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Exhibit 10.25
29 DECEMBER 2000
AMERSHAM PHARMACIA BIOTECH UK LIMITED
NYCOMED AMERSHAM PLC
_________________________________
CONTRACT RESEARCH AND
DEVELOPMENT AGREEMENT
_________________________________
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THIS AGREEMENT is made on 29 December 2000
BETWEEN:
1. AMERSHAM PHARMACIA BIOTECH UK LIMITED whose registered
office is at Xxxxxxxx Xxxxx, Xxxxxx Xxxxxxxx, Xxxxxxxxxxxxxxx XX0 0XX
(APBIOTECH); and
2. NYCOMED AMERSHAM PLC whose registered office is at Xxxxxxxx Xxxxx,
Xxxxxx Xxxxxxxx, Xxxxxxxxxxxxxxx XX0 0XX (NYCOMED AMERSHAM).
WHEREAS:
APBiotech has been conducting and will continue to conduct research on behalf of
Nycomed Amersham plc into the metabolic applications of Carbon 13 via the DMP
method on the terms and conditions set out below.
NOW IT IS AGREED as follows:
INTERPRETATION
1.1 In this agreement, unless the context otherwise requires:
APBIOTECH YEAR END is, in any one year, 31 December (or such other date as
APBiotech may select from time to time);
BUSINESS DAY means any day other than Saturday or Sunday or a Bank or Public
Holiday;
BUSINESS HOURS means the hours of 3:30 a.m. to 5:30 p.m.;
DEVELOPMENTS means any development, enhancement or derivative of any Product, or
its design or manufacturing process or services which arise out of the Research
and Development;
FORCE MAJEURE means in relation to either party, any circumstances beyond the
reasonable control of that party (including, without limitation, any strike,
lockout or similar form of industrial action);
INTELLECTUAL PROPERTY RIGHTS means patents, trade marks, service marks, trade
names, design rights, copyright (including rights in computer software), rights
in know-how and other intellectual property rights, in each case whether
registered or unregistered and including applications for the grant of any such
rights and all rights or forms of protection having equivalent or similar
effect anywhere in the world;
LIBOR means the arithmetic mean (rounded upward to five decimal places) of the
rates quoted by the principal office in London of Lloyds Bank plc and National
Westminster Bank plc to leading banks in the London Interbank market at or
about 11:00 a.m. on the relevant date for the offering of deposits in sterling
for a one-month period;
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NII means the United Kingdom Nuclear Installations Inspectorate;
Products means any product for use in metabolic toxicology studies in drug
development processes;
Research and development means the research into and the development of the
Products carried on at the Site by APBiotech under the terms of this Agreement
as described in Schedule 2;
Site means Cardiff Laboratories;
Subsidiary means a subsidiary company as defined in the UK Companies Xxx 0000
(as amended).
1.2 References to statutory provisions shall, except where the context requires
otherwise, be construed as references to those provisions as respectively
amended or re-enacted or as their application is modified by other
statutory provisions (whether before or after the date hereof) from time to
time.
1.3 Headings are inserted for convenience only and shall not affect the
construction of this Agreement or the Schedules hereto.
SUPPLY OF RESEARCH AND DEVELOPMENT SERVICES
2.1 Following the exception of this Agreement, both parties shall nominate
suitably qualified employees acceptable to each other to liaise on a
continuing basis on matters concerning Research and Development and
APBiotech shall, as a result of such meetings, undertake such Research and
Development for Nycomed Amersham as Nycomed Amersham may (through such
nominee) reasonably request. APBiotech shall be obliged to employ such
additional manpower as Nycomed Amersham may request in order to carry out
the Research and Development.
2.2 APBiotech shall use all reasonable endeavours to ensure that the personnel
supplying the Research and Development services are suitably qualified. In
connection with the supply of the Research and Development services
hereunder, APBiotech will comply in all material respects with all
applicable laws, regulations and safety guidelines of all governmental
entities.
2.3 APBiotech and Nycomed Amersham agree that APBiotech may nominate any
Subsidiary of APBiotech to provide the Research and Development services in
favour of such Subsidiary of Nycomed Amersham as Nycomed Amersham may
correspondingly nominate.
2.4 APBiotech shall not supply Research and Development services at the Site to
any party other than Nycomed Amersham or such other parties as Nycomed
Amersham may direct.
2.5 Without prejudice to the generality of clause 2.3:
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(a) Nycomed Amersham shall provide APBiotech with details of any
Development belonging to Nycomed Amersham which it wishes to be
incorporated into Products or any other modification which it wishes
to be made to the Products from time to time as a result of any
Development; and
(b) APBiotech shall provide Nycomed Amersham with details of any
Development which is made, developed or acquired by APBiotech from
time to time and, in particular, any such Development which improves
any Product or extends the range of Products.
2.6 The title to and all Intellectual Property Rights in respect of any
Development made, developed or acquired shall belong to Nycomed Amersham.
For the avoidance of doubt, costs associated with patenting (including
acquiring, filing and defending any patents or patent applications) or
otherwise protecting any Intellectual Property Rights to which Nycomed
Amersham is entitled (and which APBiotech undertakes on behalf of Nycomed
Amersham) under this Agreement shall be borne by Nycomed Amersham.
2.7 This Agreement shall be deemed to have come into effect on, and shall
include all Research and Development carried out from 1 July 1999.
COSTS
3.1 o o o o o o o o o o o o o o o
o o o o o o o o o o o o o o o
All prices quoted shall be exclusive of VAT or any other taxes or
customs/excise duties and APBiotech shall be entitled to charge these items
to Nycomed Amersham at the rate applicable at the date of invoice. Subject
to any special terms agreed in writing between APBiotech and Nycomed
Amersham;
(a) APBiotech shall invoice Nycomed Amersham at the end of the following
calendar month in respect of the Research and Development undertaken
pursuant to this Agreement in the previous calendar month; and
(b) Subject to Nycome Amersham's rights under this clause, Nycomed
Amersham shall pay the price stated in each invoice submitted by
APBiotech pursuant to sub-clause (a) above within 30 days of the date
of the invoice.
3.2 If Nycomed Amersham shall not pay any amount on the due date therefrom in
accordance with this Agreement, any amount unpaid shall bear interest at a
rate of 1% above the rate from time to time of LIBOR from the date of due
payment to and including the date of payment, whether before or after
judgement.
3.3 In the event that Nycomed Amersham disagrees with any one invoice delivered
by APBiotech pursuant to clause 3.1 above, APBiotech shall, upon
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request, supply Nycomed Amersham with such information as is reasonably
necessary to support the calculations contained in such invoice. APBiotech
shall also permit Nycomed Amersham to have such access as it may reasonably
request on reasonable notice to the books and records maintained by
APBiotech in connection with the provision of the Research and Development
services to enable Nycomed Amersham to verify such information. The parties
shall use all reasonable endeavours (in conjunction with their appropriate
professional advisers) to meet and discuss the basis of the calculations
contained in such invoice but if they fail to reach agreement within twenty
Business Days of delivery of the invoice, then, unless the parties agree
otherwise, the dispute shall be referred to a partner of an independent
internationally recognised firm of chartered accountants agreed upon by the
parties or, failing agreement, to be selected by the president for the
time being of the Institute of Chartered Accountants in England and Wales.
The terms of reference set out in Clause 12 shall apply.
3.4 Nycomed Amersham shall have no right to set off any amounts owing to or
alleged to be owing to it by APBiotech against unpaid invoices due to
APBiotech.
3.5 Where Research and Development is conducted at the Cardiff site the related
overhead would not include any element related to the cost of maintaining
an NII licensed site.
PLANT AND EQUIPMENT
4.1 Nycomed Amersham may request APBiotech to install new plant and equipment
at the Site or make alterations to and improvements of the premises at the
Site (the Premises).
4.2 APBiotech shall agree to any request of Nycomed Amersham made under
Clause 4.1 unless it has reasonably determined that complying with such
request would not be feasible or would be materially adverse to APBiotech
as a result of APBiotech's obligations to comply with the requirements of
the NII, any safety regulations or any relevant statutes (together, the
Requirement Obligations). In that event, APBiotech shall, upon request,
supply to Nycomed Amersham the details of such Requirement Obligations. The
parties shall use all reasonable endeavours to meet and discuss the
Requirement Obligations, but if they fail to reach agreement within twenty
Business Days of APBiotech's refusal, then, unless the parties agreed
otherwise, the dispute shall be referred to a partner of an independent
internationally recognised firm of chartered accountants agreed upon by the
parties or, failing agreement, to be selected by the president for the
time being of the Institute of Chartered Accountants in England and Wales.
The terms of reference set out in Clause 12 shall apply.
4.3 All cost of any new plant and equipment requested by Nycomed Amersham
under Clause 4.1 and its installation and the cost of any capital
expenditure at the Premises shall be borne by, and shall be the property
of, Nycomed Amersham.
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LIABILITY
5.1 Without prejudice to any other limitation or exclusion of liability under
this Agreement (and without prejudice to the rights of either party to xxx
the other for damages for breach of this Agreement):
(a) APBiotech shall not be liable to Nycomed Amersham for any loss of
profits or other indirect or consequential loss of any kind, as a
result of the provision of the Research and Development services
(excluding, for the avoidance of doubt, any loss or liability arising
from death or personal injury due to the negligence of APBiotech);
(b) the total liability of APBiotech to Nycomed Amersham in respect of any
one event, or series of connected events, shall not exceed the total
charges paid by Nycomed Amersham to APBiotech for the provision of the
Research and Development services in the twelve month period prior to
the occurrence of such event or series of events less any amount
already paid in that period to Nycomed Amersham by APBiotech under any
warranty, indemnity or other obligation under this Agreement or in
respect of any breach of this Agreement.
5.2 Subject to Clause 6.1, APBiotech will indemnify Nycomed Amersham and hold
it harmless from and against any claim or action (including reasonable
litigation costs and expenses including reasonable legal fees), brought by
any third party against Nycomed Amersham arising from any negligent or
reckless act or omission on the part of APBiotech or any of the personnel
of APBiotech.
5.3 Nycomed Amersham will indemnify APBiotech for any loss or damage (including
reasonable litigation costs and expenses including reasonable legal fees)
which APBiotech suffers as a result of any claim or action brought by a
third party against APBiotech in respect of any Research and Development
services provided by APBiotech hereunder, which claim or action has not
arisen from any negligent or reckless act or omission on the part of
APBiotech or any of the personnel of APBiotech.
5.4 Where Research and Development services are provided to Nycomed Amersham,
Nycomed Amersham shall satisfy itself that Research and Development
services are suitable for its use and, subject to clause 5.1, APBiotech
shall not be liable in any way for the suitability of quality of any
Research and Development services provided.
CONFIDENTIALITY
6.1 Neither party shall, either during the period of this Agreement or at any
subsequent time, disclose to any other person any information disclosed to
it by the other party pursuant to this Agreement, and shall use its best
endeavours to keep the same confidential (whether marked as such or not),
except as provided by clause 6.2 or 6.3.
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6.2 Any of the information referred to in clause 6.1 may be disclosed to:
(a) any governmental or other authority or regulatory body; or
(b) any directors or employees of the party in question; to such extent
only as is necessary for the purposes contemplated by this Agreement
or as required by law.
6.3 Any of the information referred to in clause 6.1 may be used by the party
in question for any purpose, or disclosed by that party to any other
person, to the extent only that any part of it is now, or hereafter
becomes, public knowledge through no fault of the party in question,
provided that in doing so that party does not disclose any information
which is not public knowledge.
DURATION AND TERMINATION
7.1 This Agreement shall be deemed to have come into force on 1 July 1999 and
shall continue in force unless and until terminated in accordance with the
following provisions of this clause 7.
7.2 Either party shall be entitled forthwith to terminate this Agreement by
written notice to the other if:
(a) that other party commits any material breach of any of the provisions
of this Agreement (save for any breach which is caused by the party
seeking to rely on it) and, in the case of such a breach which is
capable of remedy, fails to remedy the same within 30 days after
receipt of a written notice giving reasonable information concerning
the breach;
(b) an encumbrancer takes possession of, or a receiver is appointed over,
a substantial proportion of the property or assets of that other
party;
(d) that other party goes into liquidation (except for the purposes of an
amalgamation, reconstruction or other reorganisation and in such
manner that the company resulting from the reorganisation effectively
agrees to be bound by or to assume the obligations imposed on that
other party under this Agreement); or
(e) that other party ceases, or is likely to cease, to carry on business.
7.3 For the purpose of Clause 7.2 (a), a breach shall be considered capable of
remedy if the party in breach can comply with the provision in question in
all respects other than as to the time of performance.
7.4 The Agreement may terminate at any time with the written agreement of all
parties.
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EFFECT OF TERMINATION
8.1 Upon the termination of this Agreement for any reason APBiotech shall cease
all Research and Development and:
(a) forthwith return to Nycomed Amersham any documents in its possession
or control which contain or record any part of any Intellectual
Property;
(b) consent to the cancellation of any formal licence granted to it, or of
any record of it in any register, in respect of any Intellectual
Property of Nycomed Amersham;
and, subject as provided in this clause and except in respect of any accrued
rights, neither party shall have any further obligation to the other.
8.2 Subject (i) to the remainder of this clause 8 and to the obligations of the
parties under Clauses 5.1, 5.2 and 6 which shall continue to have effect
following termination; (ii) to any rights or obligations which have accrued
prior to termination; and (iii) as otherwise expressly provided in this
Agreement, upon the termination of this Agreement for any reason, neither
party shall have any further obligation to the other under this Agreement.
8.3 Nycomed Amersham will reimburse APBiotech for such sums as may be certified
by APBiotech as equal to any costs, expenses or other liabilities incurred
by APBiotech as a result of the termination of the employment of any person
involved in providing the Research and Development services. Any amounts
payable by Nycomed Amersham under this clause shall be paid within twenty
Business Days of delivery of invoice.
8.4 In the event that Nycomed Amersham disagrees with the amount of the actual
costs referred to in clause 8.3 or any amount certified under clause 8.3,
APBiotech shall upon request, supply Nycomed Amersham with such information
as is reasonably necessary to support the calculations of such costs.
APBiotech shall allow Nycomed Amersham to have such access as it may
reasonably request on reasonable notice to the books and records maintained
by APBiotech in connection with providing the Research and Development
services to enable it to verify such information. The parties shall use all
reasonable endeavours (in conjunction with their respective accountants) to
meet and discuss the basis of the calculations of each cost but if they
fail to reach agreement within twenty Business Days of delivery of the
invoice, then, unless the parties agree otherwise, the dispute shall be
referred to a partner of an independent internationally recognised firm of
chartered accountants agreed upon by the parties or, failing agreement, to
be selected by
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the president for the time being of the Institute of Chartered Accountants
in England and Wales. The terms of reference set out in clause 12 shall
apply.
NOTICES
9.1 All notices, requests, demands, or other communications made pursuant to
this Agreement shall be made by telefax, overnight express courier or hand
delivered against receipt to the applicable party as indicated below:
(a) if to APBiotech, to:
Fax No: 00000 000000
Address: Xxxxxxxx Xxxxx
Xxxxxx Xxxxxxxx
Xxxxxxxxxxxxxxx XX0 0XX
For the attention of: X.X. Xxxxxx (Company Secretary)
(b) if to Nycomed Amersham, to:
Fax No: 00000 000000
Address: Xxxxxxxx Xxxxx
Xxxxxx Xxxxxxxx
Xxxxxxxxxxxxxxx XX0 0XX
For the attention of: X.X.X. Xxxxxxx (Group Legal Adviser)
9.2 Communications shall be deemed to have been made upon receipt if by
telefax, overnight express courier or by hand delivery, except that if any
such communication is received on a day which is not a Business Day or
after Business Hours shall be deemed to have been made at the opening of
business on the first following day that is a Business Day.
NATURE OF AGREEMENT
10.1 Nothing in this Agreement shall create, or be deemed to create, a
partnership or joint venture between the parties.
10.2 Nothing in this Agreement shall constitute one party as the agent of any
other party.
10.3 Nothing in this Agreement shall make any of the employees of one party the
employees of any other party.
10.4 Any provision of this Agreement may be modified or amended or waived only
by an instrument in writing signed by duly authorised representatives of
each of the parties, in the case of a modification or an amendment, or by
the party against whom the waiver is to be effective, in the case of a
waiver.
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10.5 If any the provisions of this Agreement is or becomes invalid, illegal or
unenforceable, the validity, legality or enforceability of the remaining
provisions shall not in any way be affected or impaired. If any provision
of this Agreement, or the application thereof to any person or entity or
any circumstance, is invalid or unenforceable, the parties shall make
suitable and equitable provision therefore in order to carry out, so far as
may be valid and enforceable, the intent and purpose of such invalid or
unenforceable provision.
TERMS OF REFERENCE FOR DISPUTES
11. In the event of a dispute arising under this Agreement, the following terms
of reference shall apply:
(a) the parties shall each use all reasonable endeavours to assist the
firm to resolve the matter and to ensure that the independent firm has
such access to all relevant working papers of each party as are
reasonably necessary for the purpose;
(b) any such independent firm shall act as an expert (and not as an
arbitrator) in making any such determination which shall be binding on
the parties;
(c) the expenses of any such determination by an independent firm shall be
borne between the parties in such proportions as the firm shall in its
discretion determine.
ARBITRATION AND GOVERNING LAW
12.1 In the event of any dispute between APBiotech and Nycomed Amersham arising
in connection with this Agreement, the parties, shall use all reasonable
endeavours to resolve the matter on an amicable basis. If one party serves
formal written notice on the other that a material dispute of such a
description has arisen and the parties are unable to resolve the dispute
within a period of thirty (30) days from the service of such notice, then
the dispute shall be referred to the respective chief executive officers of
APBiotech and Nycomed Amersham with a view to the dispute being resolved as
early as possible.
12.2 If any dispute is unresolved by the chief executive officers within a
period of thirty (30) days from the date such referral of such dispute to
them, such dispute may after the expiry of such period of thirty (30) days
be referred by either party to and finally settled by arbitration under the
Rules of the London Court of International Arbitration by one or more
arbitrators appointed in accordance with those Rules. The place of
arbitration shall be London. The language of arbitration proceedings shall
be English.
12.3 This Agreement shall be governed by and construed in all respects in
accordance with the laws of England.
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AS WITNESS this Agreement has been signed by the duly authorised representatives
of the parties the day and year first before written.
SIGNED by /s/ X.X.X. Xxxxxxx )
for and on behalf of )
AMERSHAM PHARMACIA BIOTECH UK LIMITED )
in the presence of: )
SIGNED by /s/ X.X.X. Xxxxxxx )
for and on behalf of )
NYCOMED AMERSHAM PLC )
in the presence of: )
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SCHEDULE 1
COSTS
CRITERIA FOR CALCULATING THE COST OF RESEARCH AND DEVELOPMENT
All expenditure related to discovery, development, clinical trials and
regulatory approval of:
(a) new products or services
(b) new or extended indications for existing products or services
together with expenditure associated with the acquisition, filing and defence of
patents and other intellectual property up to the date of product launch.
In the case of products which require a marketing licence to be granted by a
regulatory authority before they can be sold, all expenditure incurred in order
to obtain (but not to maintain) such a licence is considered shall be a Research
and Development cost (other than consumables manufactured by APBiotech for
resale).
Expenditure includes payroll and related costs of employees; payments to third
parties for extra-mural contract work; laboratory supplies and consumables;
depreciation and expenses relating to laboratory facilities, equipment and pilot
[plants; costs associated with dossier preparation, translation and submission
to regulatory agencies; payments to third parties for access to know-how,
compounds, designs and technology; patent agent fees; costs or patent filling
and of defending patents.
For the purposes of this Agreement "Research and Development" will also include
"Technical Support" which is defined as any expenditure which does not fall
under the definition of Research and Development or Selling cost but which is
related to:--
(a) the generation (other than by clinical trials) of supplementary information
on products which have already been granted a marketing licence (in the
case of products subject to licensing controls) or which have already been
launched (in the case of all other products).
(b) The technical promotion of such products.
In the case of products which require a marketing licence to be granted by a
regulatory authority before they can be sold, all expenditure incurred in order
to maintain the validity of an existing licence is considered to be Technical
Support Expense.
Note that all clinical trial expenditure is considered to be Research and
Development expense.
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SCHEDULE 2
RESEARCH AND DEVELOPMENT
THE R&D PROGRAM COMPRISES:
o Proof of concept studies of molecular detection using o
techniques and development of algorithms for the assignment of structure to
decomposition products or metabolics of target substrates.
o NMR structural analysis.
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