitted assigns. |
14.15 | This Agreement is governed by the laws of Victoria, Australia. |
14.16 | Each party irrevocably and unconditionally: |
(a) | submits to the non-exclusive jurisdiction of the courts of Victoria in relation to any dispute or claim arising out of or in connection with the subject matter of this agreement; |
(b) | waives, without limitation, any claim or objection based on absence of jurisdiction or inconvenient forum. |
Signed
for and on behalf of
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Orgapharm S.A.S.
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by its authorised representative:
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Signature of authorised representative
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Name (please print)
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Title (please print)
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Signed
for and on behalf of
Prana Biotechnology Ltd
ACN
080 699 065
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by its authorised representative:
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Signature of authorised representative
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Name (please print)
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Title (please print)
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1. | Background |
2. | Description of Services and Deliverables |
3. | Responsibilities |
4. | Project Timeline |
5. | Fees, Reimbursable Expenses and Payment Schedule |
6. | Any other applicable terms and conditions not covered in the MSA |
7. | Exhibits to the Work Order (e.g. specifications, Quality Agreement) |
Orgapharm S.A.S
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Prana Biotechnology Ltd
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By:
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By:
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Name:
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Name:
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Title:
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Title:
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Commencement Date
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1 September, 2015
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Parties
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IDT Australia Limited
ACN 066 522 970
of 45 Wadhurst Drive, Boronia Victoria 3155
(
IDT
)
|
Prana Biotechnology Ltd
ACN 080 699 065
of Level 2, 369 Royal Parade, Parkville Victoria Australia 3052
(
Prana
)
(each a
party
and collectively, the
parties
)
|
A | Prana is in the business of developing drug candidates for the treatment of neurodegenerative diseases. |
B | IDT is in the business of formulating, developing and manufacturing API and finished dosage forms, analytical testing (including stability and microbiological testing), clinical packaging and distribution of pharmaceutical products from its facilities in Boronia, Victoria. |
C | Prana has sought the assistance of IDT to formulate, develop and manufacture API and finished dosage forms, analytical testing (including stability and microbiological testing), clinical packaging and distribution of clinical trial materials for Prana’s proprietary product/s such as PBT434 and PBT2 and matching placebo for clinical trials. There may also be occasions in future where Prana may call on IDT to provide other pharmaceutical manufacturing and related services. |
D | This Agreement contains the terms and conditions upon which IDT will provide services to Prana. |
1 | Definitions and Interpretation |
1.1 | In this Agreement: |
(a) | the Deliverables; and |
(b) | the Results, |
(b) | Prana’s input in pursuance of this Agreement to facilitate the performance of the Services by IDT; and |
(c) | the use of the Agreement IP by Prana for its business purposes. |
(b) | receipt by IDT of an FDA Form 483 of the type specified in clause 4.3(b)(iii) or Warning Letter or other like document from the TGA or any other regulatory authority; |
(c) | any audit, inspection or product, documentation or information request by the FDA, TGA or other regulatory authority which is specific to Prana’s Products. |
(a) | prior to the Commencement Date; or |
(b) | independent of this Agreement and without the use of the other party’s Confidential Information, |
(a) | Proposals; and |
(b) | all: |
(i) | Existing IP of IDT; |
(ii) | information concerning IDT’s affairs, assets or property or any business, property or transaction in which it may be or may have been concerned or interested; |
(iii) | information which, by its nature or by the circumstances of its disclosure, is or could reasonably be expected to be regarded as confidential to IDT, |
(a) | an application is made to a court for an order that a party be wound-up or that a provisional liquidator be appointed (unless the application is withdrawn, struck out or dismissed within 45 days of it being made); |
(b) | a liquidator is appointed in respect of a party; |
(c) | a resolution is passed or a decision taken to appoint an administrator, receiver or receiver and manager in respect of a party or there is a Controller (as defined in the Corporations Law) appointed in relation to a party or in respect of any of its assets; |
(d) | except to reconstruct or amalgamate while solvent on terms approved by the other party, a party enters into, or resolves to enter into, an arrangement or composition with, or assignment for the benefit of, all or any of its creditors, or it, or anyone on its behalf, proposes a reorganisation, moratorium, deed of company arrangement or other administration involving any of them or the winding up or dissolution of the party; |
(e) | a party is, states that it is or is presumed under any applicable law to be, insolvent; and |
(f) | anything having a substantially similar effect to any of the events specified above happens under the law of any jurisdiction. |
(a) | the Compounds; |
(b) | RFPs; |
(c) | Agreement IP; and |
(d) | all: |
(i) | Existing IP of Prana, including all data, results, information, analyses, papers, materials, records, notes, documents and reports concerning: |
(A) | the Compounds; |
(B) | the synthesis or commercial manufacture of the Compounds; |
(C) | research, tests, trials and studies planned or conducted in relation to the Compounds; |
(ii) | information concerning Prana’s affairs, assets or property or any business, property or transaction in which it may be or may have been concerned or interested; |
(iii) | information which, by its nature or by the circumstances of its disclosure, is or could reasonably be expected to be regarded as confidential to Prana, |
(b) | any subsequent project for the delivery of agreed Services by IDT to Prana under this Agreement. |
(a) | information which, at the time of disclosure, was published, known publicly or otherwise in the public domain; |
(b) | information which, after disclosure, is published, becomes known publicly, or otherwise becomes part of the public domain through no fault of the receiving party; |
(c) | information which, prior to the time of disclosure, is known to the receiving party as evidenced by its written records or other tangible evidence; |
(d) | information which is made available to the receiving party in good faith by a third party who is under no obligation of confidence to the disclosing party; |
(e) | information which the receiving party is required to disclose by law, provided the receiving party has given the disclosing party prompt prior notice and assistance in any reasonable effort to obtain confidential treatment with respect to such disclosure; or |
(f) | information which is independently developed by or for the receiving party without use of, reliance upon, or with reference to the disclosing party’s Confidential Information. |
(a) | all results, data, information, processes, procedures, methodologies, techniques, concepts, ideas, compounds, formulations, materials, reports, analyses, documents, items or things; and |
(b) | all discoveries, inventions, developments, modifications, innovations, enhancements or improvements, |
(a) | recorded in or annexed to a Work Order or incorporated therein by reference; or |
(b) | prepared and agreed by the parties during the course of a Project. |
(a) | proprietary compounds, samples, prototypes, formulations, ideas, knowledge, concepts, methods, techniques, processes, procedures, trade secrets, technology, discoveries, inventions, know-how, data, technical and scientific information, research and development results, development plans, test results, procedures for experiments and tests and manufacturing scale-ups, methods or schemes for synthesising chemicals and compounds, isolation and purification methods, hardware and software; |
(b) | patents, patentable inventions, designs, trade marks, works of copyright and rights in confidential information; |
(c) | all other intellectual property of any kind, whether or not protectable under patent, trade mark, copyright, design or other intellectual property laws. |
1.2
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In this Agreement, unless the context requires another meaning:
|
(a) | a reference to: |
(ii) | a document (including this Agreement) is a reference to that document (including any Schedules and Annexures) as amended, consolidated, supplemented, novated or replaced; |
(iii) | an item, Recital, clause, Schedule or Annexure is to an item, Recital, clause, Schedule or Annexure of or to this Agreement; |
(iv) | a notice means a notice, approval, demand, request, nomination or other communication given by one party to another under or in connection with this Agreement; |
(v) | a person (including a party) includes an individual, company, other body corporate, association, partnership, firm, joint venture, trust or government agency; and |
(vi) | the words "including" or "includes" means "including, but not limited to", or "includes, without limitation" respectively; |
(b) | where a word or phrase is defined, its other grammatical forms have a corresponding meaning; and |
(c) | headings are for convenience only and do not affect interpretation of this Agreement. |
2 | Term |
3 | Services and Work Orders |
3.1 | If at any time during the Term Prana wishes to engage IDT to provide Services to it, then subject to the parties entering a Work Order in respect of the Services, IDT agrees to provide the Services on the terms and conditions contained in this Agreement. |
3.2 | Each Work Order: |
(a) | is incorporated herein by reference; |
(b) | shall be in written form similar to the sample Work Order attached to this Agreement as Annexure A; |
(c) | shall include a description of the specific services to be performed by IDT, the Deliverables, timelines, protocols, Specifications, fees and charges payable by Prana and such other details and terms as are agreed to by the parties; and |
(d) | is taken to include the Quality Agreement and all applicable Specifications. |
3.3 | In the event of any conflict between the terms and conditions of a Work Order and a provision of this Agreement, the terms and conditions of this Agreement shall prevail unless the Work Order expressly specifies that the particular term of the Work Order takes precedence. |
3.4 | Any change to a Work Order must be mutually agreed and documented by IDT in a written amendment to the Work Order (a “ Change Order ”). When a signed Change Order is received from Prana, the Change Order shall constitute an amendment to the applicable Work Order and shall be considered part of this Agreement. No changes to a Work Order will take effect and IDT must not commence any new or changed Services unless and until it has received a signed Change Order from Prana. |
4 | IDT’s Obligations and Warranties |
4.1 | IDT will perform each Project and the associated Services at the Premises: |
(a) | using suitably qualified Representatives; |
(b) | using commercially reasonable endeavours to perform each Project and the associated Services in a timely manner in accordance with the Work Order; |
(c) | with due care and skill and to the best of IDT’s knowledge and expertise; |
(d) | in accordance with relevant local industry standards, best practice and guidelines or where none apply, relevant international industry standards, best practice and guidelines; |
(e) | in accordance with cGMP, the Work Order and all Laws applicable to the operation of the Premises; |
(f) | in accordance with any reasonable direction given by Prana; and |
(g) | otherwise in accordance with the provisions of this Agreement. |
4.2 | IDT represents and warrants that: |
(a) | it has the right to enter into this Agreement; |
(b) | it has and will maintain the requisite licences from the FDA, TGA and all other applicable governmental, municipal and public agencies, bodies and authorities for the conduct of its business at each of its premises; |
(c) | it has and will maintain all: |
(i) | rights, title, licences and interests in its Existing IP; |
(ii) | property, equipment and resources, |
(d) | it and its Representatives have the necessary experience, skill, knowledge and competence to perform each Project and the associated Services. |
4.3 | IDT will: |
(a) | permit all relevant inspections by the FDA, TGA or other regulatory authorities of its premises, procedures and documentation; |
(b) | notify Prana: |
(i) | within three (3) Business Days of receiving any notice of inspection from the FDA, TGA or other regulatory authority only to the extent such an inspection relates to Prana’s IMP/Compounds or may impact on IDT’s ability to supply such products; |
(ii) | within one (1) Business Day of receiving any request from the FDA, TGA or other regulatory authority for Prana’s IMP, Compounds, products or samples or related batch or other documentation or information; |
(iii) | within one (1) Business Day of receiving any FDA Form 483 or Warning Letter or other like document from the TGA or any other regulatory authority which relates to Prana’s IMP/Compounds or which may impact on IDT’s ability to supply such products (in accordance with a Work Order) or the facilities used to produce, test or package them, |
4.4 | IDT must: |
(a) | take out and maintain during the term of this Agreement and for 12 months thereafter, appropriate public and product liability insurance policies with a reputable insurer which give coverage against all usual risks and for an amount of at least $10,000,000 per occurrence. |
(b) | at Prana’s request provide Prana with certificates of currency for those policies. |
5 | Project Obligations |
5.1 | For each Project: |
(a) | IDT will designate a project leader to liaise with Prana in relation to IDT’s performance of the Services and the provision of the Deliverables (the “ Project Leader ”); and |
(b) | Prana will designate a contact who will be the point of contact for the Project Leader (the “ Prana Contac t”). |
5.2 | The parties must agree in writing on the Specifications for each Deliverable and IDT must receive written authority from the Prana Contact or Prana’s Chief Operating Officer before commencing any Sub-Project. Without such agreement and authority for a given Sub-Project, IDT must not undertake and may not charge Prana its fee for the Sub-Project or any other amount. If in relation to a given Sub-Project, Prana provides written authority to undertake the Sub-Project after the relevant commencement date specified in the Work Order, then IDT shall commence the Sub-Project as soon as is reasonably practicable thereafter. |
5.3 | IDT must provide the following updates and reports to the Prana Contact for each Project: |
(a) | prompt email notification of any material technical or operational problems or issues encountered by IDT; |
(b) | fortnightly email updates (in a format acceptable to Prana) of the work undertaken and the Results obtained for the fortnight, problems encountered by IDT, the stage of each Project or Sub-Project, as applicable that IDT is up to and any other information that would be relevant to Prana in relation to the Project; and |
(c) | such reports specified in the applicable Work Order for the Project. |
5.4 | IDT must create a separate project folder in the applicable department directory in its computer system: |
(a) | which is dedicated to Prana Projects; and |
(b) | accessible only by those IDT Representatives working on such projects. |
5.5 | Copies of all letters, reports, memos, notes, documents and other written materials created or brought into existence by IDT in relation to each Project shall be saved electronically and stored by IDT in the Prana project folder. |
5.6 | All Results arising out of the Project must be recorded in a written format. The results captured in a written format must: |
(a) | be maintained and signed in accordance with IDT’s information retention policies and practices; and |
(b) | be made available for inspection by Prana upon request by Prana in writing. |
5.7 | If they have not already done so, the parties agree to put a quality agreement in place for the purpose of the Services to be undertaken by IDT under this Agreement. |
5.8 | On 14 days prior written notice, IDT must allow Prana to undertake an audit of its Premises, procedures actions and documentation in relation to Prana’s Projects, IMPs, Compounds and Agreement IP and IDT’s observance of obligations under this Agreement and the Quality Agreement. Prana audits shall be limited to one audit with a maximum of two (2) auditors for two (2) days (or otherwise as may be negotiated in advance and agreed by the parties) per calendar year except if Prana reasonably believes that a Cause Event has occurred or may occur in which case Prana may conduct an additional audit with 5 days prior written notice (or such shorter period of notice agreed by the parties in good faith having regard to the urgency of the situation). |
5.9 | If at any time during or after the termination of this Agreement, Prana requires a third party to perform any work relating to a Compound, including its manufacture, then IDT must, at the request of Prana, co-operate with Prana and the third party and provide such assistance, advice, documentation and information (including the relevant Results) as is necessary to enable the third party to perform the work requested by Prana. Prana agrees to pay all out-of-pocket expenses reasonably incurred by IDT, provided that any anticipated expenses in excess of USD$1,000 are approved by Prana in writing before they are incurred. |
5.10 | If any Deliverable is not produced by IDT to Specification in accordance with this Agreement as a direct result of the negligence of, or breach of GMP or any IDT Standard Operating Procedure by, IDT or any Representative of it, then Prana may reject the Deliverable and: |
(b) | terminate the applicable Work Order in whole or in part, in which case Prana will not be liable to pay for, and IDT must immediately refund any moneys paid by Prana (if any) on account of, the Work Order or the terminated part of it, as applicable. |
6 | Fees and Charges |
6.1 | IDT shall invoice Prana in a manner consistent with the payment schedule and other terms and conditions set out in the relevant Work Order. Payment of invoices shall be due thirty (30) days after the date of each invoice. |
7 | GST |
7.1 | Except where express provision is made to the contrary, and subject to this clause, any amount that may be payable under this Agreement is exclusive of any GST . If GST is or becomes payable on a supply made under or in connection with this Agreement, an additional amount ( Additional Amount ) is payable by the party providing consideration for the supply ( Recipient ) equal to the amount of GST payable on that supply as calculated by the party making the supply ( Supplier ) in accordance with the GST Law. |
7.2 | The Additional Amount payable under clause 7.1 must be paid at the same time and in the same manner as the consideration for the supply, subject to receipt by the Recipient of a valid tax invoice. |
7.3 | If the rate of GST payable in respect of supplies made (or deemed to be made) in connection with this Agreement changes, the amount payable must be adjusted so that the economic benefit of this Agreement to the party receiving each payment remains the same, irrespective of the rate of GST which applies . |
7.4 | Notwithstanding any other provision of this Agreement, if either party is required to reimburse or indemnify the other party for any cost, expense or other amount, the amount to be reimbursed or indemnified must be reduced by any part which is recoverable as an input tax credit by the party which incurred it (or representative member of that party's GST group). |
7.5 | Terms used in this clause 7 (including "supply", "consideration", "representative member", "tax invoice" and "GST group") have the same meaning as defined in the GST Law. |
8 | Risk and Property |
8.1 | Property in any Products produced by IDT pursuant to a Work Order will pass to Prana upon payment for them in full. Risk in the Products will remain with IDT while in storage at IDT’s premises but will otherwise pass to Prana on despatch from its premises to Prana or Prana’s nominee. |
9 | Intellectual Property |
9.1 | The parties acknowledge and agree that all Agreement IP will vest in and be solely owned by Prana. IDT hereby assigns all of IDT’s right, title and interest (if any) in the Agreement IP to Prana with effect from the time it is generated or comes into existence. |
9.2 | IDT and its Representatives must give Prana all reasonable assistance and advice and execute all documents as may be required by Prana from time to time in relation to: |
(a) | any assignment that may be required to transfer Agreement IP to Prana; |
(b) | any applications by Prana for patents or other registrable Intellectual Property Rights in respect of the Agreement IP; |
(c) | any applications, submissions or other documents that Prana seeks to file with a regulatory authority or other government department, agency or body to obtain an approval or consent in relation to its proprietary compounds; |
(d) | any other purpose reasonably arising from or incidental to this Agreement. |
9.3 | This Agreement will not affect the ownership of a party’s Existing IP which is, and will continue to be, solely owned by that party. |
9.4 | IDT grants Prana a non-exclusive, perpetual, worldwide, royalty-free licence (with the right to grant sublicenses) to use, reproduce and adapt its Existing IP only to the extent necessary to enable Prana to use the Agreement IP for its business purposes. |
10 | Confidentiality |
10.1 | Each party: |
(a) | acknowledges and agrees that the Confidential Information of the other party will at all times remain the exclusive property of that other party; and |
(b) | undertakes to keep the Confidential Information of the other party secret and to protect and preserve the confidential nature and secrecy of that Confidential Information. |
10.2 | Prana agrees and acknowledges in relation to IDT Confidential Information, and IDT agrees and acknowledges in relation to Prana Confidential Information, that it: |
(a) | may only use or reproduce the other party’s Confidential Information for the Approved Purposes; |
(b) | must not disclose the other party’s Confidential Information to any person except as permitted by this Agreement; |
(c) | must not permit unauthorised persons to have access to the other party’s Confidential Information; |
(d) | must not make, or assist or permit any person (including its Representatives) to make any unauthorised use, disclosure or reproduction of the other Party’s Confidential Information; |
(e) | must ensure that any person who has access to the other party’s Confidential Information does not make any unauthorised use, reproduction or disclosure of that information; |
(f) | must enforce the confidentiality obligations imposed or required to be imposed by this Agreement, including diligently prosecuting at its cost any breach or threatened breach of those confidentiality obligations by a person to whom that party has disclosed the other Party’s Confidential Information and, where appropriate, making applications for interim or interlocutory relief; and |
(g) | must provide assistance reasonably requested by the other party, in relation to any proceedings the other party may take against any person for unauthorised use, copying or disclosure of the other Party’s Confidential Information. |
10.3 | A party may disclose the other party’s Confidential Information to a Representative on a need to know basis but in each case, only to the extent necessary for the Approved Purposes, and provided the Representatives are placed under confidentiality obligations no less onerous than those set out in this Agreement. |
10.4 | Each party must: |
(a) | establish and maintain effective security measures to safeguard the other party’s Confidential Information from access or use not authorised under this Agreement; |
(b) | keep the other party’s Confidential Information under its own control; |
(c) | immediately notify the other party of any suspected or actual unauthorised use, copying or disclosure of the other party’s Confidential Information; |
10.5 | Either party may at any time by notice in writing to the other party request the return, deletion or destruction of all Material Forms of its Confidential Information in the possession, power or control of the other party or any of its Representatives (whether or not those Material Forms were created by the other party or its Representatives) and the other party must immediately comply with such request. In the case of Prana Compounds to be returned by IDT, the parties acknowledge and agree that IDT may retain samples of any Compounds manufactured by it so that it may comply with its cGMP obligations. |
10.6 | The return, deletion or destruction, as applicable, of the Material Forms of Confidential Information under clause 10.5 does not release a Party from its obligations under this clause 10. |
10.7 | Each party acknowledges and agrees that: |
(a) | its breach of this Agreement would be harmful to the business interests of the other party; |
(b) | monetary damages alone would not be a sufficient remedy for a breach of this Agreement; and |
(c) | in addition to any other remedy which may be available in law or equity, a party is entitled to interim, interlocutory and permanent injunctions or any of them, to prevent breach of this Agreement and to compel specific performance of it. |
11
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Liability
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11.1 | Except as expressly provided to the contrary in this Agreement, all terms, conditions, warranties, guarantees, undertakings or representations of any kind made by or on behalf of a party, prescribed by statute or implied in relation to the subject matter of this Agreement are, to the fullest extent permitted by law, excluded. |
11.2 | Subject to clause 11.4, IDT’s liability in respect of all and any claims arising under this Agreement in relation to a Work Order, including any breach of this Agreement by IDT or any negligence of IDT or its Representatives, cannot exceed the agreed aggregate contract price for all works specified in the Work Order. |
11.3 | Notwithstanding any other provision of this Agreement, neither party shall have any liability to the other for any consequential loss suffered or incurred by the other party, however arising. |
11.4 | Clauses 11.2 and 11.3 shall have no application to any claim arising from a breach by either party of clause 10. |
11.5 | Prana shall indemnify and hold harmless IDT in respect of any and all claims or demands by any third party against IDT alleging loss, damage, personal injury or death arising out of the Deliverables provided by IDT save and except for claims for loss, damage, injury or death arising directly or indirectly from any gross negligence or recklessness on the part of IDT or any intentionally harmful act or omission by IDT or any Representative of it. |
12 | Termination |
12.1 | Either party may terminate this Agreement and/or any Work Order by written notice to the other party with immediate effect from that or any later date that it may nominate if: |
(a) | the other party materially breaches this Agreement and fails to remedy such breach within 30 days of receipt of notice from the first party specifying the breach and requiring it to be remedied; |
(b) | the other party materially breaches this Agreement and the breach is incapable of remedy; or |
(c) | an Insolvency Event happens to the other party. |
12.2 | Prana may terminate this Agreement and/or or any Work Order (or any part of a Work Order) by giving IDT 30 days written notice. For any incomplete Work Order, IDT must, unless otherwise directed by Prana, cease work immediately and use its commercially reasonable efforts to mitigate any reimbursable expenses or non-cancellable commitments properly incurred in accordance with this Agreement or the applicable Work Order. |
12.3 | Upon the termination of this Agreement or any Work Order pursuant to clauses 12.1, 12.2 or 13.2, IDT may invoice Prana for Services and reimbursable expenses and non-cancellable commitments properly performed or incurred in accordance with this Agreement and the applicable Work Order through to the date of termination ( Final Invoice ). In the absence of any offsetting claim, Prana agrees to immediately pay all outstanding invoices and otherwise pay the Final Invoice (or so much thereof as may be due having regard to any up-front fees already paid) within 30 days of the date of the invoice. If after raising the Final Invoice, Prana’s account is in credit, then IDT shall immediately refund the credit balance. |
12.4 | The expiry or termination of this Agreement will not affect or limit any accrued rights of the parties. |
12.5 | Clauses 1, 4.2, 4.4, 5.9, 7, 8, 9, 10, 11, 12, 15.15 and 15.16 shall survive the termination of this Agreement. |
13 | Force Majeure |
13.1 | If any party to this Agreement is unable to carry out any obligation (other than to pay money), by reason of Force Majeure, then that obligation will be suspended so far as it is affected by the Force Majeure for the duration of the Force Majeure. The party affected must promptly give written notice to the other party of the Force Majeure with full particulars thereof and so far as is known, the probable extent to which that party will be unable to perform or will be delayed in performing the obligation. |
13.2 | If: |
(a) | performance of an obligation is prevented by Force Majeure; or |
(b) | a delay caused by Force Majeure exceeds 90 days, |
14 | Notices |
14.1 | All notices must be: |
(a) | in legible writing and in English; |
(b) | addressed to the recipient at the address or facsimile number set out below or to any other address or facsimile number that a party may notify to the other: |
to IDT:
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Address:
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45 Wadhurst Drive
Boronia Victoria 3155
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Attention:
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Managing Director
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Facsimile no:
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(03) 9801 8773
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to Prana:
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Address: | Level 2, 369 Royal Parade | |
Parkville Victoria 3052 | ||
Australia | ||
Attention:
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Dianne Angus | |
Facsimile no:
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9348 0377 |
(c) | signed by the party or, where the sender is a company, by an authorised representative of the sender; and |
(d) | sent to the recipient by hand, prepaid post or facsimile. |
14.2 | Without limiting any other means by which a party may be able to prove that a notice has been received by the other party, a notice will be considered to have been received: |
(a) | if sent by hand, when left at the address of the recipient; |
(b) | if sent by prepaid post, 2 days after the date of posting; or |
(c) | if sent by facsimile, on receipt by the sender of an acknowledgment or transmission report generated by the sender's machine indicating that the whole facsimile was sent to the recipient's facsimile number; |
15 | General provisions |
15.1 | This Agreement and any other documents referred to in this Agreement or executed in connection with this Agreement is the entire agreement of the parties about the subject matter of this Agreement and supersedes all other representations, negotiations, arrangements, understandings or agreements and all other communications. No party has entered into this Agreement relying on any representations made by or on behalf of the other, other than those expressly made in this Agreement. For the avoidance of doubt, IDT’s terms and conditions for consulting/project work will have no application, |
15.2 | Each party must, at its own expense, whenever reasonably requested by the other party, promptly do or arrange for others to do, everything reasonably necessary or desirable to give full effect to this Agreement and the transactions contemplated by this Agreement. |
15.3 | Each party must pay its own costs in respect of this Agreement and the documents and transactions contemplated by this Agreement. |
15.4 | IDT must not subcontract the Services or assign or otherwise transfer, create any charge, trust or other interest in, or otherwise deal in any other way with any of its rights under this Agreement without the prior written consent of Prana. IDT shall remain responsible for any Services performed by any subcontractors to the same extent as if such Services were being performed by IDT itself. |
15.5 | If a provision of this Agreement is invalid or unenforceable in a jurisdiction: |
(a) | it is to be read down or severed to the extent of the invalidity or unenforceability; and |
(b) | that fact does not affect the validity or enforceability of the remaining provisions. |
15.6 | A waiver by a party of a provision of or of a right under this Agreement is binding on the party granting the waiver only if it is given in writing and is signed by the party or an authorised representative of the party granting the waiver. |
15.7 | A waiver is effective only in the specific instance and for the specific purpose for which it is given. |
15.8 | A single or partial exercise of a right by a party does not preclude another exercise of that right or the exercise of another right. |
15.9 | Failure by a party to exercise or delay in exercising a right does not prevent its exercise or operate as a waiver. |
15.10 | This Agreement may be amended only by a document signed by all parties. |
15.11 | This Agreement may be signed in counterparts, both of which shall be deemed to be an original but when taken together shall constitute one and the same agreement and shall become effective when a counterpart has been signed by each of the parties hereto and delivered to the other (by facsimile, pdf or otherwise). |
15.12 | The rights, remedies and powers of the parties under this Agreement are cumulative and do not exclude any other rights, remedies or powers. |
15.13 | A party may give its approval or consent conditionally or unconditionally or withhold its approval or consent in its absolute discretion unless this Agreement expressly provides otherwise. |
15.14 | This Agreement is binding on, and has effect for the benefit of, the parties and their respective successors and permitted assigns. |
15.15 | This Agreement is governed by the laws of Victoria. |
15.16 | Each party irrevocably and unconditionally: |
(a) | submits to the non-exclusive jurisdiction of the courts of Victoria in relation to any dispute or claim arising out of or in connection with the subject matter of this agreement; |
(b) | waives, without limitation, any claim or objection based on absence of jurisdiction or inconvenient forum. |
Signed
for and on behalf of
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IDT Australia Limited
ACN 066 522 970
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by its authorised representative:
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Signature of authorised representative
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Dr Paul D R MacLeman
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Name (please print)
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Title (please print)
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Signed
for and on behalf of
Prana Biotechnology Ltd
ACN
080 699 065
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by its authorised representative:
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Signature of authorised representative
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Dianne Angus
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Name (please print)
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Chief Operating Officer
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Title (please print)
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1. | Background |
2. | Description of Services and Deliverables |
3. | Responsibilities |
4. | Project Timeline |
5. | Fees, Reimbursable Expenses and Payment Schedule |
6. | Any other applicable terms and conditions not covered in the MSA |
7. | Exhibits to the Work Order (e.g. specifications, Quality Agreement) |
IDT Australia Limited
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Prana Biotechnology Ltd
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By:
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By:
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Name:
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Name:
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Title:
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Title:
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/s/ Geoffrey P. Kempler *
Geoffrey P. Kempler
Chief Executive Officer
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/s/ Kathryn Andrews *
Kathryn Andrews
Chief Financial Officer
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/s/ Geoffrey P. Kempler *
Geoffrey P. Kempler
Chief Executive Officer
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/s/ Kathryn Andrews *
Kathryn Andrews
Chief Financial Officer
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