Registration
No.
333-139422
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Republic
of Italy
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Not
Applicable
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(State
or other jurisdiction of incorporation
or organization)
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(I.R.S.
Employer Identification
No.)
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Approximate
date of commencement of proposed sale to the public:
As soon as practicable after this registration statement becomes
effective.
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If
only securities being registered on this Form are being offered pursuant
to dividend or interest reinvestment plans, please check the following
box. ¨
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If
any of the securities being registered on this Form are offered on
a
delayed or continuous basis pursuant to Rule 415 under the Securities
Act
of 1933, check the following box. x
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If
this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the
following box and list the Securities Act registration statement
number of
the earlier effective registration statement for the same offering.
¨
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If
this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities
Act registration statement number of the earlier effective registration
statement for the same offering. ¨
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If
this Form is a registration statement pursuant to General Instruction
I.C.
or a post-effective amendment thereto that shall become effective
upon
filing with the Commission pursuant to Rule 462(e) under the Securities
Act, check the following box. ¨
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If
this Form is a post-effective amendment to a registration statement
filed
pursuant to General Instruction I.C. filed to register additional
securities or additional classes of securities pursuant to Rule 413(b)
under the Securities Act, check the following box. ¨
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Exhibit
Number
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Description
of Documents
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1.1
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Underwriting
Agreement, dated June 16, 2005, between Gentium S.p.A. and Maxim
Group LLC
and I-Bankers Securities Inc., incorporated by reference to Exhibit
1.1 to Amendment No. 1 to the Registration Statement on Form F-1,
Registration No. 333-130796, previously filed with the Securities
and
Exchange Commission on January 26, 2006.
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1.2
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Form
of Representatives’ Purchase Option between Gentium S.p.A. and Maxim Group
LLC and I-Bankers Securities Inc., incorporated by reference to
Exhibit 1.2 to Amendment No. 5 to the Registration Statement on Form
F-1,
Registration No. 333-122233, previously filed with the Securities
and
Exchange Commission on June 9, 2005.
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1.3
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Form
of Lock-Up Agreement, incorporated by reference to Exhibit 1.3 to
Amendment No. 4 to the Registration Statement on Form F-1, Registration
No. 333-122233, previously filed with the Securities and Exchange
Commission on May 31, 2005.
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3(i)
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Articles
of Association of Gentium S.p.A., formerly known as Pharma Research
S.r.l.
dated November 11, 1993, incorporated by reference to Exhibit 3(i) to
the Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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3(ii)
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Amended
and Restated Bylaws of Gentium S.p.A. dated April 28, 2006, incorporated
by reference to Exhibit 1(ii) to the Annual Report on Form 20-F for
the
year ended December 31, 2005, previously filed with the Securities
and
Exchange Commission on May 30, 2006.
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4.2.1
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Form
of Series A senior convertible promissory note, incorporated by
reference to Exhibit 4.2.1 to the Registration Statement on Form
F-1,
Registration No. 333-122233, previously filed with the Securities
and
Exchange Commission on January 24, 2005.
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4.2.2
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Form
of warrant, incorporated by reference to Exhibit 4.2.2 to the Registration
Statement on Form F-1, Registration No. 333-122233, previously filed
with
the Securities and Exchange Commission on January 24,
2005.
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4.2.3
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Pledge
Agreement between FinSirton S.p.A. (previously known as Finanziaria
Sirton
S.p.A.) and I-Bankers Securities Inc. as representative of the
holders of the Series A senior convertible promissory notes dated
October 15, 2004, incorporated by reference to Exhibit 4.2.3 to
Amendment No. 1 to the Registration Statement on Form F-1, Registration
No. 333-130796, previously filed with the Securities and Exchange
Commission on January 26, 2006.
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4.2.4
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Form
of Investors’ Rights Agreement between Gentium S.p.A. and holders of the
Series A senior convertible promissory notes and warrants dated
October 15, 2004, incorporated by reference to Exhibit 4.2.4 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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4.2.5
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Form
of subscription agreement for Series A senior convertible promissory
note and warrant, incorporated by reference to Exhibit 4.2.5 to Amendment
No. 1 to the Registration Statement on Form F-1, Registration No.
333-122233, previously filed with the Securities and Exchange Commission
on April 7, 2005.
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4.2.6
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Amendment
No. 1 to Gentium S.p.A. Series A Senior Convertible Promissory
Notes, Warrants, Subscription Agreements and Investor Rights Agreements
among Gentium S.p.A. and the other parties thereto dated May 27,
2005, incorporated by reference to Exhibit 4.2.6 to Amendment No.
4 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on May
31,
2005.
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4.3
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Investors’
Rights Agreement by and among Gentium S.p.A., Alexandra Global Master
Fund Ltd. and Generation Capital Associates made as of
January 10, 2005, incorporated by reference to Exhibit 4.3 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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4.4
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Intentionally
omitted.
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4.5
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Investors’
Rights Agreement by and among Gentium S.p.A. and Sigma Tau Finanziaria
S.p.A. made as of April 4, 2005, incorporated by reference to Exhibit
4.5 to Amendment No. 1 to the Registration Statement on Form F-1,
Registration No. 333-122233, previously filed with the Securities
and
Exchange Commission on April 7, 2005.
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4.6
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Form
of Deposit Agreement among Gentium S.p.A., The Bank of New York and
the
owners and beneficial owners from time to time of American Depositary
Receipts (including as an exhibit the form of American Depositary
Receipt), incorporated by reference to Exhibit 4.6 to Amendment No.
5 to
the Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on June
9,
2005.
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4.7
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Form
of American Depositary Receipt (see Exhibit 4.6).
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4.8.1
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Securities
Subscription Agreement among Gentium S.p.A. and the other parties
thereto
dated as of October 3, 2005, incorporated by reference to Exhibit
4.8.1 to
the Registration Statement on Form F-1, Registration No. 333-130796,
previously filed with the Securities and Exchange Commission on December
30, 2005.
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4.8.2
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Form
of American Depositary Shares Purchase Warrant by Gentium S.p.A.
dated
October 14, 2005, incorporated by reference to Exhibit 4.8.2 to the
Registration Statement on Form F-1, Registration No. 333-130796,
previously filed with the Securities and Exchange Commission on December
30, 2005.
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4.8.3
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Registration
Rights Agreement among Gentium S.p.A. and the other parties thereto
made
and entered into as of October 14, 2005, incorporated by reference
to
Exhibit 4.8.3 to the Registration Statement on Form F-1, Registration
No.
333-130796, previously filed with the Securities and Exchange Commission
on December 30, 2005.
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4.8.4
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Escrow
Agreement between Gentium S.p.A. and The Bank of New York dated as
of
October 14, 2005, incorporated by reference to Exhibit 4.8.4 to the
Registration Statement on Form F-1, Registration No. 333-130796,
previously filed with the Securities and Exchange Commission on December
30, 2005.
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4.9.1
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Securities
Subscription Agreement among Gentium S.p.A. and the other parties
thereto
dated as of May 31, 2006, incorporated by reference to Exhibit 4.9.1
to
the Registration Statement on Form F-3, Registration No. 333-135622,
previously filed with the Securities and Exchange Commission on July
6,
2006.
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4.9.2
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Form
of American Depositary Shares Purchase Warrant by Gentium S.p.A.
dated
June 6, 2006, incorporated by reference to Exhibit 4.9.2 to the
Registration Statement on Form F-3, Registration No. 333-135622,
previously filed with the Securities and Exchange Commission on July
6,
2006.
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4.9.3
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Form
of Ordinary Share Warrant by Gentium S.p.A. dated June 6, 2006,
incorporated by reference to Exhibit 4.9.3 to the Registration Statement
on Form F-3, Registration No. 333-135622, previously filed with the
Securities and Exchange Commission on July 6,
2006.
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4.9.4
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Registration
Rights Agreement among Gentium S.p.A. and the other parties thereto
made
and entered into as of June 6, 2006, incorporated by reference to
Exhibit
4.9.4 to the Registration Statement on Form F-3, Registration No.
333-135622, previously filed with the Securities and Exchange Commission
on July 6, 2006.
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5.1
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Opinion
of Gianni, Origoni, Grippo & Partners as to the legality of the
ordinary shares underlying the American Depositary Shares being offered
by
the prospectus forming a part of this Registration
Statement.
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10.1
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Amended
and Restated 2004 Equity Incentive Plan, incorporated by reference
to
Exhibit 10.1 to the Registration Statement on Form S-8, Registration
No.
333-137534, previously filed with the Securities and Exchange Commission
on September 22, 2006.
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10.2
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Amended
and Restated Nonstatutory Share Option Plan and Agreement dated March
23,
2006, incorporated by reference to Exhibit 4.2 to the Annual Report
on
Form 20-F for the year ended December 31, 2005, previously filed
with the
Securities and Exchange Commission on May 30, 2006.
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10.3
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Loan
Agreement between Banca Nazionale del Lavoro S.p.A. and Gentium S.p.A.,
successor in interest to Crinos Industria Farmacobiologica S.p.A.,
dated
November 20, 1996, incorporated by reference to Exhibit 10.3 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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10.4
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Loan
Agreement between Banca Nazionale del Lavoro S.p.A. and Gentium S.p.A.,
successor in interest to Crinos Industria Farmacobiologica S.p.A.,
dated
May 27, 1999, incorporated by reference to Exhibit 10.4 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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10.5
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Deed
of Agreement of Assumption of Debts among Sirton Pharmaceuticals
S.p.A.,
Gentium S.p.A. and Banca Nazionale del Lavoro S.p.A. dated
February 14, 2003, regarding Loan Agreement between Banca Nazionale
del Lavoro S.p.A. and Gentium S.p.A., successor in interest to Crinos
Industria Farmacobiologica S.p.A., dated November 20, 1996, and Loan
Agreement between Banca Nazionale del Lavoro S.p.A. and Gentium S.p.A.,
successor in interest to Crinos Industria Farmacobiologica S.p.A.,
dated
May 27, 1999, incorporated by reference to Exhibit 10.5 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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10.6
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Ministry
for Universities, Scientific and Technological Research Loan granted
to
Gentium S.p.A., successor in interest to Crinos Industria Farmacobiologica
S.p.A., by Sanpaolo Imi S.p.A., dated September 27, 2000,
incorporated by reference to Exhibit 10.6 to the Registration Statement
on
Form F-1, Registration No. 333-122233, previously filed with the
Securities and Exchange Commission on January 24, 2005.
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10.7.1
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Loan
Agreement between Banca Nazionale del Lavoro S.p.A. and Gentium S.p.A.
dated July 20, 2004, incorporated by reference to Exhibit 10.7 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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10.7.2
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Deed
of Pledge by Gentium S.p.A. in favor of Banca Nazionale del Lavoro
S.p.A.
dated May 16, 2006, incorporated by reference to Exhibit 4.7.2 to
the
Annual Report on Form 20-F for the year ended December 31, 2005,
previously filed with the Securities and Exchange Commission on May
30,
2006.
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10.7.3
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Loan
Agreement between Banca Nazionale del Lavoro S.p.A. and Gentium S.p.A.
dated June 14, 2006, incorporated by reference to Exhibit 10.7.3
to the
Registration Statement on Form F-3, Registration No. 333-135622,
previously filed with the Securities and Exchange Commission on July
6,
2006.
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10.8
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Loan
Agreement between Sirton Pharmaceuticals S.p.A. and Gentium S.p.A.
dated
March 2004, incorporated by reference to Exhibit 10.8 to the Registration
Statement on Form F-1, Registration No. 333-122233, previously filed
with
the Securities and Exchange Commission on January 24,
2005.
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10.9
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Loan
Agreement between Sirton Pharmaceuticals S.p.A. and Gentium S.p.A.
dated
May 2004, incorporated by reference to Exhibit 10.9 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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10.10
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Loan
Agreement between Sirton Pharmaceuticals S.p.A. and Gentium S.p.A.
dated
June 2004, incorporated by reference to Exhibit 10.10 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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10.11
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Loan
Agreement between Sirton Pharmaceuticals S.p.A. and Gentium S.p.A.
dated
July 2004, incorporated by reference to Exhibit 10.11 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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10.12.1
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Clinical
Trial Agreement between Gentium S.p.A., successor in interest to
Crinos
Industria Farmacobiologica S.p.A., and Dana-Faber/Partners Cancer
Care, Inc. dated December 27, 1999, incorporated by reference to
Exhibit 10.12.1 to the Registration Statement on Form F-1, Registration
No. 333-122233, previously filed with the Securities and Exchange
Commission on January 24, 2005.
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10.12.2
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Amendment
No. 1 to Clinical Trial Agreement between Gentium S.p.A. and
Dana-Farber/Partners Cancer Care, Inc. dated October 19, 2000,
incorporated by reference to Exhibit 10.12.2 to the Registration
Statement
on Form F-1, Registration No. 333-122233, previously filed with the
Securities and Exchange Commission on January 24, 2005.
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10.12.3
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Amendment
No. 2 to Clinical Trial Agreement between Gentium S.p.A. and
Dana-Farber/Partners Cancer Care, Inc. dated January 28, 2004,
incorporated by reference to Exhibit 10.12.3 to the Registration
Statement
on Form F-1, Registration No. 333-122233, previously filed with the
Securities and Exchange Commission on January 24, 2005.
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10.13
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Trial
Agreement between the European Blood and Marrow Transplantation Group
and
Gentium S.p.A. dated February 26, 2004, incorporated by reference to
Exhibit 10.13 to the Registration Statement on Form F-1, Registration
No.
333-122233, previously filed with the Securities and Exchange Commission
on January 24, 2005.
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10.14.1
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Research
Agreement between Gentium S.p.A., successor in interest to Crinos
Industria Farmacobiologica S.p.A., and Consorzio Mario Negri Sud
dated
June 14, 2000, incorporated by reference to Exhibit 10.14.1 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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10.14.2
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Letter
from Gentium S.p.A. to Consorzio Mario Negri Sud dated February 23,
2004 extending Research Agreement between Gentium S.p.A., successor
in
interest to Crinos Industria Farmacobiologica S.p.A., and Consorzio
Mario
Negri Sud dated June 14, 2000, incorporated by reference to Exhibit
10.14.2 to the Registration Statement on Form F-1, Registration No.
333-122233, previously filed with the Securities and Exchange Commission
on January 24, 2005.
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10.15
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License
and Supply Agreement by and between Gentium S.p.A. and Sigma-Tau
Pharmaceuticals, Inc. (assignee of Sigma Tau Industrie Farmaceutiche
Riunite S.p.A.) dated December 7, 2001, incorporated by reference to
Exhibit 10.15 to the Registration Statement on Form F-1, Registration
No.
333-122233, previously filed with the Securities and Exchange Commission
on January 24, 2005.
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10.16
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Umbrella
Agreement among Sirton Pharmaceuticals S.p.A. (formerly known as
Crinos
Industria Farmacobiologica S.p.A.), Gentium S.p.A., Crinos S.p.A.
and SFS
Stada Financial Services Ltd dated May 17, 2002, incorporated by
reference to Exhibit 10.16 to the Registration Statement on Form
F-1,
Registration No. 333-122233, previously filed with the Securities
and
Exchange Commission on January 24, 2005.
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10.17
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License
Agreement between Crinos S.p.A. and Gentium S.p.A. dated July 15,
2004, incorporated by reference to Exhibit 10.17 to the Registration
Statement on Form F-1, Registration No. 333-122233, previously filed
with
the Securities and Exchange Commission on January 24,
2005.
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10.18
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Purchase
Agreement by and among Sirton Pharmaceuticals S.p.A., Gentium S.p.A.
and
Axcan Pharma Inc. dated October 9, 2002, incorporated by
reference to Exhibit 10.18 to the Registration Statement on Form
F-1,
Registration No. 333-122233, previously filed with the Securities
and
Exchange Commission on January 24, 2005.
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10.19
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Agreement
between Sirton Pharmaceuticals S.p.A. and Gentium S.p.A. dated
October 9, 2002, regarding the Purchase Agreement with Axcan
Pharma Inc., incorporated by reference to Exhibit 10.19 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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10.20
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License
and Supply Agreement between Gentium S.p.A. and Abbott S.p.A. dated
June 11, 2002, incorporated by reference to Exhibit 10.20 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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10.21
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Supply
Agreement between Gentium S.p.A. and La.bu.nat. S.r.l. dated
January 12, 2004, incorporated by reference to Exhibit 10.21 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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10.22
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Supply
Agreement between Gentium S.p.A. and La.bu.nat. S.r.l. dated
January 12, 2004, incorporated by reference to Exhibit 10.22 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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10.23
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Supply
Agreement between Gentium S.p.A. and Samil Pharm. Co. Ltd. dated
November 11, 2003, incorporated by reference to Exhibit 10.23 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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10.24.1
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Active
Pharmaceutical Ingredient Agreement between Sirton Pharmaceuticals
S.p.A.
and Gentium S.p.A. dated January 2, 2004, incorporated by reference
to Exhibit 10.24 to the Registration Statement on Form F-1, Registration
No. 333-122233, previously filed with the Securities and Exchange
Commission on January 24, 2005.
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10.24.2
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Contract
to Supply Active Ingredients between Sirton Pharmaceuticals S.p.A.
and
Gentium S.p.A. dated January 2, 2006, incorporated by reference to
Exhibit 4.24.2 to the Annual Report on Form 20-F for the year ended
December 31, 2005, previously filed with the Securities and Exchange
Commission on May 30, 2006.
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10.25.1
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Agreement
for the Supply of Services between FinSirton S.p.A. and Gentium S.p.A.
dated January 2, 2004, incorporated by reference to Exhibit 10.25 to
the Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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10.25.2
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Service
Agreement between FinSirton S.p.A. and Gentium S.p.A. dated
January 2, 2006, incorporated by reference to Exhibit 10.25.2 to the
Annual Report on Form 20-F for the year ended December 31, 2005,
previously filed with the Securities and Exchange Commission on May
30,
2006.
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10.26.1
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Agreement
for the Supply of Services between Sirton Pharmaceuticals S.p.A.
and
Gentium S.p.A. dated January 2, 2004, incorporated by reference to
Exhibit 10.26 to the Registration Statement on Form F-1, Registration
No.
333-122233, previously filed with the Securities and Exchange Commission
on January 24, 2005.
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10.26.2
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Service
Agreement between Sirton Pharmaceuticals S.p.A. and Gentium S.p.A.
dated
January 2, 2006, incorporated by reference to Exhibit 10.26.2 to the
Annual Report on Form 20-F for the year ended December 31, 2005,
previously filed with the Securities and Exchange Commission on May
30,
2006.
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10.27
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Service
Agreement between Sirton Pharmaceuticals S.p.A. and Gentium S.p.A.
dated
January 2, 2004, incorporated by reference to Exhibit 10.27 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on January
24, 2005.
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10.28
|
Lease
Agreement between Sirton Pharmaceuticals S.p.A. (formerly known as
Crinos
Industria Farmacobiologica S.p.A.) and Gentium S.p.A. (formerly known
as
Pharma Research S.r.L.) dated January 2, 2001, incorporated by
reference to Exhibit 10.28 to the Registration Statement on Form
F-1,
Registration No. 333-122233, previously filed with the Securities
and
Exchange Commission on January 24, 2005.
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10.29
|
8%
Promissory Note in the amount of €106,000 issued by Gentium S.p.A. to
Alexandra Global Master Fund Ltd. dated March 29, 2005,
incorporated by reference to Exhibit 10.29 to Amendment No. 1 to
the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on April
7,
2005.
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10.30
|
General
Consulting Agreement between Gentium S.p.A. and Bradstreet Clinical
Research & Associates, Inc., dated March 19, 2004,
incorporated by reference to Exhibit 10.30 to Amendment No. 1 to
the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on April
7,
2005.
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10.31
|
Consulting
Agreement between Gentium S.p.A. and KKS-UKT, GmbH, dated April 20,
2004, incorporated by reference to Exhibit 10.31 to Amendment No.
1 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on April
7,
2005.
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10.32
|
Commercial
Lease Agreement between Gentium S.p.A. and FinSirton S.p.A. dated
January 1, 2005, incorporated by reference to Exhibit 10.32 to
Amendment No. 2 to the Registration Statement on Form F-1, Registration
No. 333-122233, previously filed with the Securities and Exchange
Commission on May 10, 2005.
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10.33
|
Commercial
Lease Agreement between Gentium S.p.A. and Sirton Pharmaceuticals
S.p.A.
dated January 1, 2005, incorporated by reference to Exhibit 10.33 to
Amendment No. 2 to the Registration Statement on Form F-1, Registration
No. 333-122233, previously filed with the Securities and Exchange
Commission on May 10, 2005.
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10.34
|
Form
of indemnification agreement between Gentium S.p.A. and each officer
and
director, incorporated by reference to Exhibit 10.34 to Amendment
No. 2 to
the Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on May
10,
2005.
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10.35
|
Services
Agreement between MDS Pharma Services s.r.l. and Gentium S.p.A. dated
October 24, 2005, incorporated by reference to Exhibit 4.35 to the
Annual
Report on Form 20-F for the year ended December 31, 2005, previously
filed
with the Securities and Exchange Commission on May 30,
2006.
|
10.36
|
Financing
Contract between Banca Intesa Mediocredito S.p.A. and Gentium S.p.A.
dated
April 20, 2006, incorporated by reference to Exhibit 4.36.2 to the
Annual
Report on Form 20-F for the year ended December 31, 2005, previously
filed
with the Securities and Exchange Commission on May 30,
2006.
|
23.1
|
Consent
of Reconta Ernst & Young S.p.A. dated December 19,
2006.
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23.2
|
Consent
of Gianni, Origoni, Grippo & Partners (included in Exhibit
5.1).
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24.1
|
Power
of Attorney (included on the signature page).
*
|
GENTIUM,
S.p.A
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|
By:
/s/
Laura
Ferro
Dr.
Laura Ferro,
President
and Chief Executive Officer
(Principal
Executive Officer)
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Signature
|
|
Title(s)
|
|
Date
|
*
_____________________________
Dr.
Laura Ferro
|
|
President,
Chief Executive Officer and Director (principal executive
officer)
|
|
December
19, 2006
|
*
_____________________________
Gary
Gemignani
|
Executive
Vice-President, Chief Financial Officer and Authorized Representative
(principal financial officer)
|
December
19, 2006
|
||
*
_____________________________
Salvatore
Calabrese
|
Vice-President,
Finance and Secretary (controller)
|
December
19, 2006
|
||
*
_____________________________
Dr.
Kenneth Anderson
|
Director
|
|
December
19, 2006
|
|
*
_____________________________
Gigliola
Bertoglio
|
Director
|
December
19, 2006
|
||
*
_____________________________
Luca
Breveglieri
|
Director
|
December
19, 2006
|
||
*
_____________________________
Marco
Codella
|
Director
|
|
December
19, 2006
|
|
*
_____________________________
David
E. Kroin
|
Director
|
|
December
19, 2006
|
|
*
____________________________
Dr.
Lee M. Nadler
|
Director
|
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December
19, 2006
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Exhibit
Number
|
Description
of Documents
|
1.1
|
Underwriting
Agreement, dated June 16, 2005, between Gentium S.p.A. and Maxim
Group LLC
and I-Bankers Securities Inc., incorporated by reference to Exhibit
1.1 to Amendment No. 1 to the Registration Statement on Form F-1,
Registration No. 333-130796, previously filed with the Securities
and
Exchange Commission on January 26, 2006.
|
1.2
|
Form
of Representatives’ Purchase Option between Gentium S.p.A. and Maxim Group
LLC and I-Bankers Securities Inc., incorporated by reference to
Exhibit 1.2 to Amendment No. 5 to the Registration Statement on
Form F-1,
Registration No. 333-122233, previously filed with the Securities
and
Exchange Commission on June 9, 2005.
|
1.3
|
Form
of Lock-Up Agreement, incorporated by reference to Exhibit 1.3
to
Amendment No. 4 to the Registration Statement on Form F-1, Registration
No. 333-122233, previously filed with the Securities and Exchange
Commission on May 31, 2005.
|
3(i)
|
Articles
of Association of Gentium S.p.A., formerly known as Pharma Research
S.r.l.
dated November 11, 1993, incorporated by reference to Exhibit 3(i) to
the Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
3(ii)
|
Amended
and Restated Bylaws of Gentium S.p.A. dated April 28, 2006, incorporated
by reference to Exhibit 1(ii) to the Annual Report on Form 20-F
for the
year ended December 31, 2005, previously filed with the Securities
and
Exchange Commission on May 30, 2006.
|
4.2.1
|
Form
of Series A senior convertible promissory note, incorporated by
reference to Exhibit 4.2.1 to the Registration Statement on Form
F-1,
Registration No. 333-122233, previously filed with the Securities
and
Exchange Commission on January 24, 2005.
|
4.2.2
|
Form
of warrant, incorporated by reference to Exhibit 4.2.2 to the Registration
Statement on Form F-1, Registration No. 333-122233, previously
filed with
the Securities and Exchange Commission on January 24,
2005.
|
4.2.3
|
Pledge
Agreement between FinSirton S.p.A. (previously known as Finanziaria
Sirton
S.p.A.) and I-Bankers Securities Inc. as representative of the
holders of the Series A senior convertible promissory notes dated
October 15, 2004, incorporated by reference to Exhibit 4.2.3 to
Amendment No. 1 to the Registration Statement on Form F-1, Registration
No. 333-130796, previously filed with the Securities and Exchange
Commission on January 26, 2006.
|
4.2.4
|
Form
of Investors’ Rights Agreement between Gentium S.p.A. and holders of the
Series A senior convertible promissory notes and warrants dated
October 15, 2004, incorporated by reference to Exhibit 4.2.4 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
4.2.5
|
Form
of subscription agreement for Series A senior convertible promissory
note and warrant, incorporated by reference to Exhibit 4.2.5 to
Amendment
No. 1 to the Registration Statement on Form F-1, Registration No.
333-122233, previously filed with the Securities and Exchange Commission
on April 7, 2005.
|
4.2.6
|
Amendment
No. 1 to Gentium S.p.A. Series A Senior Convertible Promissory
Notes, Warrants, Subscription Agreements and Investor Rights Agreements
among Gentium S.p.A. and the other parties thereto dated May 27,
2005, incorporated by reference to Exhibit 4.2.6 to Amendment No.
4 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
May 31,
2005.
|
4.3
|
Investors’
Rights Agreement by and among Gentium S.p.A., Alexandra Global
Master
Fund Ltd. and Generation Capital Associates made as of
January 10, 2005, incorporated by reference to Exhibit 4.3 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
4.4
|
Intentionally
omitted.
|
4.5
|
Investors’
Rights Agreement by and among Gentium S.p.A. and Sigma Tau Finanziaria
S.p.A. made as of April 4, 2005, incorporated by reference to Exhibit
4.5 to Amendment No. 1 to the Registration Statement on Form F-1,
Registration No. 333-122233, previously filed with the Securities
and
Exchange Commission on April 7, 2005.
|
4.6
|
Form
of Deposit Agreement among Gentium S.p.A., The Bank of New York
and the
owners and beneficial owners from time to time of American Depositary
Receipts (including as an exhibit the form of American Depositary
Receipt), incorporated by reference to Exhibit 4.6 to Amendment
No. 5 to
the Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
June 9,
2005.
|
4.7
|
Form
of American Depositary Receipt (see Exhibit 4.6).
|
4.8.1
|
Securities
Subscription Agreement among Gentium S.p.A. and the other parties
thereto
dated as of October 3, 2005, incorporated by reference to Exhibit
4.8.1 to
the Registration Statement on Form F-1, Registration No. 333-130796,
previously filed with the Securities and Exchange Commission on
December
30, 2005.
|
4.8.2
|
Form
of American Depositary Shares Purchase Warrant by Gentium S.p.A.
dated
October 14, 2005, incorporated by reference to Exhibit 4.8.2 to
the
Registration Statement on Form F-1, Registration No. 333-130796,
previously filed with the Securities and Exchange Commission on
December
30, 2005.
|
4.8.3
|
Registration
Rights Agreement among Gentium S.p.A. and the other parties thereto
made
and entered into as of October 14, 2005, incorporated by reference
to
Exhibit 4.8.3 to the Registration Statement on Form F-1, Registration
No.
333-130796, previously filed with the Securities and Exchange Commission
on December 30, 2005.
|
4.8.4
|
Escrow
Agreement between Gentium S.p.A. and The Bank of New York dated
as of
October 14, 2005, incorporated by reference to Exhibit 4.8.4 to
the
Registration Statement on Form F-1, Registration No. 333-130796,
previously filed with the Securities and Exchange Commission on
December
30, 2005.
|
4.9.1
|
Securities
Subscription Agreement among Gentium S.p.A. and the other parties
thereto
dated as of May 31, 2006, incorporated by reference to Exhibit
4.9.1 to
the Registration Statement on Form F-3, Registration No. 333-135622,
previously filed with the Securities and Exchange Commission on
July 6,
2006.
|
4.9.2
|
Form
of American Depositary Shares Purchase Warrant by Gentium S.p.A.
dated
June 6, 2006, incorporated by reference to Exhibit 4.9.2 to the
Registration Statement on Form F-3, Registration No. 333-135622,
previously filed with the Securities and Exchange Commission on
July 6,
2006.
|
4.9.3
|
Form
of Ordinary Share Warrant by Gentium S.p.A. dated June 6, 2006,
incorporated by reference to Exhibit 4.9.3 to the Registration
Statement
on Form F-3, Registration No. 333-135622, previously filed with
the
Securities and Exchange Commission on July 6, 2006.
|
4.9.4
|
Registration
Rights Agreement among Gentium S.p.A. and the other parties thereto
made
and entered into as of June 6, 2006, incorporated by reference
to Exhibit
4.9.4 to the Registration Statement on Form F-3, Registration No.
333-135622, previously filed with the Securities and Exchange Commission
on July 6, 2006.
|
5.1
|
Opinion
of Gianni, Origoni, Grippo & Partners as to the legality of the
ordinary shares underlying the American Depositary Shares being
offered by
the prospectus forming a part of this Registration
Statement.
|
10.1
|
Amended
and Restated 2004 Equity Incentive Plan, incorporated by reference
to
Exhibit 10.1 to the Registration Statement on Form S-8, Registration
No.
333-137534, previously filed with the Securities and Exchange Commission
on September 22, 2006.
|
10.2
|
Amended
and Restated Nonstatutory Share Option Plan and Agreement dated
March 23,
2006, incorporated by reference to Exhibit 4.2 to the Annual Report
on
Form 20-F for the year ended December 31, 2005, previously filed
with the
Securities and Exchange Commission on May 30, 2006.
|
10.3
|
Loan
Agreement between Banca Nazionale del Lavoro S.p.A. and Gentium
S.p.A.,
successor in interest to Crinos Industria Farmacobiologica S.p.A.,
dated
November 20, 1996, incorporated by reference to Exhibit 10.3 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
10.4
|
Loan
Agreement between Banca Nazionale del Lavoro S.p.A. and Gentium
S.p.A.,
successor in interest to Crinos Industria Farmacobiologica S.p.A.,
dated
May 27, 1999, incorporated by reference to Exhibit 10.4 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
10.5
|
Deed
of Agreement of Assumption of Debts among Sirton Pharmaceuticals
S.p.A.,
Gentium S.p.A. and Banca Nazionale del Lavoro S.p.A. dated
February 14, 2003, regarding Loan Agreement between Banca Nazionale
del Lavoro S.p.A. and Gentium S.p.A., successor in interest to
Crinos
Industria Farmacobiologica S.p.A., dated November 20, 1996, and Loan
Agreement between Banca Nazionale del Lavoro S.p.A. and Gentium
S.p.A.,
successor in interest to Crinos Industria Farmacobiologica S.p.A.,
dated
May 27, 1999, incorporated by reference to Exhibit 10.5 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
10.6
|
Ministry
for Universities, Scientific and Technological Research Loan granted
to
Gentium S.p.A., successor in interest to Crinos Industria Farmacobiologica
S.p.A., by Sanpaolo Imi S.p.A., dated September 27, 2000,
incorporated by reference to Exhibit 10.6 to the Registration Statement
on
Form F-1, Registration No. 333-122233, previously filed with the
Securities and Exchange Commission on January 24, 2005.
|
10.7.1
|
Loan
Agreement between Banca Nazionale del Lavoro S.p.A. and Gentium
S.p.A.
dated July 20, 2004, incorporated by reference to Exhibit 10.7 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
10.7.2
|
Deed
of Pledge by Gentium S.p.A. in favor of Banca Nazionale del Lavoro
S.p.A.
dated May 16, 2006, incorporated by reference to Exhibit 4.7.2
to the
Annual Report on Form 20-F for the year ended December 31, 2005,
previously filed with the Securities and Exchange Commission on
May 30,
2006.
|
10.7.3
|
Loan
Agreement between Banca Nazionale del Lavoro S.p.A. and Gentium
S.p.A.
dated June 14, 2006, incorporated by reference to Exhibit 10.7.3
to the
Registration Statement on Form F-3, Registration No. 333-135622,
previously filed with the Securities and Exchange Commission on
July 6,
2006.
|
10.8
|
Loan
Agreement between Sirton Pharmaceuticals S.p.A. and Gentium S.p.A.
dated
March 2004, incorporated by reference to Exhibit 10.8 to the Registration
Statement on Form F-1, Registration No. 333-122233, previously
filed with
the Securities and Exchange Commission on January 24,
2005.
|
10.9
|
Loan
Agreement between Sirton Pharmaceuticals S.p.A. and Gentium S.p.A.
dated
May 2004, incorporated by reference to Exhibit 10.9 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
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10.10
|
Loan
Agreement between Sirton Pharmaceuticals S.p.A. and Gentium S.p.A.
dated
June 2004, incorporated by reference to Exhibit 10.10 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
10.11
|
Loan
Agreement between Sirton Pharmaceuticals S.p.A. and Gentium S.p.A.
dated
July 2004, incorporated by reference to Exhibit 10.11 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
10.12.1
|
Clinical
Trial Agreement between Gentium S.p.A., successor in interest to
Crinos
Industria Farmacobiologica S.p.A., and Dana-Faber/Partners Cancer
Care, Inc. dated December 27, 1999, incorporated by reference to
Exhibit 10.12.1 to the Registration Statement on Form F-1, Registration
No. 333-122233, previously filed with the Securities and Exchange
Commission on January 24, 2005.
|
10.12.2
|
Amendment
No. 1 to Clinical Trial Agreement between Gentium S.p.A. and
Dana-Farber/Partners Cancer Care, Inc. dated October 19, 2000,
incorporated by reference to Exhibit 10.12.2 to the Registration
Statement
on Form F-1, Registration No. 333-122233, previously filed with
the
Securities and Exchange Commission on January 24, 2005.
|
10.12.3
|
Amendment
No. 2 to Clinical Trial Agreement between Gentium S.p.A. and
Dana-Farber/Partners Cancer Care, Inc. dated January 28, 2004,
incorporated by reference to Exhibit 10.12.3 to the Registration
Statement
on Form F-1, Registration No. 333-122233, previously filed with
the
Securities and Exchange Commission on January 24, 2005.
|
10.13
|
Trial
Agreement between the European Blood and Marrow Transplantation
Group and
Gentium S.p.A. dated February 26, 2004, incorporated by reference to
Exhibit 10.13 to the Registration Statement on Form F-1, Registration
No.
333-122233, previously filed with the Securities and Exchange Commission
on January 24, 2005.
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10.14.1
|
Research
Agreement between Gentium S.p.A., successor in interest to Crinos
Industria Farmacobiologica S.p.A., and Consorzio Mario Negri Sud
dated
June 14, 2000, incorporated by reference to Exhibit 10.14.1 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
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10.14.2
|
Letter
from Gentium S.p.A. to Consorzio Mario Negri Sud dated February 23,
2004 extending Research Agreement between Gentium S.p.A., successor
in
interest to Crinos Industria Farmacobiologica S.p.A., and Consorzio
Mario
Negri Sud dated June 14, 2000, incorporated by reference to Exhibit
10.14.2 to the Registration Statement on Form F-1, Registration
No.
333-122233, previously filed with the Securities and Exchange Commission
on January 24, 2005.
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10.15
|
License
and Supply Agreement by and between Gentium S.p.A. and Sigma-Tau
Pharmaceuticals, Inc. (assignee of Sigma Tau Industrie Farmaceutiche
Riunite S.p.A.) dated December 7, 2001, incorporated by reference to
Exhibit 10.15 to the Registration Statement on Form F-1, Registration
No.
333-122233, previously filed with the Securities and Exchange Commission
on January 24, 2005.
|
10.16
|
Umbrella
Agreement among Sirton Pharmaceuticals S.p.A. (formerly known as
Crinos
Industria Farmacobiologica S.p.A.), Gentium S.p.A., Crinos S.p.A.
and SFS
Stada Financial Services Ltd dated May 17, 2002, incorporated by
reference to Exhibit 10.16 to the Registration Statement on Form
F-1,
Registration No. 333-122233, previously filed with the Securities
and
Exchange Commission on January 24, 2005.
|
10.17
|
License
Agreement between Crinos S.p.A. and Gentium S.p.A. dated July 15,
2004, incorporated by reference to Exhibit 10.17 to the Registration
Statement on Form F-1, Registration No. 333-122233, previously
filed with
the Securities and Exchange Commission on January 24,
2005.
|
10.18
|
Purchase
Agreement by and among Sirton Pharmaceuticals S.p.A., Gentium S.p.A.
and
Axcan Pharma Inc. dated October 9, 2002, incorporated by
reference to Exhibit 10.18 to the Registration Statement on Form
F-1,
Registration No. 333-122233, previously filed with the Securities
and
Exchange Commission on January 24, 2005.
|
10.19
|
Agreement
between Sirton Pharmaceuticals S.p.A. and Gentium S.p.A. dated
October 9, 2002, regarding the Purchase Agreement with Axcan
Pharma Inc., incorporated by reference to Exhibit 10.19 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
10.20
|
License
and Supply Agreement between Gentium S.p.A. and Abbott S.p.A. dated
June 11, 2002, incorporated by reference to Exhibit 10.20 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
10.21
|
Supply
Agreement between Gentium S.p.A. and La.bu.nat. S.r.l. dated
January 12, 2004, incorporated by reference to Exhibit 10.21 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
10.22
|
Supply
Agreement between Gentium S.p.A. and La.bu.nat. S.r.l. dated
January 12, 2004, incorporated by reference to Exhibit 10.22 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
10.23
|
Supply
Agreement between Gentium S.p.A. and Samil Pharm. Co. Ltd. dated
November 11, 2003, incorporated by reference to Exhibit 10.23 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
10.24.1
|
Active
Pharmaceutical Ingredient Agreement between Sirton Pharmaceuticals
S.p.A.
and Gentium S.p.A. dated January 2, 2004, incorporated by reference
to Exhibit 10.24 to the Registration Statement on Form F-1, Registration
No. 333-122233, previously filed with the Securities and Exchange
Commission on January 24, 2005.
|
10.24.2
|
Contract
to Supply Active Ingredients between Sirton Pharmaceuticals S.p.A.
and
Gentium S.p.A. dated January 2, 2006, incorporated by reference to
Exhibit 4.24.2 to the Annual Report on Form 20-F for the year ended
December 31, 2005, previously filed with the Securities and Exchange
Commission on May 30, 2006.
|
10.25.1
|
Agreement
for the Supply of Services between FinSirton S.p.A. and Gentium
S.p.A.
dated January 2, 2004, incorporated by reference to Exhibit 10.25 to
the Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
10.25.2
|
Service
Agreement between FinSirton S.p.A. and Gentium S.p.A. dated
January 2, 2006, incorporated by reference to Exhibit 10.25.2 to the
Annual Report on Form 20-F for the year ended December 31, 2005,
previously filed with the Securities and Exchange Commission on
May 30,
2006.
|
10.26.1
|
Agreement
for the Supply of Services between Sirton Pharmaceuticals S.p.A.
and
Gentium S.p.A. dated January 2, 2004, incorporated by reference to
Exhibit 10.26 to the Registration Statement on Form F-1, Registration
No.
333-122233, previously filed with the Securities and Exchange Commission
on January 24, 2005.
|
10.26.2
|
Service
Agreement between Sirton Pharmaceuticals S.p.A. and Gentium S.p.A.
dated
January 2, 2006, incorporated by reference to Exhibit 10.26.2 to the
Annual Report on Form 20-F for the year ended December 31, 2005,
previously filed with the Securities and Exchange Commission on
May 30,
2006.
|
10.27
|
Service
Agreement between Sirton Pharmaceuticals S.p.A. and Gentium S.p.A.
dated
January 2, 2004, incorporated by reference to Exhibit 10.27 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
January
24, 2005.
|
10.28
|
Lease
Agreement between Sirton Pharmaceuticals S.p.A. (formerly known
as Crinos
Industria Farmacobiologica S.p.A.) and Gentium S.p.A. (formerly
known as
Pharma Research S.r.L.) dated January 2, 2001, incorporated by
reference to Exhibit 10.28 to the Registration Statement on Form
F-1,
Registration No. 333-122233, previously filed with the Securities
and
Exchange Commission on January 24, 2005.
|
10.29
|
8%
Promissory Note in the amount of €106,000 issued by Gentium S.p.A. to
Alexandra Global Master Fund Ltd. dated March 29, 2005,
incorporated by reference to Exhibit 10.29 to Amendment No. 1 to
the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
April 7,
2005.
|
10.30
|
General
Consulting Agreement between Gentium S.p.A. and Bradstreet Clinical
Research & Associates, Inc., dated March 19, 2004,
incorporated by reference to Exhibit 10.30 to Amendment No. 1 to
the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
April 7,
2005.
|
10.31
|
Consulting
Agreement between Gentium S.p.A. and KKS-UKT, GmbH, dated April 20,
2004, incorporated by reference to Exhibit 10.31 to Amendment No.
1 to the
Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
April 7,
2005.
|
10.32
|
Commercial
Lease Agreement between Gentium S.p.A. and FinSirton S.p.A. dated
January 1, 2005, incorporated by reference to Exhibit 10.32 to
Amendment No. 2 to the Registration Statement on Form F-1, Registration
No. 333-122233, previously filed with the Securities and Exchange
Commission on May 10, 2005.
|
10.33
|
Commercial
Lease Agreement between Gentium S.p.A. and Sirton Pharmaceuticals
S.p.A.
dated January 1, 2005, incorporated by reference to Exhibit 10.33 to
Amendment No. 2 to the Registration Statement on Form F-1, Registration
No. 333-122233, previously filed with the Securities and Exchange
Commission on May 10, 2005.
|
10.34
|
Form
of indemnification agreement between Gentium S.p.A. and each officer
and
director, incorporated by reference to Exhibit 10.34 to Amendment
No. 2 to
the Registration Statement on Form F-1, Registration No. 333-122233,
previously filed with the Securities and Exchange Commission on
May 10,
2005.
|
10.35
|
Services
Agreement between MDS Pharma Services s.r.l. and Gentium S.p.A.
dated
October 24, 2005, incorporated by reference to Exhibit 4.35 to
the Annual
Report on Form 20-F for the year ended December 31, 2005, previously
filed
with the Securities and Exchange Commission on May 30,
2006.
|
10.36
|
Financing
Contract between Banca Intesa Mediocredito S.p.A. and Gentium S.p.A.
dated
April 20, 2006, incorporated by reference to Exhibit 4.36.2 to
the Annual
Report on Form 20-F for the year ended December 31, 2005, previously
filed
with the Securities and Exchange Commission on May 30,
2006.
|
23.1
|
Consent
of Reconta Ernst & Young S.p.A. dated December 19,
2006.
|
23.2
|
Consent
of Gianni, Origoni, Grippo & Partners (included in Exhibit
5.1).
|
24.1
|
Power
of Attorney (included on the signature page).
*
|