**Exhibit 10.1**

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**Execution Date: May 31,2006**

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**AMENDED AND RESTATEDSUPPLY AND DISTRIBUTION AGREEMENT**

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**between**

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**SUPERGEN, INC.(SUPPLIER)**

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**and**

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**WYETH(DISTRIBUTOR)**

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**Made Effective: 1 June2006**

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**CONFIDENTIAL**

 

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**INDEX**
| **CLAUSE 1**   | ** ** | **DEFINITIONS**                                     | ** ** | **3**      | ** ** |
|----------------|------------|-----------------------------------------------------|------------|------------|------------|
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **CLAUSE 2**   | ** ** | **APPOINTMENT OF DISTRIBUTOR**                      | ** ** | **7**      | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **CLAUSE 3**   | ** ** | **TRANSITION OF SERVICES**                          | ** ** | **10**     | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **CLAUSE 4**   | ** ** | **PURCHASE OF UNLABELED BULK  VIALS OF PRODUCT**    | ** ** | **14**     | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **CLAUSE 5**   | ** ** | **PACKAGING, TESTING AND  DISTRIBUTION OF PRODUCT** | ** ** | **16**     | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **CLAUSE 6**   | ** ** | **ADVERSE EVENT REPORTING AND  PRODUCT RECALL**     | ** ** | **17**     | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **CLAUSE 7**   | ** ** | **CONFIDENTIALITY**                                 | ** ** | **18**     | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **CLAUSE 8**   | ** ** | **WARRANTIES AND INDEMNITIES**                      | ** ** | **19**     | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **CLAUSE 9**   | ** ** | **INTELLECTUAL PROPERTY**                           | ** ** | **21**     | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **CLAUSE 10**  | ** ** | **TERM AND TERMINATION**                            | ** ** | **21**     | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **CLAUSE 11**  | ** ** | **CONSEQUENCES OF TERMINATION**                     | ** ** | **21**     | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **CLAUSE 12**  | ** ** | **OTHER PROVISIONS**                                | ** ** | **22**     | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **SCHEDULE 1** | ** ** | **MARKETING AUTHORIZATIONS AND  TERRITORY**         | ** ** | **27**     | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **SCHEDULE 2** | ** ** | **SAFETY DATA EXCHANGE PROCEDURE**                  | ** ** | **28**     | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **SCHEDULE 3** | ** ** | **PROJECT LEADERS AND JTT MEMBERS**                 | ** ** | **36**     | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **SCHEDULE 4** | ** ** | **TIME TABLE FOR REMITTING PROFIT**                 | ** ** | **37**     | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |
| **SCHEDULE 5** | ** ** | **THIRD PARTY OBLIGATIONS**                         | ** ** | **38**     | ** ** |
| ** **     | ** ** | ** **                                          | ** ** | ** ** | ** ** |

 

Exhibit A - Original Distribution Agreement as amended

 

Exhibit B - Technical Agreement

 

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**THIS AMENDMENT AND RESTATEMENT (“Agreement”) ismade the 31st day of May 2006**

**BY ANDBETWEEN:**

(1)            **WYETH**, a corporation organized in the State of Delaware,USA, with offices at Five Giralda Farms, Madison, New Jersey 07940 (“Distributor”);and

(2)            **SUPERGEN, INC.**, a corporation organized in the State of Delaware,USA, with offices at 4140 Dublin Boulevard, Suite 200, Dublin, California94568 (“Supplier”).

**Background**

WHEREAS, Distributor and Supplier are the successorsin interest to that certain distribution agreement between American CyanamidCompany and Warner-Lambert Company, respectively, dated June 1, 1992 as amendedon February 6, 1996 (the “Distribution Agreement”; attached heretoas Exhibit A), pursuant to which Distributor agreed, through one or moreof its Affiliates, to distribute the *Pentostatin*-containing**products under the trademark NIPENT;

WHEREAS, Supplier has requested the termination of theDistribution Agreement and the return of the rights to the Product grantedthereunder;

WHEREAS, the Parties now desire to amend and restatethe Distribution Agreement as set forth herein in accordance with Section 6.5thereof in order to formalize their understandings respecting the terminationof the Distribution Agreement and to effectuate the transition of services fromDistributor to Supplier.

NOW, THEREFORE, in consideration of the mutualcovenants contained herein and intending to be legally bound hereby, theParties hereto agree as follows:

**CLAUSE 1   DEFINITIONS**

1.1.         SpecificDefinitions.   As used in this Agreement, the following terms shallhave the following meanings:

(a)            **“Affiliate”** means a legal entity directly or indirectlycontrolling, controlled by or under common control with the Party in question. “Control”means owning at least forty percent (40%) of the voting shares of equity orhaving the right to appoint directors holding forty percent (40%) of the voteor having the right to manage, in fact, the day-to-day operations of the entityin question.

(b)           **“Applicable Laws”** means all laws, statutes, regulations ofany Competent Authority having jurisdiction over the Products in the Territory,as may be in effect from time to time during the Term.

(c)            **“Business Day”** means 9:30 am to 5:30 pm on any dayexcluding Saturdays, Sundays and public holidays.

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(d)           **“cGMP”** means current good manufacturing practice (asprovided for in EU Directive 2003/94/EC, as amended), together with any locallyimposed requirements.

(e)            **“Catania Cost”** means the sum of Distributor’s Purchase Pricefor Unfinished Product, plus freight, insurance and all other direct costsincurred by Distributor to deliver Unfinished Product to Distributor’s Plantplus Distributor Packaging and Testing Cost.

(f)              **“Competent Authority”** means any governmental or regulatorybodies including the European Commission, The Court of First Instance and theEuropean Court of Justice, local or national agencies, minister, ministryofficials, departments or entities, whether or not located in the Territory, whichregulate, direct or control commercial, medical and other related activities inor with the Territory or which have jurisdiction over the activities of theAgreement or any of the Parties under this Agreement.

(g)           **“Compound”** means (R)-3-(2-deoxy-beta-D-erythropentofuranosyl)-3,6,7,8-tetrahydroimidazo[4,5-d] [1,3]diazapin-8-o1 (identified by Supplier as Pentostatin), whichformula has been approved by the United States Food and Drug Administration.

(h)           **“Confidential Information”** means any information and datadisclosed by one Party or its Affiliates to the other Party or its Affiliatespursuant to or in connection with this Agreement or the supply or distributionof Product hereunder (whether or not such information is expressly stated to beconfidential), including without limitation, information relating totechnology, processes, packaging specifications, inventions, designs, tradesecrets, know how and information of a commercially sensitive nature.

(i)               **“Designee”** means a person or legal entity designated bySupplier to act on its behalf as set forth herein.

(j)               **“Distributor’s Plant”** means Distributor’s productmanufacturing and packaging facility located at XV Strada, Zone Industriale,95030 Catania, Sicily.

(k)            **“EEA”** means the European Economic Area as constituted fromtime to time.

(l)               **“Force Majeure”** means, in relation to either Party, anycircumstances beyond the reasonable control of that Party (including, withoutlimitation, any strike, lockout or other form of industrial action).

(m)         **“Intellectual Property”** means a patent, copyright,registered design, the Trademark or any other trademark, ConfidentialInformation or other industrial or intellectual property right subsisting inthe Territory in respect of the Product, and applications for any of theforegoing.

(n)           **“Losses”** means any and all Third Party losses, claims,damages, liabilities, reasonable costs and expenses, including reasonable legalfees (but excluding lost profit, loss of custom, consequential, incidental,unforeseen or punitive 

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damages) arising from orrelated to, any claim, action or proceeding made or brought by a Third Party.

(o)           **“Marketing Authorization”** means the product authorization tomarket and sell the Product in the Territory as listed in Schedule 1.

(p)           **“Net Sales”** means the actual gross sales proceeds receivedby a Party from Third Parties for the Product less each and all of thefollowing: trade, quantity and cash discounts, if any, actually allowed or paidwith respect to the Product; returns, allowances, rebates and adjustmentsactually granted to customers; ; outbound freight or transportation charges andall taxes including value added taxes and excise taxes (except income taxes),tariffs, duties and all other existing or future governmental charges paid by aParty.

(q)           **“Packaging and Testing Cost”** means Distributor’s standardcost for packaging and testing Unfinished Product, calculated in accordancewith Distributor’s standard accounting practices, which shall, for 2006 be €14.50(fourteen Euros and 50 cents) per 10mg vial.

(r)              **“Packaging and Testing Instructions”** means the instructions,in strict accordance with the approved Marketing Authorization, provided bySupplier to Distributor to package and test the Product; said Packaging andTesting Instructions are held on file at Supplier’s offices and in the qualitydepartment at Distributor’s Plant.

(s)            **“Packaging Materials”** means packaging and testing materialsand packaging inserts for the packaging and testing of the Products, in eachcase to the extent such material do not include any Distributor trademarks;provided, however, packaging materials for labelling product in Greece whichcontain Distributor’s Lederle logo shall constitute Packaging Material. For theavoidance of doubt, the Parties acknowledge and agree that packaging andtesting materials and packaging inserts which merely mention Distributor or itsAffiliate as a distributor of Product shall be considered Packaging Materials.

(t)              **“Party”** means Supplier or Distributor, as the case may be;and both Supplier and Distributor when used in the plural.

(u)           **“Person”** means any individual, corporation, general orlimited partnership, limited liability company, joint venture, estate, trust,association, organization, labor union, or other entity or Competent Authority.

(v)           **“Product”** means the finished pharmaceutical preparation ofthe Compound (for human use).

(w)         **“Project Leader”** means each of the two individuals (onerepresentative from Supplier and one representative from Distributor) who shallco-chair the Joint Transition Team and act in the capacity of a project managerfor the respective Party during the Transition Period.

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(x)             **“QP”** means Supplier’s representative appointed as qualifiedperson under GMP.

(y)           **“RHA”** means any relevant government health authority (orsuccessor agency thereof) in any country of the Territory whose approval isnecessary to market the Product in the relevant country of the Territory.

(z)             **“Specification”** means the specifications for the Product asset forth in the relevant Marketing Authorization, which Supplier or itsrelevant Affiliate shall amend pursuant to changes required by any RHA andprovide notification to Distributor in accordance with Clause 12.4.

(aa)      **“Technical Agreement”** means the Technical and QualityAgreement executed by Supplier’s Affiliate and Distributor’s Affiliateeffective as of February 1, 2006, a copy of which is attached hereto as ExhibitB, setting forth the quality provisions applicable to the manufacture ofthe Product pursuant to this Agreement.

(bb)    **“Territory”** means all countries in the world where theProduct is or has been approved for sale except for the United States ofAmerica and its territories and possessions (including the Commonwealth ofPuerto Rico), Mexico, Canada and Japan.

(cc)      **“Third Party”** or **“Third Parties”**means any Person other than Supplier, Distributor or their respectiveAffiliates.

(dd)    **“Trademark”** means the trademarks, NIPENT, ONCOPENT, or suchother trademarks, trade names and designs associated with the Product, whetherregistered or unregistered.

(ee)      **“Unfinished Product”** means the bulk unlabelled vials ofProduct which are manufactured by Supplier to Specification and purchased byDistributor for labeling and packaging into finished Product at Distributor’sPlant.

1.2.         Indexof Other Definitions:

In addition, the following definitions have themeanings in the Clauses corresponding thereto, as set forth below:

| Definition                     | ** ** | **Clause** |
|--------------------------------|------------|------------|
| Acceptable  Product            |       | 5.8.2      |
| Acceptable  Unfinished Product |       | 4.8.3      |
| Additional  Distribution Fee   |       | 2.2        |
| CoA                            |       | 4.8.1      |
| Claim                          |       | 8.7        |
| Closing Date                   |       | 3.2        |
| Country Handover  Date         |       | 3.5.1      |
| Distribution Fee               |       | 2.2        |

 

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| Distributor’s Purchase Price |   | 4.2   |
|-----------------------------------|--------|-------|
| Effective Date                    |   | 10.1  |
| JTT                               |   | 3.7   |
| Transfer Cost                     |   | 2.3.3 |
| Release and Waiver                |   | 3.6   |

 

**CLAUSE 2  APPOINTMENT OF DISTRIBUTOR**

2.1.         Appointment:

2.1.1                             Supplierhereby appoints Distributor and authorizes Distributor to designate itself orits Affiliates, as the exclusive distributor of the Product for Supplier in allthe countries in the Territory during the Term, except in Italy where Suppliershall have the right to appoint, in addition to Distributor, its Affiliate or aThird Party such that its Affiliate or a Third Party and Distributor shall bethe semi-exclusive distributors of the Product during the Term of thisAgreement as it relates to Italy.

2.1.2                             Pursuantto Clause 3.5.1 below, upon a Country Handover Date, Distributor’s appointmentshall be deemed terminated as to that specific country in the Territory.

2.1.3                             Pursuantto Clause 3.2 below, upon the Closing Date, Distributor’s appointment shall bedeemed terminated as to all countries in the Territory.

2.2.         Acceptanceand Compensation.   Distributor hereby accepts the appointment setforth in Clause 2.1.1. The compensation to Distributor for sales of Product inthe Territory during the initial six-month period following the Effective Dateshall be five percent (5%) of Net Sales (“Distribution Fee”). If Distributorhas any sales of Product in accordance with this Agreement in any country ofthe Territory following the initial six (6) months after the Effective Datehereof, Distributor shall be compensated at a rate of twenty percent (20%) ofNet Sales for such sales occurring after such initial six-month period untilClosing (“Additional Distribution Fee”).

2.3.         Remittanceof Profit to Supplier.   In accordance with the time frames as outlinedin Schedule 4, Distributor shall remit to Supplier Product Net Sales invoicedby Distributor for the month, if any, minus:

2.3.1                             Distributor’sDistribution Fee (or any Additional Distribution Fee, if applicable);

2.3.2                             CataniaCost;

2.3.3                             “TransferCost”, which shall mean a mark-up amount equal to five percent (5%) of theCatania Cost, plus actual freight, insurance and any other direct delivery costsincurred by Distributor from Distributor’s Plant to/from its relevant Affiliate’s(or Supplier’s Designee’s) premises for subsequent sale of the Product tocustomers, provided however that the mark-up amount shall be twentypercent (20%) of the Catania Cost where sale to an Affiliate 

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or SupplierDesignee occurs between the period beginning six (6) months after the EffectiveDate until Closing;

2.3.4                             anycustomer receivable arising during the relevant month which remains overdue toDistributor by sixty (60) days or more; provided however, that Suppliershall have the opportunity to review and approve standard terms (includingpayment terms) for established customers based on local practices.

2.4.         Advertisingand Promotion.

2.4.1                             Beginningupon the Effective Date, Supplier shall, at its expense and control, beresponsible for developing and submitting, as appropriate, promotionalmaterials to any RHA having jurisdiction over the use of such materials in theTerritory. Supplier shall inform Distributor of any submission to any RHA and,upon reasonable request by Distributor, provide to Distributor a copy of suchsubmissions. Supplier shall be solely responsible for obtaining any necessaryapproval by any RHA of the promotional materials for the Product and Suppliershall be solely responsible for conducting or implementing any advertising orpromotional activities relating to the Product.

2.4.2                             Alladvertising and promotional expenses incurred by Supplier relating to Supplier’sdistribution or Distributor’s distribution of Product in the Territory shall beborne by Supplier.

2.4.3                             Suppliershall comply with all Applicable Laws regarding the marketing and promotion ofProduct in the Territory.

2.5.         Reports,Forecasts and Audits.  From time totime during the Term of this Agreement:

2.5.1                             Distributorshall furnish to Supplier, such periodic forecasts and recommendations for eachcountry of the Territory as Distributor may reasonably develop for the properand reasonably timely exit from the business by Distributor and transition ofpackaging, testing, distributing and related services regarding the Product toSupplier or its Designee.

2.5.2                             Distributorshall submit to Supplier sales and inventory reports in such form and suchfrequency as agreed by the Joint Transition Team for the purpose of updatingthe Parties on the progress of the transition during the Transition Period.

2.5.3                             TheParties hereto shall keep or cause to be kept accurate records in sufficientdetail to enable all payments hereunder to be determined.

2.5.4                             Distributorshall keep accurate records and books of account for the purpose of showing allamounts to be calculated under this Agreement. Such records and books ofaccount shall be kept for five (5) years following the end of the calendar yearto which they relate and certified extracts of such records and books ofaccount shall be open to inspection by Supplier or its 

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representatives atany time with notice of at least (5) Business Days during ordinary businesshours for the purpose of verifying any matter relevant to this Agreement.

Uponthe request of Supplier, Distributor shall permit (i) an independentpublic accountant selected by Supplier and reasonably approved by Distributorto have access, during ordinary business hours, to such records and books ofaccounts relevant to this Agreement; and (ii) Supplier reasonableinspection of that relevant portion of Distributor’s Plant relating toDistributor’s activities pursuant to this Agreement. The cost of such audit orinspection shall be the responsibility of Supplier, except if such auditdiscloses an error benefiting Distributor by more than five percent (5%) inrespect of monies due to Supplier, then Distributor shall promptly reimburseSupplier for its costs incurred for such audit.

2.5.5                             Notlater than five (5) Business Days after the beginning of each calendar month,Distributor’s Plant shall provide the Joint Transition Team a rolling month bymonth forecast (the “Rolling Forecast”) of the expected orders of Productduring the Term. In accordance with Clause 4.6 below, such Rolling Forecast maytake into account quantities requested by Supplier and agreed by Distributorfor special order purposes. Within ten (10) days of the first day of eachcalendar month if Supplier (by way of the Joint Transition Team) does notaccept the Rolling Forecast for the first month of such forecast, the Partieswill negotiate and agree to a new forecast. The requirements indicated for the firsttwo (2) calendar months in such agreed upon Rolling Forecast shall beconsidered firm for the purposes of production planning in Distributor’s Plantand cannot thereafter be amended except by mutual agreement in writing or uponunanimous approval by the Joint Transition Team. Under no circumstances shallany order quantity designated for the purpose of Supplier’s stock build bebinding upon Distributor. No monthly amount set forth in any Rolling Forecastmay increase from the immediately preceding Rolling Forecast for such month bymore than twenty percent (20%), without the prior written consent of theParties.

2.5.5.1                    Informationregarding the Rolling Forecast or special orders (as provided in Clause 4.6below) shall be communicated as follows:
|        | To Distributor: |                                          | Attention: Stefania Barbettani |
|--------|-----------------|-----------------------------------------------|--------------------------------|
|   |            | Telephone: 39 095 59 84 54                    |
|   |            | E-mail: barbets@Wyeth.com                     |
|   |            | Address: Wyeth lederle SpA, XV Strada, Zone   |
|   |            | Industriale, 95030 Catania, Sicily            |
|   |            |                                          |
|   | To Supplier:    |                                          | Attention: Chris Ninomoto      |
|   |            | Title: Director, Commercial Operations        |
|   |            | Telephone: +925 560-0100 x. 386               |
|   |            | E-mail: cninomoto@supergen.com                |
|   |            | Address: 4140 Dublin Blvd, Suite 200, Dublin, |
|   |            | CA 94568, USA                                 |

 

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2.6.         ExpiredProduct.   Distributor shall not distribute or sell any Product whichis expired or outdated and shall follow Supplier’s instructions regardingexpired Product and its destruction or return to Supplier.

2.7.         Goodwill.

2.7.1                             EachParty shall use its best reasonable efforts to preserve the goodwill of theProduct.

2.7.2                             Distributorshall continue to have the right to use the Trademark applied to the Product tofulfil its obligations in accordance with this Agreement. Distributor shallequally be entitled to trade upon and use the name or goodwill of Distributorin connection with its activities hereunder. Upon the Closing Date, neitherParty shall thereafter use the other’s name in the promotion of its business oroffer for sale any goods which by their packaging, labeling or constructionwould reasonably create a claim by the other Party that such goods areimitative of any goods, products or packages or trade dress of the other Party.

**CLAUSE 3  TRANSITION OF SERVICES**

3.1.         Onthe Effective Date hereof, Supplier agrees to pay Distributor, by wire transferin immediately available funds to a bank account designed by Distributor, thesum of two million one hundred thousand US dollars ($2,100,000.00).

3.2.         Subjectto Clause 3.4 below, the effective date of expiration of this Agreement andtermination of the distribution relationship between the Parties, including allpackaging, testing, and distribution obligations hereunder, as to all countrieswithin the Territory shall be at the close of business on the date six (6) monthsafter the Effective Date (i.e. close of business on December 1, 2006) (“ClosingDate” or “Closing”) provided that, upon reasonable request fromDistributor, Supplier provides such reasonable assurances regarding Supplier’scapability (itself or through one or more Third Parties) to test, package anddistribute Product in the Territory at the levels supported by Distributor asof the Effective Date. The termination upon Closing shall be deemed toconstitute a termination by mutual agreement and shall not be deemed atermination for default, and neither Party shall have any responsibility orliability as a result of such termination except as otherwise expresslyprovided herein. The Parties hereby waive all rights to notice of terminationor compensation relating to termination as may be otherwise provided underApplicable Laws.

3.3.         Supplieracknowledges that as prerequisites to Closing, Supplier shall: (1) obtainall necessary variations to Marketing Authorizations for its or its Designee’spackaging and testing contractor and in-country sales order and distributionarrangements for the Product, together with obtaining any approvals forassociated changes to artwork and labeling as may be required by any relevantCompetent Authority; and (2) satisfy any other conditions for regulatoryapprovals to effectuate the transition of the services provided hereunder fromDistributor to Supplier.

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3.4.         Subjectto Clause 3.2 above, in the circumstance where: (1) as a prerequisiteto Supplier assuming all distribution, packaging, testing, marketing and saleof Product in a country of the Territory, Supplier has made the necessarysubmissions for approval to the relevant Competent Authorities and suchsubmission(s) have not yet been approved; or (2) Supplier is unable to providereasonable assurances to Distributor pursuant to Clause 3.2 above and asevidenced by gaps or incomplete processes in Supplier’s (or its Designee’s)infrastructure for supporting testing, packaging and distribution operations,then Distributor, in Distributor’s sole discretion, may extend the Closing Datehereof to the date of the last anticipated approval or to the anticipated datewhen Supplier can provide such reasonable assurances. If Distributor decides toso extend the Closing, Distributor shall notify Supplier in writing. Under nocircumstances shall the Closing Date be extended beyond March 25, 2007.

3.5.         The“Transition Period” is that period of time from the Effective Date hereof tothe Closing Date. Distributor and Supplier agree to work diligently, act ingood faith, use commercially reasonable efforts, cooperate and provide suchreasonable assistance to each other during the Transition Period to effectuatethe orderly and reasonably timely transfer of packaging, testing anddistribution services from Distributor to Supplier.

3.5.1                             Duringthe Transition Period and prior to Closing, the respective Project Leaders mayagree, in writing, to Supplier assuming all distribution responsibilities forthe Product in a specific country on a specified date (“Country Handover Date”).Said writing shall include whether the associated packaging and testingresponsibilities also transfer to Supplier for that particular country and ifnot, the date of transfer of the packaging and testing responsibilities shallbe specified, which date shall not be after the Closing Date. The CountryHandover Date (which may vary country-by-country) for each country shall be adate on or prior to the Closing Date.

3.5.1.1                    On the CountryHandover Date for a particular country, Distributor (or its Affiliate) shalldiscontinue all distribution activities regarding the Product in that specificcountry. In accordance with this Clause 3.5.1, Distributor shall alsodiscontinue packaging and testing activities regarding the Product for thatspecific country as agreed upon in writing by the Project Leaders.

3.6.         Supplieragrees to forever release Distributor from any claims which may arise fromSupplier’s activities regarding the Product in a specific country after theCountry Handover Date for that country and as to all countries in the Territoryafter Closing (“Release and Waiver”). Supplier shall execute a Release andWaiver in a form mutually agreed by the Parties upon each Country Handover Dateand upon Closing.

3.7.         JointTransition Team.   Within five (5) Business Days following theEffective Date hereof, the Parties shall establish a Joint Transition Team (the“JTT”) to manage the transition of the packaging, testing and distributionservices from Distributor to Supplier. The JTT shall be comprised of an equalnumber of representatives from each Party, with each Party having one ProjectLeader participate as a member of the JTT. The JTT shall:

 

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3.7.1                             becomprised of at least a Project Manager, regulatory representative, technical/qualityoperations representative, and logistics specialist designated by each Party;

3.7.2                             meeta minimum of twice per month (either face-to-face or by teleconference); eachParty shall be responsible for its own costs in respect of travel and accommodationexpenses in attending meetings; at such meetings, Supplier shall report on theongoing progress of the transition of packaging, testing and distributionresponsibilities from Distributor to Supplier;

3.7.3                             beco-chaired by the Project Leaders;

3.7.4                             JTTshall make decisions or provide approvals as may be required from time to timepursuant to Clauses 2.5.2, 2.5.5, 4.1, 5.3, 6.6 or other relevantprovision of this Agreement.

3.8.         ReasonableSupport.   During the Transition Period, Distributor will continue to purchaseunlabeled vials of Unfinished Product pursuant to Clause 4 below, and package,test and distribute Product pursuant to Clause 5 below. Distributor agreesto also provide pharmacovigilance, medical and regulatory support (includingproviding reasonable assistance to Supplier in handling any medical orregulatory inquiries from Persons or Competent Authorities) as reasonablyrequested by Supplier to facilitate the transition of rights to Supplier.

3.8.1                             Product Complaints.In accordance with the Technical Agreement, Supplier shall be responsible forinteracting with the public or Third Parties with respect to complaintsregarding Product for any country in the Territory in which Distributor or itsAffIliates sold, packaged, distributed or provided Product on a named patientbasis.

3.9.         Inventory.   Suppliershall purchase from Distributor all quantities of Product Packaging Materialand all quantities of stock of Product and Unfinished Product with at leasttwelve (12) months of remaining shelf life (collectively the “Inventory”) inthe possession or under the control of Distributor on the Closing Date.

3.9.1                             UponClosing, Supplier is obligated to repurchase each unit of Unfinished Productwithin the Inventory remaining in Distributor’s possession or under Distributor’scontrol at a price equal to Distributor’s Purchase Price plus freight,insurance and all other direct costs incurred by Distributor to deliverUnfinished Product to Distributor’s Plant. On the Closing Date, Distributorshall submit an invoice for such Unfinished Product and Supplier shall pay suchinvoice within forty five (45) days after receipt thereof.

3.9.2                             Onthe Country Handover Date for a specific country (or upon Closing, whicheveroccurs first), Supplier is obligated to repurchase each unit of Product withinthe Inventory remaining in Distributor’s possession or under Distributor’scontrol for that particular country at a price equal to the Catania Cost plusTransfer Cost. On the applicable Country Handover Date or Closing, as the casemay be, Distributor shall submit an invoice for such 

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Product andSupplier shall pay such invoice within forty five (45) days after receiptthereof.

3.9.3                             UponClosing, Supplier is obligated to repurchase all Packaging Materials remainingin Distributor’s possession or under Distributor’s control at a price equal toDistributor’s net book value; provided that Supplier shall have no suchobligation with respect to any Packaging Materials (i) that are not withinspecification or (ii) in quantities in excess of four (4) months of normalusage, based on past experience. On the Closing Date, Distributor shall submitan invoice for such Packaging Materials and Supplier shall pay such invoicewithin forty five (45) days after receipt thereof. Supplier may repurchasecountry-specific Packaging Material upon a Country Handover Date; however, inany event, any such remaining material must be repurchased by Supplier uponClosing.

3.9.4                             Distributorshall make the Inventory available at Distributor’s premises for pick-up on theClosing Date or Country Handover Date, as the case may be.

3.9.5                             IfSupplier so desires, Supplier may, but is not obligated to, repurchaseInventory prior to the dates as described herein. For the avoidance of doubt,Supplier is obligated to repurchase all remaining Inventory upon Closing, withpayment for same due as described in this Clause 3.9 above.

3.10.                Release ofClaims.   Supplier, for itself, its successors and assigns, herebyreleases any claims or demands which Supplier has, had, may have or may havehad against Distributor, in each case arising out of any actual or allegedfailure on by or on behalf of Distributor to fulfill any of its obligations underSections 2.2 or 2.3 of the original Distribution Agreement includingrelating to any of Distributor’s acts or omissions concerning the testing,marketing, advertising, promotion or pursuit of clinical trial development workpertaining to the Product.

3.11.                Upon Closing orthe Country Handover Date (whichever occurs first) for a particular country inthe Territory, Supplier shall assume all material obligations to Third Partieswhich Distributor incurred prior to the Effective Date pursuant to theDistribution Agreement or after the Effective Date subject to Supplier’sreasonable approval. Subject to Clause 2.3.4, such material obligations toThird Parties incurred by Distributor include solely those purchase orders andnamed patient supplies filled in the ordinary course of business in accordancewith Distributor’s past practice and other obligations (contracts, agreements,and commitments relating to the Product) as set forth in Schedule 5, attachedhereto.

3.12.                Supplier representsand warrants to Distributor that at the end of the Transition Period, Suppliershall (itself or through one or more Designees) have the capability andinfrastructure necessary to, in each case consistent with Distributor’spractice during the term:

3.12.1          Comply with all relevantapplicable directives, laws and regulations relating to the manufacture,storage, marketing, packaging, testing, distribution and sale of the Product inthe Territory; and

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3.12.2                       Employ orotherwise engage sufficient trained and qualified personnel and maintainadequate facilities for the manufacture, promotion, distribution and sale ofthe Product throughout the Territory; and

3.12.3                       Maintainsufficient stocks of Product to meet all reasonably foreseeable demand for theProduct in the Territory.

**CLAUSE 4   PURCHASEOF UNLABELED BULK VIALS OF PRODUCT**

4.1.         Purchase.During the Term of this Agreement, Distributor shall purchase UnfinishedProduct, for packaging, testing and sale during the Transition Period, onlyfrom Supplier or its Designee. Supplier or its Designee shall manufacture theUnfinished Product in accordance with the Product Specifications and theTechnical Agreement (attached hereto as Exhibit B). Supplier or itsDesignee shall deliver such Unfinished Product to Distributor’s Plant. It isunderstood that the Unfinished Product shall be labelled and packaged byDistributor in accordance with Supplier’s Packaging Instructions. Upon theClosing Date and in accordance with Clause 3.2, Distributor shall have nofurther obligation whatsoever hereunder with respect to Unfinished Productexcept as provided in Clause 3.9.

Unless otherwise agreed in writing by the JTT, eachorder of Unfinished Product shall consist of a minimum of: (1) onethousand nine hundred (1,900) (10mg) unlabeled vials of Unfinished Product;plus (2) free of charge, one hundred (100) (10mg) unlabeled vials ofUnfinished Product; plus (3) free of charge, a sufficient number of (10mg)vials of Unfinished Product to meet cGMP and testing requirements.

4.2.         PurchasePrice. Supplier shall sell Unfinished Product to Distributor, excludingthose vials supplied free of charge pursuant to Clause 4.1 above, at aprice per (10mg) vial equal to two hundred and sixty five United States dollars($US265) CIF (Incoterms 2000) Catania Airport (“Distributor’s Purchase Price”).

4.3.         Payment.Supplier will issue an invoice for each shipment of bulk unlabeled vials ofUnfinished Product and Distributor agrees to pay for such Unfinished ProductUnited States dollars to an account specified by Supplier within forty five(45) days of the date of such invoice.

4.4.         Titleand Risk of Loss. Title to the Unfinished Product sold to Distributorhereunder and risk of loss thereof shall pass to Distributor when theUnfinished Product is presented for customs clearance in the country ofdestination in the Territory. Distributor shall be responsible for affectingsuch customs clearance and for paying away all expenses related thereto onbehalf of Supplier.

4.5.         Orders.Distributor understands that Supplier requires a lead time of eight (8) monthsin order to manufacture bulk unlabeled vials of Unfinished Product forpackaging and testing under this Agreement. In order to ensure continuity ofsupply of Product to the Territory during the Transition Period or until theCountry Handover Date for a particular country, Distributor will, from time totime, place firm orders of Unfinished Product with Supplier in order amounts asset forth or otherwise agreed by the Parties pursuant to Clause 2.5.5 andClause 4.1 above. 

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Promptly after receipt ofa firm order for bulk unlabeled vials of the Unfinished Product, Supplier shallnotify Distributor of Supplier’s firm commitment to deliver such UnfinishedProduct to the location specified in Distributor’s order.

4.6.         SpecialOrders.   During the Transition Period and upon reasonable approval byDistributor, Supplier may request Distributor order quantities of UnfinishedProduct from Supplier solely for packaging and testing (but not distribution)by Distributor in order to assist Supplier in stock build of Product or foreventual distribution by Supplier (or Supplier’s nominated Third Party).Supplier shall be obligated to purchase such Product so packaged and tested byDistributor at Catania Cost plus Transfer Cost.

4.7.         TechnicalAgreement.   Supplier’s Affiliate and Distributor’s Affiliate haveexecuted the Technical Agreement, a copy of which is attached hereto as Exhibit B.

4.8.         CoAand Testing of Unfinished Product.

4.8.1                             Foreach batch of each delivery of Unfinished Product, Supplier shall provide toDistributor a certificate of analysis (“CoA”) and batch documentationcertifying manufacture in accordance with cGMP, the Specifications and inaccordance with the provisions of the Technical Agreement.

4.8.2                             UnfinishedProduct supplied by Supplier shall also be free from any liens or encumbrances.

4.8.3                             Distributormay analyze the Unfinished Product in accordance with the Technical Agreementfor purposes of determining whether such Unfinished Product was manufactured bySupplier in accordance with GMP and the Specifications (“Acceptable UnfinishedProduct”).

4.8.4                             Distributorshall notify Supplier in writing within thirty (30) days of receipt of any ofthe Unfinished Product or portion thereof, which Distributor or its Affiliateis rejecting because it is not Acceptable Unfinished Product.

4.8.5                             IfSupplier disputes any finding by Distributor or its Affiliate that UnfinishedProduct is not Acceptable Unfinished Product, representative samples of such UnfinishedProduct shall be forwarded to a Third Party jointly selected by Distributor andSupplier, in their reasonable discretion, for analysis, which analysis shall beperformed in compliance with applicable regulations for re-testing ofpharmaceutical products. The findings of such analysis shall be binding uponthe Parties and the cost of such analysis shall be borne by the Party whosefindings differed from those generated by such Third Party.

4.8.6                             Suppliershall, as soon as reasonably practicable, replace any Order, or portionthereof, which is not Acceptable Unfinished Product (unless suchnon-conformance is due to any negligent or wrongful act or omission byDistributor or its agents, employees or sub-contractors), at Supplier’s costand expense. The foregoing shall be Distributor’s sole remedy in the event anyUnfinished Product is not Acceptable Unfinished Product.

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4.8.7                             Distributorshall instruct Distributor’s Affiliates as to the disposition of any Order orportion thereof determined not to be Acceptable Unfinished Product. At the soleoption of Supplier and at its expense, said Unfinished Product may be returnedto Supplier or destroyed in an environmentally acceptable manner in accordancewith Applicable Law.

**CLAUSE 5   PACKAGING,TESTING AND DISTRIBUTION OF PRODUCT**

5.1.         Untilthe occurrence of the Country Handover Date for a particular country or theClosing Date (whichever occurs first), Distributor or its Affiliate shallcontinue to act as distributor for Supplier within said country of theTerritory.

5.2.         Distributoracknowledges that the Unfinished Product supplied hereunder shall be packagedand tested by Distributor in accordance with Supplier’s Packaging and TestingInstructions and shall not be subject to any variation in packaging, except asotherwise provided in the Technical Agreement. It is understood that during theTransition Period, Supplier shall obtain regulatory approval for Supplier orits Designee to take over packaging and testing responsibilities fromDistributor.

5.3.         Suppliershall work in collaboration with the Joint Transition Team regarding thetransition of packaging, testing and distribution activities from Distributorto Supplier (or Supplier’s Designee). Supplier shall be responsible forobtaining any and all necessary regulatory approvals or other approvals fromrelevant Competent Authorities in connection therewith.

5.4.         Suppliersolely shall be responsible for ensuring the Packaging and Testing Instructionsare maintained in line with the relevant RHA’s requirements.

5.5.         Suppliershall immediately notify Distributor of changes to Supplier’s Packaging andTesting Instructions. Any cost or expenses (including any costs ofimplementation) incurred by Distributor in effectuating such changes(including, without limitation, changes to the Packaging Materials, artwork,labeling or Packaging Specifications) whether required by a Competent Authorityor otherwise requested by Supplier shall be borne by Supplier.

5.6.         Exceptas otherwise permitted hereunder, Supplier shall use no trademark or tradedress that is identical or confusingly similar to any trademark or trade dressowned by Distributor or its Affiliates. At no time following the Closing Dateshall Supplier use any trademark or trade dress of Distributor or itsAffiliates nor shall it permit, procure or facilitate the use of suchDistributor (or Distributor’s Affiliate) trademark or trade dress by any ThirdParty; provided, however, to the extent any Greek packaging repurchased bySupplier bearing Distributor’s or its Affiliate’s trademark or trade dressexists upon Closing, Supplier shall be permitted to exhaust such inventoryduring the four (4) months immediately following Closing.

5.7.         Inthe case of stock build quantities, Distributor shall deliver Product ex works(Incoterms 2000) at Distributor’s Plant to Supplier or Supplier’s Desgineewithin twelve (12) weeks of Distributor’s date of receipt of special orderquantities. In accordance with Clause 4.6 above, the price at which Suppliershall purchase such Product shall be equal to Catania Cost plus Transfer Cost.

 

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5.8.         QualityControl for Packaged Product.

5.8.1                             Distributorshall perform quality control tests on the Product and provide documentation toSupplier in accordance with the Technical Agreement.

5.8.2                             Suppliermay analyze the Product in accordance with the Technical Agreement for purposesof determining whether such Product was packaged and labelled by Distributor inaccordance with Supplier’s Packaging Instructions (“Acceptable Product”).

5.8.3                             Inthe case of stock build quantities delivered to Supplier (or Supplier’sDesignee), Supplier shall notify Distributor in writing within thirty (30) daysof receipt of any of the Product or portion thereof, which Supplier or itsDesignee is rejecting because Supplier’s belief that such Product was notpackaged in accordance with Supplier’s Packaging and Testing Instructions.

5.8.4                             Distributorshall, as soon as reasonably practicable, re-package or take such other actionas deemed appropriate and in accordance with quality control procedure andstandards with respect to any special order, or portion thereof, which is notAcceptable Product (unless such non-conformance is due to any negligent orwrongful act or omission by Distributor or its agents, employees orsub-contractors), at Supplier’s cost and expense. The foregoing shall beSupplier’s sole remedy in the event any Product is not Acceptable Product.

5.8.5                             Suppliershall instruct its Designee as to the disposition of any order or portionthereof determined not to be Acceptable Product.

**CLAUSE 6   ADVERSEEVENT REPORTING AND PRODUCT RECALL**

6.1.         TheParties shall comply with all Applicable Laws regarding the reporting ofadverse experiences to the relevant authorities and hereby agree to theprocedures attached hereto as Schedule 2 regarding such reportingand the exchange of adverse experience information.

6.2.         Inthe event of an actual or threatened recall of the Product is required orrecommended by a Competent Authority within the Territory or if recall of theProduct is (i) reasonably deemed advisable by Distributor, Distributor’sAffiliates, or by Supplier, or (ii) jointly deemed advisable byDistributor and Supplier, such recall shall be promptly implemented, directedand administered by Supplier in a manner which is appropriate and reasonable underthe circumstances and in conformity with accepted trade practices and theTechnical Agreement.

6.3.         Thecosts of the recall of the Product, including the cost of replacementquantities of Product, if any are needed or desired by Distributor, shall beborne by Supplier; provided that if the recall is due to Distributor’snegligent acts or omissions in handling, storing or packaging the Product orDistributor’s failure to comply with Applicable Laws, then the costs of therecall shall be borne by Distributor. Without limiting the generality of theforegoing, Distributor will have no obligation to pay costs of recalls ofProduct to the extent such recalls are (i) due to the withdrawal orcancellation of any approval for the Product by a Competent Authority, (ii)caused 

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by actions of ThirdParties occurring after such Product is sold by Distributor, (iii) due topackaging or labeling defects for which Supplier has responsibility or (iv) dueto any breach by Supplier of its duties under this Agreement or ApplicableLaws.

6.4.         IfSupplier is responsible for bearing the costs of a recall, Supplier willreimburse Distributor for all its reasonable costs and expenses of such recall.

6.5.         IfDistributor is responsible for bearing the costs of a recall, Distributor willreimburse Supplier for all its reasonable costs and expenses of such recall andDistributor shall be entitled but not obliged to take over and perform therecall of the Product and Supplier shall provide Distributor, at Distributor’sexpense, with all such reasonable assistance as may be required by Distributor.

6.6.         EachParty shall keep the other and the Joint Transition Team fully and promptlyinformed of any notification, event or other information, whether receiveddirectly or indirectly, which might result in a recall of Product.

6.7.         Distributorshall have no obligations pursuant to this Agreement to re-supply the Productsubject to such recall in the Territory in which such recall takes place.

**CLAUSE 7   CONFIDENTIALITY**

7.1.         TheParties shall continue to hold in the strictest confidence all ConfidentialInformation previously provided by the other Party to support such Party’sobligations hereunder.

7.2.         Eachof the Parties undertakes and agrees:

7.2.1                             onlyto use the Confidential Information received from the other Party for thepurposes set forth in this Agreement and not to use the same for any otherpurpose whatsoever;

7.2.2                             toensure that only those of its officers and employees who are directly concernedwith the carrying out of this Agreement have access to the ConfidentialInformation received from the other Party on a reasonably applied “need to know”basis and are informed of the secret and confidential nature of it; and

7.2.3                             tokeep the Confidential Information of/received from the other Party secret andconfidential and not directly or indirectly to disclose or permit to bedisclosed, make available or permit to be made available the same to any ThirdParty for any reason without the prior written consent of the disclosing Party;

unless suchConfidential Information (i) is or becomes generally available to thepublic without breach of the commitment provided for in this Clause 7;(ii) at the time of disclosure is already in the receiving Party’s possessionother than, directly or indirectly, from the disclosing Party or any of itsAffiliates, which the receiving Party can show, through written records, wascreated prior to the disclosure of the Confidential Information hereunder; or(iii) is required to be disclosed by law, order or regulation of arelevant Competent Authority; provided, however, in the case of 

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clause(iii), the receiving Party shall notify the other Party as early aspracticable prior to disclosure to allow the other Party to take appropriatemeasures to preserve the confidentiality of such information, and shall in anyevent seek and secure confidential treatment for any such ConfidentialInformation it shall determine in its reasonable business judgment must be andis disclosed to such Competent Authority, to the fullest extent permitted underApplicable Law.

7.3.         Thiscontinuing covenant of confidentiality set forth in this Clause 7 shall survivethe termination or expiration of this Agreement.

7.4.         AllConfidential Information disclosed hereunder shall remain the property of thedisclosing Party, and/or its Affiliate(s), as the case may be. The Partiesunderstand and agree that remedies in damages may be inadequate to protectagainst any breach of any of the provisions of this Clause 7 by eitherParty or their employees, officers or any other Person acting in concert withit or on its behalf. Accordingly, each Party may be entitled to seek thegranting of interim and final injunctive relief by a court of competentjurisdiction in the discretion of that court against any action thatconstitutes any breach of this Clause 7.

7.5.         Exceptas contained within the records and books of accounts maintained pursuantClause 2.5.4 or as otherwise required by Applicable Laws, each Party shalldeliver all of the Confidential Information (including all reproductionsthereof) belonging to the other Party to such other Party within ninety (90)days after the Closing Date.

**CLAUSE 8   WARRANTIESAND INDEMNITIES**

8.1.         Distributorwarrants that at the time Product leaves Distributor’s Plant, all UnfinishedProduct packaged into Product by Distributor under this Agreement shall in allmaterial respects conform to the packaging and testing Specifications and shallbe packaged and tested in accordance with the Technical Agreement and thePackaging and Testing Instructions. The foregoing warranty is exclusive, and sofar as is permissible in law is given in lieu of all other warranties (whetherwritten, oral or implied) including a warranty of merchantability on otherrespects than expressly set forth in the preceding sentence and a warranty offitness for a particular purpose.

8.2.         Supplierwarrants and agrees that (a) it shall comply in all material respects with anyApplicable Laws regarding the marketing, sale, packaging, storage, shipment orhandling of Products, and (b) it has or will obtain prior to the expiration ofthe Transition Period, and will maintain, all permits and licenses required toperform manufacturing, packaging, testing, distribution, advertising andpromotion of Product under this Agreement.

8.3.         Distributorwarrants and agrees that until the Country Handover Date for a particularcountry or Closing Date (whichever occurs first) it shall comply in allmaterial respects with any Applicable Laws pertaining to the packaging,storage, shipment, or distribution of Products in the Territory.

8.4.         Distributorshall be liable for and hereby undertakes to indemnify and hold harmlessSupplier against any Losses arising from (i) material breach byDistributor or its Affiliates of the terms of this Agreement, of anyrepresentations or warranties made 

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to Supplier, or(ii) Distributor’s (or it’s Affiliate’s) negligence or willful misconduct,except to the extent that such Losses arise as a consequence of any act,default or negligence of Supplier, its Afftliates or Designees.

8.5.         Suppliershall be liable for and hereby undertakes to indemnify and hold harmlessDistributor and its Affiliates against any Losses (including death) arisingfrom or in connection with (i) the manufacture of Product, arising from orin connection with a deviation from the Product Specifications or cGMP, orotherwise involving product liability; or (ii) Supplier’s (its Affiliate’sor its Designee’s) distribution, marketing, promotion or sale of the Product;or (iii) material breach by Supplier or by its Designee of the terms ofthis Agreement, of any representations or warranties made to Distributor, or ofany Marketing Authorization held by Supplier or its Affiliate pursuant to whichDistributor packages and tests the Product for Supplier, or (iv) Supplier’s(or it’s Affiliate’s or Designee’s) negligence or willful misconduct, except tothe extent that such Losses arise as a consequence of any act, default ornegligence of Distributor or its Afftliates.

8.6.         EachParty shall take all reasonable steps to mitigate any Losses upon becomingaware of any event which would reasonably be expected to give rise thereto andshall be responsible for its own negligence or willful misconduct.

8.7.         Conditionsto Indemnification.   The obligations of the indemnifying Party underthis Agreement are conditioned upon the delivery of written notice to theindemnifying Party of any claim (a “Claim”) as soon as reasonablypractical after it becomes aware of such Claim.

8.8.         Suppliershall obtain and maintain in full force and effect the coverage for productliability for the Product under its current insurance policies for up to € 1,000,000per occurrence and per year, or else will obtain, prior to the lapse of anysuch policy and upon written notice to Distributor, substantially similarcoverage with insurers that are reputable and financially sound or throughreasonably funded self insurance.

8.9.         Theliability of Distributor for any Claims arising out of or related to thisAgreement, regardless of the form of action and the Person or entity bringingsuch action, shall not exceed, in the aggregate, the total aggregate amount ofDistributor’s Distribution Fees and Transfer Costs obtained hereunder duringthe Term.

8.10.        TheParty seeking an indemnity shall:

8.10.1          fully and promptlynotify the other Party of any Claim or proceedings, or threatened Claim orproceedings;

8.10.2          co-operate in theinvestigation and defence of such Claim or proceedings; and

8.10.3          permit the indemnifyingParty to take full control of such Claim or proceedings, with counsel of theindemnifying Party’s choice, provided that the indemnifying Party shallreasonably and regularly consult with the indemnified Party in relation to theprogress and status of such claim or proceedings, provided, however, theindemnifying Party shall not acknowledge the validity of, compromise, orotherwise settle any Claim 

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without the priorwritten consent of the other Party, which said consent shall not beunreasonably held; in all circumstances, it shall be deemed reasonable for theindemnified Party to withhold consent with respect to any settlement orcompromise which does not release the indemnified Party from all liability orwhich involves an admission of liability of the part of the indemnified Party.

**CLAUSE 9   INTELLECTUALPROPERTY**

To the extent it becomes necessary that anyIntellectual Property owned by Supplier or its Affiliates or licensed toSupplier or its Affiliates is required for Distributor to perform itsobligations under this Agreement, Supplier hereby grants, to the extentnecessary, to Distributor a royalty-free, non-exclusive license to use andemploy any such Intellectual Property related to the Product in the Territoryfor the Term and for the purposes specified herein and Distributor in turnagrees to comply (to the extent it is reasonably able to do so) with such termsand conditions of any such license as are notified in writing to it bySupplier.

**CLAUSE 10   TERMAND TERMINATION**

10.1.                This Agreement shallbecome effective as of June 1, 2006 (“Effective Date”) and shall continuein full force until the Closing Date or, with respect to a particular countrywithin the Territory, the Country Handover Date therefor, as the case may be,in accordance with Clauses 3.2 and 3.5 above, unless terminated sooner asprovided in Clause 10.2 below (the “Term”).

10.2.                Either Party mayterminate this Agreement upon written notice to the other Party in the event ofany of the following:

10.2.1          An assignment by theother Party for the benefit of creditors; or

10.2.2          The admitted insolvencyof the other Party; or

10.2.3          The institution ofvoluntary or involuntary proceedings by or against the other Party inbankruptcy, insolvency, or moratorium or for a receivership, or for awinding-up or for the dissolution or reorganization of the other Party.

**CLAUSE 11   CONSEQUENCESOF TERMINATION**

11.1.                Upon terminationor expiration of this Agreement in its entirety, Distributor shall immediatelycease all packaging, testing, and distribution of the Product for all countriesin the Territory.

11.2.                Upon terminationor expiration of this Agreement as to any particular country in the Territory,Distributor shall immediately cease all distribution of Product for that particularcountry. Subject to Clause 4.6 above, and in Distributor’s solediscretion, 

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Distributor maypackage and test product in accordance with the terms herein in order to assistSupplier in stock build of Product or for eventual distribution by Supplier (orSupplier’s nominated Third Party). Upon Closing, Distributor shall have nofurther obligation whatsoever hereunder, in any country of the Territory,regarding packaging, testing, or distribution of Product.

11.3.                Termination uponClosing shall be deemed to constitute a termination by mutual agreement andshall not be deemed a termination for default. Neither Party shall be liable tothe other for damages, indemnity, or compensation solely on account oftermination or expiration of this Agreement, as provided herein, whether suchdamages, indemnity or compensation might be claimed for loss throughcommitments on obligations or leases, loss of investment, loss of present orprospective profits, loss of goodwill, or any other loss caused by terminationor expiration of this Agreement as provided herein.

11.4.                Supplier shallrepurchase from Distributor all quantities of Product Packaging Material andInventory in accordance with Clause 3.9 above.

11.5.                Upon terminationor expiration of this Agreement as to any particular country in the Territory,Distributor shall discontinue forthwith use of the Trademark in such country.

11.6.                Upon Closing,Distributor shall provide Supplier such regulatory documents, data pertainingto adverse events for the Product and other relevant documentation pertainingto the Product in Distributor’s or its Affiliate’s possession or control.

11.7.                Survival.   Inaddition to the right to receive payments and any clause which by its expressterm survives termination or expiration, the respective rights and obligationsof the Parties under the provisions of Clause 1, Clause 2.5.4,Clause 3.10, Clauses 6.2-6.7, Clause 7, Clauses 8.4-8.10,and Clause 12 shall also survive any termination or expiration of thisAgreement.

**CLAUSE 12   OTHERPROVISIONS**

12.1.                Governing Law;Resolution of Disputes.   All incidents of this Agreement shall beinterpreted, construed and governed under and in accordance with the applicablelaws of the State of New York. Any dispute, controversy or claim arising out ofor relating to this Agreement or the breach thereof shall be submitted to theexclusive jurisdiction of the state and Federal courts within New York City,New York.

12.2.                EntireAgreement.   The body of this Agreement together with the attachedSchedules and Exhibits contains the entire understanding between the Partiesand supersedes and cancels any and all agreements, understandings,arrangements, promises, representations, warranties and contracts, whetherwritten or oral, previously made or entered into of any form or nature withrespect to the subject matter hereof, including the Distribution Agreement(except those provisions therein that were expressly intended to survive thetermination thereof). No change, alteration or modification hereof may be madeexcept in writing signed by both Parties.

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12.3.                Force Majeure.

12.3.1          If either Party isaffected by Force Majeure it shall promptly notify the other Party of thenature and extent of such Force Majeure.

12.3.2          Neither Party shall bedeemed to be in breach of this Agreement by reason of any delay in performanceor non-performance of any of its obligations under this Agreement to the extentthat such delay or non-performance is due to any Force Majeure notified to theother Party, and the time for performance of that obligation shall be extendedaccordingly.

12.3.3          If the Force Majeure inquestion prevails for a continuous period in excess of three (3) months, theParties shall enter into discussions in good faith with a view to alleviatingits effects, or to agreeing upon such alternative arrangements as may be fairand reasonable.

12.4.                Notices.   Allnotices, requests, demands and other communications hereunder shall be inwriting and shall be deemed to have been duly given if (i) deliveredpersonally, on the date of such delivery, (ii) mailed by reputableovernight courier, on the first Business Day following the date of suchmailing, (iii) mailed by certified mail (return receipt requested), on thethird Business Day after the date of such mailing, or (iv) sent bytelecopier (confirmed thereafter by such certified mail), on the date of suchdelivery, each to the other Party at the following address (or at such otheraddress as shall be given in writing by either Party to the other in accordancewith these provisions):

(a)             If to Supplier, to:SuperGen, Inc.4140 Dublin Blvd.Dublin, California 94568USAAttention: Legal DepartmentFax: +925-551-6483

(b)            If to Distributor to:Wyeth Lederle SpaXV Strada,Zone Industriale,95030 Catania,Sicily.Attention: Wyeth Pharmaceuticals Production DirectorFax No.: +39-095-59-8254

With a required copy to:

WyethEuropaVanwall RoadMaidenheadBerkshire SL6 4UBUKAttention: Chief Legal Counsel EMEAFax No.: +44-1628-692-522

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12.5.                No Agencv.   EachParty shall be acting as an independent contractor and nothing in thisAgreement shall create or be deemed to create any relationship of agency,employment, partnership or joint venture between the Parties. Neither Partyshall hold itself out as an agent or representative of the other Party andshall not give warranties, enter into contracts or otherwise incur, assume orcreate liabilities in the name of the other Party.

12.6.                Assignment.   ThisAgreement shall be binding upon and inure to the benefit of the Parties heretoand their respective successors and permitted assigns. Neither Party may assignthis Agreement without the prior written consent of the other Party, whichconsent shall not be unreasonably withheld; provided, however, a Party shallhave the right to assign and otherwise transfer this Agreement as a wholewithout consent to any success or that acquires all or substantially all of thebusiness or assets of such Party related to this Agreement by way of merger,consolidation, other business reorganization, or the sale of stock or assets,provided that the assigning Party notifies the other Party in writing of suchassignment and the successor agrees in writing to be bound by the terms andconditions of this Agreement.

12.7.                No Third PartyBeneficiaries.   This Agreement shall be binding upon and inure solelyto the benefit of the Parties and their permitted assigns and nothing herein,express or implied, is intended to or shall confer upon any other Person anylegal or equitable right, benefit or remedy of any nature whatsoever.

12.8.                EnglishLanguage.   The Parties acknowledge and agree that this Agreement hasbeen drafted in the English language which shall prevail over any translationwhich may be made by either Party for any purpose whatsoever, including but notlimited to, the purpose of complying with local laws and regulations.

12.9.                Severability.   Ifany term or other provision of this Agreement is invalid, illegal or incapableof being enforced by any Applicable Law or public policy, all other terms andprovisions of this Agreement shall nevertheless remain in full force and effectfor so long as the economic or legal substance of the transactions contemplatedby this Agreement is not affected in any manner materially adverse to eitherParty. Upon such determination that any term or other provision is invalid,illegal or incapable of being enforced, the Parties shall negotiate in goodfaith to modify this Agreement so as to effect the original intent of theParties as closely as possible in an acceptable manner in order that thetransactions contemplated by this Agreement are consummated as originallycontemplated to the greatest extent possible.

12.10.          Counterparts.   ThisAgreement may be executed and delivered (including by facsimile transmission)in one or more counterparts, and by each Party in separate counterparts, eachof which when executed shall be deemed to be an original, but all of whichtaken together shall constitute one and the same agreement. Delivery of anexecuted counterpart of a signature page to this Agreement by facsimile shallbe effective as delivery of a manually executed counterpart of this Agreement.

12.11.          Waiver.   Thefailure of either Party to enforce at any time for any period the provisions ofor any rights deriving from this Agreement shall not be construed to be 

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a waiver of suchprovisions or rights or the right of such Party thereafter to enforce such provisions.

12.12.          Headings.   Thedescriptive headings contained in this Agreement are for convenience ofreference only and shall not affect in any way the meaning or interpretation ofthe Agreement.

[The remainder of thispage left blank intentionally; signature page follows.]

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IN WITNESS WHEREOF this agreement has been signed onbehalf of the Parties hereto the day and year first above written.
| **WYETH**                       |                                                                   |
|---------------------------------|------------------------------------------------------------------------|
|                            |                                                                   |   |
| By:                             | /s/ Paul J. Jones                                                      |   |
|                            | Name:  Paul J. Jones                                         |   |
|                            | Title:    Vice President                           |   |
|                            |                                                                   |   |
|                            |                                                                   |   |
| **SUPERGEN**                    |                                                                   |
|                            |                                                                   |   |
| By:                             | /s/ James S. Manuso, Ph.D.                                             |   |
|                            | Name:  James S. Manuso, Ph.D.                                |   |
|                            | Title:    President & Chief  Executive Officer |   |
|                            |                                                                   |   |
|                            |                                                                   |   |
| **WYETH  HOLDINGS CORPORATION** |                                                                   |
|                            |                                                                   |   |
| By:                             | /s/ Jack M. O’Connor                                              |   |
|                            | Name:  Jack M. O’Connor                                 |   |
|                            | Title:    Vice President                           |   |

 

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