EXHIBIT 10.39
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.
AGREEMENT
between
LONZA BIOLOGICS PLC
and
INHIBITEX INC
THIS AGREEMENT is made the 5th day of November 2004
BETWEEN
1. LONZA BIOLOGICS PLC, the registered office of which is at 000 Xxxx
Xxxx, Xxxxxx, Xxxxxxxxx XX0 0XX, Xxxxxxx ("LB") and
2. INHIBITEX INC of 0000 Xxxxxxxxx Xxxxxxx, Xxxxx 000, Xxxxxxxxxx, XX
00000, ("Customer").
WHEREAS
A. Customer has created the Cell Line as defined herein; and
B. LB has expertise in the evaluation and production of monoclonal
antibodies for therapeutic use using such Cell Lines; and
C. Customer wishes to contract LB for Services relating to the Cell Line
as described in this Agreement, and
D. LB is prepared to perform such Services for Customer on the terms and
conditions set out herein.
NOW IT IS AGREED AS FOLLOWS:
1. The following terms shall have the following meanings unless the
context requires otherwise:
"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;
"Agreement" means this agreement
incorporating Schedules 1
(Product Specification), 2
(Services), 3 (Price and Terms
of Payment) and Schedule 4
(Inhibitex Patents) as amended
or varied from time to time by
written agreement of the
parties;
"Batch" means the total Product obtained
from one fermentation and
associated purification using
the Process and carried out in
accordance with cGMP;
"Cell Line" means the cell line, particulars
of which are set out in Schedule
1;
"cGMP" means Good Manufacturing
Practices and General Biologics
Products Standards as
promulgated under
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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. For the
avoidance of doubt, LB's
operational quality standards
are defined in internal GMP
policy documents;
"cGMP Product" means Product which is required
under Schedule 2 to be
manufactured in accordance with
cGMP;
cGMP run(s) means the 2000 (two thousand)
liter fermentation run(s) to be
performed under this Agreement
"Customer" means Inhibitex Inc and its
successors in title and lawful
assigns;
"Customer Information" means all technical and other
information not known to LB or
not in the public domain
relating to the Cell Line, the
Process (including for the
avoidance of doubt improvements
or modifications thereto from
time to time) and the Product,
from time to time supplied by
the Customer to LB;
"Customer Materials" means the Materials supplied by
Customer to LB (if any) and
identified as such by Schedule 1
hereto;
"Customer Patent Rights" means all patents and patent
applications of any kind
throughout the world owned by or
licensed to Customer that are
necessary or useful in
performance of the Services
excluding the LB Patent Rights;
"Deliver", "Delivered" or "Delivery" has the meaning given to it in
Clause 4.1;
"FDA" means the United States Food and
Drug Administration;
"LB" means Lonza Biologics plc and
its Affiliates and successors in
title and lawful assigns;
"LB Know-How" means all technical and other
information relating directly or
indirectly to the Process known
to LB from time to time other
than Customer Information and
information in the public
domain;
"LB 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;
"Price" means the price specified in
Schedule 3 for the Services;
"Process" means the process for the
production of the Product from
the Cell Line, including any
improvements or modifications
thereto from time to time;
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"Product" means all or any part of the
product manufactured using the
Process (including any sample
thereof), particulars of which
are set out in Schedule 1 and
includes all derivatives thereof
made by LB;
"Services" means all or any part of the
services which are the subject
of the Agreement (including,
without limitation, cell culture
evaluation, purification
evaluation, assay evaluation and
qualification, a 130 liter pilot
run, master, working and
extended cell bank creation,
sample and bulk production, and
characterization, cGMP
manufacture), particulars of
which are set out in Schedule 2;
"Specification" means the specification for
Product, particulars of which
are set out in Schedule 1;
"Terms of Payment" means the terms of payment
specified in Schedule 3;
"Testing Laboratories" means any third party instructed
by LB to carry out tests on the
Cell Line or the Product.
References to the singular number include the plural and vice versa,
references to Clauses and Schedules are references to clauses and
schedules to this Agreement.
2 CUSTOMER OBLIGATIONS, WARRANTIES AND INDEMNITIES
2.1 Customer shall pay the Price set out in Schedule 3 for provision of the
Services together with any additional costs and expenses that fall due
under this Agreement in accordance with the Terms of Payment, provided
that any such additional costs and expenses are agreed to in advance by
Customer. Resin for the cGMP run shall be procured by LB and billed to
Customer at LB's cost with no xxxx up or premium added. Customer shall
pay for the Resins prior to the start of the cGMP run. LB shall use the
Resins only in the performance of the Services. The Resins shall at all
times remain the property of Customer, and at the Customer's request
and option, LB shall destroy or return to the Customer all of the
Resins at the termination of this Agreement.
2.2 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 and/or
the Customer Information supplied to LB shall remain vested in the
Customer.
2.3 The Customer hereby grants LB the non-exclusive right to use the Cell
Line, the Customer Materials and the Customer Information only for the
purpose of the Agreement.
2.4 The Customer warrants to LB that:
2.4.1 Customer has the right to enter into this Agreement;
2.4.2 Customer has and shall at all times throughout the term of
this Agreement have the right to supply the Cell Line, the
other Customer Materials and the Customer Information to LB
and the necessary rights to licence or permit LB to use the
same only for the purpose of the Services;
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2.4.3 To the best of the Customer's knowledge and belief as of the
date of this Agreement the patents and patent applications and
corresponding international applications and patents listed on
Schedule 4 relating to any of the Cell Line, the other
Customer Materials, Customer Information and Customer Patent
Rights not owned by Customer are licensed to Customer under a
licence which will permit their use by LB to perform the
Services;
2.4.4 to the best of Customer's knowledge and belief as of the date
of this Agreement, the use by LB of the Cell Line, other
Customer Materials, Customer Information and Customer Patent
Rights for the Services (including without limitation the
manufacture of the Product) will not infringe any intellectual
property rights of any third party other than third parties
from whom customer is a sublicensee through LB (provided,
however, that LB shall waive any breach of this warranty which
arises if a court of competent jurisdiction determines that
the use by LB of the Cell Line, other Customer Materials,
Customer Information or Customer Patent Rights for the
Services infringes the intellectual property rights of a third
party, provided that and for so long as Customer actually
indemnifies LB pursuant to Clauses 2.5 and 2.6); this warranty
is limited to the Cell Line, other Customer Materials,
Customer Information and Customer Patent Rights; Customer
makes no warranty as to the Process or the Services; and
2.4.5 Customer will promptly notify LB in writing if it receives or
is notified of a claim from a third party that the Cell Line,
other Customer Materials, Customer Information or the Customer
Patent Rights or that the use by LB thereof for the provision
of the Services infringes any intellectual property rights of
such third party.
Clause 2.4 is in lieu of all conditions, warranties and statements in respect of
the Cell Line, Customer Information, Customer Patent Rights and/or Customer
Materials 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 Cell Line, Customer
Patent Rights, Customer Materials and Customer Information, their fitness or
suitability for a particular purpose or use under any conditions whether or not
known to Customer) and any such condition, warranty or statement is hereby
excluded.
2.5 The Customer undertakes to indemnify and to maintain LB promptly
indemnified against any direct loss, damage, costs and expenses
(including court costs and legal fees), that LB may suffer arising
directly out of any breach of the warranties given by the Customer
under Clause 2.4 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 (other than third parties
from whom Customer is a sublicense through LB) (whether or not the
Customer knows or ought to have known about the same).
2.6 The Customer shall further indemnify and maintain LB promptly
indemnified against all claims, actions, costs, expenses (including
court costs and legal fees on a full indemnity basis) or other
liabilities whatsoever in respect of:
2.6.1 any product liability in respect of Product, except to the
extent such liability is caused by (1) the negligent or
willful act or omission of LB in the production and/or supply
of Product or provision of Services, or (2) breach of any
warranty by LB, or (3) breach of a term of this Agreement by
LB; and
2.6.2 any negligent or willful act or omission of the Customer in
relation to the use, processing, storage or sale of the
Product.
2.7 Customer shall not be liable for the following loss or damage howsoever
caused (even if foreseeable or in the contemplation of LB or the Customer):
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2.7.1 loss of profits, business or revenue whether suffered by LB or
any other person; or
2.7.2 special, indirect or consequential loss, whether suffered by
LB or any other person; and
2.7.3 any loss arising from any claim made against LB by any other
person.
2.8 Customer shall obtain and maintain clinical trial insurance with a reputable
and solvent insurance provider in the amount of five million dollars per event
or linked events. Customer shall supply LB with a copy of such insurance policy
on reasonable request and shall not terminate or amend (other than amending to
increase the level of cover) such policy without prior written notice to LB.
2.9 The obligations of the Customer under this Clause 2 shall survive the
termination for whatever reason of the Agreement.
3 PROVISION OF THE SERVICES
3.1.1 LB shall diligently carry out the Services as provided in
Schedule 2, shall initiate the first cGMP run prior to the end
of March 2005, and shall use all reasonable efforts to achieve
the estimated timescales and Specifications set out in that
Schedule, with the aim of ensuring that the Product is
accepted by the FDA for use in a Phase III clinical trial.
3.1.2 If due to the negligence or willful misconduct of LB:
(i) the Product does not meet the Specification; or
(ii) the Product meets the Specification but for other
reasons cannot be used in a clinical trial;
then the Customer shall be under no obligation to pay for the
cGMP batch that produced such Product (in which case LB shall
refund amounts already paid by Customer in respect of such
batch), and shall at its discretion have the option of
terminating this Agreement in accordance with the principles
of Clause 8.1 below (including making a pro-rata payment in
respect of Services performed other than the cGMP batch that
produced such Product) or requiring LB to repeat the
appropriate cGMP batch, for which the Customer shall pay LB in
accordance with the payment terms set out in Schedule 3
applicable to a cGMP batch. In the event Customer requires LB
to replace such Product, LB shall use all reasonable efforts
to do so with the minimum delay having regard to its
commitments to third parties in the timing of such
replacement.
If failure to meet Specification is due to acts or omissions
of both LB and Customer, then the cost to replace Product
shall be apportioned to the extent fault lies with each party.
3.1.3 If for reasons related to the inherent qualities of the Cell
Line or Product:
(i) the Product does not meet the Specification; or
(ii) the Product meets the Specification but for other
reasons cannot be used in a clinical trial; then the Customer
shall pay to LB the sum of [ *** ] for the cGMP batch that
produced such Product.
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If the Services cannot be completed for scientific or
technical reasons not the fault of either party then the
provisions of section 8.1 (termination) shall apply.
3.1.4 For the cGMP runs (Stages 8 and 16) Customer shall perform the
potency testing as set forth in Schedule 1 within thirty (30)
days of sample receipt from LB. LB shall perform the remaining
tests as set forth in Schedule 1 within thirty (30) days of
completion of the run. Each party is entitled to audit the
other party's test procedures. Prior to the start of the cGMP
run the parties shall agree on the tests to be run and on the
test results necessary for the Product to meet Specification.
Costs incurred by Customer in auditing LB's tests shall be
born by Customer. Costs incurred by LB in auditing Customer's
test shall be born by LB. The Price shall include the actual
costs incurred by LB in auditing Customer's test.
3.1.5 LB shall commence the first cGMP batch (Stage 8) within 15
weeks of the completion of Stage 6 (bulk fill of 130L pilot
batch) but in no event later than March 31, 2005. If due to
any delays or actions or inactions caused solely by LB and not
specifically related to Customer's Material this first cGMP
batch is not commenced by such date, then the Customer shall
be entitled to terminate this Agreement in accordance with
Clause 8.1.
3.1.6 If LB is unable to perform any or all of the Services for a
period of at least thirty (30) days due to restrictions placed
upon LB by the FDA or any other regulatory authority, Customer
may terminate this Agreement in accordance with Clause 8.1
below.
3.1.7 Prior to the start of the cGMP run each party shall designate
in writing a Project Manager who shall be the primary contact
for each party during the provision of the Services. Prior to
the start of the cGMP Run the parties shall enter into a
written Quality Agreement which shall be attached as an
appendix hereto and incorporated by reference as a part of
this agreement.
3.1.8 In accordance with the Quality Agreement, LB shall make
available to Customer such data and documentation as may be
necessary for Customer to include in its regulatory filings
with the FDA. LB shall cooperate as reasonably requested by
Customer, at Customer's expense, in support of Customer's
regulatory filings. Any such filings shall be the sole and
exclusive property of Customer.
3.1.9 The parties shall comply with all terms of the Quality
Agreement.
3.2 LB shall comply with the International Committee for Harmonisation
regulatory requirements and all applicable local, state and federal
regulatory requirements including but not limited to FDA regulations
from time to time applicable to the Services as set out in Schedule 2.
3.3 LB hereby undertakes not to use the Cell Line, the Customer Materials
or the Customer Information (or any part thereof) for any purpose
except as set forth in this Agreement.
3.4 LB shall:
3.4.1 at all times 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;
3.4.2 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
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3.4.3 procure that all Testing Laboratories are subject to
obligations of confidence substantially in the form of those
obligations of confidence imposed on LB under this Agreement.
3.5 In providing the Services LB shall employ its most current, most
efficient and best available LB Know How and LB Patent Rights.
4 DELIVERY, TRANSPORTATION OF PRODUCT AND CUSTOMER TESTS
4.1 Product shall be Delivered EXW (ex-works) LB premises (as defined by
Incoterms 2000) which means (a) when LB places Product at the disposal
of Customer at LB's premises not cleared for export and not loaded onto
any collecting vehicle and (b) risk and title to Product pass to
Customer upon Delivery ("Deliver," "Delivery," or "Delivered," as
appropriate). Subject to Clause 4.2, unless otherwise instructed by
Customer, LB shall not Deliver Product to Customer or place Product at
the disposal of Customer until after Customer has received the
Certificate of Analysis and approved (in writing) Product for Delivery.
Transportation of Product, whether or not under any arrangements made
by LB on behalf of Customer, shall be made at the sole risk and expense
of the Customer. Notwithstanding the forgoing, Delivery by LB shall not
be interpreted as the agreement by Customer that the Product meets the
Specification.
4.2 At Customer's request, LB will Deliver Product in quarantine prior to
delivery of the Certificate of Analysis. Such request shall be
accompanied by Customer's written acknowledgement that the Product has
been Delivered without the transmittal to Customer of a Certificate of
Analysis and, that accordingly the Product cannot be administered to
humans until transmittal of the Certificate of Analysis, and that
Customer nevertheless accepts full risk of loss, title and ownership of
the Product. The Delivery of Product in quarantine shall be subject to
such testing requirements as LB may reasonably require.
4.3 Unless otherwise agreed in writing, LB shall package and label Product
for Delivery 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 labeling requirements for Product.
Customer shall be responsible for validating any special packaging or
vessels requested by Customer. All actual additional costs and expenses
of whatever nature incurred by LB in complying with such special
written requirements shall be charged to the Customer in addition to
the Price.
4.4 If requested in writing by the Customer, LB will (acting as agent for
Customer) arrange for insurance of Product whilst held by LB after
Delivery (awaiting transportation) for a maximum of thirty (30) days on
terms equivalent to those under which LB insures product prior to
Delivery. All actual additional costs and expenses of whatever nature
incurred by LB in arranging such insurance shall be charged to the
Customer in addition to the Price.
4.5 If requested in writing 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 actual 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.
4.6 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:
4.6.1 visible damage to or total or partial loss of Product in
transit shall be given in writing to LB and the carrier within
five (5) working days of receipt by Customer; or
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4.6.2 non-Delivery shall be given in writing to LB within ten (10)
days after Customer's receipt of LB's dispatch notice.
4.7 The Customer shall make damaged Product and associated packaging
materials 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.
4.8 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 LB, the Customer, or any third party
after Delivery, or if there is any dispute in relation to clauses 3.1.2
and/or 3.1.3, 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 Biotechnology
Industry Organization. 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.
4.9 The provisions of clauses 3.1.2, 3.1.3 and 4.8 shall be the sole remedy
available to the Customer in respect of Product that fails to meet
Specification. This limitation of remedy applies only to Customer's
remedy with respect to its procurement of such Product and the
provisions of Article 6 shall nevertheless apply.
5 PRICE AND TERMS OF PAYMENT
5.1 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.
5.2 In default of payment on due date:
5.2.1 interest shall accrue on any amount overdue at the prime
lending rate in the United States, interest to accrue on a day
to day basis both before and after judgment; and
5.2.2 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 this Agreement as
repudiated on not less than thirty (30) days' prior notice in
writing to Customer given at any time thereafter.
6 LB WARRANTIES AND INDEMNITY
6.1 LB warrants that:
6.1.1 the Services shall be performed in accordance with the terms
of section 3 and the Quality Agreement and schedule 1 of this
Agreement, and the cGMP batch (Stages 8 and 16) shall in
addition be performed in accordance with LB's standard
operating procedures and cGMP.
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6.1.2 unencumbered title (save for any unlicensed third party
intellectual property rights which may exist) to Product will
be conveyed to Customer upon Delivery;
6.1.3 as of the date of this Agreement the LB Know How and LB Patent
Rights are owned by LB or LB is otherwise entitled to use them
for the purposes of providing Services under this Agreement
and during the term of this Agreement LB shall not do or cause
anything to be done which would adversely affect their
ownership or entitlement to use the same for those purposes;
6.1.4 LB has the necessary corporate authorisations to enter into
this Agreement;
6.1.5 as of the date of this Agreement to the best of LB's knowledge
and belief, the use by LB of the Process (excluding any
modifications or steps made or developed by Customer, the
Customer Materials, Customer Information and Customer Patent
Rights) and LB Patent Rights and LB Know How for the
performance of the Services as provided herein will not
infringe any rights (including without limitation any
intellectual or industrial property rights) vested in any
third party; and
6.1.6 LB will notify Customer in writing immediately if it receives
or is notified of a claim from a third party that the use by
LB of the Process and/or the LB Know How or the LB Patent
Rights for Services infringes any intellectual property rights
vested in such third party.
6.2 This Agreement including but not limited to Clause 6.1 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 or suitability 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.
6.3 LB undertakes to indemnify and to maintain Customer promptly
indemnified against any direct loss, damage, costs and expenses
(including court costs and legal fees) that Customer may suffer arising
directly out of any breach of the warranties given by LB in Clause 6.1
or any claims alleging that LB's use of LB Know-How (excluding use of
LB Know-How with Customer Materials or Customer Information) infringes
any rights (including without limitation any intellectual or industrial
rights) vested in a third party (whether or not LB knows or ought to
have known the same).
6.4 LB shall further indemnify and maintain Customer promptly indemnified
against all claims, actions, costs, expenses (including court costs and
legal fees on a full indemnity basis) or other liabilities whatsoever
in respect of:
6.4.1 any clinical trial liability or product liability in respect
of Product, except to the extent such liability is caused by
the negligent or willful act or omission of Customer in the
provision of the Customer Materials or Customer Information to
LB; and
6.4.2 any negligent or willful act or omission of LB in relation to
the processing, or storage of the Product or provision of the
Services.
6.5 LB's aggregate liability for direct damages arising out of or in
connection with this Agreement or the transactions contemplated hereby
shall not exceed [ * * * ], except that the foregoing limitation shall
not apply in the case of (a) breach of Clause 7 (Confidentiality) by
LB, (b) personal injury or death caused by the negligence of LB, or (c)
grossly negligent or intentionally wrongful acts or omissions of LB.
The foregoing limitation shall also not apply to claims arising under,
or LB's breach of, Clause 6.1 (LB Warranties and Indemnity); provided,
however, that LB's aggregate liability for direct damages arising out
of or in connection with claims arising
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under, or LB's breach of, Clause 6.1 (LB Warranties and Indemnity),
shall not exceed [ *** ].
6.6 NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY INCIDENTAL,
PUNITIVE, INDIRECT, OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING
LOST PROFITS, LOST DATA, LOST REVENUES, AND LOSS OF BUSINESS
OPPORTUNITY, WHETHER OR NOT THE OTHER PARTY WAS AWARE OR SHOULD HAVE
BEEN AWARE OF THE POSSIBILITY OF THESE DAMAGES, EXCEPT THAT THE
FOREGOING LIMITATION SHALL NOT APPLY IN THE CASE OF (a) BREACH OF
CLAUSE 7 (CONFIDENTIALITY) BY EITHER PARTY, (b) PERSONAL INJURY OR
DEATH, OR (c) NEGLIGENT OR INTENTIONALLY WRONGFUL ACTS OR OMISSIONS.
6.7 LB shall obtain and maintain product liability insurance with a reputable
and solvent insurance provider in the amount of not less than [ * * * ] per
event or linked. LB shall supply Customer with a copy of such insurance policy
on reasonable request and shall not terminate or amend (other than amending to
increase the level of cover) such policy without prior written notice to
Customer.
6.8 Nothing contained in this Agreement shall purport to exclude or restrict any
liability for death or personal injury resulting directly from negligence by LB
in carrying out the Services or any liability for breach of the implied
undertakings of LB as to title.
6.9 The obligations of LB and of the Customer under this Clause 6 shall survive
the termination for whatever reason of the Agreement.
7. CONFIDENTIALITY
7.1 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 7.5, 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 LB
Information or such Customer Information to be disclosed to any third
party save as expressly provided herein.
7.2 The Customer and LB shall each procure that all their respective
employees, consultants, contractors and persons for whom it is
responsible having access to confidential LB Know-How or LB Information
or confidential Customer Information shall be subject to the same
obligations of confidence as the principals pursuant to Clauses 7.1 and
7.3 and shall be bound by secrecy agreements in support of such
obligations.
7.3 LB and the Customer each undertake not to disclose or permit to be
disclosed to any third party (including any contractors or consultants
not previously approved in writing by LB, such approval not to be
unreasonably withheld or delayed), or otherwise make use of or permit
to be made use of (a) 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. or (b) the commercial terms of this
Agreement except to the extent that the same is required to be
disclosed pursuant to subpoena, court order, judicial process or
otherwise by law, provided the Receiving Party provides prompt notice
to the Disclosing Party of such requirement in order to give the
Disclosing Party an opportunity to timely seek a protective order or
other appropriate judicial relief. In the event the Disclosing Party is
unable to obtain a protective order or other appropriate judicial
relief, the Receiving Party shall disclose only that portion of the
Disclosing Party's Confidential Information which
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is legally required to be disclosed, and ensure that all such
Confidential Information of the Disclosing Party shall be redacted to
the fullest extent permitted by law prior to such disclosure and that
the Disclosing Party shall be given an opportunity to review the
Confidential Information prior to its disclosure.
7.4 The obligations of confidence referred to in this Clause 7 shall not
extend to any information which:
7.4.1 is or becomes generally available to the public otherwise than
by reason of a breach by the Receiving Party of the provisions
of this Clause 7;
7.4.2 is known to the Receiving Party and is at its free disposal
prior to its receipt from the Disclosing Party;
7.4.3 is subsequently disclosed to the Receiving Party without being
made subject to an obligation of confidence by a third party;
7.4.4 LB or the Customer may be required to disclose under any
statutory, regulatory or similar legislative requirement
including but not limited to the U.S. Securities and Exchange
Commission requirements for registrations to sell securities
to the public , subject to the imposition of obligations of
secrecy wherever possible in that relation; or
7.4.5 is developed by any servant or agent of the Receiving Party
without access to or use or knowledge of the information by
the Disclosing Party.
7.5 The Customer and LB acknowledge that:
7.5.1 without prejudice to any other rights and remedies that the
parties may have, the parties agree that the Confidential
Information is valuable and that damages may not be an
adequate remedy for any breach of the provisions of Clauses
7.1, 7.2, 7.3 and 7.4. The parties agree that the relevant
party will be entitled without proof of special damage to the
remedies of an injunction and other equitable relief for any
actual or threatened breach by the other party;
7.5.2 the Customer shall not at any time have any right, title,
licence or interest in or to LB Know-How, the LB Patent Rights
or any other intellectual property rights relating to the
Process which are vested in LB or to which LB is otherwise
entitled except as otherwise agreed in writing by the parties;
and
7.5.3 LB acknowledges that save as provided herein LB shall not at
any time have any right, title, licence or interest in or to
the Customer Information, Customer Patent Rights or any other
intellectual property rights vested in Customer or to which
the Customer is entitled.
7.6 Ownership of any technique, process, apparatus, material, product,
data, formula, software, design, trade secret, Confidential
Information, improvement, know-how, or invention, whether patentable or
not, made in performing the services will, save as set out in this
section 7.6 follow the United States laws of inventorship, and
inventors shall be the owners.
7.6.1 In the event that LB develops an invention which relates exclusively to
the LB Process, Know-how or Patent Rights, and not to Customer
Material, Information or Patent Rights, LB shall own all right, title
and interest in and to such invention.
7.6.2 In the event that LB develops an invention which relates exclusively to
the Customer Material, Information or Patent Rights, and not to the LB
Process, Know-how or Patent Rights, LB shall promptly provide written
notice to Customer of such invention and will,
12
upon request of Customer, assign such invention to Customer on
commercially reasonable terms to be negotiated in good faith between
the parties. For the avoidance of doubt an invention shall not relate
exclusively to the Customer material if such invention is capable of
application by LB to materials other than Customer Material.
7.6.3 In the event that LB develops an invention using the Customer Material
for which no Customer employee is an inventor and which is an invention
not described in either section 7.6.1 or 7.6.2 above, then LB shall,
upon request by Customer, grant a nonexclusive license to Customer of
such invention on commercially reasonable terms to be negotiated in
good faith by the parties.
7.6.4 In the event that Customer develops an invention relating to the LB
Process, Know-how or Information during its interaction with LB in the
performance of the Services, then Customer shall, upon request by LB,
grant a nonexclusive license to LB of such invention on commercially
reasonable terms to be negotiated in good faith by the parties.
7.6.5 All notices described in this section 7.6 shall include a detailed
description of the invention.
7.7 The obligations of LB and the Customer under this Clause 7 shall
survive the termination for whatever reason of the Agreement.
8. TERMINATION
8.1 If the parties agree at any stage in the provision of the Services that
it will not be possible to successfully complete the Services for
scientific or technical reasons not the fault of either party, a thirty
(30) day period shall be allowed for good faith discussion and attempts
to resolve such problems. If such problems are not resolved within such
period, or if the parties do not agree that scientific or technical
reasons prohibit successful completion of the Services, 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 including the costs of terminating
any third party commitments entered into pursuant to the Agreement,
such sum not to exceed the Price.
8.2 Customer may in its sole discretion terminate the Services at any time
for any reason by giving not less than (thirty) 30 days' notice in
writing to LB. In the event of termination pursuant to this Clause 8.2
and subject to Clauses 8.3 and 8.4 the Customer shall pay LB a
termination sum calculated by reference to the Services actually
performed by LB prior to termination including a pro rata proportion of
the Price for any stage of the Services which is in process at the date
of termination including costs of terminating any third party
commitments entered into pursuant to this Agreement, such sum not to
exceed the Price. plus:
8.2.1 in the event notice to terminate Services pursuant to this
Clause 8.2 is issued to LB six (6) months or less before LB's
then estimated start date for Stage 8 or Stage 16, or at any
time during such Stages, Customer shall pay LB a sum equal to
the full price of that stage or those stages in question,
which payment shall fall due to LB thirty days from the date
of termination of such Services. (For the avoidance of doubt,
per Schedule 3 the first cGMP run, i.e. Stage 8, is already
planned to start no later than the end of March 2005;
therefore this clause will require full payment if the first
cGMP run is cancelled) ; or
8.2.2 in the event notice to terminate Services pursuant to this
Clause 8.2 is issued to LB more than six (6) months but not
more than twelve (12) months before LB's then estimated start
date for Stage 8, Customer shall pay LB a sum equal to 85%
13
(eighty-five percent) of the full price of Stage 8, which
payment shall fall due to LB thirty days from the date of
termination of such Services; or
8.2.3 in the event notice to terminate Services pursuant to this
Clause 8.2 is issued to LB more than six (6) but not more than
nine (9) months before LB's then estimated start date for
Stage 16, Customer shall pay LB a sum equal to twenty five
percent (25%) of the full price of that stage or those stages
in question; which payment shall fall due to LB thirty days
from the date of termination of such Services.
8.2.4 in the event notice to terminate Services pursuant to this
Clause 8.2 is issued to LB more than nine (9) months before
LB's then estimated start date for Stage 16 then no payment
shall be due to LB (For the avoidance of doubt, per Schedule
3, the second cGMP run, i.e. Stage 16 is now planned to start
by the end of December 2005; therefore if Customer cancels
this run prior to the end of March 2005 then no payment shall
be owed to LB for the second cGMP run) .
LB shall use reasonable efforts to mitigate loss and the obligation to
make payment under Clause 8.1 or clause 8.2 shall be reduced
(retrospectively, and hence LB shall make an appropriate refund to
Customer) to the extent that LB mitigates its loss in this regard (and
LB shall promptly notify the Customer of any such mitigation). This
provision shall not entitle the Customer to be refunded an amount
greater than that paid by customer to LB pursuant to this Clause 8.
8.3 For the avoidance of doubt activities relating to the start or
commencement of a run shall be deemed to commence with the date of
removal of the vial of cells for the performance of the fermentation
from frozen storage.
8.4 The parties may each terminate the Agreement forthwith by notice in
writing to the other party upon the occurrence of any of the following
events:
8.4.1 if the other commits a material breach of the Agreement (which
shall include a breach of the warranties set out in Clauses 2
and 6 respectively) which in the case of a breach capable of
remedy is not remedied within thirty (30) days of the receipt
by the other of written notice identifying the breach and
requiring its remedy; or
8.4.2 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 its assets to
which this agreement pertains 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.
8.5 Upon the termination of the Agreement for whatever reason:
8.5.1 LB shall promptly return to the Customer all Customer
Information 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;
8.5.2 the Customer shall promptly return to LB all LB Know-How it
has received from LB;
8.5.3 the Customer shall not thereafter use or exploit the LB Patent
Rights or the LB Know-How in any way whatsoever unless subject
to a separate written license or agreement;
8.5.4 LB and the Customer shall do all such acts and things and
shall sign and execute all such documents as necessary to
evidence compliance with this Clause 8.5.
14
8.6 Termination of this 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.
8.6.1 The term of this Agreement shall commence on the date first written
above and shall expire upon completion of the Services and payment
therefor, unless earlier terminated as provided herein.
8.7 During the course of this Agreement, and at any time prior to 31st
December 2007, Customer may request and if requested, LB shall provide
to Customer a license and technology transfer agreement for relevant
technical know-how related to the Process, excluding the content of
LB's proprietary feed additives, to allow Customer or its designee to
duplicate the Process, under a technology transfer agreement mutually
agreed upon, subject to commercially reasonable pricing and other terms
associated with technology transfer. The financial terms for the
technology transfer shall be negotiated in good faith by the parties,
and the total fee for such technology transfer will depend on the
extent of LB's proprietary know-how used in the Process. For the
avoidance of doubt, the terms of any such technology transfer do not
include a licence to LB's proprietary glutamine synthetase (GS) gene
expression system.
8.8 If prior to 31st December 2006, LB and Customer agree that additional
cGMP product is to be produced by LB for Customer then the terms for
such further production at the 2000L scale shall include a price not to
exceed the Price under this Agreement. All other terms of that
agreement will be substantially as set forth in this Agreement.
8.9 Should the Customer seek future commercial supply of the Product at
2000L or 5000L scale Lonza will enter into good faith negotiations in
respect of such supply. The price for such supply will be dependent
upon selected scale, total product requirements and campaign size.
9. FORCE MAJEURE
9.1 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.
9.2 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 or which LB could not reasonably
prevent or mitigate; provided, however that unanticipated scientific or
technical problems shall not constitute Force Majeure. Customer shall
have the right to terminate this Agreement if a force majeure event
continues for a period longer than two months.
10. GOVERNING LAW, JURISDICTION AND ENFORCEABILITY
10.1 The construction, validity and performance of the Agreement shall be
governed by the laws of the United States and the State of New York,
and LB and the Customer submit to the non-exclusive jurisdiction of the
Courts.
10.2 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.
15
10.3 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.
11. NOTICES
11.1 Any notice or other communication to be given under this Agreement
shall be delivered personally or sent by facsimile transmission and by
first class pre-paid post addressed as follows:
11.1.1 If to Lonza Biologics to: Lonza Biologics plc
000 Xxxx Xxxx
Xxxxxx
Xxxxxxxxx XX0 0XX
England
Facsimile: 01753 777001
For the attention of: The Head of Legal Services
11.1.2 If to the Customer to: Inhibitex Inc
0000 Xxxxxxxxx Xxxxxxx
Xxxxx 000
Xxxxxxxxxx
XX 00000, XXX
Facsimile: (000) 000 0000
For the attention of: Xxxxxx Xxxxxxxxx
or to such other destination as either party hereto may hereafter
notify to the other in accordance with the provisions of this Clause
11.
11.2 All such notices or other communications shall be deemed to have been
served as follows:
11.2.1 if delivered personally, at the time of such delivery;
11.2.2 if sent by facsimile, upon receipt of the transmission
confirmation slip showing completion of the transmission;
11.2.3 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.
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 party shall be
entitled without the prior written consent of the other to assign,
transfer, charge, sub-contract, deal with or in any other manner make
over the benefit and/or burden of this Agreement to any company with
which such party may merge or to any company to which such party may
transfer or license 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,
16
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.
12.4 No variation of or addition to this Agreement or any part thereof shall
be effective unless in writing and signed on behalf of both parties.
Notwithstanding the above the parties hereby confirm that amendments to
the Specification shall be effective if reduced to writing and signed
by the quality and/or regulatory representative of both parties, which
quality and/or regulatory representative shall be nominated from time
to time by each party
AS WITNESS the hands of the duly authorised representatives of the parties
hereto the day and year first above written.
LONZA BIOLOGICS PLC
Signed for and on behalf of /s/ X.X. Xxxxxxx
Nov. 5, 2004 -------------------------------
X.X. Xxxxxxx
Head of LBP
-------------------------------
TITLE
INHIBITEX INC
Signed for and on behalf of /s/ Xxxxxx Xxxxxxxxx
Nov. 5, 2004 -------------------------------
Xxxxxx Xxxxxxxxx
VP Business Development
-------------------------------
TITLE
17
SCHEDULE 1
[ * * * ]
18
[ * * * ]
19
[ * * * ]
20
[ * * * ]
21
[ * * * ]
22
[ * * * ]
23
SCHEDULE 2
[ * * * ]
24
[ * * * ]
25
[ * * * ]
26
[ * * * ]
27
[ * * * ]
28
[ * * * ]
29
[ * * * ]
30
[ * * * ]
31
[ * * * ]
32
[ * * * ]
33
[ * * * ]
34
[ * * * ]
35
[ * * * ]
36
[ * * * ]
37
[ * * * ]
38
[ * * * ]
39
[ * * * ]
40
[ * * * ]
41
[ * * * ]
42
[ * * * ]
43
SCHEDULE 3
Price and Terms of Payment
1. Price
In consideration for LB carrying out the Services as detailed in Schedule 2 the
Customer shall pay LB as follows:
PRICE(1)
STAGE (UK (pound) STERLING)
Stage 1 [ * * * ] [ * * * ]
Individual invoice
may be issued
for each sub-stage.
Stage 2 [ * * * ] [ * * * ]
Stage 3 [ * * * ] [ * * * ]
Stage 4 [ * * * ] [ * * * ] plus
testing laboratory
charges actually
incurred by LB
estimated to be [ * * * ]
Stage 5 [ * * * ] [ * * * ] plus
testing laboratory
charges estimated
to be [ * * * ]
Stage 6 [ * * * ] [ * * * ]
Stage 7 [ * * * ] [ * * * ]
Stage 8 [ * * * ] [ * * * ]
Stage 9 [ * * * ] (pound)[ * * * ] plus
testing laboratory
charges actually
incurred by LB
estimated to be [ * * * ]
Stage 10 [ * * * ] [ * * * ]
Stage 11 [ * * * ] [ * * * ] per time
point
Stage 12 [ * * * ] [ * * * ]
Stage 13 [ * * * ] [ * * * ] per time
point
44
Stage 14 [ * * * ] Depending on Scope
for IND preparation
Estimated to be [* * * ]
Stage 15 [ * * * ] [ * * * ]
Stage 16 [ * * * ] [ * * * ]
Notes:
(1) [ * * * ]
(2) [ * * * ]
(3) [ * * * ]
(4) [ * * * ]
(5) [ * * * ]
(6) [ * * * ]
45
2. Payment
Payment by the Customer of the Price for each Stage shall be made
against LB's invoices as follows(1):
2.1 For Stage 1
50% upon commencement of Stage 1.
50% upon completion of Stage 1.
2.2 For Stage 2
50% upon commencement of Stage 2.
50% upon completion of Stage 2.
2.3 For Stage 3
50% upon commencement of Stage 3.
50% upon completion of Stage 3.
2.4 For Stage 4
50% upon commencement of Stage 4.
50% upon completion of Stage 4.
2.5 For Stage 5
50% upon commencement of Stage 5.
50% upon completion of Stage 5.
2.6 For Stage 6
50% upon commencement of Stage 6.
50% upon completion of Stage 6.
2.7 For Stage 7
50% upon commencement of Stage 7.
50% upon completion of Stage 7.
2.8 For Stage 8
50% upon removal of an ampoule of MCB out of freeze.
50% upon completion of Stage 8.
2.9 For Stage 9
50% upon commencement of Stage 9.
50% upon completion of Stage 9.
Testing Laboratory charges will be invoiced separately.
2.10 For Stage 10
50% upon commencement of Stage 10.
50% upon completion of Stage 10.
Testing Laboratory charges will be invoiced separately.
2.11 For Stage 11
50% upon commencement of Stage 11.
50% upon completion of Stage 11.
2.12 For Stage 12
100% payment per issued time point
2.13 For Stage 13
100% payment per issued time point
2.14 For Stage 14
Price depends on scope of work(6)
2.15 For Stage 15
46
50% upon commencement of Stage 15
50% upon completion of Stage 15
2.16 For Stage 16
50% upon removal of an ampoule of MCB out of freeze.
50% upon completion of Stage 16.
Notes: see "1 Price", above, in this Schedule 3.
47
SCHEDULE 4
Inhibitex Patents
1. U.S. 6,008,341 (ClfA DNA); U.S. 6,177,084 (ClfA protein)
2. U.S. 6,635,473 (SdrG DNA)
3. U.S. 10/056,052 (ClfA monoclonal application)
The Inhibitex Patents also include divisional and continuation applications as
well as all corresponding international applications.
48
