SERVICE AGREEMENT
Between:
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§
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SIRTON
PHARMACEUTICALS S.p.A.,
whose registered office is in Villa Guardia (CO), Piazza XX Settembre
nr.
2, Tax Code 01192270138, represented by xx. Xxxxx Xxxx Xxxxx, Deputy
Chairwoman (hereinafter referred to as SIRTON)
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AND
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§
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GENTIUM
S.p.A.,
whose registered office is in Villa Guardia (CO), Piazza XX Settembre
nr.
2. Tax Code 02098100130, represented by dr. Xxxxxxxxx Xxxxxxxxx,
Director
of Administration (hereinafter referred to as GENTIUM);
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WHEREAS:
| § |
GENTIUM
has asked SIRTON to provide various services (hereinafter referred
to as
the “Services” and
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§
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SIRTON
has, within its own organisation, a structure dedicated to the performance
of all of the activities required to render said Services,
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Now,
therefore, GENTIUM AND SIRTON (hereinafter referred to as the “Parties”) agree
as follows:
| 1) |
SIRTON
undertakes to provide GENTIUM with the Services indicated below and
described in the specific attachments.
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a)
Quality control for batch release
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Attachment
A
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b)
Analytical support for R&D
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Attachment
B
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c)
Engineering services
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Attachment
C
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d)
General services and car hire
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Attachment
D
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e)
Services for utilities
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Attachment
E
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f)
Maintenance service
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Attachment
F
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Gentium
shall have the right to provide guidance for the performance of said services
in
accordance with legislation in force.
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2)
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Unless
otherwise agreed by the parties, invoices will be issued on a monthly
basis and payment will be made by direct bank transfer 60 days from
the
end of the month in which the invoice is dated.
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3)
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This
agreement will be effective as of 02/01/2006 and will expire on 31/12/2006
and will be considered tacitly renewed from year to year unless one
of the
parties gives notice to the other, sent at least one month before
expiry.
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4)
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The
Parties reserve the right to revise the contractual conditions on
expiry
or during the life of the contract if there are any significant changes
to
the services rendered or the cost of
such.
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1
The
Parties shall have the right to withdraw from the contract if the revised
conditions are not accepted
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5)
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The
Parties acknowledge, with immediate effect, the right to negotiate
variations of the fees established above on the basis of the actual
amount
of services rendered.
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6)
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Any
correspondence between the Parties must be addressed as
follows:
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If
to
SIRTON:
SIRTON
PHARMACEUTICALS S.p.A ,
Villa
Guardia (CO), Piazza XX Settembre n. 2,
for
the
attention of xx. Xxxxx Xxxx Xxxxx,
If
to
GENTIUM:
Villa
Guardia (CO), Piazza XX Settembre n. 2.
for
the
attention of dr. Xxxxxxxxx Xxxxxxxxx
| 7) |
This
agreement will be regulated by Italian law.
Any dispute regarding this Contract
will
be settled by a Board of Arbitration; each of the Parties will nominate
its own arbitrator, who in turn will choose the third member of the
Board
of Arbitration, who will act as Chairman of said
Board.
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8)
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This
Contract cancels and replaces all previous service agreements between
the
Parties and may not be amended or changed in any way with the exception
of
that expressly provided for herein or with the written agreement
of the
Parties signed by their authorised
representatives.
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9)
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Together
with the issue of the invoice, Sirton undertakes to provide Gentium
with
all the support documentation and computation information (e.g. hour
sheets, statements of telephone costs as per charges made by telephone
service providers, vehicle hire invoices, certificates of analysis)
relative to the services rendered. If said support documentation
and proof
of the services rendered is not submitted, Gentium reserves the right
to
suspend payment of the invoice.
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Read,
confirmed and signed.
Villa
Guardia, 2 January 2006
| /s/ Xxxxx Xxxx Xxxxx | /s/ Xxxxxxxxx Xxxxxxxxx | ||
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Sirton Pharmaceuticals S.p.A |
Gentium S.p.A. |
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Deputy
Chairwoman
(xx.Xxxxx
Xxxx Xxxxx)
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Director
of
Administration
(dr. Xxxxxxxxx
Xxxxxxxxx)
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2
ATTACHMENT
A
Quality
control for batch release and stability
In
accordance with specific instructions received from Gentium,
SIRTON will
perform all Quality Control activities for the release of batches and on
stability relevant to ordinary production activities and in accordance with
legislative provisions for the pharmaceutical sector.
Invoices
will be issued quarterly on the basis of the certificates issued. Certificates
must be issued within the terms indicated in the analysis requests issued by
Gentium. Difficulty in issuing said certificates of analysis within the terms
requested or unforeseen circumstances must be notified promptly (within two
working days of the receipt of the order or the occurrence of the unforeseen
circumstance) to Gentium’s purchasing office. Gentium will charge Sirton and
Sirton shall pay Gentium, a 7% penalty if the above is attributable to Sirton,
up to a maximum of 20% of the fee established for each week of delay in
delivering the certificates. For the sole purpose of having prompt information
on any irregularities encountered (out of specification) during the analyses
and
before the certificate of analysis is issued, Sirton undertakes to notify
Gentium’s Quality Manager of any irregularities encountered within and not
beyond one working day following said analyses. If necessary, Sirton will
provide Gentium’s Technical Director with the support documentation relative to
the analyses as well as the results of the individual analyses conducted.
Following notice and internal activities permitting, Sirton will allow Gentium
to conduct inspections of its laboratories. Sirton will not be charged for
said
inspections.
As
payment for the services rendered,
GENTIUM
undertakes to pay a fee per certificate, as indicated in the tables
below
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Description
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Full
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Reduced
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Certificates
of stability
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800.00
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400.00
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For
batch releases:
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Product
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Cost
of the certificate for batch analysis
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Injectable
Defibrotide
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7,500.00
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Oral
Defibrotide
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5,600.00
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Inject.
Calcium Heparin
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3,100.00
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Raw
Heparin
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400.00
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Heparin
Std Bottles
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1,000.00
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Pure
Urokinase
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3,000.00
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Sulglicotide
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2,650.00
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Glucidamine
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2,300.00
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3
ATTACHMENT
B
Analytical
support for R&D
On
the
basis of the availability of its facilities and laboratories, and following
a
specific request from Gentium, SIRTON
undertakes to make its facilities and professional staff available to the same,
meeting all of GENTIUM’s requirements in terms of laboratory analyses regarding
production processes and products that specifically relate to R&D activities
underway on its own products.
SIRTON
acknowledges that its internal professional staff employed in meeting GENTIUM’s
requirements and satisfying its requests, in working hours, will be exclusively
dedicated to GENTIUM. For internal reporting and management control purposes,
said professional staff will draw up monthly reports detailing the activities
they have been working on.
The
fee
established is € 9,100 + VAT and will terminate after January 2006.
4
ATTACHMENT
C
Engineering
Services
SIRTON
will
make a technician specialised in technical work both on production equipment
and
property fully available to Gentium; said professional figure will assist
GENTIUM’s technical staff and external engineering firms in planning and
carrying out rebuilding and revamping work, commissioning of systems and
maintenance work during start-up.
Invoicing
will be monthly on the basis of the hours actually worked, recorded in specific
hour-tables which will be completed and signed by the technicians in question
and signed by Sirton’s Departmental Manager and countersigned by Gentium’s
Technical Director.
The
fee
established is € 33.57 per hour + VAT.
5
ATTACHMENT
D
General
services and car hire
SIRTON
will
make its facilities dedicated to general activities such as: security, telephone
switchboard and door staff available to GENTIUM as well as equipment for general
use such as envelope machine, binding machine. This equipment may be used both
directly by GENTIUM staff or through SIRTON staff that work in the office in
question.
SIRTON
will pay
the external costs of services for general use such as postal services,
telephones and security, for all of the above-illustrated
activities.
Telephone
expenses Telephone
expenses for land-lines will be charged on the basis of the costs recorded
for
users Gentium is responsible for by means of a specific switchboard program
and
the costs of mobile phones on the basis of the invoices relative to users
Gentium is responsible for.
Other
general services broken
down as follows:
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Switchboard
and door staff
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€
875 + VAT
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Security
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€
2,980+VAT until February
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€
2,280+ VAT from 1st
March
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Delivery/errand
staff
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€
3,600 + VAT January
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€
1,800 + VAT February
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Laundry
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€
1,200+ VAT to January
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€
600 + VAT February
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The
delivery and laundry services will terminate from March
2006.
| Hire of photocopiers 0xx xxxxx Xxxxxxx office block | |
| (dr. Moltrasio - Xx. Xxxxxxxx) | hire instalment recharged until transfer of contract |
Cars As
regards the management of service vehicles hired for GENTIUM, the latter will
be
charged the cost of the car hire in question.
6
ATTACHMENT
E
Services
for utilities
SIRTON
manages
utilities such as gas and water, paying the relative costs of such and providing
them to GENTIUM, which uses them to heat its offices and in its production
processes.
SIRTON
undertakes to make said utilities available to GENTIUM to the extent required
for latter’s operations.
SIRTON
will
make
a charge for the service rendered, which will equal the consumption of the
utilities employed, calculated, where meters have not been installed, by tables
which indicate the theoretical monthly consumption, completed by Sirton’s
technical office on the basis of the installed capacities of GENTIUM’s
production plants.
The
above
tables will be reviewed and approved by GENTIUM’s Maintenance
Manager.
Said
services will be invoiced on a monthly basis, at market prices and terms.
7
ATTACHMENT
F
Maintenance
service
SIRTON
will
make
its organisation available to Gentium, guaranteeing maintenance work to support
the Gentium facilities such as:
a.
electrical work;
b.
workshop activities;
c.
maintenance of furniture;
d.
work
on the telephone lines.
All
of
the above work will be performed with the prior agreement of GENTIUM.
If
its
own organisation is not able to perform a specific job,
SIRTON
guarantees that it will use highly specialised external firms for such, the
cost
of which will be charged directly to GENTIUM, following the approval of the
same.
For
the
maintenance service, Sirton will charge Gentium the number of hours worked
at an
hourly rate of €
25.00 + VAT.
Invoicing
will be made monthly, based on the hours actually worked and recorded in
specific hour-sheets completed and signed by the workers in question and signed
by SIRTON’s Departmental Manager and countersigned by GENTIUM’s Maintenance
Manager.
8
Attachment
“A”
TO
THE CONTRACT TO SUPPLY ACTIVE INGREDIENTS BETWEEN
SIRTON
PHARMACEUTICALS S.p.A and GENTIUM S.p.A. dated 2/01/2006
Price
for sale of active ingredients 2006
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Product
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Unit
of measure
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Unit
price
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Pure
Urokinase
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M.U.
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53.00
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Inject.
Calcium Heparin
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M.U.
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8.80
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Inject.
Defibrotide
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K.S.
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2,300.00
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Oral
Defibrotide
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K.S.
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660.00
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Sulglicotide
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K.S.
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390.00
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Glucidamine
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K.S.
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160.00
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Without
prejudice to all provisions of the relative contract.
Villa
Guardia, 2 January 2006
| Sirton Pharmaceuticals
S.p.A
Deputy
Chairwoman
(xx.
Xxxxx Xxxx Xxxxx)
|
Gentium
S.p.A.
Director
of Administration
(dr.
Xxxxxxxxx Xxxxxxxxx)
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| /s/ Xxxxx Xxxx Xxxxx | /s/ Xxxxxxxxx Xxxxxxxxx | ||
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Sirton
Pharmaceuticals S.p.A Gentium
S.p.A.
Deputy
Chairwoman
Director
of Administration
(xx.
Xxxxx Xxxx Xxxxx)
(dr. Xxxxxxxxx Xxxxxxxxx)
9
