EXHIBIT 4.11
[ASHURST ▇▇▇▇▇▇ ▇▇▇▇▇ LOGO]
Supply Agreement
Selborne Biological Services (Australia) Pty Limited
and
Protherics Australasia Pty Limited
21st October 2002
CONTENTS
CLAUSE PAGE
1. DEFINITIONS AND INTERPRETATION...................................................1
2. SUPPLY OF THE SERUM PRODUCTS AND BULK IMMUNOGEN..................................4
3. CONDITIONS OF SALE...............................................................8
4. TECHNICAL AGREEMENT..............................................................8
5. PRODUCTION AND DELIVERY..........................................................9
6. SHEEP TO BE USED IN THE PRODUCTION OF SERUM PRODUCTS............................10
7. PRICE AND PAYMENT...............................................................13
8. DEFECTS.........................................................................17
9. INTELLECTUAL PROPERTY...........................................................17
10. IMPROVEMENTS AND INVENTIONS.....................................................18
11. QUALITY CONTROL AND COMPLIANCE WITH REGULATIONS.................................20
12. WARRANTIES......................................................................21
13. LIMITATION OF LIABILITY.........................................................23
14. FORCE MAJEURE...................................................................23
15. DURATION AND TERMINATION........................................................24
16. CONFIDENTIALITY.................................................................25
17. COSTS...........................................................................27
18. VARIATIONS......................................................................27
19. WAIVER..........................................................................27
20. INVALIDITY......................................................................28
21. NOTICES.........................................................................28
22. NO PARTNERSHIP..................................................................29
23. ASSIGNMENT AND SUB-CONTRACTING..................................................29
24. GOVERNING LAW AND JURISDICTION..................................................30
25. EXCLUSION OF THIRD PARTY RIGHTS.................................................31
26. ENTIRE AGREEMENT................................................................31
SCHEDULE 1...............................................................................32
Serum Products...........................................................................32
SCHEDULE 2...............................................................................33
Technical Agreement......................................................................33
SCHEDULE 3...............................................................................34
Protherics Australasia Pty Limited's standard terms and conditions of purchase...........34
SCHEDULE 4...............................................................................35
Template Certificate of Analysis.........................................................35
THIS AGREEMENT is made on 21st October, 2002
BETWEEN:-
(1) SELBORNE BIOLOGICAL SERVICES (AUSTRALIA) PTY LIMITED (ACN No.
054877975) whose registered office is at ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇
▇▇▇▇, ▇▇▇▇▇▇▇▇▇ (the "SUPPLIER"); and
(2) PROTHERICS AUSTRALASIA PTY LIMITED (No. 062369724) whose registered
office is at ▇/▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇, 91 King ▇▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ (the "CUSTOMER").
RECITALS
(A) The Supplier carries on the business of producing and selling serum
products, such as the Serum Products defined below.
(B) The Customer's Group, as defined below, carries on the business of
selling Finished Products, as that term is also defined below, and the
Customer wishes to purchase Serum Products from the Supplier in
connection with that business.
(C) The Supplier is willing to supply Serum Products to the Customer on the
terms set out in this agreement.
THE PARTIES AGREE AS FOLLOWS:-
1. DEFINITIONS AND INTERPRETATION
1.1 In this agreement the following words and expressions shall have the
following meanings, unless the context otherwise requires:-
"ACT" means A New Tax System (Goods and Services Tax) ▇▇▇ ▇▇▇▇ No. 55
of 1999;
"AFFILIATE" means any company, partnership or other entity which
directly or indirectly controls, is controlled by or is under the
common control of the Customer or the Supplier, as applicable;
"BULK IMMUNOGEN" means the Customer's proprietary antigens prepared
into lyophilised multiple dose format for use by the Supplier in the
production of Serum Products;
"BUSINESS DAY" means any day (excluding Saturdays) on which banks
generally are open in Sydney for the transaction of normal banking
business;
"BUSINESS INFORMATION" means all business, commercial, economic,
financial, operational, technical, administrative, marketing, planning
and staff information relating to a party or its interests;
"C OF A" means Certificate of Analysis in the format set out in
schedule 4 hereto;
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"CHANGE CONTROL" means the Customer's system of evaluating, notifying
and documenting planned changes from previously accepted practice and
the impact thereof on the quality, safety and efficacy of Finished
Products as regards the materials, components (including without
limitation packaging, raw materials such as Serum Products and
labeling), products, processes, computer systems, utilities or testing
procedures used or involved in or relating to the production of
Finished Products, whenever, howsoever and wherever in the course of
such production they are relevant;
"CHANGE CONTROL COMMITTEE" means the committee established and
appointed by the Customer from time to time, which is responsible for
operating Change Control;
"CUSTOMER'S GROUP" means the Customer, its subsidiaries, its holding
company and the other subsidiaries of its holding company;
"CYCLE" means each consecutive period of four weeks during the term of
this agreement, the first such period to commence on the Effective
Date;
"EFFECTIVE DATE" means 8 June 2001;
"FINISHED PRODUCTS" means the Customer's proprietary antibody products;
"GOODS AND SERVICES TAX" has the meaning ascribed to it in Chapter 6,
section 195-1 of the Act;
"HUSBANDRY FEE" means a fee of [*] ;
"IMPROVEMENT" means all improvements, modifications and adaptations to
any part of the process of producing the Serum Products, whether or not
referred to in the Technical Agreement, which might reasonably be of
commercial interest to either party in the design, manufacture or
supply of the Serum Products and/or to the Customer in the design,
manufacture or supply of the Finished Products and which may be made
during the term of this agreement;
"IMMUNISATION" means the procedure, conducted in accordance with this
agreement, of inoculating with Immunogen Emulsion the sheep maintained
by the Supplier pursuant to this agreement and used in the production
of Serum Products, and "Immunise" shall be interpreted accordingly;
"IMMUNISATION FEE" means a fee of [*] conducted in accordance with this
agreement;
"IMMUNOGEN EMULSION" means Bulk Immunogen solution for use in the
Immunisation of sheep, prepared in accordance with the provisions of
the Technical Agreement;
"INTELLECTUAL PROPERTY RIGHTS" means any and all trade marks, rights in
designs, get-up, trade, business or domain names, copyrights, future
copyrights, patents, rights in databases (whether registered or not and
any applications to register or rights to apply for registration
* Material has been omitted pursuant to a request for confidential treatment
and has been filed separately with the Commission.
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of any of the foregoing), rights in inventions, know how, trade secrets
and other confidential information and all other intellectual property
rights of a similar or corresponding nature which may now or in the
future subsist in any part of the world;
"PRIMING PERIOD" means the period of ten (10) Cycles following the
Effective Date;
"PRODUCT INFORMATION" means all technical information and data relating
to the Serum Products or their manufacture or to the Technical
Agreement, including without limitation to and of the Customer's system
for recording and tracing all procedures conducted in respect of sheep
used in the production of Serum Products, known as "Tabpacs";
"REGULATORY INSPECTION" means an inspection of the Supplier's premises,
processes and/or equipment used in the production, storage or packaging
of the Serum Products or in keeping or otherwise using or in relation
to keeping or otherwise using such sheep as are used therein, by any
appropriate regulatory authority including, but not limited to, the
United States Food and Drug Administration ("FDA") or by any officer in
the performance of their duties pursuant to any legislation to which
the Supplier is required to comply, in whole or in part, hereby,
including without limitation, the Prevention of Cruelty to Animals ▇▇▇
▇▇▇▇ (South Australia) and the Animal Welfare Act 1993 (Tasmania);
"REVIEW DATE" means the anniversary date of this agreement and each
subsequent anniversary;
"SERUM PRODUCTS" means the products set out in schedule 1;
"STANDARD OPERATING PROCEDURES" OR "SOPS" means the Supplier's
directions, as amended from time to time, for performing operations and
procedures within the process of manufacturing Serum Products,
including without limitation, those relating to cleaning, the use of
protective clothing, environmental control and processing and sampling
equipment operation;
"TAXABLE SUPPLY" has the same meaning as in the Act;
"TECHNICAL AGREEMENT" means the specification for the Serum Products
and their manufacture by the Supplier, agreed between the parties on
the same date as the date hereof, a copy of which is appended to this
agreement as schedule 2;
"TEST BLEED" means the test bleeding of sheep to be used in the
production of Serum Products prior to the commencement thereof but
otherwise in the same way as such bleeding would be conducted in the
course of such production;
"TEST BLEED FEE" means a fee of [*] conducted in accordance with this
agreement;
"VALUE ADDED TAX" means Value Added Tax or any other tax of a similar
nature that may be substituted for or levied in addition to it, in each
case at the rate current from time to time; and
* Material has been omitted pursuant to a request for confidential treatment
and has been filed separately with the Commission.
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"YEAR" means a period of twelve (12) months from the date of this
agreement and each consecutive period of twelve (12) months thereafter
during the term of this agreement.
1.2 In this agreement unless otherwise specified, reference to:-
(a) a "SUBSIDIARY" or "HOLDING COMPANY" is to be construed in
accordance with section 9 of the Corporations ▇▇▇ ▇▇▇▇;
(b) a party means a party to this agreement and includes its
permitted assignees and/or the respective successors in title
to substantially the whole of its undertaking;
(c) a person includes any person, individual, company, firm,
corporation, government, state or agency of a state or any
undertaking (whether or not having separate legal personality
and irrespective of the jurisdiction in or under the law of
which it was incorporated or exists);
(d) a statute or statutory instrument or any of their provisions
is to be construed as a reference to that statute or statutory
instrument or such provision as the same may have been or may
from time to time hereafter be amended or re-enacted;
(e) words denoting the singular shall include the plural and vice
versa and words denoting any gender shall include all genders;
(f) recitals, clauses, paragraphs or schedules are to recitals,
clauses, and paragraphs of and schedules to this agreement.
The schedules form part of the operative provisions of this
agreement and references to this agreement shall, unless the
context otherwise requires, include references to the recitals
and the schedules;
(g) "CONTROL" is to be construed in accordance with section 50AA
of the Corporations ▇▇▇ ▇▇▇▇ and "CONTROLLING" and
"CONTROLLED" shall be construed accordingly.
1.3 The index to and headings in this agreement are for information only
and are to be ignored in construing the same.
2. SUPPLY OF THE SERUM PRODUCTS AND BULK IMMUNOGEN
2.1 (a) Subject to clause 2.1(b) below and provided that the Customer
complies with its obligations pursuant to clause 2.10(a)
below, the Supplier shall supply and the Customer shall
purchase such quantities of the Serum Products as the Customer
may order from the Supplier from time to time in accordance
with this agreement.
(b) The Supplier shall not be required to involve, at any given
time, more than five thousand (5000) sheep in the production
of Serum Products and shall not be required to supply the
Customer with greater quantities of Serum Products than can be
derived from such number of sheep, unless and until these
limitations are amended pursuant to clause 2.l (c) below.
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(c) The Supplier shall, as and when requested by the Customer,
enter into good faith negotiations with the Customer to amend
this clause 2.1 to:
(i) provide for an increase in the maximum number of
sheep that the Supplier may be required to involve,
at any given time, in the production of Serum
Products; and
(ii) raise the limit imposed by clause 2.1(b) above on the
maximum quantities of Serum Products which the
Supplier may be required to provide to the Customer
in accordance with this agreement.
2.2 The Customer shall notify the Supplier in writing of:-
(a) its estimated forecast for the Serum Products the Customer
will require during the following twenty six (26) Cycles, on a
rolling basis at the beginning of every fourth Cycle, the
first such notification to be made by the Customer to the
Supplier within ten (10) Business Days following the date of
this agreement; and
(b) any revisions to those estimated forecast requirements as soon
as reasonably practicable after such revisions are made.
2.3 (a) The Customer shall, on each occasion that it gives the
Supplier notice of its estimated forecast requirements for
Serum Products pursuant to clause 2.2(a) above, give the
Supplier its order for those Serum Products with which it will
require the Supplier to supply it during the subsequent
thirteen (13) Cycles, the first such order to be made within
ten (10) Business Days following the date of this agreement,
provided that where any such order relates to any Cycle(s) in
respect of which the Customer has already given its order to
the Supplier, such order shall, to that extent, restate the
order previously placed.
(b) Each such order shall specify:
(i) the exact type and quantity of the Serum Products
required by the Customer; and
(ii) the date(s) on which, during the relevant period of
thirteen (13) Cycles, such Serum Products shall be
delivered to the Customer in accordance with this
agreement.
(c) No order made pursuant to this clause 2.3 shall be for a
larger quantity of Serum Products than the Customer's
estimated forecast requirements in respect of the period to
which such order relates.
2.4 Orders for the Serum Products shall be given by the Customer to the
Supplier in writing or, if not, shall be confirmed in writing within
ten (10) Business Days.
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2.5 The Supplier shall be responsible for manufacturing adequate supplies
of the Serum Products in accordance with this agreement to meet the
Customer's estimated forecast requirements.
2.6 Notwithstanding the above, the Supplier shall be under no obligation to
provide Serum Products to the Customer during the Priming Period.
2.7 The Supplier will notify the Customer in a timely manner of any
material changes in the health status of the sheep flocks used to
produce the Serum Products, or of any regulatory or legal changes
affecting the management of such sheep flocks, or of any other aspect
of the manufacturing process of the Serum Products that could have a
material impact on the future supplies of or the quality of the raw
materials required for manufacturing the Serum Products or, in each
case, of the Serum Products themselves.
2.8 (a) The Supplier shall permit and provide all reasonable
assistance to further the objectives of any Regulatory
Inspections which any appropriate regulatory authority desires
to undertake, including without limitation by answering all
inquiries made in the course thereof and providing the
relevant regulatory authority with access to relevant records.
(b) The Supplier shall notify the Customer of any pending
Regulatory Inspection at the earliest opportunity and the
Customer shall be granted the option of sending, at its own
cost, a representative to be present at such Regulatory
Inspection and shall receive copies of all reports produced
therefrom, provided that the Customer shall ensure that such
representative shall at all times comply with the Supplier's
regulations and instructions relating to the safety and
conduct of persons on its premises.
2.9 (a) If it becomes apparent that the Supplier will not be able to
meet any order from the Customer for Serum Products, whether
on the date(s) specified in that order or at all, the Supplier
shall, as soon as practicable, notify the Customer and the
Customer shall, without liability to the Supplier, be entitled
to obtain Serum Products from any other person, in order that
it acquires the quantities of Serum Products ordered from the
Supplier. For the avoidance of doubt, if the Customer rejects
any Serum Products pursuant to clause 8.1 below and the
Supplier does not replace the same in accordance with clause
8.3, the Supplier shall, for the purposes of this clause, be
deemed not to have met the order for Serum Products to which
the same relates.
(b) If the Supplier subsequently notifies the Customer that it is
able and willing to resume the supply of Serum Products in
accordance with the Customer's orders, the Customer shall,
without liability to the Supplier, remain entitled to fulfill
its then existing contractual commitments to obtain Serum
Products from any other supplier(s), prior to recommencing its
orders for or acceptance of deliveries of Serum Products from
the Supplier.
2.10 (a) The Customer shall supply, at no cost, the Supplier with such
Bulk Immunogen as is sufficient, in the Customer's reasonable
opinion, to enable the Supplier to produce, in accordance with
this agreement, the Serum Products ordered by the Customer
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pursuant hereto. The Customer shall ensure that during
transport to the Supplier, such Bulk Immunogen is kept at
temperatures between two (2) and eight (8) degrees Celsius and
that each batch of Bulk Immunogen is accompanied by a
completed C of A.
(b) The Customer shall supply Bulk Immunogen in accordance with
this clause 2.10 on such dates as are notified to it in
writing by the Supplier, provided that, in each case, the
Supplier gives the Customer at least two (2) Cycles' notice of
such dates, failing which, the Customer will satisfy such
requests as soon as it is reasonably able.
(c) Supplies of Bulk Immunogen pursuant to this clause 2.10 shall
be made at the Customer's expense, provided that if the
Supplier requires the Customer to supply additional Bulk
Immunogen, the Supplier shall pay for such additional
supplies, payment to be made at the end of the month in which
the Supplier receives the Customer's invoice therefor. For the
avoidance of doubt, the Supplier shall pay for any Bulk
Immunogen provided by the Customer additional to that which,
in the Customer's reasonable opinion the Supplier would need
to produce, in accordance with this agreement, the Serum
Products ordered by the Customer, where Bulk Immunogen has
been lost or otherwise cannot be used in the production of
Serum Products through the Supplier's breach of this agreement
or other default.
(d) The Supplier shall be responsible for obtaining any relevant
Australian Quarantine and Inspection Service permits necessary
to import Bulk Immunogen into Australia from the United
Kingdom or elsewhere.
2.11 (a) The Supplier shall obtain and maintain throughout the term of
this agreement all relevant or necessary licences under the
Animal Welfare Act 1993 (Tasmania) to ensure its compliance
therewith and shall otherwise comply in all respect with such
legislation. The Supplier shall provide the Customer with
copies of all such licences promptly upon obtaining the same.
(b) Throughout the term of this agreement, the Supplier shall, in
the performance of its obligations hereunder, comply in all
respects with the provisions of the:
(i) Animal Welfare ▇▇▇ ▇▇▇▇ (Tasmania);
(ii) Animal Health ▇▇▇ ▇▇▇▇ (Tasmania);
(iii) Animal Farming (Registration) ▇▇▇ ▇▇▇▇ (Tasmania) and
all Regulations issued thereunder;
(iv) Environmental Management and Pollution Control Act
1994 (Tasmania), including without limitation in
respect of its waste disposal and management
procedures;
(v) Workplace Health and Safety ▇▇▇ ▇▇▇▇ (Tasmania); and
(vi) Export Control Act 1982 (Commonwealth).
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(c) The Supplier shall obtain and maintain throughout the term of
this agreement all applicable permits under the Environmental
Management and Pollution Control Act 1994 (Tasmania) and shall
provide the Customer with copies thereof upon obtaining the
same.
3. CONDITIONS OF SALE
All sales of the Serum Products pursuant to this agreement shall, to
the extent that they are applicable, be made on the Customer's standard
terms and conditions of purchase which the Customer may issue from time
to time and which are annexed to this agreement as schedule 3, save to
the extent that:
(a) any provision of such terms and conditions is inconsistent
with any provision of this agreement, in which case the latter
shall prevail; or
(b) the Supplier and the Customer agree in writing to vary those
terms and conditions of purchase.
4. TECHNICAL AGREEMENT
4.1 The Serum Products and their manufacture, storage and transport, and
the manufacture, storage and transport of the materials from and with
which they are produced, shall comply with the Technical Agreement in
all respects and the Customer shall be entitled, in accordance with
clause 8.1 below, to reject any Serum Products which do not so conform
and to return such defective Serum Products to the Supplier or, at the
Supplier's option, otherwise dispose of such defective Serum Products
as the Supplier may direct and at the Supplier's expense.
4.2 The Customer shall provide such technical support and information to
the Supplier as is reasonably requested to assist the Supplier to
manufacture Serum Products in accordance with this agreement and shall
be entitled to invoice the Supplier therefor in the event that the
provision of such support or information causes the Customer expense in
excess of [*] .
4.3 The parties shall meet from time to time to discuss possible amendments
to the Technical Agreement.
4.4 Either party may propose an amendment to the Technical Agreement to
take account of changes in relevant technology or any enactment or
other change in relevant legislation or regulations and, where such
amendment is proposed for such reason, the consent of the other party
thereto shall not be unreasonably withheld or delayed.
4.5 All proposed amendments to the Technical Agreement made by the Supplier
concerning the manufacturing of Serum Products or the testing thereof
must be presented by the Supplier to the Customer in such a manner and
format as to enable the Change Control Committee properly and fully to
implement Change Control or in any other appropriate way to assess the
impact, if any, of each such proposal on the quality, safety, efficacy
and composition of
* Material has been omitted pursuant to a request for confidential treatment
and has been filed separately with the Commission.
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the Serum Products and Finished Products and no such proposed amendment
shall be implemented until the Change Control Committee has, acting
reasonably, so properly and fully implemented Change Control or
otherwise assessed the impact of such proposed amendment, as is
appropriate in the Customer's opinion.
4.6 Whilst the terms of the Technical Agreement are incorporated into this
agreement, in the event of any conflict between the terms of the
Technical Agreement and of this agreement, the terms of the Technical
Agreement shall prevail.
5. PRODUCTION AND DELIVERY
5.1 The Supplier shall produce and maintain, in accordance with the
Technical Agreement, sufficient stocks of Serum Products to meet the
Customer's orders.
5.2 The Supplier shall use no antigens in the production of Serum Products
other than Bulk Immunogen supplied by the Customer.
5.3 (a) Subject as provided in clause 5.4 below, the Supplier shall
deliver the Serum Products ordered by the Customer either to
an address within Australia or to an international airport in
England or Wales, in each case on the date(s) specified in the
relevant order(s) therefor, and shall notify the Customer at
least two (2) Business Days in advance of each delivery and,
where such delivery is to an airport in England and Wales,
shall inform the Customer at the same time of the name of that
airport and of the number of the flight on which the delivery
will be made.
(b) Time for delivery shall be of the essence but the Supplier
shall not be deemed to be in breach of this agreement for any
failure to deliver on the specified date for such delivery,
unless and until the Customer has given the Supplier ten (10)
Business Days written notice requiring delivery, such notice
not to be given until delivery is overdue.
5.4 (a) Until the Customer has been granted a licence by the FDA to
manufacture Finished Products from Serum Products produced by
the Supplier and to sell the same for human therapeutic use,
the Customer shall store all Serum Products manufactured
pursuant to this agreement at its facility and, for the
avoidance of doubt, at temperatures between - 10 (negative
ten) and - 26 (negative twenty six) degrees Celsius.
(b) Notwithstanding clause 5.4(a) above, the Supplier shall
deliver to the Customer such quantities of Serum Products as
are stored by the Supplier pursuant to clause 5.4(a) upon
demand and in accordance with the provisions of this agreement
relevant to the delivery of Serum Products, including without
limitation those of clause 5.3.
(c) Upon receiving the licence referred to in clause 5.4(a) above,
the Customer shall notify the Supplier that it has received
the same, whereupon the parties shall agree a timetable for
the delivery to the Customer of all Serum Products stored by
the Supplier pursuant to clause 5.4(a), such deliveries in any
event to be made in
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accordance with the provisions of this agreement relevant to
the delivery of Serum Products, including without limitation
those of clause 5.3.
5.5 (a) The Supplier shall ensure that all Serum Products delivered
to the Customer are packaged and handled in a manner
appropriate to maintaining their condition and preventing its
deterioration during transport, such measures to include, but
not be limited to, the maintenance of temperature control and
security of packaging.
(b) To the extent that it is applicable, the Supplier shall comply
in all respects with the provisions of the Environment and
Pollution Control ▇▇▇ ▇▇▇▇ (Tasmania) in delivering Serum
Products to the Customer.
5.6 The Supplier shall procure from a reputable insurer comprehensive
insurance against all risks in respect of each and every lot of Serum
Products to be delivered to the Customer, including but not limited to
goods in transit insurance and insurance of the Serum Products against
fire and other risks while at the Supplier's premises. The Supplier
shall not be required by this clause 5.6 to obtain insurance cover for
each lot of Serum Products above the invoice value thereof.
5.7 The Supplier shall ensure that each lot of Serum Products to be
delivered to the Customer is accompanied by documentation appropriate
to comply with the formalities of any applicable regulatory authorities
including, but not limited to, in the case of deliveries to the United
Kingdom, the UK Ministry of Health and HM Customs & Excise and any
shipping regulations, including commercial invoices, and with
health/veterinary certificates and the applicable, completed C of A.
Furthermore, the Supplier shall be responsible for obtaining any
applicable licences or other consents for its export of Serum Products
out of Australia when delivering the same to the United Kingdom.
5.8 Delivery of the Serum Products shall take place when they are received
by the Customer or its agent at the address or airport to which they
are delivered pursuant to clause 5.3 above.
6. SHEEP TO BE USED IN THE PRODUCTION OF SERUM PRODUCTS
6.1 The Supplier hereby acknowledges that the 1093 live sheep transferred
by the Customer to the Supplier's facility at ▇▇▇▇▇▇▇▇▇, Longford,
Tasmania, on 8 June 2001 (the "ORIGINAL SHEEP"), are and shall remain
the sole property of the Customer.
6.2 The Supplier shall acquire no sheep for use in the production of Serum
Products additional to the Original Sheep ("ADDITIONAL SHEEP"), without
the prior, written approval of the Customer.
6.3 (a) Subject to clause 6.2 above, the Supplier shall be responsible
for determining whether, at any time, it will require any
Additional Sheep in order to manufacture Serum Products
ordered by the Customer and if so, how many Additional Sheep
it will so require.
(b) The Supplier shall promptly notify the Customer upon
determining that it will require any Additional Sheep in order
to manufacture Serum Products ordered by the
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Customer and, at the same time, shall inform the Customer of
the number of Additional Sheep it considers that it will so
require and by when it will require them.
(c) The Supplier shall promptly provide the Customer with such
evidence as the Customer may request to verify any assessment
by the Supplier that it will require Additional Sheep and of
the number the Supplier considers it will so require.
6.4 In the event that the Customer notifies the Supplier in writing that
it approves the acquisition of Additional Sheep by the Supplier, the
Supplier shall purchase the same from sources and at prices approved
in writing by the Customer, for and on behalf of the Customer and at
the Customer's expense, and such Additional Sheep shall be and shall
remain the sole property of the Customer. The Supplier shall arrange
for the cost of all Additional Sheep acquired pursuant to this clause
6.4 to be invoiced directly to the Customer by the vendors thereof.
6.5 Notwithstanding that the same shall at all times be the Customer's
property, the Supplier shall be responsible for the Original Sheep and
any Additional Sheep, shall keep the same at its facility separately
from any other livestock thereat and shall be responsible for the
proper upkeep thereof in an appropriate manner and to appropriate
standards prescribed by legislation for the use of the same in the
production of Serum Products, (including, without limitation, by
providing veterinary services therefor). For the purposes of this
clause 6.5, applicable legislation with which the Supplier must comply
includes but is not limited to those pieces of legislation referred to
in clause 2.11.
6.6 (a) During the Priming Period, the Supplier shall charge the
Customer, per Original Sheep:
(i) the Husbandry Fee;
(ii) the Immunisation Fee; and
(iii) the Test Bleed Fee;
such fees to be invoiced by the Supplier to the Customer at
the end of the Cycle during which the same are incurred and
to be payable in accordance with the terms of clause 7.
(c) In the event that any Additional Sheep are acquired on
behalf of the Customer pursuant to clause 6.4 above, the
Supplier shall charge the Customer, per Additional Sheep,
during and in respect of the ten (10) Cycles following its
acquisition:
(i) the Husbandry Fee;
(ii) the Immunisation Fee; and
(iii) the Test Bleed Fee;
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such fees to be invoiced by the Supplier to the Customer at
the end of the Cycle in which the same are incurred and to
be payable in accordance with the terms of clause 7.
6.7 The Customer shall procure from a reputable insurance company insurance
against the loss of the Original Sheep and any Additional Sheep used or
to be used in the production of Serum Products and against the loss of
their use in the production of Serum Products resulting therefrom or
from their incapacity or unsuitability for use in the production of
Serum Products for any other reason, and the Supplier shall provide the
Customer with all information and other assistance as the Customer may
reasonably require to assist it in procuring and maintaining such
insurance.
6.8 (a) In the event that the Supplier, acting reasonably and on the
basis of orders and forecasts for Serum Products received from
the Customer pursuant to clauses 2.2 and 2.3 above, believes
that it has more sheep available to use in the production of
Serum Products than it requires to fulfill orders made
pursuant to clause 2.3 above, the Supplier shall forthwith
give notice to the Customer of the number of sheep it so
considers to be surplus to its requirements and the date from
when such sheep shall so become surplus to its requirements.
(b) On receipt of such notice, the Customer shall, in its
discretion, be entitled to require the Supplier to, in which
event the Supplier shall:
(i) maintain and Immunise all or some of such surplus
sheep as the Customer specifies, without using the
same in the manufacture of Serum Products but
otherwise to the same standard as if they were so
used, in respect of which the Customer shall pay the
Husbandry Fee and the Immunisation Fee per sheep so
maintained and Immunised without being used in the
manufacture of Serum Products, until such time as it
is again so used in such manufacture; or
(ii) maintain without Immunising all or some of such
surplus sheep as the Customer specifies, without
using the same in the manufacture of Serum Products
but otherwise to the same standard as if they were so
used, in respect of which the Customer shall pay the
Husbandry Fee per sheep so maintained without being
used in the manufacture of Serum Products, until such
time as it is again so used in such manufacture;
provided that in neither case shall such sheep be used in the
production of Serum Products until the Customer notifies the
Supplier otherwise in writing.
(c) The Customer shall be entitled, at will, to require the
Supplier to maintain and Immunise sheep in accordance clause
6.8(b)(i) above which were previously simply maintained in
accordance with clause 6.8(b)(ii), and vice versa, provided
that the sums payable by the Customer in respect of such
sheep, as specified in such clauses, shall be substituted
accordingly.
(d) In the event that and notwithstanding that the Customer does
not, following receipt of a notice under clause 6.8(a) above,
require the Supplier to maintain any or all such
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surplus sheep or otherwise decides that the same should not be
maintained, the Supplier may only destroy or otherwise dispose
of the number of sheep stated in such notice or any of them
after receiving prior written notice from the Customer
authorising it to do as much. The Customer shall be
responsible for all reasonable expenses related to such
destruction or disposal.
(e) In the event that, within fifteen (15) Business Days of the
Customer's receipt of a notice under clause 6.8(a) above, the
Customer does not require the Supplier to maintain and/or
Immunise such surplus sheep, or all of them, in accordance
with clause 6.8(b) above, the Supplier shall maintain those
sheep for which the Customer does not specify any such
requirement in a good and proper manner but shall be under no
obligation necessarily to maintain them as if the same were to
be used in the production of Serum Products.
6.9 The Supplier shall be entitled to use the Original Sheep and any
Additional Sheep in the production of Serum Products for the Customer
in accordance with this agreement but for no other purpose without the
express written consent of the Customer, which may be withheld for any
reason.
7. PRICE AND PAYMENT
7.1 (a) Subject to clause 7.1(b) below, the Supplier shall at the time
of each delivery of Serum Products issue a tax invoice in
Australian Dollars to the Customer in respect of that
delivery.
(b) Until the Customer has been granted a licence by the FDA to
manufacture Finished Products from Serum Products produced by
the Supplier and to sell the same for human therapeutic use,
the Supplier shall, in respect of all Serum products stored by
the Supplier pursuant to clause 5.4(a) and upon completion of
their manufacture, invoice the Customer in Australian Dollars
eighty (80%) percent of the price otherwise payable therefor.
The Supplier shall invoice the remainder of the price payable
for such Serum Products at the time of each delivery thereof
to the Customer.
7.2 The price payable by the Customer for the Serum Products shall be as
set out in schedule 1, and such price, the Husbandry Fee, the
Immunisation Fee and the Test Bleed Fee shall remain fixed unless
varied in accordance with this agreement, with no such variation,
subject to clause 7.7 below, to be made other than on a Review Date.
7.3 (a) The parties shall meet either in person or by telephone at
least fifty (50) Business Days in advance of each Review Date
and shall negotiate in good faith to agree the percentage
change, if any, over the preceding thirteen (13) Cycles in the
cost to the Supplier of manufacturing and delivering the Serum
Products in accordance with this agreement and in the event
that they agree on that percentage, the price payable by the
Customer for the Serum Products during the thirteen (13)
Cycles following the next Review Date shall be increased or
decreased, as applicable, by the same percentage. At the same
time, the parties shall negotiate in good faith to agree the
percentage changes, if any, over the preceding thirteen (13)
Cycles in each of the
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cost to the Supplier of maintaining sheep as if used in the
production of Serum Products where the same are not so used,
of Immunising sheep and of conducting Test Bleeds, and in the
event that they agree on those percentages, the Husbandry Fee,
the Immunisation Fee and the Test Bleed Fee during the
thirteen (13) Cycles following the next Review Date shall
respectively be increased or decreased, as applicable, by the
same percentages.
(b) In the event that thirty (30) Business Days before such Review
Date, the parties have not reached agreement in accordance
with clause 7.3(a) above, they shall refer the matter for
determination in accordance with clause 7.8, whereupon the
price payable by the Customer for the Serum Products, the
Husbandry Fee, the Immunisation Fee and the Test Bleed Fee
during the thirteen (13) Cycles following the next Review Date
shall respectively be increased or decreased, as applicable,
by the same percentages as the percentage changes, if any, in
the cost to the Supplier over the preceding thirteen (13)
Cycles of manufacturing and delivering the Serum Products in
accordance with this agreement, of maintaining sheep as if
used in the production of Serum Products where the same are
not so used, of Immunising sheep and of conducting Test
Bleeds, each as determined pursuant to clause 7.8.
(c) Notwithstanding the above, if neither party requests a meeting
pursuant to clause 7.3(a) within fifty (50) Business Days
before the relevant Review Date, the price payable by the
Customer for the Serum Products and the Husbandry Fee, the
Immunisation Fee and the Test Bleed Fee during the thirteen
(13) Cycles following such Review Date shall be the same as
during the thirteen (13) Cycles preceding it, subject to any
change to the price payable by the Customer for the Serum
Products made pursuant to clause 7.7 below.
7.4 (a) Unless clearly indicated to the contrary, the prices set out
in schedule 1, as amended, and all other amounts and
consideration to be provided under or in connection with this
agreement ("Agreed Prices") are exclusive of any Goods and
Services Tax and Of any Value Added Tax or other United
Kingdom taxes which is/are or may become payable as a
consequence of importing Serum Products into the United
Kingdom, but otherwise reflect the total prices payable by the
Customer's Group for the Serum Products.
(b) Where an Agreed Price is exclusive of Goods and Services Tax,
the Customer will pay to the Supplier such Agreed Price plus
the amount of any Goods and Services Tax for which the
Supplier becomes liable in respect of any Taxable Supply made
by the Supplier in consideration for that Agreed Price.
(c) A member of the Customer's Group shall pay any Value Added Tax
due at the point of import into the United Kingdom of Serum
Products exported thereto by the Supplier.
7.5 The price of the Serum Products shall include all costs of packaging,
carriage and insurance therefor.
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7.6 The Customer shall pay the Supplier the amount stated on each invoice
for Serum Products issued pursuant to clause 7.1 at the end of the
month following the date on which such invoice or the relevant Serum
Products themselves are received by the Customer, whichever is the
later.
7.7 If at any time during the term of this agreement the Customer requests
material changes to be made to the Technical Agreement which concern
the manufacturing procedures used to manufacture Serum Products and
which the Supplier can prove will increase the costs to the Supplier to
manufacture Serum Products or which the Customer can prove will
decrease such costs, the parties will negotiate in good faith to agree
revised prices for the Serum Products to reflect such increased or
decreased costs, such revised prices to take effect when the parties
agree, provided that if the parties have not reached such agreement
within a reasonable time, they shall refer the matter for determination
in accordance with clause 7.8, whereupon any increase or decrease in
such costs will be as determined pursuant to clause 7.8.
7.8 (a) In the event that clause 7.3(b) applies, or in the event that
the Customer and the Supplier are unable to agree a change in
the price for the Serum Products pursuant to clause 7.7, the
parties shall refer the matter to a partner for the time being
of any of the "big five" accountancy firms acceptable to both
the Customer and the Supplier or failing him to such other
person as the Customer and the Supplier may agree or in the
absence of agreement such person as shall be appointed by the
President for the time being of the Institute of Chartered
Accounts in Australia upon the application of either party
(the "EXPERT").
(b) The Expert shall act as an expert and not as an arbitrator,
his decision shall (in the absence of manifest error) be final
and binding on the parties and he shall use all reasonable
endeavours to determine, within twenty (20) Business Days:
(i) in the case of a referral under clause 7.3(b), the
percentage change, if any, over the preceding
thirteen (13) Cycles in the cost to the Supplier of
manufacturing and delivering Serum Products in
accordance with this agreement, of maintaining sheep
as if used in the production of Serum Products where
the same are not so used, of Immunising sheep or of
conducting Test Bleeds, as applicable; or
(ii) in the case of a referral under clause 7.7, a revised
price for the Serum Products which reflects the
change in the cost to the Supplier of manufacturing
the same as a result of material changes to the
Technical Agreement made at the Customer's request.
In making a determination pursuant to clause 7.8(b)(i) above,
the Expert shall reduce his calculation of any percentage
change over the preceding thirteen (13) Cycles in the cost to
the Supplier of manufacturing and delivering Serum Products in
accordance with this agreement, of maintaining sheep as if
used in the production of Serum Products where the same are
not so used, of Immunising sheep or of conducting Test Bleeds,
as applicable, to discount any increases in the foregoing
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which have already been reflected by increases, pursuant to
clauses 7.7 or 7.8(b)(ii), in the price payable by the
Customer for Serum Products.
(c) Each party shall co-operate fully with the Expert and shall
bear the entire cost to it arising out of the discharge of its
obligations pursuant to this clause and the expenses of all
counsel and other advisers, witnesses and employees retained
by it for the purposes of the determination, save that the
costs and expenses of the Expert shall be borne by the parties
in such proportions as he may direct or, in the absence of
direction, equally.
(d) Subject to any rule of law or of any regulatory body or to any
provision of any contract entered into prior to the date of
this agreement to the contrary and to appropriate obligations
of confidentiality, the Customer and the Supplier shall each
give to the other and to the Expert such access to premises,
papers, books, accounts, records, returns and other documents
in their respective possession or control as may be required
by the Expert to make his determination.
7.9 (a) Notwithstanding the contrary provisions of clauses 7.3 and
7.8, in the event that in respect of any period of thirteen
(13) Cycles following a Review Date (the "FOLLOWING YEAR"),
the quantities of Serum Products ordered by the Customer
pursuant to clause 2.3(a) are at least fifteen (15) per cent.
higher than those ordered in respect of the thirteen (13)
Cycles preceding such Review Date (the "PREVIOUS YEAR"), the
price payable by the Customer for the Serum Products during
the Following Year shall not be increased or decreased, as
applicable, by a percentage equal to the percentage change, if
any, in the cost to the Supplier of manufacturing and
delivering the Serum Products in accordance with this
agreement during the Previous Year, whether determined by
agreement of the parties pursuant to clause 7.3 or by the
Expert pursuant to clause 7.8(b), but shall be increased or
decreased, as applicable, by a percentage equal to the
projected percentage change, if any, in the cost to the
Supplier of manufacturing and delivering the Serum Products in
accordance with this agreement during the Following Year.
(b) In the event that clause 7.9(a) applies, the parties shall
endeavour to agree the projected percentage change, if any, in
the cost to the Supplier of manufacturing and delivering the
Serum Products in accordance with this agreement during the
Following Year at their meetings held pursuant to clause
7.3(a) and, in the event that they agree such percentage
within thirty (30) Business Days before the relevant Review
Date, the price payable by the Customer for the Serum Products
shall be increased or decreased, as applicable, by the same
percentage. In the event that the parties do not so agree such
percentage within thirty (30) Business Days before the
relevant Review Date, the matter shall be referred to the
Expert who shall determine such percentage in accordance with
clause 7.8.
8. DEFECTS
8.1 The Customer shall, within fifty (50) Business Days of the delivery of
any shipment of Serum Products, notify the Supplier of any defect
therein by reason of which the Customer alleges that such Serum
Products do not comply with, or that their manufacture, storage or
transport, or the manufacture, storage or transport of the materials
from which they were
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produced, has not complied with the requirements of this agreement, in
which case the Customer shall be deemed to have rejected such shipment
of Serum Products.
8.2 If the Customer fails to give such notice then, except in respect of
any defect which is not apparent on reasonable inspection, the Customer
shall be deemed to have accepted delivery of the Serum Products in such
shipment, and the Supplier shall have no liability to the Customer in
respect of late or missed delivery.
8.3 In the event that the Customer rejects any Serum Products pursuant to
clause 8.1 above, the Supplier shall, within twenty (20) Business Days
of being requested to do so, supply replacement Serum Products which
accord with and whose manufacture, storage and transport, and the
manufacture, storage and transport of the materials from which they
were made accord with the requirements of this agreement, at no extra
cost to the Customer.
9. INTELLECTUAL PROPERTY
9.1 All Intellectual Property Rights in the Serum Products and the Finished
Product and in the process of producing Finished Products from Serum
Products or otherwise, and in all Product Information furnished by or
on behalf of the Customer to the Supplier and in any other subject
matter supplied to the Supplier in relation to the production of the
Serum Products shall belong to and be and remain vested exclusively in
the Customer, and the Supplier shall, without charge, assign and
transfer to the Customer, with full title guarantee, all Intellectual
Property Rights in the foregoing and each part of each and every one of
them, for the remainder of the term during which the said rights and
any renewals or extensions thereof shall subsist, including the rights
to ▇▇▇ for the past infringements of such Intellectual Property Rights
and to retain any damages obtained as a result of such action.
9.2 The Supplier shall execute and do all such documents, deeds, matters,
acts and things as the Customer may at any time require properly to
vest the Intellectual Property Rights in the Serum Products and the
Finished Products or any part of or any one or more of them in the
Customer or, at the Customer's direction, any other member company of
the Customer's Group, or otherwise to perfect the Customer's or such
other member company of the Customer's Group's title thereto or to
assist the Customer in enforcing its entitlement hereunder to ▇▇▇ for
any past infringement thereof. The Customer shall pay the Supplier's
reasonable expenses in performing its obligations under this clause 9.2
but, for the avoidance of doubt, the Customer shall make no additional
charge for performing such obligations.
9.3 All the Intellectual Property Rights in the process of producing the
Serum Products shall, from the outset, and as between the parties, be
vested exclusively in the Supplier, save to the extent that they or the
materials, technologies or techniques in which they subsist have been
provided to the Supplier by or on behalf of the Customer or any other
member company of the Customer's Group, in which case and to which
extent they shall belong exclusively to the Customer or such other
company, as applicable,
9.4 (a) The Customer shall provide and license the Supplier, for the
term of this agreement, use of such Intellectual Property
Rights in the Product Information owned by the Customer as
shall be necessary for the Supplier to produce Serum Products
in accordance with this agreement but for no other purpose and
the Supplier shall keep
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the same in the strictest confidence in accordance with the
provisions of clause 16 hereto.
(b) Upon the termination of this agreement, the Supplier shall
promptly return all materials provided by the Customer
pursuant to this clause 9.4, along with all copies and notes
thereof, whether of the whole of such materials or part only,
in whatever form the same exist.
(c) Other than as expressly provided by this clause 9.4 or
otherwise in writing, the Supplier has no entitlement to and
shall make no use of any Intellectual Property Rights owned by
or licensed to the Customer.
9.5 In performing its obligations pursuant to this agreement, the Supplier
shall not knowingly infringe the Intellectual Property Rights of any
third party and shall use its reasonable endeavours not to infringe any
such Intellectual Property Rights.
10. IMPROVEMENTS AND INVENTIONS
10.1 If the Supplier makes or acquires an Improvement, it shall promptly and
fully disclose and explain the same in confidence to the Customer to
the extent that it is not prohibited by law, by any undertaking given
to others or by considerations relating to the securing of a patent or
other Intellectual Property Right protection.
10.2 The Supplier shall, at the Customer's request, grant a world-wide,
non-exclusive, royalty free, irrevocable licence (including the right
to grant sub-licences thereunder) to the Customer in respect of any
Improvement it makes and discloses to the Customer under clause 10.1
above. The provisions of this clause 10.2 shall survive the termination
of this agreement for whatever reason.
10.3 If any patent is obtained by the Supplier in respect of any
Improvement, the Supplier shall, at the Customer's request, grant a
non-exclusive, royalty free, irrevocable licence (including the right
to grant sub-licences thereunder) to the Customer in all the countries
in which patent protection is obtained, for the full term of such
patent. The provisions of this clause 10.3 shall survive the
termination of this agreement for whatever reason.
10.4 Any Improvement arising from work carried out jointly shall belong to
the parties equally unless they shall otherwise agree. Each party:-
(a) shall have the irrevocable right to use such joint Improvement
independently of the other;
(b) shall have, to the extent necessary for such use, a licence in
respect of all jointly held Intellectual Property Rights
relating thereto including the right to grant sub-licences
thereunder; and
(c) hereby undertakes that, on request, it will confirm to any
prospective licensee of the other the right of that other
pursuant to this clause to grant such a licence.
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10.5 (a) Where the Supplier has developed an Improvement it shall not
publish the same or do anything that might prejudice the
validity of any patent that might subsequently be granted on
such Improvement until the Customer has had at least fifteen
(15) Business Days from disclosure to it in writing of all
information relating to such Improvement to consider whether
patent or other protection should be applied for in respect
thereof.
(b) The Supplier will, on request, notify the Customer whether it
intends to seek any patent protection in respect of such
Improvement and if it does not, it shall, on request, assign
to the Customer or such other member company of the Customer's
Group as the Customer may direct all rights therein and the
obligation on the Supplier in clause 10.5(a) above shall
continue for such time as may be reasonably required in order
for the Customer or such other company, as applicable, to
prepare and file an application for such patent protection.
10.6 The Supplier may, at any time in respect of an Improvement, elect not
to pursue further an application for patent protection either jointly
or on its own behalf or to maintain any such patent protection as it
may have obtained but shall notify the Customer of any such election
and shall offer the rights in such Improvement or patent to the
Customer and shall, if so requested by the Customer, assign all rights
it may have therein to the Customer, or such other member company of
the Customer's Group as the Customer may direct, provided that the
Supplier shall be entitled to a full, irrevocable, world-wide,
perpetual, royalty free, non exclusive licence under all relevant
rights with the right to sub-license and assign the same.
10.7 Each party shall bare its own costs in respect of any patent
applications it makes but the parties shall share equally the costs of
filing and prosecuting, to the fullest extent possible, any future
joint patent applications and of maintaining in all countries every
patent granted pursuant to such applications.
10.8 (a) Each party shall inform the other of any infringement of any
patent obtained in respect of any Improvement (for the
purposes of this clause, a "PATENT") forthwith upon such
infringement coming to its notice.
(b) In the event of such infringement and in the event that the
party which owns a Patent chooses to pursue the infringer, the
other party shall, at the first party's expense, provide all
reasonable assistance to the first party, (including without
limitation the use of its name in or being joined as a party
to proceedings) in connection therewith.
(c) In the event of such infringement and in the event that the
party which owns the relevant Patent chooses not to pursue the
infringer, the other party may take all legitimate steps to
halt the infringement and the first party shall, at the other
party's expense, provide all reasonable assistance to the
other party, (including without limitation the use of its name
in or being joined as a party to proceedings) in connection
with such steps.
(d) Except as expressly provided above, each party shall bear the
costs of any proceedings taken in respect of such
infringement.
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11. QUALITY CONTROL AND COMPLIANCE WITH REGULATIONS
11.1 The Supplier shall at all times maintain, in a clean, safe and hygienic
condition and in accordance with all appropriate statutes and
regulations:-
(a) the premises at which it produces Serum Products;
(b) the equipment located in such premises which is used in
connection with the production and packaging of Serum
Products; and
(c) all packaging to be used in connection with Serum Products.
11.2 (a) In addition to the rights granted to the Customer by the
Supplier by clause 2.8 above, the Supplier shall, on
reasonable notice, permit the Customer's authorised
representatives from time to time and during normal working
hours to enter, assess and inspect the premises at which the
Supplier produces Serum Products and its personnel involved in
such production, in order to observe the Supplier's operations
and methods, provided that the Customer shall ensure that such
representatives shall at all times comply with the Supplier's
regulations and instructions relating to the safety and
conduct of persons on its premises.
(b) The Supplier shall provide all reasonable assistance to the
Customer and its authorised representatives in conducting any
assessment or inspection pursuant to this clause 11.2,
including without limitation by answering all inquiries made
in the course thereof and by providing access to relevant
records.
11.3 The Supplier shall, on the fifteenth (15th) day of each month, provide
the Customer with a written report providing any information which
might reasonably be of interest to the Customer relating to the
following matters, such report to relate to the calendar month prior to
that in which it is provided;
(a) the health status of the sheep involved in the production of
Serum Products;
(b) the process of immunising and bleeding such sheep in the
course of producing Serum Products;
(c) the yields of Serum Products obtained from such sheep; and
(d) any issues relating to quality control, non-compliance with
Standard Operating Procedures, regulatory requirements,
excursions or incidents involving such sheep or any aspect of
the production of Serum Products.
11.4 The obligations of clause 11.3 above shall not apply insofar as the
Supplier gives the Customer information which it would otherwise be
required to do thereunder pursuant to other provisions of this
agreement, including, for the avoidance of doubt, the Technical
Agreement.
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11.5 The Supplier shall dispose of any unused Bulk Immunogen and of any and
all unneeded, unused or unusable Serum Products or the production
stages thereof, of which it disposes for whatever reason, whether
pursuant to this agreement or otherwise, at its own cost,
appropriately, promptly and safely, in compliance with all applicable
environmental and health and safety laws, regulations and legislation.
11.6 Without prejudice to the foregoing, the Supplier shall comply in all
respects, including without limitation, in respect of workplace safety
and the condition of the premises at which it produces the Serum
Products, with the provisions of the Workplace Health and Safety ▇▇▇
▇▇▇▇ (Tasmania).
11.7 The Customer shall have no liability to the Supplier for any claims
brought by the Supplier's employees or agents pursuant to the Workers
Rehabilitation and Compensation ▇▇▇ ▇▇▇▇ (Tasmania) or for breaches of
the Workplace Health and Safety ▇▇▇ ▇▇▇▇ (Tasmania) in respect of the
premises on which such employees or agents work.
11.8 The Customer shall have no liability to the Supplier for any payments
to the Supplier's employees or agents, whether by remuneration, long
service leave, or any other entitlements, or for any claims brought by
the Supplier's employees or agents, whether pursuant to common law or
any legislation.
12. WARRANTIES
12.1 The Supplier warrants to the Customer that it shall produce, handle,
store and transport Serum Products and all materials and components
used in their production with skill, competence, care and attention and
in accordance with all appropriate legislation, regulations and other
requirements of any appropriate regulatory authority which apply from
time to time.
12.2 The Supplier warrants to the Customer that the Serum Products shall be
of satisfactory quality and shall conform with the Technical Agreement
and that the Supplier shall comply with the Technical Agreement and the
requirements of all SOPs referred to therein in all respects.
12.3 The Supplier warrants to the Customer that the Serum Products are and
shall continue to be, until title to them is transferred to the
Customer (which shall occur when the Serum Products are delivered to
the Customer or its agent pursuant to clause 5.8 above), its absolute
property, free from any mortgage, charge, pledge, lien or third party
right or interest of any kind, but for the avoidance of doubt, this
clause 12.3 shall not operate to restrict the Supplier from offering
its assets, other than Serum Products and the production stages
thereof, as security for indebtedness which it incurs in the normal
course of its business.
12.4 The Supplier warrants to the Customer that it shall keep all sheep used
or to be used in the production of Serum Products at its facility
separately from any other livestock thereat in an appropriate manner
and to appropriate standards prescribed by legislation for the use of
the same in such production including, without limitation, by providing
veterinary services therefor.
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12.5 The Supplier warrants to the Customer that it shall comply with all
legislative or regulatory requirements imposed upon it by virtue of the
performance of its obligations or the exercise of its rights pursuant
to this agreement, including but not limited to the:
(i) Animal Welfare ▇▇▇ ▇▇▇▇ (Tasmania);
(ii) Animal Health ▇▇▇ ▇▇▇▇ (Tasmania);
(iii) Environmental Management and Pollution Control ▇▇▇
▇▇▇▇ (Tasmania);
(iv) Environment Protection ▇▇▇ ▇▇▇▇ (Tasmania);
(v) Export Control ▇▇▇ ▇▇▇▇ (Commonwealth);
(vi) Workplace Health and Safety ▇▇▇ ▇▇▇▇ (Tasmania); and
(vii) Workers Rehabilitation and Compensation ▇▇▇ ▇▇▇▇
(Tasmania);
and, to the extent applicable, that it has given due
consideration thereto and to any other appropriate legislation
in preparing the SOPs, such that the SOPs, and the manufacture
of Serum Products and the upkeep of the sheep used therein in
accordance with such SOPs, comply and shall comply with such
requirements.
12.6 The Supplier warrants that it shall comply with the Trade Practices ▇▇▇
▇▇▇▇ (Commonwealth) in the provision of services to the Customer
pursuant to this agreement.
12.7 Each party warrants to the other that it has obtained all corporate
authorisations and all other applicable governmental, statutory,
regulatory or other consents, licences, waivers or exemptions required
to empower it to enter into and to perform its obligations under this
agreement.
12.8 Each party warrants to the other that its entering into this agreement
will not be a breach of any other agreement to which it is a party.
13. LIMITATION OF LIABILITY
13.1 The Supplier's liability to the Customer for:-
(a) death or injury resulting from its own negligence, or that of
its employees, agents or subcontractors; and
(b) all loss or damage suffered by the Customer as a result of
breach by the Supplier of statutorily implied terms in respect
of the Serum Products relating to title, quiet possession and
freedom from encumbrances;
shall not be limited.
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13.2 Subject to clause 13.1 above, the Supplier's liability for any single
breach of this agreement shall be limited to [*] .
13.3 The Customer shall not be responsible in any way for ensuring or
assisting the Supplier's compliance with such legislation as the
Supplier is required to comply with hereby or otherwise, and shall have
no liability to the Supplier for and in the event of the Supplier's
failure so to comply with such legislation or any part thereof.
14. FORCE MAJEURE
14.1 "EVENT OF FORCE MAJEURE" means, in relation to either party, an event
or circumstance beyond the reasonable control of that party (the
"CLAIMING PARTY") including, without limitation, strikes, lock-outs and
other industrial disputes (in each case, whether or not relating to the
Claiming Party's workforce).
14.2 The Claiming Party shall not be deemed to be in breach of this
agreement or otherwise liable to the other party (the "NON-CLAIMING
PARTY") for any delay in performance or any non-performance of any
obligations under this agreement (and the time for performance shall be
extended accordingly) to the extent that the delay or non-performance
is due to an Event of Force Majeure, provided that:-
(a) the Claiming Party could not have avoided the effect of the
Event of Force Majeure by taking precautions which, having
regard to all matters known to it before the occurrence of the
Event of Force Majeure and all relevant factors, it ought
reasonably to have taken but did not take; and
(b) the Claiming Party has used reasonable endeavours to mitigate
the effect of the Event of Force Majeure and to carry out its
obligations under this agreement in any other way that is
reasonably practicable.
14.3 The Claiming Party shall promptly notify the Non-Claiming Party of the
nature and extent of the circumstances giving rise to the Event of
Force Majeure.
14.4 If the Event of Force Majeure in question prevails for a continuous
period in excess of three (3) months after the date on which it began,
the Non-Claiming Party may give notice to the Claiming Party
terminating this agreement. The notice to terminate must specify the
termination date, which must not be less than thirty (30) clear days
after the date on which the notice to terminate is given. Once the
notice to terminate has been validly given, this agreement will
terminate on the termination date set out in the notice. Neither party
shall have any liability to the other in respect of termination of this
agreement due to an Event of Force Majeure, but rights and liabilities
which have accrued prior to termination shall subsist, including
without limitation those under clause 16.
15. DURATION AND TERMINATION
15.1 (a) This agreement shall come into effect on the Effective Date
and shall continue in force for a period of [*] (the "INITIAL
TERM"), unless terminated earlier pursuant to this clause 15.
* Material has been omitted pursuant to a request for confidential treatment
and has been filed separately with the Commission.
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(b) Following the expiry of the Initial Term, and provided that
neither party has given the other notice of termination, such
notice to be given at least eighteen (18) months prior to the
end of the Initial Term, this agreement shall remain in force
until terminated by either party giving to the other party not
less than eighteen (18) months' written notice.
15.2 A party (the "INITIATING PARTY") may terminate this agreement with
immediate effect by written notice to the other party (the "BREACHING
PARTY") on or at any time after the occurrence of any of the following
events:
(a) the Breaching Party being in continuing or material breach of
an obligation under this agreement and, if the breach is
capable of remedy, failing to remedy the breach within thirty
(30) Business Days starting on the day after receipt of
written notice from the Initiating Party giving full details
of the breach and requiring the Breaching Party to remedy the
breach;
(b) the Breaching Party passing a resolution for its winding-up or
a court of competent jurisdiction making an order for the
Breaching Party's winding-up or dissolution;
(c) the making of an administration order in relation to the
Breaching Party or the appointment of a receiver over, or an
encumbrancer taking possession of or selling an asset of the
Breaching Party; and
(d) the Breaching Party making an arrangement or composition with
its creditors generally or making an application to a court of
competent jurisdiction for protection from its creditors
generally.
15.3 For the purpose of clause 15.2(a):
(a) a breach will be considered capable of remedy if time is not
of the essence in performance of the obligation in question
and if the Breaching Party can comply with the obligation
within the thirty (30) Business Day period referred to in such
clause; and
(b) without limitation, a breach by either party of any
legislative or regulatory requirement with which it is
required to comply hereunder shall constitute a material
breach of an obligation under this agreement.
15.4 Notwithstanding the above, the Customer may terminate this agreement
forthwith and without liability to the Supplier in the event that:
(a) the Customer receives notification that the FDA will not grant
its approval to sale of Finished Products for human therapy if
manufactured from Serum Products produced for the Customer by
the Supplier;
(b) the Customer does not receive such approval within a
reasonable time following the Effective Date;
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(c) such approval, if granted, is withdrawn; or
(d) the Customer determines in its reasonable discretion not to
request such approval on the basis that it does not reasonably
consider that the FDA will grant the same.
15.5 Following the termination of this agreement for whatever reason, the
parties shall negotiate in good faith the removal of the Original Sheep
and any Additional Sheep from the Supplier's premises but until the
same are so removed, the Supplier shall maintain them at the Customer's
expense in such manner as immediately prior to such termination or as
the Customer otherwise directs.
15.6 Upon the termination of this agreement, for whatever reason, the
Supplier shall promptly execute all such documents, deeds, matters,
acts and things as the Customer may require properly to vest in the
Customer or, at the Customer's direction, any other member of the
Customer's Group, such Intellectual Property Rights to which the
Customer is entitled pursuant to this agreement and which have not,
prior to such termination, been so executed. The Customer shall pay the
Supplier's reasonable expenses in performing its obligations under this
clause 15.6 but, for the avoidance of doubt, the Customer shall make no
charge for performing such obligations.
16. CONFIDENTIALITY
16.1 Each party shall, during the full term of this agreement and
thereafter, keep secret and confidential the contents of this
agreement, the Technical Agreement and all Business Information and
Product Information disclosed to it by or on behalf of the other party
or otherwise belonging to the other party (and shall procure that its
agents and/or employees are similarly bound) and shall not disclose the
same to any person, save to the extent necessary to perform its
obligations under this agreement in accordance with its terms and save
as expressly authorised in writing to be disclosed by the other party.
16.2 The obligation of confidentiality contained in clause 16.1 shall not
apply or (as the case may be) shall cease to apply to Business
Information or Product Information which:-
(a) at the time of its disclosure by the disclosing party is
already in the public domain or which subsequently enters the
public domain other than by breach of the terms of this
agreement by the receiving party;
(b) is already known to the receiving party (as evidenced by
written records) at the time of its disclosure by the
disclosing party and was not otherwise acquired by the
receiving party from the disclosing party under any
obligations of confidence;
(c) is at any time after the date of this agreement acquired by
the receiving party from a third party having the right to
disclose the same to the receiving party without breach of
obligation owed by that third party to the disclosing party;
or
(d) is required to be disclosed by applicable law or order of a
court of competent jurisdiction or government department or
agency or by the rules and standards of the
-▇▇-
▇▇▇▇▇▇ ▇▇▇▇▇ Exchange plc or the Listing Rules of the UK
Listing Authority or the rules and requirements of any other
regulatory body, including without limitation, the Australian
Securities and Investments Commission, provided that prior to
such disclosure the receiving party shall advise the
disclosing party of the proposed form of the disclosure.
16.3 Notwithstanding the foregoing provisions of this clause 16, the
Customer and any of its sub-licensees pursuant to this agreement shall
be entitled to disclose Business Information or Product Information of
the Supplier to:
(i) actual or potential customers for Finished Products,
insofar as such disclosure is reasonably necessary to
promote the sale or use of Finished Products; and
(ii) any other member company of the Customer's Group.
16.4 Each party shall procure that all its employees, contractors,
consultants, advisers and sub-licensees pursuant to this agreement (if
any) who have access to any information of the other to which the
obligations of clause 16.1 apply shall be made aware of and subject to
these obligations and shall further procure that so far as is
reasonably practicable, all such employees, contractors and
sub-licensees shall enter into written undertakings in favour of the
other party to this end.
16.5 Any disclosures made by a party under this agreement to the other party
which are specific or a combination of features shall not be deemed to
fall within the above exceptions merely because any specific disclosure
is covered by a general disclosure or because individual features are
within or subsequently enter the public domain or the other party's
possession and the above exceptions shall only apply in the case of
disclosure of a combination of features if the combination and its
principle of operation is within or subsequently enters the public
domain or the other party's possession following acquisition by that
other party from a third party entitled to make such disclosure without
breach of any obligation of confidence.
17. COSTS
Save as expressly otherwise provided in this agreement each of the
parties shall bear its own legal, accountancy and other costs, charges
and expenses connected with the negotiation, preparation and
implementation of this agreement and any other agreement incidental to
or referred to in this agreement.
18. VARIATIONS
18.1 This agreement may be varied only by a document signed by each of the
Supplier and the Customer, except that:
(a) the Customer may amend at will its standard terms and
conditions of purchase annexed hereto as schedule 3; and
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(b) in the event that the Customer reasonably requests amendments
to be made to the Technical Agreement, such amendments shall
take effect upon the Customer giving notice thereof to the
Supplier.
18.2 In the event that the Customer amends its standard terms and conditions
of purchase annexed hereto as schedule 3, it shall promptly notify the
Supplier of such amendments.
19. WAIVER
19.1 A waiver of any term, provision or condition of, or consent granted
under this agreement shall be effective only if given in writing and
signed by the waiving or consenting party and then only in the instance
and for the purpose for which it is given.
19.2 No failure or delay on the part of any party in exercising any right,
power or privilege under this agreement shall operate as a waiver
thereof, nor shall any single or partial exercise of any such right,
power or privilege preclude any other or further exercise thereof or
the exercise of any other right, power or privilege.
19.3 No breach of any provision of this agreement shall be waived or
discharged except with the express written consent of the parties.
19.4 The rights and remedies herein provided are cumulative with and not
exclusive of any rights or remedies provided by law.
20. INVALIDITY
If any provision of this agreement is or becomes (whether or not
pursuant to any judgment or otherwise) invalid, illegal or
unenforceable in any respect under the law of any jurisdiction:-
(a) the validity, legality and enforceability under the law of
that jurisdiction of any other provision; and
(b) the validity, legality and enforceability under the law of any
other jurisdiction of that or any other provision, shall not
be affected or impaired in any way thereby.
21. NOTICES
21.1 Any notice, demand or other communication given or made under or in
connection with the matters contemplated by this agreement shall be in
writing and shall be delivered by hand or sent by prepaid post (airmail
if sent abroad) or sent by facsimile transmission and immediately
confirmed by hand delivery or registered post:-
In the case of the Supplier to:
Address: ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇
Fax: ▇▇▇ (▇)▇ ▇▇▇▇ ▇▇▇▇
Attention: The General Manager
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In the case of the Customer to:
Address: Protherics Australasia Pty Ltd, RSD ▇▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇,
▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇
Fax: ▇▇▇ (▇)▇ ▇▇▇▇ ▇▇▇▇
Attention: Operations Director
and a notice given in accordance with this clause shall be deemed
received:-
(a) if delivered by hand, upon the date of delivery;
(b) if sent by pre-paid post, seven (7) Business Days after the
date of posting;
(c) if sent by fax, on the day the transmission is sent (but only
if the sender has a confirmation report specifying a facsimile
number of the recipient, the number of pages and date of
transmission),
provided that if, in accordance with the above provision, any such
notice, demand or other communication would otherwise be deemed to be
given or made after 5.00 p.m., such notice, demand or other
communication shall be deemed to be given or made at 9.00 a.m. on the
next Business Day.
21.2 A party may notify the other party to this agreement of a change to its
name, relevant addressee, address or fax number for the purposes of
clause 21.1 provided that such notification shall only be effective
on:-
(a) the date specified in the notification as the date on which
the change is to take place; or
(b) if no date is specified or the date specified is less than
five (5) Business Days after the date on which notice is
given, the date falling five (5) Business Days after notice of
any such change has been given.
22. NO PARTNERSHIP
22.1 Nothing in this agreement and no action taken by the parties pursuant
to this agreement shall constitute, or be deemed to constitute, the
parties a partnership, association, joint venture or other co-operative
entity.
22.2 At no time shall either of the parties have the authority to hold
itself out as the agent of the other or as being empowered to bind the
other in any way whether contractually or otherwise.
23. ASSIGNMENT AND SUB-CONTRACTING
23.1 Subject to clause 23.2, this agreement is personal to the parties to it
and accordingly, neither party may, without the prior written consent
of the other, assign the benefit of all or any its obligations under
this agreement, nor any benefit arising under or out of this agreement.
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23.2 The Customer shall be entitled without the prior written consent of the
Supplier to assign, transfer or in any manner make over the benefit
and/or burden of this agreement to an Affiliate or member company of
the Customer's Group or to any joint venture company where it is the
beneficial owner of at least fifty (50) per cent. of the issued share
capital thereof or to any company with which it may merge or to any
company to which it may transfer its assets and undertaking provided
that such Affiliate or other company undertakes and agrees in writing
to assume, observe and perform the rights and powers and/or duties and
obligations of the Customer under this agreement.
23.3 This agreement shall be binding upon the successors and assignees of
the parties hereto and the name of a party appearing herein shall be
deemed to include the name of its successors and assignees, provided
always that nothing shall permit any assignment by either party except
as expressly provided herein.
23.4 The Supplier may sub-contract any of its obligations under this
agreement, provided that:
(a) it has used all due diligence in selecting the third party to
which it sub-contracts such obligations, by evaluating the
competency of such third party to undertake the same;
(b) it advises the Customer in advance of its intention to
sub-contract such obligations to a third party and at such
time identifies such third party to the Customer and informs
the Customer of the terms of such proposed sub-contracting
arrangement; and
(c) the Customer consents in writing to such sub-contracting to
such party on such terms, which consent may be withheld for
any reason.
23.5 Notwithstanding any sub-contracting of its obligations to a third
party, the Supplier shall remain fully responsible for the performance
of its obligations under and fully liable for any breach of this
agreement.
23.6 In the event that the Supplier sub-contracts any of its obligations
under this agreement to a third party, the Supplier shall conduct
audits of such third party's performance on at least an annual basis
and promptly report the results of such audits to the Customer.
24. GOVERNING LAW AND JURISDICTION
24.1 This agreement (and any dispute, controversy, proceedings or claims of
whatever nature arising out of or in any way relating to this agreement
or its formation) shall be governed by and construed in accordance with
the laws of South Australia.
24.2 Each of the parties to this agreement irrevocably agrees that the
courts of South Australia shall have non-exclusive jurisdiction to hear
and decide any suit, action or proceedings, and/or to settle any
disputes, which may arise out of or in connection with this agreement
and, for these purposes, each party irrevocably submits to the
non-exclusive jurisdiction of the courts of South Australia.
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24.3 Neither party not commence any court or arbitration proceedings in
relation to any dispute arising out of the subject matter of this
agreement unless (except where such party seeks urgent interlocutory
relief) it:
(a) gives written notice to the other party specifying the nature
of the dispute; and
(b) then endeavours to resolve the dispute with the other party
expeditiously using formal dispute resolution techniques such
as mediation, expert evaluation or determination or similar
techniques agreed by them,
24.4 If the parties do not agree within seven (7) days of service of the
notice referred to in clause 24.3(a) (or such further period as they
may agree in writing) as to:
(a) the dispute resolution techniques and procedures to be
adopted;
(b) the timetable for all steps in those procedures; and
(c) the selection and compensation of the independent person
required for such technique;
the parties shall mediate the dispute in accordance with
Practice Direction ▇▇. ▇▇ ▇▇ ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇ (Guidelines for Conduct of Mediation) and execute an
agreement to mediate in a form approved by the Law Society of
South Australia. The President of the Law Society of South
Australia or the President's nominee will select the mediator
and determine the mediator's remuneration.
25. EXCLUSION OF THIRD PARTY RIGHTS
This agreement is not for the benefit of any person who is not a party
signatory hereto or specifically named as a beneficiary herein.
26. ENTIRE AGREEMENT
Other than in the case of any claim or proceeding based upon fraud
(including without limitation fraudulent concealment), this agreement,
incorporating the Technical Agreement, constitutes the entire and only
agreement and understanding of the parties and supersedes all prior
oral or written agreements, undertakings, representations or
arrangements between them relating to the subject matter of this
agreement. Neither party shall be entitled to rely on any agreement,
understanding, representation or arrangement which is not expressly
contained in this agreement.
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IN WITNESS whereof this agreement has been executed on the date first above
written.
Signed by
for and on behalf of SELBORNE BIOLOGICAL SERVICES (AUSTRALIA) PTY LIMITED
/s/ ▇. ▇. ▇▇▇▇ (Signature)
------------------------------
Signed by
for and on behalf of PROTHERICS AUSTRALASIA PTY LIMITED
/s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ (Signature)
------------------------------
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