EXHIBIT 10.15
CONTRACT MANUFACTURE
AGREEMENT
XXXXX MEDICAL
LIMITED
AND
AVIRON
APRIL 16, 1997
[ * ] = Certain information in this exhibit has been omitted and filed
separately with the Commission. Redacted portions of the exhibit are indicated
by an asterix within brackets ([ * ]), and a legend appears on the appropriate
pages. Confidential treatment has been requested with respect to the omitted
portions.
1. Definitions................................................................ 1
2. Contract Manufacture....................................................... 5
3. Technical Agreement........................................................ 8
4. Duration and Interpretation................................................ 9
5. Forecast and Supply........................................................ 9
6. Intellectual Property and Improvements..................................... 11
7. Prices..................................................................... 12
8. Indemnity.................................................................. 13
9. Confidentiality............................................................ 14
10. Liaison.................................................................... 14
11. Change of Control.......................................................... 14
12. Termination................................................................ 15
13. Associated Companies....................................................... 17
14. Force Majeure.............................................................. 18
15. Notices.................................................................... 18
16. Michigan License........................................................... 19
17. General.................................................................... 20
18. Public Disclosure.......................................................... 21
Schedule 1- Technical Agreement ................................................. 23
Schedule 2 - Price for Production................................................ 33
Schedule 3 - Trademarks ......................................................... 35
Schedule 4 - Development Agreement............................................... 36
Schedule 5 - Michigan Agreement.................................................. 37
Schedule 6- Aviron's Assets...................................................... 38
CONTRACT MANUFACTURE AGREEMENT
THIS AGREEMENT is made the 16/th/ day of April 1997
BETWEEN
"Xxxxx" Xxxxx Medical Limited whose registered office is at Xxxxx House, Regent
Park, Xxxxxxxx Xxxx, Xxxxxxxxxxx, Xxxxxx, XX00 0XX, Xxxxxx Xxxxxxx
and
"Aviron" Aviron (a Delaware Corporation) whose registered office is at 000 Xxxxx
Xxxxxxxx Xxxxxx, Xxxxxxxx Xxxx, Xxxxxxxxxx 00000, Xxxxxx Xxxxxx of America
RECITALS:
X. Xxxxx carries on the business of, inter alia, Manufacture, assembly and
packaging of pharmaceutical products.
B. Aviron wishes Xxxxx to Manufacture the Products (as hereinafter defined)
and Xxxxx is willing to Manufacture the Products on the terms and
conditions hereinafter set out.
C. Aviron is the exclusive licensee of the University of Michigan to certain
live attenuated influenza Virus Seeds and the technology associated with
and required for the production of certain reassortants therefrom.
THE PARTIES AGREE AS FOLLOWS:
1. DEFINITIONS
1.1. In this Agreement the following terms shall have the following
meanings unless the context otherwise requires:
1.1.1. "Agency" means any governmental body responsible for
licensing of the Product for commercial sale and the
licensing of premises and facilities of the Manufacturer.
1.1.2. "Associated Companies" means (i) in respect of Xxxxx 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 under s736 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.
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1.1.3. "Aviron Assets" means capital equipment purchased by Aviron
for use in the Manufacture of the Product as more
particularly specified in (Schedule 6).
1.1.4. "Bulk Monovalent Intermediates" means material produced from
one or all Working Seeds in quantities sufficient for
Manufacture of Product.
1.1.5. "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.
1.1.6. "Consistency Lot" means batches of Product Manufactured at
Commercial Manufacturing scale for the purposes of obtaining
Agency approval to market, distribute, and sell the Product.
1.1.7. "Commercial Manufacturing" means any Manufacture of the
Product intended for sale, and also any Manufacture of
samples of the Product, and materials necessary for the
marketing, testing, quality control, and stability studies of
such Manufacture.
1.1.8. "Development" means the development of a manufacturing
process for Manufacture of Product.
1.1.9. "Effective Date" means 1st May 1997.
1.1.10. "FDA" means Food and Drug Administration of the United States
of America.
1.1.11. "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.
1.1.12. "Manufacture" means the production of the Product from the
Raw Materials and shall include production of Working Seeds
from Virus Seeds, production of Bulk Monovalent Intermediates
from Working Seeds, blending, assembly, packaging, testing
and quality control and "Manufactured", "Manufacturing", and
"Manufacturer" shall be interpreted accordingly.
1.1.13. "Master Strains" shall mean the live attenuated influenza
vaccine seeds exclusively licensed from Michigan to Aviron,
and which are modified at Aviron to produce Virus Seeds.
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1.1.14. "Manufacturing Records" means all documentation associated
with Manufacture of the Product, including, without
limitation, all batch information regarding analysis,
distribution and Manufacture.
1.1.15. "MPB" means Multi-Purpose Bacterials which is a manufacturing
area designated as such within Xxxxx' Liverpool facility.
1.1.16. "Michigan" means the Regents of the University of Michigan, a
constitutional corporation of the State of Michigan with
offices located at Wolverine Tower, Room 2071, 0000 Xxxxx
Xxxxx Xxxxxx, Xxx Xxxxx, Xxxxxxxx, 00000-0000, XXX.
1.1.17. "Michigan Agreement" means the Material Transfer and
Intellectual Property Agreement dated February 24, 1995
between Michigan and Aviron.
1.1.18. "Price for Production" means specific price for facilities,
and activities conducted by Xxxxx for the Manufacture of the
Products as defined in Schedule 2.
1.1.19. "Process Improvements" means all improvements, modifications
or adaptations to the process, or method of Manufacture used,
created or discovered by Xxxxx and not solely and
specifically related to the Manufacture of the Product which
arise in association with the process of Manufacture of the
Product.
1.1.20. "Product" means either Working Seed, Bulk Monovalent
Intermediate, Vaccine, or any of the three, as specified by
Aviron, a description of which is set out in the Technical
Agreement.
1.1.21. "Raw Materials" means the components defined in the Technical
Agreement and required by Xxxxx in the Manufacture of the
Product.
1.1.22. "Restricted Information" means (i) Master Strains, Virus
Seeds and Working Seeds; (ii) all Technical Information
relating to Master Strains, the Virus Seeds and the
Manufacture of the Product; (iii) all information relating to
the Discloser's business; and (iv) all information arising
pursuant to this Agreement, disclosed by one party to this
Agreement (the "Discloser") to the other (the "Recipient") in
connection with this Agreement, excluding any such
information which:
0.0.00.0.xx or was already known to the Recipient at the time
of disclosure by the Discloser; or
1.1.22.2.was at the time of such disclosure or communication
by the Discloser or thereafter becomes or became
published, accessible to
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the public or otherwise in the public domain other
than through any act or omission of the Recipient;
or
1.1.22.3.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
1.1.22.4.must be disclosed by the Recipient to the relevant
Agency in the course of applying for, obtaining or
maintaining regulatory approval; or
0.0.00.0.xx 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
0.0.00.0.xx required to be disclosed by law.
1.1.23. "Specifications" means requirements and specifications for
the Manufacture of Product attached to the Technical
Agreement (Schedule 1), as may be amended from time to time
by agreement between both parties.
1.1.24. "Technical Agreement" means the Technical Agreement, which
may be amended from time to time, to be entered into between
the parties (Schedule 1) prior to Commercial Manufacturing of
the Product.
1.1.25. "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 Product or its design,
Manufacture, formulation, handling, storage and use.
1.1.26. "Trade Xxxx" means the trade marks set out in Schedule 3
which are either owned by Aviron or to which Aviron has a
right of use (with the right to sub-license).
1.1.27. "Vaccine" means the blended, filled and from time to time
packaged cold-adapted multivalent influenza vaccine
incorporating Bulk Monovalent Intermediates grown from
Working Seeds.
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1.1.28. "Virus Seeds" means certain reassortants produced by Aviron
from the Master Strain.
1.1.29. "Working Seeds" means the virus reassortants produced by
Xxxxx, from time to time, from the Virus Seeds, and from
which the Bulk Monovalent Intermediate is produced.
1.2. Any reference in this Agreement to "writing" or cognate expressions
includes a reference to telex, cable, facsimile transmission or
comparable means of communication.
1.3. Words in this Agreement importing the singular meaning shall where the
context so admits include the plural meaning and vice versa.
1.4. The headings in this Agreement are for convenience only and shall not
affect its interpretation.
2. CONTRACT MANUFACTURE
2.1. Aviron hereby appoints Xxxxx and Xxxxx accepts the appointment as
Manufacturer of the Product for the term of this Agreement. During the
period of this Agreement Xxxxx will Manufacture for Aviron the Product
in accordance with this Agreement and the Technical Agreement.
2.2. Aviron shall be responsible for and shall bear all risks associated
with the importation and supply to Xxxxx of the Virus Seeds into the
United Kingdom. Aviron shall be responsible for export of the Product
from the United Kingdom and any costs and expenses associated
therewith or relevant thereto. Xxxxx shall assist at Aviron's
reasonable request and at Aviron's expense with the export of the
Product from the United Kingdom.
2.3. Xxxxx covenants that:
2.3.1. it will carry out the Manufacture in accordance with this
Agreement and the Technical Agreement;
2.3.2. all Raw Materials supplied by Xxxxx and used in Manufacture
will comply with the Technical Agreement;
2.3.3. it will keep under review the conditions of the Virus Seed,
Raw Materials and Product in storage as such conditions are
defined in the Technical Agreement;
2.3.4. it will upon written request of Aviron, and at Aviron's
expense, supply Aviron with samples of the Product
Manufactured by it prior to delivery of ordered Product;
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2.3.5 it shall retain for a minimum of seven (7) years and make
available to Aviron on reasonable notice all Manufacturing
Records;
2.3.6. it will Manufacture all Product in compliance with current FDA
Good Manufacturing Practices as set forth in the United States
Code of Federal Regulations as amended from time to time, and
other applicable rules and regulations of the FDA and other
United States governmental or regulatory agencies, and any
current practices of any relevant UK agency, with jurisdiction
over the manufacture, use or sale of the Products as then in
effect;
2.3.7. it will permit Aviron periodically and upon reasonable notice
to Xxxxx, representatives of Aviron, its Associated Companies
previously authorized by Xxxxx, such authorization not to be
unreasonably withheld, and any Agency to have access to any
relevant records in connection with such Manufacture, and to
audit and observe Xxxxx' operations in relevant parts of the
premises where Manufacture of Product is carried out, and
assess its compliance with current FDA Good Manufacturing
Practices, and any current practices of any relevant UK
agency, and to discuss any related issues with Xxxxx'
management personnel;
2.3.8. it will notify Aviron of any recall of the Product of which it
becomes aware and will provide Aviron at Aviron's cost with
any and all assistance in connection with a recall of the
Products as may reasonably be requested by Aviron. In the
event of a voluntary recall, the party initiating the recall
shall bear the expenses incurred in connection with such
voluntary recall. In the event of a mandatory recall, Xxxxx
shall meet the cost of such a recall where the recall is
solely the result of the negligence of Xxxxx, but in all other
cases Aviron shall bear all costs and expenses incurred in
connection with the recall.
2.3.9. MPB, in addition to other facilities as required, will be made
available for the Manufacture of the Product during the term
of this Agreement subject to any periods of closure or
unavailability for the purposes of the conduct of maintenance
and repair in respect of which Xxxxx shall give reasonable
notice to Aviron. Furthermore and subject to Aviron's
agreement, MPB may be used for the conduct of research and
development towards the improvement of the Product and the
Manufacture, provided however, that any and all proprietary
rights to such improvements shall be governed by Clause 6.4.
2.3.10. it is in possession of, and during the term of the Agreement
will maintain, a current Manufacturing License No ML 0039/02
granted pursuant to the Medicines Xxx 0000 permitting Xxxxx to
Manufacture the Vaccine.
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2.4. Aviron covenants that:
2.4.1. prior to Xxxxx' obligations to Manufacture the Product
hereunder arising it will supply and transfer to Xxxxx all
Technical Information in its possession (unless it has
previously supplied Xxxxx with the Technical Information
pursuant to the terms of the Technical Agreement) which is
necessary to enable Xxxxx to Manufacture the Product, including
all information regarding health, safety, environmental, and
FDA regulations, as it becomes known;
2.4.2. it will provide such technical assistance, at Aviron's expense,
as may be required to enable the effective transfer of the
Technical Information under 2.4.1 such that Xxxxx should
reasonably be expected to be able to Manufacture the Product on
the basis of such Technical Information;
2.4.3. where Raw Materials and other supplies are to be provided by
Aviron, Aviron will ensure that they comply with the Technical
Agreement and where appropriate shall be accompanied by a
Certificate of Analysis;
2.4.4. it shall notify Xxxxx of any special requirements in respect of
recordkeeping that may be necessary to comply with Aviron's
Recall Procedure. Xxxxx shall have the right to refuse such
request if it deems the request is unreasonable or to require
specific further compensation should the request entail costs
to be incurred by Xxxxx.
2.5. Xxxxx 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 Commercial Manufacture of the
Product, the cost of which Aviron shall pay to Xxxxx upon receipt of a
valid invoice therefor. Notwithstanding the above, Xxxxx shall not
purchase and/or install any such equipment, tooling or parts or make
such modifications where the cost of any one item would exceed US$5,000
or where the total cost of such items in one calendar month will exceed
US$15,000 in relation to the Agreement without first obtaining the
prior written consent of Aviron. Such equipment, tooling or parts shall
be the property of Aviron and form part of Aviron's Assets and shall be
deemed included in Schedule 6. Where the cost of one item would exceed
US$5,000, Xxxxx may at its discretion demand from Aviron such assurance
as Xxxxx deems necessary, up to but not exceeding the expected cost of
the said item, prior to the order for the purchase of the said item
being placed. Xxxxx will be the final arbiter of the specification of
such items with regard to the said item's compliance with the
requirements of the Agency and with health and safety. Any equipment or
tooling purchased by Xxxxx hereunder and paid for by Aviron shall not
be used by Xxxxx for any purpose outside the scope of this Agreement or
the Development Agreement without the consent of Aviron.
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2.6 Those items of capital equipment identified as Aviron's Assets in
Schedule 6 are owned by Aviron and shall at all times be at the risk
of Aviron, except in the case of Xxxxx' negligence in which
circumstance such Aviron's Assets shall be deemed, for the purpose of
this Agreement, to be at the risk of Xxxxx. Aviron shall insure and
provide evidence to Xxxxx' reasonable satisfaction that such equipment
is appropriately insured and that such insurance covers any loss of or
damage to Xxxxx' 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 of Xxxxx. Xxxxx
is responsible for determining the need for, and managing the
maintenance of Aviron's Assets to Xxxxx' specification. Aviron shall
be responsible for the reasonable cost of maintaining such equipment
in good working order and repair as might be desirable for the
purposes of Manufacture of the Products by Xxxxx. Upon expiry or
termination of this Agreement, Aviron shall, within ninety (90) days
thereof, remove the said equipment from Xxxxx' premises and shall
repair and restore to the condition it was prior to the equipment
being installed, any part of Xxxxx' premises where such equipment
shall have been situated or installed at Aviron's cost unless Xxxxx
chooses to purchase such equipment at a price to be negotiated at that
time. At the point of Xxxxx purchasing such equipment from Aviron, all
Aviron's responsibility under the terms of this clause stop. Should
Aviron fail to remove the equipment and make good any damage within
the ninety day period, Xxxxx may arrange, all at Aviron's cost,
disposal of the said equipment and repair and restoration of the said
premises.
3. TECHNICAL AGREEMENT
3.1. The respective responsibilities of Xxxxx and Aviron relating to the
Manufacture of the Product, the way in which each batch of the 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 (Schedule 1).
3.2. Xxxxx shall be responsible for ensuring the safe operation of the
process of Manufacture of the Product and in particular that the
Technical Information supplied by Aviron can be safely used in Xxxxx'
premises. However, prior to Xxxxx' obligations to Manufacture Product
hereunder arising Aviron will supply Xxxxx with all information in its
possession at the time of such transfer regarding any hazardous
aspects relating to Manufacture of the Product unless previously
supplied to Xxxxx. Should Xxxxx consider in its reasonable opinion the
said hazardous aspect to be unacceptable then it shall so notify
Aviron in writing prior to undertaking the Manufacture and thereafter
shall have the right not to proceed with the Manufacture of the
Product until such hazardous aspect has been abated,
8
if possible. If such abatement is not possible, this Agreement will
terminate and the provisions of Clause 12.6 shall apply.
3.3. Aviron and Xxxxx may request changes to the Technical Agreement from
time to time. No changes will be made unless agreed by both parties.
4. DURATION AND INTERPRETATION
4.1. Unless sooner terminated as provided under Section 12, this Agreement
shall come into force on the Effective Date hereof and shall continue
in force until the earlier of 31 December, 2000, or the date two (2)
years following initial Product commercial sale. Provided that if the
parties so agree on or before 30 April 1998, the Agreement may be
extended to 31 December 2001.
4.2. Aviron and Xxxxx entered into that certain Manufacturing and
Development Agreement dated November 7, 1995 (the "Development
Agreement") (attached as Schedule 4) and currently wish to enter into
arrangements with regard to the further development and Manufacture
by Xxxxx of Bulk Monovalent Intermediates and/or cold adapted
influenza vaccine. It is intended that the Development Agreement will
run concurrently with this Agreement and that this Agreement will not
subvert any obligations, commitments, or definitions in the
Development Agreement.
5. FORECAST AND SUPPLY
5.1. Upon the signing of this Agreement Aviron will provide a forecast of
Product and manufacturing requirements for each year during the term
of this Agreement. During the term of this Agreement Aviron will
submit to Xxxxx by March 1 of each year, a purchase order for
Manufacture and dates for delivery of the Product for the following
calendar year.
5.2. Prior to submission of the first purchase order, the parties will
agree on the format of the purchase orders to be used under this
Agreement. The nature of the services Xxxxx shall perform and/or the
Product to be provided to Aviron pursuant to this Agreement will be
determined on a purchase order by purchase order basis and will be
subject except where otherwise provided in this Agreement to the
reasonable terms and conditions of sale of Xxxxx.
5.3. Within ten (10) days of receipt of such purchase orders Xxxxx shall
notify Aviron in writing of its acceptance or otherwise of such
purchase orders as binding orders or, if different, such confirmation
shall indicate what portion of the amounts of Manufacture covered by
such purchase orders Xxxxx is willing to accept as a binding order.
Dispatch of such confirmation shall constitute the acceptance of a
binding order for the amounts of Manufacture covered by such
confirmation. Such confirmation shall also confirm the delivery date
or specify alternate delivery dates.
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5.4. Xxxxx will use its reasonable endeavors to supply to Aviron, at
Aviron's request, additional Manufacturing in excess of that ordered
or forecasted in accordance with this clause 5 having due regard for
Xxxxx' production capacity and other manufacturing commitments.
5.5. Xxxxx will at the request of Aviron deliver the Product to any
address as Aviron may specify but the Price for Production is Ex-
Works (Speke) (as defined in Incoterms 1990) and Aviron shall bear
the cost of delivery, insurance, export duties, and all such other
costs, to any such address plus the cost of palletization.
5.6. Aviron may in accordance with this clause 5.6 reject any delivery of
Product which does not conform with the Specifications. Any notice of
rejection shall be in writing and shall indicate the reasons for such
rejection. In order to reject delivery of the Product, Aviron must
give written notice to Xxxxx of its rejection of any delivery within
thirty (30) days after receipt of such delivery. If no such notice of
rejection is received, Aviron shall be deemed to have accepted such
delivery of Product within thirty (30) days of delivery of the
shipment. Once Aviron accepts a shipment of Product, Aviron shall
have no recourse against Xxxxx if the Product is subsequently deemed
unsuitable for use for any reason, except as provided in Section 8
below.
If Aviron rejects any Product, Aviron shall cooperate with Xxxxx in
determining whether rejection is necessary or justified. Xxxxx will
evaluate process issues and other reasons for such non-compliance.
Xxxxx shall notify Aviron as promptly as reasonably possible whether
it accepts Aviron's basis for any rejection. If Xxxxx agrees with
Aviron's determination that certain Product does not meet the
Specifications, and promptly on receipt of a notice of rejection of a
shipment of Product from Aviron, Xxxxx shall use reasonable and
timely efforts at Aviron's request to (i) replace such rejected
Product subject to Aviron providing Xxxxx with such free issue
materials (such as Virus Seeds) as may be required to carry out such
Manufacture; or (ii) credit Aviron's account in an amount equal to
the amount paid by Aviron to Xxxxx for Product determined not to meet
the relevant specifications. If Xxxxx disagrees with Aviron's
determination that certain Product does not meet the Specifications,
promptly on receipt of a notice of rejection of a shipment of
Product, Xxxxx shall use reasonable and timely efforts at Aviron's
request to replace such rejected Product. The rejected Product shall
be submitted to a mutually acceptable, third party laboratory, which
shall determine whether such Product meets the Specifications. The
parties agree that such laboratory's determination shall be final and
binding. The party against whom the third .party tester rules shall
bear all costs of the third party testing. If the third party tester
rules that the Product meets Specifications, Aviron guarantees to
purchase such Product at the Price for Production, irrespective of
whether Xxxxx has already replaced it. If the third-party tester
rules that the Product does not meet Specifications and the Product
was not replaced, Xxxxx shall credit Aviron's
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account in an amount equal to the Price for Production of the rejected
Product or refund that sum to Aviron.
6. INTELLECTUAL PROPERTY AND IMPROVEMENTS
6.1. Aviron hereby authorizes Xxxxx to use the Trade Marks on a non-
exclusive basis solely in connection with packaging Vaccine pursuant
to and during the term of this Agreement. Xxxxx shall not at any time
do or permit any act to be done which may in any way impair the rights
of Aviron in the Trade Marks. In order to comply with Aviron's quality
control standards with respect to the Trade Marks, Xxxxx shall (i) use
the Trade Marks in compliance with all relevant laws and regulations;
and (ii) not modify any of the Trade Marks in any way and not use any
of the Trade Marks on or in connection with any goods or services
other than the Vaccine.
6.2. Except as expressly provided in this Agreement, each party hereby
acknowledges that it shall not acquire any rights in respect of any of
the other party's intellectual property in relation to the Products or
the Manufacture thereof or of the goodwill associated therewith.
6.3. Other than as is necessary for the proper performance of this
Agreement by the parties, or as is expressly provided in this
Agreement or the Development Agreement, no license, expressed or
implied, is granted by this Agreement by either party to the other
under any of its intellectual property rights.
6.4. Title to and property in all Manufacturing Records shall be and remain
at all times exclusively vested in Xxxxx. Title to and property in
Process Improvements and other process technology is as follows:
6.4.1. Xxxxx acknowledges and agrees that process technology specific
solely to the Vaccine and developed by Xxxxx in the course of
this Agreement shall be [*]. All Process
Improvements developed by Xxxxx pursuant to this Agreement
shall be [*];
6.4.2. in respect of Process Improvements developed by Xxxxx pursuant
to this Agreement which is the property of Xxxxx, [*]
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[*] = Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with respect
to the omitted portions.
[*];
6.5 The Manufacturing Records shall be treated as Restricted Information
of Xxxxx and shall not be used by Aviron other than for the purposes
associated with Manufacture of the Product and where necessary for
disclosing to the relevant Agency in order to comply with regulatory
requirements relating to the Product and its Manufacture by Xxxxx.
Aviron may request to retain a copy of all Manufacturing Records, for
the purposes of complying with the requirements of the relevant
Agency, to which request Xxxxx may not unreasonably withhold its
consent. Aviron may disclose the Restricted Information to the
relevant Agency, having previously made reasonable efforts to obtain
an obligation of confidentiality from the said Agency concerning the
Restricted Information
7. PRICES
7.1. All orders for Product and Manufacture during the term of this
Agreement will (subject as provided in this clause 7.1 and clause 7.3
below) be at the Price for Production defined in Schedule 2. Upon
annual review by the parties, the Price for Production may be
increased or decreased by the percentage increase or decrease (if any)
in the Producers Price Index for the immediately preceding twelve (12)
month period for the location of Manufacture. In addition, Xxxxx may
propose to Aviron an annual increase in the Price for Production to
take account of any increased Manufacturing costs which are specific
to the Product including cost of materials, provided, however, that
Xxxxx shall consult with Aviron concerning such price increase and
must provide, to Aviron's reasonable satisfaction, sufficient
documentation to support its proposed increase in the Price for
Production.
7.2. Invoices will be submitted to Aviron monthly to cover the Price for
Production for the preceding month of Manufacture. Aviron will pay to
Xxxxx the full invoice amount for the Price for Production within
thirty (30) days after the date of the invoice. If Aviron so requires,
payment will be made direct into Xxxxx' bank account by bank transfer
and upon written request by Aviron, Xxxxx will provide Aviron with the
necessary details of Xxxxx' bank account and will take whatever
actions are necessary to facilitate payment by bank transfer.
7.3. If as a result of any inspection of Xxxxx' facilities and
manufacturing operations and records as referred to in clause 2.3.4,
or otherwise a requirement is imposed which leads to a material change
in the Price for Production or to the Technical Agreement of the
Product, then upon written notification by Xxxxx to Aviron, Xxxxx and
Aviron will meet to discuss any increase or decrease to the Price for
Production of the Product deemed appropriate and the date upon which
such price increase will take effect as well as other consequences
arising from such changes. If as a consequence of such a material
change either party is unable to fulfill its
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[*] = Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with respect
to the omitted portions.
obligations under the terms of this Agreement this may by mutual
agreement of both Xxxxx and Aviron initiate negotiations of a revision
to this Agreement.
8. INDEMNITY
8.1. Aviron shall be liable for and shall indemnify Xxxxx against:
8.1.1. all claims for loss or damage arising from the supply or use
or Manufacture of Virus Seed or Product except to the extent
that such claims, loss or damage arise as a consequence of
Xxxxx' negligence or through unauthorized deviation from the
Technical Agreement in which case Xxxxx shall be liable for
direct losses incurred, and shall indemnify Aviron
accordingly; and
8.1.2. all claims, loss or damage arising as a consequence of any
allegations of Michigan against Xxxxx or any claims by
Michigan against Xxxxx whether or not under any indemnity
provided by Xxxxx to Michigan hereunder, provided, however
that Xxxxx was at all times in material compliance with the
terms of this Agreement, and that such claims, loss or damage
did not arise as a result of Xxxxx' negligence or unauthorized
material deviation from the Technical Agreement.
8.2. Xxxxx shall be liable for any loss of or damage to Aviron Assets,
materials, components or Product arising from Xxxxx' negligence whilst
at Xxxxx risk up to replacement value.
8.3. 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 Agreement. At
either party's request, the other party shall provide the requesting
party with evidence of the existence and maintenance of such coverage.
8.4. Aviron shall disclose to Xxxxx all health, safety, and environmental
issues at any time regarding the Product known by Aviron to be
required for Manufacture.
8.5. Notwithstanding anything contained in this Agreement, Xxxxx' liability
in contract tort (including breach of statutory duty) or otherwise
arising by reason of or in connection with this Agreement or any
agreement or indemnity contemplated hereunder (except in relation to
death or personal injury caused by the negligence of Xxxxx or its
employees while acting in the course of their employment) shall be
limited to the lesser of (Pounds)1,000,000 or the revenue earned by
Xxxxx and paid by Aviron under this Agreement in the 12 month period
prior to the event giving rise to such liability.
8.6. In no event, and notwithstanding anything contained in this Agreement,
shall either party be liable in contract tort (including breach of
statutory duty) or
13
otherwise howsoever, and whatever the cause thereof, for any special,
indirect or consequential loss, damage costs or expenses of any nature
whatsoever.
8.7 All indemnities under this 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.
9. CONFIDENTIALITY
9.1. On the expiry or termination of this 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.
9.2. In this Clause references to the Discloser or Recipient shall be
deemed to include any Associated Companies of that party.
9.3. 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 Agreement and
not to use such Restricted Information except as provided in this
Agreement. The obligations set forth in this Clause 9.3 shall apply
during the period of this Agreement and for a period of the longer of
(i) ten (10) years after the termination or expiry of the Michigan
Agreement or (ii) ten (10) years after the termination of this
Agreement.
9.4. 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 Agreement and shall inform each of
such employees of the confidential nature 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.
10. LIAISON
Upon signature of this Agreement the parties will each identify in writing
the person responsible for the day to day operation of this 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.
11. CHANGE OF CONTROL
Neither party may assign any of its rights or delegate any of its
obligations under this Agreement (other than by Xxxxx 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
15
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 Agreement relates) without the prior written consent of the
other party, except as expressly provided herein.
This Agreement shall be binding upon and shall inure to the benefit of
Xxxxx and Aviron and their respective permitted successors and assignees
(if any). The parties acknowledge and agree that any change of ownership or
control of either Xxxxx or Aviron shall not affect, either at law, or as
between the parties, that party's rights and obligations under this
Agreement, to the extent that the party undergoing such change of ownership
or control survives such change of ownership or control.
Each party ("the Changing Party") shall forthwith notify the other if there
is an effective change of ownership or control of the Changing Party; or if
the Changing Party sells all or substantially all of the assets or all or
substantially all of the business to which this Agreement relates. In the
case where [*] is the Changing Party, within a period. of four (4) calendar
months of receipt of such notice or actual sale, should [*] in its
reasonable opinion decide that the party assuming effective ownership or
control of, or purchasing the assets or business of [*] is [*] of
[*] or a party [*] [*] may by a further four (4) weeks' notice [*].
Any purported assignment in violation of this section by either party shall
be voidable by the other party.
12. TERMINATION
12.1. Either party shall be entitled forthwith to terminate this Agreement
by written notice to the other if:
12.1.1.that other party is in material breach of any of the
provisions of this 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
12.1.2.an encumbrancer takes possession or a receiver is appointed
over any of the property or assets of that other party; or
12.1.3.the other party becomes subject to an administration order; or
12.1.4.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 Agreement.
15
[*] = Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with respect
to the omitted portions.
12.1.5.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
12.1.2 to 12.1.4 above.
12.2. For the purposes of clause 12.1.1 a material breach shall be
considered capable of remedy if the party in breach can comply with
the provision in question in all respects other than as to the time of
performance provided that time of performance is not of the essence.
12.3. Any waiver by either party of a breach of any provision of this
Agreement shall not be considered as a waiver of any subsequent breach
of the same or any other provision thereof.
12.4. The rights to terminate this Agreement given by this Clause shall be
without prejudice to any other right or remedy of either party in
respect of the material breach concerned (if any).
12.5. Upon termination of this Agreement for breach by Xxxxx, Xxxxx shall
provide to Aviron all Manufacturing data and information necessary to
permit a competent manufacturer to Manufacture the Product and Aviron
may use such data and information or disclose it to a third party
manufacturer under an obligation of confidentiality for the purpose of
Manufacturing the Product.
12.6. On expiration or termination of this Agreement for any reason:
12.6.1.Xxxxx shall, at its option, immediately cease Manufacture of
the Product or complete the Manufacture of the Product then in
the course of Manufacture, provided, however, that if such
termination is made at Aviron's election, Aviron shall
determine whether Xxxxx shall cease Manufacture immediately or
complete Manufacture of the Product then in the course of
Manufacture;
12.6.2.subject to 12.6.1 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;
12.6.3.Aviron shall pay outstanding invoices or invoices due to be
raised according to terms specified in this Agreement. In the
event Xxxxx shall exercise its option under 12.6.1 above not to
complete the Manufacture of the Product, then such unfinished
Product shall be paid for at a price to be agreed or failing
agreement at the price equal to the Price for Production
incurred up to the time Manufacture was discontinued;
12.6.4.Aviron will be obliged to purchase and Xxxxx will be obliged to
supply all stocks of Raw Materials purchased by Xxxxx in
support of purchase orders
16
or forecasts submitted by Aviron at a price to be agreed or
failing agreement within a reasonable time, at Manufacturer's
cost;
12.6.5.Aviron will collect all Raw Materials supplied to Xxxxx free of
charge save for any Raw Materials required to complete the
Manufacture of the Product in the event of Xxxxx exercising its
option to complete such Manufacture under 12.6.1 above.
12.6.6.Termination of this Agreement for any reason shall not bring to
an end any provisions of this Agreement which, in order to give
effect to their meaning, need to survive its termination and
such provisions shall remain in full force and effect
thereafter and in particular but without limiting the scope of
foregoing the obligations of the parties under clauses 8, 9,
and this clause 12.
12.6.7.Upon cessation or completion of the Manufacture of the Product
Xxxxx shall return to Aviron or destroy all Master Strains,
Virus Seeds and related material as instructed by Aviron.
To the extent that this Agreement terminates pursuant to clause
4.1 and/or clause 12 and results in Xxxxx having to terminate
the employment of any employee working specifically on the
Manufacture of the Product and Xxxxx is required to make
payments to such employee in connection with such termination
of employment ("Severance Payment"), then Aviron will pay to
Xxxxx the Xxxxxxxxx Payment incurred by Xxxxx for each
employee. In no event shall Aviron's payment exceed thirty
percent (30%) of each such employee's annual base salary. Xxxxx
shall make a good faith effort to redeploy such employee before
terminating such employee's employment. Xxxxx shall keep
complete and accurate records pertaining to (i) the allocation
of such employees to work specifically on the Manufacture for
Aviron, (ii) Xxxxx' good faith efforts to redeploy such
employee and (iii) the accuracy of the Severance Payments made
to such employee. Aviron shall have the right to audit such
records to confirm the accuracy of the Severance Payment made
hereunder.
13. ASSOCIATED COMPANIES
Xxxxx shall be entitled to perform any of the obligations undertaken by it
and to exercise any of the rights granted to it under this 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 Agreement be deemed to be the act or
omission of Xxxxx. For the purposes of such delegated performance Xxxxx
shall be entitled to disclose only on a need to know basis Aviron's
Restricted Information to employees of relevant Associated Companies.
17
14. FORCE MAJEURE
14.1. 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 at its own cost and expense take
all reasonable steps as may be necessary to overcome the Force
Majeure and to minimize its effects.
14.2. Neither party shall be deemed to be in breach of this 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.
14.3. All Price for Production incurred up to the suspension due to Force
Majeure are to be paid by Aviron.
14.4. 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.
14.5. 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 Agreement.
15. NOTICES
15.1. Any notices or other information required or authorized by this
Agreement to be given by either party to the other may be given by
hand or sent to the other by first class registered pre-paid post,
telex, facsimile transmission or comparable means of communication.
The same shall be sent or delivered to the other party at the
address shown for that party at the beginning of this Agreement or
to such other address which may be notified in writing to the other
party from time to time. Six (6) days should be allowed for
delivery.
15.2. Any notice or other information given by post pursuant to clause
15.1 which is not returned to the sender as undelivered shall be
deemed to have been given on the third 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.
15.3. 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 registered pre-paid
post to the other party at the address referred to in clause 15.1
within twenty-four (24) hours after transmission.
18
16. MICHIGAN LICENSE
Xxxxx accepts:
16.1. The Virus Seeds or the Working Seeds may be used only for the
Manufacture of Product; and
16.2. Xxxxx shall not provide any Virus Seeds, Working Seeds or
derivatives thereof to any third party. Xxxxx shall limit access to
the Virus Seed supplied by Aviron and Working Seeds made by Xxxxx to
those employees reasonably requiring such access for the purpose of
Development and Manufacture of the Product, which employees are
governed by Xxxxx' customary confidentiality obligations.
16.3. Aviron shall:
16.3.1.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,
16.3.2.promptly notify Xxxxx of any amendment to the Michigan
Agreement; and,
16.3.3.make every reasonable effort to notify Xxxxx in writing of
the expiry or termination of the Michigan Agreement at least
six weeks prior to either event.
16.4. Xxxxx will use every reasonable effort to Manufacture and store the
Virus Seeds and Product in accordance with all applicable government
laws and regulations.
16.5. Aviron, on Michigan's behalf, may request from Xxxxx at reasonable
times and in reasonable quantities at a cost equal to Xxxxx' Price
for Production of Product as it may desire, PROVIDED THAT Xxxxx
shall be under no obligation under this sub-clause or otherwise to
produce extra batches of Product solely or substantially to meet
Michigan's requirements. Any requirements of Michigan shall be
supplied from Product Manufactured for Aviron with Aviron being
solely responsible for apportioning such part thereof to Michigan as
Aviron sees fit.
16.6. Xxxxx acknowledges Michigan's warranty disclaimer and limitation of
liability contained in the Michigan Agreement but makes no
assessment or admission of its validity or reasonableness.
Notwithstanding such, Xxxxx will not make any statements,
representations or warranties inconsistent with such warranty
disclaimer or limitation of liability other than in pursuance or
prosecution of its own rights and remedies.
16.7. Subject to those limitations of liability contained in clauses 8.5
and 8.6, hereof, and subject to 8.1.2, Xxxxx will indemnify
Michigan, its fellows, officers,
19
employees and agents for and against any and all claims, damages,
losses and expenses of any nature resulting from, but not limited
to, death, personal injury, illness or property damage, arising
directly and solely as a result of:
16.7.1.any Manufacture, use or other disposition by Xxxxx of the
Virus Seeds or Product;
16.7.2.the use by Xxxxx, its agents or employees of Virus Seeds or
Product made or used by Xxxxx;
16.7.3.the use, handling, storage or disposal of Virus Seeds, any
derivatives or Product by Xxxxx; or
16.7.4.the unauthorized and negligent use by Xxxxx 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 Xxxxx as being sub-licensed to Aviron by Michigan)
or developed by Xxxxx pursuant to the Manufacture,
where but only where such claims, damages, losses and expenses are a
direct consequence of the negligence of Xxxxx, its agents or
employees.
16.8. Xxxxx shall not use the name of Michigan in publicity or advertising
concerning the Product the 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.
17. GENERAL
17.1. No variation or amendment of this Agreement shall bind either party
unless made in writing in the English language and agreed to in
writing by duly authorized officers of both parties.
17.2. If any provision of this Agreement is agreed by the parties to be
illegal void or unenforceable under any law that is applicable
hereto or if any court of competent jurisdiction in a final decision
so determines this Agreement shall continue in force save that such
provision shall be deemed to be excised here from with effect from
the date of such agreement or decision or such earlier date as the
parties may agree.
17.3. This Agreement shall be governed by and construed in all respects in
accordance with the Laws of England. Either party shall be entitled
to enforce any order of the English Courts in any other
jurisdiction.
20
17.4. If there is a provision of this Agreement, or of any agreement or
arrangement of which this agreement may form part, which causes or
would cause this agreement or any other agreement or arrangement to
be subject to registration under the Restrictive Trade Practices Act
1976 (as amended), then that provision shall not take effect until
the date after particulars of this 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 (as amended).
18. PUBLIC DISCLOSURE
No public announcement of any kind shall be made in respect of or in
connection with this Agreement except as specifically agreed in writing
between the parties, or except to the extent that an announcement is
required by law or by 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.
21
IN WITNESS whereof this Agreement has been executed by the duly authorized
representatives of the parties the day and year first above written
Signed: /s/ Xxxx Xxxxxxxx
--------------------
FOR AND ON BEHALF OF
XXXXX MEDICAL LIMITED
---------------------
Signed: /s/ Leighton Read
--------------------
FOR AND ON BEHALF OF
AVIRON
------
22
SCHEDULE 1
----------
TECHNICAL AGREEMENT
-------------------
1. Cold Adapted Influenza Vaccine
TECHNICAL AGREEMENT
FOR CONTRACT MANUFACTURE
BETWEEN XXXXX MEDICAL LIMITED ("XXXXX"), WHOSE REGISTERED
OFFICE IS AT XXXXX HOUSE, REGENT PARK, XXXXXXXX XXXX,
XXXXXXXXXXX, XXXXXX, XX00 0XX, XXXXXX XXXXXXX.
AND AVIRON (A DELAWARE CORPORATION), ("AVIRON"), WHOSE
REGISTERED OFFICE IS AT 000 XXXXX XXXXXXXX XXXXXX,
XXXXXXXX XXXX, XXXXXXXXXX 00000, XXXXXX XXXXXX OF
AMERICA.
XXXXX AND AVIRON ARE THE "PARTIES".
IT IS AGREED THIS 1ST DAY OF MAY 1997
1. BACKGROUND
----------
The Parties have entered into a Manufacturing and Development Agreement,
effective November 7, 1995, (the "Development Agreement") to provide for
the production of cold adapted influenza vaccine. Material produced under
the Development Agreement is to be used primarily for development research
and Phase I, II and early Phase III clinical trials.
In addition, the Parties have entered in to a Contract Manufacturing
Agreement, effective April 1, 1997 (the "Manufacturing Agreement"), for the
production of commercial quantities of cold adapted influenza vaccine.
This Technical Agreement for Contract Manufacture (the "Technical
Agreement") is attached as Schedule I to the Manufacturing Agreement.
Definitions adopted in the Manufacturing Agreement will govern the
Technical Agreement.
Under the Technical Agreement, Xxxxx will be responsible for the
Manufacture of the Products, as ordered by Aviron and specified in Appendix
I ("the Products"), in accordance with Specifications agreed in writing
with Aviron in Appendix II ("Specifications"), and in accordance with the
contained in the United States 21 Code of Federal Regulations Part 210 and
211. The Specifications may be changed from time to time by mutual
agreement of the Specifications Working Group ("SWG") as defined in Section
7.0 below.
2. COMPETENCE
----------
Aviron hereby declares and agrees that it has assessed and is satisfied
with the competence and ability of Xxxxx to undertake and complete
successfully the work contemplated by this Agreement. Such declaration is
not a waiver of Aviron's rights under any other agreements between Xxxxx
and Aviron.
3. STARTING MATERIALS AND PACKAGING MATERIALS SOURCED BY XXXXX
-----------------------------------------------------------
3.1. Xxxxx will be responsible for ensuring that each batch of Raw
Materials and Packaging Materials (other than those supplied by
Aviron) complies with the Specifications. "Raw Materials" are defined
as any component required for the Manufacture and quality control of
the Products. "Packaging Materials" are defined as any component
accompanying the Vaccine as it is provided to Aviron or designated
recipient.
3.2. Xxxxx will ensure that Raw Materials and Packaging Materials (other
than those supplied by Aviron) are only sourced from suppliers that
satisfy all requirements of the Specifications.
4. MANUFACTURING INSTRUCTIONS
--------------------------
Xxxxx will supply to Aviron a master copy of the relevant Manufacturing
Records for Aviron to authorize and approve in writing as being consistent
with the Specifications and the Agency Approval for the Product prior to
the said documents being used. Significant changes to such documents
similarly will be agreed prior to implementation.
5. QUALITY CONTROL
---------------
5.1. Aviron will supply to Xxxxx Virus Seed or Working Seed and associated
documentation to confirm that the said Virus Seed and Working Seed is
suitable for Manufacture of Products.
5.2. Xxxxx shall be responsible for carrying out appropriate quality
control of the Raw Materials, except those items agreed to in writing
by the Parties, to ensure that the Raw Materials comply with the
Specifications.
5.3. Xxxxx shall be responsible for carrying out appropriate quality
control on the Product to ensure that the Product complies with the
Specifications.
5.4. Notwithstanding anything contained in this Agreement, provided that
Xxxxx shall not be in material breach of its obligations under this
Agreement, Aviron shall be solely responsible for the Products and any
Raw Material provided by Aviron in respect of its safety efficacy or
fitness for purpose.
6. INFORMATION PROVIDED BY AVIRON
------------------------------
Aviron represents that it has provided or intends to provide to Xxxxx
promptly and in good time prior to such information being required in
carrying out work in relation to the Product, all information of which it
is aware, and which is in Aviron's possession, and is reasonably necessary
to undertake the work contemplated by this Agreement. Aviron further
represents that to the best of it's knowledge it has disclosed to Xxxxx all
problems
and hazards posed to Xxxxx' premises, equipment, personnel other products
or materials and specific to the Product or its manufacture. To comply with
the terms of this clause and to enable Xxxxx to perform its obligations,
Aviron confirms that the Specifications will include, directly or by
reference, the following information (unless the parties have agreed that
any such information is not relevant to the work being performed by Xxxxx)
for each of the Products.
a) The Manufacturing methods as set out in the relevant Product License
once approval has been granted by the relevant Agency.
b) In process test procedures (if any) as set out in the said Product
Licenses.
c) Raw Material, Virus Seed and Product Specifications including Working
Seed named suppliers and all relevant testing methods as set out in the
said Product Licenses.
d) Packaging material specifications as set out in the said Product
Licenses, including artwork in the event of Xxxxx being responsible for
purchase of such materials.
e) Information on the known hazards of the formulation Raw Materials
supplied by Aviron (if any).
f) Where such information is included by reference Aviron confirms that it
intends to supply to Xxxxx accounts and complete copies of documents
containing such information.
7. CHANGES IN STANDARDS, SPECIFICATIONS AND/OR PROCEDURES
------------------------------------------------------
Within 60 days of executing the Technical Agreement, the Parties will form
a Specifications Working Group ("SWG"). The purpose to the SWG shall be to
review and adopt the Specifications that govern the Manufacturing
Agreement.
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 the SWG
members. Decision of the SWG shall be unanimous. In the event the SWG is
unable to reach a unanimous decision, or in the event of any controversy or
claim arising out of or referring to any Specification that can not be
resolved by the SWG, the SWG shall refer the disputed matter to the
appointed senior executive of Xxxxx and Aviron.
Xxxxx and Aviron will each nominate a senior representative to the SWG.
The senior representatives will have the authority to approve
Specifications on behalf of Xxxxx or Aviron, respectively. All
Specifications established by the SWG will be reduced to writing, signed on
behalf of the Parties by the senior representatives and appended to this
Technical Agreement in Appendix II. The SWG will be responsible for the
timely
adoption of all Specifications necessary for all regulatory filings in
areas intended for commercial sale of the Product by Aviron or its
designee/nominee.
As a reference for the SWG the Parties have appended Specification adopted
under the Development Agreement. The Parties recognize that Specifications
necessary under the Manufacturing Agreement will be different from, and
more extensive than, the Specifications of the Development Agreement.
7.1. Xxxxx will notify Aviron of any proposed changes in the standards,
Specifications and/or processes for Manufacture of the Product, and
Such changes will be agreed upon by the SWG and shall be verified in
writing prior to the change being introduced.
7.2. Aviron will ensure that Xxxxx is informed promptly of any changes
that are to be made to the terms of the Product Licenses for the
Products which may require a change to the Specifications and such
changes when approved in writing by the SWG shall be deemed to be an
amendment to the Specifications for the purposes of this Agreement.
8. REWORKED AND REJECTED PRODUCTS
------------------------------
Before Manufacture under the terms of the Manufacturing Agreement both
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 investigate all incidences of the Product non-compliance to the
Specifications. The chairperson of the PET will be designated by Aviron
from among the PET members and membership can be changed from time to time
by the respective Party. The report and recommendation of the PET will be
communicated to the responsible persons of the respective Parties in
Quality Assurance.
8.1. Xxxxx will not subject any Products Manufactured by it under this
Agreement to any re-processing unless it uses a method agreed to by
Aviron.
9. AVIRON RELEASE OF PRODUCT
-------------------------
9.1. Aviron's Responsible Head is responsible for release of the Products.
Xxxxx will supply to Aviron a Certificate of Analysis and all
relevant batch documentation as provided for in the Specifications to
allow Aviron's Responsible Head to perform the release. Responsible
Head is defined as "Aviron's designated senior executive or assignee
responsible for review of documentation and release of Product". Each
Party will designate a quality assurance person to be responsible for
review of documentation and recommend release of Product to
Responsible Head. The quality assurance person may be changed from
time to time with written notification to the other Party.
10. BATCH DOCUMENTATION
-------------------
10.1. Xxxxx will keep under safe and secure storage the manufacturing,
packaging and quality control and quality assurance records for each
batch of Product for a period of seven (7) years. Xxxxx must ensure
this documentation is available for inspection by authorized Aviron
personnel at reasonable notice.
10.2. Xxxxx will submit to Aviron, promptly following a written request
from Aviron, copies of all the manufacturing, packaging, quality
control and quality assurance records relating to the Products.
11. AUDITS
------
Aviron reserves the right in normal business hours (after giving reasonable
written notice and causing minimum disruption to Xxxxx' operations) to
inspect areas of Xxxxx' premises connected with the Products, Raw Materials
and Packaging Materials.
12. CUSTOMER COMPLAINTS
-------------------
Aviron will notify Xxxxx of all complaints and adverse reactions associated
with the use of Products. Xxxxx shall promptly supply to Aviron and Aviron
shall promptly supply to Xxxxx all information needed for the investigation
of customer complaints, adverse event or other concerns with respect to the
quality of the Products. The responsibility to reply to the customer will
be with Aviron.
13. RECALLS
-------
The decision to initiate a recall must rest with Aviron unless an
appropriate regulatory authority requires a batch recall to be implemented.
In any case the Responsible Head of Aviron must receive all essential
information from Xxxxx. In the event Xxxxx disagrees with Aviron's
decision to not conduct a recall, Aviron assumes liability for claims
arising from the Product batch in dispute.
14. THE RETENTION OF SAMPLES
------------------------
14.1. A sample of finished Product, bulk active ingredients and starting
materials (excluding solvents, gasses and water) will be retained
and stored under conditions consistent with the product labeling. An
accounting of the items, respective quantities and the duration for
which they are to be stored, which may be amended from time to time,
is attached as Appendix III. Xxxxx will allow Aviron access to these
samples on reasonable written notice in normal business hours.
14.2. The sample size of each batch of finished Product or active
ingredient will be not less than twice the amount required to fully
test the Product for compliance with Specification.
14.3. Samples of finished Product and bulk active ingredients will be
stored for one year beyond the expiry of the formulated product.
14.4 Samples of starting materials will be kept for minimum of five years
if their stability allows.
15. DISPOSAL OF SAMPLES PRINTED PACKAGING MATERIALS AND REJECTED PRODUCT
--------------------------------------------------------------------
Samples, printed packing materials and rejected Product will be disposed of
by Xxxxx in a safe and controlled manner.
16. SUB-CONTRACTING
---------------
Xxxxx shall not sub-contract any part of its obligations hereunder unless
prior agreement and written authorization is obtained from Aviron.
IN WITNESS hereof this Agreement has been executed by the duly authorized
representatives of the parties the day and year first before written
SIGNED BY )
duly Authorized for and on ) /s/ Xxxx Xxxxxxxx
behalf of XXXXX )
MEDICAL LIMITED )
in the presence of:) )
SIGNED BY )
duly Authorized for and on ) /s/ Leighton Read
behalf of AVIRON )
In the presence of: )
APPENDIX I - PRODUCT(S)
-----------------------
1. Cold Adapted Influenza Vaccine
TO BE ESTABLISHED CONCURRENT WITH THE FDA LICENSE APPLICATION
-------------------------------------------------------------
SIGNATURE DATE
------------------------------------------------------------
XXXXX Xxxxx Medical Ltd. /s/ Xxxx Xxxxxxxx 18/4/97
------------------------------------------------------------
AVIRON Aviron /s/ L. Read 24/4/97
------------------------------------------------------------
APPENDIX II - SPECIFICATIONS
----------------------------
VIRUS SEED SPECIFICATIONS
----------------------------------------
TO BE ESTABLISHED CONCURRENT WITH THE FDA LICENSE APPLICATION
-----------------------------------------------------------------------------
WORKING SEED SPECIFICATIONS
----------------------------------------
TO BE ESTABLISHED CONCURRENT WITH THE FDA LICENSE APPLICATION
--------------------------------------------------------------
RAW MATERIAL & PACKAGING COMPONENT SUPPLY
----------------------------------------
DESCRIPTION AVIRON TO SUPPLY XXXXX TO SUPPLY
-----------------------------------------------------------------------------
Active Ingredient [
Eggs
Excipients
Labels *
Syringes
Carton
Leaflet ]
FINISHED PRODUCT TESTING
------------------------
Xxxxx will test finished product with respect to the following specification:
Test Specification
---- -------------
TO BE ESTABLISHED CONCURRENTLY WITH THE FDA LICENSE APPLICATION
---------------------------------------------------------------
SIGNATURE DATE
----------------------------------------------------------------
XXXXX Xxxxx Medical Ltd. /s/ Xxxx Xxxxxxxx 18/4/97
----------------------------------------------------------------
AVIRON Aviron /s/ L. Read 24/4/97
----------------------------------------------------------------
[*] = Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with respect
to the omitted portions.
APPENDIX III - RETAINED SAMPLES
-------------------------------
TO BE ESTABLISHED CONCURRENT WITH THE FDA LICENSE APPLICATION
-------------------------------------------------------------
SIGNATURE DATE
-------------------------------------------------------------
XXXXX Xxxxx Medical Ltd. /s/ Xxxx Xxxxxxxx 18/4/97
-------------------------------------------------------------
AVIRON Aviron /s/ L. Read 24/4/97
-------------------------------------------------------------
SCHEDULE 2
----------
PRICE FOR PRODUCTION
--------------------
SUPPLIES
--------
Cost of supplies purchased for Aviron by Xxxxx on a monthly basis will be
passed through to Aviron.
PERSONNEL
---------
Cost for Xxxxx personnel allocated to Aviron under this Agreement will be
charged monthly based upon involvement, at a defined [*] rate. The
composition of staff allocated under this Agreement shall be no less than [*]
with previous influenza Commercial Manufacture experience or similar process.
PRIMARY PRODUCTION
------------------
[ * ] for Multi Purpose Bacterials [ * ] per year.
[ * ] rate [ * ] for an operative
[ * ] for a supervisor/
engineer/technical
support person.
Egg waste disposal [ * ] per egg processed.
SECONDARY PRODUCTION
--------------------
Cold Adapted Influenza Virus Vaccine in syringes [ * ] per dose.
Any Product supplied over [ * ] doses in a single year, commencing on 1
January of that year, will be at a price of [ * ] per dose, up to [ * ] doses.
Similarly, any Product supplied over [ * ] doses in a single
year, commencing on 1 January of that year, will be at a price of [ * ] per
dose. The price will then revert to [ * ] per dose for the first [ * ] in the
following year.
[ * ] = Certain information on this page has been omitted and filed separately
with the Commission . Confidential treatment has been requested with respect to
the omitted portions.
Example
-----------------------------------------------
First Year [ * ] ordered
[ * ] @ [ * ] = [ * ]
[ * ] @ [ * ] = [ * ]
TOTAL FOR FIRST YEAR = [ * ]
Second year [ * ] ordered
[ * ] @ [ * ] = [ * ]
[ * ] @ [ * ] = [ * ]
[ * ] @ [ * ] = [ * ]
TOTAL FOR SECOND YEAR = [ * ]
NB: All prices set out herein are subject to review in accordance with
Clause 7.
[ * ] = Certain information on this page has been omitted and filed separately
with the Commission . Confidential treatment has been requested with respect to
the omitted portions.
SCHEDULE 3
----------
TRADE MARKS
-----------
[Pursuant to an agreement between the parties, this Schedule will not be
completed until late 1997.]
SCHEDULE 4
----------
DEVELOPMENT AGREEMENT
---------------------
[This Agreement was filed as Exhibit 10.8 to the Company's Registration
Statement on Form S-1, File No. 333-05209, filed June 5, 1996, as amended, which
is hereby incorporated by reference.]
SCHEDULE 5
----------
MICHIGAN AGREEMENT
------------------
[This Agreement was filed as Exhibit 10.3 to the Company's Registration
Statement on Form S-1, File No. 333-05209, filed June 5, 1996, as amended, which
is hereby incorporated by reference.]
SCHEDULE 6
----------
AVIRON'S ASSETS
---------------
[Pursuant to an agreement between the parties, this Schedule will not be
completed until late 1997.]
