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EXHIBIT 10.45
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
Dated 11th October 2000
(1) XXXXX VACCINES LIMITED
(2) AVIRON UK LIMITED
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AGREEMENT RELATING TO
THE SHARING AND PROVISION
OF CERTAIN SERVICES
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Xxxxxx & Xxxxxxx
00 Xxxxxxxxxxx
Xxxxxx XX0X 0XX
Tel: x00 (0) 00 0000 0000
Fax: x00 (0) 00 0000 0000
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[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
TABLE OF CONTENTS
PAGE
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1. DEFINITIONS AND INTERPRETATION ....................................... 1
2. OBLIGATIONS OF THE PARTIES ........................................... 6
3. INSPECTIONS .......................................................... 6
4. INTELLECTUAL PROPERTY AND IMPROVEMENTS ............................... 8
5. PAYMENT FOR SERVICES ................................................. 9
6. INDEMNITY ............................................................ 11
7. CONFIDENTIALITY ...................................................... 14
8. LIAISON .............................................................. 15
9. ASSIGNMENT AND CHANGE OF CONTROL ..................................... 15
10. TERM AND TERMINATION ................................................. 16
11. NOTICES .............................................................. 17
12. GENERAL .............................................................. 18
13. PUBLIC DISCLOSURE .................................................... 19
14. ENTIRE AGREEMENT ..................................................... 19
15. FORCE MAJEURE ........................................................ 19
16. DISPUTES ............................................................. 19
17. ASSETS ............................................................... 20
18. [***] ................................................................ 20
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THIS AGREEMENT is made the 11th day of October 2000 BETWEEN:
(1) Xxxxx Vaccines Limited (registered in England and Wales under
Company Number: 3970089) the registered office of which is at Xxxxxx House,
Xxxxxx Xxxxxxxx Xxxxxx, Xxxxxx, Xxxxxxxxxxx XX0 0XX ("Xxxxx"); and
(2) Aviron UK Limited (registered in England and Wales under Company
Number: 3854275) the registered office of which is at Carmelite, 00 Xxxxxxxx
Xxxxxxxxxx, Xxxxxx, XX0X 0XX ("Aviron UK").
WHEREAS:
(A) Pursuant to an Amended and Restated Contract Manufacture Agreement
dated 7th June, 1999 (the "CMA") Aviron, a company registered in Delaware, the
registered office of which is at 000 Xxxxx Xxxxxxxx Xxxxxx, Xxxxxxxx Xxxx,
Xxxxxxxxxx 00000, Xxxxxx Xxxxxx of America ("Aviron") the holding company of
Aviron UK, appointed Medeva Pharma Limited ("Medeva") to manufacture the
Intermediate Product in accordance with the provisions of the CMA.
(B) Pursuant to an agreement dated 7th September 2000 Xxxxx acquired
from Medeva the business, carried on by Medeva at the premises situated in
Xxxxxxx Road and Xxxxx Road, Speke, Liverpool, of the manufacture, assembly and
packaging of pharmaceutical products, or components thereof (the "Medeva Sale
Agreement").
(C) On 28th September 2000, being the date of completion of the Medeva
Sale Agreement, the CMA was assigned from Medeva to Xxxxx, in accordance with
its terms.
(D) Aviron UK wishes to manufacture the Intermediate Product on behalf
of Aviron and, accordingly, the parties have decided to vary the CMA in
accordance with the provisions of a deed of variation entered into on today's
date.
(E) The parties now wish to enter into this Agreement which concerns the
sharing and provision of certain services as set out in this Agreement.
1. DEFINITIONS AND INTERPRETATION
In this Agreement, the following words shall have the meanings:
"AGENCY" means any governmental body responsible for licensing of the
Finished Product for commercial sale and the licensing of premises and
facilities of the manufacturer;
"AGREEMENT" means this agreement and the schedules hereto;
"ANNUAL PRODUCTION FORECAST" means the schedule of production prepared
by Aviron UK in respect of each Manufacturing Period incorporating, inter alia,
details of the Maximum Dose Number and the Minimum Dose Number;
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[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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"ASSOCIATED COMPANIES" means in respect of any party, any company which
at the relevant time is a subsidiary of that party's ultimate holding company or
any subsidiary of such a subsidiary where the term subsidiary shall have the
meaning as defined in section 736 of the Companies Xxx 0000 (as amended);
"AVIRON REGULATORY RECORDS" means records generated by Aviron (and
previously by Medeva) in connection with the manufacture of the Intermediate
Product at the Premises;
"AVIRON UNIT" means the manufacturing facilities where the Intermediate
Product is manufactured (including the QA/QC Area) as more particularly
described in the relevant Property Agreement;
"AVIRON RESTRICTED MATERIAL" means (i) Master Donor Strains, Master
Virus Seeds, Manufacturer's Working Seeds, Monovalent Virus Harvest and NAF; and
(ii) all Technical Information;
"BUSINESS" means the business of the contract manufacture of the
Intermediate Product as more fully described in the CMA prior to its amendment
and restatement pursuant to an agreement made on the date of this Agreement
between Xxxxx and Aviron;
"BUSINESS DAY" means any day that is not a Saturday, a Sunday or a bank
or public holiday in England and Wales;
"CAIV PRODUCT" means a live, attenuated, intranasally deliverable
cold-adapted influenza vaccine;
"CUSTOMS" means HM Customs & Excise;
"DOSE NUMBER" means the Maximum Dose Number and/or the Minimum Dose
Number;
"EVENT OF FORCE MAJEURE" means (i) the occurrence of an event or
circumstance wholly beyond the reasonable control of the parties and/or (ii)
which could not have been avoided by the party so affected using all reasonable
efforts and includes (insofar as beyond such control but without prejudice to
the foregoing expression) a war (declared or undeclared), insurrection, civil
commotion, military action, or an act of sabotage or material vandalism, a
strike, lockout or industrial action, dispute or disturbance of any kind, the
application of an import or export law or policy, an act of God and a xxxxx,
xxxxxxx, fire, flood, earthquake or other natural calamity or occurrence;
"FDA" means Food and Drug Administration of the United States of
America;
"FINISHED PRODUCT" means the Vaccine in its final form packaged for the
sale to the consumer;
"FLU SEASON" means, in respect of the northern hemisphere, the period of
time during a calendar year anticipated to start approximately at the beginning
of August and ending
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COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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approximately in January in which it is anticipated that the Vaccine will be
used to vaccinate patients;
"cGMP" means current FDA Good Manufacturing Practices as set forth in
the United States 21 Code of Federal Regulations Parts 210 and 211 as amended
from time to time, and the corresponding regulations of PIC and the EU, [***]
during the term of this Agreement;
"GSA" means the general services area which provides the cleaning
services for reusable equipment used in the Aviron Unit;
"INTERMEDIATE PRODUCT" means Monovalent Virus Harvest and/or NAF,
manufactured according to and conforming with the Specifications which is
intended for use in the manufacture of the Vaccine;
"IP LICENSE" means the know-how and technology license agreement to be
entered into by the parties on the date of this Agreement;
"MANUFACTURING PERIOD" means a period of one year starting with [***]
and ending [***] of the next calendar year during the term of this Agreement and
that the first Manufacturing Period (the "First Manufacturing Period") shall be
the period commencing on [***] and ending [***].
"MANUFACTURER'S WORKING VIRUS SEEDS" means the virus reassortants to be
produced by Aviron, from time to time, from the Master Virus Seeds and from
which the Monovalent Virus Harvest is produced;
"MASTER DONOR STRAINS" shall mean the live attenuated influenza strains
derived by Xx. Xxxxxxx and designated Type A/Xxx Arbor/6/60-H2N2 and Type B/Xxx
Arbor/1/66, exclusively licensed from Michigan to Aviron, and which are used to
produce Master Virus Seeds;
"MASTER VIRUS SEEDS" means certain reassortants produced by Aviron from
the Master Donor Strains;
"MAXIMUM DOSE NUMBER" shall be the dose number for the relevant
Manufacturing Period as provided by Aviron UK to American Home Products and as
notified to Xxxxx in accordance with sub-clause 5.2;
"MICHIGAN" means the Regents of the University of Michigan, a
constitutional corporation of the State of Michigan with offices located at
Wolverine Tower, Room 2071, 0000 Xxxxx Xxxxx Xxxxxx, Xxx Xxxxx, Xxxxxxxx, 00000
1280, USA;
"MILESTONE PAYMENTS" means the annual payments to be made by Aviron UK
to Xxxxx pursuant to clauses 3.1.2 to 3.1.6 (inclusive) of the IP License;
"MINIMUM DOSE NUMBER" means:
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[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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(i) in respect of the First Manufacturing Period, [***]
doses;
(ii) in respect of the Manufacturing Period beginning [***]
and ending on [***], [***] doses;
(iii) in respect of the Manufacturing Period beginning on
[***] and ending on [***], [***] doses;
(iv) in respect of the Manufacturing Period beginning on
[***] and ending on [***], [***] doses;
(v) in respect of the Manufacturing Period beginning on
[***] and ending on [***], [***] doses; and
(vi) in respect of the Manufacturing Period beginning on
[***] and ending on [***], [***] doses;
"MONOVALENT VIRUS HARVEST" means each of the three virus strains to be
incorporated in. the Vaccine for a given Flu Season in bulk form;
"NAF" means "Normal Allantoic Fluid" used as a diluent in the Vaccine
and/or any other materials used as a diluent in the Vaccine;
"OTHER SERVICES" means the services described in part B of Schedule 1;
"PIC" means the Pharmaceutical Inspection Convention;
"PLI" means pre-license inspection or any other pre-approval inspections
by an Agency;
"PREMISES" means parts of the premises at Xxxxxxx Road and Xxxxx Road,
Speke, Liverpool, at which the Business has been conducted by Medeva (and which
has been acquired by Xxxxx pursuant to the Medeva Sale Agreement);
"PROPERTY AGREEMENTS" means the agreements for sub-lease of the Aviron
Unit and the sub-lease of the extension to the Aviron Unit and the three
licenses to jointly occupy and access certain areas of the Premises;
"QA/QC AREA" means the quality assurance, quality control and
administrative area of approximately 2,500 square feet as described in the
relevant Property Agreement;
"QUALITY AGREEMENT" means the quality agreement, as amended from time to
time, entered into between Xxxxx and Aviron UK on the date of this Agreement;
"RAW MATERIALS" means the components required by Aviron UK in the
manufacture of the Intermediate Product;
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[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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"REGULATORY RECORDS" means environmental monitoring and cleaning,
quality control and quality assurance and batch records generated by Xxxxx in
connection with the manufacture by Aviron UK of the Intermediate Product at the
Premises;
"RESTRICTED INFORMATION AND MATERIALS" means (i) the Aviron Restricted
Material; (ii) all information relating to the Discloser's (as defined below)
business; and (iii) all information arising pursuant to this Agreement, and the
CMA, disclosed by one party to this Agreement (the "Discloser") to the other
(the "Recipient") or to an Agency or any other third party at the request of the
other party in connection with this Agreement, excluding any such information
which:
(a) is or was already known to the Recipient at the time
of disclosure by the Discloser as evidenced by the written records of the
Recipient; or
(b) was at the time of such disclosure or communication
by the Discloser or thereafter becomes or became published, accessible to the
public or otherwise in the public domain other than through any act or omission
of the Recipient; or
(c) must be disclosed to government inspectors in the
discharge of statutory obligations provided that before disclosure the Recipient
shall use reasonable endeavours as it would in respect of its own Restricted
Information and Materials to obtain from such government inspectors any
assurances as regards confidentiality as may be afforded to such information in
the circumstances; or
(d) must be disclosed by the Recipient to the relevant
Agency in the course of applying for, obtaining or maintaining regulatory
approval provided that before disclosure the Recipient shall use reasonable
endeavours as it would in respect of its own Restricted Information and
Materials to obtain from such Agency any assurances as regards confidentiality
as may be afforded to such information in the circumstances; or
(e) is hereafter disclosed to the Recipient by a third
party, who to the knowledge of the Recipient does not have any obligations of
confidentiality to any third party or who has not, to the actual knowledge of
the Recipient, derived it directly or indirectly from the Discloser provided
that before disclosure the Recipient shall use reasonable endeavours as it would
in respect of its own Restricted Information and Materials to obtain from such
third party any assurances as regards confidentiality as may be afforded to such
information in the circumstances; or is required to be disclosed by law provided
that before disclosure the Recipient shall use reasonable endeavours as it would
in respect of its own Restricted Information and Materials to obtain from the
recipient as regards confidentiality as may be afforded to such information in
the circumstances.
"SERVICES" means the services described in Schedule 1;
"SPECIFICATIONS" means requirements and specifications for the
Intermediate Product and its manufacture as provided by Aviron UK to Xxxxx from
time to time;
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[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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"SPF UNIT" means the area of the facility on Xxxxx Road, Speke,
Liverpool where [***] eggs are [***] as described in the relevant Property
Agreement;
"TECHNICAL INFORMATION" means all registration data, know-how,
experience, formulation, manufacturing instructions, standard operating
procedures, policies, instructions, standards, methods, test and trial results,
manufacturing and formulation processes, hazard assessments, quality control
standards, formulae, specifications, storage and data, samples, drawings,
designs, description of packaging materials and all other relevant information
relating to the Intermediate Product or its design, manufacture, formation,
handling, storage, testing and use and/or Master Donor Strains and/or Master
Virus Seeds;
"TRANSACTION AGREEMENTS" shall have the same meaning ascribed to it as
in a Master Agreement dated the date of this Agreement and entered into, inter
alia, by the parties to this Agreement;
"VACCINE" means Aviron's CAIV Product;
"VAT" means value added tax under the Value Added Tax Xxx 0000 ("VATA").
2. OBLIGATIONS OF THE PARTIES
2.1 Obligations of Xxxxx
In consideration of the payment of the sums referred to in clause 5 of
this Agreement, Xxxxx agrees to provide the Services for the time periods set
out in Schedule 1 at all such times:
(a) in accordance with cGMP (where specifically stated
to be so pursuant to Schedule I and/or where such standard is required by an
Agency);
(b) in accordance with all regulatory or legal
requirements ;
(c) in a good and workmanlike manner and in a manner
consistent with the accepted standards within the industry.
2.2 Obligations of Aviron UK
Aviron UK undertakes to Xxxxx that it shall not [***] (either for itself
or any other person) or cause the [***] in the [***].
2.3 In the event that one of the parties considers that the scope,
extent or pricing of the Services requires amendment or variation then such
party will notify the other and both parties shall endeavour to agree on such
amendment or variation, acting always in good faith in accordance with the
provisions of clause 16.
3. INSPECTIONS
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COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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3.1 Subject to sub-clause 3.4, Xxxxx will permit, no more than [***] of
this Agreement (in addition to any times required pursuant to sub-clause 3.2(b))
and during normal business hours and upon reasonable notice, representatives of
Aviron UK and its Associated Companies who have been [***] (such [***] not to be
unreasonably withheld or delayed) to have access to the Regulatory Records and
to inspect the relevant parts of the Premises occupied and/or owned by Xxxxx or
any of its Associated Companies to assess its compliance with cGMP and any
current practices of any relevant Agency, solely in respect of Aviron UK's
manufacture of the Intermediate Product and/or in relation to the provision of
the Services pursuant to this Agreement, and to discuss any related issues with
Xxxxx'x management personnel (provided always that a representative of Xxxxx is
present at ` said inspection). Following such an inspection Aviron UK will
provide to Xxxxx [***] within [***] of the inspection. If any issues concerning
compliance with cGMP or any practices of any relevant Agency are raised in the
audit Xxxxx shall, within [***] provide a [***] to Aviron UK. Xxxxx will permit
on reasonable notice and in normal business hours a follow-up access to the
relevant parts of the Premises and audit by Aviron UK, if reasonably necessary,
to confirm corrective actions that may be agreed by the parties are completed.
3.2
(a) Subject to-sub-clause 3.4, Aviron UK shall, during
normal business hours and upon reasonable notice, have the right and Xxxxx will
allow representatives of any Agency to inspect the relevant parts of the
Premises occupied and/or owned by Xxxxx or any of its Associated Companies
(provided always that a representative of Xxxxx is present at said inspection),
to inspect the Regulatory Records and to ensure compliance with cGNT and other
practices or regulations but only in so far as they relate to the manufacture of
the Intermediate Product and/or any other matters required by law.
(b) Xxxxx shall, during normal business hours and upon
reasonable notice, have the right and Aviron UK will allow the representative of
any Agency to inspect the [***] (provided always that a representative of Aviron
UK is present at said inspection). Xxxxx shall have the right to have a
representative of Xxxxx present at any inspection of the [***] by any Agency at
any time. Aviron UK shall give Xxxxx reasonable notice of all such inspections.
3.3 Xxxxx shall inform Aviron UK of any questions or recommendations
made by an Agency and shall provide to Aviron UK copies of any written questions
or recommendations received from an Agency insofar as they pertain to the
manufacture of the Intermediate Product, the Aviron Unit, the GSA or the SPF
Unit (including, without limitation, warning letters, 483(b)s, and other written
communications). Xxxxx and Aviron UK shall, prior to responding to any Agency,
[***] to any written questions and recommendations of the Agency and responses
to any verbal questions or recommendations of the Agency or regulatory body that
do not require an immediate response subject always to [***] right to have the
[***] the contents of any response to a question or recommendation of an agency
that pertains to [***] (after [***] any comments of [***] with respect to issues
directly related to the [***]), and save where the response to the question or
recommendation of the Agency pertains solely to the [***], in which case [***]
shall have [***] as to the contents of such response having taken reasonable
account of the comments of [***]. Xxxxx shall promptly send to Aviron UK a copy
of any reports,
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COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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citations, or warning letters received by Xxxxx in connection with an Agency
inspection to the extent such documents relate to or affect [***] and Aviron UK
shall promptly send Xxxxx a copy of any reports, citations or warning letters
received by Aviron UK in connection with such Agency inspection.
3.4 Each of the parties undertakes to the other that, other than as
required by law or regulatory requirements, it shall not communicate with any
Agency with the intention of causing such Agency to inspect or otherwise audit
the other party or with the intention of causing an Agency to withdraw or
otherwise take any steps pertaining to any license or authorization held by the
other party.
4. INTELLECTUAL PROPERTY AND IMPROVEMENTS
4.1 Except as expressly provided in this Agreement, each party hereby
acknowledges that it shall not acquire any rights in respect of any of the other
party's intellectual property.
4.2 Other than as is necessary for the proper performance of this
Agreement by the parties, or as is expressly provided in this Agreement, no
license, expressed or implied, is granted by this Agreement by either party to
the other under any of its intellectual property rights.
4.3 [***] all Regulatory Records shall [***], shall be treated as [***],
and shall not be [***] as provided in the Quality Agreement or for the purposes
associated with manufacture of the Vaccine and where necessary for disclosing to
the relevant Agency and to its licensees and distributors in order to comply
with regulatory requirements and to prepare for regulatory filings or PLIs.
Aviron UK may [***] of all Regulatory Records, for the purposes of complying
with the requirements of the relevant Agency. Aviron UK may [***] the Restricted
Information and Materials to [***], having previously made reasonable efforts to
obtain an obligation of confidentiality from the said [***] concerning the
Restricted Information and Materials. Provided always that: (i) nothing in this
sub-clause 4.3 shall limit Aviron UK's right and ability to [***] intellectual
property or know how [***] pursuant to and on the terms of any [***] from time
to time; and (ii) nothing in this sub-clause 4.3 shall in any way relate to or
affect the [***], title to and property in which Xxxxx agrees and acknowledges
is exclusively vested in Aviron UK.
4.4 Save as may be required by law or any other regulatory authority,
Xxxxx hereby warrants to Aviron UK that:
(a) it is not in possession of any materials, records or
other information (whether in written form or in digital) which relates to or
derives from the [***] and if such [***] comes into its possession it shall
immediately transfer or send such materials, records or information to Aviron UK
and further undertakes not to keep any copies of the same;
(b) it is not in possession of any of the physical
materials which comprise the [***]; and
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[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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(c) Xxxxx warrants that (i) it has not received any
notice and [***] has received any notice that any of the licenses, consents,
permits, or approvals necessary for the carrying on of the Business have been
suspended, cancelled or revoked; and (ii) is not actually aware of [***] any
such licenses, consents, permits, or approvals referred to in paragraph (i) are
[***] within a [***] period following the date of this Agreement.
5. PAYMENT FOR SERVICES
5.1
(a) Aviron UK shall pay for the Services at the rates
specified for the various Services as set out in Schedule 2.
(b) Xxxxx will submit to Aviron UK a [***] invoice (the
"Invoice") for all costs and expenses incurred in the performance of the
Services within thirty (30) days following the end of each of the following days
in any given calendar year ([***] (each a "Quarter Day") in respect of the
period ending on (but not including) such Quarter Day and beginning on the
immediately preceding Quarter Day. The first such Invoice shall be submitted in
respect of the period commencing on the date of this Agreement and ending on
(but not including) [***].
(c) Each Invoice shall describe in reasonable detail the
Services for which reimbursement is being sought and the price of such Services,
including the costs of providing such Services.
(d) Xxxxx shall furnish [***] supporting all charges and
costs for the Services provided that the furnishing of such documentation shall
[***] to the payment obligation of Aviron UK as provided herein. If, upon later
examination by Aviron UK, [***] any costs and expenses that have been paid has
not been provided by to Aviron UK by Xxxxx after Aviron UK's reasonable request
therefor, Xxxxx shall [***] for which [***] has not been furnished.
(e) Xxxxx shall keep or cause to be kept [***] records
of costs and expenses to be paid for the provision of the Services and shall
cause such records to be made available for inspection by the duly authorized
representatives of Aviron UK during reasonable business hours [***].
(f) Aviron UK shall promptly pay all Invoices submitted
by Xxxxx not later than the date which is [***] following the receipt of the
relevant invoice.
(g) Aviron UK shall not be obliged to pay for Services
which it has already paid for or for which it has been invoiced as a tenant
pursuant to any of the Property Agreements.
5.2 Within two weeks of the date of this Agreement Aviron UK shall
deliver to Xxxxx the Annual Production Forecast in respect of the First
Manufacturing Period. Thereafter on or
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COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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before [***] in each year of this Agreement Aviron UK shall deliver to Xxxxx a
copy of the Annual Production Forecast for the forthcoming Manufacturing Period.
5.3 Within [***] of receipt of the Annual Production Forecast, Xxxxx
shall submit any queries to Aviron UK in respect of the Maximum Dose Number and
the reasons for such disagreement provided always that Xxxxx shall not be
entitled to raise a query with regard to the Maximum Dose Number if such number
does not exceed [***]. If Xxxxx has provided such a submission, the parties'
Designated Person (as defined and identified in clause 8) shall, as soon as
reasonably practicable following receipt by Aviron UK of Xxxxx' submission, meet
and discuss in good faith the issues raised by Xxxxx with a view to resolving
those issues and, in particular, with a view to agreeing the proposed Maximum
Dose Number and, in the absence of agreement clause 16 of this Agreement shall
apply.
5.4 If Aviron UK reasonably considers that Xxxxx is failing to perform
its obligations pursuant to clause 2.1 of this Agreement and such failure is
[***] with the result that the [***], Aviron UK shall notify Xxxxx' Designated
Person within five (5) Business Days of Aviron UK become aware of such [***]
provided always that if Aviron UK shall fail to so notify Xxxxx' Designated
Person within such time period then Aviron UK shall be precluded from taking
such [***] into account in claiming a [***] as defined in and pursuant to
sub-clause [***]. In this event, the Designated Persons shall, as soon as
reasonably practicable, meet for discussion in good faith with a view to
resolving the issues raised by Aviron UK to enable Xxxxx to rectify such breach
within a reasonable time period in relation to such breach.
5.5 In the event that Xxxxx fails to remedy such breach, in accordance
with sub-clause 5.4, in the time period reasonably applicable to such breach
then Aviron UK shall [***].
5.6 Aviron UK agrees that it shall, [***] any loss or damage which it
may suffer in consequence of any fact, matter, event or circumstance undertaken
by or on behalf of Xxxxx in the performance of the Services and shall [***].
5.7
5.7.1 On the first Business Day which falls on or following
[***] in each year, the Designated Persons shall meet to review the operation of
this Agreement in the previous Manufacturing Period and in particular, to review
the [***] manufactured by Aviron UK in that Manufacturing Period.
5.7.2 If the actual number of doses of the Vaccines so
manufactured is less than the Minimum Dose Number for that Manufacturing Period
(the "Shortfall"), the Designated Persons shall [***] and, if the Designated
Persons agree that [***] to the actions or omissions of Xxxxx in the performance
of the Services, Aviron UK shall, subject to sub-clauses 5.8 and 6.6, be
entitled to recover (the "Dose Recovery") the [***] of the loss of production
(calculated [***]). Subject to clause 5.8, Aviron UK shall be entitled to [***]
on the next following due date of payment of such [***].
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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5.7.3 If the actual number of doses of the Vaccines so
manufactured is greater than or equal to the Minimum Dose Number for that
Manufacturing Period but is less than the Maximum Dose Number (the "Shortfall"),
the Designated Persons shall [***] and, if the Designated Persons agree that
[***] to the actions or omissions of Xxxxx in the performance of the Services,
Aviron UK shall, subject to sub-clauses 5.8 and 6.6, be entitled to recover (the
"Dose Recovery") the [***] of the loss of production (calculated [***]). Subject
to clause 5.8, Aviron UK shall be entitled to [***] on the next following due
date of payment of such [***].
5.8 Xxxxx shall not be required to [***], nor shall Aviron UK be
entitled to [***] any amounts in respect of any [***] if.
(i) Aviron UK has [***];
(ii) Aviron UK has [***] manufactured by or on
behalf of Aviron UK in the relevant Manufacturing Period; or
(iii) the parties [***] during the relevant
Manufacturing Period, in which case Aviron UK shall [***].
5.9 If the Designated Persons cannot reach agreement following their
discussions as referred to in sub-clause 5.7 then the provisions of clause 16
shall apply. The parties agree that the Designated Persons, in their
discussions, and any Expert so appointed in accordance with clause 16 to resolve
a disagreement concerning clause 5.7, shall take into account in their
discussions or in reaching the Expert's determination:
(a) any costs and expenses (including, without
limitation, capital expenditure [***] in the steps so taken; and
(b) any [***] which the parties cannot agree or has not
been determined in accordance with clause 16 is an [***] which has occurred
within the relevant Manufacturing Period.
5.10 In the event that the procedures set out in clause 16 are in
process and have not been resolved by a date on which a [***] is due and
payable, Aviron UK shall be entitled to [***] following the determination of the
[***] in accordance with sub-clause 5.9 (the "[***] Amount"). In the Event that
the [***] Amount is greater than that determined by the [***] then Aviron UK
shall make the appropriate adjusting payment [***] within [***] of the [***]
determination.
6. INDEMNITY
6.1 Subject to sub-clauses 6.2, 6.3, 6.4, 6.5 and 6.6, but
notwithstanding anything contained in this Agreement, Xxxxx indemnifies and
shall keep Aviron UK indemnified against all losses, damages, costs, actions,
awards, penalties, fines, proceedings, claims, demands, liabilities and expenses
suffered or incurred by Aviron UK to the extent they arise from the acts or
omissions of Xxxxx, its Associated Companies or their respective employees or
agents.
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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6.2 Xxxxx shall not be liable under the indemnity provided under clause
6.1 above:
(a) to the extent that any failure of the Intermediate
Product to comply with the Specifications results from the failure of the Master
Donor Strains and/or the eggs supplied by Aviron UK or Aviron UK's suppliers to
comply with Specifications; and/or
(b) for any factor occurring after the Intermediate
Product leaves the Premises or any other premises occupied by Xxxxx or any of
its Associated Companies; and/or
(c) to the extent that such liability arises as a
consequence of any [***] of Aviron UK, its Associated Companies or their
respective employees or agents.
6.3 In no event, and notwithstanding anything contained in this
Agreement, shall either party be liable in contract, tort (including breach of
statutory duty) or otherwise howsoever, and whatever the cause thereof, for any
special, indirect or consequential loss (including, without limitation, loss of
profit), damage, costs or expenses of any nature whatsoever.
6.4 If Xxxxx makes a payment under the indemnity in sub-clause 6.1 above
and Aviron UK or any of its Associated Companies receives a payment otherwise
than from Xxxxx in respect of the same loss, claim, demand, damage, cost,
charge, expense or liability giving rise to a claim in respect of which that
payment was made under the indemnity, Aviron UK or any of its Associated
Companies shall, once it has received such payment, forthwith repay to Xxxxx an
amount equal to the lesser of such payment and the payment under the indemnity
in either such case less the reasonable costs and expenses of obtaining any such
payment and irrecoverable [***] (if any) thereon.
6.5 The provisions of this sub-clause shall apply to any claim by a
third party against Aviron UK in respect of a matter which has given rise to a
claim pursuant to the indemnity given in sub-clause 6.1 above (in each case a
"Relevant Claim"). Aviron UK shall [***] give written notice of the Relevant
Claim and subject to Aviron UK being fully indemnified against any reasonable
costs, liabilities and expenses thereby incurred:
6.5.1 [***];
6.5.2 [***];
6.5.3 [***];
6.5.4 [***];
6.5.5 [***];
6.5.6 [***]:
(a) [***];
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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(b) [***];
Provided always that nothing in this sub-clause 6.5 shall require Aviron
UK to take any action which is reasonably likely to have a [***] on the [***] of
Aviron UK and its Associated Companies.
6.6 Subject always to clause 6.3, other than in respect of claims caused
by any [***] of Xxxxx, its Associated Companies and their respective employees
or agents, Xxxxx'x liability in contract, tort (including breach of statutory
duty) or otherwise arising by reason of or in connection with this Agreement or
any agreement or indemnity contemplated hereunder shall be limited to [***] in
any [***] period. For the avoidance of doubt, only one claim is permitted to be
made in respect of any one incident.
6.7 Subject to sub-clauses 6.3, 6.8, 6.9 and 6.10 Aviron UK indemnifies
and shall keep Xxxxx indemnified against all losses, damages, costs, actions,
awards, penalties, fines, proceedings, claims, demands, liabilities and expenses
suffered or incurred by Xxxxx to the extent they arise from the acts or
omissions of Aviron UK its Associated Companies, and their respective employees
or agents provided always that Aviron UK shall not be liable pursuant to this
clause to the extent that the liability arises as a consequence of any [***] of
Xxxxx, its Associated Companies or their respective employees or agents.
6.8 If Aviron UK makes a payment under the indemnity in sub-clause 6.7
above and Xxxxx or any of its Associated Companies receives a payment otherwise
than from Aviron UK in respect of the same loss, claim, demand, damage, cost,
charge, expense or liability giving rise to a claim in respect of which that
payment was made under the indemnity, Xxxxx or any of its Associated Companies
shall, once it has received such payment, forthwith repay to Aviron UK an amount
equal to the lesser of such payment and the payment under the indemnity in
either such case less the reasonable costs and expenses of obtaining any such
payment and irrecoverable [***] (if any) thereon.
6.9 The provisions of this sub-clause shall apply to any claim by a
third party against Xxxxx in respect of a matter which has given rise to a claim
pursuant to the indemnity given in sub-clause 6.7 above (in each case a
"Relevant Claim"). Xxxxx shall as soon as reasonably practical give written
notice of the Relevant Claim and subject to Xxxxx being fully indemnified
against any reasonable costs, liabilities and expenses thereby incurred:
6.9.1 keep Aviron UK informed of all material developments
relating to the Relevant Claim;
6.9.2 consult (so far as is reasonably practicable in the
circumstances) with Aviron UK in relation to the Relevant Claim and afford
Aviron UK (so far as it is lawfully able) all reasonable facilities to
investigate the same including, without limitation, reasonable access to the
personnel and premises of Xxxxx;
6.9.3 take all steps as Aviron UK may require to pursue,
litigate, defend, resist or compromise the Relevant Claim, provided such steps
are reasonable;
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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6.9.4 preserve all relevant documents in relation to the
Relevant Claim and allow access to Aviron UK on reasonable notice to inspect and
take copies of all such documents;
6.9.5 not make any admission of liability or fault nor settle or
compromise any Relevant Claim without the prior written consent of Aviron UK not
to be unreasonably withheld or delayed;
6.9.6 allow Aviron UK to take over the conduct of and/or
proceedings in relation to the Relevant Claim provided always that Aviron UK
shall:
(a) keep Xxxxx fully informed in respect of such
Relevant Claim and copy all material documents relating thereto to Xxxxx;
(b) make no settlement or compromise of the Relevant
Claim or agree any matter in the conduct of the Relevant Claim which is likely
to affect the amount thereof, without the prior written approval of Xxxxx (such
consent not to be unreasonably withheld or delayed);
Provided always that nothing in this sub-clause 6.9 shall require Xxxxx
to take any action which is reasonably likely to have a material adverse effect
on the business of Xxxxx and its Associated Companies.
6.10 Subject always to clause 6.3, other than in respect of claims
caused by any willful misfeasance or willful default of Aviron UK its Associated
Companies and their respective employees or agents, Aviron UK's liability in
contract, tort (including breach of statutory duty) or otherwise arising by
reason of or in connection with this Agreement or any agreement or indemnity
contemplated hereunder shall be limited to [***] in any [***] period. For the
avoidance of doubt, only one claim is permitted to be made in respect of any one
incident.
7. CONFIDENTIALITY
7.1 The Recipient undertakes to keep confidential all Restricted
Information and Materials received by it directly or indirectly from the
Discloser or obtained by it pursuant to the performance of this Agreement and
not to use such Restricted Information and Materials except as provided in this
Agreement. The obligations set forth in this Clause 7.1 shall apply [***].
7.2 The Recipient shall allow access to the Discloser's Restricted
Information and Materials exclusively to those of its employees who have
reasonable need to see and use it for the purposes of this Agreement and shall
inform each of such employees of the confidential nature of the Restricted
Information and Materials and of the obligations on the Recipient with respect
to such Restricted Information and Materials and shall ensure that each of its
employees having access to the Restricted Information and Materials is
contractually bound by obligations of confidentiality and shall take such steps
as may be necessary to enforce such obligations.
7.3 On the expiry or termination of this Agreement, the Recipient will
return to the Discloser all Restricted Information and Materials of the
Discloser in its possession and the
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Recipient shall, save in respect of the Aviron Restricted Material (other than
where the Recipient can demonstrate that copies of the same are required by any
Agency), have the option to retain (1) copy, but shall not make any further use
of that information save for record keeping purposes or in order to comply with
regulatory requirements from time to time.
7.4 In this clause 7 references to the Discloser or Recipient shall be
deemed to include any Associated Companies of that party.
8. LIAISON
The parties will each identify in writing the person responsible for the
day to day operation of this Agreement. The person responsible may be changed
from time to time with written notification to the other party. From the date of
signature of this Agreement Aviron UK's designated person pursuant to this
clause shall be [***] and Xxxxx'x shall be [***].
9. ASSIGNMENT AND CHANGE OF CONTROL
9.1 [***] may assign [***] its rights or delegate [***] its obligations
under this Agreement (other than [***] as the case may be provided that such
assignee [***] and provided further that before such assignee [***] will procure
that the benefit of this Agreement is re assigned to [***] or (upon giving
further written notice to [***]) to [***] (subject always to the foregoing
provisions of this clause) [***] the prior written consent of [***], except as
expressly provided herein.
9.2 This Agreement shall be binding upon and shall inure to the benefit
of Xxxxx and Aviron UK and their respective permitted successors and assignees
(if any).
9.3 The parties acknowledge and agree that any change of ownership or
control of either Xxxxx or Aviron UK shall not affect, either at law, or as
between the parties, that party's rights and obligations under this Agreement,
to the extent that the party undergoing such change of ownership or control
survives such change of ownership or control.
9.4 Xxxxx shall forthwith notify Aviron UK if there is an effective
change of ownership or control of Xxxxx (which in these circumstances shall
mean: (i) a change in the composition of the majority of the board directors of
either Xxxxx or its ultimate holding company; (ii) the acquisition by some other
entity or person of the power (whether directly or indirectly) to appoint and/or
remove all the members of the board of directors of either Xxxxx or its ultimate
holding company; or (iii) if Xxxxx sells all or substantially all of the assets
or all or substantially all of the business to which this Agreement relates.
Within a period of [***] of receipt of such notice or actual sale,
should Aviron UK in its reasonable opinion decide that the party assuming
effective ownership or control of, or purchasing the assets or business of Xxxxx
[***] or a party [***] Aviron UK [***] then Aviron UK may by a further [***]
written notice terminate this Agreement.
9.5 Any purported assignment in violation of this section by either
party shall be voidable by the other party.
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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10. TERM AND TERMINATION
10.1 Unless sooner terminated as provided under Clauses 9, 10.2 or 10.3
this Agreement shall come into force on the date hereof and shall continue in
force until 30th June 2006 (the "Initial Period"). Following expiry of the
Initial Period this Agreement shall terminate, provided always that from the
date which is on or about 18 months from the end of the Initial Period the
parties will enter into good faith discussions concerning their ongoing
relationship concerning this Agreement and provided further that there shall be
no obligation on Xxxxx to provide all or any Services to Aviron UK (whether
similar to the Services or otherwise) on expiry of the Initial Period and
provided further that each party shall be entitled to consider the interests of
their own business operations at such time.
10.2 Either party shall be entitled forthwith to terminate this
Agreement by written notice to the other if:
(a) the other party makes serious or persistent default
in performing and observing any of its obligations under this Agreement or is
guilty of any conduct or omission which in any such case, in the reasonable
opinion of the non-defaulting party, materially prejudices its interests and
(where such default, conduct or omission is remediable) fails to remedy it
within 30 days after service of written notice from the non defaulting party
requiring such remedy;
(b) an encumbrancer takes possession or a receiver is
appointed over any of the property or assets of that other party; or
(c) the other party becomes subject to an administration
order; or
(d) that other party goes into liquidation except for
the purposes of solvent amalgamation or reconstruction and in such manner that
the company resulting therefrom effectively agrees to be bound by or assumes the
obligations imposed on that other party under this Agreement;
(e) that other party is the subject of any proceeding or
order or other event in any applicable jurisdiction which would have an effect
analogous to any of the events mentioned in sub-clauses 10(b) to (c).
10.3 The parties acknowledge and agree that Xxxxx shall not be obliged
to provide any of the Services from the date on which Aviron UK or any of its
Associated. Companies cease to occupy the AVU Unit and from such date Aviron UK
shall not be entitled to recover any amounts under a Dose Recovery (pursuant to
sub-clause 5.7) in respect of the curtailment of the Services in such
circumstances.
10.4 For the purpose of Clause 10.2(a) a default shall be considered
capable of remedy if the party in breach can comply with the provisions in
question in all respects other than as to time of performance provided that time
of performance is not of the essence.
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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10.5 Save as specifically provided in this Agreement, a failure by any
party to exercise and any delay, forbearance or indulgence by any party in
exercising any right, power or remedy under this Agreement shall not operate as
a waiver of that right, power or remedy or preclude its exercise at any
subsequent time or on any subsequent occasion. The single or partial exercise of
any right, power or remedy shall not preclude any other or further exercise of
that right, power or remedy. No custom or practice of the parties at variance
with the terms of this Agreement shall constitute a waiver of the rights of any
party under this Agreement. The rights, powers and remedies provided in this
Agreement are cumulative and not exclusive of any rights, powers or remedies
provided by law.
10.6 The rights to terminate this Agreement given by this clause shall
be without prejudice to any other right or remedy of either party in respect of
the material breach concerned (if any).
10.7 On expiration or termination of this Agreement for any reason:
(a) Subject to 7.3, each party shall deliver up to the
other all materials, reports, and other documents (including copies thereof) in
its possession or control containing Restricted Information and Materials of the
other party, and each will cease to make use of the others Restricted
Information and Materials;
(b) Aviron UK will be obliged to purchase and Xxxxx will
be obliged to supply all stocks of Raw Materials purchased by Xxxxx in support
of purchase orders submitted by Aviron UK at [***];
(c) Aviron UK will collect all Raw Materials supplied to
Xxxxx free of charge. In the event that Aviron UK has not collected all Raw
Materials within [***] of the date of termination of this Agreement, Xxxxx may,
after [***], destroy such other Raw Materials and [***] a [***] such Raw
Materials.
(d) Termination of this Agreement for any reason shall
be without prejudice to any rights or obligations which shall have accrued prior
to such termination and shall not bring to an end any provisions of this
Agreement which, in order to give effect to their meaning, need to survive its
termination and such provisions shall remain in full force and. effect
thereafter and in particular, but without limiting the scope of foregoing the
rights and obligations of the parties under clauses 4, 5, 6, 7, 10 and 12.
11. NOTICES
11.1 Any notices (other than a notice given pursuant to sub-clause
5.4)or other information required or authorized by this Agreement to be given by
either party to the other may be given in writing, by hand or sent to the other
by first class airmail registered pre-paid post, telex facsimile transmission or
comparable means of communication. The same shall be sent or delivered to the
other party at the address shown for that party at the beginning of this
Agreement or to such other address which may be notified in writing to the other
party from time to time. Six (6)-working days should be allowed for delivery.
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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11.2 Any notice or other information given by post pursuant to clause
11.1 which is not returned to the sender as undelivered shall be deemed to have
been given on the sixth working day after the envelope containing the same was
so posted. Proof that the envelope containing any such notice or information was
properly addressed, pre-paid, registered and posted, and that it has not been so
returned to the sender, shall be sufficient evidence that such notice or
information has been duly given.
11.3 Any notice or other information sent by facsimile transmission or
comparable means of communication shall be deemed to have been duly sent on the
date of transmission, provided that a confirming copy thereof is sent by first
class airmail registered pre-paid post to the other party at the address
referred to in clause 11.1 within one working day after transmission.
12. GENERAL
12.1 Any reference in this Agreement to "writing" or cognate expressions
includes a reference to facsimile transmission or any legible reproduction of
words delivered in permanent and tangible form (but does not include e-mail).
12.2 The headings in this Agreement are for convenience only and shall
not affect its interpretation.
12.3 No variation or amendment of this Agreement shall bind either party
unless made in writing in the English language and agreed to in writing by duly
authorized officers of both parties.
12.4 If any provision of this Agreement is agreed by the parties to be
illegal void or unenforceable under any law that is applicable hereto or if any
court of competent jurisdiction in a final decision so determines this Agreement
shall continue in force save that such provision shall be deemed to be excised
here from with effect from the date of such agreement or decision or such
earlier date as the parties may agree.
12.5 This Agreement shall be governed by and construed in all respects
in accordance with the [***] and the parties hereby submit to the exclusive
jurisdiction of the [***] for the determination of any dispute arising
hereunder. Either party shall be entitled to enforce any order of the [***] in
any other jurisdiction.
12.6 The parties agree that the provisions of the [***] shall not apply
to this Agreement.
12.7 This Agreement may be executed in two or more counterparts, each of
which shall be deemed to be an original, and which together shall constitute one
and the same Agreement. Unless otherwise provided in this Agreement, this
Agreement shall become effective and be dated (and each counterpart shall be
dated) on the date on which this Agreement (or a counterpart of this Agreement)
is signed by the last of the parties to execute this Agreement or, as the case
may be, a counterpart thereof.
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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12.8 In the event of a conflict between this Agreement and the Quality
Agreement the provisions of this Agreement shall prevail in all respects and for
the avoidance of doubt, the Quality Agreement shall not impose any further
obligations on any of the parties.
13. PUBLIC DISCLOSURE
No public announcement of any kind shall be made in respect of or in
connection with this Agreement except as specifically agreed in writing between
the parties, or except to the extent that an announcement is required by law or
by any applicable stock exchange or any regulatory or governmental body to which
either party is subject but in such event any announcement by either party
shall, if reasonably practicable, be issued after prior discussion with the
other.
14. ENTIRE AGREEMENT
14.1 This Agreement and the Quality Agreement are the entire agreements
and understandings between the parties relating to the subject matter of this
Agreement, and supersedes any previous agreement between the parties.
14.2 Each of the parties acknowledges and agrees that in entering into
this Agreement, and the documents referred to in it, it does not rely on and
shall have no remedy in respect of, any statement, representation, warranty or
understanding (whether negligently or innocently made and whether written or
oral) of any person (whether party to this Agreement or not) other than as
expressly set out in this Agreement.
14.3 Nothing in this clause shall operate to limit or exclude any
liability from fraud.
15. FORCE MAJEURE
15.1 If Xxxxx is prevented, hindered or delayed from performing any of
its obligations under this agreement by an Event of Force Majeure, then as long
as that situation continues, Xxxxx shall be excused from performance of such
obligation to the extent it is so prevented, hindered or delayed, and the time
for performance of such obligation shall be extended accordingly.
15.2 If affected by an Event of Force Majeure, Xxxxx shall promptly
notify Aviron UK of its occurrence and its effect or likely effect, and subject
to clause 15.3 use all reasonable endeavours to minimize the effect of the Event
of Force Majeure and to bring it to an end.
15.3 Neither party shall be obliged to settle any strike or other
industrial action, dispute or disturbance of any kind, except on terms wholly
satisfactory to it.
15.4 During the period of an Event of Force Majeure Aviron UK shall not
be obliged to pay for any of the Services which are directly affected by such
Event of Force Majeure.
16. DISPUTES
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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16.1 If any dispute or difference (the "Dispute") arises in respect of
the construction, meaning or effect of this Agreement or any matter arising out
of or in connection with this Agreement, then such Dispute shall in the first
instance, [***] of a written request of one party to the other, [***].
16.2 If the Dispute is not resolved as a result of [***], Aviron UK or
Xxxxx may refer the Dispute to [***] or to [***], who shall meet for discussion
in good faith with a view to resolution of the Dispute, without recourse to
legal proceedings. If such persons fail to reach agreement within [***] of the
referral of the Dispute to them, the matter may be referred by either party
immediately to [***], or in the absence of such agreement within [***] of notice
by one party to the other requiring such appointment, the [***] and shall be
instructed to determine the resolution of the Dispute between the parties. The
[***] shall notify both parties of his or her determination as soon as possible
and in any event shall be requested so to notify within [***] of his or her
appointment. The findings of the [***] shall be final and binding on the
parties. Costs arising out of or in connection with instructing the [***] under
this clause 16.2 shall be borne by [***] or in such other proportions as the
[***] may determine to be fair and reasonable. The [***] may instruct [***] to
assist him or her in arriving at his or her decision and the fees and expenses
of any such [***] shall be payable by [***]. The [***] shall act as [***].
17. ASSETS
Xxxxx agrees and acknowledges that the assets [***], belong to Aviron UK
and Xxxxx has no right, title or interest in such assets.
18. [***]
18.1 Notwithstanding anything contained in this Agreement, if any of the
amounts payable by Aviron UK to Xxxxx under this Agreement are expressed to be
[***] then [***] shall only be payable [***] if:
(a) [***] on such sums or amounts; and
(b) a proper [***] invoice is submitted to [***].
18.2 If [***] under this Agreement, in accordance with clause 18.1, or,
notwithstanding clause 18.1, if (as applicable) no ruling under clause 18.3 has
been received to the effect that [***] in respect of any relevant amount by the
date on which any [***] under this Agreement, then it shall be [***] on the date
of this Agreement within 14 Business Days of the date of this Agreement and in
any other case on the date on which [***].
18.3
(a) The parties consider that the transactions detailed
in the Transaction Agreements shall not together constitute a [***] or [***] for
[***] purposes, and agree that [***] shall prepare a [***] to this effect. This
[***] shall be sent first to [***] or its agents for approval (such approval not
to be unreasonably withheld or delayed) and once approved shall be sent to
[***].
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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(b) The parties shall use their reasonable endeavours to
ensure that the [***] is obtained on or before the date of this Agreement. If no
[***] by the date of this Agreement the parties should use their reasonable
endeavours to ensure that within 5 Business Days of the date of this Agreement a
letter is sent to [***]. [***] shall send a copy of any [***] to [***] and [***]
within 5 Business Days of receipt of it from [***].
(c) If no such [***] has been obtained by the time that
[***] or [***] (as the case may be) is due to [***] which include a [***] it may
notify [***] that they have [***] on a transfer of assets which has not been
treated as [***].
18.4
(a) If [***] that any or all of the [***] which are
being treated as [***] under any of the Transaction Agreements constitute a
[***] or [***] or a [***]:
(i) [***], if it has not submitted a [***] on
which it has accounted for the [***] on the date on which such [***], will
forthwith issue [***] which has been [***] in which case [***] will on the date
of [***] as applicable the [***] detailed in the applicable [***]; or
(ii) [***], if it has submitted a [***] on which
the [***] has been accounted for, will make an [***] as appropriate for recovery
of the applicable [***] from [***] and will account to [***] as appropriate on
the date of such [***] and will issue at that date [***] which has been [***].
(b) For the avoidance of doubt any failure by [***] to
comply with any conditions detailed in the [***] under which a [***] is made
(such that [***] do not receive a [***] or only receive a [***] from [***]) will
not affect the obligation of [***] to refund to [***] any [***] and for the
purposes of clause 18.4 (a) (ii) it shall be regarded as having [***] on the
date on which it would have [***] were it not for such failure.
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
21
24
IN WITNESS WHEREOF, this Agreement has been executed by the duly
authorized representatives of the parties the day and year first above written.
XXXXX VACCINES LIMITED
By: /s/ C. S. W. Xxxxxxxxx
------------------------------
Name: C. S. W. Xxxxxxxxx
Title: Director
AVIRON UK LIMITED
By: /s/ Xxxx Xxxxxxx
------------------------------
Name: Xxxx Xxxxxxx
Title: SVP & CFO
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
25
SCHEDULE 1
THE SERVICES
[
--------------------------------------------------------------------------------
[***] [***]
--------------------------------------------------------------------------------
1. [***] [***]
--------------------------------------------------------------------------------
2. [***] [***]
--------------------------------------------------------------------------------
3. [***] [***]
--------------------------------------------------------------------------------
4. [***] [***]
--------------------------------------------------------------------------------
5. [***] [***]
--------------------------------------------------------------------------------
6. [***] [***]
--------------------------------------------------------------------------------
7. [***] [***]
--------------------------------------------------------------------------------
8. [***] [***]
--------------------------------------------------------------------------------
9. [***] [***]
--------------------------------------------------------------------------------
10- [***] [***]
--------------------------------------------------------------------------------
10. [***] [***]
--------------------------------------------------------------------------------
11. [***] [***]
--------------------------------------------------------------------------------
12. [***] [***]
--------------------------------------------------------------------------------
13. [***] [***]
--------------------------------------------------------------------------------
14. [***] [***]
--------------------------------------------------------------------------------
15. [***] [***]
--------------------------------------------------------------------------------
16. [***] [***]
--------------------------------------------------------------------------------
17. [***] [***]
--------------------------------------------------------------------------------
19. [***] [***]
--------------------------------------------------------------------------------
20 [***] [***]
--------------------------------------------------------------------------------
21 [***] [***]
--------------------------------------------------------------------------------
22 [***] [***]
--------------------------------------------------------------------------------
23 [***] [***]
--------------------------------------------------------------------------------
24 [***] [***]
--------------------------------------------------------------------------------
25 [***] [***]
--------------------------------------------------------------------------------
26 [***] [***]
--------------------------------------------------------------------------------
27 [***] [***]
--------------------------------------------------------------------------------
28 [***] [***]
--------------------------------------------------------------------------------
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
1
26
]
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
2
27
SCHEDULE 2
SERVICES CHARGES
[
--------------------------------------------------------------------------------
[***]
--------------------------------------------------------------------------------
[***] [***] [***]
----------------------------------------------------------------
[***] [***]
----------------------------------------------------------------
[***] [***]
----------------------------------------------------------------
[***] [***]
----------------------------------------------------------------
[***] [***]
----------------------------------------------------------------
[***] [***]
----------------------------------------------------------------
[***] [***]
----------------------------------------------------------------
[***] [***]
----------------------------------------------------------------
[***] [***]
----------------------------------------------------------------
[***] [***]
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
[***] [***] [***]
--------------------------------------------------------------------------------
[***] [***] [***]
--------------------------------------------------------------------------------
[***] [***] [***]
--------------------------------------------------------------------------------
[***] [***] [***]
--------------------------------------------------------------------------------
[***] [***] [***]
--------------------------------------------------------------------------------
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
3
28
--------------------------------------------------------------------------------
[***]
--------------------------------------------------------------------------------
[***] [***] [***]
--------------------------------------------------------------------------------
[***] [***] [***]
--------------------------------------------------------------------------------
[***] [***] [***]
----------------------------------------------------------------
[***] [***]
----------------------------------------------------------------
[***] [***]
--------------------------------------------------------------------------------
[***] [***] [***]
----------------------------------------------------------------
[***] [***]
--------------------------------------------------------------------------------
[***] [***] [***]
--------------------------------------------------------------------------------
[***] [***] [***]
--------------------------------------------------------------------------------
[***] [***] [***]
----------------------------------------------------------------
[***] [***]
--------------------------------------------------------------------------------
[***] [***] [***]
--------------------------------------------------------------------------------
[***] [***] [***]
--------------------------------------------------------------------------------
[***] [***] [***]
--------------------------------------------------------------------------------
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
4
29
--------------------------------------------------------------------------------
[***]
--------------------------------------------------------------------------------
[***] [***] [***] [***]
--------------------------------------------------------------------------------
[***] [***] [***] [***]
-----------------------------------------
[***] [***]
-----------------------------------------
[***] [***]
--------------------------------------------------------------------------------
[***] [***] [***] [***]
--------------------------------------------------------------------------------
[***] [***] [***] [***]
--------------------------------------------------------------------------------
[***] [***] [***] [***]
---------------------------------------------------------------------------------
[***] [***] [***] [***]
---------------------------------------------------------------------------------
[***] [***] [***] [***]
---------------------------------------------------------------------------------
]
[***] - CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
[***] HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
5
