EXHIBIT 10
RESEARCH, DEVELOPMENT AND LICENCE AGREEMENT DATED MAY 11, 1999 BETWEEN
PRAXIS PHARMACEUTICALS, INC. AND ▇▇▇▇▇▇▇▇▇ INTERNATIONAL INC.
RESEARCH, DEVELOPMENT AND LICENCE AGREEMENT DATED THE 11TH DAY OF MAY,
1999
BETWEEN:
PRAXIS PHARMACEUTICALS, INC.,
a body corporate incorporated pursuant to the laws of the State of Utah, one of
the United States of America and having an office at ANUTECH Court, North Road,
in the City of Canberra, ACT, Australia ("Praxis")
- and -
▇▇▇▇▇▇▇▇▇ INTERNATIONAL INC.,
a body corporate incorporated pursuant to the laws of the Province of British
Columbia, Canada and having an office at ▇▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇ of
Vancouver, British Columbia, Canada ("▇▇▇▇▇▇▇▇▇")
WHEREAS:
A. The Australian National University is the owner of certain patents related to
the invention entitled "Phosphosugar-based anti-inflammatory and/or
immunosuppressive drugs" and certain patent applications related to an invention
entitled "Novel phosphosugars and phosphosugar-containing compounds having
anti-inflammatory activity" which are described in more detail herein;
B. ANUTECH PTY Ltd. ("Anutech"), the commercialization company of the Australian
National University, has entered into an agreement as agent for and on behalf of
the Australian National University with Praxis pursuant to which Praxis has been
granted an exclusive licence for the use of the inventions described above in
specified areas of application;
C. Praxis has and intends to continue to conduct research and development
related to the above described inventions;
D. Praxis wishes to obtain funding from ▇▇▇▇▇▇▇▇▇ to conduct research in the
area of arthritis and dermal wrinkles and related to the above inventions;
▇. ▇▇▇▇▇▇▇▇▇ wishes to obtain an exclusive, world-wide licence to make, use and
sell products and processes developed by Praxis relating to arthritis and dermal
wrinkles;
NOW THEREFORE, in consideration of the mutual terms and conditions contained
herein, the parties hereto agree as follows:
PART I - DEFINITIONS AND INTERPRETATION
SECTION 1 - DEFINITIONS
In this Agreement, including this Section, the following defined terms have the
meanings indicated:
(a) "Anutech Licence Agreements" means the agreement entered into
between Anutech and Praxis dated 27th October, 1997, a copy of which
is attached hereto as Schedule "D";
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(b) "Closing Date" means September 30th, 1999
(c) "Confidential Information" means confidential or proprietary
information, trade secrets, know-how and technical information
related to the inventions claimed pursuant to the Patents and any
other information disclosed in confidence by Praxis to ▇▇▇▇▇▇▇▇▇ or
by ▇▇▇▇▇▇▇▇▇ to Praxis;
(d) "Field of Use" means arthritis and dermal wrinkles;
(e) "Intellectual Property" means any and all methods, devices,
techniques, discoveries, inventions (whether or not patentable),
know-how, ideas, processes, trade secrets and other proprietary
information, including any patent right, copyright, trade secret or
similar right;
(f) "Licensed Patent Applications" means:
(i) the patent applications relating to the invention entitled
"Novel phosphosugars and phosphosugar-containing compounds
having anti-inflammatory activity", including United State
Patent Application No. 08/953305, Australian Application No.
41866/97 and any patent applications filed now or in the
future in any country which disclose and claim the same
inventions or the priority of Australian Provisional
Application PO 3098/96, filed October 18, 1996; and
(ii) all patent applications related to the New Intellectual
Property;
(g) "Licensed Patents" means:
(i) the patents described on Schedule "A" hereto;
(ii) all patents issued out of the Patent Applications;
(iii) any patents issued in any country disclosing and claiming the
same inventions as those claimed in the patents referred to in
clauses (i) and (ii) hereof; and
(iv) all divisions, re-issues, re-examinations, continuations,
renewals and extensions of the foregoing;
(h) "Licensed Product" means any product the manufacture or use of which
is covered by a Valid Claim;
(i) "Licensed Technology" means:
(i) the inventions disclosed and claimed in the Licensed Patent
Applications and Licensed Patents;
(ii) any additional Intellectual Property related to the inventions
referred to in clause (i), their description, use, or
application; and
(iii) all Confidential Information in any way related to the
inventions referred to in clause (i) hereof and the
Intellectual Property referred to in clause (ii) hereof;
(j) "Net Revenue" means all consideration received by ▇▇▇▇▇▇▇▇▇:
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(i) for the sale or other disposition of Licensed Products; and
(ii) pursuant to the terms of any sublicences granted by ▇▇▇▇▇▇▇▇▇
in accordance with Section 11(3); less the following:
(A) all costs incurred by ▇▇▇▇▇▇▇▇▇ in the development of
Licensed Products, including, without limitation,
payments made by ▇▇▇▇▇▇▇▇▇ to Praxis pursuant to Section
8, costs and expenses incurred by ▇▇▇▇▇▇▇▇▇ pursuant to
Section 13 and expenses incurred by ▇▇▇▇▇▇▇▇▇ in
connection with obtaining Regulatory Approvals,
including those referred to in Section 17;
(B) all costs of direct materials, labour and overhead
expenses required in the manufacture and production of
Licensed Products;
(C) costs incurred by ▇▇▇▇▇▇▇▇▇ in connection with the
marketing, selling and distribution of Licensed
Products;
(D) any tax or government charge (other than an income tax)
levied on the sale, transportation or delivery of
Licensed Product;
(E) trade and quantity discounts or rebates actually allowed
and taken; and
(F) credits or allowances given or made for rejection or
return of previously sold Licensed Products;
(k) "New Intellectual Property" means Intellectual Property that is
developed by Praxis during the conduct of the Research Projects
performed by Praxis in accordance with Section 8;
(l) "Regulatory Approval" means any approvals, licenses, registrations
or authorizations of any relevant authority having jurisdiction
necessary for the development, use, importation, packaging,
marketing, distribution, sale, storage and transportation of the
Licensed Products;
(m) "Research Projects" means the Research and Development Projects
relating to dermal wrinkles and arthritis conducted in accordance
with Section 8;
(n) "Shares" means shares in the capital stock of ▇▇▇▇▇▇▇▇▇ described as
Class A Common and having the rights set out on Schedule "B" hereto;
(o) "Valid Claim" means a claim of any issued and unexpired Licensed
Patent which claim has not been held unenforceable, unpatentable or
invalid by a decision of a court or government body of competent
jurisdiction, unappealable or unappealed within the time allowed for
appeal, which has not been rendered unenforceable through disclaimer
or otherwise, and which has not been lost through an interference
proceeding or by abandonment.
SECTION 2 - GOVERNING LAW AND JURISDICTION
This Agreement shall be governed by and interpreted in accordance with the laws
in force in the Province of British Columbia. The parties hereby submit to the
jurisdiction of the Courts of British Columbia.
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SECTION 3 - CURRENCY
All monetary units, except as expressly stated otherwise in this Agreement, are
in United States dollars.
SECTION 4 - AFFILIATES
For the purpose of this Agreement, a company is an Affiliate of a party if:
(a) the party owns or controls, directly or indirectly, 50% or more of
the voting stock of that company;
(b) the party owns or controls, directly or indirectly, sufficient
voting stock in that company to elect a majority of the directors of
that company;
(c) that company owns or controls, directly or indirectly, 50% or more
of the voting stock of the party;
(d) that company owns or controls, directly or indirectly, sufficient
voting stock in the party to elect a majority of the directors of
the party;
(e) an organization owns or controls, directly or indirectly, 50% or
more of the voting stock of the party and that company; or
(f) an organizations owns or controls, directly or indirectly,
sufficient voting stock in the party and the company to elect a
majority of the directors of the party and that company.
SECTION 5 - SCHEDULES
The following Schedules are incorporated into and form part of this Agreement:
Schedule "A" - Patents
Schedule "B" - Share Rights
Schedule "C" - Research Projects
Schedule "D" - Anutech Licence
PART II - PURCHASE AND SALE OF SHARES
SECTION 6 - SUBSCRIPTION AND PURCHASE
(1) In consideration for the licensing rights to the Praxis Intellectual
Property, ▇▇▇▇▇▇▇▇▇ hereby agrees to transfer, on or before the Closing
Date, 260,000 pre-split shares or 2.6 million post-split shares of
▇▇▇▇▇▇▇▇▇ International Inc. to Praxis, and guarantees that the Shares
will be issued as fully paid up and non-accessible Shares; that the Shares
be allotted and that a certificate for the Shares be issued to Praxis.
(2) Praxis shall certify as at the Closing Date that the following
representations and warranties are correct:
(a) Praxis is engaged primarily in the business of developing a unique
panel of natural carbohydrate based compounds and exploiting
commercial applications of such;
(b) there are no material lawsuits against Praxis, or its directors or
officers that are related to the business of Praxis, nor, to the
best of the knowledge of Praxis and its directors and officers are
any being contemplated;
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(c) Praxis is current in all taxes owed, including payroll taxes, and on
all debts, accounts payable and leases;
(d) Praxis has provided copies of its most recent financial statements
to ▇▇▇▇▇▇▇▇▇ and the information contained in such financial
statements is complete and accurately reflects Praxis' situation,
financial and otherwise;
(e) a copy of every material executed lease, licence, partnership or
collaboration agreement (whether technical, marketing, manufacturing
or other) stockholder agreement, loan agreement, employment
agreement, purchase and sale agreement has been provided to
▇▇▇▇▇▇▇▇▇;
(f) a comprehensive listing and description of all Intellectual Property
in the name of Praxis or obtained by Praxis through licensing has
been provided to ▇▇▇▇▇▇▇▇▇ as have copies of file wrappers for all
Licensed Patent Applications and there are no existing or potential
patent disputes of which Praxis is aware or for which Praxis has not
provided full and complete disclosure to ▇▇▇▇▇▇▇▇▇;
(g) a complete and current listing of Praxis' capital structure and the
terms and conditions associated therewith has been provided to
▇▇▇▇▇▇▇▇▇, including a list of all shareholders, options, Warrants,
puts and other instruments that may affect ▇▇▇▇▇▇▇▇▇'▇ equity
position after shareholdings are fully diluted;
(h) there are no material written or oral agreements with any other
person or corporation pursuant to which Praxis or it directors or
officers have agreed to do anything beyond the requirements of the
formal written contracts referred to in clause (e);
(i) the transfer of the Shares to Praxis contemplated by this Agreement
will not constitute a breach of any contract or commitment to which
▇▇▇▇▇▇▇▇▇ is a party;
(j) Praxis has filed all necessary tax returns;
(k) this Agreement has been duly authorized, executed and delivered by
Praxis and is a legal, valid and binding obligations of Praxis
enforceable by ▇▇▇▇▇▇▇▇▇ in accordance with its terms, except as
enforcement may be limited by bankruptcy, insolvency and other laws
affecting the rights of creditors generally;
(l) the execution and delivery of this Agreement by Praxis and the
completion of the transactions herein will not result in a breach or
violation of any of the provisions of any obligation of Praxis under
any contract to which Praxis may be a party; any judgment, decree,
order or award of any court, governmental body or arbitrator having
jurisdiction over Praxis; or any applicable law, statute, ordinance,
regulation or rule;
(m) the issue of the Shares to Praxis is in compliance with the
constating documents of ▇▇▇▇▇▇▇▇▇; and
(n) Praxis is not a non-resident of Canada within the meaning of Section
116 of the Income Tax Act (Canada).
(3) If at any time prior to the Closing Date:
(a) Praxis shall have failed to comply with any term or condition
contained herein;
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(b) any representations and warranties set out in Section 6(2) is
incorrect in any material respect;
(c) there is any material default under debts owed by Praxis which
default has not been cured within any applicable grace period; or
(d) any material final judgments are rendered against Praxis;
▇▇▇▇▇▇▇▇▇ may terminate this Agreement upon written notice to Praxis.
(4) All registration and recording fees payable to third parties in connection
with the closing of the transactions outlined in this Section 6 shall be
borne by Praxis.
SECTION 7 - PURCHASE OF ADDITIONAL SHARES
Praxis shall not purchase any Shares in addition to those to which Praxis is
entitled pursuant to Section 6 unless such purchase is made in conjunction with
or pursuant to an agreement between Praxis and ▇▇▇▇▇▇▇▇▇ for the acquisition by
Praxis of voting control of ▇▇▇▇▇▇▇▇▇.
PART III - RESEARCH AND DEVELOPMENT
SECTION 8 - RESEARCH PROJECTS
(1) Praxis shall conduct the Research Projects and perform all work described
in Schedule "C".
(2) Praxis shall commence work on October 1st, 1999 and shall use reasonable
efforts to complete the Research Projects in accordance with the work
schedule included as part of Schedule "C".
(3) The Research Projects shall be performed by Praxis in a thorough and
diligent manner in accordance with Good Laboratory Practices and normal
professional standards.
(4) Praxis shall report to ▇▇▇▇▇▇▇▇▇ at the times and in the manner set forth
in Schedule "C".
(5) ▇▇▇▇▇▇▇▇▇ shall pay to Praxis the total sum of $250,000.00 USD, after
deduction for any loans to the company, payable as an initial payment of
$62,500 USD and then in three equal quarterly instalments of $50,000 USD
payable on the first day of each month commencing on January 1st, 2000 and
a single, and final, quarterly payment of $37,500 USD on October 1st,
2000, such payments to be exclusive of any taxes, whether municipal,
provincial, federal or Goods and Services. The funds paid by ▇▇▇▇▇▇▇▇▇ to
Praxis pursuant to this Section 8 shall only be used by Praxis for the
conduct of the Research Projects and shall only be expended in accordance
with the budget included as part of Schedule "C", unless Praxis obtains
prior written authorization from ▇▇▇▇▇▇▇▇▇.
(6) ▇▇▇▇▇▇▇▇▇ and Praxis shall, not less than once every three (3) months,
review and evaluate progress on the Research Projects. Following such
reviews milestones as set out in Schedule C may be revised as and when
needed by mutual agreement between ▇▇▇▇▇▇▇▇▇ and Praxis.
(7) Praxis shall use reasonable efforts to ensure that the technology used in
the Research Projects does not infringe on any patents or proprietary
rights of other persons.
SECTION 9 - RECORDS AND CONFIDENTIALITY
(1) Praxis shall maintain complete and accurate records of the activities
conducted and results obtained pursuant to the Research Projects, all in
accordance with good scientific practice. Upon
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written request from ▇▇▇▇▇▇▇▇▇, Praxis shall provide copies of any such
records to ▇▇▇▇▇▇▇▇▇.
(2) Praxis shall keep full, accurate and complete records of books of account
relating to financial aspects of the Research Projects. ▇▇▇▇▇▇▇▇▇, or a
designate of ▇▇▇▇▇▇▇▇▇, may from time to time upon reasonable prior
written notice to Praxis examine, audit or have examined or audited the
records and books of account of Praxis.
(3) All data, reports, plans, records, logs and other information relating to
the Research Projects shall be treated by Praxis and ▇▇▇▇▇▇▇▇▇ as the
confidential property of both parties and both parties shall use all
reasonable efforts to ensure that such information is kept strictly
confidential during the term of this Agreement and for a period of ten
(10) years thereafter. Nothing herein shall prevent Praxis from using,
disclosing or authorizing disclosure of information:
(a) which is or becomes part of the public domain through no act or
failure on the part of Praxis;
(b) which was in Praxis' possession prior to its development pursuant to
the Research Projects or prior to receipt or acquisition from
▇▇▇▇▇▇▇▇▇;
(c) which is disclosed to Praxis by a third party without a covenant of
confidentiality, provided that such third party is, to the knowledge
of Praxis, under no obligation of confidentiality with respect to
the information; or
(d) with the prior written authorization of ▇▇▇▇▇▇▇▇▇.
SECTION 10 - OWNERSHIP OF NEW INTELLECTUAL PROPERTY
(1) New Intellectual Property shall promptly be disclosed by Praxis to
▇▇▇▇▇▇▇▇▇ and thereafter shall be included as part of the Licensed
Technology and licensed to ▇▇▇▇▇▇▇▇▇ pursuant to Section 11.
(2) All expenses connected with preparing, filing, prosecuting, obtaining,
maintaining and enforcing intellectual property rights related to the New
Intellectual Property shall be borne by ▇▇▇▇▇▇▇▇▇.
PART IV - LICENCE
SECTION 11 - GRANT
(1) Praxis hereby grants to ▇▇▇▇▇▇▇▇▇ an exclusive, world-wide sublicence
under the Licensed Patent Applications and Licensed Patents, and an
exclusive, world-wide sublicence under the New Intellectual Property, to
use the Licensed Technology and to make, use and sell any products,
compounds, compound uses, processes, applications, methods or procedures
within the Field of Use.
(2) ▇▇▇▇▇▇▇▇▇ shall be entitled to grant further sublicences of the rights
granted by Praxis to ▇▇▇▇▇▇▇▇▇ pursuant to Section 11(1) hereof. ▇▇▇▇▇▇▇▇▇
shall advise Praxis in writing of any and all sublicences granted by
▇▇▇▇▇▇▇▇▇ in accordance with this Section 11(3) and shall provide Praxis
with the following information:
(a) name of the sublicencee;
(b) the amount of any licence fee or royalties payable by the
sublicencee; and
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(c) such further information as may be reasonably requested by Praxis.
(3) ▇▇▇▇▇▇▇▇▇ may assign this Agreement to an Affiliate of ▇▇▇▇▇▇▇▇▇ or may
transfer or assign the rights and obligations of ▇▇▇▇▇▇▇▇▇ pursuant to
Parts III, IV or V, or any combination thereof, to an Affiliate of
▇▇▇▇▇▇▇▇▇.
▇▇▇▇▇▇▇▇▇ shall advise Praxis in writing of any such transfer or
assignment.
Notwithstanding any such transfer or assignment, ▇▇▇▇▇▇▇▇▇ shall at all
times remain liable to Praxis for the performance of the obligations set
out herein, including the obligation to pay to Praxis a share of Net
Revenue in accordance with Section 12.
SECTION 12 - REVENUE
(1) Net Revenue shall be apportioned between the parties and ▇▇▇▇▇▇▇▇▇ shall
pay to Praxis an amount equal to thirty five percent (35%) of Net Revenue
of Praxis products for so long as there are Valid Claims.
(2) All payments required to be made pursuant to Section 12(1) shall be made
according to Section 8(5).
SECTION 13 - RECORDS AND REPORTS
(1) ▇▇▇▇▇▇▇▇▇ shall keep full, accurate and complete records and books of
account relating to Net Revenue and any amounts payable by ▇▇▇▇▇▇▇▇▇ to
Praxis pursuant to Section 12 hereof.
(2) All payments made by ▇▇▇▇▇▇▇▇▇ to Praxis pursuant to Section 12 shall be
accompanied by a report providing such information as is reasonably
required by Praxis to determine an accurate determination of the amounts
payable by ▇▇▇▇▇▇▇▇▇ to Praxis in accordance with Section 12.
(3) Praxis may from time to time, upon reasonable prior notice to ▇▇▇▇▇▇▇▇▇
have the records and books of account maintained by ▇▇▇▇▇▇▇▇▇ in
accordance with Section 13(1) hereof audited or examined by a duly
authorized independent chartered accountant to ascertain the accuracy of
the payments made. All costs of any audit, examination or report shall be
payable by Praxis, unless the report discloses an underpayment of five
(5%) percent or more, in which case the cost of the audit, examination or
report shall be payable by ▇▇▇▇▇▇▇▇▇.
SECTION 14 - PROTECTION, ENFORCEMENT AND INFRINGEMENTS
(1) Praxis shall permit ▇▇▇▇▇▇▇▇▇ to control and direct (including the
selection of patent agents or patent attorneys) the preparation, filing
and prosecution of all patent applications the subject of this Agreement
included within the Field of Use of the Licensed Technology, including the
New Intellectual Property.
Without limiting the generality of the foregoing, Praxis shall, upon
▇▇▇▇▇▇▇▇▇'▇ request and at ▇▇▇▇▇▇▇▇▇'▇ cost and expense, file and
prosecute patent applications to protect the Licensed Technology in any
country that a patent application has not been filed. ▇▇▇▇▇▇▇▇▇ shall
consult with Praxis on the content of all patent applications and related
filings. Praxis shall bear all costs related to the preparation, filing,
prosecution and maintenance with respect to the Licensed Patents described
on Schedule "A", the Licensed Patent Applications described in Section
1(g)(i) and any other patents or Licensed Patent Applications that
disclose and claim the same
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inventions. ▇▇▇▇▇▇▇▇▇ shall pay all costs of preparing, filing,
prosecuting and maintaining all Licensed Patent Applications and Licensed
Patents related to the New Intellectual Property.
(2) If either party believes that any Licensed Patents are being infringed by
another person, that party shall promptly notify the other party and shall
provide any evidence of infringement which is reasonably available.
▇▇▇▇▇▇▇▇▇ shall have the first right and option, but not the obligation,
to bring an action for infringement, at ▇▇▇▇▇▇▇▇▇'▇ sole cost and expense,
against the alleged infringer. If ▇▇▇▇▇▇▇▇▇ elects to take such action,
the conduct of the action shall be entirely under the direction and
control of ▇▇▇▇▇▇▇▇▇. If ▇▇▇▇▇▇▇▇▇ exercises the rights contained herein,
▇▇▇▇▇▇▇▇▇ may name Praxis as a party plaintiff in such action, suit or
proceeding, if reasonably necessary under the circumstances, provided that
▇▇▇▇▇▇▇▇▇ shall indemnify and hold Praxis and Anutech harmless from any
costs or expenses incurred in connection with such action, suit or
proceeding. Any damages or sums recovered by ▇▇▇▇▇▇▇▇▇ in any such action,
suit or proceeding, or any settlement thereof, shall be retained by
▇▇▇▇▇▇▇▇▇, but, to the extent that the recovery reflects lost sales of
Licensed Products, the net amount after deducting expenses incurred by
▇▇▇▇▇▇▇▇▇, shall be included as part of Net Revenue.
(3) If ▇▇▇▇▇▇▇▇▇ elects not to pursue an action for infringement, whether
alone or jointly with Praxis, Praxis shall have the right and option, but
not the obligation, at Praxis's sole cost and expense, to bring the action
for infringement against the alleged infringer. Any damages or sums
recovered by Praxis in such action, suit or proceeding, or any settlement
thereof, shall be retained by Praxis, but, to the extent that the recovery
reflects lost sales of Licensed Products, Praxis shall pay to ▇▇▇▇▇▇▇▇▇
one-half of the net amount after deducting expenses incurred by Praxis.
(4) The parties shall cooperate in defending any impeachment, interference or
infringement action, suit or proceeding brought against either Praxis or
▇▇▇▇▇▇▇▇▇ related to the Licensed Technology.
(5) The parties shall not take any actions that may be reasonably known to
compromise the position of the other party with respect to legal
proceedings commenced or to be commenced or being defended by the other
party.
(6) The parties shall render all reasonable assistance, including providing
all documents in their possession and any witnesses as are or may be
required in the conduct of any proceedings referred to herein. If any
party renders such assistance at the request of another party, the
requesting party shall reimburse the assisting party for expenses incurred
to render such assistance.
SECTION 15 - WARRANTIES, INDEMNITIES AND INSURANCE
(1) Praxis represents and Warrants to ▇▇▇▇▇▇▇▇▇ that, as of the Closing Date:
(a) Praxis owns or has valid and enforceable licenses of the Licensed
Technology free and clear of all liens, charges, security interests
and encumbrances, licences and other restrictions;
(b) the Anutech Licence Agreement is in full force and effect, unamended
and that neither Praxis nor Anutech are in default of any of the
terms and conditions contained therein;
(c) to the best of Praxis's knowledge and belief, the practicing of the
Licensed Technology will not infringe the rights of any other
person; and
(d) to the best of Praxis's knowledge and belief, it is not aware of any
activities or conduct of any other person that would constitute
infringement of the Licensed Technology.
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(2) The parties shall assume and be liable for their own losses, damages and
expenses of any nature whatsoever which they may suffer, sustain, pay or
incur by reason of any matter or thing arising out of, or in any way
related to this Agreement, except for such losses, costs, damages and
expenses as are the result of the wilful breach of any term herein by the
other party or the wilful or negligent acts or omissions of the other
party.
(3) Each party shall indemnify and hold harmless the other party, its
employees and agents, from and against any and all claims, demands and
costs whatsoever that may arise out of, directly or indirectly, the
indemnifying party's performance of this Agreement or that of the
indemnifying party's employees or agents. Such indemnifications shall
survive this Agreement.
(4) Praxis shall, at its own expense and without limiting its liabilities
herein, maintain comprehensive or commercial general liability insurance
with an insurer in an amount not less than $1,000,000.00 per occurrence
(annual general aggregate, if any, not less than $2,000,000.00), insuring
against bodily injury, personal injury and property damage, including loss
of use thereof. Such insurance shall include blanket contractual
liability.
(5) From the date that any Product arising out of the the Licenced Technology
is first applied for therapeutic human use (and for the term or
foreseeable term of the human use) ▇▇▇▇▇▇▇▇▇ undertakes to hold product
liability insurance to the value of at least $10,000,000.00. Such policies
shall name Praxis as additional insureds and shall be purchased from a
reputable insurer. Certificates evidencing the coverage shall be provided
to Praxis.
SECTION 17 - REGULATORY APPROVALS
(1) ▇▇▇▇▇▇▇▇▇ shall use reasonable efforts to obtain Regulatory Approvals.
(2) Praxis shall assist ▇▇▇▇▇▇▇▇▇ in obtaining Regulatory Approvals in the
various countries by providing such information and data as may be in the
possession of Praxis necessary for or of assistance in obtaining any
Regulatory Approvals. ▇▇▇▇▇▇▇▇▇ shall be responsible for all regulatory,
agency, filing, inspection and other fees and expenses and charges
incurred in connection with obtaining any Regulatory Approvals pursuant to
Section 17(1).
(3) Praxis shall ensure that all information and data generated by Praxis that
is related to the Clinical Trials or would be of any assistance to
▇▇▇▇▇▇▇▇▇ in obtaining Regulatory Approvals shall be maintained in a form
suitable for submission to regulatory authorities and shall at all times
be kept secure and confidential.
PART VI - GENERAL
SECTION 18 - TERM AND TERMINATION
(1) The term of this Agreement shall expire on the expiration of the last
Licensed Patent. Upon the expiration of this Agreement, ▇▇▇▇▇▇▇▇▇'▇
licence pursuant to Section 11 shall become a fully paid-up, perpetual
licence.
(2) This Agreement may be terminated at any time upon the mutual agreement of
the parties.
(3) If:
30
(a) either party has breached any of its obligations pursuant to this
Agreement and fails to remedy such breach or to commence and
diligently pursue reasonable steps to remedy such breach within
sixty (60) days after notice in writing from the other party;
(b) either party becomes bankrupt or insolvent or takes the benefit of
any statute for bankrupt or insolvent debtors or makes any proposal,
assignment or arrangement with its creditors, or any steps are taken
or proceedings commenced by any person for the dissolution, winding
up or termination of either parties existence or the liquidation of
its assets; or
(c) a trustee, receiver, receiver manager or like person is appointed
with respect to the business or assets of a party; the party in
default may terminate this Agreement by giving written notice to the
party in default.
(4) If Praxis is in default of any of its obligations related to the
performance of the Research Projects, and has failed to remedy such breach
within sixty (60) days after notice in writing from ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇
may terminate the Research Projects immediately upon written notice to
Praxis. If ▇▇▇▇▇▇▇▇▇ terminates the Research Projects in accordance with
this Section 18(4):
(a) ▇▇▇▇▇▇▇▇▇ shall reimburse Praxis for costs and expenses incurred in
accordance with the budget included as part of Schedule "C" to the
date of termination;
(b) ▇▇▇▇▇▇▇▇▇ shall have no further obligation with respect to the
conduct of the Research Projects or any costs and expenses related
thereto;
(c) notwithstanding the termination of the Research Project, all New
Intellectual Property developed prior to the date of termination
shall be disclosed by Praxis to ▇▇▇▇▇▇▇▇▇ and shall be included as
part of the Licensed Technology and licensed to ▇▇▇▇▇▇▇▇▇ pursuant
to Section 11; and
(d) ▇▇▇▇▇▇▇▇▇ shall have the right to complete the Research Project, or
any part thereof at its own cost and expense and any results;
improvements to Intellectual Property sublicenced from Praxis under
the terms of this Agreement; new patents and patent applications
arising from this shall be deemed to be New Intellectual Property.
(5) The following sections shall survive termination of this Agreement: 1, 2,
3, 4, 5, 9 and 15.
SECTION 19 - PUBLICITY
(1) A copy of all public announcements and press releases which either party
intends to release or make regarding products or technology covered by the
licence shall be provided to the other party prior to being released or
made.
Any public announcement or news release that names, refers to or in any
way identifies both parties shall be approved by both parties prior to
being released or made. Each party shall respond to a request for approval
within five (5) working days of receipt of the copy and the approval of
each party shall not be unreasonably withheld.
(2) If either party is prevented from complying with Section 19(1) as a result
of the requirements of a Securities Commission or other regulatory body,
the party shall not be considered to be in breach of this Agreement, but
shall use reasonable efforts to consult with and keep the other party
informed.
31
(3) The parties shall not use each other's name in any advertising material
without the prior written consent of the other party, which consent may be
arbitrarily withheld.
(4) Subject to subsection (3), ▇▇▇▇▇▇▇▇▇ shall be responsible for and have
control of labelling of Licensed Products.
SECTION 20 - COMPLIANCE WITH LAWS
The parties shall observe and comply with all applicable laws, ordinances, codes
and regulations of Government agencies, including Federal, Provincial, Municipal
and local governing bodies having jurisdiction.
SECTION 21 - RELATIONSHIP
Nothing in this Agreement shall be construed as:
(a) constituting either party as the agent, employee or representative
of the other party; or
(b) creating a partnership or as imposing upon either party any
partnership duty, obligation or liability to the other party.
SECTION 22 - NOTICES
All notices or other communications required or permitted to be given hereunder
shall be in writing and shall be sent to the following addresses or such other
addresses as the relevant party may notify from time to time:
TO: ▇▇▇▇▇▇▇ ▇ ▇▇▇▇▇▇, CEO
Praxis Pharmaceuticals Inc.
GPO Box 1978
▇▇▇▇▇▇▇▇, ▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇▇▇
Facsimile: 61 2 6279 9758
TO: ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇ INTERNATIONAL Inc.
#▇▇▇ - ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
Notices sent by prepaid registered mail shall be deemed to be received by the
addressee on the 7th day (excluding Saturdays, Sundays, statutory holidays and
any period of postal disruption) following the mailing thereof. Notices
personally served or transmitted by facsimile shall be deemed received when
actually delivered or transmitted, provided such delivery shall be made during
normal business hours.
SECTION 23 - ASSIGNMENT
Except as expressly permitted pursuant to Section 11, the parties shall not
assign this Agreement or any part thereof, or any rights hereunder without the
prior written consent of the other party, such consent not to be unreasonably
withheld.
SECTION 24 - FURTHER ASSURANCES
32
The parties shall with reasonable diligence take all action, do all things,
attend or cause their representatives to attend all meetings and execute all
further documents, agreements and assurances as may be required from time to
time in order to carry out the terms and conditions of this Agreement in
accordance with their true intent.
SECTION 25 - SETTLEMENT OF DISPUTES
(1) If there is any dispute or disagreement related to or arising out of this
Agreement (the "Disagreement") the parties shall refer the Disagreement
for resolution to their respective Chief Executive Officers, or their
nominees.
(2) If the Disagreement is not resolved pursuant to Section 25(1) within
thirty (30) days (or such longer period as agreed upon between the
parties), a mediator shall be appointed by the parties who shall assist
the parties in resolving the Disagreement.
(3) If the Disagreement is not resolved under Section 25(2) within thirty (30)
days (or such longer period as agreed upon between the parties) either
party may refer the Disagreement to be resolved by arbitration conducted
as follows:
(a) either party may require arbitration by giving written notice to
arbitrate to the other party, which written notice shall identify
the nature of the Disagreement;
(b) if the parties are able to agree upon a single arbitrator, the
arbitration shall be conducted before the single arbitrator;
(c) if the parties have been unable to agree upon the selection of a
single arbitrator within two (2) weeks after receipt of the notice
requiring arbitration, each party shall within one (1) further week,
by notice in writing given to the other party, nominate one neutral
arbitrator. If either party fails to nominate an arbitrator in
accordance with this clause, the arbitrator so nominated shall
proceed to conduct the arbitration alone. If both parties nominate
neutral arbitrators in accordance with this clause, the two
arbitrators so nominated shall nominate a third arbitrator within
one (1) week of their nomination;
(d) the arbitrator or arbitrators shall immediately proceed to hear and
determine the Disagreement. The parties agree that it is important
that all Disagreements be resolved promptly and the parties
therefore agree that the arbitration shall be required to be
conducted expeditiously and that the final disposition shall be
accomplished within two (2) weeks. The parties shall ensure that the
arbitrator or arbitrators upon accepting the nomination shall agree
that the arbitrator has time available for the timely handling of
the arbitration in order to achieve final disposition within two (2)
weeks;
(e) the decision of the arbitrator or arbitrators shall be rendered in
writing, without reasons and shall be promptly served upon both
parties. If the arbitration is being conducted before a panel of
three arbitrators, the decision of any two of the three arbitrators
shall be decision of the arbitration panel. The decision of the
arbitrator or arbitrators shall be binding upon the parties;
(f) in the event of the death, resignation, incapacity, neglect or
refusal to act of any arbitrator, and if the neglect or refusal
continues for a period of five (5) days after notice in writing of
such has been given by either party, another arbitrator shall be
nominated to replace the arbitrator by the person who has originally
nominated that arbitrator;
33
(g) the costs of the arbitration shall be in the discretion of the
arbitrators, and shall be borne by the parties in accordance with
the decision of the arbitrators;
SECTION 26 - ENUREMENT
This Agreement shall enure to the benefit of and be binding upon the parties
hereto and their respective successors and permitted assigns.
IN WITNESS WHEREOF the parties hereto have executed this Agreement as of the day
and year first above written.
PRAXIS PHARMACEUTICALS, INC.
Per: /S/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ (PRESIDENT)
▇▇▇▇▇▇▇▇▇ INTERNATIONAL INC.
Per: /S/ ▇▇▇▇▇ ▇▇▇
34
SCHEDULE A
LICENSED PATENTS
PHOSPHOSUGAR-BASED ANTI-INFLAMMATORY AND/OR IMMUNOSUPPRESSIVE DRUGS
International Application No. PCT/AU89/00350
Inventors - ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
Priority date - 18 August 1988
International filing date - 18 August 1989
ANUTECH reference 140
COUNTRY APPLICATION NO. PATENT NO. STATUS
Australia 41875/89 627500 granted
Europe 89909685.3 0429522 granted
Japan 509079/89 examination requested
USA 988001 5506210* granted - 9 April 1996
NOVEL PHOSPHOSUGARS AND PHOSPHOSUGAR-CONTAINING COMPOUNDS HAVING
ANTIINFLAMMATORY ACTIVITY
Inventors - ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
Priority date - 18 October 1996
ANUTECH reference 278
COUNTRY APPLICATION NO. PATENT NO. STATUS
Australia PO3098/96 INT on 18 October ▇▇▇▇
▇▇▇▇▇▇▇▇▇ 41866/97 examination requested
USA 08/953305 examination requested
35
SCHEDULE D
PRAXIS PHARMACEUTICALS INC.
and
ANUTECH PTY LIMITED
----------------------
LICENCE AGREEMENT
----------------------
PRAXIS Pharmaceuticals Inc.
▇▇▇ ▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇
Tel: (▇▇) ▇▇▇▇ ▇▇▇▇
36
Fax: (▇▇) ▇▇▇▇ ▇▇▇▇
TABLE OF CONTENTS
1. DEFINITIONS AND INTERPRETATION......................................... 1
2. GRANT OF LICENCE....................................................... 4
3. LICENCE CONSIDERATION.................................................. 4
4. LICENCE TERM........................................................... 4
5. PERFORMANCE OF PRAXIS.................................................. 4
6. RIGHT TO SUBLICENSE.................................................... 5
7. GST.................................................................... 5
8. OWNERSHIP.............................................................. 6
9. PROTECTION OF PATENTS.................................................. 6
10. INFRINGEMENT AND ENFORCEMENT OF PATENTS................................ 7
11. REPORTS, PAYMENTS AND ACCOUNTING....................................... 7
12. CONFIDENTIALITY........................................................ 8
13. PUBLICATION............................................................ 9
14. USE OF NAME............................................................ 9
15. INDEMNITY AND INSURANCE................................................ 9
16. WARRANTIES............................................................. 10
17. ASSIGNMENT, TRANSFER................................................... 11
37
18. TERMINATION............................................................ 11
19. MISCELLANEOUS PROVISIONS............................................... 12
20. TERMINATION OF LICENCE AND RESEARCH & DEVELOPMENT AGREEMENT............ 15
21. SCHEDULE 1 - ANU Intellectual Property................................. 17
38
THIS AGREEMENT IS MADE ON THE 14TH DAY OF OCTOBER 1999 BETWEEN:
ANUTECH PTY LIMITED, ACN 008 548 650 with its registered office at ANUTECH
Court, Cnr ▇▇▇▇▇ Drive and ▇▇▇▇▇ Road, Acton, Australian ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ("ANUTECH").
AND:
PRAXIS PHARMACEUTICALS INC., a company incorporated in Utah with its office at
▇▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇, ▇▇▇▇▇▇ ("Praxis").
RECITALS:
A. Praxis was incorporated on 20 June 1997 with the intention that it raise
capital, acquire intellectual property and research, develop and
commercialise pharmaceuticals.
B. ANU possesses intellectual property in the area of phosphosugars and their
analogues as anti-inflammatory agents.
C. Praxis wishes to license the ANU intellectual property in order to
undertake further research and development and commercialisation of the
intellectual property.
D. In accordance with the terms and conditions set forth in this agreement,
ANUTECH is willing to grant such a licence to Praxis with its term
dependant on Praxis achieving research and commercialisation milestones.
E. ANUTECH is the commercial subsidiary of the ANU and regularly provides
services to its clients by engaging the services of the ANU.
IT IS AGREED AS FOLLOWS:
DEFINITIONS AND INTERPRETATION
1.1 In this Agreement, unless there is something inconsistent with the
context, the following terms and expressions shall have the following
meanings:
"AFFILIATE" means, in relation to a person, the person's related bodies
corporate (within the meaning of the Corporations Law), entities who are
partners or joint venturers of or trustees for the person or with whom the
person is acting in concert and the directors agents, officers and
employees of the person or any of those related bodies corporate or
entities.
"ANU INTELLECTUAL PROPERTY" means the following intellectual property
owned by the ANU:
(a) Intellectual Property in relation to phosphosugars and their
anti-inflammatory activity; and
(b) the patents and patent applications set out in Schedule 1, including
all divisions, continuations, continuations-in-part, renewals,
extensions and additions thereof.
"COMMENCEMENT DATE" means the day of 1999.
"CONFIDENTIAL INFORMATION" means any information whether written, oral,
electronic or in any other form which is disclosed by a party or its
representatives, is claimed as confidential to itself and which relates to
the ANU Intellectual Property, Research, Results,
39
Products, Agreement and business of the parties. It includes all copies
and notes generated from the disclosure but does not include information
which:
(a) is in the public domain at the time of disclosure;
(b) becomes a part of the public domain after disclosure, otherwise than
as a result of any unauthorised activity and/or omission on the part
of the recipient;
(c) the recipient can prove is already in its own possession at the time
of disclosure and which was not acquired from the other party
directly or indirectly;
(d) is rightfully acquired from a third party who did not obtain it
under an obligation of confidentiality; or
(e) is legally required to be disclosed - the party required to make
disclosure shall notify the other to allow that party to assert
whatever exclusions are available.
"DOLLAR", "DOLLAR" OR "$" means Australian dollars unless otherwise
indicated.
"FIELD" means the use of phosphosugars as neutriceuticals, complementary
medicines or cosmetics for the treatment of any applicable condition and
expressly excludes:
(a) the use of phosphosugars as ethical therapeutics; and
(b) topical application for wound care; and
(c) use of fructose-1,6-diphosphate, administered non-topically, for the
treatment or prophylaxis of ischaemic disorders in humans, which
includes transplantation and immunosuppression.
"GST" means a tax on goods and services as defined by Commonwealth
legislation.
"INTELLECTUAL PROPERTY" shall mean all intellectual property rights and
includes:
(a) Trade Marks: means any trade ▇▇▇▇ or trade name whether registered
or not under, or by reference to which, a product or service is
known;
(b) Patents: meaning any patents or patent applications including all
divisions, continuations, renewals, extensions and patents of
addition thereof which have been or are in the future filed and
granted as a patent;
(c) Copyright subsisting in any form or manner whether written or stored
in any form (whether visible or not) including without limitation
brochures, design logos, insignia, computer programs, software,
firmware and hardware;
(d) Designs (whether or not registered); and
(e) Know-How: meaning the unpatented, technical information, processes,
formulae, technical and technological documentation, reports,
computer programs, biological materials, procedures or methods, all
current and accumulated knowledge, skills and experience.
"NET SALES" means:
40
(a) for an arms length sale of any Product means the gross amount
invoiced by Praxis, or its Affiliates less the following:
(i) transport and insurance related charges actually allowed and
taken;
(ii) trade, quantity or cash discounts or rebates actually allowed
and taken;
(iii) credits or allowances given or made on account of price
adjustments, recalls or destruction requested or made by an
appropriate government agency; and
(iv) any tax (excluding income tax), excise or other government
charge upon or measured by the sale, transportation, delivery
or use of the Product which is actually incurred by the
seller.
(b) for a non-arms length sale, means the highest of the most recent Net
Sales at which Praxis, its Affiliates, its subsidiaries, joint
venturers licensees or agents has sold similar quantities of
Products in an arms length sale.
"PRODUCTS" means any matter, article or thing which incorporates or arises
from the whole or partial use of ANU Intellectual Property or Results.
"RESULTS" means all Intellectual Property, materials (including
substances, compounds, biological material, products, samples and devices)
in whatever form and information however known or recorded (including
trade secrets, processes, techniques, designs, plans, data, test results,
findings, evaluations and reports) generated as a result of any
exploitation of or in any connection with any research and development
conducted at the ANU within the Field.
"SUBLICENSE FEES" means all payments to Praxis in consideration for rights
to the ANU Intellectual Property, Results and Products pursuant to a
sublicence, assignment, joint venture, strategic alliance or other
arrangement.
Sublicence Fees shall not include:
(a) fees for research and development undertaken by Praxis including for
example preclinical research and clinical studies; nor
(b) the royalty percentage above that is required to be paid by Praxis
pursuant to clause 3 (License Consideration).
1.2 In this Agreement unless the contrary intention appears:
(a) a reference to a clause, schedule, attachment, annexure or appendix
is a reference to a clause of or schedule, attachment, annexure or
appendix to this Agreement and references to this Agreement include
any recital, schedule annexure, attachment, or appendix;
(b) a reference to this Agreement or another instrument includes any
variation or replacement of either of them;
(c) a reference to a statute, ordinance, code or other law includes
regulations and other instruments under it and consolidations,
amendments, re-enactments or replacements of any of them;
41
(d) the singular includes the plural and vice versa;
(e) if a period of time is specified and dates from a given day or the
day of an act or event, it is to be calculated exclusive of that
day;
(f) if an event must occur on a stipulated day which is not a business
day, then the stipulated day will be taken to be the next business
day;
(g) headings are inserted for convenience and do not affect the
interpretation of this Agreement;
(h) words importing any one gender shall mean and include masculine,
feminine and/or neuter where appropriate;
(i) words importing natural persons shall (where appropriate) mean and
include corporations and unincorporated associations and vice versa;
(j) schedules and attachments form part of and are incorporated in this
Agreement.
(k) no provision of this Agreement will be construed adversely to a
party solely on the ground that the party was responsible for the
preparation of this agreement or that provision; and
(l) an expression importing a natural person includes any company,
partnership, joint venture, association, corporation or other body
corporate and any government, governmental, administrative, judicial
or semi-governmental agency or body.
1.3 For the avoidance of doubt the recitals to this Agreement shall form part
of this Agreement and in the event of any inconsistency between the
recitals and the other provisions of this Agreement the other provisions
of this Agreement shall prevail.
GRANT OF LICENCE
1.4 ANUTECH grants to Praxis an exclusive, worldwide licence to use and
exploit the ANU Intellectual Property and Results within the Field,
including the right to sublicense pursuant to clause 6 (Right to
Sublicense).
LICENCE CONSIDERATION
1.5 In consideration for the grant of the licence Praxis will pay to ANUTECH:
a) a 4% royalty on Net Sales of Products by Praxis;
b) 50% of all royalty income on Net Sales of Products received from
sublicensees;
c) 15% of all Sublicence Fees.
d) ANUTECH shall maintain the right to hold 300,000 shares issued to
ANUTECH 31 March 1999. These shares will be held in escrow for a
period of 12 months from the date of issue.
1.6 The obligation in clause 3.1 survives the termination of the licence in
clause 2.1 or this Agreement.
42
LICENCE TERM
1.7 The Licence in clause 2.1 commences upon the Commencement Date and ends on
the expiration of the last to expire of the patents covered by this
Agreement, unless otherwise earlier terminated pursuant to clause 5
(Performance of Praxis) or clause 18 (Termination).
PERFORMANCE OF PRAXIS
1.8 If Praxis fails to comply with the following performance milestones,
ANUTECH has at its election the right to terminate this Agreement in
accordance with clause 18(Termination).
1.9 Commercialisation milestones
a) Praxis shall use best efforts to commercialise the ANU Intellectual
Property and Results by undertaking an ongoing and active research,
developmental, manufacturing, marketing, licensing or capital
raising program, as appropriate, directed toward the exploitation of
the ANU Intellectual Property and Results within the Field.
b) Part of these best efforts includes Praxis providing to ANUTECH as
soon as practicable a business plan (and any updates thereafter)
which addresses Praxis's capacities, objectives and strategies for
such a commercialisation program.
c) Praxis shall also provide ANUTECH with an annual written report (on
the anniversary of the Commencement Date) on its progress towards
achieving these commercialisation milestones.
RIGHT TO SUBLICENSE
1.10 ANUTECH grants to Praxis the right to sublicence ANU Intellectual Property
and Results within the Field, subject to:
a) the prior written approval of ANUTECH which shall not be
unreasonably withheld;
b) the sublicensee being bound to similar terms as contained in this
Agreement; and
c) the royalty and Sublicence Fee stream provided for in clause 3
(Licence Consideration) are reserved.
GST
1.11 The parties acknowledge that this Agreement, including all pricing and
compensation terms, whether by way of reimbursement, indemnity or
otherwise has been drafted without taking into account the effect, if any,
of GST. The following principles apply when determining the amount
(including royalties) payable (the Payment) for any rights, services, or
any other thing granted or supplied pursuant to this Agreement.
1.12 If GST is payable in relation to the granting of rights, supply of
services or any other thing, the Payment will be the consideration
specified herein plus GST (if any).
1.13 If the Payment is determined by reference to any cost, expense or
liability incurred by a party (the Payee), the reference to cost, expense
or liability means the actual amount incurred by the Payee less the amount
of any GST input tax credit the Payee is entitled to claim in respect
43
of that cost, expense or liability. The Payee will be assumed to be
entitled to claim full input tax credits unless it demonstrates that its
entitlement is otherwise prior to the date on which the Payment must be
made.
1.14 If the Payment is a reimbursement or indemnification of a loss determined
(including a percentage of sales revenue) by reference to revenue received
and costs incurred, the revenue will be the revenue earned net of GST and
the costs will be determined in accordance with clause 7.3.
1.15 If a party sets off an amount otherwise payable under this Agreement, the
principles set out above shall be applied to calculate the amount to be
set off as if that amount had been paid.
1.16 Each party agrees to do all things, including providing invoices or other
documentation containing stipulated information, that may be necessary or
desirable to enable or assist the other party to claim any credit, set
off, rebate or refund in relation to any GST included in any payment made
under this Agreement.
OWNERSHIP
1.17 The following shall be owned by the ANU and licensed to Praxis pursuant to
the terms of this Agreement:
a) improvements to ANU Intellectual Property ; and
b) new patents and patent applications arising from the use of ANU
Intellectual Property.
PROTECTION OF PATENTS
1.18 With respect to the existing ANU Intellectual Property patents and patent
applications:
a) the parties shall cooperate in the prosecution and maintenance of
the patents and patent applications with the relevant patent
offices;
b) from the Commencement Date, one third of any past and future costs
and expenses incurred in their filing, maintenance and renewal shall
be borne by Praxis;
c) Praxis may select the countries in which patent applications are to
be filed in the name of the ANU; and
d) if Praxis decides not to request patent protection for an invention
in any country, ANU may file or maintain at its own cost patent
applications which Praxis has declined to file or maintain, and such
patent applications or granted patents shall lie outside the
provision of this Agreement.
1.19 With respect to any new patentable inventions arising from the Results and
use of ANU Intellectual Property:
a) Praxis may request ANUTECH to file and prosecute a patent
application, in ANU's name, for the invention or agree to treat the
invention as a trade secret;
b) the parties shall cooperate in the prosecution and maintenance of
the patents and patent applications with the relevant patent
offices;
44
c) all costs and expenses incurred in filing, maintaining and renewing
the patents and patent applications shall be borne by Praxis;
d) Praxis may select the countries in which patent applications are to
be filed in the name of the ANU; and
e) if Praxis decides not to request patent protection for an invention
in any country, ANU may file or maintain at its own cost patent
applications which Praxis has declined to file or maintain, and such
patent applications or granted patents shall lie outside the
provision of this Agreement.
INFRINGEMENT AND ENFORCEMENT OF PATENTS
1.20 Infringement
In the event of any patent, the subject of this Agreement, being infringed
Praxis may at its own cost and in its own name litigate such infringement
and may settle or compromise such litigation in such a manner as Praxis
shall determine provided that Praxis shall consult with ANUTECH in good
faith in relation to those proceedings.
1.21 Enforcement
In the event that litigation is taken or threatened by a third party
against any rights associated with any patents the subject of this
Agreement, the parties shall consult in good faith and use their best
endeavours mutually to determine the manner in which these proceedings are
to be defended or resisted and to act accordingly provided always that the
parties shall first seek the opinion of counsel experienced in such
matters.
1.22 In any litigation, ANUTECH shall cooperate with Praxis in making available
all relevant records, papers, information and the like which may be
relevant and in its possession.
1.23 Nothing herein shall preclude ANUTECH from defending or pursuing any such
actions.
REPORTS, PAYMENTS AND ACCOUNTING
1.24 Within 30 days after the first day of January, April, July and October of
each year, Praxis shall provide to ANUTECH a true and accurate royalty
report. This royalty report will cover payments due under clause 3
(Licence Consideration) and specify:
a) the total quantity of Products sold or provided by it and by its
sublicensees;
b) the Net Sales price at which the Products were sold or provided;
c) the calculation of the royalty due;
d) the total royalties so calculated and due to ANUTECH; and
e) the amount of Sublicence Fees and the royalty due.
1.25 For the term of this Agreement and simultaneous with the delivery of each
such royalty report, Praxis shall pay to ANUTECH the royalty and any other
payments due under this Agreement for the period covered by such report.
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Praxis shall be responsible for all payments that are due to ANUTECH but
have not been paid by Praxis' sublicensees to Praxis.
1.26 All payments hereunder by Praxis shall be payable in Australian Dollars.
1.27 During the term of this Agreement, Praxis shall keep complete and accurate
records of its and its sublicensees sales of Products and Sublicence Fees
in sufficient detail to enable compliance with its obligations under this
Agreement to be verified.
1.28 Praxis shall permit ANUTECH or its representatives, at ANUTECH's expense,
to periodically examine its books, ledgers and records during business
hours and with 48 hours notice for the purpose of and to the extent
necessary to ensure that Praxis has complied, and is complying, with its
obligations under this Agreement.
1.29 In the event that the difference between the amount of royalty due and the
amount of royalty actually paid exceeds 5% then Praxis shall pay the
amount of the underpayment plus the cost of such examination.
1.30 If Praxis fails to pay ANUTECH an amount due under this Agreement, Praxis
shall upon notification pay to ANUTECH the amount owing together with
interest, such interest to be at the rate applicable to overdrafts charged
by the Commonwealth Bank of Australia at the date of payment, calculated
daily from the due date or the date the shortfall in payment was
effective, as the case may be. The payment of such interest shall not
preclude ANUTECH from exercising any other rights it may have because any
payment is overdue.
CONFIDENTIALITY
1.31 The parties acknowledge that the Confidential Information is valuable to
the party in question and each party undertakes to keep the Confidential
Information secret and to protect and preserve the confidential nature and
secrecy of the Confidential Information.
1.32 The recipient of Confidential Information must:
1.33 keep it confidential;
1.34 use it only for the purposes of the Agreement;
1.35 not disclose it to any person other than:
(a) to those of the recipient's employees or legal advisers who have a
need to know and who have first been directed and have undertaken
orally or in writing to keep it confidential; or
(b) to other people, such as contractors, visitors and agents who have a
need to know and who have agreed in writing to keep it confidential
in accordance with this Agreement
1.36 not copy it or any part of it other than as strictly necessary for the
purposes of this Agreement and must ▇▇▇▇ any such copy "Confidential";
1.37 promptly comply with any request by the discloser to return or destroy any
or all copies of Confidential Information; and
1.38 implement security practices against any unauthorised copying, use or
disclosure of the Confidential Information.
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1.39 Each party shall take:
a) reasonable efforts to ensure that any person who has access to
Confidential Information does not make any unauthorised use,
reproduction or disclosure of that information; and
b) reasonable steps to enforce the confidentiality obligations imposed
or required to be imposed by this agreement, including diligently
prosecuting at its cost any breach or threatened breach of such
confidentiality obligations by a person to whom it has disclosed
Confidential Information and, where appropriate, making applications
for interim or interlocutory relief.
1.40 The provisions of this clause 12 shall continue to have effect for a
period of four (4) years after termination or expiry of this Agreement.
1.41 Upon the termination or expiry of this agreement the recipient of
Confidential Information shall deliver (or with the discloser's prior
consent, destroy or erase) to the discloser all material forms of
Confidential Information in its or its representatives possession, power
or control. The return of Confidential Information under this clause does
not release either party or their representatives from their
confidentiality obligations under this clause.
PUBLICATION
1.42 If ANUTECH or its employees or agents wish to publish or otherwise
disclose any information contained in the ANU Intellectual Property or
Results, other than in accordance with clause 12 (Confidentiality),
including by way of written disclosure or any oral disclosure at any
seminar, lecture or other meeting ("Publication"), the following
procedures shall be observed:
(a) ANUTECH shall submit the Publication to Praxis 30 days prior to
disclosure;
(b) within the 30 day period Praxis will consider whether to agree to
the Publication and shall advise ANUTECH what part (if any) of the
information it does not wish published;
(c) if Praxis does not advise ANUTECH within the 30 day period that it
objects to the Publication it shall be deemed to have consented to
the Publication;
(d) if Praxis does advise ANUTECH of its objection then the information
in question will not be published:
(i) until the date upon which the complete Australian
specification in relation thereto becomes open to public
inspection at the Australian Patents Office; and
(ii) in the case of information which is not patentable or which it
is not proposed to patent, for so long as further confidential
research or development work or potential or actual commercial
exploitation is being actively pursued in relation thereto but
in any case not to exceed 2 years;
(e) where appropriate, ANUTECH will make proper acknowledgment of
Praxis.
USE OF NAME
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1.43 Any proposed use of a party's name by the other in any published material
(including prospectus information) must be approved by the other party in
writing prior to release of that published material.
INDEMNITY AND INSURANCE
1.44 Praxis hereby agrees to defend, indemnify and hold harmless ANUTECH, ANU
and their employees from and against any and all demands, claims,
liabilities, damages, costs and expenses which may be brought against or
incurred by ANUTECH, ANU and their employees as a result of the use to
which Praxis or its sublicensees make of the ANU Intellectual Property,
Results and Products the subject of the licence granted in this Agreement,
other than to the extent (if any) that the same are caused solely by the
gross negligence of ANUTECH, ANU or of any of their employees.
The indemnity above shall also apply to actions that may arise out of the
capital raising that Praxis undertakes for the purposes of this Agreement.
1.45 From the date that any Product arising out of the ANU Intellectual
Property is first applied for human use (and for the term or foreseeable
term of the human use) Praxis undertakes to hold product liability
insurance to the value of at least $5,000,000.00 .
1.46 Praxis shall at all times maintain in full force and effect general
liability insurance with limits of not less than $5,000,000.00.
1.47 Such policies shall name ANUTECH and the ANU as additional insureds and
shall be purchased from a reputable insurer. Certificates evidencing the
coverage shall be provided to ANUTECH.
WARRANTIES
1.48 Right to enter Agreement
Each Party hereby warrants to the other that it has the full right, power,
authority and liberty to enter into this Agreement and to perform all of
its respective duties and obligations hereunder. Each party warrants to
the other that it is not under any other duty or obligation which is
contrary to or inconsistent with any of its duties and obligations
hereunder.
1.49 No contrary agreements
Each party hereby warrants to the other that it will not enter into any
agreement, arrangement or understanding with any third party which is
contrary to or inconsistent with any of that party's rights, duties and
obligations under this Agreement.
1.50 Status of ANUTECH
ANUTECH warrants and covenants that it enters into this Agreement as agent
for and on behalf of ANU having full power and authority so to do, and
with the express consent of ANU, to the intent that each and every of the
warranties, covenants, terms and conditions of this Agreement are given by
and bind both ANUTECH in its own right and ANU.
1.51 Due diligence
Praxis warrants that it has undertaken a due diligence examination of the
ANU Intellectual Property licensed in this agreement and warrants that it
satisfied itself as to ANU's rights to
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and the validity of the ANU Intellectual Property, in particular the
patents and patent applications set out in Schedule 1.
1.52 ANU Intellectual Property
To the best of its knowledge ANUTECH warrants and covenants that in
respect of ANU Intellectual Property either:
(a) ANU is the sole legal and beneficial owner; or
(b) ANU has such rights to the ANU Intellectual Property, as will enable
ANUTECH to perform its obligations under this Agreement.
ANUTECH makes no warranty as to whether the US Patent 5520926 (and
corresponding international patents or applications) in the name of
British Technology Group Limited infringes the ANU Intellectual
Property.
1.53 Results achieving purpose
ANUTECH makes no representations or warranties as to the accuracy or
completeness of the Results generated by ANUTECH, or their capability to
achieve a particular purpose.
1.54 Fundamental Terms
Each party acknowledges that the warranties contained in this clause 16
(Warranties) are fundamental terms of this Agreement.
ASSIGNMENT, TRANSFER
1.55 This Agreement may not be assigned or otherwise transferred by Praxis
without the prior written consent of ANUTECH. An assignment is deemed to
include a change in greater than 50% beneficial ownership of shares in
Praxis with the exception of such a change in share holding in Praxis
through capital raising.
1.56 Any permitted assignee shall assume all obligations of its assignor under
this Agreement.
1.57 No assignment shall relieve Praxis of responsibility for the performance
of any accrued obligation(s) which Praxis then has hereunder.
TERMINATION
1.58 A party may terminate this Agreement upon 30 days written notice to the
other party on the occurrence of any of the following by the other party:
a) upon or after the bankruptcy, insolvency, dissolution or winding up
of such party (other than dissolution or winding up for the purposes
of reconstruction or amalgamation); or
b) the failure of such party to comply with its obligations under this
agreement, if such default is not cured (if capable of being cured)
within 30 days of the party not in default giving notice of the
default; or
c) if the representations and warranties made under this Agreement
prove inaccurate or false in any material respect.
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1.59 Without limiting clause 18.1 (b), ANUTECH may terminate this Agreement
upon 30 days written notice to Praxis in the event Praxis:
a) fails to make any payment which is due and payable pursuant to this
Agreement and such payment remains unpaid for more than 30 days; or
b) fails to achieve any of the performance milestones in accordance
with clause 5 and is demonstrated not to be making best efforts in
attempting to achieve these milestones and such default is not cured
(if capable of being cured) within 90 days of ANUTECH giving notice
of the default.
1.60 The provisions of this clause 18 and clauses 3.1 (Licence Consideration)
12 (Confidentiality), 11 (Reports, Payments and Accounting), 15 (Indemnity
and Insurance, 19.12 (Governing Law) and 19.9 (Dispute Resolution) shall
continue in full force and effect notwithstanding the termination, any
alterations or additions to the other provisions of this Agreement.
1.61 Upon termination of this Agreement and except as otherwise expressly
provided:
a) any rights or obligations of a party which may have arisen or
accrued prior to termination shall not be affected;
b) all licences granted to Praxis under the terms of this Agreement
shall terminate and Praxis shall cease its exploitation of the
relevant intellectual property other than provided for in clause
18.4 (d);
c) Praxis shall promptly pay to ANUTECH any amounts due under the terms
of this Agreement including royalties and Sublicence Fees which have
accrued as of the date of termination;
d) Praxis may sell all inventory of the Product that it may have on
hand at the date of termination provided that it pays royalties as
provided in this Agreement.
1.62 If any party terminates the Agreement and sublicensees are not then in
default under the terms of their sublicence agreements hereunder, ANUTECH
shall have the right (but not the obligation) to assume and continue
sublicence agreements with payments thereunder being made by the
sublicensees directly to ANUTECH without any further obligations on the
part of Praxis with respect thereto.
1.63 Waiver by either party of any breach (or a succession of breaches) of any
one or more of the provisions of this Agreement shall not deprive such
party of any right to terminate this Agreement pursuant to the terms of
this clause 18 upon the occasion of any subsequent breach.
MISCELLANEOUS PROVISIONS
1.64 Binding obligations
The duties and obligations imposed and the benefits conferred by this
Agreement are to be binding upon and to enure to the parties and to their
respective successors and permitted assigns.
1.65 Other instruments
Each party shall prepare and execute such other instruments and documents
and do such other acts and things as may be necessary or desirable to
ensure each party has such rights
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and interest as are contemplated for it by this Agreement or as may be
necessary or desirable to give full effect to the provisions of this
Agreement.
1.66 Whole Agreement
This Agreement combines the whole understanding of the Parties relating to
its subject matter and it supersedes and cancels any and all agreements,
understandings or commitments made by the same Parties with respect to the
same subject matter. Any purported representations, warranties or other
promises of the Parties not recorded in it are of no effect.
1.67 Amendment
The variation or waiver of a provision of this Agreement or a Party's
consent to a departure from a provision by another Party, will be
ineffective unless in writing executed by the Parties. The requirements
concerning variation or waiver apply to this clause itself.
1.68 No waiver
No waiver by either party of any breach (or a succession of breaches) of
any one or more of the provisions of this Agreement by the other party
shall be deemed to be a waiver of any subsequent breach of the same or any
other provision.
1.69 Illegality
If any provision of this Agreement shall be construed so as to be illegal
or invalid the legality or the validity of any other provision shall not
be affected thereby. Any legal or invalid provisions shall be severable
and all other provisions shall remain in full force and effect.
1.70 Notices
A party notifying or giving notice under this Agreement must notify
(a) in writing;
(b) addressed to the address of the recipients specified below or as
altered by notice given in accordance with this clause; and
(c) delivered by hand, facsimile, registered mail or post.
A notice shall be deemed received:
(a) if hand delivered on the date of delivery
(b) if sent by facsimile on generation of an acknowledgment that the
transmission has been successfully completed,
(c) if sent by registered mail on acknowledgment of receipt by or on
behalf of the recipient
(d) if dispatched by post, after 5 days including day of posting.
If a notice is received on a day other than a business day or after 4.30
pm on a business day, then it is deemed received on the next business day.
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Notice addresses
ANUTECH Pty Ltd Praxis Pharmaceuticals Inc.
GPO ▇▇▇ ▇ ▇▇▇ ▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇
Or
ANUTECH Court ▇▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇,
▇▇▇. ▇▇▇▇▇ ▇▇▇▇▇ and ▇▇▇▇▇ Road Vancouver, BC, Canada
ACTION ▇▇▇ ▇▇▇▇
Facsimile 02 6257 1433 Facsimile: ▇ (▇▇▇)▇▇▇ ▇▇▇▇
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1.71 Force Majeure
No party shall be responsible or liable to any other party for, nor shall
this Agreement be terminated as a result of any party's failure to perform
any of its obligations hereunder, with the exception of payment of monies
due and owing, if such failure results from circumstances beyond the
control of such party, including, without limitation, requisition by any
government authority or the effect of any statute, ordinance or
governmental order or regulations, wars, strikes, lockouts, riots,
epidemic disease, act of god, civil commotion, fire, earthquake, storm,
failure of public utilities, common carriers or suppliers, or any other
circumstances, whether or not similar to the above causes. The parties
shall use reasonable efforts to avoid or remove any such causes and shall
resume performance under this Agreement as soon as feasible whenever such
cause is removed; provided however that the foregoing shall not be
construed to require a party to settle any labour dispute or to commence,
continue or settle any litigation.
If after six months the force majeure continues, the Parties must meet in
good faith to discuss the situation and endeavour to achieve a mutually
satisfactory resolution of the problem.
1.72 Dispute resolution
If a dispute arises between the Parties out of or relating to this
Agreement (the "Dispute"), any Party seeking to resolve the Dispute must
do so strictly in accordance with the provisions of this clause.
Compliance with this clause is a condition precedent to seeking relief in
any court or tribunal in respect of the Dispute.
A Party seeking to resolve the Dispute must notify the existence and
nature of the Dispute to the other Party ("the Notification"). Upon
receipt of a Notification the Parties must refer resolution of the Dispute
to their respective chief executive officers or their nominees.
If the Dispute has not been resolved within thirty (30) days of receipt of
the Notification then any Party may refer the Dispute to the Australian
Commercial Dispute Centre Limited ("ACDC") for mediation. The parties must
negotiate in good faith, and in accordance with the Conciliation Rules of
ACDC, to resolve the Dispute.
If the Dispute has not been resolved within sixty (60) days of referral to
ACDC either Party is free to initiate proceedings in a court.
1.73 Stamp Duty
All stamp duty levied upon this agreement shall be paid by Praxis.
1.74 Costs
Each Party agrees to bear its own legal and other costs and expenses in
connection with the preparation and execution of this Agreement and of
other related documentation.
1.75 Governing law
This Agreement shall be construed in accordance with and governed by the
laws of the Australian Capital Territory, Australia, and the parties
hereby submit themselves to the jurisdiction of the courts in and of that
Territory.
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TERMINATION OF LICENCE AND RESEARCH & DEVELOPMENT AGREEMENT
1.76 The parties entered into a Licence and Research & Development Agreement
dated 27 October 1997 and an Addendum to the Licence and Research &
Development Agreement dated 8 October 1998 ("Licence and R&D Agreement").
1.77 The parties have agreed to end the Licence and R&D Agreement by mutual
agreement with effect from the Commencement Date of this Agreement.
1.78 With effect from the Commencement Date of this Agreement:
(a) the parties agree that the Licence and R&D Agreement is terminated;
and
(b) each party permanently releases each other party from any actions,
suits, causes of action, arbitration, debts, dues, costs, claims,
demands, verdicts and judgments, either at law or in equity or
arising under statute ("Claims") which but for their entry into this
termination, they or any of them have or may have against each other
arising from or in connection with the early termination of the
Licence and R&D Agreement.
1.79 Each party must:
(a) use its best efforts to do all things necessary or desirable to give
full effect to this termination; and
(b) refrain from doing anything that might hinder performance of this
termination.
IN WITNESS: this Agreement shall be duly executed and shall commence from
the Commencement Date:-
The COMMON SEAL of )
PRAXIS PHARMACEUTICALS INC )
was hereunto affixed in accordance )
with its constitution in the presence of: )
/S/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ /S/ ▇.▇. ▇▇▇▇▇▇
Director/Secretary Director
▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇.▇. ▇▇▇▇▇▇
Name Name
The COMMON SEAL of )
ANUTECH PTY LIMITED )
was hereunto affixed in accordance )
with its constitution in the presence of: )
/S/ ▇. ▇▇▇▇▇▇▇▇▇ /S/ ▇▇▇▇ ▇. ▇▇▇▇
Director/Secretary Director
▇. ▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇. ▇▇▇▇
COMPANY SECRETARY MANAGING DIRECTOR
Name Name
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