1
EXHIBIT 10.25
AGREEMENT
FOR SERVICES RELATING TO THE [*]
EXPRESSING [*]
BETWEEN
LONZA BIOLOGICS PLC
AND
XCYTE THERAPIES, INC.
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
2
AGREEMENT
For Services Relating to the [*]
Expressing [*]
between
LONZA BIOLOGICS PLC
and
XCYTE THERAPIES, INC.
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
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THIS AGREEMENT is made the 6 day of June, 2000
BETWEEN
1. LONZA BIOLOGICS PLC, the registered office of which is at 000 Xxxx Xxxx,
Xxxxxx, Xxxxxxxxx XX0 0XX, Xxxxxxx ("LB"), and
2. XCYTE THERAPIES, INC., of 0000 Xxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxx,
Xxxxxxxxxx 00000, XXX, ("Customer").
WHEREAS
A. Customer is the proprietor of, or licensed to use, the [*] (designated
at LB as [*]) expressing [*], and
B. LB has the expertise in the development of process for and manufacture
of similar products, and
C. Customer wishes to contract with LB for services to develop a Process
for and manufacture Product, and
D. LB is prepared to perform such Services for Customer on the terms and
conditions set out herein, and
E. LB will where scientifically possible perform such Services in parallel
with Services to produce [*] for Customer.
NOW THEREFORE it is agreed as follows:
1. In this Agreement, its recitals and the schedules hereto, the words and
phrases defined in Schedule 4 hereto and in the Standard Terms for
Contract Services set out in Schedule 5 hereto shall have the meanings
set out therein.
2. Subject to the Standard Terms for Contract Services set out in Schedule
5 and any Special Terms, LB agrees to perform the Services and the
Customer agrees to pay the Price together with any additional costs and
expenses that fall due hereunder.
3. 3.1 Any notice or other communication to be given under this
Agreement shall be delivered personally or sent by facsimile
transmission, or if facsimile transmission is not available, by
first class pre-paid post addressed as follows:
3.1.1 if to LB to:
Lonza Biologics plc
000 Xxxx Xxxx
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
\
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Xxxxxx
Xxxxxxxxx XX0 0XX
Facsimile: 01753 777001
For the attention of the Head of Legal Services
3.1.2 if to the Customer to:
Xcyte Therapies, Inc.
0000 Xxxxxxxx Xxxxxx
Xxxxx 000
Xxxxxxx
Xxxxxxxxxx 00000
Facsimile: 000 000 0000
For the attention of Director, Business Development
or to such other destination as either party hereto may
hereafter notify to the other in accordance with the provisions
of this clause.
3.2 All such notices or other communications shall be deemed to have
been served as follows:
3.2.1 if delivered personally, at the time of such delivery;
3.2.2 if sent by facsimile, upon receipt of the transmission
confirmation slip showing completion of the
transmission;
3.2.3 if sent by first class pre-paid post, ten (10) business
days (Saturdays, Sundays and Bank or other public
holidays excluded) after being placed in the post.
AS WITNESS the hands of the duly authorised representatives of the parties
hereto the day and year first above written.
Signed for and on behalf of /s/ XXXXX XXXXXX
-------------------------------------
LONZA BIOLOGICS PLC
President Title
-------------------------------
Signed for and on behalf of /s/ Xxxxxx Xxx Xxxxxxxx
-------------------------------------
XCYTE THERAPIES, INC.
President & CEO Title
-------------------------------
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SCHEDULE 1
[*]
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
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SCHEDULE 2
SERVICES
CONTENTS
[*]
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
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SCHEDULE 3
PRICE AND TERMS OF PAYMENT
1.0 Price
In consideration for LB carrying out the Services as detailed in
Schedule 2 the Customer shall pay LB, as follows
STAGE PRICE (UK (POUND) STERLING)
1 [*] (pound) 105,000
2 [*] (pound) 64,000(1)
3 [*] (pound) 73,500
4 [*] (pound) 26,250
5 [*] (pound) 79,000
6 [*] (pound) 295,000(2)
7 [*] (pound) 17,000(3)
8 [*] (pound) 40,000(4)
9 [*] (pound) 30,000
10 [*] (pound) 57,750
11 [*] (pound) 12,500 per time point
12 [*] (pound) 50,000
13 [*] (pound) 7,000
[*]
2.0 Payment
Payment by the Customer of the Price for each Stage shall be made
against LB invoices on the following basis:
[*]
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
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SCHEDULE 4
SPECIAL TERMS
[*]
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
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SCHEDULE 5
TERMS FOR CONTRACT SERVICES FOR [*]
FOR XCYTE THERAPIES, INC.
1. Interpretation
1.1 In these Standard Terms, unless the context requires otherwise:
1.1.1 "Affiliate" means any Company, partnership or other
entity which directly or indirectly controls, is
controlled by or is under common control with the
relevant party to this Agreement. "Control" means the
ownership of more than fifty per cent (50%) of the
issued share capital or the legal power to direct or
cause the direction of the general management and
policies of the party in question.
1.1.2 "Agreement" means any contract between LB and a Customer
incorporating these Standard Terms.
1.1.3 "Cell Line" means the cell line, particulars of which
are set out in Schedule 1.
1.1.4 "cGMP" means Good Manufacturing Practices and General
Biologics Products Standards as promulgated under the US
Federal Food Drug and Cosmetic Act at 21CFR (Chapters
210, 211, 600 and 610) and the Guide to Good
Manufacturing Practices for Medicinal Products as
promulgated under European Directive 91/356/EEC. LB's
operational quality standards are defined in internal
GMP policy documents. Additional product-specific
development documentation and validation work may be
required to support regulatory applications to conduct
clinical trials or market a product.
1.1.5 "Customer" includes any person to whom a Proposal is
issued by LB.
1.1.6 "Customer information" means all technical and other
information not known to LB or in the public domain
relating to the Cell Line, the Process and the Product,
from time to time supplied by the Customer to LB.
1.1.7 "Customer Materials" means the Materials supplied by
Customer to LB (if any) and identified as such by
Schedule 1 hereto.
1.1.8 "Customer Tests" means the tests to be carried out on
the Product immediately following receipt of the Product
by the Customer, particulars of which are set out in
Schedule 1.
1.1.9 "ex works" means LB has fulfilled its obligation to
deliver when it has made the object of delivery
available at its premises to the Customer or the
Customer's agent (or to LB's carrier if the provisions
of Clause 5.1 of this Schedule 5 apply). For the
avoidance of doubt, unless otherwise agreed in writing,
LB is not responsible for loading the object of delivery
on to the vehicle provided by the Customer or the
Customers agent (or to LB's nominated carrier if Clause
5.1 of this Schedule 5 applies) or for delaying the
object of delivery for export.
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
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1.1.10 "LB Know-How" means all technical and other information
relating to the Process known to LB from time to time
other than confidential Customer Information and
information in the public domain.
1.1.11 "Patent Rights" means all patents and patent
applications of any kind throughout the world relating
to the Process which from time to time LB is the owner
of or is entitled to use but not in any case any patent
rights owned or controlled by Customer or its
licensor/supplier.
1.1.12 "Price" means the price specified in Schedule 3 for the
Services.
1.1.13 "Process" means the process for the production of the
Product from the Cell Line, including any improvements
thereto from time to time.
1.1.14 "Product" means all or any part of the product
(including any sample thereof), particulars of which are
set out in Schedule 1.
1.1.15 "Proposal" means any proposal or quotation issued by LB.
1.1.16 "Services" means all or any part of the services the
subject of the Agreement or Proposal (including, without
limitation, cell culture evaluation, purification
evaluation, master, working and extended cell bank
creation, and sample and bulk production), particulars
of which are set-out in Schedule 2.
1.1.17 "Special Term" means any term additional or supplemental
to these Standard Terms from time to time agreed in
writing between LB and the Customer. Particulars of any
Special Terms at the date of the Agreement are set out
in Schedule 4.
1.1.18 "Specification" means the specification for Product,
particulars of which are set out In Schedule 1.
1.1.19 "Terms of Payment" means the terms of payment specified
in Schedule 3.
1.1.20 "Testing Laboratories" means any third party instructed
by LB to carry out tests on the Cell Line or the
Product.
1.2 Unless the context requires otherwise, words and phrases defined
in any other part of the Agreement shall bear the same meanings
in these Standard Terms, references to the singular number
include the plural and vice versa, references to Schedules are
references to schedules to the Agreement, and references to
Clauses are references to clauses of these Standard Terms.
1.3 In the event of a conflict between a Special Term and these
Standard Terms, the Special Term shall prevail.
2. Applicability of Standard Terms
2.1 Unless agreed otherwise, these Standard Terms shall apply to
every Proposal and Agreement, and to any services additional to
the Services requested by a Customer. LB shall not be bound by
any terms which may be inconsistent with these Standard Terms
and the Special Terms. No variation of or addition to these
Standard Terms and the Special Terms or any other term of an
Agreement shall be effective unless in writing and signed for
and on behalf of LB and Customer. For the avoidance of doubt,
amendments to the draft Specification or Specification for
Product shall be effective if reduced to writing and signed by
the regulatory
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representative of both Parties, which regulatory representative
shall be nominated from time to time by the parties.
2.2 Unless previously withdrawn, a Proposal is open for acceptance
within the period stated therein. Where no period is stated, the
Proposal shall be open for acceptance within thirty (30) days
from the date it is issued unless withdrawn in the meantime. Any
acceptance by a Customer of a Proposal shall not create a
binding contract.
2.3 A binding contract shall only be created when LB has accepted in
writing an offer placed by a Customer.
3. Supply by Customer
3.1 Prior to or immediately following the date of the Agreement the
Customer shall supply to LB the Customer Information, together
with full details of any hazards relating to the Cell Line
and/or the Customer Materials, their storage and use. On review
of this Customer Information, the Cell Line and/or the Customer
Materials shall be provided to LB at LB's request. Property in
the Cell Line and/or the Customer Materials supplied to LB shall
remain vested in the Customer.
3.2 The Customer hereby grants LB [*]. LB hereby undertakes not to
use the Cell Line, the Customer Materials or the Customer
Information (or any part thereof) for any other purpose.
3.3 LB shall:
3.3.1 at all times use all reasonable endeavours to keep the
Cell Line and/or the Customer Materials secure and safe
from loss and damage in such manner as LB stores its own
material of similar nature;
3.3.2 not part with possession of the Cell Line and/or the
Customer Materials or the Product, save for the purpose
of tests at the Testing Laboratories; and
3.3.3 procure that all Testing Laboratories are subject to
obligations of confidence and restrictions to use and
transfer substantially in the form of those obligations
of confidence imposed on LB under these Standard Terms.
3.4 The Customer warrants to LB that:
3.4.1 the Customer is and shall at all times throughout the
duration of the Agreement remain entitled to supply the
Cell Line, the Customer Materials and Customer
Information to LB;
3.4.2 to the best of the Customer's knowledge and belief the
use by LB of the Cell Line, the Customer Materials or
and the Customer Information for the Services will not
infringe any rights (including, without limitation, any
intellectual or industrial property rights) vested in
any third party; and
3.4.3 the Customer will notify LB, in writing, immediately it
knows or ought to know that it is no longer entitled to
supply the Cell Line, the Customer Materials and/or the
Customer Information to LB or that the use by LB of the
Cell Line, the Customer Materials or the Customer
Information for the Services infringes or is alleged to
infringe any rights (including, without limitation, any
intellectual or industrial property rights) vested in
any third party.
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
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3.5 Provided that LB gives Customer prompt written notice and full
particulars of any claim, tenders to Customer, full control of
any defense or settlement and co-operates fully with Customer,
the Customer undertakes to indemnify and to maintain LB promptly
indemnified against any loss, damage, costs and expenses of any
nature (including court costs and legal fees on a full indemnity
basis), whether direct or consequential, and whether or not
foreseeable or in the contemplation of LB or the Customer, that
LB may suffer arising out of or incidental to any breach of the
warranties given by the Customer under Clause 3.4 above or any
claims alleging LB's use of the Cell Line, the Customer
Materials or the Customer Information infringes any rights
(including, without limitation, any intellectual or industrial
property rights) vested in any third party (whether or not the
Customer knows or ought to have known about the same), however
it is agreed that LB will retain its own independent legal
counsel with settlement of any claim requiring LB's prior
written consent which shall not be unreasonably withheld.
3.6 The obligations of LB and the Customer under this Clause 3 shall
survive the termination for whatever reason of the Agreement.
4. Provision of the Services
4.1 LB shall diligently carry out the Services as provided in
Schedule 2 and shall use all reasonable efforts to achieve the
estimated timescales therefor.
4.2 Due to the unpredictable nature of the biological processes
involved in the Services, the timescales set down for the
performance of the Services (including without limitation the
dates for production and delivery of Product) and the quantities
of Product for delivery set out in Schedule 2 are estimated
only.
4.3 Provided that LB has complied with Section 4.1 the Customer
shall not be entitled to cancel any unfulfilled part of the
Services or to refuse to accept the Services on grounds of late
performance, late delivery or failure to produce the estimated
quantities of Product for delivery. LB shall not be liable for
any loss, damage, costs or expenses of any nature, whether
direct or consequential, occasioned by:
4.3.1 any delay in performance or delivery howsoever caused;
or
4.3.2 any failure to produce the estimated quantities of
Product for delivery.
4.4 LB shall comply with the regulatory requirements from time to
applicable to the Services as set out in Schedule 2 hereto,
including without limitation all relevant requirements of
current Good Manufacturing Practices under the policies and
practices of the US FDA and European Regulatory Authorities and
shall consider ICH and other relevant regulatory guidance
documents whether or not set forth with precision in said
Schedule 2. If the Customer requests LB to comply with any other
regulatory or similar legislative requirements LB shall use all
reasonable commercial endeavours to do so provided that:
4.4.1 the Customer shall be responsible for informing LB in
writing of the precise foreign requirements which the
Customer is requesting LB to observe;
4.4.2 such foreign requirements do not conflict with any
mandatory requirements under the laws of England;
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4.4.3 LB shall be under no obligation to ensure that such
written information complies with the applicable
requirements of any foreign jurisdiction; and
4.4.4 all costs and expenses incurred by LB in complying with
such foreign requirements shall be charged to the
Customer in addition to the Price.
4.5 Delivery of Product shall be ex-works LB's premises (Incoterms
1990). Risk in and title to Product shall pass on delivery.
Transportation of Product, whether or not under any arrangements
made by LB on behalf of the Customer, shall be made at the sole
risk and expense of the Customer.
4.6 Unless otherwise agreed, LB shall package and label Product for
delivery ex-works in accordance with its standard operating
procedures. It shall be the responsibility of the Customer to
inform LB in writing in advance of any special packaging and
labelling requirements for Product. All additional costs and
expenses of whatever nature incurred by LB in complying with
such special requirements shall be charged to the Customer in
addition to the Price.
5. Transportation of Product and Customer Tests
5.1 If requested by the Customer, LB will (acting as agent of the
Customer for such purpose) arrange the transportation of Product
from LB's premises to the destination indicated by the Customer
together with insurance cover for Product in transit at its
invoiced value. All additional costs and expenses of whatever
nature incurred by LB in arranging such transportation and
insurance shall be charged to the Customer in addition to the
Price.
5.2 Where LB has made arrangements for the transportation of
Product, the Customer shall diligently examine the Product as
soon as practicable after receipt. Notice of all claims (time
being of the essence) arising out of:
5.2.1 damage to or total or partial loss of Product in transit
shall be given in writing to LB and the carrier within
three (3) working days of delivery; or
5.2.2 non-delivery shall be given in writing to LB within ten
(10) days after the date of LB's dispatch notice.
5.3 The Customer shall make damaged Product available for inspection
and shall comply with the requirements of any insurance policy
covering the Product notified by LB to the Customer. LB shall
offer the Customer all reasonable assistance (at the cost and
expense of the Customer) in pursuing any claims arising out of
the transportation of Product.
5.4 Promptly following receipt of Product or any sample thereof, the
Customer shall carry out the Customer Tests. PROVIDED ALWAYS the
Specification for such Product is not stated to be in draft
form, if the Customer Tests show that the Product fails to meet
Specification, the Customer shall give LB written notice thereof
within forty-five (45) days from the date of delivery of the
Product ex-works and shall return such Product to LB's premises
for further testing. In the absence of such written notice
Product shall be deemed to have been accepted by the Customer as
meeting Specification. If LB is satisfied that Product returned
to LB fails to meet Specification and that such failure is not
due (in whole or in part) to acts or omissions of the Customer
or any third party after delivery of such Product ex-works, LB
shall at Customer's discretion refund that part of the Price
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that relates to the production of such Product or replace such
Product at its own cost and expense. In the event Customer
requires LB to replace such Product, LB shall be entitled to
have regard to its commercial commitments to third parties in
the timing of such replacement and will consider Customer's
requirements in as fair and equal manner as it considers other
third party customer requirements, Customer acknowledges that
there may, therefore, be a delay in the timing of the
replacement of such Product.
FOR THE AVOIDANCE OF DOUBT, WHERE THE SPECIFICATION IS STATED
TO BE IN DRAFT FORM LB SHALL BE OBLIGED ONLY TO USE ITS
REASONABLE ENDEAVOURS TO PRODUCE PRODUCT THAT MEETS
SPECIFICATION.
5.5 If there is any dispute concerning whether Product returned to
LB, fails to meet Specification or whether such failure is due
(in whole or in part) to acts or omissions of the Customer or
any third party after delivery of such Product ex-works, such
dispute shall be referred for decision to an independent expert
(acting as an expert and not as an arbitrator) to be appointed
by agreement between LB and the Customer or, in the absence of
agreement by the President for the time being of the Association
of the British Pharmaceutical Industry. The costs of such
independent expert shall be borne equally between LB and the
Customer. The decision of such independent expert shall be in
writing and, save for manifest error on the face of the
decision, shall be binding on both LB and the Customer.
5.6 The provisions of Clauses 5.4 and 5.5 shall be the sole remedy
available to the Customer in respect of Product that fails to
meet Specification.
6. Price and Terms of Payment
6.1 The Customer shall pay the Price in accordance with the Terms of
Payment.
6.2 Unless otherwise indicated in writing by LB. all prices and
charges are exclusive of Value Added Tax or of any other
applicable taxes, levies, imposts, duties and fees of whatever
nature imposed by or under the authority of any government or
public authority, which shall be paid by the Customer (other
than taxes on LB's income). All Invoices are strictly net and
payment must be made within thirty (30) days of date of invoice.
Payment shall be made without deduction, deferment, set-off,
lien or counterclaim of any nature.
6.3 In default of payment on due date:
6.3.1 interest shall accrue on any amount overdue at the rate
of [*] above the base lending rate from time to time of
HSBC Bank plc, interest to accrue on a day to day basis
both before and after judgement; and
6.3.2 LB shall, at its sole discretion, and without prejudice
to any other of its accrued rights, be entitled to
suspend the provision of the Services or to treat the
Agreement as repudiated by notice in writing to the
Customer exercised at any time thereafter.
7. Warranty and Limitation of Liability
7.1 LB warrants that:
7.1.1 the Services shall be performed in accordance with
Clause 4.1; and
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
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7.1.2 the Product shall meet Specification on delivery, save
where the Specification is stated to be in draft form
when LB shall be obliged only to use its reasonable
endeavours to produce Product that meets Specification.
7.2 Clause 7.1 is in lieu of all conditions, warranties and
statements in respect of the Services and/or the Product whether
expressed or implied by statute, custom of the trade or
otherwise (including but without limitation any such condition,
warranty or statement relating to the description or quality of
the Product, its fitness for a particular purpose or use under
any conditions whether or not known to LB) and any such
condition, warranty or statement is hereby excluded.
7.3 Without prejudice to the terms of Clauses 5.6, 7.1. 7.2, 7.4 and
7.6, the liability of LB for any loss or damage suffered by the
Customer as a direct result of any breach of the Agreement or of
any other liability of LB (including misrepresentation and
negligence or third party claim brought against Customer
relating solely to LB know-how) in respect of the Services
(including without limitation the production and/or supply of
the Product) shall be limited to the payment by LB of damages
which shall not exceed [*].
7.4 Subject to Clause 7.6, LB shall not be liable for the following
loss or damage howsoever caused (even if foreseeable or in the
contemplation of LB or the Customer):
7.4.1 loss of profits, business or revenue whether suffered
by the Customer or any other person; or
7.4.2 special, indirect or consequential loss, whether
suffered by the Customer or any other person; and
7.4.3 any loss arising from any claim made against the
Customer by any other person.
7.5 Provided that LB gives Customer prompt written notice and full
particulars of any claim, tenders to Customer, full control of
any defense or settlement, and co-operate fully with Customer,
the Customer shall indemnify and maintain LB promptly
indemnified against all claims, actions, costs, expenses of any
nature (including court costs and legal fees on a full indemnity
basis) or other liabilities whatsoever in respect of the
following, it been agreed, however that LB will retain its own
independent legal counsel with settlement of any claim requiring
LB's prior written consent which will not be unreasonably
withheld:
7.5.1 any liability under the Consumer Protection Xxx 0000,
unless such liability is caused by the negligent act or
omission of LB in the production and/or supply of the
Product; and
7.5.2 any product liability (other than that referred to in
Clause 7.5.1) in respect of Product, unless such
liability is caused by the negligent act or omission of
LB in the production and/or supply of Product; and
7.5.3 any negligent or willful act or omission of the Customer
in relation to the use, processing, storage or sale of
the Product.
7.6 Nothing contained in these Standard Terms shall purport to
exclude or restrict any liability for death or personal injury
resulting directly from negligence by LB in
*Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has
been requested with respect to the omitted portions.
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carrying out the Services or any liability for breach of the
implied undertakings of LB as to title.
7.7 The obligations of LB and the Customer under this Clause 7 shall
survive the termination for whatever reason of the Agreement.
8. Customer Information, LB Know-How and Patent Rights
8.1 The Customer acknowledges that LB Know-How and LB acknowledges
that Customer Information with which it is supplied by the other
pursuant to the Agreement is supplied, subject to Clause 8.4, in
circumstances imparting an obligation of confidence and each
agrees to keep such LB Know-How or such Customer Information
secret and confidential and to respect the other's proprietary
rights therein and not at any time for any reason whatsoever to
disclose or permit such LB Know-How or such Customer Information
to be disclosed to any third party save as expressly provided
herein.
8.2 The Customer and LB shall each procure that all their respective
employees, consultants and contractors having access to
confidential LB Know-How or confidential Customer Information
shall be subject to the same obligations of confidence as the
principals pursuant to Clause 8.1 and shall enter into secrecy
agreements in support of such obligations. Insofar as this is
not reasonably practicable, the principals shall take all
reasonable steps to ensure that any such employees, consultants
and contractors are made aware of such obligations.
8.3 LB and the Customer each undertake not to disclose or permit to
be disclosed to any third party, or otherwise make use of or
permit to be made use of, any trade secrets or confidential
information relating to the technology, business affairs or
finances of the other, any subsidiary, holding company or
subsidiary or any such holding company of the other, or of any
suppliers, agents, distributors, licensees or other customers of
the other which comes into its possession under this Agreement.
8.4 The obligations of confidence referred to in this Clause 8 shall
not extend to any information which:
8.4.1 is or becomes generally available to the public
otherwise than by reason of a breach by the recipient
party of the provisions of this Clause 8;
8.4.2 is known to the recipient party and is at its free
disposal prior to its receipt from the other;
8.4.3 is subsequently disclosed to the recipient party without
being made subject to an obligation of confidence by a
third party;
8.4.4 LB or the Customer may be required to disclose under any
statutory, regulatory or similar legislative
requirement, subject to the imposition of obligations of
secrecy wherever possible in that relation; or
8.4.5 is developed by any servant or agent of the recipient
party without access to or use or knowledge of the
information by the disclosing party.
8.5 The Customer acknowledges that:
8.5.1 LB Know-How and the Patent Rights are vested in LB or LB
is otherwise entitled thereto; and
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8.5.2 the Customer shall not at any time have any right,
title, licence or interest in or to LB Know-How, the
Patent Rights or any other intellectual property rights
relating to the Process which are vested in LB or to
which LB is otherwise entitled.
8.6 LB acknowledges that:
8.6.1 Customer has undertaken that the Customer Information is
vested in the Customer or the Customer is otherwise
entitled thereto; and
8.6.2 save as provided herein LB shall not at any time have
any right, title, license or interest in or to the
Customer information or any other Intellectual Property
rights vested in Customer or to which the Customer is
entitled.
8.7 The obligations of LB and the Customer under this Clause 8 shall
survive the termination for whatever reason of the Agreement.
9. Termination
9.1 If it becomes apparent to either LB or the Customer at any stage
in the provision of the Services that it will not be possible to
complete the Services for scientific or technical reasons, a
sixty (60) day period shall be allowed for discussion to resolve
such problems. If such problems are not resolved within such
period, LB and the Customer shall each have the right to
terminate the Agreement forthwith by notice in writing. In the
event of such termination, the Customer shall pay to LB a
termination sum calculated by reference to all the Services
performed by LB prior to such termination (including a pro rata
proportion of the Price for any stage of the Services which is
in process at the date of termination) and all expenses
reasonably incurred by LB in giving effect to such termination,
including the costs of terminating any commitments entered into
under the Agreement, such termination sum not to exceed the
balance of the Price for the remaining services not yet
commenced, LB will engage in good faith efforts to offer to
other third party customers those development resources or
manufacturing slots which become available due to termination by
Customer of this Agreement, and Customer will not be required to
pay for that portion of the Services and related expenses that
LB is able to charge to such other customers.
9.2 Customer shall be entitled to terminate this Agreement at any
time for any reason by sixty (60) days' notice to LB in writing.
In the event of Customer serving notice to terminate this
Agreement which notice is expressed to be given pursuant to this
Clause 9.2, Customer shall:
9.2.1 pay LB a termination sum calculated in accordance with
the principles of Clause 9.1 above, and
9.2.2 In the event notice to terminate this Agreement pursuant
to this Clause 9.2 is issued to LB within six (6) months
of LB's then estimated start date for any stage of the
Services which includes cGMP fermentation activities,
Customer shall pay LB a sum (to the extent not already
payable as noted above in accordance with the principles
of Clause 9.1) equal to not less than ten percent (10%)
nor more than eighty-five percent (85%) of the full
Price of that stage, or those stages, in question, as
provided in Clause 9.2.3
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below. Such payment shall fall due to LB on or before
the date of termination of the Services. For the
avoidance of doubt activities relating to cGMP
fermentation shall be deemed to commence with the date
of removal of the vial of cells for the performance of
the fermentation from frozen storage.
9.2.3 In the event of Customer serving notice to terminate
this Agreement in the circumstances described in Clause
9.2.2, LB shall use reasonable endeavours to substitute
a requirement for the manufacturing slot which becomes
available due to Customer of the Agreement. If LB finds
such an alternative third party selling the
manufacturing slot, which third party requirement is not
for business (i.e. LB shall not be required to
reschedule parties), the fee payable by Customer under
Clause 10% of the price for the manufacturing slot
originally amount, if any, by which the fees to be paid
for such customer is less than 85% of the price under
this originally reserved for Customer. If LB is
substitute a third party requirement for the such
manner, Customer shall be liable to of the price under
this Agreement third party termination by and is
successful in previously contracted existing commitments
to third parties), the fee payable by Customer under
Clause 9.2.2 shall equal the greater of (a) reserved for
Customer and (b) the manufacturing slot by such other
Agreement for the manufacturing slot unable, by using
reasonable endeavours, to manufacturing slot reserved
for Customer in pay LB under Clause 9.2.2 a sum equal to
85% for the manufacturing slot.
9.3 LB and the Customer may each terminate the Agreement forthwith
by notice in writing to the other upon the occurrence of any of
the following events:
9.3.1 if the other commits a breach of the Agreement which (in
the case of a breach capable of remedy) is not remedied
within thirty (30) days of the receipt by the other of
notice identifying the breach and requiring its remedy;
or
9.3.2 if the other ceases for any reason to carry on business
or compounds with or convenes a meeting of its creditors
or has a receiver or manager appointed in respect of all
or any part of its assets or is the subject of an
application for an administration order or of any
proposal for a voluntary arrangement or enters into
liquidation (whether compulsorily or voluntarily) or
undergoes any analogous act or proceedings under foreign
law.
9.4 Upon the termination of the Agreement for whatever reason:
9.4.1 LB shall promptly return all Customer Information to the
Customer and shall dispose of or return to the Customer
the Customer Materials (and where supplied by Customer
the Cell Line) and any materials therefrom, as directed
by the Customer;
9.4.2 the Customer shall promptly return to LB all LB Know-How
it has received from LB;
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9.4.3 the Customer shall not thereafter use or exploit the
Patent Rights or the LB Know-How in any way whatsoever;
9.4.4 LB may thereafter use or exploit the Patent Rights or
the LB Know-How in any way whatsoever without
restriction; and
9.4.5 LB and the Customer shall do all such acts and things
and shall sign and execute all such deeds and documents
as the other may reasonably require to evidence
compliance with this Clause 9.4.
9.5 Termination of the Agreement for whatever reason shall not
affect the accrued rights of either LB or the Customer arising
under or out of this Agreement and all provisions which are
expressed to survive the Agreement shall remain in full force
and effect.
10. Force Majeure
10.1 If LB is prevented or delayed in the performance of any of its
obligations under the Agreement by Force Majeure and shall give
written notice thereof to the Customer specifying the matters
constituting Force Majeure together with such evidence as LB
reasonably can give and specifying the period for which it is
estimated that such prevention or delay will continue, LB shall
be excused from the performance or the punctual performance of
such obligations as the case may be from the date of such notice
for so long as such cause of prevention or delay shall continue.
10.2 The expression "Force Majeure" shall be deemed to include any
cause affecting the performance by LB of the Agreement arising
from or attributable to acts, events, acts of God, omissions or
accidents beyond the reasonable control of LB.
11. Governing Law, Jurisdiction and Enforceability
11.1 The construction, validity and performance of the Agreement
shall be governed by the laws of England, to the jurisdiction of
whose courts LB and the Customer submit.
11.2 No failure or delay on the part of either LB or the Customer to
exercise or enforce any rights conferred on it by the Agreement
shall be construed or operate as a waiver thereof nor shall any
single or partial exercise of any right, power or privilege or
further exercise thereof operate so as to bar the exercise or
enforcement thereof at any time or times thereafter.
11.3 The illegality or invalidity of any provision (or any part
thereof) of the Agreement or these Standard Terms shall not
affect the legality, validity or enforceability of the remainder
of its provisions or the other parts of such provision as the
case may be.
12. Miscellaneous
12.1 Neither party shall be entitled to assign, transfer, charge or
in any way make over the benefit and/or the burden of this
Agreement without the prior written consent of the other which
consent shall not be unreasonably withheld or delayed, save that
either LB or the Customer shall respectively be entitled without
the prior written consent of the other to assign, transfer,
charge, sub-contract, deal with or
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in any other manner make over the benefit and/or burden of this
Agreement to an Affiliate or to any 50/50 joint venture company
of which either party is the beneficial owner or fifty per cent
(50%) of the issued share capital thereof or to any company with
which either party may merge or to any company to which that
party may transfer its assets and undertakings.
12.2 The text of any press release or other communication to be
published by or in the media concerning the subject matter of
the Agreement shall require the prior written approval of LB and
the Customer.
12.3 The Agreement embodies the entire understanding of LB and the
Customer and there are no promises, terms, conditions or
obligations, oral or written, expressed on implied, other than
those contained in the Agreement. The terms of the Agreement
shall supersede all previous agreements (if any) which may exist
or have existed between LB and the Customer relating to the
Services.
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