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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
------------------------
FORM 10-K/A
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(MARK ONE)
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
FOR THE FISCAL YEAR ENDED DECEMBER 31, 1999
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD TO .
COMMISSION FILE NUMBER: 0-20815
AVIRON
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
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<S> <C>
DELAWARE 77-0309686
(STATE OR OTHER JURISDICTION OF (I.R.S. EMPLOYER
INCORPORATION OR ORGANIZATION) IDENTIFICATION NO.)
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297 NORTH BERNARDO AVENUE, MOUNTAIN VIEW, CALIFORNIA 94043
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES INCLUDING ZIP CODE)
(650) 919-6500
(REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE)
SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT
NONE
SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT
COMMON STOCK, $.001 PAR VALUE
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
Registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes [X] No [ ]
Indicate by check mark if disclosure of delinquent filers pursuant to Item
405 of Regulation S-K is not contained herein, and will not be contained, to the
best of Registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. [ ]
Based on the closing sale price of $39.6875 on March 1, 2000, the aggregate
market value of the voting stock held by non-affiliates of the Registrant was
$551,770,193.
On March 1, 2000, there were outstanding 17,163,183 shares of the
Registrant's Common Stock.
DOCUMENTS INCORPORATED BY REFERENCE
(TO THE EXTENT INDICATED HEREIN)
Part III -- Portions of the Registrant's Definitive Proxy Statement for the
Registrant's Annual Meeting of Stockholders to be held June 1, 2000, which will
be filed with the Securities and Exchange Commission, are incorporated by
reference to the extent stated here.
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PART IV.
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K.
(a)
(1) INDEX TO FINANCIAL STATEMENTS
The Financial Statements required by this item were previously filed in a
separate section in our Annual Report on Form 10-K for the year ended December
31, 1999, File No. 0-20815, filed with the SEC on March 8, 2000.
(2) INDEX TO FINANCIAL STATEMENTS SCHEDULES
All schedules are omitted because they are not applicable or the required
information is shown in the Financial Statements or in the notes thereto.
(3) EXHIBITS
See Exhibit Index.
(b) REPORTS ON FORM 8-K
No reports were filed on Form 8-K during the last quarter of the period
covered by this report.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the Registrant has duly caused this Form 10-K/A to be
signed on its behalf by the undersigned, thereunto duly authorized, on April 3,
2000.
AVIRON
By: /s/ C. BOYD CLARKE
------------------------------------
C. Boyd Clarke
President and Chief Executive
Officer
In accordance with the requirements of the Securities Exchange Act of 1934,
this report has been signed below by the following persons on behalf of the
Registrant in the capacities and on the dates stated.
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SIGNATURE TITLE DATE
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/s/ C. BOYD CLARKE President, Chief Executive Officer and April 3, 2000
- -------------------------------------- Director
C. Boyd Clarke (Principal Executive Officer)
/s/ FRED KURLAND Senior Vice President and Chief April 3, 2000
- -------------------------------------- Financial Officer
Fred Kurland (Principal Financial and Accounting
Officer)
/s/ J. LEIGHTON READ, M.D.* Chairman of the Board April 3, 2000
- --------------------------------------
J. Leighton Read, M.D.
/s/ REID W. DENNIS* Director April 3, 2000
- --------------------------------------
Reid W. Dennis
/s/ DENNIS M. FENTON, PH.D.* Director April 3, 2000
- --------------------------------------
Dennis M. Fenton, Ph.D.
/s/ WAYNE T. HOCKMEYER, PH.D.* Director April 3, 2000
- --------------------------------------
Wayne T. Hockmeyer, Ph.D.
/s/ PAUL H. KLINGENSTEIN* Director April 3, 2000
- --------------------------------------
Paul H. Klingenstein
/s/ BERNARD ROIZMAN, SC.D.* Director April 3, 2000
- --------------------------------------
Bernard Roizman, Sc.D.
/s/ JANE E. SHAW, PH.D.* Director April 3, 2000
- --------------------------------------
Jane E. Shaw, Ph.D.
*By: /s/ C. BOYD CLARKE
- --------------------------------------
C. Boyd Clarke
Attorney-in-fact
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EXHIBIT INDEX
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ITEM DESCRIPTION
---- -----------
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3.1 Bylaws of the Registrant(2).
3.2 Restated Certificate of Incorporation of the Registrant(2).
4.1 Reference is made to Exhibits 3.1 and 3.2.
4.2 Specimen Stock Certificate(1).
4.3 Warrant for Series A Preferred Stock, issued to The Mount
Sinai School of Medicine of the City of New York(1).
4.4 Warrant for Series A Preferred Stock, issued to The Mount
Sinai School of Medicine of the City of New York(1).
4.5 Warrant for Series A Preferred Stock, issued to The Mount
Sinai School of Medicine of the City of New York(1).
4.6 Warrant or Series A Preferred Stock, issued to The Mount
Sinai School of Medicine of the City of New York(1).
4.7 Warrant for Series C Preferred Stock, issued to Raymond,
James & Associates(1).
4.8 Investors Rights Agreement, dated July 18, 1995, among the
Registrant and the investors named therein(1).
4.9 Common Stock Purchase Agreement between the Registrant and
Biotech Target, S.A., dated as of March 27, 1997(3).
4.10 Rights Agreement between the Registrant and BankBoston,
N.A., dated as of October 8, 1997(5).
4.11 Common Stock Purchase Agreement between the Registrant and
American Home Products Corporation, dated as of December 16,
1999(14).
4.12 Common Stock Purchase Agreement between the Registrant and
American Home Products Corporation, dated as of December 30,
1999(14).
4.13 Common Stock Purchase Agreement between the Registrant and
American Home Products Corporation, dated as of February 3,
2000(14).
4.14 Warrant for Common Stock, issued to University of
Michigan(14).
+10.1 License Agreement between the Registrant and ARCH
Development Corporation, dated July 1, 1992(1).
+10.2 Technology Transfer Agreement between the Registrant and The
Mount Sinai School of Medicine of the City University of New
York, dated February 9, 1993(1).
+10.3 Materials Transfer and Intellectual Property Agreement
between the Registrant and the Regents of the University of
Michigan, dated February 24, 1995(1).
10.4 Stock Transfer Agreement between the Registrant and the
Regents of the University of Michigan, dated February 24,
1995(1).
+10.5 Development and License Agreement between the Registrant and
Sang-A Pharm. Co., Ltd., dated May 3, 1995(1).
+10.6 Cooperative Research and Development Agreement between the
Registrant and the National Institutes of Health, dated May
30, 1995(1).
+10.7 Heads of Agreement between the Registrant and SmithKline
Beecham Biologicals S.A., dated October 8, 1995(1).
+10.8 Manufacturing and Development Agreement between the
Registrant and Evans Medical Limited, dated November 7,
1995(1).
*10.9 1996 Equity Incentive Plan(1).
*10.10 1996 Non-Employee Directors' Stock Option Plan(1).
*10.11 1996 Employee Stock Purchase Plan(1).
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ITEM DESCRIPTION
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10.12 Industrial lease between the Registrant and the Vanni
Business Park General Partnership, dated August 29, 1995(1).
+10.13 First Amendment to License Agreement between the Registrant
and ARCH Development Corporation dated March 15, 1996(1).
+10.14 Biological Materials License Agreement between the
Registrant and the National Institutes of Health, dated May
31, 1996(1).
+10.15 Contract Manufacture Agreement between the Registrant and
Evans Medical Limited, dated as of April 16, 1997(4).
+10.16 Production Agreement between the Registrant and Packaging
Coordinators, Inc., dated as of October 31, 1997(6).
10.17 Facility Reservation Agreement between the Registrant and
Packaging Coordinators, Inc., dated as of October 31,
1997(6).
+10.18 Influenza Vaccine Collaboration and License Distributor
Agreement between the Registrant and CSL Limited, dated June
19, 1998(7).
+10.19 Supply Agreement between the Registrant and Becton Dickinson
and Company dated July 1, 1998(8).
+10.20 United States License and Co-Promotion Agreement between the
Registrant and Wyeth Lederle Vaccines dated January 11,
1999(9).
+10.21 International FluMist(TM) License Agreement between the
Registrant and Wyeth dated January 11, 1999(9).
+10.22 FluMist(TM) Supply Agreement between the Registrant and
Wyeth Lederle Vaccines dated January 11, 1999(9).
+10.23 Credit Agreement between the Registrant and American Home
Products Corporation dated January 11, 1999(9).
+10.24 Letter Amendment to the Materials Transfer and Intellectual
Property Agreement between the Registrant and the Regents of
the University of Michigan dated February 24, 1999(10).
10.25 Real Property Lease by and between the Registrant and
Spieker Properties, L.P. dated February 5, 1999(11).
+10.26 First Amendment to the Influenza Vaccine Collaboration and
License and Distribution Agreement by and between the
Registrant and CSL Limited, A.C.N. dated June 7, 1999(11).
10.27 Loan and Security Agreement by and between the Registrant
and Transamerica Business Credit Corporation dated June 23,
1999(11).
10.28 Master Loan and Security Agreement by and between the
Registrant and FINOVA Capital Corporation dated July 23,
1999(12).
++10.29 Amended and Restated Contract Manufacture Agreement by and
between the Registrant and Medeva Pharma Limited dated June,
1999, as amended.(13)
10.30 Real Property Lease by and between the Registrant and MELP
VII L.P., dated October 12, 1999(14).
10.31 Offer Letter, as amended, by and between the Registrant and
C. Boyd Clarke, dated November 24, 1999(14).
10.32 Employment Agreement by and between the Registrant and J.
Leighton Read, dated December 6, 1999(14).
10.33 Amendment No. 1 to Stock Transfer Agreement by and between
the Registrant and The Regents of the University of
Michigan, dated February 16, 2000(14).
23.1 Consent of Ernst & Young LLP, Independent Auditors.
24.1 Power of Attorney. See Signature Page(14).
27.1 Financial Data Schedule(14).
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+ Confidential treatment has been granted for portions of this exhibit.
++ Confidential treatment has been requested for portions of this exhibit.
* Compensatory Plan or Agreement
(1) Incorporated by reference to the correspondingly numbered exhibit to our
Registration Statement on Form S-1, File No. 333-05209, filed June 5, 1996,
as amended.
(2) Incorporated by reference to the correspondingly numbered exhibit to our
Quarterly Report on Form 10-Q, File No. 0-20815, for the quarter ended
September 30, 1996, filed December 20, 1996.
(3) Incorporated by reference to the correspondingly numbered exhibit to our
Quarterly Report on Form 10-Q for the quarter ended March 31, 1997, File
No. 0-20815, filed May 15, 1997.
(4) Incorporated by reference to the correspondingly numbered exhibit to our
Current Report on Form 8-K, File No. 0-20815, dated April 16, 1997 and
filed July 21, 1997.
(5) Incorporated by reference to the correspondingly numbered exhibit to our
Current Report on Form 8-K, File No. 0-20815, dated October 8, 1997 and
filed October 10, 1997.
(6) Incorporated by reference to the correspondingly numbered exhibit to our
Registration Statement on Form S-3, File No. 333-41649, filed December 10,
1997.
(7) Incorporated by reference to the correspondingly numbered exhibit to our
Quarterly Report on Form 10-Q for the quarter ended June 30, 1998, File No.
0-20815, filed August 14, 1998.
(8) Incorporated by reference to the correspondingly numbered exhibit to our
Quarterly Report on Form 10-Q for the quarter ended September 30, 1998,
File No. 0-20815, filed November 16, 1998.
(9) Incorporated by reference to the correspondingly numbered exhibit to our
Annual Report on Form 10-K for the year ended on December 31, 1998, File
No. 0-20815 filed March 31, 1999.
(10) Incorporated by reference to the correspondingly numbered exhibit to our
Quarterly Report on Form 10-Q for the quarter ended March 31, 1999, File
No. 0-20815, filed May 13, 1999.
(11) Incorporated by reference to the correspondingly numbered exhibit to our
Quarterly Report on Form 10-Q for the quarter ended June 30, 1999, File No.
0-20815, filed August 13, 1999.
(12) Incorporated by reference to the correspondingly numbered exhibit to our
Quarterly Report on Form 10-Q for the quarter ended September 30, 1999,
File No. 0-20815, filed November 15, 1999.
(13) Replaces previous exhibit filed in our Annual Report on Form 10-K for the
year ended December 31, 1999, File No. 0-20815, filed March 8, 2000.
(14) Incorporated by reference to the corresponding numbered exhibit to our
Annual Report on Form 10-K for the year ended December 31, 1999, File No.
02815, filed March 8, 2000.
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
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.
EXHIBIT 10.29
AMENDED AND RESTATED
CONTRACT MANUFACTURE AGREEMENT
THIS AGREEMENT (the "Restated Agreement") is made the June of 1999,
between MEDEVA PHARMA LIMITED ("Medeva"), with offices at Gaskill Road, Speke,
Liverpool L24 9GR, United Kingdom, and AVIRON ("Aviron") with offices at 297
North Bernardo Avenue, Mountain View, California 94043, United States of
America.
RECITALS
A. Medeva carries on the business of, inter alia, manufacture, assembly and
packaging of pharmaceutical products, or components thereof.
B. Medeva and Aviron have collaborated on the development of the manufacturing
process for the Intermediate Product under the terms of that certain
Manufacturing and Development Agreement dated 7th November 1995 (the "1995
Development Agreement").
C. Aviron wishes Medeva to Manufacture the Intermediate Product (as hereinafter
defined), and Medeva is willing to Manufacture the Intermediate Product on the
terms and conditions hereinafter set out.
D. Aviron is the exclusive licensee of the University of Michigan to certain
live attenuated influenza Master Virus Seeds and the technology associated with
and required for the production of certain reassortants therefrom;
E. Aviron and Medeva have entered into that certain Contract Manufacture
Agreement dated April 16, 1997 (the "1997 Contract Manufacture Agreement"), and
wish to amend and restate said agreement as provided in this Restated Agreement.
AGREEMENT
In consideration of the mutual covenants herein set forth, the adequacy of which
consideration is hereby acknowledged, the parties agree as follows:
1 AMENDMENT AND RESTATEMENT.
The parties hereby amend and restate the Contract Manufacture Agreement
dated April 16, 1997, to read in full as set forth below.
2 DEFINITIONS
In this Restated Agreement, the terms below shall have the meanings as
defined herein. Terms defined in the singular form shall include the
plural meaning and vice versa.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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
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2.1 "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.
2.2 "Associated Companies" means (i) in respect of Medeva, 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 English Companies Act 1985 (as amended); and, (ii) in respect of
Aviron, any entity that directly or indirectly owns, is owned by or
is under common ownership with Aviron, where own or ownership means
direct or indirect possession of at least fifty percent (50%) of the
outstanding voting securities of a corporation or a comparable
equity interest in any other type of entity.
2.3 "Aviron Assets" means capital equipment purchased by Aviron for use
in the Manufacture of the Intermediate Product as more particularly
specified in Schedule 1.
2.4 "Aviron Process Technology" means all technology (including
improvements, modifications, or adaptations to the process or method
of Manufacture) specific solely to the Manufacture of the
Intermediate Product or the Vaccine and which was developed and/or
disclosed by Medeva during the Term of this Restated Agreement, the
1997 Contract Manufacture Agreement or the 1995 Development
Agreement, and which is not in the public domain or otherwise
generally available to the public.
2.5 "Aviron Unit" or "AVU" means the manufacturing facility where the
Intermediate Product is Manufactured, as further described and
delineated in the map attached as Schedule 2, and as expanded from
time to time by mutual agreement of the parties. For the avoidance
of doubt, all plant and machinery save for the Aviron Assets and all
buildings, fixtures and fittings comprising the Aviron Unit belong
to and are owned and operated by Medeva.
2.6 "Best Endeavours" shall mean that the relevant party shall take such
action in complying with its obligations for which such endeavors
are required that is, having regard to costs and degree of
difficulty, commercially practicable, and that Medeva is not
required to take any action pursuant to this clause which would
undermine its commercial goodwill or standing or lead to its
financial ruin.
2.7 "BLA"shall have the meaning as defined in the Technical Agreement.
2.8 "CAIV Product" means a live, attenuated, intranasally deliverable
cold-adapted influenza vaccine which, when [ * ] produces an [ * ]
that is not less than [ * ] of the [ * ] produced in [ * ].
2.9 "Certificate of Analysis" means documentation provided by suppliers
specifying the characteristics of materials being supplied as such
term is understood in U.K. pharmaceutical manufacturing practice.
2.10 "Consistency Lot" means batches of Intermediate Product Manufactured
for the purposes of establishing that the process of Manufacture of
the Intermediate Product can be consistently repeated, as required
for obtaining Agency approval to market, distribute, and sell the
Vaccine.
2.11 "Development" means the development of a process for Manufacture of
Intermediate Product.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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
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2.12 "Direct Damages" means the [ * ] incurred for [ * ] Intermediate
Product rejected by Aviron pursuant to Clause 6.4.2, and [ * ] of
such Intermediate Product, [ * ].
2.13 "Effective Date" means the date first written above.
2.14 "Eggs" means the specific pathogen-free eggs supplied by Aviron
or its supplier to Medeva for the Manufacture of the Intermediate
Product.
2.15 "ELA" means Medeva's Establishment License Application to be
submitted to the FDA in order to receive the manufacturing
license for the Manufacture of the Intermediate Product.
2.16 "FDA" means Food and Drug Administration of the United States of
America.
2.17 "Finished Product" means the Vaccine in its final form packaged
for sale to the consumer.
2.18 "Flu Season" means, in respect of the northern hemisphere, the
period of time during a calendar year anticipated to start
approximately in the beginning of August and ending approximately
in January in which it is anticipated that the Vaccine will be
used to vaccinate patients.
2.19 "Force Majeure" means, in relation to either party, any
circumstances beyond the reasonable control of that party
including, without limitation, any Act of God, fire, explosion,
flood, war or hostilities, acts of Government appointed agents,
embargoes or other export restrictions, or perils of the sea.
2.20 "GSA" means the general service area as described in Schedule 4.
2.21 "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
Restated Agreement.
2.22 "Harvest" shall have the meaning as defined in the Technical
Agreement.
2.23 "Improvement" means any improvements, modifications or
adaptations to the process of Manufacture of the Intermediate
Product;
2.24 "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.
2.25 "Manufacture" means the production of the Intermediate Product
from the Raw Materials and shall include production of [ * ],
production of [ * ] and "Manufactured," "Manufacturing," and
"Manufacturer" shall be interpreted accordingly.
2.26 "Manufacturing Instructions" means the documentation of the
Manufacturing process and applicable standard operating
procedures which must be followed by Medeva in the
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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
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Manufacture of the Intermediate Product incorporated as part of
Appendix 2 to the Technical Agreement.
2.27 "Manufacturing Period" means a period of one year starting with
[ * ] and ending [ * ] of the next calendar year during the term
of this Restated Agreement.
2.28 "Manufacturing Records" "Manufacturing Records" means
manufacturing, facility/systems and environmental monitoring and
cleaning, packaging and quality control and quality assurance
records generated by Medeva in the course of the Manufacture,
including, without limitation, the Manufacturing Instructions,
production, packaging, quality control, and quality assurance
records.
2.29 "Manufacturing Working Virus Seeds" means the virus reassortants
produced by Medeva, from time to time, from the Master Virus
Seeds, and from which the Monovalent Virus Harvest is produced.
2.30 "Master Donor Strains" shall mean the live attenuated influenza
strains derived by Dr. Maassab and designated Type A/Ann
Arbor/6/60-H2N2 and Type B/Ann Arbor/1/66, exclusively licensed
from Michigan to Aviron, and which are modified at Aviron to
produce Master Virus Seeds.
2.31 "Master Virus Seeds" means certain reassortants produced by
Aviron from the Master Donor Strain.
2.32 "Medeva Process Technology" means all technology (including
improvements, modifications, or adaptations to the process or
method of Manufacture) developed, owned, controlled or licensed
(with the right to sub-license) by Medeva pertaining to [ * ] or
any other formulation of a product [ * ] which is not Aviron
Process Technology including such process technology arising from
the 1995 Development Agreement and the 1997 Contract Manufacture
Agreement between the parties, and which is not in the public
domain or otherwise generally available to the public.
2.33 "Michigan" means the Regents of the University of Michigan, a
constitutional corporation of the State of Michigan with offices
located at Wolverine Tower, Room 2071,3003 South State Street,
Ann Arbor, Michigan, 48109-1280, USA.
2.34 "Michigan Agreement" means the Material Transfer and Intellectual
Property Agreement dated February 24, 1995 between Michigan and
Aviron, as amended annexed hereto as Schedule 5.
2.35 "Monovalent Virus Harvest" means each of the three virus strains
to be incorporated in the Vaccine for a given Flu Season in bulk
form.
2.36 "MPU" stands for Media Preparation Unit and means the facility
where media for Manufacture is prepared, as further described in
Schedule 6.
2.37 "NAF" means "Normal Allentoic Fluid" used as a diluent in the
Vaccine.
2.38 "Named Executives" means a director of Medeva and a vice
president of Aviron designated and replaced from time to time by
the respective party. As of the Effective Date the Named
Executive of Medeva shall be Mike Harvey and the Named Executive
of Aviron shall be Fred Kurland.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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2.39 "PAI" means pre-approval inspection.
2.40 "PIC" means the Pharmaceutical Inspection Convention.
2.41 "PPI" means the Producer Price Index produced by the UK
Statistics Office.
2.42 "Process Evaluation Team" shall have the meaning as set forth in
the Technical Agreement.
2.43 "Raw Materials" means the components defined in the Technical
Agreement and required by Medeva in the Manufacture of the
Intermediate Product.
2.44 "Recruited" means the person concerned is on the payroll of
Medeva or has formally accepted an offer of employment with
Medeva and Recruitment shall be interpreted accordingly.
2.45 "Restricted Information" means (i) Master Donor Strains, Master
Virus Seeds and Working Seeds; (ii) all Technical Information
relating to Master Donor Strains, the Master Virus Seeds and the
Manufacture of the Intermediate Product; (iii) all information
relating to the Discloser's business; and (iv) all information
arising pursuant to this Restated Agreement, the 1995 Development
Agreement and the 1997 Contract Manufacture Agreement between the
parties, disclosed by one party to this Restated Agreement (the
"Discloser") to the other (the "Recipient") in connection with
this Restated Agreement, excluding any such information which:
2.45.1 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
2.45.2 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
2.45.3 must be disclosed to government inspectors in the
discharge of statutory obligations provided that before
disclosure the Recipient shall use reasonable endeavors as
it would in respect of its own Restricted Information to
obtain from such government inspectors any assurances as
regards confidentiality as may be afforded to such
information in the circumstances; or
2.45.4 must be disclosed by the Recipient to the relevant Agency
in the course of applying for, obtaining or maintaining
regulatory approval; or
2.45.5 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 or the
University of Michigan; or
2.45.6 is required to be disclosed by law.
2.46 "Specifications" means requirements and specifications for the
Intermediate Product and its Manufacture, attached to the
Technical Agreement, as may be amended from time to time in
accordance with the terms of this Agreement.
2.47 "Specifications Working Group" or "SWG" shall have the same
meaning as set forth in the Technical Agreement.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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
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2.48 "SPF Unit" means the facility where Eggs are [ * ], as further
described in Schedule 7.
2.49 "Technical Agreement" means the Technical Agreement, as amended
from time to time, entered into between the parties on even date
herewith and attached hereto and incorporated herein as Schedule
8.
2.50 "Technical Information" means all registration data, know-how,
experience, 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,
formulation, handling, storage and use.
2.51 "Term of Agreement" means the period from April 16, 1997 until
the expiration or termination of this Restated Agreement as
provided in Clause 15.
2.52 "Trained" means the employee of Medeva has undergone Medeva's
induction process which covers the basic theory and principles of
Health and Safety, cGMP, work in cleanrooms and basic
microbiology and has started in depth job training.
2.53 "Vaccine" means Aviron's live, attenuated, intranasally delivered
cold adapted influenza vaccine in the frozen formulation made
using the Master Donor Strains (i.e. which, during the dating
period established by the FDA, maintains stability at
temperatures of [ * ] and may maintain stability at temperatures
of [ * ] but does not maintain stability at [ * ] or at [ * ] as
further described in the FDA BLA.
2.54 "W-A" means Wyeth-Ayerst Laboratories Division of America Home
Products, Corp. or any entity that directly or indirectly owns,
is owned by or is under common ownership with W-A, where own or
ownership means direct or indirect possession of at least fifty
percent (50%) of the outstanding voting securities of a
corporation or a comparable equity interest in any other type of
entity.
3 CONTRACT MANUFACTURE
3.1 APPOINTMENT. Aviron hereby appoints Medeva and Medeva accepts the
appointment as a contract Manufacturer of the Intermediate
Product for the term of this Restated Agreement. During the term
of this Restated Agreement, Medeva will Manufacture for Aviron
the Intermediate Product in accordance with this Restated
Agreement, the Technical Agreement and the Specifications.
3.2 SUPPLY OF MASTER VIRUS SEEDS; EXPORT OF INTERMEDIATE PRODUCT.
Aviron shall be responsible for and shall bear all risks
associated with the importation into the United Kingdom and
delivery to Medeva of the Master Virus Seeds and the Eggs used
for growing the Manufacturing Working Virus Seeds. Aviron shall
be responsible for export of the Intermediate Product from the
United Kingdom and shall bear any costs, expenses and risk in
accordance with the EXW delivery terms set forth in Clause 6.3.
Medeva shall assist, at Aviron's reasonable request and at
Aviron's expense, with the export of the Intermediate Product
from the United Kingdom.
3.3 COORDINATION. Technical staff of Aviron and Medeva shall
cooperate and coordinate closely the points of intersection
between tasks relating to the Manufacture, release and shipping
of the Intermediate Product performed by Medeva and by Aviron.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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3.4 SAMPLING. Samples of the Intermediate Product and the Raw
Materials shall be retained, stored and provided to Aviron in the
manner set forth in the Technical Agreement.
3.5 RELEASE. The release of the Product shall be carried out in the
manner set forth in the Technical Agreement.
3.6 RECORD MAINTENANCE. All provisions pertaining to the
maintenance and retention of Manufacturing Records are set
forth in the Technical Agreement;
3.7 OTHER OBLIGATIONS OF MEDEVA. Medeva covenants the following:
3.7.1 MANUFACTURE. It will carry out the Manufacture in
accordance with this Restated Agreement the Technical
Agreement and the Specifications;
3.7.2 MAINTENANCE. It will maintain the GSA, the MPU, the SPF
Unit, the Aviron Unit and Medeva's equipment used in the
Manufacture pursuant to Medeva's standard procedure
pertaining to the maintenance of equipment of a similar
nature to the Aviron Unit and Medeva's equipment in
compliance with Clauses 3.7.1, 3.7.6 and 3.7.7;
3.7.3 SUPPLY OF RAW MATERIALS. All Raw Materials supplied by
Medeva and used in Manufacture will comply with the
Technical Agreement and the Specifications;
3.7.4 STORAGE OF MATERIALS. It will keep the Master Virus Seed,
the Manufacturing Working Virus Seed, any other Raw
Materials and Intermediate Product under environmental
conditions as defined in the Technical Agreement and the
Specifications;
3.7.5 COMPLIANCE WITH CGMP. It will Manufacture all
Intermediate Product in compliance with cGMP; provided,
that if the [ * ] of the [ * ] and [ * ] the parties will
[ * ] and [ * ]
3.7.6 COMPLIANCE WITH HEALTH AND SAFETY AND ENVIRONMENTAL
REGULATIONS. It will comply with applicable UK and EU
health and safety and environmental laws and regulations
in the Manufacture of the Intermediate Product.
3.7.7 INSPECTIONS BY AVIRON
3.7.7.1 It will permit, [ * ] of this Agreement and during
normal business hours and upon reasonable notice,
representatives of Aviron and its Associated
Companies [ * ] including a representative of W-A
[ * ] any such [ * ] of any representatives of
Aviron, its Associated companies or W-A [ * ] to
have access to any relevant records in connection
with such Manufacture, and to inspect the relevant
parts of the premises where Manufacture of
Intermediate Product is carried out, and assess
its compliance with cGMP and any current practices
of any relevant Agency, and to discuss any related
issues with Medeva's management personnel.
3.7.7.2 Notwithstanding the foregoing, Medeva's
obligation to allow such visitors is on condition
that: (a) Aviron, Aviron's Associated Companies
and W-A, respectively, procure agreement from such
visitors in writing
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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to observe the regulations of Medeva regarding
security, health and safety and any other
applicable regulations at the relevant premises,
and confidentiality obligations corresponding to
those contained in this Restated Agreement; (b)
any visit shall be under the specific supervision
of Medeva [ * ] and (c) Aviron, Aviron's
Associated Companies and W-A, respectively, [ * ]
and shall [ * ] to [ * ] or any [ * ] or [ * ] or
[ * ] on [ * ] and (d) Aviron, Aviron's
Associated Companies and W-A use their Best
Endeavours to ensure that the visit is of minimal
disruption to Medeva's day to day business.
3.7.8 INSPECTIONS BY AGENCIES.
3.7.8.1 It will allow representatives of any Agency to
inspect the relevant parts of its premises where
the Manufacture of the Intermediate Product is
carried out and to inspect the Manufacturing
Records to ensure compliance with cGMP and other
practices or regulations. In the event that an
Agency inspects those areas of Medeva's premises
used in the Manufacture of the Intermediate
Product, Medeva shall provide as much notice as
practicable of such inspection to Aviron and shall
permit representatives of Aviron to [ * ] said
inspection. Aviron acknowledges that its
representatives [ * ] the [ * ] to [ * ] in [ * ]
except that [ * ] the [ * ] to [ * ] in the [ * ]
of [ * ] and [ * ] any wrap-up sessions conducted
by the Agency representative which relate solely
to the Manufacture of the Intermediate Product
and/or the Aviron Unit.
3.7.8.2 In connection with the PAI, Medeva will permit
[ * ] Aviron's [ * ] to be present and participate
[ * ] relating to the Vaccine; provided, however,
that Medeva shall have the right [ * ] where he
would become privy to confidential information not
related to the Vaccine. Furthermore, in
preparation of the PAI, Medeva shall [ * ] and
during the PAI shall make accessible to the Agency
[ * ] all documentation specifically associated
with the Manufacture of the Intermediate Product.
3.7.8.3 Medeva shall inform Aviron of any questions or
recommendations made by the Agency and shall
provide to Aviron copies of any written questions
or recommendations received from the Agency
insofar as they pertain to the Manufacture of the
Intermediate Product. Medeva and Aviron shall
[ * ] any written questions and recommendations of
the Agency and [ * ] 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 contents
of any response to a question or recommendation of
an agency that pertains to [ * ] and save where
the response to the question or recommendation of
the agency pertains [ * ] in which case [ * ]
shall have [ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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[ * ] as to the contents of such response. In the
case of a question or recommendation made by the
Agency requiring [ * ] Medeva's representatives
present during said inspection shall [ * ] and
shall [ * ] the response made. Further, Medeva
shall promptly send to Aviron a copy of any
reports, citations, or warning letters received by
Medeva in connection with an Agency Inspection to
the extent such documents relate to or affect the
Manufacture of the Intermediate Product.
3.7.9 RECALL OF THE FINISHED PRODUCT. It will, [ * ] provide to
Aviron such assistance with any recall of the Finished Product
as reasonably necessary.
3.7.10 MANUFACTURING LICENSE. It is in possession of, and during the
term of the Restated Agreement will [ * ] to maintain, a
current Manufacturing License No ML 0039/02 granted pursuant
to the Medicines Act 1968.
3.7.11 RESOURCES. It will [ * ] from time to time and [ * ]
reasonably necessary to perform its obligations under this
Restated Agreement, in particular in the areas of:
o training of employees who will be engaged in the
Manufacture
o quality assurance
o quality services
o regulatory affairs
o Manufacture
o quality control
o validation
o documentation
o facility maintenance
o GSA, SPF Unit, and MPU operation
o warehousing
o calibration
o release and shipping
Aviron and Medeva agree to discuss and review on an ongoing
basis such staffing and resources. Medeva shall be entitled to
amend staffing levels in accordance with clauses 9.2.6.4,
9.2.6.5. and 9.2.6.6.
3.7.12 TECHNICAL SUPPORT. It shall provide its personnel for
technical support as set forth in Schedule 9, including,
without limitation, for:-
3.7.12.1 [ * ] the Specifications Working Group; and
3.7.12.2 [ * ] the Process Evaluation Team; and
3.7.12.3 assisting Aviron with its post-approval FDA BLA
maintenance, preparation, filing and post-approval
maintenance of BLAs in territories other than the
USA.
3.7.12.4 PAIs of Agencies other than the FDA.
3.7.13 Any reasonable assistance to Aviron with obtaining FDA
approval of the BLA, preparation and attendance of FDA's PAI,
training of Medeva employees,
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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continuing validation, engineering changes which are
[ * ] to the Manufacturing process, routine post-approval
inspections, PAIs, maintenance of documentation ([ * ]),
transfer of Medeva Process Technology to Aviron's
sublicensees [ * ] over the life of the Restated
Agreement (out-of-pocket expenses and travel as provided
in Medeva's company travel policy to be invoiced and
charged separately to Aviron), [ * ] in the [ * ] of the
[ * ] set forth in Schedule 9. Any additional [ * ] will
be provided pursuant to Clause 3.7.12
3.7.14 The cost of any actions or assistance to be undertaken or
provided by Medeva relating only to the Vaccine required by an
Agency after BLA approval will be [ * ] based on [ * ].
3.7.15 MANUFACTURE OF MANUFACTURING WORKING VIRUS SEEDS. During each
manufacturing period Medeva shall manufacture, [ * ] strains
of Manufacturing Working Virus Seeds for which Aviron has
supplied the Master Virus Seeds, in sufficient quantities to
undertake the Manufacture of Monovalent Virus Harvest. Should
Aviron require [ * ] Manufacturing Working Virus Seeds to be
manufactured by Medeva it shall notify Medeva of such and
shall [ * ] for each additional Manufacturing Working Virus
Seed manufactured by Medeva.
3.7.16 Y2K Medeva confirms that it has reviewed its principal
systems for Y2K compliance and that a programme is in place
for the review of other areas of potential concern such as
embedded microchips.
3.7.17 SPF UNIT. Medeva will reorganize its internal manufacturing
processes for products other than the Intermediate Product in
such a manner that within [ * ] from the Effective Date, any
eggs processed in the Aviron incubators in the SPF Unit will
be used only in the Manufacture of the Intermediate Product.
3.8 OTHER OBLIGATIONS OF AVIRON. Aviron covenants the following:
3.8.1 SUPPLY OF TECHNICAL INFORMATION. It will supply to Medeva
and promptly update all Technical Information in its
possession which is necessary to enable Medeva to
Manufacture the Intermediate Product, including all
information regarding health, safety, environmental
issues, and FDA regulations, as it becomes known;
3.8.2 TECHNICAL ASSISTANCE. It will provide such technical
assistance, [ * ] as may be required to enable the
effective transfer of the Technical Information under
3.8.1 such that Medeva should reasonably be expected to be
able to Manufacture the Intermediate Product on the basis
of such Technical Information;
3.8.3 SUPPLY OF RAW MATERIALS. It shall provide the Raw
Materials set forth in Schedule 10 to Medeva in accordance
with the requirements for such agreed between the parties
pursuant to clause 6.2. Such Raw Materials shall comply
with the Technical Agreement and the Specifications, and
where appropriate shall be accompanied by a Certificate of
Analysis;
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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3.8.4 INSTRUCTIONS REGARDING RECORD KEEPING. It shall notify
Medeva of, and Medeva shall comply with any special
requirements in respect of record keeping that may be
necessary to comply with Aviron's Product Tracking and/or
Recall Procedure or other Agency requirements. If such
requirements of Aviron [ * ] of [ * ] of Medeva , [ * ] on
[ * ] including, without limitation by [ * ] should the
compliance with such requirements [ * ] Medeva.
3.8.5 RECALL OF THE FINISHED PRODUCT. Aviron shall notify Medeva
of any recall of the Finished Product and shall, in that
notice, provide as much detail as possible of the reason
for the recall.
3.8.6 Y2K. Aviron confirms that it has reviewed its principal
systems and the systems of its suppliers of Raw Materials
for Y2K compliance and that a programme is in place for
the review of other areas of potential concern such as
embedded microchips.
3.9 NOTIFICATION.
3.9.1 Aviron shall notify Medeva of [ * ] in any [ * ] of the
[ * ] and any [ * ] of [ * ] the Finished Product for a
[ * ] for [ * ] and its [ * ] If any regulatory
requirements [ * ] with the then-current requirements
applicable to the Manufacture of the Intermediate Product
under this Restated Agreement (including without
limitation, cGMP, and applicable health, safety and
environmental regulations) or [ * ] of the Finished
Product [ * ] in relation to [ * ] or its [ * ] the
parties will discuss [ * ] on how to [ * ] and Aviron
shall [ * ] the Finished Product [ * ] or for the [ * ]
the [ * ] how to [ * ] or [ * ]. Medeva hereby
acknowledges that the Finished Product is anticipated to
be marketed in [ * ], and that there are no conflicts or
difficulties regarding product liability insurance
regarding those territories.
3.9.2 Aviron shall notify Medeva promptly upon receiving any
request of Michigan for the transfer of Medeva Process
Technology or Manufacturing Instructions as provided under
the terms of the Michigan Agreement.
4 AVIRON UNIT.
4.1 USE OF AVIRON UNIT. The Aviron Unit, in addition to other
facilities as required, will be made available for the
Manufacture of the Intermediate Product during the term of this
Restated Agreement [ * ] and [ * ] in respect of [ * ]
Furthermore and subject to Aviron's agreement, the Aviron Unit
may be used by Medeva for the conduct of research and development
towards the improvement of the Intermediate Product and the
Manufacture, provided however, that any and all proprietary
rights to such improvements shall be governed by Clause 7. Aviron
shall pay to Medeva the sums set forth in Schedule 11 for use of
the Aviron Unit. [ * ] pursuant to
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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[ * ] the Aviron Unit shall not be used by Medeva outside the
scope of this Restated Agreement without the consent of
Aviron.
4.2 AVIRON ASSETS.
4.2.1 PURCHASE. Medeva shall be entitled to purchase and install
equipment, all replacement tooling or parts or make
modifications to the buildings and services as may be
required for the Manufacture of the Intermediate Product,
[ * ] of which [ * ] to [ * ] upon [ * ] Notwithstanding
the above, Medeva shall not purchase and/or install any
such equipment, tooling or parts or make such
modifications [ * ] or where the [ * ] in relation to the
Restated Agreement without first obtaining the prior
written consent of Aviron. Such equipment, tooling or
parts form part of Aviron Assets and shall be deemed
included in Schedule 1. Where the [ * ] Medeva may at its
discretion [ * ] from Aviron such [ * ] up to [ * ] the
[ * ] prior to [ * ]. Medeva will ensure that such items
are in compliance with the requirements of the Agency and
with health and safety and environmental regulations. Any
equipment or tooling purchased by Medeva hereunder and
[ * ] shall [ * ] by Medeva for any purpose outside the
scope of this Restated Agreement without the consent of
Aviron.
4.2.2 OWNERSHIP AND LIABILITY. All Aviron Assets are owned by
Aviron. Aviron shall bear the risk of loss or damage to
Aviron Assets, except for loss or damage caused by
Medeva's negligence or willful misconduct in which
circumstance Medeva shall be liable to Aviron for such
loss or damage. Aviron shall insure and provide evidence
to Medeva's reasonable satisfaction that Aviron Assets are
appropriately insured and that such insurance covers any
loss of or damage to Medeva's property, personnel or
business as a consequence of any damage whatsoever caused
to or by such equipment or its loss, damage, or
destruction, unless due to the negligence or willful
misconduct of Medeva.
4.2.3 MAINTENANCE OF AVIRON ASSETS. Medeva shall maintain the
Aviron Assets in compliance with Clauses 3.7.1, 3.7.6 and
3.7.7 and in accordance with Medeva's operating procedure
pertaining to maintenance of equipment of a similar nature
to the Aviron Assets. [ * ] shall be responsible for the
reasonable cost of maintaining such equipment.
4.2.4 EFFECT OF EXPIRY OR TERMINATION. Upon expiry or
termination of this Restated Agreement, Aviron shall,
[ * ] remove the Aviron Assets from Medeva's premises and
shall [ * ] to the [ * ] to the [ * ] (except for [ * ]
from the [ * ] of the Intermediate Product), any part of
[ * ] where such [ * ] at [ * ] unless [ * ] such
equipment [ * ]. At the point of Medeva purchasing such
equipment from Aviron, all of Aviron's obligations [ * ]
relating to such assets terminates. Should Aviron fail to
remove the Aviron Assets [ * ] as provided in this clause
4.2.4 within the [ * ] Medeva may arrange,
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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[ * ] of the [ * ] and [ * ].
5 TECHNICAL AGREEMENT AND REGULATORY MATTERS
5.1 SCOPE. The respective responsibilities of Medeva and Aviron
relating to the Manufacture of the Intermediate Product, the way
in which each batch of the Intermediate Product has been
Manufactured and checked for compliance with and adherence to the
Technical Agreement, the responsibility for purchasing materials,
testing and releasing materials and undertaking production and
quality control including in-process controls as well as sampling
and analysis shall be as specified in the Technical Agreement.
5.2 MANUFACTURING HAZARDS. Medeva shall be responsible for ensuring
the safe operation of the process of Manufacture of the
Intermediate Product set forth in, inter alia, the Technical
Information and the Technical Agreement. Aviron and Medeva shall
continuously provide the other with any pertinent information of
which they become aware relating to any hazardous aspect of the
Manufacture, the Raw Materials or the Intermediate Product
including but not limited to any information pertaining to the
possibility of any cross contamination of any other products
being manufactured or stored by Medeva. Should [ * ] that any
[ * ] of the Manufacture of the Intermediate Product [ * ] then
it shall so notify [ * ] of such in writing and both parties
shall use their Best Endeavours, [ * ] (at [ * ] set forth in
Schedule [ * ], to [ * ] prior to undertaking the Manufacture. If
such [ * ] shall have the [ * ] with the Manufacture of the
Intermediate Product. If [ * ] that such [ * ] either party may
[ * ] on the provision of [ * ].
5.3 AMENDMENTS TO THE TECHNICAL AGREEMENT AND THE SPECIFICATIONS.
5.4 Any amendment to the Technical Agreement, including an amendment
to the Specifications, shall be made by [ * ] as provided in the
Technical Agreement. Aviron shall [ * ] in connection with the
implementation of such amendments to the Technical Agreement or
the Specifications. The parties shall discuss and agree in good
faith on [ * ] including, without limitation, a [ * ] or an [ * ]
and on [ * ] to [ * ] resulting from [ * ] or [ * ] resulting
from such amendments.
5.5 REGULATORY APPLICATIONS.
5.5.1 BLA. Aviron will file the BLA in its own name and will own
all rights thereto. Medeva will submit to Aviron in a
timely fashion data and information relating to the
Manufacture of the Intermediate Product for inclusion by
Aviron in the BLA as requested by Aviron from time to
time, and will [ * ] in a [ * ] such data and information
once included.
5.5.2 ELA. Medeva will file a supplement to the existing ELA for
Manufacture of Intermediate Product in the Aviron Unit at
Speke plant concurrently with filing of BLA by Aviron.
Subject to CBER consent, certain confidential information
regarding the Aviron Unit or any processes and equipment
which is filed with the ELA will be [ * ]. If
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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[ * ] such [ * ] will be [ * ] subject to the
confidentiality obligations of this Restated Agreement.
6 CAPACITY, FORECAST, AND SUPPLY
6.1 CAPACITY.
6.1.1 The parties acknowledge and agree that the [ * ] amount of
the Intermediate Product that Medeva can Manufacture in
any Manufacturing Period shall be determined, inter alia,
by the [ * ] of the respective Master Donor Strains and
therefore such Manufacturing capacity [ * ] until such
[ * ] are [ * ] The parties also acknowledge and agree
that such [ * ] of the respective Manufacturing Working
Virus Seeds will generally not [ * ] of any year. Hence,
the parties shall, once the [ * ] of the respective
Manufacturing Working Virus Seeds for the relevant year
are [ * ] the Manufacturing capacity for Medeva for [ * ]
and the [ * ] based on the factors set forth in Schedule
12. The parties agree that the Manufacturing capacity for
the first Manufacturing Period starting [ * ] and ending
[ * ] is [ * ] of Finished Product. For the second and any
subsequent Manufacturing Periods, the parties shall set a
[ * ] Manufacturing capacity by [ * ] prior to the
Manufacturing Period in question based on the capacity of
the then current Manufacturing Period and the factors set
forth in Schedule 12.
6.1.2 During any Manufacturing Period the Manufacturing capacity
of Medeva determined in accordance with clause 6.1.1 above
shall be [ * ] in the event of:-
6.1.2.1 the [ * ] the Raw Materials as provided in clause
3.8.3, the [ * ] of the Raw Materials; and
6.1.2.2 any [ * ] to carry out [ * ] in relation to the
process of Manufacture which prevents Medeva from
Manufacturing the Intermediate Product for any
time; and
6.1.2.3 any specific requirement [ * ] of the
Intermediate Product which results in [ * ] the
Aviron Unit and the Raw Materials; and
6.1.2.4 any [ * ] the [ * ] of the Master Working Virus
Seed and the [ * ] of the Monovalent Virus
Harvest.
6.1.3 The extent of any [ * ] in the Manufacturing capacity of
Medeva arising under clause 6.1.2 shall be [ * ] by the
[ * ] of the [ * ] within [ * ] after the end of each
Manufacturing Period.
6.1.4 Medeva will [ * ] during each Manufacturing Period to the
capacity determined pursuant to Clauses 6.1.1 to 6.1.3
above.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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 FORECASTING.
6.2.1 On the [ * ] Aviron shall provide to Medeva its written
forecast of its requirements for technical support in man
days and AVU days as set forth in Schedule 9, NAF and
Monovalent Virus Harvest for [ * ]. On or before [ * ] of
each year of this Restated Agreement Aviron shall provide
to Medeva its written forecast of its requirements for
technical support [ * ] as set forth in Schedule 9, NAF
and Monovalent Virus Harvest for [ * ] of [ * ] to [ * ]
of the [ * ]. On or before [ * ] of each year of this
Restated Agreement Aviron shall provide to Medeva its
written forecast of its requirements for technical support
[ * ] as set forth in Schedule 9, NAF and Monovalent Virus
Harvest for [ * ] of the [ * ] to [ * ] of the [ * ]. On
or before [ * ] of the [ * ] of this Restated Agreement
and each year thereafter Aviron shall provide to Medeva
its written forecast of its requirements for technical
support [ * ] as set forth in Schedule 9, NAF and
Monovalent Virus Harvest for [ * ] of [ * ] to [ * ] of
the [ * ]. On or before [ * ] and each year thereafter
Aviron shall provide to Medeva a forecast of its
requirements for technical support [ * ] as set forth in
Schedule 9, NAF and Monovalent Virus Harvests until [ * ]
of the Manufacturing Period and for the period from [ * ]
of that [ * ] to [ * ] of the [ * ].
6.2.2 Within [ * ] of receipt of any forecast from Aviron Medeva
shall [ * ] in writing any factors of which Medeva is
aware which [ * ] to be [ * ]. In the event that Medeva
has provided such a written indication, the parties shall,
[ * ] of receipt by Aviron of Medeva's notice regarding
such, [ * ] the issues raised by Medeva. If the parties
[ * ] then Aviron shall submit [ * ]. If it is [ * ] that
a [ * ] of the [ * ] is [ * ] then the [ * ] shall
continue to apply. If Medeva has provided a notification
pursuant to this clause and the parties have [ * ] and the
factors notified to Aviron [ * ] Intermediate Product in
the forecasted quantities, then, [ * ] is [ * ] or at the
end of any [ * ] shall [ * ] to [ * ] those [ * ] which
[ * ] to [ * ] provided that [ * ] to [ * ] any such [ * ]
or [ * ].
6.2.3 Medeva shall use Best Endeavours to supply the
Intermediate Product in the [ * ] pursuant to clause 6.2.2
[ * ] shall [ * ] in respect of the quantities forecast by
Aviron in excess of the Manufacturing capacity [ * ]
pursuant to clause 6.1
6.3 DELIVERY TERMS. Medeva will at the request of Aviron deliver
the Intermediate Product packaged for shipment under [ * ]
delivery terms (as defined in Incoterms 1990). [ * ] the [ * ] or
[ * ] in the Intermediate Product, [ * ] the Intermediate Product
[ * ] to [ * ] until [ * ] of [ * ] of the Intermediate Product
has been [ * ] and [ * ] by Medeva.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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6.4 ACCEPTANCE TESTING AND REJECTION.
6.4.1 RELEASE OF THE PRODUCT. The Intermediate Product will be
released by Medeva in accordance with Clause 10 of the
Technical Agreement and the Intermediate Product shall be
released by Aviron in accordance with Clause 11of the
Technical Agreement.
6.4.2 NOTICE OF REJECTION. Aviron may, within [ * ] of
completion of testing of the Intermediate Product by
Aviron or its designee, in accordance with this Clause 6.4
reject (in whole or in part) any batch of Intermediate
Product which contains Intermediate Product that does not
conform with the Specifications. Any notice of
rejection shall be in writing and shall indicate, in
sufficient detail to allow Medeva to investigate, the
reasons for such rejection. If no such notice of rejection
is received, Aviron shall be deemed to have accepted such
delivery of the Intermediate Product, except for defects
which could not reasonably be detected with the acceptance
tests performed pursuant to Clause 10 of the Technical
Agreement.
6.4.3 EVALUATION BY THE PROCESS EVALUATION TEAM The Process
Evaluation Team shall [ * ] the cause of any
non-conformance with Specifications detected by Medeva
upon testing pursuant to Clause 10.1 of the Technical
Agreement or by Aviron pursuant to Clause 11.1 of the
Technical Agreement. Both parties shall provide to the
Process Evaluation Team such samples (including the sample
retained by Medeva pursuant to Clause 6.4.1 for testing by
the independent laboratory as set forth in Clause 6.4.5)
and such information as the Process Evaluation Team
requests in order to [ * ] as to the defect and the cause
thereof.
6.4.4 DISPUTE RESOLUTION If [ * ] the [ * ] of the Process
Evaluation Team or if the Process Evaluation Team [ * ]
regarding the defect or cause thereof within [ * ] after
receipt of the notice of rejection by Medeva, the matter
shall be referred to the [ * ] of Medeva and Aviron. If
such [ * ] are unable to find a mutually agreeable
solution, the dispute shall be referred to the [ * ] for
good faith discussion and resolution within thirty (30)
days of such referral.
6.4.5 INDEPENDENT LABORATORY. At any time in the course of the
investigation by the PET or the dispute resolution
proceeding set forth in Clause 6.4.4, either party may
require that an independent laboratory mutually agreed
between the parties [ * ] the [ * ] in [ * ] shall be
asked to determine whether a further sample of the
Intermediate Product complies with the Specification or
not, and the determination of such independent laboratory
shall be [ * ] with respect to the issue of whether or not
the Intermediate Product complies with Specifications.
6.4.6 REMEDIES. If Medeva accepts that the non-conformance of
the Intermediate Product was the result of the [ * ] then
Medeva shall either (i) Manufacture and deliver to Aviron
[ * ] a [ * ] of the Intermediate Product [ * ] the
non-conforming batch or batches [ * ] Medeva with such
[ * ]
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BRACKETS, 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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[ * ], and providing a [ * ] by Aviron, or (ii) [ * ] due
to [ * ] Aviron with an [ * ] to the [ * ] by Aviron [ * ]
for the rejected shipment, plus [ * ] incurred by Aviron.
The parties shall discuss the possibility of [ * ]
Intermediate Product and [ * ] before Aviron [ * ] of the
aforementioned methods of compensation it [ * ]. Any [ * ]
paid or credited [ * ] are subject to the [ * ] set forth
in [ * ].
6.4.7 If Aviron accepts that the relevant batches of
Intermediate Product were Manufactured in accordance with
the Specifications and that any non-conformity of the
Intermediate Product with the Specifications was not the
result of the [ * ] or [ * ] and Aviron shall [ * ] of
such Intermediate Product and [ * ] as [ * ] to [ * ].
6.4.8 If the Process Evaluation Team or the [ * ] of the
parties designated in [ * ] come to the conclusion that
[ * ] the cause of the defect which caused Medeva not to
release Intermediate Product as provided in Clause 10 of
the Technical Agreement, or Aviron to reject the
Intermediate Product as provided in Clause 6.4.2,
[ * ] relating to the Manufacture of such product, and
neither party [ * ] for [ * ] Intermediate Product not
released by Medeva or rejected by Aviron.
7 INTELLECTUAL PROPERTY AND IMPROVEMENTS
7.1 OWNERSHIP. Except as expressly provided in this Restated
Agreement, each party hereby acknowledges that it shall not
acquire any rights in respect of any of the other party's
intellectual property in relation to the Intermediate Product or
the Manufacture thereof or of the goodwill associated therewith.
7.2 NO LICENSES. Other than as is necessary for the proper
performance of this Restated Agreement by the parties, or as is
expressly provided in this Restated Agreement, no license,
expressed or implied, is granted by this Restated Agreement by
either party to the other under any of its intellectual property
rights. The parties may grant further licenses if mutually
agreeable.
7.3 OWNERSHIP OF MANUFACTURING RECORDS. [ * ] all Manufacturing
Records shall [ * ] shall be treated as [ * ] and shall not be
[ * ] as provided in the Technical 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 PAIs. Aviron may [ * ] of
all Manufacturing Records, for the purposes of complying with the
requirements of the relevant Agency. Aviron may [ * ] the
Restricted Information to [ * ], having previously made
reasonable efforts to obtain an obligation of confidentiality
from the said [ * ] concerning the Restricted Information.
Nothing in
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BRACKETS, 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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this Clause 7.3 shall limit Aviron's right and ability to
disclose Medeva Process Technology to third parties pursuant to
the license granted under Clause 7.5.
7.4 PROCESS TECHNOLOGY.
7.4.1 Aviron Process Technology. Medeva acknowledges and
agrees that Aviron Process Technology shall be the
property of Aviron.
7.4.2 Medeva Process Technology. All Medeva Process Technology
shall be the property of Medeva.
7.5 LICENSE TO AVIRON.
7.5.1 Medeva hereby grants to Aviron a worldwide, non-royalty
bearing sublicenseable (as provided in Clause 7.5.2) sole
license under Medeva Process Technology to make, have
made, use, import, offer for sale and sell CAIV Products.
The term "sole" as used herein shall mean that Medeva
shall have the right to independently develop CAIV
Products which do not incorporate the Master Donor Strains
or any derivatives or reassortants thereof, but shall not
have the right to manufacture for commercial sale or sell
CAIV Products during the term of this Restated Agreement
other than the Manufacture for Aviron or its designee or
W-A under this Restated Agreement. For the avoidance of
doubt:-
7.5.1.1 Medeva shall not, for the term of this Restated
Agreement, manufacture, in eggs, cell culture, or
by other means, for itself or a third party any
CAIV Product based on the Master Donor Strains,
the Master Virus Seeds or any reassortants or
derivatives thereof, and Medeva shall not conduct
any research or development activities using the
Master Donor Strains, Master Virus Seeds,
reassortants or derivatives thereof, which have
not been not authorized in writing by Aviron,
including but not limited to any replication of
said in cell-based culture systems, but otherwise
nothing in this Restated Agreement shall prevent
Medeva from manufacturing for a third party a CAIV
Product (other than any CAIV Product based on the
Master Donor Strains, the Master Virus Seeds or
any reassortants or derivatives thereof) in
circumstances where that third party provides to
Medeva complete technical information pertaining
to the process of manufacture of the third party's
CAIV Product and Medeva is not required to utilize
Medeva Process Technology to help develop or
enhance the third party's process of manufacture
of its CAIV Product.; and
7.5.1.2 Aviron may utilize those aspects of the Medeva
Process Technology that are in the public domain
to make, have made, use, import, offer for sale
and sell products other than CAIV Products. If
Aviron is in any doubt as to whether or not a
particular aspect of the Medeva Process Technology
is in the public domain, it shall provide to
Medeva a written request for guidance setting
forth sufficient detail to allow Medeva to make
its decision and Medeva shall, within twenty eight
(28) days of receipt of such written request,
provide to Aviron an answer to its question;
provided, that if the parties disagree whether or
not a particular aspect of Medeva Process
Technology is in the public domain, the matter
shall be submitted for expert opinion in
accordance with Schedule 14. Thereafter, if there
is still a dispute between the parties as to
whether or not a
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BRACKETS, 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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particular aspect of Medeva Process Technology is
in the public domain the matter shall be referred
to the respective Chief Executive Officers of the
parties and, thereafter, if the matter is still
unresolved, either party may issue proceeding to
have the matter determined by a court of law in
accordance with clause 21.5; and
7.5.1.3 Nothing in this Agreement shall in any way hinder
the right of Medeva to use the Medeva Process
Technology in relation to non-CAIV Products.
7.5.2 Aviron shall have the right to grant sublicenses under the
license granted under Clause 7.5.1 above to its Associated
Companies, contract manufacturers and licensees of CAIV
Products. For the sake of clarity and in no way limiting
the generality of the rights provided to Aviron pursuant
to the licence, Aviron's Associated Companies, contract
manufacturers and licensees may only use the Medeva
Process Technology in relation to CAIV Products. Aviron
shall ensure that any sub-licence contains appropriate
restrictions on the use of the Medeva Process Technology
to ensure it shall not be used for any purpose other than
in relation to CAIV Products. Aviron shall, prior to
signing any sub-license, submit to the solicitors to
Medeva a redacted version of the sub-license showing the
sections of the agreement pertaining to the grant of
rights to the sub-licensee and Medeva's solicitors shall,
within seven (7) working days, provide to Aviron comments
on the proposed sub-license. If, in the reasonable opinion
of Medeva's solicitors, the sub-license seeks to confer on
the sub-licensee right which would result in a breach of
the terms of this Restated Agreement, Medeva's solicitors
shall notify both Aviron and Medeva and Aviron shall amend
the terms of the sub-licence so that it complies with the
terms of this Restated Agreement.
7.5.3 The restriction on the use of the Medeva Process
Technology imposed by the license granted to Aviron under
Clause 7.5.1 shall continue and survives termination or
expiration of this Agreement.
7.5.4 Notwithstanding anything in this Clause 7.5, Medeva shall
have the right to manufacture CAIV Products using Medeva
Process Technology and Aviron Process Technology for
licensees of Aviron of the CAIV Product to the extent that
such licensees are permitted by the license and supply
agreements that the licensees have with Aviron to have the
licensed CAIV Product manufactured by a party other than
Aviron
7.6 IMPROVEMENTS
7.6.1 Any Improvement developed by Medeva [ * ] shall be the
property of Aviron and Aviron shall own all intellectual
property pertaining to that Improvement. Medeva shall
promptly disclose such Improvement to Aviron. Aviron shall
grant to Medeva a [ * ] license to utilise such
Improvements in the Manufacture of the Intermediate
Product. Medeva shall be entitled to utilise freely and
without limitation from Aviron any aspect of any such
Improvement that is [ * ] or otherwise [ * ].
7.6.2 Should Medeva, in carrying out manufacture of any of its
[ * ] develop a manufacturing technique which may be able
to be utilised in the Manufacture of the Intermediate
Product, it shall [ * ]
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BRACKETS, 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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[ * ] such to Aviron and Medeva shall
own the manufacturing technique and any intellectual
property rights pertaining thereto. If Medeva [ * ] such
manufacturing technique to Aviron, it shall do so under
strict obligations of confidentiality and the parties
[ * ] the aforesaid manufacturing technique.
7.6.3 Should Medeva, in Manufacturing the Intermediate Product
[ * ] that [ * ] shall be part of [ * ] and the terms
pertaining to the use of [ * ] set forth in clause [ * ]
shall apply to that Improvement.
7.6.4 Any Improvement developed by Aviron shall be owned by
Aviron and Aviron shall own all intellectual property
rights in the Improvement. Aviron shall have the [ * ]
such Improvement to Medeva. If Aviron [ * ] such
Improvement to Medeva, it shall do so under strict
obligations of confidentiality and the parties [ * ] the
aforesaid Improvement.
8 PRICES
8.1 PRICE.
8.1.1 PRICE FOR THE INTERMEDIATE PRODUCT. Aviron shall pay to
Medeva a price for Monovalent Virus Harvest and for NAF
conforming to Specifications as set forth in Schedule 15
(the "Supply Price").
8.1.2 PRICE FOR USE OF [ * ]. Aviron shall pay Medeva for the
use of the [ * ] as set forth in Schedule 11. The price
payable by Aviron for the use of the [ * ] shall [ * ]
related to the [ * ]. If the [ * ] is unusable due to
[ * ], or as a consequence of [ * ] (unless such [ * ]),
the price payable by Aviron for the relevant year of this
Agreement for the use of [ * ] shall be [ * ] the [ * ] is
[ * ].
8.1.3 PRICE FOR [ * ]. Aviron shall [ * ] Medeva for [ * ] by
Medeva as a result of having to have the Intermediate
Product or any of the Raw Materials [ * ].
8.2 PAYMENT.
8.2.1 Once the quantity for any forecast has been determined
pursuant to clause 6.2.2, Medeva shall render to Aviron a
[ * ] invoice for the price of [ * ] of the quantity of
the Intermediate Product pertaining to the then current
Manufacturing Period so determined, such price to be
determined pursuant to Schedule 15.
8.2.2 If the forecast of quantities of [ * ] provided pursuant
to Clause 6.2.1 (or as revised pursuant to Clause 6.2.2)
differs from the immediately preceding forecast of such
quantities, the monthly invoice amount shall be
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BRACKETS, 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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[ * ] as provided in Clause 8.2.1 above. Furthermore,
the [ * ] shall be [ * ], and Medeva shall [ * ] or [ * ]
as the case may be.
8.2.3 Aviron will pay to Medeva the full invoice amount for the
Supply Price within [ * ] after receipt. Payment will be
made direct into Medeva's bank account by bank transfer.
Medeva will provide Aviron with the necessary details of
Medeva's bank account and will take whatever actions are
necessary to facilitate payment by bank transfer.
8.2.4 As soon as practicable following the end of any
Manufacturing Period, the parties shall, by mutual
agreement, [ * ] by Aviron [ * ] and the
sum payable by Aviron to Medeva in respect of that
quantity of the Intermediate Product. If the sum payable
by Aviron so determined [ * ] pursuant to this clause 8.2,
Medeva shall render to Aviron an invoice for the balance
outstanding and Aviron shall pay such invoice in
accordance with the terms of this clause 8.2. If the sum
payable by Aviron so determined is [ * ] pursuant to this
clause 8.2, Aviron shall render to Medeva an invoice for
the amount of the over-payment and Medeva shall [ * ]
direct to the bank account of Aviron by bank transfer.
Aviron will provide Medeva with the necessary details of
Aviron's bank account and will take whatever actions are
necessary to facilitate payment by bank transfer.
8.3 PAYMENT FOR OTHER CHARGES. Invoices will be submitted to Aviron
[ * ] to cover the costs set forth in clauses [ * ] and [ * ]
above. Invoices will be submitted to Aviron [ * ] to cover the
costs set forth in clause 8.1.2 above. Aviron will pay to Medeva
the [ * ] within [ * ] after the date of the invoice. Payment
will be made direct into Medeva's bank account by bank transfer,
and upon written request by Aviron, Medeva will provide Aviron
with the necessary details of Medeva's bank account and will take
whatever actions are necessary to facilitate payment by bank
transfer.
8.4 PRICE CHANGES. The Supply Price is fixed until [ * ]. The Supply
Price supplied thereafter during the Manufacturing Period
starting on [ * ] will be subject to a price adjustment according
to the change in the [ * ] as determined by the [ * ] over the
[ * ]. Thereafter, for the remainder of the term of the Restated
Agreement, the parties shall meet each [ * ] to take effect in
the following Manufacturing Period. If the parties [ * ] the
Supply Price [ * ] according to [ * ] between the [ * ] of the
Manufacturing Period [ * ] the Manufacturing Period for which the
[ * ] is to take effect.
8.4.1 If applicable, [ * ] on any of the amounts payable by
Aviron pursuant to clauses 8.1 and 8.3 and Aviron shall
[ * ].
9 SIGNING AND OTHER PAYMENTS
Upon [ * ] set forth below, Aviron will make to Medeva the
corresponding payments, which shall be due, except where
otherwise expressly stated, [ * ] after the date on which the
event was achieved. For the sake of clarity,
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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failure of Medeva to achieve any of the aforementioned
deadlines shall [ * ] and shall [ * ] other than by [ * ] save
where the event is the [ * ] other than [ * ] whereupon [ * ]
available in the event of [ * ] as set forth in this
Agreement.
9.1 UPFRONT PAYMENT. Aviron shall pay to Medeva US$1 million upon
signing of this Restated Agreement [ * ] by [ * ].
9.2 OTHER PAYMENTS.
9.2.1 [ * ].
9.2.1.1 In the event that Medeva completes [ * ] and [ * ]
and [ * ] , for such [ * ] by [ * ] which [ * ]
confirm that [ * ] have been met, Aviron will pay
to Medeva [ * ].
9.2.1.2 Save as provided below, the payment made under
clause 9.2.1.1 shall be [ * ] in the event of a
[ * ] on [ * ] pursuant to this clause 9.2.1 or
[ * ]. Such [ * ] as contemplated by this clause
shall be made by [ * ] of the parties reviewing any
[ * ] and agreeing that its [ * ] on the reports or
information provided by Medeva pursuant to this
clause 9.2.1 or not provided despite Aviron's
request, or [ * ] on the reports or information
provided by Medeva pursuant to this clause 9.2.1 or
not provided despite Aviron's request. If the [ * ]
resulted from any report or information provided by
Medeva where that report or information was [ * ]
the payment shall [ * ] as otherwise provided in
this clause 9.2.1.2.
9.2.1.3 In the event that Medeva successfully completes
[ * ] for the [ * ] Aviron will pay to Medeva
[ * ].The [ * ] will be deemed successfully
completed if[ * ] performed by Aviron pursuant to
the Technical Agreement, and if the [ * ] have an
overall [ * ] of [ * ] and if no [ * ] has a [ * ]
of [ * ].
9.2.2 [ * ].
9.2.2.1 If as of [ * ] Medeva [ * ] relating to the
Manufacture of the Vaccine within [ * ] of receipt
of [ * ] made
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BRACKETS, 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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from time to time in writing and describing in as much
details as is practicable the [ * ] Aviron will pay to
Medeva [ * ]. The payment under this Section 9.2.2 will
be due and payable if Medeva [ * ] in accordance with
the previous sentence and [ * ] or, in the event of a
[ * ] if such [ * ] on the documents or information of
the [ * ] provided by Medeva (or not provided despite
Aviron's request). Aviron may inform Medeva of [ * ] if,
even with all reasonable , [ * ].
9.2.2.2 For the purposes of this clause 9.2.2, Aviron's [ * ]
shall be [ * ], [ * ], and shall originate from [ * ]
(or any replacement of [ * ] notified by Aviron in
writing from time to time) of Aviron, and shall be sent
by fax addressed to [ * ] (or any replacement of [ * ]
notified by Medeva in writing from time to time) at the
fax numbers notified to Aviron in writing from time to
time. Such [ * ] is deemed received by Medeva the
working day after the date indicated on the transmission
report by Aviron.
9.2.3 [ * ]. Upon confirmation by the FDA that [ * ] or if [ * ], if (a)
any [ * ] will not [ * ] or (b) any [ * ] relate to the [ * ] and
[ * ] Aviron will pay to Medeva [ * ]. For the avoidance of doubt,
the payment under this Clause 9.2.3 will not be owed if [ * ] based
[ * ] by Medeva and [ * ].
9.2.4 [ * ]. Upon [ * ] Aviron will pay to Medeva [ * ].
9.2.5 [ * ].
9.2.5.1 Upon [ * ] of the lesser of either the [ * ] for the [ * ] or
[ * ] corresponding to [ * ] determined by the parties
pursuant to Clause 6.1 as calculated promptly after the end of
the Manufacturing Period, Aviron will pay to Medeva [ * ].
Notwithstanding anything in clause 6.1, the payment under this
clause 9.2.5.1 shall be due and payable only in the event that
Medeva has [ * ] for at least [ * ] of the Vaccine save where
Aviron has [ * ] in relation to the Manufacture of the
Intermediate Product which [ * ] of the Aviron Unit and the
Raw Materials in which
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BRACKETS, 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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case the [ * ] accordingly.
9.2.5.2 [ * ] of the lesser of either the [ * ] for the
[ * ] or the [ * ] corresponding to [ * ]
determined by the parties pursuant to Clause 6.1
as calculated promptly after the end of the
Manufacturing Period, Aviron will pay to Medeva
[ * ].
9.2.5.3 [ * ] in the [ * ] and each [ * ] thereafter of
[ * ] or the [ * ] corresponding to [ * ]
determined by the parties pursuant to Clause 6.1
as calculated promptly after the end of the
Manufacturing Period, for the [ * ] Manufacturing
Period, Aviron will pay to Medeva [ * ] of the
Intermediate Product.
9.2.5.4 For the sake of clarity, the [ * ] that give rise
to payment under clauses 9.2.5.1 to 9.2.5.3 shall
not exceed [ * ] set forth in clause 6.1 as
calculated promptly after the end of the
Manufacturing Period.
9.2.6 [ * ]. Upon attaining [ * ] Aviron agrees to pay Medeva
[ * ] as set forth below:
9.2.6.1 [ * ] and [ * ] as set forth in Schedule 17 by
[ * ], Aviron will pay Medeva [ * ], to be payable
[ * ].
9.2.6.2 [ * ] and [ * ] set forth in Schedule 17 for [ * ]
Aviron will pay Medeva [ * ] on [ * ].
9.2.6.3 [ * ] that [ * ] at Medeva have been sufficient to
[ * ] at Medeva as determined in accordance with
clause 6.1, and that no [ * ] due from the
[ * ] but payable only after proof of [ * ] as
provided for in this clause 9.2.6.3 has been
provided to Aviron.
9.2.6.4 Medeva shall have the right to [ * ] under this
Clause 9.2.6 with properly [ * ] on a [ * ] if
necessary to make up for [ * ] and shall use Best
Endeavours to [ * ] with [ * ].
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BRACKETS, 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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9.2.6.5 The aforementioned [ * ] apply, subject to clauses
9.2.6.6 and 9.2.6.7, to the [ * ] and thereafter
Medeva [ * ] subject to it being able to achieve in
each year, the Manufacturing capacity agreed
pursuant to clause 6.1, after prior consultation
with Aviron.
9.2.6.6 The parties may, by mutual agreement, reduce the
[ * ] set forth in this clause 9.2.6. Further,
Medeva shall be [ * ] except if Aviron [ * ] the
[ * ] of the [ * ] (as defined in Clause [ * ]).
9.2.6.7 Medeva shall [ * ], as a factor in [ * ] agreed
pursuant to clause 6.1, [ * ] if those levels have
been [ * ] or action, below the levels set forth
above in this clause 9.2.6, or if Medeva [ * ] the
[ * ] set forth above in this clause 9.2.6.
9.3 [ * ]
9.3.1 Save as provided below, within [ * ] from the end of each
calendar quarter, Aviron shall pay to Medeva an amount
corresponding to [ * ] of [ * ] licensed under Section
7.5, up to a total of [ * ] provided that any amount of
said [ * ] not paid on [ * ] shall be due and payable
within [ * ] days of such date.
9.3.2 Aviron's obligation to make any [ * ] to Medeva pursuant
to clause 9.3.1 shall not commence until such time as
[ * ] exceeds an amount equal to [ * ] up to the time of
[ * ] and thereafter [ * ] up to the date Medeva's [ * ]
such sum. For the avoidance of doubt, Medeva's total [ * ]
pursuant to clause 9.3.1 shall be reduced by the amount
equal to [ * ] calculated in accordance with this clause
9.3.2.
9.3.3 As used herein, [ * ] means the [ * ] [ * ] by Aviron, its
Associated Companies [ * ] from person or entities
[ * ], less the following [ * ], but only to the extent
such [ * ], or are [ * ]
9.3.3.1[ * ];
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BRACKETS, 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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9.3.3.2[ * ]
9.3.3.3[ * ] other than those described above;
9.3.3.4[ * ] (to the extent that the foregoing [ * ] do
not exceed [ * ] of the sum of all amounts [ * ]
and all other consideration [ * ] (or, when in a
form other than cash or its equivalent, the fair
market value thereof when received));
9.3.3.5[ * ]; and
9.3.3.6[ * ]
[ * ] not intended for [ * ], and made [ * ] shall not be
[ * ] Under no circumstances shall the combined reductions
from [ * ] attributable to the factors listed in clauses
9.3.3.1 and 9.3.3.4 [ * ]
9.3.4 Medeva shall be entitled, upon reasonable notice and
during normal business hours, to have an independent
auditor reasonably acceptable to Aviron inspect the
financial records of Aviron pertaining to sales of CAIV
Products to confirm the accuracy of any report or
information provided to Medeva concerning [ * ] and Medeva
and Aviron shall make available to said independent
auditor such records, in whatever form.
10 [ * ] PAYMENTS
10.1 Medeva shall receive from Aviron payments [ * ] for the [ * ] and
payments [ * ] for [ * ] (such payments to include payments under
[ * ] but excluding payments under [ * ] above) during the Term of
this Restated Agreement until the below mentioned [ * ] is reached.
If Medeva has not received payments from Aviron under this Restated
Agreement [ * ], Aviron shall [ * ] corresponding to [ * ] between
the [ * ] as set forth in this clause and the [ * ]. Aviron shall
[ * ] under this Clause 10 upon [ * ] Medeva within [ * ] from
receipt of [ * ]. Such obligation shall expire at the time Medeva
has [ * ] from Aviron [ * ] under [ * ].
10.2 Payments made by Aviron under this Restated Agreement prior to [ * ]
shall be counted towards the amount of [ * ] due for the [ * ].
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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10.3 The amount of the [ * ] pursuant to Clause 10.1 shall be [ * ] of
the time during which Medeva is unable to Manufacture Intermediate
Product for reasons caused as a consequence of any inspections or
actions of a U.S. or U.K. Agency; provided, however, that Medeva
shall not [ * ] except if Aviron undertakes to make [ * ].
11 INDEMNITY
11.1 Subject to clauses 11.2, 11.3, 11.8 and 11.9 Medeva indemnifies and
shall keep Aviron indemnified against any third party claims for
losses, damages and costs (including court costs and reasonable
attorney's fees) to the extent they arise from
11.1.1 Medeva's failure to Manufacture the Intermediate Product in
accordance with the Technical Agreement and the
Specifications; and
11.1.2 Medeva's failure to store the Intermediate Product while it
is in Medeva's control in accordance with the Specifications;
and
11.1.3 the negligence or willful malfeasance of Medeva, its
employees or agents
11.2 Medeva shall not be liable under the indemnity provided under clause
11.1 above:-
11.2.1 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 or
Aviron's suppliers to comply with Specifications; and/or
11.2.2 for any factor occurring after the Intermediate Product
leaves Medeva's premises.
11.3 Medeva's liability for Direct Damages in respect of Intermediate
Product that does not comply with the Technical Agreement and the
Specifications shall be determined in compliance with clause 6.4,
Schedule 3 and clauses 11.8 and 11.9
11.4 Aviron indemnifies Medeva against all third party claims for losses,
damages and costs (including court costs and reasonable attorney's
fees) arising in relation to the Intermediate Product, the Vaccine
and the Finished Product except under the circumstances which give
rise to an indemnity in favour of Aviron by Medeva as set forth in
the Clauses 11.1 and 11.2 above.
11.5 Medeva shall be liable for any loss of or damage to Aviron Assets
(fair wear and tear excepted), Raw Materials, components or
Intermediate Product arising from Medeva's negligence whilst at
Medeva up to replacement value, provided, however, that any Aviron
Assets replaced by Medeva at its own cost will be owned by Medeva
upon expiration or termination of this Restated Agreement.
11.6 Aviron hereby indemnifies and will keep Medeva indemnified against
all costs, damages or liabilities up to a maximum of Pound Sterling
2,000,000 in any twelve month period of this Agreement and excluding
indirect or consequential losses, costs, damages or liabilities,
arising from any disruption of Medeva's business, any contamination
of Medeva's premises or any damages to Medeva's premises, plant or
machinery caused by the Eggs supplied by Aviron or Aviron's agent or
the Master Donor Seeds save where
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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such interruption, contamination or damage is caused by the
negligence, willful malfeasance or default of Medeva or its
employees.
11.7 Each party undertakes to ensure that it has in place product
liability insurance with a reputable insurer in an amount
appropriate for its business and products of the type the subject
of this Restated Agreement. At either party's request, the other
party shall provide the requesting party with evidence of the
existence and maintenance of such coverage.
11.8 Notwithstanding anything contained in this Restated Agreement,
Medeva's liability in contract, tort (including breach of
statutory duty) or otherwise arising by reason of or in
connection with this Restated Agreement or any agreement or
indemnity contemplated hereunder (except in relation to death or
personal injury caused by the negligence of Medeva or its
employees while acting in the course of their employment) shall
be limited to Pound Sterling 2,000,000 in any twelve month period
of this Restated Agreement. For the avoidance of doubt, only one
claim is permitted to be made in respect of any one incident and
Aviron shall not be permitted to make claims in later years
pertaining to an incident for which a claim has already been
made.
11.9 In no event, and notwithstanding anything contained in this
Restated 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, damage costs or expenses of any nature
whatsoever.
11.10 All indemnities under this Restated Agreement given by either
party shall be subject to English common law, duties and defenses
including without limitation, the duty to mitigate, contributory
negligence, and issues of causation and remoteness.
11.11 If Medeva is subject to a change of control as described in
Clause 14.4, and where the third party acquiring control is a
competitor or potential competitor to Aviron , and, through its
actions or inactions willfully or intentionally breaches or
causes Medeva to breach its obligations under this Restated
Agreement, the aforementioned limitations of direct, indirect and
consequential losses and damages shall cease to apply.
11.12 Should UK Customs and Excise determine that VAT is payable in
respect of any aspect of this Restated Agreement or the 1995
Development Agreement or the 1997 Contract Manufacture Agreement,
Aviron accepts that it shall be charged VAT on any such aspects
and agrees to pay. In the event that U.S. Customs and Excise make
such a ruling Medeva shall, at Aviron's cost, use all reasonable
endeavours to reduce the exposure of both Medeva and Aviron to
the Taxburden including, but not limited to, appealing against
the ruling of UK Customs and Excise.
12 CONFIDENTIALITY
12.1 The Recipient undertakes to keep confidential all Restricted
Information received by it directly or indirectly from the
Discloser or obtained by it pursuant to the performance of this
Restated Agreement and not to use such Restricted Information
except as provided in this Restated Agreement. The obligations
set forth in this Clause 12.1 shall apply during the period of
this Restated Agreement and for a period of the longer of (i)
[ * ] after the termination or expiry of the Michigan
Agreement or (ii) [ * ] after the termination of this Restated
Agreement.
12.2 Recipient shall allow access to the Discloser's Restricted
Information exclusively to those of its employees who have
reasonable need to see and use it for the purposes of this
Restated Agreement and shall inform each of such employees of the
confidential nature
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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of the Restricted Information and of the obligations on the
Recipient with respect to such Restricted Information and
shall ensure that each of its employees having access to the
Restricted Information is contractually bound by obligations
of confidentiality and shall take such steps as may be
necessary to enforce such obligations.
12.3 On the expiry or termination of this Restated Agreement,
Recipient will return to Discloser all Restricted Information of
Discloser in its possession and the Recipient shall have the
option to retain one (1) copy, but shall not make any further use
of that information save for record keeping purposes.
12.4 In this Clause 12 references to the Discloser or Recipient shall
be deemed to include any Associated Companies of that party.
12.5 Aviron's shall have the right to disclose Medeva Process
Technology to permitted sublicensees only to the extent permitted
by its licence under clause 7.5.1 and under obligations of
confidentiality not less stringent than those contained herein.
For the sake of clarity and in no way limiting the generality of
the foregoing, Aviron shall not be entitled to disclose any
Medeva Process Technology otherwise than in respect of the
manufacture of CAIV Products.
13 LIAISON
The parties will each identify in writing the person responsible
for the day to day operation of this Restated Agreement including
production planning relating to forecast requirements. The person
responsible may be changed from time to time with written
notification to the other party. From the date of signature of
this Restated Agreement Aviron's designated person pursuant to
this clause shall be [ * ] and Medeva's shall be [ * ]
14 ASSIGNMENT AND CHANGE OF CONTROL
14.1 [ * ] party may assign any of its rights or delegate any of its
obligations under this Restated Agreement (other than by Medeva
to its Associated Companies or Aviron to its Associated Companies
as the case may be, or in the event of a merger or consolidation
of a party with or into any other entity, including a triangular
merger involving such party or a sale of all or substantially all
of the assets or business unit to which this Restated Agreement
relates) [ * ] the prior written consent of the other party,
except as expressly provided herein.
14.2 This Restated Agreement shall be binding upon and shall inure to
the benefit of Medeva and Aviron and their respective permitted
successors and assignees (if any).
14.3 The parties acknowledge and agree that any change of
ownership or control of either Medeva or Aviron shall not affect,
either at law, or as between the parties, that party's rights and
obligations under this Restated Agreement, to the extent that the
party undergoing such change of ownership or control survives
such change of ownership or control.
14.4 Each party (the Notifying Party) shall forthwith notify the other
party (the Receiving Party) if there is an effective change of
ownership or control of the Notifying Party; or if the Notifying
Party sells all or substantially all of the assets or all or
substantially all of the business to which this Restated
Agreement relates. Within a period of [ * ] of receipt of such
notice or actual sale, should the Receiving Party [ * ] that the
party assuming effective ownership or control of, or purchasing
the assets or business of the Notifying Party
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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[ * ] or a party [ * ] the Receiving Party [ * ] then:-
14.4.1 in the event that the Receiving Party is [ * ] it may,
subject to clause 14.6 below, by a [ * ] written notice
terminate this Restated Agreement; and
14.4.2 in the event that the Receiving party is [ * ] it may
terminate this Restated Agreement, [ * ], on provision of
[ * ] notice and, [ * ] on provision of [ * ] notice
subject to expiration or termination of this Restated
Agreement pursuant to other clauses of the Restated
Agreement.
14.5 If Aviron terminates this Restated Agreement pursuant to clause
14.4 above at a time [ * ] is, at that time, [ * ] Aviron shall
pay to the party that acquires Medeva [ * ] pursuant to [ * ] at
the date of such termination.
14.6 Any purported assignment in violation of this section by either
party shall be voidable by the other party.
15 TERM AND TERMINATION
15.1 TERM OF AGREEMENT. Unless sooner terminated as provided under
Clauses 14 or 15, this Restated Agreement shall come into force
on the Effective Date hereof and shall continue in force until
31 December, 2005.
15.2 TERMINATION FOR BREACH OR BANKRUPTCY. Either party shall be
entitled forthwith to terminate this Restated Agreement by
written notice to the other if:
15.2.1 that other party is in material breach of any of the
provisions of this Restated Agreement and, in the case of
a material breach capable of remedy, fails to remedy the
same within thirty (30) days of receipt of a written
notice specifying the material breach and requiring its
remedy; or
15.2.2 an encumbrancer takes possession or a receiver is
appointed over any of the property or assets of that
other party; or
15.2.3 the other party becomes subject to an administration
order; or
15.2.4 that other party goes into liquidation except for the
purposes of 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 Restated Agreement;
15.2.5 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
Clauses 15.2.2 to 15.2.4 above.
15.3 For the purpose of Clause 15.2.1 a material breach 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
BRACKETS, 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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<PAGE> 31
15.4 This Restated Agreement shall terminate upon the termination of
the Michigan Agreement. In such event, at Michigan's option as
notified to Medeva by Aviron, Medeva shall, at Aviron's cost, (1)
destroy or return to Aviron as required all Master Virus Seeds,
Manufacturing Working Virus Seeds, derivatives thereof and all
finished and unprocessed Vaccine, (2) provide to Michigan copies
of all Manufacturing Instructions and Manufacturing Records and
(3) grant to Michigan a royalty free license to use the
Manufacturing Instructions and the Manufacturing Records. .
15.5 NO WAIVERS. Any waiver by either party of a breach of any
provision of this Restated Agreement shall not be considered as a
waiver of any subsequent breach of the same or any other
provision thereof.
15.6 OTHER REMEDIES. The rights to terminate this Restated 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).
15.7 EFFECTS OF EXPIRATION OR TERMINATION.
15.7.1 On expiration or termination of this Restated Agreement
for any reason:
15.7.1.1 Medeva shall, [ * ] immediately cease
Manufacture of the Intermediate Product or
complete the Manufacture of the Intermediate
Product then in the course of Manufacture,
provided, however, that if [ * ] is made [ * ]
whether Medeva shall cease Manufacture immediately
or complete Manufacture of the Intermediate
Product then in the course of Manufacture;
15.7.1.2 subject to 15.7.1.1 and 12.3, 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 of the other party, and each will
cease to make use of the others Restricted
Information;
15.7.1.3 Aviron shall pay outstanding invoices or
invoices for accepted Intermediate Product due to
be raised according to terms specified in this
Restated Agreement. In the event Medeva shall
[ * ] not to complete the Manufacture of the
Materials, then such unfinished Intermediate
Product shall be [ * ] or [ * ] at the [ * ]
incurred up to the time Manufacture was
discontinued;
15.7.1.4 Aviron will be obliged to purchase and Medeva
will be obliged to supply all stocks of Raw
Materials purchased by Medeva in support of
purchase orders or forecasts submitted by Aviron
[ * ] within a reasonable time, [ * ]
15.7.1.5 Aviron will collect all Raw Materials supplied
to Medeva free of charge save for any Raw
Materials required to complete the Manufacture of
the Intermediate Product in the event of [ * ] In
the event that Aviron has not collected the Eggs
within [ * ] and all other Raw Materials within
[ * ] of the date of termination of this
Agreement, Medeva may, after [ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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destroy such Eggs and, after [ * ] destroy such
other Raw Materials and [ * ] a [ * ] such Raw
Materials.
15.7.1.6 Termination of this Restated Agreement for any
reason shall not bring to an end any provisions of
this Restated 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 3.6.6, 3.6.7, 3.6.10, 3.6.11, 3.9.2,
4.2.2, 4.2.4, 6, 7, 8, 9.1, 9.2.4, 9.2.5, 9.3, 10,
11, 12, 15, 17, 20.5, and 21 .
15.8 Upon expiry or termination of this Restated Agreement Medeva
shall return to Aviron or destroy all Master Donor Strains,
Master Virus Seeds and related material as instructed by Aviron.
15.9 - EMPLOYMENT CLAUSE
15.9.1 For the purposes of this sub-clause 15.9:
15.9.2 "Employee" shall mean any employee of Medeva working more
than [ * ] of his or her time specifically on the
Manufacture of the Intermediate Product for Aviron during
the period of [ * ] to termination of such employee, or
the term of employment, if shorter.
15.9.3 [ * ] shall mean the [ * ] for each relevant Employee
during any part of the relevant [ * ] when the Employee is
[ * ].
15.9.4 [ * ] shall mean the [ * ] each relevant Employee the
[ * ] to which he/she [ * ].
15.9.5 [ * ] shall mean the [ * ] to all its employees of
comparable skill, experience, tenure and position at the
Speke plant.
15.9.6 If at any time during the period of or on the termination
of the Restated Agreement, Aviron's requirements for
Employees reduce or cease, other than due to a breach of
this Agreement by or bankruptcy of Medeva, which results
in Medeva having to find suitable alternative employment
for, or to retrain, or terminate the employment of any
Employee the parties agree as follows:
15.9.7 Aviron shall notify Medeva of any anticipated
reduction in the required staffing levels in sufficient
time for Medeva to comply with its statutory and
contractual obligations regarding redundancy notification
and consultation with the Employees and their
representatives before notices of termination of
employment are given to the Employees. Aviron may at any
time request from Medeva a summary of the current
applicable law and statutory obligations pertaining to
redundancy notification and consultation with Employees
and Medeva shall provide such summary [ * ]. If the timing
does not allow Medeva to comply with its statutory
obligations, [ * ] all claims, actions, proceedings,
Employment Tribunal awards and compensation, protective
awards, legal costs
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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and expenses resulting from Medeva's failure to comply
with its statutory obligations.
15.9.8 Medeva shall make a good faith effort to retrain or to
find suitable alternative employment for Employees before
terminating any Employee's employment.
15.9.9 Medeva shall make a good faith effort to effect any
necessary dismissals fairly and in accordance with their
usual Human Resources procedures.
15.9.10 [ * ] against the following costs and expenses:
15.9.10.1 All reasonable [ * ] resulting from Medeva's [ * ]
for the Employees [ * ] of the [ * ] and the [ * ]
for the relevant Employee
15.9.10.2 All [ * ] and [ * ] paid by [ * ] in connection
with the [ * ] of the Employees.
15.9.10.3 All claims, demands, actions, proceedings,
Employment Tribunal awards and compensation,
protective awards, interest, legal costs and
expenses in respect of the Employees arising from
[ * ] in the event that the [ * ] of the
Manufacture of the Intermediate Product or [ * ] of
the Restated Agreement is deemed to be a [ * ] for
the purposes of the [ * ] as may be amended from
time to time.
15.9.10.4 Any claims, demands or proceedings in [ * ] (other
than those referred to in clause 10.14.9.2 (iii)
above) arising from the [ * ] of any Employee shall
be [ * ] in accordance with the chart set out in
Schedule 18. For the purposes of the chart in
Schedule 18:
15.9.10.4.1 [ * ] shall mean [ * ] and the
provision of sufficient information relating
to a [ * ] as is reasonably required [ * ]
to make an informed decision on the
appropriate course of action to be taken
with respect to an [ * ]
15.9.10.4.2 [ * ] shall mean all payments made
[ * ] in order [ * ] any such [ * ] or
[ * ], and interest and all reasonable legal
fees and expenses. It shall not include the
[ * ] and [ * ] incurred by [ * ].
15.9.10.4.3 "Notice" shall mean notice in writing
to Aviron together with a copy of [ * ]
received by [ * ], such notice to be given
as soon as is reasonably practicable after
Medeva receives [ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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15.9.10.5 Medeva shall keep complete and accurate
records relating to:
15.9.10.6 the allocation of the Employees;
15.9.10.7 Medeva's good faith efforts [ * ] and/or
[ * ]; and
15.9.10.8 the accuracy of the [ * ] and the [ * ] of
payments made to such Employees.
Aviron shall have the right on reasonable notice to audit such
records to confirm the accuracy of the allocation of Employees to
the Manufacture, and the [ * ], and Medeva's efforts to [ * ] at
Medeva or to [ * ].
16 EXCHANGE RATE
16.1 Any sums payable in US$ pursuant to this Agreement are based on
the $US/Pound Sterling exchange rate of [ * ]
16.2 Should the [ * ] against the US$ compared to the exchange rate
set forth in Clause 16.1, any payments denominated in US$ under
this Restated Agreement shall [ * ] so that Medeva shall receive
such payments in amounts calculated based on an exchange rate of
[ * ]
16.3 Should the [ * ] against the US$ compared to the exchange rate
set forth in Clause 16.1, any payments denominated in US$ under
this Restated Agreement shall [ * ] so that Aviron shall make
such payments in amounts calculated based on an exchange rate of
[ * ]
17 ASSOCIATED COMPANIES
Medeva shall be entitled to perform any of the obligations
undertaken by it and to exercise any of the rights granted to it
under this Restated Agreement through any of its Associated
Companies with Aviron's consent, such consent not to be
unreasonably withheld, and any act or omission of any such
company shall for the purposes of this Restated Agreement be
deemed to be the act or omission of Medeva. For the purposes of
such delegated performance Medeva shall be entitled to disclose
only on a need to know basis Aviron's Restricted Information to
employees of relevant Associated Companies.
18 FORCE MAJEURE
18.1 If either party is affected by Force Majeure it shall forthwith
notify the other party of the nature and extent thereof. The
affected party shall additionally [ * ] take all reasonable steps
as may be necessary to overcome the Force Majeure and to minimize
its effects.
18.2 Neither party shall be deemed to be in breach of this Restated
Agreement, or otherwise be liable to the other by reason of any
delay in performance, or non-performance, of any its obligations
hereunder to the extent that such delay or non-performance is due
to any Force Majeure of which it has notified the other party and
the time for performance of that obligation shall be extended
accordingly.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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18.3 All sums due and payable at the time of suspension due to Force
Majeure [ * ] by Aviron.
18.4 The party affected by Force Majeure shall give notice to the
other party as soon as practical after the matter constituting
Force Majeure has arisen or occurred giving the other party full
particulars of the nature and extent of such matter.
18.5 In the event of any Force Majeure occurrence the parties shall
consult with a view to determining what steps they may agree to
take, appropriate to the Force Majeure circumstances, in relation
to this Restated Agreement.
19 NOTICES
19.1 Any notices or other information required or authorized by this
Restated 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 Restated 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
save that such six (6) working day period shall not apply to
notice to be provided under clause 9.2.2
19.2 Any notice or other information given by post pursuant to Clause
19.1 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.
19.3 Any notice or other information sent by telex, 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 19.1 within one working day after
transmission.
20 MICHIGAN LICENSE
20.1 Medeva accepts:
20.2 The Master Virus Seeds or the Working Seeds may be used only for
the Manufacture of Intermediate Product; and
20.3 Medeva shall not provide any Master Virus Seeds, Manufacturing
Working Virus Seeds or derivatives thereof to any third party
save as is required by independent third party laboratories for
testing as provided in Clause 6.4. Medeva shall limit access to
the Master Virus Seed supplied by Aviron and Manufacturing
Working Virus Seeds made by Medeva to those employees reasonably
requiring such access for the purpose of Development and
Manufacture of the Intermediate Product, which employees are
governed by Medeva's customary confidentiality obligations.
20.4 Aviron shall:
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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20.4.1 use every reasonable effort to honor and observe its
obligations under the Michigan Agreement and shall not act
or fail to act in any way which might jeopardize or cause
to be terminated the Michigan Agreement; and,
20.4.2 promptly notify Medeva of any amendment to the Michigan
Agreement; and,
20.4.3 make every reasonable effort to notify Medeva in writing
of the expiry or termination of the Michigan Agreement at
least [ * ] to either event.
20.5 Medeva will use every reasonable effort to store the Master Virus
Seeds and Manufacture Intermediate Product in accordance with all
applicable government laws and regulatory agency requirements .
20.6 Aviron, on Michigan's behalf, may request from Medeva at
reasonable times and in reasonable quantities at a cost [ * ] of
Intermediate Product as it may desire, provided that Medeva shall
[ * ] under this sub-clause or otherwise to produce extra batches
of Intermediate Product [ * ] Any requirements of Michigan shall
be supplied from [ * ] with [ * ] such part thereof to Michigan [
* ] Any Intermediate Product provided to Michigan pursuant to
this clause shall [ * ] of the then relevant production payment
set forth in clause 9.
20.7 Medeva acknowledges Michigan's warranty disclaimer and limitation
of liability contained in Section 13 of the Michigan Agreement [
* ] Notwithstanding such, Medeva will not make any statements,
representations or warranties or accept any liabilities or
responsibilities whatsoever to or with regard to any person or
entity which are inconsistent with any disclaimer or limitation
of liability contained in said Section 13.
20.8 Subject to those limitations of liability contained in Clauses
11.8 and 11.9 hereof, Medeva will indemnify Michigan, its
fellows, officers, employees and agents for and against any and
all claims, damages, losses and expenses of any nature (including
attorney's fees and other litigation expenses) resulting from,
but not limited to, death, personal injury, illness or property
damage, arising from or in connection with the following:
20.8.1 any Manufacture, use, sale other disposition by Medeva of
the Master Virus Seeds or Intermediate Products; or
20.8.2 the use, handling, storage or disposal of Master Virus
Seeds, any derivatives or Intermediate Products by
Medeva; or
20.8.3 the use by Medeva of any know-how, or technical data
sub-licensed to Aviron from Michigan (and of which
know-how and technical data Aviron has expressly notified
Medeva as being sub-licensed to Aviron by Michigan) or
developed by Medeva pursuant to this Restated Agreement
that is necessary or useful to the manufacture or use of
the cold-adapted influenza vaccine product derived from
Master Donor Strains; or
20.8.4 No approval, review, inspection nor receipt by Michigan of
any such know-how or technical data or samples or
otherwise or representations made with respect thereto
shall in any manner relieve Medeva of the responsibilities
under this Clause 20.8,
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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where but only where such claims damages losses or expenses [ *
]. Nothing in this indemnity shall in any way reduce or limit the
extent of the indemnity provided by Aviron in favour of Medeva
pursuant to clause 11.4.
20.9 Medeva shall not use the name of Michigan in publicity or
advertising concerning the Intermediate Product or the Master
Virus Seed without the prior written consent of Michigan, such
consent not to be unreasonably or arbitrarily withheld nor
delayed. Reports in scientific literature and presentations of
joint research and development work are not considered publicity
for the purpose of this clause.
21 GENERAL
21.1 Any reference in this Restated Agreement to "writing" or cognate
expressions includes a reference to telex, cable, facsimile
transmission or comparable means of communication.
21.2 The headings in this Restated Agreement are for convenience only
and shall not affect its interpretation.
21.3 No variation or amendment of this Restated 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.
21.4 If any provision of this Restated 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 Restated 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.
21.5 This Restated Agreement shall be governed by and construed in all
respects in accordance with the [ * ] and the parties hereby
submit to the 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.
21.6 Unless this Restated Agreement or any agreement or arrangement of
which this Restated Agreement forms a part is a non-notifiable
agreement for the purpose of section 27A of the Restrictive Trade
Practices Act 1976, if there is a provision of this Restated
Agreement or any such agreement or arrangement which causes or
would cause this Restated Agreement or any such agreement or
arrangement to be subject to registration under the Restrictive
Trade Practices Act 1976, that provision shall not take effect
until the date after particulars of this Restated Agreement (or
of that agreement or arrangement as the case may be) have been
furnished to the Director General of Fair Trading pursuant to
section 24 of the Restrictive Trade Practices Act 1976.
22 PUBLIC DISCLOSURE
No public announcement of any kind shall be made in respect of or in
connection with this Restated Agreement except as specifically agreed in
writing between the parties, or except to the extent that an
announcement is required by law or by the US or UK stock exchange as the
case may be but in such event any announcement by either party shall
only be issued after prior consultation with the other, having taken
reasonable account of any comment or reasonable requirement of the
other.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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23 ENTIRE AGREEMENT
23.1 This Restated Agreement, the Technical Agreement (etc etc) are
the entire agreements and understandings between the parties
relating to the subject matter of this Restated Agreement and,
save as provide in clause 24 below, supersedes and previous
agreement between the parties.
23.2 Each of the parties acknowledges and agrees that in entering into
this Restated 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 Restated Agreement or not)
other than as expressly set out in this Restated Agreement.
23.3 Nothing in this clause shall operate to limit or exclude any
liability for fraud.
23.4 The terms of this Restated Agreement shall supersede any
conflicting standard terms and conditions, purchase orders,
acceptance notices and other documents exchanged between the
Parties in the course of ordering and supplying Intermediate
Product under this Restated Agreement, and any such terms and
conditions conflicting with or in addition to the terms of this
Restated Agreement are hereby expressly rejected.
24 PROVISIONS PERTAINING TO PREVIOUS AGREEMENTS
24.1 All sums due and owing to Medeva as at [ * ] pursuant to the 1995
Development Agreement and the 1997 Contract Manufacture Agreement
in the amount of [ * ] shall be paid by Aviron to Medeva on the
Effective Date. All sums due and owing to Medeva for work
performed by Medeva under the 1997 Contract Manufacture Agreement
or the 1995 Development Agreement between [ * ] and the [ * ]
will be paid under the terms of the 1997 Contract Manufacture
Agreement or the 1995 Development Agreement as is appropriate.
24.2 Medeva shall notify Aviron should it be approached by any third
party wishing to exploit the process technology developed by
Medeva pursuant to the 1995 Development Agreement, the 1997
Contract Manufacture Agreement, or this Restated Agreement in
respect of [ * ] and, within [ * ] of receipt of such
notification, Aviron may request that the parties enter
negotiations for a licence in respect thereof. If Aviron does not
so request the commencement of negotiations, or if the parties
have not executed a license agreement after [ * ] of good faith
negotiations, [ * ] such process technology relating to [ * ]
to a [ * ].
24.3 Clause 8.1 (other than the first two sentences) and clauses 8.3,
8.4, 10.10, 14, 15 and 16 of the 1995 Development Agreement
survive the termination of the 1995 Development Agreement.
24.4 Notwithstanding anything in clause 20.3 of the 1995 Development
Agreement, said section is hereby terminated.
24.5 Any materials purchased by [ * ] pursuant to clause [ * ] of the
1995 Development Agreement shall be deemed to be [ * ] and the
terms concerning such set forth in this Restated Agreement shall
apply.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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24.6 Any costs for plant and facilities to be recovered by Medeva
pursuant to clause 7.5 of the 1995 Development Agreement shall be
deemed to be and are included in the payment from Aviron to
Medeva for use of the Aviron Unit.
24.7 Any Virus Seeds, the Working Seed and the Vaccine referred to in
clause 9.5 of the 1995 Development Agreement shall be used or
disposed of as provided in this Restated Agreement.
24.8 Sections 6.1 and 6.2 of the 1995 Development Agreement are hereby
terminated. All process technology referred to in clauses 6.1 and
6.2 of the 1995 Development Agreement shall be deemed to be
Medeva Process Technology and Aviron Process Technology and the
terms of this Restated Agreement shall apply to such accordingly.
24.9 Subject to the above, the 1995 Development Agreement is hereby
terminated. Neither party shall have any further rights,
obligations or liabilities to the other party under the terms of
the 1995 Development Agreement unless expressly stated herein and
except for rights, obligations and liabilities under any
surviving clauses set forth in Clause 24.3.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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IN WITNESS WHEREOF, this Restated Agreement has been executed by the duly
authorized representatives of the parties the day and year first above written
MEDEVA PHARMA LIMITED AVIRON
By: /s/ M. J. Harvey By: /s/ Fred Kurland
-------------------------------- --------------------------
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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SCHEDULE 1
AVIRON ASSETS
[ * ] [ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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SCHEDULE 2
AVIRON UNIT
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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SCHEDULE 3
DIRECT DAMAGES
1. [ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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SCHEDULE 4
GSA
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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SCHEDULE 5
MICHIGAN AGREEMENT
The Michigan Agreement was filed with the SEC by Aviron as Exhibit 10.3 to
Aviron's Registration Statement on Form S-1, File No. 333-05209, filed June 5,
1996, as amended, which exhibit was titled "Materials Transfer and Intellectual
Property Agreement between Aviron and the Regents of the University of
Michigan, dated February 24, 1995," and is hereby incorporated by reference.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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SCHEDULE 6
MPU
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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SCHEDULE 7
SPF UNIT
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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SCHEDULE 8
TECHNICAL AGREEMENT
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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MEDEVA PHARMA LIMITED
and
AVIRON
------------------
TECHNICAL AGREEMENT
FOR CONTRACT MANUFACTURE
------------------
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES ACT OF 1934, AS AMENDED.
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TECHNICAL AGREEMENT FOR CONTRACT MANUFACTURE
between
(1) MEDEVA PHARMA LIMITED having its registered office at Medeva House, Regent
Park, Kingston Road, Leatherhead, Surrey KT22 7PQ (`Medeva')
and
(2) AVIRON, a Delaware corporation having its registered office at 297 North
Bernardo Avenue, Mountain View, California 94043, United States of America.
(`Aviron')made by and between the parties on this _____th day of May 1999.
1. BACKGROUND
In November 1995, the parties entered into a Manufacturing and
Development Agreement (the "Development Agreement") and a technical
agreement pertaining to the manufacture of cold adapted influenza
vaccine for the purposes of the Development Agreement.
In April 1997, the parties entered into a Contract Manufacturing
Agreement (the "Old Manufacturing Agreement") and a technical agreement
pertaining to the manufacture of cold adapted influenza vaccine for the
purpose of the Old Manufacturing Agreement.
This Technical Agreement is intended to replace the technical agreements
pertaining to the Development Agreement and the Old Manufacturing
Agreement and will be annexed to and form part of the Commercial
Agreement.
Under this Technical Agreement, Medeva will be responsible for the
Manufacture of the Intermediate Product, in accordance with
Specifications and in accordance with cGMP.
2. DEFINITIONS
In this agreement the following words and phrases shall have the
meanings set forth below. Any capitalized terms not defined herein shall
have the meaning as defined in the Commercial Agreement:
"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.
"Associated Companies" means (i) in respect of Medeva, 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 English
Companies Act 1985 (as amended); and, (ii) in respect of Aviron, any
entity that directly or indirectly owns, is owned by or is under common
ownership with Aviron, where own or ownership means direct or indirect
possession of at least fifty percent (50%) of the outstanding voting
securities of a corporation or a comparable equity interest in any other
type of entity.
"Aviron Materials" means the Raw Materials and Packaging Materials
listed in Appendix 1A.
"Aviron Materials Specifications" means that part of the Specifications
that relates to the Aviron Materials.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES ACT OF 1934, AS AMENDED.
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"BLA" means Aviron's Biological License Application for the FluMist(TM)
vaccine to be submitted to the FDA or a corresponding application
submitted to another Regulatory Authority.
"Commercial Agreement" means the agreement entered into between the
parties on the same date as this agreement setting forth the commercial
terms pertaining to the Manufacture of the Intermediate Product by
Medeva for Aviron.
"Consistency Lot" means batches of Intermediate Product Manufactured for
the purpose of establishing that the process of Manufacture of the
Intermediate Product can be consistently repeated, as required for
obtaining approval of a Regulatory Authority to market, distribute, and
sell the Vaccine.
"Eggs" means the specific pathogen-free eggs supplied by Aviron or its
supplier to Medeva for the Manufacture of the Intermediate Product.
"Finished Product" means the Vaccine in its final form packaged for 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 in the
beginning of August and ending 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.
"Harvest" means the manufacturing step during which the allentoic fluid
in the Egg is aseptically processed or collected.
"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.
"Manufacture" means the production of the Intermediate Product from the
Raw Materials and shall include production of [*], production of [*],
and "Manufactured," and "Manufacturing" shall be interpreted
accordingly.
"Manufacturing Instructions" means the documentation of the
Manufacturing process and applicable standard operating procedures which
must be followed by Medeva in the Manufacture of the Intermediate
Product, attached hereto and incorporated herein in as part of
Specifications in Appendix 2.
"Manufacturing Records" means manufacturing, facility/systems and
environmental monitoring and cleaning, packaging and quality control and
quality assurance records generated by Medeva in the course of the
Manufacture, including, without limitation, the Manufacturing
Instructions, production, packaging, quality control, and quality
assurance records.
"Manufacturing Working Virus Seeds" means the virus seeds produced by
Medeva, 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 Dr. Maassab and designated Type A/Ann Arbor/6/60-H2N2 and
Type B/Ann Arbor/1/66, exclusively licensed
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES ACT OF 1934, AS AMENDED.
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from Michigan to Aviron, and which are modified at Aviron to produce
Master Virus Seeds.
"Master Virus Seeds" means certain reassortants produced by Aviron from
the Master Donor Strain.
"Medeva Materials" means the Raw Materials and Packaging Materials
listed in Appendix 1B.
"Medeva Materials Specifications" means that part of the Specifications
that relates to the Medeva Materials.
"Michigan" means the Regents of the University of Michigan, a
constitutional corporation of the State of Michigan with offices located
at Wolverine Tower, Room 2071,3003 South State Street, Ann Arbor,
Michigan, 48109-1280, USA.
"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.
"Packaging Material" means any packaging materials accompanying the Raw
Materials or Intermediate Product during the course of shipment to and
from Medeva.
"Raw Materials" means any component required for the Manufacture of the
Intermediate Product.
"Regulatory Authority" means any supranational, national, regional,
state, provincial or local regulatory agency, department, bureau,
commission, council or other governmental entity, with jurisdiction over
the review and granting of approvals, licenses, registrations or
authorizations necessary for the Manufacture, use, storage, importation,
export, transport or sale of the Vaccine in a regulatory jurisdiction in
the world.
"Responsible Head" shall have the meaning assigned to it in Clause 11.1.
"Specifications" means requirements and specifications for the Raw
Materials, Master Virus Seed, Manufacturing Working Virus Seed, and the
Intermediate Product and its Manufacture, incorporated herein and
attached hereto as Appendix 2, as may be amended from time to time in
accordance with Clause 7.3
"Vaccine" means Aviron's live, attenuated, intranasally delivered cold
adapted influenza vaccine in the frozen formulation made using the
Master Donor Strains (i.e. which, during the dating period established
by the FDA, maintains stability at temperatures of [*] and may maintain
stability at temperatures of [*] but does not maintain stability at [*]
or at [*] as further described in the FDA BLA.
"W-A" means Wyeth-Ayerst Laboratories Division of America Home Products,
Corp. or any entity that directly or indirectly owns, is owned by or is
under common ownership with W-A, where own or ownership means direct or
indirect possession of at least fifty percent (50%) of the outstanding
voting securities of a corporation or a comparable equity interest in
any other type of entity.
"Working Virus Seed"
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES ACT OF 1934, AS AMENDED.
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3. COMPETENCE
Aviron hereby declares and agrees that it has assessed and is satisfied
with the competence and ability of Medeva to undertake and complete
successfully the work contemplated by this agreement. Such declaration
and agreement is not a waiver of Aviron's rights or Medeva's obligations
under this or any other agreements between Medeva and Aviron.
4. RAW MATERIALS AND PACKAGING MATERIALS
4.1 Medeva will ensure that the Medeva Materials are sourced from qualified
suppliers and comply with the Medeva Materials Specifications.
4.2 Aviron will ensure that the Aviron Materials are sourced from qualified
suppliers and comply with the Aviron Materials Specifications.
5. QUALITY CONTROL
5.1 Aviron will supply to Medeva the Master Virus Seeds and the Eggs
together with documentation which confirms that the Master Virus Seeds
and the Eggs are suitable for Manufacture of the Working Virus Seeds and
the Monovalent Virus Harvest.
5.2 Medeva shall be responsible for appropriate quality control testing of
the Medeva Materials and the Aviron Materials, except those items agreed
to in writing by the parties, to ensure that such Materials comply with
the Medeva Materials Specifications and the Aviron Materials
Specifications.
5.3 Medeva shall be responsible for carrying out [*] and, if requested to do
so by Aviron, [*] on the [*] Aviron shall be responsible for [*] on the
[*]
6. INFORMATION PROVIDED BY AVIRON
Aviron will transfer to Medeva in accordance with the provisions of the
Commercial Agreement such information as is necessary to enable Medeva to
Manufacture the Intermediate Product.
7. AMENDMENTS TO THE TECHNICAL AGREEMENT AND THE SPECIFICATIONS.
7.1 Within 30 days of executing this agreement, the Parties will form a
Specifications Working Group ("SWG"). The purpose to the SWG shall be
from time to time to review and discuss changes to this Technical
Agreement and the Specifications.
7.2 The SWG shall be comprised of two (2) members from each of the Parties,
appointed and substituted for each Party as necessary from time to time.
The chairperson of the SWG shall be named by Aviron from among its SWG
members. Medeva and Aviron will each nominate a senior representative to
the SWG. The senior representatives will have the authority to approve
changes to this Technical Agreement and the Specifications on behalf of
Medeva or Aviron, respectively, as provided in Clause 7.3 below. All
changes to this Technical Agreement and the Specifications will be
reduced to writing, signed on behalf of the Parties by the senior
representatives and appended to this Technical aAgreement in Appendix 2.
7.3 The senior representative of Aviron in the SWG shall have the deciding
vote on any amendment to this Technical Agreement and the
Specifications, taking into due consideration the discussions and
concerns raised in the SWG, provided, that the senior representative of
Medeva will have the right to
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES ACT OF 1934, AS AMENDED.
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reject changes to this Technical Agreement or the Specifications if
their implementation would cause non-compliance with applicable health,
safety or environmental regulations or cGMP.
8. NON-COMPLIANCE WITH SPECIFICATION
Within 30 days of executing this agreement, the Parties will appoint one
(1) representative each from operations/manufacturing, regulatory
affairs, quality assurance and quality control to serve on the Product
Evaluation Team, ("PET"). The purpose of the PET is to [*] of the
Intermediate Product's non-compliance to the Specifications. The
chairperson of the PET will be designated by Aviron from among its PET
members and membership can be changed from time to time by the
respective Party. The [*] of the PET will be communicated to the
responsible persons of the respective Parties in quality assurance.
9. CHANGE CONTROL
9.1 Aviron shall be notified of and authorise any changes which will or
could impact the regulatory status of the Vaccine or the performance of
the Manufacture. In particular, and without limitation, Aviron shall be
notified of any planned changes to the site of the Manufacture,
utilities, building, equipment, organization or process used in the
Manufacture.
9.2 Aviron shall be notified of any specific changes required by Regulatory
Authorities to the Manufacture, site of the Manufacture or the equipment
used in the Manufacture. If a Regulatory Authority does not require
specific changes, but declares certain aspects of the Manufacture to be
deficient, the SWG shall discuss and agree on how to change this
Technical Agreement, the Specifications, the site of Manufacture or
equipment used in the Manufacture in order to remedy the deficiency
noted by the Regulatory Authority, as provided in Clause 7 above.
10. TESTING AND RELEASE TO AVIRON OF INTERMEDIATE PRODUCT BY MEDEVA
10.1 Medeva shall [*] ship the Intermediate Product to Aviron or its designee
only after [*] and if requested by Aviron, [*] and when the
documentation referred to in clause 10.2 is available. For the avoidance
of any doubt, Aviron will bear ultimate release responsibilities for the
Intermediate Product subsequent to the release by Medeva. The [*] (and
[*] shall be performed as provided in the Specifications within [*] days
after Manufacture of a batch of Monovalent Virus Harvest or NAF.
10.2 Medeva will supply to Aviron with each shipment of Intermediate Product
all relevant batch documentation as provided for in the Specifications,
and a Certificate of Compliance showing that the Intermediate Product
[*] and was Manufactured in accordance with the Manufacturing
Instructions and cGMP.
11. TESTING AND RELEASE OF INTERMEDIATE PRODUCT BY AVIRON
11.1 Aviron shall designate the senior executive of Aviron or its contractor
(the "Responsible Head") who is responsible for review of the
documentation provided by Medeva pursuant to Clause 10.2 and for the
release of the quarantined Intermediate Product received by Aviron or
its contractor from Medeva. The Responsible Head will release the
Intermediate Product based on a satisfactory Certificate of Compliance
received from Medeva and upon [*] by Aviron or its contractor pursuant
to Clause 11.2 below.
11.2 Aviron will perform the [*] of the Intermediate Product as provided in
the Specifications, and will send the [*] to Medeva for its files.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES ACT OF 1934, AS AMENDED.
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11.3 Each Party will designate a quality assurance person to be responsible
for review of documentation and recommend release of Intermediate
Product to the Responsible Head. The quality assurance person may be
changed from time to time with written notification to the other Party.
12. MANUFACTURING RECORDS
12.1 Medeva will keep under safe and secure storage the Manufacturing Records
for each batch of Intermediate Product for a period of [*} or the term
of the Commercial Agreement, if shorter. Medeva will ensure that this
documentation is available for inspection by authorised Aviron personnel
on reasonable notice. At the end of [*] or the prior expiration or
termination of the Commercial Agreement, Medeva shall transfer the
Manufacturing Records to Aviron at Aviron's expense, or may otherwise
dispose of such records if such transfer is not desired by Aviron.
12.2 Medeva will submit to Aviron, promptly following a written request from
Aviron, copies of all the Manufacturing Records relating to the
Intermediate Product.
13. SCOPE OF MEDEVA RESPONSIBILITIES
Medeva is responsible for the Manufacture of the Intermediate Product
from Raw Materials, including the following Manufacturing steps:
[*]
14. AUDITS
14.1 Medeva will permit, [*] of this agreement and during normal business
hours and upon reasonable notice, representatives of Aviron and its
Associated Companies [*] including a representative of W-A [*] any such
[*]of any representatives of Aviron, its Associated companies or W-A [*]
to have access to any relevant records in connection with such
Manufacture, and to inspect the relevant parts of the premises where
Manufacture of Intermediate Product is carried out, and assess its
compliance with cGMP and any current practices of any relevant Agency,
and to discuss any related issues with Medeva's management personnel.
Notwithstanding the foregoing, Medeva's obligation to allow such
visitors is on condition that: (a) Aviron, Aviron's Associated Companies
and W-A, respectively, procure that such visitors agree in writing to
observe the regulations of Medeva regarding security, health and safety
and any other applicable regulations at the relevant premises, and
confidentiality obligations corresponding to those contained in this
Restated Agreement; (b) any visit shall be under the specific
supervision of Medeva [*] and (c) Aviron, Aviron's Associated Companies
and W-A, respectively, [*] and shall [*] to Medeva's property or any
personal injury which is caused by any act or omission of any of
Aviron's or W-A's employees or authorised agents or nominated visitors
on Medeva's premises; and (d) Aviron, Aviron's Associated Companies and
W-A use their best endeavours to ensure that the visit is of minimal
disruption to Medeva's day to day business.
14.2 INSPECTIONS BY AGENCIES. Medeva will allow representatives of any Agency
to inspect the relevant parts of its premises where the Manufacture of
the Intermediate Product is carried out and to inspect the Manufacturing
Records to ensure compliance with cGMP and other practices or
regulations. In the event that an Agency inspects those areas of
Medeva's premises used in the Manufacture of the Intermediate Product,
Medeva shall provide as much notice as practicable of such inspection to
Aviron and shall permit representatives of Aviron to [*] said
inspection. Aviron acknowledges that its representatives [*] the [*] to
[*] in [*] except that [*] the [*] to [*] in the [*] of [*] and [*] any
wrap-up sessions conducted by the Agency representative which relate
solely to the Manufacture of the Intermediate Product and/or the Aviron
Unit. Medeva shall inform Aviron of any questions or recommendations
made by the Agency and shall provide to Aviron copies of any written
questions
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES ACT OF 1934, AS AMENDED.
55
<PAGE> 56
or recommendations received from the Agency insofar as they pertain to
the Manufacture of the Intermediate Product. Medeva and Aviron shall [*]
any written questions and recommendations of the Agency and [*] 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 contents of any response to a question or recommendation of
an agency that pertains to [*] and save where the response to the
question or recommendation of the agency pertains [*] in which case [*]
shall have [*] as to the contents of such response. In the case of a
question or recommendation made by the Agency requiring [*] Medeva's
representatives present during said inspection shall [*] and shall [*]
the response made. Further, Medeva shall promptly send to Aviron a copy
of any reports, citations, or warning letters received by Medeva in
connection with an Agency Inspection to the extent such documents relate
to or affect the Manufacture of the Intermediate Product.
15. RETENTION OF SAMPLES
15.1 Medeva will draw and retain [*] samples of each of:
[*]
Medeva shall retain one of each of the samples taken in accordance with
clause 15.2. Aviron shall be responsible for shipping, on separate
shipments and on separate carriers, and retaining the remaining [*]
samples. Sample size and the procedures determining the timing and
manner of sample drawing and shipping and other matter relating to the
sampling procedures will be determined in standard operating procedures
to be agreed by the parties within 30 days after the date of this
agreement.
15.2 Retained samples of Intermediate Product will be stored for [*] beyond
the expiry date of the Vaccine which was manufactured with the batch of
Intermediate Product from which that sample was drawn. Retained samples
of Raw Materials will be kept for minimum of [*] if their stability
allows.
16. DISPOSAL OF MATERIALS
Any Raw Materials which are not stored or retained by Medeva under the
terms of this agreement or the Commercial Agreement will be disposed of
by Medeva in a safe and controlled manner following internal standard
operating procedures and any applicable health and safety regulations.
17. STORAGE
17.1 Medeva will be responsible for the maintenance, calibration, validation
and inventory control of Raw Materials and Intermediate Product and
sample storage equipment and areas. The storage of Intermediate Product
and samples will be performed in compliance with the Specifications,
standard operating procedures, the Manufacturing Instructions and cGMP.
All refrigerators and freezers used for samples and Intermediate Product
will be validated.
17.2 Raw Material and Intermediate Product storage areas will be utilized to
control quarantined and released materials. The storage areas will be
controlled to restrict access as required by cGMP.
17.3 Medeva shall provide Aviron written inventory reports of Raw Materials
and Intermediate Product on a [monthly] basis. At the request of Aviron,
such reports will be made in electronic form.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES ACT OF 1934, AS AMENDED.
56
<PAGE> 57
IN WITNESS hereof this agreement has been signed by a duly authorized officer of
each party the day and year first before written.
MEDEVA PHARMA LIMITED
............................ (Sign)
............................ (Name)
............................ (Title)
in the presence of:
............................ (Sign)
............................ (Name)
............................ (Title)
AVIRON
............................ (Sign)
............................ (Name)
............................ (Title)
in the presence of:
............................ (Sign)
............................ (Name)
............................ (Title)
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES ACT OF 1934, AS AMENDED.
57
<PAGE> 58
APPENDIX 1A
RAW MATERIALS TO BE SUPPLIED BY AVIRON
[*]
<TABLE>
<CAPTION>
Signature Date
----------------------------------------
<S> <C> <C>
Medeva Pharma Ltd
Aviron
</TABLE>
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES ACT OF 1934, AS AMENDED.
58
<PAGE> 59
APPENDIX 1B
RAW MATERIALS TO BE SUPPLIED BY MEDEVA
1.
2.
3.
4.
<TABLE>
<CAPTION>
Signature Date
----------------------------------------
<S> <C> <C>
Medeva Pharma Ltd
Aviron
</TABLE>
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES ACT OF 1934, AS AMENDED.
59
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APPENDIX 2
SPECIFICATIONS
The attached Specifications include the following items:
<TABLE>
<CAPTION>
SUPPLIED SUPPLIED BLA
ITEM BY AVIRON BY MEDEVA REFERENCE
- ----------------------------------------------------------------------------------------------
<S> <C> <C> <C>
[*]
1.
- ----------------------------------------------------------------------------------------------
2.
- ----------------------------------------------------------------------------------------------
3.
- ----------------------------------------------------------------------------------------------
4.
- ----------------------------------------------------------------------------------------------
5.
- ----------------------------------------------------------------------------------------------
6.
- ----------------------------------------------------------------------------------------------
7.
- ----------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------
1.
- ----------------------------------------------------------------------------------------------
2.
- ----------------------------------------------------------------------------------------------
3.
- ----------------------------------------------------------------------------------------------
4.
- ----------------------------------------------------------------------------------------------
5.
- ----------------------------------------------------------------------------------------------
6.
- ----------------------------------------------------------------------------------------------
7. [*]
- ----------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------
</TABLE>
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES ACT OF 1934, AS AMENDED.
60
<PAGE> 61
<TABLE>
<CAPTION>
Signature Date
---------------------------------------
<S> <C> <C>
Medeva Pharma Ltd
Aviron
</TABLE>
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES ACT OF 1934, AS AMENDED.
61
<PAGE> 62
SCHEDULE 9
TECHNICAL SUPPORT
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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SCHEDULE 10
RAW MATERIALS SUPPLIED BY AVIRON
1. [ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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SCHEDULE 11
[ * ]
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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.
64
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SCHEDULE 12
MANUFACTURING CAPACITY
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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.
65
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SCHEDULE 13
FORMAT OF FORECAST
- -------------------------------------------------------------------------------
[ * ] [ * ] [ * ] [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
EGG QUANTITY
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
DELIVERY DATE OF EGGS
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
INTENDED USE (NAF/MVH)
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
DELIVERY DATE OF MVS
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
SET DATE
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
AVAIL DATE OF MWVS
FOR INOC.
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
INOCULATION DATE
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
HARVEST DATE
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
PLANNED STRAIN
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
Q.A RELEASE.
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
SHIP DATE OF
INTERMEDIATE PRODUCT
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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SCHEDULE 14
EXPERT DISPUTE RESOLUTION PROCEDURES
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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SCHEDULE 15
SUPPLY PRICE
[ * ]
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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SCHEDULE 16
LIST OF CRITICAL EQUIPMENT
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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SCHEDULE 17
EMPLOYMENT LEVELS
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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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Schedule 18
[ * ]
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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.
71
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Medeva Pharma Limited
Vale of Bardsley, Ashton-under-Lyne
Lancashire OL7 9RR
Telephone +44 (0)161 330 4531
FAX +44 (0)161 343 5083
Our ref: MJH/KAM
30 June 1999
Mr. Fred Kurland
Senior Vice President and CFO
Aviron
297 North Bernardo Avenue
Mountain View, California 94043 BY FACSIMILE & POST
Dear Sirs:
Medeva Pharma Limited and Aviron hereby, in consideration for the mutual
covenants set forth herein, the adequacy of which is agreed by both parties,
agree to the following amendments of the Contract Manufacture Agreement entered
into between the parties in June 1999.
Clause 2.38 - shall be amended to read "Named Executives" means a director of
Medeva and Vice President of Aviron designated and replaced from time to time by
the respective party. As of the Effective Date the Named Executives of the
respective parties shall be those persons set forth in Schedule 19.
Clause 3.7.8.2 shall be amended to read "In connection with the PAI, Medeva will
permit Aviron's [ * ], currently the individual whose name is set forth in
Schedule 19, to be present and participate [ * ] relating to the Vaccine
provided, however, that Medeva shall have the right [ * ] where he would become
privy to confidential information not related to the Vaccine. Furthermore, in
preparation of the PAI, Medeva shall [ * ] and during the PAI shall make
accessible to the Agency [ * ], all documentation specifically associated with
the Manufacture of the Intermediate Product. Aviron may, in relation to this
clause 3.7.8.2, change the individual who is entitled to be present and
participate [ * ] from the individual names in Schedule 19 [ * ], such [ * ] not
to be [ * ].
A new clause 3.7.15 shall be inserted which shall read "Medeva shall make
available the GSA, AVU, MPU and SPF Unit to Aviron for purposes other than
Manufacture of Intermediate Product intended for use in Vaccines for commercial
sale, as requested from time to time by Aviron. Aviron shall pay to Medeva for
any such use the [ * ] as set forth in Schedule 9. For the avoidance of doubt,
Aviron shall not pay any [ * ] in connection with such use".
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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.
<PAGE> 73
Clause 3.7.17 - shall be amended by the addition of the following words "The
specification of any other eggs processed by Medeva in the SPF Unit shall be the
same or higher than the specification of the Eggs. Medeva shall provide to
Aviron promptly after the Effective Date a draft SOP pertaining to the [ * ] of
the Eggs in the SPF Unit. Aviron may, by written request, [ * ] such SOP and
[ * ], the requested amendments are reasonable to ensure that the processing of
the Eggs for the Manufacture of the Intermediate Product is not compromised,
[ * ] make such alterations to the procedures and SOP's. Medeva shall provide to
Aviron a written [ * ] any amendment [ * ] has [ * ].
Clause 6.1.2 - shall be amended so that the word [ * ] in the second line shall
be replaced by the word [ * ].
Clause 6.1.3 - shall be amended so that the word [ * ] in the first line shall
be replaced by the word [ * ].
Clause 6.2.1 - there shall be two changes to this clause. In the last sentence,
the reference to [ * ] shall be replaced by [ * ]. Further, the following words
shall be added at the end of Clause 6.2.1.
"Any forecast provided by Aviron shall be in the format set forth in Schedule
13".
Clause 6.4.6 - the emboldened square bracket in the seventh line shall be
deleted.
Clause 7.2 - shall be amended by addition at the end of the following sentence
added "For the avoidance of doubt, Medeva does not have a license to use the
Aviron Process Technology except for the purpose of Manufacturing the
Intermediate Product pursuant to this Restated Agreement or for Aviron's
licensees as provided in Clause 7.5.4"
Clause 9.2.1.1 - shall be deleted and replaced with the following "In the event
that Medeva [ * ] and [ * ] and [ * ] which shall be [ * ], for such [ * ] which
[ * ], Aviron shall pay to Medeva [ * ].
Clause 9.2.2.1 - the word "endeavors" shall be inserted after the words "all
reasonable" in the penultimate line.
Clause 9.3.3 - the sentence reading "under no circumstances shall the combined
reductions from [ * ]" shall be deleted.
Clause 11.6 - shall be deleted and replaced with the following: "Aviron hereby
indemnifies and shall keep Medeva indemnified against all costs, damages or
liabilities up to a maximum of [ * ] of this Agreement arising from
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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.
<PAGE> 74
[ * ] save where such [ * ] is caused by the negligence, willful malfeasance or
default of Medeva or its employees in which case Aviron shall have no liability
to Medeva pursuant to the indemnity set forth in this clause 11.6. Aviron shall
not be liable under the indemnity set forth in this Clause 11.6 for any indirect
or consequential losses, costs, damages or liabilities suffered by Medeva as a
result of the contamination or interruption to the business of Medeva
contemplated by this Clause 11.6
Clause 16.1 - shall be amended by the deletion of [ * ] and replacing such with
[ * ].
Clause 16.2 - shall be amended by replacing [ * ] with [ * ].
Clause 16,3 - shall be amended by deletion of [ * ] and replacing such with [ *
].
By insertion of a new Clause 20.9 which shall read "Upon termination of the
Michigan Agreement, Medeva shall assist Aviron in complying with its obligations
under Clauses 15.5 and 15.6 of the Michigan Agreement".
Clause 23.1 - By deletion of"(etc etc)" from the first line of Clause 23.1.
Schedule 9 - In the section at the end of Schedule 9 under the heading
"Definitions" the following amendments shall be made: (a) the following words
shall be added to the sentence which reads [ * ]; "this figure includes costs
pertaining to the relevant part of the GSA, SPF and MPU utilised for that day".
(b) The following words shall be added to the sentence which reads [ * ],
"except in relation to [ * ] in which circumstances Aviron will pay to Medeva
[ * ]
By insertion of a new Schedule 19 as attached.
Yours faithfully
/s/ M. J. Harvey
M J Harvey
New Business Development Director
Signed for and on behalf of Aviron
/s/ Fred Kurland Date 7/14/99
- ----------------------------------------- ----------
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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.
<PAGE> 75
SCHEDULE 19
RELEVANT INDIVIDUALS
The individuals pursuant to Clause 2.38 are [ * ].
The individuals pursuant to Clause 3.7.8.2 are [ * ].
The individuals pursuant to Clause 13 are [ * ].
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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.
<PAGE> 76
Medeva Pharma Limited
Gaskill Road, Speke
Liverpool L24 9GR
Telephone +44 (0)151 486 1866
FAX: +44 (0)151 486 5033
2nd July 1999
Mr. Fred Kurland
Senior Vice President and CFO
Aviron
297 North Bernardo Avenue
Mountain View, California 94043 BY FACSIMILE & POST
Dear Sirs:
Medeva Pharma Limited and Aviron hereby, in consideration for the mutual
covenants set forth herein, the adequacy of which is agreed by both parties,
agree to the following amendments of the Contract Manufacture Agreement entered
into between the parties in June 1999 as amended by the letter agreement dated
June 30, 1999.
Clause [ * ] shall be deleted and replaced with the following:
"SPF Unit. Medeva will [ * ] for products manufactured in the SPF Unit [ * ] in
such a manner that within [ * ] from the Effective Date, any [ * ] in the SPF
Unit [ * ] of the Manufacturing Working Virus Seed and the Intermediate Product.
Notwithstanding the foregoing, Aviron hereby [ * ], for the period of [ * ], at
[ * ], to use Aviron Assets in the SPF Unit for the processing of [ * ] for use
in products other than the Intermediate Product and the Working Virus Seed. The
[ * ] processed by Medeva in the SPF Unit shall be the [ * ] than the [ * ].
Medeva shall provide to Aviron promptly after the Effective Date draft SOPs and
procedures pertaining to the [ * ] in the SPF unit. Medeva shall ensure any SOPs
that pertain to [ * ] processed in the SPF unit are [ * ], such that any
procedure carried out or required by [ * ] with any [ * ] of [ * ] where the
meaning of [ * ] for the purposes of this provision shall include but not be
limited to [ * ] or the [ * ] carried out in the SPF Unit. If in the reasonable
opinion of an independent competent third party, appointed by agreement of
Medeva and Aviron (such third party having experience and expertise appropriate
to resolve such an issue) that [ * ] with the [ * ],
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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.
<PAGE> 77
Medeva [ * ] those SOPs [ * ] in the SPF Unit so that they [ * ] pertaining to
the [ * ]. Medeva is not obligated to provide Aviron with [ * ] of [ * ] after
they have [ * ] SPF Unit."
Clause 9.2.1.1 - shall be amended by the deletion of " , save for PQ014 which
shall be delivered by August 31, 1999,".
Clause 11.1 shall be amended by deleting the reference to Clause 11.9 so that
the first sentence shall commence:
"Subject to Clauses 11.2, 11.3 and 11.8 Medeva indemnifies ...."
Clause 11.9 shall be amended so that the first sentence shall commence:
"Subject to Clause 11.1...."
Yours faithfully
/s/ M. J. Harvey
M J Harvey
New Business Development Director
Signed for and on behalf of Aviron
/s/ Fred Kurland Date 7/2/99
- -------------------------------------- ---------
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, 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.
<PAGE> 1
EXHIBIT 23.1
CONSENT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS
We consent to the incorporation by reference in the Registration Statements
(Forms S-8, No. 333-17029, 333-58955, 333-87183 and 333-91607) pertaining to the
1996 Equity Incentive Plan, Employee Stock Purchase Plan, 1996 Non-Employee
Directors' Stock Option Plan, Non-Plan Option Grants and the 1999 Non-Officer
Equity Incentive Plan and in the Registration Statements (Forms S-3, No.
333-41649, 333-50505 and 333-87185) of Aviron of our report dated February 17,
2000, with respect to the financial statements of Aviron included in this Annual
Report (Form 10-K/A) for the year ended December 31, 1999.
/s/ Ernst & Young LLP
Palo Alto, California
April 3, 2000
