Document:

Exhibit 4.2(p)

 

“CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL
PORTIONS OF THIS DOCUMENT HAVE BEEN OMITTED AND HAVE BEEN SEPARATELY FILED WITH
THE COMMISSION.  CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.”

 

Research
Agreement’

 

 

Date:

 

AUTOGEN PTY LTD, ACN 074 636 847

(“Autogen”)

 

 

DEAKIN UNIVERSITY

(“Deakin University”)

 

 

INTERNATIONAL DIABETES INSTITUTE

ACN 007 342 412 (“IDI”)

 

 

THIS
AGREEMENT is made the 28th day of February 1997

 

BETWEEN

 

AUTOGEN
PTY LTD ACN 074 636 847 of 8th Floor, 580 St Kilda Road,
Melbourne, Victoria, 3004 (“Autogen”)

 

DEAKIN UNIVERSITY
a body corporate and politic established pursuant to Deakin University Act 1974
through its School of Nutrition and Public Health, Geelong Campus of Pigdons Road,
Geelong, Victoria, 3217 (“Deakin University”)

 

AND

 

INTERNATIONAL DIABETES INSTITUTE
ACN 007 342 412 of 260 Kooyong Road, Caulfield, Victoria,
3162 (“IDI”)

 

WHEREAS:

 

A.            Autogen
proposes to engage in research in the fields of diabetes, obesity, allergy, asthma
and autoimmunity (“the Research Fields”).

 

B.            Deakin University through its
School of Nutrition and Public Health has expertise in one or more areas of the
Research Fields (“the Research Expertise”), and owns or has an exclusive
licence of the Pre-existing Intellectual Property. Deakin University and IDI
have been collaborating for several years using the Research Expertise. The
Patent has been licensed exclusively to Deakin University by the Patent
Applicants for use in the Project.

 

C.            Autogen desires to collaborate
with Deakin University and to provide the Funding for the Project using the
Research Expertise in return for the joint ownership and a licence of all
Intellectual Property in the result of the Project on the terms set out in this
Agreement.

 

D.            The parties wish to ensure that
the Research Expertise is applied to the Project and that the results of the
Project are, if appropriate, commercialised by Autogen.

 

E.             IDI is the owner of a Sand Rat
colony based at Deakin University and has agreed to make the Sand Rats
available to Deakin University for the purposes of the Project.

 

F.             Autogen is a subsidiary of AWI,
which is listed on the Stock Exchange.  IDI
and Deakin University are aware that the Corporations Law prohibits insider
trading and shall use their best endeavours to ensure that their employees and
contractors are also made aware of such prohibition.  IDI and Deakin University are aware of the
continuous disclosure requirements applicable to companies listed on the Stock
Exchange and shall use their best endeavours to ensure that their employees and
contractors are also aware of such requirements and shall advise Autogen in
writing of any material advancements or developments as they occur.

 

 

NOW THIS AGREEMENT WITNESSES
as follows:

 

1 .            DEFINITIONS AND INTERPRETATION

 

1. 1          Definitions

 

In this Agreement the following
words and expressions shall have the meanings ascribed thereto as follows
(unless the context otherwise requires):

 

“AWI”
means Australia Wide Industries Limited ACN 000 248 304.

 

“Budgets
and Workplans” means the detailed budgets and
time plans and schedules for work to be carried out under the R&D Program
and attached in Schedule 3 as may be amended from time to time by agreement
between Autogen and Deakin University.

 

“Commencement
Date” means the date specified in Item 3 of Schedule
1.

 

“Confidential
Information” means in relation to Autogen, information that:

 

(a)           is by its nature confidential;

 

(b)           is designated by Autogen as
confidential; or

 

(c)           Deakin University and/or IDI
knows or ought to know is confidential; and includes -

 

(d)           information comprised in or
relating to any Intellectual Property rights of Autogen;

 

(e)           information relating to the
financial position of Autogen and in particular includes information relating
to the assets or liabilities of Autogen and any other matter that does or may
affect the financial position or reputation of Autogen;

 

(f)            information relating to the
internal management and structure of Autogen, or the personnel, policies and
strategies of Autogen;

 

(g)           information of Autogen to which
Deakin University and/or IDI has access other than information referred to in
paragraphs (d), (e) and (f) that has any actual or potential commercial value
to Autogen or to the person or corporation which supplied that information;

 

(h)           information in the possession of
Deakin University and/or IDI relating to Autogen’s clients or suppliers, and
like information;

 

(i)            information of Autogen disclosed
to Deakin University and/or IDI before or after the Commencement Date.

 

“Dr Collier”
means Dr Gregory Royce Collier of 22 Kestral Place, Ocean Grove, Victoria, 3226
Principal Investigator at Deakin University.

 

“Funding” means:

 

(a)           in respect of the Initial Term
the amount specified in Item 1 of Schedule 1; and

 

(b)           in respect of any period after
the Initial Term, the amount agreed in writing by the parties to be paid by
Autogen for that Period.

 

“Initial
Term” means the period of one year from the
Commencement Date.

 

 

“Intellectual
Property” includes intellectual and industrial property or
rights of any nature throughout the world and all reversionary interests
therein, including inventions, rights to or arising from inventions, letters
patent, applications for letters patent, utility models, copyright in works of
any nature, industrial designs, registered designs, rights to or arising from
any industrial design, computer programs of any nature, Confidential
Information, trade secrets, “know how”, technical or commercial expertise or
knowledge and any ideas or information of a commercial or valuable nature.

 

“Net
Sales Revenue” means the revenue in Australian
dollars received by Autogen or any Related Body Corporate from all sales of the
Products or licence fees or royalties derived from licensing of the Intellectual
Property to produce, market and sell the Products, after the deduction of all
trade discounts, returns of sales, foreign exchange charges, withholding tax,
sales tax or similar tax such as consumption tax, goods or services tax or
value added tax and insurance and freight costs under a cost insurance and
freight arrangement before the deduction of administrative, marketing and
manufacturing costs and corporate income tax.

 

“Patent” means
the Australian Patent Application in the names of the Patent Applicants
specified in Schedule 4 and any patent applications in Australia or elsewhere
based thereon.

 

“Patent
Applicants” means the applicants for the
Patent specified in Schedule 4.

 

“Pre-existing
Intellectual Property” means the Intellectual Property
developed before the Commencement Date, owned solely by Deakin University and
specified in Schedule 4 to be made available for use in the Project or owned by
the Patent Applicants, Iicenced to Deakin University and specified in Schedule
4 to be made available by Deakin University with the consent of the Patent
Applicants for use in the Project.

 

“Products”
means the products
and results of the Project.

 

“Project”
means scientific research using the Research Expertise
into the role of potential pharmaceutical agents on food intake, body weight
control and parameters of insulin resistance and diabetes as examined in
studies into therapeutic regulators of food intake and appetite conducted by
Deakin University pursuant to this Agreement.

 

“Project
Location” means the School of Nutrition and Public Health,
Deakin University, Pigdons Road, Geelong, Victoria, 3217.

 

“‘Research
Expertise” means the fields of expertise of Deakin University
specified in Item 2 of Schedule 1.

 

“Research
Fields” means the fields of diabetes, obesity, allergy,
asthma and autoimmunity and such other fields as Autogen may include from time
to time.

 

“Research
Proposal” means the proposal developed by Dr Collier and
IDI and attached in Schedule 2 of this Agreement.

 

“R&D
Program” means the program of research and development
work to be carried out by or on behalf of Deakin University pursuant to this
Agreement in relation to the Project.

 

“Sand
rats” means Psammomys obesus.

 

“Stock
Exchange” means Australian Stock Exchange Limited.

 

“Term” means
the Initial Term of this Agreement and any agreed extension in accordance with
clause 3.

 

 

1.2           Interpretation

 

Where the context so permits,
words importing the masculine gender shall include the feminine and neuter
genders and vice versa and words importing persons shall include corporations
and vice versa and words importing the singular number shall include the plural
and vice versa (unless repugnant or inconsistent to the context in which they
are used).

 

Any table of contents to this
Agreement and any headings and marginal notations in this Agreement have been
inserted for convenience only and shall not in any way limit or govern the
construction of the terms of this Agreement.

 

2.             APPOINTMENT OF DEAKIN UNIVERSITY

 

2.1           Autogen hereby appoints, and
Deakin University accepts the appointment of, Deakin University to conduct the
Project in accordance with the Research Proposal such appointment to take
effect on and from the Commencement Date.

 

2.2           Deakin University shall
provide the services of Dr Collier as the principal scientist to conduct the
Project and supervise and direct the scientific staff engaged in the conduct of
the Project.

 

2.3           The Project shall be
carried out at the Project Location or as Dr Collier shall direct from to time.

 

2.4           Dr Collier shall select and
Deakin University shall employ or engage, on contract, such scientific staff as
shall be necessary to conduct the Project.

 

2.5           Deakin University may,
subject to the prior written consent of Autogen, sub-contract the performance
of any part or parts of the work for the Project provided that in so doing the
sub-contractor first enters into a confidentiality agreement on terms
reasonably acceptable to Autogen including:

 

•              a
covenant not to infringe any Intellectual Property rights of Autogen, Deakin
University and IDI;

 

•              an
acknowledgement that all Intellectual Property Rights arising from the carrying
out of the sub-contracted work shall belong to Autogen, Deakin University and
IDI in accordance with this Agreement.

 

2.6           Deakin
University shall at all times use its best endeavours to ensure that completion
of the respective stages of the Project is achieved substantially in accordance
with the timetable set out in the Project and in the Budgets and Work-plans.

 

2.7           Deakin
University shall at all times indemnify, hold harmless and defend Autogen and
its respective officers, employees and agents (in this clause 2.7 referred to
as “those indemnified”) from and against any loss (including reasonable legal
costs and expenses) or liability reasonably incurred or suffered by any of
those indemnified arising from any suit, action or proceeding by any person
against any of those indemnified where such loss or liability was caused by any
wilful, unlawful or negligent act or omission of Deakin University, its
employees, agents or sub-contractors in connection with this Agreement or by
any Products infringing any person’s Intellectual Property rights where such
infringement was caused by any wilful, unlawful or negligent act or omission of
Deakin University.

 

2.8           IDI
shall make available to Deakin University, for the Project, Sand Rats owned by
IDI.

 

 

3.             TERM

 

This Agreement shall commence on
the Commencement Date and shall continue (subject to the provisions as to
termination hereunder) for the Initial Term. Not less than three months prior
to the expiration of the Initial Term the parties shall determine whether this
Agreement is to continue by mutual agreement. 
If no agreement is reached between the parties by the end of the Initial
Term, this Agreement shall terminate at the end of the Initial Term. If
agreement is reached between the parties prior to the end of the Initial Term,
this Agreement shall continue to apply for the further term agreed by the
parties subject to any written variations to this Agreement agreed by the
parties.

 

4.             FUNING OF THE PROJECT

 

4.1           Subject
to this Agreement, Autogen shall provide the Funding to finance the Project
over the Term, in accordance with the payment program in Item 1 of Schedule 1.

 

4.2           Subject
to this Agreement, Autogen shall provide the Funding for the Initial Term
however Deakin University shall be required to achieve the milestones set in
the Budgets and Workplans to an appropriate standard as specified in this
Agreement.

 

4.3        Subject to sub-clauses 4.4 and 4.5, the Funding shall be
used to pay for salaries of staff engaged in the conduct of the Project (save
and except for Dr Collier whose
salary shall continue to be paid by Deakin University).

 

4.4           Subject to sub-clauses 4.3
and 4.5, Deakin University shall ensure that no more than [*] of the Funding
shall be used for administration and infrastructure costs and that the balance
of the Funding is properly applied directly to the Project-.

 

4.5           Subject to sub-clauses 4.3
and 4.4, Deakin University shall use the Funding for the Project in accordance
with the Budgets and Workplans or for such other research in the Research
Fields as shall be agreed in writing by the parties.

 

4.6           Any equipment or materials
purchased for use in the Project by Deakin University using the Funding and not
incorporating any of the Intellectual Property shall become the property of
Deakin University upon purchase, except where this Agreement is terminated
pursuant to clause 10.1(a) hereof in which case such equipment and materials
shall be the sole property of Autogen.

 

5.             PERFORMANCE REVIEW

 

5.1           The parties shall review
the progress of the Project every three (3) months.

 

5.2           The purpose of the reviews
shall be to ascertain whether the stages targeted and milestones set in the Budgets
and Workplans are being met at the appropriate times and to an appropriate
standard.

 

5.3           Dr Collier shall three (3) months
after the date of this Agreement, and every three months thereafter, provide
Autogen and Deakin University with a written report for the purposes of the
review setting out adequate details of the following:

 

(a)           the progress of the Project work
during the preceding 3 months, and whether all milestones which ought to have
been reached during that period have been reached and best professional
standards maintained;

 

(b)           any material advances or
developments;

 

 

(c)           any material delays or unforeseen
problems in the conduct of the Project;

 

(d)           any recommendations on changes to
the Project or associated Budgets and Workplans, including changes in direction
of the Project;

 

(e)           any other relevant information
relating to or affecting the Project.

 

The report from Dr Collier shall
be provided to the parties within fourteen (14) days of the end of the relevant
three (3) month period.

 

5.4           Within fourteen (14) days after
receipt of a report from Dr Collier pursuant to clause 5.3, Autogen may
request, in writing to Deakin University, that any stage or part of the Project
be varied, suspended or declared completed.

 

5.5           In addition to the reports under
clause 5.3, Dr Collier on behalf of Deakin University will immediately advise
Autogen in writing of any material advancements or developments as they occur.

 

5.6           Any dispute between the parties
concerning a request made under clause 5.4 hereof, shall be determined under
the provisions of clause 13 hereof.

 

5.7           If so requested by Autogen, the
parties shall meet to consider the report from Dr Collier pursuant to clause
5.3, and to discuss the progress of the Project and any variation or suspension
of the R&D Program.

 

5.8           Subject to clause 4.2, if Autogen
after consulting with the parties is, in Autogen’s sole and absolute
discretion, satisfied as to the progress of the Project after each review
pursuant to this clause 5, and the R&D Program has not been suspended or
declared completed pursuant to clause 5.4, Autogen shall make the Funding
payment specified in Item 1 of Schedule 1.

 

6.             OWNERSHIP OF INTELLECTUAL PROPERTY

 

6.1           The
parties acknowledge and agree that all Intellectual Property developed acquired
or created either directly or ancillary to the Project shall belong to and be
the property of Autogen as to [*] %, Deakin University as to [*] % and IDI as
to [*] %.

 

6.2           The parties acknowledge and agree
that all Pre-existing Intellectual Property is owned by Deakin University
except the Patent which is owned by the Patent Applicants and has been
exclusively licensed to Deakin University. Deakin University shall make
available all Pre-existing Intellectual Property including, with the consent of
the Patent Applicants, the Patent free of charge for use in the Project. Deakin
University warrants the written consent of the Patent Applicants has been
obtained for the purposes stated.

 

6.3           All
discoveries inventions secret processes designs or improvements in procedure or
methods made or discovered by any party during the currency of this Agreement
arising from the Project, shall belong to Autogen, Deakin University and IDI in
the proportions specified in clause 6.1.

 

6.4           Autogen,
Deakin University and IDI may jointly take out and maintain appropriate
protection for all new discoveries and developments made under the Project and
the parties shall assist each other in applying for letters patent, or other
Intellectual Property protection in Australia or in any other part of the world
for all such discoveries and developments and execute all instruments and do
all things necessary for vesting the said letters patent or other Intellectual
Property protection and rights when obtained and all right and title to and
interest in the same in Autogen, Deakin University and IDI. Autogen, Deakin
University and IDI shall bear the costs of taking out and maintaining
appropriate protection for all new discoveries and developments made under the
R&D Program in the proportions specified in clause 6.1.

 

 

6.5           Deakin
University and IDI hereby grant to Autogen for a term of twenty-five (25)
years, from the Commencement Date, an exclusive, worldwide licence of the Pre­-Existing
Intellectual Property and the Intellectual Property and Autogen shall have the
right to sub-licence its rights and to decide in its absolute discretion as to
how the Intellectual Property and the Products are to be commercially
exploited.

 

6.6           If
the Products are successfully commercialised, Autogen shall pay to Deakin
University an annual royalty based on [*] percent [*] % of the Net Sales
Revenue.

 

6.7           If
the Products are successfully commercialised, Autogen shall pay to IDI an
annual royalty based on [*] percent [*] % of the Net Sales Revenue.

 

6.8           Autogen
shall solely decide upon whether and, if so, the terms and conditions upon
which, to develop and commercially exploit the Intellectual Property and the
Products whether by licensing or otherwise, throughout the world. All income
and royalties derived from the development and commercialisation of the
Intellectual Property and the Products shall, subject to clauses 6.6 and 6.7,
belong to Autogen solely.

 

7.             CONFIDENTIALITY

 

7.1           All
information relating to the Project which is supplied by or on behalf of Autogen,
or which relates to or arises from the Project, shall be treated by Deakin
University, IDI and Dr Collier as confidential and shall be used solely during
the Term of and in accordance with this Agreement to enable Deakin University
and its sub-contractors to carry out the Project.

 

7.2           Prior
to disclosing any of the Confidential Information to any of Deakin University’s
or IDI’s employees or subsidiaries or related companies or sub-contractors
Deakin University or IDI (as the case may be) will procure the execution by the
party in question of a Deed as set out in Schedule 5 or otherwise in the form
and substance satisfactory to Autogen whereby the person to whom it is intended
to disclose any of the Confidential Information undertakes to maintain the same
in confidence and acknowledges Autogen’s interest therein.

 

7.3           Deakin
University and IDI hereby undertake and agree that, except for such disclosure
as is prudent and reasonably necessary for the purposes of this Agreement, no
part of the Confidential Information given to it pursuant to this Agreement
shall be disclosed to anyone who is not an employee or sub-contractor of Deakin
University and/or IDI except with Autogen’s prior written approval which if
given shall be on the basis that the recipient of any part of the Confidential
Information shall first be bound to Deakin University and Autogen or IDI and
Autogen as the case may be by contract to maintain the same in confidence.
Without prejudice to the foregoing Deakin University and/or IDI shall use its
best endeavours to take all reasonably necessary steps to prevent the
Confidential Information from passing into the public domain.

 

7.4           Nothing
stated herein shall be construed as restricting or creating any liability for
the disclosure or communication of Confidential Information which:

 

(a)           is now or becomes publicly known
through no wrongful act of Deakin University and/or IDI as the case may be;

 

(b)           is received from a third party
without restriction and without breach of this Agreement;

 

(c)           is now or comes to be contained
in any published patent or published or otherwise generally known to the trade
through no wrongful act of Deakin University and/or IDI as the case may be; or

 

 

(d)           is disclosed pursuant to
governmental legislative or judicial requirement, including disclosure by AWI
pursuant to its obligations under the Corporations Law or the Stock Exchange
listing rules.

 

7.5           The
obligations set out in this clause 7 shall remain in full force and effect, and
shall continue to bind each of the parties, notwithstanding that this Agreement
may have been terminated, or one of the parties may have ceased to be a party
to this Agreement, for any reason.

 

8.             LIABILITY AND OBLIGATIONS

 

8.1           Each
party agrees during the period of this Agreement and at all times thereafter to
indemnify and hold harmless the other parties against any and all actions,
suits, proceedings, claims, demands, costs, penalties, expenses (legal or
otherwise) or losses whatsoever which may arise out of or in respect of or in any
way connected with the conduct of the Project in that party’s laboratories or
which any tests or trials that may be carried out in connection therewith or as
a result of any act or omission of any servant or agent or sub-contractor of
that party in respect of the foregoing.

 

8.2           Each
party covenants and undertakes that the work under the Project including the
carrying out of all tests and trials will at all times be conducted to the
highest possible professional standards and in accordance with all applicable
rules, regulations and conditions and in particular will procure that no
actions suits or proceedings will be made against the other parties in respect
of or in connection with the conduct of the work under the Project.

 

8.3           Deakin University shall be responsible
for obtaining necessary regulatory approval (if any), by any and all government
agencies, for conducting research and development work in the field of the
Project in Australia.  Deakin University
shall deliver copies of all such approvals (if any) to Autogen within seven (7)
days of receipt of such approvals by Deakin University. Deakin University may
pay from the Funding the costs of any infrastructure required in order to
obtain regulatory approval provided that the limitation for use of the Funding
in clause 4.4 shall not be exceeded.

 

8.4           Autogen
is a subsidiary of AWI, which is listed on the Stock Exchange.  IDI and Deakin University are aware that the
Corporations Law prohibits insider trading and shall use their best endeavours
to ensure that their employees and contractors are also made aware of such
prohibition.  IDI and Deakin University
are aware of the continuous disclosure requirements applicable to companies
listed on the Stock Exchange and shall use their best endeavours to ensure that
their employees and contractors are also aware of such requirements and shall
advise Autogen in writing of any material advancements or developments as they
occur.

 

9.             PUBLICATION

 

9.1           Neither
Deakin University nor IDI shall (and shall procure that Dr Collier shall not),
without the prior written approval of Autogen, publish in academic or
scientific publications the results of any part of the Project. Autogen may
withhold its approval if in its opinion that, having regard to commercial
considerations, publication would not be appropriate in the circumstances.

 

9.2           Prior
to submission for publication of any proposed paper, the party proposing to
publish the same shall forward a copy of the paper to Autogen, at the same time
as requesting approval for publication.

 

9.3           Each
such request for approval for publication shall be made in sufficient time to
allow for the filing (on behalf of Autogen, Deakin University and IDI) of
provisional patent applications, if considered appropriate.

 

 

9.4           The
publishing party shall make appropriate acknowledgement in the publication, of
Autogen’s involvement and interest in the subject matter of the publication.

 

9.5           If
Autogen has not developed and commercially exploited the Intellectual Property
and the Products within eighteen (18) months of the expiration of this
Agreement, Deakin University may seek approval in writing from Autogen to
publish in academic or scientific publications the results of any part of the
Project.  Autogen shall solely decide if such
approval shall be granted.  If such
approval is granted, it may be on such conditions as Autogen may, in its
absolute discretion, specify.

 

10.          TERMINATION

 

10.1         For
the purposes of this clause, a ground of termination shall occur under this
Agreement:

 

(a)           if Deakin University fails to
commence work on the Project within thirty (30) days of the date of this
Agreement; or

 

(b)           if Deakin University fails to
achieve the milestones set out in the Budgets and Workplans or maintain the
best professional standards; or

 

(c)           the Project is not, in the
opinion of Autogen, producing or likely to produce results from the Project
which can be commercialised by Autogen; or

 

(d)           Deakin University does not
utilise Dr Collier or such other researchers as Autogen in its absolute discretion
deems appropriate to work on the Project; or

 

(e)           if the parties do not agree by
the end of the Initial Term to continue this Agreement as required by clause 3.

 

10.2         In
the event of Deakin University being in default under this Agreement as
specified in clause 10.1, Autogen may, by notice in writing to Deakin
University and IDI immediately terminate this Agreement in whole or in part
without prejudice to any right of action or remedy which has accrued or which
may accrue in favour of either parry.

 

10.3         In
the event of termination under this clause 10, Autogen may, by notice in
writing to Deakin University, require Deakin University to make available to
Autogen all information relating to the Project and to assign any Intellectual
Property relating to the Project not already owned by Autogen to Autogen by the
date specified in the notice.

 

10.4         If
Autogen ceases to provide the Funding pursuant
to clause 5.8 hereof, Deakin University and/or IDI may give thirty (30)
days written notice to Autogen of the intention of Deakin University and/or IDI
to terminate this Agreement and unless Autogen resumes payment of the Funding
within the 30 day period, this Agreement shall terminate at the expiration of
the thirty (30) day period.

 

11.          CO-OPERATION AND ASSISTANCE

 

11.1         Deakin
University shall, and shall use reasonable efforts to ensure that all persons
employed or contracted by Deakin University working on the Project shall,
co-operate fully with Autogen both during the Term of this Agreement and after
the termination of this Agreement to provide Autogen with such information
concerning the Project as Autogen may require from time to time and such
assistance as Autogen may require in applying for Intellectual Property rights
throughout the world.

 

11.2         Deakin
University shall, and shall use reasonable efforts to ensure that all persons
employed or contracted by Deakin University working on the Project shall,
ensure that all information concerning the Project is promptly communicated to
Autogen and that Autogen is provided

 

 

with all necessary technical
explanations and data to ensure that Autogen is fully informed as to the
progress and status of the Project.

 

11.3         Deakin
University shall, and shall use reasonable efforts to ensure that all persons
employed or contracted by Deakin University working on the Project shall,
provide such assistance to Autogen as may be required by Autogen both during
the term of this Agreement and thereafter during the commercialisation period
in the commercialisation of the results of the Project.

 

11.4         After
the expiration or earlier termination of this Agreement, none of IDI, Dr
Collier or Deakin University shall be engaged in any research project similar
to the Project using the Research Expertise for a period of six months
thereafter throughout Australia.

 

12.          GENERAL

 

12.1         This
Agreement shall be governed by, and construed in accordance with the laws of
the State of Victoria, Australia, and the parties hereto submit to the
non-exclusive jurisdiction of the courts of such State. All disputes arising
between the parties out of or in connection with this Agreement in any way,
shall also be resolved or determined according to the laws of the State of
Victoria, or if those laws are inapplicable, then the laws of the Commonwealth
of Australia.

 

12.2         If
it is held by a court of competent jurisdiction that:

 

(a)           any part of this Agreement is
void voidable illegal or unenforceable; or

 

(b)           this Agreement would be void
voidable illegal or unenforceable unless any part of this Agreement was severed
from this Agreement,

 

that part shall be severable from
and shall not affect the continued operation of the rest of this Agreement

 

13.          ARBITRATION

 

13.1         The
parties agree that in the event of any dispute arising under or in connection
with this Agreement, such dispute shall be referred for determination by an
arbitrator, appointed by the President of the Institute of Arbitrators
Australia.

 

13.2         In
determining any dispute arising under or in connection with this Agreement, the
arbitrator appointed pursuant to clause 13.1 hereof shall be required to
restrict himself to deciding which of the views of the parties in dispute is
correct, and shall make a determination in accordance with that decision.

 

13.3         Subject
to clause 13.2 any arbitration carried out hereunder shall be in accordance
with the provisions of the Commercial Arbitration Act 1984, and the parties
agree that they shall have the right to be legally represented before the
arbitrator.

 

13.4         The
arbitrator’s decision shall be accepted by the parties as a final determination
of the matter in dispute and binding upon them.

 

13.5         A
party may commence court proceedings relating to any dispute arising from this
Agreement at any time where that party seeks urgent interlocutory relief.

 

14.          NOTICES

 

14.1         Any
notice (which expression shall also include a demand, request, consent or
instrument required or authorised to be given to or served on any parry under
this Agreement)

 

 

(a)           shall be in writing and signed by
or in the case of a facsimile transmission shall be a true copy of an original
signed by (in the case of a notice by Autogen) any director or the secretary of
Autogen; (in the case of a notice by Deakin University), the Vice Chancellor or
any Deputy or Assistant Vice Chancellor of Deakin University or (in the case of
a notice by IDI) by the Chief Executive Officer of IDI;

 

(b)           shall be given either:

 

by being delivered by hand to (in
the case of a notice to Autogen) its above mentioned address, attention:
Company Secretary; or (in the case of a notice to Deakin University) its
abovementioned address, attention: Vice Chancellor; or (in the case of a notice
to IDI) its abovementioned address, attention: Chief Executive Officer; or

 

(ii)           by
facsimile transmission to (in the case of Autogen) 95102248, attention: Company
Secretary; or (in the case of Deakin University) 52278500 attention: Vice
Chancellor; or (in the case of IDI) 92585090 attention: Chief Executive
Officer;

 

and a notice given by facsimile
transmission, shall be deemed to have been given upon the issue to the
transmitter of a satisfactory transmission control
report indicating due transmission without error.

 

14.2         The
undermentioned signatories hereby acknowledge that they have not received
notice of the revocation of the authorisation under which they have
respectively executed this Agreement.

 

15.          CONTINUING OBLIGATIONS

 

The provisions of clauses 2.7,
4.2, 6, 7, 8.1, 9 and 11 shall remain in full force and effect, and shall
continue to bind each of the parties, notwithstanding that this Agreement may
have been terminated, or one of the parties may have ceased to be a party to
this Agreement for any reason.

 

 

IN WITNESS WHEREOF
this Agreement has been duly executed by the parties hereto on the day and year
first hereinbefore written.

 

THE COMMON SEAL of AUTOGEN PTY
LTD ACN 074 636 847 was affixed by the authority of the Board of Directors in
the presence of:

 

	
   

  	
   

  	
   

  	
   

  
	
  (Signature of
  Secretary/Director)

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  (Name of Secretary/Director in
  Full)

  	
   

  	
  (Name of Director in Full)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  SIGNED by the authorised
  representatives for DEAKIN UNIVERSITY

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Signatory

  	
   

  	
  Signatory

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Print Name of Signatory

  	
   

  	
  Print Name of Signatory

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Position of Signatory

  	
   

  	
  Position of Signatory

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  By executing this Agreement the
  signatories warrant that they are duly authorised to execute this Agreement
  on behalf of DEAKIN UNIVERSITY.

  
	
   

  	
   

  	
   

  
	
  THE COMMON SEAL of
  INTERNATIONAL DIABETES INSTITUTE ACN 007 342 412 was affixed by the authority
  of the Board of Directors in the presence of:

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  (Signature of Secretary)

  	
   

  	
  (Signature of Director

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  (Name of Secretary in Full)

  	
   

  	
  (Name of Director in Full)

  	
   

  
						

 

 

SCHEDULE
1

 

Item 1     Funding: $[*] per annum.

 

Payable by Autogen to Deakin
University as follows:

 

$[*] upon signing this Agreement

 

$[*] upon commencement of the
R&D Program

 

$[*] upon satisfactory completion
of 3 month review

 

$[*] upon satisfactory completion
of 6 month review

 

$[*] upon satisfactory completion
of 9 month review

 

Commencement of the R&D
Program shall be notified to Autogen in writing by Deakin University and Dr
Collier following the commencement of the work required by the Budgets and
Workplans. Upon receipt of such written notice Autogen shall pay to Deakin
University the payment due upon the commencement of the R&D Program.

 

Funding:
       If
this Agreement is extended beyond the Initial Term pursuant to clause 3, the
parties shall agree in writing the Funding for the Term. Payments shall be upon
receipt by Autogen of further three monthly reports as required pursuant to
clause 5.3.

 

Item 2     Research Expertise: The
fields of obesity and diabetes.

 

Item 3     Commencement Date: 14
February 1997.

 

 

SCHEDULE 2

 

Research Proposal

 

LAY DESCRIPTION OF THE PROJECT

 

Novel therapies for the treatment of obesity

 

The primary aim of this research program is to
discover novel genes that will be integral to the development of new
therapeutic approaches directed at the treatment and prevention of obesity.

 

The unique feature of this program is the availability
of the Israeli Sand Rat colony at Deakin University. The Israeli Sand Rat is
the only animal model which develops a broad spectrum of defects in food
intake, body fat and diabetes comparable to similar defects measured in humans.  For example, it is possible in the Israeli Sand
rat to find 2 offspring from the same parents, one will remain lean and free
from diabetes, while the other overeats and subsequently develops obesity. Both
of these animals have exactly the same environmental influences - Why does one
overeat??

 

By utilising the latest techniques available in
molecular biology (gene fingerprinting) we will be able to determine the
different genes being expressed in obese animals - isolate these genes and
determine their role in obesity development. Novel genes uncovered will be
patented and their metabolic potential determined. Over 50 studies have been
published this year utilising this new and powerful technique. These
publications have covered a wide range of disciplines including cancer, botany,
respiratory disease, muscular dystrophy, osteoporosis and obesity and have
resulted in the description of a number of novel genes.

 

Another separate, but complimentary component of this
program will be the testing in the Israeli Sand Rat of new therapeutic
approaches to obesity control.  The
unique feature of the Israeli Sand Rat also makes it the animal of choice when
determining the potential of new drug therapies.

 

We currently have a number of developmental drugs to
be tested. One example is our research interest in nicotine analogues. We have
interesting preliminary data linking smoking with increased sensitivity to a
potential satiety signal (leptin) in humans. 
Our data supports the notion that nicotine withdrawal after cessation of
smoking may result in increased appetite and subsequent weight gain. This opens
therapeutic avenues to explore nicotine analogues (without the detrimental side
effects of nicotine) to be tested in the Israeli Sand rat.  We have a patent application covering this
developmental research and in collaboration with chemists at the Institute for
Diabetes Discovery in CT, USA a variety of nicotine analogues will be prepared
and tested for therapeutic potential in the Israeli Sand rat.

 

In summary, the availability of
first class animal research facilities at Deakin University coupled with new
molecular biology techniques and the unique features of the Israeli Sand rat
makes this an exciting prospect for major new discoveries.

 

 

PROJECT OUTLINE

 

Introduction

 

A major feature of this research
program is the availability of a unique animal model for the study of obesity
and diabetes, the Israeli Sand rat (Psammomys obesus). At
Deakin University we breed one of only 3 research colonies of this animal in
the world.  The Israeli Sand rat is an
excellent animal model for the study of obesity and NIDDM as it appears to
mimic the development of obesity and diabetes in susceptible human populations.
In the wild state, animals remain lean and free from diabetes, however, in the
laboratory with food available ad libitum, a
broad spectrum of hyperglycaemia, hyperinsulinemia, impaired glucose tolerance,
and obesity develops. Over the past five years we have established a colony of
sand rats at Deakin University and during the last three years further
characterised the metabolic defects that appear in this animal model.

 

Despite our extensive studies
characterising the defects that occur in sand rats, the underlying reason why
some animals develop obesity and diabetes while others remain lean and healthy
is unclear.  These animals display
characteristics similar to predisposed human populations at increased risk of
developing obesity and NIDDM, and both could carry the “thrifty gene”. In this
research program we have the opportunity to combine physiological and molecular
biology techniques to discover novel genes involved in the heterogeneous
development of diabetes and obesity in this colony.

 

Explanation of Commercial
Potential

 

The discovery of new genes
related to the development of diabetes and obesity will have far-reaching
implications for prevention and treatment of these major western diseases. In
addition the animal model because of its characterised features similar to
human obesity and NIDDM make it the animal of choice when testing potential new
therapies aimed at either prevention or treatment of these conditions.

 

Overall Research Plan

 

The overall research plan will
span a 5 year period, but can be broadly divided into 2 major stages:

 

Stage 1:

 

This stage will aim to uncover
new genes involved in the development of NIDDM and obesity. The genes
discovered will be sequenced and if novel will be patented and their protein
products expressed.

 

Stage 2:

 

This stage will involve
investigating the physiological role of newly discovered peptides from stage
1.  In addition, intervention and
prevention studies will be performed in the Israeli Sand rat using potential
new therapies.

 

Stage 1 of the proposal will be ongoing
for the duration of the program.  The
experiments involved are labour intensive and will uncover many differentially
expressed genes in obese or diabetic tissues. The ability to discover new genes
is exciting and potentially very rewarding. Stage 2 will not only investigate
the new gene products discovered in Stage l, but will immediately
begin with the testing of a number of existing new therapies as outlined below.

 

The final outcome of this 5 year research program will
be the discovery of new potential therapies tested physiologically in the best
animal model available for obesity and NIDDM and ready for progression to the
next stage of development.

 

 

Brief Research Outline

 

Israeli Sand Rat Colony:

 

The success of this project is dependent on a healthy
and viable colony of Israeli Sand rats. The colony at Deakin University will be
expanded to facilitate the planned experiments over the 5 year period. The
animal housing facility, both breeding and experimental housing at the
university are first class and will not provide excellent infrastructure for
the program.  To expand the colony and
maintenance of the ongoing animal demands and the continual care and health of
the colony will require recruitment of suitably trained staff.  In addition, initial infrastructure costs for
the expansion of the colony, including caging and racks will be needed in the
first year.

 

Stage 1:

 

As described above this part of the research will
continue for the 5 years of the program.

 

Why do some animals develop these physiological
defects and proceed through obesity to diabetics, while other animals (even in
the same family) remain lean and non-diabetic? The specific aim of this project
will be to utilise the new and exciting technique of differential display
polymerase chain reaction (ddPCR) to uncover differences in tissue gene
expression in sand rats that naturally develop obesity and diabetes compared
with lean non-diabetic animals. ddPCR is a powerful procedure for detection of
differentially expressed genes. It permits the simultaneous identification of
genes that are up or down regulated under different conditions.

 

Two recent publications have highlighted the
effectiveness of this technique. A recent report in Nature, identified that
melanin concentrating hormone (MCH) was differentially expressed in ob/ob mice and when purified and
injected into the brain of ob/ob mice
dramatically increased food intake. Previously MCH had no known physiological
function! In another recent publication a new gene product was discovered
expressed in the adipose tissue of obese mice and called ADIPOQ. In the current
research program, various tissues including brain, liver and skeletal muscle
will be isolated from lean, non-diabetic and obese sand rats and ddPCR will be
performed to examine all differentially expressed genes. This technique has
been established in our laboratory over the past 12 months. By linking defects
exposed by this technique with physiological defects in animals, we will be
able to pursue metabolic pathways not previously linked with development of
diabetes and obesity.

 

 

 

As discussed above this is a large ongoing project and
will require the appointment of 2-3 key experienced researchers. This will
increase the productivity and allow the systematic examination of very large
numbers of tedious but potentially rewarding experiments. There will also be an
initial outlay for infrastructure costs to increase the productivity of the
current research laboratory to ensure that the numbers of experiments can be
carried out during the program maximising the change of success.

 

Stage 2:

 

The Israeli Sand rat has already been used
successfully in our laboratory in a number of intervention and treatment
experiments. In intervention studies the effects of fatty acid oxidation
inhibition have been examined with daily intraperitoneal injections of a
specific inhibitor, Etomoxir. These studies demonstrated the ability of_ this
treatment to improve glucose metabolism and insulin sensitivity in diabetic
animals. In addition, exercise interventions and energy restriction experiments
have highlighted the reversible nature of the defects in energy balance and
glucose metabolism. We have also performed prevention studies, limiting the
food intake of animals from weaning. These 

 

 

experiments clearly demonstrated the prevention of
diabetes development with the restriction of energy intake. These studies
highlight the suitability of this animal model for experiments testing the
efficacy and mode of action of new potential drug therapies.

 

This stage will involve investigation of the
physiological role of new peptides found in Stage 1 described above and the
immediate testing of a number of possible therapeutic agents to treat diabetes,
obesity and cardiovascular disease.

 

Obesity

 

Structurally altered nicotine based agents will be
tested for their therapeutic potential. We have applied for provisional
patents. The structural chemistry can be performed in collaboration with a
company with structural chemistry expertise and we will perform the
physiological experiments at Deakin University.

 

Important factors essential for a successful research program

 

1.             First class
facilities.

 

2.             Top quality research
scientists.

 

3.             Unique research plan.

 

4.             Constant interaction
with leading international research groups.

 

5.             Continual
international peer review of research findings.

 

 

SCHEDULE 3

 

Budgets and Workplans

 

STAGE

 

	
  Equipment

  	
   

  	
  [*]

  	
   

  	
  thermal cycler

  	 

	
   

  	
   

  	
  [*]

  	
   

  	
  power supplies

  	 

	
   

  	
   

  	
  [*]

  	
   

  	
  ddPCR apparatus

  	 

	
   

  	
   

  	
  [*]

  	
   

  	
  -85° freezer

  	 

	
   

  	
   

  	
  [*]

  	
   

  	
  -20° freezer, fridges, etc

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
  Administration

  	
   

  	
  [*]

  	
   

  	
  computers, journals, etc.

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
  Maintenance

  	
   

  	
  [*]

  	
   

  	
  ddPCR, radiochemicals and consumables

  	 

	
   

  	
   

  	
  [*]

  	
   

  	
  physiological experiments, assays, and consumables

  	 

	
   

  	
   

  	
  [*]

  	
   

  	
  animal colony maintenance

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
  Staff

  	
   

  	
  [*]

  	
   

  	
  post-doctoral scientist (+on-cost)

  	 

	
   

  	
   

  	
  [*]

  	
   

  	
  graduate research scientist (+on-costs)

  	 

	
   

  	
   

  	
  [*]

  	
   

  	
  part-time animal technician support (+on-cost)

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
  University
  infrastructure costs

  	
   

  	
  [*]

  	
   

  	
  10% University, 5% Faculty, 5% School

  	 

	
   

  	
   

  	
   

  	
   

  	
   

  	 

	
  TOTAL
  BUDGET

  	
  $

  	
  [*]

  	
   

  	
   

  
							

 

 

STAGE l:               NOVEL
THERAPIES FOR THE TREATMENT OF OBESITY MILESTONES FOR OCTOBER 1996 - SEPTEMBER
1997

 

1.             OCTOBER -
DECEMBER 1996

 

The first three months of the project will involve
recruitment of new staff and purchasing of new equipment necessary for the
project. The equipment to purchase and the staff necessary are outlined in
Stage 1 of the research proposal. The specific milestones to be reached in the
first three months are outlined below.

 

(a)           New equipment purchased and established in
laboratory.

 

(b)           Appointment of a key post-doctoral position (3
years) to begin as early as possible (January 1997).

 

(c)           Appointment of an animal technician to maintain
the Israeli Sand Rat (Psammomys obesus) colony;
continue to increase breeding pair numbers to accommodate the new projects.

 

(d)           Begin preliminary studies investigating the
effectiveness of nicotinic acid in regulating energy balance and body weight
control in Psammomys obesus.

 

2.             JANUARY -
MARCH 1997

 

(a)           Appointment of second full-time position -
dedicated to the discovery of new genes expressed in obesity using the ddPCR
technique.

 

(b)           Establish the reproducibility and reliability
of the ddPCR technique. At this stage, ddPCR should be a routine technique in
our laboratories.

 

(c)           Finish preliminary studies of the effectiveness
of nicotinic acid in energy balance and body weight control.  At this stage, the future of these studies
should be decided.

 

3.             APRIL -
JUNE 1997

 

(a)           Initial comparisons of differentially expressed
genes in hypothalamus and adipose tissue of lean and obese animals.  This stage will involve a large number of
experiments attempting to amplify via PCR large numbers of differentially
expressed genes in obese and lean animals.

 

(b)           Further physiological studies on nicotinic acid
or derivatives.

 

4.             JULY -
SEPTEMBER 1997

 

During this stage the initial genes of interest will
be identified by comparing lean and obese gene expression. Preliminary
screening will be undertaken to
eliminate false positives or spurious bands. Based on the appearance of
differentially expressed genes in obese animals, bands will be cloned and
sequenced. At this stage, is expected that a number of key genes will be
identified for future studies.

 

 

SCHEDULE 4

 

Pre-existing
Intellectual Property

 

The Patent

 

Australian Provisional
Patent Application No. PO 1085/96 (annexed hereto) entitled “Treatment of
Obesity” filed on 18 July 1996.

 

The Patent Applicants

 

IDI, Paul Zev Zimmet of 24
Linlithgow Road Toorak Victoria 3142, Roderick Alan Westerman of care of 260
Kooyong Road Caulfield Victoria 3162 and Dr Collier

 

Licence Agreement

 

Between the Patent Applicants and
Deakin University dated the 20th day of February 1997 (annexed hereto).

 

 

THIS
LICENCE AGREEMENT made at Melbourne on 20 February                                 1997.

 

 

BETWEEN

 

 

PAUL ZEV
ZIMMET of 24 Linlithgow Road, Toorak 3142

 

 

RODERICK
ALAN WESTERMAN, of 260 Kooyong Road Caulfield
3162

 

 

GREGORY
ROYCE COLLIER of 22 Kestrel Avenue Ocean Grove
3226 (jointly “the

 

Patentors”)

 

- and -

 

DEAKIN
UNIVERSITY a body politic and corporate established

pursuant to the Deakin University Act 1974
of Geelong 3217 in the State of

Victoria (hereinafter called “Deakin”)

 

RECITALS

 

A.            The
Patentors are the beneficial owners of Australian Provisional Patent
Application No PO 1085/96 entitled “Treatment of Obesity” (`the Patent”).

 

B.            Deakin,
having research expertise in the field of obesity, proposes to enter into a
Research Agreement (“the Principal Agreement”) with Autogen Pty Ltd ACN 074 636
847 of 8th Floor, 580 St Kilda Road, Melbourne 3004, and International Diabetes
Institute ACN 007 342 412 of 260 Kooyong Road, Caulfield, 3162 to which this
Licence annexed.

 

C.            The
Patentors have licensed the Patent exclusively to Deakin to enable it to better
perform its obligations pursuant to the Research Agreement.

 

THE PARTIES AGREE:

 

l.              This
Agreement shall commence on 31 January 1997 and shall continue for the duration
of the Principal Agreement and any extensions thereof.

 

2.             The
Patentors hereby grant to Deakin a licence with a right to grant sub-licences
to use the intellectual property contained in the Patent for the purposes and
to the extent required by Deakin’s responsibilities under the Principal
Agreement.

 

 

3.             The
Patentors represent, warrant and undertake to Deakin that:

 

(a)           neither the execution of this Agreement nor the
performance by the Patentors of their obligations will cause the Patentors to
be in breach of any agreement to which they are a party or are subject:

 

(b)           the Patent is presently subsisting and the
particulars as set out in this Agreement are true and correct;

 

(c)           the Patentors have the full right and title to
the Patent and the invention the subject of the Patent;

 

(d)           the Patent Application (comprised in the
Patent) has been made in the prescribed form and the prescribed manner;

 

(e)           the Patentors have not granted any licences or
other user rights to any person in relation to any right, title or interest in
the Patent or the invention the subject of the Patent;

 

(f)            the Patentors have
not entered into any agreement or arrangement involving the sale, mortgage,
pledge, granting of options or any other rights over the Patentors’ right,
title and interest in the Patent or the invention the subject of the Patent;

 

(g)           the use by Deakin and any sub-licensee of
Deakin of the Patent or the invention the subject of the Patent will not
infringe any patent, trade mark, registered design, copyright or similar or
other industrial commercial property right of any person nor give rise to
payment by Deakin or any sub-licensee of Deakin of any royalty to any third
party or any liability to pay compensation;

 

(h)           the Patentors are not aware of any fact by
which the Patent may be declared invalid or any claim by which the Patent
should be amended; and

 

(i)            the Patentors shall
use their best endeavours to obtain a grant of letters patent in respect of the
invention the subject of the Patent.

 

4.             The Patentors will
provide the intellectual property contained in the Patent together with any
know how and trade secrets to Deakin for the purposes of this Agreement.

 

5.             Deakin will pay to
the Patentors a one-off licence fee of One Dollar ($1.00), receipt of which is
hereby acknowledged.

 

6.             If any dispute arises
between the parties hereto pursuant to this Agreement, it shall:

 

(j)            upon mutual agreement
of the parties, be referred to mediation: or

 

(k)           at either party’s option or by mutual
agreement, be referred to arbitration in accordance with the Commercial Arbitration Act 1984 (Vic),
and each party may be represented by a qualified legal practitioner or by the
representative of their choice.

 

7.             Each party may
terminate this Agreement at any time upon written notice of the other if the
other party defaults by failing to perform any substantial obligation on its
party. The termination will become effective thirty days after receipt of
written notice unless during the relevant period of thirty days the defaulting
party has remedied the default or (if the default is not capable of remedy
within thirty days) is diligently proceeding to cure the default by

 

 

taking active, effective and continuing steps to do so
and the default is in fact cured within a reasonable period of time after
receipt of the relevant notice.

 

8.             Variations of this
Agreement shall be made in writing and signed for and on behalf of the parties
to this Agreement.

 

SIGNED as an agreement.

 

SIGNED by PAUL ZEV ZIMMETT in the prese

 

 

	
   

  	
   

  	
   

  	
   

  
	
  (Name of Witness in Full)

  	
   

  	
  (Signature)

  

 

 

SIGNED by RODERICK ALAN WESTERMAN in the presence of

 

 

	
   

  	
   

  	
   

  	
   

  
	
  (Signature of Witness)

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (Signature)

  
	
   

  	
   

  	
   

  
	
  (Name of Witness in Full)

  	
   

  	
   

  

 

 

	
  SIGNED by GREGORY ROYCE

  COLLIER in the presence of

  	
  )

  )

  	
   

  	
   

  	
   

  	
   

  
	
  (Signature)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (Signature of Witness)

  	
   

  	
   

  	
   

  	
   

  
	
  ,

  	
   

  	
   

  	
   

  	
   

  
	
  (Name of Witness in Full)

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SIGNED for and on behalf of
  DEAKIN

  	
  )

  	
  Vice-Chancellor

  	
   

  	
   

  
	
  UNIVERSITY by its duly
  authorised

  	
  )

  	
   

  	
   

  	
   

  
	
  officers in the presence of

  	
  )

  	
  Vice-President (Administration)

  	
   

  	
   

  

 

By executing this Agreement the
signatories warrant that they are duly authorised to execute this Agreement on
behalf of DEAKIN UNIVERSITY.

 

 

International Diabetes Institute

AND

Paul Zev Zimmet

AND

Roderick Alan Westerman

AND

Gregory Collier

 

[*]

 

 

FIGURE SCHEDULE 5

DEED OF CONFIDENTIALITY

 

THIS DEED is made on the date set out in Item 1 of Schedule 1.

 

BETWEEN:      THE COMPANY OR ENTITY WHOSE NAME AND
ADDRESS IS SET OUT IN ITEM 2 OF SCHEDULE   1 (“Discloser”)

 

AND:                 THE PERSON OR COMPANY WHOSE NAME AND ADDRESS IS
SET OUT IN ITEM 3 OF SCHEDULE 1 (“Recipient”)

 

RECITALS

 

A.            The Discloser has or may acquire certain
Confidential Information.

 

B.            The Recipient wishes to have disclosed to it the
Confidential Information and The Discloser is prepared to disclose the
Confidential Information to the Recipient subject to various terms set out in
this Agreement.

 

C.            In consideration of The Discloser agreeing to
disclose the Confidential Information to the Recipient, the Recipient has
agreed to accept confidentiality obligations on the terms set out in this
Agreement.

 

NOW THIS DEED WITNESSES AS FOLLOWS:

 

1.             DEFINITIONS AND
INTERPRETATION

 

1.1           The following definitions apply in this Deed
unless otherwise indicated:

 

“Autogen Research” means Autogen Research Pty Ltd ACN 074 636
847.

 

“Confidential Information” includes:

 

(a)           all of the terms of this Deed; and

 

(b)           Confidential Information as defined in the
Research, Licence and Commercialisation Agreement between Autogen Research and
Deakin University dated the       day of                 2000.

 

“Acknowledgement of Obligation of Confidentiality” means the document set out in Schedule 2.

 

1.2           In this Deed unless otherwise indicated:

 

(a)           any right or obligation which affects more
than one person shall affect those persons jointly and severally;

 

(b)           headings are used for convenience only and
shall have no binding effect;

 

(c)           use of the singular shall, where necessary,
include the plural and vice versa; and

 

 

(d)           “person” includes a firm, body corporate,
unincorporated association, or authority and such reference shall include that
person’s successors and assigns.

 

2.             OBLIGATION OF
CONFIDENTIALITY

 

2.1           The Recipient:

 

(a)           acknowledges that the Confidential
Information has been disclosed to the Recipient in circumstances of confidence;

 

(b)           shall maintain such confidence and, subject
to this Deed, refrain from disclosing or causing to be disclosed the
Confidential Information to any person; and

 

(c)           shall only make use of the Confidential
Information for the purpose, and to the extent, expressly authorized in writing
by the Discloser.

 

2.2           The Recipient may disclose Confidential
Information to any of its officers, employees, agents or advisers only after
taking the following steps:

 

(a)           informing Autogen as to all persons who will
be receiving the Confidential Information;

 

(b)           making available a copy of this Deed to such
person or persons;

 

(c)           ensuring that such person or persons sign an
Acknowledgement of Obligation of Confidentiality; and

 

(d)           ensuring that the signed Acknowledgement of
Obligation of Confidentiality is delivered to Autogen.

 

2.3           The obligations of confidentiality owed by
the Recipient pursuant to this Deed shall be enforceable by Autogen Research in
accordance with this Deed as if Autogen Research were named as the Discloser in
this Deed.

 

3.             QUALITY OF INFORMATION AND
RELEASE

 

3.1           The Discloser makes no warranty or
representation whatsoever as to the quality or accuracy of any Confidential
Information which is the subject of this Deed. 
The Discloser hereby excludes, to the full extent allowed by law, any
condition or warranty that the Confidential Information has been prepared using
reasonable care.

 

3.2           To the extent that the Recipient will rely on
any Confidential Information the subject of this Deed, the Recipient will only
do so after receiving independent advice, from an appropriately qualified
person, that it is appropriate to do so. 
The Recipient releases the Discloser from all claims, actions, damages,
remedies arising from a failure to act on this independent advice.

 

4.             INDEMNITY

 

4.1           The Recipient acknowledges the interest of
Autogen in the Confidential Information and that Autogen Research may suffer
harm or loss or incur a liability if the Recipient breaches this Deed.

 

4.2           The Recipient acknowledges that the Discloser
may suffer harm or loss or incur a liability if the Recipient breaches this
Deed.

 

 

4.3           Accordingly, the Recipient undertakes to
indemnify Autogen Research and the Discloser from all such loss, harm or
liability which may flow, directly or indirectly, from a breach of this Deed by
the Recipient.

 

5.             BREACH AND COMPULSORY
DISCLOSURE

 

5.1           As soon as the Recipient becomes aware of any
actual or threatened breach of this Deed, it must immediately notify the
Discloser.  Furthermore, the Recipient is
obliged to do everything reasonably within its power to prevent or stop any
actual or threatened breach of this Deed.

 

5.2           If the Recipient is required by a law or
court of competent jurisdiction to disclose any Confidential Information to any
unauthorized person, it must, without delay:

 

(a)           inform the Discloser in writing;

 

(b)           follow the Discloser’s lawful direction in
opposing or restricting such disclosure; and

 

(c)           as far as possible, only disclose the
Confidential Information on terms which will maintain its confidentiality.

 

6.             CONFIDENTIALITY INFORMATION
NO LONGER REQUIRED

 

6.1           Except as otherwise provided in any other
contract in writing signed by the parties, the Discloser may request in writing
the delivery up of Confidential Information. 
Following such request, the Recipient must immediately furnish such
Confidential Information to the Discloser, in each and every form in which it
is held.

 

7.             COMMUNICATIONS WITH AUTOGEN

 

7.1           All communications to the Discloser relating
to this Deed shall be directed to the address of the Discloser appearing in
this Deed or such other address as may be notified to the Recipient from time
to time.  All such communications shall
be:

 

(a)           in writing; and

 

(b)           marked to the attention of the relevant person
specified in clause 14.1 of the Research, Licence and Commercialisation
Agreement referred to in clause 1.1(b) of this Deed.

 

8.             INTELLECTUAL PROPERTY

 

The
Recipient assigns to the Discloser, or to such other person as the Discloser
nominates, all present and future intellectual property rights in all subject
matter created pursuant to the Recipient’s use of the Confidential Information.

 

9.             GENERAL

 

9.1           All rights and obligations under this Deed
are cumulative and shall not affect or be affected by any other rights,
obligations or remedies available at law.

 

 

9.2           No right under this Deed shall be deemed to
be waived except by notice in writing signed by both Autogen and the
Recipient.  Any such waiver will not
prejudice that party’s rights in respect of any subsequent breach of this Deed.

 

9.3           The obligations of confidentiality under this
Deed survive the termination of this Deed.

 

9.4           Remedies available to the Discloser for any
breach or threatened breach by the Recipient of this Deed include, at the
option of the Discloser, damages, specific performance, or injunction and any
other remedies available to the Discloser at law.

 

9.5           If any provision in this Deed is held
invalid, unenforceable or illegal for any reason, this Deed shall remain
otherwise in force apart from such provision, which shall be deemed deleted.

 

9.6           This Deed will be governed and construed
according to the laws in force in the state of Victoria, Commonwealth of
Australia and the parties agree to submit to Courts and Tribunals of that
jurisdiction.

 

EXECUTED as a Deed.

 

	
  SIGNED SEALED AND DELIVERED for

  and on behalf of THE DISCLOSER by
in the presence of:

  	
  )

  )

  )

  )

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (Signature)

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (Signature
  of Witness)

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (Name
  of Witness in Full)

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SIGNED SEALED AND DELIVERED for

  and on behalf of THE RECIPIENT
  in the

  presence of:

  	
  )

  )

  )

  )

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (Signature)

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (Signature
  of Witness)

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (Name
  of Witness in Full)

  	
   

  	
   

  	
   

  	
   

  

 

 

DEED OF CONFIDENTIALITY

 

SCHEDULE 1

 

1.             Date of this Deed

 

2.             The Discloser

 

Name:

 

Address:

 

Telephone No:

 

Facsimile No:

 

Contact Person:

 

3.             The Recipient

 

Name:

 

Address:

 

Telephone No:

 

Facsimile No:

 

Contact Person:

 

 

SCHEDULE 2

 

ACKNOWLEDGEMENT OF OBLIGATION OF CONFIDENTIALITY

 

Date:

 

Autogen
Limited

 

Dear
Sir

 

Pursuant
to the Deed of Confidentiality made between [                              ]
(the “Discloser”) and [                                  ]
(the “Recipient”) [insert date of Deed] the
Recipient proposes to disclose Confidential Information the subject of the said
Deed of Confidentiality to me/us. 
Accordingly, I/we undertake as follows:

 

1.             I/We acknowledge that I am/we are aware of
and understand the obligations on the Recipient under the said Deed of
Confidentiality.

 

2.             I/We will take all steps necessary to ensure
that the Confidential Information remains confidential.

 

3.             I/We will not disclose any of the
Confidential Information to any unauthorised person or persons.

 

4.             I/We acknowledge that remedies available to
the Discloser for any breach or threatened breach by me/us of this
Acknowledgement include, at the option of Autogen, damages, specific
performance, or injunction and any other remedies available to the Discloser at
law.

 

5.             Except as otherwise provided in any written
agreement between the Discloser and Recipient, the Discloser may request in
writing the delivery up of Confidential Information.  Following such request, I/we undertake to
immediately furnish to you such Confidential Information, in each and every
form in which it is held.

 

6.             I/We further agree to observe the terms of
the Deed of Confidentiality in favour of the Discloser to the same extent as if
I/each of us had been named as the Recipient under the Deed of Confidentiality.

 

7.             I/We acknowledge that the terms of this
undertaking survive the termination of the deed of Confidentiality.

 

8.             Any expressions used in this Acknowledgement
shall have same meaning as in the Deed of Confidentiality.

 

	
  Name

  	
   

  	
  Capacity

  	
   

  	
  Signature

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

1Exhibit 4.2(q)

 

“CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN OMITTED AND HAVE BEEN
SEPARATELY FILED WITH THE COMMISSION. 
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.”

 

Research,
Licence and Commercialisation

Agreement

 

Date: 14 January 1998

 

 

AUTOGEN
PTY LTD ACN 074 636 847

(“Autogen”)

 

 

INTERNATIONAL
DIABETES INSTITUTE ACN 007 342 412

(“IDI”)

 

 

TABLE
OF CONTENTS

 

	
  Clause

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  1.

  	
  DEFINITIONS AND INTERPRETATIONS

  	
   

  
	
   

  	
   

  	
   

  
	
  1.1

  	
  Definitions

  	
   

  
	
  1.2

  	
  Interpretation

  	
   

  
	
   

  	
   

  	
   

  
	
  2.

  	
  APPOINTMENT OF IDI

  	
   

  
	
   

  	
   

  	
   

  
	
  3.

  	
  TERM

  	
   

  
	
   

  	
   

  	
   

  
	
  4.

  	
  FUNDING OF THE PROJECT

  	
   

  
	
   

  	
   

  	
   

  
	
  5.

  	
  PERFORMANCE REVIEW

  	
   

  
	
   

  	
   

  	
   

  
	
  6.

  	
  OWNERSHIP OF INTELLECTUAL PROPERTY

  	
   

  
	
   

  	
   

  	
   

  
	
  7.

  	
  CONFIDENTIALITY

  	
   

  
	
   

  	
   

  	
   

  
	
  8.

  	
  LIABILITY AND OBLIGATIONS

  	
   

  
	
   

  	
   

  	
   

  
	
  9.

  	
  PUBLICATION

  	
   

  
	
   

  	
   

  	
   

  
	
  10.

  	
  TERMINATION

  	
   

  
	
   

  	
   

  	
   

  
	
  11.

  	
  CO-OPERATION AND ASSISTANCE

  	
   

  
	
   

  	
   

  	
   

  
	
  12.

  	
  GENERAL

  	
   

  
	
   

  	
   

  	
   

  
	
  13.

  	
  ARBITRATION

  	
   

  
	
   

  	
   

  	
   

  
	
  14.

  	
  NOTICES

  	
   

  
	
   

  	
   

  	
   

  
	
  15.

  	
  CONTINUING OBLIGATIONS

  	
   

  
	
   

  	
   

  	
   

  
	
  SCHEDULE 1

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  SCHEDULE 2

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  SCHEDULE 3

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  SCHEDULE 4

  	
   

  	
   

  

 

 

THIS AGREEMENT is made the fourteenth day of January 1998

 

BETWEEN:

 

AUTOGEN PTY LTD ABN
074 636 847 of 8th Floor,
580 St Kilda Road, Melbourne, Victoria 3004 (“Autogen”)

 

AND

 

INTERNATIONAL
DIABETES INSTITUTE ACN 007 342 412 of
260 Kooyong Road, Caulfield, Victoria 3162 (“IDI”)

 

WHEREAS:

 

A.            Autogen proposes to
engage in research in the fields of diabetes, obesity, allergy, asthma and
autoimmunity (“the Research Fields”).

 

B.            Autogen desires to
collaborate with IDI and to provide the Funding for the Project using the
Research Expertise in return for the joint ownership and a licence of all
Intellectual Property resulting from the Project on the terms set out in this
Agreement.

 

C.            The Parties wish to
ensure that the Research Expertise is applied to the Project and that the
results of the Project are, if appropriate, commercialised by Autogen.

 

D.            Autogen is a
subsidiary of AWI, which is listed on the Stock Exchange.  IDI is aware that the Corporations Law
prohibits insider trading and shall use its best endeavours to ensure that its
employees and contractors are also made aware of such prohibition.  IDI is aware of the continuous disclosure
requirements applicable to companies listed on the Stock Exchange and shall use
its best endeavours to ensure that its employees and contractors are also aware
of such requirements and shall advise Autogen in writing of any material
advancements or developments as they occur.

 

NOW THIS AGREEMENT
WITNESSES as follows:

 

1.             DEFINITIONS AND
INTERPRETATION

 

1.1          Definitions

 

In
this Agreement the following words and expressions shall have the meanings
ascribed thereto as follows (unless the context otherwise requires):

 

“AWI” means AWI Administration Services Pty Ltd ABN 32 006 804 708

 

“Budgets and Workplans” means the detailed budgets and time
plans and schedules for work to be carried out under the R&D Program and
attached in Schedule 3 as may be amended from time to time by agreement
between Autogen and IDI.

 

“Commencement
Date” means the date specified in
Item 3 of Schedule 1.

 

“Confidential
Information” means information that:

 

(a)           is by its nature
confidential;

 

(b)           is designated by either
party as confidential; or

 

1

 

(c)           either party knows or ought
to know is confidential;

 

and includes -

 

(d)           information comprised in or
relating to any Intellectual Property rights of either party;

 

(e)           information relating to the
financial position of either party an din particular includes information
relating to the assets or liabilities of either party and any other matter that
does or may affect the financial position or reputation of either party;

 

(f)            information relating to
the internal management and structure of either party, or the personnel,
policies and strategies of either party;

 

(g)           information of a party to
which the other party has access other than information referred to in
paragraphs (d), (e) and (f) that has any actual or potential
commercial value to the first party or to the person or corporation which
supplied that information;

 

(h)           information in the
possession of the other party relating to the first party’s clients;

 

(i)            information of a party
disclosed to the other party before or after the Commencement Date.

 

“Funding” means:

 

(a)           in respect of the Initial
Term the amount specified in Item 1 of Schedule 1; and

 

(b)           in respect of any
period after the Initial Term, the amount agreed in writing by the parties to
be paid by Autogen for that Period.

 

“Initial Term” means the period of one year from the Commencement Date.

 

“Intellectual Property” means intellectual and industrial
property or rights of any nature throughout the world and all reversionary
interests therein, including inventions, rights to or arising from inventions,
letters patent, applications for letters patent, utility models, copyright in
works of any nature, industrial designs, registered designs, rights to or
arising from any industrial design, computer programs of any nature,
Confidential Information, trade secrets, “know how”, technical or commercial
expertise or knowledge and any ideas or information of a commercial or valuable
nature developed or created on or after the Commencement Date pursuant to the
R&D program.

 

“Net Sales Revenue” means the revenue in Australian dollars
received by Autogen or any Related Body Corporate from all sales of the Products
or licence fees or royalties derived from licensing of the Intellectual
Property to produce, market and sell the Products, or from any other revenue
producing use of the Intellectual Property or the Products, after the deduction
of all trade discounts, return of sales, foreign exchange charges, withholding
tax, sales tax or similar tax such as consumption tax, goods or services tax or
value added tax and insurance and freight costs under a cost insurance and
freight arrangement before the deduction of administrative, marketing and
manufacturing costs and corporate income tax.

 

2

 

“Professor Zimmet” means Professor Paul Zev Zimmet AM,
Chief Executive Officer of IDI, of 24 Linlithgow Road, Toorak, Victoria 3142.

 

“Products” means the products and results of the Project.

 

“Project”
means scientific research using the Research Expertise into genes and diabetes
and non-insulin dependent diabetes conducted by IDI pursuant to this Agreement.

 

“Project Location” means International Diabetes Institute,
260 Kooyong Road, Caulfield, Victoria 3162.

 

“Research Expertise” means the field or fields of expertise
of IDI specified in Item 2 of Schedule 1.

 

“Research Fields” means the fields of diabetes, obesity,
allergy, asthma and autoimmunity and such other fields as Autogen may include
from time to time.

 

“Research Proposal” means the proposal developed by
Professor Zimmet and IDI and attached in Schedule 2 of this Agreement.

 

“R&D Program” means the program of research and development
work to be carried out by or on behalf of IDI pursuant to this Agreement in
relation to the Project.

 

“Stock
Exchange” means Australian Stock
Exchange Limited.

 

“Term”
means the Initial Term of this Agreement and any agreed extension in accordance
with clause 3.

 

1.2          Interpretation

 

Where
the context so permits, words importing the masculine gender shall include the
feminie and neuter genders and vice versa and words importing persons shall
include corporations and vice versa and words importing the singular number
shall include the plural and vice versa (unless repugnant or inconsistent to
the context in which they are used).

 

Any
table of contents to this Agreement and any headings and marginal notations in
this Agreement have been inserted for convenience only and shall not in any way
limit or govern the construction of the terms of this Agreement.

 

2.             APPOINTMENT OF IDI

 

2.1           Autogen hereby appoints,
and IDI accepts the appointment of, IDI to conduct the Project in accordance
with the Research Proposal such appointment tot take effect on and from the
Commencement Date.

 

3

 

2.2           IDI shall provide the
services of Professor Zimmet and the principal scientist to conduct the Project
and supervise and direct the scientific staff engaged in the conduct of the
Project.

 

2.3           The Project shall be
carried out at the Project Location or as Professor Zimmet shall direct from
time to time.

 

2.4           Professor Zimmet shall
select and IDI shall employ or engage, on contract, such scientific staff as
shall be necessary to conduct the Project.

 

2.5           IDI may, subject to the
prior written consent of Autogen, sub-contract the performance of any part or
parts of the work for the Project provided that in so doing the sub-contractor
first enters into a confidentiality agreement on terms reasonably acceptable to
Autogen including:

 

•              a covenant not to
infringe any Intellectual Property rights of Autogen and IDI;

 

•              an acknowledgement
that all Intellectual Property Rights arising from the carrying out of the
sub-contracted work shall belong to Autogen and IDI in accordance with this
Agreement.

 

2.6           IDI shall at all times use
its best endeavours to ensure that completion of the respective stages of the
Project is achieved substantially in accordance with the timetable set out in
the Project and in the Budgets and Workplans.

 

2.7           IDI shall at all times
indemnify, hold harmless and defend Autogen and its respective officers,
employees and agents (in this clause 2.7 referred to as “those indemnified”)
from and against any loss (including reasonable legal costs and expenses) or
liability reasonably incurred or suffered by any of those indemnified arising
from any suit, action or proceeding by any person against any of those
indemnified where such loss or liability was caused by any wilful, unlawful or
negligent act or omission of IDI, its employees, agents or sub-contractors in
connection with this Agreement or by any Products infringing any person’s
Intellectual Property rights where IDI is or ought reasonably to have been
aware of such rights and such infringement was caused by any wilful, unlawful
or negligent act or omission of IDI.

 

3.             TERM

 

This
Agreement shall commence on the Commencement Date and shall continue (subject
to the provisions as to termination hereunder) for the Initial Term.  Not less than three months prior to the
expiration of the Initial Term the parties shall determine whether this
Agreement is to continue by mutual agreement. 
If no agreement is reached between the parties by the end of the Initial
Term, this Agreement shall terminate at the end of the Initial Term.  If agreement is reached between the parties
prior to the end of the Initial Term, this Agreement shall continue to apply
for the further term agreed by the parties subject to any written variations to
this Agreement agreed by the parties.

 

4.             FUNDING OF THE PROJECT

 

4.1           Subject to this Agreement,
Autogen shall provide the Funding to finance the Project over the Term, in
accordance with the payment program in Item 1 of Schedule 1.

 

4.2           Subject to this Agreement,
Autogen shall provide the Funding for the Initial Term however IDI shall be
required to achieve the milestones set in the Budgets and Workplans to an
appropriate standard as specified in this Agreement.  Although

 

4

 

Autogen may terminate this
Agreement pursuant to clause 10.1, Autogen shall provide the Funding for the
Initial Term irrespective of such termination except where termination is
pursuant to clause 10.1(a) in which case the Funding shall not be provided
by Autogen.

 

4.3           Subject to sub-clauses 4.4
and 4.5, the Funding shall be used to pay for salaries of staff engaged in the
conduct of the Project (save and except for Professor Zimmet whose salary shall
continue to be paid by IDI).

 

4.4           Subject to sub-clause 4.5,
IDI shall ensure that no more than [*] of the Funding shall be used for
administration and infrastructure costs and that the balance of the Funding is
properly applied directly to the Project.

 

4.5           IDI shall use the Funding
for the Project in accordance with the Budgets and Workplans or for such other
research in the Research Fields as shall be agreed in writing by the parties.

 

4.6           Any equipment or materials
purchased for use in the Project by IDI using the Funding and not incorporating
any of the Intellectual Property shall become the property of IDI upon
purchase, except where this Agreement is terminated pursuant to clause 10.1(a) hereof
in which case such equipment and materials shall be the sole property of
Autogen.

 

5.             PERFORMANCE REVIEW

 

5.1           The parties shall review
the progress of the Project every three (3) months.

 

5.2           The purpose of the reviews
shall be to ascertain whether the stages targeted and milestones set in the
Budgets and Workplans are being met at the appropriate times and to an
appropriate standard.

 

5.3           Professor Zimmet shall
there (3) months after the date of this Agreement, and every three months
thereafter, provide Autogen and IDI with a written report for the purposes of
the review setting out adequate details of the following:

 

(a)           the progress of the Project
work during the preceding three (3) months, and whether all milestones
which ought to have been reached during that period have been reached and best
professional standards maintained;

 

(b)           any material advances or
developments;

 

(c)           any material delays or
unforeseen problems in the conduct of the Project;

 

(d)           any recommendations on
changes to the Project or associated Budgets and Workplans, including changes
in direction of the Project;

 

(e)           any other relevant
information relating to or affecting the Project.

 

The report from Professor
Zimmet shall be provided to the parties within fourteen (14) days of the end of
the relevant three (3) month period.

 

5.4           Within fourteen (14) days
after receipt of a report from Professor Zimmet pursuant to clause 5.3, Autogen
may request, in writing to IDI, that any stage or part of the Project or the
R&D Program be varied, suspended or declared completed.

 

5

 

5.5           In addition to the reports
under clause 5.3, Professor Zimmet on behalf of IDI will immediately advise
Autogen in writing of any material advancements or developments as they occur.

 

5.6           Any dispute between the
parties concerning a request made under clause 5.4 hereof, shall be determined
under the provisions of clause 13 hereof.

 

5.7           If so requested by Autogen,
the parties shall meet to consider the report from Professor Zimmet pursuant to
clause 5.3, and to discuss the progress of the Project and any variation or
suspension of the R&D Program.

 

5.8           If Autogen after consulting
with the parties is, in Autogen’s sole and absolute discretion, satisfied as to
the progress of the Project after each review pursuant to this clause 5, and
the R&D Program has not been suspended or declared completed pursuant to
clause 5.4, Autogen shall make the Funding payment specified in Item 1 of Schedule 1.  This clause 5.8 shall not apply during the
Initial Term.

 

6.             OWNERSHIP OF INTELLECTUAL
PROPERTY

 

6.1           The parties acknowledge and
agree that all Intellectual Property developed acquired or created pursuant to
the Project shall belong tot and be the property of Autogen as to [*]% and IDI
as to [*]%.

 

6.2           All discoveries inventions
secret processes designs or improvements in procedure or methods made or
discovered by any party during the currency of this Agreement arising from the
Project, shall belong to Autogen and IDI in the proportions specified in clause
6.1.

 

6.3           Autogen and IDI may jointly
take out and maintain appropriate protection for all new discoveries and
development made under the Project and the parties shall assist each other in
applying for letters patent, or other Intellectual Property protection in
Australia or in any other part of the world for all such discoveries and
developments and execute all instruments and do all things necessary for
vesting the said letters patent or other Intellectual Property protection and
rights when obtained and all right and title to and interest in the same in
Autogen and IDI.  Autogen and IDI shall
bear the costs of taking out and maintaining appropriate protection fro all new
discoveries and developments made under the R&D Program in the proportions
specified in clause 6.1.

 

6.4           IDI hereby grants to
Autogen for a term of twenty-five (25) years, from the Commencement Date, an
exclusive, worldwide licence to use the Intellectual Property for the purpose
of developing and commercially exploiting the results of the Project and
Autogen shall have the right to sub-licence its rights and to decide in its
absolute discretion as to how the Intellectual Property and the Products are to
be commercially exploited.

 

6.5           If the Products are
successfully commercialised, Autogen shall pay to IDI an annual royalty based
on two percent (2%) of the Net Sales Revenue.

 

6.6           Autogen shall solely decide
upon whether and, if so, the terms and conditions upon which, to develop and
commercially exploit the Intellectual Property and the Products whether by
licensing or otherwise, throughout the world. 
All income and royalties derived from the development and
commercialisation of the Intellectual Property and the Products shall, subject
to clauses 6.5, belong to Autogen solely.

 

6

 

6.7           Autogen shall diligently
pursue commercial exploitation of the Intellectual Property and the Products,
but Autogen shall solely decide whether and, if so, the terms and conditions
upon which to develop and commercially exploit the Intellectual Property and
the Products whether by sub-licensing or otherwise, throughout the world.  All income and royalties derived from the
development and commercialisation of the Intellectual Property and the Products
shall, subject to clause 6.5 belong to Autogen solely.

 

6.8           If Autogen has not
developed and commercially exploited the Intellectual Property and the
Products, or licensed one or more third parties to do so, within one (1) year
of the expiration of the Term, IDI may seek approval in writing from Autogen to
develop and commercially exploit the Intellectual Property and the
Products.  Autogen shall solely decide if
such approval shall be granted but shall not unreasonably withhold such
approval.  If such approval is granted to
IDI, IDI shall pay to Autogen an annual royalty equal to [*] of the Net Sales
Revenue.

 

6.9           Autogen shall keep proper
financial records and books of account in relation to the commercial
exploitation of the Intellectual Property and the Products so that royalty
payments may be verified.  IDI or its
authorised representatives shall be entitled at IDI’s cost to inspect the
financial records and books of account but only respect of commercialisation of
the Intellectual Property and the Products and only once in each year.  Inspection shall take place at the principal
office of Autogen during normal business hours at a mutually agreed time.  If IDI commercially exploits the Intellectual
Property and the Products pursuant to clause 6.8 of this Agreement, the
provisions of this clause shall apply mutatis mutandis.

 

7.             CONFIDENTIALITY

 

7.1           All information relating to
the Project which is supplied by or on behalf of any party, or which relates to
or arises from the Project, shall be treated by both parties as confidential
and shall be used solely during the Term of an din accordance with this
Agreement to enable IDI and sub-contractors to carry out the Project or to
enable the commercialisation of the Intellectual Property and the Products in
accordance with this Agreement.

 

7.2           Prior to disclosing any of
the Confidentiality Information to any employees or subsidiaries or related
companies or sub-contractors, the relevant party will procure the execution by
the party in question of a Deed as set out in Schedule 4 or otherwise in
the form and substance satisfactory to both parties or otherwise procure the
person to whom it is intended to disclose any of the Confidential Information
to undertake to maintain the same in confidence and acknowledge the interest
therein of the party whose Confidential Information is disclosed.

 

7.3           Both parties hereby
undertake and agree, that, except for such disclosure as is prudent and
reasonably necessary for the purposes of this Agreement, no part of the
Confidential Information given to it pursuant to this Agreement shall be
disclosed to anyone who is not an employee or sub-contractor of a party except
with the prior written approval of the party whose Confidential Information is
disclosed which consent, if given, shall be on the basis that the recipient of
any part o f the Confidential Information shall first be bound to IDI and
Autogen by contract to maintain the same in confidence.  Without prejudice to the foregoing each party
shall use its best endeavours to take all reasonably necessary steps to prevent
the Confidential Information from passing into the public domain.

 

7

 

7.4           Nothing stated herein shall
be construed as restricting or creating any liability for the disclosure or
communication of Confidential Information which:

 

(a)           is now or becomes publicly
known through no wrongful act of either party;

 

(b)           is received from a third
party without restriction and without breach of this Agreement;

 

(c)           is now or comes to be
contained in any published patent or published or otherwise generally known to
the trade through no wrongful act of either party; or

 

(d)           is disclosed pursuant to
governmental, legislative or judicial requirement, including disclosure by AWI
pursuant to its obligations under the Corporations Law or the Stock Exchange
listing rules.

 

7.5           The obligations set out in
this clause 7 shall remain in full force and effect, and shall continue to bind
each of the parties, notwithstanding that this Agreement may have been
terminated, or one of the parties may have ceased to be a party to this
Agreement, for any reason.

 

8.             LIABILITY AND OBLIGATIONS

 

8.1           Each party agrees during
the period of this Agreement and at all times thereafter to indemnify and hold
harmless the other parties against any and all actions, suits, proceedings,
claims, demands, costs, penalties, expenses (legal or otherwise) or losses
whatsoever which may arise out of or in respect of or in any way connected with
the conduct of the Project in that party’s laboratories or which any tests or
trials that may be carried out in connection therewith or as a result of any
act or omission of any servant or agent or sub-contractor of that party in
respect of the foregoing.

 

8.2           Each party separately
covenants and undertakes that the work done by that party under the Project
including the carrying out of all tests and trials will at all times be
conducted to the highest possible professional standards and in accordance with
all applicable rules, regulations and conditions and in particular will
indemnify the other parties against any actions suits or proceedings made
against the other parties in respect of or in connection with the conduct of
the work under the Project.

 

8.3           IDI shall be responsible
for obtaining necessary regulatory approval (if any), by any and all government
agencies, for conducting research and development work in the field of the
Project in Australia.  IDI shall deliver
copies of all such approvals (if any) to Autogen within seven (7) days of
receipt of such approvals by IDI.  IDI
may pay from the Funding the costs of any infrastructure required in order to
obtain regulatory approval provided that the limitation for use of the Funding
in clause 4.4 shall not be exceeded.

 

8.4           Autogen is a subsidiary of
AWI, which is listed on the Stock Exchange. 
IDI is aware that the Corporations Law prohibits insider trading and
shall use its best endeavours to ensure that its employees and contractors are
also made aware of such prohibition.  IDI
is aware of the continuous disclosure requirements applicable to companies
listed on the Stock Exchange and shall use its best endeavours to ensure that
is employees and contractors are also aware of such requirements and shall
advise Autogen in writing of any material advancements or developments as they
occur.

 

8

 

9.             PUBLICATION

 

9.1           IDI shall not (and shall
procure that Professor Zimmet shall not), without the prior written approval of
Autogen, publish in academic or scientific publications the results of any part
of the project.  Autogen may withhold its
approval if in its reasonable opinion, having regard to commercial
considerations, publication would not be appropriate in the circumstances.

 

9.2           Prior to submission for
publication of any proposed paper, the party proposing to publish the same
shall forward a copy of the paper to Autogen, at the same time as requesting
approval for publication.  Autogen shall
use reasonable endeavours to respond to the request for approval for
publication within thirty (30) days of receipt of the request and the paper
but, if Autogen has not responded within thirty (3) days, Autogen is
deemed to have refused approval for publication.  Such refusal does not preclude reassessment
by Autogen and the later granting of approval. 
The party proposing to publish may resubmit the request for approval for
publication at any time.

 

9.3           Each such request for
approval for publication shall be made in sufficient time to allow for the
filing (on behalf of Autogen and IDI) of provisional patent applications, if
considered appropriate.

 

9.4           The publishing party shall
make appropriate acknowledgement in the publication, of Autogen’s involvement
and interest in the subject matter of the publication.

 

9.5           If Autogen has not
developed and commercially exploited the Intellectual Property and the Products
within eighteen (18) months of the expiration of this Agreement, IDI may seek
approval in writing from Autogen to publish in academic or scientific
publications the results of any part of the Project.  Autogen shall solely decide if such approval
shall be granted.  If such approval is
granted, it may be on such conditions as Autogen may, acting reasonably but in
its absolute discretion, specify.

 

10.          TERMINATION

 

10.1         For the purposes of this
clause, a ground of termination shall occur under this Agreement if:

 

(a)           IDI fails to commence work
on the Project within thirty (30) days of the Commencement Date; or

 

(b)           IDI fails to achieve the
milestones set out in the Budgets and Workplans or maintain the best professional
standards; or

 

(c)           The Project is not, in the
opinion of Autogen, producing or likely to produce results from the Project
which can be commercialised by Autogen; or

 

(d)           IDI does not utilise
Professor Zimmet or such other researchers as Autogen in its absolute
discretion deems appropriate to work on the Project; or

 

(e)           The parties do not agree by
the end of the Initial Term to continue this Agreement as required by clause 3.

 

10.2         In the event that a
ground of termination shall occur under this Agreement, Autogen may give thirty
(30) days written notice to IDI of the intention of Autogen to terminate this
Agreement without prejudice to any right of action or remedy which has accrued
or

 

9

 

which
may accrue in favour of either party, and this Agreement shall terminate at the
expiration of the thirty (30) day period.

 

10.3         In the event of
termination under this clause 10, Autogen may, by notice in writing to IDI,
require IDI to make available to Autogen all information relating to the
Project and to assign any Intellectual Property relating to the Project not
already owned by Autogen to Autogen by the date specified in the notice.

 

10.4         If Autogen fails to provide
the Funding at all or does not provide all the Funding for the Initial Term or
ceases to provide the Funding pursuant to clause 5.8 hereof, IDI may give
thirty (30) days written notice to Autogen of the intention of IDI to terminate
this Agreement and unless Autogen resumes payment of the Funding within the
thirty (30) day period, this Agreement shall terminate at the expiration of the
thirty (30) day period.

 

10.5         In the event of termination
under clause 10.1(a) Autogen is hereby released from any obligations to
provide the Funding in the Initial Term or otherwise.

 

10.6         In the event of termination
under clauses 10.1(b), (c), (d) or (3):

 

10.6.1      Autogen shall:

 

(a)           provide the Funding for the
Initial Term;

 

(b)           retain its ownership in the
Intellectual Property as specified in clause 6.1;

 

(c)           retain its licence to use
the Intellectual Property for a term of 25 years pursuant to clause 6.4; and

 

(d)           comply with its obligations
pursuant to clause 6.5 to pay the royalties to IDI; and

 

10.6.2      IDI shall:

 

(a)           retain its ownership in the
Intellectual Property as specified in clause 6.1;

 

(b)           maintain the licence to
Autogen to use the Intellectual Property for a term of 25 years pursuant to
clause 6.4; and

 

(c)           comply with its obligations
pursuant to clause 6.8 to pay royalties.

 

10.7         In the event of termination under clause 10.4:

 

10.7.1      if Autogen has not made any
payment of the Funding at all or has not made all payments of the Funding for
the Initial Term then:

 

(a)           Autogen is hereby released
from any obligations to provide the Funding in the Initial Term or otherwise;

 

(b)           the licence to Autogen to
use the Intellectual Property pursuant to clause 6.4 is hereby revoked; and

 

10

 

(c)           both parties are released
from any obligations to pay royalties pursuant to clauses 6.5 and 6.8, and

 

10.7.2      if Autogen has made all payments
of the Funding for the Initial Term then the provisions of clauses 10.6.1 and
10.6.2 shall apply.

 

11.          CO-OPERATION AND ASSISTANCE

 

11.1         IDI shall, and shall use
reasonable efforts to ensure that all persons employed or contracted by IDI
working on the Project shall, co-operate fully with Autogen both during the
Term of this Agreement and after the termination of this Agreement to provide
Autogen with such information concerning the Project as Autogen may require
from time to time and such assistance as Autogen may require in applying for
Intellectual Property rights throughout the world.

 

11.2         IDI shall, and shall use
reasonable efforts to ensure that all persons employed or contracted by IDI
working on the Project shall, ensure that all information concerning the
Project is promptly communicated to Autogen and that Autogen is provided with
all necessary technical explanations and data to ensure that Autogen is fully
informed as to the progress and status of the Project.

 

11.3         IDI shall, and shall use
reasonable efforts to ensure that all persons employed or contracted by IDI
working on the Project (in this clause called “the Researchers”) shall, provide
such assistance to Autogen as may be required by Autogen both during the term
of this Agreement and thereafter during the commercialisation period in the
commercialisation of the results of the Project.  The assistance referred to in this clause
11.3 shall include, but is not limited to:

 

(a)           assistance in the
preparation and prosecution of patent applications and other applications for
Intellectual Property including signing all necessary documentation;

 

(b)           assistance in all aspects
of the commercialisation process; and

 

(c)           the provision of consultancy
services to Autogen to problem solve and advise.

 

Where it is, in the reasonable
opinion of Autogen, appropriate to do so, Autogen may enter into commercial
arrangements with the Researchers to provide the assistance and consultancy
services referred to in clauses 11.3(b) and 11.3(c), and Autogen shall
reimburse the Researchers for any reasonable costs incurred by the Researchers
in providing the assistance and consultancy services referred to in this clause
11.3.

 

11.4         After the expiration or earlier
termination of this Agreement, neither IDI nor Professor Zimmet shall be
engaged in any research project similar to the Project using the Research
Expertise for a period of six months thereafter throughout Australia.

 

12.          GENERAL

 

12.1         This Agreement shall be
governed by, and construed in accordance with the laws of the State of
Victoria, Australia, and the parties hereto submit to the non-exclusive
jurisdiction of the courts of such State. 
All disputes arising between the parties out of or in connection with
this Agreement in any way, shall also be resolved or determined according to
the laws of the State of Victoria, or if those laws are inapplicable, then the
laws of the Commonwealth of Australia.

 

11

 

12.2         If it is held by a court of
competent jurisdiction that:

 

(a)           any part of this Agreement
is void voidable illegal or unenforceable; or

 

(b)           this Agreement would be
void voidable illegal or unenforceable unless any part of this Agreement was
severed from this Agreement,

 

that part shall be severable
from and shall not affect the continued operation of the rest of this
Agreement.

 

13.          ARBITRATION

 

13.1         The parties agree that in the
event of any dispute arising under or in connection with this Agreement, such
dispute shall be referred for determination by an arbitrator, appointed by the
President of the Institute of Arbitrators Australia.

 

13.2         In determining any dispute
arising under or in connection with this Agreement, the arbitrator appointed
pursuant to clause 13.1 hereof shall be required to restrict himself to
deciding which of the views of the parties in dispute is correct, and shall
make a determination in accordance with that decision.

 

13.3         Subject to clause 13.2 any
arbitration carried out hereunder shall be in accordance with the provisions of
the Commercial Arbitration Act 1984, and the parties agree that they shall have
the right to be legally represented before the arbitrator.

 

13.4         The arbitrator’s decision
shall be accepted by the parties as a final determination of the matter in
dispute and binding upon them.

 

13.5         A party may commence court
proceedings relating to any dispute arising from this Agreement at any time
where that party seeks urgent interlocutory relief.

 

14.          NOTICES

 

14.1         Any notice (which expression
shall also include a demand, request, consent or instrument required or
authorised to be given to or served on any party under this Agreement):

 

(a)           shall be in writing and
signed by or in the case of a facsimile transmission shall be a true copy of an
original signed by (in the case of a notice by Autogen) any director or the
secretary of Autogen; or (in the case of a notice by IDI) by the Chief
Executive Officer of IDI;

 

(b)           shall be given either:

 

(i)            by being delivered by hand
to (in the case of a notice to Autogen) its above mentioned address, attention:
Company Secretary; or (in the case of a notice to IDI) its abovementioned
address, attention: Chief Executive Officer; or

 

(ii)           by facsimile transmission
to (in the case of Autogen) 9234 1198, attention: Company Secretary; or (in the
case of IDI) 9258 5090, attention: Chief Executive Officer;

 

12

 

and a notice given by facsimile
transmission shall be deemed to have been given upon the issue to the
transmitter of a satisfactory transmission control report indicating due
transmission without error.

 

14.2         The undermentioned
signatories hereby acknowledge that they have not received notice of the
revocation of the authorisation under which they have respectively executed
this Agreement.

 

15.          CONTINUING OBLIGATIONS

 

The
provisions of clauses 2.7, 4.2, 6, 7, 8.1, 9 and 11 shall remain in full force
and effect, and shall continue to bind each of the parties, notwithstanding
that this Agreement may have been terminated, or one of the parties may have
ceased to be a party to this Agreement for any reason.

 

13

 

IN WITNESS WHEREOF this Agreement has been
duly executed by the parties hereto on the day and year hereinbefore written.

 

 

	
  THE COMMON SEAL of AUTOGEN PTY LTD ABN 074 636
  847 was affixed by the authority of the Board of Directors in the
  presence of:

  	
   

  	
  )

  )

  )

  )

  )

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (Signature of Secretary/Director)

  	
   

  	
   

  	
  (Signature of Director)

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  David H Simcox

  	
   

  	
   

  	
  Eduard Eshuys

  	
   

  
	
  (Name of Secretary/Director in Full)

  	
   

  	
   

  	
  (Name of Director in Full)

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  THE COMMON SEAL of INTERNATIONAL DIABETES
  INSTITUTE ACN 007 342 412 was affixed by the authority of the
  Board f Directors in the presence of:

  	
   

  	
  )

  )

  )

  )

  )

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (Signature of Secretary)

  	
   

  	
   

  	
  (Signature of Director)

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Arthur Leslie Walmsley

  	
   

  	
   

  	
  Geoffrey Phillip Connard

  	
   

  
	
  (Name of Secretary in Full)

  	
   

  	
   

  	
  (Name of Director in Full)

  	
   

  

 

14

 

SCHEDULE 1

 

	
  Item 1

  	
   

  	
  Funding: [*] for the Initial Term.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Payable by Autogen to IDI as follows:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [*] upon signing this Agreement

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [*] upon commencement of the R&D Program

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [*] upon receipt by Autogen of the 3 month
  review report referred to in clause 5.3

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [*] upon receipt by Autogen of the 6 month
  review report referred to in clause 5.3

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [*] upon receipt by Autogen of the 9 month
  review report referred to in clause 5.3

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Commencement of the R&D Program shall be
  notified to Autogen in writing by IDI and Professor Zimmet following the
  commencement of the work required by the Budgets and Workplans. Upon receipt
  of such written notice Autogen shall pay to IDI the payment due upon the
  commencement of the R&D Program.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Funding: If this Agreement is extended beyond
  the Initial Term pursuant to clause 3, the parties shall agree in writing the
  Funding for the Term. Payments shall be upon receipt by Autogen of further
  three monthly reports as required pursuant to clause 5.3.

  
	
   

  	
   

  	
   

  
	
  Item 2

  	
   

  	
  Research Expertise: The field of diabetes.

  
	
   

  	
   

  	
   

  
	
  Item 3

  	
   

  	
  Commencement Date: 1 January 1998.

  

 

15

 

SCHEDULE 2

 

Research Proposal

 

 

COLLABORATIVE
RESEARCH PROGRAM SEARCHING FOR DIABETES GENES AND

NEW THERAPIES

 

Principal Researcher:
Professor P Zimmet AM, MB, BS, MD, PhD, FRACP

 

International
Diabetes Institute

 

 

 

“The first company to show biological relevance in an
animal model wins”.

Walter Heseltine, CEO, Human Genome Sciences

 

16

 

GENOME RESEARCH

 

Introduction

 

Genome research provides great promise for new
discoveries relating to the identification of genes for major inherited
disorders, complex traits and regulatory metabolic pathways. The genes
discovered by this process, as discussed below, become the preferred candidates
for:

 

•              new predictive genetic tests for subjects at

 

•              risk new genetic diagnostic tests

 

•              new drugs for therapy

 

This proposal is one of the several Autogen
funded programmes that will be given a boost and support from
the separate funding by Autogen of a genome facility to be based at the
International Diabetes Institute.

 

Diabetes mellitus

 

Diabetes currently affects 120 million worldwide
and will increase to 240 million by 2010 AD. The annual cost to the USA
is over $100 billion and that for Australia is probably in excess of $2.5
billion.

 

Non-insulin dependent diabetes mellitus (NIDDM) has
now reached epidemic proportions in countries in Asia and Oceania including Australia.    The
Australian Bureau of Statistics National Health Survey (1989-90) found at
least 350,000 Australians are known to have diabetes. As there is one
undiagnosed for every known case, there are ~700,000 persons with diabetes in
Australia.  Diabetes in its different
forms will be one of the most common and challenging health problems facing
Australia and other nations in the 21st century (WHO, 1994).

 

Classification of diabetes
mellitus

 

Diabetes mellitus is a collection of closely related
diseases.  The classification is based on
differences in causation, natural history and clinical presentation.

 

•                    Insulin-dependent
diabetes mellitus (IDDM) or Type 1 diabetes ranks as one of the most common
childhood diseases in developed nations. Although formerly known as “juvenile-onset”
diabetes, approximately 1/z of all new-onset IDDM cases occur in
adults. IDDM is believed to be caused by an autoimmune process, meaning that
the “protective” immune system mistakenly attacks the body’s own insulin
producing cell.  This results in a slow
destruction of pancreatic islet betacells, resulting in the permanent loss of
insulin production.

 

Persons with IDDM are
dependent on up to 4 insulin injections each day to sustain life and need to
follow a strict diet and exercise program. Even so they are at risk of
complications that have potential life-shortening effects. This disorder is the
subject of another Autogen funded project.

 

•                    Non-insulin dependent
diabetes mellitus (NIDDM) or Type 2 diabetes constitutes about 85 to 90% of all
diabetes in developed countries, but makes up virtually 100%. The high genetic
susceptibility of many populations in developing countries provides an ideal
environment in which to study the molecular biology of NIDDM.

 

17

 

The onset usually occurs
after the age of 40 years although the age of onset is often a decade earlier
in developing or newly urbanised communities. NIDDM can be without symptoms for
many years and diagnosis is often made from associated complications or
incidentally through an abnormal blood or urine glucose test. NIDDM is often,
but not always, associated with obesity, which can cause insulin resistance and
lead to elevated blood sugar levels.

 

Insulin may be needed to
control the diabetes if weight reduction or tablet therapy fails. NIDDM is
strongly familial, but the actual susceptibility genes have not been clearly
identified. The patterns of NIDDM prevalence in developing, newly
industrialised, and migrant populations strongly suggest that factors inherent
in Western lifestyles are involved and that NIDDM is to a degree a life-style
disease, emerging in people who have the genetic susceptibility.

 

Genes, genetic data-bases and
therapy for NIDDM

 

This project will focus on NIDDM and will take a broad
approach to try to define potential genes involved in disease causation. This
is important as it highlights “at risk” subjects for prevention, and the
knowledge of which gene/s are involved allows rational approaches to developing
new drugs to target the metabolic abnormalities resulting in the disease
process.

 

The work program encompasses 3 interrelated projects:

 

•                    The International
Diabetes Institute serum/DNA data-base and bank

 

•                    The Tasmanian genome
database (IDI/Menzies Centre collaboration)

 

•                    Creation of a tissue
bank

 

The International Diabetes Institute will also carry
out clinical trials relating to the NIDDM and obesity research and can provide
statistical support for these and the other Autogen projects, where required.

 

Commercial Potential

 

The discovery of new genes related to the development
of NIDDM and obesity is certain to have far-reaching implications for their
prevention and treatment. We can develop tests to predict NIDDM ie. at risk
subjects and develop new drugs to target the genes involved.

 

There are over 120 million people with each of these
conditions worldwide with the numbers set to double over the next 10
years.  The access to such a unique
collection of genetic material and sera from a variety of ethnic groups such as
maintained at the International Diabetes Institute is unprecedented.

 

Project components

 

1.             Serum/DNA
bank

 

The International Diabetes Institute has one of the
largest collections of serum samples in the world. Along with DNA from many of
these, it covers thousands of subjects, normal and with glucose intolerance,
from Australia, Pacific Islands and Asia and many other parts of the world due
to an extensive network of collaborations (Appendix 1 & 2).

 

18

 

In addition, a large collection of patients with IDDM
and NIDDM is being established through collections in Tasmania with the Menzies
Centre for Population Research headed by Professor T. Dwyer and at the
International Diabetes Institute. The Tasmanian family database could be one of
the most valuable available and there are many research groups attempting to
access it. The data base is already being accessed by AMRAD for other diseases
such as glaucoma.

 

By participation in funding this 5 year program,
Autogen will be in a unique position in molecular biology research in the
search for potential gene associations not only for NIDDM but also obesity,
heart disease etc.  Such banks of
biological samples are currently in great demand and major pharmaceutical
companies are paying millions of dollars to research groups to access such
specimens. Access (but not ownership - for ethical reasons) to this collection
will be licensed to Autogen as part of this project.  The value of this has been set at over $3
million (subject to valuation) and can be amortised over the 5 years of
funding.

 

2.             Genetic
studies

 

For nearly every disease, biotechnology companies are
searching for related genes, then the gene products not only to understand the
disease causation, but also for prediction of people at risk and for drug
therapy.  The objective of this project
is to discover new genes related to NIDDM and its complications, obesity and
insulin resistance.  These discoveries
will then be used to develop new therapies aimed at preventing NIDDM in at risk
subjects or for treatment of NIDDM.

 

2.1           Brief Research
Outline

 

2.1.1        Diabetes Genome Scan

 

This study will utilise the improved technology in
high-throughput genotyping. The generation of large numbers of microsatellite
repeats has resulted in genome-wide marker maps allowing the search for genes
involved in complex, polygenic diseases such as NIDDM. It has been proposed
that a set of 300 evenly-spaced markers can be used to map the entire human
genome at an average density of approximately 10 cm (Botsein et al 1980). These
can be chosen from publicly available marker libraries.      The study will consist of two DNA data sets:
one selected from DNA samples collected in several populations with high
prevalence of diabetes in the South Pacific (eg. Nauru, Western Samoa), and the
other from collections eg. the Tasmanian genetic database. 300 patients with
300 markers is a total of 90,000 genotypes. With currently available automated
techniques and appropriate funding, this type of analysis could be completed
within a year.

 

2.1.2        Sample selection and collection of phenotypic data

 

The Menzies Centre will be responsible for
implementing the study design based on questionnaires and protocols for blood
collecting. Clinical and epidemiological data will be collected from selected
families in Tasmania in which the NIDDM and Latent Autoimmune Diabetes in
Adults (LADA) are present either separately or with both forms.  These data will be stored on computer
programs containing all appropriate “phenotypic” data.

 

In addition the collected blood samples will be stored
for further analysis as outlined below by IDI. Procedures for collecting,
transporting and storing of blood samples and quality control will be part of
the detailed contract.

 

19

 

2.1.3        DNA extractions and sample preparation

 

It is anticipated that the blood samples will be
collected over a 6-12 month period. Samples will be stored and DNA
extracted in batches as outlined below.

 

The following procedures will be carried out at IDI,
Melbourne.

 

a.             DNA extraction -
either manually or using an automated instrument (eg. Genepure). A minimum of
20μg DNA is required for genomic analysis.

 

b.             DNA quantification -
either spectrophotometric or fluorometric method. The concentration of DNA will
be adjusted and stored in 96 well plates (a number of wells in each plate need
to be reserved for future controls). 
This process is achieved by utilising a multiprobe robotics system. A 96-channel
pipetting robotic is then used to dispense the DNA and each 96-well plate
is either stored dry for later analysis or immediately used. It is useful when
possible to group families on a single 96-well plate.

 

2.1.4        Genome scan

 

The actual number of markers needed in a genome scan
will depend on the strength of the genetic signal, the number of genes
involved, and the number of available affected individuals.

 

Preselected fluorescent microsatellite marker sets
that span the human genome are available from several commercial sources
(including Perkin Elmer). These commercially available kits may need routine
optimisation within our laboratories.

 

a.             The individual
markers for PCR are set up in 96-well format using multiprobe robotics
for preparation and mixing PCR;

 

b.             Thermal cycling step;

 

c.             Robotics will pool
reactions from various 96-well plates (multiplexing) to form one
masterplate;

 

d.             Dried and resuspended
with fluorescent standards;

 

e.             Electrophoresis using
ABI 377 instrument.

 

This results in generation of finished genotypes which
require error analysis, correction of errors and compilation of data on a
suitable program for genetic analysis. The genome scanning may be performed in
house or contract to the Australian Genome Centre, depending on most cost-effective
situation.

 

2.1.5        Data analysis

 

One of the challenges of high throughput genotyping is
creating the capacity to support large amounts of incoming genetic information
on appropriate data bases. There will be an enormous amount of data continually
needing input and manipulation. This requires a dedicated central faculty for
all information including phenotypic data, pedigree information, DNA sample
information, and genotypes.

 

One of the requirements of continual use of genotyping
machinery will be the removal of collected information from genotyping
instruments. To achieve this, two computers are required per

 

20

 

automated sequencer, to allow data collection on one
computer while the other is used for data analysis.

 

2.1.6        Timetable (see Schedule 3 for full details)

 

Month 1 to 3:

 

•                    identification of
target NIDDM families and populations

 

•                    obtain permission to
access

 

Month 2 to 12:

 

•                    blood samples from
the selected families will be collected

 

•                    samples will be
stored and DNA extracted in appropriately sized batches.

 

Month 6 to 18:

 

•                    genotyping commenced
with approximately 300 markers will be arranged into c-multiplexed sets.
Genotyping will require 2-3 staff over a 6-12 month period with one
genotyping instrument (ABI 373 or 377) and the appropriate robotics and
informatics components. The initial screening of approximately 300 individuals
could be completed in 12-18 months.

 

2.2           Candidate gene
approach

 

There are a number of key regulatory steps in
metabolism that are suggested to be important in the development of NIDDM.
These key steps provide a number of possible candidate genes for diabetes
development and potential targets for therapy. Utilising the unique DNA data
base collected from South Pacific communities with high diabetes prevalence, we
can quickly screen a number of known candidate genes for linkage with obesity,
insulin resistance or diabetes.      Some of these candidate genes include: leptin
receptor, ob gene, NPY-5 receptor, glycogen synthase, and beta-3
adrenergic receptors.

 

3.             Diabetes
tissue bank and the discovery of novel genes in diabetes development

 

It is important to plan our research efforts to be in
a position to capitalise on advances made following the completion of the Human
Genome Project. It is apparent that a significant percentage of drug
development research fails because the proposed new drug target be it an
enzyme, hormone or specific receptor agonist/antagonist is not important in the
human disease process. Molecular genetics has the ability to reveal many new
genes, however the relevance in human disease is critical for the development
of new therapies. Developing a tissue bank which would include a variety of
human tissues eg. adipose, muscle, and liver, from diabetic and non-diabetic
humans (accident victims, unsuitable organ donors, etc.) would place our
research group in a key position to capitalise on new discoveries once the
human genome has been sequenced. The relevance of newly-discovered genes can be
immediately assessed by directly quantifying mRNA in normal and diseased
tissues.

 

This project (in collaboration with Dr G Collier,
Deakin University) will utilise the new and exciting technique of differential
display polymerase chain reaction (ddPCR) to uncover differences in tissue gene
expression in subjects with obesity and NIDDM compared with lean non-diabetic.
ddPCR is a powerful procedure for detection of differentially expressed genes. It

 

21

 

permits the simultaneous identification of genes that
are up or down regulated under different conditions.

 

In this project various tissues including fat and
skeletal muscle will be isolated and ddPCR will be performed to examine all
differentially expressed genes. This technique is currently being developed in
Dr Collier’s laboratory. By linking defects exposed by this technique with
physiological defects in animals, we will be able to pursue metabolic pathways
not previously linked with development of NIDDM and obesity.

 

As discussed in Dr Collier’s research plan which is
also being funded by Autogen for obesity research, the use of the most
contemporary technique in molecular biology, differential display PCR (ddPCR)
makes this research endeavour unique.

 

Differential display analysis (ddPCR) is a powerful
procedure for the detection of differentially expressed genes.  The novel feature of this method is the
simultaneous identification of genes that are turned on or off under different
environmental conditions. The technique is based on the polymerase chain
reaction (PCR) amplifications of mRNA. Gene expression is then visualised by
autoradiography after electrophoretic separation. Novel bands can then be
re-amplified by PCR and sequenced.

 

We will be able to systematically examine the
differences in gene expression between diabetics and non-diabetics and obese
and lean people. This technique will also let us examine which genes are turned
on or off with various therapeutic approaches.

 

This is a large ongoing project and will require the
appointment of 2 key experienced scientists. There will be an initial outlay
for infrastructure costs to upgrade the laboratory for some of the new
technologies.

 

Phase 1: This phase will aim to discover new genes
involved in the development of human NIDDM, its complications and obesity. If
an associated gene is found, it will be sequenced and, if novel, will be
patented and protein products examined.

 

Phase 2:  This
phase will involve investigating the physiological role of newly discovered
substances from phase 1. In addition, intervention and prevention studies will
be performed in the Israeli Sand Rat colony at Deakin, and other animal models
of NIDDM, using potential new therapies.

 

Phase 1 of the proposal will commence in the second
year and be ongoing for the duration of the program. The experiments involved
are labour intensive and will uncover many differentially expressed genes in
NIDDM subjects. The ability to discover new genes is exciting and potentially
very rewarding.  Phase 2 will not only
investigate the new gene products discovered in Stage 1, but will immediately
begin with the testing of a number of existing new therapies, initially in
animal models, as outlined below.

 

Research Team

 

The chief investigators leading this research program
are well established scientists in the field of diabetes, molecular biology and
population research with ongoing successful research programs.  This is evidenced by the publication and
presentation of hundreds of research papers at national and international
scientific meetings in the past 5 years alone. 
However, to maintain the success of new research programs and the
quality of research scientists within the program, a number of key strategies must
be followed. The program will be directed by a management committee of
Professors Paul Zimmet, Bob Williamson and Terry Dwyer and Drs Greg Collier and
Maximilian DeCourten and it is anticipated that two permanent research
scientists will be involved in the study

 

22

 

for the initial 4-5 years.  In addition, eachyear we will try to attract
two senior post-doctoral scientists from key international research
laboratories to allow continual importation of new techniques, advances and
international collaboration into our research programs. Interaction and
collaborative projects between research staff and post-doctoral scientists will
ensure the ongoing training of our research laboratories. We will endeavour to
arrange an annual visit by a distinguished molecular biologist from overseas to
spend three months in our laboratories involved with research activities and
providing another level of peer review to continually assist in our endeavour
for research excellence.

 

Research Budget

 

The initial stage of funding of $250,000 will help
establish the core infrastructure and start up experiments and equipping for
this research initiative. The genetic data base alone is worth substantially
more than the initial funding and this will need to be accounted for in the
next round of fund negotiations. The equipment needed to commence the genetic
studies eg. ABI genotyper is forthcoming through another Autogen funded
initiative as it would exceed the initial funds available.

 

23

 

SCHEDULE 3

 

Budgets
and Workplans

 

Budget January 1998
- December 1998

 

a. International Diabetes
Institute

 

	
   

  	
   

  	
  Quarters

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  January

  	
   

  	
  April

  	
   

  	
  July

  	
   

  	
  October

  	
   

  	
  Total

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Access fee Serum Bank #

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Research nurse (0.4)(Inc. on costs)

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Laboratory technician

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Storage refrigerators

  	
   

  	
  [*]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Storage containers

  	
   

  	
  [*]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Administration & infrastructure costs  (power/electricity, maintenance/plus other oncosts/overheads, patent costs)

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Subtotal

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  

 

#The
real cost of accessing this bank annually will be built into the next funding
stage.

 

b. Menzies Centre Tasmanian project budget*

 

	
  Menzies staff, running costs for collection

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Access to Tasmanian genome database#

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Administration & infrastructure costs (including patents)

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Subtotal

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  c. Tissue Bank

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  To commence in Year 2

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  	
  [*]

  	
   

  

 

#The real cost of accessing this
bank approx. $100,000 annually will be built into the next year’s funding

 

*This will be covered in a back
to back agreement between IDI and the Menzies Centre

 

24

 

WORKPLAN

 

Year 1: Milestones

 

Quarter 1

 

•                    commence staff
recruitment

•                    equip laboratory

•                    research program for
1997-8 delineated including negotiations for various data bases including
Tasmania, Busselton, specific families of patients if International Diabetes
Institute

•                    identification of
target NIDDM families

•                    obtain permission to
access including applications for ethic committees

•                    setting up ABI 377
and the appropriate robotics and informatics components

•                    quarterly report to
Autogen

 

Quarter 2

 

•                    commence blood sample
collections from the selected families

•                    collection of data on
family pedigrees by genetic epidemiologist

•                    samples stored and
DNA extracted in appropriately sized batches

•                    preparation of DNA
from existing stored samples from Pacific and Indian Ocean populations

•                    genotyping commenced
with ABI 377 and the appropriate robotics and informatics components

•                    quarterly report to
Autogen

 

Quarter 3

 

•                    genotyping continues

•                    continue blood sample
and pedigree information from the selected families

•                    samples stored and
DNA extracted in appropriately sized batches

•                    continue to identify
new target population groups for sampling

•                    quarterly report to
Autogen

 

Quarter 4

 

•                    collection of blood
samples from the selected families continued

•                    DNA extracted in
appropriately sized batches from collected samples

•                    continue genotyping

•                    data analysis of
genotyped families

•                    report preparation
for Autogen on research for the year and prepare work program, milestones and
budget for 1998-9.

 

25

 

SCHEDULE 4

 

DEED
OF CONFIDENTIALITY

 

THIS DEED is made on the date set out in Item 1 of Schedule 1.

 

	
  BETWEEN:

  	
  THE COMPANY OR ENTITY WHOSE
  NAME AND ADDRESS IS SET OUT IN ITEM 2 OF SCHEDULE 1 (“Discloser”)

  
	
   

  	
   

  
	
  AND:

  	
  THE PERSON OR COMPANY WHOSE
  NAME AND ADDRESS IS SET OUT IN ITEM 3 OF SCHEDULE 1 (“Recipient”)

  

 

 

RECITALS

 

	
  A.

  	
  The Discloser has or may acquire certain
  Confidential Information.

  
	
   

  	
   

  
	
  B.

  	
  The Recipient wishes to have disclosed to
  it the Confidential Information and the Discloser is prepared to disclose the
  Confidential Information to the Recipient subject to various terms set out in
  this Agreement.

  
	
   

  	
   

  
	
  C.

  	
  In consideration of the Discloser agreeing
  to disclose the Confidential Information to the Recipient, the Recipient has
  agreed to accept confidentiality obligations on the terms set out in this
  Agreement.

  

 

NOW THIS DEED WITNESSES AS FOLLOWS:

 

1.             DEFINITIONS
AND INTERPRETATION

 

1.1           The following definitions
apply in this Deed unless otherwise indicated:

 

“Autogen”
means Autogen Research Pty Ltd ACN 074 636 847 (formerly Autogen Pty Ltd).

 

“Confidential
Information” includes:

 

	
  (a)

  	
  all of the terms of this Deed; and

  
	
   

  	
   

  
	
  (b)

  	
  Confidential Information as defined in the
  Research, Licence and Commercialisation Agreement between Autogen and the
  International Diabetes Institute ACN 007 342 412 dated the 14th
  day of January 1998.

  

 

 

“Acknowledgement
of Obligation of Confidentiality” means the document set out in Schedule 2.

 

1.2           In this Deed unless
otherwise indicated:

 

	
  (a)

  	
  any right or obligation which affects more
  than one person shall affect those persons jointly and severally;

  
	
   

  	
   

  
	
  (b)

  	
  headings are used for convenience only and
  shall have no binding effect;

  

 

26

 

(c)           use of the singular shall,
where necessary, include the plural and vice versa; and

 

(d)           “person” includes a firm,
body corporate, unincorporated association, or authority and such reference
shall include that person’s successors and assigns.

 

2.             OBLIGATION
OF CONFIDENTIALITY

 

2.1           The Recipient

 

(a)           acknowledges that the
Confidential Information has been disclosed to the Recipient in circumstances
of confidence;

 

(b)           shall maintain such
confidence and, subject to this Deed, refrain from disclosing or causing to be
disclosed the Confidential Information to any person; and

 

(c)           shall only make use of the
Confidential Information for the purpose, and to the extent, expressly
authorised in writing by the Discloser.

 

2.2           The Recipient may disclose
Confidential Information to any of its officers, employees, agents or advisers
only after taking the following steps:

 

(a)           informing the Discloser as
to all persons who will be receiving the Confidential Information;

 

(b)           making available a copy of
this Deed to such person or persons;

 

(c)           ensuring that such person
or persons sign an Acknowledgement of Obligation of Confidentiality: and

 

(d)           ensuring that the signed
Acknowledgement of Obligation of Confidentiality is delivered to the Discloser.

 

2.3           The obligations of
confidentiality owed by the Recipient pursuant to this Deed shall be
enforceable by Autogen in accordance with this Deed as if Autogen were named as
the Discloser in this Deed.

 

3.             QUALITY
OF INFORMATION AND RELEASE

 

3.1           The Discloser makes no
warranty or representation whatsoever as to the quality or accuracy of any
Confidential Information which is the subject of this Deed.  The Discloser hereby excludes, to the full
extent allowed by law, any condition or warranty that the Confidential
Information has been prepared using reasonable care.

 

3.2           To the extent that the
Recipient will rely on any Confidential Information the subject of this Deed,
the Recipient will only do so after receiving independent advice, from an
appropriately qualified person, that it is appropriate to do so.  The Recipient releases the Discloser from all
claims, actions, damages, remedies arising from a failure to act on this
independent advice.

 

27

 

4.             INDEMNITY

 

4.1           The Recipient acknowledges
the interest of Autogen in the Confidential Information and that Autogen may
suffer harm or loss or incur a liability if the Recipient breaches this Deed.

 

4.2           The Recipient acknowledges
that the Discloser may suffer harm or loss or incur a liability if the
Recipient breaches this Deed.

 

4.3           Accordingly, the Recipient
undertakes to indemnify Autogen and the Discloser from all such loss, harm or
liability which may flow, directly or indirectly, from a breach of this Deed by
the Recipient.

 

5.             BREACH
AND COMPULSORY DISCLOSURE

 

5.1           As soon as the Recipient
becomes aware of any actual or threatened breach of this Deed, it must
immediately notify the Discloser. 
Furthermore, the Recipient is obliged to do everything reasonably within
its power to prevent or stop any actual or threatened breach of this Deed.

 

5.2           If the Recipient is
required by a law or court of competent jurisdiction to disclose any
Confidential Information to any unauthorised person, it must, without delay:

 

(a)           inform the Discloser in
writing;

 

(b)           follow the Discloser’s
lawful direction in opposing or restricting such disclosure; and

 

(c)           as far as possible, only
disclose the Confidential Information on terms which will maintain its confidentiality.

 

6.             CONFIDENTIAL
INFORMATION NO LONGER REQUIRED

 

6.1           Except as otherwise
provided in any other contract in writing signed by the parties, the Discloser
may request in writing the delivery up of Confidential Information.  Following such request, the Recipient must
immediately furnish such Confidential Information to the Discloser, in each and
every form in which it is held.

 

7.             COMMUNICATIONS
WITH THE DISCLOSER

 

7.1           All communications to
the Discloser relating to this Deed shall be directed to the address of the
Discloser appearing in this Deed or such other address as may be notified to
the Recipient from time to time.  All
such communications shall be:

 

(a)           in writing; and

 

(b)           marked to the attention of
the Managing Director.

 

28

 

8.             INTELLECTUAL
PROPERTY

 

The Recipient assigns to the
Discloser, or to such other person as the Discloser nominates, all present and
future intellectual property rights in all subject matter created pursuant to
the Recipient’s use of the Confidential Information.

 

9.             GENERAL

 

9.1           All rights and obligations
under this Deed are cumulative and shall not affect or be affected by any other
rights, obligations or remedies available at law.

 

9.2           No right under this Deed
shall be deemed to be waived except by notice in writing signed by both the
Discloser and the Recipient.  Any such
waiver will not prejudice that party’s rights in respect of any subsequent
breach of this Deed.

 

9.3           The obligations of
confidentiality under this Deed survive the termination of this Deed.

 

9.4           Remedies available to the
Discloser for any breach or threatened breach by the Recipient of this Deed
include, at the option of the Discloser, damages, specific performance, or
injunction and any other remedies available to the Discloser at law.

 

9.5           If any provision in this
Deed is held invalid, unenforceable or illegal for any reason, this Deed shall
remain otherwise in force apart from such provision, which shall be deemed
deleted.

 

9.6           This Deed will be governed
and construed according to the laws in force in the State of Victoria,
Commonwealth of Australia and the parties agree to submit to Courts and
Tribunals of that jurisdiction.

 

EXECUTED as a Deed.

 

	
  SIGNED SEALED AND DELIVERED for

  	
   

  	
  )

  	
   

  
	
  and on behalf of THE
  DISCLOSER by

  	
   

  	
  )

  	
   

  
	
  in the presence of:

  	
   

  	
  )

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  (Signature)

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (Signature of Witness)

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (Name of Witness in Full)

  	
   

  	
   

  	
   

  	
   

  

 

29

 

	
  SINGED SEALED AND DELIVERED for

  	
   

  	
  )

  	
   

  	
   

  
	
  and on behalf of THE
  RECIPIENT BY

  	
   

  	
  )

  	
   

  	
   

  
	
  in the presence of:

  	
   

  	
  )

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  (Signature)

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  (Signature of Witness)

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  (Name of Witness in Full)

  	
   

  	
   

  	
   

  

 

30

 

DEED OF CONFIDENTIALITY

 

SCHEDULE 1

 

1.             Date
of this Deed

 

2.             The
Discloser

 

Name:

 

Address:

 

Telephone No:

 

Facsimile No:

 

Contact Person:

 

3.             The
Recipient

 

Name:

 

Address:

 

Telephone No:

 

Facsimile No:

 

Contact Person:

 

31

 

DEED
OF CONFIDENTIALITY

 

SCHEDULE 2

 

ACKNOWLEDGEMENT
OF OBLIGATION OF CONFIDENTIALITY

 

Date:

 

[The Discloser]

 

Dear Sir

 

Pursuant to the Deed of Confidentiality made between the [International
Diabetes Institute] (the “Discloser”) and
[                                            ]
(the “Recipient”) [insert date
of Deed], the Recipient proposes to disclose Confidential
information the subject of the said Deed of Confidentiality to me/us.  Accordingly, I/we undertake as follows:

 

1.             I/We acknowledge that I am/we are aware of and understand the
obligations on the Recipient under the said Deed of Confidentiality.

 

2.             I/We will take all steps necessary to ensure
that the Confidential Information remains confidential.

 

3.             I/We will not disclose any of the
Confidential Information to any unauthorised person or persons.

 

4.             I/We acknowledge that remedies available to the Discloser for any
breach or threatened breach by me/us of this Acknowledgement include, at the
option of the Discloser, damages, specific performance, or injunction and any
other remedies available to the Discloser at law.

 

5.             Except as otherwise provided in any written agreement between the
Discloser and Recipient, the Discloser may request in writing the delivery up
of Confidential Information.  Following
such request, I/we undertake to immediately furnish to you such Confidential
Information, in each and every form in which it is held.

 

6.             I/We further agree to observe the terms of the Deed of Confidentiality
in favour of the Discloser to the same extent as if I/each of us had been named
as the Recipient under the Deed of Confidentiality.

 

7.             I/We acknowledge that the terms of this undertaking survive the
termination of the Deed of Confidentiality.

 

8.             Any expressions used in this Acknowledgement shall have same meaning as
in the Deed of Confidentiality.

 

	
  Name

  	
   

  	
  Capacity

  	
   

  	
  Signature

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

32

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