TECHNICAL TRANSFER SERVICES AGREEMENT
CONFIDENTIAL
TREATMENT REQUESTED BY GENTIUM S.p.A
| 1. Parties: |
Patheon International A.G.
(“Patheon”)
▇▇▇▇▇▇▇▇▇▇▇▇▇
▇▇,
▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇
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Gentium
S.p.A. (“Gentium” or “Customer”)
Piazza
XX Settembre, 2
Villa Guardia (Como)
Italy
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| 2. Product: | Defibrotide (“Product”) | |||
| 3. Subcontractor: |
Patheon Italia
S.p.A.
▇▇▇ ▇.▇. ▇▇▇▇▇▇▇ ▇.▇▇▇
▇▇▇▇▇ (▇▇) - ▇▇▇▇▇
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|||
| 4. Facility: |
Patheon
Italia S.p.A,
▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇,
▇▇▇▇▇▇▇▇▇ (▇▇) - ▇▇▇▇▇
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5. Contract:
|
This
document - including the Project Scope, Budget Summary, Standard Terms and
Conditions for the Technical Transfer Services (“Terms and Conditions”) -
when accepted by Customer shall become a contract binding on the parties
(“Contract”).
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6.
Description of
Services, Payment and Currency:
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See Project Scope (Part A). | |||
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7. Legal
Terms:
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See
Terms and Conditions (Part B).
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8. Effective
Date:
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2
February, 2009
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9. Term:
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From the Effective Date until
completion by Patheon of the Technical Transfer Services
(“Services”).
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10. Date:
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2
February, 2009
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Patheon
International A.G.
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By:
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/s/ ▇▇▇▇ ▇▇▇▇▇
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By:
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/s/ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇
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Name:
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▇▇▇▇ ▇▇▇▇▇
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Name:
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▇▇▇▇
▇▇▇▇▇▇▇▇▇
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Title:
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President
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Title:
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Executive
Vice President and Chief Financial
Officer
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|
CONFIDENTIAL
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as ***. A complete version of this exhibit has been filed with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Act of 1934, as amended.
part a
PROJECT
SCOPE
1. PROJECT
BRIEF
Defibrotide
is a single-stranded polydeoxyribonucleotide extracted from porcine intestinal
mucosa. It has been shown that Defibrotide has protective effects on vascular
endothelial cells, particularly those of small vessels. Defibrotide has
antithrombotic, anti inflammatory and antiischaemic properties. After binding to
endothelial cells Defibrotide enhances fibrinolysis. These effects of
Defibrotide appear to be predominantly localized within the vascular bed, and
there appear to be no significant effects on systemic
coagulation.
Favorable
responses have been seen in previous clinical studies in about 45% of patients
treated with Defibrotide for the treatment of Severe Hepatic ▇▇▇▇-Occlusive
Disease (VOD). There have also been no significant toxicities
related to the study drug in the majority of patients treated in previous
clinical studies.
Recent
preclinical studies have demonstrated that Defibrotide used in conjunction with
Granulocyte Colony-Stimulating Factor (rhG-CSF) significantly increases the
number of Peripheral Blood Progenitor Cells (Stem cells). The benefit of this
increase in stem cells may be crucial for a variety of clinical indications,
including graft engineering procedures and gene therapy programs.
Manufacturing
process steps: Solution Preparation, Filling, Inspection, Secondary
Packaging. Terminal sterilization is not required.
Target
Production Site –The target site for the
production of the Defibrotide liquid vials will be the Sterile 2 suite at
the
Ferentino
Site near Rome, Italy.
Project
Timing – Validation Batches to be manufactured within ▇▇ ▇▇▇▇. Patheon is
aware that timing is essential for the success of the Project; therefore Patheon
will use its very best efforts to procure the manufacturing of the validation
batches by the above mentioned timing, provided that this Contract, with respect
to the manufacturing services described herein, will be executed by 2nd February
2009.
2. KEY PRODUCT PARAMETER
OVERVIEW
Batch
Size: -
approximately 40K vials
Fill
Volume: - 2,5
ml
Primary
Packaging components: – 3 ml vials (blown glass
vials, clear glass, Type I, 13 mm neck finish); West 4023/50 ▇▇▇▇ stoppers, for
liquid, ready to sterilize; 13 mm flip off seals, aluminium feruled with
polypropylene colored cap. Sterile.
3. KEY MANUFACTURING SUPPLY
ASSUMPTION
Health
and Safety evaluation – a preliminary EH&S toxicity classification of
the API has been procured by Patheon. It has been determined that the API
molecule is Category 2, on a scale of 1-4, 4 being the most potent. Category 2
products present no issue from a EH&S perspective.
API
|
§
|
It
has been assumed that Gentium will provide the released API free issue to
Patheon, that will require only an ID test (FT-IR
test).
|
|
§
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API
supplied at Room Temperature, with temperature recorder (data logger).
Data logger information to be sent back to Gentium. API to be stored at
Controlled Room Temperature (15 – 30
°C).
|
|
§
|
Mixing
of API lots for solution compounding is
allowed.
|
CONFIDENTIAL
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as ***. A complete version of this exhibit has been filed with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Act of 1934, as amended.
Page 2 of
15
|
§
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API
Container: The container closure system for the API Defibrotide is a
multi-bag system, consisting of two LDPE bags within a multilayered
aluminium bag, thermally sealed in a heat sealing machine. The
multilayered aluminium bag serves as a barrier to moisture transmission.
Each container of API supplied with a side sample, for API incoming
identity testing. Standard GMP and EH&S requirements will be adhered
to throughout the whole process. Special care will be taken from operators
during compounding, according to procedures supplied by
Gentium.
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|
§
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Patheon
will receive the API pre-dispensed per each batch to be
manufactured.
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§
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API
value: € *** per Kg.
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Finished
Product storage and shipment – Controlled room
temperature (15 – 30 °C). If required, Patheon will procure the use of a proper
and agreed number of Temperature recorders per each shipment. Costs of
Temperature recorders will be sustained by Gentium.
Materials Procurement:
Components and Excipients
|
§
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Patheon
will supply components (primary packaging materials and secondary
packaging materials) and excipients for the manufacture from Patheon
qualified suppliers (i.e., Patheon supplies
everything excluding API). Should Gentium require Patheon to source any
materials from Gentium’s specified suppliers, then these suppliers shall
remain under the Quality audit control of Gentium unless an agreement is
reached for Patheon to take on this
responsibility.
|
|
§
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Components
and excipients to be supplied by Patheon in accordance with client’s
specifications. Subcontractor will issue formal Subcontractor
specifications for each component following the Gentium’s component
requirements. Each lot of incoming components will be sampled and tested
according to the agreed
specifications.
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|
§
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Listed
below are the components for the solution
preparation:
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Component
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Reference
to Standard Quality
|
Concentration
per ml
|
|
Sodium
Citrate, Dihydrate
|
USP
- EP
|
10
mg
|
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Sodium
hydroxide 1M or hydrochloric acid 1M
|
NF
- EP
|
-
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API
(Defibrotide)
|
Supplied
from Gentium
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80
mg
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Filter
Validation – It is assumed that all
the filters (0,22 µm and 0,45 µm) are fully validated by the filter supplier.
All the additional revalidation work for those filters will be performed by the
suppliers of the filters with costs being met by Gentium.
Sealing
& Visual Inspection – According to the Subcontractor standard
process: filling stoppering and crimping will be performed in Class A/B. One run
of 100% visual inspection will be performed by manual or semi-automatic means
with qualified operators (defect characteristics and AQL limits to be
established and agreed).
Cleaning
Validation – cleaning validation will
be required throughout the process, including dedicated and non dedicated
equipment i.e. general equipment, mixing and holding tanks, filling line.
Specific cleaning method is available at Gentium and will be
transferred.
Batch
Release – Subcontractor (QP) performs the batch release to Gentium,
issuing Certificate of Analysis and Certificate of Compliance. The Batch Release
to the market has to be performed by Gentium.
Product
Holding Time – The Holding Times of
the process has to be developed and validated, including the overnight storage
of the bulk solution.
Silicon
Tubing – It is assumed that in case Silicon tubing (platinum cured) will
be used for transfer line, they will be used for at least 5
batches.
Compatibility
Studies – It is assumed that
compatibility studies between the product and the following surfaces of the
process are available in Gentium: stainless steel, glass, PVC, Nylon, PE,
silicone, ceramic.
Compatibility
and Stability data – Analytical tests for compatibility and stability
studies between the product and the stoppers are available
in Gentium.
In case
dedicated leachable and extractable studies will be required, those tests will
be performed by the suppliers of the stoppers with costs being met by client.
Quotation for such studies will be provided to Gentium.
CONFIDENTIAL
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as ***. A complete version of this exhibit has been filed with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Act of 1934, as amended.
Page 3 of
15
Process
Flow Description – Patheon assumes the
following production process, based on current information provided by
Gentium.
Quality
Control
|
§
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All
the analytical methods are fully validated; related protocols and reports
are available at Gentium.
|
|
§
|
Gentium’s
Laboratory is available for the chemical analytical Transfer: the
analytical results of three (3) released batches of Defibrotide liquid
Product obtained in Gentium’s Lab (the Transferring lab) will be compared
to those obtained in Subcontractor’s Lab (the Receiving Lab). When
required additional analytical performance characteristics will be
evaluated. Dedicated protocols and reports will be shared and
issued.
|
|
§
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IPC
and FP to be tested in accordance with Gentium specifications. It has been
assumed that the testing is to standardised EP/USP requirements. Any
client or product specific testing requirements would require a full
assessment.
|
|
§
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It
is assumed that Patheon will supply the following tests (IPC and FP).
Analytical methods descriptions are already available (to date Gentium’s
Reference “Scheda di analisi PF001/06 ed.
03”):
|
IPC tests required as
follows:
|
o
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pH,
Appearance, Density, Bioburden, Assay (the assay is not a stop test. To
date the Method has not been
defined)
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Chemical
tests on FP required as follows:
|
o
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Appearance,
Colour, pH, Volume in container
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|
o
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ID
(λ Maximum absorption)
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o
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Mean
Molecular weight, polydispersity index and fraction above 12 KDa by
HPLC
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o
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Nucleic
Phosphorus: Optical Emission spectroscopy Identity and
Assay
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o
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Free
Phosphorus: Ionic chromatography
Assay
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o
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Free
nucleic bases and other unknown impurities: HPLC
Assay
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|
o
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Particulate
Matter in injection: USP <788> method
I
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Biological
tests on FP required as follows:
|
o
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Bacterial
endotoxins test: As per USP <85> kinetic method
(Turbidimetric)
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|
o
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Sterility:
As per USP <71>
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CONFIDENTIAL
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as ***. A complete version of this exhibit has been filed with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Act of 1934, as amended.
Page 4 of
15
Secondary
Packaging
|
§
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Secondary
packaging configuration, specifications and drawings for each secondary
packaging component not yet defined by Gentium. As per Gentium request,
Patheon makes the following proposal. This proposal is subject to review
following receipt and discussion of the detailed secondary packaging
requirements between the parties:
|
o Vials: labeled by
automatic means
o Carton: 1 carton
containing 10 labeled vials in the packaging tray and 1 leaflet packed by
automatic means.
§ Labeled
vials and 1 leaflet inserted into carton by automatic means
§ Batch
data automatically printed in line on the carton.
o Box: 1 box containing
the cartons (i.e. 20, TBD).
§ Cartons
manually inserted into the box. Box labeling included (manual).
o Shipping Box: 1
carton pallet containing the boxes (i.e. 100, TBD).
§ Boxes
manually inserted into the shipping box. Shipping Box labeling included
(manual).
4. TECHNOLOGY TRANSFER (TT)
COSTING ESTIMATES
|
ITEM
|
TOTAL
COST (€)
|
|
API
Health & Safety Evaluation
|
***
|
|
QA
documentation preparation.
Review
and supply of “Technical Data Pack” for Gentium’ regulatory submission.
Provision of all the information and data on components,
packaging materials, drug product specifications and methods,
manufacturing process, process validation, as well as Patheon’s relevant
information (i.e.: drawings of material and personnel flows, differential
pressures schemes, environmental control practices etc. that
are needed for the preparation of the regulatory
documentation.
This
work also covers preparation of Master Batch Record, ▇▇▇▇ Of Materials,
components specs and analytical methods.
|
***
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|
Project
controlling documentation – Technology transfer protocol and subsequent
closure report.
|
***
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|
Process
Validation: protocol preparation, execution, QC testing and reporting.
Stability/Registration/Process Validation batches (3 full scale Batches,
secondary packaging excluded) (1)
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***
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|
Business
/ Project Management (10% of TT cost)(2)
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Free
of charge
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TOTAL
|
***
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(1)
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This
cost does not include vials price. Vials will be sold at the agreed unit
price
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(2)
|
Patheon
agrees to hold face to face or telephone meetings with Gentium at least
once every two weeks to provide a general update on the status of the
project and understand any key outstanding items. Patheon will
not charge Gentium for these meetings or for any follow-ups, outside of
specific regulatory activities described in Section 5
below.
|
Technology Transfer cost is
charged at 40% up front payment in the form of a purchase order from
Gentium upon Patheon being awarded the project and then 20% on completion
of the feasibility batch and the remaining 40% on completion and submission to
Gentium of the Process Validation Report and the batch certificates of
analysis.
5.
REGULATORY SUPPORT
WORK
Patheon
will procure by the Subcontractor the assistance necessary to support
Gentium with their submissions. The scope and depth of regulatory support
procured by Patheon, based on data generated in course of performing the
Services, can be agreed upon depending on customer’s needs.
An
example of the routine regulatory support is reported below:
|
§
|
Customer
provides Subcontractor with the list of information (i.e. list of CTD
sections) they will include within the submission file. Complete list of
information will be shared between the Parties in a separate
document.
|
CONFIDENTIAL
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as ***. A complete version of this exhibit has been filed with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Act of 1934, as amended.
Page 5 of
15
|
§
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Subcontractor
will provide the Customer with the required information (i.e. protocols,
reports, specification, CoA, executed batch record, etc.) and, upon
request, also with summaries of such documents. All documents
will be provided preferably in English unless requested otherwise. When
certified translations will be needed, costs will be borne by
Gentium.
|
|
§
|
Customer
will write the filing and Subcontractor will review the sections
pertaining to Subcontractor.
|
Other
regulatory services:
|
§
|
Regulatory
administrative support (i.e. authentifiction / notarisation /
certification/ apostille)
|
|
§
|
Regulatory
consulting to specific administrative requests (i.e. assessment and
provision of regulatory guidance).
|
Regulatory
work will be charged at €
***/hour. Patheon will inform Gentium when regulatory
activities are being undertaken that will be billed. It is Gentium’s
understanding that informal phone calls and simple requests will not be charged
for.
In
addition to the Regulatory work hourly rate charge, Gentium will have to incur
all the costs pertaining to documents legalization (i.e. authentification,
notarisation, certification, apostille) or for any other relevant regulatory
activity. Patheon will inform Gentium when such costs will be
billed.
6.
STABILITY
TESTING PROGRAMME
If
required Patheon can procure the storage and testing services in
accordance with an agreed protocol and ICH guidelines. A typical charge per
sample time point is indicated below. This fee is to be confirmed upon receipt
of the full stability testing analysis required.
Charge
per time point is €
1,800.
7.
PRICING
INDICATION
|
Batch
size
(#
vials)
|
Manufacturing
Conversion
Price
|
Components
cost
|
Secondary
packaging
Conversion
Price
|
Total
unit price (**)
|
|
*** vials
|
€*** /
vial
|
€***
/ vial
|
€***
/ vial
|
€***
/
vial
|
|
|
(**): This
price doesn’t include the Secondary packaging components cost. It will be
evaluated once defined the Secondary packaging materials
specification.
|
8. FEASIBILITY
ASSESSMENT
In view
of the commercial manufacturing services to be potentially supplied by Patheon
on behalf of the Customer, an assessment of the feasibility of the manufacturing
process of the Product, with respect to the fixtures and fittings incorporated
into the Facility, is needed. To this aim, Patheon requested to the
Subcontractor, upon the Customer’s consent, to perform the activities detailed
in this Section 8.
The
Parties agree that the costs of such assessment will be directly invoiced by the
Subcontractor to the Customer. Each Subcontractor invoice will be due and
payable within 45 days of the date of the relevant invoice.
8.1. Feasibility
activities
|
ITEM
|
TOTAL
COST (€)
|
|
[Analytical
Methods Transfer/Validation]:
Micro
(3, validation):
Bioburden, BET and
sterility
|
***
|
| Chemical
(6):
Mean molecular weight,
polydispersity and fraction above 12 (transfer)
Identification, UV
(transfer)
Nucleic P
(validation)
Free P
(transfer)
Free nucleic bases and other
unknown impurities (transfer)
Particulate
matter in inj (transfer)
|
|
|
Cleaning
process Validation – Cleaning method transfer & entire equipment train
– protocol preparation, execution, QC testing and
reporting.
|
***
|
|
Validation
master plan & Sterility assurance / re-qualification work (autoclave /
tunnel)
|
***
|
|
One
Feasibility batch (full scale) - protocol preparation, execution, QC
testing – vials not for human use (for stability purpose) (1)
|
***
|
|
Filter
Validation
|
***
|
|
TOTAL
|
***
|
(1) In
case more than one feasibility batch will be needed, each feasibility batch will
be charged to Gentium at the above mentioned price.
(2) Face
to face or telephone meetings with Gentium will be held at least once every two
weeks to provide a general update on the status of the project and understand
any key outstanding items. No additional costs will be charged to
Gentium for these meetings or for any follow-ups.
The Feasibility Activities
cost is charged at 40% up front payment in the form of a purchase order from
Gentium upon Patheon being awarded the project and then 20% on completion
of the feasibility batch and the remaining 40% on completion and submission to
Gentium of the Process Validation Report and the batch certificates of
analysis.
CONFIDENTIAL
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as ***. A complete version of this exhibit has been filed with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Act of 1934, as amended.
Page 6 of
15
8.2. Media
Fill
Up to 3
media fills runs may be performed using the specific parameters for the batch
manufacturing. Gentium will be charged fully for each of the Media Fill run
Subcontractor will have to manufacture dedicated to the project.
Charge
per each Media Fill Run is €
***
In case
it transpires that Subcontractor has data applicable to cover the Defibrotide
process, so that Subcontractor won’t need to manufacture any Media fill run
dedicated to the project, then only 25% of the media fill runs charges will be
levied on Gentium (€ ***).
8.3. Capex
Proposal and Costing
All CapEx
items will be agreed with Gentium against specific “User Requirements” and will
be purchased by the Subcontractor. Gentium will contribute at “cost plus 9%.” The handling
fee is to reflect Subcontractor’s time and money for developing the equipment
specifications, negotiation with suppliers and procurement of the equipment. The
handling fee charge is not included in the below mentioned prices.
The
capital proposal is subject to review, following technical discussion between
the Subcontractor and Gentium on the proposed assumptions and process
scheme.
Gentium
will provide Subcontractor with a Purchase Order for the overall Capital cost
(relating Production CapEx and QC CapEx, as described below) upon Patheon being
awarded the project. Such costs will be invoiced as follows:
|
·
|
Equipments
costs: 80% upfront - remaining 20% on delivery of the
tanks
|
|
·
|
Qualification
costs: 100% at the beginning of the qualification
activities
|
|
·
|
Handling
fee costs: 100% on delivery of the
tanks.
|
|
·
|
Contingency
costs: only if / when necessary
|
Secondary
Packaging CapEx will be charged at the beginning of the Secondary Packaging
Transfer activities.
CONFIDENTIAL
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as ***. A complete version of this exhibit has been filed with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Act of 1934, as amended.
Page 7 of
15
Supplier
quotations / invoices can be provided if / when necessary, including multiple
competing bids if available. All purchases would be clearly discussed and
defined with Gentium prior to purchase and supported by supplier
proposals.
|
§
|
Production CAPex: The
following items are required for the manufacture of Defibrotide
Batches.
|
|
ITEM
|
TOTAL
COST (€)
|
|
Bosch
filling machine change parts – contact parts -
|
***
|
|
Piping
|
***
|
|
Software
modifications and electric works
|
***
|
|
2 x
100 liters stainless steel tanks
|
***
|
|
Small
equipment for solution preparation (glass containers,
stirrers)
|
***
|
|
Dedicated
equipment installation and qualification work - protocol preparation,
execution and reporting, samples.
|
***
|
|
Subtotal
|
***
|
|
Contingency
(10%)
|
***
|
|
TOTAL
|
***
|
It is
assumed that dedicated tanks and transfer lines are required.
|
§
|
QC CAPex: The following
items are required for the Analytical Testing of Defibrotide Batches
(Gentium’s Ref. Method PF001/06 ed. 03: PF001/06_06; PF001/06_07;
PF001/06_08; PF001/06_11).
|
|
ITEM
|
TOTAL
ESTIMATED COST (€)
|
|
Ionic
chromatograph Metrohm 761 compact IC
(Ref.
PF001/06_08)
|
***
|
|
Software
modification
(Ref.
PF001/06_06)
|
***
|
|
Lamp
and if necessary works on the equipment already in house (AA ▇▇▇▇▇▇ ▇▇▇▇▇)
(1)
(Ref.
PF001/06_07)
|
***
|
|
Equipment
installation and qualification
|
***
|
|
Subtotal
|
***
|
|
Contingency
(10%)
|
***
|
|
TOTAL
|
***
|
|
|
(1):
For the transfer of the release test ”Nucleic Phosphorus, Optical Emission
spectroscopy Identity and Assay (Gentium’s Ref. Method PF001/06 ed. 03:
PF001/06_07)” Subcontractor is not equipped with the ICP instrument, so
Subcontractor proposed the following two
options:
|
|
o
|
Option # 1: Transfer of
the current Gentium’s method (Plasma). In that case Subcontractor will
have to purchase the ICP equipment, at the cost (approx. € ***) to be met
by client.
|
|
o
|
Option # 2: Validation
of a new method (Graphite Furnace). In that case Subcontractor will have
to adapt the equipment already in house (AA ▇▇▇▇▇▇ ▇▇▇▇▇) with a new lamp
with cost to be met by client (approx. €
***).
|
Gentium
agreed on the above Option # 2 and the relevant cost has been included in the
above capital table. In case it will transpire that the equipment already in
house don’t have the sensitivity necessary for the analysis, Gentium will have
to re-evaluate the Option # 1 or the possibility to use a third party
laboratory.
CONFIDENTIAL
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as ***. A complete version of this exhibit has been filed with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Act of 1934, as amended.
Page 8 of
15
|
§
|
Secondary Packaging CAPex:
The Secondary packaging CAPex will be evaluated once Gentium will
define the specification of the Secondary packaging configuration. As
follows the capital estimation costs, limited to the assumption
made:
|
|
ITEM
|
TOTAL
COST (€)
|
|
Samples
for packaging configuration set-up
|
***
|
|
Subtotal
|
***
|
|
Contingency
(10%)
|
***
|
|
TOTAL
|
***
|
CONFIDENTIAL
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as ***. A complete version of this exhibit has been filed with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Act of 1934, as amended.
Page 9 of
15
part b
standard terms and
conditions for technical transfer services
|
1.
|
Services:
|
|
|
(a)
|
Patheon
hereby agrees to procure the performance of the Technical Transfer
Services described in the Project Scope (“Services”), in accordance with
the Specifications provided by the Customer, the current Good
Manufacturing Practices (“cGMPs”) and all the other conditions provided in
this Contract. The Customer hereby agree that Patheon may subcontract to
its Affiliate, Patheon Italia S.p.A (“Subcontractor”), any Services under
this Contract. In such case, Customer will have a right of access to the
relevant Subcontractor’s Facility for auditing purposes. It is understood
that Patheon shall enter into an agreement with its Affiliate that
contains any terms necessary to ensure that Patheon meets its obligations
under this Contract. For avoidance of doubt the subcontracting of any
Services hereunder to the Subcontractor by Patheon shall not relieve
Patheon of, and Patheon shall remain solely liable, vis-a-vis the Customer,
for its obligations under this Contract. Given the foregoing the Parties
hereby agree that the Services will be performed at the facility, owned
and operated by Patheon Italia S.p.A, that is located at ▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇,
▇▇▇▇▇▇▇▇▇ (▇▇) - ▇▇▇▇▇ (“Facility”).
For
the purposes of this Contract, the term Affiliate means any corporation
which, directly or indirectly through one or more intermediaries, controls
or is controlled by or is under common control with such party and, for
the purpose of this definition, “control” means the ownership of shares
carrying at least a majority of the votes in respect of the election of
the directors of a
corporation.
|
|
|
(b)
|
Parties
must agree in writing on changes, deletions or additions to the Services
(“Changes”).
|
|
|
(c)
|
Minor
Changes shall be confirmed by electronic mail, facsimile or other written
document. Significant Changes (such as a request by the
Customer to change the Project Scope) shall be confirmed by a Change of
Scope Agreement, which shall be agreed to by both
parties.
|
|
|
(d)
|
In
the event the Customer has more than one option in relation to a
particular Service (as written in the Project Proposal or within a Change
of Scope as the case may be) then the Customer shall confirm in writing
which option it wishes Patheon to perform prior to the commencement of the
relevant Service to which the option relates. The Customer shall be
charged the fee quoted for the option
taken.
|
|
2.
|
Payment:
|
A. Payment
|
|
(a)
|
Customer
shall pay Patheon for the Services as outlined in Part A of this Contract
and for any agreed Changes which shall be invoiced separately at the fees
quoted by Patheon. It is agreed upon between the Parties that the Services
detailed in Section 8 of Part A of this Contract, will be invoiced to the
Customer directly by the
Subcontractor.
|
|
|
(b)
|
If
Customer causes any delay to Patheon’s provision of Services for reason
within its control (such as a delay in responding to a Patheon and/or
Subcontractor inquiry or a delay in the delivery of the active
pharmaceutical ingredient (“API”)), then Patheon shall be entitled to
charge the Customer for any additional costs incurred in the provision of
the Services as a result of the delay. In addition to the foregoing,
should the delay in delivery the API cause the postponement or the
cancellation of any batch of Product, Section 5(f) will be
applied.
|
|
|
(c)
|
Each
Patheon invoice shall be due and payable within 45 days of the date of the
relevant invoice. All amounts mentioned in this Contract will be deemed
mentioned or specified in Euros.
|
|
|
(d)
|
In
no event, complaints or objections to the amount of the invoices or
related to the Services will suspend the payment obligations
of the Customer. Interest on past due accounts will accrue at
an annual rate of eight percent per annum
(8%).
|
|
3.
|
Supply
of API and Materials:
|
|
|
(a)
|
Customer
shall, at its expense, supply Patheon, at the agreed Facility, with
sufficient quantities of the API to be used in performing the
Services.
|
|
|
(b)
|
All
materials required to perform the Services (“Materials”) shall be
purchased by Patheon. If Materials ordered by Patheon in order to carry
out the Services are not used in performing the Services, then to the
extent Patheon’s other customers cannot utilize such Materials, the
Customer shall pay to Patheon the costs for such Materials (including all
costs incurred by Patheon in connection with the purchase and handling of
such Components).
|
|
|
(c)
|
In
the event that Patheon is required to procure any product from specified
suppliers indicated by the Customer, in order to complete the Services,
Customer acknowledges that all such purchases shall be made by Patheon on
behalf of the Customer and that Patheon shall assume absolutely no
responsibility or liability whatsoever with respect to such
product.
|
CONFIDENTIAL
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as ***. A complete version of this exhibit has been filed with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Act of 1934, as amended.
Page 10
of 15
|
|
(d)
|
If applicable, Patheon and
the Customer will cooperate and provide such assistance to each other as
may be reasonably necessary to permit the import of the API and other
materials into the country where the Services will be
performed.
|
4. Equipment:
|
|
(a)
|
In order to perform the
Services, certain capital expenditures are necessary in respect of Capital
Equipment required to be acquired and installed at Facility located at ▇▇▇
▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇▇▇▇▇ (▇▇), ▇▇▇▇▇; therefore, the Customer hereby agree
to deliver to Subcontractor the estimated amount, as better detailed in
the Part A (Section 8) above, in respect of purchasing the Capital
Equipment. It is understood that, should additional capital expenditures
be necessary in order to carry out the Services, the Parties will jointly
determine the revised aggregate amount contributable by the
Customer.
|
|
|
(b)
|
All capital expenditures for
the purchasing of the Capital Equipment shall be paid, as outlined in Part
A of this Contract, by the
Customer.
|
|
|
(c)
|
The Customer shall have
legal ownership of the Capital Equipment, with the exception
of any software upgrade and any structural modifications to the
Subcontractor’s existing lines and will assign such Capital Equipment to
Subcontractor for its use.
|
|
|
(d)
|
Patheon shall be responsible
for the costs and expenses of routine maintenance and servicing of the
Capital Equipment, so long as the Capital Equipment remains at the
Facility. Customer shall be responsible for the cost of non-routine
maintenance and servicing of the Capital Equipment (such as major repairs
and parts replacement).
|
5. Termination,
Cancellation and Postponement:
|
|
(a)
|
Either
party may terminate this Contract if the other party is in material breach
of any provisions of this Contract and the other party fails to remedy
such breach within 30 days of the date of notice of such breach by the
non-breaching party.
|
|
|
(b)
|
Customer
may terminate this Contract immediately for any business
reason.
|
|
|
(c)
|
Any
re-scheduling of any part of the Services beyond 120 days requested by
Customer shall, at Patheon’s option, be deemed to be a termination of the
Contract.
|
|
|
(d)
|
If
the Customer terminates the Contract for any business reason or if Patheon
terminates the Contract because of: (i) Customer’s failure to cure any
default within the 30 day notice period; or (ii) Customer rescheduling any
part of the Services beyond the 120 days, then Customer shall pay to
Patheon:
|
- any fees
and expenses due to Patheon for the Services rendered up to the date of
termination;
- all
actual costs incurred by Patheon to complete activities associated with the
termination and close of the Services rendered up to the date of termination;
and
- any
additional costs incurred by Patheon in connection with the Services that are
required to fulfill applicable regulatory and contractual
requirements;
- the cost
of all materials (to the extent that such materials cannot be utilized for other
Patheon’s customers) and equipment which were purchased or maintained by Patheon
in contemplation of the Services as outlined in the Project Scope prior to
notice of termination being given (to the extent such equipment cannot be
utilized by Patheon’s other customers). In addition to the foregoing, Customer
shall satisfy the purchase price payable pursuant to Patheon's orders with
suppliers of materials and equipment, provided such orders were made by Patheon
in reliance on Services and they are not subject to cancellation without
penalty.
| (e) |
Customer
shall arrange for the pickup from the Facility of all materials and
supplies owned by Customer within 20 business days after the earlier of
the termination or expiration of this Contract. Patheon shall charge a
thirty Euro (€30.00) per pallet space per month storage fee for all
materials, supplies and Products stored at the Facility after twenty
business day following the termination of the Contract.
|
|
|
|
(f)
|
In
the event of termination, cancellation or postponement by the Customer
within 60 calendar days of the due start date of manufacture of any batch
of Product, for whatever reason, the Customer agrees to pay to Patheon a
sum equal to 25% of the fees quoted for such manufacturing Services in
Part A of this Contract. In the event of termination,
cancellation or postponement by Customer within 30 calendar days of the
due start date of manufacture of any batch of Product, for whatever
reason, the Customer agrees to pay to Patheon a sum equal to 50% of the
fees quoted for such manufacturing Services in Part A of this
Contract. If termination, cancellation or postponement is
within 15 calendar days of the due start date of manufacture of any batch
of Product, the Customer agrees to pay a sum equal to 75% of the fees
quoted for such manufacturing Services in Part A. If work is stopped
within 5 working days of the week of manufacture of any batch of Product,
for whatever reason, the Customer agrees to pay a sum equal to 90% of the
fees quoted in Part A.
|
CONFIDENTIAL
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as ***. A complete version of this exhibit has been filed with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Act of 1934, as amended.
Page 11
of 15
6. Intellectual
Property:
|
|
(a)
|
The
term “Intellectual Property” includes, without limitation, rights in
patents, patent applications, formulae, trade-marks, trade-▇▇▇▇
applications, trade-names, trade secrets, inventions, copyright,
industrial designs and know-how.
|
|
|
(b)
|
For
the term of this Contract, Customer hereby grants to Patheon and to the
Subcontractor, a non-exclusive, paid-up, royalty-free, non-transferable
license of Customer’s Intellectual Property which Patheon must use in
order to perform the Services.
|
|
|
(c)
|
Patheon
covenants, represents and warrants that, all Intellectual Property
generated or derived in the course of performing the Services, to the
extent it is specific to the development, manufacture, use and sale of the
Customer’s Product that is the subject of the Services, shall be the
exclusive property of Customer.
|
|
|
(d)
|
All
Intellectual Property generated or derived by Subcontractor in the course
of performing the Services which are not specific to, or dependent upon,
Customer’s Product and which have application to manufacturing processes
or formulation development of drug products or drug delivery systems shall
be the exclusive property of Subcontractor. Patheon
hereby warrants to Customer, a non-exclusive, paid-up, royalty-free,
transferable license of such Intellectual Property which Customer may use
for the manufacture of Customer’s
Product.
|
|
7.
|
Indemnity:
|
|
|
A. Indemnification by
Customer
|
Subject
to Sections 7B and 7C(c), Customer shall defend, indemnify and hold Patheon, its
Affiliates and their respective directors, officers, employees and agents
(collectively, "Patheon Indemnitees") harmless from and against any and all
third-party actions, causes of action, costs (including reasonable legal fees),
claims, damages, liabilities and expenses (collectively, “Losses”) relating to
or arising from:
|
·
|
the
distribution of the Customer’s Product or the use of the Customer’s
Product by patients either as part of or outside of the scope of any
clinical trials;
|
|
·
|
the
performance of the Services in accordance with the terms of this
Contract;
|
|
·
|
any
misrepresentation, negligence or willful misconduct by Customer or any of
its affiliates and their respective directors, officers, employees and
agents (collectively, "Customer
Indemnitees");
|
|
·
|
any
breach by the Customer of the Customer's obligations or warranties under
this Contract; or
|
|
·
|
any
claim of infringement or alleged infringement of any third party's
intellectual property rights in respect of the Customer’s
Product.
|
|
|
This indemnity shall not apply to the extent that such Losses
are:
|
|
·
|
determined
to have resulted from gross negligence or willful misconduct of
Patheon;
|
|
·
|
determined
that Patheon has failed to manufacture and test the Product in compliance
with the Customer’s Specifications, cGMPs and the terms of this Contract;
or
|
|
·
|
for
which Patheon is obligated to indemnify the Customer Indemnitees pursuant
to Section 7B.
|
|
|
B. Indemnification by
Patheon
|
Subject
to Sections 7A and 7C(c), Patheon shall defend, indemnify and hold the Customer
Indemnitees harmless from and against any and all Losses resulting from,
relating to or arising from the breach by Patheon of its obligations or
warranties under this Contract except to the extent that such Losses
are:
· determined
to have resulted from gross negligence or willful misconduct of Customer;
or
· for which
Customer is obligated to indemnify the Patheon Indemnitees pursuant to Section
7A.
|
|
C. Limitation
of Liability
|
|
|
(a) If
any part of the Services procured by Patheon are not materially performed
in accordance with the Customer’s Specifications, the cGMPs and the terms
of this Contract, then Customer's sole remedy shall be to request Patheon
to:
|
· repeat
that part of the Service at Patheon’s costs, provided that Customer provides the
API; or
· reimburse
Customer for the price for that part of the Service, excluding the cost of the
API.
|
|
(b) Under
no circumstances whatsoever shall Patheon reimburse Customer for the cost
of the API.
|
|
|
(c) Under
no circumstances whatsoever shall either party be liable to the other in
contract, tort, negligence, breach of statutory duty or otherwise for any
loss of profits, of production, of anticipated savings, of business or
goodwill or for any liabilities, damages, costs or expenses of any kind
incurred by the other party of an indirect or consequential nature,
regardless of any notice of the possibility of such
damages.
|
|
|
D. No Warranty |
PATHEON
MAKES NO WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW,
OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS CONTRACT. PATHEON MAKES
NO WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY OF MERCHANTABILITY
IN RESPECT OF THE CUSTOMER’S PRODUCT.
CONFIDENTIAL
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as ***. A complete version of this exhibit has been filed with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Act of 1934, as amended.
Page 12
of 15
8. Regulatory
Filings:
|
(a)
|
Customer
shall have the sole responsibility for filing of all documents with the
applicable regulatory authority (such as the United States Food and Drug
Administration (“FDA”), the Medicines and Healthcare Products Regulatory
Agency ("MHRA") or the European Medicine Evaluation Agency (collectively
the “Regulatory Authority”) and to take any other actions that may be
required for the receipt of approval from the Regulatory Authority for the
commercial manufacture of the Customer’s
Product.
|
|
(b)
|
Where
documents generated by Subcontractor in relation to the Services are to be
filed by the Customer with any Regulatory Authority and such filing is
liable to cause Subcontractor to be scrutinized by such Regulatory
Authority or the filing thereof may create the possibility of a Regulatory
Authority audit, inspection or review of Subcontractor then, at least 21
days prior to filing any such documents with the Regulatory Authority,
Customer shall provide Subcontractor with a copy of the documents
incorporating such data so as to give Subcontractor the opportunity to
verify the accuracy and regulatory validity of such documents as it
relates to the generated data. Subcontractor will inform
Customer as soon as reasonably possible as regards the accuracy and
regulatory validity of the documents. The time taken to review
the documents will be charged back to Customer at the rates detailed in
the Part A above.
|
|
(c)
|
At
least 21 days prior to filing with the Regulatory Authority any
documentation which is or is equivalent to the FDA’s Chemistry and
Manufacturing Controls (“CMC”) portion of the New Drug
Application or of the Abbreviated New Drug Application, as the case may
be, Customer shall provide Subcontractor with a copy of the CMC portion as
well as all supporting documents which have been relied upon to prepare
the CMC portion so as to permit Subcontractor to verify that the CMC
portion accurately describes the Services performed and the manufacturing
processes to be performed pursuant to this Contract. However, Customer may
submit certain sections of the CMC section as they are finalized and
Subcontractor will do its best efforts to verify, as soon as reasonably
possible, that the described work and manufacturing processes are
accurate. The time taken to review the documents will be charged back to
Customer at the rates detailed in the Part A
above.
|
|
(d)
|
If
Customer does not provide Subcontractor with the documentation requested
above within the time stipulated and if Subcontractor reasonably believes
that Subcontractor’s relationship with the Regulatory Authority may be
jeopardized, Subcontractor may, in its sole discretion, but only to the
extent that is reasonable, delay or postpone the Regulatory Authority
inspection which is or is equivalent to the FDA’s pre-approval inspection
(“PAI”) until such time as Subcontractor has reviewed the requested
documentation and is satisfied with its
contents.
|
|
(e)
|
If
in Subcontractor’s sole discretion, acting reasonably, Subcontractor
determines that any of the information provided by the Customer is
inaccurate or deficient in any manner whatsoever (the “Deficiencies”),
Subcontractor shall notify the Customer in writing of such Deficiencies.
Until such Deficiencies have been resolved or agreement has been reached
with the Customer for such resolution, Subcontractor reserves the right
not to participate in the PAI. In no event, Subcontractor’s
non-participation in the PAI shall be construed as a Patheon’s breach of
any of its obligations under this
Contract.
|
|
(f)
|
Not
withstanding the foregoing, a notification of 14 business days will be
deemed a sufficient notice for an audit or regulatory inspection of the
Facility, including a PAI.
|
9.
Shipping:
Shipments
of Customer’s Product shall be made [EXW] (as defined in INCOTERMS
2000) from Facility unless otherwise mutually agreed. Risk of loss or
of damage to such Product shall transfer to the Customer when the Product is
loaded onto the carrier’s vehicle by Patheon for shipment at the EXW
point. The Product shall be transported in accordance with the
Customer’s instructions. Any shipment from Customer to Patheon shall
be made DDP (as per INCOTERMS 2000) the relevant Facility.
10. Miscellaneous:
A.
Quality
Agreement
|
|
Within
90 days after the signing of the Tech Transfer Agreement and in any event
before the start date of manufacture of the first batch of Product, the
Parties and the Subcontractor shall enter into a Quality Agreement that
shall include provisions addressing, among other things, each party's
responsibilities for cGMPs manufacturing and testing of the Product. The
Quality Agreement shall be prepared in accordance with the European Union
and U.S. FDA current good manufacturing practice
standards.
|
B. Assignment
|
|
Neither
this Contract, nor any of either party’s rights hereunder, may be assigned
or otherwise transferred by either party without the prior written consent
of the other party, which consent shall not be unreasonably
withheld.
|
|
|
Notwithstanding
the aforementioned it is understood and agreed that Patheon may
subcontract the Services hereunder to the above mentioned Subcontractor.
In addition, either party may, without such consent, assign this Agreement
and its rights or delegate its obligations hereunder to an Affiliate, to
the purchaser of all or substantially all of its assets related to the
subject matter of this Agreement or its business, or to its successor
entity or acquirer in the event of a merger, consolidation or change in
control of such party, provided that such assignee executes an agreement
with the non-assigning party hereto whereby it agrees to be bound
hereunder.
|
CONFIDENTIAL
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as ***. A complete version of this exhibit has been filed with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Act of 1934, as amended.
Page 13
of 15
C. Force
Majeure
|
|
Except
for payment obligations, neither party will be responsible for delay or
failure in performance resulting from acts beyond the reasonable control
and without the fault or negligence of such party, including, but not
limited to, strikes or other labor disturbances, lockouts, quarantines,
communicable disease outbreaks, riots, wars, acts of terrorism, fires,
floods, storms, interruption of or delay in transportation, defective
equipment, lack of or inability to obtain fuel, power or components or
compliance with any order or regulation of any government
entity.
|
|
|
D.
|
Survival
|
|
|
Any
termination or expiration of this Contract shall not affect any
outstanding obligations or payments due hereunder prior to such
termination or expiration, nor shall it prejudice any other remedies that
the parties may have under this Contract. The Confidentiality Agreement
and Sections 4, 5, 6, 7 and 8 of the Contract shall survive the
expiration or termination of this
Contract.
|
E. Independent
Contractors
|
|
The
parties are independent contractors and this Contract shall not be
construed to create between Patheon and the Customer any other
relationship such as, by way of example only, that of employer-employee,
principal, agent, joint-venturer, co-partners or any similar
relationship.
|
|
|
F.
|
Confidentiality
|
|
|
Each
Party shall keep confidential and shall not use for any purpose other than
the performance of such Party’s obligations under this Contract, all
information acquired from the other Party, in connection with this
Contract and the transactions contemplated hereby, other than any
information that: (i) is or hereafter becomes generally available to the
public other than by reason of any default with respect to a
confidentiality obligation; (ii) was already known to the receiving Party
as evidenced by prior written documents in the receiving Party’s
possession; or (iii) is disclosed to the receiving Party by a third party
who or which is not in default of any confidentiality obligation to the
disclosing Party (such information to which none of the foregoing
exceptions applies, “Confidential Information”). Each receiving
Party shall transmit Confidential Information only to those of its
employees, agents, representatives or Affiliates who shall need same for
the purpose of this Contract and shall take all necessary measures to
assure that such employees, agents or representatives do not reveal such
Confidential Information to any third party without prior written
authorization from the disclosing Party for as long as the receiving Party
is obliged to hold such information in confidence hereunder, regardless of
the respective terms of employment of such employees. The confidentiality
obligations under this Section shall continue for the term of this
Contract and for 5 years
thereafter.
|
G. Taxes
In the
event that any taxes or duties, of whatever nature, excluding any taxes levied
on profits, income or revenue which are the responsibility of Patheon and /or of
the Subcontractor, are required to be withheld on payments made by Customer
pursuant to this Contract by any state, federal, provincial or foreign
government, including, but not limited to, Value Added Tax, Customer shall be
responsible and promptly pay said taxes and duties to the appropriate taxing
authority without any deduction to any amount owed to Patheon and /or to the
Subcontractor. Customer shall secure and deliver to Patheon upon request any
official receipt for any such taxes paid.
H. Other
Terms
|
|
No
terms, provisions or conditions of any purchase order or other business
form or written authorization used by Customer or Patheon will have any
effect on the rights, duties or obligations of the parties, or otherwise
modify, this Contract, regardless of any failure of Customer or Patheon to
object to such terms, provisions, or conditions unless such document
specifically refers to this Contract and is signed by both
parties.
|
|
|
I.
|
Insurance
|
|
|
Each
party shall maintain during the term of this Contract general liability
and product liability insurance. Either party may request
evidence of such insurance.
|
J.
Entire Agreement
|
|
This
Contract constitutes the complete agreement between the parties with
respect to this subject matter and supersedes all other prior agreements
and understandings, whether written or oral. Any modifications, amendment
or supplement to this Contract must be in writing and signed by authorized
representatives of both parties.
|
K. Facsimile
This Contract may be signed in
counterparts and by facsimile.
L. Choice
of Law
|
|
CONFIDENTIAL
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as ***. A complete version of this exhibit has been filed with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Act of 1934, as amended.
Page 14
of 15
M.
Notices
|
|
Any
notice or other communication required to be given by one party to the
other under the Contract shall be in writing and shall be deemed to have
been served: (i) if personally delivered, when actually delivered; or
(ii) if sent by facsimile, the same day of confirmation receipt of
transmission; or (iii) if delivered by certified or registered mail
to the respective addresses of the parties set out below, or to such other
address or addresses as any of the parties hereto may from time to time in
writing designate to the other party hereto pursuant to this Section
10(M):
|
|
|
If
to Patheon International A.G.
|
|
|
Attention: General Counsel
Europe
|
|
|
▇▇▇▇▇▇▇▇▇▇▇▇▇
▇▇,
|
|
|
▇▇▇▇
▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇
|
|
|
Facsimile:
|
|
|
And
a copy to
|
|
|
Attention: Department
of Legal Services
|
|
|
▇▇▇▇▇
▇.▇. ▇▇▇▇▇▇▇ ▇. ▇▇▇
|
|
|
▇▇▇▇▇
(▇▇) - ▇▇▇▇▇
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Facsimile:
+ 39 039 2027 219
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If
to Customer at:
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Executive
Vice President and Chief Financial
Officer
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And
a copy to
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Facsimile:
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CONFIDENTIAL
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as ***. A complete version of this exhibit has been filed with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
Act of 1934, as amended.
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