Exhibit 3.2(z)
"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 SUPPLY AND DISTRIBUTION AGREEMENT
Made on June 27, 2005
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BETWEEN CHEMGENEX PHARMACEUTICALS LIMITED ACN 000 248 304
(`CHEMGENEX')
AND STRAGEN INVESTMENT B.V. , XXXXXXXXXXX 00, 0000XX XXXXXXXXX.
(`STRAGEN')
BACKGROUND
A. Stragen has an expertise in the manufacture and supply of
semi-synthetic homoharringtonine (HHT) pharmaceutical products, product
registration and distribution in Europe, and holds patents and
intellectual property licences for the method of manufacture of
semi-synthetic HHT and for HHT analogs.
B. ChemGenex desires to obtain the exclusive right to distribute HHT
products manufactured by Stragen throughout the world with the
exception of Europe.
C. Stragen is prepared to manufacture HHT products for ChemGenex on an
exclusive basis.
D. Stragen and ChemGenex agree to the terms of supply and distribution as
contained in this Agreement.
E. ChemGenex and Stragen agree to form a joint venture in Europe which
will be the sole owner of market authorization and sole distributor of
HHT in Europe.
OPERATIVE PROVISIONS
1. DEFINITIONS
In this Agreement, except to the extent the context otherwise requires:
`AFFILIATE' means, with respect to any Person, any other Person which,
directly or indirectly, owns or controls, or is owned or controlled by,
or is under common control with, the specified Person. 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 Supply and Distribution Agreement;
`APPROVAL' means approval of a Licensed Product by the FDA for sale by
ChemGenex or its Affiliates or Subdistributors for any specific
indication in the Field to independent third parties in the United
States of America;
`BULK HHT' means bulk formulation HHT conforming to the specifications
in Annexure B.
`CHEMGENEX' means ChemGenex Pharmaceuticals Limited and includes any of
its Affiliates;
`CONFIDENTIAL INFORMATION' 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 and includes the
information the subject of the mutual non-disclosure agreement dated
March 22, 2005 and signed between ChemGenex Pharmaceutical, Inc and
Stragen Pharma SA; provided, however, that Confidential Information
shall not include:
(a) information which 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
(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;
`DEVELOPMENT AND COMMERCIALISATION AGREEMENT' means the agreement for
the development and commercialisation of Products made between the
parties on the same date as this Agreement;
`EFFECTIVE DATE' means the date of this Agreement;
`EUROPE' 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;
`EUROPEAN JOINT VENTURE' means the joint venture for Europe referred to
in the Development and Commercialisation Agreement;
`FDA' means the United States Food and Drug Administration or any
successor entity;
`FIELD' means the treatment of cancer in humans;
`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;
`JOINT VENTURE AGREEMENT' means the joint venture agreement referred to
in clause 7.1;
`JOINT VENTURE ENTITY' means the European Joint Venture entity referred
to in the Development and Commercialisation Agreement;
`JV TERRITORY' means Europe;
`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;
`NET SALES' means ChemGenex's and its Affiliates' gross sales prices of
Licensed Product billed to unaffiliated customers in the future (if
any) less:
(a) to the extent such amounts are included in the invoiced sales
prices, credits for spoiled, damaged, returned, rejected or
out-dated product or billing errors;
(b) quantity and other trade discounts and early settlement
discounts actually allowed or paid;
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(c) reasonable commissions paid to third party distributors,
brokers or agents other than sales personnel and sales
representatives employed by ChemGenex;
(d) transportation, insurance and handling expenses to the extent
chargeable to such sales;
(e) sales, value-added and other direct taxes incurred with
respect to the sales;
(f) customs duties and surcharges and other governmental charges
incurred in connection with the exportation or importation of
the Licensed Product; and
(g) legally mandated rebates, if any;
Sales between or among ChemGenex and its Affiliates will be excluded
from the computation of Net Sales, but the subsequent and final sales
to third parties by such Affiliates will be included within Net Sales.
Any part of Net Sales received by ChemGenex or an Affiliate of
ChemGenex that is computed in a currency other than US Dollars will be
translated into US Dollars as follows: the exchange rate will be the
average of:
(h) the rate applicable on the last business day of the month
prior to the month of sale; and
(i) the rate applicable on the last business day of the month in
which the sale was made (each published in the New York
edition of the Wall Street Journal); provided that if between
the date such sales were made and the date the royalty with
respect to such sales is payable pursuant to clause 5.4 the
exchange rates change to such a degree so as to result in
significant economic detriment to one of the parties, the
parties will mutually agree on an exchange rate to apply to
such Net Sales that allocates such detriment equally to both
parties;
`OFF-LABEL STUDIES' means pilot or marketing directed studies
(including current and planned Phase 2 studies in CML, MDS and AML) not
related to medical agencies requests or to registration or confirmation
studies;
`PERSON' means any individual, corporation, partnership, limited
liability company, business trust, business association, governmental
entity, governmental authority or other legal entity;
`PRODUCTS' means any pharmaceutical product containing HHT as a
therapeutically active ingredient, including without limitation,
finished and packaged dosage units of the Products and formulated
Products in bulk;
`SPECIFICATIONS' means the specifications contained in Annexures A and
B of this Agreement;
`STRAGEN' means Stragen Investments B.V. and includes any of its
Affiliates;
`STRAGEN KNOW-HOW' means proprietary techniques and data 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:
(j) Stragen discloses to ChemGenex under this Agreement; and
(k) is within the control of Stragen;
`STRAGEN PATENT RIGHTS' has the meaning given to that term in the
Development and Commercialisation Agreement;
`SUBDISTRIBUTORS' shall mean such subdistributors or clinical trial
services agents as ChemGenex may appoint in accordance with clause 3;
`TECHNOLOGY' means data, manufacturing know-how, regulatory submissions
and other intellectual property that is either in the possession of
Stragen as of the date hereof or developed by Stragen during the term
of this Agreement in relation to the Licensed Products or in connection
with any additional regulatory approvals to market 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
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Stragen or any of its Affiliates in either case, owned, controlled by,
or licensed (with the right of sub-licence to Stragen) 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; and
`VALID CLAIM' has the meaning given to that term in the Development and
Commercialisation Agreement.
2. APPOINTMENT AND LICENCE GRANTS
2.1 APPOINTMENT
(a) Subject to sub-clause 2.1(c) and clause 2.1(d) of the
Development and Commercialisation Agreement, and in
consideration for the covenants provided by ChemGenex under
this Agreement and the Development and Commercialisation
Agreement, Stragen licenses ChemGenex and the Joint Venture
Entity as its exclusive distributors to promote, advertise,
distribute and sell the Licensed Product in every country in
the Territory and JV Territory, respectively, during the term
of this Agreement.
(b) Subject to sub-clause 2.1(c), during the term of this
Agreement Stragen will not manufacture (or cause to be
manufactured) any HHT Products for distribution or sale by any
Person other than ChemGenex or its Subdistributors or
sublicensees within the Territory, or the Joint Venture Entity
within the JV Territory.
(c) Until the Joint Venture Entity is established, Stragen will be
entitled to sell HHT Products in the JV Territory for
compassionate use. The right given under this sub-clause will
terminate upon the establishment of the Joint Venture Entity.
2.2 CONDITION PRECEDENT
The execution of the Development and Commercialisation Agreement by
both parties is a condition precedent to this Agreement.
3. SUBDISTRIBUTORS
ChemGenex may appoint one or more of its Affiliates or one or more
other Persons to act as a subdistributor or clinical trial services
agent for the Licensed Product in the Territory, provided that:
(a) no such appointment will reduce the liability of ChemGenex
under this Agreement; and
(b) ChemGenex shall be liable for the actions and omissions of any
Subdistributor as if the action or omission were ChemGenex's
own.
4. SUPPLY
4.1 EXCLUSIVE SUPPLY REQUIREMENTS
(a) Stragen will sell to ChemGenex or its Subdistributors or
sublicensees all of their HHT requirements for:
(i) the Licensed Products for sale in the Field by
ChemGenex or its Subdistributors or sublicensees;
(ii) conducting clinical trials of HHT Products in the
Field anywhere in the world; and
(iii) Bulk HHT for use outside of the Field or for the
manufacture of HHT Products other than Licensed
Products for sale within the Field, anywhere in the
world,
at the prices set out in clause 5.
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(b) Subject to subclauses (c) and (d) below, Stragen will not, and
must ensure that its subcontractors do not, sell HHT Products
to any Person other than ChemGenex or ChemGenex's
Subdistributors or sublicensees.
(c) Stragen will supply to the Joint Venture Entity all of its
requirements for Licensed Products for sale in the Field in
the JV Territory at the following price:
(i) *** per vial of 5mg of the Licensed Products (CIP -
Incoterms 2000).
(d) ChemGenex will purchase from Stragen all of its HHT
requirements for:
(i) the sale of the Licensed Products in the Field within
the Territory by ChemGenex or a ChemGenex
Subdistributor;
(ii) conducting clinical trials of Licensed Products in
the Field anywhere in the world; and
(iii) Bulk HHT required for the manufacture for sale by
ChemGenex or ChemGenex's Subdistributors of:
(A) HHT Products (including for the avoidance of
doubt Licensed Products) outside of the
Field; or
(B) HHT Products other than Licensed Products in
the Field.
4.2 STRAGEN'S SUPPLY RESPONSIBILITIES
(a) Stragen shall use all commercially reasonable endeavours to
manufacture or otherwise supply sufficient quantities of the
HHT Products to ChemGenex to satisfy ChemGenex's purchase
requirements as notified in accordance with clause 5.3, or as
notified by the joint steering committee pursuant to the
Development and Commercialisation Agreement.
(b) Stragen will be solely responsible for all regulatory
compliance required with respect to the manufacture, testing
and supply of HHT Products.
(c) Stragen will at its own cost be responsible for primary
labelling and packaging of all HHT Products supplied under
this Agreement in accordance with all regulatory requirements
for commercial supply.
4.3 PURCHASE REQUIREMENTS
ChemGenex and the Joint Venture Entity (when established) shall during
the term of this Agreement provide regular *** monthly rolling
forecasts in writing of its requirements for HHT Products for the
period of *** months ahead and any revisions to those estimates,
promptly after they are made and for order purposes, no later than ***
days before the beginning of each *** monthly period. Any orders for
HHT Products shall be delivered by ChemGenex and the Joint Venture
Entity to Stragen at least *** days before the required date for
delivery of such Products. Orders can not be less than ***% or more
than ***% of the amount indicated in the previous *** monthly rolling
forecast unless previously agreed with Stragen.
4.4 ORDERS
ChemGenex and the Joint Venture Entity must submit to Stragen a firm
purchase order using the standard form of purchase order attached as
Annexure C. Any purchase orders for HHT Product submitted by ChemGenex
or the Joint Venture Entity must reference this Agreement and will be
governed exclusively by the terms contained herein. Any term or
condition in any purchase order, confirmation, or other document
furnished by ChemGenex, the Joint Venture Entity or Stragen that is in
any way inconsistent with the terms and conditions of this Agreement is
hereby expressly rejected.
4.5 SHIPPING TERMS
(a) Each shipment of Licensed Products and Bulk HHT shall be
delivered to ChemGenex or its Subdistributor or sublicensee or
the Joint Venture Entity CIP (Incoterms 2000) to the
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destination specified by ChemGenex or the Joint Venture Entity
in their purchase order form.
(b) For clinical studies Licensed Products will be delivered CIP
(Incoterms 2000) to the subcontractor of ChemGenex and
ChemGenex will be responsible for the preparation of clinical
kits and dispatching to investigating sites.
4.6 TESTING OF HHT PRODUCTS
Stragen must test or cause to be tested, all HHT Products in accordance
with the Specifications before delivery. Stragen will at its own
expense provide ChemGenex or the Joint Venture Entity with all
necessary manufacturing test data required by either and ChemGenex and
the Joint Venture Entity will be responsible for releasing each lot of
HHT Products for either clinical or commercial use. Each test conducted
by Stragen must set forth the items tested, specifications and test
results in a certificate of analysis, which shall accompany each lot
delivered. ChemGenex and the Joint Venture Entity shall be entitled to
rely on such certificate for all purposes of this Agreement.
4.7 ACCEPTANCE
(a) ChemGenex and the Joint Venture Entity shall, within 30 days
of receipt of each shipment of HHT Products, notify Stragen in
writing of any defect by reason of which ChemGenex or the
Joint Venture Entity alleges that the HHT Products delivered
fails to meet the specifications warranted by Stragen as
provided in clause 8.1 and which should be apparent on
reasonable inspection. If ChemGenex or the Joint Venture
Entity notifies Stragen of any defect in a shipment of HHT
Products, Stragen shall have the right, but not the
obligation, to send one or more quality control
representatives to retest such Products in co-operation with
quality control representatives of ChemGenex or the Joint
Venture Entity. ChemGenex and the Joint Venture Entity shall
store all shipments of the Products in accordance with storage
specifications established by Stragen. In the event of a
disagreement between ChemGenex or the Joint Venture Entity and
Stragen regarding the quality of one or more shipments of HHT
Products, the parties shall submit samples of the shipment in
question to an independent testing laboratory (selected by
mutual agreement of ChemGenex and Stragen) to make a
determination, which shall be binding upon the parties, as to
the compliance or lack of compliance of such shipment with the
specifications warranted by Stragen.
(b) Neither ChemGenex nor the Joint Venture Entity will be obliged
to accept any defective shipments, nor the cost of carriage or
insurance of defective shipments, and may at ChemGenex's or
the Joint Venture Entity's election return the defective
shipment to Stragen at Stragen's cost. Stragen shall promptly
credit ChemGenex or the Joint Venture Entity for all
reasonable costs incurred by ChemGenex or the Joint Venture
Entity in respect of any defective shipments. Title and risk
in any defective shipments notified to Stragen in accordance
with this clause will be with Stragen. ChemGenex and the Joint
Venture Entity will be entitled to offset any payments
required to be made by them to Stragen under this Agreement,
or under the Development and Commercialisation Agreement, with
any amounts payable by Stragen to them pursuant to this
clause.
(c) If ChemGenex or the Joint Venture Entity fail to give such a
notice under this clause then, except in respect of any defect
which is not apparent on reasonable inspection, the HHT
Products shall be presumed to meet the specifications
warranted by Stragen as provided in clause 8.1, and
accordingly ChemGenex or the Joint Venture Entity shall be
deemed to have accepted the delivery of the HHT Products in
question.
4.8 CHEMGENEX ACCESS TO PREMISES
Stragen will provide or use its best endeavours to procure for
ChemGenex the right to access any facilities used for manufacturing or
packaging HHT Products on 3 months notice and during normal business
hours.
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4.9 INTERRUPTION OF SUPPLY
Stragen agrees to keep a minimal stock equivalent to *** months of HHT
Products beyond already accepted firm orders. In case of any
interruption of supply by Stragen, whether as a result of force majeure
events or failure of Stragen for any reason to meet ChemGenex's or the
Joint Venture Entity's supply requirements, the parties will cooperate
to seek to provide ChemGenex or the Joint Venture Entity with an
alternate source of supply (including seeking to validate an
alternative manufacturing source) for the period in which (or for the
amount of Products that) Stragen is unable to supply ChemGenex or the
Joint Venture Entity.
4.10 CONFLICTING TERMS
Subject to the Development and Commercialisation Agreement, this
Agreement sets forth the entire understanding between the parties
relating to the subject matter hereof and shall govern all transactions
between the parties contemplated hereby. Except for terms relating only
to: quantities, ship dates, packaging instructions and delivery
destinations, none of the terms and conditions contained on any
purchase order, invoice or similar document shall have any effect upon
or change the provisions of this Agreement unless signed by both
parties and clearly indicating that the parties intend to vary the
terms hereof.
4.11 THIRD PARTY MANUFACTURE AND SUPPLY
ChemGenex acknowledges that Stragen has appointed or may appoint a
third party agent or sub-contractor as shall be reasonably acceptable
to ChemGenex to manufacture Products on Stragen's behalf. Stragen shall
be liable to ChemGenex and the Joint Venture Entity for all the actions
and omissions of the agent or sub-contractor as if the action or
omission were Stragen's own.
5. PRODUCT PRICING; PAYMENT
5.1 PURCHASE PRICE
ChemGenex (or the Joint Venture Entity, where applicable) shall
purchase the HHT Products from Stragen at the following prices:
(a) For HHT Product intended for use in registration directed
clinical trials, including but not limited to CML tyrosine
kinase inhibitors failure study and CML 315 mutation study:
(i) *** per 5 milligram vial PROVIDED THAT ChemGenex will
within 45 days after receipt of the relevant
Approval, pay Stragen a further *** for each 5
milligram vial purchased from Stragen for use in the
registration directed trials prior to the Approval.
(b) For Licensed Products intended for re-sale by ChemGenex or a
ChemGenex Subdistributor to unaffiliated third parties in the
Field in the Territory, or where ChemGenex enters into
co-promotion agreement with another company for the
commercialisation of Licensed Products in the Field and in the
Territory:
(i) ***% of Net Sales.
(c) For Licensed Products purchased by a sublicensee of
ChemGenex's rights under the Development and Commercialisation
Agreement in the Field, ChemGenex must pay Stragen's
Manufacturing Cost and ChemGenex must pay the royalty payable
to Stragen under clause 3.1(b) or clause 3.1(c) of the
Development and Commercialisation Agreement (if any).
(d) For Licensed Products intended for re-sale by the Joint
Venture Entity in the Field in the JV Territory:
(i) Stragen's Manufacturing Cost.
(e) For HHT Product intended for use in Phase 4 confirmation
studies required by regulatory agencies as a condition to
accelerated approval based on Phase 2 studies:
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(i) Stragen's Manufacturing Cost.
(f) For HHT Product intended for use in Off-Label Studies,
including current and future Phase 2 studies in CML, AML and
MDS, and for pre-clinical and toxicology studies:
(i) No charge.
(g) For Bulk HHT intended for use outside of the Field or for the
manufacture of HHT Products other than Licensed Products in
the Field:
(i) *** per milligram for development quantities and ***
per milligram for commercial quantities.
5.2 WITHHOLDING TAX
Any tax which ChemGenex is required to pay or withhold from payments to
be made to Stragen under this Agreement will be deducted from the
amount otherwise due, provided that, in regard to any such deduction,
ChemGenex must give Stragen such assistance as may be reasonably
necessary to enable or assist Stragen to claim an exemption or a
reduction and will provide Stragen with an official tax certificate as
soon as possible.
5.3 INVOICES FOR PAYMENTS
(a) Stragen shall submit a written invoice addressed to ChemGenex
or the Joint Venture Entity for each shipment to be made to
ChemGenex or its sublicensees or to the Joint Venture Entity
under clauses 5.1(a), 5.1(d), 5.1(e), 5.1(f) or 5.1(g) of this
Agreement. For Licensed Products to which clause 5.1(b)
applies, Stragen will submit an invoice based on an estimated
Net Sales price per vial (as agreed to by ChemGenex from time
to time, acting reasonably). The estimated Net Sales price
will be adjusted quarterly to reflect actual Net Sales. If
there is a difference:
(i) in favour of ChemGenex, ChemGenex will be paid by
Stragen in free Products, or
(ii) in favour of Stragen, Stragen will issue a
supplementary invoice.
Stragen shall submit these written invoices within a
reasonable period following request from ChemGenex or the
Joint Venture Entity.
(b) For Licensed Products to which clause 5.1(c) applies, Stragen
will submit an invoice to ChemGenex after each shipment made
to the sublicensee's specified destination. For the avoidance
of doubt, the parties agree that the cost per vial will be
billed at Stragen's Manufacturing Cost which is defined as ***
per 5 milligram vial.
5.4 PAYMENT
TIMING
(a) Payments required to be made by ChemGenex under this Agreement
must be paid to Stragen within 45 days after receipt of the
Products.
CURRENCY OF PAYMENT
(b) All payments by ChemGenex or the Joint Venture Entity to
Stragen under this Agreement must be made in US Dollars.
5.5 REPORTING
After the first Approval and for the remainder of the term of this
Agreement, ChemGenex must submit quarterly sales reports to Stragen
within 30 days following the end of each calendar quarter. Such reports
must include:
(a) an accounting of Net Sales within the Field and the Territory
during such quarter on a country by country basis;
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(b) an accounting of the sale price of the units of Licensed
Products sold in the Field and in the Territory during such
quarter; and
(c) the calculation of the amounts owing to Stragen pursuant to
this Agreement, including, if applicable, the exchange rates
used in determining the amount of US Dollars.
5.6 NO OTHER ROYALTIES
The payments set out in this clause and clause 5.4 are the only amounts
payable by ChemGenex to Stragen in connection with the exclusive
distributor and purchase arrangements and licences for HHT Products
granted herein.
6. COMPLAINTS/RECALLS
6.1 COMPLAINTS
To the extent that it has knowledge thereof, Stragen must promptly
notify ChemGenex in writing of:
(a) any defect in, or condition of, the HHT Products which may
cause the HHT Products to violate the applicable laws and
regulations of any country in the Territory; and
(b) all data on complaints respecting HHT Products.
6.2 RECALL
(a) In the event that either party has reason to believe that one
or more lots of HHT Products should be recalled or withdrawn
from distribution, that party must immediately notify the
other party in writing.
(b) Unless otherwise required by the relevant health regulatory
authorities, Stragen must be notified before ChemGenex
initiates any recall, but the decision as to whether or not to
initiate a recall of HHT Products in any country in the
Territory will be for ChemGenex alone. ChemGenex must maintain
adequate sales and service records to enable it to carry out
any HHT Product recall and to conduct such recall. If the
recall is required because of a failure of the HHT Products to
conform to the Specifications or its specifications as
provided to the health authorities in any specific country in
connection with the registration of the HHT Products, Stragen
shall reimburse ChemGenex for the costs and expenses of such
recall, and Stragen shall promptly elect to either replace
recalled HHT Products or credit or refund the purchase price
of recalled HHT Products. If the recall is required because of
a negligent act or omission of ChemGenex in handling, storage
or distribution of the HHT Products, then such recall shall be
conducted by ChemGenex, with the cooperation of Stragen, at
ChemGenex's sole cost and expense and ChemGenex shall not be
entitled to any such credits, replacements or refunds from
Stragen. If such recall is required because of a joint act or
omission, ChemGenex, with the cooperation of Stragen, shall
conduct the recall and the parties shall negotiate in good
faith an appropriate allocation of the costs and expense of
such recall.
6.3 REGULATORY RECORDS; ADVERSE REACTIONS
Each party shall be responsible for maintaining such records and making
such reports as may be required in connection with any regulatory
approval held by the party. Each party shall promptly inform the other
of all adverse drug experience reports and other information relating
to the safety or effectiveness of the HHT Products which come to its
attention, in a form and within time periods necessary to permit
compliance with the law and regulations of each of the countries within
the Territory.
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7. EUROPEAN JOINT VENTURE
7.1 ESTABLISHMENT OF JOINT VENTURE
(a) The Development and Commercialisation Agreement provides that
the parties have agreed to create a European Joint Venture for
the promotion, advertisement, , distribution and sale of
Licensed Products in the JV Territory.
(b) Stragen agrees that upon the establishment of the Joint
Venture Entity the covenants it has given in favour of the
Joint Venture Entity under this Agreement will be enforceable
by the Joint Venture Entity upon the Joint Venture Entity
giving notice of acceptance to Stragen, and that Stragen has
received valuable consideration for those covenants. If
requested by the Joint Venture Entity, Stragen will sign a
deed pursuant to which it agreed to be bound by the covenants
given in favour of the Joint Venture Entity under this
Agreement, subject to the Joint Venture Entity agreeing to
observe the obligations purporting to bind the Joint Venture
Entity under this Agreement.
8. WARRANTIES AND INDEMNIFICATION
8.1 MANUFACTURING WARRANTY
Stragen warrants that:
(a) the HHT Products will be produced in accordance with the
Specifications and current good manufacturing practices of
each country within the Territory in which the HHT Products
are then being marketed or sold;
(b) when shipped the HHT Products will not be adulterated or
misbranded; and
(c) the HHT Products will be otherwise manufactured in accordance
with written manufacturing procedures and finished product
specifications (including packaging specifications) which will
meet the requirements set forth in the governmental approvals
of the health regulatory authorities in the Territory.
8.2 CORPORATE AUTHORITY, ETC
Each party warrants and represents to the other:
(a) that it has the full right and authority to enter into this
Agreement;
(b) that all corporate action necessary to authorise the execution
and delivery of this Agreement by such party has been duly and
properly taken;
(c) that this Agreement constitutes a valid obligation of it,
legally binding on it and enforceable in accordance with its
terms, subject to applicable bankruptcy, insolvency,
moratorium, reorganisation or similar laws from time to time
in effect affecting creditor's rights generally;
(d) that it is not under any obligation (contractual or otherwise)
to any third party that conflicts with or is inconsistent with
the provisions of this Agreement or impedes its ability to
carry out its obligations under this Agreement; and
(e) that it is not aware of any other impediment that would
inhibit its ability to perform its obligations under this
Agreement.
8.3 CHEMGENEX INDEMNIFICATION
With respect to HHT Products sold by ChemGenex in the Territory,
ChemGenex will defend Stragen, its agents, directors, officers and
employees at its cost and expense, and will indemnify and hold harmless
Stragen, its agents, directors, officers, and employees from and
against all claims, demands, costs, losses, expenses or liabilities
(collectively `Liabilities') suffered or
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incurred by Stragen directly arising from or in relation to a breach by
ChemGenex of its obligations under this Agreement.
8.4 STRAGEN INDEMNIFICATION
Stragen will defend ChemGenex, its agents, directors, officers and
employees at its cost and expense, and will indemnify and hold harmless
ChemGenex, its agents, directors, officers and employees, from and
against any and all Liabilities arising out of a breach by Stragen of
the warranty set forth in clause 8.1 above, including, but not limited
to, any actual or alleged injury, damage, death or other consequence
occurring to any person as a result, directly or indirectly, of the
possession, use or consumption of any HHT Products, whether claimed by
reason of negligence, product defect or otherwise, and regardless of
the form in which any such claim is made.
8.5 INDEMNIFICATION PROCEDURES
(a) Promptly after the receipt by any party hereto of notice under
clause 8.3 or clause 8.4 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
11
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.
8.6 INSURANCE COVERAGE
(a) As soon as is reasonably practicable after the signing of this
Agreement, each party shall purchase and maintain from
insurance carriers reasonably acceptable to the other
insurance at its own expense to cover liabilities that it may
incur in the testing, manufacture, distribution, sale or use
of the HHT Products. Each party agrees to obtain, at minimum
unless otherwise agreed between the parties, Commercial
General Liability Insurance and Product Liability/Clinical
Studies Liability, covering not less than $1,000,000 per
occurrence.
(b) In the event that any such policies are on a claims made
basis, coverage shall be maintained for a period of at least 7
years after the termination of this Agreement. Each party
shall furnish to the other certificates of insurance,
evidencing such insurance and naming the other party as an
additional insured.
9. TERM AND TERMINATION
9.1 TERM
This Agreement shall commence on the Effective Date and, with respect
to each country, will continue until the later of:
(a) the tenth (10th) anniversary of the first Approval; and
(b) the last to expire Valid Claim of the Stragen Patent Rights
covering Licensed Product in that country (the `Initial
Term').
The term will then be extended for additional successive 2 year
periods, unless either party notifies the other party, in writing, of
its intention to cancel any such extension as at the end of the then
current term. Any non-extension notice must be given not less than 180
days prior to the end of the then current term. (The Initial Term and
all successive periods, if any, will collectively be known as the `term
of this Agreement').
9.2 TERMINATION RIGHTS
Either party shall have the right to terminate this Agreement:
(a) 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
(b) to the extent permitted by law, upon notice to the other in
the event the other party:
(i) becomes insolvent;
(ii) fails generally to pay its debts as they fall due;
(iii) 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;
(iv) makes an assignment for the benefit of creditors; or
(v) applies for or consents to the appointment of a
receiver or trustee of a substantial party of its
property;
(c) upon notice to the other party in the event that the
Development and Commercialisation Agreement expires or is
terminated.
12
9.3 RIGHTS AND OBLIGATIONS UPON TERMINATION
(a) Termination of this Agreement in whole or in part shall not
relieve the parties of any amounts owing between them, nor
shall it relieve the parties of their obligations with respect
to the HHT Products distributed hereunder, or with respect to
limiting disclosure and use of Confidential Information.
(b) Upon termination of this Agreement:
(i) as a result of Stragen's breach, ChemGenex shall have
the right either to sell its then inventory of the
Licensed Products for a period of 12 months following
termination, or to return such inventory to Stragen;
and
(ii) for any reason other than Stragen's breach, at
Stragen's cost, ChemGenex shall have the right to
sell Licensed Products, in the ordinary course of
business, for a period of 3 months following
termination or Stragen may require ChemGenex to
return such inventory to Stragen at Stragen's cost.
9.4 ADDITIONAL RIGHTS UPON TERMINATION BY CHEMGENEX
If ChemGenex terminates this Agreement on the basis of a failure by
Stragen to supply HHT Products in accordance with this Agreement
including the rolling forecasts provided by ChemGenex or the joint
steering committee established under the Development and
Commercialisation Agreement:
(a) ChemGenex may seek and obtain an alternative supply source for
the HHT Products; and
(b) Stragen must provide and licence to ChemGenex, its
Subdistributors, Affiliates or sublicensees all Technology
reasonably necessary to establish an alternative manufacturing
or supply arrangement. In that event, ChemGenex shall pay
Stragen 5% of Net Sales of Licensed Products after recovering
direct and indirect costs associated with the establishment of
an alternative supplier; and
(c) ChemGenex will have a continuing right to use Stragen's
Confidential Information, Stragen Know-How and the Technology
in connection with the promotion, advertising, distribution
and sale of HHT Products.
10. CONFIDENTIALITY
10.1 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 10.1(a) 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.
13
10.2 ADVERTISING AND PUBLICITY
Subject to clause 10.3 and 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 (such as, by way of example but
not limitation, the securities laws of the United States), 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:
(a) this Agreement;
(b) the Development and Commercialisation Agreement;
(c) the terms of this Agreement or the Development and
Commercialisation Agreement;
(d) the supply, development or commercialisation of the HHT
Products; or
(e) the publication or presentation of scientific data,
Stragen will have the right to review public announcement relating to
HHT Products prior to public release by ChemGenex.
10.3 DISCLOSURE REQUIRED BY LAW
In the event that Stragen or ChemGenex 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.
11. MISCELLANEOUS
11.1 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.
11.2 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.
11.3 ACCOUNTING AUDITS
(a) ChemGenex must maintain books of account relating to its Net
Sales in accordance with generally accepted accounting
principals.
(b) Annually, within 90 days after the end of its relevant
financial year, ChemGenex will provide, at its expense, a
worldwide sales report detailed by countries and reconciling
Net
14
Sales, where applicable, and certified by its auditors, being
a firm approved by SEC for public companies.
(c) Stragen will have the right, at its own expense, to have an
independent certified public accountant of its own selection,
reasonably acceptable to ChemGenex, examine at a time
reasonably acceptable to ChemGenex, during normal business
hours but not more than once each calendar year, the relevant
books and records of account of ChemGenex, to determine
whether appropriate accounting has been made.
(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.
11.4 MANUFACTURING AUDITS
ChemGenex shall have, and Stragen must grant or procure for ChemGenex,
the right to conduct an audit of any facility where the HHT Products
are being manufactured at least annually or more frequently if any
questions about the quality of the HHT Products are raised by either
party or by a third party.
11.5 INTEREST DUE ON LATE PAYMENTS
If any amount payable by under this Agreement by one of the parties 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.
11.6 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.
11.7 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.
11.8 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 the
successor or assignee of all or substantially all of a party's business
relating to the
15
HHT Products, or to a party's Affiliate. In the event all or such part
is assigned or transferred, each party shall notify the other prior to
such assignment or transfer.
11.9 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
Xxxxxxx Xxxx
Xxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxx, 0000
Fax x00 0 0000 0000
STRAGEN INVESTMENT B.V.
c/- Stragen Pharma S.A.
0, xxx Xxxx-xx-Xxxxxx
X.X. Xxx 000
XX-0000 Xxxxxx 4
Fax + 00 00 000 00 00
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.
11.10 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 HHT Product, epidemic, destruction of
production facilities, 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 11.10 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, PROVIDED that if the force majeure
event prevents Stragen meeting the manufacturing needs of ChemGenex for
Stragen Product for more than 90 days, ChemGenex may terminate this
Agreement by giving Stragen notice in writing.
11.11 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 and
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.
16
11.12 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.
11.13 COUNTERPARTS; ENGLISH LANGUAGE
(a) 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.
(b) This Agreement is entered into in the English language.
(c) 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.
12. DISPUTES
12.1 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 established under the Development and
Commercialisation Agreement (if it is still constituted):
(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.
17
(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).
12.2 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: 6, 8, 9.4, 10, 11.5, 11.6, 12.
13. 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;
(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 `***' or dollars are to *** unless otherwise
indicated.
18
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
Xxxx Xxxxxxx Xxxxx Xxxxxxxx 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
Xxx Xxxxxxxx Xxxxx Xxxxxxxx
--------------------------------------------------- -------------------------------------------------
/~ Full name of director /~ Full name of director/secretary
19
ANNEXURE A
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
- - not more than 6000
- > 25 im
- - 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)
> 0,15%
- Total - > 0,5%
-
> 0,3%
To be determined > 1,0%
----------------------------------------------------------------------------------------------------------------------
Assay (HPLC) 95,0% - 105,0%
----------------------------------------------------------------------------------------------------------------------
Uniformity of content (USP (905)) Complies Xxx.Xx. and USP requirements
----------------------------------------------------------------------------------------------------------------------
Sterility (USP (717)) Sterile
----------------------------------------------------------------------------------------------------------------------
Bacterial endotoxins (USP (85)) Not more than 38,8 EU/mg
----------------------------------------------------------------------------------------------------------------------
20
ANNEXURE B
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
----------------------------------------------------------------------------------------------------------------------
21
ANNEXURE C
Purchase Order Form
-------------------------------------------------------------------------------------------------------------------
CHEMGENEX PHARMACEUTICALS, LTD.
0000 Xxxxxx Xxx, Xxxxx X
Xxxxx Xxxx, XX 00000 [GRAPHIC OMITTED]
000-000-0000 Fax 000-000-0000
THE FOLLOWING NUMBER MUST APPEAR ON ALL RELATED CORRESPONDENCE, SHIPPING PAPERS,
AND INVOICES:
P.O. NUMBER:
VENDOR NAME/ID:
XXXX TO: SHIP TO:
ChemGenex Pharmaceuticals, Ltd.
0000 Xxxxxx Xxx Xxxxx X
Xxxxx Xxxx, XX 00000
--------------------------------------------------------------------------------------------------------------------
P.O. DATE REQUISITIONER SHIP VIA F.O.B. POINT TERMS
--------------------------------------------------------------------------------------------------------------------
See below
--------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------
QTY UNIT DESCRIPTION UNIT PRICE TOTAL
--------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------
SUBTOTAL
SALES TAX
SHIPPING & HANDLING N/C
OTHER
----------------
TOTAL
----------------
1. Please send one copy of your invoice.
2. Enter this order in accordance with the prices, terms, delivery method, and
specifications listed above.
3. Please notify Xxxx Xx immediately if you are unable to perform the service as
specified.
4. Send invoice to:
Xxxx Xxxxxxx
ChemGenex Pharmaceuticals, Ltd.
0000 Xxxxxx Xxx, Xxxxx X Xxxxx Xxxx, XX 00000
000-000-0000,; Fax 000-000-0000
---------------------------------------------------
Authorized by Date
22
TABLE OF CONTENTS
-------------------------------------------------------------------------
1. DEFINITIONS....................................................1
2. APPOINTMENT AND LICENCE GRANTS.................................4
3. SUBDISTRIBUTORS................................................4
4. SUPPLY.........................................................4
5. PRODUCT PRICING; PAYMENT.......................................7
6. COMPLAINTS/RECALLS.............................................9
7. EUROPEAN JOINT VENTURE........................................10
8. WARRANTIES AND INDEMNIFICATION................................10
9. TERM AND TERMINATION..........................................12
10. CONFIDENTIALITY...............................................13
11. MISCELLANEOUS.................................................14
12. DISPUTES......................................................17
13. INTERPRETATION................................................18
ANNEXURE A.............................................................20
Licensed Product Specifications...............................20
ANNEXURE B.............................................................21
Specifications for Bulk HHT...................................21
ANNEXURE C.............................................................22
Purchase Order Form...........................................22
