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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
consultants have
appropriate qualifications and experience to perform its
obligat