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Exhibit 4.2.5    
    

SUBSCRIPTION AGREEMENT  

        SUBSCRIPTION AGREEMENT (this "Agreement") made as of the date set forth on the signature page hereof between
Gentium S.p.A., a joint stock company (societá per azioni) incorporated and organized under the laws of the Republic of Italy having a
place of business at Piazza XX Settembre, n. 2, 22079 Villa Guardia, Como, Italy (the "Company"), and the undersigned (the  "Subscriber"). 

W I T N E S S E T H:  

        WHEREAS, the Company desires to sell up to eight million and ten thousand dollars (the "Maximum Amount") of
investment units of the Company (the "Units"), with each Unit consisting of: (i) a Series A Senior Secured Convertible Promissory Note
(the "Note") and (ii) a warrant to purchase shares of common stock, par value €1 per share ("Common Stock") of the Company, at an
exercise price set forth in the warrant, (the "Warrant"); 

        WHEREAS,
each Note shall bear interest at a rate of 7% until March 31, 2005, 10% from April 1, 2004 until the Maturity Date, as defined in the Note, and Libor, as defined
in the Note, plus 12% thereafter, and, shall be convertible at the option of the holder thereof into shares of Common Stock prior to the stated redemption date of such Note, all as more fully set
forth in the Form of Note attached hereto as Exhibit A; 

        WHEREAS,
Finanziaria Sirton S.p.A., the sole shareholder of the Company ("Finanziaria Sirton"), will enter into a Pledge Agreement with a
representative of the holders of the Notes (the "Pledge Agreement"), pursuant to which Finanziaria Sirton will secure the performance of all of the
obligations of the Company under the Notes through a pledge to the holders of the Notes of up to one million six hundred fifty thousand (1,650,000) shares constituting thirty-three percent (33%) of
the shares of outstanding Common Stock of the Company (the "Pledged Shares"), with the actual number of Pledged Shares to depend upon the principal
amount of Notes sold in the Offering (as defined below) and to amount to twenty thousand five hundred ninety-nine (20,599.00) shares per one hundred thousand dollars ($100,000) of Notes
sold; 

        WHEREAS,
the Warrants will be exercisable into shares of Common Stock (the "Warrant Shares"), on the terms set forth in the Form of
Warrant attached hereto as Exhibit B (the Warrant Shares, together with the Conversion Shares are sometimes hereinafter referred to as the  "Shares" and the Units, the Notes, the Warrants and the
Shares are sometimes hereinafter referred to as the  "Securities"); 

        WHEREAS,
the Company is offering (the "Offering") the Units to a limited number of "accredited investors" (as that term is defined by
Rule 501(a) of Regulation D of the Securities Act of 1933, as amended (the "Act")); 

        WHEREAS,
each Subscriber will also enter into the Investors' Rights Agreement, dated the applicable Closing Date (as defined below) with the Company, substantially in the form attached
thereto as Exhibit C (the "Investors' Rights Agreement"); and 

        WHEREAS,
the Subscriber desires to purchase that number of Units set forth on the signature page hereof on the terms and conditions hereinafter set forth. 

        NOW,
THEREFORE, in consideration of the promises and the mutual representations and covenants hereinafter set forth, the parties hereto do hereby agree as follows: 

 
 

ARTICLE I.
  SUBSCRIPTION FOR UNITS AND REPRESENTATIONS BY SUBSCRIBER    
    

        1.1.  Subject
to the terms and conditions hereinafter set forth, Subscriber hereby subscribes for and agrees to purchase from the Company such number of Units, and the
Company agrees to sell such 

 

number
of Units to Subscriber, as is set forth upon the signature page hereof against payment made by personal or business check, or money order made payable to "Wells Fargo Bank" (the  "Escrow Agent"), F/B/O
[Subscriber]," at the address set forth in Section 3.2, contemporaneously with the execution and
delivery of this Agreement. Subscribers may also pay by wire transfer of immediately available funds to: 

Wells
Fargo Bank, NA

San Francisco, CA

ABA # 121000248

Credit: Corporate Trust Clearing Acct #0001038377

FCC: Gentium S.p.A. Subscription Esc

Attn: Denise Smith at 214-777-4073

[                             ]

[Subscriber] 

        The
Escrow Agent shall accept and hold in escrow all such funds so received by it in a special account established by the Company pursuant to an escrow agreement attached hereto as
Exhibit A (the "Escrow Agreement") between the Company and the Escrow Agent. The Escrow Agent shall release all funds received from Subscribers
under the terms and conditions set forth in the Escrow Agreement. The Notes and the Warrants (in the form attached hereto), will be delivered by the Company within 10 days following the
applicable Closing (as defined in Section 3.1 below) of the Offering as set forth in Article III hereof. 

        1.2.  The
Subscriber recognizes that the purchase of the Securities involves a high degree of risk including, but not limited to, the following: (i) an investment in
the Company is highly speculative, and only investors who can afford the loss of their entire investment should consider investing in the Company and the Securities; (ii) the Subscriber may not
be able to liquidate his, her or its investment; (iii) transferability of the Securities is extremely limited; (iv) in the event of a disposition of the Securities, the Subscriber could
sustain the loss of his, her or its entire investment; (v) the risks described in the Private Placement Memorandum (as defined below); and (vi) the Company has not paid any dividends on
its Common Stock since inception and does not anticipate the payment of dividends in the foreseeable future. 

        1.3.  The
Subscriber represents that the Subscriber is an "accredited investor" as such term is defined in Rule 501 of Regulation D promulgated under the Act,
as indicated by the Subscriber's responses to the questions contained in ARTICLE VI hereof. If the Subscriber is a natural person, the Subscriber
has reached the age of majority in the state or other jurisdiction in which the Subscriber resides. In addition, the Subscriber represents that such Subscriber has adequate means of providing for the
Subscriber's current financial needs and contingencies, is able to bear the substantial economic risks of an investment in the Securities for an indefinite period of time, has no need for liquidity in
such investment and, at the present time, could afford a complete loss of such investment. In addition, the Subscriber represents that on each date that the Subscriber exercises any portion of the
Warrant or, if applicable, converts any portion of the Note, the Subscriber will be an "accredited investor." 

        1.4.  The
Subscriber hereby acknowledges and represents that (i) the Subscriber has prior investment experience, including investment in securities which are
non-listed, unregistered and/or not traded on the Nasdaq National or SmallCap Market, a national stock exchange or on the National Association of Securities Dealers, Inc. (the  "NASD") automated
quotation system for actively traded stocks ("Nasdaq"), or the Subscriber has employed
the services of an investment advisor, attorney and/or accountant to read all of the documents furnished or made available by the Company to the Subscriber and to all other prospective investors in
the Units and to evaluate the merits and risks of such an investment on the Subscriber's behalf; (ii) the Subscriber recognizes the highly speculative nature of this investment; and
(iii) the Subscriber is able to bear the economic risk which the Subscriber hereby assumes. 

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        1.5.  The
Subscriber hereby acknowledges that it has been furnished with, or has had an opportunity to acquire and carefully review, the Confidential Private Placement
Memorandum describing the terms of the Offering, dated September 3, 2004, as supplemented by the Amendments, dated October 1, 2004 and October 8, 2004 (together, the  "Private Placement
Memorandum"). The Subscriber further represents that the Subscriber has been furnished by the Company during the course of this
transaction with all information regarding the Company which the Subscriber, its investment advisor, attorney and/or accountant has requested or desired to know, has been afforded the opportunity to
ask questions of and receive answers from duly authorized officers or other representatives of the Company concerning the terms and conditions of the Offering, and has received any additional
information which the Subscriber has requested. This Subscription Agreement, including the Note, the Warrant, the Investors' Rights Agreement and the Private Placement Memorandum are collectively
referred to herein as the "Offering Documents."

        1.6.  (a)
The Subscriber has relied solely upon the information provided by the Company in making the decision to invest in the Units. The Subscriber is familiar with and
understands the terms of the Offering, including the rights to which the Subscriber is entitled under this Agreement, the Note, the Warrant, the Investors' Rights Agreement. The Subscriber has been
furnished with and has carefully read the Offering Documents. In evaluating the suitability of an investment in the Company, the Subscriber has not relied upon any representation or other information
(whether oral or written) from the Company, or any agent, employee or affiliate of the Company or any other third party other than as set forth in the Offering Documents and the results of
Subscriber's own independent investigation. To the extent necessary, the Subscriber has retained, at his/its sole expense, and relied upon appropriate professional advice regarding the investment, tax
and legal merits and consequences of this Agreement and the purchase of the Units hereunder. 

        (b)   The
Subscriber represents that no Securities were offered or sold to it by means of any form of general solicitation or general advertising, and in connection therewith
the Subscriber did not: (A) receive or review any advertisement, article, notice or other communication published in a newspaper or magazine or similar media or broadcast over television or
radio whether closed circuit, or generally available; or (B) attend any seminar meeting or industry investor conference whose attendees were invited by any general solicitation or general
advertising. 

        1.7.  The
Subscriber hereby represents that the Subscriber, either by reason of the Subscriber's business or financial experience or the business or financial experience of
the Subscriber's professional advisors (who are unaffiliated with, and who are not compensated by, the Company or any affiliate or selling agent of the Company, including the Maxim Group LLC and
I-Bankers Securities, Inc. (collectively, the "Placement Agents"), or any selected dealers, directly or indirectly, has the capacity
to protect the Subscriber's own interests in connection with the transaction contemplated hereby. The Subscriber acknowledges that the Placement Agents are acting as placement agents for the Units
being offered hereby and will be compensated by the Company for acting in such capacity. The Subscriber further acknowledges that the Placement Agents have acted solely as agents of the Company in
connection with the offering of the Units by the Company, that the information and data provided to the Subscriber in connection with the transactions contemplated hereby have not been subjected to
independent verification by the Placement Agents, and that the Placement Agents make no representation or warranty with respect to the accuracy or completeness of such information, data or other
related disclosure material. 

        1.8.  The
Subscriber hereby acknowledges that the Offering has not been reviewed by the United States Securities and Exchange Commission (the  "SEC" or the "Commission") or any state securities regulatory authority or other governmental body or
agency, since the Offering is intended to be exempt from the registration requirements of Section 5 of the Act pursuant to Regulation D, and/or the provisions of Regulation S,
promulgated under the Act. The Subscriber shall not sell or otherwise transfer the Securities unless they are registered under the Act or unless an exemption from such 

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registration
is available. The Subscriber understands that if required by the laws or regulations or any applicable jurisdictions, the Offering contemplated hereby will be submitted to the appropriate
authorities of such state(s) for registration of exemption therefrom. 

        1.9.  The
Subscriber understands that the Securities have not been registered under the Act by reason of a claimed exemption under the provisions of the Act which depends, in
part, upon the Subscriber's investment intention. In this connection, the Subscriber hereby represents that the Subscriber is purchasing the Securities for the Subscriber's own account for investment
purposes only and not with a view toward the resale or distribution to others and has no contract, undertaking, agreement or other arrangement, in existence or contemplated, to sell, pledge, assign or
otherwise transfer the Securities to any other person. The Subscriber, if an entity, also represents that it was not formed for the purpose of purchasing the Securities. 

        1.10. The
Subscriber understands that Rule 144 promulgated under the Act ("Rule 144") requires, among other
conditions, a one-year holding period prior to the resale (in limited amounts) of securities acquired in a non-public offering without having to satisfy the registration
requirements under the Act. The Subscriber understands and hereby acknowledges that the Company is under no obligation to register any of the Securities under the Act or any state securities or "blue
sky" laws or assist the Subscriber in obtaining an exemption from various registration requirements, other than as set forth in the Investors' Rights Agreement. The Subscriber agrees to hold the
Company and its directors, officers, employees, controlling persons and agents (including the Placement Agents and their officers, directors, employees, counsel, controlling persons and agents) and
their respective heirs, representatives, successors and assigns harmless and to indemnify them against all liabilities, costs and expenses incurred by them as a result of (i) any
misrepresentation made by the Subscriber contained in this Agreement (including the Confidential Investor Questionnaire contained in ARTICLE VI herein),
(ii) any sale or distribution by the Subscriber in violation of the Act or any applicable state securities or "blue sky" laws or (iii) any untrue statement of a material fact made by the
Subscriber and contained herein. 

        1.11. The
Subscriber consents to the placement of a legend on any certificate or other document evidencing the Securities substantially as set forth below, that such
Securities have not been registered under the Act or any state securities or "blue sky" laws and setting forth or referring to the restrictions on transferability and sale thereof contained in this
Agreement. The Subscriber is aware that the Company will make a notation in its appropriate records with respect to the restrictions on the transferability of the Securities. 

THE
SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE "ACT"), OR ANY STATE SECURITIES LAWS AND
NEITHER SUCH SECURITIES NOR ANY INTEREST THEREIN MAY BE OFFERED, SOLD, PLEDGED, ASSIGNED OR OTHERWISE TRANSFERRED UNLESS (1) A REGISTRATION STATEMENT WITH RESPECT THERETO IS EFFECTIVE UNDER THE
ACT AND ANY APPLICABLE STATE SECURITIES LAWS, OR (2) ISSUER RECEIVES AN OPINION OF COUNSEL TO THE HOLDER OF SUCH SECURITIES, WHICH COUNSEL AND OPINION ARE REASONABLY SATISFACTORY TO ISSUER,
THAT SUCH SECURITIES MAY BE OFFERED, SOLD, PLEDGED, ASSIGNED OR TRANSFERRED IN THE MANNER CONTEMPLATED WITHOUT AN EFFECTIVE REGISTRATION STATEMENT UNDER THE ACT OR APPLICABLE STATE SECURITIES LAWS. 

        1.12. The
Subscriber agrees to supply the Company, within five (5) days after the Subscriber receives the request therefor from the Company, with such additional
information concerning the Subscriber as the Company deems necessary or advisable. 

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        1.13. The
Subscriber hereby represents that the address of the Subscriber furnished by Subscriber on the signature page hereof is the Subscriber's principal residence if
Subscriber is an individual or its principal business address if it is a corporation or other entity. 

        1.14. The
Subscriber represents that the Subscriber has full power and authority (corporate, statutory and otherwise) to execute, deliver, and perform this Agreement and to
purchase the Securities. This Agreement constitutes the legal, valid and binding obligation of the Subscriber, enforceable against the Subscriber in accordance with its terms. 

        1.15. If
the Subscriber is a corporation, partnership, limited liability company, trust, employee benefit plan, individual retirement account, Keogh Plan, or other entity
(a) it is authorized and qualified to become an investor in the Company and the person signing this Agreement on behalf of such entity has been duly authorized by such entity to do so and
(b) it is duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization. 

        1.16. The
Subscriber acknowledges that if he or she is a Registered Representative of an NASD member firm, he or she must give such firm the notice required by the NASD
Rules of Fair Practice, receipt of which must be acknowledged by such firm in Section 6.4 below. 

        1.17. Omitted.

        1.18. The
Subscriber understands, acknowledges and agrees with the Company that this subscription (the "Subscription") may be
rejected, in whole or in part, by the Company, in the sole and absolute discretion of the Company, at any time before any Closing Date, as defined in Section 3.1 below, notwithstanding prior
receipt by the Subscriber of notice of acceptance of the Subscriber's Subscription. 

        1.19. The
Subscriber understands, acknowledges and agrees with the Company that, except as otherwise set forth herein, the subscription hereunder is irrevocable by the
Subscriber, that, except as required by law, the Subscriber is not entitled to cancel, terminate or revoke this Agreement or any agreements of the Subscriber hereunder and that this Agreement and such
other agreements shall survive the death or disability of the Subscriber and shall be binding upon and inure to the benefit of the parties and their heirs, executors, administrators, successors, legal
representatives and permitted assigns. If the Subscriber is more than one person, the obligations of the Subscriber hereunder shall be joint and several and the agreements, representations, warranties
and acknowledgments herein contained shall be deemed to be made by and be binding upon each such person and his/her heirs, executors, administrators, successors, legal representatives and permitted
assigns. 

        1.20. The
Subscriber understands, acknowledges and agrees with the Company that, the Offering is intended to be exempt from registration under the Securities Act by virtue
of Section 4(2) of the Securities Act and the provisions of Regulation D thereunder, and/or the provisions of Regulation S which is in part dependent upon the truth, completeness
and accuracy of the statements made by the Subscriber. 

        1.21. The
Subscriber understands, acknowledges and agrees with the Company that, there can be no assurance that the Subscriber will be able to sell or dispose of the
Securities. It is understood that in order not to jeopardize the Offering's exempt status under Section 4(2) of the Securities Act and Regulation D, as well as Regulation S, any
transferee may, at a minimum, be required to fulfill the investor suitability requirements thereunder. 

        1.22. The
Subscriber understands that all information regarding the Offering is confidential and represents that it will not be used for any purpose other than in connection
with his or her consideration of a purchase of the Units and agrees to treat it in a confidential manner. 

        1.23. The
Subscriber acknowledges that the information contained in the Offering Documents or otherwise made available to the Subscriber is confidential and
non-public and agrees that all such information shall be kept in confidence by the Subscriber and neither used by the Subscriber for the 

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Subscriber's
personal benefit (other than in connection with this Subscription) nor disclosed to any third party for any reason, notwithstanding that a Subscriber's subscription may not be accepted by
the Company; provided, however, that this obligation shall not apply to any such information that (i) is part of the public knowledge or literature and readily accessible at the date hereof,
(ii) becomes part of the public knowledge or literature and readily accessible by publication (except as a result of a breach of this provision) or (iii) is received from third parties
(except third parties who disclose such information in violation of any confidentiality agreements or obligations, including, without limitation, any subscription or other similar agreement entered
into with the Company). 

        1.24. If
the Subscriber is purchasing the Securities in a fiduciary capacity for another person or entity, including without limitation a corporation, partnership, trust or
any other entity, the Subscriber has been duly authorized and empowered to execute this Agreement and all other subscription documents, and such other person fulfills all the requirements for purchase
of the shares as such requirements are set forth herein, concurs in the purchase of the Securities and agrees to be bound by the obligations, representations, warranties and covenants contained
herein. Upon request of the Company, the Subscriber will provide true, complete and current copies of all relevant documents creating the Subscriber, authorizing its investment in the Company and/or
evidencing the satisfaction of the foregoing. 

        1.25. No
authorization, approval, consent or license of any person is required to be obtained for the purchase of the Securities by the Subscriber, other than as have been
obtained and are in full force and effect. The execution and delivery of this Agreement does not, and the consummation of the transactions contemplated hereby will not, result in any violation of or
constitute a default under any material agreement or other instrument to which the Subscriber is a party or by which the Subscriber or any of its properties are bound, or to the best of the
Subscriber's knowledge, any permit, franchise, judgment, order, decree, statute, rule or regulation to which the Subscriber or any of its businesses or properties is subject. 

        1.26. The
representations, warranties and agreements of the Subscriber contained herein and in any other writing delivered in connection with the transactions contemplated
hereby shall be true and correct in all respects on and as of the Closing Date of the sale of the Securities to the Subscriber as if made on and as of such date and shall survive the execution and
delivery of this Agreement and the purchase of the Securities. 

        1.27. The
Subscriber acknowledges that the Placement Agents (including any of their members, managers, employees, agents or representatives) have not made any
representations or warranties to the Subscriber concerning the Company and its subsidiaries and their respective businesses, condition (financial or otherwise) or prospects. 

        1.28. The
Placement Agents shall be entitled to rely upon the representations, warranties and covenants of the Subscriber set forth in this Agreement. 

        1.29. The
Subscriber understands that (i) the Offering is not contingent upon the sale of any minimum number of Units, and the Company may close on the Subscriber's
subscription upon receipt of a properly executed copy of this Agreement from the Subscriber and the purchase price for the number of Units being purchased by the Subscriber and (ii) that the
Company is under no obligation to, and there can be no assurance that, the Company will receive or accept subscriptions for the Maximum Amount (or any other amount). 

        1.30. The
Subscriber agrees to the terms and conditions set forth in the Pledge Agreement, and hereby acknowledges and agrees to the appointment of I-Bankers
Securities, Inc. as Noteholders' Representative (as the term is defined in the Pledge Agreement). 

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ARTICLE II.
  REPRESENTATIONS BY AND COVENANTS OF THE COMPANY    
    

        The Company hereby represents and warrants to the Subscriber that: 

        2.1.    Organization, Good Standing and Qualification.    The Company is a joint stock company duly organized, validly
existing and in good standing under the laws of the Republic of Italy and has full corporate power and authority to conduct its business as currently conducted. The Company is duly qualified as a
foreign corporation to do business and is in good standing in every jurisdiction in which the property owned or leased by the Company or the nature of the business conducted by the Company makes such
qualification necessary, except to the extent that the failure to be so qualified or in good standing would not have, individually or in the aggregate, a material adverse effect on the business,
operations, conditions (financial or otherwise), assets or results of operations of the Company (a "Material Adverse Effect").

        2.2.    Capitalization.    (a) The authorized capital stock of the Company consists of 13,330,100 shares of
capital stock, all of which are classified as Common Stock. There are 5,000,000 shares of Common Stock issued and outstanding. All of the issued and outstanding shares of Common Stock of the Company
are duly authorized, validly issued, fully paid and nonassessable, free of any liens or encumbrances and are not subject to preemptive rights. All of the securities issued by the Company have been
issued in accordance with all applicable securities laws. Other than as contemplated in this Agreement or as set forth on Schedule 2.2(a), there are no other options, warrants, calls, rights,
commitments or agreements of any character to which the Company is a party or by which either the Company is bound or obligating the Company to issue, deliver, sell, repurchase or redeem, or cause to
be issued, delivered, sold, repurchased or redeemed, any shares of the capital stock of the Company or obligating the Company to grant, extend or enter into any such option, warrant, call, right,
commitment or agreement. There are no preemptive rights or rights of first refusal or similar rights which are binding on the Company permitting any person to subscribe for or purchase from the
Company shares of its capital stock pursuant to any provision of law, the Company's Certificate of Incorporation as in effect on the date hereof (the "Certificate of
Incorporation") or the Company's Articles of Association as in effect on the date hereof (the "By-laws") or by
agreement or otherwise. Except as set forth in the Offering Documents, there are no securities or instruments containing anti-dilution or similar provisions that may be triggered by the
issuance of the Securities. 

        (b)   Upon
issuance of the Warrants and payment of the purchase price therefor in accordance with the terms of this Agreement, the Warrants will be duly authorized, validly
issued, fully paid and nonassessable, and free and clear of any restrictions on transfer and any taxes, claims, liens, pledges, options, security interests, purchase rights, preemptive rights, trusts,
encumbrances or other rights or interests of any other person (other than any restrictions under the Act). The Warrant Shares and, if applicable, the Conversion Shares, when issued in accordance with
the terms of the Warrants or the Notes, respectively, will be duly authorized, validly issued, fully paid and non-assessable, and free and clear of any restrictions on transfer and any
taxes, claims, liens, pledges, options, security interests, purchase rights, preemptive rights, trusts, encumbrances or other rights or interests of any other person (other than any restrictions under
the Securities Act). A sufficient number of authorized but unissued shares of Common Stock have been reserved for issuance upon the exercise of the Warrants and, if applicable, the conversion of the
Notes, assuming that (i) the Company sells the full eight million, ten thousand dollars ($ 8,010,000) of Units; (ii) the warrant coverage is 66% of the dollar amount invested; and
(iii) the conversion price of the Notes and the exercise price of the Warrants is no less than $6.00 per share of Common Stock. 

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        (c)   The
Company does not presently own or control, directly or indirectly, any interest in any subsidiary, corporation, association or other business entity. The Company is
not a party to any joint venture, partnership or similar arrangement. 

        2.3.    Authorization; Enforceability.    The Company has all corporate right, power and authority to enter into this
Agreement and to execute and deliver the Notes, the Warrants, the Investors' Rights Agreement, and the Escrow Agreement and to consummate the transactions contemplated hereby and thereby. All
corporate action on the part of the Company, its directors and stockholders necessary for the authorization, execution, delivery and performance of this Agreement, the Notes, the Warrants, the
Investors' Rights Agreement, and the Escrow Agreement by the Company, the authorization, sale, issuance and delivery of the Securities contemplated herein and the performance of the Company's
obligations hereunder and thereunder has been taken or will be taken prior to Closing. Each of this Agreement, the Notes, the Warrants, the Investors' Rights Agreement, and the Escrow Agreement has
been or will upon issuance be duly executed and delivered by the Company and constitutes a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its
terms, subject to laws of general application relating to bankruptcy, insolvency and the relief of debtors and rules of law governing specific performance, injunctive relief or other equitable
remedies, and to limitations of public policy. The issuance and sale of the Securities contemplated hereby will not give rise to any preemptive rights or rights of first refusal on behalf of any
person. 

        2.4.    No Conflict; Governmental and Other Consents.    

        (a)   The
execution and delivery by the Company of this Agreement, the Notes, the Warrants, the Investors' Rights Agreement, and the Escrow Agreement and the consummation of
the transactions contemplated hereby and thereby will not result in the violation of any law, statute, rule, regulation, order, writ, injunction, judgment or decree of any court or governmental
authority to or by which the Company is bound, or of any provision of the Certificate of Incorporation or By-Laws,
and will not conflict with, or result in a breach or violation of, any of the terms or provisions of, or constitute (with due notice or lapse of time or both) a default under, any lease, loan
agreement, mortgage, security agreement, trust indenture or other agreement or instrument to which the Company is a party or by which the Company is bound or to which any of the Company's properties
or assets is subject, nor result in the creation or imposition of any lien upon any of the properties or assets of the Company except, other than with respect to violations of the Certificate of
Incorporation, for such violation, conflicts, breaches, defaults or liens, which would not have, individually or in the aggregate, a Material Adverse Effect. 

        (b)   No
consent, approval, authorization or other order of any governmental authority or other third-party is required to be obtained by the Company in connection with the
authorization, execution and delivery of this Agreement or with the authorization, issue and sale of the Securities, except such filings as may be required to be made with the Commission or with any
state or foreign blue sky or securities regulatory authority. 

        2.5.    Litigation.    Other than as described in the Offering Documents, there is no pending or, to the actual
knowledge of any officer or director of the Company, after due investigation, threatened legal or governmental proceedings to which the Company is a party which could materially adversely affect the
business, property, financial condition or operations of the Company or the Company's ability to perform its obligations under this Agreement, the Notes and the Warrants. 

        2.6.    Accuracy of Offering Documents.    The Offering Documents delivered to the Subscribers in connection with the
transactions contemplated hereby do not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements contained therein, in light of the
circumstances under which they were made, not misleading. 

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        2.7.    Investment Company.    The Company is not an "investment company" within the meaning of such term under the
Investment Company Act of 1940, as amended, and the rules and regulations of the Commission thereunder. 

        2.8.    Use of Proceeds.    The Company intends to use the net proceeds of the Offering as set forth in the Private
Placement Memorandum. 

        2.9.    Company's Line of Business.    The Company and its subsidiaries are engaged only in the business described in
the Offering Documents and the Offering Documents contains a complete and accurate description in all material respects of the business of the Company, as of the date hereof. 

        2.10.    Financial Statements.    The Company has delivered to each Investor its audited financial statements (balance
sheet and statement of operations, including the supplementary note thereto, and the auditors' report pursuant to article 2420 of the Italian civil code) at December 31, 2003 and for the
fiscal year then ended, and its unaudited financial statements (balance sheet and statement of operations) as, at
and for the six-month period ended June 30, 2004 (the "Financial Statements"). The Financial Statements have been prepared in accordance with Italian generally accepted accounting
principles applied on a consistent basis throughout the periods indicated and with each other, except that unaudited Financial Statements may not contain all footnotes required by generally accepted
accounting principles. The Financial Statements fairly present the financial condition and operating results of the Company as of the dates, and for the periods, indicated therein, subject in the case
of unaudited Financial Statements to normal year-end audit adjustments. Except as set forth in the Financial Statements, the Company has no material liabilities, contingent or otherwise,
other than (i) liabilities incurred in the ordinary course of business subsequent to June 30, 2004 and (ii) obligations under contracts and commitments incurred in the ordinary
course of business and not required under Italian generally accepted accounting principles to be reflected in the Financial Statements, which, in both cases, individually or in the aggregate, are not
material to the financial condition or operating results of the Company. Except as disclosed in the Financial Statements, the Company is not a guarantor or indemnitor of any indebtedness of any other
person, firm or corporation. The Company maintains and will continue to maintain a standard system of accounting established and administered in accordance with Italian generally accepted accounting
principles. 

        2.11.    Changes.    Since June 30, 2004 there has not been: 

        (a)   any
change in the assets, liabilities, financial condition or operating results of the Company from that reflected in the Financial Statements, except changes in the
ordinary course of business that have not been, in the aggregate, materially adverse; 

        (b)   any
damage, destruction or loss, whether or not covered by insurance, materially and adversely affecting the assets, properties, financial condition, operating results
or business of the Company; 

        (c)   any
waiver by the Company of a valuable right or of a material debt owed to it; 

        (d)   any
satisfaction or discharge of any lien, claim or encumbrance or payment of any obligation by the Company, except in the ordinary course of business and that is not
material to the assets, properties, financial condition, operating results or business of the Company; 

        (e)   any
material change or amendment to a material contract or arrangement by which the Company or any of its assets or properties is bound or subject; 

        (f)    any
material change in any compensation arrangement or agreement with any employer; or 

        (g)   any
agreement or commitment by the Company to do any of the things described in this Section 2.11, except as set forth on Schedule 2.11. 

9

 

        2.12.    Compliance with Laws.    Except as set forth in the Offering Documents, the Company is in compliance in all
material respects with all laws, rules, regulations, orders, judgments or decrees that are applicable to it, the conduct of its business as presently conducted and as proposed to be conducted, and the
ownership of its property and assets, and the Company is not aware of any state of facts, events, conditions or occurrences which may now or hereafter constitute or result in a violation of any of
such laws, rules, regulations, orders, judgments or decrees or which may give rise to the assertion of any such violation, except where such violation or violations do not have a Material Adverse
Effect. 

 
 

ARTICLE III.
  TERMS OF SUBSCRIPTION    
    

        3.1.  The
purchase and sale of the Securities shall take place at the offices of Kramer Levin Naftalis & Frankel LLP ("Kramer Levin"), 919 Third Avenue, New York, New
York 10022, and shall terminate at 11:59 p.m. New York City time on November 30, 2004 (subject to extension at the Company's or the Placement Agents' discretion without notice to
Subscriber for up to 60 days) (the "Expiration Date") or such other date on which all of the Units are sold (the  "Termination Date"), which time and
place are designated as the "Closing." The Offering is not
contingent upon the sale of any minimum number of Units. The Company may close on the Subscriber's subscription upon receipt of a properly executed copy of this Agreement from the Subscriber and the
purchase price for the number of Units being purchased by the Subscriber (the "Initial Closing") and may conduct additional closings (each an "Interim
Closing") until all of the Units are sold (the date of each such Closing, the "Closing Date"). 

        3.2.  Pending
the sale of the Units, all funds paid hereunder shall be deposited by the Company in escrow with the Escrow Agent, having a branch at 1445 Ross Avenue, 2nd
Floor, Dallas, Texas 75202, USA. 

        3.3.  The
Subscriber hereby authorizes and directs the Company to deliver the Units to be issued to the Subscriber pursuant to this Agreement to the residential or business
address indicated on the signature page hereto. 

        3.4.  The
Subscriber hereby authorizes and directs the Company to return, without interest, any funds for unaccepted subscriptions (including any subscriptions that were not
accepted as a result of the termination of the Offering) to the same account from which the funds were drawn, including any customer account maintained with the Placement Agents. 

        3.5.  The
Company's agreement with each Subscriber is a separate agreement and the sale of the Units to each Subscriber is a separate sale. 

 
 

ARTICLE IV.
  CONDITIONS TO OBLIGATIONS OF THE SUBSCRIBERS    
    

        4.1.  The
Subscribers' obligation to purchase the Units at the Closing is subject to the fulfillment on or prior to the Closing of the following conditions, which conditions
may be waived at the option of each Subscriber to the extent permitted by law: 

        (a)   Representations and Warranties Correct.    The representations and warranties made by the Company in  ARTICLE II hereof shall be true and correct in
all material respects when made, and shall be true and correct in all material respects on the Closing
Date with the same force and effect as if they had been made on and as of said date. 

        (b)   Covenants.    All covenants, agreements and conditions contained in this Agreement to be performed by the
Company on or prior to such purchase shall have been performed or complied with in all material respects. 

10

 

        (c)   No Legal Order Pending.    There shall not then be in effect any legal or other order enjoining or restraining
the transactions contemplated by this Agreement. 

        (d)   No Law Prohibiting or Restricting Such Sale.    There shall not be in effect any law, rule or regulation
prohibiting or restricting such sale or requiring any consent or approval of any person which shall not have been obtained to issue the Units (except as otherwise provided in this Agreement). 

        (e)   Legal Opinion from Counsel for the Company; Opinion of Italian Counsel.    There shall be made available to
each Subscriber the written opinion of Kramer Levin, counsel for the Company as to enforceability of the Offering Documents. The subscriber shall have received from Studio Santa Maria, Italian counsel
to the Company, a favorable opinion, dated the date of closing as to due authorization and execution of the Offering Documents, and authorization and validity of the Pledge Agreement. 

        (f)    Number of Pledged Shares under the Pledge Agreement.    The number of Pledged Shares under the Pledge Agreement
shall amount to no less than twenty thousand five hundred ninety-nine (20,599) shares per one hundred thousand dollars ($100,000) of Notes sold in the Offering. 

 
 

ARTICLE V.
  MISCELLANEOUS    
    

        5.1.    Notices.    Except as otherwise expressly specified herein, all notices, requests and other communications
required or permitted hereunder shall be in writing and shall be sent by an internationally recognized overnight courier service; by certified or registered mail, return receipt requested (or, in the
case of a notice sent to an address in Italy, by international express mail, return receipt requested); by facsimile transmission; or by hand delivery. 

        The
address for such notices and communications shall be as follows: 

If
to the Company: 

Gentium
S.p.A.

Piazza XX Settembre, 2

22079 Villa Guardia Como

Italy

Attention: Dott. Sauro Carsana

Fax: +39 031 385333 

If
to a Subscriber: 

To
the address set forth under such Subscriber's name on the signature pages hereto. 

        Any
party may designate a different notice address, contact person, telephone number or facsimile number with respect to such party by providing a notice describing such changes to the
other party hereto in accordance with the provisions of this Section 5.1. Any notice sent by internationally recognized overnight mail courier service shall be deemed to be delivered to the
address shown on the mailing receipt on the expected date of delivery upon proper evidence of mailing for purposes of this Section 5.1. Any notice sent by certified or registered mail, return
receipt requested (or, in the case of a notice sent to an address in Italy, by international express mail, return receipt requested), shall be deemed to be delivered five business days after mailing.
Any notice sent by facsimile transmission shall be deemed delivered as of the open of business on the business day following the date on which sent provided the sender receives written confirmation of
transmission and provided that within 24 hours such notice is also sent by regular mail or by an internationally-recognized overnight mail courier 

11

 

service
to the appropriate address specified above. Any notice sent by hand delivery shall be deemed delivered as of the date of delivery. 

        5.2.  Any
term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance and either
retroactively or prospectively), only with the written consent of the Company and the holders of a majority in interest of the Securities sold pursuant to the Offering, which holders shall include
Generation Capital Associates. Any amendment or waiver effected in accordance with this paragraph shall be binding upon each holder of any Securities purchased pursuant to the Offering at the time
outstanding, each future holder of all such securities and the Company. 

        5.3.  This
Agreement shall be binding upon and inure to the benefit of the parties hereto and to their respective heirs, legal representatives, successors and assigns. This
Agreement sets forth the entire agreement and understanding between the parties as to the subject matter hereof and merges and supersedes all prior discussions, agreements and understandings of any
and every nature among them. Notwithstanding the foregoing, if any of the provisions of this Agreement are inconsistent with the terms of the Summary of Proposed Terms and Conditions included in the
Private Placement Memorandum, the terms of the Summary of Proposed Terms and Conditions shall govern. 

        5.4.  Upon
the execution and delivery of this Agreement by the Subscriber, this Agreement shall become a binding obligation of the Subscriber with respect to the purchase of
the as herein provided; subject, however, to the right hereby reserved to the Company to revoke this subscription in accordance with  Section 1.18, enter into the same agreements with other
subscribers and to add and/or delete other persons as subscribers. 

        5.5.  NOTWITHSTANDING
THE PLACE WHERE THIS AGREEMENT MAY BE EXECUTED BY ANY OF THE PARTIES HERETO, THE PARTIES EXPRESSLY AGREE THAT THIS AGREEMENT SHALL BE CONSTRUED IN
ACCORDANCE WITH AND GOVERNED BY THE LAWS OF THE STATE OF NEW YORK WITHOUT REGARD TO PRINCIPLES OF CONFLICTS OF LAW. IN THE EVENT THAT A JUDICIAL PROCEEDING IS NECESSARY, THE EXCLUSIVE FORUMS FOR
RESOLVING DISPUTES ARISING OUT OF OR RELATING TO THIS AGREEMENT ARE EITHER THE SUPREME COURT OF THE STATE OF NEW YORK IN AND FOR THE COUNTY OF NEW YORK OR THE FEDERAL COURTS FOR SUCH STATE AND COUNTY,
AND ALL RELATED APPELLATE COURTS, THE PARTIES HEREBY IRREVOCABLY CONSENT TO THE JURISDICTION OF SUCH COURTS AND AGREE TO SAID VENUE. 

        5.6.  The
holding of any provision of this Agreement to be invalid or unenforceable by a court of competent jurisdiction shall not affect any other provision of this
Agreement, which shall remain in full force and effect. If any provision of this Agreement shall be declared by a court of competent jurisdiction to be invalid, illegal or incapable of being enforced
in whole or in part, such provision shall be interpreted so as to remain enforceable to the maximum extent permissible consistent with applicable law and the remaining conditions and provisions or
portions thereof shall nevertheless remain in full force and effect and enforceable to the extent they are valid, legal and enforceable, and no provisions shall be deemed dependent upon any other
covenant or provision unless so expressed herein. 

        5.7.  It
is agreed that a waiver by either party of a breach of any provision of this Agreement shall not operate, or be construed, as a waiver of any subsequent breach by
that same party. 

        5.8.  The
parties agree to execute and deliver all such further documents, agreements and instruments and take such other and further action as may be necessary or
appropriate to carry out the purposes and intent of this Agreement. 

12

 

        5.9.  This
Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which shall together constitute one and the same
instrument. 

        5.10. (a)
The Subscribers severally agree not to issue any public statement with respect to the Subscribers' investment or proposed investment in the Company or the terms of
any agreement or covenant between them and the Company without the Company's prior written consent, except such disclosures as may be required under applicable law or under any applicable order, rule
or regulation. 

        (b)   The
Company agrees not to disclose the names, addresses or any other information about the Subscribers, except as required by law and to satisfy its obligations under
the Investors Rights' Agreement. 

        5.11. (a)
Each Subscriber severally represents and warrants that it has not engaged, consented to nor authorized any broker, finder or intermediary to act on its behalf,
directly or indirectly, as a broker, finder or intermediary in connection with the transactions contemplated by this Agreement. Each Subscriber hereby severally agrees to indemnify and hold harmless
the Company from and against all fees, commissions or other payments owing to any such person or firm acting on behalf of such Subscriber hereunder. 

        (b)   The
Company has engaged, consented to and authorized the Placement Agents to act as agents for the Company in connection with the transactions contemplated by this
Agreement. The Company shall pay the Placement Agents a commission and reimburse the Placement Agents' expenses in accordance with the Placement Agency Agreement between the Company and the Placement
Agents dated April 30, 2004, and the Company shall indemnify and hold harmless the Subscribers from and against all fees, commissions or other payments owing by the Company to the Placement
Agents or any other person or firm acting on behalf of the Company hereunder. 

 
 

ARTICLE VI.
  CONFIDENTIAL INVESTOR QUESTIONNAIRE

        6.1.  The
Subscriber represents and warrants that he, she or it comes within one category marked below, and that for any category marked, he, she or it has truthfully set
forth, where applicable, the factual basis or reason the Subscriber comes within that category. ALL INFORMATION IN RESPONSE TO THIS SECTION WILL BE KEPT STRICTLY CONFIDENTIAL except as otherwise
required by law. The undersigned agrees to furnish any additional information which the Company deems necessary in order to verify the answers set forth below. 

	Category A        	 	The undersigned is an individual (not a partnership, corporation, etc.) whose individual net worth, or joint net worth with his or her spouse, presently exceeds $1,000,000.
	 	 	Explanation. In calculating net worth you may include equity in personal property and real estate, including your principal residence, cash, short-term investments, stock and securities. Equity in personal property and
real estate should be based on the fair market value of such property less debt secured by such property.
	 	 	 

13

 

	

Category B        	
 	

The undersigned is an individual (not a partnership, corporation, etc.) who had an income in excess of $200,000 in each of the two most recent years, or joint income with his or her spouse in excess of $300,000 in each of those years (in each case
including foreign income, tax exempt income and full amount of capital gains and losses but excluding any income of other family members and any unrealized capital appreciation) and has a reasonable expectation of reaching the same income level in
the current year.
	

Category C        	
 	

The undersigned is a director or executive officer of the Company which is issuing and selling the Securities.
	

Category D        	
 	

The undersigned is a bank; a savings and loan association; insurance company; registered investment company; registered business development company; licensed small business investment company ("SBIC"); or employee benefit plan within the meaning of
Title 1 of ERISA and (a) the investment decision is made by a plan fiduciary which is either a bank, savings and loan association, insurance company or registered investment advisor, or (b) the plan has total assets in excess of $5,000,000
or (c) is a self directed plan with investment decisions made solely by persons that are accredited investors. (describe entity)
	

 	
 	

	

 	
 	

	

Category E        	
 	

The undersigned is a private business development company as defined in section 202(a)(22) of the Investment Advisors Act of 1940. (describe entity)
	

 	
 	

	

 	
 	

	

Category F        	
 	

The undersigned is either a corporation, partnership, Massachusetts business trust, or non-profit organization within the meaning of Section 501(c)(3) of the Internal Revenue Code, in each case not formed for the specific purpose of acquiring
the Securities and with total assets in excess of $5,000,000. (describe entity)
	

 	
 	

	

 	
 	

	

Category G        	
 	

The undersigned is a trust with total assets in excess of $5,000,000, not formed for the specific purpose of acquiring the Securities, where the purchase is directed by a "sophisticated investor" as defined in Regulation 506(b)(2)(ii) under
the Act.
	

 	
 	

	

 	
 	

	

Category H        	
 	

The undersigned is an entity (other than a trust) in which all of the equity owners are "accredited investors" within one or more of the above categories. If relying upon this Category alone, each equity owner must complete a separate copy of this
Agreement. (describe entity)
	

 	
 	

14

 

	

Category I	
 	

The undersigned is not within any of the categories above and is therefore not an accredited investor.

        The
undersigned agrees that the undersigned will notify the Company at any time on or prior to the Closing Date in the event that the representations and warranties in this Agreement
shall cease to be true, accurate and complete. 

        6.2.    SUITABILITY    (please answer each question) 

        (a)   For
an individual Subscriber, please describe your current employment, including the company by which you are employed and its principal business: 

        (b)   For
an individual Subscriber, please describe any college or graduate degrees held by you: 

        (c)   For
all Subscribers, please state whether you have you participated in other private placements before: 

YES                             NO         
                
 

        (d)   If
your answer to question (d) above was "YES", please indicate frequency of such prior participation in private
placements of: 

	 
	 	Public Companies
	 	Private Companies

	
 	
 	

 	
 	

 
	Frequently	 	
	 	

	

Occasionally	
 	

	
 	

	

Never	
 	

	
 	

        (e)   For
individual Subscribers, do you expect your current level of income to significantly decrease in the foreseeable future: 

YES                             NO         
                

        (f)    For
trust, corporate, partnership and other institutional Subscribers, do you expect your total assets to significantly decrease in the foreseeable future: 

YES                             NO         
                

        (g)   For
all Subscribers, do you have any other investments or contingent liabilities which you reasonably anticipate could cause you to need sudden cash requirements in
excess of cash readily available to you: 

YES                             NO         
                

15

 

        (h)   For
all Subscribers, are you familiar with the risk aspects and the non-liquidity of investments such as the securities for which you seek to subscribe? 

YES                             NO         
                

	(i)
	For
all Subscribers, do you understand that there is no guarantee of financial return on this investment and that you run the risk of losing your entire investment? 

YES                             NO         
                

        6.3.  MANNER IN WHICH TITLE IS TO BE HELD (circle one) 

        (a)   Individual
Ownership 

        (b)   Community
Property 

        (c)   Joint
Tenant with Right of Survivorship (both parties must sign) 

        (d)   Partnership*

        (e)   Tenants
in Common 

        (f)    Company* 

        (g)   Trust*

        (h)   Other

        *If
Securities are being subscribed for by an entity, the attached Certificate of Signatory must also be completed. 

        6.4.  NASD AFFILIATION.

        Are
you affiliated or associated with an NASD member firm (please check one): 

YES                             NO         
                

        If
Yes, please describe: 

        *If
Subscriber is a Registered Representative with an NASD member firm, have the following acknowledgment signed by the appropriate party: 

        The
undersigned NASD member firm acknowledges receipt of the notice required by Article 3, Sections 28(a) and (b) of the Rules of Fair Practice. 

	
 Name of NASD Member Firm	 
	

By:	

 Authorized Officer	

 
	

Date:	

	

 

        6.5.  The
undersigned is informed of the significance to the Company of the foregoing representations and answers contained in the Confidential Investor Questionnaire
contained in this Section 7 and such answers have been provided under the assumption that the Company will rely on them. 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

16

 
 

SIGNATURE PAGE TO SUBSCRIPTION AGREEMENT    
    

        EXECUTION OF THIS AGREEMENT BY ANY PURCHASER SHALL BE DEEMED TO CONSTITUTE EXECUTION OF THE INVESTORS RIGHTS AGREEMENT ANNEXED HERETO AS
EXHIBIT A BY SUCH PURCHASER.

"Purchase
Price" =                               X
$                   = $                  

                              Number of Units 

	
 Signature	 	
 Signature (if purchasing jointly)
	

 Name Typed or Printed	
 	

 Name Typed or Printed
	

 Entity Name	
 	

 Entity Name
	

 Address	
 	

 Address
	

 City, State and Zip Code	
 	

 City, State and Zip Code
	

 Telephone-Business	
 	

 Telephone—Business
	

 Telephone-Residence	
 	

 Telephone—Residence
	

 Facsimile-Business	
 	

 Facsimile—Business
	

 Facsimile-Residence	
 	

 Facsimile—Residence
	

 Tax ID # or Social Security #	
 	

 Tax ID # or Social Security #

Name
in which securities should be
issued:                                        
           

Dated:                               ,
2004 

This
Subscription Agreement is agreed to and accepted as of
                                         
        2004.
 

	 	 	Gentium S.p.A.
	

 	
 	

By:	

	 	 	Name:

Title:

 
 

CERTIFICATE OF SIGNATORY    
    

(To
be completed if Securities are being subscribed for by an entity) 

        I,
                                         
       , am the
                                         
        of
                                         
        (the "Entity").
 

        I
certify that I am empowered and duly authorized by the Entity to execute and carry out the terms of the Subscription Agreement and to purchase and hold the Securities, and certify
further that the Subscription Agreement has been duly and validly executed on behalf of the Entity and constitutes a legal and binding obligation of the Entity. 

        IN
WITNESS WHEREOF, I have set my hand this                     day of
                                         
        

	

 	
 	

 (Signature)

 
 

SCHEDULE 2.2(a)    
    

Finanziaria
Sirton, the holder of 100% of the outstanding Common Stock of the Company, has preemptive rights under Italian law with respect to the issuance of securities by the Company and has waived
its preemptive rights with respect to this Offering. 

 
 

SCHEDULE 2.10    
    

Loan
agreement with Finrex SA in the amount of $370,000 

 
 

SCHEDULE 2.11    
    

Loan
agreement dated July 7, 2004 with Sirton S.p.A. in the amount of € 600,000 

Loan
agreement dated July 20, 2004 with Banca Nazionale del Lavoro in the amount of € 2,000,000 

Loan
agreement dated July 9, 2004 with Cassa di Risparmio di Parma e Piacenza in the amount of € 487,100 

Loan
agreement dated August 4, 2004 with Cassa di Risparmio di Parma e Piacenza in the amount of € 387,760 

Loan
agreement with Finrex SA in the amount of $370,000 

 
 

EXHIBIT A    
    

QuickLinks

Exhibit 4.2.5

ARTICLE I. SUBSCRIPTION FOR UNITS AND REPRESENTATIONS BY SUBSCRIBER

ARTICLE II. REPRESENTATIONS BY AND COVENANTS OF THE COMPANY

ARTICLE III. TERMS OF SUBSCRIPTION

ARTICLE IV. CONDITIONS TO OBLIGATIONS OF THE SUBSCRIBERS

ARTICLE V. MISCELLANEOUS

ARTICLE VI. CONFIDENTIAL INVESTOR QUESTIONNAIRE

SIGNATURE PAGE TO SUBSCRIPTION AGREEMENT

CERTIFICATE OF SIGNATORY

SCHEDULE 2.2(a)

SCHEDULE 2.10

SCHEDULE 2.11

EXHIBIT AQuickLinks
 -- Click here to rapidly navigate through this document
  

 
 

Exhibit 4.5    
    

 
 

INVESTORS' RIGHTS AGREEMENT    
    

        THIS INVESTORS' RIGHTS AGREEMENT is made as of the 4th day of April, 2005, by and between Gentium S.p.A., a joint stock company  (società per
azioni) incorporated and organized under the laws of the Republic of Italy (the "Company"), on the one hand, and Sigma Tau
Finanziaria S.p.A., a corporation incorporated under the laws of Italy ("Sigma Tau"), on the other hand. 

 
 

RECITALS

        WHEREAS,
Sigma Tau has purchased shares of ordinary shares of the Company from FinSirton S.p.A (the "Majority Shareholder") pursuant to the terms of a share purchase agreement, dated
April 5, 2005 (the "Share Purchase Agreement"); 

        WHEREAS,
the net proceeds of the sale of shares by FinSirton under the Share Purchase Agreement will be contributed to the Company; 

        WHEREAS,
in order to induce Sigma Tau to enter into the transactions contemplated by the Share Purchase Agreement, Sigma Tau and the Company hereby agree that this Agreement shall govern
the rights of Sigma Tau to cause the Company to register the shares of Ordinary Shares purchased pursuant to the Share Purchase Agreement and certain other matters as set forth herein; 

        NOW,
THEREFORE, THE PARTIES HEREBY AGREE AS FOLLOWS: 

        1.    Registration Rights.    The Company covenants and agrees as follows: 

        1.1.    Definitions.    For purposes of this Agreement: 

        (a)   The
term "Act" means the Securities Act of 1933, as amended. 

        (b)   The
term "Form F-3" means such form under the Act as in effect on the date hereof or any registration form under the Act subsequently adopted by the
SEC which permits inclusion or incorporation of substantial information by reference to other documents filed by the Company with the SEC. 

        (c)   The
term "Holder" means Sigma Tau and any person owning or having the right to acquire Registrable Securities or any person to whom the rights under Section 1
have been transferred in accordance with Section 1.13 hereof. 

        (d)   The
term "1934 Act" means the Securities Exchange Act of 1934, as amended. 

        (e)   The
term "Ordinary Shares" means the ordinary shares, par value €1 per share, of the Company. 

        (f)    The
term "register," "registered," and "registration" refer to a registration effected by preparing and filing a registration statement or similar document in compliance
with the Act, and the declaration or ordering of effectiveness of such registration statement or document. 

        (g)   The
term "Registrable Securities" means (i) the Shares, (ii) any additional Ordinary Shares issued as Repricing Shares pursuant to Section 1.7 of
the Share Purchase Agreement, and (iii) any other securities issued or issuable with respect to or in exchange of any of the securities referenced in (i) or (ii), subject to appropriate
adjustment for any share split, share dividend, recapitalization, merger or other reorganization; provided,  however, that securities shall only be treated
as Registrable Securities if and only for so long as they (A) have not been disposed of pursuant
to a registration statement declared effective by the SEC; (B) have 

1

 

not
been sold in a transaction exempt from the registration and prospectus delivery requirements of the Act so that all transfer restrictions and restrictive legends with respect thereto are removed
upon the consummation of such sale; (C) are held by a Holder or a permitted transferee pursuant to Section 1.13; or (D) have not become eligible for sale pursuant to
Rule 144(k) (or any successor thereto) under the Act. 

        (h)   The
term "SEC" shall mean the Securities and Exchange Commission. 

        (i)    The
term "Shares" means the Ordinary Shares purchased pursuant to the Share Purchase Agreement. 

        1.2.    Request for Registration.    

        (a)   If
the Company shall receive at any time after six (6) months following the effective date of the first registration statement for a public offering of securities
of the Company (other than a registration statement relating either to the sale of securities to employees of the Company pursuant to a share option, share purchase or similar plan or an SEC
Rule 145 transaction), a written request from the Holders of a majority of the Registrable Securities then outstanding that the Company file a registration statement under the Act
covering the registration of the Registrable Securities then outstanding with an aggregate offering price, net of underwriting discounts and commissions of no less than two million dollars
($2,000,000), then the Company shall: 

          (i)  within
ten (10) days of the receipt thereof, give written notice of such request to all Holders in accordance with Section 3.5; and 

         (ii)  effect
as soon as practicable the registration under the Act of all Registrable Securities which the Holders request to be registered, subject to the limitations of
subsection 1.2(b), within twenty (20) days of the mailing of such notice by the Company in accordance with Section 3.5. 

        (b)   If
the Holders initiating the registration request in accordance with Section 1.2(a)(ii) ("Initiating Holders") intend to distribute the Registrable
Securities covered by their request by means of an underwriting, they shall so advise the Company as a part of their request made pursuant to subsection 1.2(a)(ii), and the Company shall include such
information in the written notice referred to in subsection 1.2(a)(ii). The underwriter will be selected by the Company and shall be reasonably acceptable to a majority in interest of the Initiating
Holders. In such event, the right of any Holder to include its Registrable Securities in such registration shall be conditioned upon such Holder's participation in such underwriting and the inclusion
of such Holder's Registrable Securities in the underwriting (unless otherwise mutually agreed by a majority in interest of the Initiating Holders and such Holder) to the extent provided herein. All
Holders proposing to distribute their securities through such underwriting shall (together with the Company as provided in subsection 1.4(e)) enter into an underwriting agreement in customary form
with the underwriter or underwriters selected for such underwriting. Notwithstanding any other provision of this Section 1.2, if the underwriter advises the Initiating Holders in writing that
marketing factors require a limitation of the number of shares to be underwritten, then the Initiating Holders shall so advise the Company, and the Company shall so advise all Holders of Registrable
Securities which would otherwise be underwritten pursuant hereto, and the number of shares of Registrable Securities that may be included in the underwriting shall be allocated among all Holders
thereof in accordance with Section 1.8 hereof. 

        (c)   Notwithstanding
the foregoing, if the Company shall furnish to Holders requesting a registration statement pursuant to Section 1.2(a)(ii), a certificate signed by
the Chief Executive Officer of the Company stating that in the good faith judgment of the Board of Directors of 

2

 

the
Company, it would be seriously detrimental to the Company and its shareholders for such registration statement to be filed and it is therefore essential to defer the filing of such registration
statement, the Company shall have the right to defer taking action with respect to such filing for a period of not more than 120 days after receipt of the request of the Initiating Holders;
provided, however, that the Company may not utilize this right more than once in any twelve-month period. 

        (d)   In
addition, the Company shall not be obligated to effect, or to take any action to effect, any registration pursuant to this Section 1.2(a)(ii): 

          (i)  After
the Company has effected two registrations pursuant to this Section 1.2(a)(ii) and such registrations have been declared or ordered effective; 

         (ii)  During
the period starting with the date sixty (60) days prior to the Company's good faith estimate of the date of filing of, and ending on a date one hundred
eighty (180) days (or, if shorter, the date the market stand-off time period expires pursuant to Section 1.14) after the effective date of, a registration subject to
Section 1.3 hereof; provided that the Company is actively employing in good faith all reasonable efforts to cause such registration statement to become effective; or 

        (iii)  If
the Initiating Holders propose to dispose of shares of Registrable Securities that are eligible to be registered on Form F-3 pursuant to a
request made pursuant to Section 1.12 below. 

        1.3.    Company Registration.    If (but without any obligation to do so) the Company proposes to register (including
for this purpose a registration effected by the Company for shareholders other than the Holders) any of its Ordinary Shares or other securities under the Act in connection with the public offering
(other than an initial public offering which shall be governed by the provisions in Section 1.2(a)(i)) of such securities solely for cash (other than a registration relating solely to the sale
of securities to participants in a Company share plan, a registration on any form which does not include substantially the same information as would be required to be included in a registration
statement covering the sale of the Registrable Securities or a registration in which the only Ordinary Shares being registered are Ordinary Shares issuable upon conversion of debt securities which are
also being registered), the Company shall, at such time, promptly give each Holder written notice of such registration in accordance with Section 3.5. Upon the written request of each Holder
given within twenty (20) days after mailing of such notice by the Company in accordance with Section 3.5, the Company shall, subject to the provisions of Section 1.8, cause to be
registered under the Act all of the Registrable Securities that each such Holder has requested to be registered; provided, however, that the Company shall not be obligated to effect any such
registration pursuant to this Section 1.3 if the Holders propose to sell Registrable Securities at an aggregate price to the public (net of any underwriters' discounts or commissions) of less
than one million dollars ($1,000,000). 

        1.4.    Obligations of the Company.    Whenever required under this Section 1 to effect the registration of any
Registrable Securities, the Company shall, as expeditiously as reasonably possible: 

        (a)   Prepare
and file with the SEC a registration statement with respect to such Registrable Securities and use its reasonable commercial efforts to cause such registration
statement to become effective, and, upon the request of the Holders of a majority of the Registrable Securities registered thereunder, keep such registration statement effective for a period of up to
one hundred twenty (120) days or until the distribution contemplated in the Registration Statement has been completed; provided, however, that (i) such 120-day period shall
be extended for a period of time equal to the period the Holder refrains from selling any 

3

 

securities
included in such registration at the request of an underwriter of Ordinary Shares (or other securities) of the Company; and (ii) in the case of any registration of Registrable
Securities on Form F-3 which are intended to be offered on a continuous or delayed basis, such 120-day period shall be extended, if necessary, to keep the registration
statement effective until all such Registrable Securities are sold, provided that Rule 415, or any successor rule under the Act, permits an offering on a continuous or delayed basis, and
provided further that applicable rules under the Act governing the obligation to file a post-effective amendment permit, in lieu of filing a post-effective amendment
which (I) includes any prospectus required by Section 10(a)(3) of the Act or (II) reflects facts or events representing a material or fundamental change in the information set
forth in the registration statement, the incorporation by reference of information required to be included in (I) and (II) above to be contained in periodic reports filed pursuant to
Section 13 or 15(d) of the 1934 Act in the registration statement. 

        (b)   Prepare
and file with the SEC such amendments and supplements to such registration statement and the prospectus used in connection with such registration statement as
may be necessary to comply with the provisions of the Act with respect to the disposition of all securities covered by such registration statement. 

        (c)   Furnish
to the Holders such numbers of copies of a prospectus, including a preliminary prospectus, in conformity with the requirements of the Act, and such other
documents as they may reasonably request in order to facilitate the disposition of Registrable Securities owned by them. 

        (d)   Use
its reasonable commercial efforts to register and qualify the securities covered by such registration statement under such other securities or Blue Sky laws of such
jurisdictions as shall be reasonably requested by the Holders; provided that the Company shall not be required in connection therewith or as a condition thereto to qualify to do business or to
file a general consent to service of process in any such states or jurisdictions. 

        (e)   In
the event of any underwritten public offering, enter into and perform its obligations under an underwriting agreement, in usual and customary form, with the managing
underwriter of such offering. Each Holder participating in such underwriting shall also enter into and perform its obligations under such an agreement. 

        (f)    Notify
each Holder of Registrable Securities covered by such registration statement at any time when a prospectus relating thereto is required to be delivered under the
Act of the happening of any event as a result of which the prospectus included in such registration statement, as then in effect, includes an untrue statement of a material fact or omits to state a
material fact required to be stated therein or necessary to make the statements therein not misleading in the light of the circumstances then existing. 

        (g)   Cause
all such Registrable Securities registered pursuant hereunder to be listed on each securities exchange on which similar securities issued by the Company are then
listed. 

        (h)   Provide
a transfer agent and registrar for all Registrable Securities registered pursuant hereunder and a CUSIP number for all such Registrable Securities, in each case
not later than the effective date of such registration. 

        (i)    Furnish,
at the request of any Holder requesting registration of Registrable Securities pursuant to this Section 1, on the date that such Registrable Securities
are delivered to the underwriters for sale in connection with a registration pursuant to this Section 1, if such securities are being sold through underwriters, (i) an opinion, dated
such date, of the counsel representing the Company for the purposes of such registration, in form and substance as is customarily given to underwriters in an underwritten public offering, addressed to
the 

4

 

underwriters,
if any, and to the Holders requesting registration of Registrable Securities and (ii) a letter dated such date, from the independent certified public accountants of the Company,
in form and substance as is customarily given by independent certified public accountants to underwriters in an underwritten public offering, addressed to the underwriters and to the Holders
requesting registration of Registrable Securities. 

        1.5.    Furnish Information.    It shall be a condition precedent to the obligations of the Company to take any action
pursuant to this Section 1 with respect to the Registrable Securities of any selling Holder that such Holder shall furnish to the Company such information regarding itself, the Registrable
Securities held by it, and the intended method of disposition of such securities as shall be required to effect the registration of such Holder's Registrable Securities. 

        1.6.    Expenses of Demand Registration.    All expenses other than underwriting discounts and commissions incurred in
connection with registrations, filings or qualifications pursuant to Section 1.2, including (without limitation) all registration, filing and qualification fees, printers' and accounting fees,
fees and disbursements of counsel for the Company (including fees and disbursements of counsel for the Company in its capacity as counsel to the selling Holders hereunder; if Company counsel does not
make itself available for this purpose, the Company will pay the reasonable fees and disbursements of one counsel for the selling Holders) shall be borne by the Company; provided, however, that the
Company shall not be required to pay for any expenses of any registration proceeding begun pursuant to Section 1.2(a)(ii) if the registration request is subsequently withdrawn at the
request of the Holders of a majority of the Registrable Securities to be registered (in which case all participating holders shall bear such expenses), unless the Holders of a majority of the
Registrable Securities agree to forfeit their right to one demand registration pursuant to Section 1.2. 

        1.7.    Expenses of Company Registration.    The Company shall bear and pay all expenses incurred in connection with
any registration, filing or qualification of Registrable Securities with respect to the registrations pursuant to Section 1.3 for each Holder (which right may be assigned as provided in
Section 1.13), including (without limitation) all registration, filing, and qualification fees, printers and accounting fees relating or apportionable thereto and the fees and disbursements of
counsel for the Company in its capacity as counsel to the selling Holders hereunder; if Company counsel does not make itself available for this purpose, the Company will pay the reasonable fees and
disbursements of one counsel for the selling Holders selected by them, but excluding underwriting discounts and commissions relating to Registrable Securities. 

        1.8.    Underwriting Requirements.    In connection with any offering involving an underwriting of Ordinary Shares,
the Company shall not be required under Section 1.2 or 1.3 to include any of the Holders' Shares in such underwriting unless they accept the terms of the underwriting as agreed upon between the
Company and the underwriters selected by it (or by other persons entitled to select the underwriters), and then only in such quantity as the underwriters determine in their sole discretion will not,
jeopardize the success of the offering by the Company. If the total amount of securities, including Registrable Securities, requested by shareholders to be included in such offering exceeds the amount
of securities sold other than by the Company that the underwriters determine in their sole discretion is compatible with the success of the offering, then the Company shall be required to include in
the offering only that number of such securities, including Registrable Securities, which the underwriters determine in their sole discretion will not jeopardize the success of the offering (the
securities so included to be apportioned pro rata among the selling shareholders according to the total amount of securities entitled to be included therein owned by each selling shareholder or in
such other proportions as shall mutually be agreed to by such selling shareholders) but in no event shall the amount of Shares of the selling Holders included in the offering be reduced below fifty
percent (50%) of the total amount of Registrable Securities requested by such selling Holders to be included in the offering, unless there are no selling 

5

 

shareholders,
other than the selling Holders, in the offering, in which case the amount of securities of the selling Holders included in the offering may be reduced below fifty percent (50%). For
purposes of the preceding parenthetical concerning apportionment, for any selling shareholder which is a holder of Registrable Securities and which is a partnership or corporation, the partners,
retired partners and shareholders of such holder, or the estates and family members of any such partners and retired partners and any trusts for the benefit of any of the foregoing persons shall be
deemed to be a single "selling shareholder," and any pro-rata reduction with respect to such "selling shareholder" shall be based upon the aggregate amount of shares carrying registration
rights owned by all entities and individuals included in such "selling shareholder," as defined in this sentence. 

        1.9.    Delay of Registration.    No Holder shall have any right to obtain or seek an injunction restraining or
otherwise delaying any such registration as the result of any controversy that might arise with respect to the interpretation or implementation of this Section 1. 

        1.10.    Indemnification.    In the event any Registrable Securities are included in a registrationstatement under
this Section 1: 

        (a)   To
the extent permitted by law, the Company will indemnify and hold harmless each Holder, any underwriter (as defined in the Act) for such Holder and each person, if
any, who controls such Holder or underwriter within the meaning of the Act or the 1934 Act, against any losses, claims, damages, or liabilities (joint or several) to which they may become subject
under the Act, or the 1934 Act, insofar as such losses, claims, damages, or liabilities (or actions in respect thereof) arise out of or are based upon any of the following statements, omissions or
violations (collectively a "Violation"): (i) any untrue statement or alleged untrue statement of a material fact contained in such registration statement, including any preliminary prospectus
or final prospectus contained therein or any amendments or supplements thereto, (ii) the omission or alleged omission to state therein a material fact required to be stated therein, or
necessary to make the statements therein not misleading, or (iii) any violation or alleged violation by the Company of the Act, the 1934 Act, or any rule or regulation promulgated under the
Act, or the 1934 Act; and the Company will pay to each such Holder, underwriter or controlling person any legal or other expenses reasonably incurred by them in connection with investigating or
defending any such loss, claim, damage, liability, or action; provided, however, that the indemnity agreement contained in this subsection 1.10(a) shall not apply to amounts paid in settlement of any
such loss, claim, damage, liability, or action if such settlement is effected without the consent of the Company (which consent shall not be unreasonably withheld), nor shall the Company be liable in
any such case for any such loss, claim, damage, liability, or action to the extent that it arises out of or is based upon a Violation which occurs in reliance upon and in conformity with written
information furnished expressly for use in connection with such registration by any such Holder, underwriter or controlling person. 

        (b)   To
the extent permitted by law, each selling Holder will indemnify and hold harmless the Company, each of its directors, each of its officers who has signed the
registration statement, each person, if any, who controls the Company within the meaning of the Act, any underwriter, any other Holder selling securities in such registration statement and any
controlling person of any such underwriter or other Holder, against any losses, claims, damages, or liabilities (joint or several) to which any of the foregoing persons may become subject, under the
Act or the 1934 Act insofar as such losses, claims, damages, or liabilities (or actions in respect thereto) arise out of or are based upon any Violation, in each case to the extent (and only to the
extent) that such Violation occurs in reliance upon and in conformity with written information furnished by such Holder expressly for use in connection with such registration; and each such Holder
will pay any legal or other expenses reasonably incurred by 

6

 

any
person intended to be indemnified pursuant to this subsection 1.10(b), in connection with investigating or defending any such loss, claim, damage, liability, or action; provided, however, that the
indemnity agreement contained in this subsection 1.10(b) shall not apply to amounts paid in settlement of any such loss, claim, damage, liability or action if such settlement is effected without the
consent of the Holders of a majority-in-interest of the then outstanding Registrable Securities, which consent shall not be unreasonably withheld; provided, that, in no event
shall any indemnity under this subsection 1.10(b) exceed the gross proceeds from the offering received by such Holder. 

        (c)   Promptly
after receipt by an indemnified party under this Section 1.10 of notice of the commencement of any action (including any governmental action), such
indemnified party will, if a claim in respect thereof is to be made against any indemnifying party under this Section 1.10, deliver to the indemnifying party a written notice of the
commencement thereof and the indemnifying party shall have the right to participate in, and, to the extent the indemnifying party so desires, jointly with any other indemnifying party similarly
noticed, to assume the defense thereof with counsel mutually satisfactory to the parties; provided, however, that an indemnified party (together with all other indemnified parties which may be
represented without conflict by one counsel) shall have the right to retain one separate counsel, with the reasonable fees and expenses to be paid by the indemnifying party, if representation of such
indemnified party by the counsel retained by the indemnifying party would be inappropriate due to actual or potential differing interests between such indemnified party and any other party represented
by such counsel in such proceeding. The failure to deliver written notice to the indemnifying party within a reasonable time of the commencement of any such action, if prejudicial to its ability to
defend such action, shall relieve such indemnifying party of any liability to the indemnified party under this Section 1.10, but the omission so to deliver written notice to the indemnifying
party will not relieve it of any liability that it may have to any indemnified party otherwise than under this Section 1.10. 

        (d)   If
the indemnification provided for in this Section 1.10 is held by a court of competent jurisdiction to be unavailable to an indemnified party with respect to
any loss, liability, claim, damage, or expense referred to therein, then the indemnifying party, in lien of indemnifying such indemnified party hereunder, shall contribute to the amount paid or
payable by such indemnified party as a result of such loss, liability, claim, damage, or expense in such proportion as is appropriate to reflect the relative fault of the indemnifying party on the one
hand and of the indemnified party on the other in connection with the statements or omissions that resulted in such loss, liability, claim, damage, or expense as well as any other relevant equitable
considerations. The relative fault of the indemnifying party and of the
indemnified party shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission to state a material fact relates to
information supplied by the indemnifying party or by the indemnified party and the parties' relative intent, knowledge, access to information, and opportunity to correct or prevent such statement or
omission. 

        (e)   Notwithstanding
the foregoing, to the extent that the provisions on indemnification and contribution contained in the underwriting agreement entered into in connection
with the underwritten public offering are in conflict with the foregoing provisions, the provisions in the underwriting agreement shall control. 

        (f)    The
obligations of the Company and Holders under this Section 1.10 shall survive the completion of any offering of Registrable Securities in a registration
statement under this Section 1, and otherwise. 

7

 

        1.11.    Reports Under Securities Exchange Act of 1934.    With a view to making available to the Holders the benefits
of Rule 144 promulgated under the Act and any other rule or regulation of the SEC that may at any time permit a Holder to sell securities of the Company to the public without registration or
pursuant to a registration on Form F-3, the Company agrees to: 

        (a)   make
and keep public information available, as those terms are understood and defined in SEC Rule 144, at all times after ninety (90) days after the
effective date of the first registration statement filed by the Company for the offering of its securities to the general public; 

        (b)   take
such action, including the voluntary registration of its Ordinary Shares under Section 12 of the 1934 Act, as is necessary to enable the Holders to utilize
Form F-3 for the sale of their Registrable Securities, such action to be taken as soon as practicable after the end of the fiscal year in which the first registration statement
filed by the Company for the offering of its securities to the general public is declared effective; 

        (c)   file
with the SEC in a timely manner all reports and other documents required of the Company under the Act and the 1934 Act; and 

        (d)   furnish
to any Holder, so long as the Holder owns any Registrable Securities, forthwith upon request (i) a written statement by the Company that it has complied
with the reporting requirements of SEC Rule 144 (at any time after one (1) year after the effective date of the first registration statement filed
by the Company), the Act and the 1934 Act (at any time after it has become subject to such reporting requirements), or that it qualifies as a registrant whose securities may be resold pursuant to
Form F-3 (at any time after it so qualifies), (ii) a copy of the most recent annual report of the Company and such other reports and documents so filed by the Company, and
(iii) such other information as may be reasonably requested in availing any Holder of any rule or regulation of the SEC which permits the selling of any such securities without registration or
pursuant to such form. 

        1.12.    Form F-3 Registration.    In case the Company shall receive from any Holder or Holders a
written request or requests that the Company effect a registration on Form F-3 and any related qualification or compliance with respect to all or a part of the Registrable
Securities owned by such Holder or Holders, the Company will: 

        (a)   promptly
give written notice of the proposed registration, and any related qualification or compliance, to all other Holders; and 

        (b)   as
soon as practicable, effect such registration and all such qualifications and compliances as may be so requested and as would permit or facilitate the sale and
distribution of all or such portion of such Holder's or Holders' Registrable Securities as are specified in such request, together with all or such portion of the Registrable Securities of any other
Holder or Holders joining in such request as are specified in a written request given within 15 days after receipt of such written notice from the Company; provided, however, that the Company
shall not be obligated to effect any such registration, qualification or compliance, pursuant to this section 1.12: (i) if Form F-3 is not available for such offering
by the Holders; (2) if the Holders propose to sell Registrable Securities at an aggregate price to the public (net of any underwriters' discounts or commissions) of less than one million
dollars ($1,000,000); (3) if the Company shall furnish to the Holders a certificate signed by the President of the Company stating that in the good faith judgment of the Board of Directors of
the Company, it would be seriously detrimental to the Company and its shareholders for such Form F-3 Registration to be effected at such time, in which event the Company shall have
the right to defer the filing of the Form F-3 registration statement for a period of not more than one hundred twenty (120) days after receipt of the request of the Holder or
Holders under 

8

 

this
Section 1.12; provided, however, that the Company shall not utilize this right more than once in any twelve month period; (4) if the Company has, within the twelve (12) month
period preceding the date of such request, already effected two registrations on Form F-3 for the Holders pursuant to this Section 1.12; or (5) in any particular
jurisdiction in which the Company would be required to qualify to do business or to execute a general consent to service of process in effecting such registration, qualification or compliance. 

        (c)   Subject
to the foregoing, the Company shall file a registration statement covering the Registrable Securities and other securities so requested to be registered
as soon as practicable after receipt of the request or requests of the Holders. All expenses incurred in connection with a registration requested
pursuant to Section 1.12, including (without limitation) all registration, filing, qualification, printer's and accounting fees and the reasonable fees and disbursements of counsel for the
selling Holder or Holders and counsel for the Company, but excluding any underwriters' discounts or commissions associated with Registrable Securities, shall be borne by the Company. Registrations
effected pursuant to this Section 1.12 shall not be counted as demands for registration or registrations effected pursuant to Sections 1.2 or 1.3, respectively. 

        1.13.    Assignment of Registration Rights.    The rights to cause the Company to register Registrable Securities
pursuant to this Section 1 may be assigned (but only with all related obligations) by a Holder to a transferee or assignee of such securities who, after such assignment or transfer, holds at
least 100,000 shares of Registrable Securities (subject to appropriate adjustment for share splits, share dividends, combinations and other recapitalizations), provided: (a) the Company is,
within a reasonable time after such transfer, furnished with written notice of the name and address of such transferee or assignee and the securities with respect to which such registration rights are
being assigned; (b) such transferee or assignee agrees in writing to be bound by and subject to the terms and conditions of this Agreement, including without limitation the provisions of
Section 1.14 below; and (c) such assignment shall be effective only if immediately following such transfer the further disposition of such securities by the transferee or assignee is
restricted under the Act. For the purposes of determining the number of shares of Registrable Securities held by a transferee or assignee, the holdings of transferees and assignees of a partnership
who are partners or retired partners of such partnership (including spouses and ancestors, lineal descendants and siblings of such partners or spouses who acquire Registrable Securities by gift, will
or intestate succession) shall be aggregated together and with the partnership; provided that all assignees and transferees who would not qualify individually for assignment of registration rights
shall have a single attorney-in-fact for the purpose of exercising any rights, receiving notices or taking any action under this Section 1. 

        1.14.    "Market Stand-Off" Agreement.    Sigma Tau hereby agrees that, during the period of duration
specified by the Company and an underwriter of Ordinary Shares or other securities of the Company, following the effective date of a registration statement of the Company filed under the Act, it shall
not, to the extent requested by the Company and such underwriter, directly or indirectly sell, offer to sell, contract to sell (including, without limitation, any short sale), grant any option to
purchase or otherwise transfer or dispose of (other than to donees who agree to be similarly bound) any Shares of the Company purchased by it except Ordinary Shares included in such registration;
provided, however, that: 

        (a)   all
officers and directors of the Company and all other persons with registration rights (whether or not pursuant to this Agreement) enter into similar agreements; and 

        (b)   such
market stand-off time period shall not exceed one hundred eighty (180) days for an initial public offering of the Company's securities and for
ninety (90) days for a follow-on offering of the Company's securities. 

9

 

        In
order to enforce the foregoing covenant, the Company may impose stop-transfer instructions with respect to the Registrable Securities of Sigma Tau (and the shares or
securities of every other person subject to the foregoing restriction) until the end of such period. 

        Notwithstanding
the foregoing, the obligations described in this Section 1.14 shall not apply to a registration relating solely to employee benefit plans on
Form F-1 or Form S-8 or similar forms which may be promulgated in the future, or a registration relating solely to a Commission Rule 145 transaction on
Form S-4 or similar forms which may be promulgated in the future. 

        1.15.    Termination of Registration Rights.    

        (a)   No
Holder shall be entitled to exercise any right provided for in this Section 1 after three (3) years following the consummation of the sale of securities
pursuant to a registration statement filed by the Company under the Act in connection with the initial firm commitment underwritten offering of its securities to the general public. 

        (b)   In
addition, the right of any Holder to request registration or inclusion in any registration pursuant to Section 1.3 shall terminate on the closing of the first
Company- initiated registered public offering of Ordinary Shares of the Company if all shares of Registrable Securities held by such Holder may immediately be sold under Rule 144 during any
90-day period, or on such date after the closing of the first Company-initiated registered public offering of Ordinary Shares of the Company as all shares of Registrable Securities held by
such Holder may immediately be sold under Rule 144 during any 90-day period; provided, however, that the provisions of this subsection 1.15(b) shall not apply to any Holder who owns
more than two percent (2%) of the Company's outstanding Ordinary Shares until such time as such Holder owns less than two percent (2%) of the outstanding Ordinary Shares of the Company. 

        2.    Covenants of the Company.    

        2.1.    Delivery of Financial Statements.    The Company shall deliver to Sigma Tau for so long as Sigma Tau holds
Shares: 

        (a)   as
soon as practicable, but in any event within ninety (90) days after the end of each fiscal year of the Company, an income statement for such fiscal year, a
balance sheet of the Company and statement of shareholder's equity as of the end of such year, and a schedule as to the sources and applications of funds for such year, such year-end
financial reports to be in reasonable detail, prepared in accordance with Italian generally accepted accounting principles ("GAAP"), and audited and certified by independent public accountants of
nationally recognized standing selected by the Company; 

        (b)   as
soon as practicable, but in any event within forty-five (45) days after the end of each of the first three (3) quarters of each fiscal year
of the Company, an unaudited profit or loss statement, schedule as to the sources and application of funds for such fiscal quarter and an unaudited balance sheet as of the end of such fiscal quarter. 

        (c)   within
thirty (30) days of the end of each month, an unaudited income statement and schedule as to the sources and application of funds and balance sheet for and
as of the end of such month, in reasonable detail; 

        (d)   as
soon as practicable, but in any event thirty (30) days prior to the end of each fiscal year, a budget and business plan for the next fiscal year, prepared on a
monthly basis, including balance sheets and sources and applications of funds statements for such months and, as soon as prepared, any other budgets or revised budgets prepared by the Company; 

10

 

        (e)   with
respect to the financial statements called for in subsections (b) and (c) of this Section 2.1, an instrument executed by the Chief Financial
Officer or President of the Company and certifying that such financials were prepared in accordance with GAAP consistently applied with prior practice for earlier periods (with the exception of
footnotes that may be required by GAAP) and fairly present the financial condition of the Company and its results of operation for the period specified, subject to year-end audit
adjustment; 

        (f)    such
other information relating to the financial condition, business, prospects or corporate affairs of the Company as Sigma Tau or any assignee of Sigma Tau may from
time to time request, provided, however, that the Company shall not be obligated under this subsection (f) or any other subsection of Section 2.1 to provide information which it deems in
good faith to be a trade secret or similar confidential information. 

        2.2.    Inspection.    The Company shall permit Sigma Tau, at Sigma Tau's expense, to visit and inspect the Company's
properties, to examine its books of account and records and to discuss the Company's affairs, finances and accounts with its officers, all at such reasonable times as may be requested by Sigma Tau;
provided, however, that the Company shall not be obligated pursuant to this Section 2.2 to provide access to any information which it reasonably considers to be a trade secret or similar
confidential information. 

        2.3.    Termination of Information and Inspection Covenants.    The covenants set forth in subsections 2.1(c),
(d) and (f) and Section 2.2 shall terminate as to Sigma Tau and be of no further force or effect when the sale of securities pursuant to a registration statement filed by the
Company under the Act in connection with the firm commitment underwritten offering of its securities to the general public is consummated or when the Company first becomes subject to the periodic
reporting requirements of Sections 12(g) or 15(d) of the 1934 Act, whichever event shall first occur. 

        2.4.    Right of First Refusal on Dispositions by Sigma Tau.    

        (a)   If
at any time Sigma Tau desires to sell all or any part of Sigma Tau's Shares to a third party (the "Proposed Sigma Tau Transferee"), Sigma Tau shall first submit to
the Majority Shareholder and the Company (i) a bona fide written offer from the Proposed Sigma Tau Transferee to purchase such Shares (which, upon acceptance by Sigma Tau, would constitute a
legally binding obligation) and (ii) a written offer from Sigma Tau (the "Sigma Tau Offer") to sell such Shares (the "Sigma Tau Offered Securities") to the Majority Shareholder and the Company
on terms and conditions, including price, not less favorable than those on which Sigma Tau proposes to sell such Sigma Tau Offered Securities to the Proposed Sigma Tau Transferee. The Sigma Tau Offer
shall disclose the identity of the Proposed Sigma Tau Transferee, the Sigma Tau Offered Securities proposed to be sold, the total number of Shares owned by Sigma Tau, the terms and conditions,
including price, of the proposed sale, and any other material facts relating to the proposed sale and shall include a copy of the Sigma Tau Offer to purchase from the Proposed Sigma Tau Transferee.
The Sigma Tau Offer shall further state that the Majority Shareholder and the Company may acquire, in accordance with the provisions of this Agreement, all, but not less than all, of the Sigma Tau
Offered Securities for the price and upon the other terms and conditions, including deferred payment (if applicable), set forth therein. 

        (b)   If
the Majority Shareholder and/or the Company desires to purchase all, but not less than all, of the Sigma Tau Offered Securities, the Majority Shareholder and/or the
Company, as applicable, shall communicate in writing its election to purchase to Sigma Tau within fifteen (15) days of the date the Sigma Tau Offer was made to the Majority Shareholder and the
Company. Such communications shall, when taken in conjunction with the Sigma Tau Offer, 

11

 

be
deemed to constitute valid, legally binding and enforceable agreement(s) for the sale and purchase of such Sigma Tau Offered Securities. 

        (c)   If
the Majority Shareholder and/or the Company elects to purchase the Sigma Tau Offered Securities, the sales of such Sigma Tau Offered Securities to the Majority
Shareholder and/or the Company, as applicable, pursuant to this Section 2.4 shall be made at the offices of the Company or counsel to the Company on the 30th day following the date the Sigma
Tau Offer was made pursuant to subsection (a) above (or if such day is not a business day, then on the next succeeding business day). Such sale shall be effected by Sigma Tau's delivery to the
Majority Shareholder and/or the Company, as applicable, of certificates or other instruments evidencing the Sigma Tau Offered Securities to be
purchased by it, duly endorsed for transfer, against payment to Sigma Tau of the purchase price therefor by the Majority Shareholder and/or the Company, as applicable. 

        (d)   If
neither the Majority Shareholder nor the Company elects to purchase all of the Sigma Tau Offered Securities, the Sigma Tau Offered Securities may be sold by Sigma Tau
at any time within 30 days after the date the Sigma Tau Offer was accepted, rejected or lapsed pursuant to subsection (b) above. Any such sale shall be to the Proposed Sigma Tau
Transferee and at not less than the price and upon other terms and conditions, if any, not more favorable to the Proposed Sigma Tau Transferee than those specified in the Sigma Tau Offer. Any Sigma
Tau Offered Securities not sold within such 30-day period shall continue to be subject to the requirements of a prior offer pursuant to this Section 2.4. 

        (e)   The
Majority Shareholder's and the Company's right of first refusal provided in this Section 2.4 shall not apply (i) in conjunction with the sale of the
Company to an unaffiliated third party whether by merger, consolidation or sale of shares in a transaction in which the Majority Shareholder's shares are also sold or transferred; or (ii) in
conjunction with a public offering pursuant to an effective registration statement under the Act. 

        (f)    If
Sigma Tau is subject to a transfer of its Shares by any bankruptcy or insolvency law or proceeding, any divorce proceeding or otherwise by operation of law (other
than by death), or if any transfer of Shares is made or attempted contrary to the provisions of this Agreement, the Majority Shareholder and the Company will have the right to purchase any or all of
such Shares from Sigma Tau, his, her or its legal representative or transferees at any time before or after the transfer, at the price, if any, paid for or proposed to be paid for such Shares or for
fair market value as determined under subsection (g), whichever is less. 

        (g)   The
fair market value of the Shares subject to purchase pursuant to subsection (f) will be jointly determined by Sigma Tau and the Majority Shareholder and the
Company, as applicable, who elect to purchase, or if they are unable to agree, by such other appraiser as Sigma Tau and the Majority Shareholder and the Company, as applicable, may jointly choose.
Sigma Tau shall bear all of the fees and expenses arising out of the appraisal. 

        (h)   The
agreements set forth in this Section 2.4 shall terminate and be of no further force or effect when the sale of Shares pursuant to a registration statement
filed by the Company under the Act in connection with the firm commitment underwritten offering of its securities to the general public is consummated or when the Company first becomes subject to the
periodic reporting requirements of Sections 12(g) or 15(d) of the 1934 Act, whichever event shall first occur. 

        2.5.    Right of First Refusal on Dispositions by the Majority Shareholder.    

        (a)   If
at any time the Majority Shareholder desires to sell all or any part of the Majority Shareholder's Ordinary Shares to a third party (the "Proposed Majority
Shareholder Transferee"), the Majority Shareholder shall first submit to Sigma Tau (i) a bona fide written 

12

 

offer
from the Proposed Majority Shareholder Transferee to purchase such Ordinary Shares (which, upon acceptance by the Majority Shareholder, would constitute a legally binding obligation) and
(ii) a written offer from the Majority Shareholder (the "Majority Shareholder Offer") to sell such Ordinary Shares (the "Majority Shareholder Offered Securities") to Sigma Tau on terms and
conditions, including price, not less favorable than those on which the Majority Shareholder proposes to sell such Majority Shareholder Offered Securities to the Proposed Majority Shareholder
Transferee. The Majority Shareholder Offer shall disclose the identity of the Proposed Majority Shareholder Transferee, the Majority Shareholder Offered Securities proposed to be sold, the total
number of Ordinary Shares owned by the Majority Shareholder, the terms and conditions, including price, of the proposed sale, and any other material facts relating to the proposed sale and shall
include a copy of the Majority Shareholder Offer to purchase from the Proposed Majority Shareholder Transferee. The Majority Shareholder Offer shall further state that Sigma Tau may acquire, in
accordance with the provisions of this Agreement, all, but not less than all, of the Majority Shareholder Offered Securities for the price and upon the other terms and conditions, including deferred
payment (if applicable), set forth therein. 

        (b)   If
Sigma Tau desires to purchase all, but not less than all, of the Majority Shareholder Offered Securities, Sigma Tau shall communicate in writing its election to
purchase to the Majority Shareholder within two (2) business days of the date the Majority Shareholder Offer was made to Sigma Tau. Such communications shall, when taken in conjunction with the
Majority Shareholder Offer, be deemed to constitute valid, legally binding and enforceable agreement(s) for the sale and purchase of such Majority Shareholder Offered Securities. 

        (c)   If
Sigma Tau elects to purchase the Majority Shareholder Offered Securities, the sales of such Majority Shareholder Offered Securities to Sigma Tau, pursuant to this
Section 2.4 shall be made at the offices of the Company or counsel to the Company on the fifth (5th) business day following the date the Majority Shareholder Offer was made pursuant to
subsection (a) above (or if such day is not a business day, then on the next succeeding business day). Such sale shall be effected by the Majority Shareholder's delivery to Sigma Tau of
certificates or other instruments evidencing the Majority Shareholder Offered Securities to be purchased by it, duly endorsed for transfer, against payment to the Majority Shareholder of the purchase
price therefor by Sigma Tau. 

        (d)   If
Sigma Tau does not elect to purchase all of the Majority Shareholder Offered Securities, the Majority Shareholder Offered Securities may be sold by the Majority
Shareholder at any time within five business days after the date the Majority Shareholder Offer was accepted, rejected or lapsed pursuant to subsection (b) above. Any such sale shall be to the
Proposed Majority Shareholder Transferee and at not less than the price and upon other terms and conditions, if any, not more favorable to the Proposed Majority Shareholder Transferee than those
specified in the Majority Shareholder Offer. Any Majority Shareholder Offered Securities not sold within such five business day period shall continue to be subject to the requirements of a prior offer
pursuant to this Section 2.4. 

        (e)   Sigma
Tau's right of first refusal provided in this Section 2.5 shall not apply (i) in conjunction with the sale of the Company to an unaffiliated third
party whether by merger, consolidation or sale of shares in a transaction in which the Majority Shareholder's shares are also sold or transferred; or (ii) in conjunction with a public offering
pursuant to an effective registration statement under the Act. 

        (f)    If
the Majority Shareholder is subject to a transfer of its Ordinary Shares by any bankruptcy or insolvency law or proceeding, any divorce proceeding or otherwise by
operation 

13

 

of
law (other than by death), or if any transfer of Ordinary Shares is made or attempted contrary to the provisions of this Agreement, Sigma Tau will have the right to purchase any or all of such
Ordinary Shares from the Majority Shareholder, his, her or its legal representative or transferees at any time before or after the transfer, at the price, if any, paid for or proposed to be paid for
such Ordinary Shares or for fair market value as determined under subsection (g), whichever is less. 

        (g)   The
fair market value of the Ordinary Shares subject to purchase pursuant to subsection (f) will be jointly determined by the Majority Shareholder and Sigma Tau,
or if they are unable to agree, by such other appraiser as the Majority Shareholder and Sigma Tau may jointly choose. The Majority Shareholder shall bear all of the fees and expenses arising out of
the appraisal. 

        (h)   The
agreements set forth in this Section 2.5 shall terminate and be of no further force or effect when the sale of Ordinary Shares pursuant to a registration
statement filed by the Company under the Act in connection with the firm commitment underwritten offering of its securities to the general public is consummated or when the Company first becomes
subject to the periodic reporting requirements of Sections 12(g) or 15(d) of the 1934 Act, whichever event shall first occur. 

        2.6.    Drag-Alone Rights.    At any time prior to an initial public offering of securities of the
Company, in the event that (i) the Company receives a bona fide offer from any party unaffiliated with any party to this Agreement (such party a "Third Party Offeror" and such an offer the
"Third Party Offer") to purchase all or substantially all of the Company's issued and outstanding Ordinary Shares in a transaction (including a merger) for consideration equal to not less than $9 per
share (such price subject to equitable adjustments for share splits, share dividends, combinations, recapitalizations, reclassifications and similar events occurring after the effective date hereof),
(ii) such transaction is approved by the Board of Directors of the Company, and (iii) the holders (the "Proposing Shareholders") of shares representing a majority of the votes
represented by all then outstanding Ordinary Shares of the Company approve or otherwise consent in writing to such transaction, then Sigma Tau will be required, if so demanded by the Proposing
Shareholders, to vote Sigma Tau's Shares in favor thereof, and otherwise consent to and raise no objection to such transaction, and waive any dissenters' rights, appraisal rights or similar rights
that Sigma Tau may have in connection therewith, and take all necessary and desirable actions as directed by the Company's Board of Directors and the Proposing Shareholders in connection with the
consummation of such transactions, including, to the extent applicable, executing a purchase agreement and selling, exchanging or otherwise transferring all
of the Shares held by Sigma Taus to such Third Party Offeror at the same price and upon the same terms and conditions as the Third Party Offer. If Sigma Tau fails or refuses to vote its Shares as
required by the terms of this Section 2.6, the President of the Company shall be deemed to be granted by Sigma Tau an irrevocable proxy, coupled with an interest, to vote Sigma Tau's Shares in
accordance with this Section 2.6. 

        3.    Miscellaneous.    

        3.1.    Successors and Assigns.    Except as otherwise provided herein, the terms and conditions of this Agreement
shall inure to the benefit of and be binding upon the respective successors and assigns of the parties (including transferees of any shares of Registrable Securities). Subject to Sections 2.4, 2.5 and
2.6, if applicable, nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies,
obligations, or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement. 

14

 

        3.2.    Governing Law.    This Agreement shall be construed in accordance with and governed by the laws of the State
of New York without regard to principles of conflicts of laws. In the event that a judicial proceeding is necessary, the exclusive forums for resolving disputes arising out of or relating to this
Agreement are either the Supreme Court of the State of New York in and for the County of New York or the federal courts for such State and County, and all related appellate courts, the parties hereby
irrevocably consent to the jurisdiction of such courts and agree to said venue. 

        3.3.    Counterparts.    This Agreement may be executed in two or more counterparts, each of which shall be deemed an
original, but all of which together shall constitute one and the same instrument. 

        3.4.    Titles and Subtitles.    The titles and subtitles used in this Agreement are used for convenience only and are
not to be considered in construing or interpreting this Agreement. 

        3.5.    Notices.    Except as otherwise expressly specified herein, all notices, requests and other communications
required or permitted hereunder shall be in writing and shall be sent by an internationally recognized overnight courier service; by certified or registered mail, return receipt requested (or in the
case of a notice sent to an address in Italy, by international express mail, return receipt requested); by facsimile transmission or by hand delivery. 

        The
address for such notices and communications shall be as follows: 

If
to the Company:

Gentium S.p.A.

Piazza XX Settembre, 2

22079 Villa Guardia Como

Italy

Attention: Dott. Sauro Carsana

Fax: +39 031 385333 

If
to Sigma Tau: 

To
the address set forth in the Share Purchase Agreement or such other address as provided by Sigma Tau to the Company in writing. 

Any
party may designate a different notice address, contact person, telephone number or facsimile number with respect to such party by providing a notice describing such changes to the other party
hereto in accordance with the provisions of this Section 3.5. Any notice sent by internationally recognized overnight mail courier service shall be deemed to be delivered to the address shown
on the mailing receipt on the expected date of delivery upon proper evidence of mailing for purposes of this Section 3.5. Any notice sent by certified or registered mail, return receipt
requested (or, in the case of a notice sent to an address in Italy, by international express mail, return receipt requested), shall be deemed to be delivered five business days after mailing. Any
notice sent by facsimile transmission shall be deemed delivered as of the open of business on the business day following the date on which sent provided the sender receives written confirmation of
transmission and provided that within 24 hours such notice is also sent by regular mail or by an internationally-recognized overnight mail courier service to the appropriate address specified
above. Any notice sent by hand delivery shall be deemed delivered as of the date of delivery. 

        3.6.    Expenses.    If any action at law or in equity is necessary to enforce or interpret the terms of this
Agreement, the prevailing party shall be entitled to reasonable attorneys' fees, costs and necessary disbursements in addition to any other relief to which such party may be entitled. 

        3.7.    Amendments and Waivers.    Any term of this Agreement may be amended and the observance of any term of this
Agreement may be waived (either generally or in a particular 

15

 

instance
and either retroactively or prospectively), only with the written consent of the Company and the holders of a majority-in-interest of the Registrable Securities then
outstanding. Any amendment or waiver effected in accordance with this paragraph shall be binding upon each holder of any Registrable Securities then outstanding, each future holder of all such
Registrable Securities, and the Company. 

        3.8.    Severability.    The holding of any provision of this Agreement to be invalid or unenforceable by a court of
competent jurisdiction shall not affect any other provision of this Agreement, which shall remain in full force and effect. If any provision of this Agreement shall be declared by a court of competent
jurisdiction to be invalid, illegal or incapable of being enforced in whole or in part, such provision shall be interpreted so as to remain enforceable to the maximum extent permissible consistent
with applicable law and the remaining conditions and provisions or portions thereof shall nevertheless remain in full force and effect and enforceable to the extent that they are valid, legal and
enforceable, and no provisions shall be deemed dependent upon any other covenant or provision unless so expressed herein. 

        3.9.    Entire Agreement.    This Agreement sets forth the entire agreement and understanding between the parties as
to the subject matter hereof and merges and supersedes all prior discussions, agreements and understandings of any and every nature among them. 

[Remainder
of page intentionally left blank] 

16

        IN
WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written. 

	 	 	GENTIUM S.P.A.
	 	 	By:	 	/s/ Laura Iris Ferro
	 	 	 	 	
 Name:

Title: L'amministratore Unico
	 	 	SIGMA TAU FINANZIARIA SpA
	 	 	By:	 	/s/ Antonio Nicolai
	 	 	 	 	
 Name: Antonio Nicolai

Title: Amministratore Delegato

QuickLinks

Exhibit 4.5

INVESTORS' RIGHTS AGREEMENT

RECITALS

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