EXHIBIT 10.1
XXXXX XXXXXX XXXXXXX
L A W Y E R S
--------------------
AMENDED AND RESTATED
LICENCE AGREEMENT
NOVOGEN RESEARCH PTY LIMITED
ABN 87 060 202 931
XXXXXXXX XXXXXXX PTY LIMITED
ABN 36 099 665 675
Xxxxx 00
000 Xxxxxx Xxxxxx
Xxxxxx XXX 0000
Telephone: x00 0 0000 0000 00 SEPTEMBER 2003
Fax: x00 0 0000 0000 REF: SJD.BLM.00-0000-0000
(C) XXXXX XXXXXX XXXXXXX 2002-2003
CONTENTS
1. INTERPRETATION 1
1.1 DEFINITIONS 1
1.2 RULES FOR INTERPRETING THIS DOCUMENT 7
1.3 BUSINESS DAYS 8
2. LICENCE TO EXPLOIT THE PRODUCT 8
2.1 GRANT OF LICENCE 8
2.2 EXCLUSIVITY 9
2.3 EXPIRATION OF LICENSED PATENT RIGHTS 9
2.4 SUB-LICENCES 9
2.5 SUB-CONTRACTORS 9
3. CLINICAL TRIALS 10
3.1 CLINICAL TRIALS TO DATE 10
3.2 OBLIGATION TO CONDUCT CLINICAL TRIALS 10
3.3 CONDUCT OF CLINICAL TRIALS 10
3.4 CLINICAL TRIAL MATERIALS 11
3.5 FACILITIES AND PERSONNEL 11
3.6 RECORDS OF CLINICAL TRIALS 11
3.7 INSPECTION OF RECORDS 11
3.8 REPORTS ON CLINICAL TRIALS 11
3.9 PUBLICATION OF RESULTS OF CLINICAL TRIALS 11
3.10 INTELLECTUAL PROPERTY RIGHTS IN CLINICAL TRIAL MATERIALS 11
4. DEVELOPMENTS 12
4.1 MEPL DEVELOPMENTS 12
4.2 NOVOGEN DEVELOPMENTS 12
5. MARKETING AND COMMERCIALISATION 12
5.1 MARKETING AND COMMERCIALISATION 12
5.2 COMMERCIALISATION 12
5.3 RECORDS AND CUSTOMER RELATIONS 12
5.4 MARKETING AND PROMOTION 13
5.5 APPROVAL OF PROMOTIONAL AND ADVERTISING MATERIAL 13
5.6 COMPLIANCE WITH LAWS 13
5.7 STORAGE AND HANDLING 13
5.8 COMPLIANCE WITH LAWS 14
5.9 PACKING AND TRANSPORT OF PRODUCTS 14
6. START GRANT AGREEMENT 14
6.1 ACKNOWLEDGMENT 14
6.2 COMPLIANCE WITH THE START GRANT AGREEMENT 14
6.3 COMPLIANCE WITH REASONABLE DIRECTIONS 14
7. LICENCE FEES 15
7.1 FIRST LUMP SUM LICENCE FEE 15
7.2 SECOND LUMP SUM LICENCE FEE 15
7.3 ROYALTIES DURING THE EXCLUSIVITY PERIOD 15
7.4 ROYALTIES AFTER THE EXCLUSIVITY PERIOD 16
7.5 MILESTONE LICENCE FEES 16
8. PAYMENT TERMS 16
8.1 PAYMENTS 16
8.2 INTEREST ON OVERDUE ACCOUNTS 16
9. REPORTS AND ACCOUNTING 16
9.1 BOOKS AND RECORDS 16
9.2 AUDITOR'S CERTIFICATES 16
9.3 QUARTERLY STATEMENTS 17
9.4 CERTIFICATION 17
9.5 ADJUSTMENTS 17
9.6 INTEREST ON ADJUSTMENTS 18
9.7 INSPECTION 18
10. OTHER COSTS 18
10.1 MAINTENANCE OF LICENSED PATENT RIGHTS 18
10.2 REIMBURSEMENT BY MEPL 18
10.3 REGISTRATION OF PRODUCTS 18
11. GOODS AND SERVICES TAX 18
11.1 GST LAW DEFINITIONS 18
11.2 GST PAYABLE IN ADDITION TO OTHER AMOUNTS 19
11.3 TAX INVOICE 19
11.4 ADJUSTMENTS 19
11.5 GST WHERE MEPL SUPPLIES NOVOGEN RESEARCH 20
12. OTHER DEDUCTIONS AND WITHHOLDINGS 20
13. INTELLECTUAL PROPERTY RIGHTS 20
13.1 ACKNOWLEDGMENT 20
13.2 MAINTENANCE OF LICENSED INTELLECTUAL PROPERTY 20
13.3 NOTIFICATION 20
13.4 PROCEEDINGS BY MEPL 21
13.5 DIRECTIONS BY NOVOGEN RESEARCH 21
13.6 JOINDER OF NOVOGEN RESEARCH 21
13.7 PROCEEDINGS BY NOVOGEN RESEARCH 21
13.8 JOINDER OF MEPL 21
ii.
13.9 DAMAGES AND SETTLEMENT AMOUNTS 21
13.10 ASSIGNMENT OF INTELLECTUAL PROPERTY RIGHTS 21
14. CONFIDENTIAL INFORMATION 22
14.1 CONFIDENTIALITY 22
14.2 SECURITY 22
14.3 EXCEPTIONS TO OBLIGATIONS OF CONFIDENTIALITY 22
14.4 PUBLIC DOMAIN 22
15. REPRESENTATIONS AND WARRANTIES 22
15.1 WARRANTIES OF EACH PARTY 22
15.2 REPRESENTATIONS AND WARRANTIES BY NOVOGEN RESEARCH 23
15.3 VALIDITY OF LICENSED PATENT RIGHTS 24
15.4 RELIANCE ON REPRESENTATIONS AND XXXXXXXXXX 00
00. LIMITATION OF LIABILITY 24
16.1 LIMITATION OF LIABILITY OF NOVOGEN RESEARCH 24
16.2 LIABILITY FOR INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS 25
16.3 EXCLUSION OF CONDITIONS AND WARRANTIES 25
16.4 INDIRECT AND CONSEQUENTIAL LOSS 25
17. INDEMNITIES AND INSURANCE 25
17.1 CLINICAL TRIAL INDEMNITY 25
17.2 COMMERCIALISATION INDEMNITY 26
17.3 MEPL'S INSURANCE POLICIES 26
17.4 NAME OF NOVOGEN RESEARCH 26
17.5 CERTIFICATES OF CURRENCY 26
17.6 DEFAULT 26
17.7 EXPIRY 26
17.8 NOVOGEN RESEARCH'S INSURANCE 27
18. FORCE MAJEURE 27
18.1 NOTICE AND SUSPENSION OF OBLIGATIONS 27
18.2 EFFORT TO OVERCOME 27
18.3 TERMINATION 27
19. TERM AND TERMINATION 27
19.1 TERM 27
19.2 TERMINATION BY NOVOGEN RESEARCH 27
19.3 TERMINATION BY MEPL 28
19.4 CONSEQUENCES TO MEPL OF TERMINATION 28
19.5 CONSEQUENCES TO NOVOGEN RESEARCH OF TERMINATION 29
19.6 SURVIVAL AND ACCRUED RIGHTS 29
iii.
20. DISPUTE RESOLUTION 29
20.1 DISPUTES 29
20.2 NOTICE OF DISPUTE 29
20.3 NEGOTIATION 29
20.4 RESOLUTION OF DISPUTE 30
20.5 MEDIATION 30
21. NOTICES 30
22. AMENDMENT AND ASSIGNMENT 30
22.1 AMENDMENT 30
22.2 ASSIGNMENT 31
23. GENERAL 31
23.1 GOVERNING LAW 31
23.2 LIABILITY FOR EXPENSES 31
23.3 RELATIONSHIP OF THE PARTIES 31
23.4 GIVING EFFECT TO THIS DOCUMENT 31
23.5 WAIVER OF RIGHTS 31
23.6 OPERATION OF THIS DOCUMENT 32
23.7 OPERATION OF INDEMNITIES 32
23.8 CONSENTS 32
23.9 EXCLUSION OF CONTRARY LEGISLATION 32
23.10 COUNTERPARTS 32
SCHEDULE 1: PRODUCT PATENT RIGHTS 34
SCHEDULE 2: MANUFACTURING PATENT RIGHTS 36
iv.
AMENDED AND RESTATED
LICENCE AGREEMENT
DATE 24 September 2003
PARTIES
NOVOGEN RESEARCH PTY LIMITED ABN 87 060 202 931 ("NOVOGEN RESEARCH")
XXXXXXXX XXXXXXX PTY LIMITED ABN 36 099 665 675 ("MEPL")
RECITALS
A. Novogen Research is the proprietor of certain patents, the applicant
for certain patent applications and the owner of certain know how
relating to:
(a) a method of preparation of the compound known as
"phenoxodiol"; and
(b) agents comprising phenoxodiol and compositions containing it
and its use as a human therapeutic treatment.
B. MEPL wishes to conduct clinical trials relating to the use of
phenoxodiol and to exploit phenoxodiol throughout the world for certain
human therapeutic uses.
C. In May 2002 Novogen Research agreed to grant to MEPL a licence to
conduct clinical trials and to exploit phenoxodiol on terms and
conditions set out in a licence agreement between the parties (the
"ORIGINAL LICENCE AGREEMENT").
D. The parties have agreed to amend and restate the terms of the Original
Licence 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.
"AFFILIATE" means:
(a) in relation to a body corporate, each of:
(i) that body's related bodies corporate;
(ii) that body's directors; and
(iii) the persons who have a substantial holding (as that
term is defined in the Corporations Act) in that
body; and
(b) in relation to a natural person, any:
(i) spouse;
(ii) relative by blood or adoption of that person or that
person's spouse; and
(iii) body corporate in which that person and Affiliates of
that person hold in aggregate more than 20% of the
voting shares.
"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 Limited;
(e) Control of more than half the voting rights attaching to
shares in Novogen Limited; or
(f) Control of more than half the issued shares of Novogen Limited
(not counting any share 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.
"CLINICAL TRIAL MATERIALS" means all medication, Trial Protocols,
results of Clinical Trials, case report forms, study aids, and any
other materials used in, or arising out of, the conduct of Clinical
Trials.
"CLINICAL TRIAL SUBJECT" means a person who is enrolled in a Clinical
Trial, whether or not that person meets all eligibility criteria for
enrolment into the Clinical Trial set out in any Trial Protocol or
otherwise.
2.
"COMMENCEMENT DATE" means the date the Original Licence Agreement was
executed by the last of the parties to execute it.
"COMMERCIALISATION INCOME" means all gross income received by or on
behalf of MEPL or its related bodies corporate (other than Novogen
Research and Novogen Laboratories) as a result of or in connection with
any assignment, sublicensing, or other dealing with MEPL's rights under
this document, other than income received solely in consideration of
the sale, hiring or other disposal of Product.
"COMMONWEALTH" means the Commonwealth of Australia.
"CONFIDENTIAL INFORMATION" means:
(a) in relation to Novogen Research, the Clinical Trial Materials,
the Licensed Know How, all Novogen Developments and MEPL
Developments, all documents, records and reports relating to
the Licensed Intellectual Property or Products, which are
provided by MEPL under this document and all other written or
oral information disclosed by Novogen Research to MEPL under
this document, other than information which MEPL can
establish:
(i) was in the public domain when it was given to MEPL;
(ii) becomes, after being given to MEPL, part of the
public domain, except through disclosure contrary to
this document; or
(iii) was lawfully received by MEPL from another person
having the unrestricted legal right to disclose that
information without requiring the maintenance of
confidentiality; and
(b) in relation to MEPL, all written or oral information disclosed
by MEPL to Novogen Research under this document, other than
information referred to in paragraph (a) and information which
Novogen Research can establish:
(i) was in the public domain when it was given to it;
(ii) becomes, after being given to it, part of the public
domain, except through disclosure contrary to this
document; or
(iii) was lawfully received by it 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 Xxx 0000 (Cth).
3.
"DEED OF ACKNOWLEDGMENT AND UNDERTAKING" means the document so entitled
to be entered into between Novogen Limited and the Industry Research
and Development Board for and on behalf of the Commonwealth.
"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.
"DISCLOSING PARTY" in relation to any information means the party who
disclosed to another party that information.
"DISPUTE" has the meaning given to that term in clause 20.1.
"DISPUTE NOTICE" has the meaning given to that term in clause 20.2.
"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 Xxx 0000 (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.
"EXCLUSIVITY PERIOD" means the period commencing on the Commencement
Date and ending the later of:
(a) the date of expiration or lapsing of the last Patent Right in
the patents and patent applications set out in schedule 1 and
2; or
(b) the date of expiration or lapsing of the last Licensed Patent
Right which MEPL would, but for the licence granted in clause
2.1, infringe in any country in the Territory by doing in that
country any of the things set out in clause 2.1.
"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.
"FIXED AND FLOATING CHARGE" means the document entitled "Deed of Fixed
and Floating Charge" between Novogen Research and St Xxxxxx Bank
Limited dated 30 June 1997.
"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:
4.
(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) Xxx 0000 (Cth).
"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.
"LICENSED INTELLECTUAL PROPERTY" means the Licensed Patent Rights and
the Intellectual Property Rights in the Licensed Know How.
5.
"LICENSED KNOW HOW" means the Manufacturing Know How, all existing Know
How of Novogen Research in relation to Products and its uses in the
Field and all Know How in Clinical Trial Materials, Novogen
Developments and MEPL Developments.
"LICENSED PATENT RIGHTS" means the Product Patent Rights, the
Manufacturing Patent Rights and all Patent Rights in any Novogen
Developments and MEPL Developments.
"MANUFACTURING KNOW HOW" means all existing Know How of Novogen
Research in relation to the synthesis and manufacture of Products.
"MANUFACTURING LICENCE AND SUPPLY AGREEMENT" means the agreement of
that title between MEPL and Novogen Laboratories dated on or about the
date of this document.
"MANUFACTURING PATENT RIGHTS" means all Patent Rights in the patents
and patent applications set out in schedule 2.
"MEPL DEVELOPMENTS" means all developments, improvements, enhancements,
adaptations and new Know How, whether patentable or otherwise, in
relation to the Product or the Licensed Intellectual Property, which
during the Term are made or acquired by MEPL, its employees, agents or
contractors.
"MILESTONE LICENCE FEE" means:
(a) for the calender year ending 31 December 2003: US$1,000,000;
(b) for the calender year ending 31 December 2004: US$2,000,000;
(c) for the calender year ending 31 December 2005: US$4,000,000;
and
(d) for each calender year during the Exclusivity Period following
the year ending 31 December 2005: US$8,000,000,
less any amount payable to Novogen Research during that calendar year
under clause 7.1.
"NET SALES" in relation to any Product means the gross invoice or
contract price of that Product sold, hired or otherwise disposed of by
MEPL, its Affiliates (other than Novogen Laboratories) or sub-licensees
(which for avoidance of doubt does not include mere distributors) to
the first person who is not an Affiliate or sub-licensee of MEPL, after
deducting (to the extent not already deducted):
(a) trade and quantity discounts; and
(b) returns, rebates and allowances actually taken.
"NOVOGEN DEVELOPMENTS" means all developments, improvements,
enhancements, adaptations and new Know How, whether patentable or
otherwise, in the Field in relation to the Product or the Licensed
Intellectual Property which during the Term are made or acquired by
Novogen Research, its employees or agents, which Novogen Research is
free to license or disclose.
"NOVOGEN LIMITED" means Novogen Limited ABN 37 063 259 754.
6.
"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 1.
"QUARTER" means, in respect of any calender year in the Term, the four
quarters of that year, the first of which commences on the first day of
that year.
"START GRANT AGREEMENT" means the agreement entitled "R & D Start Grant
Agreement No: STG/00220" between Novogen Limited and the Industry
Research and Development Board for and on behalf of the Commonwealth,
dated 24 December 1998.
"TAX" means a tax, levy, duty, charge, deduction or withholding,
however it is described, that is imposed by a Government Agency,
together with any related interest, penalty, fine or other charge.
"TERM" means the term of this document as determined under clause 19.
"TERRITORY" means the world.
"TRIAL PROTOCOL" means a protocol for the conduct of a Clinical Trial
as may be developed by MEPL from time to time.
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;
7.
(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.
(h) A reference to "US$" is to the currency of the United States
of America.
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 Licence 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 Licence Agreement.
2. LICENCE TO EXPLOIT THE PRODUCT
2.1 GRANT OF LICENCE
Novogen Research by this document grants to MEPL for the Term a
non-transferable licence under the Licensed Patent Rights and the
Intellectual Property Rights in the Licensed Know How to:
(a) make, have made, sell, hire or otherwise dispose of Products
in the Territory for use in the Field;
8.
(b) offer to make, sell, hire or otherwise dispose of Products in
the Territory for use in the Field;
(c) use and import Products into any country in the Territory for
the purpose of exercising its rights under paragraphs (a) and
(b);
(d) use, reproduce, apply, develop, modify and enhance the
Licensed Know How in the Field;
(e) keep Products and the Licensed Know How for the purpose of
doing any of the things in paragraphs (a) to (d); and
(f) use any method or process claimed or disclosed in the
Manufacturing Patent Rights or forming part of the
Manufacturing Know How for the purpose of exercising its
rights under paragraphs (a) to (e).
2.2 EXCLUSIVITY
The licence granted in clause 2.1 is:
(a) exclusive in the Field and in the Territory during the
Exclusivity Period; and
(b) non-exclusive in the Field and in the Territory from the date
of expiration of the Exclusivity Period until the end of the
Term.
2.3 EXPIRATION OF LICENSED PATENT RIGHTS
If during the Term all Licensed Patent Rights in any country in the
Territory lapse or are held invalid, then subject to clause 19.1, 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 Licensed Know How only.
2.4 SUB-LICENCES
(a) Subject to paragraphs (b) and (c), MEPL may not grant
sub-licences under any of the rights granted to it under this
document without the prior written consent of Novogen
Research.
(b) MEPL may grant a sub-licence to Novogen Laboratories on the
terms and conditions of the Manufacturing Licence and Supply
Agreement.
(c) Novogen Research must grant its consent to any sub-licence
proposed to be granted by MEPL in the circumstances set out in
clause 3.9 of the Manufacturing Licence and Supply Agreement
provided that sub-licence is in terms substantially consistent
with those in the Manufacturing Licence and Supply Agreement.
2.5 SUB-CONTRACTORS
MEPL may not engage agents or sub-contractors to perform its
obligations under this document:
(a) without the prior written consent of Novogen Research; and
9.
(b) unless such agents or sub-contractors first agree in writing:
(i) to comply with confidentiality obligations
substantially identical to those of MEPL under this
document; and
(ii) to assign to Novogen Research all Intellectual
Property Rights in the Field created or acquired by
them in the course of their engagement.
3. CLINICAL TRIALS
3.1 CLINICAL TRIALS TO DATE
Novogen Research represents and warrants to MEPL that:
(a) Novogen Limited has sponsored and funded phase 1 Clinical
Trials in Australia;
(b) Novogen Limited has obtained the FDA Approval; and
(c) the FDA Approval has not been revoked or amended.
3.2 OBLIGATION TO CONDUCT CLINICAL TRIALS
MEPL shall continue current Clinical Trials and undertake further
Clinical Trials on the terms and conditions of this document.
3.3 CONDUCT OF CLINICAL TRIALS
MEPL must and must ensure that its agents, contractors and
sub-licensees:
(a) fund or arrange adequate third party funding of Clinical
Trials;
(b) use all reasonable endeavours to design and conduct Clinical
Trials to generate outcomes which are calculated to result in
regulatory approval of a Product for use in the Field;
(c) conduct Clinical Trials diligently, in good scientific manner,
in compliance with any applicable laws, rules and regulations
of any Government Agency in the Territory (including any laws
governing the protection and privacy of personal information),
in accordance with any Trial Protocol and any other reasonable
directions given by Novogen Research from time to time, and
consistently with the requirements of any applicable good
laboratory practices;
(d) ensure that all Clinical Trial Materials are handled
appropriately and stored securely by MEPL, its employees,
contractors and agents for the duration of the Clinical
Trials;
(e) ensure that MEPL's employees, contractors, sub-licensees and
agents who are involved in carrying out Clinical Trials fully
understand and adhere to any Trial Protocol; and
(f) take all reasonable measures, in consultation with Novogen
Research, to protect Clinical Trial Subjects at risk following
a serious adverse drug experience.
10.
3.4 CLINICAL TRIAL MATERIALS
MEPL shall be solely responsible for providing all Clinical Trial
Materials necessary for the conduct of Clinical Trials.
3.5 FACILITIES AND PERSONNEL
In order to comply with its obligations under this clause 3, MEPL must,
and must ensure that its employees, agents, contractors and
sub-licensees use appropriate skill, experience, equipment and
facilities.
3.6 RECORDS OF CLINICAL TRIALS
MEPL must maintain complete and accurate records in good scientific
manner, which fully record:
(a) all work done and results achieved in the course of Clinical
Trials;
(b) details of MEPL's employees, agents, contractors and
sub-licensees engaged to conduct Clinical Trials, all Clinical
Trial Subjects and all other persons involved in Clinical
Trials; and
(c) the Clinical Trial Materials.
3.7 INSPECTION OF RECORDS
Novogen Research or its nominee may, during normal business hours and
upon reasonable notice to MEPL, inspect and copy the records maintained
by MEPL under clause 3.6, and may take and retain such copies as
Novogen Research thinks fit.
3.8 REPORTS ON CLINICAL TRIALS
(a) Within 5 Business Days of a written request by Novogen
Research from time to time during the Term, MEPL shall submit
a written report to Novogen Research on the status of all
Clinical Trials.
(b) MEPL shall immediately report to Novogen Research any serious
adverse drug experience which occurs during the course of
Clinical Trials, and if requested by Novogen Research, MEPL
shall cooperate in reporting that experience to any relevant
third party or Government Agency.
3.9 PUBLICATION OF RESULTS OF CLINICAL TRIALS
MEPL must not, and must ensure that its employees, agents, contractors
and sub-licensees do not, publish, present in public or make available
to any third party the results of any Clinical Trials without the prior
written consent of Novogen Research.
3.10 INTELLECTUAL PROPERTY RIGHTS IN CLINICAL TRIAL MATERIALS
By this document, MEPL assigns to Novogen Research absolutely and as
beneficial owner, the entire right, title and interest in all
Intellectual Property Rights in all Clinical Trial Materials.
11.
4. DEVELOPMENTS
4.1 MEPL DEVELOPMENTS
MEPL shall disclose to Novogen Research all MEPL Developments as soon
as is reasonably practicable after becoming aware of them, and by this
document MEPL assigns to Novogen Research absolutely and as beneficial
owner the entire right, title and interest in all Intellectual Property
Rights in all MEPL Developments.
4.2 NOVOGEN DEVELOPMENTS
Novogen Research shall disclose to MEPL all Novogen Developments as
soon as is reasonably practicable after becoming aware of them.
5. MARKETING AND COMMERCIALISATION
5.1 MARKETING AND COMMERCIALISATION
Subject to clauses 5.2 to 5.9, MEPL may, at its sole cost and expense,
exploit Products in the Field in the Territory in such manner as it
thinks fit.
5.2 COMMERCIALISATION
MEPL must, and must procure that each of its agents, contractors and
sub-licensees:
(a) conduct any marketing and commercialisation activities on a
commercially reasonable basis, in compliance with any
applicable laws, rules and regulations of any Government
Agency;
(b) observe all reasonable directions and instructions given to it
by Novogen Research about marketing and commercialisation of
any Product, including directions about the preparation of or
amendment of any advertising, publicity, sales literature or
other document relating to the Product; and
(c) otherwise act as it reasonably considers to be most beneficial
to the interests of MEPL and Novogen Research.
5.3 RECORDS AND CUSTOMER RELATIONS
MEPL must, and must procure that each of its agents, contractors and
sub-licensees:
(a) keep accurate and separate records and accounts of the supply
of Products sufficient to enable the recall of Products by
batch number, and must submit copies of those records to
Novogen Research immediately upon request by Novogen Research;
(b) note details of any customer complaints about Products and
details of any return of any Product and must provide those
details to Novogen Research in writing as soon as is
practicable after becoming aware of them;
(c) provide all reasonable assistance to Novogen Research if
Novogen Research wishes to investigate any customer complaint
or return of any Product; and
12.
(d) consult with Novogen Research regarding any action to be taken
about any customer complaint or return of any Product.
5.4 MARKETING AND PROMOTION
MEPL must, and must procure that its agents, contractors and
sub-licensees:
(a) act in good faith towards Novogen Research and actively
promote sales of Products and develop markets for Products
throughout the Territory;
(b) not during the Term do anything which might injure or destroy
the market in the Territory for Products;
(c) subject to applicable laws and regulations in the Territory,
advertise Products to keep customers and potential customers
informed of them;
(d) subject to applicable laws and regulations in the Territory,
disseminate samples of Products and technical and promotional
literature about Products; and
(e) subject to applicable laws and regulations in the Territory,
establish advertising or promotional programs for Products.
5.5 APPROVAL OF PROMOTIONAL AND ADVERTISING MATERIAL
MEPL must, and must procure that its agents, contractors and
sub-licensees:
(a) submit to Novogen Research for prior approval by Novogen
Research representative samples of any promotional piece,
advertising or technical narrative in relation to Products;
(b) use promotional pieces, advertising and technical narratives
only in accordance with the prior written consent of Novogen
Research and any conditions attaching to that consent; and
(c) make no representation or warranty about Products except with
the prior written consent of Novogen Research.
5.6 COMPLIANCE WITH LAWS
No consent granted by Novogen Research under clause 5.5 shall relieve
MEPL of its obligations under this clause 5 and MEPL remains solely
responsible for the compliance of any promotional activity with
applicable laws despite any consent by Novogen Research under clause
5.5.
5.7 STORAGE AND HANDLING
MEPL must, and must procure that its agents, contractors and
sub-licensees:
(a) store Products safely and securely and in accordance with the
reasonable written directions of Novogen Research from time to
time; and
13.
(b) permit Novogen Research to inspect Products in the possession,
custody or control of MEPL, its agents, contractors and
sub-licensees.
5.8 COMPLIANCE WITH LAWS
MEPL must, and must procure that its agents, contractors and
sub-licensees, ensure that all Products comply with the requirements of
all applicable laws in jurisdictions within the Territory in which MEPL
exploits those Products, and MEPL must inform Novogen Research
immediately in writing upon becoming aware of any failure to comply
with those requirements.
5.9 PACKING AND TRANSPORT OF PRODUCTS
MEPL must, and must procure that its agents, contractors and
sub-licensees, ensure that all Products are stored and packed in a
secure and appropriate manner so that the Products are reasonably
likely to reach their destination in good condition under normal
conditions of transport.
6. START GRANT AGREEMENT
6.1 ACKNOWLEDGMENT
MEPL acknowledges to Novogen Research that:
(a) Novogen Limited has obligations to the Commonwealth under the
START Grant Agreement with respect to the conduct of Clinical
Trials and the commercialisation of Products; and
(b) Novogen Limited has undertaken (or proposes to undertake) to
the Commonwealth under the Deed of Acknowledgment and
Undertaking to procure that certain of its obligations under
the START Grant Agreement are fulfilled by its subsidiaries,
including MEPL.
6.2 COMPLIANCE WITH THE START GRANT AGREEMENT
MEPL must not, and must procure that its agents, contractors and
sub-licensees do not:
(a) exercise MEPL's rights or perform MEPL's obligations in a
manner which is inconsistent with the obligations of Novogen
Limited under the START Grant Agreement; or
(b) otherwise do anything which may cause Novogen Limited to be in
default of its obligations under the START Grant Agreement or
the Deed of Acknowledgment and Undertaking.
6.3 COMPLIANCE WITH REASONABLE DIRECTIONS
If at any time during the Term Novogen Limited is in default of its
obligations to the Commonwealth under the START Grant Agreement or the
Deed of Acknowledgment and Undertaking, MEPL must comply with all
reasonable directions of Novogen Research to rectify that default.
14.
7. LICENCE FEES
7.1 FIRST LUMP SUM LICENCE FEE
In consideration of the licence granted in clause 1.4, MEPL must pay to
Novogen Research a first lump sum licence fee of US$5,000,000 on the
later of:
(a) 1 November 2002; or
(b) the date on which the cumulative total of any:
(i) funding (whether debt or equity);
(ii) Commercialisation Income; and
(iii) income as a result of or in connection with the sale,
hiring or other disposal of Products,
received by MEPL and its related bodies corporate (other than
Novogen Research and Novogen Laboratories), exceeds
US$25,000,000.
7.2 SECOND LUMP SUM LICENCE FEE
In further consideration of the licence granted in clause 1.4, MEPL
must pay to Novogen Research a second lump sum licence fee of
US$5,000,000 on the later of:
(a) 1 November 2003; or
(b) the date on which the cumulative total of any:
(i) funding (whether debt or equity);
(ii) Commercialisation Income; and
(iii) income as a result of or in connection with the sale,
hiring or other disposal of Products,
received by MEPL and its related bodies corporate (other than
Novogen Research and Novogen Laboratories), exceeds
US$50,000,000.
7.3 ROYALTIES DURING THE EXCLUSIVITY PERIOD
In further consideration of the licence granted in clause 1.4, MEPL
must, during the Exclusivity Period, pay to Novogen Research:
(a) 2.5% of all Net Sales of Products in the Territory, Quarterly
in arrears, within 30 days of the end of each Quarter; and
(b) 25% of all Commercialisation Income, Quarterly in arrears
within 30 days of the end of each Quarter.
15.
7.4 ROYALTIES AFTER THE EXCLUSIVITY PERIOD
In further consideration of the licence granted in clause 1.4, MEPL
must, from the expiration of the Exclusivity Period until the end of
the Term, pay to Novogen Research 1.5% of all Net Sales of Products in
the Territory, Quarterly in arrears, within 30 days of the end of each
Quarter.
7.5 MILESTONE LICENCE FEES
In further consideration of the licence granted in clause 1.4, MEPL
must pay to Novogen Research the Milestone Licence Fee for each
calendar year during the Exclusivity Period. MEPL must pay the
Milestone Licence Fee within 30 days following the end of the relevant
calendar year.
8. PAYMENT TERMS
8.1 PAYMENTS
All amounts due and payable under clause 7 must be calculated and paid
in United States dollars and must be paid by bank cheque or electronic
transfer to an account notified by Novogen Research in writing.
8.2 INTEREST ON OVERDUE ACCOUNTS
Interest shall accrue at the Default Rate on the outstanding balance of
all overdue amounts payable under clause 7, calculated daily.
9. REPORTS AND ACCOUNTING
9.1 BOOKS AND RECORDS
In addition to those records which MEPL must make and keep under
clauses 3.6 and 5.3, MEPL must, and must ensure that its agents,
contractors and sublicensees, make, keep and maintain for the Term and
a period of six years after the end of the Term, separate and complete
records and books of account relating to:
(a) all marketing, sale, distribution, exploitation and
commercialisation of Products; and
(b) any assignment, sublicensing, or other dealing with MEPL's
rights under this document,
which must contain clear particulars sufficient to enable the
calculation of all amounts payable under clause 7.
9.2 AUDITOR'S CERTIFICATES
Within 60 days of a written request by Novogen Research at any time
during the Term or within six years after the end of the Term, MEPL
must produce a certificate by the auditors or accountants of MEPL as to
the accuracy and completeness of the records and books of account
referred to in clause 13.1.
16.
9.3 QUARTERLY STATEMENTS
MEPL must, and must procure that its agents, contractors and
sub-licensees, prepare statements for each Quarter showing:
(a) the progress of marketing and commercialisation of Products;
(b) details of any Commercialisation Income received by or on
behalf of MEPL and its subsidiaries in the period to which the
statement relates;
(c) details of any funding received by or on behalf of MEPL and
its subsidiaries, by way of debt, equity or otherwise;
(d) details of all income received by or on behalf of MEPL and its
subsidiaries as a result of or in connection with the sale,
hiring or other disposal of Product; and
(e) the calculation of any payments due under clause 7;
and must submit those statements to Novogen Research within 30 days of
the end of the Quarter to which they relate, together with payment of
the amount due to Novogen Research under clause 7. All figures in the
statements must be in United States dollars.
9.4 CERTIFICATION
Novogen Research may give notice to MEPL at any time that it disputes
any statement submitted by MEPL under clause 9.3 and that it wishes to
have the statement certified by an independent accountant at its own
cost. In order to do so, Novogen Research and its nominee may inspect
MEPL's records and books of account, and those of MEPL's contractors
and sub-licensees under clause 9.7.
9.5 ADJUSTMENTS
(a) A certification of a statement under clause 9.4 is final and
binding on the parties.
(b) Within 14 days of notice in writing by Novogen Research of the
certification under clause 9.4, the parties must make any
adjustments required as a result of the certification,
including:
(i) any refund by Novogen Research to MEPL of the amount
of any overpayment; and
(ii) any payment by MEPL to Novogen Research of the amount
of any underpayment.
(c) If the certification reveals the amount paid to Novogen
Research was underestimated by 5% or more, then within 14 days
of notice of the certification, MEPL must also reimburse
Novogen Research the cost of certification.
17.
9.6 INTEREST ON ADJUSTMENTS
Interest at the Default Rate (calculated daily) on the amounts payable
under clause 9.5 accrues from and including the 14th day after the date
of notice of the certification by Novogen Research to MEPL.
9.7 INSPECTION
Novogen Research may, during normal business hours and upon reasonable
notice, by its authorised representatives (including accountants and
auditors) inspect the records and books of account referred to in
clause 9.1. Such authorised representatives may take such copies and
extracts of the records and books of account as they think fit and MEPL
must, and must ensure that its contractors and sublicensees give such
authorised representatives such assistance as is necessary, including
by providing access to facilities, hardware, software and documents, to
enable the Commercialisation Income and all amounts payable by MEPL to
Novogen Research under this document to be ascertained or verified.
10. OTHER COSTS
10.1 MAINTENANCE OF LICENSED PATENT RIGHTS
Subject to clause 10.2, Novogen Research is responsible at its sole
cost and expense for filing, prosecution and maintenance in the
Territory of the Licensed Patent Rights.
10.2 REIMBURSEMENT BY MEPL
MEPL must reimburse Novogen Research one half of the costs incurred by
Novogen Research during the Exclusivity Period in filing, prosecuting
and maintaining the Licensed Patent Rights, within 30 days of
presentation by Novogen Research of invoices for those amounts,
together with copies of all invoices, receipts and other documents
evidencing those costs.
10.3 REGISTRATION OF PRODUCTS
MEPL must, at its own cost and expense:
(a) register and maintain the registration of Products for use in
the Field in accordance with any applicable laws, rules and
regulations of any Government Agency; and
(b) do everything necessary to apply for and obtain each
Authorisation from a Government Agency required by any
applicable law in the Territory for the importation,
promotion, distribution, storage, sale and use of Products in
the Field.
11. GOODS AND SERVICES TAX
11.1 GST LAW DEFINITIONS
Words defined in the GST Law have the same meaning in this clause 11,
unless the context makes it clear that a different meaning is intended.
18.
11.2 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 Research an amount equal to any GST payable on
any supply by Novogen Research under or in connection with
this document without deduction or set-off of any other
amount;
(b) make that payment:
(i) if Novogen Research 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;
(ii) if Novogen Research 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
Research issued that invoice; and
(iii) if Novogen Research must pay GST upon the occurrence
of some other event - within 5 Business Days of a
written request by Novogen Research for payment for
the GST, which may be in the form of a tax invoice
(or an adjustment note); and
(c) indemnify Novogen Research against, and pay Novogen Research
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 11, for example, any
additional tax, penalty tax, fine, interest or other
charge under a GST Law.
11.3 TAX INVOICE
Within 28 days of a written request from MEPL, Novogen Research must
issue a tax invoice (or an adjustment note) to MEPL for any supply for
which Novogen Research 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.
11.4 ADJUSTMENTS
Novogen Research must refund to MEPL any overpayment by MEPL for GST,
but Novogen Research need not refund to MEPL any amount for GST paid to
the Commissioner of Taxation unless Novogen Research has received a
refund or credit of that amount.
19.
11.5 GST WHERE MEPL SUPPLIES NOVOGEN RESEARCH
If MEPL must pay GST for anything provided or supplied by MEPL under
this document, Novogen Research must pay to MEPL an amount equal to
that GST in exactly the same way as MEPL must so do for any GST Novogen
Research must pay, and this clause 11 applies to that GST as if MEPL
was Novogen Research, and Novogen Research was MEPL.
12. OTHER DEDUCTIONS AND WITHHOLDINGS
If at any time an applicable law obliges MEPL to make a deduction or
withholding in respect of any Tax from any payment by MEPL to Novogen
Research under this document, MEPL must:
(a) notify Novogen Research of the obligation promptly after MEPL
becomes aware of it;
(b) ensure that the deduction or withholding does not exceed the
minimum amount required by law;
(c) pay to the relevant Government Agency on time the full amount
of the deduction or withholding and promptly deliver to
Novogen Research a copy of any receipt, certificate or other
proof of payment; and
(d) indemnify Novogen Research against the deduction or
withholding, by paying to Novogen Research, at the time that
the payment is due, an additional amount that ensures that,
after the deduction or withholding is made, Novogen Research
receives a net sum equal to the sum that it would have
received if the deduction or withholding had not been made.
13. INTELLECTUAL PROPERTY RIGHTS
13.1 ACKNOWLEDGMENT
Each party acknowledges that nothing in this document effects an
assignment or transfer to MEPL of any right, title or interest in the
Licensed Intellectual Property, and MEPL 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.
13.2 MAINTENANCE OF LICENSED INTELLECTUAL PROPERTY
MEPL must do all things necessary in storing, manufacturing, packing,
supplying, commercialising and otherwise dealing with the Products to
maintain the Licensed Intellectual Property and must not cause or
permit to be done anything which may damage or endanger the Licensed
Intellectual Property.
13.3 NOTIFICATION
MEPL must notify Novogen Research immediately upon becoming aware of:
(a) any actual or apparent infringement by any person of the
Licensed Intellectual Property; or
20.
(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.
13.4 PROCEEDINGS BY MEPL
Subject to clauses 13.5 and 13.7, MEPL may in its discretion and for
its own benefit enforce and defend in the Territory the Licensed
Intellectual Property during the Exclusivity Period, and in the event
it does so, MEPL shall have the conduct and control of any proceedings,
including the right to settle them.
13.5 DIRECTIONS BY NOVOGEN RESEARCH
During the Exclusivity Period, MEPL shall take such proceedings in
respect of any actual or suspected infringement in the Territory of the
Licensed Intellectual Property, and shall defend any claim of
infringement against the parties, as directed by notice in writing by
Novogen Research from time to time.
13.6 JOINDER OF NOVOGEN RESEARCH
If it is necessary that Novogen Research be a party to any proceedings
commenced by MEPL, Novogen Research 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.
13.7 PROCEEDINGS BY NOVOGEN RESEARCH
If MEPL fails to take or defend any proceedings within 28 days of
receipt of a notice under clause 13.5, then without prejudice to any
other right Novogen Research may have, Novogen Research may commence or
defend those proceedings itself, and in the event it does so Novogen
Research shall have the conduct and control of the proceedings
including the right to settle them.
13.8 JOINDER OF MEPL
If it is necessary that MEPL be a party to any proceedings taken under
clause 13.7, MEPL shall join such proceedings as a plaintiff and shall
provide all reasonable assistance, and execute any documents Novogen
Research reasonably requests, in relation to the proceedings.
13.9 DAMAGES AND SETTLEMENT AMOUNTS
If in any proceedings commenced by Novogen Research under clause 13.7,
damages or an account of profits are awarded to any party to this
document, or an amount is received by any party by way of settlement of
those proceedings, all such damages, profits and settlement amounts
must be paid to Novogen Research within 5 Business Days of receipt.
13.10 ASSIGNMENT OF INTELLECTUAL PROPERTY RIGHTS
For the avoidance of doubt, if in any proceedings commenced or defended
under this clause 13, a court makes an order in favour of a party to
this document other than Novogen Research in relation to the ownership
of any Intellectual Property Rights
21.
forming part of the Licensed Intellectual Property, the parties agree
that those Intellectual Property Rights are by this document assigned
absolutely to Novogen Research.
14. CONFIDENTIAL INFORMATION
14.1 CONFIDENTIALITY
Each party must:
(a) keep and maintain all Confidential Information of the other
party strictly confidential;
(b) use Confidential Information of the other parties only for the
purposes for which it is disclosed; and
(c) not disclose any Confidential Information of another party
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.
14.2 SECURITY
For the purposes of clause 14.1, each party must establish and maintain
effective security measures to safeguard the Confidential Information
of the other party from unauthorised use or access and must notify the
Disclosing Party immediately upon becoming aware of any suspected or
actual unauthorised use or disclosure of its Confidential Information.
14.3 EXCEPTIONS TO OBLIGATIONS OF CONFIDENTIALITY
The obligations in clauses 14.1 and 14.2 do not apply to the extent
that a party is required by law to disclose any Confidential
Information, provided the party promptly gives notice to the Disclosing
Party of that requirement and discloses only that portion of its
Confidential Information which it is legally required to disclose.
14.4 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.
15. REPRESENTATIONS AND WARRANTIES
15.1 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
22.
(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
(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.
15.2 REPRESENTATIONS AND WARRANTIES BY NOVOGEN RESEARCH
Novogen Research represents and warrants that:
(a) (OWNERSHIP) to the best of its knowledge Novogen Research 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;
23.
(b) (NO DEALINGS) subject to the START Grant Agreement, it has not
assigned or granted to any person any right, title or interest
in or in relation to the Licensed Intellectual Property;
(c) (NO ENCUMBRANCE) subject to the Fixed and Floating Charge, the
Licensed Intellectual Property is free from any Encumbrance;
(d) (FILING, PROSECUTION AND MAINTENANCE) Novogen Research has
diligently filed, prosecuted and maintained the patents and
patent applications listed in schedule 1 and as at the
Commencement Date all filing, prosecution and maintenance fees
have been paid;
(e) (CONFIDENTIALITY) to its knowledge Novogen Research has kept
the Licensed Know How confidential and to its knowledge there
has been no breach of that confidentiality;
(f) (NO INFRINGEMENT) to its knowledge the exercise by MEPL, in
any country in which a patent application in schedule 1 has
been filed, of the rights granted to MEPL under this document
with respect to the Licensed Intellectual Property does not
infringe the Intellectual Property Rights of any person; and
(g) (NO FURTHER PATENT RIGHTS) other than the Licensed Patent
Rights, Novogen Research has no Patent Rights which are
necessary in order for MEPL to exercise its rights and perform
its obligations under this document.
15.3 VALIDITY OF LICENSED PATENT RIGHTS
MEPL acknowledges that Novogen Research makes and has made no
representation, warranty, statement or promise to the effect that:
(a) any letters patent will be granted in respect of the Licensed
Intellectual Property in any country in the Territory; or
(b) if any letters patent are granted in respect of the Licensed
Intellectual Property in any country in the Territory, such
letters patent will be valid.
15.4 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 document.
16. LIMITATION OF LIABILITY
16.1 LIMITATION OF LIABILITY OF NOVOGEN RESEARCH
Subject to clause 16.2 and to the extent permitted by law, the
liability of Novogen Research to MEPL under this document and any other
liability of Novogen Research to MEPL, whether in contract, tort
(including negligence and breach of statutory duty) or otherwise is
limited to US$200,000.
24.
16.2 LIABILITY FOR INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS
Clause 16.1 does not apply to any liability which Novogen Research may
have to MEPL with respect to any breach by Novogen Research of the
representations and warranties in clauses 15.2(a), (b), (c) and (f).
16.3 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.
16.4 INDIRECT AND CONSEQUENTIAL LOSS
Notwithstanding any other provision of this document, and to the extent
permitted by law, in no circumstances is Novogen Research 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.
17. INDEMNITIES AND INSURANCE
17.1 CLINICAL TRIAL INDEMNITY
MEPL must indemnify and keep indemnified Novogen Research, 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 a Clinical Trial Subject
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 the Clinical Trial Subjects 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 an action or omission of MEPL in accordance with
a direction given by Novogen Research under this document or from any
negligence (including breach of statutory duty) of Novogen Research or
any breach by Novogen Research of its obligations under this document.
25.
17.2 COMMERCIALISATION INDEMNITY
MEPL must indemnify and keep indemnified Novogen Research, 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 licensing or sub-licensing of the Licensed Intellectual
Property;
(b) the sale, distribution or other commercialisation or
exploitation of Products; or
(c) 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 an action or omission of MEPL in accordance with a direction
given by Novogen Research under this document, from the negligence
(including breach of statutory duty) of Novogen Research or the breach
by Novogen Research of its obligations under this document.
17.3 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
Research.
17.4 NAME OF NOVOGEN RESEARCH
If requested by Novogen Research, MEPL must ensure that that Novogen
Research is included on the policies referred to in clause 17.3 as a
joint insured or loss payee.
17.5 CERTIFICATES OF CURRENCY
At the request of Novogen Research from time to time, MEPL must provide
to Novogen Research a certificate of currency evidencing its compliance
with its obligations under this clause 17.
17.6 DEFAULT
If within 15 Business Days of a request by Novogen Research under
clause 17.5, MEPL does not comply with its obligations under that
clause, Novogen Research may (but is not obliged to) take out and
maintain the insurance and may recover any premiums paid as a debt due
by MEPL.
17.7 EXPIRY
MEPL shall maintain each insurance policy referred to in clause 17.3
until the expiry date of the last Product sold, hired or otherwise
disposed of by or on behalf of MEPL or its sub-licensees.
26.
17.8 NOVOGEN RESEARCH'S INSURANCE
Novogen Research 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.
18. FORCE MAJEURE
18.1 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:
(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.
18.2 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.
18.3 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 parties.
19. TERM AND TERMINATION
19.1 TERM
(a) Subject to paragraph (b), 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 19.
(b) The variations made by this document to the Original Licence
Agreement are effective from the date of this document.
19.2 TERMINATION BY NOVOGEN RESEARCH
Novogen Research may terminate this document at any time:
27.
(a) immediately if MEPL defaults in the performance of any of its
obligations under this document which in Novogen Research's
reasonable opinion is capable of remedy and fails to remedy
that default within 21 days of receiving written notice from
Novogen Research 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 Research's 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
Research's 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.
19.3 TERMINATION BY MEPL
MEPL may terminate this document at any time:
(a) on three month's written notice to Novogen Research;
(b) immediately if Novogen Research 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 Research 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 Research is involved in an Insolvency Event;
or
(ii) Novogen Research ceases for any reason to be able
lawfully to carry out all the transactions which this
document contemplates may be carried out by Novogen
Research.
19.4 CONSEQUENCES TO MEPL OF TERMINATION
Upon termination of this document MEPL must:
(a) immediately cease using and exploiting the Products;
28.
(b) within 14 Business Days return to Novogen Research or destroy
at Novogen Research's election, all Products, Clinical Trial
Materials, all copies (including electronic copies) of any
labelling and packaging materials relating to Products and any
other Confidential Information of Novogen Research in MEPL's
possession, custody or power; and
(c) cooperate with Novogen Research and do everything necessary to
bring about the orderly and medically and ethically
permissible termination of all Clinical Trials,
provided that MEPL may complete in accordance with its obligations
under this document any contracts for sale or supply of Products to
which MEPL is bound prior to the date of termination.
19.5 CONSEQUENCES TO NOVOGEN RESEARCH OF TERMINATION
Upon termination of this document Novogen Research must return to MEPL
or destroy at MEPL's election within 10 Business Days, all Confidential
Information of MEPL in the possession, custody or power of Novogen
Research.
19.6 SURVIVAL AND ACCRUED RIGHTS
Upon termination under this clause 19, 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, 3.6, 3.7, 3.9,
5.3, 9, 13.1, 13.9, 14, 16, 17, 20, 21 and 23 (except clause
23.4) and this clause 19 which survive termination.
20. DISPUTE RESOLUTION
20.1 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 20 except where the party seeks urgent interlocutory relief.
20.2 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").
20.3 NEGOTIATION
Upon receipt by a party of a Dispute Notice, Novogen Research and MEPL
must procure that their respective Managing Directors meet to endeavour
to resolve the Dispute expeditiously by negotiation.
29.
20.4 RESOLUTION OF DISPUTE
If the parties have not resolved the Dispute under clause 20.3 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.
20.5 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.
21. 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.
(b) The parties' addresses and fax numbers are those set out
below, or as a party notifies the other:
NOVOGEN RESEARCH
Address: 000 Xxxxx Xxxx, Xxxxx Xxxx XXX 0000 XXXXXXXXX
Fax number: Int + 612 9878 0055
Attention: Managing Director
MEPL
Address: 000 Xxxxx Xxxx, Xxxxx Xxxx XXX 0000 XXXXXXXXX
Fax number: Int + 612 9878 0055
Attention: Managing Director
22. AMENDMENT AND ASSIGNMENT
22.1 AMENDMENT
This document can only be amended, supplemented, replaced or novated by
another document signed by the parties.
30.
22.2 ASSIGNMENT
(a) MEPL may only dispose of, declare a trust over or otherwise
create an interest in its rights under this document with the
prior written consent of Novogen Research.
(b) Novogen Research may dispose of, declare a trust over or
otherwise create an interest in its rights under this document
without the consent of MEPL, and may disclose to any potential
holder of the right or interest any information relating to
this document or any party to it.
23. GENERAL
23.1 GOVERNING LAW
(a) This document is governed by the law in force in New South
Wales.
(b) Each party submits to the non-exclusive jurisdiction of the
courts exercising jurisdiction in New South Wales, and any
court that may hear appeals from any of those courts, for any
proceedings in connection with this document, and waives any
right it might have to claim that those courts are an
inconvenient forum.
23.2 LIABILITY FOR EXPENSES
Each party must pay its own expenses incurred in negotiating,
executing, stamping and registering this document.
23.3 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.
23.4 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.
23.5 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;
(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
31.
(c) the exercise of a right does not prevent any further exercise
of that right or of any other right.
23.6 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.
23.7 OPERATION OF INDEMNITIES
(a) Each indemnity in this document survives the expiry or
termination of this document.
(b) A party may recover a payment under an indemnity in this
document before it makes the payment.
23.8 CONSENTS
Where this document contemplates that a party may agree or consent to
something (however it is described), that party may:
(a) agree or consent, or not agree or consent, in its absolute
discretion; and
(b) agree or consent subject to conditions,
unless this document expressly contemplates otherwise.
23.9 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.
23.10 COUNTERPARTS
This document may be executed in counterparts.
32.
EXECUTED as an agreement.
EXECUTED by NOVOGEN RESEARCH PTY LIMITED
/s/ Xxxxxxxxxxx Xxxxxxxx /s/ Xxxxxx Xxx Xxxxxx
____________________________________ _______________________________
Signature of director Signature of director/secretary
Xxxxxxxxxxx Xxxxxxxx Xxxxxx Xxx Xxxxxx
____________________________________ _______________________________
Name of director Name of director/secretary
EXECUTED by XXXXXXXX XXXXXXX PTY LIMITED
/s/ Xxxxxxxxxxx Xxxxxxxx /s/ Xxxxx Xxxxxx
____________________________________ _______________________________
Signature of director Signature of director/secretary
Xxxxxxxxxxx Xxxxxxxx Xxxxx Xxxxxx
____________________________________ _______________________________
Name of director Name of director/secretary
33.
SCHEDULE 1
PRODUCT PATENT RIGHTS
Application/patent No. Status
Australia 731951 Granted
Australia 19723/01 Under examination
Australia 750031 Granted
Xxxxxxxxx XX0000 Completed provisional
patent application
Xxxxxxxxx XX0000 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
Xxxxxxxxx 00000 Xxxxxxx
Xxxxxxxxx 00000 Granted
Sweden 2286-3 Under examination
Turkey TR19990885B Granted
Turkey 0000/0000 Xxxxxxx
Xxxxxx Xxxxxxx 0000000 Xxxxxxx
Xxxxxx Xxxxxx 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
SCHEDULE 2
MANUFACTURING PATENT RIGHTS
APPLICATION NO. STATUS
Australia 26510/00 Under examination
Australia PP8685 Completed provisional patent
application
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
International PCT/AU00/00103 National phase entry
completed
