Exhibit 3.2(y)
"CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT
IDENTIFIED BY *** HAVE BEEN OMITTED AND HAVE BEEN SEPARATELY FILED WITH THE
COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS."
HHT DEVELOPMENT AND COMMERCIALISATION AGREEMENT
Made on June 27, 2005
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BETWEEN CHEMGENEX PHARMACEUTICALS LIMITED ACN 000 248 304
(`CHEMGENEX')
AND STRAGEN INVESTMENT B.V. , ▇▇▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
(`STRAGEN')
AND STRAGEN PHARMA S.A.
(`STRAGEN PHARMA')
BACKGROUND
A. ChemGenex has expertise in clinically developing and commercialising
pharmaceutical products.
B. Stragen has expertise in manufacturing, supplying, registering and
distributing pharmaceutical products in Europe.
C. Stragen and ChemGenex have both conducted clinical trials of products
including the compound known as homoharringtonine for the treatment of
human haematological malignancies.
D. Stragen and ChemGenex wish to collaborate to continue the clinical
development of homoharringtonine for the treatment of cancer worldwide.
OPERATIVE PROVISIONS
1. DEFINITIONS
In this Agreement, except to the extent the context otherwise requires:
`AFFILIATE' means, in the case of either party, a corporation or other
entity which, directly or indirectly, controls, is controlled by or is
under common control with, that party. A corporation or other entity
shall be regarded as in control of another corporation or entity if it
owns or directly or indirectly controls 50% (fifty percent) or more of
the voting stock or other ownership interest of the other corporation
or entity, or if it possesses, directly or indirectly, the power to
direct or cause the direction of the management and policies of the
corporation or other entity;
`AGREEMENT' means this Development and Commercialisation Agreement;
`APPROVAL DATE' means the first date upon which any of the Licensed
Products are approved for sale, in any jurisdiction in the JV
Territory, for any specific indication in the Field, to independent
third parties;
`BULK HHT' means bulk formulation HHT conforming to the specifications
in Annexure C;
`CHEMGENEX' means ChemGenex Pharmaceuticals Limited ACN 000 248 304, a
listed public company incorporated under Australian law, and includes
its Affiliates;
`CHEMGENEX REVENUE' has the meaning given to that term in clause
3.1(b);
`CLAIMS' has the meaning given to that term in clause 12.1;
`CONFIDENTIAL INFORMATION' includes the mutual non-disclosure agreement
date March 22, 2005 and signed between Chemgenex Pharmaceutical, Inc
and Stragen Pharma SA , it means information relating to the business,
products or services of a party to this Agreement which is either
non-public, confidential or proprietary in nature; provided, however,
that Confidential Information will not include:
(a) information which is generally known in the pharmaceutical
industry or by the public at large at the time of disclosure,
and has come within the public domain through no fault or
action of the other party;
(b) information that was known to the other party on prior to its
disclosure hereunder or in connection with the negotiation of
this Agreement; or
(c) information which becomes rightfully available to the other
party on a non-confidential basis from any third party, the
disclosure of which to such other party does not violate any
contractual or legal obligation the third party has to the
first party with respect to such Confidential Information.
Without limiting the generality of the foregoing, Confidential
Information will also include information which relates to HHT Products
and their manufacture, sale or use, including financial statements,
costs and expense data, marketing and consumer data, production data,
know-how, trade secrets, secret processes and formulae, technical data
and reports including pharmacological, clinical, chemical, biochemical,
toxicological, pharmacokinetic, manufacturing and formulation data, or
any other information relating to the HHT Products which is not
generally ascertainable from public or published information,
regardless of whether such information was provided pursuant to the
terms of this Agreement, by request of the other party or in any other
manner;
`CONTACT OFFICER' in respect of each party means the person nominated
as such in the Schedule or such substitute or replacement officer as
may be notified in writing from time to time;
`CONTROL' means the ability, whether by ownership or license, to grant
a license or sublicense as provided for herein without violating the
terms of any agreement or other right of any Third party;
`CRO' means clinical research organisation;
`DRUG APPROVAL APPLICATION' means an application for Regulatory
Approval required before commercial sale or use of a product as a drug
in a regulatory jurisdiction;
`EMEA' means the European Agency for Evaluation of Medicinal Products;
`FDA' means the US Food and Drug Administration or any successor entity
thereto;
`FIELD' means the treatment of cancer in humans;
`FIRST COMMERCIAL SALE' means, with respect to a Licensed Product, the
first bona fide sale to an end-user customer in a country in the
Territory after Regulatory Approval has been granted by the appropriate
governing health authorities in such country;
`HHT' means homoharringtonine and derivatives, analogs and homologs
thereof;
`HHT PRODUCTS' means any pharmaceutical product containing HHT as a
therapeutically active ingredient, including, without limitation,
finished and packaged dosage units of products, oral and patch dosage
forms of products and formulated HHT Products in bulk;
`IND' means an Investigational New Drug application, or an
Investigational Device Exemption (IDE), as defined in the US Food, Drug
and Cosmetic Act, as it may be amended from time to time, and the
regulations promulgated thereunder, or as the context requires, any
corresponding application in a country other than the USA;
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`INTELLECTUAL PROPERTY RIGHTS' means:
(a) copyright, inventions, formula, patents, know-how,
confidential information, data, and rights in trade marks and
designs (whether registered or unregistered);
(b) applications for registration, and the right to apply for
registration, for any of the same; and
(c) all other intellectual property rights and equivalent or
similar forms of protection existing anywhere in the world;
`JOINT STEERING COMMITTEE' means the committee established pursuant to
clause 7.1;
`JOINT VENTURE AGREEMENT' means the joint venture agreement referred to
in clause 6.1;
`JOINT VENTURE ENTITY' means the entity referred to in clause 6.1(c);
`JV TERRITORY' means all of the member states comprising the European
Union as at the date of this Agreement and Norway, Switzerland,
Romania, Bulgaria, Croatia, Serbia, Russia and Turkey;
`LICENSED PRODUCT' means intravenous and subcutaneous dosage
formulations of semi-synthetic HHT, being the compound having the
chemical name CEPHALOTAXINE, 4'METHYL
(2'R)-HYDROXYL-2'-(4"-HYDROXYL-4"-METHYLPENTYL) BUTANEDIOATE (ESTER),
[3R] and the empirical formula C29-H39-N-09 homoharringtonine, current
specifications for which are attached as Annexure A, and such
additional HHT Products as may be agreed by the parties in writing from
time to time;
`MANUFACTURING COST' means the cost for raw materials, filling, primary
packaging and labelling fixed at *** per vial of 5 mg;
`NDA' means a New Drug Application, Supplemental New Drug Application
or Abbreviated New Drug Application for an HHT Product, as defined in
the US Food, Drug and Cosmetic Act and the regulations promulgated
thereunder, or the corresponding applications for authorization for
marketing a pharmaceutical in any other country or group of countries,
as defined in the applicable laws and regulations;
`OPTION' means the option referred to in clause 16;
`PARTY' means either Stragen or ChemGenex as the context requires and
`PARTIES' means, collectively, Stragen and ChemGenex;
`REGULATORY APPROVAL' means any approval, licence, registration or
authorisation of any supra-national, federal, state or local regulatory
agency or government authority necessary for the manufacture, use,
storage, import, export, transport or sale of a HHT Product in a
regulatory jurisdiction, including where applicable, pricing approval;
`ROYALTY TERM' means the period referred to in clause 3.3, ending on
the later of the dates referred to;
`SAE' means a serious adverse event related to a human research
protocol;
`SEC' means the United States Securities and Exchange Commission;
`STRAGEN' means Stragen Investment B.V. and includes its Affiliates;
`STRAGEN KNOW-HOW' means proprietary techniques and data in relation to
HHT Products within the Field, including inventions, practices,
methods, knowledge, know-how, assays, compositions of matter, test data
(including pharmacological, toxicological and clinical test data),
analytical and quality control data, manufacturing data and
descriptions, which:
(d) Stragen discloses to ChemGenex under this Agreement; and
(e) is within the control of Stragen or Stragen Pharma;
`STRAGEN PATENT RIGHTS' means Stragen and/or Stragen Pharma's issued
patents and pending patent applications (whether provisional or
otherwise) in any countries in the Territory that cover the
manufacture, use, sale, offer for sale, and/or importation of HHT in
the Field, and any applications and/or patents claiming priority to
said patents or applications, including all divisions, continuations,
reissues, re-examinations, continuations-in-part, continued prosecution
applications (`CPA'), requests for continued examination (`RCE'),
extensions and substitutions thereof, and any
3
applications filed under the Patent Cooperation Treaty and includes the
current list of Stragen patents attached as Annexure A;
`SCHEDULE' means the schedule to this Agreement;
`SUPPLY AND DISTRIBUTION AGREEMENT' means the agreement for supply and
distribution of Licensed Products made between the parties dated the
same date as this Agreement;
`TAXES' means sales taxes, VAT taxes and other similar taxes but
excludes income tax;
`TECHNOLOGY' means data, manufacturing know-how, regulatory submissions
and other intellectual property and technical and scientific
information that is either in the possession of Stragen or Stragen
Pharma as of the date hereof or developed by Stragen or Stragen Pharma
during the term of this Agreement in relation to the Licensed Products,
manufacturing processes for any Licensed Products, or in connection
with any additional regulatory approvals to market Licensed Products
(including without limitation any clinical data from pivotal studies
relating to the Licensed Products as well as additional clinical
studies relating to the Licensed Products conducted from time to time
by Stragen, Stragen Pharma or any of their Affiliates in either case,
owned, controlled by, or licensed (with the right of sub-licence to
Stragen or Stragen Pharma) and that is necessary or useful to register,
manufacture, distribute, market or sell Licensed Products in the
Territory;
`TERRITORY' means all of the world except for the JV Territory;
`TRADE MARKS' means the marks referred to in clause 2.1(c);
`VALID CLAIM' means a claim of an issued patent within the Stragen
Patent Rights that has not, at the time in issue, lapsed, expired, been
cancelled, disclaimed or become abandoned, and has not been held
invalid or unenforceable by decision of a court or agency of competent
jurisdiction, said decision being unappealable or unappealed within the
time allowed for appeal.
2. SCOPE OF LICENCE
2.1 GRANT
Subject to clause 5 and in consideration for the grant of the Option by
ChemGenex and the covenants provided by ChemGenex under this Agreement
and the Supply and Distribution Agreement, Stragen grants to ChemGenex:
(a) an exclusive licence, with the right to grant sublicenses, to
use the Stragen Patent Rights and Stragen Know-How and the
Technology necessary or useful for the clinical development of
HHT Products and the commercialisation of HHT Products in the
Territory; and
(b) a non-exclusive licence to use and refer to all regulatory
filings and submissions made by Stragen for the development,
sale, supply and/or manufacturing of HHT Products in the
Field;
(c) an exclusive, royalty free, licence to use the trade marks
`MYELOSTAT', `CEFLATONIN' and such other ▇▇▇▇(s) as Stragen or
Stragen Pharma shall cause to be registered anywhere in the
world for HHT Product from time to time in connection with the
promotion, advertising, distribution or sale of HHT Product.
If ChemGenex elects to use a Trade ▇▇▇▇, ChemGenex will upon
request reimburse Stragen for any trade ▇▇▇▇ registration
renewal fees paid by Stragen with respect to the relevant
Trade ▇▇▇▇. ChemGenex will not be obliged to reimburse Stragen
with respect to any Trade ▇▇▇▇ it has ceased using;
(d) subject to clauses 2.2(c) and 6, an exclusive right to grant
sublicenses to use the Stragen Patent Rights and Stragen
Know-How and the Technology necessary or useful for the
clinical development of HHT Products and the commercialisation
of HHT Products in the Field in the JV Territory. The right
given under this sub-clause will terminate upon the
establishment of the Joint Venture Entity.
4
2.2 LIMITATIONS ON GRANT
(a) During the term of the Supply and Distribution Agreement,
ChemGenex may not itself commercialise, or sublicense a third
party to commercialise, Licensed Products in the Field, other
than in accordance with the Supply and Distribution Agreement.
(b) Clause 6 applies with respect to the JV Territory.
(c) Notwithstanding clause 2.1(d), Stragen will be entitled to
sell HHT Products in the JV Territory for compassionate use
until such time as the Joint Venture Entity is established.
The right given under this sub-clause will terminate upon the
establishment of the Joint Venture Entity.
2.3 SUBLICENSING
ChemGenex will have the right to grant sublicenses of its rights under
this Agreement to Affiliates and/or third parties without Stragen's
prior written approval.
2.4 CHEMGENEX'S AUTHORITY
Without limitation to clause 2.1, during the term of this Agreement,
and except as otherwise expressly herein provided, ChemGenex shall have
the right to take such actions with respect to the Licensed Products as
would normally be done in accordance with accepted business practices
in the marketing of pharmaceutical products and legal requirements to
obtain and maintain the authorisation and/or ability to market a
pharmaceutical product in the countries in the Territory and to market
the Licensed Products within such countries, including, without
limitation, the following:
(a) conducting human clinical trials of the Licensed Products as
ChemGenex determines are reasonable, necessary or desirable;
(b) making appropriate filings for the registration of one or more
indications for the therapeutic use of the Licensed Products;
(c) marketing the Licensed Products in such regions, at such
prices and on such other terms and conditions as ChemGenex
determines are reasonable, necessary or desirable;
(d) developing patient and physician educational programs as may
be required by the appropriate health regulatory authorities;
(e) responding to product and medical complaints relating to the
Licensed Products (as called for by the Supply and
Distribution Agreement, each party shall promptly advise the
other of any such complaints which it receives from
regulators, customers or patients in the Territory);
(f) with the cooperation of Stragen, handling all returns of the
Licensed Products;
(g) handling, in accordance with the relevant terms in the Supply
and Distribution Agreement, all recalls of the Licensed
Products;
(h) communicating with any governmental agencies and satisfying
their requirements regarding the authorisation and/or
continued authorisation to market the Licensed Products in
commercial quantities in the Territory; and
(i) handling Licensed Product distribution, inventory and
receivables.
3. ROYALTIES
3.1 LICENSED PRODUCT
(a) Where Stragen supplies any HHT Products in accordance with the
Supply and Distribution Agreement, ChemGenex will have no
additional obligation to pay any royalties, licence fees or
other amounts with respect to the Licensed Products under this
Agreement.
(b) In the event that ChemGenex sublicenses the rights under this
agreement to develop and/or commercialise the Licensed
Products in the Field and in the Territory, Stragen shall
receive a copy of the corresponding agreement between
ChemGenex and its sublicensee and shall receive a royalty
based on the following formula:
5
30% (ChemGenex Revenue less the
Stragen Manufacturing Cost for the
corresponding HHT Product purchased
from Stragen and paid for in
accordance with clause 5.1(c) of the
Supply and Distribution Agreement)
(c) In the event that ChemGenex sublicenses the rights under this
agreement to develop and/or commercialise the Licensed
Products in the Field and in the JV Territory prior to the
formation of the Joint Venture Entity, Stragen shall receive a
copy of the corresponding agreement between ChemGenex and its
sublicensee and shall receive a royalty based on the following
formula:
51% (ChemGenex Revenue less the
Stragen Manufacturing Cost for the
corresponding HHT Product purchased
from Stragen and paid for in
accordance with clause 5.1(c) of the
Supply and Distribution Agreement)
(d) In the event that ChemGenex enters into co-promotion agreement
with another company for the commercialisation of Licensed
Products in the Field and in the Territory, clause 5.1(b) of
the Supply and Distribution Agreement will apply and ChemGenex
will have no additional obligation to pay any royalties or
licence fees with respect to the Licensed Products under this
Agreement.
(e) In this clause:
CHEMGENEX REVENUE = all amounts (excluding
Taxes) actually received by
ChemGenex or any of its Affiliates
with respect to the
commercialisation or exploitation of
Licensed Products within the Field,
including royalties, milestone
payments, licence fees and
technology transfer fees (but only
after ChemGenex recovers the
clinical and development expenses up
to (euro)5 million, including but
not limited to CRO's cost ,
products, special packaging,
investigators and consulting fees,
data management and non clinical
studies) LESS:
(I) reasonable commissions paid by
ChemGenex to third party
distributors, brokers or agents
other than sales personnel and sales
representatives employed or engaged
by ChemGenex with respect to the
sale of such Licensed Products; and
(II) customs duties and surcharges and
other governmental charges incurred
by ChemGenex in connection with the
exportation or importation of such
Licensed Products; and
STRAGEN MANUFACTURING COST = *** per 5 milligram vial.
3.2 HHT PRODUCTS OUTSIDE OF THE FIELD
In the event that ChemGenex determines to pursue commercialisation,
either itself or through its sub-distributors or Affiliates of any HHT
Products (including, for the avoidance of doubt, Licensed Products)
outside of the Field or HHT Products other than Licensed Products in
the Field, ChemGenex will:
(a) have no obligation to pay any royalties or licence fees to
Stragen; and
(b) purchase the Bulk HHT required for those products from Stragen
at a price of *** per milligram for development quantities and
*** per milligram for commercial quantities, in accordance
with the Supply and Distribution Agreement.
3.3 PAYMENT OF ROYALTIES
Royalties payable under clause 3.1(b) must be paid with respect to each
country of the Territory from the date of First Commercial Sale of a
Licensed Product in such country until the later of:
6
(a) the last to expire Valid Claim of the Stragen Patent Rights
covering such Licensed Product in such country; or
(b) Ten (10) years following the First Commercial Sale of such
Licensed Product in such country.
At the end of the Royalty Term in each country, ChemGenex will have a
fully paid-up licence in that country.
3.4 PAYMENT DATES FOR ROYALTIES
(a) Royalties on revenues other than Licensed Products sales by
sublicensees must be paid within 30 days after the relevant
amounts are paid to ChemGenex;
(b) Royalties on Licensed Products sales by sublicensees must be
paid within 45 days after the date of receipt of Products by
ChemGenex's sublicensee. Such payments must be accompanied by
a statement showing the calculation of ChemGenex Revenue on a
product-by-product basis in each country of the Territory, and
all information reasonably necessary to accurately calculate
the amount of royalty payments due, including without
limitation, a description of the number of units sold, average
sales price and any amounts deducted from gross amounts
invoiced for sales of Licensed Product.
3.5 ACCOUNTING FOR ROYALTIES
Royalties will be payable in US dollars, and any payment amounts
denominated in other than US dollars must be translated into US dollars
in accordance with US generally accepted accounting principles using
the rate of exchange at the date at which the payment is due to
Stragen.
3.6 RECORDS AND AUDIT RIGHTS
(a) During the Royalty Term ChemGenex shall keep full, true and
accurate books of account and records in accordance with
generally accepted United States accounting principles,
consistently applied, containing all particulars and
reasonable supporting documentation as may be necessary for
the purpose of determining royalty payments under this
Agreement.
(b) Annually during the Royalty Term, and within 90 days from the
end of its financial year, ChemGenex must provide, at its
expense, a worldwide detailed ChemGenex Revenue report
detailed by countries and products, and certified by their
auditors, being a firm approved by SEC for public companies.
(c) All such books of account, records and supporting
documentation shall be open for inspection at a time mutually
acceptable to the parties, during normal business hours no
more frequently than once per year, for three (3) years
following the end of each calendar year to which they apply,
by any independent certified public accountant retained by
Stragen (reasonably acceptable to ChemGenex) on behalf of
Stragen for the purpose of verifying ChemGenex's reports and
royalty payments. If such audit discloses an underpayment,
ChemGenex shall promptly pay to Stragen the amount of such
underpayment. The costs and expenses of performing such audits
shall be borne by Stragen; provided, however, that if the
amount of an underpayment for the audited period is five
percent (5%) or more of the amount actually due, then the
costs and expenses of performing such audit shall be promptly
reimbursed by ChemGenex.
(d) Stragen must ensure that the independent certified accountant
enters into a confidentiality deed with ChemGenex which
includes an obligation not to disclose to Stragen or its
Affiliates any information other than that which is relevant
to the rights of Stragen under this Agreement.
(e) In the event of a dispute between the independent certified
public accountants of ChemGenex and Stragen with respect to
any matter called for by this Agreement, the parties shall
select a third independent public accounting firm to arbitrate
the dispute, provided, that such firm shall have the authority
only to select from among the positions of the original two
firms that position which it deems most accurate. The fees of
such third firm shall be borne by the party whose position is
not approved of by such arbitrator.
7
4. DEVELOPMENT EXCLUSIVITY
Each party agrees not to research or develop Licensed Products for use
in the Field in the Territory during the term of this Agreement other
than as provided for under this Agreement.
5. CONDITION PRECEDENT
The execution of the Supply and Distribution Agreement by both parties
is a condition precedent to this Agreement.
6. EUROPEAN JOINT VENTURE
6.1 ESTABLISHMENT
(a) The parties agree to form a joint venture for the
registration, marketing, distribution and sale of Licensed
Products used in the Field in the JV Territory within *** days
from the execution of this Agreement.
(b) ChemGenex agrees to provide at no cost to the Joint Venture
Entity, that clinical and toxicology data it has in its
possession or control and that is necessary to prepare a
submission for EMEA marketing approval of a Licensed Product,
on the basis that ChemGenex retains all Intellectual Property
Rights with respect to that data. The Joint Venture Entity may
only use the data for the purpose contemplated by this
subclause.
(c) The parties agree the following terms will be incorporated
into a Joint Venture Agreement:
(i) the establishment of a Joint Venture Entity, in the
form of a Swiss societe anonyme with an initial
capital of CHF ***, in which the parties' respective
holdings and entitlement to profits are as follows:
(A) ChemGenex - 49%; and
(B) Stragen - 51%.
(ii) Stragen to supply Licensed Product to the Joint
Venture Entity at the Manufacturing Cost;
(iii) the Joint Venture Entity to be responsible for
registration, marketing, distribution and sale of the
Licensed Products in the JV Territory;
(iv) the Joint Venture Entity will book sales from named
patient sales of HHT in the JV Territory and will be
responsible for timely SAE and regulatory reporting
to ChemGenex;
(v) the Joint Venture Entity to contract for services
from respective parties and hire employees when
appropriate in the JV Territory;
(vi) a method for calculating profits and expenses for
marketing and sale of Licensed Product and other
products within the JV Territory;
(vii) a method for either parties to contribute additional
products to the joint venture;
(viii) a right of last refusal for either party to purchase
the other party's share in the Joint Venture Entity
in the event that the other party wishes to dispose
of all or part of their share, or in the event of a
change in control of the other party;
(ix) The Joint Venture Entity will be responsible and bear
all costs for Regulatory Approvals in the JV
Territory; except that:
(A) Stragen is to supply the joint venture
entity with copies of all:
(I) pre-clinical data;
(II) clinical data; and
(III) regulatory submissions and filings,
8
in the possession or control of Stragen that relate
to HHT Products in the Field; and
(B) Stragen will be responsible for all filings
with the regulatory authorities with respect
to potential HHT Products for use in the
Field in the JV Territory , including, but
not limited to, Drug Approval Applications
and seeking Regulatory Approvals for HHT
Products, including preparation of reports
necessary as part of a Drug Approval
Application, at the Joint Venture Entity's
reasonable expense. Without limiting the
foregoing Stragen is to be responsible for
preparing the Chemistry, Manufacturing and
Controls (`CMC') section of an IND and NDA
(and their equivalents), together with any
other pre- or post-approval CMC
documentation any government regulatory
agency may request or require in the JV
Territory for HHT Products in the Field, at
Stragen's expense; and
(x) The Joint Venture Entity to solely
own all Intellectual Property
Rights in relation to the works
referred to in subclause (ix). All
registrations, permits and licences
in the JV Territory to be obtained
in the name of the Joint Venture
Entity or its nominee.
(xi) ChemGenex to license free of charge
the Joint Venture Entity to use the
name `ChemGenex Europe'; and
(xii) Other terms and conditions
typically contained in joint
venture agreements of the type
contemplated by this clause.
7. JOINT STEERING COMMITTEE
7.1 ESTABLISHMENT OF JOINT STEERING COMMITTEE
Upon the execution of this Agreement the parties must form a Joint
Steering Committee for the purposes of:
(a) collectively meeting, reviewing and evaluating the ongoing
relationship between the parties;
(b) considering short, medium and long term development and
commercialisation goals and strategic direction;
(c) considering development, expense sharing. manufacturing,
supply and commercialisation of new dosage forms of HHT
Products, including oral and patch dosage forms;
(d) reporting on the research, development and other work
conducted by the parties, including any discoveries or
potentially commercially valuable Intellectual Property Rights
created since the last meeting of the Joint Steering
Committee;
(e) recommending any activities or other steps which should be
taken to further develop, or commercially exploit HHT Products
in the Field;
(f) discussing new opportunities; and
(g) attempting to settle any disputes or disagreements between the
parties.
7.2 MEMBERSHIP
(a) The Joint Steering Committee will have an equal number of
representatives from each party and the size of the Joint
Steering Committee must not exceed a total of 6 members.
(b) Members of the Joint Steering Committee will be executive
personnel of the parties. One member of the Joint Steering
Committee selected by Stragen and one member of the Joint
Steering Committee selected by ChemGenex must have substantial
experience in pharmaceutical product research and development.
(c) The initial members of the Joint Steering Committee will be
the persons named in the Schedule.
9
(d) Members of the Joint Steering Committee will serve on such
terms and conditions as determined by the party selecting the
person for membership on the Joint Steering Committee.
(e) An alternate member designated by a party may serve
temporarily in the absence of a permanent member designated by
such party.
7.3 MEETINGS OF THE JOINT STEERING COMMITTEE
The Joint Steering Committee:
(a) will hold meetings at such times and places as shall be
determined by a majority of the entire membership of the Joint
Steering Committee but in no event shall such meetings be held
less frequently than once every quarter, except as may be
agreed by the Joint Steering Committee;
(b) may conduct meetings in person or by telephone conference,
provided that any decision made during a telephone conference
meeting is evidenced in writing signed by one of each party's
members of the Joint Steering Committee from each of the
parties;
(c) must keep minutes reflecting actions taken at meetings.
7.4 FUNCTIONS AND POWERS OF THE JOINT STEERING COMMITTEE
(a) The activities of the parties under this Agreement shall be
managed by the Joint Steering Committee only to the extent set
forth in this clause.
(b) ChemGenex will make all ultimate decisions regarding the
development and commercialisation in the Territory of the HHT
Products.
8. CONTACT OFFICERS
Each party must nominate a Contact Officer to serve as the primary
point of contact for the other party with respect to this Agreement. As
at the date of this Agreement each party's Contact Officer will be as
set out in the Schedule.
9. CLINICAL DEVELOPMENT AND DILIGENCE OBLIGATIONS
9.1 COMMERCIALLY REASONABLE EFFORTS
Subject to the general budget and financing plan to be approved by a
resolution of the ChemGenex board of directors, and all applicable laws
and regulatory requirements, ChemGenex will use commercially reasonable
efforts, consistent with accepted business practices and legal
requirements relating to pharmaceutical drug development, to:
(a) conduct scientific, technical and clinical (but not
manufacturing) activities, required for the sale of Licensed
Products for use in the Field in the Territory;
(b) to pursue and maintain necessary governmental approvals for
Licensed Products for use in the Field in the Territory; and
(c) to market Licensed Products for use in the Field in the
Territory after appropriate Regulatory Approval, provided
however, that the approvals for all manufacturing activities
will be the sole responsibility of Stragen.
9.2 CLINICAL DEVELOPMENT AND REGULATORY FILINGS
(a) ChemGenex will be responsible for financing, overseeing and
conducting the clinical development of Licensed Products in
order to obtain Regulatory Approvals on a worldwide basis
.ChemGenex will be responsible for ongoing regulatory filings
to support clinical development worldwide including the JV
Territory.
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(b) ChemGenex will be responsible for preparing and filing all
filings with the regulatory authorities with respect to
potential HHT Products for use in the Field in the Territory,
including, but not limited to, Drug Approval Applications and
seeking Regulatory Approvals for HHT Products, including
preparation of reports necessary as part of a Drug Approval
Application. ChemGenex will solely own all Intellectual
Property Rights in relation to the works referred to in this
clause. All such registrations, permits and licences in the
Territory shall be obtained in the name of ChemGenex or one of
its Affiliates or Subdistributors.
(c) Stragen will be responsible for filing with regulatory
authorities for marketing approval of HHT Products for use in
the Field in the JV Territory in accordance with clause
6.1(c)(ix)(B) and 6.1(c)(x).
(d) Stragen must provide ChemGenex with such information and other
material in English as ChemGenex shall reasonably request (or
as the appropriate health regulatory authorities shall
require) in support of applications for Licensed Product
registrations (including regulatory filings to support
clinical development of Licensed Products) including without
limitation:
(i) all preclinical and clinical data; and
(ii) all regulatory submissions and filings; (iii) all
chemistry, manufacturing and controls data,
in Stragen's possession relating to the Licensed Products.
(e) ChemGenex agrees to proceed with Stragen Pharma's Phase 2
Study Protocols in Accelerated Phase Chronic Myeloid Leukemia
(Study HHT-CML/INTL/04.2 and 04.3) and to reimburse Stragen
for the payment it has made to Inveresk Research Limited (CRO)
(`INVERESK') on January 1st, 2006 (as per the invoice
contained in Annexure D) subject to Stragen providing
ChemGenex with proof of payment. ChemGenex agrees to contract
directly with Inveresk and pay bills issued by Inveresk for
services performed for ChemGenex from the date of execution of
this Agreement (in accordance with its obligations under the
contracts it makes with Inveresk). For the avoidance of doubt,
the parties agree that ChemGenex will not be obliged to make
or reimburse Stragen or Stragen Pharma for any additional
payments payable by Stragen Pharma or Stragen to Inveresk.
9.3 CLINICAL SUPPLIES
The Joint Steering Committee will advise Stragen of the amounts of
Licensed Product required by ChemGenex to conduct clinical trials.
Stragen must supply such amounts of Licensed Product in a timely manner
and upon the terms and conditions provided for in the Supply and
Distribution Agreement.
9.4 REGULATORY CHANGES
Each party shall promptly advise the other party of any known new
instructions or specifications relating to HHT Products required by the
health regulatory authorities of any country within the Territory, and
the parties shall confer with respect to the best mode of compliance
with such new requirements.
10. REPRESENTATIONS AND WARRANTIES 10.1 REPRESENTATIONS AND WARRANTIES
Each party represents and warrants to the other that:
DUE AUTHORISATION
(a) It is duly authorised to execute and deliver this Agreement
and to perform its obligations hereunder, and any person
executing this Agreement on its behalf has been duly
authorised to do so by all requisite corporate action.
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BINDING AGREEMENT
(b) This Agreement is legally binding upon such party and
enforceable in accordance with its terms, subject to the
effects of bankruptcy, insolvency or other laws of general
application affecting the enforcement of creditor rights and
judicial principles affecting the availability of specific
performance and general principles of equity whether
enforceability is considered a proceeding at law or equity.
The execution, delivery and performance of this Agreement by
itself does not conflict with any material agreement,
instrument or understanding, oral or written, to which it is a
party or by which it may be bound, nor violate any material
law or regulation of any court, governmental body or
administrative or other agency having jurisdiction over it.
10.2 REPRESENTATIONS AND WARRANTIES OF STRAGEN
Stragen makes the following representations and/or warranties to
ChemGenex:
(a) Stagen represents and warrants that, to Stragen's knowledge:
(i) Stragen owns the entire right, title and interest in
and to the Stragen Know-How and Technology in the
Field;
(ii) Stragen owns the entire right, title and interest in
and to the Stragen Patent Rights in the Field and the
Trade Marks;
(iii) Stragen has not at the date of this Agreement granted
any licences or rights that are inconsistent with the
licences and other rights granted to ChemGenex under
this Agreement; and
(iv) as at the date of this Agreement, no third party has
charged in writing that any aspect of the Stragen
Know-How or the Stragen Patent Rights or Stragen's
use of the Trade Marks infringes any existing
intellectual property of such third party, and
Stragen is not aware of the existence of any
reasonable basis for the assertion of any such third
party claim.
10.3 DISCLAIMER OF WARRANTIES
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES
ANY REPRESENTATION OR WARRANTY TO THE OTHER PARTY OF ANY KIND, AND
HEREBY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, ANY WARRANTY OF NON-INFRINGEMENT, MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE. STRAGEN MAKES NO WARRANTY OR
REPRESENTATION AS TO THE VALIDITY OR SCOPE OF STRAGEN PATENT RIGHTS, OR
THAT ANY LICENSED PRODUCT WILL BE FREE FROM AN INFRINGEMENT ON PATENTS
OR OTHER INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR THAT NO
THIRD PARTIES ARE IN ANY WAY INFRINGING STRAGEN PATENT RIGHTS COVERED
BY THIS AGREEMENT.
11. INTELLECTUAL PROPERTY 11.1 OWNERSHIP
(a) Each party will own all Intellectual Property Rights in and to
any of their respective inventions, discoveries, methods,
processes, technical processes, know-how, work or improvements
conceived, made, done or reduced to practise in relation to
HHT Products including, without limitation, any potential uses
of HHT Products.
(b) Intellectual Property Rights in and to any of the inventions,
discoveries, methods, processes, technical processes, know-how
or improvements referred to in the preceding subclause that
are conceived, made, done or reduced to practice by the
parties jointly, will be held by the parties jointly.
(c) Within 60 days of request, each party must execute, sign and
deliver all written assignments, deeds, agreements,
applications, notices, information and other documents
necessary or
12
convenient to assign to the other party their Intellectual
Property Rights, or as otherwise required to evidence or vest
ownership of the Intellectual Property Rights in accordance
with this clause.
11.2 ENFORCEMENT
(a) If any Stragen Patent Right is infringed by a third party in
the Territory during the term of this Agreement, the party to
this Agreement first having knowledge of such infringement
must promptly notify the other in writing.
(b) The notice must set out the perceived facts of such
infringement in reasonable detail.
(c) Stragen will have the primary right, but not the obligation,
to institute, prosecute and control any action or proceeding
by its own counsel with respect to infringement or
misappropriation of such Stragen Patent Rights and ChemGenex
shall have the right, at its own expense, to be represented in
such action by its own counsel.
(d) If Stragen fails to bring any such action or proceeding within
a period of 180 days after receiving written notice from
ChemGenex or otherwise having knowledge of such infringement,
and the infringement relates to the Field and Territory, then
ChemGenex will have the right to bring and control any such
action by counsel of its own choice, and Stragen shall have
the right, at its own expense, to be represented in any such
action or proceeding.
(e) In any event, each party agrees to be joined as a party to
proceedings if required by law to maintain the action or if
reasonably requested and, in any event, to give the non joined
party all reasonable assistance and authority to file and to
prosecute such suit.
(f) The costs and expenses of all suits brought by either party
under this clause will be reimbursed to both parties out of
any damages or other monetary awards recovered in favour of
Stragen and/or ChemGenex.
(g) ChemGenex may not enter into any settlement or consent
judgment or other voluntary final disposition of a suit under
this clause, without the express written consent of Stragen
(which consent shall not be unreasonably withheld, conditioned
or delayed). Stragen may not enter into any settlement or
consent judgment or other voluntary final disposition of a
suit under this clause that relates specifically to the Field
and Territory, without the express written consent of
ChemGenex (which consent shall not be unreasonably withheld,
conditioned or delayed).
11.3 PATENT TERM RESTORATION
The parties must give reasonable cooperation to each other in obtaining
patent term restoration or supplemental protection certificates or
their equivalents in any country in the Territory where applicable to
the Licensed Products.
11.4 REGISTRATION AS LICENSEE
(a) ChemGenex may at any time during the term of this Agreement
request Stragen to grant to ChemGenex licences for the Stragen
Patent Rights in a form which complies with the requirements
of the law and public authorities in each part of the
Territory to enable ChemGenex at its expense to become duly
registered as a licensee under the relevant patent/s. (b)
ChemGenex must bear all costs and expenses incurred in the
grant and registration of formal licences under clause (a).
11.5 REGISTRATION AND MAINTENANCE OF PATENTS (a) Stragen must
do all acts, matters and things (including the payment of all
renewal fees) and execute all documents necessary to maintain
the Stragen Patent Rights in force, and must produce to
ChemGenex 30 days before the last day for the payment of the
renewal fees evidence satisfactory to ChemGenex that
registration of the relevant patent/s has been renewed. If
ChemGenex is not satisfied that registration of the patent/s
has been renewed,
13
it may pay the renewal fees and deduct the amount paid from
the royalties or payments payable to Stragen under this
Agreement.
(b) Stragen must at its own cost defend every action or
proceedings instituted for the revocation of the Stragen
Patent Rights.
(c) In the event that no exclusivity exists as a consequence of
the invalidity, revocation or expiration of the Stragen Patent
Rights in any country comprising part of the Territory the
obligations contained in this Agreement for ChemGenex to pay
royalties upon sales or commercialisation within that part of
the Territory cease from the date of such invalidity,
revocation or expiration.
(d) With respect to Intellectual Property Rights, other than the
Stragen Patent Rights, owned solely by one of the parties:
(i) the party who owns the Intellectual Property Rights
will be responsible for filing, prosecuting and
maintaining patent applications and patents to
protect their Intellectual Property Rights; and
(ii) the other party will have a right to review and
comment on such filings and related correspondence,
however the party who owns the Intellectual Property
Rights will have the sole discretion as to:
(A) whether or not to apply for, prosecute
and/or maintain patents; and
(B) the countries in which patent protection is
sought or maintained.
(e) With respect to Intellectual Property Rights owned jointly by
the parties:
(i) the decision as to whether or not to seek and/or
maintain patent protection will be made by the Joint
Steering Committee;
(ii) both parties will have a right to review and comment
on any filings and related correspondence; and
(iii) the parties will share the expenses of filing,
prosecuting and maintaining such applications
jointly.
11.6 INFRINGEMENT OF TRADE MARKS
(a) In the event that a third party at any time provides written
notice of a claim to, or brings an action, suit or proceeding
against, either party or any of its Affiliates, claiming
infringement of its trade ▇▇▇▇ rights by virtue of the use by
ChemGenex of any of the Trade Marks, that party must promptly
notify the other party of the claim or the commencement of
such action, suit or processing, enclosing a copy of the
claims and/or all papers served.
12. INDEMNIFICATION
12.1 INDEMNIFICATION BY CHEMGENEX
Subject to the terms of the Supply and Distribution Agreement,
ChemGenex hereby agrees to defend, indemnify and hold harmless Stragen
and its Affiliates, officers, directors, employees, consultants and
agents from and against any and all suits, claims, actions, demands,
liabilities, expenses and or losses, including reasonable attorneys'
fees and other costs of defence (`CLAIMS'):
(a) resulting from the use, handling, storage, offer for sale,
sale or other disposition of HHT Product by ChemGenex, its
Affiliates, agents or sublicensees, but only to the extent
such Claims do not result from the negligence or intentional
misconduct of, or material breach of this Agreement or the
Supply and Distribution Agreement by Stragen;
(b) resulting directly from a material breach of this Agreement by
ChemGenex; or
(c) from the negligence or intentional misconduct of ChemGenex,
its Affiliates, sublicensees, officers, directors, employees,
contractors or agents.
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12.2 INDEMNIFICATION BY STRAGEN
Stragen and Stragen Pharma hereby agree to defend, indemnify and hold
harmless ChemGenex and its Affiliates, officers, directors, employees,
consultants and agents from and against any and all Claims resulting
from a material breach of this Agreement or the Supply and Distribution
Agreement by Stragen or Stragen Pharma or from the negligence or
intentional misconduct of Stragen, Stragen Pharma or either of their
Affiliates, officers, directors, employees, contractors or agents.
12.3 INDEMNIFICATION PROCEDURES
(a) Promptly after the receipt by any party hereto of notice under
clause 12.1 or clause 12.2 of:
(i) any claim; or
(ii) the commencement of any action or proceeding,
such party (the `AGGRIEVED PARTY') will, if a claim with
respect thereto is to be made against any party obligated to
provide indemnification (the `INDEMNIFYING PARTY') pursuant to
such sections, give such Indemnifying Party written notice of
such claim or the commencement of such action or proceeding
and shall permit the Indemnifying Party to assume the defence
of any such claim or any litigation resulting from such claim,
and, upon such assumption, shall cooperate fully with the
Indemnifying Party in the conduct of such defence. Failure by
the Indemnifying Party to notify the Aggrieved Party of its
election to defend any such action within a reasonable time,
but in no event more than 15 days after notice thereof shall
have been given to the Indemnifying Party, shall be deemed a
waiver by the Indemnifying Party of its right to defend such
action. If the Indemnifying Party assumes the defence of any
such claim or litigation resulting therefrom, the obligations
of the Indemnifying Party as to such claim shall be limited to
taking all steps necessary in the defence or settlement of
such claim or litigation resulting therefrom and to holding
the Aggrieved Party harmless from and against any and all
losses, damages and liabilities caused by or arising out of
any settlement approved by the Indemnifying Party or any
judgment in connection with such claim or litigation resulting
therefrom. The Aggrieved Party may participate, at its
expense, in the defence of such claim or litigation provided
that the Indemnifying Party shall direct and control the
defence of such claim or litigation. The Indemnifying Party
shall not, in the defence of such claim or any litigation
resulting therefrom, consent to entry of any judgment, except
with the written consent of the Aggrieved Party, or enter into
any settlement, except with the written consent of the
Aggrieved Party, which does not include as an unconditional
term thereof the giving by the claimant or the plaintiff to
the Aggrieved Party of a release from all liability in respect
of such claim or litigation.
(b) If the Indemnifying Party shall not assume the defence of any
such claim or litigation resulting therefrom within a period
of 15 days from the date of issue of the claim, the Aggrieved
Party may defend against such claim or litigation in such
manner as it may deem appropriate and, unless the Indemnifying
Party shall deposit with the Aggrieved Party a sum equivalent
to the total amount demanded in such claim or litigation
within a period of 15 days from the date of issue of the
claim, or shall deliver to the Aggrieved Party a surety bond
in form and substance reasonably satisfactory to the Aggrieved
Party, the Aggrieved Party may settle such claim or litigation
on such terms as it may deem appropriate, and the Indemnifying
Party shall promptly reimburse the Aggrieved Party for the
amount of all reasonable expenses, legal or otherwise,
incurred by the Aggrieved Party in connection with the defence
against or settlement of such claims or litigation. If no
settlement of such claim or litigation is made, the
Indemnifying Party shall promptly reimburse the Aggrieved
Party for the amount of any judgment rendered with respect to
such claim or in such litigation and of all reasonable
expenses, legal or otherwise, incurred by the Aggrieved Party
in the defence against such claim or litigation.
13. LIMITATION ON LIABILITY
IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR
CONSEQUENTIAL DAMAGES RESULTING FROM THE GRANT OR EXERCISE OF
15
RIGHTS UNDER THIS AGREEMENT OR THE USE OR SALE OF LICENSED PRODUCTS.
14. TERM AND TERMINATION
14.1 TERM
This Agreement shall commence on the date of this Agreement and will
continue in each country in the Territory until the last day of the
Royalty Term with respect to such country, unless terminated earlier in
accordance with this Agreement.
14.2 TERMINATION
(a) Either party shall have the right to terminate this Agreement:
(i) Upon 30 days prior notice to the other in the event
that the other commits any material breach of its
obligations under this Agreement and (where the
breach is capable of remedy) fails to remedy the same
within a reasonable time after being called upon in
writing to do so; or
(ii) to the extent permitted by law, upon notice
to the other in the event the other party:
(A) becomes insolvent;
(B) fails generally to pay its debts as
they fall due;
(C) files a voluntary petition or any
answer admitting the material
allegations of, or consents to, an
involuntary petition pursuant to or
purporting to be pursuant to any
reorganization or insolvency law of
any jurisdiction;
(D) makes an assignment for the benefit
of creditors; or
(E) applies for or consents to the
appointment of a receiver or
trustee of a substantial party of
its property; or Effect of
Expiration or Termination of this
Agreement.
(b) The rights and obligations set forth in this Agreement shall
extend beyond the term or termination of the Agreement only to
the extent expressly provided for herein, or the extent that
the survival of such rights or obligations are necessary to
permit their complete fulfilment or discharge.
14.3 ACCRUED RIGHTS, SURVIVING OBLIGATIONS
(a) Termination, relinquishment or expiration of the Agreement for
any reason shall be without prejudice to any rights which
shall have accrued to the benefit of either party prior to
such termination, relinquishment or expiration, including
damages arising from any breach hereunder.
(b) The following clauses will survive termination or expiration
of this Agreement: 3.3, 3.4, 3.5, 3.6,10,11.1, 12,13,
15(a),17, 18, 19.3,19.4,20.
15. ADVERTISING AND PUBLICITY
(a) Except for such disclosures as are deemed necessary in
Stragen's or ChemGenex's, as the case may be, reasonable
judgment to comply with applicable law, only ChemGenex may
make any publicly disseminated oral or written disclosure
relating or referring to, or use any advertising or publicity
which relates or makes reference to:
(i) this Agreement;
(ii) the Supply and Distribution Agreement
(iii) the terms of this Agreement or the Supply and
Distribution Agreement;
(iv) the development or commercialisation of HHT Products;
or
(v) the publication or presentation of scientific data.
16
(b) Stragen will have the right to review public
announcement relating to HHT Products prior to public
release by ChemGenex.
16. OPTION
16.1 GRANT
ChemGenex grants to Stragen an option to subscribe for one million
(1,000,000) ordinary shares in ChemGenex for consideration of *** per
share (`THE OPTION'), exercisable on the terms and subject to the
conditions set out in this clause.
16.2 CONDITION
(a) The grant of the Option is subject to the Australian Stock
Exchange (ASX) listing rules (`LISTING Rules') and is upon the
approval of the shareholders of ChemGenex in accordance with
Listing Rule 7.1.5 if required.
(b) If approval is required, ChemGenex will do all things
reasonably necessary to procure the approval at the next
annual general meeting of ChemGenex or any prior extraordinary
general meeting of ChemGenex, but not later than October 30,
2005.
16.3 CERTIFICATE
ChemGenex will procure the delivery of a certificate in respect of the
Option following the grant, evidencing the Option and setting out the
terms of the Option.
16.4 ASSIGNMENT
The Option is personal to Stragen and may not be assigned to or
exercised by any other entity or person.
16.5 TIME FOR EXERCISE
The Option may not be exercised until that day which is 12 months after
the date of this Agreement and expires on the earlier of:
(a) the failure of a condition applicable to the Option; and
(b) that day which is 5 years after the date of this Agreement
(`THE EXPIRY DATE').
16.6 TERMS OF EXERCISE
(a) The Option must be exercised before the Expiry Date and may be
exercised once only, whether in relation to all or part of the
one million (1,000,000) shares.
(b) All shares issued pursuant to the exercise of the Option
together will rank pari passu in all respects with shares on
issue at the time of allotment.
(c) The Option will confer no right on Stragen to participate in
new issues of securities by ChemGenex without exercising the
Option.
16.7 METHOD OF EXERCISE
(a) The Option must be exercised by delivering to the registered
office of ChemGenex a notice stating that Stragen is
exercising the Option, which is signed by Stragen.
16.8 ACKNOWLEDGEMENT
(a) Stragen acknowledges that any liabilities incurred by Stragen
as a result of the issue of the Option and/or shares in
ChemGenex are liabilities of Stragen and not ChemGenex.
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17. CONFIDENTIALITY
17.1 CONFIDENTIALITY
(a) For a period of ten (10) years from the Effective Date
of this Agreement or five (5) years from the
termination hereof, whichever occurs later:
(i) each party shall refrain from the use of Confidential
Information furnished by the other party for any
purpose inconsistent with this Agreement; and
(ii) each party shall treat Confidential Information
furnished by the other party as if it were its own
proprietary information and shall not disclose it to
any third party other than its Affiliates or
consultants without the prior written consent of the
other party who furnished such information and subject
to the same obligations of Confidentiality as set out
in this Agreement.
(b) Clause 17.1(a)(ii) above shall not apply where such
Confidential Information is:
(i) disclosed to comply with the requirements of any law,
governmental order (including a court order) or
regulation; or
(ii) information disclosed by Stragen for the purpose
obtaining any Regulatory Approvals for HHT Products
including all material and information submitted to
and/or filed with a governmental regulatory agency or
any other equivalent agency covering the HHT Products
and information related to the HHT Products contained
in all documents submitted in connection with
regulatory submissions throughout the world covering
the HHT Products.
17.2 DISCLOSURE REQUIRED BY LAW
In the event that either party is required to make disclosure of the
other's Confidential Information as a result of the issuance of a court
order or other government process, the party subject to such
requirement promptly, but in not event more than 48 hours after
learning of such court order or other government process, shall notify
the other party and, at the other party's expense, the party subject to
such requirements shall:
(a) take all reasonably necessary steps requested by the other
party to defend against the enforcement of such court order or
other government process; and
(b) permit the other party to intervene and participate with
counsel of its choice in any proceeding relating to the
enforcement thereof.
18. LICENSE OF INTELLECTUAL PROPERTY RIGHTS FROM STRAGEN PHARMA TO STRAGEN
18.1 CONSIDERATION
The covenants given in this Agreement by Stragen Pharma in favour of
ChemGenex are given in consideration for:
(a) ChemGenex entering into this Agreement and the Supply and
Distribution Agreement at the request of Stragen Pharma; and
(b) the covenants given by ChemGenex in clause (e) of this
Agreement to proceed with Stragen Pharma's Phase 2 Study
Protocols in Accelerated Phase Chronic Myeloid Leukemia (Study
HHT-CML/INTL/04.2 and 04.3), pay the Inveresk invoice and
enter into direct service contracts with Inveresk; and
(c) all of the covenants given by ChemGenex in favour of Stragen
and Stragen's Affiliates, under both this Agreement and the
Supply and Distribution Agreement.
18.2 LICENSE OF STRAGEN RIGHTS
(a) Stragen Pharma:
18
(i) warrants and represents to ChemGenex that Stragen is
exclusively licensed and authorised by Stragen Pharma
to grant the rights Stragen has purported to give to
ChemGenex under clause 2.1 and the other clauses
contained in this Agreement, and the under the Supply
and Distribution Agreement (`THE STRAGEN LICENCE');
and
(ii) agrees that in the event and to the extent that the
Stragen Licence is terminated, invalidated, revoked,
or otherwise is, or becomes, ineffective to grant to
ChemGenex the rights purported to be given to it by
Stragen under this Agreement or under the Supply and
Distribution Agreement:
(A) Stragen will grant to ChemGenex a direct
licence giving ChemGenex the same rights as
it has under the Stragen Licence; and
(B) any references to Stragen in this Agreement
and in the Supply and Distribution Agreement
will be construed as a reference to Stragen
Pharma, and Stragen Pharma will perform the
obligations of Stragen under this Agreement
and the Supply and Distribution Agreement.
(b) The licence referred to in sub-clause 18.2(a)(ii)(A) will take
effect immediately without the need for any further action by
either party, however if requested by ChemGenex, Stragen
Pharma must promptly sign all documents and do all other
things reasonably required by ChemGenex to give effect to this
clause.
18.3 INDEMNITY
(a) Stragen Pharma agrees to indemnify and hold harmless ChemGenex
and its Affiliates, officers, directors, employees,
consultants and agents from and against any and all Claims
resulting from a material breach of this Agreement or the
Supply and Distribution Agreement by Stragen or Stragen Pharma
or from the negligence or intentional misconduct of Stragen,
Stragen Pharma or either of their Affiliates, officers,
directors, employees, contractors or agents.
19. MISCELLANEOUS
19.1 GOVERNING LAW; CHOICE OF FORUM
The parties agree that this Agreement shall be governed by and
construed in accordance with the laws of Switzerland, state of Geneva,
and irrevocably submit to the non-exclusive jurisdiction of the courts
of that state.
19.2 RELATIONSHIP
(a) Nothing contained in this Agreement will be deemed to create
any association, partnership, joint venture, or relationship
of principal and agent between the parties to this Agreement
or any of their respective Affiliates, or to provide either
party with the right, power or authority, whether express or
implied, to create any such duty or obligation on behalf of
the other party.
(b) No employee or representative of a party will have any
authority to bind or obligate the other party to this
Agreement for any sum or in any manner whatsoever, or to
create or impose any contractual or other liability on the
other party without relevant party's authorised written
approval.
19.3 INTEREST DUE ON LATE PAYMENTS
If any amount payable by under this Agreement by one party to the other
is not paid when due, then without limiting any other rights which the
relevant party may have as a result of such late payment, the amount
unpaid shall bear interest until paid at a rate per annum equal to the
prime rate published and as changed from time to time by Citibank, N.A.
New York, New York (as reported in The Wall Street Journal) plus two
and one-half percent (2.5%), with such interest to be paid on demand
together with all costs incurred by Stragen to collect the amounts due
hereunder, including but not limited to reasonable attorneys fees and
disbursements.
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19.4 TAXES
Each party shall bear all taxes imposed on it as a result of the
performance by such party under this Agreement including, but not
limited to, any sales tax, any tax on or measured by any payment
required to be made hereunder, any registration tax, or any tax imposed
with respect to the granting of licences or other rights hereunder. The
parties shall cooperate fully with each other in obtaining and filing
all requisite certificates and documents with the appropriate
authorities and shall take such further action as may reasonably be
necessary to avoid the deduction of any withholding or similar taxes
from any remittance of funds by ChemGenex to Stragen hereunder.
19.5 EMPLOYEES
Neither party shall have any responsibility for the hiring, firing or
compensation of the other party's employees or for any employee
benefits of the other party's employees.
19.6 ASSIGNMENT
This Agreement shall be binding upon, and shall inure to the benefit of
successors to a party hereto, but shall not otherwise be assignable
without the prior written consent of both parties, except to:
(a) the successor or assignee of all or substantially all of a
party's business relating to HHT Products; or
(b) a party's Affiliate; or
(c) another entity in a party's corporate group,
in which cases no prior consent will be required.
In the event all or part of a party's interest under this Agreement is
assigned or transferred, that party must notify the other at least 30
days prior to such assignment or transfer.
19.7 NOTICES
Any notice required or permitted to be made or given hereunder shall
(except as otherwise expressly provided herein) be in writing and shall
be made or given to the other party by personal in-hand delivery; by
facsimile, by airmail, postage prepaid; or by air courier to the
mailing or facsimile numbers set forth below:
CHEMGENEX PHARMACEUTICALS LIMITED
▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇
Fax ▇▇▇ ▇ ▇▇▇▇ ▇▇▇▇
STRAGEN INVESTMENT B.V.
c/- Stragen Pharma S.A.
▇, ▇▇▇ ▇▇▇▇-▇▇-▇▇▇▇▇▇
▇.▇. ▇▇▇ ▇▇▇
▇▇-▇▇▇▇ ▇▇▇▇▇▇ 4
Fax + ▇▇ ▇▇ ▇▇▇ ▇▇ ▇▇
STRAGEN PHARMA S.A.
▇, ▇▇▇ ▇▇▇▇-▇▇-▇▇▇▇▇▇
▇.▇. ▇▇▇ ▇▇▇
▇▇-▇▇▇▇ ▇▇▇▇▇▇ 4
Fax + ▇▇ ▇▇ ▇▇▇ ▇▇ ▇▇
20
or to such other address or facsimile numbers as either party
shall designate by notice, similarly given, to the other
party. Notices shall be deemed to have been sufficiently made
or given:
(a) if by personal in-hand delivery, or by facsimile with
confirmed transmissions, when performed;
(b) if mailed by air mail, 14 days after being deposited in the
mail, postage prepaid; or
(c) by air courier, 3 days after delivery to the air courier
company.
19.8 FORCE MAJEURE
In the event that either party is prevented from performing or is
unable to perform any of its obligations under this Agreement due to
any act of God, fire, casualty, flood, war, strike, lockout, failure of
public utilities, injunction or any act, exercise, assertion or
requirement of governmental authority, including any governmental law,
order regulation permanently or temporarily prohibiting or reducing the
level of the manufacture of Licensed Product, epidemic, destruction of
production facilitates, riots, insurrection, inability to procure or
use materials, labour, equipment, transportation or energy sufficient
to meet manufacturing needs; or any other cause beyond the reasonable
control of the party invoking this clause 19.8 provided such party
shall have used its best efforts to avoid such occurrence; such party
shall give notice to the other party in writing promptly, and thereupon
the affected party's performance shall be excused and the time for
performance shall be extended for the period of delay or inability to
perform due to such occurrence.
19.9 WAIVER
The waiver by either party of a breach or a default of any provision of
this Agreement by the other party shall not be construed as a waiver of
any succeeding breach of the same or any other provision, nor shall any
delay or omission on the part of either party to exercise or avail
itself of any right, power or privilege that it has or may have
hereunder operate as a waiver of any right, power or privilege by such
party.
19.10 PARTIAL INVALIDITY
The parties to this Agreement desire and intend that the terms and
conditions of this Agreement be enforced to the fullest extent
permissible under the laws and public policies applied in each
jurisdiction where enforcement is sought. If any particular term or
condition of this Agreement is adjudicated , or becomes by operation of
law, invalid or unenforceable, this Agreement will be deemed amended to
delete the portion which is adjudicated, or which becomes by operation
of law, invalid or unenforceable, provided, however, that where
possible, a particular term or condition will be reduced to the extent
necessary to permit the remainder of the particular term or condition
to be enforced, the deletion or reduction to apply only with respect to
the operation of the term or condition and the remainder of this
Agreement to remain in full force and effect. A deletion or reduction
of any term or condition will apply only with respect to the operation
of that term or condition in the particular jurisdiction in which such
adjudication is made or becomes by operation of law, invalid or
unenforceable.
19.11 COUNTERPARTS; ENGLISH LANGUAGE
This Agreement may be executed in any number of counterparts, each of
which shall be deemed an original but all of which together shall
constitute one and the same instrument. This Agreement is entered into
in the English language. In the event of any dispute concerning the
construction or meaning of this Agreement, reference shall be made only
to this Agreement as written in English and not to any translation
hereof into any other language, and this English language version shall
be controlling for all purposes.
21
20. DISPUTES
20.1 ALTERNATIVE DISPUTE RESOLUTION PROCEDURE
(a) A party must not start arbitration or court proceedings
(except proceedings seeking interlocutory relief) in respect
of a dispute arising out of this Agreement (`DISPUTE') unless
it has complied with this clause.
(b) A party claiming that a Dispute has arisen must notify the
other party to the Dispute, specifying the nature of the
Dispute.
(c) Within 14 days after a notice is given under clause (b), each
party to the Dispute must nominate in writing a representative
authorised to settle the Dispute on its behalf.
(d) Each party must ensure that, during the 30 day period after a
notice is given under clause (b) (or longer period agreed
between the parties), its representative uses his or her best
endeavours, with the other representatives and the Joint
Steering Committee:
(i) to resolve the Dispute; or
(ii) to agree on:
(A) a process to resolve all or at least part of
the Dispute without arbitration or court
proceedings, (eg mediation, conciliation,
executive appraisal or independent expert
determination);
(B) the selection and payment of any third party
to be engaged by the parties and the
involvement of any dispute resolution
organisation;
(C) any procedural rules;
(D) the timetable, including any exchange of
relevant information and documents; and
(E) the place where meetings will be held.
(e) The role of any third party is to assist in negotiating a
resolution of the Dispute. A third party may not make a
decision that is binding on a party unless that party's
representative has so agreed in writing.
(f) Each party:
(i) must keep confidential all information or documents
disclosed by a representative under this clause; and
(ii) must not use such information or documents except to
attempt to settle the Dispute.
(g) Each party must bear its own costs of resolving a Dispute
under this clause and the parties must bear equally the costs
of any third party engaged.
(h) After the 30 day period referred to in clause (d) (or longer
period agreed between the parties), a party that has complied
with clauses (b) to (d) may terminate the dispute resolution
process by giving notice to the other parties to the Dispute.
(i) If a party to a Dispute does not comply with any provision of
clauses (a) to (d) the other parties to the Dispute are not
bound by clauses (a) to (d).
21. INTERPRETATION
In this Agreement, except to the extent the context otherwise requires:
(a) the singular includes the plural and vice versa and a gender
includes other genders;
(b) a reference to a party is to be construed as a reference to a
party to this Agreement;
(c) a reference to a party to this Agreement or any other document
or agreement includes its successors and permitted assigns;
(d) a reference to an item in the Background, clause, schedule,
annexure or appendix is a reference to an item in the
Background, clause of or schedule, annexure or appendix to
this Agreement and references to this Agreement include its
schedules and any annexures;
22
(e) where a word or phrase is given a particular meaning, other
parts of speech or grammatical forms of that word or phrase
have corresponding meanings;
(f) a reference to a document or agreement including this
Agreement includes a reference to that document or agreement
as amended, novated, supplemented, varied or replaced from
time to time;
(g) in the interpretation of this Agreement, headings are to be
disregarded;
(h) references to `***' are to *** unless otherwise indicated.
23
SCHEDULE
--------------------------------------------------------------------------------
JOINT STEERING COMMITTEE MEMBERS ChemGenex: ▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Stragen: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
2nd member to be advised
CONTACT OFFICER ChemGenex: ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Stragen: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
24
EXECUTED as an agreement.
EXECUTED for and on behalf of )
CHEMGENEX PHARMACEUTICALS LIMITED )
by authority of the directors in the presence of:)
)
--------------------------------------------------- -------------------------------------------------
/~ Director /~ Director/Secretary
▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ Authorised signatory
--------------------------------------------------- -------------------------------------------------
/~ Full name of director /~ Full name of director/secretary
EXECUTED for and on behalf of )
STRAGEN INVESTMENT B.V. by authority )
of the directors in the presence of: )
)
--------------------------------------------------- -------------------------------------------------
/~ Director /~ Director/Secretary
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
--------------------------------------------------- -------------------------------------------------
/~ Full name of director /~ Full name of director/secretary
EXECUTED for and on behalf of )
STRAGEN PHARMA S.A. by authority of the)
directors in the presence of: )
)
--------------------------------------------------- -------------------------------------------------
/~ Director /~ Director/Secretary
▇▇▇▇ ▇▇▇ Tetard ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
--------------------------------------------------- -------------------------------------------------
/~ Full name of director /~ Full name of director/secretary
25
ANNEXURE A
Stragen Patents
-------------------------------------------------------------------------------------------------------------------------
PATENTS PORTFOLIO OF STRAGENPHARMA
Liste des Criteres de selections
Titre abrege cephalotaxanes
-------------------------------------------------------------------------------------------------------------------------
Short title Country Protected as Status Your Based on Filing Filing Date of Number
ref date number grant of grant
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES US Patent in FR 98 30/03/2001 09/817 176 02/09/2003 6,613,900
(Continuation in force 03492
part)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES FR Patent in 20/03/1998 98 03492 10/09/2004 98 03492
force
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES US Patent in FR 98 16/03/1999 09/ 270 14/12/2004 6,831,180
force 03492 006
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES AT European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES BE European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES CH European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES CY European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES DE European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES DK European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES EP European patent Validated FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
----------------- 03492
(Euro/PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES ES European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES FI European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES FR European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES GB European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES GR European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES IE European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES IT European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES LU European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES MC European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES NL European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
06 JUIN 2005 PAGE 1 DE 2
26
PATENTS PORTFOLIO OF STRAGENPHARMA
Liste des Criteres de selections
Titre abrege cephalotaxanes
-------------------------------------------------------------------------------------------------------------------------
Short title Country Protected as Status Your Based on Filing Filing Date of Number
ref date number grant of grant
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES PT European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES SE European patent in FR 98 17/03/1999 99942587.9 16/02/2005 1 064 285
(Validation) force 03492
(PCT)
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES JP Patent in FR 98 17/03/1999 2000-537877
application (PCT) force 03492
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES CN Patent in FR 98 17/03/1999 99806044.5
application (PCT) force 03492
-------------------------------------------------------------------------------------------------------------------------
CEPHALOTAXANES US Application for in FR 98 25/06/2004 10/877 067
continuation in force 03492
part
-------------------------------------------------------------------------------------------------------------------------
06 JUIN 2005 PAGE 2 DE 2
27
PATENTS PORTFOLIO OF STRAGENPHARMA
Liste des Criteres de selections
Titre abrege HOMOHARRINGTONINE COMBINATION%
---------------------------------------------------------------------------------------------------------------------------------
Short title Country Protected as Status Your Based on Filing Filing Date of Number
ref date number grant of grant
---------------------------------------------------------------------------------------------------------------------------------
HOMOHARRINGTONINE EP European patent in US 60/316 05/09/2002 02772653.8
COMBINATION THERAPY FOR application force 967
CML (Euro/PCT)
---------------------------------------------------------------------------------------------------------------------------------
HOMOHARRINGTONINE HK Patent in US 60/316 05/09/2002 05101068 0
COMBINATION THERAPY FOR application by force 967
CML registration
---------------------------------------------------------------------------------------------------------------------------------
HOMOHARRINGTONINE US Application for in US 60/316 05/09/2002 10/397,267
COMBINATION THERAPY FOR continuation in force 967
CML part (PCT)
---------------------------------------------------------------------------------------------------------------------------------
HOMOHARRINGTONINE CA Patent in US 60/316 05/09/2002 2,459,822
COMBINATION THERAPY FOR application (PCT) force 967
CML
---------------------------------------------------------------------------------------------------------------------------------
HOMOHARRINGTONINE JP Patent in US 60/316 05/09/2002 2003-524561
COMBINATION THERAPY FOR application (PCT) force 967
CML
---------------------------------------------------------------------------------------------------------------------------------
06 JUIN 2005 PAGE 1 DE 1
28
PATENTS PORTFOLIO OF STRAGENPHARMA
Liste des Criteres de selections
Titre abrege HOMOHARRINGTONINE COMBINATION%
---------------------------------------------------------------------------------------------------------------------------------
Short title Country Protected as Status Your Based on Filing Filing Date Number
ref date number of of ▇▇▇▇▇
▇▇▇▇▇
---------------------------------------------------------------------------------------------------------------------------------
HOMOHARRINGTONINE EP European patent in US 60/316 05/09/2002 02772653.8
COMBINATION THERAPY FOR CML application force 967
(Euro/PCT)
---------------------------------------------------------------------------------------------------------------------------------
HOMOHARRINGTONINE HK Patent in US 60/316 05/09/2002 05101068 0
COMBINATION THERAPY FOR CML application by force 967
registration
---------------------------------------------------------------------------------------------------------------------------------
HOMOHARRINGTONINE US Application for in US 60/316 05/09/2002 10/397,267
COMBINATION THERAPY FOR CML continuation in force 967
part (PCT)
---------------------------------------------------------------------------------------------------------------------------------
HOMOHARRINGTONINE CA Patent in US 60/316 05/09/2002 2,459,822
COMBINATION THERAPY FOR CML application (PCT) force 967
---------------------------------------------------------------------------------------------------------------------------------
HOMOHARRINGTONINE JP Patent in US 60/316 05/09/2002 2003-524561
COMBINATION THERAPY FOR CML application (PCT) force 967
---------------------------------------------------------------------------------------------------------------------------------
06 JUIN 2005 PAGE 1 DE 1
29
ANNEXURE B
Licensed Product specifications
----------------------------------------------------------------------------------------------------
HOMOHARRINGTONINE FOR INJECTION, 5MG VIAL
DRUG PRODUCT SPECIFICATIONS
-----------------------------------------------------------------------------------------------------
TESTS SPECIFICATIONS
-----------------------------------------------------------------------------------------------------
Appearance White to off-white lyophilized powder
-----------------------------------------------------------------------------------------------------
Identification
o Retention time matches the reference standard.
o HPLC
-----------------------------------------------------------------------------------------------------
Constituted solution (2,5ml NaC1 0,9%)
- Appearance - Complete dissolution,
- Colorless and clear, free from foreign particles
-----------------------------------------------------------------------------------------------------
- Particulate matter (USP(788))
- > 10im
-
- > 25 im - not more than 6000
- - not more than 600
-----------------------------------------------------------------------------------------------------
pH (2,5ml NaC1 0,9%) 5,5 - 7,0
-----------------------------------------------------------------------------------------------------
Water content (USP (921)) > 5.0% (to be confirmed)
-
-----------------------------------------------------------------------------------------------------
Related substances (HPLC) At release At shelf-life
- Single (largest)
- Total > 0,15% > 0,5%
- -
> 0,3% To be determined > 1,0%
- -
-----------------------------------------------------------------------------------------------------
Assay (HPLC) 95,0% - 105,0%
-----------------------------------------------------------------------------------------------------
Uniformity of content (USP (905)) Complies ▇▇▇.▇▇. and USP requirements
------------------------------------------------------------------------------------------------------
Sterility (USP (717)) Sterile
-----------------------------------------------------------------------------------------------------
Bacterial endotoxins (USP (85)) Not more than 38,8 EU/mg
------------------------------------------------------------------------------------------------------
30
ANNEXURE C
Specifications for bulk HHT
---------------------------------------------------------------------------------------------------
HOMOHARRINGTONINE
DRUG SUBSTANCE SPECIFICATIONS
----------------------------------------------------------------------------------------------------
TESTS SPECIFICATIONS
----------------------------------------------------------------------------------------------------
Appearance White to off-white powder
----------------------------------------------------------------------------------------------------
Identification
o Spectrum similar to the reference spectrum
o IR spectrum o Retention time matches the reference standard
o HPLC
----------------------------------------------------------------------------------------------------
- not more than 3.0%
Water content (USP <921>)
----------------------------------------------------------------------------------------------------
Related substances (HPLC)
- 4 DMHHT - not more than 0,15%
- HHT (+,+) - not more than 0,15%
- Other single impurity - not more than 0,10%
- Total impurities - not more than 0,30%
----------------------------------------------------------------------------------------------------
Assay (HPLC) 97.0% - 102.0% (anhydrous substance)
----------------------------------------------------------------------------------------------------
Residual solvents (GC)
- Dichloromethane - not more than 600ppm
- Methanol - not more than 3000ppm
----------------------------------------------------------------------------------------------------
- not more than 0,2%
Sulphated ash
----------------------------------------------------------------------------------------------------
Heavy metals (USP (231)) < 20 ppm
-
----------------------------------------------------------------------------------------------------
31
ANNEXURE D
Inveresk Invoice
--------------------------------------------------------------------------------
[GRAPHIC OMITTED]
Stragen Pharma S.A
3 rue ▇▇▇▇-▇▇-▇▇▇▇▇▇
▇▇ ▇▇▇ ▇▇▇
▇▇-▇▇▇▇ ▇▇▇▇▇▇ ▇
▇▇▇▇▇▇▇▇▇▇▇
ATTN: ▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
MEDICAL DIRECTOR
VAT NO GB 735349127
INVOICE
8925
18-Feb-05 Ref: AO2362/05/01/SK
SERVICES FOR THE CLINICAL CONDUCT OF A STUDIES IN PATIENTS WITH
ACCELERATED PHASE CHRONIC MYELOID LEUKAEMIA (CML)
AND PATIENTS WITH ACCELERATED PHASE ACUTE MYELOID LEUKAEMIA (AML)
DIRECT COSTS EUR
Signature of LOI ***
TOTAL AMOUNT DUE ***
Please arrange a transfer in the sum of (EURO)***
to the following account:
The Royal Bank of Scotlalnd Plc
St ▇▇▇▇▇▇▇ Square Office
▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇
Sort Code 83-06-08
Account No 837070 ▇▇▇▇▇▇▇▇
Account Name Inveresk Research Ltd
IBAN G850 RBOS 8375 7010 0261 03
BIC RBOS ▇▇ ▇▇
PAYMENT DUE WITHIN 30 DAYS
Send Cheques Remittance Advice For The Attention of ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇,
Inveresk Research Limited, Tranent, EH33 2NE, Scotland
Tranent, ▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇, ▇▇ Tel: + ▇▇ (▇) ▇▇▇▇ ▇▇▇▇▇▇
Fax + ▇▇ (▇) ▇▇▇▇ ▇▇▇▇▇▇
Email: ▇▇▇▇@▇▇▇▇▇▇▇▇.▇▇▇ ▇▇▇.▇▇▇▇▇▇▇▇.▇▇▇
32
TABLE OF CONTENTS
-------------------------------------------------------------------------------------------------------------------
1. DEFINITIONS..............................................................................................1
2. SCOPE OF LICENCE.........................................................................................4
3. ROYALTIES................................................................................................5
4. DEVELOPMENT EXCLUSIVITY..................................................................................8
5. CONDITION PRECEDENT......................................................................................8
6. EUROPEAN JOINT VENTURE...................................................................................8
7. JOINT STEERING COMMITTEE.................................................................................9
8. CONTACT OFFICERS........................................................................................10
9. CLINICAL DEVELOPMENT AND DILIGENCE OBLIGATIONS..........................................................10
10. REPRESENTATIONS AND WARRANTIES..........................................................................11
11. INTELLECTUAL PROPERTY...................................................................................12
12. INDEMNIFICATION.........................................................................................14
13. LIMITATION ON LIABILITY.................................................................................15
14. TERM AND TERMINATION....................................................................................16
15. ADVERTISING AND PUBLICITY...............................................................................16
16. OPTION..................................................................................................17
17. CONFIDENTIALITY.........................................................................................18
18. LICENSE OF INTELLECTUAL PROPERTY RIGHTS FROM STRAGEN PHARMA TO STRAGEN..................................18
19. MISCELLANEOUS...........................................................................................19
20. DISPUTES................................................................................................22
21. INTERPRETATION..........................................................................................22
ANNEXURE A.......................................................................................................26
Stragen Patents.........................................................................................26
ANNEXURE B.......................................................................................................30
Licensed Product specifications.........................................................................30
ANNEXURE C.......................................................................................................31
Specifications for bulk HHT.............................................................................31
ANNEXURE D.......................................................................................................32
Inveresk Invoice........................................................................................32
ii