Eurand (EURX) 20-F 2008 FY Annual report (foreign)

Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “***”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

License Agreement

Made as of the 2nd day of April 2008 (the “EFFECTIVE DATE”)

by and between

Chiesi Farmaceutici S.p.A.

a company duly organized and existing under the laws of Italy, with its principal place of business at Via Palermo 26/A, 43100 Parma, Italy

(hereinafter referred to as “LICENSOR”)

and

Eurand Pharmaceuticals Inc.

a company duly organized and existing under the laws of Delaware, with its principal place of business at 790 Township Line Road, Suite 250, Yardley, Pennsylvania 19067 U.S.A.

(hereinafter referred to as “LICENSEE”)

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WITNESSETH

WHEREAS,LICENSORhas developed theLICENSED PRODUCT(hereinafter defined) containing theCOMPOUND (hereinafter defined) andLICENSORowns orCONTROLS(hereinafter defined) theLICENSED KNOW HOW (hereinafter defined) andLICENSED TRADEMARK(hereinafter defined), all of them relevant to theLICENSED PRODUCT;

WHEREAS,LICENSEEhas the capabilities, directly or indirectly, to develop, register, manufacture, distribute, market and sell pharmaceutical specialties in theTERRITORY(as hereinafter defined);

WHEREAS,LICENSEEhas reasonably investigated theLICENSED KNOW HOW;

WHEREAS,LICENSEEafter having reasonably investigated theLICENSED KNOW HOW, desires to acquire a license to further develop theLICENSED PRODUCTand to manufacture, use, market, promote, sell and distribute theLICENSED PRODUCTunder aLICENSED TRADEMARKin theLICENSED FIELD(hereinafter defined) in theTERRITORY, andLICENSORis willing to provideLICENSEEwith such license, subject to the terms and conditions of thisAGREEMENT;

NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, and intending to be bound, and it being understood that the above recitals shall be deemed to be incorporated into and form part of thisAGREEMENT, the parties hereby agree as follows:

Article 1.00 — Definitions

For the purpose of thisAGREEMENTthe following definitions shall be applicable.

1.01 “AFFILIATE” shall mean any company or business entity controlled by, controlling or under common control with a party to thisAGREEMENT. For this purpose, “control” shall mean the power, directly or indirectly, to direct or cause the direction of the management and policies of a company and control is conclusively presumed in

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case of direct or indirect ownership of more than 50% (fifty percent) of the voting stock of such company.

1.02 “AGREEMENT” shall mean this License Agreement by and betweenLICENSORandLICENSEEtogether with all its Appendices.

1.03 “COMPOUND” shall mean the active ingredient known as “Beclomethasone dipropionate”.

1.04 “CONTROLLED” or “TO CONTROL” shall in relation to anyINTELLECTUAL PROPERTY RIGHTSmean suchINTELLECTUAL PROPERTY RIGHTSin the possession (whether by ownership, licence or other right, other than pursuant to thisAGREEMENT) by a party or itsAFFILIATESwith the ability to grant to the other party access and/or a licence (or sublicence) as provided herein under such right without violating the terms of any agreement or other arrangement with anyTHIRD PARTYand without requiring any further consent from suchTHIRD PARTY.

1.05 “DEVELOPMENT PLAN” shall mean a detailed development plan, including study protocols, timelines and associated budget, *** relating to the further development of theLICENSED PRODUCTin accordance with the terms of thisAGREEMENT. A first outline of theDEVELOPMENT PLAN, as agreed upon between the parties, shall be attached hereto as Appendix A *** below, which shall be considered an integral part of thisAGREEMENT.

1.06 “FIRST COMMERCIAL SALE” shall mean the first sale of theLICENSED PRODUCTin each country of theTERRITORYbyLICENSEE, directly or indirectly, to an unrelatedTHIRD PARTYon a commercial basis.

1.07 “FDA” shall mean the United States Food and Drug Administration or any successor entity thereto.

1.08 “HPB” shall mean the Health Protection Branch in Canada or any successor entity thereto.

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1.09 “IMPROVEMENT” shall mean any discovery, development, invention, enhancement or modification, patentable or otherwise, relating to theLICENSED PRODUCTowned orCONTROLLEDbyLICENSORorLICENSEE, including any analytical methodology, ingredients, preparation, presentation, means of delivery or administration, indication, use or packaging of theLICENSED PRODUCT.

1.10 “IND” shall mean an Investigational New Drug Application in respect of theLICENSED PRODUCT in theTERRITORY.

1.11 “INTELLECTUAL PROPERTY RIGHTS” shall mean patents, trade marks, service marks, logos, trade names, rights in designs, copyright, utility models, rights in know how and other intellectual property rights, in each case whether registered or unregistered and including applications for registration, and all rights or forms of protection having equivalent or similar effect anywhere in the world.

1.12 “LICENSED FIELD” shall mean the treatment of inflammatory bowel diseases and related complications.

1.13 “LICENSED KNOW HOW” shall mean, in relation to theLICENSED PRODUCT, all information, procedures (including, but not limited to manufacturing and packaging), instructions, techniques, data, technical information, knowledge and experience (including toxicological, pharmaceutical, clinical, non-clinical, medical data and health registration data), designs, manufacturing processing, processing specifications and technology to the extent necessary, useful or used to develop, make, package, market, promote, distribute, sell, or offer for sale theLICENSED PRODUCTin theTERRITORY, whether in written electronic or other form, in each case as owned orCONTROLLEDbyLICENSORas of theEFFECTIVE DATEor during theTERM.

1.14 “LICENSED PRODUCT”shall mean the finished,i.e.formulated and packaged ready for use on human patients, pharmaceutical product containing the

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COMPOUNDas the pharmaceutically active ingredient, in a tablet form, manufactured under theLICENSED KNOW HOW.

1.15 “LICENSED TECHNOLOGY” shall mean theLICENSED KNOW HOW, theLICENSED TRADEMARKand anyIMPROVEMENTS CONTROLLEDbyLICENSOR.

1.16 “LICENSED TRADEMARK” shall mean the trademark belonging to orCONTROLLEDbyLICENSOR, which shall be used byLICENSEEto market and sell theLICENSED PRODUCTin theTERRITORYand which is set out in Appendix B, which shall be considered an integral part of thisAGREEMENT.

1.17 “MARKETING EXCLUSIVITY PERIOD”shall mean that period of regulatory exclusivity conveyed by theFDAand theHPBfor the firstLICENSED PRODUCTto achieve anNDAand anNDS, respectively.

1.18 “NDA” shall mean a New Drug Application approved by theFDA, and any renewals, amendments or supplements thereto in respect of theLICENSED PRODUCT.

1.19 “NDS” shall mean a New Drug Submission approved by theHPB, and any renewals, amendments or supplements thereto in respect of theLICENSED PRODUCT.

1.20 “NET SALES” shall ***

1.21 “PATENT” or “PATENTS” shall mean any and all patent(s) and patent applications owned orCONTROLLEDas of theEFFECTIVE DATEor during theTERMbyLICENSORas well as any extension thereof, including supplementary protection certificates, together with any continuations, continuations-in-part, divisions and reissues thereof, in each case which if not licensed herein would be infringed by using, developing, manufacturing, packaging, registering, storing, handling, promoting, distributing, marketing, selling or otherwise transferring physical possession of or otherwise transferring title in or to theLICENSED PRODUCT.

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1.22 “TERRITORY” shall mean the United States of America (including the US Virgin Islands and Puerto Rico) and Canada.

1.23 “THIRD PARTY” shall mean any entity other thanLICENSOR,LICENSEEand their respectiveAFFILIATES.

Article 2.00 — Grant

2.01

LICENSORhereby grants toLICENSEE, subject to the terms and conditions herein contained, andLICENSEEhereby accepts fromLICENSOR, (a) a non-exclusive license outside theTERRITORY, under theLICENSED TECHNOLOGY,to use, develop, make and have made (including, manufacturing and packaging), store and handle, theLICENSED PRODUCTandIMPROVEMENTS(owned orCONTROLLEDbyLICENSOR)in theLICENSED FIELDbut solely for subsequent export thereof in theTERRITORYfor resale, and (b) an exclusive (even as toLICENSOR) non-transferable license (including the right to grant sub-licenses in the limits set forth under Section 2.02 below) in theTERRITORY, under theLICENSED TECHNOLOGY, to use, develop, make and have made (including, manufacturing and packaging), register, import, store, handle, market, promote, distribute, sell and/or offer for sale, theLICENSED PRODUCTandIMPROVEMENTS(owned orCONTROLLEDbyLICENSOR)in theLICENSED FIELD. For purposes of clarity, the above license grants include the ability to subcontract toTHIRD PARTIESthe above allowed activities of using, developing, making and having made (including, manufacturing and packaging), storing and handling and the engagement of a contract sales force for the marketing and sale of theLICENSED PRODUCTin theTERRITORY. Furthermore, the license granted in paragraph (a) above also includes a non exclusive unblocking license under anyPATENTto the extent strictly necessary toLICENSEEto perform the activities as set out in such paragraph (a).

2.02

Except to itsAFFILIATESor toTHIRD PARTIESas specifically set forth under Section 2.01 above,LICENSEE***.

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2.03

Except to the extent permitted under thisAGREEMENT,*** *** Without prejudice to the foregoing, in the event thatLICENSORdecides to license theLICENSED PRODUCTin theTERRITORYfor use in the Gastrointestinal field, thenLICENSEE***

2.04

All rights and licenses granted toLICENSEEunder this Article 2.00 are, and shall be deemed to be, for purposes of applicable bankruptcy law (including section 365(n) of the United States Bankruptcy Code), licenses of rights to “intellectual property” (including as such term is defined under section 101(35A) of the United States Bankruptcy Code).

Article 3.00 — Milestone Payments

3.01

In consideration of the rights granted toLICENSEEunder thisAGREEMENT,LICENSEEshall make toLICENSORtotal milestone payments of USD *** United States Dollars) made up as follows:

A. USD *** United States Dollars) ***;
B. USD *** United States Dollars) ***;
C. USD *** United States Dollars) ***;
D. USD *** United States Dollars) ***.

3.02

All milestone payments to be made byLICENSEEtoLICENSORunder this Article 3.00 shall be ***.

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Article 4.00 — Development and Regulatory Activities

4.01

Promptly after theEFFECTIVE DATE,LICENSORshall disclose and transfer toLICENSEE,at its own expense, all existingLICENSED KNOW HOW, including, without limitation the documents set forth on Appendix C and, promptly thereafter, throughout theTERMdisclose and transfer allLICENSED KNOW HOWthatLICENSORshallCONTROLnot previously disclosed and transferred toLICENSEE. In addition and in order to supportLICENSEEin carrying out theDEVELOPMENT PLAN,LICENSORshall collaborate withLICENSEE, for maximum 3 (three) meetings of 1 (one) day each at times and locations to be agreed upon, for the time necessary to file anINDin theTERRITORY. Any further reasonable assistance possibly required byLICENSEEfrom time to time for the above purposes may be furnished byLICENSORat reasonable terms to be agreed upon in due course.

4.02

LICENSEEshall use all commercially reasonable efforts (commensurate with those efforts used byLICENSEEin connection with its own products of similar nature, value and status) (“ALL COMMERCIALLY REASONABLE EFFORTS”) to ***.

4.03

LICENSEEundertakes to keepLICENSORduly and fully informed of the activities made byLICENSEE pursuant to Section 4.02 herein above by providingLICENSORon an annual basis with detailed reports in writing informingLICENSORof the progress made and results of the studies undertaken pursuant to theDEVELOPMENT PLAN. Furthermore,LICENSEEshall ***. Finally, it is also agreed that the parties shall meet on a regular schedule (at least twice every year) at a location mutually agreed, to review the progress of the development hereunder and to discuss possible issues emerging from such development.

4.04

LICENSEEshall useALL COMMERCIALLY REASONABLE EFFORTSto obtain, at its own costs, approval of anNDAand anNDSand thereafter,LICENSEEshall undertake

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all commercially reasonable steps to maintain theNDAand theNDSthroughout theTERM, including but not limited to any renewals thereof and any necessary submissions of information concerning the efficacy and safety of theLICENSED PRODUCT.
LICENSEEshall provideLICENSOR, without unreasonable delay, with a full copy in electronic form of theNDAand theNDS, any renewals thereof, any and all relevant communications with theFDAand theHPBand/or comparable foreign authority concerning theNDAand theNDS; provided that suchNDA,NDS and any other documentation provided hereunder are the confidential information ofLICENSEE (subject to Section 11.02 below) and such copy shall not be reproduced or copied and shall be kept in the legal archival files ofLICENSORand furthermore shall not be used for any purpose (except as allowed under Article 5 hereunder) or disclosed to anyTHIRD PARTYwithout the prior written consent ofLICENSEE, unless the provisions of Section 12.06 below shall apply.

4.05

No later than 10 (ten) weeks after execution of thisAGREEMENT, the parties shall promptly develop and agree appropriate procedures for exchange of adverse event and pregnancy exposure data concerning theLICENSED PRODUCT(the “PHARMACOVIGILANCE AGREEMENT”). Until thePHARMACOVIGILANCE AGREEMENTis agreed, the parties shall exchange such data in a manner that enables each party to fulfil regulatory requirements within their own territories (and within any other limits of thisAGREEMENT).

Article 5.00 — Grant Back

5.01

Each party shall promptly disclose to the other party material, information and data that solely results from its pharmacological and/or clinical and/or other investigations of theLICENSED PRODUCTand anyIMPROVEMENTto theLICENSED PRODUCTand/or its manufacture it develops or obtains or it otherwiseCONTROLSduring theTERM, provided that such material, information, data andIMPROVEMENTSprovided hereunder are the confidential information of the party providing such to the other party (subject to Article 11 below) and such items shall not be used or disclosed to anyTHIRD PARTYwithout the prior written consent of the disclosing party except as specifically allowed hereunder. Upon

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the written request ofLICENSOR, LICENSEEshall hereby grantLICENSORa *** license, *** to use, solely in relation to theLICENSED PRODUCT, all such material, information, data andIMPROVEMENTS in theLICENSED FIELDoutside theTERRITORYsolely in countries whereLICENSORhas a direct marketing organization on the date of the aboveLICENSOR’s written request; furthermore, upon the written request ofLICENSOR,LICENSEEshall hereby grantLICENSORsuch license for all other countries outside theTERRITORYupon payment byLICENSORtoLICENSEEof royalties equal to *** percent) on net sales (defined as theNET SALEShereunder) ofLICENSED PRODUCTin such other countries on the same terms as those applicable to the payment of royalties byLICENSEEhereunder.LICENSORshall pay the above royalties until such time asLICENSORhas paid toLICENSEEan amount equal to *** percent) of the duly documented direct costs incurred byLICENSEE(with an audit right forLICENSORpursuant to the terms of Section 7.04 below) for generating the above material, information, data andIMPROVEMENTS.

Article 6.00 — Marketing of LICENSED PRODUCT

6.01

LICENSEEundertakes to useALL COMMERCIALLY REASONABLE EFFORTSto make theFIRST COMMERCIAL SALEin the United States within *** from the date of obtaining theNDA. IfLICENSEE, through no fault ofLICENSORor otherwise due to applicable laws or factors beyond its reasonable control, fails to so launch theLICENSED PRODUCTwithin such period,LICENSORmay terminate thisAGREEMENTin the United States upon *** written notice toLICENSEE,provided, however, that ifLICENSEEmakes theFIRST COMMERCIAL SALEwithin said *** period, then thisAGREEMENTshall continue in full force and effect;further provided, that in the event thatLICENSEEhas a good faith belief that it can effect aFIRST COMMERCIAL SALEbut requires a commercially reasonable extension of the requisite timelines, the parties shall make good faith efforts to meet and discuss such extension.

6.02

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LICENSEEshall useALL COMMERCIALLY REASONABLE EFFORTSto promote, market, create a demand and continuously develop the sales of theLICENSED PRODUCTin theTERRITORYthroughout theTERM. Specifically,LICENSEEcovenants that it will useALL COMMERCIALLY REASONABLE EFFORTSto develop and maintain sales and marketing staff sufficient for the coverage of the selected target (physicians, non-physician prescribers, managed care organizations, pharmacies and wholesalers), including a minimum number of medical contacts per calendar year and top ranking position in the detailing list.LICENSEE, in promoting and marketing theLICENSED PRODUCThereunder, covenants to comply with any and all applicable laws in theTERRITORY.

6.03

LICENSEEshall submit toLICENSORfrom time to time, but not less frequently than every ***, a report on the market situation in theTERRITORY.

Article 7.00 — Royalties and Sales Reports

7.01

In further consideration of the rights granted toLICENSEEunder Section 2.01 herein above,LICENSEEshall pay toLICENSOR,in addition to the milestone payments referred to in Article 3.00 herein above, (a) for the period until the expiry of theMARKETING EXCLUSIVITY PERIODin a country in theTERRITORYroyalties at the rate of *** percent) up to USD *** United States Dollars) ofNET SALESin such country in theTERRITORYand *** percent) above USD *** United States Dollars) ofNET SALESin a country in theTERRITORYand (b) following the period described in (a) above royalties at the rate of *** percent) ofNET SALESin such country in theTERRITORY, during theTERMas defined in Section 12.01 below. Notwithstanding the above, in the event thatLICENSEEdetermines that it must procure and maintain aTHIRD PARTYlicense in order to use, develop, make and have made (including, manufacturing and packaging), register, store, handle, market, promote, distribute, sell and/or offer for sale theLICENSED PRODUCTand it is necessary forLICENSEEto make royalty payments and/or other payments to suchTHIRD PARTYto secure such license (collectively, the “THIRD PARTY PAYMENTS”),LICENSEEwill be entitled to offset all suchTHIRD PARTY

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PAYMENTSagainst up to *** percent) of any royalties owed toLICENSORpursuant to this Section 7.01 during theTERM.

7.02

LICENSEEshall provideLICENSORwithin *** after the end of each calendar quarter, with a report, divided into one-month periods, stating the volume ofLICENSED PRODUCTdistributed free of charge, gross sales in units and values and deductions therefrom in computingNET SALESand the amount of royalties accrued in such quarter. The amount of royalties accrued for sales within Canada shall be stated in the local currency for Canada and converted into USD$ for each month in such calendar quarter on the basis of the average of the daily closing official exchange rate(s) within such months quoted in theLondon Financial Timesor any successor publication. ***,LICENSEEshall transfer, by wire, the due amount of royalties to such bank account asLICENSORmay indicate from time to time. Payment of all royalties due hereunder shall be made in USD$.

7.03

In the event that any payment due hereunder is not made when due, the payment shall accrue interest, beginning on the first day following the calendar quarter to which such payment relates, calculated at the annual rate of the sum of (a) ***percent), plus (b) the yield rate of the US 10 Year Treasury Note as quoted in theLondon Financial Timesor any successor publication on the date said payment is due, or on the date the payment is made, whichever is higher, the interest being compounded on the last day of each calendar quarter, provided that in no event shall said annual rate exceed the maximum legal interest rate for corporations. Such royalty payment, when made, shall be accompanied by all interest so accrued.

7.04

LICENSEEshall keep full and accurate books and records setting forth the volume ofLICENSED PRODUCTdistributed free of charge, gross sales in units and values and deductions therefrom in computingNET SALESand the amount of royalties accrued. UponLICENSOR’s request,LICENSEEshall permitLICENSOR,atLICENSOR’s expense, by independent certified public accountant reasonably acceptable toLICENSEE, to examine such books and records at any reasonable time, but not later than *** following the date of any such reports, accountings, and payments and not more frequently than ***.

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7.05

Any taxes, imposts, withholdings or other amounts required by law to be paid or withheld byLICENSEEfor the account ofLICENSOR,on amounts payable toLICENSORunder thisAGREEMENT, shall be deducted at the rates specified by the applicable law, provided thatLICENSEEshall promptly provideLICENSORwith receipts from the tax authorities evidencing payment of such taxes.LICENSEE shall take all commercially reasonable steps atLICENSOR’s request and sole cost in order to allowLICENSORto take advantage of the relevant double taxation treaty(ies) for the purpose of avoiding or minimizing withholding taxes on such amounts, if any.

Article 8.00 — Representations and Warranties

8.01

LICENSEErepresents and warrants, on its own behalf and on behalf of itsAFFILIATES, toLICENSOR that as of theEFFECTIVE DATE:

(a)

LICENSEEis a corporation duly organized, validly existing and in good standing under the laws of state of Delaware.

(b)

The execution, delivery and performance of thisAGREEMENThas been fully authorized by the Board of Directors ofLICENSEE, and there is no hindrance, by law, agreement or otherwise, preventing it from entering into thisAGREEMENTor from performing fully its obligations thereunder. ThisAGREEMENThas been duly executed and delivered byLICENSEEand constitutes its legal, valid and binding obligation, enforceable against it in accordance with the terms thereof.LICENSEEhas the full right to enter into thisAGREEMENTand to fully perform its obligations hereunder.LICENSEEhas not previously granted, and during theTERMwill not knowingly make any commitment or grant any rights which are in conflict in any material way with the rights and licenses granted herein.LICENSEEwill not, during theTERM, encumber its interest in theLICENSED TECHNOLOGYwith liens, mortgages, security interests or another similar interest that would give the holder the right to convert the interest into patent or other intellectual property ownership, unless the encumbrance is expressly subject to the licenses herein.

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(c) Neither the execution and delivery of thisAGREEMENTnor the consummation of the transactions contemplated hereby will (i) violate or result in a breach of or default under (A) any of the present provisions of its governing instruments, or (B) any mortgage, indenture, contract, agreement, license, franchise, permit, instrument, trust, power, judgment, decree, order, ruling or statute or regulation to which it is presently a party or by which it or its properties may be bound, (ii) result in the creation or imposition of any lien, claim, charge, restriction or encumbrance of any kind whatsoever upon, or give to any other person any interest or right (including any right of termination or cancellation) in or with respect to any of its properties, assets, business, agreements or contracts, or (iii) require any consent, approval or waiver of, filing with, or notification to any person (including, without limitation, any governmental authority), not heretofore obtained or effected, except regulatory filings and approvals contemplated in the performance of thisAGREEMENT.

8.02

LICENSORrepresents and warrants, on its own behalf and on behalf of itsAFFILIATES, toLICENSEE that as of theEFFECTIVE DATE:

(a)

LICENSORis a corporation duly organized, validly existing and in good standing under the laws of Italy.

(b)

The execution, delivery and performance of thisAGREEMENThas been fully authorized by the Board of Directors ofLICENSOR, and there is no hindrance, by law, agreement or otherwise, preventing it from entering into thisAGREEMENTor from performing fully its obligations thereunder. ThisAGREEMENThas been duly executed and delivered byLICENSORand constitutes its legal, valid and binding obligation, enforceable against it in accordance with the terms thereof.LICENSORhas the full right to enter into thisAGREEMENT, and to fully perform its obligations hereunder.LICENSORhas not previously granted, and during theTERMwill not make any commitment or grant any rights which are in conflict in any material way with the rights and licenses granted herein.LICENSORwill not, during theTERM, encumber its interest in theLICENSED TECHNOLOGYwith liens, mortgages, security interests or another similar interest that would give the holder the right to

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convert the interest into patent or other intellectual property ownership, unless the encumbrance is expressly subject to the licenses herein.

(c)	Neither the execution and delivery of thisAGREEMENTnor the consummation of the transactions contemplated hereby will (i) violate or result in a breach of or default under (A) any of the present provisions of its governing instruments, or (B) any mortgage, indenture, contract, agreement, license, franchise, permit, instrument, trust, power, judgment, decree, order, ruling or statute or regulation to which it is presently a party or by which it or its properties may be bound, (ii) result in the creation or imposition of any lien, claim, charge, restriction or encumbrance of any kind whatsoever upon, or give to any other person any interest or right (including any right of termination or cancellation) in or with respect to any of its properties, assets, business, agreements or contracts, or (iii) require any consent, approval or waiver of, filing with, or notification to any person (including, without limitation, any governmental authority), not heretofore obtained or effected, except regulatory filings and approvals contemplated in the performance of thisAGREEMENT.
(d)	LICENSORis the legal and beneficial owner of, orCONTROLS, and has the unencumbered right to license toLICENSEEin the manner set forth in thisAGREEMENT, theLICENSED TECHNOLOGYin theTERRITORYand no further approvals or consents are required to effect such license which have not been obtained.
(e)	TheLICENSED TECHNOLOGYconstitute all of the intellectual property that isCONTROLLEDbyLICENSORand used in the development, manufacture or commercialization ofLICENSED PRODUCT and, toLICENSOR’s knowledge, the development, manufacture or commercialization ofLICENSED PRODUCTin theTERRITORYdoes not infringe theINTELLECTUAL PROPERTY RIGHTSof anyTHIRD PARTY.
(f)	There are no claims, judgments or settlements against or owed byLICENSOR, nor any pending reissue, reexamination, interference, opposition or similar proceedings, with respect to theLICENSED TECHNOLOGY, andLICENSORhas not received written notice as of theEFFECTIVE DATEof any threatened claims or litigation or any reissue, reexamination, interference, opposition or similar proceedings seeking to invalidate or otherwise challenge theLICENSED TECHNOLOGY.

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(g)	LICENSORundertakes to use allCOMMERCIALLY REASONABLE EFFORTSto maintain the confidential status, including, where applicable, the trade secret status, of allLICENSED KNOW-HOW.
(h)	LICENSORand itsAFFILIATEShave not been debarred or subject to debarment pursuant to Section 306 of the United States Federal Food, Drug and Cosmetic Act, or subject of a conviction described in such Section 306.

8.03

THE LIMITED WARRANTIES CONTAINED IN THIS ARTICLE 8.00 ARE THE SOLE WARRANTIES GIVEN BY THE PARTIES WITH RESPECT TO THE SUBJECT MATTER OF THISAGREEMENTAND ARE MADE EXPRESSLY IN LIEU OF AND EXCLUDE ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE MANUFACTURE, USE AND/OR SALE OF THELICENSED PRODUCTIN THETERRITORY, WILL NOT INFRINGE ANY PATENTS OR OTHERINTELLECTUAL PROPERTY RIGHTSHELD BY ATHIRD PARTY. ALL OTHER IMPLIED REPRESENTATIONS AND WARRANTIES PROVIDED BY COMMON LAW, STATUTE OR OTHERWISE ARE HEREBY DISCLAIMED BY BOTH PARTIES.

Article 9.00 — Liability

9.01

Each party shall notify the other if it becomes aware of any claims, actions, suits, losses, liability costs or expenses alleged to be caused by or resulting from the use or consumption of theLICENSED PRODUCTin theTERRITORY (“CLAIMS”).LICENSORandLICENSEEshall cooperate to the extent possible, in the defense of any suchCLAIMS, and each party may, at its expense, have counsel of its choice present at proceedings on any suchCLAIMSor negotiations pertaining thereto. Neither party shall take any action with respect to suchCLAIMSto materially prejudice the interest of the other party. As to any suchCLAIMSin which a party is named as a party, defendant, or is or could be liable, each party

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agrees that no settlement of any suchCLAIMSshall be concluded without the prior consent of the other party, which consent shall not be unreasonably withheld.

9.02

LICENSEEshall indemnify and holdLICENSORand itsAFFILIATES, and their officers, directors and employees, free and harmless from any loss, damage, claim, suit, cost or expense (including attorneys’ fees) arising from (i) *** *** ***.

9.03

LICENSORshall indemnify and holdLICENSEEand itsAFFILIATES, and their officers, directors and employees, free and harmless from any loss, damage, claim, suit, cost or expense (including attorney’s fees) arising from ***.

9.04

During theTERMand for a period of *** thereafter, each party at its sole expense, shall obtain and/or maintain insurance, including, but not limited to, product liability insurance in such amount as is reasonable and adequate given its responsibilities and liabilities under thisAGREEMENTand the product and country the subject of thisAGREEMENT. Upon request, each party shall provide the other party with a duplicate original copy of such insurance policy.

9.05

Notwithstanding any provision to the contrary in thisAGREEMENT, in no event (including fault, negligence or strict liability of either party) shall either party be liable to the other for indirect, incidental or consequential or punitive damages or loss of profit or loss of use related to any claim, cause of action, proceedings or judgement arising in connection with thisAGREEMENT.

9.06

The provisions of this Article 9.00 shall survive the termination or expiration of thisAGREEMENT.

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Article 10.00 — LICENSED TECHNOLOGY

10.01

LICENSEEshall market and sell theLICENSED PRODUCTin theTERRITORY, using exclusively theLICENSED TRADEMARK.Without prejudice to the above provisions, in the event thatLICENSEE reasonably determines to use another trademark other than theLICENSED TRADEMARKto market and sell theLICENSED PRODUCTin theTERRITORY(“OTHER TRADEMARK”),LICENSEEshall be entitled to do so andLICENSEEshall own suchOTHER TRADEMARK. In the eventLICENSEEmarkets and sells theLICENSED PRODUCTunder theOTHER TRADEMARK, then during theTERM, and after its termination for any reason whatsoever,LICENSORshall not, directly or indirectly, use, file or register theOTHER TRADEMARK or trade name identical with or confusingly similar to theOTHER TRADEMARK.

10.02

To the extent permitted by applicable law and regulation, the parties hereby agree that the packaging of theLICENSED PRODUCT, as well as the written promotional materials used byLICENSEEin theTERRITORYfor theLICENSED PRODUCT, shall bear the legend “Under license of Chiesi Farmaceutici S.p.A.”. Notwithstanding the foregoing, all packaging and promotional materials used byLICENSEE with respect to theLICENSED PRODUCTshall fully comply with applicable laws where sold in theTERRITORY. Without prejudice to the foregoing, samples of all packaging and written promotional materials, solely to the extent related to theLICENSED PRODUCT, shall be ***.

10.03

LICENSEEacknowledges the validity ofLICENSOR’s right, title and interest in and to theLICENSED TECHNOLOGYandLICENSORmay terminate thisAGREEMENTin accordance with the provisions of Section 12.02 herein below ifLICENSEEtakes any action which:

10.03.01 - materially impairs any such right, title or interest in theTERRITORY; or

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10.03.02 - challenges the validity, scope or enforceability of theLICENSED TRADEMARK, or the substantial and secret nature of theLICENSED KNOW HOW, each in theTERRITORY.

10.04

During theTERM, and after its termination for any reason whatsoever,LICENSEEshall not, directly or indirectly, use, file or register any trademark or trade name identical with or confusingly similar to theLICENSED TRADEMARK, provided the above prohibition shall not apply with respect to theOTHER TRADEMARK. Furthermore, during theTERM, and after its termination for any reason whatsoever,LICENSEEshall not apply, before any authority of any country, for the registration of any internet domain name (nor any other creative expression that may be the subject of registration), containing, in any form or graphic character, the name “CHIESI” and/or theLICENSED TRADEMARK(excluding theOTHER TRADEMARK) used hereunder (and/or any other denomination confusingly similar to the aforesaid names).

10.05

Forthwith, on termination of thisAGREEMENT,LICENSEEshall cease all use of theLICENSED TRADEMARK in connection with, or in relation to, theLICENSED PRODUCTexcept to the extent necessary for sales permitted under Section 12.06 (a) below.

10.06

LICENSORandLICENSEEshall promptly notify each other of any infringement of theLICENSED TECHNOLOGY,which may come to their attention.***may, at its option, undertake reasonable efforts to obtain discontinuance of the aforesaid infringement and, if not successful,***may at its option bring suit against such infringer, at its own expense. Any monetary award received as a result of proceedings contemplated by this Section 10.06 shall first be used to compensate***and***for their respective reasonable expenses incurred in connection with such proceedings (provided that if the monetary award is not sufficient to compensate both***and***for their reasonable expenses incurred in connection with such proceedings, then such monetary award shall be apportioned pro-rata based on the reasonable expenses of each of the parties). Any award monies remaining after such reimbursement shall be equally shared between the parties. No settlement or consent judgment or other voluntary

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final disposition of a suit under this Section 10.06 may be entered into by either party without the prior written consent of the other party, such consent not to be unreasonably withheld.

If***elects not to undertake or stop undertaking reasonable efforts in order to obtain a discontinuance of said infringement within a reasonable amount of time and/or elects not to bring suit against suchTHIRD PARTY,***shall promptly notify***in writing of its election, and of the circumstance of such infringement. In such event***shall have the right, but not the obligation, to take any and all action, at its own cost and expense, to obtain a discontinuance of the alleged infringement and/or to bring suit against suchTHIRD PARTY. Any monetary award received as a result of proceedings contemplated by this Section 10.06 shall first be used to compensate***and***for their respective reasonable expenses incurred in connection with such proceedings (provided that if the monetary award is not sufficient to compensate both***and***for their reasonable expenses incurred in connection with such proceedings, then such monetary award shall be apportioned pro-rata based on the reasonable expenses of each of the parties). Any award monies remaining after such reimbursement shall be added toNET SALESfor the calendar quarter in which they are received and then dealt with in the manner prescribed in thisAGREEMENT. No settlement or consent judgment or other voluntary final disposition of a suit under this Section 10.06 may be entered into by either party without the prior written consent of the other party, such consent not to be unreasonably withheld. Each party shall execute such legal papers in connection with the foregoing as may be reasonably requested by the other party.

The parties shall reasonably cooperate with each other in all actions or proceedings described in this Section 10.06, to the extent pertaining to an alleged infringement. The non-controlling party agrees to be joined as a party plaintiff if necessary to prosecute the action or proceeding and shall provide all reasonable cooperation (including any necessary use of its name) required to prosecute such litigation; provided that the controlling party shall reimburse the non-controlling party for out-of-pocket expenses reasonably incurred in providing such cooperation at the controlling party’s request. The non-controlling party will be entitled to be represented by counsel of its own choice at its own expense.

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10.07

In the event of any claim, threat or suit by aTHIRD PARTYagainst eitherLICENSEEorLICENSOR alleging infringement by theLICENSED PRODUCTof any patents or otherINTELLECTUAL PROPERTY RIGHTS of suchTHIRD PARTY, the party receiving such notice shall promptly notify the other party in writing of such fact, and the parties shall defend in close cooperation with each other against such claim, threat or suit.

10.08

In the event that a conflict arises between the interests ofLICENSORandLICENSEEin any litigation described in this Article 10.00, the party that is not funding the litigation shall have the right to be represented by counsel of its own choice and at its sole expense.

Article 11.00 — Confidentiality

11.01

Except as otherwise provided in this Article 11,LICENSEEundertakes to maintain in strict confidence and secret and not to disclose to others, except insofar as it may be necessary in carrying out the purposes of thisAGREEMENTand to bind its employees to hold to confidence and secret, theLICENSED TECHNOLOGYand any other information and data of a confidential nature which will be furnished toLICENSEEby or on behalf ofLICENSORpursuant to thisAGREEMENT. The obligation of confidentiality shall remain in force for *** after any termination or expiration of thisAGREEMENT, provided, that such obligation shall not terminate or expire to the extent that such confidential information relates to a trade secret, unless the provisions of Section 11.05 below shall apply.

11.02

Except as otherwise provided in this Article 11,LICENSORundertakes to maintain in strict confidence and secret and not to disclose to others, except insofar as it may be necessary in carrying out the purposes of thisAGREEMENTand to bind its employees to hold to confidence and secret, any information and data of a confidential nature which will be furnished toLICENSORby or on behalf ofLICENSEEpursuant to thisAGREEMENT. The obligation of confidentiality shall remain in force for *** after any termination or

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expiration of thisAGREEMENT, provided, that such obligation shall not terminate or expire to the extent that such confidential information relates to a trade secret, unless the provisions of Section 11.05 below shall apply.

11.03

LICENSORrecognizes thatLICENSEEand/or itsAFFILIATESmay need to publish or otherwise present the methods and results of clinical trial activities undertaken pursuant to thisAGREEMENTand agrees thatLICENSEEand/or itsAFFILIATESshall be permitted to present at conferences, symposia and professional meetings and to publish in journals and other publications, methods and results of clinical trials, provided, however, that***.

11.04

Notwithstanding the foregoing, in the event that either party receives a request to disclose all or any part of the confidential information of the other party under the terms of a valid and effective subpoena or order issued by a court of competent jurisdiction, such party agrees to (i) immediately notify the other party of the existence, terms and circumstances surrounding such a request, and (ii) consult with the other party on the advisability of taking legally available steps to resist or narrow such request, and (iii) if disclosure of such information is required, exerciseALL COMMERCIALLY REASONABLE EFFORTSto obtain an order or other reliable assurance that confidential treatment will be accorded to such portion of the undisclosed information which the other party so designates.

11.05

The obligations of non-disclosure and non-use set forth in this Article 11 shall not apply to confidential information which:

(a)	was, at the time of disclosure, in the possession of the receiving party (as evidenced by its written records) and was not previously acquired from or on behalf of the disclosing party on a confidential basis,
(b)	was in the public domain prior to disclosure, or became, after disclosure, publicly known through no fault of the receiving party or any person to whom the receiving party directly or indirectly provided such confidential information,
(c)	was received from aTHIRD PARTYwho rightfully made such disclosure,

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(d)	was approved for use or release by written authorization from the disclosing party prior to such use or release by the receiving party,
(e)	is required to be disclosed by operation of law, governmental regulation or court order provided the receiving party gives the disclosing party written notice of such required disclosure prior to making such disclosure, and the receiving party uses all reasonable effort to cooperate in securing confidential protection for such information; or
(f)	is required to be disclosed to any governmental authority or regulatory authority to the extent that such disclosure is reasonably necessary to obtain authorizations to conduct a clinical trial with, to manufacture and to market commercially products based on theLICENSED TECHNOLOGY, provided the disclosing party is otherwise entitled to engage in such activities under thisAGREEMENTand provided that confidentiality is in any case maintained on such confidential information to the extent permitted by any such authority.

Any specific confidential information shall not be deemed to fall within Section 11.05 (a), (b), (c), (d), (e) or (f) above merely because it falls within the scope of more general information within one of these exceptions.

Article 12.00 — Term and Termination

12.01

ThisAGREEMENTshall become effective on theEFFECTIVE DATEand shall remain in force for a term of 10 (ten) years starting from theFIRST COMMERCIAL SALEin theTERRITORY, on a country-by-country basis (the “TERM”). Thereafter,LICENSEEshall have a paid-up, royalty-free, *** license under theLICENSED TECHNOLOGYto use, develop, make and have made (including, manufacturing and packaging), register, store, handle, market, promote, distribute, sell and/or offer for sale theLICENSED PRODUCTandIMPROVEMENTS(owned orCONTROLLEDbyLICENSOR)in theLICENSED FIELDin theTERRITORY.

12.02

In the event thatLICENSEEorLICENSORsubstantially defaults or breaches any material provision of thisAGREEMENT, the other party shall have the right to terminate this

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AGREEMENTupon *** written notice to the other party, provided, however, that if the party in question cures such default or breach, or presents a commercially reasonable plan providing a reasonably short timeline for cure of such default or breach, within said *** period, then thisAGREEMENTshall continue in full force and effect. Without limitations breaches of Section 10.03 and Article 11 herein above are incapable of cure.

12.03

In the event that either party:

(i)	is adjudicated as bankrupt or insolvent and, if such adjudication be involuntary, it is not vacated within ***; or
(ii)	any proceeding is commenced by or against such party seeking relief under any bankruptcy or insolvency law and if such proceeding be involuntary, it remains undismissed for ***; or such party, by action or answer, approves of, consents to or acquires in such proceeding or admits the material allegations of or defaults in answering a petition filed in such proceeding; or
(iii)	admits in writing its inability to pay its debts as they become due; or
(iv)	makes an assignment for the benefit of creditors;

then, in any such case, such party shall be deemed in default hereunder and the other party shall have the right, upon *** prior notice, to terminate thisAGREEMENT.

12.04

In the event, through no fault ofLICENSORor otherwise due to applicable laws or factors beyond its reasonable control,LICENSEEhas not filed anNDAin the US and/or anNDSin Canada by ***,LICENSORshall have the right to *** terminate this Agreement with respect to such country/ies upon a *** prior written notice;provided, however, that ifLICENSEEfiles theNDAand/orNDS within said *** period, then thisAGREEMENTshall continue in full force and effect;further provided, that in the event thatLICENSEEhas a good faith belief that it can file theNDAand/orNDS,but requires a commercially

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reasonable extension of the requisite timelines, the parties shall make good faith efforts to meet and discuss such extension.

12.05

“CHANGE OF CONTROL” means, with respect to a party, (a) the acquisition (directly or indirectly, whether by merger, consolidation, purchase and sale, share exchange or otherwise) by aTHIRD PARTY(other than anAFFILIATEor any trust or fund created under a profit-sharing or other benefit plan for employees of the party undergoing the acquisition) of a beneficial interest in the securities of such party representing more than fifty percent (50%) of the combined voting power of the party’s then outstanding securities; or (b) the transfer, sale or assignment of more than fifty percent (50%) of the assets of such party to aTHIRD PARTY.

(i) Notwithstanding Section 2.03 above, in the event thatLICENSEEis subject to aCHANGE OF CONTROLwith aTHIRD PARTY, whichTHIRD PARTYwas, at the date of suchCHANGE OF CONTROL, marketing, promoting and/or selling aLICENSEE COMPETING PRODUCTthen, within *** of the completion of suchCHANGE OF CONTROLto be communicated in writing byLICENSEEtoLICENSOR,LICENSEEshall provide written notification toLICENSORspecifying election of one of the following two (2) alternatives:

(a)	LICENSEEaccepts to divest suchLICENSEE COMPETING PRODUCTwithin a period of *** following the completion date of suchCHANGE OF CONTROL; or
(b)	LICENSEEelects to terminate thisAGREEMENTwhich shall become effective *** from such notification ofLICENSEE’s election to terminate theAGREEMENTin its entirety.

(ii) In the event thatLICENSEEis subject to aCHANGE OF CONTROLwith aTHIRD PARTY, which, at the date of suchCHANGE OF CONTROLis in material litigation withLICENSOR,LICENSORshall be entitled to causeLICENSEEto elect Section 12.05(i)(b) above.

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(iii) In the event of aCHANGE OF CONTROLofLICENSOR,LICENSORshall continue to be bound by all terms and conditions of thisAGREEMENT, including the provisions of Section 11.02 above.

12.06

Upon termination of thisAGREEMENTpursuant to Section 3.01 A. or 12.05, or byLICENSORpursuant to Section 6.01, 12.02 or 12.04:

(a)	LICENSEEshall promptly cease selling theLICENSED PRODUCT(exceptLICENSED PRODUCTcurrently in stock) and using theLICENSED TECHNOLOGY;
(b)	LICENSEEshall promptly return or transfer free of charge toLICENSOR, with external administrative expenses, if any, to be paid byLICENSOR, all pharmacological, toxicological and clinical original data in its possession and all technical information, andLICENSED TECHNOLOGYor material relating to theLICENSED PRODUCTin its possession; and
(c)	LICENSEEshall promptly transfer free of charge toLICENSOR, with external administrative expenses, if any, to be paid byLICENSOR, or to a company designated byLICENSORanyIND,NDA,NDSand other authorizations obtained with respect to theLICENSED PRODUCT.

12.07

Upon termination of thisAGREEMENTfor any reason whatsoever:

(a)	Sections 7.04, 10.01 (last sentence only) and 10.04 and Articles 9.00, 11.00, 14.00, 16.00, 17.00, 18.00, 19.00, 20.00, 21.00, 22.00 and 23.00 shall survive termination of thisAGREEMENT;
(b)	Except as herein otherwise provided all other rights and obligations of the parties to each other shall terminate, provided, however, thatLICENSEEshall not be released from the liability to make any and all outstanding payments toLICENSOR.

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Termination of thisAGREEMENTfor any reason shall not release any party from any liability, obligation or agreement which has already accrued nor affect the survival of any provision hereof which is expressly stated to survive such termination.

Article 13.00 — Assignment

13.01

Either party may assign or transfer the rights granted to it under thisAGREEMENTto anAFFILIATE in theTERRITORY,as required to enable such party to fulfill the purposes thereof, provided that such party shall guarantee the performance of all obligations of suchAFFILIATEarising out of or resulting from thisAGREEMENT. Without prejudice to the provisions of Sections 2.01 and 2.02 above,***. Subject to Section 12.05 above, but notwithstanding the foregoing, either party may assign thisAGREEMENTto aTHIRD PARTYin connection with the sale or transfer of all or substantially all of its assets with respect to the business (whether by merger, asset sale or otherwise) to which thisAGREEMENTis related to suchTHIRD PARTY.

Article 14.00 — Notice

14.01

Notices toLICENSEEshall be addressed to:

Eurand Pharmaceuticals Inc.
790 Township Line Road, Suite 250
Yardley, Pennsylvania 19067
USA

Telephone number: +1.267.759.9322
Telecopy: +1.215.968.2941
Attention: General Counsel

And notices toLICENSORshall be addressed to:

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Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43100 Parma
ITALY

Phone: +39.0521.2791
Fax: +39.0521.774468
Attention: Managing Director
Copy to: Corporate Licensing Director + Legal and Corporate
Affairs Director

Either party may change its address by giving notice to the other party.

14.02

Any notice required or provided for by the terms of thisAGREEMENTshall be in writing and sent by registered mail, prepaid and properly addressed in accordance with Section 14.01.

Article 15.00 — Force Majeure

15.01

Failure of either party to perform its obligations under thisAGREEMENT(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 public enemy, fire, explosion, flood, drought, war, riot, sabotage, embargo, strikes, or other labour 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, including regulatory agency, or committee thereof, which compliance has also caused a delay in the performance hereunder, or by compliance with a request authorized by such government 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 forgoing beyond the reasonable control of the party so failing. The party suffering an event of force majeure shall immediately notify the other party and both parties will cooperate in good faith in order to minimize the damages for both parties; provided, however, that the party whose performance has not been hindered by the force majeure shall have the right to terminate thisAGREEMENTupon *** prior notice to the other, such notice to take effect only if an event of force majeure continues for more ***. Termination pursuant

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to the application of this Section 15.01 shall not constitute a material breach of thisAGREEMENT on the part of either party.

Article 16.00 — Governing Law

16.01

ThisAGREEMENTshall be governed by and construed according to the laws of ***, without regard to the principles of conflicts of law.

Article 17.00 — Jurisdiction

17.01

In the event of any controversy or claim arising out of or relating to any provision of thisAGREEMENTor breach thereof, the parties shall try to settle those conflicts amicably between themselves. Should they fail to agree, the parties hereby agree to resolve any controversy or claim arising from thisAGREEMENT(“DISPUTE”) by submitting suchDISPUTEto arbitration under the Rules of Arbitration of International Chamber of Commerce (“ICC”). Unless, the parties agree otherwise in writing, the number of arbitrators shall be three. One arbitrator shall be appointed by each party and the third arbitrator shall be appointed by the International Court of Arbitration of theICC. The place of arbitration will be Milan, Italy. The language of the arbitration will be in English. Prior to the commencement of hearings, each of the arbitrators appointed must provide an oath of undertaking of impartiality. Judgment upon the award rendered by the arbitrators may be entered into any court having jurisdiction thereof. The cost of any such arbitration will be divided equally between the parties, with each party bearing its own attorneys’ fees and costs. The arbitration proceedings and the decision of the arbitrators will be kept confidential by the parties and the arbitrators.

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Article 18.00 — Entire Agreement

18.01

ThisAGREEMENTconstitutes the entire agreement between the parties hereto with respect to the subject matter and supersedes all previous agreements and understandings, whether written or oral. No modification or alteration shall be binding unless in writing and signed by both parties.

Article 19.00 — Fees and Expenses

19.01

Except as otherwise expressly provided in thisAGREEMENT, each of the parties shall bear and pay all fees, costs and expenses incurred by it in connection with the origin, preparation, negotiation, execution and delivery of thisAGREEMENTand the transactions and other agreements and documents contemplated hereby (whether or not such transactions are consummated), including, without limitation, any fees, expenses or commissions of its representatives.

Article 20.00 — Severability and No Waiver

20.01

The parties hereto are desirous of adhering faithfully to the laws and formalities (including fiscal formalities) to which each is subject. Should any provision of thisAGREEMENTbe held to be unenforceable or otherwise in conflict with or in violation of such laws, the remainder of thisAGREEMENTshall remain binding upon the parties and only those provisions shall be deemed to be null and void.

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20.02

The waiver by either party of any right hereunder, or of a failure to perform, or of a breach by the other party, shall not be deemed a waiver of any other right hereunder, or of any other breach or failure by said party, whether of a similar nature or otherwise.

Article 21.00 — Negation of Agency

21.01

It is understood and agreed that neither party is by thisAGREEMENTor anything herein contained, constituted or appointed the agent or representative of the other party for any purpose whatsoever, nor shall anything herein contained be deemed or construed as granting to a party any right or authority to assume or to create any obligation or responsibility, express or implied, for or on behalf of, or in the name of the other party, or to bind the other party in any way or manner whatsoever.

Article 22.00 — Headings

22.01

Headings are inserted for convenience and shall not by themselves determine the interpretation of thisAGREEMENT.

Article 23.00 — Publicity

23.01

All public notices toTHIRD PARTIESand all other publicity concerning the transactions contemplated by thisAGREEMENT, including the existence or any of the terms and conditions thereof, shall be jointly planned and coordinated byLICENSEEandLICENSORand no party shall act unilaterally in this regard without the prior written approval of the other party (such approval not to be unreasonably withheld), except with regard to disclosures made in order to comply with law or government or stock exchange regulations; provided, however,

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that the other party shall have an opportunity to review and promptly comment on such disclosures before they are made and the parties shall agree on the provisions of thisAGREEMENTfor which the parties shall seek confidential treatment, it being understood that if one party determines to seek confidential treatment for a provision for which the other party does not, then the parties will use reasonable efforts in connection with such filing to seek the confidential treatment of any such provision. The parties shall cooperate, each at its own reasonable expense, in such filing, registration or notification, including without limitation such confidential treatment request, and shall execute all documents reasonably required in connection therewith.

IN WITNESS THEREOF, the parties hereto have caused thisAGREEMENTto be duly executed in duplicate by their authorized officers as of theEFFECTIVE DATE.

CHIESI FARMACEUTICI S.p.A.	EURAND PHARMACEUTICALS INC.
/s/ Dr. Alberto Chiesi	/s/ Mr. Gearoid M. Faherty
Dr. Alberto Chiesi	Mr. Gearoid M. Faherty
President & Chief Executive Officer	Chief Executive Officer

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APPENDIX A

To the License Agreement dated April 2, 2008 and signed between CHIESI FARMACEUTICI S.p.A. and EURAND PHARMACEUTICALS INC.

DEVELOPMENT PLAN OUTLINE

***

CHIESI FARMACEUTICI S.p.A.	EURAND PHARMACEUTICALS INC.
(signature)	(signature)

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APPENDIX B

To the License Agreement dated April 2, 2008 and signed between CHIESI FARMACEUTICI S.p.A. and EURAND PHARMACEUTICALS INC.

LICENSED TRADEMARK

***

CHIESI FARMACEUTICI S.p.A.	EURAND PHARMACEUTICALS INC.
(signature)	(signature)

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APPENDIX C

To the License Agreement dated April 2, 2008 and signed between CHIESI FARMACEUTICI S.p.A. and EURAND PHARMACEUTICALS INC.

• Complete dossier of MRP 1^st wave Marketing Authorization Application (MAA), including any interaction (pre and post submission) with the concerned regulatory authority,includes Response Document to the questions raised by the concerned member states.

• Complete documentation relevant to any variation, renewal or additional application relevant to the Marketing Authorization granted in the EU.

• Complete Pharmacovigilance data/PSURs and post approval clinical studies.

• All further correspondence with any regulatory authority relevant to any module of the MAAs dossier.

• Any data related to the product not included in the MAAs dossier (i.e. complete documentation relevant to any data generated during product development).

• All clinical development plans and data generated — retrospective and current: to be updated on an ongoing basis.

• Any freedom to operate searches (a list of the most pertaining documents emerged from our searches already provided on the occasion of the Due Diligence process)

• All marketing materials (if relevant — according to field of use — to be provided in due course).

• Any additional information covered under the term “LICENSED KNOW HOW” and to be updated with new “KNOW HOW” as it is generated.

CHIESI FARMACEUTICI S.p.A.	EURAND PHARMACEUTICALS INC.
(signature)	(signature)

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