Document:

Exhibit 4.2(h)

 

“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

 

Gene Discovery in Depression

 

 

Dated 16 August 2000

 

 

AUTOGEN RESEARCH PTY LTD ACN 074 636 847

 

(“Autogen Research”)

 

 

DEAKIN UNIVERSITY

 

(“Deakin University”)

 

 

RESEARCH, LICENCE AND COMMERCIALISATION AGREEMENT -

GENE DISCOVERY IN DEPRESSION

 

	
   

  	
  AGREEMENT
  dated

  	
  16
  August 2000

  

 

BETWEEN

 

AUTOGEN
RESEARCH PTY LTD ACN 074 636 847 of 210 Kings Way, South Melbourne, Victoria, 3205 (“Autogen
Research”)

 

AND

 

DEAKIN
UNIVERSITY a body
corporate and politic established pursuant to the Deakin
University Act 1974 of Geelong, Victoria, 3217 (“Deakin
University”)

 

RECITALS

 

A.            Autogen Research currently engages in, or
proposes to engage in, research in the fields of diabetes,
obesity, respiratory diseases, allergy, asthma, depression and autoimmunity.

 

B.            Deakin University has the Research Expertise.

 

C.            Autogen Research desires to collaborate with
Deakin University to provide the Funding for the R&D Program using the
Research Expertise in return for sole ownership by Autogen Research of all intellectual property created by the R&D Program on
the terms set out in this Agreement.

 

D.            The parties wish to ensure that the Research
Expertise is applied to the R&D Program and that the results of the R&D Program are, if appropriate,
commercialised.

 

E.             Autogen Research is a subsidiary of Autogen Limited, which is listed on the Stock Exchange.
Deakin University is 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. Deakin University is 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 Research in writing of any material
advancements or developments as they occur.

 

AGREEMENT

 

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):

 

“Agreement” means this agreement and includes the recitals,
schedules and annexures (if any) thereto.

 

 

“Autogen  Limited” means
Autogen 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
the parties.

 

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

 

“Confidential Information” means:

 

information that:

 

(a)           is by its nature confidential; or

 

(b)           is reasonably designated by a party as
confidential,

 

 

and includes -

 

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

 

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

 

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

 

(f)            information of a party to which another party
or parties has access other than information referred to in paragraphs (iii),
(iv) and (v) that has any actual or potential commercial value to the first
party or to the person or corporation which supplied that information;

 

(g)           information in the possession of another party or parties relating to
the first party’s clients or suppliers, and like information; and

 

(h)           information of a party disclosed to another party or parties before or
after the Commencement Date, but does not include information that:

 

(i)            is in the public domain or subsequently enters
the public domain without the fault of a party;

 

(j)            at the date of disclosure is known (and is
declared as known within 10 days of disclosure with supporting written evidence
of such knowledge) by the recipient party unless the parties agree that it
should be deemed Confidential Information;

 

(k)           is mutually agreed not to be confidential; or

 

 

(1)           at any time is received in good faith by any party from a third party
which is lawfully in possession of the information and had the right to
disclose it.

 

“Funding” means:

 

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

 

(a)           in respect of any period after the Initial
Term, the amount agreed in writing by the parties to be paid by Autogen
Research for that period in accordance with the terms of Schedule 1.

 

“GST” means any goods and services tax which is
levied on the value of goods and services supplied.

 

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

 

“Intellectual
Property” means all
intellectual and industrial property or rights of any nature throughout the
world and 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:

 

(a)               the revenue in Australian dollars received by
Autogen Research or any Related Body Corporate of Autogen Research 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; and

 

(b)           the cash value of any non-cash consideration
received by Autogen Research or a Related Body Corporate of Autogen Research
from sales of Products, and from licensing of the Intellectual Property to
produce, market and sell the Products, which is in settlement of monies owing
or which would otherwise be owing to Autogen Research or a Related Body
Corporate for sales of Products or licensing of Intellectual Property,
(provided that the accumulated cash value of such non-cash consideration shall
not be taken into account in determining net sales revenue until Autogen
Research has received sufficient revenue pursuant to paragraph (a) above to
meet the payment of any royalties payable pursuant to this Agreement),

 

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, but before the deduction of
administrative, marketing and manufacturing costs and corporate income tax.

 

“Pre-existing
Intellectual Property”
means the intellectual and industrial property developed before the Commencement
Date, owned by Deakin University and described in Schedule 4, to be made
available by Deakin University exclusively for use in the R&D Program.

 

 

“Principal
Scientist” means the
person appointed as such, or any replacement for that person, appointed in each
case as provided for in clause 2.2.

 

“Products” means the products and results of the R&D
Program.

 

“Project
Location” means the
Metabolic Research Unit of Deakin University at Geelong, Victoria.

 

“Related
Body Corporate” has the
meaning stated in Section 9 of the Corporations Law.

 

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

 

“Research
Proposal” means the
proposal attached in Schedule 2 of this Agreement involving scientific research
using the Research Expertise into the area of gene discovery in depression.

 

“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 Research
Proposal.

 

“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 Research hereby appoints, and Deakin
University accepts the appointment of, Deakin University to conduct the R&D
Program 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
a suitably qualified and experienced person, approved of by Autogen Research,
as the principal scientist to conduct the R&D Program and supervise and
direct the scientific staff engaged in the conduct of the R&D Program. If
at any time during the Term Deakin University is not able to provide the services
of that person as the Principal Scientist, the parties shall meet to discuss a
suitable replacement and then, subject to the written consent of Autogen
Research, which consent shall not be unreasonably withheld, Deakin University
shall provide the services of another suitably qualified and experienced person
as the Principal Scientist.

 

2.3           The R&D Program shall be carried out at the
Project Location or at such other location as Deakin University and Autogen
Research may agree from time to time.

 

2.4           Deakin University shall employ or engage, on
contract, such scientific staff as shall be necessary and in accordance with
the Funding and the Budgets and Workplans to conduct the R&D Program.

 

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

 

• a
covenant not to infringe any Intellectual Property rights of Deakin University
or Autogen Research;

 

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

 

Deakin University agrees that it is liable in respect
of the performance of any work for the R&D Program by its sub-contractors
as if Deakin University itself had performed that work.

 

2.6           Deakin University shall at all times use its
best endeavours to ensure that completion of the respective stages of the
R&D Program is achieved substantially in accordance with the timetable set
out in the R&D Program and in the Budgets and Workplans.

 

2.7           Deakin University hereby warrants:

 

(a)           it has the Research Expertise to conduct the
R&D Program in accordance with the Research Proposal and the Budgets and
Workplans;

 

(b)           it has the facilities at the Project Location
to conduct the R&D Program in accordance with the Research Proposal and the
Budgets and Workplans;

 

(c)           at the Commencement Date the Principal
Scientist is employed by Deakin University as principal scientist to conduct
the R&D Program and supervise and direct the scientific staff engaged in
the conduct of the R&D Program;

 

 

(d)           it shall employ or engage on contract suitably
qualified scientific staff to conduct the R&D Program in accordance with
the Research Proposal;

 

(e)           it will make available for the Term the
Pre-existing Intellectual Property for the conduct of the R&D Program;

 

(f)            it will not
sub-contract the performance of any part or parts of the R&D Program
without the prior written consent of Autogen Research;

 

(g)           it will not knowingly do, permit to be done or
cause to be done any action which may infringe any person’s intellectual
property rights; and

 

(h)           to the best of its knowledge, the Intellectual
Property and the Products will not infringe any person’s intellectual property
rights.

 

2.8           Deakin University shall at all times indemnify
and hold harmless each of Autogen Research and its respective officers,
employees and agents (in this clause 2.8 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 breach of warranty
or wilful, unlawful or negligent act or omission of Deakin University, its
employees, agents or sub-contractors in connection with this Agreement.

 

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 Research
shall provide the Funding to finance the R&D Program over the Term, in
accordance with the payment program in Item 1 of Schedule 1.

 

4.2           Subject to this Agreement, Autogen Research
shall provide the Funding for the Initial Term. Deakin University shall be
required to achieve the milestones set out in the Budgets and Workplans to an
appropriate standard as specified in this Agreement. Although Autogen Research
may terminate this Agreement pursuant to clause 10.1, Autogen Research 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 Research.

 

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
R&D Program (save and except for the Principal Scientist’s salary which
shall continue to be paid by Deakin University).

 

 

4.4           Deakin University shall ensure that no more
than [*] per centum ([*]%) of the Funding shall be used for administration and
infrastructure costs and that the balance of the Funding is applied directly to
the R&D Program.

 

4.5           Deakin University shall use the Funding for the
R&D Program in accordance with the Budgets and Workplans or for such other
research within the Research Expertise as shall be agreed in writing by the
parties.

 

4.6           Deakin University acknowledges that Autogen Research
may from time to time seek funding from public or private sector third parties
(“third party funding”) in respect of the R&D program and that any third
party funding so obtained (whether in the sole name of Autogen Research or of
Deakin University or any combination thereof) in respect of the R&D Program
shall for the purposes of this Agreement be deemed to meet (in part or whole as
the case may be and on a dollar for dollar basis) any obligation of Autogen
Research to provide the Funding then outstanding or which may be incurred by
Autogen Research pursuant to this Agreement.

 

4.7           Deakin University shall use best endeavours to
assist Autogen Research in making applications or submissions either in the
sole name of Autogen Research or of Deakin University or any combination
thereof as Autogen Research may reasonably require for third party funding for
the R&D Program including the provision of scientific information required
for the preparation of the applications or submissions. Deakin University shall
not make application or submission for third party funding for the R&D
Program without the prior written consent of Autogen Research even if such
applications or submissions are to be solely in the name of Deakin University. This
clause 4.7 does not require Deakin University to agree to any changes to this
Agreement.

 

5.             PERFORMANCE REVIEW

 

5.1           The parties shall review the progress of the
R&D Program 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           The Principal Scientist shall three (3) months
after the Commencement Date, and every three (3) months thereafter, provide the
parties with a written report for the purposes of the review setting out
adequate details of the following:

 

(a)           the progress of the R&D Program 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 R&D Program;

 

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

 

(e)           any other relevant information relating to or
affecting the R&D Program.

 

The
report from the Principal Scientist 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 the Principal Scientist and pursuant to clause 5.3, Autogen
Research may request, in writing to Deakin University, that any stage or part
of the R&D Program be varied, suspended or declared completed, but the
R&D Program will not be terminated other than in accordance with clause 10.

 

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

 

5.6           The parties shall meet to consider the report
from the Principal Scientist pursuant to clause 5.3, and to discuss the
progress of the R&D Program and any variation or suspension of the R&D
Program.

 

5.7           If Autogen Research is, in Autogen Research’s
sole and absolute discretion, satisfied as to the progress of the R&D
Program 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
Research shall make the Funding payment specified in Item 1 of Schedule 1. This
clause 5.7 shall not apply during the Initial Term.

 

6.             OWNERSHIP OF INTELLECTUAL
PROPERTY

 

6.1           The parties acknowledge and agree that, subject
to this Agreement, all Intellectual Property shall belong to and be the sole
property, legally and beneficially, of Autogen Research.

 

6.2           Deakin University warrants that it shall make
available for the purposes of the Research Proposal and use in the R&D
Program, and any commercialisation of the results of the R&D Program, all
Pre-existing Intellectual Property.

 

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 R&D Program shall be
the sole property, legally and beneficially, of Autogen Research.

 

6.4           (a)           Autogen Research may take out and maintain appropriate protection for
all new discoveries and developments made under the R&D Program and Deakin
University shall assist Autogen Research in applying for letters patent, or
other intellectual property protection in Australia or in any other part of the
world for any 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 Research. Autogen Research shall
bear the costs of taking out and maintaining appropriate protection for all new
discoveries and developments made under the R&D Program.

 

(b)           Autogen Research hereby grants to Deakin
University a non-exclusive, nontransferable and non-delegable fee-free and
royalty-free licence within the state of Victoria to use the Intellectual
Property for the sole purpose of carrying out Deakin’s own internal,
not-for-profit research.

 

 

6.5           Autogen Research shall pay to Deakin University:

 

(a)               if Autogen Research commercialises the
Products, a royalty equal to [*] percent ([*] % ) of the Net Sales Revenue

 

(b)           if Autogen Research licenses one or more third
parties to commercialise the Products, a royalty equal to [*] percent ([*] % )
of the Net Sales Revenue.

 

6.6           Autogen Research shall diligently pursue
commercial exploitation of the Intellectual Property and the Products, but
Autogen Research 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 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 Research solely.

 

6.7           If Autogen Research 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, Deakin University may seek approval in writing from Autogen Research
to develop and commercially exploit the Intellectual Property and the Products.
Autogen Research shall solely decide if such approval shall be granted but
shall not unreasonably withhold such approval. If such approval is granted to
Deakin University, Deakin University shall pay to Autogen Research an annual
royalty equal to [*] percent ([*]%) of the Net Sales Revenue.

 

6.8           Autogen Research 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. Deakin University or its authorized representative shall be entitled
to inspect the financial records and books of account but only in respect of
the development and commercialisation of the Intellectual Property and the
Products and only once in each year. Inspection shall take place at the
principal office of Autogen Research during normal business hours at a mutually
agreed time and shall be at the cost of Deakin University. If Deakin University
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 Confidential Information, which shall
include any information relating to the Research Proposal and R&D Program
which is supplied by or on behalf of any party, or which relates to or arises
from the R&D Program, shall be treated by both parties as confidential and
shall be used solely during the Term and in accordance with this Agreement to
enable Deakin University and its sub-contractors to carry out the R&D
program, 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 Confidential Information to any employees
or subsidiaries or related companies or sub-contractors or third parties from
whom funding is sought, the relevant party will procure the execution by the
person in question of a Deed as set out in Schedule 5 or otherwise in a form
and substance satisfactory to all parties or otherwise procure that the person
to whom it is intended to disclose any of the Confidential Information
undertakes to maintain the same in confidence and acknowledges 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
them or any of them 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 of the
Confidential Information shall be bound to Deakin University and Autogen
Research 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.

 

7.4           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 any 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 any party; or

 

(d)           is disclosed pursuant to governmental,
legislative or judicial requirement including disclosure by Autogen Limited
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
party 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 the conduct of the R&D Program by that party or as
a result of any unlawful or negligent 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 R&D Program 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.

 

8.3           Deakin University shall be responsible for
obtaining necessary regulatory approval (if any), required by any and all
government agencies, for conducting research and development work in the field
of the Research Proposal and R&D Program in Australia.

 

 

Deakin
University shall deliver copies of all such approvals (if any) to Autogen
Research within seven (7) days of receipt of such approvals by Deakin
University.

 

8.4           Autogen Research is a subsidiary of Autogen
Limited, which is listed on the Stock Exchange. Deakin University 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. Deakin University 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 Research in writing of any
material advancements or developments as they occur.

 

8A.          INSURANCE

 

8A.1        At all times during the Term Deakin University
must, at its own expense, establish and keep current the insurance policies of
standard form, and subject to exclusions and sub-limits appropriate for this
Agreement, and otherwise as specified in clauses 8A.2 and 8A.3.

 

8A.2        The policies of insurance required under clause
8A.1 are as follows:

 

(a)           public liability insurance with a limit of
liability of not less than $20 million for any one occurrence;

 

(b)           product liability insurance with a limit of
liability of not less than $20 million for any one occurrence and in the annual
aggregate;

 

(c)           workers’ compensation insurance in accordance
with the laws in force in Victoria; and

 

(d)           professional indemnity insurance with a limit
of liability of not less than $15 million for any one claim made. Professional
indemnity cover is to be maintained throughout the Term and until 7 years after
the end of the Term.

 

8A.3        Each policy of insurance referred to in this clause 8A must:

 

(a)           be made available for inspection upon
reasonable request by Autogen Research at any time during the Term, together
with certificates evidencing those policies, the payment of premiums and other
reasonable documentation which confirms that the policies are valid, current
and meet the requirements of this Agreement;

 

(b)           name Autogen Research as co-insured so that the
policy will respond as if there is a separate contract of insurance between
each co-insured person and the insurer;

 

(c)           include a clause enabling one insured person to
claim against the insurer where another insured person would have been entitled
to claim against the insurer but is precluded from doing so for any reason
including, but not limited to, a breach of the policy by that other insured
person; and

 

 

(d)           include a cross-liability clause enabling one
insured person to claim against the insurer even if the person making the claim
against that insured person is also insured under the policy.

 

8A.4        If Deakin University fails to effect or keep in
force any of the insurances which it is required by this Agreement to effect
and maintain, Autogen Research may, but shall not be obliged to:

 

(a)           effect and keep in force any such insurance and
pay such premiums and other moneys as may be necessary for that purpose and may
recover as a debt due from Deakin University on demand the amount so paid plus
an administrative charge of [*]%; or

 

(b)           refuse to perform its obligations under this
Agreement until the insurance policies and a receipt for the payment of
premiums are made available by Deakin University for inspection.

 

Notwithstanding
that Autogen Research may effect such insurances, Deakin University will be
deemed to have indemnified Autogen Research against all claims, demands,
proceedings, costs, charges and expenses which may arise as a result of Deakin University’s
failure to so insure.

 

9.             PUBLICATION

 

9.1           Deakin University shall not (and shall procure
that no person who is or who has been the Principal Scientist shall), without
the prior written approval of Autogen Research, during the term of this Agreement
and any extension or renewal thereof and for a period of twelve (12) months
after termination of this Agreement or any extension or renewal thereof publish
in academic or scientific publications the results of any part of the R&D
Program. Autogen Research 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 Research, at the same time as requesting approval for
publication. Autogen Research 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 Research has not responded within thirty
(30) days, Autogen Research is deemed to have refused approval for publication.
Such refusal does not preclude reassessment by Autogen Research 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
Research and Deakin University) of provisional patent applications, if
considered appropriate.

 

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

 

9.5           Autogen Research recognises the desire of Deakin
University to publish in academic or scientific publications the results of
part or all of the R&D Program and may have

 

 

regard
to such desire when deciding whether or not to grant its approval to publish
when so requested.

 

9.6           Subject to the continuous disclosure
obligations of Autogen Limited, Autogen Research shall, prior to publication,
use its reasonable endeavours to submit by facsimile to Deakin University for
comment, the text of any publicity statement, press release or other statement
intended to be made to the public which includes reference to the scientific
progress or the results of the R&D Program, or uses the name of Deakin
University, provided that Autogen Research shall not be restricted in making
whatever disclosures are necessary for the purposes of fulfilling the
requirements applicable to Autogen Limited as a company listed on the Stock
Exchange and Autogen Research shall be under no obligation to delay the public
release of the text. Without limiting Autogen Research’s rights hereunder,
Autogen Research shall use reasonable endeavours to allow Deakin University at
least twelve hours to respond to any text submitted to it. Deakin University
shall use its reasonable endeavours to respond to Autogen Research promptly
when any text is submitted to Deakin University for comment pursuant to this
clause 9.6.

 

10.          TERMINATION AND CONSEQUENCES

 

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 R&D Program within thirty (30) days of the Commencement Date; or

 

(b)           if Deakin University fails to achieve the
milestones set out in the Budgets and Workplans or maintain the best
professional standards appropriate to the nature of the R&D Program; or

 

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

 

(d)           if, subject to clause 2.2, Deakin University
does not utilise the Principal Scientist or such other researchers as Autogen
Research may approve pursuant to clause 2.2 to work on the R&D Program; or

 

(e)           if within 30 days of the first meeting of
representatives under clause 4.2(a) in the event of introduction of a GST or
any change in a GST, Autogen Research and Deakin University have not been able
to agree on the Funding which will apply to the performance of the R&D
Program; or

 

(f)            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 that a ground of termination shall
occur under this Agreement as specified in clause 10.1, Autogen Research may
give thirty (30) days written notice to Deakin University of the intention of
Autogen Research to terminate this Agreement without

 

 

any
right of action or remedy which has accrued or which may accrue in favour of
any party, and this Agreement shall terminate at the expiration of the thirty (30)
day period.

 

10.3         Except in the event of termination under clause
10.4, Autogen Research may, by notice in writing to Deakin University, require
Deakin University to make available to Autogen Research all information
relating to the R&D Program and Deakin University shall supply to Autogen
Research such information within thirty (30) days of the date of the notice.

 

10.4         If Autogen Research 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 5.7 hereof, Deakin University
may give thirty (30) days written notice to Autogen Research of the intention
of Deakin University to terminate this Agreement and unless Autogen Research
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 Research 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), (e) or (f):

 

10.6.1      Autogen
Research shall:

 

(a)           provide the Funding for the Initial Term;

 

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

 

(c)           comply with its obligations pursuant to clause
6.5 to pay the royalties to Deakin University.

 

10.6.2      Deakin
University shall:

 

(a)           maintain its licence from Autogen Research to
use the Intellectual Property pursuant to clause 6.4(b); and

 

(b)           comply with its obligations pursuant to clause
6.7 to pay royalties.

 

10.7         In the event of termination under clause 10.4:

 

 

10.7.1      if Autogen
Research 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 Research is hereby released from any
obligations to provide the Funding in the Initial Term or otherwise; and

 

(b)           all parties are released from any obligations
to pay royalties pursuant to clauses 6.5 and 6.7.

 

10.7.2      if Autogen
Research 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.

 

10.8         Subject to clause 6.4(b), in the event of
termination under clause 10.1(c), Autogen Research shall enter into good faith
discussions with Deakin University with a view to reaching agreement on a basis
for permitting the academic staff of Deakin University to continue research
using the Pre-existing Intellectual Property and the Intellectual Property
whether such research is pursuant to the R&D program or any similar
research program.

 

10.9         If this Agreement is terminated under clause
10.4 and clause 10.7.1 applies, Deakin University shall no longer be bound by
clauses 9.1, 9.2 and 9.3 of this Agreement. In the event of termination under clause
10.1, or if clause 10.7.2 applies to a termination under clause 10.4, the
parties shall enter into good faith discussions as to whether clause 9 shall
continue to operate, provided that Autogen Research is not required to agree
that clause 9 shall cease to operate.

 

11.          CO-OPERATION AND ASSISTANCE

 

11.1         Deakin University shall, and shall use all
reasonable efforts to ensure that all persons employed or contracted by Deakin
University working on the R&D Program shall, cooperate fully with Autogen
Research both during the Term and after the expiration or earlier termination
of this Agreement to provide Autogen Research with such information concerning
the R&D Program as Autogen Research may reasonably require from time to
time and such assistance as Autogen Research may reasonably require in applying
for Intellectual Property rights throughout the world.

 

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

 

11.3         Deakin University shall use all reasonable
efforts to ensure that all persons employed or contracted by Deakin University
working on the R&D Program (in this clause called “the Researchers”) shall,
provide reasonable assistance to Autogen Research both during the Term and
thereafter in the commercialisation of the results of the R&D Program. 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
Research to problem solve and advise.

 

Where
it is, in the reasonable opinion of Autogen Research, appropriate to do so,
Autogen Research 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 Research 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, and subject to the rights of Deakin University pursuant to
clause 6.4(b), Deakin University shall not be engaged in any research project
similar to or which is the same as the R&D Program 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 Australasian Dispute Centre.

 

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 Research) any director or the secretary of
Autogen Research or authorised delegate for the purpose of this Agreement; (in
the case of a notice by Deakin University), Vice-Chancellor of Deakin
University or authorised delegate for the purpose of this Agreement;

 

(b)           shall be given either:

 

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

 

(ii)           by facsimile transmission to (in the case of
Autogen Research) 9234 1255, attention: Company Secretary; or (in the case of
Deakin University) 5227 8500 attention: Vice-Chancellor,

 

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.

 

 

16.          GOODS AND SERVICES TAX

 

If
at any time during the Term there is any new GST introduced in Australia, or if
there is any change to any GST then in force or the method of its imposition,
then the following provisions will apply:

 

(a)           representatives of Deakin University and
Autogen Research will meet to renegotiate the Funding and the royalty amounts
(if any) payable under clauses 6.6 and 6.8;

 

(b)           the terms of this Agreement (including, but not
limited to, the Funding and the royalty amounts payable under clauses 6.6 and
6.8) will continue to apply until the renegotiation is completed and the
parties agree in writing to any amendment of those terms; and

 

(c)           in any renegotiation which occurs pursuant to
paragraph (a), the parties will apply the following objectives:

 

(i)            Deakin University should recover from Autogen
Research amounts equal to:

 

(1)           any liability to remit GST incurred by Deakin
University because of the conduct of the R&D Program by Deakin University;

 

(2)           any liability to remit GST incurred by Deakin
University because of the payment of royalties by Autogen Research to Deakin
University; and

 

(3)           any reduction in the cost to Autogen Research
of paying royalties to Deakin University where such reduction is a result of
the GST or of the associated abolition or change in rate or method of imposition
of any other tax, excise, duty or impost;

 

(ii)           Autogen Research should recover from Deakin
University amounts equal to:

 

(1)           any liability to remit GST incurred by Autogen
Research because of the payment of royalties by Deakin University to Autogen
Research;

 

(2)           any reduction in the cost to Deakin University
of conducting the R&D Program where such reduction is a result of the GST
or of the associated abolition or change in rate or method of imposition of any
other tax, excise, duty or impost; and

 

(3)           any reduction in the cost to Deakin University
of paying royalties to Autogen Research where such reduction is a result of the
G5T or of the associated abolition or change in rate or method of imposition of
any other tax, excise, duty or impost.

 

 

EXECUTED
as an agreement

 

	
  THE
  COMMON SEAL of AUTOGEN

  	
  )

  	
   

  
	
  RESEARCH
  PTY LTD ACN 074 636 847

  	
  )

  	
   

  
	
  was
  affixed in accordance with its Constitution

  	
  )

  	
   

  
	
  in
  the presence of:

  	
  )

  	
   

  

 

 

	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (Signature
  of Secretary/Director)

  	
   

  	
  Signature
  of Director

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name
  of Secretary in Full

  	
   

  	
  (Name
  of Director in Full)

  

 

 

	
  THE
  COMMON SEAL of DEAKIN

  	
  )

  	
   

  
	
  UNIVERSITY
  was hereunto affixed on the

  	
   )

  	
   

  
	
              day
  of             by
  direction of

  	
  )

  	
   

  
	
  the
  Vice-Chancellor in the presence of:

  	
  )

  	
   

  

 

 

	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Vice-Chancellor

  	
   

  	
  Vice-President
  (Administration)

  

 

 

SCHEDULE 1

General

 

Item
1 – Funding

 

For the
Initial Term:           Payable by Autogen Research to Deakin
University as follows:

 

$[*]
upon commencement of the R&D Program or execution of this Agreement,
whichever is later

 

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

 

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

 

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

 

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

 

For any Further Term:              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 Research of
further three monthly reports as required pursuant to clause 5.3.

 

Item 2     Research
Expertise: Gene discovery in depression and anxiety

 

Item 3     Commencement
Date: 1 April 2000

 

 

SCHEDULE 2

 

Research Proposal

 

Refer
to the following 5 pages.

 

 

NEW PROJECT: DEPRESSION IN
PSAMMOMYS OBESUS

 

 

Market
Overview

 

Worldwide
pharmaceutical sales continue to climb steadily, at a rate of 7-8% per year,
and exceeded $300 billion per annum in 1998. Central nervous system drugs
represent the third largest category of pharmaceutical sales (after
cardiovascular and alimentary/metabolism), approximately 14% of the total
market or $23.4 billion. Sales of CNS products increased by 12% in both 1997 and
1998. Antidepressants ranked as the world’s highest selling drug class, showing
a growth rate of 19.6% in the 12 months to June 1998 compared with the same
period in the previous year. According to Scrip’s Complete Guide to CNS
Disorders (1999, PJB Publications, Surrey), antidepressants account for 47% of
the worldwide psychiatric-related drug sales. This was approximately $9.4
billion in 1998, and will increase to $15 billion in 2002. Established
therapeutic approaches include tricyclic antidepressants and selective
serotonin reuptake inhibitors, as well as a number of newer compounds acting on
monoamine oxidase, noradrenaline reuptake, the dopaminergic system and various
other pathways.

 

Depression

 

Stress-related
disorders have become increasingly common throughout the latter half of the
previous century. Noticeably, the prevalence rates of psychiatric diseases such
as anxiety and depression have steadily increased in recent decades. Depression
refers to a variety of human behavioural states related to feelings of sadness,
apathy, futility and despair. As with most psychological states, the definition
of clinical depression is complicated by a variety of factors. Depression is a
complex disorder with both genetic and environmental contributing factors, which
are not well defined. It is generally accepted that depression can be broadly
classified into two forms:

 

1)     individuals
who exhibit symptoms of depression and anxiety

 

2)     those who
exhibit symptoms of depression and schizophrenia.

 

Although the
term depression will be used extensively here, it should be remembered that
anxiety and depression probably represent a continuum of mood disorders
resulting from particular stresses in susceptible individuals. For the purposes
of this study, we are assuming that the neurobiological processes underlying
these mood disorders may be common to both.

 

 

The American
Psychiatric Association characterizes depression as a dysphoric mood or loss of
interest in activities that would normally be enjoyed, plus at least four of
the following eight symptoms:

 

1)             psychomotor
retardation

 

2)             feelings
of worthlessness, self-reproach or inappropriate guilt

 

3)             thoughts
of suicide

 

4)             decreased
ability to concentrate

 

5)             loss
of energy

 

6)             decreased
sex drive

 

7)             sleep
disturbance

 

8)             appetite
disturbance.

 

The evaluation
of animal models of depression has been based on three criteria. Face validity
refers to the degree of symptomatic resemblance between the model and the
clinical condition; predictive validity concerns the extent to which the model
responds appropriately to drugs that are clinically effective and those that
are not; construct validity addresses the theoretical rationale of the model.

 

A number of
approaches have been used to generate animal models of depression, with varying
degrees of success. These include:

 

1)             Non-simulations:

 

a)             Reserpine
reversal

 

b)            Amphetamine
potentiation

 

c)             Waiting
behavior models

 

d)            Circadian
rhythm models

 

2)             Stress
models:

 

a)             Learned
helplessness

 

b)            Behavioural
despair

 

c)             Failure
to adapt to stress

 

d)            Chronic
unpredictable stress

 

e)             Chronic
mild stress

 

f)             Amphetamine
withdrawal

 

 

3)             Separation
models:

 

a)             Non-human
primate models

 

b)            Distress
calling in isolated chicks

 

c)             Separation
in pair-bonded hamsters

 

d)            Social
isolation in rats

 

4)             Brain
damage models:

 

a)             Olfactory
bulbectomy

 

5)             Genetic
model:

 

a)             Flinders
Sensitive Line rats

 

Each of these
animal models has both positive and negative aspects when evaluated using the
above criteria (reviewed by Willner 1990; Overstreet et al. 1995). We have
chosen to use Psammomys obesus as a separation
model of depression, based on our previous observations over a number of years.
The animals are normally housed 2-3 to a cage, but are separated into
individual cages for all experiments where food intake is to be measured. This
usually occurs at the age of 16 weeks. We have consistently found that
immediately after separation the animals are anorexic for several days and tend
to lose a small amount of body weight (up to about 5%). For these reasons, all
such studies are prefaced by a two-week run-in period, after which time the
animals have usually restored appetitive function sufficiently to regain their
original body weight.

 

Separation
models have been extensively used to investigate aspects of depression. Studies
in monkeys, hamsters, chickens and rats have identified a range of atypical
behaviors including decreased motor activity, appetite and sleep disturbances.
Separation models, especially when conducted in non-human primates, have been
accepted as having face validity and construct validity, while the predictive
validity of these models has not been well studied. Several authors have noted
that peer-peer separation is a more reliable and predictable animal model of
depression than infant-mother separation (Lewis et al. 1976; Jesberger and
Richardson 1985).

 

 

RESEARCH
PROPOSAL

 

We will
utilize the separation model to investigate genes involved in behavioural
traits consistent with depression in Psammomys obesus.

 

Experimental animals

 

Both male and
female animals will be used in this study. The animals will be weaned at 4
weeks of age into cages containing two same-sex siblings. The animals will have
ad libitum access to food and water, and will be maintained in a temperature
(22±1°C) and humidity controlled
environment. At 16 weeks of age, the animals will be separated into individual
cages in a different room, and sacrificed after 0, 4, 8 or 24 h and 2, 4, 6 or
14 days (n=8 in each group). Phenotypic behavior in response to separation will
be assessed including: food and water consumption, body weight changes, body
temperature, metabolic rate, total energy expenditure and physical activity
(both total and ambulatory). Information obtained will account for four of the
eight symptoms listed above as characteristic of depression: psychomotor
retardation, loss of energy, sleep disturbance and appetite disturbance. The
control animals for all timepoints in the experiment will be animals sacrificed
without being separated into individual cages. Immediately after sacrifice, the
hypothalamus of each animal will be removed and snap frozen in liquid nitrogen,
then stored at -80°C.

 

Gene expression

 

Analysis of
global gene expression will be conducted using microarray technology. A cDNA
library from the hypothalamus of Psammomys obesus
will be constructed by Life Technologies Inc. (Maryland, USA). 20,000 clones
from this library will be spotted onto glass substrates using an automated
microarray apparatus. Pooled RNA samples from the hypothalamus of separated
animals will be labeled with a fluorescent dye (Cy3), while RNA from control
animals will be labeled with Cy5. These two-labeled samples will be
competitively hybridized to the glass substrates, and the results analyzed by
scanning laser microscopy.

 

 

Using this
protocol, the expression of up to 20,000 genes (a mixture of known and unknown)
can be assessed in the control and separated hypothalamic samples to
investigate genes which are differentially regulated in response to the stress
of separation. When this is conducted for each of the timepoints detailed
above, a time course of gene expression changes in response to separation will
be obtained. The data will be analyzed using bioinformatics software to
identify potential targets for the treatment of stress-related behavioural
disorders.

 

We expect to
find a number of genes which are initially up- or down-regulated as the animals
become depressed.  Some of these genes
are expected to revert back to normal expression levels over time, as the
depression phenotype disappears.

 

It is expected
that these experiments will generate powerful data allowing us to identify gene
expression changes associated with the development of depression, as well as
compensatory changes as the animals adapt over time and respond to the
isolation stress.

 

 

SCHEDULE
3

 

 

Budgets
and Workplans

 

Refer to the following 3 pages

 

 

BUDGET FOR PREPARATION AND USE OF 100
MICROARRAY SLIDES:

APRIL 1, 2000 – APRIL 1, 2001.

 

	
  Breeding of animals (n=[*] @ [*] each)

  	
   

  	
  $

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Animal
  characterisation (n=[*] @ [*] each)

  	
   

  	
  $

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Sacrifice/RNA
  extraction (n=[*] @ [*] each)

  	
   

  	
  $

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  cDNA
  library synthesis(1)

  	
   

  	
  $

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Colony
  plating

  	
   

  	
  $

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Colony
  picking

  	
   

  	
  $

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Microarray
  gene preparation (20,000 genes)(2)

  	
   

  	
  $

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Microarray
  substrate preparation(3)

  	
   

  	
  $

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Slide
  arraying/fixing

  	
   

  	
  $

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Experimental
  sample preparation (100 @ [*] each)

  	
   

  	
  $

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Hybridisation

  	
   

  	
  $

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Personnel:
  Research Assistant Full-Time (+ on-costs) (4)

  	
   

  	
  $

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  SUBTOTAL

  	
   

  	
  $

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [*]%
  Infrastructure costs

  	
   

  	
  $

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  TOTAL

  	
   

  	
  $

  	
  [*]

  	
   

  

 

 

Budget
Justification

 

(1) cDNA
library synthesis costs are for the preparation of an amplified library from
minimal starting material. The procedure used produces at least 3 x 106
cfu, with an average insert size of >1 kb.

 

(2) Microarray
gene preparation consists of a number of steps necessary to amplify and purify
20,000 cDNAs for arraying. Steps and costs involved include colony growing
(culture media, 96-well deep-well plates - 
$0.30/clone), lysis of colonies (lysis reagent – $0.20/clone), PCR
(384-well plates, dNTPs, modified primers, Taq polymerase enzyme, tips for PCR
robot - $1.50/clone), agarose gel electrophoresis (96-well plates, agarose,
buffer, size markers, loading dye – $0.08/clone), and alcohol precipitation and
resuspension (ethanol, sodium acetate - $0.025/clone).

 

(3) The costs
listed for microarray substrate preparation, arraying and fixing are for 100
slides. The principal cost is in the purchase of aldehyde-modified slides for
microarraying.

 

(4) Mary
Malakellis has been employed to fill this position, her contract started on
April 1, 2000 and is for 1 year.

 

 

Timeline

 

 

April - June 2000

 

•      install arrayer and scanner

 

•      purchase consumables required to construct arrays

 

•      training in use of arrayer and scanner

 

•      synthesis of a cDNA library

 

•      animal collection (separation, sacrifice, tissue harvest)

 

July - September 2000

 

•      install colony picker/training

 

•      construct test array

 

•      animal collection (separation, sacrifice, tissue harvest)

 

•      pick 20,000 colonies

 

Oct - Dec 2000

 

•      prepare clones for arraying (PCR, clean-up, AGE)

 

•      array 100 slides

 

•      fix slides

 

•      RNA extraction and hybridisation

 

•      animal collection (separation, sacrifice, tissue harvest)

 

Jan - Mar 2001

 

•      scan slides

 

•      data analysis

 

•      confirmation of differential expression of primary targets

 

•      report

 

 

SCHEDULE 4

 

Pre-existing Intellectual Property

 

NOT
APPLICABLE

 

 

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:

 

 

DEED OF CONFIDENTIALITY

 

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

  	
   

  	
  SignatureExhibit 4.2(i)

 

“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.”

 

	
  DATE

  	
   

  	
  14 March 2003

  

 

 

AUTOGEN
LIMITED

 

and

 

MERCK
SANTE s.a.s

 

 

COMMERCIALISATION
LICENCE

(Field of
Diabetes and Obesity)

“AGT 203”

 

 

 

TABLE OF CONTENTS

 

	
  1.
  INTERPRETATION

  	
   

  	
   

  
	
  1.1
  Definitions

  	
   

  	
   

  
	
  1.2
  Construction

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  2.
  GRANT OF LICENCE

  	
   

  	
   

  
	
  2.1 Grant of licence

  	
   

  	
   

  
	
  2.2 Autogen’s Rights

  	
   

  	
   

  
	
  2.3 Scope of exclusive licence

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  3.
  ROYALTIES

  	
   

  	
   

  
	
  3.1
  Royalty Obligation

  	
   

  	
   

  
	
  3.2
  Royalty on unprotected products

  	
   

  	
   

  
	
  3.3
  Multiple royalties

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  4.
  REPORTS

  	
   

  	
   

  
	
  4.1
  Reporting requirements

  	
   

  	
   

  
	
  4.2
  Products which don’t attract royalty

  	
   

  	
   

  
	
  4.3
  Time of Sale

  	
   

  	
   

  
	
  4.4
  Foreign currencies

  	
   

  	
   

  
	
  4.5
  Payment mechanics

  	
   

  	
   

  
	
  4.6
  Merck to keep accounts and records

  	
   

  	
   

  
	
  4.7
  Inspection of accounts

  	
   

  	
   

  
	
  4.8
  Settlement of discrepancies

  	
   

  	
   

  
	
  4.9
  Cost of audit

  	
   

  	
   

  
	
  4.10
  Advance royalty

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  5.
  SUB-LICENSING

  	
   

  	
   

  
	
  5.1
  Scope of sub-licence provisions

  	
   

  	
   

  
	
  5.2
  Right to sub-Licence

  	
   

  	
   

  
	
  5.3
  Sub-licenses to Affiliates

  	
   

  	
   

  
	
  5.4
  Sub-licences - non-Affiliate

  	
   

  	
   

  
	
  5.5
  Calculation of royalty for all Sub-licensees

  	
   

  	
   

  
	
  5.6
  Royalty reporting

  	
   

  	
   

  
	
  5.7
  Enforcement of Sub-licences

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  6.
  COMMERCIALISATION

  	
   

  	
   

  
	
  6.1
  General reporting

  	
   

  	
   

  
	
  6.2
  Decision-making

  	
   

  	
   

  
	
  6.3
  Registration of Product

  	
   

  	
   

  
	
  6.4
  Ceasing to pursue registration

  	
   

  	
   

  
	
  6.5
  Refusal of Registration

  	
   

  	
   

  
	
  6.6
  Maintenance of Registrations

  	
   

  	
   

  
	
  6.7
  Marketing of Products

  	
   

  	
   

  
	
  6.8
  Commencement of Marketing

  	
   

  	
   

  
	
  6.9
  General reports

  	
   

  	
   

  
	
  6.10
  Marketing reports

  	
   

  	
   

  
	
  6.11
  Restriction on clinical trials

  	
   

  	
   

  

 

 

	
  7.
  CONFIDENTIAL INFORMATION

  	
   

  	
   

  
	
  7.1
  Obligations to Autogen

  	
   

  	
   

  
	
  7.2
  Obligations to Merck

  	
   

  	
   

  
	
  7.3
  Exceptions to obligations

  	
   

  	
   

  
	
  7.4 Rights in Know-How

  	
   

  	
   

  
	
  7.5 Term of obligation

  	
   

  	
   

  
	
  7.6 Permitted disclosures

  	
   

  	
   

  
	
  7.7 Delivery-up of Know-How

  	
   

  	
   

  
	
  7.8 Terms of this Agreement

  	
   

  	
   

  
	
  7.9 Public Announcement

  	
   

  	
   

  
	
  7.10 Continuous disclosure obligations

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  8. LIABILITY

  	
   

  	
   

  
	
  8.1 Responsibility for Products

  	
   

  	
   

  
	
  8.2 Autogen not liable

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  9. INDEMNITIES

  	
   

  	
   

  
	
  9.1 Indemnity by Merck

  	
   

  	
   

  
	
  9.2 Indemnity by Autogen

  	
   

  	
   

  
	
  9.3 Notification regarding indemnity

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  10. INSURANCE

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  11. TERM AND TERMINATION

  	
   

  	
   

  
	
  11.1 Term

  	
   

  	
   

  
	
  11.2 Termination for breach

  	
   

  	
   

  
	
  11.3 Termination in default of payment

  	
   

  	
   

  
	
  11.4 Grounds for immediate termination

  	
   

  	
   

  
	
  11.5 Reconstruction exception

  	
   

  	
   

  
	
  11.6 Termination by Autogen

  	
   

  	
   

  
	
  11.7 Termination by Merck

  	
   

  	
   

  
	
  11.8 Termination to be without prejudice

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  12. OBLIGATIONS AND RIGHTS ON TERMINATION

  	
   

  	
   

  
	
  12.1 Obligations of Merck

  	
   

  	
   

  
	
  12.2 Obligations of Autogen

  	
   

  	
   

  
	
  12.3 Limitation of Merck’s rights

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  13. WARRANTIES

  	
   

  	
   

  
	
  13.1 General warranties

  	
   

  	
   

  
	
  13.2 Specific warranty re Licensed Patents

  	
   

  	
   

  
	
  13.3 Warranties by Merck

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  14. PROTECTION OF LICENSED PATENTS

  	
   

  	
   

  
	
  14.1 Maintenance of Licensed Patents

  	
   

  	
   

  
	
  14.2 Reporting infringements

  	
   

  	
   

  
	
  14.3 Conduct of proceedings regarding Rights

  	
   

  	
   

  
	
  14.4 Royalties

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  15. INFRINGEMENT OF OTHERS RIGHTS

  	
   

  	
   

  
	
  15.1 Notification of action

  	
   

  	
   

  
	
  15.2 Autogen action

  	
   

  	
   

  

 

i

 

	
  15.3 Merck action

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  16. CONSTRUCTION OF PATENTS

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  17. FORCE MAJEURE

  	
   

  	
   

  
	
  17.1 Party not liable

  	
   

  	
   

  
	
  17.2 Notice of Force Majeure

  	
   

  	
   

  
	
  17.3 Termination in case of Force Majeure

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  18. ARBITRATION

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  19. NOTICES

  	
   

  	
   

  
	
  19.1 Form of Notice

  	
   

  	
   

  
	
  19.2 Manner of Service

  	
   

  	
   

  
	
  19.3 Address for Service

  	
   

  	
   

  
	
  19.4 Time of Service

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  20. MISCELLANEOUS

  	
   

  	
   

  
	
  20.1 Time of essence

  	
   

  	
   

  
	
  20.2 Severance

  	
   

  	
   

  
	
  20.3 Waiver

  	
   

  	
   

  
	
  20.4 Relationship of parties

  	
   

  	
   

  
	
  20.5 Injunctive relief

  	
   

  	
   

  
	
  20.6 Proper law

  	
   

  	
   

  
	
  20.7 Rule of construction

  	
   

  	
   

  
	
  20.8 Variation

  	
   

  	
   

  
	
  20.9 Assignment

  	
   

  	
   

  
	
  20.10 Further documents

  	
   

  	
   

  
	
  20.11 Affiliates’ actions

  	
   

  	
   

  
	
  20.12 Costs and Taxes

  	
   

  	
   

  
	
  20.13 Interest on overdue amounts

  	
   

  	
   

  
	
  20.14 Withholding taxes

  	
   

  	
   

  
	
  20.15 Counterparts

  	
   

  	
   

  
	
  20.16 Registration of agreement

  	
   

  	
   

  
	
  20.17 Not obliged to act contrary to law

  	
   

  	
   

  
	
  20.18 Statutory rights not limited

  	
   

  	
   

  
	
  20.19 Consents

  	
   

  	
   

  
	
  20.20 Entire agreement

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Schedule 1

  	
  Autogen
  Patents

  	
   

  	
   

  
	
  Schedule 2

  	
  Stage
  1 Patents

  	
   

  	
   

  

 

ii

 

	
  THIS AGREEMENT is made on

  	
   

  	
  14
  March 2003

  

 

 

BETWEEN

 

Autogen
Limited ACN 074 636 847

of PO
Box 1069, Grovedale, Victoria, Australia

(“Autogen”)

 

AND

 

Merck
Sante s.a.s

of 37
rue Saint Romain, 69379 Lyon, CEDEX 08, France

 

(“Merck”)

 

RECITALS:

 

A.           Lipha SA having signed a
Research and License agreement with Autogen Research Pty Ltd on April 28th,
1999 (regarding Obesity and Diabetes fields for Sand Rats program) and a Research
and License agreement with Autogen Research Pty on February 11th, 2002
(regarding Obesity and Diabetes fields for Strategic Alliance in Human Gene
program) has changed its corporate structure and name from Lipha S.A (Societe
Anonyme) to Lipha S.A.S. (Societe par Actions Simplifiees) and then to MERCK
SANTE s.a.s

 

B.            Merck has exercised its
option to take a licence in respect of certain intellectual property and to
conduct further research and development of the same with a view to the
development and commercialisation of certain products.

 

C.            Autogen has agreed to
grant this licence to certain intellectual property on the terms and conditions
set out.

 

D.            Merck has agreed to pay to
Autogen certain payments as and by way of royalty in respect of the use by it
of certain intellectual property licensed to it by Autogen and either used by
it directly in the commercialisation of certain products or used by it in the
research and development which has led to those products.

 

OPERATIVE PROVISIONS:

 

1.            INTERPRETATION

 

1.1          Definitions

 

In this agreement the following expressions
have the following meanings:

 

“Affiliate”
means with respect to a party, any person which directly or indirectly
Controls, or is Controlled by, or is under common Control with, such party.

 

 

“Arms Length”
means in relation to a transaction or dealing, a transaction or dealing which
might reasonably be expected to operate or apply between independent
enterprises dealing wholly independently with one another and where neither
bears the other any special duty or obligation and no special relationship
exists between them and where the only consideration is cash.

 

“Autogen Know-How”
means Know-How owned by or licensed to Autogen in relation to the Autogen
Patents in relation to the AGT 203 Gene Product.

 

“Autogen Patents”
the patents and patent applications owned by or licensed to Autogen related to
the Licensed Field including but not limited to those referred to in Schedule 1 and including:

 

(i)            any re-issue, renewal or extension of such a patent or patent
application (whether in whole or in part) and any patent of addition thereto;
and

 

(ii)           any supplementary protection certificate or other form of extension
based on or arising from such patents or patent applications.

 

“Base Rate”
means the PIBOR rate published as such by the French Association of Banks
(Association Francaise de Banque (AFB)) or EURIBOR rate applicable on 1 January 2002
or at any later date, should such date be postponed for any reason and
published as such by the European Federation of Banks (Federation Europeenne de
Banque (FEB)) plus in either case the amount of 1.5% per annum.

 

“AGT 203 Gene Product”
means the novel gene the subject of the Autogen Patents, and any novel proteins
or novel antigens based on such novel gene, and any product arising from
transcription of such gene.

 

“Business Day”
means a day on which the trading banks are open for general banking business in
both Melbourne, Australia and Lyon, France.

 

“Claim Asserted in Good
Faith” means and is limited to any claim asserted in any Project
Patent which can reasonably be considered to be patentable under the laws of
the country where filed having regard to any and all references, prior art,
novelty, inventiveness, utility and any and all other relevant legal criteria.

 

“Commencement Date”
means the date of execution of this agreement by the party last signing it.

 

“Control” means
the possession, directly or indirectly, of the power to direct or cause the
direction of the management of policies of a person, whether through the
ownership of voting securities, by contract or otherwise.

 

“Covered By”
means when used in the context that a Product is covered by a Subsisting Claim
or a Claim Asserted in Good Faith, that the Product or the normal method of
operation or customarily intended use of such Product must, when such Product
is manufactured, sold, or otherwise Exploited by Merck or a Sub-Licensee
constitute (but for the Licence or Merck’s ownership of Stage 2 Patents) an
infringement of a Subsisting Claim or in the period of 5 years from the
Commencement Date an infringement of a Claim Asserted in Good Faith, considered
as if it were a Subsisting Claim.

 

2

 

“Dollars” or “$”
means Australian dollars.

 

“EUR” means the
new European currency called EURO.

 

“Exploit” means
in respect of a:

 

(i)            Product - to make, have made, hire, sell or otherwise dispose of the
Product, to offer to make, sell, hire or otherwise dispose of the Product, to
use or import it or keep it for the purpose of doing any of those things;

 

(ii)           Process - use the method or process or do any act in respect of a
product resulting from such use which falls within paragraph (a);

 

“FFR” means
French Francs.

 

“Final Judgment”
means a Judgment or decree which becomes not further appealable or reviewable
through the exhaustion of all permissible applications for appeal, rehearing or
review by any superior court or tribunal or through the expiration of time
permitted for such applications.

 

“Force Majeure”
means any cause which is not within the reasonable control of the party
affected by it including, but not limited to, acts of God, industrial disputes
of any kind, war declared or undeclared, civil disturbance, acts or omissions
of Government or other competent authority, fire, lightning, explosion or
flood.

 

“Insolvency Event”
means any event of insolvency, bankruptcy or liquidation of the relevant party,
including any voluntary or involuntary judicial liquidation or re-organisation
proceedings.

 

“Know-How” means
technical, commercial and other information, data, know-how, drawings,
specifications and/or designs, animal or other models, methodologies and
biological materials embodied in some Material Form, and without prejudice to
the generality of the foregoing includes:

 

(i)            all experimental, manufacturing, process, analytical, packaging,
product, warehousing, quality control and quality assurance and marketing
specifications, standards, procedures, processes, methods, instructions and
techniques, samples, prototypes, formulae, writings of any kind, opinions or
otherwise unwritten data or in the form of computer software or computer
programs or any part thereof in any code; and

 

(ii)           all other information and other material supplied to or received by
a party or its Representatives from another party or Representatives on a
confidential basis pursuant to this agreement.

 

“Licence” means
the right and licence granted by Autogen to Merck pursuant to this agreement.

 

“Licensed Field”
means the field of human therapeutic applications for the treatment or
prevention of Diabetes and as a secondary field, the field of human therapeutic
applications for the treatment or prevention of diabetes and its
complications.  For clarity it is noted
that this does not include diagnostics or veterinary applications.

 

3

 

“Licensed Patents”
means the Autogen Patents and the Stage 1 Patents.

 

“Licensed Technology”
means the Autogen Know-How and Stage 1 Know-How.

 

“Loss” means any
loss, damage, cost, interest, expense, fee, penalty, fine, forfeiture,
assessment, demand, action, suit, claim, proceeding, cause of action, liability
or damages incurred by a person, and includes:

 

(i)            the cost of any action taken by the person to protect itself against
any loss or to preserve any right it has under this agreement; and

 

(ii)           where applicable, reasonable legal costs.

 

“Marketing”
means the promotion, advertising, distribution and sale of the Product and
includes a product launch campaign.

 

“Material Form”
in relation to information includes any form (whether visible or not) of
storage from which information can be reproduced, and any form in which
Information is embodied or encoded.

 

“Month” means
calendar month.

 

“Net Sales Value”
of a Product means in the case of an Arms Length sale the gross amount invoiced
by Merck (or the relevant Sub-licensee) to any customer less any and all of the
following:

 

(i)            any discount or rebates on sales of the Products;

 

(ii)           insurance and freight;

 

(iii)          the selling price of any returned goods or free replacements; and

 

(iv)          taxes imposed on sales of the Products such as value added tax,
excise tax and consumption tax.

 

“Party” means
Autogen or Merck and their respective successors and permitted assigns and “Parties”
means both of them.

 

“Patent” means
any patent or patent application as defined in the Patents Act
1952 (C’th) and any similar international, national or regional
patent or patent application and includes any and all extensions, renewals,
continuations, patent-of-addition and/or supplementary protection certificates
to any of the foregoing and includes any corresponding patent or patent
application taken out or applied for in any country in the Territory which is
fairly based upon or derived from any of the aforesaid patents.

 

“Products” means
any products produced or arising out of use of the results of Stage 1 Research
or Stage 2 Research or arising out of all and any further development by Merck
pursuant to Stage 1 Research or Stage 2 Research or both.

 

“Project Patents”
means the Autogen Patents, the Stage 1 Patents and/or the Stage 2 Patents.

 

“Project Research”
means the research in the area of Diabetes and of novel genes involved in
Diabetes and the research arising therefrom, consisting of the Stage 1 Research
and the Stage 2 Research.

 

4

 

“Quarter” means
each period of three months commencing on the first days of each January,
April, July and October during the Term.

 

“Registration”
in respect of a country means the gaining of all permissions from all
Regulatory Authorities in that country necessary to permit the commencement of
Marketing in that country and includes any approval in respect of packaging or
labelling and further includes the agreement of relevant authorities as to the
level of pricing or reimbursement in respect of the relevant Products, where
such registration is mandatory or a practical commercial imperative.

 

“Regulatory Authority”
in respect of a country means any and all bodies and organisations regulating
the importation, distribution, marketing or sale of the Product in any part of
that country.

 

“Representatives”
of a party means that party’s directors, officers, employees or agents.

 

“Required Insurance” means:

 

(i)            public liability insurance in respect of Losses up to a limit of
$5,000,000 covering property damage and personal injury as may be relevant to
the performance of each party’s obligations under this agreement to the other,
including (without limitation) liability, loss or damage due to negligent or
malicious damage, data corruption or loss, fire, theft, electrical and water
damage; and

 

(ii)           if the relevant party sells a Product, product liability insurance
in respect of Losses up to a limit of $20,000,000 covering any liability
associated with use or misuse of the Product including , personal injury and
consequential loss.

 

“Research Agreement”
means the Research and Licence Agreement in the field of Diabetes between the
parties dated 28 April 1999.

 

“Rights” means
the Licensed Patents and the Licensed Technology.

 

“Royalty Period”
means each Quarter during the Term provided that where the Term commences or
ends on a day other than first day of a Quarter the first and last reports will
be for only so much of the Royalty Period as occurs during the Term.

 

“Significant Competition”
means competition or potential competition to the Product from a third party’s
product which, notwithstanding the fact that it does not breach any Project
Patent:

 

(i)            is in whole or in part intended to have the same function or effect
as the Product; or

 

(ii)           in the country of manufacture or sale has taken or has the potential
to take significant market share from the Product or has prevented or deterred
or has the capacity to prevent or deter the Product from obtaining significant
market share.

 

“Stage 1 Know-How”
means the Know-How relating to or arising out of Stage 1 Research in relation
to the AGT 203 Gene Product.

 

5

 

“Stage 1 Patents”
means Patents relating to or arising out of Stage 1 Research including in
particular the Patents set out in Schedule 2.

 

“Stage 1 Research”
means the Research so described conducted under the Research Agreement.

 

“Stage 2 Know-How”
means the Know-How relating to or arising out of the Stage 2 Research program
in relation to the AGT 203 Gene Product.

 

“Stage 2 Patents”
means Patents relating to or arising out of the Stage 2 Research program in
relation to the AGT 203 Gene Product.

 

“Stage 2 Research”
means generally antibody production, large scale protein production, structural
analysis, screening of compounds affecting the relevant novel gene product,
combinatorial chemistry, toxicological studies and first clinical studies in
obese patients and completion of dose efficiency relationship studies in obese
patients (clinical Phase 2).

 

“Sub-licence”
means a sub-licence granted to an Affiliate or other third party under clause 5.

 

“Sub-licensee”
means the person in favour of whom a Sub-licence is granted in accordance with clause 5

 

“Subsisting Claim”
means and is limited to any valid claim of a validly issued unexpired and
non-lapsed Project Patent which has not been held permanently revoked,
unenforceable or invalid in a judgment or decree which becomes not further
appealable or reviewable through the exhaustion of all permissible applications
for appeal, rehearing or review by any superior court or tribunal or through
the expiration of time permitted for such applications, (which judgment or
decree has not been admitted to be invalid or unenforceable through reissue or
disclaimer or otherwise).  If there
should be two or more decisions within the same country which are conflicting
with respect to the invalidity of the same claim, the decision of the highest
tribunal will thereafter control. 
However should the tribunals be of equal authority, then the decision or
decisions holding the claim valid will prevail where the conflicting decisions
are equal in number and the majority of decisions will prevail where the
conflicting decisions are not equal in number. 
Where a Project Patent has been issued in a country other than Australia
without a separate and independent examination by the relevant authorities of
that country that patent will be deemed to have a scope equivalent to the scope
of the claims of any corresponding Australian Patent which has had examination
in Australia.

 

“Term” means the
period during which this agreement is in force pursuant to clause 11.

 

“Territory”
means the whole of the world

 

“Year” means
each period of twelve months commencing on the first day of each January during
the Term.

 

1.2          Construction

 

In this agreement unless the context
otherwise requires:

 

6

 

(a)           Business Day.  If any day appointed or specified by this
agreement for the payment of any money or the doing of any act or thing falls
on a day that is not a Business Day, the day so appointed or specified is
deemed to be the next day which is a Business Day.

 

(b)           Collective references.  Reference to any thing (including, without
limitation, any amount) is a reference to the whole or any part of it and a
reference to a group of things or persons is a reference to any one or more of
them.

 

(c)           Defined expressions.  If a word or phrase is defined, cognate words
and phrases have corresponding definitions.

 

(d)           Gender.  Words importing any gender include the other
genders.

 

(e)           Headings.  Headings must be ignored in construing this
document.

 

(f)            Joint liability.  An obligation of two or more parties binds
them jointly and severally.

 

(g)           Joint obligations.  An obligation incurred in favour of two or
more parties is enforceable by them jointly and severally.

 

(h)           Month.  Means a calendar month.

 

(i)            Numbers.  Words importing the singular include the
plural and vice versa.

 

(j)            Parts of agreement.  References to this agreement include its
recitals, schedules and annexures.

 

(k)           Persons.  References to persons include corporations
and bodies politic.

 

(l)            Reconstituted bodies.  References to a body which has ceased to
exist or has been reconstituted, amalgamated, reconstructed or merged, or the
functions of which have become exercisable by any other person or body in its
place, is taken to refer to the person or body established or constituted in
its place or the person or body by which its functions have become exercisable.

 

(m)          Representatives and assigns.  References to a person
include the legal personal representatives, successors and permitted assigns of
that person.

 

(n)           Statutory amendments.  A reference to a statute, ordinance, code or
other law includes regulations and other statutory instruments under it and
consolidations, amendments, re-enactments or replacements of any of them
(whether of the same or any other legislative authority having jurisdiction).

 

(o)           Variation.  References to this or any other document
include the document as varied or replaced, and notwithstanding any change in
the identity of the parties.

 

(p)           Writing.  References to writing include any mode of
representing or reproducing words in tangible and permanently visible form, and
include telex and facsimile transmissions.

 

7

 

2.            GRANT OF LICENCE

 

2.1          Grant of licence

 

Autogen grants to Merck with effect on and
from the Commencement Date until expiry of the Term an exclusive licence within
the Licensed Field, that is to the exclusion of Autogen and third parties, in
the Territory within that Licensed Field, to use the Licensed Patents and the
Licensed Technology and to Exploit the Products utilising the Licensed Patents
and Licensed Technology.

 

2.2          Autogen’s Rights

 

Autogen and Merck agree and acknowledge
that during the Term, except as set out in or permitted by this agreement:

 

(a)           Autogen must not within the Licensed Field Exploit the Products in
the Territory utilising the Licensed Patents or Licensed Technology; and

 

(b)           must not grant or purport to grant to any third party any right in
respect of the Licensed Patents or Licensed Technology which is inconsistent
with the right and licence granted in clause 2.1.

 

2.3          Scope of exclusive licence

 

The grant of the exclusive licence contained in clause 2.1 does not preclude:

 

(a)           the licensing of the Licensed Patents and Licensed Technology for
use or exploitation outside of the Licensed Field; or

 

(b)           the use of the Licensed Patents or Licensed Technology by Autogen,
the International Diabetes Institute or Deakin University for the purposes of
their own internal research.

 

3.            ROYALTIES

 

3.1          Royalty Obligation

 

In consideration of the grant of the
Licence, Merck agrees to pay to Autogen in respect of sales of Products Covered
By Project Patents in the Territory a royalty equal to the following
percentages of the Net Sales Value of such Products:

 

(a)           for yearly Net Sales Value of Products up to US$[*], at the rate of [*]%;
and

 

(b)           until the yearly Net Sales Value of Products reaches US$[*], in
respect of yearly Net Sales Value between US$[*] and US$[*], [*]%; and

 

(c)           once the yearly Net Sales Value of Products exceeds US$[*], in
respect of all yearly Net Sales Value in excess of US$[*], at the rate of [*]%.

 

In this clause, yearly means from 1 January to 31
December in any year.

 

8

 

Where in accordance with the terms set out
in the Research Agreement Merck pursues the Joint Venture Option, the dollar
amounts of US$[*] and US$[*] above will be replaced with US$[*] and US$[*]
respectively.

 

3.2          Royalty on unprotected products

 

If the manufacture, sale or use of a
Product in a particular country is not Covered By a Project Patent for any
reason then so long as there is in respect of that Product no Significant
Competition, royalties will still be payable in respect of such a Product as if
it were Covered By a Project Patent, but at a rate equal to [*]% of the royalty
rate applicable to Products which are actually Covered By a Project Patent.

 

3.3          Multiple royalties

 

If the manufacture, use or sale of a
Product, which attracts a royalty obligation under clauses 3.1
or 3.2, and also attracts a royalty
obligation to a third party or parties, not being Affiliates of Merck, and the
aggregate of all such third party non-Affiliate royalties exceeds [*]% of Net
Sales Value, then the royalty rate payable under clause 3.1
may be reduced in accordance with the following formula:

 

 

Where:

 

(a)           Rnew is the new royalty rate

 

(b)           Rtotal is the total of the royalties payable in respect of the
Product to third party non-Affiliates, including the royalty payable to Autogen

 

(c)           Rold is the rate of royalty otherwise payable under clause 3.1,

 

provided that Rnew must not be less than half Rold.

 

4.            REPORTS

 

4.1          Reporting requirements

 

Merck must within 60 days of the end of
each Royalty Period provide to Autogen a written report setting out in
reasonably specific detail on a country by country basis:

 

(a)           the gross sales value of all Products which have been sold by Merck
and its Sub-licensees during the preceding Royalty Period and the calculation
of Net Sales Value from such gross sales,

 

(b)           the calculation of the royalty payable on such Products, including
details of the currency conversion rates used, any taxes or other amounts
withheld and any adjustments on account of returns.

 

9

 

4.2          Products which don’t attract royalty

 

Royalty will not be payable in respect of
any Products supplied, used or consumed by Merck or any of its Affiliates or
Sub-licensees (provided Merck itself receives no royalty in the following
circumstances) for the purposes of testing, obtaining Registration or in good
faith pre-marketing or post marketing studies or reasonable quantities of
normal commercial samples.

 

4.3          Time of Sale

 

A Product is deemed to be sold at the time
it is invoiced to the buyer.

 

4.4          Foreign currencies

 

Merck will calculate royalties in local
currencies and convert the same to Dollars (or to such other currency as
Autogen may nominate from time to time) at the ruling rate of exchange as on
the last day of the Royalty Period.

 

4.5          Payment mechanics

 

The royalty payable to Autogen must be paid
to a bank account nominated by Autogen in Melbourne, Australia (or at such
other location as Autogen may stipulate from time to time) within 60 days of
the end of each Royalty Period.

 

4.6          Merck to keep accounts and records

 

Merck must keep and retain at least for a
period of 36 months after the end of the Royalty Period to which they relate,
true and particular accounts and records of all sales of Products sufficient to
verify Merck’s calculation of Net Sales Value of Products sold, the calculation
of royalty based thereon and conversion of such amounts into the relevant
currency.

 

4.7          Inspection of accounts

 

During the Term and for a period of 2 years
thereafter, Autogen or its duly authorised representatives reasonably
acceptable to Merck have the right to inspect and audit from time to time the
accounts and records referred to in clause 4.6 and
such other matters as are directly relevant to the calculation of the amount of
any payment due by Merck to Autogen under this agreement and are entitled to
take copies of such records, on the following conditions:

 

(a)           inspection is limited to 2 times in any 12 month period;

 

(b)           inspections must take place during normal business hours and upon
reasonable prior notice to Merck;

 

(c)           the Representatives of Autogen who inspect such accounts and records
must be suitably qualified personnel reasonably acceptable to Merck and must:

 

(i)            prior to inspecting such records and accounts, enter into a
confidentiality agreement with Merck containing undertakings similar to those
in clause 7;

 

10

 

(ii)           whilst inspecting such records and accounts, abide by all of Merck’s
standard rules and regulations; and

 

(iii)          Autogen must indemnify and hold Merck harmless from all liability
resulting from any negligence or any other activities on the part of Autogen’s
Representatives inspecting such records and accounts.

 

4.8          Settlement of discrepancies

 

If any discrepancy is found by Autogen then
the amount thereof, together with interest at the Base Rate from the proper
date for payment, must be paid within 7 days of demand therefor to Autogen.

 

4.9          Cost of audit

 

Autogen must bear the cost of any such
examination unless a discrepancy of 5% or more in the amount of any royalty
payment is detected, in which event Merck must bear the reasonable expense of
the examination.

 

4.10        Advance royalty

 

Where any advance royalty has been paid by
Merck to Autogen, then until such time as such advance royalty has been fully
recouped from royalties due to Autogen, Merck will be obliged to calculate and
report but not pay the royalties otherwise due to Autogen under this agreement.

 

5.            SUB-LICENSING

 

5.1          Scope of sub-licence provisions

 

Merck acknowledges and agrees that the
provisions of this agreement dealing with sub-licences apply equally to
licences by Merck of Stage 2 Patents, to the extent that any licence by Merck
of a Stage 2 Patent will be subject to the same restrictions and requirements,
including royalty entitlements, as if they were Licensed Patents owned by
Autogen.

 

5.2          Right to sub-Licence

 

Except as required under this agreement,
Merck may grant sub-licences of Project Patents upon such terms and conditions
as it may arrange.

 

5.3          Sub-licenses to Affiliates

 

Merck has the right to grant sub-licences
to an Affiliate in respect of a particular country or group of countries in
respect of the Product provided that the sub-licence complies with the
following:

 

(a)           the Affiliate being granted the sub-licence has the commercial
capacity to promote and exploit the relevant Product with due diligence and
probity and has at least sufficient skills and resources to comply with the
obligations placed upon Merck in relation to that Product in the relevant
country or countries;

 

11

 

(b)           the sub-licence is wholly consistent with the terms of this Licence
and in particular:

 

(i)            such sub-licence does not purport to extend or continue in any
circumstances where this Licence may be terminated, and

 

(ii)           the sub-licensee acknowledges that Autogen owns or is the valid
licensee of the Rights;

 

(c)           the sub-licence prohibits the sub-licensee from taking any action or
allowing any action to be taken which detracts from the ownership of the Rights
by Autogen or conflicts with the provisions contained in this Licence in
relation to prosecuting or defending the Project Patents or defending any
allegation of infringement of the Rights;

 

(d)           the sub-licence is in the English language, executed by the
sub-licensee and giving its place of business;

 

(e)           the sub-licence requires the sub-licensee to maintain all books,
records and accounts necessary to enable verification of Net Sales Value and
royalties and other income required to be paid by Merck to Autogen and permits
inspection by Autogen on terms essentially identical to clauses
 4.6
and 4.7;

 

(f)            the sub-licence limits the duration of the sub-licence in respect of
any Product for the term of this agreement and further provides for the
sub-licence to terminate automatically upon the termination of this agreement,
or upon an Insolvency Event occurring in relation to the sub-licensee;

 

(g)           the sub-licence prohibits the sub-licensee without the consent of
Autogen from assigning, transferring, mortgaging or parting with any of its
rights under the sub-licence;

 

(h)           the sub-licence provides that the sub-licence will terminate in the
event that the relevant company ceases to be an Affiliate of Merck;

 

(i)            the sub-licence obliges the sub-licensee to maintain the insurances
referred to in clause 10 or Merck does so itself
in respect of the Products that may be sold in the sub-licence territory; and

 

(j)            the sub-licence provides that all the terms and conditions of the
sub-licence may be enforced by Autogen against the sub-licensee notwithstanding
that Autogen is not a party to the sub-licence or any rule of law or
equity to the contrary.

 

If the sub-licence to be granted by Merck is in favour
of an Affiliate, and complies in all material respects with the above
requirements, it is not necessary for Merck to seek the consent of Autogen to
the granting of such sub-licence, however, Merck is obliged within 3 months of
the entering into of such sub-licence to notify Autogen of the granting of the
licence and is further obliged to provide Autogen with general details of the
sub-licensee, including information as to its financial affairs and resources
and a copy of the executed sub-licence.

 

12

 

5.4          Sub-licences - non-Affiliate

 

Merck may not grant any sub-licence to a non-Affiliate
without the prior written consent of Autogen, such consent not to be withheld
unless Autogen reasonably believes and can objectively justify its view that:

 

(a)           any proposed sub-licensee will not properly perform and discharge
all of the obligations of Merck under this agreement in respect of the relevant
sub-licensed Territory;

 

(b)           that the proposed sub-licensee is not financially sound or will be
unable to pay royalties and other amounts payable under the relevant
sub-licence as and when they fall due;

 

(c)           there are reasonable grounds to believe that the proposed
sub-licensee is likely to conduct itself in a manner likely to endanger or
cause injury to Autogen’s reputation, or the reputation, quality, image or
character of the Product, in this regard Merck must provide to Autogen full
information detailing any products manufactured, distributed or sold by the
proposed sub-licensee in the proposed sub-licence territory which are
competitive with the Product;

 

(d)           the proposed sub-licence is not wholly consistent with the terms of
this licence and in particular complies with clauses 5.3
(a), (b) (c), (d), (e), (f), (g), (i) and (j); and

 

(e)           the proposed sub-licensee or any of its Affiliates is engaged in
litigation with Autogen or its Affiliates.

 

Merck must provide full and adequate
information to Autogen on the above matters. 
Autogen undertakes to give its consent within a period not exceeding one
month of receipt from Merck of all information reasonably required to make a
determination under this clause, including written confirmation by Merck that
the proposed licence agreement is in compliance with this clause.  If no response is given in that period,
Autogen will be deemed to have consented to the sub-licence.

 

5.5          Calculation of royalty for all Sub-licensees

 

Where any Product is Exploited by a
Sub-licensee, the Net Sales Value of any Products sold by such Sub-licensee to
a person or persons who is not a Sub-licensee is to be included in Net Sales
Value pursuant to clause 3.1 and
bear royalty payable by Merck in accordance with clauses 3
and 4 as if it was Net Sales Value of
Product sold by Merck, not as a
proportion of the royalties or other receipts which may be paid by such
Sub-licensee to Merck pursuant to any sub-licence granted by Merck.

 

5.6          Royalty reporting

 

Any payments due to Autogen under this clause 5 must be included with Merck’s reports and payments
to be made under the provisions of clause 4 for
the Royalty Period in which any such amounts become due and payable to Merck.

 

13

 

5.7          Enforcement of Sub-licences

 

Merck must, if so directed by Autogen, take
all commercially and legally reasonable steps to enforce the terms of any
Sub-licence.

 

6.            COMMERCIALISATION

 

6.1          General reporting

 

Merck will at all times during Stage 2 Research and
subsequent steps, including commercialisation, keep Autogen timely and fully
informed of:

 

(a)           the progress of development and commercialisation, including
internal milestones and approvals;

 

(b)           broad details of any competing products being marketed by Merck or
its Affiliates;

 

(c)           any decision to suspend the continuation of the development or
commercialisation of the Products.

 

6.2          Decision-making

 

Where Merck intends to make a decision which may
result in the suspension or termination of Stage 2 Research or the further
development and commercialisation of Products or which is otherwise materially
adverse to such activities  then:

 

(a)           it will give Autogen advance notice of such decision making and the
reasons why such decision may be made; and

 

(b)           it will give Autogen an opportunity to submit material to and make a
presentation to the Merck decision makers in respect of such decision prior to
such decision being made,

 

it being acknowledged that having followed
the above procedures, Merck’s decision will be in Merck’s entire discretion and
will not be fettered or reviewable in any way by Autogen.

 

6.3          Registration of Product

 

After completion of the relevant Stage 2
Research program Merck must use reasonable endeavours to promptly complete
Phase III clinical trials, and to apply for and gain Registration in its own
name in respect of one or more Products. 
The cost of undertaking all such trials and further development and
making and prosecuting such applications is to be borne by Merck.

 

6.4          Ceasing to pursue registration

 

If, following the process of clause 6.2,
Merck in its reasonable opinion decides not to continue to pursue Registration
of any Product on the basis of efficacy, safety or medical reasons, concerns
about the validity of Project Patents or a substantial change in economic
factors, then it must promptly advise Autogen in writing, together with written
reasons for such decision.  In such a
case this licence will terminate and Autogen may request a 

 

14

 

licence in respect of Stage 2 Know-How and Stage 2
Patents, in which case the Parties will negotiate in good faith the terms of a
licence (which may be exclusive or non-exclusive and limited to the
discontinued Novel Gene Product and necessary related technology being part of
Stage 2 Know-How and Stage 2 Patents) for the commercialisation of such
Know-How and Patents.

 

6.5          Refusal of Registration

 

If an application by Merck for Registration
is refused, Merck is obliged to re-apply for Registration when so required by
Autogen but such requirement must only be imposed if Autogen is of the
reasonable belief, following discussions with Merck, that the re-application
will be approved.  The cost of making and
prosecuting any such re-application will be borne by Merck.

 

6.6          Maintenance of Registrations

 

Merck agrees to do all things necessary to
ensure that all product registrations and approvals in respect of the Products
are maintained and to provide Autogen with any and all documentation and
information concerning any variations to such product registrations or
approvals.  Such product registrations
and approvals include without limitation any registration concerning the
packaging or labelling of the Products.

 

6.7          Marketing of Products

 

Following Registration of the Product,
Merck must use its best endeavours, at the expense of Merck, to:

 

(a)           promote, distribute and sell the Products in the Territory in order
to obtain the optimum market potential for the Products;

 

(b)           provide and maintain such suitable places of business for the
storage, handling and sale of the Products at such locations throughout the
Territories as Merck thinks suitable;

 

(c)           provide and maintain such marketing, sales and office staff to
promote and sell the Products in accordance with this agreement, such personnel
to be deemed the agents, representatives or employees of Merck and not those of
Autogen;

 

(d)           maintain in each country in the Territory sufficient stocks of the
Products to meet the market demand for the Products;

 

(e)           where Merck or its Affiliates or sub-licensees are marketing
Competing Products, provide information about the comparative efforts being
made;

 

(f)            no later than 2 months prior to the commencement of each year during
the Term prepare sales and marketing plans in respect of the Product in the
Territories for discussion with Autogen; and

 

(g)           provide to Autogen yearly reports of Merck’s market intelligence and
proposed marketing strategy and performance goals other than where there is a
material change in the market intelligence, proposed marketing strategy or
performance goals, in which case Merck will promptly provide to Autogen a
report of those material changes.

 

15

 

6.8          Commencement of Marketing

 

If Marketing by Merck has not commenced in any country
in the Territories within 6 months of Merck obtaining Registration or within
such other time as agreed by the parties and such failure to so commence
Marketing is not attributable to any failure by Autogen to comply with its
obligations under this agreement, Autogen may by notice in writing to Merck
convert the licence to a non exclusive licence, in respect of that country.

 

6.9          General reports

 

Merck must within one month of the relevant
dates advise Autogen, at Merck’s cost, in respect of each country in the
Territory of:

 

(a)           the making of an application for Registration and the gaining of
Registration of any Product; and

 

(b)           details of the date of commencement of Marketing and details of the
establishment of or change to any facilities referred to in clause 6.7(b).

 

6.10        Marketing reports

 

Merck must every year provide to Autogen a
written report detailing its proposed Marketing activities in relation to the
Products in the coming year.  The initial
marketing plan is to be provided no later than one month prior to the
commencement of Marketing in the relevant country and subsequent Marketing
plans are to be provided at least three months prior to each anniversary of
such initial date.  The marketing plan
will specify objectives and strategies in respect to the following and any
related matters necessary to ensure optimum market penetration in the relevant
country:

 

(a)           pricing and margin structure;

 

(b)           distribution channels;

 

(c)           sales and distribution targets;

 

(d)           accumulation of market data including assessment of total market
size and segmentation in units and dollars;

 

(e)           overview of trading for the current year and objectives and
strategies for the following year;

 

(f)            assessment of competition;

 

(g)           advertising and promotional expenses;

 

(h)           overall advertising and promotional strategy.

 

Merck will allow Autogen to provide comment on the
marketing plan (if any) and will consider such comments in good faith.

 

16

 

6.11        Restriction on clinical trials

 

Merck must not conduct or knowingly supply
Product to any person who intends to conduct any clinical trials or scientific
study concerning or utilising Products (other than where such trial or study is
to involve less than 15 human subjects and does not require any prior
Regulatory Authority approval) unless such trial or study has first been
discussed at and approved by the Scientific Advisory Board established by the
parties.

 

7.            CONFIDENTIAL INFORMATION

 

7.1          Obligations to Autogen

 

Subject to clauses 7.3
and 7.6, Merck covenants with Autogen as
follows:

 

(a)           to keep all Know-How belonging to Autogen or supplied to it by
Autogen, including the existence of such Know-How, strictly secret and
confidential (including from all its employees, servants and agents),
exercising at least the same degree of care as it uses to maintain its own
Know-How;

 

(b)           to provide proper and secure storage for such Know-How within its
possession or control;

 

(c)           to use such Know-How only for the purposes of this agreement and not
for any other activity or purpose whatsoever without the prior written approval
of Autogen; and

 

(d)           to not copy or reduce to writing or any other medium any part of
such Know-How except as may be reasonably necessary for the purposes of this
agreement.

 

7.2          Obligations to Merck

 

Subject to clauses 7.3
and 7.6, Autogen covenants with Merck as
follows:

 

(a)           to keep all Know-How belonging to Merck or supplied to it by Merck,
including the existence of such Know-How, strictly secret and confidential
(including from all its employees, servants and agents), exercising at least
the same degree of care as it uses to maintain its own Know-How;

 

(b)           to provide proper and secure storage for such Know-How within its
possession or control;

 

(c)           to use such Know-How only for the purposes of this agreement and not
for any other activity or purpose whatsoever without the prior written approval
of Merck; and

 

(d)           to not copy or reduce to writing or any other medium any part of
such Know-How except as may be reasonably necessary for the purposes of this
agreement.

 

7.3          Exceptions to obligations

 

The obligations of confidence set out in clauses 7.1 and 7.2 do not
extend to Know-How which:

 

17

 

(a)                                  at the time of disclosure to a party is in the public domain;

 

(b)                                 after disclosure to a party becomes part of the public domain
otherwise than as a result of the wrongful act of that party or one of that
party’s disclosees;

 

(c)                                  a party can show was in its possession at the time of disclosure and
was not acquired directly or indirectly from the other party; or

 

(d)                                 is received from a third party provided that it was not acquired
directly or indirectly by that third party from a party to this agreement or
under an obligation of confidence;

 

(e)                                  is required by compulsion of law to be disclosed,

 

provided that:

 

(f)                                    the onus is on the party alleging the same to prove that one of the
above exceptions has application; and

 

(g)                                 in any case of uncertainty as to whether the obligations in clauses 7.1 or 7.2 have
application to any information, such information must be treated as subject to
the obligations until advised otherwise by the party to whom the obligations
are owed.

 

7.4                              Rights in Know-How

 

Each party acknowledges and agrees that
each other party has made a substantial investment in that party’s Know-How and
has a legitimate right to protect itself against wrongful disclosure or use of
such Know-How.

 

7.5                              Term of obligation

 

The obligations in this clause 7 survive the expiry or termination of this agreement
for whatever reason and continue  for a
period of 10 years, subject always to the exceptions included in clause 7.3.

 

7.6                              Permitted disclosures

 

Each party (“the first party”) is permitted
to disclose Know-How belonging to another party or supplied to it by another
party (“the other party”) to such of the first party’s Representatives as
require access to such information for the purposes of this agreement, provided
that:

 

(a)                                  only such Know-How as needs to be disclosed to a person for the
purposes of this agreement will be disclosed to that person; and

 

(b)                                 the first party must:

 

(i)                                     have obtained from each such person undertakings in favour of the
other party substantially in the form of the relevant obligations and
undertakings in this clause 7 (but
not this clause 7.6);

 

(ii)                                  be responsible for the performance of its Representatives’
undertakings referred to in clause 7.6(b)(i);
and

 

18

 

(iii)                               take whatever steps are reasonably necessary, including the
institution of legal proceedings, to ensure that each of its Representatives is
bound by and observes the terms of the undertakings referred to in clause 7.6(b)(i).

 

7.7                              Delivery-up of Know-How

 

All of a party’s Know-How and all materials
containing or embodying such Know-How and all copies of or extracts from or
notes on the same in the possession, power or control of another party or any
of its employees, servants or agents together with all forms and other
materials relating to practices and procedures in relation to the Know-How to
the extent possible must:

 

(a)                                  in the event of the expiration or sooner termination of this
agreement, be delivered up by the other party to the first party at the expense
of the other party; and

 

(b)                                 in the event of any demand made by the first party be delivered up
by the other party to the first party at the expense of the first party.

 

7.8                              Terms of this Agreement

 

Merck and Autogen shall not disclose any
terms or conditions of this agreement to any third party without the prior
consent of the other party, except as required by applicable law or to a third
party with whom Autogen or Merck has entered into or proposes to enter into a
business relationship, provided that such third party shall enter into a
confidentiality agreement with, or otherwise owe a duty or confidentiality to
Merck or Autogen, as applicable.

 

7.9                              Public Announcement

 

Except as required by law, order or
regulation of a governmental agency or a court of competent jurisdiction, no
other announcement, public release or notice of any kind may be issued without
the express written consent of both parties, which consent shall not be
unreasonably withheld, provided, however, the parties shall prepare a joint press
release announcing the transaction set forth in this agreement to be issued
promptly upon execution of this agreement.

 

7.10                       Continuous disclosure obligations

 

Autogen is a subsidiary of Australia Wide
Industries Limited (“AWI”) ACN 000 248 304, which is listed on the Australian
Stock Exchange (“ASX”).  As such Autogen
is subject to the continuous disclosure requirements of the ASX.  The obligations of Autogen under this
agreement will not restrict it or AWI from making whatever disclosures are
necessary for the purposes of fulfilling the requirements applicable to AWI as
a company listed on the ASX, and neither Autogen or AWI is under any obligation
to delay the public release of any required announcement pending the provision
of any consent or approval from Merck. 
The above provision will also apply with such adaptations as are
necessary to disclosure obligations imposed upon Merck as a subsidiary of its
listed parent Merck KGaA.

 

19

 

8.                                     LIABILITY

 

8.1                              Responsibility for Products

 

Merck must ensure at all times during the
Term that Products are tested, manufactured, used and sold strictly in
accordance with all relevant applicable requirements and standards of relevant
jurisdictions and Merck will be responsible for conducting its own independent
examination and verification of the accuracy and suitability of Licensed
Patents and Licensed Technology and for ensuring the same are suitable for the
purposes for which they are provided.

 

8.2                              Autogen not liable

 

Except as provided in clauses 9.2
and 13.2, Autogen is not liable (in
contract or tort or otherwise) to compensate Merck for any loss howsoever
arising suffered by Merck arising directly or indirectly from the use of the
Licensed Patents or  Licensed Technology
or the sale of Products.

 

9.                                     INDEMNITIES

 

9.1                              Indemnity by Merck

 

Merck agrees to indemnify Autogen against
and hold Autogen harmless from any and all Losses arising from or in connection
with:

 

(a)                                  a breach by Merck of any of its warranties or obligations under this
agreement;

 

(b)                                 the manufacture of the Products by Merck or any Sub-licensee;

 

(c)                                  the storage, use, sale, shipping and Marketing of the Product by
Merck or any Sub-licensee;

 

(d)                                 any representations, express, implied or statutory made by Merck or
any Sub-licensee as to the efficacy or safety or use to be made by any
purchaser of the Product including, without limitation, representations made by
reference to the labelling or packaging or the Product; and

 

(e)                                  it must be a term of any Sub-licence granted by Merck that the
Sub-licensee agrees to the same extent and in the same terms as the indemnities
contained in clauses 9.1 (b), (c) and (d) to indemnify Autogen and the Sub-licensee
specifically agrees that it will not challenge the standing of Autogen in the
event of Autogen seeking to rely upon such indemnification;

 

provided that neither Merck nor any
sub-licensee is required to indemnify Autogen for any Losses, to the extent
they result from Autogen’s or its Representatives negligence or breach of any
of Autogen’s warranties or obligations under this agreement.

 

9.2                              Indemnity by Autogen

 

Autogen agrees to indemnify Merck and hold
Merck all harmless from any and all Losses, arising from or in connection with
a breach by Autogen of any of its warranties or obligations under this
agreement provided that Autogen is not required to indemnify 

 

20

 

Merck for any Losses, to the extent they
result from Merck’s or its Representatives negligence or breach of any of Merck’s
warranties or obligations under this agreement.

 

9.3                              Notification regarding indemnity

 

Each party must promptly notify the other
of any claims or suits for which the first party may assert indemnification
from the other party and the first party will permit the other party and its
insurer at the other party’s expense to assume or participate in the defence of
any such claims or suits and the first party will co-operate with the other
party or its insurers in such defence when reasonably requested to do so.

 

10.                              INSURANCE

 

Each party must have and must maintain for
the Term the relevant Required Insurance. 
The Required Insurance must be with a reputable insurer and name the
other party as an additional insured. 
Each party will at the others request provide to that party a
certificate from a reputable insurance broker confirming that the insurance
required by this clause in currently in effect.

 

11.                              TERM AND TERMINATION

 

11.1                       Term

 

Subject to the further provision of this clause 11, the term of this agreement and the rights granted
to Merck under this agreement is for so long as any Product is still Covered By
a Project Patent.

 

11.2                       Termination for breach

 

If one party breaches any term, provision
or obligation of this agreement (the “Defaulting Party”) and the Defaulting
Party fails to:

 

(a)                                  remedy such breach within 60 days after receipt of notice from the
other party requiring remedy of the breach; or

 

(b)                                 if the breach cannot be remedied within the said 60 day period,
commence action within the said 60 day period to remedy the breach and
undertake in writing to the other party to complete remedy of the breach as
soon as practicable thereafter,

 

the other party has the right to terminate
this agreement immediately upon the expiration of the said period of 60 days by
written notice to the Defaulting Party.

 

11.3                       Termination in default of payment

 

This agreement may be forthwith terminated
by a party by giving notice to the other party if that other party defaults in
the payment of any money due by that other party to the first party under this
agreement and such default continues for a period of 30 days after notice has
been given to the other party demanding the payment of such money.

 

21

 

11.4                       Grounds for immediate termination

 

Subject to clause 11.5
this agreement may be terminated by a party giving notice to the other party
upon the happening of any of the following events in respect of that other
party:

 

(a)                                  an Insolvency Event; or

 

(b)                                 if the other party is in breach of an undertaking given pursuant to clause 11.2(b).

 

11.5                       Reconstruction exception

 

A winding up or liquidation for the
purposes of reconstruction or amalgamation by the other party is not an event
permitting or giving rise to termination if after that reconstruction or
amalgamation the resulting corporation becomes bound by the terms of this
agreement by way of assignment or novation.

 

11.6                       Termination by Autogen

 

Autogen may terminate this agreement upon
notice to Merck if:

 

(a)                                  there is a change of greater than 50% in the control of the issued
voting capital of Merck or a holding company (if any) of Merck other than for
the purpose of internal re-construction;

 

(b)                                 a person or persons not previously in Control of Merck obtain
Control of Merck or a holding company (if any) of Merck; or

 

(c)                                  if Merck or any of its Affiliates or any Sub-licensee or any of its
Affiliates challenges or seeks or causes to be challenged the validity of the
Project Patents, provided that in respect of a Sub-licensee not being an
Affiliate, termination will be limited to the country or countries to which
such Sub-licence relates.

 

11.7                       Termination by Merck

 

Merck may terminate this agreement upon
notice to Autogen if there is a change of greater than 50% in the control of
the issued voting capital of Autogen or a holding company (if any) of Autogen
other than for the purpose of internal re-construction.

 

11.8                       Termination to be without prejudice

 

Any termination of this agreement is
without prejudice to the rights which a party has against the other in respect
of anything done or omitted to be done hereunder prior to such termination or
in respect of any sums or other claims outstanding at the time of termination.

 

12.                              OBLIGATIONS AND RIGHTS ON TERMINATION

 

12.1                       Obligations of Merck

 

Immediately upon termination or expiration
of this agreement, but subject to clause 12.3,
Merck must:

 

22

 

(a)                                  pay all outstanding balances with respect to the Product within the
terms of this agreement;

 

(b)                                 remove all signs, advertising displays, labels and the like
identifying Merck as a licensee of the Product and thereafter Merck will not
use such signs and displays in connection with any business conducted by it and
will not in any way refer to its previous association with the Product for any
commercial purpose whatsoever; and

 

(c)                                  not conduct its business so as to falsely reflect discredit on
Autogen or the Product.

 

12.2                       Obligations of Autogen

 

Immediately upon termination or expiration
of this agreement, Autogen must:

 

(a)                                  as soon as conveniently possible reconcile all accounts relating to
Merck; and

 

(b)                                 accept all outstanding balances within existing terms of settlement
within the terms of this agreement.

 

12.3                       Limitation of Merck’s rights

 

Merck is not in any circumstances entitled
to compensation for goodwill which may have accrued to the marketing of the
Product in the Territory.

 

13.                              WARRANTIES

 

13.1                       General warranties

 

Each party represents and warrants to the
other that:

 

(a)                                  it has all powers and authorisations necessary to enter into this
agreement and observe its obligations hereunder and allow this agreement to be
enforced against it; and

 

(b)                                 all necessary consents, approvals and authorisations of all governmental
authorities required to be obtained by that party in connection with this
agreement have been obtained; and

 

(c)                                  the execution and delivery of this agreement does not contravene any
law, regulation or official directive or any obligations or undertakings,
contractual or otherwise, by which it or any of its assets are bound or cause a
limitation on its powers to be exceeded; and

 

(d)                                 the performance of the party’s obligations under this agreement:

 

(i)                                     do not and will not conflict with or violate any requirement of
applicable laws or regulations; and

 

(ii)                                  do not and will not conflict with, or constitute a default under any
contractual obligation of that party; and

 

23

 

(e)                                  there does not presently exist any event which would either now or
with the effluxion of time entitle the other party to terminate this agreement
pursuant to clause 11; and

 

(f)                                    it is not a party to any pending or threatened action or proceeding
affecting it or any of its assets before a court, governmental agency,
commission or arbitrator where an adverse outcome could reasonably be expected
to adversely impact upon the performance of its obligations under this
agreement; and

 

(g)                                 it has no immunity from the jurisdiction of a court or from legal
process (whether through service of notice, attachment prior to judgment,
attachment in aid of execution, execution or otherwise).

 

13.2                       Specific warranty re Licensed Patents

 

Autogen warrants to Merck that:

 

(a)                                  as at the date of this agreement it has disclosed to Merck details
of all prior art sighted by Autogen by way of international search in relation
to the Licensed Patents; and

 

(b)                                 at the date of this agreement it is unaware of any other Patent
which has not been disclosed to Merck and which may be infringed by Merck
exercising the Licensed Patents in accordance with the terms of this agreement.

 

13.3                       Warranties by Merck

 

Merck warrants to Autogen that:

 

(a)                                  it will obtain or has obtained from its Representatives who have
access to the Licensed Technology written obligations to treat such information
as confidential strictly in accordance with this agreement; and

 

(b)                                 that it has made its own enquiries into the validity and
enforceability of the Licensed Patents and satisfied itself that the usage by
Merck, its Affiliates or sub-licensees of the Licensed Patents and the Licensed
Technology do not and will not infringe the intellectual property rights of any
third party.

 

14.                              PROTECTION OF LICENSED PATENTS

 

14.1                       Maintenance of Licensed Patents

 

Autogen is responsible for the cost of
preparing, filing, prosecuting and maintaining the Autogen Patents but nothing
expressed or implied herein necessarily obliges Autogen to institute legal
proceedings to protect same.  The party
responsible for the cost of preparing, filing, prosecuting and maintaining the
Stage 1 Patents will be determined in accordance with the Research
Agreement.  Merck is responsible for the
cost of preparing, filing, prosecuting and maintaining the Stage 2
Patents.  Nothing expressed or implied
herein necessarily obliges Merck to institute legal proceedings to protect
Stage 1 Patents or Stage 2 Patents.

 

24

 

14.2                       Reporting infringements

 

A party must promptly report to the other
in writing particulars of any action or activity of which the first party
becomes aware which might reasonably amount to infringement of or challenge to
any of the Rights.

 

14.3                       Conduct of proceedings regarding Rights

 

Merck has the first right to take control of
and conduct any infringement proceedings in respect of the Rights where such
infringement is within the Licensed Field. 
Should Merck undertake such proceedings Autogen must fully co-operate
with Merck in relation to such action including the lending of Autogen’s name
to the action and assistance by personnel of Autogen.  The costs and expenses of any such action
will be borne by Merck, and the proceeds of such action after payment of Merck’s
reasonable external costs will be divided between Autogen and Merck on the
basis that Autogen gets 50% and Merck the balance.  In the event Merck does not wish to undertake
the conduct of such proceedings on its own, Autogen and Merck must discuss
whether they will undertake joint proceedings and if so on what basis.  If no such agreement can be reached Autogen is
entitled to bring an action in its own name, and Merck must provide Autogen
with all reasonable assistance including lending Merck’s name to such
action.  Autogen must bear all the costs
of such an action, and the proceeds of any such action belongs to Autogen
absolutely.

 

14.4                       Royalties

 

Merck is not entitled to withhold or deduct any amount
from any royalty payable to Autogen on account of any proceeding as referred to
in clause 14.3.

 

15.                              INFRINGEMENT OF OTHERS RIGHTS

 

15.1                       Notification of action

 

In the event that legal action is
threatened or commenced against Merck or any Sub-licensee arising out of Merck’s
use of Autogen Patents or Autogen Know-How, Merck must not make any admissions
or enter into any substantive steps in connection therewith but must promptly
notify Autogen.

 

15.2                       Autogen action

 

If such legal action against Merck or a
Sub-licensee arises out of the use of the Autogen Patents or Autogen Know-How
in accordance with the terms and conditions of this agreement in relation to
Products, then Autogen must defend and/or assist in the defence of such
litigation, and must bear the reasonable costs and expenses of such
defence.  If any damages or awards are assessed
against Merck, then provided that Merck has at all times followed the
instructions of, or otherwise obtained the consent of, Autogen in respect of
the defence of such claims, then such damages or awards must, as well as any
and all reasonable costs incurred by Merck, be satisfied and paid by Autogen.

 

15.3                       Merck action

 

If such legal action against Merck related
to the use by Merck, Merck Affiliates or Sub-licensee of the Autogen Patents or
Autogen Know-How or use of Stage 1 Patents, Stage 1 

 

25

 

Know-How or Stage 2 Patents or Stage 2
Know-How other than in accordance with the terms and conditions of this
agreement Merck must promptly notify Autogen of the commencement of legal
action. Merck must bear all its own costs and expenses and must be responsible
for awards against it and Autogen, as well as any and all reasonable costs
incurred by Autogen, to the extent that indemnification, warranties and other
claims may not be available against Autogen. 
If any amounts are recovered by or awarded or paid to Merck from or by a
third party as a result of any such action or litigation, Merck must from such
amounts reimburse Autogen for all costs and amounts paid by Autogen in
connection with such action or litigation and must, after deducting the legal
costs incurred by it in taking such legal or other action, pay to Autogen from
any compensation recovered thereby, Autogen’s part thereof determined in
accordance with the respective interests of the parties in such compensation.

 

16.                              CONSTRUCTION OF PATENTS

 

If in any proceedings in which the validity
infringement or priority of any claim of any patent or patent application
included in Licensed Patents is in issue a Final Judgment is obtained the
construction placed upon any such claim by such a Final Judgment must be
thereafter followed not only as to such claim but as to all claims to which
such construction applies with respect to acts occurring thereafter.

 

17.                              FORCE MAJEURE

 

17.1                       Party not liable

 

Where a party is required under this
agreement to perform an obligation or do any act or thing by a designated time
or date (other than an obligation to make payment) (“Obligation”),
the part is not be liable for any delay in performing or for failure to perform
an Obligation where the delay or failure arises from Force Majeure and that
party has complied with this clause.

 

17.2                       Notice of Force Majeure

 

A party who claims Force Majeure must:

 

(a)                                  give the other party prompt notice of the Force Majeure with
reasonably full particulars and an estimate of the extent and duration of its
delay in performance, or inability to perform; and

 

(b)                                 use all possible diligence to remove the Force Majeure as quickly as
possible provided that this will not oblige the party to settle on terms
unsatisfactory to that party any strike, lockout or other labour difficulty, or
any investigation or proceeding by any governmental authority or any litigation
by any third party.

 

17.3                       Termination in case of Force Majeure

 

If the delay continues beyond 30 Business
Days, after the notice given under clause 17.2,
the parties must meet to discuss in good faith a mutually satisfactory
resolution of the problem and, if unable to achieve such a resolution within a
further 30 Business Days, either party may elect to terminate this agreement by
5 Business Days prior written notice to the other.

 

26

 

18.                              ARBITRATION

 

In case of any disputes arising between the
parties or arising out of the performance or non-performance of the obligations
of either party hereunder, or the termination of this agreement, the parties
will endeavour to settle such disputes amicably between themselves.  If the parties fail to resolve such disputes,
then such disputes shall be finally resolved by arbitration in accordance with
the Rules of Conciliation and Arbitration of the International Chamber of
Commerce (ICC) by one or more arbitrators appointed in accordance with the said
rules.

 

Any such arbitration will be held in
English language and take place in Paris - FRANCE.

 

19.                              NOTICES

 

19.1                       Form of Notice

 

Any notice, approval, consent or other
communication (“notice”) from one party to another (“Recipient”) must be in
writing and be signed by a person duly authorised by the person giving the
notice.

 

19.2                       Manner of Service

 

A notice must be served by:

 

(a)                                  leaving it at the Recipient’s address;

 

(b)                                 sending it by ordinary pre-paid post (airmail if being sent from or
to a place outside of Australia) to the Recipient’s address; or

 

(c)                                  sending it by facsimile to the facsimile number of the Recipient.

 

19.3                       Address for Service

 

Until other details are specified by a
Party as its address or facsimile number for service the following apply:

 

Autogen

 

Address :                                             PO Box 1069, Grovedale, Victoria, Australia

 

Facsimile :                                          61 3 5227 2752

 

Attention :                                       Company Secretary

 

Merck

 

Address :                                             37 rue Saint Romain, 69379 Lyon, CEDEX 08, France

 

Facsimile :                                          33-4-78-75-39-05

 

Attention :                                       Head of Legal Department

 

27

 

19.4                       Time of Service

 

A letter or facsimile will be taken to be
served:

 

(a)                                  in the case of a delivered letter, on the day of delivery, unless
delivery is made on a non Business Day or after 4:30 p.m. (local time in
the place of receipt) on a Business Day, in which case it will be taken to be
served on the next Business Day;

 

(b)                                 in the case of a posted letter, on the third (or seventh in the case
of airmail) Business Day after posting; and

 

(c)                                  in the case of a facsimile, on receipt by the party giving the
notice of a transmission confirmation report, unless within one Business Day of
receipt the Recipient has informed the party giving the notice that the
transmission was incomplete or garbled, provided that in any case if
transmission is completed after 4:30 p.m. (local time in the place of receipt)
or is received on a non Business Day, the notice will be taken to be served on
the next Business Day.

 

20.                              MISCELLANEOUS

 

20.1                       Time of essence

 

Time will be of the essence of the
obligations of each party to each other under this agreement.

 

20.2                       Severance

 

This agreement is severable and is deemed
to apply separately as to each country comprising the Territory.  A material breach of this agreement in
respect of one or more countries in the Territory will not affect the validity
or enforceability of this agreement as to the other countries comprising the
Territory.  If any provision is held
invalid or unenforceable, in whole or in part in any jurisdiction, then such
invalidity or unenforceability will only affect such provision or part thereof
in such jurisdiction, and will not in any manner affect the provision in this
agreement in any other jurisdiction.  To
the extent legally permissible an arrangement which reflects the original
intent of the parties must be substituted for such invalid or unenforceable
provision.

 

20.3                       Waiver

 

The failure, delay, relaxation or
indulgence by any party in exercising any power or right given to that party
under this agreement will not operate as a waiver of that power or right, nor
will any single exercise of a power or right preclude any other or further
exercise of it or the exercise of any other power or right under this
agreement.  A power or right may only be
waived in writing, signed by the party to be bound by the waiver.

 

20.4                       Relationship of parties

 

Nothing contained in this agreement is to
be construed so as to place any party in the relationship of principal,
employee, agent, partner, joint venturer or legal representative of any other
party.  The parties expressly agree and
acknowledge that each of the parties is an independent contracting party and
does not, unless expressly provided, have the 

 

28

 

authority or power for or on behalf of any
other party to enter into any contract, to incur debts, to accept money, to
assume any obligations or to make any warranties or representations.

 

20.5                       Injunctive relief

 

If there is any conduct or threatened
conduct which is or may be a breach of this agreement, both parties acknowledge
that damages may be inadequate compensation for such a breach and that the
other party is entitled to apply to any court of competent jurisdiction for
interim or permanent injunctive relief or both restraining the other party from
committing any breach or threatened breach of this agreement without showing or
proving any actual damage sustained by it. 
Such rights and remedies will be cumulative and in addition to any other
rights or remedies which that party may be entitled to at law or in equity.

 

20.6                       Proper law

 

This agreement must be construed in
accordance with and governed by the laws of the United Kingdom and its form,
execution, validity, construction and effect is to be determined in accordance
with the laws of the United Kingdom.

 

20.7                       Rule of construction

 

No rule of construction applies to
this agreement to the disadvantage of a party because that party was
responsible for the preparation of this agreement or any part of it.

 

20.8                       Variation

 

Any modification, alteration, change or
variation of any term or condition of this agreement must be in writing,
executed by all parties.

 

20.9                       Assignment

 

This agreement is personal to the respective parties
and neither is entitled to assign in whole or in part without the prior written
consent of the other party.

 

20.10                Further documents

 

Each party agrees that it will forthwith
upon the request of the other party execute and deliver all such instruments
and agreements and will take all such other actions as the other party may
reasonably request from time to time in order to give effect to the provisions
and purposes of this agreement.

 

20.11                Affiliates’ actions

 

Each party will ensure that none of its
Affiliates takes any action which is inconsistent with that party’s obligations
under this agreement, or which if it was done or not done under this agreement
by that party would amount to a breach of this agreement by that party.

 

29

 

20.12                Costs and Taxes

 

Each party must pay its own costs and
expenses in relation to the negotiation, preparation, execution, delivery,
stamping and registration, completion, variation and discharge of this
agreement and Merck must pay any Tax in respect of the execution, delivery,
performance, release, discharge, amendment, enforcement or attempted
enforcement or otherwise of any of the following:

 

(a)                                  this agreement;

 

(b)                                 any agreement or document entered into or signed under this
agreement;

 

(c)                                  any transaction contemplated under this agreement; and

 

(d)                                 any payment made or received in respect of this agreement,

 

except in any case to the extent to which
such Tax is payable in Australia or on or in respect of the income of Autogen.

 

20.13                Interest on overdue amounts

 

If any amount due under this agreement is
not paid when due, then the party obliged to make payment must pay to the other
party interest at the Base Rate on the amount due and payable, accruing from
day to day and to be computed from the date for payment of the amount until
payment of the amount in full.

 

20.14                Withholding taxes

 

If Merck is legally obliged to deduct or
withhold any tax from any payment, in particular any royalty payment, to be
made to Autogen hereunder, then if such payment is made from its country of
domicile (for tax purposes) Merck must on request provide Autogen with receipts
and any other evidence from relevant revenue authorities which may be required
by Autogen for its own tax affairs, provided that in no circumstances may the
amount withheld be more than the minimum amount required to be withheld under
the double tax treaty between France and Australia and to the extent the
withholding is greater than the minimum amount, Merck is obliged to gross up
such payment so that the net payment actually received by Autogen is not less
than the full payment less the minimum amount.

 

20.15                Counterparts

 

This agreement may be executed in
counterparts, and by the parties on separate or the same counterparts, each of
which is deemed an original, but all of which constitute one and the same
instrument.

 

20.16                Registration of agreement

 

If this agreement or any associated
transaction is required by the law of any country, except Australia, to be
either approved or registered in any country or with any governmental agency,
Merck is responsible for obtaining such approval or registration including without
limiting the generality of the foregoing, causing this agreement to be stamped,
recorded and registered at its cost in such country.  Autogen agrees to co-operate 

 

30

 

in any such application or registration
procedure.  Merck must furnish proof of
compliance with the foregoing to Autogen when and if Autogen so requires.

 

20.17                Not obliged to act contrary to law

 

No party is obliged to carry out or perform
any of the terms of this agreement where doing so would constitute a violation
of any treaty, law, code or regulation of any governmental authority whether
local, national or supranational.  In any
event the other terms of this agreement nevertheless continue and the parties
must use all reasonable endeavours to re-negotiate and amend this agreement so
that the performance of this agreement as so amended will not involve any such
violation.

 

20.18                Statutory rights not limited

 

The powers, remedies and rights conferred
upon the parties by or under any statute are (except to the extent inconsistent
with the terms and provisions expressed in this agreement) be in addition to
the powers, remedies and rights conferred by this agreement.

 

20.19                Consents

 

Unless this agreement provides otherwise
and to the extent permitted by law, a party may, in its absolute discretion,
conditionally or unconditionally give or withhold any approval or consent
permitted or required to be given by it pursuant to this agreement.

 

20.20                Entire agreement

 

This agreement constitutes the entire
agreement between the parties in relation to the subject matter of this
agreement.  Any prior arrangements,
agreements, representations or undertakings are superseded and, except as
expressly provided, each party acknowledges that it has not relied on any
arrangement, agreement, representation or understanding which is not expressly
set out in this agreement.

 

31

 

SCHEDULE 1

 

Autogen
Patents

 

(Referred
to in clause 1.1, definition of “Autogen
Patents”)

 

1. Patent application entitled “A gene and
uses therefor” (AGT-106, AGT-113, AGT-201, AGT-202, AGT-203). National
applications and their status are shown in the following table

 

	
  Country

  	
   

  	
  Appl. No./Patent No.

  	
   

  	
  Filing/Patent Date

  	
   

  	
  Status

  	
   

  
	
  PCT

  	
   

  	
  PR2950/01

  	
   

  	
  07.02.2001

  	
   

  	
  Dormant

  	
   

  
	
  International

  	
   

  	
  PCT/AU02/00109

  	
   

  	
  05.02.2002

  	
   

  	
  Pending

  	
   

  

 

2. Australian patent application PR2950/01 “A
gene and uses therefor” filed on 2 February 2001, in the name of Autogen
Research Pty Ltd.

 

32

 

SCHEDULE 2

 

Stage 1
Patents

 

The
following is a list all of the patent applications (in addition to those
described in Schedule 1)
relating to or arising out of Stage 1 Research.

 

1.
Invention entitled “A novel gene and uses
therefor” Beacon (claiming priority from Australian Patent
Application Nos. PP0117/97 and PP0323/97), filed in the name of Deakin
University and International Diabetes Institute.

 

	
  Country

  	
   

  	
  Appl. No./ 

  Patent No.

  	
   

  	
  Filing/ 

  Patent Date

  	
   

  	
  Status

  	
   

  
	
  Australia

  	
   

  	
  10112/99
  (742651)

  	
   

  	
  30.10.1998

  	
   

  	
  Granted

  	
   

  
	
  Canada

  	
   

  	
  2307839

  	
   

  	
  30.10.1998

  	
   

  	
  Pending
  -

  	
   

  
	
  Europe

  	
   

  	
  98952412.9

  	
   

  	
  30.10.1998

  	
   

  	
  Pending

  	
   

  
	
  Hong
  Kong

  	
   

  	
  00107656.0

  	
   

  	
  29.11.2000

  	
   

  	
  Pending

  	
   

  
	
  Israel

  	
   

  	
  135822

  	
   

  	
  30.10.1998

  	
   

  	
  Pending

  	
   

  
	
  Japan

  	
   

  	
  2000-519076

  	
   

  	
  30.10.1998

  	
   

  	
  Pending

  	
   

  
	
  Mexico

  	
   

  	
  0004223

  	
   

  	
  30.10.1998

  	
   

  	
  Pending

  	
   

  
	
  New
  Zealand

  	
   

  	
  504327

  	
   

  	
  30.10.1998

  	
   

  	
  Accepted

  	
   

  
	
  New
  Zealand

  	
   

  	
  520101
  (Division of NZ Application No. 504327)

  	
   

  	
  10.7.2002

  	
   

  	
  Under
  examination

  	
   

  
	
  Singapore

  	
   

  	
  200002303-6

  	
   

  	
  30.10.1998

  	
   

  	
  Granted

  	
   

  
	
  U.S.A.

  	
   

  	
  09/331,930

  	
   

  	
  30.10.1998

  	
   

  	
  Accepted

  	
   

  
	
  U.S.A.

  	
   

  	
  not
  yet available (divisional of USSN 09/331,930)

  	
   

  	
  30.10.1998

  	
   

  	
  Pending

  	
   

  

 

2.
Invention entitled “A ligand of the protein ‘beacon’”,
claiming priority from Australian Patent Application Nos. PP9919/99 and
PQ6454/00, filed in the name of Autogen Research Pty Ltd.

 

	
  Country

  	
   

  	
  Appl. No./Patent No.

  	
   

  	
  Filing/Patent Date

  	
   

  	
  Status

  	
   

  
	
  PCT

  	
   

  	
  PCT/AU00/00342

  	
   

  	
  19.4.2000

  	
   

  	
  Dormant

  	
   

  
	
  Australia

  	
   

  	
  39469/00

  	
   

  	
  19.4.2000

  	
   

  	
  Pending
  – examination requested

  	
   

  
	
  Canada

  	
   

  	
  2370286

  	
   

  	
  19.4.2000

  	
   

  	
  Pending

  	
   

  
	
  Europe

  	
   

  	
  00918579.4

  	
   

  	
  19.4.2000

  	
   

  	
  Pending

  	
   

  
	
  Hong
  Kong

  	
   

  	
  02106821.0

  	
   

  	
  18.9.2002

  	
   

  	
  Pending

  	
   

  
	
  Israel

  	
   

  	
  146035

  	
   

  	
  19.4.2000

  	
   

  	
  Pending

  	
   

  
	
  Japan

  	
   

  	
  2000-614280

  	
   

  	
  19.4.2000

  	
   

  	
  Pending

  	
   

  
	
  Mexico

  	
   

  	
  PA/2001/010743

  	
   

  	
  19.4.2000

  	
   

  	
  Pending

  	
   

  
	
  New
  Zealand

  	
   

  	
  514754

  	
   

  	
  19.4.2000

  	
   

  	
  Under
  examination

  	
   

  
	
  Singapore

  	
   

  	
  200106345-2

  	
   

  	
  19.4.2000

  	
   

  	
  Pending

  	
   

  
	
  U.S.A.

  	
   

  	
  09/959,164

  	
   

  	
  19.4.2000

  	
   

  	
  Pending

  	
   

  

 

33

 

3.Invention
entitles “Novel genes and their use in
modulation of obesity, diabetes and energy imbalance”, (B38, B55 (Tanis), B60),
claiming priority from US Provisional Patent application No. 60/141,441.

 

	
  Country

  	
   

  	
  Appl. No./Patent No.

  	
   

  	
  Filing/Patent Date

  	
   

  	
  Status

  	
   

  
	
  PCT

  	
   

  	
  PCT/AU00/00786

  	
   

  	
  29.6.2000

  	
   

  	
  Dormant

  	
   

  
	
  Australia

  	
   

  	
  55129/00

  	
   

  	
  29.6.2000

  	
   

  	
  Pending
  – examination requested

  	
   

  
	
  Canada

  	
   

  	
  2377784

  	
   

  	
  26.9.2000

  	
   

  	
  Pending

  	
   

  
	
  Europe

  	
   

  	
  00940047.4

  	
   

  	
  29.6.2000

  	
   

  	
  Pending

  	
   

  
	
  Hong
  Kong

  	
   

  	
  60/141441

  	
   

  	
  26.6.2000

  	
   

  	
  Pending

  	
   

  
	
  Israel

  	
   

  	
  147183

  	
   

  	
  29.6.2000

  	
   

  	
  Pending

  	
   

  
	
  Japan

  	
   

  	
  2001-508333

  	
   

  	
  29.6.2000

  	
   

  	
  Pending

  	
   

  
	
  Mexico

  	
   

  	
  PA/2001/013425

  	
   

  	
  29.6.2000

  	
   

  	
  Pending

  	
   

  
	
  New
  Zealand

  	
   

  	
  516211

  	
   

  	
  29.6.2000

  	
   

  	
  Under
  examination

  	
   

  
	
  Singapore

  	
   

  	
  00108084-5

  	
   

  	
  29.6.2000

  	
   

  	
  Pending

  	
   

  
	
  U.S.A.

  	
   

  	
  10/039,050

  	
   

  	
  29.6.2000

  	
   

  	
  Pending

  	
   

  

 

4.
Invention entitled “A method of treatment and
agents for same” (modulator of calpain, calpastain & myofibrillar
protein), claiming priority from Australian Patent Application No. PQ6565/00,
filed in the name of Autogen Research Pty Ltd.

 

	
  Country

  	
   

  	
  Appl. No./Patent No.

  	
   

  	
  Filing/Patent Date

  	
   

  	
  Status

  	
   

  
	
  PCT

  	
   

  	
  PCT/AU01/00348

  	
   

  	
  28.3.2001

  	
   

  	
  Lapsed
  – national phase applications not proceeded with

  	
   

  

 

5.
Invention entitled “A novel gene and uses therefor”
(H24, H15, H20), filed in
the name of Autogen Research Pty Ltd, International Diabetes Institute
and Deakin University.

 

	
  Country

  	
   

  	
  Appl. No./Patent No.

  	
   

  	
  Filing/Patent Date

  	
   

  	
  Status

  	
   

  
	
  PCT

  	
   

  	
  PCT/AU02/01099

  	
   

  	
  13.8.2002

  	
   

  	
  Pending

  	
   

  
	
  Australia

  	
   

  	
  PR7042/01

  	
   

  	
  14.8.2001

  	
   

  	
  Dormant
  – continued as PCT/AU02/01099

  	
   

  
	
  U.S.A

  	
   

  	
  60/323,281

  	
   

  	
  18.9.2001

  	
   

  	
  Dormant
  – continued as PCT/AU02/01099

  	
   

  

 

6.
Invention entitled “A gene and uses therefor”
(AGT-106, AGT-113, AGT-201, AGT-202 and AGT-203), filed in the name of Autogen
Research Pty Ltd, International Diabetes Institute and Deakin University.

 

	
  Country

  	
   

  	
  Appl. No./Patent No.

  	
   

  	
  Filing/Patent Date

  	
   

  	
  Status

  	
   

  
	
  PCT

  	
   

  	
  PCT/AU02/00109

  	
   

  	
  5.2.2002

  	
   

  	
  Pending

  	
   

  
	
  Australia

  	
   

  	
  PR2950/01

  	
   

  	
  7.2.2001

  	
   

  	
  Dormant
  – continued as PCT/AU02/00109

  	
   

  

 

34

 

7.
Invention entitled “A gene and uses therefor”
(L25, L27, L28, S6, S9, S10, S15 and S31), filed in the name of Autogen Research Pty Ltd, International
Diabetes Institute and Deakin University.

 

	
  Country

  	
   

  	
  Appl. No./Patent No.

  	
   

  	
  Filing/Patent Date

  	
   

  	
  Status

  	
   

  
	
  PCT

  	
   

  	
  PCT/AU02/00628

  	
   

  	
  21.5.2002

  	
   

  	
  Pending

  	
   

  
	
  Australia

  	
   

  	
  PR5137/01

  	
   

  	
  21.5.2001

  	
   

  	
  Dormant
  – continued as PCT/AU02/00628

  	
   

  

 

8.
Invention entitled “A gene and uses therefor”
(AGT-109, AGT-407, AGT-408, AGT-409, AGT-601, AGT-204), filed in the name of Autogen
Research Pty Ltd, International Diabetes Institute and Deakin University.

 

	
  Country

  	
   

  	
  Appl. No./Patent No.

  	
   

  	
  Filing/Patent Date

  	
   

  	
  Status

  	
   

  
	
  PCT

  	
   

  	
  PCT/AU02/01173

  	
   

  	
  28.9.2002

  	
   

  	
  Pending

  	
   

  
	
  USA

  	
   

  	
  60/315,743

  	
   

  	
  29.8.2001

  	
   

  	
  Dormant
  – continued as PCT/AU02/01173

  	
   

  

 

9.
Invention entitled “A gene and uses therefor”
(AGT-119, AGT-120, AGT-121, AGT-122, AGT-422,
AGT-123 and AGT-504),
filed in the name of Autogen Research Pty Ltd, International Diabetes
Institute and Deakin University.

 

	
  Country

  	
   

  	
  Appl. No./Patent No.

  	
   

  	
  Filing/Patent Date

  	
   

  	
  Status

  	
   

  
	
  USA

  	
   

  	
  60/330,149

  	
   

  	
  16.10.2001

  	
   

  	
  Pending

  	
   

  

 

10.
Invention entitled “A gene and uses therefor”
(AGT-124, AGT-125, AGT-126, AGT-131, and
AGT-432), filed in
the name of Autogen Research Pty Ltd.

 

	
  Country

  	
   

  	
  Appl. No./Patent No.

  	
   

  	
  Filing/Patent Date

  	
   

  	
  Status

  	
   

  
	
  USA

  	
   

  	
  60/353,355

  	
   

  	
  1.2.2002

  	
   

  	
  Pending

  	
   

  

 

11.
Invention entitled “Modulation of
physiological processes and agents useful for the same”, (apolipoprotein
{modulator of Tanis}).

 

	
  Country

  	
   

  	
  Appl. No./Patent No.

  	
   

  	
  Filing/Patent Date

  	
   

  	
  Status

  	
   

  
	
  PCT

  	
   

  	
  Not
  yet available

  	
   

  	
  1.2003

  	
   

  	
  Pending

  	
   

  
	
  Australia

  	
   

  	
  Not
  yet available

  	
   

  	
  1.2003

  	
   

  	
  Pending

  	
   

  

 

35

 

EXECUTED as an agreement

 

 

	
  The common seal of Autogen Limited is

  affixed in accordance with its articles of

  association in the presence of:

  	
   

  	
  )

  )

  )

  )

   

   

  
	
   

  	
   

  	
   Greg
  Collier

  
	
  Director

  	
   

  	
   (name printed)

   

   

  
	
   

  	
   

  	
   Steven Cole

  
	
  Director/Secretary

  	
   

  	
   (name printed)

  

 

 

	
  The common seal of Merck S.A. is affixed

  in accordance with its articles of association

  in the presence of:

  	
   

  	
  )

  )

  )

  )

   

   

  
	
   

  	
   

  	
   Jean-Noel
  Treilles

  
	
  Director

  	
   

  	
   (name printed)

   

   

   Remi Delansorne

  
	
  Director/Secretary

  	
   

  	
   (name printed)

  

 

36

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