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Exhibit 10.4
BLAKE DAWSON WALDRON
LAWYERS
AMENDED AND RE-STATED
AGENCY AGREEMENT
GLYCOTEX, INC.
NOVOGEN LABORATORIES PTY LIMITED
ABN 42 002 489 947
Level 35
225 George Street
Sydney NSW 2000
Telephone: +61 2 9258 6000
Fax: +61 2 9258 6999 REF: BLM SJH 02 1389 1453
(C) BLAKE DAWSON WALDRON 2005
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CONTENTS
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1. INTERPRETATION 1
1.1 Definitions 1
1.2 Rules for interpreting this document 4
1.3 Business Days 5
2. APPOINTMENT OF AGENT 5
2.1 Appointment 5
2.2 Acceptance of appointment 5
3. AGENCY OBLIGATIONS 6
3.1 Negotiation of Clinical Trial Agreements 6
3.2 Execution of Clinical Trial Agreements 6
3.3 Performance of Clinical Trial Agreements 6
3.4 Appropriate personnel 6
3.5 Care, skill, etc. 6
3.6 Judgment 7
3.7 Assistance by Glycotex 7
4. FEES 7
4.1 Fees and disbursements 7
4.2 Invoices 7
4.3 Payment of invoices 7
4.4 Payments 7
4.5 Interest on overdue accounts 7
5. GOODS AND SERVICES TAX 8
5.1 GST Law definitions 8
5.2 GST payable in addition to other amounts 8
5.3 Tax invoice 8
5.4 Adjustments 9
5.5 GST where Glycotex supplies Novogen Laboratories 9
6. MATERIALS AND INTELLECTUAL PROPERTY RIGHTS 9
6.1 Materials and information 9
6.2 Intellectual Property Rights 9
7. CONFIDENTIAL INFORMATION 9
7.1 Confidentiality 9
7.2 Exceptions to obligations of confidentiality 10
7.3 Public domain 10
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8. REPRESENTATIONS AND WARRANTIES 10
8.1 Warranties of each party 10
8.2 Reliance on representations and warranties 11
8.3 Exclusion of conditions and warranties 11
9. LIMITATION OF LIABILITY AND INDEMNITY 11
9.1 Indirect and consequential loss 11
9.2 Indemnity 11
10. FORCE MAJEURE 12
10.1 Notice and suspension of obligations 12
10.2 Effort to overcome 12
10.3 Termination 12
11. TERM AND TERMINATION 12
11.1 Term 12
11.2 Termination by Glycotex 12
11.3 Termination by Novogen Laboratories 13
11.4 Consequences of termination 13
11.5 Survival and accrued rights 13
12. DISPUTE RESOLUTION 14
12.1 Disputes 14
12.2 Notice of Dispute 14
12.3 Negotiation 14
12.4 Resolution of Dispute 14
12.5 Mediation 14
13. NOTICES 15
14. AMENDMENT AND ASSIGNMENT 15
14.1 Amendment 15
14.2 Assignment 15
15. GENERAL 15
15.1 Governing law 15
15.2 Liability for expenses 15
15.3 Relationship of the parties 16
15.4 Giving effect to this document 16
15.5 Waiver of rights 16
15.6 Operation of this document 16
15.7 Exclusion of contrary legislation 16
15.8 Counterparts 17
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ii.
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AMENDED AND RE-STATED AGENCY AGREEMENT
DATE SEPTEMBER 2005
PARTIES
GLYCOTEX, INC., a company incorporated under the laws of
Delaware, United
States of America, c/- 1 Landmark Square, Suite 240, Stamford
Connecticut
06901, USA (GLYCOTEX)
NOVOGEN LABORATORIES PTY LTD ABN 42 002 489 947 (NOVOGEN
LABORATORIES)
RECITALS
A. Glycotex has a worldwide exclusive licence to exploit certain
Intellectual
Property Rights relating to Glucan Products.
B. Novogen Laboratories has expertise and experience in the
arrangement and
negotiation of agreements for the conduct of clinical trials
of
pharmaceutical products in Australia and the conduct of such
clinical
trials.
C. Glycotex appointed Novogen Laboratories as its agent to
negotiate and enter
into Clinical Trial Agreements on the terms and conditions of an
Agency
Agreement dated 30 April 2003.
D. The parties now amend and re-state the Agency Agreement in
accordance with
this document.
OPERATIVE PROVISIONS
1. INTERPRETATION
1.1 DEFINITIONS
The following definitions apply in this document.
BUSINESS DAY means a day that is not a Saturday, Sunday or
public holiday
in Sydney, Australia.
CHANGE IN CONTROL, in relation to Glycotex means:
(a) the acquisition by any Person or Group other than Novogen
Limited of
more than 50% of the combined voting power of the then
outstanding
securities entitled to vote generally in the election of
directors of
Glycotex; or
(b) any merger, consolidation, reorganization, recapitalization,
tender or
exchange offer or any other transaction with or effecting
Glycotex as
a result of which a Person or Group other than the stockholders
of
Glycotex immediately before the transaction owns after the
transaction
more than 50% of the combined voting power of the then
outstanding
securities entitled to vote generally in the election of the
directors
of Glycotex,
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but does not include any acquisition as a result of, or
transaction
involving, an initial public offering of Glycotex's common
stock.
CLINICAL TRIAL means a clinical evaluation of the stability,
tolerability,
synergy or efficacy of a Glucan Product in the Field.
CLINICAL TRIAL AGREEMENTS means agreements for the conduct of
Clinical
Trials with:
(a) Royal North Shore Hospital;
(b) Blacktown Hospital; and
(c) Sutherland Hospital,
and such other parties as Glycotex notifies Novogen Laboratories
from time
to time during the Term.
COMMENCEMENT DATE means the date this document is executed by
the last of
the parties to execute it.
CONFIDENTIAL INFORMATION means:
(a) all Know How relating to Glucan Products and Clinical
Trials;
(b) all Know How created in the course of or as a result of
Clinical
Trials;
(c) all written or oral information disclosed by Glycotex to
Novogen
Laboratories under this document; and
(d) all written or oral information coming to the knowledge of
Novogen
Laboratories in the performance of its obligations as agent
under this
document,
other than information which Novogen Laboratories can
establish:
(e) was in the public domain when it was given to Novogen
Laboratories;
(f) becomes, after being given to Novogen Laboratories, part of
the public
domain, except through disclosure contrary to this document;
or
(g) was lawfully received by Novogen Laboratories from another
person
having the unrestricted legal right to disclose that
information
without requiring the maintenance of confidentiality.
CORPORATIONS ACT means the Corporations Act 2001 (Cth).
DEFAULT RATE means, in relation to an amount which has not been
paid to a
party, a rate equal to the sum of that party's cost of funding
the amount
(if that party were to borrow that amount and as determined
conclusively by
that party) and 2% per annum.
DISPUTE has the meaning given to that term in clause 12.1.
2.
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DISPUTE NOTICE has the meaning given to that term in clause
12.2.
FIELD means the fields of:
(a) therapeutic treatment of skin ulceration (including pressure
sores,
bed sores, venous ulcers, diabetic ulcers and burns) in
humans;
(b) treatment of bone fracture and the enhancement of fixation
of
implanted orthopaedic devices (including pins, screws and
artificial
joints) in humans;
(c) prevention/treatment of ultraviolet light induced skin
damage in
humans;
(d) treatment of injured connective tissues (including injuries
to tendons
and ligaments, such as sporting injuries, inflammation and
surgical
injury) in humans;
(e) joint repair (particularly with artificial joints) in
humans; and
(f) treatment of poorly healing surgically dissected or
transected tissue
in humans.
GLUCAN PRODUCT means any product or formulation containing
(beta)-(1,3)(1,6) glucan for use in the Field.
GOVERNMENT AGENCY means:
(a) a government or government department or other body;
(b) a governmental, semi-governmental or judicial person; or
(c) a person (whether autonomous or not) who is charged with
the
administration of a law.
GROUP means two or more Persons acting as a partnership,
limited
partnership, syndicate, or other group for the purpose of
acquiring,
holding, or disposing of any securities.
GST means:
(a) the same as in the GST Law; and
(b) any other goods and services tax, or any tax applying to
this
transaction in a similar way; and
(c) any additional tax, penalty tax, fine, interest or other
charge under
a law for such a tax.
GST LAW means the same as "GST law" means in A New Tax System
(Goods and
Services Tax) Act 1999 (Cth).
INSOLVENCY EVENT means, for a person, being in liquidation or
provisional
liquidation or under administration, having a controller or
analogous
person appointed to it or any of its property, being taken to
have failed
to comply with a statutory demand, being unable to pay its debts
or
otherwise insolvent, dying, ceasing to be of full legal capacity
or
otherwise
3.
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becoming incapable of managing its own affairs for any reason,
taking any
step that could result in the person becoming an insolvent
under
administration, entering into a compromise or arrangement with,
or
assignment for the benefit of, any of its members or creditors,
or any
analogous event.
INTELLECTUAL PROPERTY RIGHTS means any and all existing and
future
intellectual and industrial property rights throughout the
world, whether
conferred by statute, common law or equity, including rights in
relation to
copyright, trade marks, designs, circuit layouts, plant
varieties, business
and domain names, trade secrets and Know How (including the
right to apply
for registration of any such rights), Patent Rights and other
results of
intellectual activity in the industrial, commercial, scientific,
literary
or artistic fields.
KNOW HOW means technical and other information which is not in
the public
domain including inventions, discoveries, concepts, data,
formulae, ideas,
specifications, procedures for experiments and tests, results
of
experimentation and testing, results of research and development
and
information in laboratory records, data collected during the
course of
clinical trials, case reports, data analyses and summaries and
submissions
to and information from ethics committees and regulatory
authorities.
PATENT RIGHTS means existing and future patents (including any
divisions,
continuations, continuations in part, renewals, reissues,
extensions,
supplementary protection certificates, utility models and
foreign
equivalents thereof) and rights with respect to existing and
future patent
applications and patentable inventions, including the right to
apply for
registration of any such rights.
PERSON means a natural person, company, government, or
political
subdivision, agency, or instrumentality of a government.
TERM means the term of this document as determined under clause
11.
1.2 RULES FOR INTERPRETING THIS DOCUMENT
Headings are for convenience only, and do not affect
interpretation. The
following rules also apply in interpreting this document, except
where the
context makes it clear that a rule is not intended to apply.
(a) A reference to:
(i) legislation (including subordinate legislation) is to
that
legislation as amended, re-enacted or replaced, and includes
any
subordinate legislation issued under it;
(ii) a document or agreement, or a provision of a document
or
agreement, is to that document, agreement or provision as
amended, supplemented, replaced or novated;
(iii) a party to this document or to any other document or
agreement
includes a permitted substitute or a permitted assign of
that
party;
4.
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(iv) a person includes any type of entity or body of persons,
whether
or not it is incorporated or has a separate legal identity,
and
any executor, administrator or successor in law of the
person;
and
(v) anything (including a right, obligation or concept) includes
each
part of it.
(b) A singular word includes the plural, and vice versa.
(c) A word which suggests one gender includes the other
genders.
(d) If a word is defined, another part of speech has a
corresponding
meaning.
(e) If an example is given of anything (including a right,
obligation or
concept), such as by saying it includes something else, the
example
does not limit the scope of that thing.
(f) The word AGREEMENT includes an undertaking or other
binding
arrangement or understanding, whether or not in writing.
(g) The words SUBSIDIARY, HOLDING COMPANY and RELATED BODY
CORPORATE have
the same meanings as in the Corporations Act.
1.3 BUSINESS DAYS
If the day on or by which a person must do something under this
document is
not a Business Day:
(a) if the act involves a payment that is due on demand, the
person must
do it on or by the next Business Day; and
(b) in any other case, the person must do it on or by the
previous
Business Day.
2. APPOINTMENT OF AGENT
2.1 APPOINTMENT
Glycotex appoints Novogen Laboratories as its agent to:
(a) arrange and negotiate Clinical Trial Agreements;
(b) enter into Clinical Trial Agreements on reasonable
commercial terms;
and
(c) perform Glycotex's obligations under Clinical Trial
Agreements.
2.2 ACCEPTANCE OF APPOINTMENT
Novogen Laboratories accepts its appointment under clause 2.1 on
the terms
and conditions of this document.
5.
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3. AGENCY OBLIGATIONS
3.1 NEGOTIATION OF CLINICAL TRIAL AGREEMENTS
Novogen Laboratories must:
(a) use all reasonable endeavours to negotiate Clinical Trial
Agreements
on the most favourable commercial terms available;
(b) keep Glycotex regularly informed of the status and progress
of the
negotiation of Clinical Trial Agreements;
(c) comply with Glycotex's reasonable directions in the
negotiation of
Clinical Trial Agreements; and
(d) enter into Clinical Trial Agreements as agent for Glycotex
on
Glycotex's written direction.
3.2 EXECUTION OF CLINICAL TRIAL AGREEMENTS
Novogen Laboratories must not enter into any Clinical Trial
Agreement or
commit Glycotex to any obligation under any Clinical Trial
Agreement
without Glycotex's prior written consent.
3.3 PERFORMANCE OF CLINICAL TRIAL AGREEMENTS
Novogen Laboratories must:
(a) perform the obligations of Glycotex under any Clinical
Trial
Agreements as agent for Glycotex;
(b) not cause Glycotex to breach any obligation under any
Clinical Trial
Agreements; and
(c) keep Glycotex regularly informed of the performance of
Clinical Trial
Agreements and the status and progress of all Clinical
Trials.
3.4 APPROPRIATE PERSONNEL
Novogen Laboratories shall ensure that its employees, agents
and
co
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