<PAGE>
Exhibit 10.1
BLAKE DAWSON WALDRON
LAWYERS
AMENDED AND RE-STATED
TECHNOLOGY LICENCE
AGREEMENT
NOVOGEN RESEARCH PTY LIMITED
GLYCOTEX, INC.
Level 35, Grosvenor
Place
225 George Street
SYDNEY NSW 2000
Telephone: 9258 6000
Fax: 9258 6999
REF: BLM SJH 02 1389 1453
(C) BLAKE DAWSON WALDRON 2005
<PAGE>
CONTENTS
<TABLE>
<S>
<C>
1. INTERPRETATION
1
1.1 Definitions
1
1.2 Rules for
interpreting this document
5
1.3 Business Days
6
2. LICENCE
6
2.1 Grant of licence
6
2.2 Rights included
6
2.3 No sub-licence
6
2.4 Sub-contractors
6
3. RESEARCH AND DEVELOPMENT
7
3.1 Research and
development
7
3.2 Glucan Material
7
3.3 Conduct of
research
7
3.4 Facilities and
personnel
7
3.5 Records
7
3.6 Inspection
7
4. DEVELOPMENTS
7
4.1 Novogen
Developments
7
4.2 Glycotex
Developments
8
5. MARKETING AND
COMMERCIALISATION
8
5.1 Marketing and
Exploitation
8
5.2 Exploitation
obligations
8
5.3 Compliance with
laws
8
5.4
Commercialisation Income
8
5.5 Books and
records
9
5.6 Auditors'
certificates
9
5.7 Inspection
9
5.8 Assistance
9
6. ROYALTIES
9
6.1 Royalties
9
6.2 Payment
10
6.3 Statements
10
6.4 Disputed
statements
10
6.5 Certification
10
6.6 Adjustments
11
7. DEDUCTIONS AND WITHHOLDINGS
11
</TABLE>
1.
<PAGE>
<TABLE>
<S>
<C>
8. PATENTS
11
8.1 Maintenance of
patents
11
8.2 Patent costs
11
8.3 Glycotex's
option
11
9. INTELLECTUAL PROPERTY RIGHTS
12
9.1 Acknowledgment
12
9.2 Notification
12
9.3 Proceedings
involving Glycotex
12
9.4 Directions by
Novogen Research
12
9.5 Joinder of
Novogen Research
13
9.6 Proceedings
involving Novogen Research
13
9.7 Joinder of
Glycotex
13
10. CONFIDENTIAL INFORMATION
13
10.1 Confidentiality
13
10.2 Security
13
10.3 Exceptions
14
11. REPRESENTATIONS AND WARRANTIES
14
11.1 Warranties by Novogen
Research
14
11.2 Warranties by Glycotex
14
11.3 Reliance on
representations and warranties
15
11.4 Acknowledgement by
Glycotex
15
11.5 Exclusion of
warranties and other terms
15
12. INDEMNITY AND INSURANCE
16
12.1 Indemnity
16
12.2 Insurance policies
16
12.3 Novogen Research's
name
16
12.4 Certificates of
currency
16
12.5 Default
17
12.6 Expiry
17
13. LIMITATION OF LIABILITY
17
13.1 No liability
17
13.2 Other claims
17
14. TERM AND TERMINATION
18
14.1 Term
18
14.2 Expiration of patents
18
14.3 Termination by Novogen
Research
18
14.4 Consequences of
termination
18
14.5 Survival and accrued
rights
18
15. DISPUTE RESOLUTION
19
</TABLE>
2.
<PAGE>
<TABLE>
<S>
<C>
15.1 Disputes
19
15.2 Notice of Dispute
19
15.3 Parties to attempt to
resolve Dispute
19
15.4 Mediation
19
16. NOTICES
19
17. AMENDMENT AND ASSIGNMENT
20
17.1 Amendment
20
17.2 Assignment
20
18. GENERAL
20
18.1 Governing law
20
18.2 Liability for expenses
20
18.3 Relationship of the
parties
21
18.4 Giving effect to this
document
21
18.5 Waiver of rights
21
18.6 Operation of this
document
21
18.7 Operation of
indemnities
21
18.8 Consents
22
18.9 Exclusion of contrary
legislation
22
18.10 Counterparts
22
SCHEDULE A
23
</TABLE>
3.
<PAGE>
AMENDED AND RE-STATED TECHNOLOGY LICENCE AGREEMENT
DATE SEPTEMBER 2005
PARTIES
NOVOGEN RESEARCH
PTY LIMITED (ACN 060 202 931) of 140 Wicks Road North
Ryde, New South
Wales 2113 (NOVOGEN RESEARCH)
GLYCOTEX, INC.,
a company incorporated under the laws of the United States
of America, of
One Landmark Square, Level 2, Stamford CT 09601 (GLYCOTEX)
RECITALS
A. Novogen Research is the
owner of certain patent applications and know how
relating to a
process of production of glucan and the use of glucan for the
treatment of
skin ulceration, bone fracture or the enhancement of fixation
of implanted
orthopaedic devices or the prevention/treatment of ultraviolet
light-induced
skin damage.
B. Novogen Research granted a
licence to Glycotex to conduct further research
and development
and to commercialise this technology for certain human
therapeutic uses
on the terms and conditions of the Technology Licence
Agreement dated
1999.
C. The parties now amend and
re-state the Technology Licence Agreement in
accordance with
this document.
OPERATIVE PROVISIONS
1. INTERPRETATION
1.1 DEFINITIONS
The following
definitions apply in this document.
BUSINESS DAY
means a day that is not a Saturday, Sunday or public holiday
in Sydney,
Australia.
CHANGE IN
CONTROL, in relation to Glycotex means:
(a) the acquisition by any Person or
Group other than Novogen Limited of
more than 50% of the combined voting power of the then
outstanding
securities entitled to vote generally in the election of directors
of
Glycotex; or
(b) any merger, consolidation,
reorganization, recapitalization, tender or
exchange offer or any other transaction with or effecting Glycotex
as
a result of which a Person or Group other than the stockholders
of
Glycotex immediately before the transaction owns after the
transaction
more than 50% of the combined voting power of the then
outstanding
securities entitled to vote generally in the election of the
directors
of Glycotex,
1.
<PAGE>
but does not
include any acquisition as a result of, or transaction
involving, an
initial public offering of Glycotex's common stock.
COMMENCEMENT
DATE means the date this document is executed by the last of
the parties to
execute it.
COMMERCIALISATION INCOME means all gross income received by or on
behalf of
Glycotex as a
result of or in connection with the sale, distribution,
production,
licensing, marketing or other commercialisation of Licensed
Products or
licensing, sub-licensing or other exploitation of the Glucan
Technology.
CONFIDENTIAL
INFORMATION means the Glucan Know How, Glycotex Developments,
Novogen
Developments and any other written or oral information disclosed
to
Glycotex which
Novogen Research considers confidential and informs Glycotex
is confidential,
other than information which Glycotex can establish:
(a) was in the public domain when it
was given to Glycotex;
(b) becomes, after being given to
Glycotex, part of the public domain,
except through disclosure contrary to this document;
(c) was in Glycotex's possession when
it was given to Glycotex and was not
otherwise acquired from Novogen Research directly or indirectly;
or
(d) was lawfully received by Glycotex
from another person having the
unrestricted legal right to disclose that information without
requiring the maintenance of confidentiality.
CORPORATIONS ACT
means the Corporations Act 2001 (Cth).
DILIGENT
EFFORTS, in relation to an obligation of a party, means the
level
of efforts
required to carry out the obligations in a sustained manner
consistent with
the efforts a reasonable person in the same position as
that party
devotes to a product of high market potential, profit potential
or strategic
value based on conditions then prevailing. Diligent Efforts
requires that a
party:
(a) promptly assign responsibility for
obligations to specific employees
who are held accountable for progress and monitor such progress on
an
on-going basis;
(b) set and consistently seek to
achieve specific and meaningful
objectives for carrying out such obligations; and
(c) consistently make and implement
decisions and allocate resources
designed to advance progress in order to fulfil such
obligations.
DISPUTE has the
meaning given to that term in clause 15.1.
DISPUTE NOTICE
has the meaning given to that term in clause 15.2.
2.
<PAGE>
EXPLOIT, in
relation to an invention, means:
(a) where the invention is a product -
make, hire, sell or otherwise
dispose of the product, offer to make, sell, hire or otherwise
dispose
of it, use or import it or keep it for the purpose of doing any
of
those things; and
(b) where the invention is a method or
process - use the method or process
or do any act mentioned in paragraph (a) in respect of a
product
resulting from such use.
FIELD means the
fields of:
(a) therapeutic treatment of skin
ulceration (including pressure sores,
bed sores, venous ulcers, diabetic ulcers and burns) in humans;
(b) treatment of bone fracture and the
enhancement of fixation of
implanted orthopaedic devices (including pins, screws and
artificial
joints) in humans;
(c) prevention/treatment of
ultraviolet light induced skin damage in
humans;
(d) treatment of injured connective
tissues (including injuries to tendons
and ligaments, such as sporting injuries, inflammation and
surgical
injury) in humans;
(e) joint repair (particularly with
artificial joints) in humans; and
(f) treatment of poorly healing
surgically dissected or transected tissue
in humans.
GLUCAN KNOW HOW
means the Know How set out in Schedule A, any Know How in
any Novogen
Developments disclosed in accordance with clause 4.1 and any
Glycotex
Developments assigned to Novogen Research in accordance with
clause 4.2, and
all other Know How in the Field concerning or relating to
the Glucan
Patent Rights.
GLUCAN MATERIAL
means documents, records, biological and chemical
substances
containing, referring to or embodying the Glucan Technology
(including any
micro-organisms, cell samples, carbohydrate materials and
solvents) in the
possession or control of Novogen Research which Novogen
Research is free
to provide or disclose to Glycotex.
GLUCAN PATENT
RIGHTS means the Patent Rights set out in Schedule A, any
Patent Rights in
any Novogen Developments disclosed in accordance with
clause 4.1 and
any Glycotex Developments assigned to Novogen Research in
accordance with
clause 4.2, and any other Patent Rights in relation to
inventions
claimed in those Patent Rights.
GLUCAN
TECHNOLOGY means the Glucan Patent Rights, the Glucan Know How,
any
Novogen
Developments disclosed in accordance with clause 4.1 and any
Glycotex
Developments in the Field assigned to Novogen Research in
accordance with
clause 4.2.
GLYCOTEX
DEVELOPMENTS means all developments, improvements,
enhancements,
adaptations and
new discoveries, inventions, applications and further Know
How, whether
patentable or otherwise, in relation to the Glucan Patent
Rights or the
Glucan Know How, which during the Term are made or acquired
by Glycotex, its
employees, agents or sub-contractors, which Glycotex is
able to
assign.
3.
<PAGE>
GOVERNMENT
AGENCY means:
(a) a government or government
department or other body;
(b) a governmental, semi-governmental
or judicial person; or
(c) a person (whether autonomous or
not) who is charged with the
administration of a law.
GROUP means two
or more Persons acting as a partnership, limited
partnership,
syndicate, or other group for the purpose of acquiring,
holding, or
disposing of any securities.
INSOLVENCY EVENT
means, for a person, being in liquidation or provisional
liquidation or
under administration, having a controller or analogous
person appointed
to it or any of its property, being taken to have failed
to comply with a
statutory demand, being unable to pay its debts or
otherwise
insolvent, dying, ceasing to be of full legal capacity or
otherwise
becoming incapable of managing its own affairs for any reason,
taking any step
that could result in the person becoming an insolvent under
administration,
entering into a compromise or arrangement with, or
assignment for
the benefit of, any of its members or creditors, or any
analogous
event.
INTELLECTUAL
PROPERTY RIGHTS means all existing and future intellectual and
industrial
property rights throughout the world, including rights in
relation to any
copyright, trade marks, designs, circuit layouts, trade
secrets and know
how (including the right to apply for registration of any
such rights) and
Patent Rights.
KNOW HOW means
unpatented technical and other information which is not in
the public
domain including inventions, discoveries, concepts, data,
formulae, ideas,
specifications, procedures for experiments and tests and
results of
experiments, experimentation and testing, results of research
and development
including laboratory records, clinical trial data, case
reports, data
analysis and summaries and information in submissions to and
information from
ethics committees and regulatory authorities.
LICENSED PRODUCT
means a preparation in final form for sale, administration
or delivery for
use in the Field which, or the process of production of
which, falls
within the claims of the Glucan Patent Rights or otherwise
embodies any
Glucan Know How, Novogen Developments or Glycotex
Developments.
NOVOGEN
DEVELOPMENTS means all developments, improvements,
enhancements,
adaptations and
new discoveries, inventions, applications and further Know
How, whether
patentable or otherwise, in the Field in relation to the
Glucan Patent
Rights or the Glucan Know How, which during the Term are made
or acquired by
Novogen Research, its employees or agents, which Novogen
Research is free
to licence.
PATENT RIGHTS
means 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 patent applications and patentable inventions,
including the
right to apply for registration of any such rights.
4.
<PAGE>
PERSON means a
natural person, company, government, or political
subdivision,
agency, or instrumentality of a government.
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 other than one that is
imposed on net
income.
TERM means the
term of this document in accordance with clause 14.
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.
5.
<PAGE>
1.3 BUSINESS DAYS
If the day on or by which a
person must do something under this document is
not a Business
Day:
(a) if the act involves a payment that
is due on demand, the person must
do it on or by the next Business Day; and
(b) in any other case, the person must
do it on or by the previous
Business Day.
2. LICENCE
2.1 GRANT OF LICENCE
Novogen Research
grants to Glycotex an exclusive, non-transferable licence
to use and
Exploit the Glucan Technology for the Term in the Territory,
solely in the
Field.
2.2 RIGHTS INCLUDED
The licence in
clause 2.1 includes the right, for the Term, in the
Territory and in
the Field, to:
(a) make, use, reproduce, market,
distribute, sell, hire or otherwise
dispose of
Licensed Products and inventions the subject of the Glucan
Patent Rights;
(b) modify, enhance, create derivative
works based on and further develop
the Glucan Technology; and
(c) keep, use, reproduce and make
adaptations of the Glucan Material
provided by Novogen Research under clause 3.2; and
(d) use any methods or processes
forming part of the Glucan Technology to
do any of the things in paragraphs (a) to (c).
2.3 NO SUB-LICENCE
Glycotex must
not grant sub-licences of any of the rights granted to it
under this
clause 2 without the prior written consent of Novogen Research.
2.4 SUB-CONTRACTORS
Glycotex may
engage agents and sub-contractors to exercise the rights and
perform its
obligations under this document in Glycotex's reasonable
discretion,
provided Glycotex shall first cause all such agents and
sub-contractors
to agree in writing:
(a) to comply with the confidentiality
obligations of Glycotex under this
document; and
(b) to assign to Glycotex all
Intellectual Property Rights in the Field
accrued or accruing to them in the course of their engagement.
6.
<PAGE>
3. RESEARCH AND DEVELOPMENT
3.1 RESEARCH AND DEVELOPMENT
Novogen Research
appoints Glycotex as its independent contractor to
undertake
further research and development in relation to the Glucan
Technology in
the Field and subject to clauses 3.3, 3.4 and 3.5 in such
manner as it
thinks fit in the Territory.
3.2 GLUCAN MATERIAL
Within 28 days
of the Commencement Date and from time to time during the
Term, Novogen
Research shall provide to Glycotex copies and samples of such
Glucan Material
as in Novogen's reasonable opinion is necessary or useful
to enable
Glycotex to have the full benefit of the licence granted under
clause 2 and to
conduct research, development and commercialisation in
accordance with
the provisions of this clause 3.
3.3 CONDUCT OF RESEARCH
Glycotex must
conduct any further research and development diligently, in
good scientific
manner and in compliance with any applicable laws, rules
and regulations
of any Government Agency and consistently with the
requirements of
any applicable good laboratory practices.
3.4 FACILITIES AND PERSONNEL
In order to
comply with its obligations under this clause 3, Glycotex shall
engage personnel
with appropriate skill and experience and use appropriate
equipment and
facilities.
3.5 RECORDS
Glycotex shall
maintain complete and accurate records in good scientific
manner, which
shall fully reflect all work done and results achieved in the
course of
research and development under this clause 3. Glycotex shall
maintain such
records in confidence and must not use such records or
information
other than in accordance with the provisions of this document.
3.6 INSPECTION
Novogen Research
shall have the right, during normal business hours and
upon reasonable
notice, to inspect and copy all records maintained by
Glycotex under
clause 3.5 and Novogen Research may retain such copies as it
thinks fit.
4. DEVELOPMENTS
4.1 NOVOGEN DEVELOPMENTS
Novogen Research
shall disclose to Glycotex all Novogen Developments as
soon as is
reasonably practicable after becoming aware of them.
7.
<PAGE>
4.2 GLYCOTEX DEVELOPMENTS
Glycotex must
disclose to Novogen Research all Glycotex Developments
immediately upon
becoming aware of them and by this document Glycotex
assigns to
Novogen Research absolutely its entire right, title and
interest
in all
Intellectual Property Rights in any Glycotex Developments.
5. MARKETING AND
COMMERCIALISATION
5.1 MARKETING AND EXPLOITATION
Subject to
clause 5.2 and 5.3, Glycotex may use, market and Exploit the
Glucan
Technology and any Licensed Product in the Field in such manner
as
it thinks fit in
the Territory and at its sole cost and expense.
5.2 EXPLOITATION OBLIGATIONS
Glycotex must
use Diligent Efforts to:
(a) identify major markets for
commercial Exploitation of Licensed
Products;
(b) further develop Licensed Products
towards commercial Exploitation;
(c) pursue opportunities in major
markets for commercial Exploitation of
Licensed Products;
(d) promote, market and Exploit
Licensed Products in major markets in the
Territory; and
(e) otherwise maximise
Commercialisation Income.
5.3 COMPLIANCE WITH LAWS
Glycotex must
c
