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Exhibit 10.15    
    

 
 

LICENSE AND SUPPLY AGREEMENT    
    By and Between    
    GENTIUM S.p.A.    
    AND    
    SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SpA    
    Dated as of December 7th, 2001    

 
 
 

TABLE OF CONTENTS    
    

	SECTION I—DEFINITIONS	 	4
	

SECTION II—LICENSE	
 	

7
	2.1	 	License Grant	 	7
	2.2	 	Trademarks	 	7
	2.3	 	Development	 	8
	2.4	 	Reservation of Ownership	 	8
	2.5	 	Gentium Know-How	 	8
	

SECTION III—DEVELOPMENT	
 	

8
	3.1	 	Development Activities	 	8
	3.2	 	Cooperation	 	8
	3.3	 	Variations	 	9
	3.4	 	Discontinuation	 	9
	

SECTION IV—REGULATORY MATTERS	
 	

10
	4.1	 	Regulatory Matters	 	10
	4.2	 	Manufacturing Facilities	 	10
	4.3	 	Meetings	 	10
	4.4	 	Clinical Studies	 	10
	

SECTION V—CONSIDERATION	
 	

10
	5.1	 	ST's Contribution in the Development	 	10
	5.2	 	Licensing Fee	 	11
	5.3	 	Royalty Payments	 	11
	5.4	 	Inspection	 	11
	

SECTION VI—MARKETING	
 	

11
	6.1	 	Marketing Obligation	 	11
	6.2	 	Recalls and Other Remedial Actions	 	12
	6.3	 	Safety Agreement	 	12
	6.4	 	Compliance with Law	 	12
	

SECTION VII—PROMOTIONAL MATERIAL AND PRODUCT PACKAGING	
 	

13
	7.1	 	Promotional Materials; Promotion of Finished Product	 	13
	7.2	 	Product Packaging	 	13
	7.3	 	Quality Audit	 	13
	

SECTION VIII—SUPPLY	
 	

14
	8.1	 	Finished Product Supply	 	14
	8.2	 	Terms of Sale	 	14
	8.3	 	Forecasts	 	14
	8.4	 	Finished Product Quality Control	 	14
	8.5	 	Inspection of Finished Product Shipped	 	15
	

SECTION IX—NEW PRODUCT	
 	

15
	9.1	 	Development of the New Product	 	15
	9.2	 	First Refusal Right	 	15
	

SECTION X—TERM AND TERMINATION	
 	

16
	10.1	 	Term	 	16
	10.2	 	Termination; General	 	16
	10.3	 	Survival of Obligations	 	17
	10.4	 	Effect of Termination	 	17
	 	 	 	 	 

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SECTION XI—CONFIDENTIAL INFORMATION	
 	

17
	11.1	 	Confidential Information	 	17
	11.2	 	Injunctive Relief	 	18
	11.3	 	Publication	 	18
	

SECTION XII—DISPUTE RESOLUTION	
 	

18
	12.1	 	Dispute Resolution	 	18
	12.2	 	Jurisdiction	 	19
	

SECTION XIII—REPRESENTATION AND WARRANTIES	
 	

19
	13.1	 	Intellectual Property	 	19
	13.2	 	Gentium Indemnification	 	20
	13.3	 	ST Indemnification	 	20
	13.4	 	Disclaimer	 	20
	

SECTION XIV—MISCELLANEOUS	
 	

20
	14.1	 	Governing Law	 	20
	14.2	 	Waiver	 	20
	14.3	 	Notices	 	21
	14.4	 	Force Majeure	 	21
	14.5	 	Entire Agreement	 	21
	14.6	 	Amendments	 	21
	14.7	 	Headings	 	21
	14.8	 	Severability	 	21
	14.9	 	Registration and Filing of the Agreement	 	22
	14.10	 	Assignment	 	22
	14.11	 	Successors and Assigns	 	22
	14.12	 	Counterparts	 	22
	14.13	 	Third-Party Beneficiaries	 	22
	14.14	 	Relationship of the Parties	 	22
	14.15	 	LIMITATION OF DAMAGES	 	22
	14.16	 	Taxes	 	23
	14.17	 	Payment Currency	 	23
	

Schedule 1—Patent	
 	

24
	Schedule 2—ST's Contribution in the Development	 	25
	Schedule 3—Development Activities	 	26
	Schedule 4—Tasks and Works for FDA's Approval of Gentium's Plant	 	27
	Schedule 5—Supply Price and Terms	 	28
	Schedule 6—Product Specifications	 	29

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LICENSE AND SUPPLY AGREEMENT    
    

        THIS AGREEMENT ("Agreement"), dated as of December 7th, 2001 (the "Effective Date"), by and between Gentium
S.p.A, a corporation organized under the laws of Italy and having a principal place of business at Piazza XX Settembre, 2, Villa Guardia (Como), Italy, capital stock Euro
5.000.000.- fully paid-up, registered with the Company register of Como No 29927, Fiscal Code and VAT Code No. 02098100130("Gentium"), and  Sigma-Tau Industrie Farmaceutiche Riunite SpA, a
corporation organized under the laws of Italy and having its registered offices at Viale
Shakespeare 47, 00144 Rome, Italy, capital stock Euro 15.860.000 fully paid-up, registered with the Company register of Rome No 1468/57, Fiscal Code No. 00410650584 and VAT Code
No. 00885531004 ("ST") (with each of Gentium and ST referred to herein individually as a "Party" and collectively as the "Parties"). 

        WHEREAS,
Gentium and its Affiliates have certain rights in the Territory in and to the Compound, which enable Gentium to make, have made, use, and sell the Product; 

        WHEREAS,
Gentium and its Affiliates desire to cooperate with ST to Market the Product in the Territory; 

        WHEREAS,
ST possesses expertise in the development and marketing of pharmaceutical products through its R&D and technical operations department as well as its Affiliates' sales
representatives and sales channels in the Territory; 

        NOW,
THEREFORE, in consideration of the following mutual promises and obligations, and for other good and valuable consideration, the adequacy and sufficiency of which are hereby
acknowledged, the Parties agree as follows: 

 
 

SECTION I—DEFINITIONS    
    

        Capitalized terms used in this Agreement, whether used in the singular or plural, except as expressly set forth herein, shall have the meanings set forth below: 

	1.1
	"Affiliate" shall mean, with respect to any Person, any other Person which controls, is controlled by, or is under common control with
such Person. A Person shall be deemed to control another Person if such Person possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of such
Person, whether through the ownership of voting securities, by contract or otherwise.

	1.2
	"Agreement" shall have the meaning set forth in the introductory paragraph.

	1.3
	"Approval" shall mean the approval, registration, license or authorization from FDA required for the manufacture, Development,
Marketing, sale, storage or transport of the Product in the Territory.

	1.4
	"Business Day" shall mean any day other than a Saturday or a Sunday or any day of the month of August or a day on which commercial
banks either in New York City, NY, USA, or Milan, Italy, are authorized or required by Law to remain closed. "Business Hours" shall mean the time period
encompassed between 9 a.m. and 5 p.m. of a Business Day.

	1.5
	"Compound" shall mean the active ingredient whose International Non-proprietary Name (INN) is defibrotide, including
isomers and polymorphs thereof and salts of the foregoing.

	1.6
	"Confidential Information" shall mean all information or materials possessed or developed by either Gentium or ST or their respective
Affiliates, whether developed before or after the Effective Date, in relation to Development, promotion, marketing, distributing and selling any Product hereunder, including, without limitation,
information or materials on substances, formulations, techniques, technology, equipment, data, reports, Know-How, sources for supply, patent position and business plans;  provided however, that
Confidential Information shall not include information 

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or
material that is (i) already in the public domain as of the Effective Date by reason of prior publication or otherwise; (ii) received by a receiving Party on an unrestricted basis
from a Third Party other than the disclosing Party, where such Third Party is authorized to disclose such information; (iii) part of the public domain after the Effective Date through no act,
omission or fault of the receiving Party; or (iv) similar in nature to the purported confidential information but has been independently created. 

	1.7
	"Develop" shall mean to engage in research or development activities (including, without limitation, clinical trials) or to have any of
those activities performed, and "Development" shall have a corresponding meaning.

	1.8
	"Effective Date" shall have the meaning set forth in the introductory paragraph.

	1.9
	"FDA" shall mean the United States Food and Drug Administration and any successor agency thereto.

	1.10
	"Finished Product" shall mean Product which has been formulated, finished and secondarily packaged by Gentium (or its designated Third
Party(ies) manufacturer(s)) in accordance with the Product Specifications. Once the relevant first refusal right leads to a licence agreement for any New Product, such New Product will be deemed to be
included in this definition of Finished Product.

	1.11
	"Force Majeure" shall have the meaning set forth in Article 14.4.

	1.12
	"Good Manufacturing Practices" or "GMP" shall mean current Good Manufacturing Practices (including without limitation good
distribution practices and guidelines) as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the manufacture, distribution or sale of
the Product in the Territory or where the Product is manufactured pursuant to its regulations, guidelines or otherwise.

	1.13
	"Governmental Authority" shall mean any court, agency, authority, department, regulatory body or other instrumentality of any
government or country or of any national, federal, state, provincial, regional, county, city or other political subdivision of any such government or any supranational organization of which any such
country is a member.

	1.14
	"IND" shall mean an Investigational New Drug Application filed with the FDA including but not limited to the case where a new drug is
designated as an "orphan drug" under Federal and State Laws applicable in the U.S.A..

	1.15
	"Know-How" shall mean any and all proprietary technical information, know-how, data, test results, knowledge,
techniques, discoveries, inventions, specifications, designs, regulatory filings, and other information (whether or not patentable) which are now or hereafter during the Term owned, licensed or
otherwise held by a Party or its Affiliates with the rights to license or sublicense the same and that relate to the Product or the Development, manufacture, use, offer for sale or sale thereof.

	1.16
	"Law" shall mean all laws, statutes, rules, regulations, orders, judgments, injunctions and/or ordinances of any Governmental
Authority.

	1.17
	"Market"/"Marketing" shall mean the distribution, sale and marketing of the Finished Product, supplied by Gentium or its designated
Affiliate, which is to be conducted independently and under the Trademark by ST or a ST Affiliate in the Territory in accordance with the terms and conditions of this Agreement.

	1.18
	"NDA" shall mean a New Drug Application filed with the FDA, including but not limited to the case where a new drug is designated as an
"orphan drug" under U.S. Federal and State Laws. 

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	1.19
	"Net Sales" shall mean the invoice price billed by ST or its Affiliates to Third Parties on sales of the Finished Product in bona fide
arm's length transactions, less value added or excise taxes of a similar nature paid on the sale of the Finished Product. Sales from ST or its Affiliates to their Affiliates shall be excluded from the
calculation of Net Sales until the sale by the Affiliate to unaffiliated third party, at which time Net Sales shall be calculated as if ST had made such sale to the unaffiliated third party on the
same terms as the sale by the Affiliate.

	1.20
	"New Product" shall mean (a) any pharmaceutical form of the Product other than "intravenous"; (b) a pharmaceutical
product containing the Compound as the active ingredient and intended for: (i) the prophylaxis of veno-occlusive disease; or (ii) the mobilisation of hematopoietic
progenitors/stem cells.

	1.21
	"Packaging Specifications" shall mean the specifications as determined by the Parties for the packaging of the Product, such
specifications to comply with all applicable current Good Manufacturing Practices, all applicable requirements necessary for FDA Approval, and any other such applicable Laws.

	1.22
	"Party" shall have the meaning set forth in the introductory paragraph.

	1.23
	"Patent" shall mean any of the issued patents and patent applications listed in Schedule 1, until such issued patents and
patent applications have not been declared invalid in the Territory in a final nonappellable order, which, for purposes of this Agreement, shall include reissue patents, patent term extensions,
supplementary protection certificates, re-examination certificates and the like, and also any other patent applications and patents which will be licensed to or owned by Gentium or its
Affiliates during the Term and that contains at least one claim that encompasses or embraces the Compound per se or a process for production relating to the Compound or a use of the Compound.

	1.24
	"Patent Rights" shall mean those rights of Gentium and its Affiliates under the Patents.

	1.25
	"Person" shall mean and include an individual, partnership, joint venture, limited liability company, a corporation, a firm, a trust,
an unincorporated organization and a government or other department or agency thereof.

	1.26
	"Product" shall mean a pharmaceutical product in intravenous formulation containing Compound as the active ingredient and intended
only for the treatment of hematopoietic stem cell transplant patients with hepatic veno-occlusive disease.

	1.27
	"Product Launch" shall mean, with respect to the Territory, the first date of commercial sale of Product (including sale for Treatment
IND once the Net Sales of the Product have reached US$ 500,000 or after six months from the first sale for Treatment IND, whichever comes first) to Third Parties in the Territory.

	1.28
	"Product Specifications" shall mean the specifications for the Product, such specifications to comply with all applicable current Good
Manufacturing Practices, all applicable requirements for Approval. The Product Specifications shall be completed upon Approval and included in Exhibit 6 hereof. Gentium may modify the Product
Specifications from time to time, subject to Approval and Good Manufacturing Practices.

	1.29
	"Promotional Material" shall have the meaning set forth in Article 7.1.

	1.30
	"Safety Agreement" shall have the meaning set forth in Article 6.4.

	1.31
	"Term" shall have the meaning set forth in Article 10.1.

	1.32
	"Territory" shall mean the United States of America.

	1.33
	"Third Party" shall mean any Person other than Gentium or ST or any Affiliate of either Party. 

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	1.34
	"Trademark" shall mean the trademark or such other trademarks, trade names, logos, trade dress and/or indicia of origin owned by
Gentium or any of its Affiliates, which are licensed to ST pursuant to Articles 2.2(a) and (b) for the purpose of identifying the Finished Product to be marketed by ST or its Affiliates in
Territory.

	1.35
	"Treatment IND" shall mean the treatment use of an investigational new drug pursuant to US 21 CFR § 312.34. 

 
 

SECTION II—LICENSE    
    

        2.1    License grant.    

        Subject
to the terms of this Agreement, including without limitation Article 9.2.2, the exceptions set forth in Article 2.4 below and the rights retained by Gentium and its
Affiliates hereunder in connection with the Product, Gentium grants to ST, for the Term, the exclusive, non-transferable, non divisible licence under the Patent Rights and the
Know-How to Market the Finished Product in the Territory, with the right to sub-license its rights to one of its Affiliates in the Territory. 

        2.2    Trademarks.    

        (a)   All
packaging, labelling, advertising and Promotional Material used in connection with Marketing the Finished Product by ST shall feature the Trademark. ST shall not
(i) use more than one trademark in connection with the Finished Product in the Territory, (ii) sell the Finished Product under its generic name, or (iii) use any trademark which
is confusingly similar or is a colorable imitation of the Trademark. 

        (b)   For
the purpose of the Article 2.2(a), Gentium, subject to Article 9.2.2, shall grant ST in the Territory exclusive, non-transferable, non
divisible license to use such Trademark in the Territory during the Term in connection with the Finished Product for purposes of this Agreement. 

        (i)    ST
acknowledges that it will acquire no rights to Trademark or any other Gentium trademark by virtue of its use, or the use by its Affiliates, of the Trademark or any
such Gentium trademark pursuant to this Agreement. Gentium shall own and retain all rights to association of trademark, service marks, copyrights, or goodwill associated therewith, and all use of a
Trademark by ST (or its Affiliate sublicensees) shall, at all times, inure to the benefit of Gentium. ST hereby agrees to use the Trademark solely in a manner that does not deleteriously affect the
rights of Gentium. All uses of the Trademark or any Gentium trademark by ST shall comply with applicable Law. 

        (ii)   ST
shall, upon request from Gentium, assist Gentium in any action reasonably necessary or desirable to protect Gentium's rights in the Trademark used or intended to be
used hereunder by ST in the Territory. 

        (iii)  Upon
request by Gentium, ST shall execute such documents as may reasonably be required by Gentium for the purpose of recording any license granted under this
Article 2.2 with any Governmental Authority. 

        (iv)  If
either Party or its Affiliates learn of a claim or assertion that the use of the Trademark infringes or otherwise violates the intellectual or industrial property
rights of any Third Party or that any Third Party violates the intellectual or industrial property rights of Gentium or its Affiliates in the Trademark, then the Party (or its Affiliate) becoming so
informed shall promptly, but in all events within ten (10) calendar days thereof, notify the other Parties to this Agreement of this claim or assertion. At its sole discretion, Gentium shall
conduct all infringement actions relating to the Trademark at its own expense and shall be entitled to any and all damages, costs and fees awarded and any amounts paid in settlement as a result of
such action. ST and its 

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Affiliates
shall assist Gentium and cooperate in any such infringement litigation at Gentium's reasonable request. 

        (v)   If
so requested in writing by Gentium, ST shall discontinue the use of the Trademark or any other Gentium trademark upon notice that such use is, on a good faith and
documented basis, an infringement of such Third Party's rights. All liability arising out of ST's continuing use of the Trademark or any other Gentium trademark shall be borne by ST. In such an event,
ST and Gentium shall attempt in good faith to agree on a new Trademark that is acceptable to both Parties for use in the Territory. 

        (vi)  Each
Party shall retain all right, title and interest in and to its respective corporate logos. 

        2.3    Development    

        Without
prejudice to Article 4.4 hereof, during the Term, ST shall not engage in any Development activities, including, without limitation, clinical trials, with respect to the
Product without the express prior written consent of Gentium; for Phase IV clinical trials the need of Gentium's consent will be limited to the relevant protocol. Nothing in this Agreement shall be
deemed to be an express or implied license under any of Gentium's intellectual property to undertake any such Development activities. 

        2.4    Reservation of Ownership.    

        Except
for rights specifically granted to ST in this Agreement, Gentium shall own and retain all right title, and interest in the Compound, Product, the Patent Rights, the Trademark, any
Know-How developed by Gentium pursuant to, or prior to, this Agreement, and all rights not specifically granted herein to ST. 

        2.5    Gentium Know-How.    

        Gentium
shall periodically disclose to ST in a timely manner in order to permit the purpose of this Agreement to be fully realized, its Know-How, and other information in its
possession or control relating to the Compound and the Product, and which it may lawfully disclose. Gentium shall also provide reasonable technical assistance to ST to permit ST to use the
Know-How. 

        During
the Term, ST shall inform Gentium in writing of any Know-How developed by ST or its Affiliates ("ST Know-How"). ST agrees to grant Gentium an exclusive but
for ST license to use the ST Know-How worldwide except, during the Term, the Territory, with the right to sublicense. Such license shall be royalty-free, unless the ST
Know-How is patentable, in which case the Parties shall negotiate in good faith the relevant terms and conditions for the grant of said license. 

 
 

SECTION III—DEVELOPMENT    
    

        3.1    Development Activities    

        Gentium
shall use all commercially reasonable efforts to continue the Development of the Product in accordance with the timing set forth in Schedule 3 hereof, provided however
that Gentium shall have reasonable flexibility in conducting the Development of the Product and in committing to it its resources. The Parties shall consult each other on a regular basis to check the
progress made on the activities listed in Schedule 3. Gentium shall be excused from any delay in completion of a stage due to an action or failure by ST or to any action or failure to act by
FDA or any other Governmental Authority whose Approval is reasonably necessary to permit Gentium to perform its activities. 

        3.2    Cooperation    

        ST
shall actively cooperate with Gentium for the Development of the Product providing its expertise and allocating to said cooperation appropriate resources. Each Party shall nominate a
Person 

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who
shall be responsible for coordinating all activities and matters arising from the Development of the Product and to whom all reports, information, instructions and other communications from either
Party shall be addressed. ST shall have the right at any time to have its representatives observe said activities and documents of Gentium relating thereto at Gentium premises upon prior reasonable
notice during Business Hours, and Gentium shall seek ST's previous agreement on the plan, milestones and schedule of the Development of the Product and on the relevant submissions to FDA or any other
Governmental Authority. Any disagreement which could not be resolved by the Persons responsible for the coordination of the Development work, shall be referred to the senior management of the Parties. 

        3.3    Variations    

        Either
Party shall promptly inform the other Party as soon as it becomes aware of any event which is likely to cause a variation or materially impair the continuation of the Development
of the Product. If such event (including but not limited to unforeseen requests by FDA or any other Governmental Authority), notwithstanding the exercise of due care, is likely to cause a material
increase of the budget allocated for the Development of the Product and/or the schedule thereof, the Parties shall discuss in good faith a revision of the Development plan and the terms and conditions
of this Agreement (including but not limited to the Consideration provided for in Section V). In the event that the Parties shall not agree upon the continuation of the Development of the
Product within thirty (30) Business Days of the starting of the negotiation, each Party shall have the right to terminate this Agreement by thirty (30) days written notice to the other
Party. 

        3.4    Discontinuation.    

        The
failure to meet an estimated completion date shall not constitute a breach of this Agreement if Gentium is using all reasonable efforts to complete a stage. However, in the event
that (i) Gentium unilaterally discontinues the Development of the Product; or (ii) this Agreement is terminated pursuant to Article 3.3 above; and Gentium, within
thirty-six (36) months of the termination resumes the Development of the Product, substantially availing itself of the stages previously completed, either independently or with a
Third Party, then Gentium shall promptly reimburse ST for all sums paid by ST according to Article 5.1 hereof, increased by the interest calculated at the Italian legal rate from the dates of
each payment. Gentium shall promptly notify ST of its decision(s) to discontinue or resume the Development of the Product and shall provide ST with any and all documentation reasonably necessary to
competently prove such discontinuation and resuming. 

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SECTION IV—REGULATORY MATTERS    
    

        4.1    Regulatory Matters.    

        Gentium
(through its Affiliates as appropriate) shall use all reasonable efforts in order to obtain, in its own name and at Gentium's expense, all Approvals necessary for Marketing the
Product in the Territory, including the IND, according to the timing set forth in Schedule 3 hereto. All Approval applications, Approvals, supporting documentation and data relating to the
Product shall be deemed the property of Gentium or its designated Affiliate and shall be treated by the Parties and their respective Affiliates as Confidential Information of Gentium. Gentium, subject
to Article 9.2.2, hereby grants to ST an exclusive, non transferable, non divisible, license to use any Approval obtained by Gentium in the Territory for purposes of this Agreement. 

        4.2    Manufacturing facilities.    

        The
Parties acknowledge that the Approval by FDA of the Gentium plant in Villa Guardia (Como), Italy, which will be obtained and maintained by Gentium in its own name and at its own
expenses, is part of the Approvals. Schedule 4 outlines the tasks and the works concurrently envisaged by the Parties, on a good faith and basis in order to obtain Approval of the Gentium
plant. Gentium shall use all reasonable efforts to complete said tasks and works consistently with Schedule 3 and the provisions of Article 3.1 and shall keep ST timely and properly
informed of such activities. Gentium shall be excused from any delay in completion of a task or work due to an action or failure to act by ST or to any action or failure to act by FDA or any other
Governmental Authority whose Approval is reasonably necessary to permit Gentium to perform said task and works. The failure to meet an estimated completion date shall not constitute a breach of this
Agreement if Gentium is using all reasonable efforts to complete a task or work. Article 3.4 shall apply, mutatis mutandis, to the tasks and
works outlined in Exhibit 4. 

        4.3    Meetings.    

        In
the event that ST or Gentium or any of their respective Affiliates receive any request from a Governmental Authority for a meeting, conference or discussions concerning the Product,
or any
Approval application or Approval relating to the Product in the Territory, each Party shall immediately notify the other of such request, and the Parties shall determine and agree upon in good faith
the manner in which the Parties should respond to any such request. It is understood by the Parties that if attendance at any meeting, conference or discussion with a Governmental Authority in the
Territory is strictly limited, attendance shall be based on expertise in relation to the Product. 

        4.4    Clinical Studies.    

        If,
after an Approval is obtained in the Territory, additional clinical studies are required by a Governmental Authority in the Territory or deemed necessary by the Parties, subject to
Article 2.3 hereof, the Parties and their respective Affiliates shall cooperate to perform such studies and shall share the costs of such studies if so agreed by the Parties at the time the
studies become necessary. 

 
 

SECTION V—CONSIDERATION    
    

        5.1    ST's contribution to the Development.    

        In
consideration for and as a contribution to Gentium's initiation of the Development and costs incurred in connection therewith, the sharing of Gentium's technical and clinical data
necessary or useful to conduct same, Gentium generating the Know-How and have its plant approved by the FDA according to Article 4.2 above, the first refusal rights granted under
Article 9.2 below, ST shall pay to Gentium the amounts specified in Schedule 2 hereto on the dates specified therein and, when appropriate, upon receiving the relevant documentation
showing the occurrence. Such payments shall 

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be
non-refundable, subject to the provisions of Article 3.4 hereof. No other compensation or reimbursement, whatsoever shall be due by ST for the Development of the Product. 

        5.2    Licensing Fee.    

        In
consideration of the rights granted hereunder in the Territory for the Product, ST shall pay Gentium a seven percent (7%) royalty on the Net Sales. 

        5.3    Royalty Payments.    

        Royalty
payments shall be determined in United States currency and ST shall pay or cause to be paid to Gentium in United States currency within forty-five (45) days
following the last day of each calendar quarter during the Term, royalties which have accrued to Gentium during such calendar quarter. Each payment shall be accompanied by a reasonably detailed
accounting of the Net Sales, the payment due and ST method of calculating such payment. 

        5.4    Inspection.    

        Gentium
shall have the right, during the Term and for a period of two (2) years following any termination of this Agreement, to have a public accountant, to whom ST has no
reasonable objection, examine the relevant books and records of ST during Business Hours to determine whether appropriate accounting and payment have been made by ST hereunder. ST shall retain any
such books and records for the period of time subject to Gentium's right of inspection. 

 
 

SECTION VI—MARKETING    
    

        6.1    Marketing Obligations.    

        ST
shall commit a commercially reasonable level of resources to promote and sell the Finished Product in the Territory. ST shall refrain, outside the Territory, from seeking actively
customers for the Finished Product by whatever means, and from establishing branches and maintaining any distribution facilities engaged in Marketing the Finished Product. 

        6.2    Recalls and Other Remedial Action.    

        (a)   ST
shall have the right to initiate any recall, withdrawal or other remedial action regarding the Finished Product in the Territory, but only where such recall,
withdrawal or other remedial action is due to or caused by the negligence, misconduct or misrepresentation of ST or any of its Affiliates, or by ST's breach of the terms of, or failure to meet its
obligations under, this Agreement, including, without limitation, with regard to the packaging for transport, transport, storage, distribution and promotion of the Finished Product by ST. 

        (b)   Except
as set forth in Article 6.3(a), Gentium, through its designated Affiliates, as appropriate, shall have the right to initiate any recall, withdrawal or
other remedial action regarding the Product in the Territory. Before Gentium, through its local Affiliates, as appropriate, initiates any recall or withdrawal, the Parties shall immediately discuss in
good faith the reasons therefor. 

        (c)   If
ST is aware that a recall, withdrawal or other remedial action is or may be required in the Territory, ST shall immediately notify Gentium in writing with a
follow-up telephone call. 

        (d)   ST
shall, at all times, maintain an effective tracking system for the Finished Product and an effective system for the recall or withdrawal of the Finished Product in
the Territory. ST shall inform Gentium of such system, which shall be subject to Gentium's approval. 

        (e)   In
the event of a recall, withdrawal or other remedial action, the implementing Party and its Affiliates shall be given any and all necessary assistance by the other
Party and its Affiliates. 

11

 

        (f)    Gentium
shall be responsible for all of the direct and indirect costs of a recall, withdrawal or other remedial action, which is the result of a failure to comply with
Product Specifications due to the negligence or misconduct of Gentium or its Affiliates or is made according to Article 6.3 (b) above. To the extent that the recall is due to or caused
by the negligence, misconduct or misrepresentation of ST or any of its Affiliates, or by ST's breach of the terms of, or failure to meet its obligations under this Agreement (including, without
limitation, with regard to the packaging for transport, transport, storage, distribution and promotion of the Product), ST shall be responsible for all costs associated with the recall. 

        6.3    Safety Agreement.    

        Both
Parties agree to be bound by a Safety Agreement to be agreed between the designated safety representatives of the Parties within four (4) months of the Effective Date. Such
Safety Agreement shall include provisions for post-Approval pharma-covigilance and related post-Approval activities. Each party agrees to give the other any and all necessary
or reasonably requested assistance in order to comply with all post-Approval requirements, including but not limited to, quarterly reports, semi-annual reports and annual
reports, company registration and drug listing. 

        6.4    Compliance with Law.    

        Notwithstanding
anything to the contrary in this Agreement, each Party shall comply (and shall cause its Affiliates to comply) with all applicable Laws, including, without limitation,
all applicable Laws with respect to the Marketing of pharmaceutical products in the Territory. No Party or any of its Affiliates shall be required to undertake any activity which violates, or which it
believes, in good faith, may violate, any Law in the Territory and/or elsewhere. 

12

  

 
 

SECTION VII—PROMOTIONAL MATERIAL AND PRODUCT PACKAGING    
    

        7.1    Promotional Materials; Promotion of Finished Product.    

        (a)   ST
will develop its own promotional, advertising, communication and educational materials relating to the Finished Product (collectively, "Promotional Materials")
strictly based on the clinical data for the Product. ST shall bear all of its own costs and expenses of advertising and promotion for the Finished Product in the Territory. ST shall promote the
Finished Product and provide information about the Finished Product as permitted by the Laws of the Territory through the distribution of Promotional Materials. ST nor its Affiliates shall make any
medical claim for the Finished Product beyond the scope of the Approvals then in effect for the Product. 

        (b)   Subject
to the provisions of Article 7.1 (a) above, in order to ensure consistency of Promotional Material with the scientific and clinical profile of the
Product, ST shall only use Promotional Materials which have been approved in writing by Gentium (or its designated Affiliate) as to the accuracy of their technical, scientific and medical content. ST
shall submit to Gentium (or its designated Affiliate) all Promotional Materials before their proposed use. Gentium (or its designated Affiliate) shall be deemed to have approved such Promotional
Materials if it does not raise any objections thereto within 10 (ten) Business Days of submission of the relevant Promotional Materials. In the event that Gentium (or its designated Affiliate) raises
any objection to any Promotional Materials, ST and Gentium (or its designated Affiliate) shall discuss and agree timely in good faith upon appropriate amendments to such Promotional Materials
consistent with the scientific and clinical profile of the Product. 

        7.2    Product Packaging.    

        The
Parties, subject to the Packaging Specifications, shall agree upon and develop the packaging and package inserts for the Finished Product. The Parties agree further that: 

        (a)   Each
Finished Product shall be packaged in accordance with the Packaging Specifications as reflected in the NDA and other Approvals for the Product. 

        (b)   Each
Finished Product shall be packaged in accordance, in all material respects, with all Laws applicable to the packaging of the Product, including, without limitation,
all GMP requirements. ST shall sell the Finished Product and distribute the Finished Product only with labels, printed packaging materials and inserts, the format, content and type (including the
appearance of the relevant Gentium company name as licensor) which shall have been submitted to and approved by Gentium in writing, such approval not to be unreasonably withheld or delayed. 

        7.3    Quality Audit.    

        ST
shall conduct its activities pursuant to this Agreement, including storage and distribution of the Finished Product, in compliance with the Law, the Good Manufacturing Practices and
all FDA post-Approval requirements. ST shall make that all records and reference samples related to the Finished Product, available for inspection by Gentium or its designated Affiliate
during Business Hours. Such inspection shall be announced by Gentium to ST in writing at least two weeks prior to the proposed date of inspection. Records made available for inspection hereunder shall
include records relevant to assessing the quality of a Finished Product in the event of a complaint or a suspected defect. Inspection by Gentium or its designated Affiliate shall be conducted only by
qualified personnel from Gentium or its designated Affiliate and shall be limited to determining whether there is compliance with this Agreement, any Approvals, Good Manufacturing Practices and other
requirements of applicable Laws. ST shall obtain and maintain, all at its cost, all licenses, consents and Approvals of applicable Governmental Authorities or Third Parties necessary or desirable in
connection with its activities. 

13

 

 
 

SECTION VIII—SUPPLY    
    

        8.1    Finished Product Supply    

        ST
shall purchase from Gentium all its requirements of Product for Marketing the same in the Territory, according to the terms and conditions set forth in Schedule 5 hereto.
Gentium or its designated Affiliate shall be the exclusive supplier of the Finished Product to ST in the Territory. Gentium undertakes to supply ST with all its requirements of the Finished Product in
the Territory during the Term. The Finished Product supplied to ST will conform to the Product Specifications. 

        8.2    Terms of Sale    

        Gentium
or its designated Affiliate shall supply the Finished Product to ST in the Territory on terms and conditions set forth in Schedule 5 hereto. 

        8.3    Forecasts.    

        (a)   ST
shall deliver to Gentium at the beginning of every month a report which forecasts the requirements of ST for the Finished Product for the next twenty-four
(24) months in quarterly intervals, the portion of the forecast for the immediately upcoming three (3) months being considered a firm commitment. ST shall place firm orders for Finished
Product not later than ninety (90) days prior to the desired delivery date from Gentium in Villa Guardia (Como), Italy. Each order shall be for a number of full batches of Finished Product, the
quantities for any batch to be communicated to ST as soon as available and part batches of Finished Product shall not be ordered by ST unless previously agreed upon between the Parties. 

        (b)   Notwithstanding
anything else in this Agreement, in the event that and so long as Gentium or its designated Affiliate is unable to provide an adequate supply of properly
forecasted amounts of the Finished Product in spite of having acted with documented reasonable diligence to satisfy its supply obligation ("Gentium non-ability"): (i) Gentium shall
immediately notify ST by giving also proper evidence of the reason of such occurrence and Gentium's obligation to supply the Finished Product shall be suspended;  provided, that Gentium shall continue to
exercise reasonable diligence to satisfy its supply obligation by also allocating then-existing
inventory equitably between ST, Gentium and other distributors; (ii) Gentium shall do its best in order to find a timely and proper alternative to Gentium non-ability, leaving
unchanged the economic terms and conditions at which ST will be supplied; (iii) should Gentium be unable to find a proper alternative to or to cure Gentium non-ability within ninety
(90) days of ST receiving the notification above, ST shall have the right to manufacture the Product so long as the Gentium non-ability lasts and ST shall be released from its purchase
obligations under Article 8.1. Provided that Gentium complies with (i) (ii) (iii) above, Gentium shall not be liable for any damages related to, arising out of or in connection
with Gentium non-ability, whether such damages be claimed in tort or contract and whether direct or indirect, special, consequential or otherwise. Notwithstanding the foregoing, under no
circumstances shall Gentium be obligated to deliver the total quantity of Finished Product ordered by ST if such quantity exceeds, by twenty percent (20%) or more, the firm commitment given by ST in
the report sent to Gentium in the immediately preceding quarter, but Gentium shall use all reasonable efforts to supply ST with the quantities exceeding the forecast, provided however that the
quantities exceeding the forecast shall not be considered in determining the Gentium non-ability. 

        8.4    Finished Product Quality Control.    

        Gentium
shall endeavor to provide proper quality assurance and quality control procedures regarding the Finished Product. Gentium, and any Third Party manufacturer or supplier acting on
its behalf, shall retain batch data records and quality control certificates for each batch of the Finished Product and, if requested by ST, will promptly provide such information to ST. Such records
shall be 

14

 

retained
for the longest period required by applicable Law. The Finished Product will be supplied to ST together with the relevant certificate of analysis and any other documentation required so that
the Finished Product is ready for sale. 

        8.5    Inspection of Finished Product Shipped.    

        Within
thirty (30) days after receipt of any shipment of Finished Product, ST will be entitled to check the quantity of Finished Product received and inspect the Finished Product
to verify that it complies with the Product Specifications. In the event the Finished Product supplied by Gentium or its designated Affiliate is less than the quantity ordered or does not conform with
the Product Specifications, ST shall inform Gentium of such fact in writing within thirty (30) days from receipt of the non-conforming Finished Product. Unless such notice relates
to a quantity shortfall, without the prior written consent of Gentium, ST and its Affiliates shall not use the alleged non-conforming Finished Product. Gentium shall replace all such
non-conforming Finished Product free of charge as promptly as practicable. Such replacement cost shall constitute the entire liability of Gentium and its Affiliates for nonconforming
Finished Product. Should Gentium contest any evidence given by ST concerning the non-conformity, both Parties shall immediately and jointly carry out the necessary analysis to verify
whether ST's complaint is justified. In the event the parties are unable to reach an agreement as to ST's complaint, the matter at stake will be submitted to an independent laboratory, chosen by
mutual agreement by the parties, which decision shall be binding and which costs shall be borne by the party who is found at fault. 

 
 

SECTION IX—NEW PRODUCT, FIRST REFUSAL RIGHTS    
    

        9.1    Development of the New Product.    

        Gentium
shall have the right to conduct upon its own initiative the Development of any New Product and shall keep ST timely and accurately informed of any such activity. Gentium shall
discretionally study and review all the available technical, chemical, pharmacological and clinical data and market information relating to the New Product to determine the feasibility and the
prospective of the Development, Approval and manufacture in commercial quantities of the New Product. 

        9.2    First Refusal Right.    

        Gentium
hereby grants to ST exclusive irrevocable rights of first refusal for an exclusive license to Market the New Product in the Territory. Such first refusal right shall be exercised
according to the following terms: 

        9.2.1    Offer.    At any time after the Effective Date, should Gentium decide to offer Marketing rights on the New
Product in the Territory, Gentium shall notify in writing to ST a proposal of an agreement granting ST the relevant license. Such proposal shall include: (a) a description of the then current
status of the Development of the New Product; (b) an outline of the investigations, tasks, and time required to achieve the Approval of the New Product in the Territory; (c) the economic
terms and conditions for the license and supply of the New Product. Gentium hereby agrees that it shall not offer Marketing rights on the New Product in the Territory prior to the lapse of a
12-month period from the Effective Date. 

        9.2.2    Negotiation.    Within thirty (30) days of the notification of the proposal from Gentium pursuant to
Article 9.2.1, Gentium and ST shall engage in good faith discussions in order to negotiate the relevant agreement. In the event the Parties do not reach an agreement within ninety
(90) days of the notification of the proposal from Gentium pursuant to Article 9.2.1, or within the agreed upon extension of said 90-day term, Gentium shall be free to offer
the New Product and the Product to any Third Party provided that such Third Party accepts the same terms and conditions already offered for the New
Product to, and refused by ST. 

15

 

        9.2.3    Within the 60-day period following the expiration of the 90-day period referenced to in
Article 9.2.2 above, ST shall have the right (a) to continue the license granted by Gentium to ST pursuant to Section II and Article 4.1 on a semi-exclusive
basis; or (b) to request that Gentium, upon the execution of the license agreement between Gentium and the Third Party (the "Third Party License Agreement") (which event shall be notified by
Gentium to ST promptly after its occurrence), buy out all Marketing rights then owned by ST or its Affiliate and all business and goodwill associated to the Product ("ST put right"). In the event that
ST does not exercise either the right to continue the license on a semi-exclusive basis or, alternatively, it does not exercise the ST put right, Gentium shall have within the following
60-day period the right to buy out all Marketing rights then owned by ST or its Affiliate and all business and goodwill associated to the Product ("Gentium call right").    

        9.2.4    The price for Gentium's buying out all Marketing rights then owned by ST or its Affiliate and all business and goodwill
associated to the Product shall be determined as follows: (a) the Net Sales of the twelve (12) months preceding the expiration of the 90-day period provided for in
Article 9.2.2 above multiplied by 2.2 (two times point two); or, in the event that the execution of the Third Party License Agreement occurs before a 12-month period from the Launch
has elapsed, (b) the amount of the contribution actually paid by ST pursuant to Article 5.1, increased by the interest calculated at Italian legal rate from the dates of each payment.
Said price shall be paid: (a) in case of the exercise of the Gentium call right, within ten (10) business days of Gentium exercising the Gentium call right; (b) in case of
exercise of the ST put right, upon the first commercial sale of the New Product by the Third Party; provided however that ST shall have the right to continue selling the Product in the Territory and
Gentium shall continue to supply ST with the Product until the first commercial sale of the New Product by the Third Party.    

        If
neither Party exercises the Gentium call right or the ST put right within 120 days of the 90-day term provided above in Article 9.2.2 or any extension
thereof, then ST shall be deemed to have exercised the right to continue the license granted by Gentium to ST pursuant Section II and Article 4.1 on a semi-exclusive basis. 

 
 

SECTION X—TERM AND TERMINATION    
    

        10.1    Term.    

        This
Agreement shall be effective from the Effective Date until: (i) the eighth anniversary of the Product Launch; or (ii) the expiration of the US Patent n. 5,223,609 or
any extension thereof, whichever occurs later. 

        10.2    Termination: General.    

        Subject
to Article 3.3, this Agreement shall be terminable forthwith, upon written notice, if one or more of the following events should occur: 

        (a)   by
either Party, if the other Party commits a material breach of this Agreement that is material to the transactions contemplated by this Agreement, which breach shall
not have been remedied within ninety (90) days from the other Party giving written notice requiring such breach to be remedied; provided, that
any such termination shall be without prejudice to the terminating Party's rights at law, at equity and otherwise; 

        (b)   by
either Party, due to the other Party's negligence, willful misconduct or misrepresentation in connection with this Agreement resulting in material harm to the
terminating Party (or its Affiliates); provided, that any such termination shall be without prejudice to the terminating Party's rights at law, at
equity and otherwise; 

16

  

        (c)   by
either Party, if the other Party or the business of the other Party including, in whole or in part, the activities and the goodwill contemplated by this Agreement, is
assigned or controlled by a Person other than the Person(s) owning or controlling such other Party as of the Effective Date; provided however that this right of termination shall not apply if the
affected Party or the business of such Party remains vested in the individuals or their family members (limited to spouse and direct relatives under Italian Law) who ultimately own or control Gentium
or ST as of the Effective Date. 

        10.3    Survival of Obligations.    

        Notwithstanding
any termination of this Agreement, (a) neither Gentium nor ST shall be relieved of any obligations incumbent upon such Party and already enforceable prior to such
termination, and (b) the obligations of the Parties with respect to the protection and nondisclosure of Confidential Information in accordance with Section XI, as well as other
provisions which by their nature are intended to survive any such termination, shall survive and continue to be enforceable. Upon any termination of this Agreement, Gentium and ST shall, and shall
ensure that their respective Affiliates shall promptly destroy (subject to written certification of the destruction) or return to the other Party all written Confidential Information, and all copies
thereof (except one copy which may be kept in a Party's restricted file for record-keeping purposes only), belonging to such other Party and ST shall have no further right with respect to, and shall
cease all activities related to Marketing of the Product in the Territory. 

        10.4    Effect of Termination.    

        Notwithstanding
any other rights or obligations a Party may have under this Agreement, or under Law, upon termination of this Agreement by Gentium under Article 10.2 above:
(i) all requisite Approvals, authorizations, permits, licenses, filings, registrations; (ii) any Approval applications thereof; and (iii) any other regulatory records obtained
pursuant to this Agreement, in the Territory, shall be assigned to, and exclusively owned by Gentium. The Parties and their Affiliates shall cooperate in informing relevant Governmental Authorities of
the cessation of ST's activities in relation to the Product and use of the Trademark. 

        Upon
termination of this Agreement by ST under Article 10.2, ST shall, at its sole discretion: i) sell to Gentium the Product in ST's inventory at the price paid to Gentium
for the supply for the finished Product; or ii) continue to sell the Product in ST's inventory for a period not exceeding six (6) months. 

        Upon
termination of this Agreement by Gentium under Article 10.2, Gentium shall, at its sole discretion: i) re-purchase the Product in ST's inventory at the
price paid by ST for the supply for the finished Product; or ii) let ST continue to sell the Product in ST's inventory for a period not exceeding six (6) months. 

        Upon
the natural expiry of this Agreement, ST or its Affiliate shall have the right to continue to use the Approvals and the Trademark in the Territory, (a) paying a royalty of
two percent (2%) on the Net Sales; or (b) royalty-free if and as long as the Parties agree on the continuation of the supply
provisions provided for in Section VIII and terms and conditions thereof. 

 
 

SECTION XI—CONFIDENTIAL INFORMATION    
    

        11.1    Confidential Information.    

        (a)   Each
of Gentium and ST acknowledges that all Confidential Information provided by the other Party or its respective Affiliates is confidential and proprietary to such
other Party or its respective Affiliates and agrees to (i) maintain such information in confidence during the Term and any extended Term of this Agreement and for a period of seven
(7) years thereafter and (ii) during the 

17

 

Term,
use such information solely for the purpose of performing its respective obligations hereunder. Each of Gentium and ST covenants that neither it nor any of its respective Affiliates shall
disclose any such information except to its employees, agents or any other Person under its authorization; provided, such employees, agents or Persons
under its authorization are subject in writing to substantially the same confidentiality obligations as the Parties and their respective Affiliates. The foregoing confidentiality obligations shall not
apply to Confidential Information which is required to be disclosed to a Governmental Authority by applicable Law, in which case the disclosing Party shall promptly notify the other Party of such
disclosure and the procedures, such as a protective order, instituted to protect the confidentiality of the Confidential Information to be disclosed. 

        (b)   ST
agrees that prior to dissemination or disclosure by it or any of its Affiliates of any technical or scientific information which may contain Confidential Information
owned or developed by either Party relating to the Compound or the Product it shall provide to Gentium an advance copy of any such proposed publication or dissemination prior to submission for
publication. Gentium shall have a reasonable opportunity to recommend any changes it reasonably believes are necessary to preserve Confidential Information and the incorporation of such recommended
changes shall not be unreasonably refused. If Gentium informs ST, within thirty (30) days of receipt of an advance copy of a proposed publication, that such publication in its reasonable
judgment could be expected to have a material adverse effect on the commercial value of any technical or scientific Confidential Information, then ST shall delay or prevent such publication as
proposed by Gentium. In the case of inventions, the delay shall be sufficiently long to permit the timely preparation and filing of a patent application(s) or application(s) for a certificate of
invention on the information involved. 

        11.2    Injunctive Relief.    

        Each
Party acknowledges that damages resulting from disclosure of the Confidential Information would be an inadequate remedy and that, notwithstanding the provisions of
Section XII, in the event of any such disclosure or any indication of an intent to disclose such information, the Party (or its Affiliates) owning such information shall be entitled to seek, by
way of private litigation, injunctive relief or other equitable relief in addition to any and all remedies available at law or in equity, including the recovery of damages and reasonable attorneys'
fees. 

        11.3    Publication.    

        During
the Term and any extension thereof, Gentium and ST agree not to issue any press releases or public announcements concerning this Agreement (and to ensure that their respective
Affiliates do not do so) without the prior written consent of the other Party to the form, timing and content of any such release or announcement, except as required by a Governmental Authority and
applicable Law. Neither Party shall unreasonably withhold or delay its consent to any such press release or announcement. Except as required by Law or any agreements under which Gentium or its
Affiliates holds the Compound Patent Rights, neither Party (or their respective Affiliates) shall disclose to any Third Party, under any circumstances, any financial terms of this Agreement that have
not been previously disclosed publicly pursuant to this Section XI without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed. 

 
 

SECTION XII—DISPUTE RESOLUTION    
    

        12.1    Dispute Resolution.    

        The
Parties agree that, subject to Article 11.2, they, including their Affiliates, as applicable, shall use commercially reasonable efforts to resolve any dispute, controversy or
claim arising out of or relating to this Agreement or the validity, breach, termination or interpretation thereof, by good faith negotiation and discussion. 

18

 

        12.2    Jurisdiction.    

        (a)   Subject
to Article 12.1, in the event that the Parties are unable to resolve any dispute, controversy or claim between the Parties arising out of or relating to
this Agreement or the validity, breach, termination or interpretation thereof, through the procedures described in Article 12.1 above, the dispute, controversy or claim shall be finally settled
by the Court of Milan (Italy), which shall have the exclusive jurisdiction. 

 
 

SECTION XIII—REPRESENTATIONS AND WARRANTIES    
    

        13.1    Intellectual Property.    

        (a)   Gentium
represents and warrants to ST that, as of the Effective Date, (i) to the best of its knowledge, it owns or has all necessary licenses or rights in the
Territory to use the subject matter claimed by any Patent, (ii) to the best of its knowledge, neither the manufacturing of any Product nor the promotion, marketing and sale of any Product by
the Parties in the Territory will infringe upon any valid rights of any other Person and neither Gentium nor any of its Affiliates has received any written notice alleging any such infringement,
(iii) the rights granted to ST hereunder do not, to Gentium' knowledge, conflict with rights granted by Gentium to any Third Party and (iv) neither Gentium nor any of its Affiliates has
received any notice concerning the institution or possible institution of any interference, opposition, reexamination, reissue, revocation or nullification involving any Patent or any administrative
proceeding challenging the validity of any Patent. 

        (b)   In
the event that patent infringement proceedings are commenced by a Third Party against ST or ST's distributors or agents (collectively "Indemnitees") for alleged
infringement by any of them in the Territory of a patent which covers an invention alleged to encompass the manufacture, use or sale of the Product, ST shall notify Gentium promptly of the
commencement thereof. Gentium agrees to defend, indemnify and hold harmless ST from liability to any Third Party for costs (including attorneys' fees) and damages awarded against Indemnitees for such
infringement of said patents of the Third Party, provided Gentium has been given the opportunity to defend such suit at its own expense. This
indemnification and hold harmless provision by Gentium shall in no case exceed an amount equal to the Licensing Fees received by Gentium pursuant to Article 5.2. 

        (c)   If
ST and Gentium should agree (or failing agreement, should an independent patent counsel appointed by Gentium advise) that a patent owned by or licensed to a Third
Party would be infringed by the activities performed by the Indemnitees under this Agreement, then Gentium shall use all reasonable endeavors to obtain at its expense a license under such patent from
the owner or licensee thereof which would enable Indemnitees to continue their activities under this Agreement. Should Gentium not obtain such license for Indemnitees, ST may directly negotiate and
obtain such license from the Third Party, in which event Gentium may credit in full any royalty paid to the Third Party for such license against any amount of royalties Indemnitees would otherwise owe
Gentium under this Agreement. 

        (d)   Each
Party shall promptly notify the other Party of any possible infringement by a Third Party of any Patent Rights. Gentium shall have the right but not the obligation
to commence proceedings in respect to such infringement and agrees to permit ST to join as a co-plaintiff if ST so desires. If Gentium fails to so commence proceedings within ninety
(90) days of infringement's notice, ST shall entitled to prosecute the infringers at its expense and Gentium shall lend ST any reasonable assistance. Recoveries in any patent infringement
proceeding shall be for the benefit of both Parties proportionately to the expenses incurred by each of them in connection with such proceedings. 

19

 

        13.2    Gentium Indemnification.    

        Gentium
shall indemnify ST from all liability to Third Parties or expenses of litigation (including attorneys' fees) resulting from or arising out of (a) clinical trials of the
Product; (b) the negligent or intentionally wrongful acts or omissions of Gentium; (c) the Development, manufacturing, handling, possession or use of the Compound, Product and Finished
Product by Gentium, its Affiliate or its designee, unless such liability arising out of or resulting from this Article 13.2 results from or arises out of (i) the breach or
misrepresentation by ST of its warranties or obligations hereunder or (ii) the negligent or intentionally wrongful acts or omissions by ST. 

        13.3    ST Indemnification.    

        ST
shall indemnify Gentium from all liability to Third Parties or expenses of litigation (including attorneys' fees) resulting from or arising out of (a) promotion, distribution,
sale, handling, possession or use of the Finished Product by ST; (b) the negligent or intentionally wrongful acts or omissions of ST; or (c) the breach or misrepresentation by ST of its
warranties or obligations hereunder; unless such liability arising out of or resulting from this Article 13.3 results from or arises out of (i) the breach or misrepresentation by Gentium
of its warranties or obligations hereunder or (ii) the negligent or intentionally wrongful acts or omissions by Gentium. 

        13.4    Disclaimer.    

        Except
as expressly set forth herein, no Party makes any express or implied warranties, statutory or otherwise, concerning the value, adequacy, freedom from fault of, other quality,
efficiency, stability, characteristics or usefulness of, or merchantability, or fitness for a particular purpose of, any Product; provided,  however,
nothing contained in this Section XIII shall be deemed a waiver of, or be deemed to limit, the obligations of each Party hereunder or
under any other agreement between the Parties. 

 
 

SECTION XIV—MISCELLANEOUS    
    

        14.1    Governing Law.    

        This
Agreement shall be governed by and construed in accordance with the Laws of Italy. 

        14.2    Waiver.    

        Waiver
by a Party of a breach hereunder by the other Party shall not be construed as a waiver of any succeeding breach of the same or any other provision. No delay or omission by a Party
in exercising or availing itself of any right, power or privilege hereunder shall preclude the later exercise of any such right, power or privilege by such Party. No waiver shall be effective unless
made in writing with specific reference to the relevant provision(s) of this Agreement and signed by a duly authorized representative of the Party granting the waiver. 

20

   
        14.3    Notices.    

        All
notices, instructions and other communications hereunder or in connection herewith shall be in writing, shall be sent to the address of the relevant Party set forth in the
introductory paragraph of this Agreement, and shall be (a) delivered personally, (b) sent by registered or certified mail, return receipt requested, postage prepaid, (c) sent via
a reputable international overnight courier service, or (d) sent by facsimile transmission (except in the case of notices of termination, which should be sent by a, b or c). Any such notice,
instruction or communication shall be delivered in the case of (a) upon receipt, (b) and (c) upon signature of the receipt by the receiving Party, and (d) when transmitted
with electronic confirmation of receipt, if such transmission is on a Business Day, or otherwise, on the next Business Day following such transmission. Either Party may change its address by giving
notice to the other Party in the manner provided above. 

        14.4    Force Majeure.    

        In
the event of strikes, lock-outs or other industrial disturbances, rebellions, mutinies, epidemics, landslides, lightning, earthquakes, fires, storms, floods, sinking,
drought, civil disturbances, explosions, acts or decisions of duly constituted municipal, state or national Governmental Authorities or of courts of Law, as well as impossibility to obtain equipment,
supplies, fuel or other required materials, in spite of having acted with reasonable diligence, or by reason of any other causes, which are not under the control of the Party requesting the abatement
of performance, or causes due to unexpected circumstances which may not be possible to eliminate or overcome with due diligence by such Party ("Force Majeure"), the Parties agree that, if either
Gentium or ST finds itself wholly or partially unable to fulfill its respective obligations in this Agreement by reasons of Force Majeure, the Party affected will advise the other Party in writing of
its inability to perform, giving a detailed explanation of the occurrence of the event which excuses performance immediately after the cause or event has occurred. If such notice is given, the
performance of the Party giving the notification shall be abated, and any time deadlines shall be extended for so long as performance may be prevented by Force Majeure. Subject to Article 8.3
(b), should one party fail to perform and fulfill its obligations stated above for more than ninety (90) consecutive days or more, the parties agree to negotiate in good faith either
(i) to resolve the contingencies or find an alternative solution, if possible; (ii) to extend by mutual agreement the time period to resolve, eliminate, cure or overcome such
contingencies; or (iii) to terminate this Agreement upon the terms and conditions agreed upon at that time. 

        14.5    Entire Agreement.    

        This
Agreement (including Schedules) contains the complete understanding of the Parties with respect to the subject matter hereof and supersedes all prior understandings and writings
relating to the Product. 

        14.6    Amendments.    

        No
provision in this Agreement shall be supplemented, deleted or amended except by a written document duly executed by Gentium and ST. 

        14.7    Headings.    

        Headings
in this Agreement are for convenience of reference only and shall not be considered in construing this Agreement. 

        14.8    Severability.    

        If
any provision of this Agreement is held unenforceable by a court or tribunal of competent jurisdiction because it is invalid or conflicts with any Law of any relevant jurisdiction,
the validity of the remaining provisions shall not be affected. The Parties shall negotiate a substitute provision that, to the extent possible, accomplishes the original business purpose. 

21

 

        14.9    Registration and Filing of the Agreement.    

        To
the extent, if any, that a Party concludes in good faith that it is required to file or register this Agreement or a notification thereof with any Governmental Authority in accordance
with applicable Law, such Party may do so; provided, however, that it provides the other Party with no
less than ten (10) Business Days' written notice of its intent to do so, and discusses in good faith with such other Party its reasons for doing so. In such situation, the Parties will request
confidential treatment of sensitive provisions of this Agreement, to the extent permitted by Law. The Parties shall promptly inform each other as to the activities or inquiries of any such
Governmental Authority relating to this Agreement and shall cooperate to respond to any request for further information therefrom. 

        14.10    Assignment.    

        Except
as otherwise expressly provided herein, neither this Agreement nor any of the rights or obligations hereunder may be assigned by either Gentium or ST without (a) the prior
written consent of ST in the case of any assignment by Gentium or (b) the prior written consent of Gentium in the case of an assignment by ST, except in each case, subject to
Article 10.3(d), to an Affiliate of the assigning Party
or to any other party who acquires all or substantially all of the business of the assigning Party by merger, sale or assets or otherwise, so long as (a) such Affiliate or other Party agrees in
writing to be bound by the terms of this Agreement; and (b) such Affiliate remains an Affiliate of the Assigning Party. Any attempted assignment in violation hereof shall be void. 

        14.11    Successors and Assigns.    

        This
Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns. 

        14.12    Counterparts.    

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

        14.13    Third-Party Beneficiaries.    

        None
of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party including, without limitation, any creditor of any Party hereto. No such Third
Party shall obtain any right under any provision of this Agreement or shall by reason of any such provision make any claim in respect of any debt, liability or obligation (or otherwise) against any
Party hereto. 

        14.14    Relationship of the Parties.    

        Each
Party shall bear its own costs incurred in the performance of its obligations hereunder without charge or expense to the other except as expressly provided in this Agreement.
Neither Gentium nor ST shall have any responsibility for the hiring, termination or compensation of the other Party's employees or for any employee compensation or benefits of the other Party's
employees. No employee or representative of a Party shall have any authority to bind or obligate the other Party to this Agreement for any sum or in any manner whatsoever, or to create or impose any
contractual or other liability on the other Party without said Party's approval. For all purposes, and notwithstanding any other provision of this Agreement to the contrary, ST's legal relationship
under this Agreement to Gentium shall be that of independent contractor. Nothing in this Agreement shall be construed to establish a relationship of partners or joint venturers. 

        14.15    LIMITATION OF DAMAGES.    

        IN
NO EVENT SHALL ST OR GENTIUM BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION, 

22

 

LOSS
OF PROFITS) SUFFERED BY THE OTHER PARTY, EXCEPT TO THE EXTENT OF INDIRECT DAMAGES PAID TO A THIRD PARTY AS PART OF A THIRD PARTY CLAIM. 

        14.16    Taxes.    

        Any
withholding or other taxes, if any, that either Party or its Affiliates are required by Law to withhold or pay on behalf of the other Party, with respect to any payments to it
hereunder, shall be deducted from such payments and paid contemporaneously with the remittance to the other Party; provided, however, that the
withholding Party shall furnish the other Party with proper evidence of the taxes so paid. Each Party shall furnish the other Party with appropriate documents to secure application of the most
favorable rate of withholding tax under applicable Law. 

        14.17    Payment Currency.    

        All
amounts due under this Agreement and any Ancillary Agreement shall be paid to the designated Party in the currency mutually agreed by the Parties for that purpose or, in the event
that no such currency has been agreed by the Parties, in the currency of United States of America. 

        IN
WITNESS WHEREOF, the Parties hereto have caused this Agreement to be signed in duplicate by their respective proper officers. 

	Gentium S.p.A.	 	 
	

By	

/s/  LAURA IRIS FERRO      
	
 	

 
	Name: Laura Iris Ferro MD

Title: Sole Administrator & C.E.O.	 	 
	

Sigma-Tau Industrie Farmaceutiche Riunite SpA	
 	

 
	

By	

/s/  EMILIO PLATE      
	
 	

 
	Name: Dr. Emilio Plate

Title: Chief Operating Officer	 	 

23

   
Schedule 1 

PATENT

US
Pat. 5,223,609; 

US
Pat. 4,985,552; 

US
Pat. 5,646,127; 

US
Pat. 5,646,268: 

PCT/EP01/04105. 

24

 

Schedule 2

ST's Contribution in the Development  

ST
shall pay the total amount of US$ 4,900,000 (United States Dollars four million nine hundred thousand) as follows upon receipt of the relevant invoices: 

US$
1,000,000 within December 31, 2001. 

US$
850,000 within April 30, 2002. 

US$
200,000 within 30 (thirty) days of the end of dose-finding study. 

US$
1,600,000 within thirty (30) days of the issuing of the IND number. 

US$
350,000 within thirty (30) days of the IND issuing for the Phase III pivotal study. 

US$
350,000 within thirty (30) days of the end of the Phase III pivotal study. 

US$
550,000 within thirty (30) days of obtaining the NDA and other Approval necessary for the Product to be Marketed in the Territory by a ST Affiliate. 

25

 

Schedule 3

Development
activities 

	Activity
 
	 	Timing
 

	Dose finding Study Completion	 	3Q 2002
	FDA pre-IND Meeting	 	3Q 2002
	IND submission	 	1Q 2003
	Phase III Pivotal Study	 	Start: 2Q 2003

End: 2Q 2004
	FDA Pre-NDA meeting	 	1Q 2004
	NDA submission	 	2Q 2004
	NDA supplement	 	4Q 2004
	Approval	 	4Q 2005

26

   Schedule 4 

Tasks and works for FDA's Approval of Gentium's Plant

Qualification of Slaughter House

Holding Tank Purchase

Holding Tank Qualification

Existing Mucosa Extraction-Collection Equipment qualification

Delivery Container Modification

Delivery Container Qualification

COMPLETION OF WORKS—1Q 2003 

Upstream Processing

Purchase and Installation of Acid/Base Holding Tanks

Purchase of an Elevator for Movement of Materials

Water Treatment System (Purified Warew and WFI)

Establishment of a Controlled Access to Manufacturing Areas

Scale Purchase and Qualification

Pumps Purchase and Qualification

Modification of Reactor R25

Filter Press System Revision

Installation of SS 316 connectors

Holding Tank S32 Modification

Construction and Installation of a Lipid Interface Detection System

R8 & R9 Tanks modification

New Closed Tank for Clarified Filtrate from Filter Press FP4

Installation for new Piping Connections

Installation of Controlled Environment for Salt addition

New Reactor Purchase and Installation

Purchase of new Piping for the Ultrafilter

Purchase and Installation of a new Tank for Ultrafiltrate Collection

COMPLETION OF WORKS—1Q 2003 

Down Stream Processing

Purchase System to Measure Volume of Process Solutions

R26 Modifications (Insulation, pH System, Piping)

Purchase and Installation of:

SS Tank for Mixing EDTA and NaOH

Scale for the Measurement of added Ingredients

Hopper to add Clarcel FLOMA to the System

HC1 PVC Holding Tank

Closure System to contain the Equipment

Purchase new UF Membranes

Improve area Lighting

Purchasing and Installation of an Enclosure for addition into R21

Installation of a closure for tank used for UF Membrane Washing

Install SS 316 Piping for R2

Purchasing and Installation of Pumps for NaOH and Acetic Acid

Construction of a closed Area to house the Equipment on the roof of the Clean Room

Purchasing and Installation of a Milling Machine

Purchasing of SS Containers for the DS 

Qualification
of all the Equipment (New and Existing)

COMPLETION OF WORKS—1Q 2003 

27

 

Schedule 5

Supply
Price and Terms 

        1.     Gentium
agrees to sell (directly or through its designated Affiliate,) to ST, and ST agrees to purchase from Gentium (or its designated Affiliate), ST's requirements of
Finished Product at a price equal to thirty-one percent (31%) of ST's Net Sales in the Territory (provided,  however, that in no event shall such price fall
below € 50 (Euro 50) per unit of Finished Product) Delivery of
Finished Products shall be EXW (ICC Incoterms 2000) Gentium' manufacturing facility in Villa Guardia, (Como), Italy. 

        2.     The
Parties shall calculate and agree on estimated prices of the Finished Product for the first year of the Term. Thereafter, the estimated prices of the Finished Product
will be based on Net Sales in the Territory during the preceding year. 

        3.     Payment
will be made to Gentium (or as directed by Gentium) within forty-five (45) days of the relevant invoice date or ST's receipt of the Finished
Product, whichever shall occur later. 

        4.     Within
thirty (30) days after the end of each calendar quarter (except for the first year following Product Launch,
where calculation shall be effected at the end of the year), ST's Net Sales shall be calculated based upon the reports provided pursuant to Article 5.3, and an adjustment of the differences
between the price for the Finished Product originally charged for the Finished Product and thirty-one percent (31%) of Net Sales shall be paid by one Party to the other as appropriate. 

        5.     Should
any events unforeseen by, and beyond the control of, the Parties occur that alter Gentium' (or its Affiliates') and/or ST's costs hereunder and materially and
detrimentally affect its economic return on the Finished Product as contemplated on the Effective Date hereof, the Parties shall consult together in order to revise the applicable prices and delivery
terms or other terms of this Agreement on a fair basis. 

28

 

Schedule 6

Product
Specifications 

To
be completed as soon as available. 

29

QuickLinks

Exhibit 10.15

LICENSE AND SUPPLY AGREEMENT By and Between GENTIUM S.p.A. AND SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE SpA Dated as of December 7th, 2001

TABLE OF CONTENTS

LICENSE AND SUPPLY AGREEMENT

SECTION I—DEFINITIONS

SECTION II—LICENSE

SECTION III—DEVELOPMENT

SECTION IV—REGULATORY MATTERS

SECTION V—CONSIDERATION

SECTION VI—MARKETING

SECTION VII—PROMOTIONAL MATERIAL AND PRODUCT PACKAGING

SECTION VIII—SUPPLY

SECTION IX—NEW PRODUCT, FIRST REFUSAL RIGHTS

SECTION X—TERM AND TERMINATION

SECTION XI—CONFIDENTIAL INFORMATION

SECTION XII—DISPUTE RESOLUTION

SECTION XIII—REPRESENTATIONS AND WARRANTIES

SECTION XIV—MISCELLANEOUSQuickLinks
 -- Click here to rapidly navigate through this document

 
 

Exhibit 10.16    
    

 
 

Umbrella Agreement
  between
  CRINOS IF / GENTIUM
  and
  CRINOS / SFS    
    

 
UMBRELLA AGREEMENT  

between 

	1.
	CRINOS—Industria Farmacobiologica S.p.A., a corporation organised and existing under the law of Italy and having its
registered offices in Piazza XX Settembre n. 2,Villa Guardia (CO) Italy, represented by its Vice President and Managing Director Dott.ssa Laura Iris Ferro 

(hereinafter
the "SELLER") 

	2.
	GENTIUM S.P.A., a corporation organised and existing under the law of Italy and having its registered office in Piazza XX Settembre n.
2, Villa Guardia (CO) Italy, represented by its President and Managing Director Dott.ssa Laura Iris Ferro 

(hereinafter
the "LICENSOR") 

(SELLER
and LICENSOR jointly referred to as the ,,SELLERS") 

and 

	1.
	CRINOS S.p.A., a corporation organised and existing under the law of Italy and having its registered office in Milan, Via Pavia, 6,
represented by its Managing Director, Mr Enrique Hausermann, 

(hereinafter
the "BUYER 1") 

	2.
	SFS Stada Financial Services Ltd., a corporation organised and existing under the law of Ireland with its registered offices in
Clonmel Healthcare, Waterford Road, Clonmel, Ireland, represented by its special procurator Mr Enrique Hausermann 

(hereinafter
the "BUYER 2") 

(BUYER
1 and BUYER 2 jointly referred to as the ,,BUYERS") 

WHEREAS  

        A)   SELLER
and LICENSOR, on the one side, and BUYER 1 and BUYER 2, on the other side, respectively do form part of the same company group. 

        B)    SELLER
is operating in the field of research and production of pharmaceuticals Specialities and its active ingredients, having also a division specialized in marketing
and sale of the pharmaceuticals products identified under Exhibit 1 (hereinafter the "Products")
attached to the present agreement. SELLER is also the owner and registered proprietor of several Trade Marks related to the Products (as enlisted in Exhibit 2
A, which will be sold to BUYER 2, and in Exhibit 2
B, which will be sold to BUYER 1) as well as of all AIC related to the Products (as enlisted in  Exhibits 3 A
and 3 B). 

        C)    LICENSOR,
a company also operating in the field of research of pharmaceutical specialties, is the owner and registered proprietor of the patents, respectively covering
the active ingredient "Defibrotide" used in the Product "Prociclide" and the formulation of "Mesalazina" used in the Products related to the trademark "Enterasin" (patents more in detail described in  Exhibits 9
and 10). 

        D)   BUYER
1 is an Italian subsidiary of an international pharmaceutical group focusing on the production, marketing and distribution of pharmaceutical specialties, generics,
OTC and similar products and is willing to acquire the aforementioned division of SELLER, who is willing to transfer to BUYER 1 its rights in the aforementioned division rights. Furthermore BUYER 1
wishes to be granted a license in order to use the patents mentioned in letter C) above for production (only with respect to "Enterasin"), distribution, promotion and sale of the Products
"Prociclide" and "Enterasin", being LICENSOR willing to grant BUYER 1 such license. 

1

 

        E)    BUYER
2 is an Irish subsidiary of the aforementioned international pharmaceutical group and is, for reason of unique company policy, within the group structure designated
to be the holder of all intellectual property rights. Therefore BUYER 2 is interested to acquire the Trademarks as listed in Exhibit 2A, which
SELLER has accepted to transfer to BUYER 2. 

        F)    All
parties have agreed to enter into this agreement which will serve as Umbrella Agreement in order to link the single contracts and agreements that will have to be
executed with regard to the above described operation to one frame agreement, setting also forth the consequences in case of breach of one contract with regard to the other contracts. 

In consideration thereof, it is agreed as follows:  

 
 

Art. 1
  Introductory Statements    
    

        The introductory statements and the enclosure to this Umbrella Agreement form an integral and substantial part
thereof. 

 
 

Art. 2
  Definitions    
    

        2.1   The
terms and expressions listed below are intended as indicated thereafter, when written with a capital. 

        2.2   Definitions:

        "AIC Transfer Agreements" shall mean the agreement between SELLER and BUYER 1 for the transfer of all AIC and authorizations related to
the Products and which are attached to the present Umbrella Agreement under Exhibit 4 A and 4 B.;

        "Assignment of Trademarks" shall mean the assignment of trademarks agreement entered into by SELLER and BUYER 2 attached hereto under  Exhibit 5;

        "Collateral Agreements" shall mean the following agreements: the Sale and Purchase
Agreement, the Assignment of Trademarks, the License Contracts and the  AIC Transfer Agreements,
 to be executed on the Closing Date and attached to the present document.
 

        "Closing Date" shall mean the date this Umbrella Agreement, as well as all other  Collateral Agreements, are executed by
the Parties thereto. 

        "Effectiveness Date" shall mean the date the Collateral Agreements and the  Umbrella Agreement become effective and shall
be the date on which the transfer to CRINOS S.p.A. of all the AIC mentioned in  Exhibit 3A has been authorized and published by the Italian Health Ministry, as defined in Article 1 of
the  Umbrella Agreement;
 

        "Debts" or "Debt" shall mean all debts of SELLER, not guaranteed by mortgages, towards
banks, suppliers, financial institutions (including, but not limited to, leasing companies) and/or lenders or portion thereof, as the context may require, existing on the  Effectiveness Date as enlisted
under Exhibit 6 of the Sale and Purchase Agreement (updated to the  Closing Date); 

        "License Contracts" shall mean the license agreements related the products containing the formulation "Mesalazina"  (Exhibit 9) and the active ingredient
"Defibrotide" (Exhibit 10),
respectively attached hereto under Exhibit 6 and Exhibit 7 entered into by LICENSOR and
BUYER 1; 

        "Ongoing Business" shall mean all assets related to the division of SELLER related to marketing and sale of the  Products in Italy and all contracts necessarily linked
to the activity of such division 

2

 

(such
as e.g. the software license agreement regarding the data transmission handled by the Agents, leasing agreements regarding the passed equipment), including in particular the following: any
turnover reached by the sales of Products in Italy from the Effectiveness Date, all AIC and any know
how, technical and administrative, or otherwise necessary documentation and information related to the Products and to the clients,  Licensing and Distribution Agreements, Deposit
Agreements, Personnel, existing agency contracts with Agents (including all necessary equipment granted
to Agents), and List of Clients, all as defined in the Sale and Purchase Agreement, as well as the
goodwill related to all of the above, all as identified in Exhibit 10 attached to the Sale and Purchase
Agreement; however, it shall not include any credits nor debts of SELLER related to its division of marketing and sale of the  Products, with the sole exception of the
Employment Liabilities;

        "Party" or "Parties" shall mean the BUYERS or the SELLERS or both, depending on the
context. 

        "Sale and Purchase Agreement" shall mean the sale and purchase agreement between SELLER and BUYER 1 relating to the  Ongoing Business of SELLER and attached hereto under
Exhibit 8; 

        "Trade Marks":    shall mean the national and international trade mark registrations and their renewals, details whereof are
shown in Exhibit 2A and 2B attached to the present Umbrella Agreement. 

        "Umbrella Agreement" shall mean the present agreement with its exhibits, undersigned by the Parties. 

        All
terms used in the present Umbrella Agreement, starting with a capital letter and/or written in bold character, shall have the same
meaning used and defined in any other Collateral Agreement.

 
 

Art. 3
  SCOPE OF THE UMBRELLA AGREEMENT    
    

        By means of the present Umbrella Agreement, the PARTIES intend to set forth their mutual understandings with
respect to all of the Collateral Agreements, which shall herewith be deemed to be linked one to the other according to the provisions set forth in the
present Umbrella Agreement. 

 
 

Art. 4
  CONTRACTUAL SCHEME    
    

1.     Sale and Purchase Agreement  

        For the purpose of the above acquisition BUYER 1 and SELLER will execute the Sale and Purchase Agreement attached
hereto under Exhibit 8; said Sale and Purchase Agreement regulates the terms and conditions of
the transfer of certain assets (indicated in Exhibit 10 attached to the Sale and Purchase Agreement) as well as the assignment of certain
agreements (Deposit Agreements and License and Distribution Agreements) to BUYER 1. 

2.     AIC Transfer Agreements  

        For the same purpose, and hence within the same acquisition transaction, BUYER 1 and SELLER will execute the AIC Transfer
Agreements attached hereto under Exhibit 4A and 4B to allow subsequent submission to the Health Ministry of the request
of transfer of all AIC and authorizations related to the Products in favour of BUYER 1. 

3.     Assignment of Trademarks  

        With respect to the Trademarks enlisted in Exhibit 2A
attached to the present Umbrella Agreement, which pursuant to mutual understanding between the Parties are considered an essential 

3

 

part
of the transaction, and which are owned by SELLER, the latter will execute the Assignment of Trademarks attached hereto under  Exhibit 5 with
BUYER 2. 

4.     License Contracts  

        With respect to the patents owned by LICENSOR for the active ingredients and/or formulations used in the Products "Enterasin" and "Prociclide" (such patents
better identified respectively under Exhibit 9 and Exhibit 10 attached to the present  Umbrella Agreement),
 LICENSOR will grant to BUYER 1 a gratuitous license to use the above patents for the production (only with regard to the product
"Enterasin"), distribution, promotion and sale of all Products containing the relevant active ingredients, which license the Parties agree to be an
essential part of the transaction. To this purpose LICENSOR and BUYER 1 will enter into the License Contracts respectively attached hereto under  Exhibit 6 and Exhibit 7. 

5.     Paying off of Debts by SELLER  

        The Parties have agreed that certain payments due by BUYER 1 to SELLER after the Effectiveness Date shall be
conditioned to prior reimbursement of Debts by SELLER pursuant to the provisions set forth under Section 3 of the Sale
and Purchase Agreement. 

 
 

Art. 5
  MUTUAL UNDERTAKINGS    
    

	5.1
	The
PARTIES herewith jointly and severally acknowledge that the above contractual scheme, reflects the mutual understandings between the PARTIES and therefore cannot for any reason be
completed, if one of the above Collateral Agreements is not executed by the parties thereto.

	5.2
	In
light of the foregoing, BUYERS and SELLERS mutually agree that any breach by either Party with respect to the relevant Collateral
Agreement, which will entitle such Party to terminate the relevant Collateral Agreement, shall entitle the counter-party to each
of any other Collateral Agreement to terminate the relevant Collateral Agreement. In particular, for the
avoidance of doubts and as mere examples and without any limitation, it is agreed as follows:

	a)
	SELLER
consents that any breach by LICENSOR to any of the License Contracts, which will entitle BUYER 1 to terminate the relevant  License Contracts, shall entitle
BUYER 1 to terminate any of the Sale and Purchase Agreement, the  AIC Transfer Agreements;

	b)
	SELLER
also consents that any breach by LICENSOR to any of the License Contracts, which will entitle BUYER 1 to terminate the relevant  License Contracts, shall
entitle BUYER 2 to terminate the Assignment of Trademarks;

	c)
	BUYER
1 consents that any breach by BUYER 2 to the Assignment of Trademarks, which will entitle SELLER to terminate the  Assignment of Trademarks, shall entitle
SELLER to terminate any of the Sale and Purchase Agreement
and/or the AIC Transfer Agreements; 

4

  

	d)
	BUYER
1 also consents that any breach by BUYER 2 to the Assignment of Trademarks, which will entitle SELLER to terminate the  Assignment of Trademarks, shall
entitle LICENSOR to terminate any of the License Contracts;

	e)
	BUYER
2 consents that any breach by BUYER 1 with respect to either of the Sale and Purchase Agreement, the AIC
Transfer Agreements and/or any of the License Contracts, which will entitle SELLER to terminate any of said contracts, will
entitle SELLER to terminate the Assignment of Trademarks.

	f)
	LICENSOR
consents that any breach by SELLER with respect to either of the Sale and Purchase Agreement, the AIC
Transfer Agreements and/or any of the License Contracts, which will entitle BUYER 1 to terminate any of said contracts, shall
entitle BUYER 2 to terminate the Assignment of Trademarks.

	5.3
	Pursuant
to Section 4.3 of the Sale and Purchase Agreement, it is further agreed that in case BUYER 1, for whatsoever reason, is not, or will not, be granted, also in part, by
the competent authorities the transfer of the AIC referred to in the AIC Transfer Agreement, the relevant value as indicated in the relevant column of
Exhibit 10 of the Sale and Purchase Agreement shall be deducted from the Purchase Price to be
paid to SELLER. In such case, BUYER 2 consents to reassign to SELLER the relevant trademark related to such AIC. Such reassignment shall be, however, conditioned to reimbursement to BUYER 2 of the
price received by SELLER for such trade mark under the Assignment of Trademarks.

	5.4
	Should
BUYER 1 not be granted the transfer of all AIC relating to a certain Product, but only of part of them, BUYER 2 shall maintain the ownership of the relevant trademark and will
grant to SELLER a gratuitous sale concession for the Products related to the AIC, which have not been transferred to BUYER 1. 

 
 

Art. 6
  Duration    
    

        The present Umbrella Agreement shall become effective on the Effectiveness Date (as defined under Section 2.2 above) and shall remain effective until full
payment of the Purchase Price by BUYER 1 to SELLER pursuant to the Sale and Purchase Agreement.. 

 
 

Art. 7
  Miscellaneous    
    

7.1   Notices  

        All reports, notices and communications required or permitted to be given or made pursuant to this Umbrella
Agreement by one Party to the other Parties shall be validly given or made if sent by registered letter to all of the other Parties hereto respectively to the following
addresses: 

To
SELLER 1:
 Crinos S.p.A.—Industria Farmacologica S.p.A.    (or respectively its new denomination as result from its undertaking to change its
current commercial name pursuant to Section 9.5 of the Sale and Purchase Agreement)

Piazza
XX Settembre n. 2

22079 Villa Guardia (CO)

To the attention of Dott.ssa Laura Ferro 

To
LICENSOR:
 Gentium S.p.A.

Piazza XX Settembre n. 2

5

 

22079
Villa Guardia (CO)

To the attention of Dott.ssa Laura Ferro 

To
BUYER 1:
 CRINOS S.p.A.

Via Pavia 6

20136 MILANO

To the attention of: Dr. Enrique Häsermann 

To
BUYER 2:
 SFS Stada Financial Services Ltd.

Clonmel Healthcare,

Waterford Road,

Clonmel, Ireland

To the attention of: Mr. Luc Siegers 

and
copy to:
 CRINOS S.p.A.

Via Pavia 6

20136 MILANO

To the attention of: Dr. Enrique Häusermann 

        The
above applies in so far as no other address is communicated later, in accordance with this Section. All notices shall be in the English language. 

7.2   Waiver  

        The failure of a Party to insist upon strict performance of the terms, conditions and provisions of this Umbrella
Agreement by the other Party shall not constitute a waiver of any of the provisions hereof and no waiver by a Party of any of such provisions shall be deemed to have been made
unless expressed in writing by such waiving Party. 

7.3   Interpretation  

	7.3.1
	The
 language of this Umbrella Agreement is English. No translation into any other language shall be taken into account in the
interpretation of the Umbrella Agreement.

	7.3.2
	The
 headings in this Umbrella Agreement are inserted for convenience only and shall not affect its construction.

	7.3.3
	Where
 appropriate, the terms defined in Article 2 here above and denoting a singular number only shall include the plural and vice versa.

	7.3.4
	References
 to any law, regulation, statute or statutory provision includes a reference to the law, regulation, statute or statutory provision as from time to time amended, extended
or re-enacted. 

7.4   Exhibits  

The
following Exhibits shall be integral part of this Umbrella Agreement:
 Exhibit 1—List of Products
 Exhibit 2 A—List of Trademarks
owned by SELLER;
 Exhibit 2 B—List of Trademarks "CRINOS" owned by SELLER;
 Exhibit 3 A—List of AIC directly owned by SELLER;

Exhibit 3 B—List of AIC held by SELLER pursuant to certain license agreements;
 Exhibit 4 A—AIC Transfer Agreement
 Exhibit 4 B—Transfer Agreement of the authorizations for the sale of food supplements
("integratori")

6

 

Exhibit 5—Assignment of Trademarks (attached without exhibits)
 Exhibit 6—Licence Contract related to "Enterasin" (attached without exhibits)

Exhibit 7—License Contract related to "Prociclide" (attached without
exhibits)
 Exhibit 8—Sale and Purchase Agreement (attached without exhibits)
 Exhibit 9—Details of the patent related to the active ingredient used for "Enterasin"
 Exhibit 10—Details of the patent related to the active ingredient used for "Prociclide" 

 
 

Art. 8
  Governing Law and Jurisdiction    
    

8.1   Governing Law  

        This Umbrella Agreement, its validity, its interpretation and performance shall be governed by Italian Law. 

8.2   Jurisdiction  

        Any disputes between the Parties arising out of or caused by this Umbrella Agreement, including the validity,
interpretation, execution and resolution of this Umbrella Agreement, which are not settled as a
result of negotiations between the Parties, shall be resolved under the exclusive jurisdiction of the Court of Milan.. 

 
 

Art. 9
  Severability    
    

        Should any provision of this Umbrella Agreement be invalid or unenforceable or should the agreement contain any
omission, the remaining provisions shall remain valid. In place of the invalid provision, a valid provision is presumed to be agreed upon by the parties, which come economically closest to the one
actually stipulated; the same will apply in case of an omission. 

        At
WITNESS the hands of duly authorised officers on behalf of the Parties hereto the day, the month and the year first above written. 

	For and on behalf of
 CRINOS—Industria Farmacobiologica S.p.A	 	For and on behalf of
 CRINOS S.p.A.,
	

/s/  LAURA IRIS FERRO      
 Dott.ssa Laura Iris Ferro

Vice President and Managing Director	
 	

/s/  ENRIQUE HÄUSERMANN      
 Dott. Enrique Häusermann

Managing Director
	

Date 17/05/02	
 	

Date 17.05.02
	

For and on behalf of
 GENTIUM S.P.A.,	
 	

For and on behalf of
 SFS Stada Financial Services Ltd.
	

/s/  LAURA IRIS FERRO      
 Dott.ssa Laura Iris Ferro

President and Managing Director	
 	

/s/  ENRIQUE HÄUSERMANN      
 Dott. Enrique Häusermann

Special Procurator
	

Date 17/05/02	
 	

Date 17.05.02

7

 
 

Exhibit 1    
    

	List of Products
	 	A.I.C. code

6 digits out of 9

or

date for food supp.

d/m/y

	ANGIPRESS	 	028196
	BIO-SISON (food supplement)	 	25 march 1999
	CORDIAX	 	025655
	ECAFAST	 	027429
	ENTERASIN	 	029480
	FLORBIOX (food supplement)	 	30 march 1998
	FOSFOCIN	 	023492
	GLIPTIDE	 	022002
	IKESTATINA	 	027013
	LITURSOL	 	024615
	PARSILID	 	025791
	PROCICLIDE	 	026111
	PROVEDIS (food supplement)	 	24 march 1999
	UROCHINASI CRINOS	 	026195
	VALPINAX	 	021168
	VENOREST (cosmetico)	 	xxxxxx
	BUFLOCIT (under distribution CT Sanremo)	 	026847
	EMOREN (under distribution IFI)	 	022866
	NIPIN (under distribution Lisafarma)	 	031806

 
 

Exhibit 2A    
    

	List of Trademarks related to the product

and owned by

Crinos Industria Farmacobiologica S.p.A.

(***** under licence)
	 	 
	 	 
	 	 
	 	 
	 	 
	 	 
	 	Expiring

	 	 
	 	 
	 	Date of

application
	 	Number of

application
	 	Date of

registration
	 	Number of

registration

	 	Country
	 	Class
	 	Day
	 	Month
	 	Year

	ANGIPRESS	 	 	 	Italia	 	5	 	15/06/1993	 	C093C000030	 	26/04/1996	 	677100	 	15	 	6	 	2003
	BIO-SISON	 	(food supplement)	 	Italia	 	5	 	11/09/1998	 	MI98C008819	 	11/09/1998	 	pending	 	11	 	9	 	2008
	CILIAR (rinnovo reg. 583937)	 	Italia	 	5	 	14/03/2000	 	MI2000C002934	 	pending	 	pending	 	14	 	3	 	2010
	CORDIAX	 	(***** under licence)	 	Italia	 	5	 	18/07/1995	 	C095C000036	 	09/03/1998	 	740615	 	18	 	7	 	2005
	ECAFAST	 	 	 	Italia	 	5	 	24/06/1994	 	C094C000032	 	15/09/1995	 	656927	 	24	 	6	 	2004
	ECAFAST	 	 	 	Marchio internazionale	 	5	 	18/07/1995	 	3803D/95	 	15/09/1995	 	644186	 	15	 	9	 	2015
	ECAFAST	 	 	 	Pakistan	 	5	 	23/02/1995	 	128968	 	pending	 	pending	 	 	 	 	 	 
	ENTERASIN	 	 	 	Italia	 	5	 	13/02/1996	 	C096C000016	 	15/10/1997	 	728719	 	13	 	2	 	2006
	ENTERASIN	 	 	 	Marchio Internazionale	 	5	 	01/10/1997	 	11248D/97	 	27/11/1997	 	681994	 	15	 	10	 	2007
	FLORBIOX	 	(food supplement)	 	Italia	 	5	 	02/03/1998	 	MI98+E101C00198	 	10/01/2001	 	830226	 	2	 	3	 	2008
	GLIPTIDE	 	 	 	Cile	 	5	 	22/07/1997	 	384597	 	29/09/1998	 	510125	 	16	 	4	 	2008
	GLIPTIDE rinnovo	 	 	 	Colombia	 	5	 	09/04/1990	 	319803	 	30/03/2000	 	85188	 	30	 	4	 	2010
	GLIPTIDE rideposito	 	 	 	Ecuador	 	5	 	01/08/1997	 	80522/97	 	26/11/1998	 	640498	 	26	 	11	 	2008
	GLIPTIDE rideposito	 	 	 	Guatemala	 	5	 	02/10/1997	 	M8178-7	 	pending	 	pending	 	0	 	0	 	0
	GLIPTIDE rinnovo	 	 	 	Italia	 	5	 	12/09/1990	 	MI2000C008389	 	18/07/2000	 	592836	 	18	 	7	 	2010
	GLIPTIDE	 	 	 	Marchio internazionale	 	5	 	22/11/1990	 	3802D/90	 	01/03/1991	 	R375746	 	1	 	3	 	2011
	GLIPTIDE rideposito	 	 	 	Uruguay	 	5	 	09/10/1997	 	298771	 	04/06/1998	 	298771	 	4	 	6	 	2008
	GLIPTIDE	 	 	 	Venezuela	 	5	 	20/11/1992	 	25500-95	 	pending	 	pending	 	0	 	0	 	0
	IKESTATINA	 	 	 	Estonia	 	5	 	27/06/1995	 	9501370	 	23/01/1997	 	22038	 	23	 	1	 	2007
	IKESTATINA	 	 	 	Italia	 	5	 	26/05/1994	 	C094C000027	 	08/05/1997	 	709669	 	25	 	5	 	2004
	IKESTATINA	 	 	 	Lituania	 	5	 	26/06/1995	 	95-1763	 	15/05/1998	 	27786	 	26	 	6	 	2005
	IKESTATINA	 	 	 	Pakistan	 	5	 	01/03/1995	 	129025	 	pending	 	pending	 	 	 	 	 	 
	IKESTATINA	 	 	 	Spagna	 	5	 	14/12/1994	 	1936372	 	05/07/1995	 	1936372/9	 	14	 	12	 	2004
	KOS rinnovo	 	 	 	Italia	 	5	 	31/01/1996	 	C096C000009	 	 	 	768337	 	28	 	3	 	2006
	LITURSOL (rinnovo reg: 440258)	 	Italia	 	5	 	10/07/2001	 	MI2001C007527	 	pending	 	pending	 	9	 	7	 	2011
	PROCICLIDE rinnovo	 	 	 	Italia	 	5	 	17/10/1994	 	C094C000049	 	08/05/1997	 	709684	 	7	 	5	 	2007
	PROVEDIS	 	(food supplement)	 	Italia	 	5	 	07/10/1998	 	MI98C009666	 	pending	 	pending	 	7	 	10	 	2008
	UROKINASI CRINOS	 	 	 	Italia	 	5	 	24/06/1994	 	C094C000033	 	08/05/1997	 	709672	 	23	 	6	 	2004
	VENOREST	 	(cosmetic)	 	Italia	 	5	 	13/03/1998	 	MI98C002525	 	10/01/2001	 	830717	 	13	 	3	 	2008

 
 

Exhibit 2B    
    

	 
	 	 
	 	 
	 	 
	 	 
	 	 
	 	 
	 	Expiring

	List of Trademarks owned

by

Crinos Industria Farmacobiologica S.p.A
	 	 
	 	 
	 	Date of

application
	 	Number of

application
	 	Date of

registration
	 	Number of

registration

	 	Country
	 	Class
	 	Day
	 	Month
	 	Year

	CRINOS	 	Estonia	 	5	 	14/03/1995	 	9500591	 	03/10/1996	 	21030	 	3	 	10	 	2006
	CRINOS	 	Grecia	 	5	 	30/11/1961	 	27731	 	16/10/2001	 	27731	 	30	 	11	 	2011
	CRINOS (rinnovo reg. 71229)	 	Irlanda	 	5	 	16/01/1988	 	71229	 	12/10/2001	 	71229	 	16	 	1	 	2012
	CRINOS rinnovo	 	Italia	 	5	 	06/10/1999	 	MI99C010059	 	06/10/1999	 	375156	 	6	 	10	 	2009
	CRINOS lettera "C" in forma grafica rinnovo reg. 378409	 	Italia	 	5	 	08/03/2000	 	MI2000C002651	 	08/03/2000	 	378409	 	8	 	3	 	2010
	CRINOS	 	Lettonia	 	5	 	18/07/1995	 	M-95-1150	 	20/08/1997	 	M38182	 	18	 	7	 	2005
	CRINOS	 	Lituania	 	5	 	06/03/1995	 	95-0654	 	01/04/1998	 	27134	 	6	 	3	 	2005
	CRINOS	 	Marchio internazionale	 	1,3,5	 	01/12/1998	 	11389D98	 	01/12/1998	 	R219189	 	20	 	4	 	2009
	CRINOS	 	Marchio internazionale	 	5	 	18/07/1995	 	3803D/95	 	26/10/1995	 	647084	 	26	 	10	 	2015
	CRINOS	 	Pakistan	 	5	 	23/02/1995	 	128967	 	pending	 	pending	 	 	 	 	 	 
	CRINOS	 	Turchia	 	5	 	01/05/1995	 	16218	 	01/05/1995	 	160707	 	1	 	5	 	2005

 
 

Exhibit 3A    
    

	A.I.C. directly owned

by Seller
 
	 	Packaging
	 	Active

principle
	 	A.I.C.

code

	ANGIPRESS	 	14 capsule rit. 300 mg	 	diltiazem	 	028196018
	ECAFAST 0,2 ml 5000 U.I.	 	10 fiale 0,2 ml	 	eparina Ca.	 	027429087
	ECAFAST 0,5 ml 12500 U.I.	 	10 fiale 0,5 ml	 	eparina Ca.	 	027429099
	ECAFAST 0,2 ml 5000 U.I.	 	10 siringhe 0,2 ml	 	eparina Ca.	 	027429113
	ECAFAST 0,5 ml 12500 U.I.	 	10 siringhe 0,5 ml	 	eparina Ca.	 	027429149
	ECAFAST 0,5 ml 12500 U.I.	 	2 siringhe 0,5ml	 	eparina Ca.	 	027429125
	ECAFAST 0,8 ml 20000 U.I.	 	10 siringhe 0,8 ml	 	eparina Ca.	 	027429152
	ECAFAST 0,2 ml 5000 U.I.	 	10 fiale 0,2 ml + 10 siringhe	 	eparina Ca.	 	027429164
	ECAFAST 0,5 ml 12500 U.I.	 	10 fiale 0,5 ml + 10 siringhe	 	eparina Ca.	 	027429176
	ECAFAST 0,8 ml 20000 U.I.	 	10 fiale 0,8 ml + 10 siringhe	 	eparina Ca.	 	027429188
	ENTERASIN capsule	 	50 capsule 400 mg	 	mesalazina	 	029480011
	ENTERASIN 2 gel rettale	 	7 contenitori monodose

2 g/60 ml con erogatore	 	mesalazina	 	029480023
	ENTERASIN 4 gel rettale	 	7 contenitori monodose

4 g/60 ml con erogatore	 	mesalazina	 	029480035
	ENTERASIN 4 sospensione rett.	 	7 contenitori monodose

4 g/100 ml con erogatore	 	mesalazina	 	029480047
	ENTERASIN compresse gast.resis.	 	24 compresse 800 mg	 	mesalazina	 	029480050
	ENTERASIN compresse gast. resist	 	50 compresse 400 mg	 	mesalazina	 	029480062
	ENTERASIN supposte	 	20 supposte 500 mg	 	mesalazina	 	029480074
	FOSFOCIN	 	12 cpr. orosol. g 1	 	fosfomicina	 	023492111
	FOSFOCIN	 	1 flac. 1 g EV	 	fosfomicina	 	023492034
	FOSFOCIN	 	1 flac. 1 g IM	 	fosfomicina	 	023492022
	FOSFOCIN	 	12 cpr. g 1	 	fosfomicina	 	023492073
	GLIPTIDE GRANULARE	 	30 buste 200 mg	 	sulglicotide	 	022002063
	GLIPTIDE MASTICABILE	 	30 compresse 200 mg	 	sulglicotide	 	022002075
	GLIPTIDE SOSP.(200mg/8ml)	 	1 flac.sosp.240 ml	 	sulglicotide	 	022002087
	IKESTATINA 250	 	1 fl.liof.0,250 mg+f,solv	 	somatostatina	 	027013046
	IKESTATINA 3000	 	1 fl.liof. 3 mg+f.solv	 	somatostatina	 	027013059
	LITURSOL 50	 	20 compresse 50 mg	 	ursodecolico	 	024615066
	LITURSOL 150	 	20 compresse 150 mg	 	ursodecolico	 	024615078
	LITURSOL 300	 	20 compresse 300 mg	 	ursodecolico	 	024615080
	LITURSOL R	 	20 capsule 450 mg	 	ursodecolico	 	024615092
	PROCICLIDE	 	10 fiale da 200 mg	 	defibrotide	 	026111029
	PROCICLIDE	 	21 capsule da 400 mg	 	defibrotide	 	026111056
	UROCHINASI CRINOS	 	flacone 25.000	 	urochinasi	 	026195091
	UROCHINASI CRINOS	 	flacone 100.000	 	urochinasi	 	026195103
	UROCHINASI CRINOS	 	flacone 250.000	 	urochinasi	 	026195115
	UROCHINASI CRINOS	 	flacone 500.000	 	urochinasi	 	026195127
	UROCHINASI CRINOS	 	flacone 1.000.000	 	urochinasi	 	026195139
	UROCHINASI CRINOS	 	siringa 250.000	 	urochinasi	 	026195141
	UROCHINASI CRINOS	 	siringa 500.000	 	urochinasi	 	026195154
	UROCHINASI CRINOS	 	siringa 1.000.000	 	urochinasi	 	026195166
	VALPINAX 20 (TM under licence)	 	30 compresse	 	ottatr+diaz	 	021168012
	VALPINAX 2% gocce (TM under licence)	 	1 flacone 30 ml	 	ottatr+diaz	 	021168048
	VALPINAX 40 (TM under licence)	 	40 compresse	 	ottatr+diaz	 	021168051
	VALPINAX 4% gocce (TM under licence)	 	1 flacone 30 ml	 	ottatr+diaz	 	021168063

1 

 
 

Exhibit 3B    
    

	A.I.C. held pursuant

to licence agreement
 
	 	Packaging
	 	Active

principle
	 	A.I.C.

code

	CORDIAX (AIC under licence)	 	28 compresse 200 mg	 	celiprololo	 	025655010
	PARSILID (AIC under licence)	 	30 compresse 250 mg	 	ticlopidina	 	025791031

1

  

 
 

EXHIBIT 4A TO THE UMBRELLA AGREEMENT    
    

 
  SCRITTURA PRIVATA
  TRA    
    

        CRINOS Industria Farmacobiologica S.p.A. con sede in Villaguardia—CO, Via XX Settembre, 2 capitale sociale € 6.195.000
(seimilioni centonovantacinquemila), interamente versato, iscritta al Registro delle Imprese di Como al n. 01192270138, codice fiscale/partita IVA 01192270138, codice SIS 0025, (qui di seguito "CRINOS
IF"), in persona del suo Vice-Presidente e Amministratore Delegato Dott.ssa Laura Iris Ferro, Milano il 03.08.1951, codice fiscale FRR LRS 51M43 F205L, domiciliata per la carica presso la
sede sociale, munita degli occorrenti poteri 

 
 

e    
    

        CRINOS S.p.A. con sede in Milano, Via Pavia 6, capitale sociale € 100.000,00 (centomila), iscritta al Registro delle Imprese di
Milano al n. 03481280968, codice fiscale/partita IVA 03481280968, codice SIS 2454, (qui di seguito "CRINOS"), in persona del suo amministratore delegato con poteri di rappresentanza Dr. Enrico
Hausermann, domiciliato per la carica presso la sede sociale, munito degli occorrenti poteri 

 
 

Premesso che:    
    

        A)   CRINOS
IF e CRINOS intendono formalizzare un contratto di cessione di ramo d'azienda avente ad oggetto la divisione di vendita e marketing di CRINOS IF delle
specialità e delle relative Autorizzazioni all'Immissione in Commercio (AIC) elencate al punto C) che segue; 

        B)    Nelle
intese raggiunte, le PARTI hanno convenuto che la predetta cessione di ramo d'azienda verrà formalizzata e diverrà efficace solo al
momento della pubblicazione dell'avvenuto trasferimento di proprietà delle relative Autorizzazioni all'Immissione in Commercio AIC (meglio individuate al punto C) che segue) a favore di
CRINOS nella Gazzetta Ufficiale; 

        C)    CRINOS
IF dichiara di essere proprietario e di avere la piena disponibilità dei diritti relativi all'Autorizzazione all'Immissione in Commercio (AIC) per
le Specialità qui di seguito indicate ed identificate dai singoli codici rilasciati dal Ministero della Sanità (d'ora innanzi congiuntamente le
"Specialità") 

	1.	 	ANGIPRESS	 	14 cps rit. 300 mg	 	cod. n. 028196018
	
2.	
 	
ECAFAST nelle confezioni:	
 	

 	
 	

 
	

 	
 	

 	
 	
"0,2 ml 5000 UI."	
 	

10 f.le 0,2 ml	
 	

cod. n. 027429087
	

 	
 	

 	
 	
"0,5 ml 12500 U.I."	
 	

10 f.le 0,5 ml	
 	

cod. n. 027429099
	

 	
 	

 	
 	
"0,2 ml 5000 U.I."	
 	

10 siringhe 0,2 ml	
 	

cod. n. 027429113
	

 	
 	

 	
 	
"0,5 ml 12500 U.I."	
 	

10 siringhe 0,5 ml	
 	

cod. n. 027429149
	

 	
 	

 	
 	
"0,5 ml 12500 U.I."	
 	

2 siringhe 0,5 ml	
 	

cod. n. 027429125
	

 	
 	

 	
 	
"0,8 ml 20000 U.I."	
 	

10 siringhe 0,8 ml	
 	

cod. n. 027429152
	

 	
 	

 	
 	
"0,2 ml 5000 U.I."	
 	

10 f.le 0,2 ml+10 siring.	
 	

cod. n. 027429164
	

 	
 	

 	
 	
"0,5 ml 12500 U.I."	
 	

10 f.le 0,5 ml+10 siring.	
 	

cod. n. 027429176
	

 	
 	

 	
 	
"0,8 ml 2000 U.I."	
 	

10 f.le 0,8 ml+10 siring.	
 	

cod. n. 027429188
	 	 	 	 	 	 	 	 	 

1

 

	
3.	
 	
ENTERASIN nelle confezioni:	
 	

 	
 	

 
	

 	
 	

 	
 	

 	
 	

50 capsule 400 mg	
 	

cod. n. 029480011
	

 	
 	

 	
 	
"2 gel rettale"	
 	

7 contenitori monodose 2 g/60 ml	
 	

 
	

 	
 	

 	
 	

 	
 	

con erogatore	
 	

cod. n. 029480023
	

 	
 	

 	
 	
"4 gel rettale"	
 	

7 contenitori monodose 4 g/60 ml	
 	

 
	

 	
 	

 	
 	

 	
 	

con erogatore	
 	

cod. n. 029480035
	

 	
 	

 	
 	
"4 sosp.rettale"	
 	

7 contenitori monodose 4 g/l00 ml	
 	

 
	

 	
 	

 	
 	

 	
 	

con erogatore	
 	

cod. n. 029480047
	

 	
 	

 	
 	
"cpr gastroresistenti"	
 	

24 cpr 800 mg	
 	

cod. n. 029480050
	

 	
 	

 	
 	
"cpr gastroresistenti"	
 	

50 cpr 400 mg	
 	

cod. n. 029480062
	

 	
 	

 	
 	
"supposte"	
 	

20 supposte 500 mg	
 	

cod. n. 029480074
	
4.	
 	
FOSFOCIN nelle confezioni:	
 	

 	
 	

 
	

 	
 	

 	
 	

 	
 	

12 cpr orosol. G 1	
 	

cod. n. 023492111
	

 	
 	

 	
 	

 	
 	

1 flac. 1 g EV	
 	

cod. n. 023492034
	

 	
 	

 	
 	

 	
 	

1 flac. 1 g IM	
 	

cod. n. 023492022
	

 	
 	

 	
 	

 	
 	

12 cpr g 1	
 	

cod. n. 023492073
	
5.	
 	
GLIPTIDE nelle confezioni:	
 	

 	
 	

 
	

 	
 	

 	
 	
"GRANULARE"	
 	

30 buste 200 mg	
 	

cod. n. 022002063
	

 	
 	

 	
 	
"MASTICABILE"	
 	

30 cpr 200 mg	
 	

cod. n. 022002075
	

 	
 	

 	
 	
"SOSP. (200 mg/8ml)"	
 	

1 flac. Sosp. 240 ml	
 	

cod. n. 022002087
	
6.	
 	
IKESTATINA nelle confezioni:	
 	

 	
 	

 
	

 	
 	

 	
 	
"250"	
 	

1 fl.liof. 0,250 mg+f.la solv.	
 	

cod. n. 027013046
	

 	
 	

 	
 	
"3000"	
 	

1 fl.liof. 3 mg+f.la solv.	
 	

cod. n. 027013059
	
7.	
 	
LITURSOL nelle confezioni:	
 	

 	
 	

 
	

 	
 	

 	
 	
"50"	
 	

20 cpr 50 mg	
 	

cod. n. 024615066
	

 	
 	

 	
 	
"150"	
 	

20 cpr 150 mg	
 	

cod. n. 024615078
	

 	
 	

 	
 	
"300"	
 	

20 cpr 300 mg	
 	

cod. n. 024615080
	

 	
 	

 	
 	
"R"	
 	

20 cps 450 mg	
 	

cod. n. 024615092
	
8.	
 	
PROCICLIDE nelle confezioni:	
 	

 	
 	

 
	

 	
 	

 	
 	

 	
 	

10 f.le 200 mg	
 	

cod. n. 026111029
	

 	
 	

 	
 	

 	
 	

21 cps 400 mg	
 	

cod. n. 026111056
	
9.	
 	
UROCHINASI CRINOS nelle confezioni:	
 	

 
	

 	
 	

 	
 	

 	
 	

flacone 25.000	
 	

cod. n. 026195091
	

 	
 	

 	
 	

 	
 	

flacone 100.000	
 	

cod. n. 026195103
	 	 	 	 	 	 	 	 	 

2

 

	

 	
 	

 	
 	

 	
 	

flacone 250.000	
 	

cod. n. 026195115
	

 	
 	

 	
 	

 	
 	

flacone 500.000	
 	

cod. n. 026195127
	

 	
 	

 	
 	

 	
 	

flacone 1.000.000	
 	

cod. n. 026195139
	

 	
 	

 	
 	

 	
 	

siringa 250.000	
 	

cod. n. 026195141
	

 	
 	

 	
 	

 	
 	

siringa 500.000	
 	

cod. n. 026195154
	

 	
 	

 	
 	

 	
 	

siringa 1.000.000	
 	

cod. n. 026195166
	
10.	
 	
VALPINAX nelle confezioni:	
 	

 	
 	

 
	

 	
 	

 	
 	
"20"	
 	

30 cpr	
 	

cod. n. 021168012
	

 	
 	

 	
 	
"2% gocce"	
 	

1 flacone 30 ml	
 	

cod. n. 021168048
	

 	
 	

 	
 	
"40"	
 	

40 cpr	
 	

cod. n. 021168051
	

 	
 	

 	
 	
"4% gocce"	
 	

1 flacone 30 ml	
 	

cod. n. 021168063

 
 

tutto ciò premesso si stipula e si conviene quanto segue:    
    

1      OGGETTO DEL CONTRATTO E GARANZIA  

	1.1
	CRINOS
IF con il presente atto, cede e vende a CRINOS, che accetta e acquista tutti i diritti di proprietà e di formula, di produzione e di vendita in Italia relativi
alle Specialità.

	1.2
	In
particolare CRINOS IF cede e trasferisce a CRINOS, che acquista, il diritto a volturare a proprio favore l'Autorizzazione all'Immissione in Commercio (di seguito AIC) nelle
formulazioni farmaceutiche indicate in premessa, e concessa per il territorio della Repubblica Italiana, Stato di San Marino e Città del Vaticano.

	1.3
	CRINOS
IF consente che CRINOS espleti tutti gli adempimenti necessari al trasferimento in capo a CRINOS stessa delle AIC relative alle Specialità presso il Ministero
della Salute, impegnandosi CRINOS IF a garantire ogni possibile collaborazione al riguardo e a fornire tutta la documentazione disponibile e di sua competenza.

	1.4
	CRINOS
IF dichiara che la composizione e la validità delle Specialità corrispondono a quanto dichiarato presso il Ministero della Salute italiano e che
non sono note a CRINOS IF, alla data odierna, altre controindicazioni, effetti collaterali o limitazioni d'uso delle Specialità al di fuori di quanto espressamente convenuto ed
indicato nei relativi Dossier e PSUR. A sua volta CRINOS dichiara di aver preso completa e dettagliata conoscenza a tutti gli effetti delle indicazioni terapeutiche delle Specialità qui
trasferite e di ben conoscere gli effetti collaterali, le limitazioni d'uso, le controindicazioni e i campi di utilizzazione delle Specialità stesse, ivi compreso tutto quanto indicato
nello PSUR. 

2.     PREZZO  

Il
corrispettivo per la cessione dei diritti prevista in questa scrittura privata è stato determinato dalle PARTI in Euro 1,00 (in lettere: un Euro) + IVA. Tale
corrispettivo è stato così determinato e ritenuto equo dalle PARTI in considerazione del fatto che il prezzo da versarsi nell'ambito della cessione di ramo d'azienda di
cui in premessa tiene conto dei diritti di cui al presente atto. 

3

 

3.     VARIE  

        Spese notarili, di registrazione e relative alle pratiche di trasferimento di titolarità delle AIC sono a carico di CRINOS. 

	CRINOS Industria Farmacobiologica S.p.A.	 	CRINOS S.p.A.
	Dott.ssa Laura Iris Ferro	 	Dr. Enrico HAUSERMANN
	Vice-Presidente ed Amministratore Delegato	 	Amministratore Delegato

4

  

 
 

EXHIBIT 4B TO THE UMBRELLA AGREEMENT
  
    SCRITTURA PRIVATA
  tra    
    

        CRINOS Industria Farmacobiologica S.p.A. con sede legale in Villaguardia—CO, Via XX Settembre, 2 capitale sociale
€ 6.195.000 (seimilioni centonovantacinquemila), interamente versato, iscritta al Registro delle Imprese di Como al n. 01192270138, codice fiscale/partita IVA 01192270138,
codice SIS 0025, (qui di seguito "CRINOS IF"), rappresentata ai fini del presente atto dal suo in persona del suo Vice-Presidente e Amministratore Delegato, Dott.ssa Laura Iris Ferro, nata
a Milano il 03.08.1951, codice fiscale FRR LRS 51M43 F205L, domiciliata per la carica presso la sede sociale, munita degli occorrenti poteri 

 
 

e    
    

        CRINOS S.p.A. con sede legale in Milano, Via Pavia 6, capitale sociale € 100.000 (Euro centomila), versato per 3/10,
iscritta al Registro delle Imprese di Milano al n. 03481280968, codice fiscale/partita IVA 03481280968, codice SIS 2454, (qui di seguito "CRINOS"), rappresentata ai fini del presente atto dal suo
amministratore delegato Dr. Enrico Hausermann, 

 
 

Premesso che:    
    

        A)   CRINOS
IF e CRINOS intendono formalizzare un contratto di cessione di ramo d'azienda avente ad oggetto la divisione di vendita e marketing di CRINOS IF di alcune
specialità farmaceutiche oltre che dei prodotti dietetici elencati al punto C) che segue; 

        B)    Nelle
intese raggiunte, le PARTI hanno convenuto che la predetta cessione di ramo d'azienda verrà formalizzata e diverrà efficace solo al
momento della pubblicazione nella Gazzetta Ufficiale dell'avvenuto trasferimento di proprietà delle Autorizzazioni all'Immissione in Commercio (AIC) relative ai prodotti oggetto di
cessione a favore di CRINOS; 

        C)    CRINOS
IF dichiara di essere titolare e di avere la piena disponibilità e proprietà dei diritti relativi ai prodotti dietetici di seguito
elencati 

	1.	 	PROVEDIS	 	20 Compresse doppio strato	 	Notificato il 24/03/1999
	2.	 	BIOSISON	 	30 Compresse doppio strato	 	Notificato il 25/03/1999
	3.	 	FLORBIOX	 	10 bustine di granulato da 5 g	 	Notificato il 30/03/1998

tutto ciò premesso si stipula e si conviene quanto segue:  

 1      OGGETTO DEL CONTRATTO E GARANZIA  

	1.1
	CRINOS
IF con il presente atto, cede e trasferisce a CRINOS, che accetta e acquista tutti i diritti di proprietà e di formula, di produzione e di vendita in Italia
relativi ai prodotti dietetici.

	1.2
	In
particolare CRINOS IF cede e trasferisce a CRINOS, che acquista, il diritto a volturare a proprio favore le Autorizzazioni dei prodotti dietetici nelle formulazioni indicate in
premessa, e concesse per il territorio della Repubblica Italiana, Stato di San Marino e Città del Vaticano.

	1.3
	CRINOS
IF consente che CRINOS espleti tutti gli adempimenti necessari al trasferimento in capo a CRINOS stessa delle Autorizzazioni relative ai prodotti dietetici presso il Ministero
della Salute, impegnandosi CRINOS IF a garantire ogni possibile collaborazione al riguardo e a fornire tutta la documentazione disponibile e di sua competenza. 

1

 
	1.4
	CRINOS
dichiara di aver preso completa e dettagliata conoscenza a tutti gli effetti delle indicazioni dei prodotti dietetici qui trasferiti e di ben conoscere gli effetti collaterali,
le limitazioni d'uso, le controindicazioni e i campi di utilizzazione dei prodotti dietetici stessi. 

2.     PREZZO  

        Il corrispettivo per la cessione dei diritti prevista in questa scrittura privata è stato determinato dalle PARTI in Euro 1,00 (in lettere: un
Euro) + IVA. Tale corrispettivo è stato cosi determinato e ritenuto equo dalle PARTI in considerazione del fatto che il prezzo da versarsi nell'ambito della cessione di
ramo d'azienda di cui in premessa tiene conto dei diritti di cui al presente atto. 

3.     VARIE  

        Spese notarili, di registrazione e relative alle pratiche di trasferimento di titolarità dei prodotti dietetici sono a carico di CRINOS. 

	/s/  Laura Iris Ferro      
	 	/s/  Enrico Hausermann      

	CRINOS IF S.r.l.	 	CRINOS S.p.A.
	Dott.ssa Laura Iris Ferro

Vice-Presidente ed Amministratore Delegato	 	Dr. Enrico HAUSERMANN

Amministratore Delegato

2

  

 
 

EXHIBIT 5 TO THE UMBRELLA AGREEMENT
  
    ASSIGNMENT OF REGISTERED TRADEMARKS    
    

between

        SFS Stada Financial Services Ltd., with its registered offices in Clonmel Healthcare, Waterford Road, Clonmel, Ireland, represented
by its special procurator Dott. Enrique Hausermann; 

(hereinafter
the "BUYER") 

and 

        CRINOS—Industria Farmacobiologica S.p.A., with its registered offices in Piazza XX Settembre n. 2, Villa Guardia (CO) Italy,
represented by its Vice-President and Managing Director Dott.ssa Laura Iris Ferro 

(hereinafter
the "SELLER") 

WHEREAS

        A)   The
SELLER is an Italian company mainly involved in the field of research and production of pharmaceutical specialties and its active substances and is the owner and
registered proprietor of several Trademarks (as defined hereinafter). 

        B)    The
BUYER is interested in the acquisition of the above mentioned intellectual property rights. 

        C)    Both
parties have agreed to enter into this Assignment of Trademarks in connection with the acquisition of the marketing
and sale division of SELLER by Crinos S.p.A., a company incorporated and existing under the laws of Italy and which is part of the BUYER's group (the "Sale and Purchase
Agreement"). The links between the Sale and Purchase Agreement and the present Assignment of
Trademarks are described in the Umbrella Agreement signed today by all parties thereto; 

        In
consideration thereof, it is agreed and drawn up as follows: 

 
 

Art. 1
  Introductory Statements    
    

        The introductory statements and the enclosures to this document form an integral and substantial part of this Assignment of
Trademarks.

 
 

Art. 2
  Definitions    
    

        2.1   The
terms and expressions listed below are intended as indicated thereafter, when written with a capital. 

        2.2   Definitions:

        "Assignment of Trademarks":    shall mean this agreement with its exhibits, undersigned by the Parties. 

        "Collateral Agreements" shall mean all agreements referred to in the Umbrella Agreement. 

        "Closing":    shall mean the date this Assignment of Trademarks is executed by
the Parties. 

        "Effectiveness Date":    shall mean the date this Assignment of Trademarks becomes effective between the Parties and shall be
the date on which the transfer to CRINOS S.p.A. of all the AIC mentioned in Exhibit 1 has been authorized and published by the Italian Health
Ministry. 

1

 

        "Documentation":    shall mean all documentation concerning the Trademarks as
provided for by the regulations in force and, in particular, the registration/renewal files, payment receipts, all documents relating to pending controversies, if applicable, as well as all further
documentation available to SELLER relating to the Trademarks.

        "Party" or "Parties":    shall mean the BUYER or the SELLER or both, depending on the context. 

        "Price":    shall mean the overall sum due to the SELLER from the BUYER as payment for the assignment of the  Trademarks.

        "Products":    shall mean the products identified by the Trademarks and listed in  Exhibit 2 attached to the present Assignment of Trademarks.

        "Trademarks":    shall mean the national and international trademark registrations and their renewals, details whereof are shown
in Exhibit 3 A attached to the present Assignment of Trademarks.

        "Umbrella Agreement" shall mean the agreement mentioned in letter C) of the introductory statements. 

 
 

Art. 3
  Object and Effectiveness of the Contract    
    

3.1   Assignment of the Trademarks  

        According to the terms and conditions provided for by the present Assignment of Trademarks, the SELLER will assign
and transfer to the BUYER, which accepts, the ownership and all related rights of the Trademarks indicated in Exhibit 3 A. To this extent the
parties agree to fulfil all formalities necessary for the effectiveness of such transfer according to the following article 3.2. 

3.2   Effectiveness Date  

        The present Assignment of Trademarks will be executed by means of a private deed of transfer of the Trademarks
written in Italian or local language to be authenticated by an Italian or local Notary, as the case may be, on the Effectiveness Date (a draft of such
deed in Italian is hereby enclosed as Exhibit 4). 

        After
Closing BUYER and SELLER will execute several license agreements (Exhibit 5), pursuant to which BUYER will grant to SELLER a
royalty free use of the Trademarks registered in certain countries, in which SELLER is commercialising the relevant Product. Such license agreement shall provide for the reimbursement by SELLER of all
costs necessary to maintain the relevant Trade Mark registration. 

        3.2.1 Immediately
after the Effectiveness Date BUYER will file all necessary applications and pay all relevant fees and taxes
as shall be required to achieve the transfer of the Trademark registrations in the name of the BUYER. If necessary SELLER will cooperate with BUYER in
order to correctly file such application (e.g. SELLER will give its consent where requested). 

        3.2.2 As
from the Effectiveness Date, the BUYER will bear the sole responsibility and all costs and expenses deriving from
the maintenance, renewal and/or prosecution costs of the Trade Mark and any further applications in respect thereof. 

2

 

 
 

Art. 4
  Price and Payment    
    

4.1   Price.  

        The consideration the BUYER will pay to the SELLER, which has been agreed upon and accepted by both Parties as the overall amount due, is EUR 3.466.000,00 (the  "Price"). 

        Such
Price is composed by the following values assigned to each single Trademark:

	Angipress:	 	EUR	 	40.000,00
	Bio-Sison (integratore):	 	EUR	 	1.000,00
	Ciliar:	 	EUR	 	1.000,00
	Cordiax:	 	EUR	 	1.000,00
	Ecafast:	 	EUR	 	600.000,00
	Enterasin:	 	EUR	 	370.000,00
	Florbiox (integratore):	 	EUR	 	1.000,00
	Gliptide:	 	EUR	 	180.000,00
	Ikestatina:	 	EUR	 	95.000,00
	Kos:	 	EUR	 	1.000,00
	Litursol:	 	EUR	 	310.000,00
	Prociclide:	 	EUR	 	1.710.000,00
	Provedis:	 	EUR	 	1.000,00
	Urokinasi Crinos:	 	EUR	 	65.000,00
	Venorest (cosmetico):	 	EUR	 	90.000,00

4.2   Payment.  

4.2.1    The
amount mentioned in the above Art. 4.1 will be paid by the BUYER on the Effectiveness Date.

4.2.2    The
payment of the Price will be made within the afore-mentioned date of expiry through a bank transfer in a fixed currency to a bank
account, of which the details will be communicated in a timely manner by the SELLER. 

 
 

Art. 5
  Representations of the SELLER    
    

        The SELLER declares and guarantees the following: 

5.1   Property  

5.1.1    SELLER
guarantees that all the Trademarks transferred with this present Assignment of
Trademarks are in its sole and undisputed ownership and that such Trademarks are free from whatsoever right from third parties. 

5.1.2    The
Trademarks have been regularly registered 1) with the competent International Registration Authorities and 2) with
the Italian Registration office of Patents and Trademarks (U.A.M.I.) and SELLER has duly and timely paid all related fees and taxes. 

5.1.3    All
relevant applications for the maintenance, renewal and/or prosecution of the Trade Mark registrations have been regularly filed in front of the competent offices and all related
fees and taxes have been regularly paid by the SELLER. 

3

 

5.1.4    SELLER
guarantees that there are no third-party rights, which might be used in order to validly oppose the registrations mentioned under 5.1.1 

5.2   Documentation

5.2.1    SELLER
shall hand over to BUYER or to BUYER's appointed nominee upon execution of the present Assignment of Trademarks all the
relevant Documentation as better defined in article 2.2 above. Any documentation which has not been handed over to BUYER within said term shall
be delivered to the latter on the date the private deed will be executed by the Parties pursuant to Section 3.2. 

5.3   Trademarks

        SELLER
herewith guarantees that the Trademarks enlisted in Exhibit 3 A  are all Trademarks,
 owned, directly or indirectly, by SELLER, in relation to the Products and that
neither SELLER nor any other company in SELLER's group, owns those Trademarks in any further country other than those enlisted in  Exhibit 3 A
attached to the present Assignment of Trademarks. Exhibit 3 B enlists, for
informative purposes only, all other Italian trademarks related to the Products, which are in ownership of SELLER or any other company belonging to seller's group. 

 
 

Art. 6
  Further obligations of SELLER    
    

        The SELLER undertakes not to file any application for registration and, as from the Closing Date on, not to make
any use of the Trademarks or any other trademark, which could be confused with these, on their own or in combination with other words or signs. 

 
 

Art. 7
  Indemnity and Compensation    
    

7.1   Warranties

        The
representations set out in the preceding article 5 (the "Warranties") shall each
constitute independent guarantees of the SELLER to BUYER and as such they are not subject to the terms and conditions provided under Article 1495 of the Italian Civil Code, shall therefore be
fully operative and in full effect from the date hereof and remain valid and binding on SELLER also after Date of Effectiveness for a period of 5 (five)
years thereafter. 

7.2   Indemnity

        In
addition to all and any other remedies provided by law, SELLER hereby agrees to hold harmless and to indemnify BUYER from and against any and all damages or losses suffered or
incurred by BUYER arising from any breach of SELLER of any of the above Warranties as well as of any other covenant or guarantee contained in the
present Assignment of Trademarks herein. 

7.3   Compensation

        In
addition to all and any other remedies provided by law, BUYER shall be entitled, subject to the terms and conditions set forth under Sections 7.4 and 7.5, to set off any such damage
or loss against any payments due to SELLER under the present Assignment of Trademarks or any other Collateral
Agreement. 

4

 

7.4   Procedure

        In
the event that BUYER seeks indemnification hereunder, the latter will give written notice to SELLER indicating the amount, to the extent known, of the claim asserted
("Claim Notice"). Notwithstanding anything contained in this Section 7, the right of BUYER to be indemnified hereunder shall not be adversely
affected by a failure to give the Claim Notice unless, and only to the extent that, SELLER is prejudiced thereby. 

        SELLER
shall pay the amount claimed by BUYER within 30 (thirty) business-days following receipt of the Claim Notice, unless SELLER has replied within above term with a
written notice of disagreement. Should SELLER however not reply within above 30 days-term and not proceed to the payment within such 30-day-term, BUYER shall
be entitled to set-off the relevant amount from any other amount due to SELLER pursuant to the present Assignment of Trademarks or any other
Collateral Agreement. 

        In
case SELLER has sent the mentioned notice of disagreement, BUYER's right to set off the relevant claim pursuant to Section 7.3 above shall apply only to the extent such claim
is finally ascertained or an enforceable title has been released by the competent Authority. 

7.5   Claims of third parties

        In
case a third party should assert that one of the Trademarks does infringe rights belonging to said third party, BUYER shall promptly
inform SELLER about said event and any eventual claim, suit, action or damage and BUYER shall agree with SELLER the relevant actions to be taken with respect to the defence, being understood that as
all corresponding costs shall be borne by SELLER, the latter has the right to appoint its attorney and to decide with reference to the strategy of the defence (BUYER however might appoint its own
attorneys at its own expenses). It is furthermore understood that BUYER's right to set off the relevant claim pursuant to Section 7.3 above shall apply only to the extent such claim is finally
ascertained or an enforceable title has been released by the competent Authority. 

 
 

Art. 8
  Fiscal Charges and Expenses    
    

        The costs, taxes, duties, expenses and other charges deriving from the present Assignment of Trademarks or
relating to the execution of the obligations herein provided for, will be borne as follows: 

	•
	each
of the Parties will attend to the compensation and the refunds due to its own consultants and professionals on its own expenses;

	•
	the
charges and expenses relating to the registration and transcription of the deed of Assignment of Trademarks pursuant to
Section 3.2 and/or the notarial expenses will be at the expense of the BUYER.

	•
	the
charges, fees, taxes and expenses relating to the transfer of the Trademark registrations in the name of the BUYER shall
be borne by the BUYER. 

 
 

Art. 9
  Confidentiality    
    

9.1   Confidential Information  

        SELLER undertakes not to disclose to any third party any information regarding this Assignment of Trademarks or
any confidential information relating to or concerning the BUYER and the BUYER's group, or any of their respective businesses, including, without limitation, any and all 

5

 

intellectual
property rights owned by the latter and any information regarding the businesses of any their respective clients ("Confidential
Information"). 

        BUYER,
on its part, undertakes not to disclose to any third party any information regarding this Assignment of Trademarks or any
confidential information relating to or concerning SELLER and SELLER's group, or any of their respective businesses, including, without limitation, any and all intellectual property rights owned by
the latter and any information regarding the businesses of any their respective clients. 

9.2   Exceptions  

        The foregoing restriction shall not restrict disclosure or use of Confidential Information that: 

	(a)
	was
in the public domain at the time of disclosure or thereafter enters into the public domain through no breach of this Assignment of
Trademarks;

	(b)
	is
independently developed by the disclosing Party after Closing Date without reliance on or access to any of the  Confidential Information; or

	(c)
	is
required to be disclosed by a Government Authority; provided that the requested Party shall first provide the other Party with prompt written notice of such required disclosure and
will take reasonable steps to allow such other Party to seek where provided by the Italian legislation, a protective order with respect to the Confidential
Information required to be disclosed. The requested Party will promptly cooperate with and assist the other Party, at its own expense, in connection with obtaining such
protective order. 

 
 

Art. 10
  Successors and Assignment of the Agreement    
    

        None of the Parties may assign its rights under this Assignment of Trademarks without the prior consent of the
other Party. Subject to the terms of the preceding sentence, the present Assignment of Trademarks will apply to, be binding in all respects upon, and
inure to the benefit of, the successors and permitted assignees of the Parties. 

 
 

Art. 11
  Miscellaneous    
    

11.1 Notices  

        All reports, notices and communications required or permitted to be given or made pursuant to this Assignment of
Trademarks by one Party to the other shall be validly given or made by registered letter to the following addresses: 

To
SELLER:
 Crinos S.p.A.—Industria Farmacologica S.p.A.(or respectively its new denomination as result from its undertaking to change its current
commercial name as agreed between the Parties)

Piazza XX Settembre n. 2

22079 Villa Guardia (CO)

To the attention of Dott.ssa Laura Ferro 

To
BUYER
 SFS Stada Financial Services Ltd;

Clonmel Healthcare,

Waterford Road,

Clonmel, Ireland

To the attention of: Mr. Luc Siegers 

6

 

with
a copy to:
 CRINOS S.p.A.

Via Pavia 6

20139 MILANO

To the attention of Dott. Enrique Hausermann 

        The
above applies in so far as no other address is communicated later, in accordance with this Section. The notices will be effective as of receipt if sent by registered letter. All
notices shall be in the English language. 

11.2 Waiver  

        The failure of a Party to insist upon strict performance of the terms, conditions and provisions of the present Assignment of
Trademarks by the other Party shall not constitute a waiver of any of the provisions hereof and no waiver by a Party of any of such provisions shall be deemed to have been made
unless expressed in writing by such waiving Party. 

11.3 Interpretation  

11.3.1    The
language of the present Assignment of Trademarks is English. No translation into any other language shall be taken into account
in the interpretation of the present Assignment of Trademarks.

11.3.2    The
headings in this Assignment of Trademarks are inserted for convenience only and shall not affect its construction. 

11.3.3    Where
appropriate, the terms defined in Article 2 here above and denoting a singular number only shall include the plural and vice versa. 

11.3.4    References
to any law, regulation, statute or statutory provision includes a reference to the law, regulation, statute or statutory provision as from time to time amended, extended
or re-enacted. 

11.4 Exhibits  

        The following Exhibits shall be integral part of this Assignment of Trademarks:

	 
	 	 

	Exhibit 1:	 	List of AIC directly owned by SELLER;
	Exhibit 2:	 	List of all Products identified by the Trademarks;
	Exhibit 3 A	 	List of Trademarks with the indication of the Extension of the Registration (National or International Registration enlisting all Nations covered by the Registration), Classes in which the Trade Mark is registered, Date
of Application, Number of Application, Date of Registration, Number of Registration and Date of Expiration;
	Exhibit 3 B	 	List of all other Italian trademarks related to the Products, which are in ownership of SELLER or any other company belonging to SELLER's group, attached for informative purposes only.
	Exhibit 4:	 	Draft of private deed of transfer of the Trademarks written in Italian (or local) language to be authenticated by an Italian (or local) Notary hereby enclosed only in its
Italian version;
	Exhibit 5:	 	Draft of the license agreements mentioned in Section 3.2

7

 
 
 

Art. 12
  Governing Law and Jurisdiction    
    

12.1 Governing Law  

        This Assignment of Trademarks, its validity, its interpretation and performance shall be governed by Italian Law. 

12.2 Jurisdiction  

        Any disputes between the Parties arising out of or caused by this Assignment of Trademarks, including the
validity, interpretation, execution and resolution of this Agreement, which are not settled as a result of negotiations between the Parties, shall be resolved under the exclusive jurisdiction of the
Court of Milan. 

 
 

Art. 13
  Entirety of the Agreement and Severability    
    

13.1 Entirety of the Agreement  

        This Assignment of Trademarks supersedes all prior agreements or understandings, whether oral or written, made by
either Party or between the Parties. It shall not be considered extended, cancelled or amended in any respect unless done so in writing and signed on behalf of the Parties hereto. 

13.2 Severability  

        Should any provision of this Assignment of Trademarks be invalid or unenforceable or should the agreement contain
any omission, the remaining provisions shall remain valid. In place of the invalid provision, a valid provision is presumed to be agreed upon by the parties, which come economically closest to the one
actually stipulated; the same will apply in case of an omission. 

        At
WITNESS the hands of duly authorised officers on behalf of the Parties hereto the day, the month and the year first above written. 

	For and on behalf of	 	For and on behalf of
	

 	
 	

 
	CRINOS—Industria Farmacobiologica S.p.A.	 	SFS Stada Financial Services Ltd.
	

/s/  Laura Iris Ferro      
 Dott.ssa Laura Iris Ferro

Vice-President and Managing Director	
 	

/s/  Enrique Hausermann      
 Dott. Enrique Hausermann

Special Procurator
	

Date	
 	

Date

8

  

 
 

EXHIBIT 6 TO THE UMBRELLA AGREEMENT    
    

 
 

LICENCE AGREEMENT
  
    between    
    

GENTIUM S.p.A.  

(Fiscal Code and Vat Code No. 02098100130), with legal offices in Piazza XX Settembre, no2, 22079 Villa Guardia (CO), acting through its President and Managing
Director Ms. Laura Iris Ferro and domiciled for his office for the purposes of this agreement at the offices of the Company (hereinafter referred to as "GENTIUM") 

and  

CRINOS S.p.a.

(Fiscal
Code and Vat Code No. 03481280968), with legal offices in Milan, via Pavia 6, acting through its Managing Director Mr. Enrique Häusermann and domiciled for his office for
the purposes of this agreement at the offices of the Company (hereinafter called "CRINOS"). 

1

 

DEFINITIONS  

        For purposes of this Agreement, all capitalized terms used herein, other than proper nouns, are defined as follows: 

	•
	"Affiliate" means, with respect to each party, any company owned, controlled, or controlling, directly or indirectly, to the
extent of fifty percent (50%) or more of the shares or outstanding securities of either Party.

	•
	"A.I.C." shall mean the marketing authorizations relevant to the Product issued by the MOH.

	•
	"Collateral Agreements" shall mean the following agreements: the Umbrella
Agreement, the Sale and Purchase Agreement, the Assignment of Trademarks and the  AIC Transfer Agreements,
 executed on the Closing Date;

	•
	"Mesalazina" means 5-aminosalicilic acid,5-ASA;

	•
	"Know-how" means the whole of technical and scientific information, which are secret and substantial;

	•
	"MOH" means the Italian Ministry of Health;

	•
	"Patent" means the patent described in Exhibit A;

	•
	"Product" means the pharmaceutical products for human use only, containing Mesalazina as the sole therapeutically active
ingredient for the indications defined in the Exhibit B and under Patent by GENTIUM;

	•
	"Territory" means Italy, San Marino and Città del Vaticano;

	•
	"Umbrella Agreement" shall mean the frame agreement entered into by GENTIUM and CRINOS Industria Farmacobiologica S.p.A. on
one side and SFS Stada Financial Services Ltd. and CRINOS on the other side in order to link the present License Agreement to the other  Collateral
Agreements.

WITNESSETH  

	A.
	WHEREAS, GENTIUM is the sole owner of the Patent which is actually licensed to CRINOS Industria Farmacobiologica S.p.A;

	B.
	WHEREAS CRINOS Industria Farmacobiologica S.p.A., an Affiliate of GENTIUM, is the owner of the Trade Mark "Enterasin" and has the rights
to distribute the Product in the Territory (as defined above) as of AIC Code 0294800XX.;

	C.
	WHEREAS, CRINOS, a company operating in the business of marketing, selling and distributing pharmaceutical products is going to acquire
from CRINOS Industria Farmacobiologica S.p.A. the A.I.C. relevant to the Trademark Enterasin, within the frame of the Collateral Agreements, and now wishes to obtain the rights to manufacture, have
manufactured, distribute, promote and sell the Product containing Mesalazina within the Territory;

	D.
	WHEREAS, CRINOS Industria Farmacobiologica S.p.A. has sold today to CRINOS the A.I.C. within the frame of the Collateral Agreements and
has obtained that GENTIUM consents to grant to CRINOS the gratuitous license object of this agreement; 

2

 
	E.
	WHEREAS, GENTIUM is willing to grant the right to manufacture, have manufactured, distribute, promote, market and sell the Product to
CRINOS in the Territory upon the following terms and conditions: 

        NOW,
THEREFORE, the parties agree as follows: 

ARTICLE 1—WHEREAS CLAUSES AND ANNEXES  

	1.1
	The definitions, whereas clauses and the annexes shall be considered as an integral part of this agreement. 

ARTICLE 2—APPOINTMENT  

	2.1
	GENTIUM hereby grants to CRINOS a semi-exclusive and gratuitous license to use the Know-how and Patent to
market in the Territory the Product containing the patented pharmaceutical formulation in the current therapeutical indications. By "Semi-exclusive" the parties mean that GENTIUM may grant
a second license but only to a third party which has been expressly approved by CRINOS. The procedure for this approval will be the following: i) GENTIUM will disclose, in writing, its
negotiation with a possible second licensee to CRINOS and will indicate, always in writing, the relevant information (name, trademark, territory) regarding the possible agreement; ii) CRINOS,
within 45 days from the receipt of the above mentioned communication, shall reply, in writing, to GENTIUM in order to communicate its position; iii) CRINOS can refuse its approval only
for reasonable motivations (e.g. the possibility that said third party may try to push CRINOS out of the relevant market). 

As
of today CRINOS declares to accept Abbott S.p.A. Campoverde (Latina) as second licensee of the Product in the Territory. GENTIUM has disclosed to CRINOS the terms and conditions of the license
agreement entered / to be entered into with Abbott. GENTIUM further guarantees that the license agreement with Abbott expressly provides for the prohibition for the latter to grant
sub-licenses to third parties. 

	2.2
	This Agreement will become effective on the date of the Effectiveness Date as provided for in the Umbrella Agreement. 

ARTICLE 3—SUPPLY OF SCIENTIFIC/TECHNICAL INFORMATION, KNOW HOW AND ASSISTANCE  

	3.1
	GENTIUM agrees to promptly provide to CRINOS the existing technical information, know how and scientific assistance, required by CRINOS
to produce, market, promote and sell the Product according to the present Agreement.

	3.2
	Personnel designated by CRINOS shall be given a opportunity to study the Product and its scientific data and to discuss such
information with GENTIUM representatives (experts, specialists). CRINOS shall let GENTIUM know in great advance, in writing, the names, interests and qualifications of the aforesaid personnel in order
for GENTIUM to have ample time to organize and provide the reasonable information needed. 

ARTICLE 4—PROMOTION AND CLINICAL STUDIES  

	4.1
	CRINOS will engage its best efforts to develop the sales of the Product in the Territory.

	4.2
	CRINOS shall promote the Product using only sales, advertising and promotional materials which are compatible with the determination of
the Product indications, and the use of which does not violate any applicable law. In any case CRINOS will submit any promotional material to GENTIUM in advance and GENTIUM will have the right to
approve it or to provide CRINOS with motivated reasons for its refusal. 

3

 
	4.3
	Any protocol for clinical study shall be previously approved by GENTIUM. 

ARTICLE 5—NEW THERAPEUTIC INDICATIONS  

	5.1
	Should GENTIUM or any of its Affiliates during the term of this Agreement develop and/or plan to market new therapeutic indications
related to Mesalazina, GENTIUM shall grant or provide that its Affiliate grants to CRINOS a first refusal right for an exclusive or semi-exclusive license for the sale and
commercialization in Italy with a royalty to be agreed between the Parties and in any case not exceeding 7% (seven percent). 

In
addition, CRINOS will also be granted a first refusal right for an exclusive or semi-exclusive license for registration, promotion, sale and commercialization in
European countries of all existing and future indications of the active ingredient Mesalazina. This first refusal right shall be granted to CRINOS independently from the possibility to patent the
relevant new therapeutic indication or improvement. 

	5.2
	The granting of both first refusal rights above mentioned shall be regulated by the following provisions: CRINOS shall exercise the
above first right of refusal free of charge within 45 days after receipt from GENTIUM of a written notice regarding (offer to market or co-market) a new therapeutic indication of
the Product. The notice shall indicate all the conditions offered by the third party negotiating with GENTIUM. CRINOS will have the right to refuse or accept them in toto and as such. 

Should
CRINOS fail to reply within the above term after receipt of the above notice from GENTIUM or notify to GENTIUM within such term that it refuses such conditions the present Agreement shall
remain in full force and effect as for the previous therapeutic indications; CRINOS's first right of refusal shall be extinguished and GENTIUM shall be free to offer such new form of the Product with
a different trademark, to third parties; provided however, that GENTIUM shall not enter into any agreement with such other third party at terms more favorable than those refused by CRINOS. Should
CRINOS accept the such offered conditions the parties shall add the new therapeutic indication to Exhibit B and shall amend the Agreement to incorporate the terms agreed upon between the
parties, which shall be negotiated in good faith. 

ARTICLE 6—OBLIGATIONS DERIVING FROM LAW No. 675/96  

	6.1
	Both the parties to this agreement undertake and guarantee that they will comply with the provisions contained in Law No. 675 of
December 31, 1996, regarding the protection of personal data, making any communication which should be necessary and obtaining any authorization of the Guarantor which should become necessary
for the execution of this agreement. 

ARTICLE 7—CONFIDENTIALITY  

	7.1
	Neither party shall disclose any information received from the other party or an Affiliate of the other party pursuant to this
Agreement or to any previous agreements between the parties or their Affiliates relating to the Product without the other party's written consent. Such information is confidential and proprietary. 

        This
obligation of confidentiality does not apply to: 

	1)
	information
which is or was known to the receiving party at the time of its disclosure pursuant to this Agreement or any previous agreement as established by such party's or its
Affiliates' written records;

	2)
	information
disclosed to the receiving party by a third party (other than its Affiliates) having the right to disclose such information; 

4

 

	3)
	information
which becomes patented, published or otherwise part of the public domain as a result of acts of the disclosing party or of a third party obtaining such information and
having the right to disclose the same.

	4)
	Information
that have to be disclosed by virtue of any applicable disposition of law.

 

	7.2
	Each party agrees that it shall not use confidential information obtained as set forth in Article 7.1 for any purpose other than
that indicated in this Agreement without the prior written approval of the other party. This obligation is not breached by the sale of Units and Samples embodying such information., pursuant of the
terms of this agreement. 

The
parties agree that the provision set forth in this article 7 survives after expiration and/or termination for any reason of this agreement until the confidential information becomes of
public knowledge, without any breach of this clause made by CRINOS. 

ARTICLE 8—RELATIONSHIP  

	8.1
	The parties are independent contractors. Neither party is an employee, officer, agent, partner, business representative or legal
representative of or joint venture with the other party. Neither party has authority to assume any obligation on behalf of the other party and shall not hold out to third parties that it has any
authority to act on the other party's behalf. Neither party shall take any action that might mislead or confuse third parties in this regard. Each party shall be responsible for its own expenses and
shall not incur expenses for the other party's account unless expressly authorized in writing to do so by the other party. 

ARTICLE 9—DISCLOSURES  

	9.1
	Each party agrees that, except as may be required by law, it shall not disclose the substance or details of this Agreement, except as
required to disclose to any of its Affiliates in the performance of its obligations or exercise of any of its rights hereunder, without the prior written consent of the other party. In cases in which
disclosure may be required by law, the disclosing party, prior to such disclosure, shall promptly notify the non-disclosing party of the contents of the proposed disclosure. 

Consistent
with applicable law, the non-disclosing party shall have the right to recommend/suggest reasonable changes or objections to the disclosure to protect its interests. The
disclosing party shall not unreasonably refuse to include such changes in its disclosure. 

ARTICLE 10—COMPLIANCE WITH LAW  

	10.1
	Each of the party shall not take any action which would, or fail to take any action where such failure would, directly or indirectly
result in or constitute a violation by CRINOS or GENTIUM of any applicable law, treaty, ruling or regulation. In performing its obligations under this Agreement, neither party nor any person acting on
its behalf shall make, directly or indirectly, any offer or promise or authorize bribes, kickback, payoff or any other payment or gift intended to improperly influence an agent, government official,
political party or candidate for public office to exercise their discretionary authority or influence in order to assist in the sale, marketing, promotion, importation, licensing or distribution of
the Products. 

ARTICLE 11 TERM (NATURAL EXPIRATION) AND TERMINATION  

	11.1
	The present Agreement will be effective and binding for the Parties starting from the date of Effectiveness date as provided in the
Umbrella Agreement. 

5

  

	11.2
	Unless terminated by either party in accordance with the provision of clause 11.3, this agreement shall remain valid and in
force at least till the expiration of the Patent on the Product. Notwithstanding the above this agreement shall remain valid between the parties at the same conditions for renewable periods of
3 years each in case the market life or the Product will be deemed in good faith by the Parties to survive after the expiration of the Patent, no notice being required. The market life of the
Product shall be deemed to survive until the Product may be sold in the Territory.

	11.3
	Without any prejudice to the other cases of termination set forth in the present Agreement, this Agreement may be terminated prior to
the expiration of the term set forth in Article 11.2 in the event one of the following conditions occur:

	1)
	either
party's 60 days' notice to the other party of a stated breach of any of the terms and conditions of this Agreement by the other party and the other party's failure to
cure its breach within the 60 days' notice period provided.

	2)
	either
party's giving 60 days' notice to the other party if an event of force majeure under Article 15 continues for more than twelve (12) months, it is clearly
understood between the parties that this clause can be applied only under request of the party that is not affected by the event of force majeure;

	3)
	without
notice, in case of communication from either party to the other party in the case of any declaration of bankruptcy or insolvency, appointment of a receiver by a court of
competent jurisdiction, assignment for the benefit of creditors, or institution of liquidation proceeding by or against the other party;

 

	11.4
	This agreement may be terminated by the non infringing party pursuant to Article 1456 of the civil code in the event of non compliance
of the other party with the essential agreements referred in Articles 4.2 e 17. 

ARTICLE 12—CONSEQUENCES OF TERMINATION  

	12.1
	In the event of termination of this Agreement, CRINOS shall stop using and:

	1)
	at
GENTIUM's request, return to GENTIUM all confidential or proprietary information and material supplied by GENTIUM to CRINOS pursuant to this Agreement;

	2)
	at
GENTIUM's option, either:

	(i)
	cancel
the Registration;

	(ii)
	assign
the Registration to GENTIUM or GENTIUM's designee;

	3)
	not
to use the Patent in any way

	4)
	both
parties shall continue to be bound by the provisions of Article 7 above for a period of five (5) years after termination of this Agreement. 

ARTICLE 13—NOTICES  

	13.1
	All notices shall be in writing addressed to the parties at the addresses set forth above. Notices shall be effective when delivered
personally or sent by telex, TWX, facsimile or other telegraphic mode or when sent by registered or certified mail, postage prepaid, so addressed. By notice a party may change its address for future
communications. 

6

 

ARTICLE 14—WAIVER  

	14.1
	No failure on the part of either party to exercise, and no delay in exercising any right or remedy shall operate as a waiver of such
right or remedy, nor shall any single or partial exercise of any right or remedy preclude any further or other exercise of such right or remedy. All rights and remedies under this Agreement are
cumulative and shall not be deemed exclusive of any other rights or remedies provided by law. 

ARTICLE 15—FORCE MAJEURE  

	15.1
	Failure of either party to perform its obligations under this Agreement (excepting the obligation to make payments) shall not subject
such party to any liability to the other if such failure is caused or occasioned by act of God, or the public enemy, fire, explosion, flood, drought, war, riot, sabotage, embargo, strikes, or other
labor trouble, interruption of or delay in transportation, compliance with any order, regulation or request of any government of competent jurisdiction or any officer, department, agency or committee
thereof, including requisition or allocation or establishment of priority, or by compliance with a request authorized by such governmental authority of any manufacturer for material to be used by it,
or by any other event or circumstance of like or different character to the foregoing beyond the reasonable control of the party so failing.

	15.2
	The party suffering an event of force majeure shall immediately notify the other party and both parties shall cooperate in good faith
in order to minimize the damages for both parties. 

ARTICLE 16—DISPUTE RESOLUTION  

	16.1
	Any disputes between the parties relating to, arising out of or in any way connected with this Agreement, with any term or condition
hereof, with the performance by either party of its obligations hereunder, whether before or after termination of this Agreement, shall be exclusively submitted to the Court of Milan. 

ARTICLE 17—PROHIBITION OF ASSIGNMENT and SUBLICENSE  

	17.1
	Each of the party shall not assign this agreement to third not Affiliated companies without the prior written consent of the other
party.

	17.2
	CRINOS shall not sublicense the Patent or dispose in any way of it without the prior written consent of GENTIUM. 

ARTICLE 18—DUTY OF DISCLOSURE  

	18.1
	Each of the parties undertakes to inform the other within 10 days of any change in the ownership of the company. 

ARTICLE 19—SEVERABILITY  

	19.1
	If any Article or part thereof contained in this Agreement is declared invalid by any court of competent jurisdiction or a government
agency having jurisdiction, such declaration shall not affect the remainder of the Article or the other Articles and each shall remain in full force and effect. 

ARTICLE 20—GOVERNING LAW  

	20.1
	The laws of Italy shall govern the interpretation, performance and enforcement of this Agreement. 

7

 

ARTICLE 21—ENGLISH LANGUAGE  

	21.1
	The English language version of this Agreement shall be controlling notwithstanding any translation of the Agreement made for any
purpose. 

ARTICLE 22—REGISTRATION TAX.  

	23.1
	The parties acknowledge that this Agreement is subject to value added tax and consequently is eligible for registration tax only in
case of use and at a fixed rate, pursuant to article 5 and 40 of Presidential Decree No. 131, dated April 26, 1986. 

        IN WITNESS WHEREOF each of the parties has by their duly authorized representatives executed this Agreement as of the date and year first
above written. 

	GENTIUM S.p.A.	 	CRINOS S.p.A.
	

/s/  Laura Iris Ferro      
	
 	

/s/  Enrique Hausermann      

	

Name: Dott.ssa Laura Iris Ferro

President and Managing Director	
 	

Name: Dott. Enrique Häusermann

Managing Director
	

 Date	

 	

 Date

        The
following clauses are expressly accepted pursuant to Articles 1341 and following of the civil code: 2.1, 4.2, 11.4, 16.1, 17. 

	GENTIUM S.p.A.	 	CRINOS S.p.A.
	

/s/  Laura Iris Ferro      
	
 	

/s/  Enrique Hausermann      

	

Name: Dott.ssa Laura Iris Ferro

President and Managing Director	
 	

Name: Dott. Enrique Häusermann

Managing Director
	

 Date	

 	

 Date

8

 
 
 

GENTIUM-CRINOS
  
    LICENSE AGREEMENT
  
    EXHIBIT A    
    

PATENT  

Stable aqueous suspension of mesalazine for topical use  

	Reg. No.
 
	 	Filed on
 

	IP 01277663	 	28/09/1996

9

 
 
 

GENTIUM-CRINOS
  
    LICENSE AGREEMENT
  
    EXHIBIT B    
    

PRODUCTS  

a-2gr/60ml
rectal gel-7 tubes (AIC 029480023) 

b-4gr/60ml
rectal gel-7 tubes (AIC 029480035) 

10

  

 
 

EXHIBIT 7 TO THE UMBRELLA AGREEMENT    
    

 
 

LICENCE AGREEMENT
  
    between    
    

GENTIUM S.p.A.  

(Fiscal Code and Vat Code No. 02098100130), with legal offices in Piazza XX Settembre, no2, 22079 Villa Guardia (CO), acting through its President and Managing
Director Ms. Laura Iris Ferro and domiciled for his office for the purposes of this agreement at the offices of the Company (hereinafter referred to as "GENTIUM") 

and  

CRINOS S.p.a.

(Fiscal
Code and Vat Code No. 03481280968), with legal offices in Milan, via Pavia 6, acting through its Managing Director Mr. Enrique Haeusermann and domiciled for his office for the purposes
of this agreement at the offices of the Company (hereinafter called "CRINOS"). 

1

 

DEFINITIONS  

        For purposes of this Agreement, all capitalized terms used herein, other than proper nouns, are defined as follows: 

	•
	"Affiliate" means, with respect to each party, any company owned, controlled, or controlling, directly or indirectly, to the
extent of fifty percent (50%) or more of the shares or outstanding securities of either Party;

	•
	"A.I.C." shall mean the marketing authorizations relevant to the Product issued by the MOH.

	•
	"Collateral Agreements" shall mean the following agreements: the Umbrella Agreement, the Sale and
Purchase Agreement, the Assignment of Trademarks and the AIC Transfer
Agreements, executed on the Closing Date;

	•
	"Defibrotide" means a poli-desoxi-ribonucleotide extracted from swine mucose;

	•
	"Know-how" means the whole of technical and scientific information, which are secret and substantial;

	•
	"MOH" means the Italian Ministry of Health;

	•
	"Patents" means the patents described in Exhibit A;

	•
	"Product" means the pharmaceutical products for human use only, containing Defibrotide as the sole therapeutically active
ingredient for the forms defined in the Exhibit B, and being commercialized under the Trademark "Prociclide";

	•
	"Territory" means Italy, San Marino and Città del Vaticano;

	•
	"Umbrella Agreement" shall mean the frame agreement entered into by GENTIUM and CRINOS Industria Farmacobiologica S.p.A., on
one side, and STS Stada Financial Services Ltd. and CRINOS, on the other side, in order to link the present License Agreement to the other  Collateral
Agreements.

WITNESSETH  

	A.
	WHEREAS, GENTIUM is the sole owner of the Patent which is now licensed to CRINOS Industria Farmacobiologica S.p.A, former owner of the
same Patent;

	B.
	WHEREAS CRINOS Industria Farmacobiologica S.p.A., an Affiliate of GENTIUM, is the owner of the Italian Trade Mark "Prociclide" and has
the rights to distribute the Product in the Territory (as defined above) as of A.I.C. n. 026111029 and A.I.C. n. 026111056;

	C.
	WHEREAS, CRINOS, a company operating in the business of marketing, selling and distributing pharmaceutical products is going to acquire
from CRINOS Industria Farmacobiologica S.p.A. the A.I.C. relevant to the Product and to the Trademark "Prociclide", within the frame of the Collateral Agreements, and now wishes to obtain the rights
to distribute, promote and sell the Product containing Defibrotide within the Territory;

	D.
	WHEREAS, CRINOS Industria Farmacobiologica S.p.A. has sold today to CRINOS the A.I.C. within the frame of the Collateral Agreements and
has obtained that GENTIUM consents to grant to CRINOS the gratuitous license object of this agreement;

	E.
	WHEREAS, GENTIUM is willing to grant the right to promote, market, sell and distribute the Product to CRINOS in the Territory upon the
following terms and conditions: 

        NOW,
THEREFORE, the parties agree as follows: 

ARTICLE 1—WHEREAS CLAUSES AND ANNEXES  

	1.1
	The definitions, whereas clauses and the annexes shall be considered as an integral part of this agreement. 

2

 

ARTICLE 2—APPOINTMENT  

	2.1
	GENTIUM hereby grants CRINOS a semi-exclusive and gratuitous license to use the know-how and Patent to market
in the Territory the Product containing the patented active ingredient in the current therapeutical indications and also with regard to the indications the MOH will grant within the procedure of
revision of the Product. 

        By
"Semi-exclusive" the parties mean that GENTIUM may grant a second license but only to a third party which has been expressly approved by CRINOS. The procedure for this
approval will be the following: i) GENTIUM will disclose, in writing, its negotiation with a possible second licensee to CRINOS and will indicate, always in writing, the relevant information
(name, trademark, territory) regarding the possible agreement; ii) CRINOS, within 45 days from the receipt of the above mentioned communication, shall reply, in writing, to GENTIUM in
order to communicate its position; iii) CRINOS can refuse its approval only for reasonable motivations (e.g. the possibility that said third party may try to push CRINOS out of the relevant
market). 

	2.2
	As of today CRINOS acknowledges that CRINOS Industria Farmacobiologica S.p.A has already entered into a license and supply contract
with Roussel Maestretti S.p.A. (now Aventis) on December 20, 1985 (the "Aventis Contract") pursuant to which CRINOS Industria Farmacobiologica S.p.A has granted a semi-exclusive
license to Aventis for the sale and commercialization in Italy of the products containing the active ingredient "Defibrotide". CRINOS will require that GENTIUM, which acquired from CRINOS Industria
Farmacobiologica S.p.A the Patents and entered to the above mentioned license contract, reports on any further development with respect to the Aventis Contract and GENTIUM (or its parent or affiliate
company) undertakes to ask for CRINOS's approval with respect to any decision to be taken in relation to the Aventis Contract. CRINOS shall also have the right to request that GENTIUM terminates the
Aventis Contract pursuant to Section 19 thereof. The parties shall agree the terms and the process of such termination in compliance with the Agreement and in order to prevent Aventis from
claiming to GENTIUM any damage. Upon successful termination CRINOS will recognize a reasonable indemnification to GENTIUM (or its parent or affiliate company) based on the latest earnings perceived by
GENTIUM/CRINOS Industria Farmacobiologica S.p.A in relation to the Aventis Contract. Such indemnification, however, shall not be due, if CRINOS will be able to maintain for GENTIUM (or its parent or
affiliate company) the same level of turnover of Prociclide as reached in the year prior to termination of the Aventis Contract by Aventis and CRINOS together. 

        It
is understood that the successful termination of the Aventis contract as above described will not affect the right of GENTIUM to grant another semi-exclusive licence
pursuant to article 2.1 of the present Agreement. 

	2.3
	This Agreement will become effective on the date of the Effectiveness Date as provided for in the Umbrella Agreement. 

ARTICLE 3—SUPPLY OF SCIENTIFIC/TECHNICAL INFORMATION, KNOW HOW AND ASSISTANCE  

	3.1
	GENTIUM agrees to provide to CRINOS the existing technical information, know how and scientific assistance, reasonably required by
CRINOS to market, promote and sell the Product according to the present Agreement. 

3

  

	3.2
	Personnel designated by CRINOS shall be given a reasonable opportunity to study the Product and its scientific data and to discuss such
information with GENTIUM representatives (experts, specialists). CRINOS shall let GENTIUM know in great advance, in writing, the names, interests and qualifications of the aforesaid personnel in order
for GENTIUM to have ample time to organize and provide the reasonable information needed.

	3.3
	CRINOS shall not engage in any development activities, including, without limitation, clinical trials, with respect to the Product
without the express prior written consent of GENTIUM. 

Should
CRINOS, for any reason or event, know or obtain any know how and/or any innovation apt to be patented, it is understood that GENTIUM will be the only owner of any rights deriving from such know
how or innovations. 

	3.4
	The PARTIES shall inform each other promptly (for serious and unexpected ADR'S within 24 hours from knowledge) of all knowledge
and of any new findings reflecting on the safety of Product which come to either Party's attention during the term of this Agreement.

	3.5
	Each Party agrees to provide the other with all the necessary, reasonable, requested assistance in order to comply with all post
approval, including but not limited to Periodic Safety Update Report.

	3.6
	CRINOS shall maintain at all time an effective tracking system of recall of the Product within the territory. 

ARTICLE 4—PROMOTION AND CLINICAL STUDIES  

	4.1
	CRINOS will engage its best efforts to develop the sales of the Product in the Territory.

	4.2
	CRINOS shall promote the Product using only sales, advertising and promotional materials which are compatible with the determination of
the Product indications, and the use of which does not violate any applicable law. In any case CRINOS will submit any promotional material to GENTIUM in advance and GENTIUM will have the right to
approve it. In order to ensure consistency of Promotional Material with the scientific and clinical profile of the Product, CRINOS shall only use Promotional Materials which have been approved in
writing by GENTIUM as to the accuracy of their technical, scientific and medical content. GENTIUM shall provide CRINOS with motivated reasons in case of its refusal. 

ARTICLE 5—NEW THERAPEUTIC INDICATIONS  

	5.1
	Should GENTIUM during the term of this Agreement develop and/or plan to market new therapeutic indications related to Defibrotide,
GENTIUM shall grant to CRINOS a first refusal right for an exclusive or semi-exclusive license for the sale and commercialization in Italy with a royalty in any case not exceeding 7%
(seven percent). 

In
addition, CRINOS will also be granted a first refusal right for an exclusive or semi-exclusive registration, promotion, sale and commercialization in all European countries of all
existing and future indications of the active ingredient Defibrotide. This first refusal right shall be granted to CRINOS independently from the possibility to patent the relevant new therapeutic
indication or improvement. 

	5.2
	The granting of both first refusal rights above mentioned shall be regulated by the following provisions: CRINOS shall exercise the
above first right of refusal free of charge within 45 days after receipt from GENTIUM of a written notice regarding (offer to market or co-market) a new therapeutic indication of
the Product. The notice shall indicate the conditions offered by the third party negotiating with GENTIUM. CRINOS will have the right to refuse or accept them in toto and as such. Should CRINOS fail
to reply or notify to GENTIUM within the above term that it refuses such conditions the present Agreement shall remain in full force and effect as for the 

4

 

previous
therapeutic indications; CRINOS's first right of refusal shall be extinguished and GENTIUM shall be free to offer such new form of the Product to third parties; provided however, that GENTIUM
shall not enter into any agreement with such other third party at terms more favorable than those refused by CRINOS. Should CRINOS accept the such offered conditions the parties shall add the new
therapeutic indication to Exhibit A and shall amend the Agreement to incorporate the terms agreed upon between the parties. 

ARTICLE 6—OBLIGATIONS DERIVING FROM LAW N°. 675/96  

	6.1
	Both the parties to this agreement undertake and guarantee that they will comply with the provisions contained in Law No. 675 of
December 31, 1996, regarding the protection of personal data, making any communication which should be necessary and obtaining any authorization of the Guarantor which should become necessary
for the execution of this agreement. 

ARTICLE 7—CONFIDENTIALITY  

	7.1
	Neither party shall disclose any information received from the other party or an Affiliate of the other party pursuant to this
Agreement or to any previous agreements between the parties or their Affiliates relating to the Product without the other party's written consent. Such information is confidential and proprietary. 

This
obligation of confidentiality does not apply to: 

	1)
	information
which is or was known to the receiving party at the time of its disclosure pursuant to this Agreement or any previous agreement as established by such party's or its
Affiliates' written records;

	2)
	information
disclosed to the receiving party by a third party (other than its Affiliates) having the right to disclose such information;

	3)
	information
which becomes patented, published or otherwise part of the public domain as a result of acts of the disclosing party or of a third party obtaining such information and
having the right to disclose the same.

	4)
	Information
that have to be disclosed by virtue of any applicable disposition of law.

 

	7.2
	Each party agrees that it shall not use confidential information obtained as set forth in Article 7 above for any purpose other
than that indicated in this Agreement without the prior written approval of the other party. This obligation is not breached by the sale of Units and Samples embodying such information., pursuant of
the terms of this agreement. 

The
parties agree that the provision set forth in this article 7 survives after expiration and/or termination for any reason of this agreement until the confidential information becomes of
public knowledge, without any breach of this clause made by CRINOS. 

ARTICLE 8—RELATIONSHIP  

	8.1
	The parties are independent contractors. Neither party is an employee, officer, agent, partner, business representative or legal
representative of or joint venture with the other party. Neither party has authority to assume any obligation on behalf of the other party and shall not hold out to third parties that it has any
authority to act on the other party's behalf. Neither party shall take any action that might mislead or confuse third parties in this regard. Each party shall be responsible for its own expenses and
shall not incur expenses for the other party's account unless expressly authorized in writing to do so by the other party. 

5

 

ARTICLE 9—DISCLOSURES  

	9.1
	Each party agrees that, except as may be required by law, it shall not disclose the substance or details of this Agreement, except as
required to disclose to any of its Affiliates in the performance of its obligations or exercise of any of its rights hereunder, without the prior written consent of the other party. In cases in which
disclosure may be required by law, the disclosing party, prior to such disclosure, shall promptly notify the non-disclosing party of the contents of the proposed disclosure.

	9.2
	Consistent with applicable law, the non-disclosing party shall have the right to recommend/suggest reasonable changes or
objections to the disclosure to protect its interests. The disclosing party shall not unreasonably refuse to include such changes in its disclosure. 

ARTICLE 10—COMPLIANCE WITH LAW  

	10.1
	Each of the party shall not take any action which would, or fail to take any action where such failure would, directly or indirectly
result in or constitute a violation by CRINOS or GENTIUM of any applicable law, treaty, ruling or regulation. In performing its obligations under this Agreement, neither party nor any person acting on
its behalf shall make, directly or indirectly, any offer or promise or authorize bribes, kickback, payoff or any other payment or gift intended to improperly influence an agent, government official,
political party or candidate for public office to exercise their discretionary authority or influence in order to assist in the sale, marketing, promotion, importation, licensing or distribution of
the Products. 

ARTICLE 11 TERM (NATURAL EXPIRATION) AND TERMINATION  

	11.1
	The present Agreement will be effective and binding for the Parties starting from the Effectiveness Date as provided for in the
Umbrella Agreement.

	11.2
	Unless terminated by either party in accordance with the provision of clause 11.3, this agreement shall remain valid and in
force at least till the expiration of the Patent on the Product. Notwithstanding the above this agreement shall remain valid between the parties at the same conditions for renewable periods of
3 years each in case the market life or the Product will be deemed in good faith by the Parties to survive after the expiration of the Patent.

	11.3
	Without any prejudice to the other cases of early termination set forth in this Agreement, this Agreement may be also terminated prior
to the expiration of the term set forth in Article 11.2 in the event one of the following conditions occur:

	1)
	either
party's giving 60 days' notice to the other party of a stated breach of any of the terms and conditions of this Agreement by the other party and the other party's failure
to cure its breach within the 60 days' notice period provided.

	2)
	either
party's giving 60 days' notice to the other party if an event of force majeure under Article 15 continues for more than twelve (12) months, it is clearly
understood between the parties that this clause can be applied only under request of the party that is not affected by the event of force majeure;

	3)
	without
notice, in case of communication from either party to the other party in the case of any declaration of bankruptcy or insolvency, appointment of a receiver by a court of
competent jurisdiction, assignment for the benefit of creditors, or institution of liquidation proceeding by or against the other party;

 

	11.4
	This agreement shall be terminated by the non infringing party pursuant to Article 1456 of the civil code in the event of non
compliance of the other party with the essential agreements referred to articles 3.3, 3.4, 3.5, 4.2, 5.1, 17. 

6

 

ARTICLE 12—CONSEQUENCES OF TERMINATION  

	12.1
	In the event of termination of this Agreement according to Article 11 and the following Article 17.3, CRINOS shall stop
using and:

	1)
	at
GENTIUM's request, return to GENTIUM all confidential or proprietary information and material supplied by GENTIUM to CRINOS pursuant to this Agreement;

	2)
	at
GENTIUM's option, either:

	(i)
	cancel
the Registration;

	(ii)
	assign
the Registration to GENTIUM or GENTIUM's designee;

	3)
	not
use any of the Trademark, or any trade name, trade dress, service marks or devices applied to or used in association with the Product except for the purposes of selling its
remaining inventory of the Product.

	4)
	not
to use the Patent in any way

	5)
	both
parties shall continue to be bound by the provisions of Article 7 above for a period of five (5) years after termination of this Agreement. 

ARTICLE 13—NOTICES  

	13.1
	All notices shall be in writing addressed to the parties at the addresses set forth above. Notices shall be effective when delivered
personally or sent by telex, TWX, facsimile or other telegraphic mode or when sent by registered or certified mail, postage prepaid, so addressed. By notice a party may change its address for future
communications. 

ARTICLE 14—WAIVER  

	14.1
	No failure on the part of either party to exercise, and no delay in exercising any right or remedy shall operate as a waiver of such
right or remedy, nor shall any single or partial exercise of any right or remedy preclude any further or other exercise of such right or remedy. All rights and remedies under this Agreement are
cumulative and shall not be deemed exclusive of any other rights or remedies provided by law. 

ARTICLE 15—FORCE MAJEURE  

	15.1
	Failure of either party to perform its obligations under this Agreement (excepting the obligation to make payments) shall not subject
such party to any liability to the other if such failure is caused or occasioned by act of God, or the public enemy, fire, explosion, flood, drought, war, riot, sabotage, embargo, strikes, or other
labor trouble, interruption of or delay in transportation, compliance with any order, regulation or request of any government of competent jurisdiction or any officer, department, agency or committee
thereof, including requisition or allocation or establishment of priority, or by compliance with a request authorized by such governmental authority of any manufacturer for material to be used by it,
or by any other event or circumstance of like or different character to the foregoing beyond the reasonable control of the party so failing.

	15.2
	The party suffering an event of force majeure shall immediately notify the other party and both parties shall cooperate in good faith
in order to minimize the damages for both parties. 

ARTICLE 16—DISPUTE RESOLUTION  

	16.1
	Any disputes between the parties relating to, arising out of or in any way connected with this Agreement, with any term or condition
hereof, with the performance by either party of its obligations hereunder, whether before or after termination of this Agreement, shall be exclusively submitted to the Court of Milan. 

7

  

ARTICLE 17—PROHIBITION OF ASSIGNMENT and SUBLICENSE  

	17.1
	Each of the party shall not assign this agreement to third not Affiliated companies without the prior written consent of the other
party.

	17.2
	CRINOS shall not sublicense the Patent or dispose in any way of it without the prior written consent of GENTIUM.

	17.3
	GENTIUM will have the right to terminate this agreement in case CRINOS ceases to have the Product manufactured by CRINOS Industria
Farmacobiologica S.p.A. except that GENTIUM consents to change the manufacturer, being however understood that such right to terminate the contract is conditioned to the fact that CRINOS Industria
Farmacobiologica S.p.A. will respect the price and payment terms provided in Section 4.1 and 4.5 second paragraph of the Production Agreement between CRINOS and CRINOS Industria
Farmacobiologica S.p.A.. 

ARTICLE 18—DUTY OF DISCLOSURE  

	18.1
	Each of the parties undertakes to inform the other within 10 days of any change in the ownership of the company. 

ARTICLE 19—SEVERABILITY  

	19.1
	If any Article or part thereof contained in this Agreement is declared invalid by any court of competent jurisdiction or a government
agency having jurisdiction, such declaration shall not affect the remainder of the Article or the other Articles and each shall remain in full force and effect. 

ARTICLE 20—GOVERNING LAW  

	20.1
	The laws of Italy shall govern the interpretation, performance and enforcement of this Agreement. 

ARTICLE 21—ENGLISH LANGUAGE  

	21.1
	The English language version of this Agreement shall be controlling notwithstanding any translation of the Agreement made for any
purpose. 

ARTICLE 22—REGISTRATION TAX.  

	23.1
	The parties acknowledge that this Agreement is subject to value added tax and consequently is eligible for registration tax only in
case of use and at a fixed rate, pursuant to article 5 and 40 of Presidential Decree No. 131, dated April 26, 1986. 

IN WITNESS WHEREOF each of the parties has by their duly authorized representatives executed this Agreement as of the date and year first above written. 

	GENTIUM S.p.A.	 	CRINOS S.p.A.
	

/s/  Laura Iris Ferro      
	
 	

/s/  Enrique Hausermann      

	

Name: Dott.ssa Laura Iris Ferro	
 	

Name: Dott. Enrique Häusermann
	

President and Managing Director	
 	

Managing Director
	

 Date	
 	

 Date

8

 

The
following clauses are expressly accepted pursuant to Articles 1341 and following of the civil code: 2.1, 3.3, 3.4, 3.5, 4.2, 5.1, 12, 16.1, 17, 20. 

	GENTIUM S.p.A.	 	CRINOS S.p.A.
	

/s/  Laura Iris Ferro      
	
 	

/s/  Enrique Hausermann      

	

Name: Dott.ssa Laura Iris Ferro	
 	

Name: Dott. Enrique Häusermann
	

President and Managing Director	
 	

Managing Director
	

 Date	
 	

 Date

9

 
 
 

GENTIUM- CRINOS
  LICENSE AGREEMENT
  EXHIBIT A    
    

PATENT  

Procedimento per l'ottenimento di polidesossiribonucleotidi clinicamente definiti  

e riproducibili e prodotto farmacologicamente attivo risultante.  

	Reg. No.	 	Filed on
	IP 11903131	 	17.04.1986

10

 
 
 

GENTIUM- CRINOS
  LICENSE AGREEMENT
  EXHIBIT B    
    

PRODUCTS  

a-100
ampoules 200mg (A.I.C. n. 026111029) 

b-21
capsules 400mg (A.I.C. n. 026111056) 

11

  

 
 

EXHIBIT 8 TO THE UMBRELLA AGREEMENT
  
    SALE AND PURCHASE AGREEMENT    
    

        This Sale and Purchase Agreement ("Sale and Purchase Agreement") is entered into as of 17.05.2002 

between  

        CRINOS—Industria Farmacobiologica S.p.A. a corporation organised and existing under the law of Italy
and having its registered office at Piazza XX Settembre n. 2, Villa Guardia (CO), represented by its Vice-President and Managing Director Mrs. Laura Ferro (hereinafter simply
referred to as "SELLER"), on the one part, 

and  

        CRINOS S.p.A., a corporation organised and existing under the law of Italy and having its registered office in
Milan, Via Pavia, 6, represented by its Managing Director, Mr Enrique Hausermann, (hereinafter simply referred to as "BUYER"), on the other part 

(BUYER
and SELLER jointly also referred to as the "PARTIES") 

WHEREAS:

	1)
	The
SELLER is operating in the field of research and production of pharmaceuticals Specialties and its active ingredients, having also a division specialized in marketing and sale in
Italy of the pharmaceuticals products identified under Exhibit 1 (the "Products" as defined
hereinafter) attached to the present Sale and Purchase Agreement.

	2)
	The
BUYER is an Italian subsidiary of an international pharmaceutical group focusing on the production, marketing and distribution of pharmaceutical specialties, generics, OTC and
similar products and is willing to acquire the aforementioned division of SELLER.

	3)
	The
SELLER is willing to transfer to BUYER its rights in the aforementioned division.

	4)
	To
this purpose on 19.3.2002 the PARTIES have signed a letter of intent, providing for the basic terms and conditions of the perpetrated acquisition;

	5)
	The
PARTIES have furthermore agreed to enter into an Umbrella Agreement in order to link the present Sale and
Purchase Agreement to the other Collateral Agreements. Such Umbrella Agreement has been signed today by all parties thereto; 

        NOW,
THEREFORE, in mutual consideration of the previous understandings and of the above premises, which the PARTIES agree that shall be a binding part of this  Sale and Purchase Agreement, and the faithful
performance of the mutual covenants hereinafter set forth, the PARTIES hereto have agreed as follows:
 

ARTICLE 1—DEFINITIONS  

        As used in this Agreement, the following terms, beginning with a capital letter and written in bold type, shall
have the following meanings: 

	1.1.
	"Assignment of Trademarks" shall mean the agreement entered into by SFS Stada Finacial
Services Ltd. and SELLER regulating the transfer and assignment of all trademarks related to the Products, a copy of which is attached to the
present Sale and Purchase Agreement under Exhibit 2.

1

 
	1.2.
	Agents" shall mean all agents and independent sales representatives working for SELLER as of Closing Date and enlisted under  Exhibit 3 attached to the present Sale and Purchase Agreement;

	1.3.
	"Sale and Purchase Agreement" shall mean the present document and the attachment
thereof;

	1.4.
	"AIC" shall mean all authorizations for the commercialisation of the  Products
attached hereto under Exhibit 4 ("Autorizzazioni all'Immissione in
Commercio"); Part A enlists all AIC directly owned by SELLER, Part Bl shows the AIC held by SELLER pursuant to certain license agreement, whose contractual partners have
consented to the assignment in favour of BUYER, Part B2 shows the AIC held by SELLER pursuant to certain other license agreements, whose contractual partner have not, as of Closing Date, consented to
the assignment in favour of BUYER; the AIC shall be transferred to BUYER pursuant to the terms and conditions set forth in the
"AIC Transfer Agreements", in draft attached to the present Sale and Purchase Agreementunder  Exhibit 5 A and 5
B;

	1.5.
	"Closing Date" shall mean the date this Sale and Purchase
Agreement is executed by the PARTIES,

	1.6.
	"Collateral Agreements" shall mean the following agreements: the  Assignment of
Trademarks, the License Contracts and the AIC Transfer
Agreements, all executed on the Closing Date and attached to the Umbrella
Agreement.

	1.7.
	"Debts" or "Debt" shall mean all debts
of SELLER, not guaranteed by mortgages, towards banks, suppliers, financial institutions (including, but not limited to, leasing companies) and/or lenders or portion thereof, as the context may
require, existing on the Effectiveness Date as enlisted under Exhibit 6 attached to the present  Sale and Purchase
Agreement (such Exhibit until now updated as of April 30, 2002);

	1.8.
	"Deposit Agreements" shall mean all deposit agreements enlisted in  Exhibit 7, which have entered into by SELLER with respect to the Ongoing Business and for which
SELLER shall have sent a notice letter prior to Closing Dateproviding for the termination of the relevant Deposit
Agreement with respect to the Products not later than December 31, 2002;

	1.9.
	"Distribution Agreements" shall mean the distribution agreements to be signed by the
PARTIES with respect to the Product, whose AIC are enlisted in Part B2 of Exhibit 4 attached to
the present Sale and Purchase Agreement, attached hereto in draft under Exhibit 21;

	1.10.
	"Effectiveness Date" shall mean the date this Sale and Purchase Agreement, all other  Collateral
Agreements and the Umbrella Agreement become effective and shall be the date on which the
transfer to CRINOS S.p.A. of all the AIC mentioned in Part A of Exhibit 4 has been authorized and published by the Italian Health
Ministry,

	1.11.
	"Employment Liabilities" shall mean all debts of SELLER related to the  Personnel as of the Effectiveness Date arising from TFR and any other accruals, which will pass by law
to BUYER, including, but not limited to, FIR/ENASARCO mandatory payments for Agents;

	1.12.
	"Forecasted Turnover" shall mean the forecasted sales in Italy for each single  Product for the year 2002 as indicated in the relevant column of Exhibit 1;

	1.13.
	"License Contracts" shall mean the license agreements regarding the sale and
commercialization of the products containing the formulation "mesalazina" and the active ingredient "Defibrotide

	1.14.
	"License and Distribution Agreements" shall mean all, and/or any of the, as the
context may require, license and distribution agreements entered into by SELLER with third parties, as better identified under Exhibit 8 attached
to the present Agreement; which also shows the contractual partners, who have given their consent to the assignment to BUYER of the relevant contract;
and those, whose consent to the assignment has not been received prior to the Closing Date; 

2

 
	1.15.
	"List of Clients" shall mean the Italian client portfolio of SELLER with respect to
the Ongoing Business and shall include all clients enlisted in Exhibit 9, which also shows the
turnovers reached by each single client with respect to the Products in the year 2001 and in the first quarter of year 2002;

	1.16.
	"Loss" or "Losses" shall mean any and
all liabilities, obligations, damages, deficiencies, losses (including, without limitation, losses resulting from third party claims), claims, actions, law suits, proceedings, judgements, demands,
costs and penalties, including, without limitation, reasonable attorney's fees, lost profits and loss of or damage to goodwill;

	1.17.
	"Ongoing Business" shall mean all assets related to the SELLER's division of
marketing and sale of the Products in Italy and all contracts necessarily linked to the activity of such division (such as e.g. the software license
agreement regarding the data transmission handled by the Agents, leasing agreements regarding the passed equipment), including in particular the
following: any turnover reached in Italy by the sales of the Products from the Effectiveness Date, all  AIC
and any know how, technical and administrative, or otherwise necessary documentation and information related to the  Products and to the clients, Licensing and Distribution
Agreements, Deposit
Agreements, Personnel, existing agency contracts with Agents (including all necessary equipment granted to  Agents), and
List of Clients, Stock, the trademark
"CRINOS", all as defined in the present Sale and Purchase Agreement, as well as the goodwill related to all of the above, all as identified in  Exhibit 10, which shows the single values for each of the above assets; however, it shall not include any credits nor debts of SELLER related to
its division of marketing and sale of the Products, with the sole exception of the Employment
Liabilities;

	1.18.
	"Personnel" shall mean all employees operating in the Ongoing
Business for SELLER as of the Effectiveness Date and identified under  Exhibit 11 (until now updated to the Closing Date, therefore to be updated later on to the
Effectivness Date) attached to present Sale and Purchase Agreement indicating name, date of birth, contract type ("a tempo
determinato o indeterminato"), yearly gross compensation, monthly instalments ("mensilita"), part-time work hours
(if applicable), hiring date, category ("livello"), job title ("qualified"), company car (if
applicable), non-competition (if applicable), travelling salesman ("indennità ditrasferta") (if applicable), additional
injuries insurance (if applicable), cellular phone (if applicable), notebook (if applicable), and all other fringe benefits.

	1.19.
	The "Production Agreement" shall mean the manufacturing and supply agreement entered
into by BUYER and SELLER and attached hereto under Exhibit 12;

	1.20.
	"Product" or "Products" shall mean
the pharmaceutical specialties enlisted in Exhibit 1 attached to the present Sale and Purchase Agreement;

	1.21.
	"Purchase Price" shall mean the price to be paid by BUYER to SELLER for the
acquisition of the Ongoing Business calculated according to the terms and conditions set forth under the present Sale and
Purchase Agreement;

	1.22.
	"Stock" shall mean the saleable quantities of finished  Products having at
least 18 (eighteen) months of residual shelf life existing at SELLER's warehouse as of Effectiveness
Date and shall include the lot quantities with respect to any of the Products, which will generally allow BUYER to satisfy
average demand over a period of 2 to 3 months from the Effectiveness Date, with the only exception agreed between the Parties. The single Stock
quantities are indicated under Exhibit 13 attached to the present Sale and Purchase Agreement;

	1.23.
	"Tax" or "Taxes" shall mean 

        (a)   any
direct or indirect tax, duty, impost, charge, levy or customs duty, whether governmental, state, provincial, local or municipal, including but not limited to  imposta sulreddito  

3

 

 della persone giuridiche or corporate income tax, advance corporate income tax, imposta locale sui redditi or local income tax,
advance local income tax, capital gains tax, inheritance tax, imposta sul valore aggiunto or value added tax, import or export duties,, stamp duty,
registration tax, ipo-cadastral taxes, transfer taxes, net worth tax, local tax on immovable properties, tax on the increase of value of immovable properties or real property,municipal tax
on land and buildings, imposta regionale sulle attivita productive or regional tax on productive activities, waste disposal tax, tax on government
franchises, tax on vehicles, national insurance and social security contributions, withholding taxes on wages, passive income or any other required source, or any item of a similar nature; and 

        (b)   any
fine, penalty, surcharge, interest or other charge relating to any direct or indirect tax, duty, impost or levy, charge or customs duty mentioned in
paragraph (a) of this definition or to any account, record, form, return or computation required to be kept, preserved, maintained or submitted to any person, whether company or individual,
private or public, for the purposes of any such direct or indirect tax, duty, impost or levy. 

	1.24
	"Trademark" or "Trademarks" shall
mean, respectively, any or all trademarks "CRINOS"indicated in Exhibit 22 attached to the present Sale and Purchase
Agreement;

	1.25
	"Umbrella Agreement" shall mean the umbrella agreement entered into by the BUYER and
SFS Stada Financial Services Ltd., on the one side, and SELLER and Gentium S.p.A., on the other part. 

        All
terms and definitions used in the present Sale and Purchase Agreement and which have not been expressly defined or described herein,
shall have the same meaning as indicated either in the Umbrella Agreement or any other Collateral
Agreement. 

ARTICLE 2—PURPOSE OF THE AGREEMENT  

        Purpose of this Sale and Purchase Agreement is to determine all obligations and rights governing the acquisition
of the Ongoing Business by BUYER. 

ARTICLE 3—ONGOING BUSINESS ACQUISITION  

	3.1.
	Subject to all terms and conditions of this Sale and Purchase Agreement, BUYER shall
acquire all rights related to the Ongoing Business of SELLER as of Effectiveness Date.

	3.2.
	For the above acquisition BUYER shall pay to SELLER the Purchase Price resulting from
the calculation set forth hereinafter. The PARTIES have agreed the total value of the Going Business to be equal to Euro 24.624.163 (in letters:
twentyfourmillion sixhundredtwentyfourthousand onehundredsixtythree) (the "Business Value"). The Business Value has been calculated on the values of
each single asset related to the Ongoing Business as shown in Exhibit 10. The PARTIES have agreed
that the Purchase Price shall be the amount resulting from the difference between the Business Value
minus the sum of the Employment Liabilities and any other debt or liability, which will pass to BUYER pursuant to mandatory provisions of law, plus the
value of Stock calculated pursuant to Section 6. The exact amount of all Employment Liabilities, temporarily fixed in Euro 2.002.460,06
(twomillion twothousand fourhundredsixty/06, including TFR, FIR, ENASARCO as well as "ratei, ferie, tredicesime e
quattordicesime"), to be deducted from the Business Value in order to calculate the correct Purchase Price will have to be
communicated by SELLER within July 31, 2002.

	3.3
	The Purchase Price will be paid pursuant to the terms and conditions set forth
hereinafter.

	i)
	On
March 19, 2002 BUYER has already paid to SELLER an amount of Euro 1.364.000 (onemillion threehundredsixtyfourthousand/00) against receipt of bank guarantee in
the same 

4

 

amount
from SELLER. Upon execution of the present Sale and Purchase Agreement BUYER will return to SELLER the above bank guarantee and SELLER will have
the right to finally retain the above payment as partial payment of the Purchase Price, which shall therefore be reduced by the aforesaid amount of Euro
1.364.000 (one million three-hundred-sixty-four-thousand) 

	ii)
	A
further instalment of Euro 3.494.626,00 (threemillion fourhundred ninety-fourthousand sixhundredtwentysix/00) shall be paid in the amount of Euro 3.471.188,74
(threemillion fourhundredthousand onehundredeightyeight/74) on the Closing Date and the remaining amount of Euro 23.437,26 (twentythreethousand
fourhundredthirtyseven/26) prior or on the Effectiveness Date.Therefore SELLER with the signature of the present Sale and
Purchase Agreement recognizes to have received the before mentioned amount of Euro 3.471.188,74 (threemillion fourhundredthousand onehundredeightyeight/74). 

SELLER
undertakes to pay off its Debts, or part thereof, for an amount of at least Euro 6.640.000,00 (sixmillion sixhundredfourtythousand/00) and to
provide BUYER with written evidence of such payments; such evidence to be submitted by SELLER on a monthly basis within the 15th day of each month following the payment of the instalment
under the present Subsection 3 ii). Such evidence shall also include a report prepared by SELLER indicating the single Debts or portion thereof,.
However, as
SELLER receives the first instalment indicated under Subsection 3 ii) above partly on the Closing Date, the Parties agree that if SELLER pays
part of its debts existing as of the Closing Date (Exhibit 6), the amount of Euro 6.640.000,00
(sixmillion sixhundredfourtythousand/00) shall be reduced by the amount of Debts paid off by SELLER between the Closing
Date and the Effectiveness Date, notwithstanding, however, SELLERS obligations as set forth in Section 5. 

The
PARTIES agree that the above payment of Debts by SELLER shall be condition for the following payments according to the provisions set forth hereinafter. 

For
the case SELLER uses an amount higher than Euro 5.810.832,12 but lower than Euro 6.640.000,00 (sixmillion sixhundredfourtythousand/00) for paying off part of its  Debts, the PARTIES agree that BUYER
shall have the right to withhold, as a guarantee for possible claims by third creditors, an amount equal to the
difference between Euro 6.640.000,00 (sixmillion sixhundredfourtythousand/00) and the amount actually used for the payment of Debts from the following
payments. The withheld amount shall become due and payable only after SELLER will have demonstrated to BUYER the payment of all Debts.

Should
SELLER not demonstrate to BUYER that it has paid out its Debts at least for an amount of Euro 5.810.832,12 (fivemillion eighthundredtenthousand eighthundredthirtytwo/12), all the payments
indicated under the following Subsection 3.3 (iii) shall become due only upon and to the extent that the above condition to pay out its Debts at least for an amount of Euro 5.810.832,12 has
been fulfilled by SELLER, whereas the payment indicated under the following Subsections (iv) and (vi) hereof shall become due and payable only upon and to the extent SELLER will have
demonstrated to BUYER the payment of all Debts.

	iii)
	To
the extent the above Debt payment conditions have been fulfilled, SELLER will have the right to receive further
instalments each equalling 14.3% of the "Residual Purchase Price" (as defined hereinafter in this Subsection 3.3. (iii)), which shall respectively
become due on September 30, 2002, October 31, 2002 and November 30, 2002. The Residual Purchase Price shall be equal to the
difference between the Purchase Price and the sum of the payments set forth under Section 3.3 (i) and (ii) above), calculated as
follows:  

Residual Purchase Price—(Purchase Price)    (Euro 4.858.626,00). 

5

 

	iv)
	A
further instalment of 28.6% of the Residual Purchase Price shall become due on January 31, 2003 only if and to
the extent SELLER will provide BUYER with written evidence according to Section 3 ii) above of having paid in full its Debts, except for
those where a controversy is pending or SELLER has reasonable motives to contest such payment; such reasons to be demonstrated in writing to BUYER. 

Should
SELLER not have paid the Debts in full by January 31, 2003 and/or fail to provide BUYER with the evidence of such payment, this 28.6%
instalment shall not become due prior to December 31, 2004. 

Should
SELLER pay out in full its Debts prior to December 31, 2004, the relevant 28.6% instalment shall become due upon submittal to BUYER of the
relevant written evidence. 

Should
SELLER fail to pay out in full its Debts within December 31, 2004, the payment of the relevant 28.6% instalment shall be conditioned to
the simultaneous delivery by SELLER of a bank guarantee payable at first demand for an amount equal to the residual Debt. Any and all costs related to
the above bank guarantee shall be exclusively borne by SELLER. 

	v)
	A
further instalment of 14.2% of the Residual Purchase Price shall then become due on June 30, 2003.

	vi)
	A
further instalment of 14.3% of the Residual Purchase Price shall then become due on December 31, 2003. Payment
of this last instalment due on December 31, 2003 shall be conditioned to the delivery by SELLER of a bank guarantee payable at first demand for any further risks for BUYER related to the
transfer of the Ongoing Business or liabilities of the SELLER for a total amount of at least Euro 2.500.000,00 (Euro twomillion fivehundredthousand/00).
Such guarantee shall have a duration of at least 3 (three) years from delivery. 

6

  

	vi)
	A
further instalment of 14.3% of the Residual Purchase Price shall then become due on December 31, 2003. Payment of this last
instalment due on December 31, 2003 shall be conditioned to the delivery by SELLER of a bank guarantee payable at first demand for any further risks for BUYER related to the transfer of the  Ongoing
Business or liabilities of the SELLER for a total amount of at least Euro 2.500.000,00 (Euro twomillion fivehundredthousand/00). Such guarantee
shall have a duration of at least 3 (three) years from delivery. 
	vii)
	For
the avoidance of doubts, it is understood that all Debt payment conditions provided in this Section 3.3 shall not include
the payment those Debts, for which there is a controversy pending or SELLER has reasonable motives to contest; such reasons to be demonstrated in writing to BUYER.

 

	3.4
	In order to secure the above payments, BUYER will deliver to SELLER bank guarantees for each of the payments indicated under the
foregoing Section 3, iii), iv), v) and vi) before the Effectiveness Date.

	3.5
	In case of delay in payment of the above instalments the SELLER shall have the right to claim interest on the due amounts at annual
rate of 5%. 

ARTICLE 4—PRICE ADJUSTMENT  

	4.1
	Within
July 31, 2002, SELLER shall deliver to BUYER an accurate and complete statement of all Employment Liabilities due or
accrued up to the Effectiveness Date, for which SELLER shall provide BUYER with all reasonable access to worksheets, schedules and other working papers
necessary to enable BUYER and its representatives to monitor accounting procedures such that BUYER may conduct its own simultaneous audit of such statement. In case of disagreement of the BUYER with
the results of the Employment Liabilities, a notice of disagreement shall be given to the SELLER within sixty (60) days from receipt of the
statement. Should such term elapse without receiving any notice of disagreement, the results in the statement of Employment Liabilities shall be
considered definitive and binding. 

The
aggregate amount of all Employment Liabilities, as agreed by the PARTIES or as otherwise finally determined, shall be deducted from the  Purchase Price.

	4.2
	The Purchase Price shall then be increased by the amount due by BUYER for the Stock to
be calculated pursuant to Section 6.

	4.3
	Should the BUYER for any reasons not be granted, also in part, the A.I.C. transfer by the competent authorities, the relevant value as
indicated in the relevant column of Exhibit 10 shall be deducted from the Purchase Price.

	4.4
	As it was agreed that SELLER's turnover of the commercial year 2001 arising from sale of the  Products should be at least Euro
21.500.000,00 (in letters: twentyonemillion fivehundredthousand/00) and a price reduction of an amount equal to 1,3
times the difference between the above turnover and the turnover actually reached by SELLER in 2001 was agreed for the case above turnover was not reached, BUYER recognizes that the certification of
Neutra S.p.A. (Exhibit 20) confirms the achievement of above turnover.

	4.5
	Should it occur that the public selling price of any of the Products represented in the  Forecasted
Turnover of Exhibit 1 is reduced by governmental measures, the  Purchase Price shall be reduced 

7

 

by
the sum of the single amounts resulting from the application of the following calculation for each single Product and which was subject to any price
reduction measure: 

 
 

Q × P1 - Q × P2    
    

being
defined the single component as follows:

"Q" shall mean the number of units sold by BUYER in the year 2002

"P1" shall mean the public selling price prior to reduction

"P2" shall mean the public selling price after reduction.

Similarly,
the same principle will apply in case the public selling price of any of the Products represented in the Forecasted
Turnover of Exhibit 1 is increased by governmental measure. 

Any  Purchase Price adjustment pursuant to the present Subsection 4.5 shall apply for the year 2002 only. 

	4.6
	Notwithstanding the termination right pursuant to Section 8.3 hereof, the PARTIES agree that in case not all of the contractual
partners to the License and Distribution Agreements enlisted in Exhibit 8 have given their
consent to the present assignment in favour of BUYER for a period of at least 5 (five) years following the Effectiveness Date, the BUYER shall have the
right to claim for a reduction of the Purchase Price in the amount of 1,3 times the Forecasted Turnover
of the relevant Product. Should the assignment to BUYER be granted for a duration of less than 5 (five) years following Closing
Date the above coefficient of 1,3 times the Forecasted Turnover shall be proportionally reduced according to the following
formula: 1,3 / 5 × (5 - the number of years granted for the assignment). The relevant Purchase Price
reduction shall become effective upon receipt by SELLER of a notice in writing given by BUYER, pursuant to which the latter declares his intention to apply the relevant reduction. Should BUYER, after
expiry of the relevant License and Distribution Agreement, be granted a renewal, pursuant to which the entire duration of the contract reaches 5 years, BUYER undertakes to pay to SELLER the
price reduction applied pursuant to the foregoing provision. 

With
respect to the Price adjustment set forth under the present Section 4.6 the PARTIES agree that the consent to assignment of any of the License and Distribution
Agreements enlisted in Exhibit 8 with respect to the AIC shown in Part B2
of Exhibit 4 shall be deemed refused in case such consent is not received in writing by BUYER within July 31, 2002. 

	4.7
	With regard to the Product "Prociclide", which as of Closing
Date is undergoing an administrative revision proceeding, the PARTIES agree that for the case the sale authorization for the  Product is suspended, as a result of such revision,
or otherwise withdrawn from the market by reason beyond of control of the Buyer or the marketing
authorization holder appointed by the latter, the SELLER shall reimburse to BUYER an amount calculated according to the following formula: 

 
 

PAF- GM accrued at the time of suspension or withdrawal of the AIC    
    

being
defined the single component as follows:

Product Acquisition Fee (PAF) = Euro 7.440.689 (sevenmillion fourhundredfourtythousand

sixhundredeightynine)

Gross Margin (GM) = TS—COGs

Total sales relating to the Product Prociclide (TS)

Cost of Goods (COGs) 

	4.8
	All of the above Purchase Price adjustments shall be deducted from the Purchase Price,
or, if not possible, by means of direct reimbursement by SELLER to BUYER to be made within 40 (forty) business days upon receipt of payment notice by BUYER. 

8

 

ARTICLE 5—PAYING OFF OF DEBTS  

Within
30 (thirty) business days following the Effectiveness Date, SELLER shall deliver to BUYER the submission of a complete list of all of SELLER's Debts existing at the Effectiveness Date, whether
they are due on such date or not. Such list shall indicate, where applicable, any single guarantee released by SELLER or third parties in relation to the relevant Debt. 

ARTICLE 6—STOCK  

	6.1
	The PARTIES herewith expressly agree that for the purposes of the present Sale and Purchase Agreement, Stock shall include the lot
quantities indicated in Exhibit 13 with respect to any of the Products. SELLER guarantees that such quantities which, based on SELLER's
representations regarding the latest status of orders for the single Products, will generally allow BUYER to satisfy average demand over a period of 2
to 3 months from theEffectiveness Date, with the exception already agreed by the Parties. Based on SELLER's representations regarding the latest  status of orders for the single Products, the
Parties have agreed on the single Stock quantities indicated in  Exhibit 13 attached to the present Sale and Purchase Agreement and to be updated to the Effectiveness Date.

	6.2
	With respect to all other finished Products existing in any of SELLER's warehouses on
the Effectiveness Date, whose residual shelf live is lower than 18 (eighteen) months after such date and/or whose quantities exceed the lot quantities
set forth in the foregoing Subsection 6.1, the PARTIES expressly agree that they shall not be transferred within the present  Sale and Purchase Agreement.
However, for the case BUYER decides to purchase them from SELLER at any time after the  Effectiveness Date, SELLER undertakes to supply BUYER with the desired quantities at a price to be agreed
separately between the PARTIES. Such price
shall be equal or lower than the relevant price set forth in the Production Agreement.

	6.3
	Any and all ownership right on the Stock shall be transferred to BUYER on the Effectiveness
Date. The price for each single item included in the Stock shall be the one indicated in the Production
Agreement and the relevant purchase price shall be paid by BUYER within the terms and conditions set forth herein in Sections 3 and 4.2 above. 

ARTICLE 7—TRANSFER OF THE ONGOING BUSINESS  

	7.1
	The transfer of full title and ownership of all rights related to the Ongoing Business
shall take place in Milan on the Effectiveness Date, or shortly thereafter, by means of assignment to be executed in the presence of a notary agreed
between the PARTIES.

	7.2
	The PARTIES agree that on the Closing Date the following actions shall simultaneously
take place; such actions are to be considered as inseparable so that the transfer in respect of the Ongoing Business shall not be deemed to have
occurred unless all such actions have taken place:

	(i)
	SELLER
will:

	(a)
	execute
the License Contracts with respect to the sale and commercialization of the products containing the active ingredients
"mesalazina" and "Defibrotide";

	(b)
	execute
the Production Agreement;

	(c)
	execute
the AIC Transfer Agreements attached hereto under Exhibit 5 A and 5 B.

	(d)
	have
obtained all required approvals for entering into the present Sale and Purchase Agreement and has provided BUYER with written
evidence thereof.

	(e)
	execute
the Distribution Agreements according to the draft attached hereto under  Exhibit 21; 

9

 

	7.3
	The PARTIES agree that the present Sale and Purchase Agreement shall become fully valid
and effective on the Effectiveness Date, provided that BUYER has delivered the bank guarantee mentioned under Section 3.4 above. 

ARTICLE 8—CONDITIONS PRECEDENT, TERMINATION  

	8.1
	The PARTIES shall not be obliged to proceed with the transfer of the Ongoing Business
unless all the following conditions precedent have occurred, or have been waived in writing by BUYER, on or prior to the Closing Date: 

(a)
SELLER has delivered to BUYER the List of Clients indicating the single turnover for the year 2001 and for the year 2002 up to March 30 for
all Clients with respect to the Products. 

(b)
SELLER has terminated all Deposit Agreements enlisted in Exhibit 7 and has provided BUYER
with written evidence of such termination. For the avoidance of doubts, the PARTIES agree that the above termination condition shall be deemed satisfied by SELLER to the extent the latter has sent a
notice letter to the third contracting parties prior to Closing Date providing for the termination of the relevant Deposit
Agreement with respect to the Products not later than December 31, 2002. 

(c)
SELLER has provided BUYER with an official certificate from the Fiscal Authorities concerning the correct and timely payment of all Taxes by SELLER. Such certificate is attached to the present
document under Exhibit 14. 

(d)
SELLER has provided BUYER with an official certificate from the Social Security Institution (INPS) concerning the correct and timely payment of all social contributions for its employees. Such
certificate is attached to the present document under Exhibit 15. 

(e)
SELLER has provided BUYER with an official certificate from the National Labour Insurance Authority (INAIL) concerning the correct and timely payment of all applicable and due contributions for
its employees. Such certificate is attached to the present document under Exhibit 16. 

(f)
the Umbrella Agreement has been validly executed by the parties thereto. 

	8.2
	If any of the conditions precedent set out in Section 8.1 above is not satisfied, waived to or otherwise disposed of, by BUYER
within thirty (30) business days of the execution of this Sale and Purchase Agreement, the latter will be automatically terminated and each PARTY
will lose any rights hereunder and shall have no obligations vis a vis the other hereunder, save for the compensation of damages in the case when such
condition precedent has not occurred as a result of the willful misconduct or gross negligence of the other.

	8.3
	Notwithstanding the provision set forth under Section 4.7, BUYER, at its own discretion, shall have the right to terminate the
present Sale and Purchase Agreement in case the Product "Prociclide" is suspended prior to the Effectiveness
Date as a result of administrative revision, which is pending at Closing Date. The contract shall be automatically terminated
upon relevant written notice by BUYER and each Party will lose any rights hereunder and shall have no obligations vis a vis the other hereunder, save
for the compensation of damages in the case the suspension has been ordered in consequence of negligent or willful misconduct by SELLER.

	8.4
	The PARTIES further expressly agree that BUYER shall have the same right to terminate the present Sale and
Purchase Agreement as provided in Section 8.3 above, in case the License Agreement relating to the Product "Valpinax" is
not transferred to BUYER for refusal by the relevant contractual party or for any other reason prior to Effectiveness Date. 

10

 

ARTICLE 9—UNDERTAKINGS OF SELLER  

	9.1
	SELLER shall promptly notify BUYER, and similarly BUYER shall notify SELLER, of all information coming into its possession regarding
the Products or any of the Products concerning unexpected side-effects, injury, toxicity or
sensitivity reactions including unexpected incidence and severity of unknown side-effects associated with commercial or clinical research uses to be definitely attributable to such  Products. SELLER
shall timely supply BUYER with a copy of any Post Marketing Surveillance reports and BUYER shall be free to use said report for any
business, also other then the one relating to the Products. After the Effectiveness date, SELLER shall cease to update the PMS reports related to the
Products and such task shall be accomplished by BUYER. If necessary, SELLER shall cooperate with BUYER in the fulfilment of such task.

	9.2
	The PARTIES agree that the transfer of the Ongoing Business to BUYER will have to be
handled in a manner which will guarantee a smooth transition. In order to guarantee such a smooth transition, SELLER undertakes to offer its maximum cooperation, offering in particular, but not
limited to, for a period up to the end of July 2002, the gratuitous use of its office, any assistance with regard to the individuation of the documentation to be given to, or otherwise
necessary for, BUYER and with regard to the data export from the software used by SELLER to the one used by BUYER.

	9.3
	SELLER, if so requested, also undertakes to invoice, according to the indications received by BUYER, in the name and on behalf of the
latter, all Products sold by BUYER in Italy to third parties and delivered by the contractual partners to the Deposit Contracts up to expiry of the
relevant contracts. Such service to be rendered by SELLER shall be paid by BUYER on a cost reimbursement basis to be agreed by the PARTIES.

	9.4
	SELLER further undertakes to actively cooperate with BUYER with the logistic supply of Products to all deposits related to the Deposit
Contracts up to the expiry of such contracts.

	9.5
	SELLER undertakes to change its current company name within 30 (thirty) days after Closing
Date into another one, which will not create any confusion with BUYER's commercial denomination.

	9.6
	With respect to the time lapse between Closing Date and Effectiveness Date, SELLER
undertakes not to significantly increase its current liabilities towards, banks, supplier, any other financial institution (including, but not limited to, leasing companies) or lender, as shown in  Exhibit 6. Such requirement shall be deemed fulfilled to the extent the single Debts shown in  Exhibit 6 are not increased other than in the ordinary course of business and in any case not in an amount higher than Euro 1.000.000,00 (one
million).

	9.7
	For purposes of determining the payment condition set forth under Section 3.3 (ii), (iii) and (iv) above, and
notwithstanding the provision set forth under the foregoing Subsection 9.6, SELLER undertakes to provide BUYER, within 30 (thirty) business days after the Effectiveness
Date, a complete list of all Debts of SELLER towards banks, suppliers, financial institutions (including, but not limited to,
leasing companies) and/or lenders updated to the Effectiveness Date.

	9.8
	If necessary, SELLER undertakes to provide BUYER, upon simple request of the latter, with all information and documentation regarding
past, existing and potential Italian clients of the Products and to disclose to BUYER all aspects related to such clients in order to support BUYER'S
negotiations.

	9.9
	With respect to the Products Angipress, Ecafast, Fosfocin, Gliptide, Ikestatina, Litursol, Urochinasi Crinos, Venorest, Provedis,
Bio-Sison and Florbiox, for which SELLER helds the relevant AIC and know how to be passed to BUYER within the present Sale & Purchase Agreement, SELLER herewith undertakes, with
respect to any future new therapeutic indication, to grant to BUYER a 

11

 

first
refusal right for the acquisition of any and all rights for sale and distribution of the relevant new therapeutic indication in the European countries. 

ARTICLE 10—UNDERTAKINGS OF BUYER  

	10.1
	BUYER herewith grants to SELLER for a period of 24 (twenty-four) months after Closing
Date a royalty free use of the trademark "CRINOS" for the commercialisation of products pertaining to Class 5 under the Trademark Classification of Nice
(7th Edition).

	10.2
	With respect to any product, for which BUYER holds or will hold the relevant AIC and whose production may not be carried out neither
by BUYER directly nor by any other company of the BUYER's group, BUYER, for the entire duration of the Production Agreement, undertakes to grant SELLER
with a first refusal right for the production and supply of said products. Such first refusal right, however, shall not apply to products, which are already produced at the Effectiveness Date by third
parties. 

ARTICLE 11—REPRESENTATIONS BY SELLER  

All
of the information and data which SELLER has provided to BUYER prior to Closing Date is complete, correct in all respects and not misleading. SELLER
has disclosed to BUYER (or BUYER's representatives) all information, which it knows or could reasonably be expected to know would be
material to a buyer. An item is deemed disclosed for the purpose of this Sale and Purchase Agreement, only if fully, fairly, accurately and specifically
disclosed to BUYER in all material respects in this Sale and Purchase Agreement. Consequently, and notwithstanding any knowledge that may be attributed
to BUYER as a result of such disclosure, it is expressly agreed that SELLER hereby makes the following representations and warranties to BUYER. SELLER hereby certifies that each such representation
and warranty is true and complete as of the date hereof, and SELLER acknowledges that BUYER is relying thereon in connection with the execution of this Sale and Purchase
Agreement. 

	11.1
	Legal ownership

	11.1.1
	SELLER has full and unrestricted power, right, capacity and authority to enter into this Sale and Purchase
Agreement and perform the obligations resulting from it.

	11.1.2
	SELLER has the full legal ownership of all assets and rights specified hereunder, and such assets are not encumbered or burdened
with whatsoever right of third parties, except where otherwise indicated. 

12

   11.2 Debts and Employment Liabilities  

11.2.1    As
of Closing Date, there is no other debt, other than the employment liabilities shown in  Exhibit 18, which will pass
to BUYER pursuant to mandatory law. 

11.2.2    Exhibit 6 contains a complete list of all outstanding liabilities (Debts) of
SELLER towards banks, suppliers and any other financial institution (including, but not limited to, leasing companies) or lender as of the Closing Date,
which will have to be updated by SELLER to the Effectiveness Date pursuant to Section 9.7. 

11.2.3    Any
risks deriving from SELLER's Debts, whose creditors are not guaranteed by mortgages, shall be eliminated, within
January 31, 2003, by paying off such debts pursuant to Section 3.3 ii), iii) and iv). This, however, shall not apply for leasing payments, which are not due by January 31,
2003. 

11.2.4    Notwithstanding
the above, SELLER herewith undertakes to hold BUYER harmless from any and all possible claims started against BUYER by creditors of the SELLER with respect to the  Debts. 

11.2.5    BUYER
will hold SELLER harmless from any liability with respect to possible labor claims related to the Employment Liabilities,
which have been deducted form the Purchase Price pursuant to Section 4 above. However, this shall not apply with respect to  Employment Liabilities,
which have not been disclosed to BUYER according to Section 4.1 above. 

11.3 Taxes  

        SELLER has filed with the appropriate government authorities all Tax returns and all formalities or documents imposed by Tax legislation or regulations required
by law to be filed and has paid in full in a timely manner, or has made adequate provisions for all Taxes and social contributions due and payable by it
with respect to the Ongoing Business. All social contributions that SELLER is or was required to withhold or collect with respect to  Personnel and Agents
have been duly withheld or collected, and timely remitted to the appropriate administrative authorities or entities. SELLER has
paid in full in a timely manner, or has made adequate provisions for all wages, bonuses or other compensation relating to its Personnel and for all  Taxes
associated therewith. 

11.4 Governmental Authorizations  

        SELLER has obtained all requisite governmental authorizations necessary for carrying on the business of the Ongoing
Business ("Governmental Authorizations") and such Governmental Authorizations will be still in force at the Effectiveness Date
and all conditions stipulated in them have been fulfilled. Such Governmental Authorizations will not be cancelled or lapse other than in due course. 

11.5 AIC  

        Exhibit 4 contains a complete and accurate list of all AIC
related to the Products. All AIC listed in Part A of  Exhibit 4 have been duly filed,
registered, obtained by SELLER, they are valid and effective as of Closing
Date and there is no event or circumstance which could prevent their transfer to BUYER. Part B of Exhibit 4 shows
a complete, accurate and updated list of all the AIC with regard to the Products whose  AIC are held by
SELLER pursuant to certain license agreements and SELLER guarantees to pass all existing  AIC related to such Products to BUYER, except for those enlisted
in Part B2 of  Exhibit 4, whose transfer will partially depend on the consent of third parties. 

        SELLER
herewith guarantees that neither SELLER nor any other company or party related to SELLER's group owns any other AIC in Italy
related to any of the Products, which can be used by 

13

 

SELLER
herewith guarantees that neither SELLER nor any other company or party related to SELLER's group owns any other AIC in Italy related to any of the  Products, which can be used by SELLER, directly or
indirectly, and/or by third parties, except for the copies of AIC related to the following  Products: Urokinasi, Somatostatina (Ikestatina), Eparina Calcium (Ecafast), Quota (Enterasin) and Dinelase
(Prociclide) (the "Copies"). Such Copies
cannot be used by SELLER nor any other company or party related to SELLER's group other than for sole export purposes and therefore not to use the Copies and its related AIC's for sales in Italy, San
Marino and Vatican. In particular, SELLER undertakes, also with respect to any other company or party related to SELLER's group according to art. 1381 cod. Civ., not to sell the AIC's related to the
Copies nor to grant any license or distribution or similar rights in relation thereto to any third party—with the sole limitation of the Copy Quota which might be give in license to one
sole third party. 

        With
respect to the transfer of the AIC, BUYER guarantees that it has all requirements to be validly granted such transfer. 

11.6 License and Distribution Agreements  

11.6.1    Exhibit 8 contains a complete, accurate and updated list of all License and Distribution
Agreements, of which SELLER hereby guarantees full validity and enforceability toward the relevant contractual partners, from whom SELLER has obtained or asked for consent to
the present Sale and Purchase Agreement. 

11.6.2    SELLER
guarantees that there are no other payments due to third licensors in relation to License and Distribution Agreements other
than the royalties indicated in the relevant column of Exhibit 8, which constitute the binding consideration for each of such  License and Distribution
Agreements. SELLER further declares that no third licensor has requested, nor threatened to apply, any increased royalty fee in
relation to the relevant License and Distribution Agreement. 

11.6.3    SELLER
is, and at all times has been, in full compliance with all applicable terms and requirements of each of the License and Distribution
Agreements under which it or its assets is bound, and each other partner to each such License and Distribution Agreements is,
and at all times has been,
in full compliance with all applicable terms and requirements of such License and Distribution Agreement. 

11.6.4    No
event has occurred or circumstance exists that may result in a default or violation of any License and Distribution Agreement,
and SELLER has not given or received from any other person any notice regarding any actual or potential default or violation of any License and Distribution
Agreement; 

11.6.5    SELLER
has not assigned, transferred or sublicensed any of its rights or obligations for commercial distribution under any License and Distribution
Agreements to any third party. 

11.6.6    All
Deposit Contracts have been terminated by SELLER prior to Closing Date and shall
be assigned to BUYER as of the Effectiveness Date only if the relevant notice period has not elapsed by such date. BUYER shall incur in no liability
with respect to possible claims by the relevant contracting partners of the Deposit Contracts, arising in particular, but not limited to, from any
indemnification recognized by law or by the national bargaining agreement to agents. BUYER shall therefore have no other cost than the payment of the deposit consideration to the contractual partners
as agreed in the single Deposit Contracts and shown in Exhibit 7.

11.7 Personnel  

11.7.1    Exhibit 11 contains a complete and accurate list of the following information for each of its  Personnel, including all full-time and part-time employees and
executives operating in the 

14

 

 Ongoing Business as of Closing Date: name, date of birth, yearly gross compensation, monthly instalments  ("mensilita"), part-time work hours (if applicable), birth date, hiring date, category  ("livello"), job title ("qualifica"),
 company car (if
applicable), non-competition (if applicable), travelling salesman ("indennità di trasferta" if applicable), additional
injuries insurance (if applicable), cellular phone (if applicable), notebook (if applicable), and all other fringe benefits. 

11.7.2    SELLER
has not undertaken any obligation to promote any of its Personnel to a higher category or to increase any of their salary. 

11.7.3    Except
as otherwise indicated herein, the Personnel does not benefit from any social benefits of any nature whatsoever other than
the mandatory social contributions, which are provided pursuant to the social security and labour laws and regulations. There are no undisclosed employment relationships between other persons and the
SELLER in relation with the Ongoing Business, nor is there any undisclosed compensation to the  Personnel. 

11.7.4    Except
as otherwise indicated herein, there is no dispute outstanding with any person of the Personnel in relation to their
employment, compensation or benefits with SELLER. SELLER, as applicable, has accrued or paid in full on or prior to Closing Date all wages, salaries,
commissions, severance pay, bonuses and compensation as well as any other payment due to all of the Personnel for all periods up to and including the  Closing Date and will accrue and/or pay all of such contributions up to Effectiveness Date.
 

11.7.5    No
employee, who is part of the Personnel indicated in Exhibit 11, has resigned from its current
position. 

11.8 Agents  

        Exhibit 3 contains a complete and accurate list of all sales agents of the SELLER promoting on behalf of
the latter the sale of the Products within the Italian territory (including the Republic of San Marino and the Vatican), with specific indication of
whether or not they are bound by a written or verbal agreement and/or to the applicable A.E.C. bargaining agreement. The social contributions owed to ENASARCO for the payment of the termination
indemnities and of the pensions to the Agents have been always regularly and fully paid. SELLER furthermore guarantees to have handed over to BUYER
prior to the Closing Date a copy of all the contracts actually in force with such Agents. 

11.9 Litigation  

        Except as set forth in Exhibit 19, no proceedings have been commenced, or is
threatened or likely to be commenced, against the SELLER. To SELLER's knowledge, no event has occurred up to Closing Date
that may give rise to a basis for the commencement of any such proceeding. There is no administrative or judicial order to which the SELLER is subject with respect to the  Ongoing Business. 

        With
respect to the pending proceeding between SELLER and Ipsopharma relating to the product "Ipsovir", which is not part of the present transaction, SELLER herewith expressly declares
that BUYER shall not incur in any liability in relation to a possible negative outcome for SELLER of such proceedings. 

11.10 Operation of the Ongoing Business  

        Since the date of execution of the Letter of Intent, and up to Closing Date, SELLER has and will have up to the  Effectiveness Date: 

	a)
	operated
the Ongoing Business solely in the ordinary course of business;

	b)
	preserved
intact the current business organization thereof; 

15

 

	c)
	neither
resolved any material changes in the current compensation or benefits granted to Personnel and Agents nor employed any new
employee or agent within the Ongoing Business;

	d)
	not
made any material accounting changes;

	e)
	not
changed any operational matters of any material nature, including, but not limited to, any sale or other disposition of any asset or property, which is part of the  Ongoing Business;

	f)
	not
sold any of the Products below its current listed price;

	g)
	informed
BUYER if any marketing activity, which SELLER intended to execute in the period May/June 2002 and thereafter and has not resolved on the execution of any such activity
without having obtained prior consent in writing from BUYER. i 

11.11 Products  

        To the best of SELLER's knowledge, there are no other collateral effects with respect to the any of the Products other than those described in the relevant PSUR
and/or packaging information. 

11.12 Trademarks  

11.12.1    SELLER
will assign and transfer to the BUYER, which accepts, the ownership and all related rights of the Trademarks indicated in  Exhibit 22. To this extent the parties agree to fulfil all formalities necessary for the effectiveness of such transfer
on the Effectiveness Date by means of a private deed of transfer of the Trade Mark written in Italian or local language to be authenticated by an
Italian or local Notary on the Effectiveness Date, or shortly thereafter, (a draft of such deed in Italian is hereby enclosed as Exhibit 22). 

11.12.2    11.12.2
SELLER herewith guarantees that the Trade Marks transferred with this present Sale and Purchase
Agreement are in its sole and undisputed ownership and that such Trademarks are free from whatsoever right from third parties. 

11.12.3    The  Trademarks have been regularly registered 1) with the competent International Registration Authorities and
2) with the Italian Registration office of Patents and Trade Marks (U.A.M.I.) and SELLER has duly and timely paid all related fees and taxes. 

11.12.4    All
relevant applications for the maintenance, renewal and/or prosecution of the Trademarks registrations have been regularly filed
in front of the competent offices and all related fees and taxes have been regularly paid by the SELLER. 

11.12.5    SELLER
guarantees that there are no third-party rights, which might be used in order to validly oppose the relevant registrations. 

11.12.6    SELLER
undertakes not to file, directly or indirectly, any application for registration and, as from the Closing Date on, not to
make any use of the Trademarks or any other trademark, which could be confused with these, on their own or in combination with other words or signs. 

11.12.7    The
PARTIES acknowledge that certain Trademarks might be ceased for non-use. 

ARTICLE 12—WARRANTIES  

	12.1
	The representations set out in Section 11 above (the "Warranties") shall each
constitute independent guarantees of the SELLER to BUYER and as such they are not subject to the terms and conditions provided under Article 1495 of the Italian Civil Code, shall therefore be
fully operative and in full effect from the date hereof, shall survive the consummation of the transfer of the Ongoing Business as contemplated herein
and remain valid and binding on SELLER for a period of 5 (five) years after the Effectiveness Date. 

16

 
	12.2
	In addition to all and any other remedies provided by law, SELLER hereby agrees to hold harmless and to indemnify BUYER from and
against any and all damages or Losses suffered or incurred by BUYER arising from any breach of SELLER of any of the Warranties contained herein as well
as of any other covenant or guarantee contained in this Sale and Purchase Agreement herein.

	12.3
	In addition to all and any other remedies provided by law, BUYER, subject to the terms and conditions set forth under Sections 13 and
14, shall be entitled to set off any such damage or loss against any payments due to SELLER under the Sale and Purchase Agreement or any other  Collateral Agreement. 

ARTICLE 13—Claims of third parties  

        In case of claims started by third parties in relation to any circumstance, which is covered by the Warranties, BUYER shall promptly inform SELLER about said
event and any eventual claim, suit, action or damage and BUYER shall agree with SELLER the relevant actions to be taken with respect to the defence, being understood that as all corresponding costs
shall be borne by SELLER, the latter has the right to appoint its attorney and to decide with reference to the strategy of the defence (BUYER however might appoint its own attorneys at its own
expenses). It is furthermore understood that BUYER's right to set off the relevant claim pursuant to Section 12.3 above shall apply only to the extent such claim is finally ascertained or an
enforceable title has been released by the competent Authority. 

ARTICLE 14—INDEMNIFICATION, REMEDIES  

	14.1
	In the event that BUYER seeks indemnification hereunder, BUYER will give written claim notice to SELLER indicating the amount, to the
extent known, of the claim asserted ("Claim Notice"). Notwithstanding anything contained in this Section 14, the right of BUYER to be indemnified
hereunder shall not be adversely affected by a failure to give the Claim Notice unless, and the only to the extent that, SELLER is prejudiced thereby.

	14.2
	SELLER shall pay the amount claimed by BUYER within 30 (thirty) business days following receipt of the Claim
Notice unless SELLER has replied within above term with a written notice of disagreement. Should SELLER however not reply within above 30 days-term and not
proceed to payment within such 30-day-term, BUYER shall be entitled to set-off the relevant amount from any other amount due to SELLER pursuant to the present  Sale and Purchase Agreement or any other
Collateral Agreement. 

        In
case SELLER has sent the mentioned notice of disagreement, BUYER's right to set off the relevant claim pursuant to Section 12.3 above shall apply only to the extent such claim
is finally ascertained or an enforceable title has been released by the competent Authority. 

17

  

ARTICLE 15—NON-COMPETITION  

	15.1
	For the purpose of assuring BUYER the full benefit of the business and goodwill of the Ongoing
Business, during the period of 5 (five) years after Closing Date, SELLER undertakes not to:

	(a)
	either
directly or indirectly, solicit, interfere with or endeavor to entice away from BUYER or take into service any Personnel, or
have such Personnel perform any activities for them, who is now or who has during the two (2) years preceding Closing
Date been, an employee within the Ongoing Business;

	(b)
	either
on its own account or for any other person, directly or indirectly, solicit, interfere with, endeavor to entice away from BUYER or approach customers of the  Ongoing Business at the time of departure, in
order to offer goods or services that are the same or partially the same as those of the division acquired
by means of the present Sale and Purchase Agreement;

	(c)
	whether
alone or jointly with, or as agent, directly or indirectly conduct or be engaged or concerned or interested in any activities related to the commercialization, in Italy, of
new products, which are the same or partially the same as those of the Ongoing Business or have the same therapeutic indication of the  Products.

 

	15.2
	The present non-competition covenant shall be extended to all companies of the group of SELLER. 

ARTICLE 16—CONFIDENTIALITY  

	16.1
	Unless legally required, SELLER undertakes not to disclose to any third party any information regarding this  Sale and Purchase Agreement or any
confidential information relating to or concerning the BUYER and the BUYER's group, or any of their respective
businesses, including, without limitation, any and all intellectual property rights owned by the latter and any information regarding the businesses of any their respective clients
("Confidential Information").

	16.2
	BUYER, on its part, undertakes not to disclose to any third party any information regarding this Assignment of Trademark or any
confidential information relating to or concerning SELLER and SELLER's group, or any of their respective businesses, including, without limitation, any and all intellectual property rights owned by
the latter and any information regarding the businesses of any of their respective clients.

	16.3
	The foregoing restriction shall not restrict disclosure or use of Confidential
Information that:

	(a)
	was
in the public domain at the time of disclosure or thereafter enters into the public domain through no breach of this Sale and Purchase
Agreement;

	(c)
	is
independently developed by the disclosing Party after Closing Date without reliance on or access to any of the  Confidential Information; or

	(d)
	is
required to be disclosed by a Government Authority; provided that the requested Party shall first provide the other Party with prompt written notice of such required disclosure and
will take reasonable steps to allow such Party to seek where provided by the Italian legislation, a protective order with respect to the Confidential
Information required to be disclosed. The requested Party will promptly cooperate with and assist the other Party, at its own expense, in connection with obtaining such
protective order.

 

	16.4
	Within 10 (ten) business days after specific request, SELLER and its external consultants shall make available upon request by BUYER
all agreements, documents, books, records and files, including, without limitation, records and files stored on computer disks or tapes or any other storage medium, and all copies thereof, in the
possession of SELLER, directly relating to the 

18

 

business
carried out by the division acquired by means of the present Sale and Purchase Agreement. 

ARTICLE 17—TAXES AND EXPENSES  

        The costs, taxes, duties, expenses and other charges deriving from this Sale and Purchase Agreement or relating to
the execution thereof, shall be borne as follows: 

	—
	each
of the PARTY will attend to the compensation and refund due to its own consultants and professionals on its own expense;

	—
	the
charges and expenses relating to the registration and transcription of the Sale and Purchase Agreement and/or notarial
expenses will be borne by BUYER. 

ARTICLE 18—SUCCESSORS AND ASSIGNMENT OF THE AGREEMENT  

        None of the PARTIES may assign its rights under this Sale and Purchase Agreement without the prior consent of the
other PARTIES. Subject to the terms of the preceding sentence, this Sale and Purchase Agreement will apply to, be binding in all respects upon, and
inure to the benefit of, the successors and permitted assignees of the PARTIES. 

ARTICLE 19—MISCELLANEOUS  

19.1. Notices  

        All reports, notices and communications required or permitted to be given or made pursuant to this Sale and Purchase
Agreement by one PARTY to the other shall be validly given or made by registered letter to the following addresses: 

To
SELLER:

Crinos S.p.A.—Industria Farmacologica S.p.A. (or respectively its new denomination as result from its undertaking to change its current commercial name pursuant to Section 8.4
above)

Piazza XX Settembre n. 2

22079 Villa Guardia (CO)

To the attention of Dott.ssa Laura Ferro 

To
BUYER

CRINOS S.p.A.

Via Pavia 6

20136 MILANO

To the attention to: Dr. Enrique Häusermann 

        The
above applies in so far as no other address is communicated later, in accordance with this Section. The notices will be effective as of receipt if sent by registered letter. All
notices shall be in the English language. 

19.2. Waiver  

        The failure of a PARTY to insist upon strict performance of the terms, conditions and provisions of this Sale and Purchase
Agreement by the other PARTY shall not constitute a waiver of any of the provisions hereof and no waiver by a PARTY of any of such provisions shall be deemed to have been made
unless expressed in writing by such waiving PARTY. 

19

 

19.3. Interpretation  

	(a)
	The
language of this Sale and Purchase Agreement is English. No translation into any other language shall be taken into account in the
interpretation of the Sale and Purchase Agreement.

	(b)
	The
headings in this Sale and Purchase Agreement are inserted for convenience only and shall not affect its construction.

	(c)
	Where
appropriate, the terms defined in Article 1 here above and denoting a singular number only shall include the plural and vice versa.

	(d)
	References
to any law, regulation, statute or statutory provision includes a reference to the law, regulation, statute or statutory provision as from time to time amended, extended or
re-enacted. 

19.4. Exhibits  

        The following Exhibits shall be integral part of this Sale and Purchase Agreement: 

        Exhibit 1:    List of the Products saled and marketed within the Ongoing
Business and which are object of the present Sale and Purchase Agreement; the Forecasted Turnover for
each of the Products is shown in the relevant column; 

        Exhibit 2:    Assignment of Trademarks (attached without exhibits) 

        Exhibit 3:    List of all Agents

        Exhibit 4:    List of all AIC, Part "A" enlists  all
AIC directly owned by SELLER, Part "Bl" enlists all AIC held by SELLER pursuant to certain license
agreement, whose contractual partners have consented to the assignment to BUYER, Part "B2" enlists all AIC held by SELLER pursuant to certain license
agreement, whose contractual partners have not, as of the Closing date, consented to the assignment to BUYER, 

        Exhibit 5 A:    AIC Transfer Agreement

        Exhibit 5 B:    Transfer Agreement for the sale authorization of food supplements
("integratori"); 

        Exhibit 6:    List of Debts of SELLER as of April 30, 2002,
indicating also—for the information of BUYER the debts guaranteed by mortgages; 

        Exhibit 7:    Deposit Contracts, showing also the consideration due the
single third contracting party. 

        Exhibit 8:    List License and Distribution Agreements (indicating, where
applicable, the relevant approval of the contractual partner) 

        Exhibit 9:    List of Clients

        Exhibit 10:    List of assets of the Ongoing Business, showing the single
business value of each asset; in particular, PART A shows the "stato patrimoniale" of the Ongoing Business, PART B enlists the values attributes to each
AIC, PART C enlists further assets and equipment. 

        Exhibit 11:    List of Personnel operating for SELLER as of  Closing Date indicating name, date of birth, yearly gross compensation, monthly instalments
("mensilita"), part-time work hours (if applicable), birth date, hiring date, category
("livello"), job title ("qualifica"), company car (if applicable), non-competition (if
applicable), travelling salesman (if applicable), additional injuries 

20

 

insurance
(if applicable), cellular phone (if applicable), notebook (if applicable), and all other fringe benefits; 

        Exhibit 12:    Production Agreement (attached without exhibits) 

        Exhibit 13:    Stock, indicating the single quantities of each finished
Products having at least 18 (eighteen) months of residual shelf life. 

        Exhibit 14:    Certificate of Fiscal Authorities. 

        Exhibit 15:    Certificate of INPS 

        Exhibit 16:    Certificate of INAIL. 

        Exhibit 17:    Minutes of Meeting of the Labour's union meeting held on April 2, 2002 containing the general
disclaimer released by trade unions to BUYER. 

        Exhibit 18:    Employment liabilities accrued up to April 30, 2002. 

        Exhibit 19:    Pending litigation proceedings of SELLER; 

        Exhibit 20:    Cerificate by Neutra S.p.A. related to SELLER's turnover for the year 2001. 

        Exhibit 21:    Distribution Agreement 

        Exhibit 22:    List of Trademarks "CRINOS" 

ARTICLE 20—GOVERNING LAW AND JURISDICTION  

	20.1
	This Sale and Purchase Agreement, its validity, its interpretation and performance
shall be governed by Italian Law.

	20.2
	Any disputes between the PARTIES arising out of or caused by this Sale and Purchase
Agreement, including the validity, interpretation, execution and resolution of this Sale and Purchase Agreement, which are not
settled as a result of negotiations between the PARTIES, shall be resolved under the exclusive jurisdiction of the Court of Milan. 

ARTICLE 21—ENTIRETY OF THE AGREEMENT AND SEVERABILITY  

	21.1
	This Sale and Purchase Agreement supersedes all prior agreements or understandings,
whether oral or written, made by either Party or between the PARTIES. It shall not be considered extended, cancelled or amended in any respect unless done so in writing and signed on behalf of the
PARTIES hereto.

	21.2
	Should any provision of this Sale and Purchase Agreement be invalid or unenforceable
or should the agreement contain any omission, the remaining provisions shall remain valid. In place of the invalid provision, a valid provision is presumed to be agreed upon by the parties, which come
economically closest to the one actually stipulated; the same will apply in case of an omission. 

21

 

        At
WITNESS the hands of duly authorised officers on behalf of the Parties hereto the day, the month and the year first above written. 

	For and on behalf of
 CRINOS—Industria Farmacobiologica S.p A.	 	For and on behalf of
 CRINOS S.p.A.
	

/s/  Laura Iris Ferro      
 Dott.ssa Laura Iris Ferro

Vice President and managing Director

Date	
 	

/s/  Enrique Hausermann      
 Dott. Enrique Hausermann

Managing Director

Date

22

 
 
 

Exhibit 9    
    

 
 

Italian Patent n. 01277663
  (enterasin)    
    

Sospensioni acquose stabili di

mesalazina per uso topico  

	Date of application	 	28/09/1995
	

Number of application	
 	

MI95A001987
	

Date of approval	
 	

11/11/1997

23

 
 
 

Exhibit 10    
    

 
 

Italian Patent n. 11903131
  (defibrotide)
  Cert.Compl. C-UB92CCP404    
    

 
 

Procedimento per l'ottenimento di
  polidesossiribonucleotidi chimicamente
  definiti e riproducibili e prodotto
  farmacologicamente attivo risultante    
    

	Date of application	 	17/04/1986
	

Number of application	
 	

20117A/86
	

Date of approval	
 	

16/02/1988

24

QuickLinks

Exhibit 10.16

Umbrella Agreement between CRINOS IF / GENTIUM and CRINOS / SFS

Art. 1 Introductory Statements

Art. 2 Definitions

Art. 3 SCOPE OF THE UMBRELLA AGREEMENT

Art. 4 CONTRACTUAL SCHEME

Art. 5 MUTUAL UNDERTAKINGS

Art. 6 Duration

Art. 7 Miscellaneous

Art. 8 Governing Law and Jurisdiction

Art. 9 Severability

Exhibit 1

Exhibit 2A

Exhibit 2B

Exhibit 3A

Exhibit 3B

EXHIBIT 4A TO THE UMBRELLA AGREEMENT

SCRITTURA PRIVATA TRA

e

Premesso che

tutto ciò premesso si stipula e si conviene quanto segue

EXHIBIT 4B TO THE UMBRELLA AGREEMENT SCRITTURA PRIVATA tra

e

Premesso che

EXHIBIT 5 TO THE UMBRELLA AGREEMENT ASSIGNMENT OF REGISTERED TRADEMARKS

Art. 1 Introductory Statements

Art. 2 Definitions

Art. 3 Object and Effectiveness of the Contract

Art. 4 Price and Payment

Art. 5 Representations of the SELLER

Art. 6 Further obligations of SELLER

Art. 7 Indemnity and Compensation

Art. 8 Fiscal Charges and Expenses

Art. 9 Confidentiality

Art. 10 Successors and Assignment of the Agreement

Art. 11 Miscellaneous

Art. 12 Governing Law and Jurisdiction

Art. 13 Entirety of the Agreement and Severability

EXHIBIT 6 TO THE UMBRELLA AGREEMENT

LICENCE AGREEMENT between

GENTIUM-CRINOS LICENSE AGREEMENT EXHIBIT A

GENTIUM-CRINOS LICENSE AGREEMENT EXHIBIT B

EXHIBIT 7 TO THE UMBRELLA AGREEMENT

LICENCE AGREEMENT between

GENTIUM- CRINOS LICENSE AGREEMENT EXHIBIT A

GENTIUM- CRINOS LICENSE AGREEMENT EXHIBIT B

EXHIBIT 8 TO THE UMBRELLA AGREEMENT SALE AND PURCHASE AGREEMENT

Q × P1 - Q × P2

PAF- GM accrued at the time of suspension or withdrawal of the AIC

Exhibit 9

Italian Patent n. 01277663 (enterasin)

Exhibit 10

Italian Patent n. 11903131 (defibrotide) Cert.Compl. C-UB92CCP404

Procedimento per l'ottenimento di polidesossiribonucleotidi chimicamente definiti e riproducibili e prodotto farmacologicamente attivo risultante

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