EXHIBIT 10.2
▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇
L A W Y E R S
--------------------
AMENDED AND RESTATED
MANUFACTURING LICENCE
AND SUPPLY AGREEMENT
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ PTY LIMITED
ACN 099 665 675
NOVOGEN LABORATORIES PTY LIMITED
ABN 42 002 489 947
▇▇▇▇▇ ▇▇
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇
Telephone: ▇▇▇ ▇ ▇▇▇▇ ▇▇▇▇ ▇▇ SEPTEMBER 2003
Fax: ▇▇▇ ▇ ▇▇▇▇ ▇▇▇▇ REF: SJD.BLM.▇▇-▇▇▇▇-▇▇▇▇
(C) ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ 2002-2003
CONTENTS
1. INTERPRETATION 1
1.1 DEFINITIONS 1
1.2 RULES FOR INTERPRETING THIS DOCUMENT 6
1.3 BUSINESS DAYS 7
1.4 APPLICATION OF THIS DOCUMENT 7
2. MANUFACTURING LICENCE 7
2.1 GRANT OF LICENCE 7
2.2 SUB-LICENCES 7
2.3 EXPIRATION OF PATENT RIGHTS 7
2.4 SUB-CONTRACTORS 8
3. SUPPLY OF COMPOUND 8
3.1 SUPPLY OF COMPOUND 8
3.2 FORECASTS OF SUPPLY REQUIREMENTS 8
3.3 NOTICE REQUIREMENTS FOR A LAUNCH DATE 8
3.4 PURCHASE ORDERS 8
3.5 CONFIRMATION OF PURCHASE ORDERS 9
3.6 FULFILMENT OF PURCHASE ORDERS 9
3.7 PLACE OF DELIVERY 9
3.8 PACKING AND TRANSPORT OF COMPOUND 9
3.9 FAILURE TO SUPPLY 9
4. TITLE AND RISK 10
4.1 PASSING OF TITLE TO COMPOUND 10
4.2 RIGHTS BEFORE PASSING OF TITLE 10
4.3 SALES TO THIRD PARTIES 10
4.4 RISK 11
5. FEES FOR THE SUPPLY OF COMPOUND 11
5.1 PURCHASE PRICE 11
5.2 INVOICES FOR PURCHASE PRICE 11
5.3 TIME FOR PAYMENT 11
5.4 REVIEWS OF THE PURCHASE PRICE 11
5.5 ADJUSTMENT OF PURCHASE PRICE 11
5.6 SUSPENSION OF SUPPLY 11
5.7 INSPECTION 12
6. PAYMENT TERMS 12
6.1 PAYMENTS 12
6.2 INTEREST ON OVERDUE ACCOUNTS 12
6.3 TERMINATION 12
7. GOODS AND SERVICES TAX 12
7.1 GST LAW DEFINITIONS 12
7.2 GST PAYABLE IN ADDITION TO OTHER AMOUNTS 12
7.3 TAX INVOICE 13
7.4 ADJUSTMENTS 13
7.5 GST WHERE MEPL SUPPLIES NOVOGEN LABORATORIES 13
8. MANUFACTURING DEVELOPMENTS AND IMPROVEMENTS 13
8.1 MANUFACTURING DEVELOPMENTS 13
8.2 MANUFACTURING IMPROVEMENTS 14
8.3 TECHNICAL ASSISTANCE 14
9. INTELLECTUAL PROPERTY RIGHTS 14
9.1 ACKNOWLEDGMENT 14
9.2 NOTIFICATION 14
9.3 JOINDER OF NOVOGEN LABORATORIES 14
10. CONFIDENTIAL INFORMATION 14
10.1 CONFIDENTIALITY 14
10.2 SECURITY 15
10.3 EXCEPTIONS TO OBLIGATIONS OF CONFIDENTIALITY 15
10.4 PUBLIC DOMAIN 15
11. REPRESENTATIONS AND WARRANTIES 15
11.1 WARRANTIES OF EACH PARTY 15
11.2 REPRESENTATIONS AND WARRANTIES BY NOVOGEN LABORATORIES 16
11.3 REPRESENTATIONS AND WARRANTIES BY MEPL 16
11.4 RELIANCE ON REPRESENTATIONS AND WARRANTIES 17
11.5 EXCLUSION OF CONDITIONS AND ▇▇▇▇▇▇▇▇▇▇ ▇▇
▇▇. LIMITATION OF LIABILITY 17
12.1 INDIRECT AND CONSEQUENTIAL LOSS 17
12.2 STATUTORY WARRANTIES 17
12.3 BARRING OF CLAIMS FOR QUANTITY SHORTFALLS OR DAMAGE 18
12.4 BARRING OF CLAIMS FOR DEFECTS IN QUALITY 18
13. INDEMNITIES AND INSURANCE 18
13.1 CLINICAL TRIAL INDEMNITY 18
13.2 COMMERCIALISATION INDEMNITY 18
13.3 MEPL'S INSURANCE POLICIES 19
13.4 NAME OF NOVOGEN LABORATORIES 19
13.5 CERTIFICATES OF CURRENCY 19
13.6 DEFAULT 19
13.7 EXPIRY 19
ii.
13.8 NOVOGEN LABORATORIES' INSURANCE 19
14. FORCE MAJEURE 19
14.1 NOTICE AND SUSPENSION OF OBLIGATIONS 19
14.2 EFFORT TO OVERCOME 20
14.3 TERMINATION 20
15. TERM AND TERMINATION 20
15.1 TERM 20
15.2 TERMINATION BY MEPL 20
15.3 TERMINATION BY NOVOGEN LABORATORIES 21
15.4 CONSEQUENCES OF TERMINATION 21
15.5 SURVIVAL AND ACCRUED RIGHTS 21
16. DISPUTE RESOLUTION 22
16.1 DISPUTES 22
16.2 NOTICE OF DISPUTE 22
16.3 NEGOTIATION 22
16.4 RESOLUTION OF DISPUTE 22
16.5 MEDIATION 22
17. NOTICES 22
18. AMENDMENT AND ASSIGNMENT 23
18.1 AMENDMENT 23
18.2 ASSIGNMENT 23
19. GENERAL 23
19.1 GOVERNING LAW 23
19.2 RELATIONSHIP OF THE PARTIES 23
19.3 GIVING EFFECT TO THIS DOCUMENT 23
19.4 WAIVER OF RIGHTS 23
19.5 OPERATION OF THIS DOCUMENT 24
19.6 EXCLUSION OF CONTRARY LEGISLATION 24
19.7 COUNTERPARTS 24
SCHEDULE 1: MANUFACTURING PATENT RIGHTS 26
SCHEDULE 2: PRODUCT PATENT RIGHTS 27
iii.
AMENDED AND RESTATED
MANUFACTURING LICENCE AND SUPPLY AGREEMENT
DATE 24 September 2003
PARTIES
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ PTY LIMITED ACN 099 665 675 whose registered office is
situated at ▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ("MEPL")
NOVOGEN LABORATORIES PTY LIMITED ABN 42 002 489 947 whose registered
office is situated at ▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇
("NOVOGEN LABORATORIES")
RECITALS
A. Novogen Research has granted to MEPL a worldwide exclusive licence to
exploit the compound known as "phenoxodiol" (or NV-06) for certain
human therapeutic uses on the terms and conditions of the Licence
Agreement.
B. Novogen Laboratories has expertise and experience in the manufacture of
synthetic isoflavone compounds.
C. MEPL granted to Novogen Laboratories a sub-licence to manufacture
phenoxodiol and to supply phenoxodiol to MEPL and Novogen Laboratories
agreed to accept that sub-licence and to supply phenoxodiol to MEPL on
the terms and conditions of the Original Manufacturing Licence and
Supply Agreement.
D. The parties have agreed to amend and restate the terms and conditions
of the Original Manufacturing Licence and Supply Agreement as set out
in this document with effect from the date of this document.
OPERATIVE PROVISIONS
1. INTERPRETATION
1.1 DEFINITIONS
The following definitions apply in this document.
"AUTHORISATION" means:
(a) an authorisation, consent, declaration, exemption,
notarisation or waiver, however it is described; and
(b) in relation to anything that could be prohibited or restricted
by law if a Government Agency acts in any way within a
specified period, the expiry of that period without that
action being taken,
including any renewal or amendment.
"BUSINESS DAY" means a day that is not a Saturday, Sunday or public
holiday in Sydney, Australia.
"CHANGE OF CONTROL" of MEPL means, a change in:
(a) Control of the composition of the board of directors of the
corporation;
(b) Control of more than half the voting rights attaching to
shares in the corporation; or
(c) Control of more than half the issued shares of the corporation
(not counting any share which carries no right to participate
beyond a specified amount in the distribution of either profit
or capital),
which, for the avoidance of doubt, does not include a change in:
(d) Control of the composition of the board of directors of
Novogen;
(e) Control of more than half the voting rights attaching to
shares in Novogen; or
(f) Control of more than half the issued shares of Novogen
(excluding any part which carries no right to participate
beyond a specified amount in the distribution of either profit
or capital).
"CLINICAL TRIAL" means a clinical evaluation of the stability,
tolerability, synergy or efficacy of a Product for use in the Field.
"COMMENCEMENT DATE" means the date the Original Manufacturing Licence
and Supply Agreement was executed by the last of the parties to execute
it.
"COMPOUND" means the compound known as "phenoxodiol" (or NV-06) in its
primary manufactured form.
"CONFIDENTIAL INFORMATION" means all Manufacturing Know How and all
written or oral information disclosed by MEPL to Novogen Laboratories
under this document, other than information which Novogen Laboratories
can establish:
(a) was in the public domain when it was given to Novogen
Laboratories;
(b) becomes, after being given to Novogen Laboratories, part of
the public domain, except through disclosure contrary to this
document; or
(c) was lawfully received by Novogen Laboratories from another
person having the unrestricted legal right to disclose that
information without requiring the maintenance of
confidentiality.
"CONTROL" means a power or control that is direct or indirect or that
is, or can be, exercised as a result of, by means of or by the
revocation or breach of a trust, an agreement, a practice, or any
combination of them, whether or not they are enforceable. It does not
matter whether the power or control is express or implied, formal or
informal, exercisable alone or jointly with someone else.
"CORPORATIONS ACT" means the Corporations ▇▇▇ ▇▇▇▇ (Cth).
2.
"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 16.1.
"DISPUTE NOTICE" has the meaning given to that term in clause 16.2.
"ENCUMBRANCE" means a mortgage, charge, pledge, lien, hypothecation or
title retention arrangement, a right of set-off or right to withhold
payment of a deposit or other money, a notice under section 255 of the
Income Tax Assessment ▇▇▇ ▇▇▇▇ (Cth), section 260-5 in schedule 1 to
the Taxation Administration Act 1953 (Cth) or any similar legislation,
or an easement, restrictive covenant, caveat or similar restriction
over property, or an agreement to create any of them or to allow any of
them to exist.
"FDA APPROVAL" means the approval by the Food and Drug Administration
of the United States of an investigational new drug (IND) application
for a Product to commence phase 1 Clinical Trials in the United States.
"FIELD" means the prevention, treatment or cure of cancer in humans by
pharmaceuticals delivered or administered by injection or by any other
means but excluding topical applications. For the avoidance of doubt,
"non-topical" applications shall be any means of administration other
than to the skin.
"FORCE MAJEURE EVENT" means any occurrence or omission as a direct or
indirect result of which the party relying on it is prevented from or
delayed in performing any of its obligations (other than a payment
obligation) under this document and that is beyond the reasonable
control of that party, including forces of nature, industrial action
and action or inaction by a Government Agency.
"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.
"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) ▇▇▇ ▇▇▇▇ (Cth).
3.
"INCOTERMS" means the international rules for the interpretation of
trade terms in foreign trade known as "Incoterms" published by the
International Chamber of Commerce.
"INSOLVENCY EVENT" means, for a person, being in liquidation or
provisional liquidation or under administration, having a controller
(as defined in the Corporations Act) or analogous person appointed to
it or any of its property, being taken under section 459F(1) of the
Corporations Act 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 becoming incapable of managing
its own affairs for any reason, taking any step that could result in
the person becoming an insolvent under administration (as defined in
section 9 of the Corporations Act), entering into a compromise or
arrangement with, or assignment for the benefit of, any of its members
or creditors, or any analogous event, otherwise than in the course of a
reorganisation, reconstruction, amalgamation or merger.
"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 ethical committees
and regulatory authorities.
"LAUNCH DATE" means in respect of a Product, the date on which that
Product is first offered for sale commercially in a country in the
Territory.
"LICENCE AGREEMENT" means the agreement of that title between Novogen
Research and MEPL dated on or about the date of this document.
"LICENSED INTELLECTUAL PROPERTY" means the rights granted to MEPL under
the Licence Agreement, which include rights under the Manufacturing
Patent Rights, the Manufacturing Know How and the Product Patent
Rights.
"MANUFACTURING DEVELOPMENTS" means all developments, improvements,
enhancements, adaptations and new Know How, whether patentable or
otherwise, in relation to the synthesis and manufacture of the Compound
which during the Term are made or acquired by MEPL, its employees or
agents, which MEPL is free to license or disclose.
"MANUFACTURING IMPROVEMENTS" means all improvements, developments,
enhancements, adaptations and new Know How, whether patentable or
otherwise, in relation to the synthesis and manufacture of the
Compound, which during the Term are made or acquired by Novogen
Laboratories, its employees, agents or contractors.
4.
"MANUFACTURING KNOW HOW" means all existing Know How of Novogen
Research in relation to the synthesis and manufacture of the Compound
and all Manufacturing Developments and Manufacturing Improvements.
"MANUFACTURING PATENT RIGHTS" means all Patent Rights in the patent
applications set out in schedule 1, and all Patent Rights in relation
to the Manufacturing Know How.
"NOVOGEN" means Novogen Limited ABN 37 063 259 754.
"NOVOGEN RESEARCH" means Novogen Research Pty Limited.
"ORIGINAL MANUFACTURING LICENCE AND SUPPLY AGREEMENT" means the
manufacturing licence and supply agreement entered into between MEPL
and Novogen Laboratories in May 2002.
"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.
"PRODUCT" means any product or formulation containing the compound
known as "phenoxodiol" (or NV-06) for delivery or administration by
injection or by any other means but excluding topical applications,
whether in primary manufactured form, final packaged form or otherwise,
and whether in combination with any other compound or component, active
or otherwise. For the avoidance of doubt "non-topical applications"
shall be any means of administration of the Product other than to the
skin.
"PRODUCT PATENT RIGHTS" means all Patent Rights in the patents and
patent applications set out in schedule 2.
"PURCHASE ORDER" has the meaning given to that term in clause 3.4.
"PURCHASE PRICE" in respect of a quantity of Compound means the total
of:
(a) the cost to Novogen Laboratories of the raw materials used or
incorporated into the Compound;
(b) labour and on costs of Novogen Laboratories in the manufacture
and delivery of the Compound;
(c) manufacturing and general overheads of Novogen Laboratories in
the manufacture and delivery of the Compound;
(d) equipment and facilities costs (including any financing costs)
of Novogen Laboratories in the manufacture and delivery of the
Compound; and
(e) any other costs incidental to the costs in paragraphs (a) to
(d) or otherwise incidental to the manufacture, supply or
delivery of the Compound under this document,
plus a markup amount of 50% of that total.
5.
"SUPPLY DATE" means a date for supply of Compound specified in a
Purchase Order.
"TERM" means the term of this document as determined under clause 15.
"TERRITORY" means the world.
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;
(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.
6.
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.
1.4 APPLICATION OF THIS DOCUMENT
(a) This document varies and amends the Original Manufacturing
Licence and Supply Agreement with effect from the date of
execution of this document.
(b) The terms and conditions of this document replace the terms
and conditions of the Original Manufacturing Licence and
Supply Agreement.
2. MANUFACTURING LICENCE
2.1 GRANT OF LICENCE
MEPL by this document grants to Novogen Laboratories for the Term a
non-transferable, exclusive sub-licence under the Licensed Intellectual
Property, to:
(a) make and keep the Compound in the Territory;
(b) supply the Compound to MEPL anywhere in the Territory;
(c) use any method or process claimed or disclosed in the
Manufacturing Patent Rights or forming part of the
Manufacturing Know How for the purposes of exercising its
rights under paragraphs (a) and (b); and
(d) keep, use, reproduce, apply, develop, modify and enhance the
Manufacturing Know How in the Territory for the purposes of
exercising its rights under paragraphs (a), (b) and (c).
2.2 SUB-LICENCES
Novogen Laboratories must not grant any sub-licence of any of the
rights granted to it under clause 2.1 without the prior written consent
of MEPL.
2.3 EXPIRATION OF PATENT RIGHTS
If during the Term all Patent Rights in the Licensed Intellectual
Property in any country in the Territory lapse or are held invalid,
then subject to clause 15.1, the licence granted in clause 2.1 shall
continue in full force and effect in that country on the same terms as
a licence under the Intellectual Property Rights in the Manufacturing
Know How only.
7.
2.4 SUB-CONTRACTORS
Novogen Laboratories must not engage agents or sub-contractors to
exercise its rights or to perform its obligations under this document
without the prior written consent of MEPL.
3. SUPPLY OF COMPOUND
3.1 SUPPLY OF COMPOUND
Novogen Laboratories agrees to supply Compound to MEPL on the terms and
conditions of this document.
3.2 FORECASTS OF SUPPLY REQUIREMENTS
Within 20 Business Days following the Commencement Date, and thereafter
at least 30 days prior to the end of each Quarter, MEPL shall provide
to Novogen Laboratories a rolling forecast which specifies MEPL's
estimated requirements for supply of Compound for the following four
Quarters, which includes:
(a) the volume of Compound estimated to be required for the
purposes of Clinical Trials;
(b) the volume of Compound estimated to be required for the
purposes of commercialisation; and
(c) the anticipated Supply Dates.
3.3 NOTICE REQUIREMENTS FOR A LAUNCH DATE
MEPL acknowledges that in order for Novogen Laboratories to manufacture
and accumulate sufficient stock of Compound prior to any launch of a
Product, Novogen Laboratories must have adequate notice of the Launch
Date. Accordingly, MEPL must provide to Novogen Laboratories at least 1
year's advance written notice of any Launch Date.
3.4 PURCHASE ORDERS
Subject to clause 3.3, at least 8 weeks prior to any proposed Supply
Date, MEPL must provide to Novogen Laboratories a written order for
Compound, having regard to the forecasts provided by MEPL under clause
3.2 (a "PURCHASE ORDER"). All Purchase Orders must include:
(a) the volume of Compound required;
(b) the indicative Supply Date; and
(c) the place at which delivery is to be made under clause 3.7.
8.
3.5 CONFIRMATION OF PURCHASE ORDERS
Within 5 Business Days of receiving a Purchase Order, Novogen
Laboratories shall notify MEPL in writing:
(a) that it has received that Purchase Order; and
(b) the volume of Compound in the Purchase Order which Novogen
Laboratories is able to supply by the Supply Date.
3.6 FULFILMENT OF PURCHASE ORDERS
Upon confirmation of a Purchase Order under clause 3.5, Novogen
Laboratories shall:
(a) ensure that it manufactures and has available for delivery by
the Supply Date the volume of Compound notified under clause
3.5(b);
(b) deliver to MEPL by the Supply Date the volume of Compound
notified under clause 3.5(b); and
(c) otherwise use all reasonable endeavours to manufacture and
have available for delivery sufficient quantities of Compound
to supply to MEPL by the Supply Date the quantity of Compound
specified in the Purchase Order.
3.7 PLACE OF DELIVERY
Novogen Laboratories shall deliver all Compound C.I.F. (Incoterms,
2000) to MEPL at a port within the Territory nominated by MEPL. Unless
the parties agree otherwise in writing, MEPL may nominate only one port
for delivery in fulfilment of each Purchase Order.
3.8 PACKING AND TRANSPORT OF COMPOUND
Novogen Laboratories must ensure that all Compound to be supplied to
MEPL under this clause 3 is packed in a secure and appropriate manner
so that it is reasonably likely to reach MEPL in good condition under
normal conditions of transport.
3.9 FAILURE TO SUPPLY
If Novogen Laboratories materially and persistently fails to supply to
MEPL by the Supply Dates the volume of Compound requested in the
Purchase Orders provided by MEPL under clause 3.4 (other than as a
result of a suspension under clause 5.6 or clause 14.1):
(a) MEPL may itself manufacture, or may enter into an agreement
with a third party, pursuant to which that third party is
licensed to manufacture and supply to MEPL, the quantity of
Compound required by MEPL which exceeds the quantity which
Novogen Laboratories is able to supply to MEPL under this
document; and
(b) Novogen Laboratories must take all reasonable steps to make
available to MEPL or the third party (as the case may be) on
reasonable commercial terms such Know How of Novogen
Laboratories as is necessary to enable MEPL or the third party
9.
(as the case may be) to manufacture the additional quantity of
Compound referred to in paragraph (a),
until such time as Novogen Laboratories demonstrates that it is
consistently able to supply the quantity of Compound which meets MEPL's
requirements.
4. TITLE AND RISK
4.1 PASSING OF TITLE TO COMPOUND
Novogen Laboratories retains property in and ownership of all Compound
supplied to MEPL until the whole amount payable to Novogen Laboratories
for that Compound has been paid to Novogen Laboratories, at which time
property and ownership passes to MEPL.
4.2 RIGHTS BEFORE PASSING OF TITLE
Until property and ownership of Compound passes to MEPL under clause
4.1:
(a) Novogen Laboratories may (but need not) call for and recover
possession of that Compound (for which purpose Novogen
Laboratories may enter MEPL's premises without any liability
to MEPL);
(b) MEPL must deliver the Compound to Novogen Laboratories if so
directed by Novogen Laboratories;
(c) subject to clause 4.3, MEPL holds the Compound in the capacity
of a fiduciary for Novogen Laboratories and must keep the
Compound in its possession and take good care of it; and
(d) subject to clause 4.3, MEPL must store the Compound in a
manner that clearly shows Novogen Laboratories' ownership.
4.3 SALES TO THIRD PARTIES
Notwithstanding the provisions of clauses 4.1 and 4.2, if Novogen
Laboratories has not been paid the amount payable in respect of any
Compound, MEPL may, as principal, in the course of its business sell
and deliver the Compound to any third party (and for that purpose
Novogen Laboratories gives to MEPL the right to pass ownership of the
Compound to the third party), provided:
(a) if MEPL is paid for the Compound by the third party, MEPL must
out of the proceeds of sale of the Compound hold the amount
payable to Novogen Laboratories on trust for Novogen
Laboratories and must pay that amount into a separate bank
account being and denoted as a trust account for Novogen
Laboratories; and
(b) if MEPL has not been paid for the Compound by the third party,
MEPL holds the debt owing to it by the third party in respect
of the sale of the Compound upon trust for Novogen
Laboratories and must assign that debt to Novogen Laboratories
upon Novogen Laboratories giving MEPL notice in writing to
that effect and for
10.
the purposes of the assignment of that debt, MEPL irrevocably
appoints Novogen Laboratories as its attorney.
4.4 RISK
Notwithstanding anything in this clause 4, all Compound is at MEPL's
risk from the first to occur of:
(a) the passing of property to MEPL under clause 4.1;
(b) the physical delivery of the Compound to MEPL; or
(c) the physical delivery of the Compound to a carrier for
delivery to MEPL (even if the carrier has not been nominated
or retained by MEPL).
5. FEES FOR THE SUPPLY OF COMPOUND
5.1 PURCHASE PRICE
In consideration of the supply of Compound to MEPL under clause 3, MEPL
must pay to Novogen Laboratories the Purchase Price on the terms and
conditions of this document.
5.2 INVOICES FOR PURCHASE PRICE
Within 5 Business Days of delivery of Compound to MEPL under clause
3.7, Novogen Laboratories must render to MEPL a written invoice setting
out the volume of Compound manufactured, packed and supplied to MEPL
pursuant to the Purchase Order, and the Purchase Price.
5.3 TIME FOR PAYMENT
MEPL must pay to Novogen Laboratories the amount stated on each invoice
correctly rendered under clause 5.2 within 14 Business Days of the date
of the invoice.
5.4 REVIEWS OF THE PURCHASE PRICE
Novogen Laboratories may review and adjust the Purchase Price once each
Quarter in accordance with clause 5.5.
5.5 ADJUSTMENT OF PURCHASE PRICE
In any Quarterly review under clause 5.4, the Purchase Price will be
adjusted by reference to the actual component costs of the Purchase
Price for the preceding Quarter, and any adjustment will be effective
for all Purchase Orders made after written notice by Novogen
Laboratories to MEPL of that adjustment.
5.6 SUSPENSION OF SUPPLY
If MEPL does not pay any amount due in accordance with this clause 5,
Novogen Laboratories may suspend the supply of any further Compound to
MEPL until payment is made.
11.
5.7 INSPECTION
MEPL may during normal business hours and upon reasonable notice by its
authorised representatives (including accountants and auditors) inspect
the records and books of account of Novogen Laboratories to determine
whether the Purchase Price has been calculated in accordance with this
document. Such authorised representatives may take such copies and
extracts of the records and books of account as they think fit and
Novogen Laboratories must, and must ensure that its agents and
contractors, give such authorised representatives such assistance as is
necessary, including by providing access to facilities, hardware,
software and documents, to enable the Purchase Price to be ascertained
or verified.
6. PAYMENT TERMS
6.1 PAYMENTS
All amounts due and payable under clause 5 must be calculated and paid
in United States dollars and must be paid by bank cheque or electronic
transfer to an account notified by the payee in writing.
6.2 INTEREST ON OVERDUE ACCOUNTS
Interest shall accrue at the Default Rate on the outstanding balance of
all overdue amounts payable under clause 5, calculated daily.
6.3 TERMINATION
At the end of the Term the price for all Compound delivered to MEPL
becomes immediately due and payable to Novogen Laboratories, despite
any other payment terms in this document.
7. GOODS AND SERVICES TAX
7.1 GST LAW DEFINITIONS
Words defined in the GST Law have the same meaning in this clause 7,
unless the context makes it clear that a different meaning is intended.
7.2 GST PAYABLE IN ADDITION TO OTHER AMOUNTS
In addition to paying all amounts payable by MEPL under this document,
MEPL must:
(a) pay to Novogen Laboratories an amount equal to any GST payable
on any supply by Novogen Laboratories under or in connection
with this document without deduction or set-off of any other
amount;
(b) make that payment:
(i) if Novogen Laboratories must pay GST on or after
receiving the consideration or any part of it - as
and when MEPL must pay or provide the consideration
or that part of it;
12.
(ii) if Novogen Laboratories must pay GST on issuing an
invoice under this document - on the earlier of the
due date for payment of that invoice, or 10 Business
Days following the end of the month in which Novogen
Laboratories issued that invoice; and
(iii) if Novogen Laboratories must pay GST upon the
occurrence of some other event - within 5 Business
Days of a written request by Novogen Laboratories for
payment for the GST, which may be in the form of a
tax invoice (or an adjustment note); and
(c) indemnify Novogen Laboratories against, and pay Novogen
Laboratories on demand the amount of:
(i) all GST on the transactions contemplated by this
document; and
(ii) any loss, liability or expense directly or indirectly
incurred in connection with or arising from or caused
by any failure by MEPL to pay any amount as and when
required by this clause 7, for example, any
additional tax, penalty tax, fine, interest or other
charge under a GST Law.
7.3 TAX INVOICE
Within 28 days of a written request from MEPL, Novogen Laboratories
must issue a tax invoice (or an adjustment note) to MEPL for any supply
for which Novogen Laboratories may recover GST from MEPL under this
document, and must include in the tax invoice (or adjustment note) the
particulars required by the GST Law for MEPL to obtain an input tax
credit for that GST.
7.4 ADJUSTMENTS
Novogen Laboratories must refund to MEPL any overpayment by MEPL for
GST, but Novogen Laboratories need not refund to MEPL any amount for
GST paid to the Commissioner of Taxation unless Novogen Laboratories
has received a refund or credit of that amount.
7.5 GST WHERE MEPL SUPPLIES NOVOGEN LABORATORIES
If MEPL must pay GST for anything provided or supplied by MEPL under
this document, Novogen Laboratories must pay to MEPL an amount equal to
that GST in exactly the same way as MEPL must so do for any GST Novogen
Laboratories must pay, and this clause 7 applies to that GST as if MEPL
was Novogen Laboratories, and Novogen Laboratories was MEPL.
8. MANUFACTURING DEVELOPMENTS AND IMPROVEMENTS
8.1 MANUFACTURING DEVELOPMENTS
MEPL shall disclose to Novogen Laboratories all Manufacturing
Developments as soon as is reasonably practicable after becoming aware
of them.
13.
8.2 MANUFACTURING IMPROVEMENTS
Novogen Laboratories shall disclose to MEPL all Manufacturing
Improvements immediately upon becoming aware of them, and by this
document Novogen Laboratories assigns to MEPL absolutely and as
beneficial owner its entire right, title to and interest in all
Intellectual Property Rights in Manufacturing Improvements.
8.3 TECHNICAL ASSISTANCE
MEPL shall promptly supply to Novogen Laboratories such technical
information and assistance as Novogen Laboratories may reasonably
request during the Term in order to exercise its rights and perform its
obligations under this document.
9. INTELLECTUAL PROPERTY RIGHTS
9.1 ACKNOWLEDGMENT
Each party acknowledges that nothing in this document effects an
assignment or transfer to Novogen Laboratories of any right, title or
interest in the Licensed Intellectual Property and Novogen Laboratories
must not represent that it has any right, title or interest in the
Licensed Intellectual Property other than the rights expressly granted
to it under this document.
9.2 NOTIFICATION
Novogen Laboratories shall notify MEPL immediately upon becoming aware
of:
(a) any actual or apparent infringement by any person of any
Intellectual Property Rights in the Licensed Intellectual
Property; or
(b) any assertion or claim by any person that the activities of a
party under this document infringe the Intellectual Property
Rights of any person.
9.3 JOINDER OF NOVOGEN LABORATORIES
If it is necessary that Novogen Laboratories be a party to any
proceedings commenced by MEPL for infringement of the Licensed
Intellectual Property, Novogen Laboratories shall join such proceedings
as a plaintiff and shall at MEPL's cost provide all reasonable
assistance, and execute any documents MEPL reasonably requests, in
relation to the proceedings.
10. CONFIDENTIAL INFORMATION
10.1 CONFIDENTIALITY
Novogen Laboratories shall:
(a) keep and maintain all Confidential Information strictly
confidential;
(b) use Confidential Information only for the purposes for which
it is disclosed; and
14.
(c) not disclose Confidential Information other than to its
employees, authorised sub-contractors, legal advisers,
auditors or other consultants requiring the information for
the purposes of this document and then only upon those persons
undertaking in writing to keep that information strictly
confidential.
10.2 SECURITY
For the purposes of clause 10.1, Novogen Laboratories shall establish
and maintain effective security measures to safeguard the Confidential
Information from unauthorised use or access and shall notify MEPL
immediately upon becoming aware of any suspected or actual unauthorised
use or disclosure of the Confidential Information.
10.3 EXCEPTIONS TO OBLIGATIONS OF CONFIDENTIALITY
The obligations in clauses 10.1 and 10.2 do not apply to the extent
that Novogen Laboratories is required by law to disclose the
Confidential Information, provided that it promptly gives notice to
MEPL of that requirement and discloses only that portion of the
Confidential Information which it is legally required to disclose.
10.4 PUBLIC DOMAIN
No Confidential Information shall be deemed to be in the public domain
merely because it contains information which is in the public domain or
is embraced by a general disclosure which is in the public domain.
11. REPRESENTATIONS AND WARRANTIES
11.1 WARRANTIES OF EACH PARTY
Each party represents and warrants that:
(a) (STATUS) it is a company limited by shares under the
Corporations Act;
(b) (POWER) it has full legal capacity and power to:
(i) own its property and to carry on its business; and
(ii) enter into this document and to carry out the
transactions that this document contemplates;
(c) (CORPORATE AUTHORITY) it has taken all corporate action that
is necessary or desirable to authorise its entry into this
document and its carrying out the transactions that this
document contemplates;
(d) (AUTHORISATIONS) it holds each Authorisation that is necessary
or desirable to:
(i) enable it to properly execute this document and to
carry out the transactions that this document
contemplates;
(ii) ensure that this document is legal, valid, binding
and admissible in evidence; or
15.
(iii) enable it to properly carry on its business,
and it is complying with any conditions to which any of these
Authorisations is subject;
(e) (DOCUMENTS EFFECTIVE) this document constitutes its legal,
valid and binding obligations, enforceable against it in
accordance with its terms (except to the extent limited by
equitable principles and laws affecting creditors' rights
generally), subject to any necessary stamping or registration;
(f) (NO CONTRAVENTION) neither its execution of this document nor
the carrying out by it of the transactions that this document
contemplates, does or will:
(i) contravene any law to which it or any of its property
is subject or any order of any Government Agency that
is binding on it or any of its property;
(ii) contravene any Authorisation;
(iii) contravene any undertaking or instrument binding on
it or any of its property;
(iv) contravene its constitution; or
(v) require it to make any payment or delivery in respect
of any financial indebtedness before it would
otherwise be obliged to do so.
11.2 REPRESENTATIONS AND WARRANTIES BY NOVOGEN LABORATORIES
Novogen Laboratories represents and warrants to MEPL at the time title
to any Compound passes from Novogen Laboratories to MEPL under clause
4, that:
(a) (OWNERSHIP) subject to any rights arising under clause 4,
Novogen Laboratories is the legal and beneficial owner of the
Compound and no other person has or shall have any right,
title or interest in or in relation to the Compound;
(b) (NO ENCUMBRANCE) the Compound is free from any Encumbrance;
(c) (QUALITY) the Compound is of merchantable quality and is fit
for the purpose for which it is intended to be used under this
document;
(d) (PURITY) the Compound is within the specifications accepted
for the purposes of the FDA Approval.
11.3 REPRESENTATIONS AND WARRANTIES BY MEPL
MEPL represents and warrants that:
(a) (OWNERSHIP) to the best of its knowledge it is the legal and
beneficial owner of the Licensed Intellectual Property and to
the best of its knowledge no other person has or shall have
any claim of ownership with respect to the Licensed
Intellectual Property;
16.
(b) (NO ENCUMBRANCE) the Licensed Intellectual Property is free
from any Encumbrance; and
(c) (NO INFRINGEMENT) to its knowledge the exercise by Novogen
Laboratories of the rights granted to Novogen Laboratories
under this document does not infringe the Intellectual
Property Rights of any person.
11.4 RELIANCE ON REPRESENTATIONS AND WARRANTIES
Each party acknowledges that the other party has executed this document
and agreed to take part in the transactions that this document
contemplates in reliance on the representations and warranties that are
made in this clause 11.
11.5 EXCLUSION OF CONDITIONS AND WARRANTIES
Except for the warranties expressly made in this document, all
conditions, warranties, undertakings or representations express or
implied arising by statute, general law or otherwise are expressly
excluded to the extent permitted by law.
12. LIMITATION OF LIABILITY
12.1 INDIRECT AND CONSEQUENTIAL LOSS
Notwithstanding any other provision of this document, and to the extent
permitted by law, in no circumstances is Novogen Laboratories liable in
contract, tort (including negligence or breach of statutory duty) or
otherwise, and whatever the cause, to compensate MEPL for:
(a) any increased costs or expenses;
(b) any economic loss, loss of profit, revenue, business,
contracts or anticipated savings; or
(c) any other special, indirect or consequential loss or damage of
any nature.
12.2 STATUTORY WARRANTIES
If legislation implies in this document any condition or warranty and
that legislation avoids or prohibits provisions in a contract excluding
or modifying the application of or exercise of or liability under such
condition or warranty, the condition or warranty shall be deemed to be
included in this document. However the liability of Novogen
Laboratories for any breach of such condition or warranty shall be
limited at the option of Novogen Laboratories to one or more of the
following:
(a) if the breach relates to goods:
(i) the replacement of the goods or the supply of
equivalent goods;
(ii) the repair of the goods;
(iii) the payment of the cost of replacing the goods or of
acquiring equivalent goods; or
17.
(iv) the payment of the cost of having the goods repaired;
and
(b) if the breach relates to services:
(i) the supplying of the services again; or
(ii) the payment of the cost of having the services
supplied again.
12.3 BARRING OF CLAIMS FOR QUANTITY SHORTFALLS OR DAMAGE
To the extent permitted by law, MEPL may not bring any claim of any
kind for shortfalls or physical damage to any Compound in a delivery
unless MEPL has given notice in writing to Novogen Laboratories setting
out details of that damage within 10 Business Days after the receipt of
the delivery.
12.4 BARRING OF CLAIMS FOR DEFECTS IN QUALITY
To the extent permitted by law, MEPL may not bring any claim of any
kind in respect of any breach of the warranties in clauses 11.2(c) and
11.2(d) unless MEPL has given notice in writing to Novogen Laboratories
setting out details of that breach within 5 Business Days after MEPL
becomes aware of the breach.
13. INDEMNITIES AND INSURANCE
13.1 CLINICAL TRIAL INDEMNITY
MEPL must indemnify and keep indemnified Novogen Laboratories, its
directors, employees and agents against all damages, costs or expenses
(including legal costs and expenses on an indemnity basis) in respect
of any claims, demands, actions, proceedings or prosecution which may
be brought or commenced as a result of or in relation to:
(a) the conduct of Clinical Trials generally; or
(b) any personal injury to or death of any person enrolled in a
Clinical Trial arising out of or relating to the
administration of the Products or any clinical intervention or
procedure provided for or required for the purposes of the
Clinical Trials to which such person would not have been
exposed but for their participation in the Clinical Trials,
except to the extent that the claim, demand, action, proceeding or
prosecution arose from any negligence (including breach of statutory
duty) of Novogen Laboratories or any breach by Novogen Laboratories of
its obligations under this document.
13.2 COMMERCIALISATION INDEMNITY
MEPL must indemnify and keep indemnified Novogen Laboratories, its
directors, employees and agents against all damages, costs or expenses
(including legal costs and expenses on an indemnity basis) in respect
of any claims, demands, actions, proceedings or prosecution which may
be brought or commenced as a result of or in relation to:
(a) the sale, distribution or other commercialisation or
exploitation of Products; or
18.
(b) any packaging, marketing, advertisement or promotion of
Products,
by MEPL, its employees, agents, contractors and sub-licensees,
including any warranty claims, product liability claims, product
recalls and claims for personal injury or property damage, except to
the extent that the claim, demand, action, proceeding or prosecution
arose from the negligence (including breach of statutory duty) of
Novogen Laboratories or the breach by Novogen Laboratories of its
obligations under this document.
13.3 MEPL'S INSURANCE POLICIES
MEPL must take out and maintain in force in the Territory comprehensive
general liability insurance including advertising and product liability
insurance for personal injury and property damage and product recall
insurance, in relation to all Products on terms satisfactory to Novogen
Laboratories.
13.4 NAME OF NOVOGEN LABORATORIES
If requested by Novogen Laboratories, MEPL must ensure that that
Novogen Laboratories is included on the policies referred to in clause
13.3 as a joint insured or loss payee.
13.5 CERTIFICATES OF CURRENCY
At the request of Novogen Laboratories from time to time, MEPL must
provide to Novogen Laboratories a certificate of currency evidencing
its compliance with its obligations under this clause 13.
13.6 DEFAULT
If within 15 Business Days of a request by Novogen Laboratories under
clause 13.5, MEPL does not comply with its obligations under that
clause, Novogen Laboratories may (but is not obliged to) take out and
maintain the insurance and may recover any premiums paid as a debt due
by MEPL.
13.7 EXPIRY
MEPL shall maintain each insurance policy referred to in clause 13.3
until the expiry date of the last Product sold, hired or otherwise
disposed of by or on behalf of MEPL or its sub-licensees.
13.8 NOVOGEN LABORATORIES' INSURANCE
Novogen Laboratories must take out and maintain in force in the
Territory comprehensive general liability insurance policies in
relation to its obligations under this document on terms reasonably
satisfactory to MEPL.
14. FORCE MAJEURE
14.1 NOTICE AND SUSPENSION OF OBLIGATIONS
If a party to this document is affected, or likely to be affected, by a
Force Majeure Event:
(a) that party must immediately give the other prompt notice of
that fact including:
19.
(i) full particulars of the Force Majeure Event;
(ii) an estimate of its likely duration;
(iii) the obligations affected by it and the extent of its
effect on those obligations; and
(iv) the steps taken to rectify it; and
(b) the obligations under this document of the party giving the
notice are suspended to the extent to which they are affected
by the relevant Force Majeure Event as long as the Force
Majeure Event continues.
14.2 EFFORT TO OVERCOME
A party claiming a Force Majeure Event must use its best endeavours to
remove, overcome or minimise the effects of that Force Majeure Event as
quickly as possible. However, this does not require a party to settle
any industrial dispute in any way it does not want to.
14.3 TERMINATION
If a Force Majeure Event continues for more than 3 months, any party
may terminate this document by giving at least 10 Business Days notice
to the other party.
15. TERM AND TERMINATION
15.1 TERM
The rights and obligations of the parties under this document begin on
the Commencement Date and continue until this document is terminated in
accordance with this clause 15.
15.2 TERMINATION BY MEPL
MEPL may terminate this document at any time:
(a) immediately by notice in writing at any time if the Licence
Agreement expires or is terminated for any reason;
(b) immediately if Novogen Laboratories defaults in the
performance of any of its obligations under this document
which in MEPL's reasonable opinion is capable of remedy and
fails to remedy that default within 21 days of receiving
written notice from MEPL specifying the default and requiring
the default to be remedied;
(c) on 21 days written notice if Novogen Laboratories defaults in
the performance of any of its material obligations under this
document which in MEPL's reasonable opinion is not capable of
remedy; and
(d) immediately by notice in writing if:
(i) Novogen Laboratories is involved in an Insolvency
Event; or
20.
(ii) Novogen Laboratories ceases for any reason to be able
lawfully to carry out all the transactions which this
document contemplates may be carried out by Novogen
Laboratories.
15.3 TERMINATION BY NOVOGEN LABORATORIES
Novogen Laboratories may terminate this document at any time:
(a) immediately if MEPL defaults in the performance of any of its
obligations under this document which in Novogen Laboratories'
reasonable opinion is capable of remedy and fails to remedy
that default within 21 days of receiving written notice from
Novogen Laboratories specifying the default and requiring the
default to be remedied;
(b) on 21 days written notice if MEPL defaults in the performance
of any of its material obligations under this document which
in Novogen Laboratories' reasonable opinion is not capable of
remedy; and
(c) immediately by notice in writing if:
(i) there is a Change of Control of MEPL without Novogen
Laboratories' written consent (which shall not be
unreasonably withheld or delayed or conditioned);
(ii) MEPL is involved in an Insolvency Event; or
(iii) MEPL ceases for any reason to be able lawfully to
carry out all the transactions which this document
contemplates may be carried out by MEPL.
15.4 CONSEQUENCES OF TERMINATION
Upon expiration or termination of this document for any reason Novogen
Laboratories must deliver to MEPL or destroy at MEPL's election, all
Compound and Confidential Information in Novogen Laboratories'
possession, custody or power and the provisions of clauses 5, 6 and 7
shall apply with respect to that Compound.
15.5 SURVIVAL AND ACCRUED RIGHTS
Upon termination under this clause 15, this document is at an end as to
its future operation except for:
(a) the enforcement of any right or claim which arises on or has
arisen before termination; and
(b) the obligations of the parties under clauses 1, 6.3, 7, 10,
11.5, 12, 13, 16, 17, 18, 19 (except clause 19.3) and this
clause 15, which survive termination.
21.
16. DISPUTE RESOLUTION
16.1 DISPUTES
If a dispute arises out of or in relation to this document (including
any dispute as to breach or termination of the document or as to any
claim in tort, in equity or pursuant to any statute) (a "DISPUTE"), a
party to this document may not commence any court or arbitration
proceedings relating to the Dispute unless it has complied with this
clause 16 except where the party seeks urgent interlocutory relief.
16.2 NOTICE OF DISPUTE
A party to this document claiming that a Dispute has arisen under or in
relation to this document must give written notice to the other party
specifying the nature of the Dispute (a "DISPUTE NOTICE").
16.3 NEGOTIATION
Upon receipt by a party of a Dispute Notice, Novogen Laboratories and
MEPL must procure that their respective Managing Directors meet to
endeavour to resolve the Dispute expeditiously by negotiation.
16.4 RESOLUTION OF DISPUTE
If the parties have not resolved the Dispute under clause 16.3 within
14 days of receipt of a Dispute Notice, the parties must endeavour to
resolve the Dispute expeditiously using informal dispute resolution
techniques such as mediation, expert evaluation or determination or
similar techniques agreed by the parties.
16.5 MEDIATION
If the parties do not agree within 28 days of receipt of a Dispute
Notice (or such further period as the parties agree in writing) as to:
(a) the dispute resolution technique and procedures to be adopted;
(b) the timetable for all steps in those procedures; and
(c) the selection and compensation of the independent person
required for such technique,
the parties must mediate the Dispute in accordance with the Mediation
Rules of the Law Society of New South Wales.
17. NOTICES
(a) A notice, consent or other communication under this document
is only effective if it is in writing, signed and either left
at the addressee's address or sent to the addressee by mail or
fax. If it is sent by mail, it is taken to have been received
3 working days after it is posted. If it is sent by fax, it is
taken to have been received when the addressee actually
receives it in full and in legible form.
22.
(b) The parties' addresses and fax numbers are those set out
below, or as a party notifies the other:
MEPL
Address: ▇▇▇ ▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇
Fax number: Int + 612 9878 0055
Attention: Managing Director
NOVOGEN LABORATORIES:
Address: ▇▇▇ ▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇
Fax number: Int + 612 9878 0055
Attention: Managing Director
18. AMENDMENT AND ASSIGNMENT
18.1 AMENDMENT
This document can only be amended, supplemented, replaced or novated by
another document signed by the parties.
18.2 ASSIGNMENT
A party may only dispose of, declare a trust over or otherwise create
an interest in its rights under this document with the other party's
consent.
19. GENERAL
19.1 GOVERNING LAW
This document is governed by the law in force in New South Wales.
19.2 RELATIONSHIP OF THE PARTIES
Nothing in this document creates a relationship of employment,
partnership or joint venture between the parties under the laws of any
applicable jurisdiction and no party may act or has the authority to
act as agent of or in any way bind or commit another party to any
obligation.
19.3 GIVING EFFECT TO THIS DOCUMENT
Each party must do anything (including execute any document), and must
ensure that its employees and agents do anything (including execute any
document), that the other party may reasonably require to give full
effect to this document.
19.4 WAIVER OF RIGHTS
A right may only be waived in writing, signed by the party giving the
waiver, and:
(a) no other conduct of a party (including a failure to exercise,
or delay in exercising, the right) operates as a waiver of the
right or otherwise prevents the exercise of the right;
23.
(b) a waiver of a right on one or more occasions does not operate
as a waiver of that right if it arises again; and
(c) the exercise of a right does not prevent any further exercise
of that right or of any other right.
19.5 OPERATION OF THIS DOCUMENT
(a) This document contains the entire document between the parties
about its subject matter. Any previous understanding,
document, representation or warranty relating to that subject
matter is replaced by this document and has no further effect.
(b) Any right that a person may have under this document is in
addition to, and does not replace or limit, any other right
that the person may have.
(c) Any provision of this document which is unenforceable or
partly unenforceable is, where possible, to be severed to the
extent necessary to make this document enforceable, unless
this would materially change the intended effect of this
document.
19.6 EXCLUSION OF CONTRARY LEGISLATION
Any legislation that adversely affects an obligation of a party, or the
exercise by a party of a right or remedy, under or relating to this
document is excluded to the full extent permitted by law.
19.7 COUNTERPARTS
This document may be executed in counterparts.
EXECUTED as an agreement.
EXECUTED by ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ PTY
LIMITED:
/s/ ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ /s/ ▇▇▇▇▇ ▇▇▇▇▇▇
_________________________________ __________________________________
Signature of director Signature of director/secretary
▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
_________________________________ __________________________________
Name Name
24.
EXECUTED by NOVOGEN LABORATORIES PTY
LIMITED:
/s/ ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ /s/ ▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇
_________________________________ __________________________________
Signature of director Signature of director/secretary
▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇
_________________________________ __________________________________
Name Name
25.
SCHEDULE 1
MANUFACTURING PATENT RIGHTS
APPLICATION NO. STATUS
Australia 26510/00 Under examination
Australia PP8685 Lapsed
Brazil 0008222-8 Pending
Canada 2362819 Pending
China 00803816.3 Under examination
Czech Republic PV 2001-2920 Pending
Europe 00904727.5 Under examination
Hong Kong 02103732.5 Pending
Hungary PO105218 Pending
Israel 144008 Pending
Japan 2000-599749 Pending
Mexico 008233 Pending
New Zealand 512696 Lapsed
New Zealand 527700 (divisional) Pending
Norway 20013945 Pending
Singapore 200103867-8 Pending
South Africa 20016502 Pending
Turkey 01/2367 Under examination
United States of America 09/889701 Under examination
26.
SCHEDULE 2
PRODUCT PATENT RIGHTS
APPLICATION/PATENT NO. STATUS
Australia 731951 Granted
Australia 19723/01 Under examination
Australia 750031 Granted
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ Completed provisional
patent application
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ Completed provisional
patent application
Australia PS1594 Completed provisional
patent application
Australia 2002950294 Completed provisional
patent application
Australia 2002951607 Completed provisional
patent application
Australia 2002953453 Completed provisional
patent application
Brazil 9713180-6 Under examination
Brazil 9814343-3 Under examination
Canada 2,265,049 Under examination
Canada 2316349 Pending
Czech Republic PV 699-99 Under examination
Europe 97937345.3 Pending
Europe 98960911.0 Pending
Hong Kong 1019553 Granted
Hungary P9903971 Under examination
Israel 128765 Under examination
Israel 136784 Pending
Japan 10-511105 Under examination
Mexico 992092 Pending
Mexico 006311 Pending
New Zealand 334025 Granted
New Zealand 506063 Under examination
New Zealand 505377 Accepted
Norway 19990965 Pending
Norway 20003201 Pending
People's Republic of China 97198690.8 Under examination
Portugal 98/08503 Pending
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Granted
Sweden 2286-3 Under examination
Turkey TR19990885B Granted
Turkey ▇▇▇▇/▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇ of America 09/254026 Under examination
United States of America Serial number not allocated Filed 6 August 2003
Continuation of 09/254026
United States of America 10/212847 Under examination
United States of America 10/176762 Under examination
United States of America 6455032 Granted
Zimbabwe 12/99 Accepted
International PCT/AU03/00427 Pending
International PCT/AU97/00563 National phase entry
completed
International PCT/AU98/01054 National phase entry
completed