EXHIBIT 4.15
Project Agreement
Neurosciences Victoria Limited
and
Prana Biotechnology Limited
Allens Xxxxxx Xxxxxxxx
Stock Exchange Centre
000 Xxxxxxx Xxxxxx
Xxxxxxxxx 0000 Xxxxxxxxx
Tel 00 0 0000 0000
Fax 00 0 0000 0000
Project Agreement
Neurosciences Victoria Ltd and Prana Biotechnology Ltd
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Table of Contents
1. Definitions and interpretation 2
1.1 Definitions 2
1.2 Interpretation 4
2. Agreement to undertake Project 5
3. Appointment, management and retention of staff 5
4. Condition Precedent and Term 6
4.1 Condition Precedent 6
4.2 Term 6
5. Project Management Committee and Reporting Requirements 7
5.1 Appointment 7
5.2 Operation of Project Management Committee 7
5.3 Semi-annual reports 7
5.4 Annual reporting review 8
5.5 Records management 8
5.6 Final report 8
6. Budget and GST 8
7. Ownership and rights in relation to Intellectual Property 9
7.1 Background IP 9
7.2 Project Results 10
7.3 NSV has no rights outside the Field 11
8. Commercialisation of IP 12
8.1 Decline of First Right of Refusal 12
8.2 Exercise of First Right of Refusal 12
8.3 Share of Proceeds l3
8.4 Use and Distribution of Proceeds 13
9. Identification, maintenance, enforcement and defence of Intellectual
Property 14
9.1 Identification of Project Results 14
9.2 Primary responsibility for Project Results 15
9.3 Reversion of Project Results 15
9.4 Assistance 15
9.5 Protection of Intellectual Property 16
9.6 Proceeds of Infringement 16
10. Confidentiality 17
10.1 Confidentiality Obligations 17
10.2 Publications 18
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11. Settlement of Disputes and Arbitration 18
11.1 Dispute Resolution 18
11.2 Arbitration 19
12. Termination and Breach 20
12.1 Breach by Prana 20
12.2 Termination for unsatisfactory progress 21
12.3 Termination of RCA with SCHERING 21
12.5 Breach by NSV 22
13. Termination without prejudice 24
14. General Warranties and Indemnities 24
14.1 IP representations and warranties 24
14.2 Indemnities in relation to the Project 24
15. Assignment and Sub-Contracting 25
16. Force majeure 25
17. Clause severance 26
18. Waiver 26
19. Governing law 26
20. Notices 27
21. Entire Agreement 27
22. Amendments 28
23. Further assurances 28
24. Counterparts 28
Schedule 1 29
Financial Terms 29
Project Synopsis 29
Schedule 2 33
Project Management Committee 33
Schedule 3 34
Addresses for Service of Notices 34
Schedule 4 35
Budget, Shares of Project Results and Proceeds of Commercialisation 35
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Date
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Parties
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1. Neurosciences Victoria Limited (ABN 56 094 548 973) a company
incorporated in the State of Victoria and having its registered
office at Xxx Xxxxxxxxx, 0 Xxxx Xxxxx, Xxxxxxxxx 0000, Xxxxxxxxx
(NSV).
2. Prana Biotechnology Limited (ABN 37 080 699 065) of 000 Xxxxxx Xx,
Xxx. Xxxxxxxxx, Xxxxxxxx (Prana)
Recitals
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A NSV is a company limited by guarantee to enhance scientific and
technological capabilities and support scientific research in
Victoria in the Field) by, amongst other things, facilitating
funding, as agent for its members and certain Victorian research
institutes.
B NSV has signed a research collaboration agreement ("RCA") with
Schering Aktiengesellschaft, 13342 Berlin, Germany, ("SCHERING"),
under which SCHERING is willing to provide financial funding to
certain Projects in the Field and NSV agrees to provide certain
rights to Project Results and Background IP to SCHERING.
C In furtherance of recital A and B, the Parties wish to conduct a
Project in the Field.
D Prana hereby appoints NSV as agent for the purpose of receipt of
Schering funding under the terms of the RCA between NSV and Schering
and to facilitate the licensing of IP to Schering through NSV and
for no other purposes.
E In furtherance of Recital A and B
(a) Prana has prepared a Project Synopsis detailing a Project that
it and NSV wish to have conducted in the Field;
(b) the Project Synopsis has been discussed with and approved by
SCHERING; and
the Parties wish to agree on the terms and conditions under which
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the research and development project will be conducted.
It is agreed as follows.
1. Definitions and interpretation
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1.1 Definitions
In this Agreement, unless a contrary intention appears from the context:
Account means an account opened in accordance with clause 6.
Background IP shall mean the Intellectual Property owned or controlled by
Prana which is already in existence prior to the Commencement Date or is
created independently of the Agreement and which is made available under
this Agreement by Prana for the Project. Patented Background IP is
identified in the Project Synopsis.
Budget means the budget for the Project set out in the Project Synopsis
and amended by the Parties only upon approval by SCHERING.
Commencement Date means the date of this Agreement.
Commercialise, in relation to Intellectual Property, means to develop,
manufacture, sell, hire or otherwise exploit a product or process, or to
provide a service, incorporating that Intellectual Property, or to license
SCHERING to do any of those things; and Commercialisation is similarly
construed.
Commercialisation Proceeds means any and all royalties, licence fees and
other receipts derived from Commercialisation of Project Results with or
without Background IP under a Sub-licence by SCHERING.
Committee means the Project Management Committee established under clause
5.1.
Confidential Information means all trade secrets and know-how, financial
information and other commercially valuable information of whatever
description and in whatever form (whether written or oral, visible or
invisible) made available as Background IP or otherwise or arising as a
result of the Project, but excludes the interpretation, analysis and
application of general information in the public domain.
Core Criteria shall mean the general criteria as laid out in Appendix 1.5
of the RCA, that need to be fulfilled independently of any specific
Project Decision Criteria in order to enable SCHERING to make its decision
as to the right of first negotiation granted by NSV to SCHERING under ss.
7 of the RCA.
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Decision Criteria means collectively the Core Criteria and the Project
Decision Criteria.
Earmarked Funds has the meaning given in the Members Agreement dated
November 2, 2001 between NSV and its founding members, namely research
funding which NSV has arranged for a particular project.
Field means compounds which bind beta amyloid for the purpose of in vivo
imaging of beta amyloid plaques in the human brain
[this space left blank]
Intellectual Property includes all industrial and intellectual property,
whether protected at common law or under statute and includes (without
limitation) all inventions (both patentable and unpatentable), designs
(both registered and unregistered), copyrights, circuit layouts, plant
variety rights, trademarks (both registered and unregistered), samples,
materials, data, know-how, results and Confidential Information.
Key Alliance Manager - Research (KAMR) means the team established in
accordance with ss. 10.4 of the RCA.
Party means a party to this Agreement.
Project means the research and development activities described in the
Project Synopsis to be undertaken by Prana under this Agreement.
Project Decision Criteria means the Project specific set of scientific
criteria (including timelines) as listed in each Project Synopsis which
have to be fulfilled and presented by NSV to SCHERING under the RCA in
order to enable SCHERING to make its decision as to the right of first
negotiation granted under the RCA.
Project Results means all Intellectual Property, whether patentable or
not, in relation to the Project that has been created, discovered or
brought into existence as a result of or in connection with the Project by
Prana at any time, excluding the Background IP.
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Project Leaders means the project leaders from Prana and SCHERING as
appointed under clause 3 (a).
Project Management Committee means the committee established in accordance
with clause 5.
Project Synopsis means the detailed description of a research project,
including a detailed work-plan for the research and/or development for the
Project (including the timeline, milestones and Decision Criteria) as set
out in Schedule 1 amended as agreed between the Parties in writing from
time to time.
Raw Data means that part of the Project Results comprising the data
contained in the lab books regardless of their form, allowing for the
verification and validation of the scientific results produced during the
performance of a Project
Steering Committee means the decision body established in ss. 10.1 of the
RCA and comprising of representatives of NSV and SCHERING.
Sub-licence is defined in clause 8.2.
Tax Invoice means a document that complies with the requirements of
subsection 29-70(1) and (if applicable) section 54-50 of the A New Tax
System (Goods and Services Tax) Xxx 0000 (Cwth).
1.2 Interpretation
In this Agreement, unless the context indicates to the contrary:
(a) the expression person includes a natural person, an institution, a
body corporate, an agency or other body;
(b) references to any Party to this Agreement will include the Party's
legal successor (including executors and administrators) and
permitted assigns;
(c) words importing the singular will include the plural (and vice
versa) and words denoting a given gender will include all other
genders;
(d) clause headings and notes in square brackets are inserted for
convenience only, and have no effect in limiting or extending the
language of provisions, except for the purpose of rectifying any
erroneous cross reference;
(e) references to any document or agreement will be taken to include
references to such document or agreement as amended, novated,
supplemented, varied or replaced from time to time;
(f) references to any legislation or to any provision of any legislation
will include any modification or re-enactment of such legislation or
any legislative provision substituted for, and ail legislation and
statutory instruments issued under such legislation;
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(g) all attachments to this Agreement form part of this Agreement;
(h) all monetary amounts referred to in this Agreement are in Australian
currency.
2. Agreement to undertake Project
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In consideration of the mutual promises and undertakings set out in this
Agreement, Prana hereby agrees to undertake the Project in accordance with
the terms and conditions of this Agreement. Without limiting the
generality of this clause 2.1, Prana must:
(a) Work to carry out and complete the Project in accordance with the
Project Synopsis, the Budget and the terms and conditions of this
Agreement and in a manner which is to the satisfaction of NSV; and
(b) obtain all licences, permits and authorities, and comply with all
laws, by-laws and regulations, which may be required for the legal
performance of its obligations under this Agreement.
3. Appointment, management and retention of staff
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Upon the start of a Project Prana must:
(a) appoint one key personnel to undertake the lead role on the Project
on behalf of Prana (Project Leader), who will manage and monitor the
day-to-day operations of the Project together with a Project Leader
nominated by SCHERING. It is agreed that the Project Leader
appointed by Prana may be a sub-contractor of Prana. Both Project
Leaders shall be members of the Project Management Committee (see
clause 5). All communication among Project Leaders shall be copied
to the KAMR. If any Project Leader of Prana dies, becomes
incapacitated or ceases to be employed by Prana, Prana will notify
NSV immediately and nominate a suitable replacement to carry out and
complete Prana`s obligations in respect of the Project under this
Agreement. If NSV or SCHERING reasonably considers that the
nominated replacement is not suitable to perform those functions,
NSV may exercise its rights under clause 12.1(b);
(b) be solely responsible for all scientists and other staff involved in
the Project on behalf of the Institute, and for all their
entitlements, including, but not limited to, any superannuation and
workers' compensation contributions, as may legally be required to
be made in respect of the engagement of each of those scientists or
other staff;
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(c) do all things reasonably within its power to ensure that all
scientists and other staff engaged by Prana undertake the Project
work and act to the best of their respective skills and abilities in
a diligent, professional and honest manner; and
(d) neither during, nor for six months after the term of this Agreement,
employ or attempt to employ any key personnel of another Party who
has been involved in the Project without the prior written consent
of that Party.
4. Condition Precedent and Term
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4.1 Condition Precedent
It is a condition precedent to this Agreement that NSV submits to Prana
(or vice versa) and NSV (or Prana, as appropriate) approves, a Project
Synopsis that fully defines the Project and includes the following in
respect of the Project:
(a) a statement of aims;
(b) an outline of the strategy to be followed;
(c) potential outcomes;
(d) milestones;
(e) the financial terms applicable to the Project as laid out in
Appendix 7.5 of the RCA.
(f) a budget for Prana's contribution to the Project;
(g) resource requirements for Prana's contribution to the Project;
(h) Background IP in existence as at the Commencement Date proposed to
be used in the Project and the terms, if any, on which Prana will
make its Background IP available for use in the conduct and
Commercialisation of the Project.
(i) Prana's share of the Commercialisation Proceeds; and
(j) the Project Decision Criteria.
4.2 Term
This Agreement will commence on the Commencement Date and will continue
until the completion of the Project, unless terminated earlier in
accordance with clause 12.
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Appendix 2.2c of the Research Collaboration Agreement. Page 6
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5. Project Management Committee and Reporting Requirements
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5.1 Appointment
As soon as practicable after the Commencement Date, the Parties shall
establish a project management committee to have overall management and
evaluation of the Project (hereinafter "Project Management Committee" or
simply "Committee").
5.2 Operation of Project Management Committee
The Committee will operate as follows:
(a) it will comprise one representative from Prana as well as the
Project Leaders of Prana and SCHERING. The initial representatives
are listed in Schedule 2;
(b) it will meet monthly to review the progress of the Project and
determine the programs of work to be undertaken under the Project
Synopsis;
(c) it may determine its own procedures and may confer by telephone or
other electronic means;
(d) a resolution of the Committee must be passed by all representatives;
and
(e) each Party bears the cost and expenses incurred by its
representatives in relation to their attendance at Committee
meetings.
5.3 Semi-annual reports
Prana's Project Leader, with support of the Schering Project Leader, must
prepare and submit to the Committee and the KAMR a semi-annual report
describing:
(a) work done and achievements made (including milestones and
deliverables completed) during the 6 months to which the report
relates;
(b) details of Project Results developed during the 6 months and steps
taken to protect it;
(c) any departure from the Project Synopsis during those 6 months;
(d) current issues relating to the performance of the Project and
recommendations as to their resolution;
(e) the amount of funding required for the next 6 months; and
(f) such other matters as each Party (or its representative or appointee
an the Committee) considers appropriate.
All reports have to be approved by the KAMR.
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5.4 Annual reporting review
During each year of the Project, the KAMR will review the adequacy of the
reporting requirements set out in clause 5.3,and decide whether, and if so
how, they should be amended for the following year of the Project.
5.5 Records management
The Committee must:
(a) maintain full and accurate data, information and records of and
concerning work carried out in the Project; and
(b) disclose or make available all such data, information and records to
the Parties as and when each Party requires;
(c) make sure that all Raw Data will be entered into a laboratory note
book, dated, signed and witnessed.
NSV and / or SCHERING has the right to review the handling of all
documents, data, records and Raw Data produced for the Project during the
term of this Agreement. Time and location of such review shall be
coordinated with Prana.
5.6 Final report
The Committee must submit through the Project Leaders to the KAMR and the
Steering Committee a final report in writing within 30 days of completion
of the Project. The final report will describe, in reasonably informative
detail:
(a) the conduct of the Project;
(b) the results;
(c) Project Results obtained in the performance of the Project;
(d) Background IP used in the performance of the Project; and
(e) Background IP required for Commercialisation of the Project Results.
6. Budget and GST
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(a) The initial Budget for the Project is set out in Schedule 4 and
shows:
(i) the amount of funds allocated to Prana to undertake and
perform its responsibilities under the Project Synopsis
(Research Funds); and
(ii) the proportion, if any, to which NSV is entitled as its
administration fee in consideration of fulfilling its
obligations under this Agreement, (NSV Proportion) provided
that the NSV Proportion will be zero where an allocation has
already been made in respect of the Project under the
arrangements set out in the Members' Agreement.
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(b) On, before, or as soon as practicable after, the Commencement Date,
NSV will, if it does not already have an appropriate account, open
an account and will deposit into that existing or new account such
funds as it has received from SCHERING as agent for Prana to enable
the Project to be conducted.
(c) In consideration of Prana undertaking the Project, NSV will draw on
the Account to provide Prana the amount set out in sub-paragraph
(a)(i) above as quarterly installments.
(d) If GST is payable on a Taxable Supply made under, by reference to or
in connection with this Agreement, the party providing the
Consideration for that Taxable Supply must also pay the GST Amount
as additional Consideration. In this Agreement 'Consideration' and
'Taxable Supply' each has the meaning given by the A New Tax System
(Goods and Services Tax) Xxx 0000 (Cth) and 'GST Amount' means in
relation to a Taxable Supply the amount of GST payable in respect of
that Taxable Supply.
(e) No Party is required to provide any amount of GST to any other (and
may withhold any amount required at law) unless the other issues a
Tax Invoice to that Party.
(f) NSV is not required to provide any amounts under this Agreement to
the extent that SCHERING who has committed to provide research
funding to NSV in respect of the Project defaults on those
commitments leaving insufficient funds in the Account to enable NSV
to provide such amounts.
(g) NSV must use all reasonable endeavours to enforce its rights against
SCHERING if SCHERING defaults on the commitments referred to in
paragraph (f).
7. Ownership and rights in relation to Intellectual Property
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7.1 Background IP
(a) For the specific purposes of allowing the Project to proceed and for
commercialisation of Project Results (and only for those
purposes), Prana will make available to the Project the Background
IP (as defined) in respect of Prana whether directly as a result of
Prana's ownership of that Background IP or as a result of agreements
entered into with the owner(s) of that Background IP.
(b) The Parties acknowledge and agree that the Background IP will remain
the property of Prana or the owner(s) referred to in paragraph (a).
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(c) The Project Leader will endeavour to maintain a register recording
such Background IP as is made available by Prana for the Project,
provided that failure to include an item of Background IP on this
register does not preclude the Parties from using Background IP as
permitted under this Agreement where that Background IP is made
available under this Agreement or is included in the definition of
'Background IP'.
(d) Prana grants to NSV, a worldwide, non-exclusive, royalty-free, sub-
licensable licence to Commercialise the Background IP but only to
the extent required for NSV to exercise its rights to Commercialise
the Project Results granted under clause 7.2.
7.2 Project Results
(a) All Project Results created in relation to the Project, upon
creation, vest in and will become and remain the property of Prana,
only subject to Prana's contractual agreements with the University
of Melbourne in relation to this Agreement. Prana is free to deal
with, Commercialise, dispose of or encumber any interest which it
might hold in Project Results outside the Field as it sees fit.
(b) Subject to clause 8.1, no Party will deal with, Commercialise,
dispose of or encumber any interest which it might hold in Project
Results in the Field, except as authorised in this Agreement, or
with the written consent of the other Party to this Agreement.
(c) Each Party will co-operate with each other Party and promptly do all
acts and things and execute all documents which may be necessary for
the purpose of vesting ownership of the Project Results in Prana as
contemplated by this clause 7.2.
(d) Prana grants to NSV, a first right of refusal to negotiate a
worldwide exclusive royalty-bearing sub-licensable licence to
Commercialise the Project Results in the Field in accordance with
clause 8 of this Agreement.
(e) As soon as the Project Leaders are notified under clause 9.1(a) of
the creation of any Project Results then, if that Project Results
alone or together with any Background IP, meets the Project Decision
Criteria, the Project Leaders will within 14 days notify all Parties
and the Steering Committee in writing that, from the date of
notification, NSV may exercise its right of first refusal to license
such Project Results and any relevant Background IP and present NSV
with sufficient data to make a decision on the exercise of its right
of first refusal.
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(f) The Parties are aware of the fact that after NSV has received such
notification and data in accordance with clause 7.2(e), NSV has the
obligation under the RCA to immediately notify SCHERING which has an
exclusive right of first negotiation for a sublicence to ail Project
Results and Background IP notified to NSV under this Agreement.
(g) Under the RCA SCHERING has the right to evaluate the relevant
Project Results and Background IP during a period of 90 days after
notification and presentation of sufficient data by NSV. The Parties
hereby acknowledge and agree to this right.
(h) SCHERING has further the right under the RCA, at its cost, to
scientifically check the data, including, where necessary and
applicable, a re-evaluation of the experiments or tests. In such
case the above mentioned period of 90 days may be extended by
another 60 days to allow for such tests. If SCHERING requires access
to Project Results in order to decide if the Project Decision
Criteria have been met, Prana hereby agree (i) to SCHERING's right
under ss. 8.2 of the RCA to perform a due diligence on the
Project Results and the Background IP and (ii) to apply reasonable
efforts to execute, support and facilitate such access for SCHERING.
(i) After SCHERING has informed NSV within the timelines mentioned in
7.2 (g) and (h) respectively above by written notice whether the
Decision Criteria have been met and whether SCHERING wishes to
obtain a sub-license from NSV, NSV will immediately notify Prana
accordingly whether NSV wants to exercise its right of first refusal
to negotiate a licence to the relevant Project Results and
Background IP.
(j) The Decision Criteria may only be amended in accordance with the
RCA. Any amendment of the Decision Criteria will be notified to
Prana in writing and will become an integral part of this Agreement
and the Project Synopsis on the date of that notification.
(i) The rights granted to NSV or SCHERING in respect of Project
Results are subject to a right in favour of Prana to use and
disclose for educational and research purposes to the extent
allowed by Clause 10 (Confidentiality and Publications)
7.3 NSV has no rights outside the Field
NSV specifically acknowledges that it has no rights to use Project Results
or Background IP outside the field. Without limiting the generality of the
foregoing, NSV specifically acknowledges that it has no rights to use
Project IP or Background IP to develop products for therapeutic use or
have any right of first
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refusal to negotiate any rights to Commercialise any Project Results or
Background IP for therapeutic purposes outside the scope of this
Agreement.
8. Commercialisation of IP
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8.1 Decline of First Right of Refusal
If NSV does not exercise its first right of refusal in accordance with
clause 7.2, unless the Parties agree otherwise, NSV's rights under clauses
7.1 and 7.2 will terminate and its rights to the Project Results and
Background IP will revert to Prana who, subject to clause 9.3, will be
free to commercialise and otherwise deal in that Intellectual Property as
they see fit.
8.2 Exercise of First Right of Refusal
If NSV does exercise its first right of refusal in accordance with clause
7.2 (i), Prana appoints NSV as its agent to negotiate a sub-licence in the
Field, (Sub-licence) with SCHERING to Commercialise the Project Results
and (as necessary to Commercialise the Project Results) the Background IP,
and the following provisions will apply:
(a) NSV will use all reasonable endeavours to negotiate the Sub-licence,
according to the following:
(i) the Sub-licence will be world-wide and exclusive in respect of
Project Results only, and non-exclusive in respect of
Background IP,
(ii) the Sub-licence will be royalty-bearing, with royalty rates
and any licence fees and milestone payments set out in
Appendix 7.5 [(financial terms)] of the RCA and royalty
payments calculated by reference to Net Sales as defined in
the RCA;
(iii) the term of the Sub-licence will be for the duration of the
last to expire anywhere in the world of the patents generated
in respect of the Project Results, provided that the royalty
obligations may expire on a country-by-country basis as patent
protection in respect of the Commercialisation of the Project
Results expires in each country; and
(iv) NSV may not enter into any binding Sub-licence without Prana's
written approval, which may not be unreasonably withheld.
(b) If any Sub-licence is entered into, Prana will be deemed to have
immediately:
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(i) granted to NSV a reciprocal licence to Commercialise the
Project Results and Background IP as necessary to enable NSV
to fulfill its obligations to SCHERING under the Sub-licence;
and
(ii) appointed NSV its agent to receive Commercialisation Proceeds
under the Sub-licence on their behalf.
(c) If NSV and SCHERING, after good faith negotiations, are unable to
agree on the terms of a Sublicense within 6 months of NSV exercising
its first right of refusal under clause 7.2,unless the Parties agree
otherwise, NSVs rights under clauses 7.1 and 7.2 will terminate and
its rights to the Project Results and Background IP will revert to
Prana who, subject to clause 9.3, will be free to commercialise and
otherwise deal in that Intellectual Property as they see fit.
8.3 Share of Proceeds
NSV will receive and hold the Commercialisation Proceeds in accordance
with clause 8.4 as agent for Prana in the proportions specified in Item 3
of Schedule 4. If no such proportions are specified, then the proportions
specified in Item 2 of Schedule 4 will apply.
8.4 Use and Distribution of Proceeds
NSV will:
(a) collect and pay all Commercialisation Proceeds and any funds NSV
receives from SCHERING for the purposes of identifying, maintaining,
enforcing or defending Intellectual Property into the Account;
(b) draw on the Account to meet its agreed administration fee payable in
connection with Commercialising the Project Results, which fee will
be 12.5% of all Commercialisation Proceeds, unless otherwise
specified in Item 3 of Schedule 4 or agreed in writing by all
Parties;
(c) draw on the Account as permitted under clause 9.2; and
(d) draw on the Account to pay any money due to the owners of Background
IP as a result of the Commercialisation.
(e) distribute the balance to Prana in accordance with the proportions
determined under clause 8.3.
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9. Identification, maintenance, enforcement and defence of Intellectual
Property
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9.1 Indentification of Project Results
(a) Prana must notify the Project Leaders of the creation of any Project
Results as soon as practicable after such creation.
(b) Prana will use its best efforts to ensure that its employees, agents
and sub-contractors under its supervision or other persons
participating in the Project:
(i) will identify Project Results generated or developed by them;
(ii) will promptly communicate details of it to the Project
Leaders; and
(iii) will promptly do all acts and things and execute all documents
necessary for the purpose of vesting ownership of the Project
Results in Prana as contemplated by clause 7.2.
(c) If Prana considers that a particular development arising from that
Project may be patentable or the subject of other forms of
Intellectual Property protection, Prana will promptly communicate
details of that development to the Project Leaders.
(d) The Project Leaders will advise the KAMR whether the development
warrants pursuing patent protection, or other forms of Intellectual
Property protection, and if it does, of what nature and in which
countries protection should be sought.
(e) If required by the KAMR, the Committee will discuss with SCHERING
the matters referred to in paragraph (d) and the question which
party shall have the obligation to file, maintain, prosecute,
enforce and defend such Intellectual Property. The Committee will
allow any final decision under this clause to be solely up to
SCHERING.
(f) All registrable Project Results will be applied for in the name of
the owner of that Project Results as determined under clause 7.2.
(g) Except as expressly stated otherwise in this Agreement:
(i) Prana will be responsible for application, prosecution,
maintenance, enforcement or defence of any form of
Intellectual Property protection in respect of its Background
IP and will keep NSV reasonably informed of, and co-operate,
at NSV's cost, with any reasonable request of NSV in
connection with, such matters; and
(ii) nothing will require Prana to apply its own funds (other than
those held by NSV on its behalf) towards the application,
prosecution,
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maintenance, enforcement or defence of any form of
Intellectual Property protection in respect of Project
Results.
9.2 Primary responsibility for Project Results
(a) NSV, subject to the rights of SCHERING and Prana referred to in
clause 7.1 above and ss. 9 of the RCA, will be responsible for
applying, maintaining, prosecuting, enforcing and defending any form
of Intellectual Property protection in respect of Project Results in
close consultation with SCHERING.
(b) NSV may meet any expenses incurred under this clause 9 out of any
funds NSV receives from SCHERING dedicated explicitly to the
purposes of maintaining, enforcing or defending any Intellectual
Property and which NSV deposits into the Project Account.
9.3 Reversion of Project Results
If:
(a) SCHERING does not take reasonably adequate steps to protect the
Project Results; or
(b) an NSV request under clause 9.2 for funds to obtain protection of
Project Results is refused,
Prana may protect the Project Results and/or incur the expense (as
the case may be) and all rights thereafter obtained as a result of
those funds will be excluded from the first right of refusal under
clause 7.2(d).
9.4 Assistance
Prana will, at its cost, provide all information to NSV and SCHERING (as
the case may be) and execute all documents and do all acts and things
necessary or desirable to enable the adequate and timely preparation of
all documents necessary or desirable for the application, prosecution,
maintenance, enforcement or defence of any registrations or other
protection of the Project Results, including, without limitation:
(a) signing, and procuring all inventors to sign, all powers of attorney
and other forms required for the orderly prosecution of said patent
applications; and
(b) lending its name to any infringement or defence action either as a
direct party or a third party.
Other than the obligations in this 9.4, Prana will not be liable for any
costs associated with an infringement or defence action initiated by NSV
or SCHERING.
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9.5 Protection of Intellectual Property
(a) Prana will disclose to NSV immediately it becomes aware, details of:
(i) any infringement or alleged infringement by any person of any
Project Results, Background IP of a third party relevant to
the Project or relevant to the Commercialisation of the
Project Results and Background IP, in the Field; and
(ii) any claim or alleged claim by any person that
Commercialisation of the Project Results, Background IP or any
Intellectual Property of a third party relevant to the
Commercialisation of the Project Results and Background IP
constitutes an infringement of the rights of that person, in
the Field.
(b) Unless the Parties otherwise agree, NSV will, in accordance with the
terms of the Sub-licence (if any) take all reasonable steps to
enforce and defend the Project Results, in the Field, as it sees
fit, in consultation with Prana, but subject to any rights of
SCHERING. At NSV's request, Prana agrees to give NSV all assistance
which may be reasonably required in order to enforce and defend the
Project Results.
(c) Prana will maintain, enforce and defend any Background IP which is
the subject of a Schering sub-license under this Agreement, at
Prana's own expense;
(d) If NSV decides not to initiate proceedings against any alleged
infringer in relation to alleged infringement of Project IP in the
Field, Prana will not do so without NSV's prior written consent,
such consent to be given at NSV's discretion and on such conditions
as NSV sees fit, including, without limitation, satisfaction of
issues such as apportionment of proceeds, recovery of NSV's costs
and indemnification of NSV against adverse judgment.
(e) NSV has the right to assign all rights vested in NSV under this
Agreement with regard to filing, maintenance, prosecution,
enforcement and defence of Project Results to SCHERING.
9.6 Proceeds of infringement
If NSV recovers any damages or accounts of profits in taking any action
against any alleged infringer of Project Results, in the Field, the
amounts of any such judgment and any costs recovered by NSV will be first
applied to reimburse reasonable external costs and expenses (including
external legal costs) incurred by NSV, Prana and SCHERING. The balance, if
any, will be apportioned in accordance
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with the terms of the Sub-licence (if any) and then to Prana in accordance
with this Agreement as if it were Commercialisation Proceeds.
10. Confidentiality
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10.1 Confidentiality Obligations
(a) Each Party agrees that it will keep secret and confidential and not
use or disclose to any other legal entity all Confidential
Information made available by another Party other than as necessary
for the purposes of this Agreement, save that NSV may disclose
Confidential Information to third parties in confidence as
reasonably necessary for the Commercialisation of the Project
Results.
(b) The obligations imposed on a Party by this clause will not apply to
Confidential Information which:
(i) prior to disclosure is in the public domain or in published
literature or subsequent to disclosure to the Party becomes
part of the public domain or is published other than as a
result of an unauthorised act or failure to act by that Party;
(ii) is received by a Party from a third party without any
obligation to hold in confidence and which has not been
obtained by that third party directly or indirectly from any
Party;
(iii) is independently developed by an employee or officer of the
Party owing the obligation of confidentiality while having no
knowledge of the other Party's Confidential Information; or
(iv) the Party claiming confidentiality has identified in writing
as being released from the obligation of confidentiality.
(c) A combination of information will not be taken to be in the public
domain merely because it contains information in the public domain.
(d) Confidential Information will not be taken to be in the public
domain merely because it is embraced by a general disclosure in the
public domain.
(e) The receiving Party has the onus of showing that any of the above
exceptions apply.
(f) Each Party will ensure that:
(i) its respective employees who participate in the Project or
acquire access to Confidential Information, will comply with
the obligations of confidentiality as though parties to this
Agreement; and
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(ii) any of the above mentioned employees who cease to be employed
by the Party will continue to be bound by such obligations of
confidentiality.
(g) The obligations of confidentiality imposed on a Party will survive
termination of this Agreement.
10.2 Publications
(a) The Parties will use their best endeavours to ensure nothing is done
which might prejudice the subsistence or Commercialisation of
Confidential Information or Project Results. In particular, the
Parties will not publish or disclose any such Confidential
Information or Intellectual Property to any third person so as to
preclude the grant of a patent in respect of the Project Results or
cause the loss of any Intellectual Property in any Confidential
Information.
(b) Prior to any publication the Party wishing to publish material (the
Requesting Party) must forward a request in writing to NSV and/or
SCHERING seeking permission to publish the material.
(c) The Requesting Party may not publish results of the Project without
the consent of SCHERING. If the Requesting Party requests in writing
that SCHERING consent to a publication, SCHERING may not withhold
that consent unless in its reasonable view the publication includes
Confidential Information being part of Project Results and within
the Field and the publication would adversely affect protection or
Commercialisation of the Project Results within the Field. If the
Requesting Party makes such a written request and receives no
response from SCHERING within 90 days, SCHERING will be deemed to
have consented to the proposed publication.
11. Settlement of Disputes and Arbitration
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11.1 Dispute Resolution
(a) If a dispute arises between the Parties in connection with the
Agreement, the Parties undertake in good faith to settle the
dispute.
(b) Any dispute or difference arising between the Parties which cannot
be resolved between them will be resolved in accordance with the
following procedure:
(i) the Party claiming that a dispute exists will notify the other
Party that a dispute exists and forthwith submit such dispute
or difference to
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the Committee for resolution. The Committee shall decide under
consultation of the KAMR.
(ii) if the Committee and the KAMR are unable to resolve the
dispute or difference within a reasonable time, a meeting will
be convened forthwith between senior representatives of the
disputing Parties not being members of the Committee for
resolution of the dispute or difference. If the dispute or
difference concerns any matter being of material interest for
SCHERING (e.g. such as rights to Background IP or Project
Results, or publication issues) the senior representatives
shall also confer with the SCHERING member(s) of the Steering
Committee to resolve the dispute or difference.
(c) Each Party acknowledges that the compliance with these provisions is
a condition precedent to any entitlement to a claim, relief or
remedy, whether by way of proceedings in a court of competent
jurisdiction or by arbitration proceedings under this Agreement or
otherwise in respect of such dispute or difference. However this
will not preclude any Party from seeking urgent interlocutory relief
in a court of competent jurisdiction.
11.2 Arbitration
If any dispute or difference arises between the Parties to this Agreement
which cannot be resolved between them in accordance with clause 11.1, and
which does not impinge upon a question of law or call for the
rectification of this Agreement, such dispute will forthwith be referred
for determination at Melbourne, by an arbitrator agreed on by the Parties
to the dispute or difference. If such Parties are unable to agree upon an
arbitrator the matter will be dealt with in accordance with the laws
relating to expedited commercial arbitration for the time being in force
in Victoria.
11.3 SCHERING as Intended Third Party Beneficiary
Reference is hereby made to the RCA between SCHERING and NSV. The Parties
recognize that as a result of the above-referenced agreement SCHERING has
a material interest in the performance of this Agreement by the Parties
hereto. Accordingly, to the extent that this Agreement grants to NSV any
right, remedy or claim under or by reason of this Agreement, SCHERING may
also enforce any such right, remedy or claim against Prana on its own
behalf. Where this Agreement refers to a provision of the RCA under which
SCHERING has a right, remedy or claim against Prana, SCHERING may enforce
that right, remedy or claim directly against Prana under this Agreement.
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12. Termination and Breach
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12.1 Breach by Prana
(a) If Prana breaches or fails to perform any material term of this
Agreement, and the breach is capable of remedy by performance or
otherwise, NSV may serve on Prana a notice requiring it to remedy
that breach. Prana must, at its cost, use its best endeavours and
take all reasonable steps to remedy the breach within 90 days of
receipt of the notice.
(b) Subject to NSV's rights under clause 3(a) Prana's inability or
failure to carry out or complete the Project due to the loss of the
services of key personnel (whether by way of resignation, dismissal,
loss of tenure or otherwise) is considered to be a breach that is
capable of remedy for the purposes of this clause 12.
(c) If Prana has not remedied the breach to NSV's reasonable
satisfaction within 90 days of receipt of the notice, NSV may, in
addition to any other rights it may have under this Agreement, take
one or more of the following steps:
(i) require Prana to continue to make available to NSV (by way of
licence, mutually agreed assignment, or otherwise), as
necessary to enable NSV to fulfill its obligations to
SCHERING, all of Prana's interest in any Project Results and
any associated Background IP on terms to be agreed in good
faith having regard to the nature of the material breach, the
nature of the Intellectual Property, the nature of NSV's
obligations to SCHERING and any other relevant factors;
(ii) if NSV enforces its right under paragraph (i) to have the
Project Results and Background IP continue to be made
available, require Prana to continue to comply with its
obligations under clause 9 of this Agreement in relation to
that Project Results and Background IP and not do anything in
relation to that Project Results and Background IP which may
prejudice NSV's ongoing rights in that Project Results and
Background IP;
(iii) terminate Prana's participation in the Project;
(iv) require Prana to assist, at Prana's cost, NSV to find a
suitable substitute to conduct any or all of Prana's
outstanding role in the Project;
(v) require Prana to fully indemnify NSV in respect of all
liabilities and expenses incurred by any of them in respect of
Prana's default
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under this Agreement, including the costs associated with
finding a suitable substitute under paragraph (iv) above; and
(vi) terminate this Agreement in respect of Prana or in respect of
all Parties without prejudice to the rights granted under
clauses 7 and 8.
(d) If NSV terminates this Agreement under this clause then the
following provisions shall apply to any funds still held by NSV as
agent for Prana:
(i) Prana hereby authorises and directs NSV to transfer the funds
as agent for Prana to another project or new projects(s) (the
new project or projects) as determined by NSV;
(ii) the participating institutes in respect of the new project or
projects may include Prana;
(iii) funds so transferred shall become 'Earmarked Funds' for the
new project or projects; and
(iv) upon NSV determining to transfer funds to a project or new
projects under this clause, NSV shall cease holding the
transferred funds as agent (and, to the extent that those
funds were also being held as agent on trust, on trust) for
Prana and commence holding them as agent (and, to the extent
that those funds will also be held as agent on trust, on
trust) for the participating institutes in respect of the
project or new projects.
12.2 Termination for unsatisfactory progress
The KAMR will regularly review the progress of the Project with the
Project Leaders and if the KAMR considers the Project is not progressing
to its reasonable satisfaction, NSV may terminate this Agreement by 6
months prior written notice to the Institute(s). If NSV terminates this
Agreement under this clause then NSV will have no further obligation to
provide funds after the effective date of termination and the provisions
of Section 12.1(d) shall apply to any funds still held by NSV.
12.3 Termination of RCA with SCHERING
If in case of termination or expiry of the RCA the Project under this
Agreement is not completed, the Project may be continued until finished in
this Agreement
12.4 Termination for Insolvency etc.
Unless the Parties agree otherwise, this Agreement will terminate if NSV:
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(a) stops or suspends or threatens to stop or suspend payment of all or
a class of its debts;
(b) is insolvent within the meaning of section 95A of the Corporations
Act;
(c) must be presumed by a court to be insolvent by reason of section
459C(2) of the Corporations Act;
(d) fails to comply with a statutory demand (within the meaning of
section 459F(1) of the Corporations Act);
(e) has an administrator appointed over all or any of its assets or
undertaking or any step preliminary to the appointment of an
administrator is taken;
(f) has a controller within the meaning of section 9 of the Corporations
Act or similar officer appointed to all or any of its assets or
undertaking; or
(g) has an application or order made, proceedings commenced, a
resolution passed or proposed in a notice of meeting, an application
to a court made or other steps taken against or in respect of it
(other than frivolous or vexatious applications, proceedings,
notices or steps or voluntary applications or proceedings for the
purposes of reconstruction) but specifically excluding voluntary
applications related to bankruptcy or insolvency for its winding up,
deregistration or dissolution or for it to enter an arrangement,
compromise or composition with or assignment for the benefit of its
creditors, a class of them or any of them.
12.5 Breach by NSV
(a) If NSV breaches or fails to perform any material term of this
Agreement, and the breach is capable of remedy by performance or
otherwise, Prana may serve on NSV a notice requiring it to remedy
that breach.
(b) NSV must, at its cost, use its best endeavours and take all
reasonable steps to remedy the breach within 90 days of receipt of
the notice.
(c) If NSV has not remedied the breach to Prana's reasonable
satisfaction within 90 days of receipt of the notice, Prana may, in
addition to any other rights it may have under this Agreement, take
one or more of the following steps:
(i) require NSV to cease representing that it is an agent for
Prana in relation to the Project;
(ii) require NSV to pay all monies held in the Project Account and
any Commercial Proceeds to Prana in the proportions applicable
under clause 8.3;
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(iii) require NSV to assign or co-operate in procuring the
assignment to Prana of the benefit of any arrangements NSV has
with SCHERING; and
(iv) require NSV to fully indemnify Prana in respect of all
liabilities and expenses incurred by it in respect of NSV's
default under this Agreement, including the costs associated
with the assignment referred to in paragraph (iii) above.
(d) In case of Section 12.5(c) Prana agrees to SCHERING having the
right, at its option, to replace NSV as a contract partner to this
Agreement to the extent that all indemnification obligations of NSV
towards Prana, which are borne prior to such substitution by
SCHERING will remain with NSV. All indemnification obligations of
SCHERING towards Prana, which are borne after such substitution of
NSV, will remain with SCHERING.
12.6 Termination report
(a) In all cases of termination of this Agreement under this clause 12,
Prana will compose a termination report containing all Project
Results created up to the date of termination of this Agreement,
clause 5.6 shall apply to the termination report accordingly. The
termination report shall be signed by the Project Leader of Prana
and the Head of Prana as well as countersigned by the KAMR. The
termination report shall be promptly submitted to the Steering
Committee which shall be considered as notification of relevant
Project Results under clause 7.2(e) giving NSV and SCHERING the
right to evaluate their interest in the Project Results and, if the
case may be, to exercise their options, in accordance with the
provisions of Project Results 7.2 and 8.
(b) If NSV has notified Prana in accordance with clause 7.2 that NSV and
SCHERING do not want to exercise their rights of first refusal,
Prana shall will be free to continue the Project at its own expense;
provided however that Prana will not raise funding from a third
party for a period of 12 months after SCHERING has declined its
option. Prana will notify NSV and SCHERING before they solicit third
party funding after the 12 months period in order to give NSV and
SCHERING the opportunity to reintegrate the Project into the Project
portfolio under the RCA and to provide the funding under the RCA.
NSV and SCHERING shall have 30 days to decide whether the Project
shall be integrated into the portfolio and the funding requested by
Prana. NSV shall notify Prana in writing upon the decision. The
Parties hereby acknowledge that Prana will have the opportunity to
demonstrate any added value created in the Project during the 12
months
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period and to re-negotiate the commercial terms which would apply to
reintegration of the Project, to reflect the added value that Prana
has created during the 12 months period.
13. Termination without prejudice
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Termination or expiry of this Agreement for any reason, does not affect:
(a) any rights and obligations of the Parties which have accrued prior
to such termination or expiry; and
(b) any rights and obligations of the Party which by their nature
survive termination including without limitation rights and
obligations under clauses 10 and 14.2.
14. General Warranties and Indemnities
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14.1 IP representations and warranties
Prana represents and warrants that:
(a) it is the owner of, or is otherwise entitled to provide, the
Background IP which it makes available under this Agreement; and
(b) it has adequate arrangements in place with its employees, agents and
sub-contractors to enable it to grant the licences to its Project
Results under this Agreement.
(c) to the best of its knowledge as at the Commencement Date any
Commercialisation of its Background IP and Project Results as
permitted this Agreement does not (and, unless it notifies NSV in
writing to the contrary during the term of this Agreement, will not)
infringe the rights of any third party.
14.2 Indemnities in relation to the Project
Each Party will indemnify (Indemnifying Party) each other Party and the
officers, employees and any scientists engaged by it (Those Indemnified)
against all claims, liability, loss, damage, costs and expenses (including
but not limited to legal costs on a solicitor and own client basis) which
may be incurred by Those Indemnified arising out of or in connection with:
(a) any personal injury suffered by or the death of Those Indemnified or
any loss or damage to property, real or personal, of Those
Indemnified caused by any negligent act or omission of the
Indemnifying Party or
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officers, employees and any scientists engaged by it in the course
of carrying out the Project;
(b) any claims, actions or proceedings by any third party against Those
Indemnified for any personal injury suffered by or the death of that
third party, or any loss or damage to property, real or personal, of
that third party caused by any negligent act or omission of the
Indemnifying Party or officers, employees and any scientists engaged
by it in the course of carrying out the Project; and
(c) any breach of any representation or warranty provided by
Indemnifying Party under this Agreement.
15. Assignment and Sub-Contracting
--------------------------------------------------------------------------------
Prana may not assign or transfer any of its rights or obligations
under this Agreement, nor sub-contract a substantial part of its
obligations under the Project, without the prior written consent of
NSV such consent not to be unreasonably withheld. NSV may not assign
or transfer any of its rights or obligations under this Agreement
without the prior written consent of Prana such consent not to be
unreasonably withheld.
16. Force majeure
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(a) Where a Party is unable, wholly or in part, by reason of force
majeure, to carry out any obligation under this Agreement, and that
Party:
(i) gives each other Party prompt notice of that force majeure
including reasonable particulars, and, in so far as known, the
probable extent to which it will be unable to perform or be
delayed in performing that obligation; and
(ii) uses all possible diligence to remove that force majeure as
quickly as possible,
that obligation is suspended so far as it is affected by force
majeure during the continuance of that force majeure and that Party
will be allowed a reasonable extension of time to perform its
obligations.
(b) If, after 30 days, the force majeure has not ceased, the Parties
will meet in good faith to discuss the situation and endeavour to
achieve a mutually satisfactory resolution to the problem.
(c) The requirement that any force majeure must be removed with all
possible diligence does not require that the settlement of strikes,
lockouts or other labour
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disputes or claims or demands by any government on terms contrary to
the wishes of the Party affected.
In this clause, force majeure means an act of God, strike, lockout or
other interference with work, war (declared or undeclared), blockade,
disturbance, lightning, fire, earthquake, storm, flood, explosion,
governmental or quasi governmental restraint, expropriation, prohibition,
intervention, direction or embargo, unavailability or delay in obtaining
governmental or quasi governmental approvals, consents, permits, licenses,
authorities or allocations, and any other cause, whether of the kind
specifically enumerated above or otherwise which is not reasonably within
the control of the Party affected.
17. Clause severance
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Any provision of this Agreement that is held void by a court of competent
jurisdiction or is voidable by a Party or is or becomes at that time
unlawful or unenforceable will, to the extent to which it is void or
voidable or is unlawful or unenforceable, be deemed to be exercised from
and not form part of this Agreement, without affecting the validity or
enforceability of the remaining provisions to the fullest extent permitted
by law or in equity.
18. Waiver
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A waiver by a Party of any rights arising from a breach or non-observance
by any other breach of a term of this Agreement will not be taken to
operate in any way as a waiver of any rights arising from any subsequent
continuation of that breach or non-observance, or any further or other
breach or non-observance of the same or any other term.
19. Governing law
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(a) This Agreement will be governed by and construed in accordance with
the law for the time being in force in Victoria.
(b) With respect to any legal action or proceedings which may be brought
in relation to this Agreement or any transaction contemplated by
this Agreement, each Party irrevocably submits to the non-exclusive
jurisdiction of courts exercising jurisdiction in Victoria.
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20. Notices
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(a) Any notice, request, consent or other communication in connection
with this Agreement must be in writing and:
(i) left at the address of the addressee;
(ii) sent by prepaid-ordinary post (airmail if posted to or from a
place outside Australia) to the address of the addressee;
(iii) sent by facsimile to the facsimile number of the addressee; or
(iv) if the addressee has given written notice of another address
or facsimile number, sent to that address or facsimile number.
(b) The address and facsimile number of each Party is as specified in
Schedule 3.
(c) A notice, request, consent or other communication takes effect from
the time it is received unless a later time is specified in it.
(d) A notification of change of address will not take effect until each
other Party notifies the Party changing its address that the notice
of change of address has been received.
(e) A letter or facsimile is taken to be received:
(i) for a posted letter, on the third (seventh, if posted to or
from a place outside Australia) day after posting; and
(ii) for a facsimile, on production of a transmission report by the
machine from which the facsimile was sent which indicates that
the facsimile was sent in its entirety to the facsimile number
of the recipient. However, if the transmission is completed
after 5.00pm on a business day or is sent on a day that is not
a business day, the message is taken to have been received at
8.00am on the next business day.
21. Entire Agreement
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This Agreement and the Agency Agreement between NSV and Prana contain the
entire agreement between the Parties with respect to their subject matter
and supersede all prior agreements and understandings between the Parties
in connection with it. In case that the Agency Agreement contradicts any
provision contained in this Agreement, the provisions of this Agreement
shall prevail.
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Appendix 2.2c of the Research Collaboration Agreement. Page 27
Project Title = Ab binding ligands for imaging of Alzheimer's Disease (AD)
3rd March 2003
Project Agreement
Neurosciences Victoria Ltd and Prana Biotechnology Ltd
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22. Amendments
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No agreement or understanding varying or extending this Agreement will be
legally binding unless it is in writing signed by all Parties.
23. Further assurances
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Each Party agrees to do all things and execute all deeds, instruments,
transfers or other documents as may be necessary or desirable to give full
effect to the provisions of this Agreement and the transactions
contemplated by it.
24. Counterparts
--------------------------------------------------------------------------------
This Agreement may be executed in any number of counterparts. All
counterparts together will be taken to constitute one instrument.
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Appendix 2.2c of the Research Collaboration Agreement. Page 28
Project Title = Ab binding ligands for imaging of Alzheimer's Disease (AD)
3rd March 2003
Project Agreement
Neurosciences Victoria Ltd and Prana Biotechnology Ltd
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Schedule 1
Financial Terms
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This is a Financial Category 4 Project (Appendix 7.5 of the Research
Collaboration Agreement)
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Payments Category 4
(Set of Lead Components plus issued patents)
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Down-Payment $AUD 400,000
New Leads from High none
Throughput Screening
IND (or equivalent) $AUD 1,000,000
Commencement of Phase III $AUD 2,000,000
Study
First Market Approval in each US $AUD 2,000,000
of US, EU or JAP EURO $AUD 1,000,000
JAP $AUD 1,000,000
Royalties 4%
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Project Synopsis
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Name of Research Project: Aa binding ligands for imaging of Alzheimer's Disease
(AD)
Appendix 2.2i of the Research Collaboration Agreement
NSV-PROJECT CODE: VI
PROJECT TEAM: MASTERS. C. (PROJECT LEADER/MELBOURNE); CAPPAI, R.:
X.XXXXXX@XXXXXXX.XXX DINKELBORG, L.: XXXXXX.XXXXXXXXXX@XXXXXXXX.XX; DYRKS, T.:
XXXXXX.XXXXX@XXXXXXXX.XX; XXXXXX, M.: XXXXXXXX.XXXXXX@XXXXXXXX.XX
START OF PROJECT: AT SIGNATURE OF NSV/SAG RESEARCH CONTRACT
RESOURCES (FOR THE FIRST RESEARCH YEAR):
NSV: TOTAL NUMBER OF FTES / POST DOCS AND TAS INVOLVED: 3
SAG: Involvement of FTEs within the first 15 month collaboration period: 0
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Appendix 2.2c of the Research Collaboration Agreement. Page 29
Project Title = Ab binding ligands for imaging of Alzheimer's Disease (AD)
3rd March 2003
Project Agreement
Neurosciences Victoria Ltd and Prana Biotechnology Ltd
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RATIONALE: Prove the concept that radiolabeled specific AB binding ligands allow
in vivo imaging of AD.
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SCIENTIFIC BACKGROUND:
Alzheimer's Disease usually comes along with progressive neurodegenerative
symptoms e.g. memory loss, confusion, apraxia and dementia. Currently no
scientific imaging method is available, since MRI, [F-18]-FDG PET and SPECT only
visualize defects which can also occur in other brain diseases. These other
causes need to be ruled out. However, this can only be achieved histologically
on post-mortem material. The deposition of amyloid plaques in an AD brain is a
key pathological marker of the disease. The ability to image plaques in a living
brain would provide an enormously powerful tool to diagnose the disease and to
monitor success of potential therapeutic strategies. Recently, various
approaches emerged aiming on detection and visualization of ab-plaques.
Compounds such as ZK810630 targeting the CCR1 are under investigation at the
moment in terms of PET imaging.
2-[4'-(4"-methylpiperazin-1-yl)phenyl]-6-iodobenzothiazole (TZPI) (Kung et al.,
J.Med.Chem., 2001, 12, 1841-2038) displayed promising results in vitro and in
vivo.
Transition metals such as copper, zinc, nickel or iron are proposed to induce
the formation process of insoluble AB-sheets. Two principal approaches for
therapy have been suggested by Victoria Neuroscience. They either intend to
remove the metals, described vide supra, out of the respective brain regions by
complexation (Clioquinol) in order to prevent the formation of AB-sheets or to
block the amyloid peptide's metal binding moieties by administration of
different structured metal bearing complex molecules that bind to the same
moiety without inducing the formation of AB-sheets.
--------------------------------------------------------------------------------
MAIN INDICATION: AD
IN VIVO IMAGING OF AB IN THE BRAIN FOR DIAGNOSIS AND MONITORING OF THERAPY.
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COMPETITOR SITUATION:
Congo red (CR) or Chrysamine G (CG) analogs such as 2-[4'-(4"-
methylpiperazin-1-yl)phenyl]-6-iodobenzothiazole (TZPI) were labeled with
I-123/I-125 for imaging. [F-18] radiofluorinated probes e.g.
1,1-dicyano-2-[6-(dimethyl-amino)naphtalen-2-yl]propene (FDDNP) (U.S.
Provisional Patent Application No.60/097,320, UCLA) were labeled for PET imaging
--------------------------------------------------------------------------------
PROPRIETARY POSITION:
US PATENT: Use of clioquinol for the therapy of Alzheimer's disease PATENT
NO.09/224,953, WO 9310459, WO 200107442
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RESEARCH PLAN FOR THE COMING 15 MONTHS:
Most of the described activities have to be done at NSV/Prana.
Clioquinol labeled with I-123/I-125
- radiolabeling of clioquinol with I-125 and I-123 at the "cold"
iodine position
- determine binding capabilities of clioquinol to AB-plaques in vitro
(Kd)
- determine blood-brain barrier passage of the labeled clioquinol in
vivo (rat/mouse)
- do an autoradiography on AD's brain samples ex vivo
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Appendix 2.2c of the Research Collaboration Agreement. Page 30
Project Title = Ab binding ligands for imaging of Alzheimer's Disease (AD)
3rd March 2003
Project Agreement
Neurosciences Victoria Ltd and Prana Biotechnology Ltd
--------------------------------------------------------------------------------
- perform imaging experiment in the animal model of AD's (established
by Victoria NS)
Phtalocyanine labeled with In-111 and Co-57, respectively
- Indium-111 and Co-57 labeling of phtalocyanine
- determine binding capabilities of indium (III) and Co(II)
phtalocyanine labeled/"cold") to AB-plaques in vitro (Kd)
- determine blood-brain barrier passage of the labeled [In-111]indium
(III) and [Co-57] cobalt(II) phtalocyanine in vivo (rat/mouse)
- do an autoradiography on AD's brain samples ex vivo
- perform imaging experiment in the animal model employing of AD's
(established by Victoria NS)
As a reference:
TZPI (Kung et al.) targeting AB-plaques
- radiolabeling of TZPI with I-123/I-125 (established by Kung et al.)
- determine binding capabilities of [I-125]TZPI to AD plaques in vitro
(Kd)
- determine blood-brain barrier passage of the labeled [I-125]TZPI in
vivo (rat/mouse)
- do an autoradiography on AD's brain samples ex vivo
- perform imaging experiment in the animal model employing [I-123]TZPI
(established by Victoria NS)
--------------------------------------------------------------------------------
Milestones:
1. radiolabeling of clioquinol and cobalt(II) phtalocyanine (to be determined
3month)
2. establishment of in-vitro assay (Prana/NSV 3 month)
3. show in vitro binding (Prana/NSV 6 month)
4. biodistribution studies (Prana/NSV 6 month)
5. autoradiography ex vivo (Prana/NSV 9 month)
6. imaging experiment in vivo (Prana/NSV 12 month)
PROJECT FEASIBILITY:
THE PROJECT'S FEASIBILITY IS GOVERNED BY THE EXPERTISE OF THE GROUP AND THEIR
CLAIM TO HAVE SUITABLE IN-VITRO AND IN-VIVO MODELS
--------------------------------------------------------------------------------
CRITICAL ISSUES:
THE ABILITY OF THE COMPOUNDS TO CROSS THE BLOOD-BRAIN BARRIER. PATHOLOGICAL
SIGNIFICANCE OF THE BINDING-PRINCIPLE/STAINED STRUCTURES/LABELLED MOLECULES.
IP-SITUATION WITH PRANA
--------------------------------------------------------------------------------
NO-GO CRITERIA:
No proof of concept in vitro with one of the two compounds within 9 months
(compound synthesis and blood-brain barrier passage).
CURRENT PROJECT STATUS: (TO BE FILLED OUT BY SAG AND TO BE DEFINED ACCORDING TO
SAG CRITERIA)
HIT TO LEAD PROCESS
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Appendix 2.2c of the Research Collaboration Agreement. Page 31
Project Title = Ab binding ligands for imaging of Alzheimer's Disease (AD)
3rd March 2003
Project Agreement
Neurosciences Victoria Ltd and Prana Biotechnology Ltd
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DEFINITION OF PROJECT STATUS / PROJECT CRITERIA(S) NECESSARY FOR EXERCISING THE
NEGOTIATION RIGHT:
--------------------------------------------------------------------------------
To exercise the Option the Lead compounds should fulfill the following criteria:
> Proven specificity in secondary in vitro (binding capabilities to
AB-plaques in vitro and to AD's brain samples ex vivo) and basic in
vivo models (transgenic AD mice) (12 month)
> Proven suitable physicochemical and toxicological properties (3
month (subsequent to proven specificity (vide supra)))
> Proven suitable pharmacokinetic properties (blood-brain barrier
passage) (6 month)
> Preliminary SAR
> Patentability: Clear patent strategy
Earliest time to exercise the option will be 15 months after the collaboration
started.
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Appendix 2.2c of the Research Collaboration Agreement. Page 32
Project Title = Ab binding ligands for imaging of Alzheimer's Disease (AD)
3rd March 2003
Project Agreement
Neurosciences Victoria Ltd and Prana Biotechnology Ltd
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Schedule 2
Project Management Committee
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Project Management Committee for Project described in Appendix 2.2i of the RCA
and entitled AB binding ligands for imaging of Alzheimer's Disease (AD)
Institute Representative: Professor Xxxxxx Xxxxx
Project Leader Institute: Xxxxxxxxx Xxxxx Xxxxxxx
Project Leader SCHERING: Xx. Xxxxxx Xxxxxxxxxx
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Appendix 2.2c of the Research Collaboration Agreement. Page 33
Project Title = Ab binding ligands for imaging of Alzheimer's Disease (AD)
3rd March 2003
Project Agreement
Neurosciences Victoria Ltd and Prana Biotechnology Ltd
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Schedule 3
Addresses for Service of Notices
--------------------------------------------------------------------------------
Prana Biotechnology (ACN 080 699 065)
Attention: Chief Operating Officer
Fax No.: x00 0 0000 0000
Address: Xxxxx 0, 0000 Xxxx Xxxxxx, Xxxxxxxx, Xxxxxxxx, 0000, Xxxxxxxxx
Neurosciences Victoria Ltd
Attention: Chief Executive Officer
Fax No.: x00 0 0000000
Address: Xxx Xxxxxxxxx, 0 Xxxx Xxxxx, Xxxxxxxxx, Xxxxxxxx, Xxxxxxxxx, 0000
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Appendix 2.2c of the Research Collaboration Agreement. Page 34
Project Title = Ab binding ligands for imaging of Alzheimer's Disease (AD)
3rd March 2003
Project Agreement
Neurosciences Victoria Ltd and Prana Biotechnology Ltd
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Schedule 4
Budget, Shares of Project Results and Proceeds of Commercialisation
--------------------------------------------------------------------------------
Item 1: Budget (clause 6(a))
With respect to this Project, NSV is providing AUD $450,000 per annum to Prana
Biotechnology. Total funds are shown for the anticipated 12-month period of this
Project.
Research Funds
The University of Melbourne $405,000
Prana Proportion $45,000(10%)
TOTAL $450,000
Item 2: Parties' ownership share of Project Results (clause 7.2)
Prana 100%
SCHERING 0%
TOTAL 100%
Item 3: Parties' entitlement to Commercialisation Proceeds (clauses 8.3 & 8.4)
NSV 12.5%
Prana 87.5%
Total 100%
Item 4: Restrictions on NSV's right to Commercialise Background IP (clause 7.1)
Rights to Commercialise Background IP are non-exclusive
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Appendix 2.2c of the Research Collaboration Agreement. Page 35
Project Title = Ab binding ligands for imaging of Alzheimer's Disease (AD)
3rd March 2003
Project Agreement
Neurosciences Victoria Ltd and Prana Biotechnology Ltd
--------------------------------------------------------------------------------
Executed in Melbourne, Victoria, Australia
Signatories to This Project Agreement:
Xx Xxxxxxxx Xxxxxxx Executive Chairman,
Prana Biotechnology Limited
Date 11/03/2003
/s/ Xxxxxxxx Xxxxxxx
--------------------------------
A/Prof Xxxxxxx Xxxx Chief Executive Officer,
Neurosciences Victoria Limited
Date 11/03/2003
/s/ Xxxxxxx Xxxx
--------------------------------
Professor Xxxxxx Xxxxx Deputy Chair
Neurosciences Victoria Limited
Date 3/03/2003
/s/ Xxxxxx Xxxxx
--------------------------------
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Appendix 2.2c of the Research Collaboration Agreement. Page 35
Project Title = Ab binding ligands for imaging of Alzheimer's Disease (AD)
3rd March 2003
