**Exhibit 10.01***Execution Copy***LICENSE AGREEMENT****by and between****MGI PHARMA, INC.****and****CILAG GmbH INTERNATIONAL**
 

 
**TABLESOF CONTENTS**     **RECITALS**  1      **ARTICLE 1 DEFINITIONS**  1      **ARTICLE 2 LICENSE**  11 2.1 License  11 2.2 Sublicenses and Affiliates  11 2.3 No Conflict  12 2.4 Right of First Offer to a Related Product  12      **ARTICLE 3 PAYMENTS AND MILESTONES**  12 3.1 Up-Front Payment  12 3.2 Milestones  12 3.3 Royalty Payments  12 3.4 Discounting  13 3.5 Bundling  13 3.6 Other  13      **ARTICLE 4 JSC, JOCs, COMMERCIALIZATION ANDDEVELOPMENTS PLANS**  13 4.1 Development and Commercialization Plans  13 4.2 Plan Contents  14 4.3 Cooperation and Efforts  15 4.4 Joint Steering Committee  15 4.5 Project Leaders  16 4.6 Joint Operating Committees  16  * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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       **ARTICLE 5 OBLIGATIONS OF THE PARTIES**  17 5.1 General  17 5.2  Development  17 5.3  Research and Development Support  18 5.4  New Indications  19 5.5  Additional Trials  21 5.6  Delivery of Information  21 5.7  Regulatory Responsibilities  22 5.8  Safety Reporting  23 5.9  Licensed Products Supplied to Named Patients  24 5.10  Commercialization  24 5.11  Voluntary and Mandatory Recalls: Potential Hazards  25 5.12  Records and Reports  26 5.13  Third Parties  26        **ARTICLE 6 SUPPLY OF PRODUCT**  26 6.1  Manufacturing and Supply Agreement  26 6.2  Pricing  30 6.3  Quality Assurance  30 6.4  Assignment of Existing Supply Agreements  31        **ARTICLE 7 PAYMENTS: BOOKS AND RECORDS**  31 7.1  Milestone Payments  31 7.2  Royalty Reports and Payments  32 7.3  Payment Method  32 7.4  Currency Conversion  32 7.5  Taxes  32 7.6  Records and Inspection  33        **ARTICLE 8 INTELLECTUAL PROPERTY OWNERSHIP: PATENTS**  34  * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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     8.1 Ownership of Inventions  34 8.2 Patent Prosecution  34 8.3 Cooperation in Prosecution  35 8.4 Patent Term Extensions  35 8.5 Third Party Infringement Claims  35 8.6 Enforcement  35 8.7 Patent Marking  36      **ARTICLE 9 TRADEMARKS**  36 9.1 Product Trademark  36 9.2 License  37 9.3 Registration  37 9.4 Ownership  37 9.5 Recordation  37 9.6 Guidelines and Approval  37 9.7 Termination  37      **ARTICLE 10 CONFIDENTIALITY**  38 10.1 Non-Use and Non Disclosure  38 10.2 Exclusions  38 10.3 Permitted Use and Disclosure  38 10.4 Prior Non-Disclosure Agreement  39 10.5 Terms of the Agreement  39 10.6 Publication of Licensed Products Information  40      **ARTICLE 11 REPRESENTATIONS AND WARRANTIES**  40 11.1 By MGI  40 11.2 By Licensee  42 11.3 Disclaimer  43  * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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     **ARTICLE 12 INDEMNIFICATION**  43 12.1 Indemnification of MGI  43 12.2 Indemnification of Licensee  44 12.3 Procedure  44 12.4 Insurance  44        **ARTICLE 13 TERM AND TERMINATION**  45 13.1 Term  45 13.2 Termination for Non-Payment and Termination Without Cause  45 13.3 Termination for Material Breach, Change of Control or TerminationSuperGen License  45 13.4 Insolvency of a Party  48 13.5 Termination on a Country-by-Country Basis  49 13.6 Tolling of Cure Period  49      **ARTICLE 14 EFFECT OF EXPIRATION OR TERMINATION**  49 14.1 Accrued Obligations  49 14.2 Effects of any Expiration or Termination  50 14.3 Rights on Expiration or Termination  50 14.4 Rights  52      **ARTICLE 15 MISCELLANEOUS**  52 15.1 Article and Section Headings, Language and Construction  53 15.2 Governing Law  53 15.3 Submission to Jurisdiction  53 15.4 Waiver of Jury Trial  53 15.5 Other Remedies  53 15.6 Injunctive Relief  53 15.7 Dispute Resolution  53 15.8 Alternative Dispute Resolution  54  * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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       15.9  Jurisdiction  58 15.10 No Implied Waivers: Rights Cumulative  58 15.11  Independent Contractors  58 15.12  Notices  58 15.13  Assignment  59 15.14  Modification  59 15.15  Severability  59 15.16  Publicity Review  60 15.17  Counterparts  60 15.18  Export Laws  60 15.19  Limitation of Liability  60 15.20  Entire Agreement  60  **SCHEDULES:**  61 Schedule 1.7 — J&J Universal Calendar — 2006    Schedule 1.18 — Decitabine     Schedule 1.51 — Licensed Patents    Schedule 1.66 — Orphan Product Designation for Decitabine in EC    Schedule 1.80 — License Agreement between SuperGen, Inc. and MGI Pharma, Inc.    Schedule 1.75 — Manufacturing and Supply Agreements    Schedule 1.90 — R&D/GCP Audit Plan    Schedule 2.0 — Press Release    Schedule 2.1 — Example of Currency Conversion    Schedule 3.0 — Initial Global Development Plan & Listing of On-going Clinical Trials    Schedule 6.1(b) —  Minimum Product Order Quantities    Schedule 6.1(c) — Licensee Initial Product Forecast    Schedule 6.1(e) — Form of Purchase Order     * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
 

 
*Execution Copy***LICENSE AGREEMENT**     THISLICENSE AGREEMENT, having an effective date as of July 3, 2006 (“Effective Date”) isentered into by and between MGI PHARMA, INC., a Minnesota corporation having its principal place ofbusiness at 5775 West Old Shakopee Road, Suite 100, Bloomington, Minnesota 55437-3174 U.S.A.(“MGI”), and Cilag GmbH International, a Limited Liability Company having its principal place ofbusiness at Landis + Gry-Strasse 1, CH-6300 Zug, Switzerland (“Licensee”). MGI andLicensee are sometimes referred to herein, individually, as a “Party” and, collectively, asthe “Parties.”**RECITALS**     WHEREAS, MGI is in the business of developing and commercializing pharmaceutical products,including oncology pharmaceutical products that meet unmet medical needs.     WHEREAS, Licensee desires to Develop and Commercialize (each as defined below) certainpharmaceutical products containing Decitabine (as defined below) for the treatment of oncologic andhematologic disorders.     WHEREAS, MGI has obtained a license from SuperGen, Inc. (“SuperGen”) to certainpatents, patent applications, know-how and data, concerning products containing Decitabine anddesires to further license its rights under such patents, patent applications, know-how, and datato a pharmaceutical company that will assist in the Development and Commercialization of suchproducts in the Territory pursuant to the terms of this Agreement.     WHEREAS, the SuperGen License Agreement has been amended to provide that SuperGen will consentto the continuation of Licensee’s rights and license granted by MGI under this Agreement under theconditions described in Section 13.3(c) herein should the SuperGen License Agreement be terminatedeither by SuperGen due to the breach of such Agreement by MGI, and such termination is not relatedto any breach by Licensee of the terms of this Agreement, or otherwise terminated by MGI.     WHEREAS, the SuperGen License Agreement has been amended to provide that MGI can Assignregulatory rights in the Territory to Licensee.     WHEREAS, MGI is willing to grant to Licensee, and Licensee desires to obtain, an exclusivelicense under such intellectual property for the Territory, all on the terms set forth herein.     NOW, THEREFORE, for and in consideration of the covenants, conditions and undertakingshereinafter set forth, the Parties hereby agree as follows: * Denotes confidential information that has been omitted from the exhibit and filed separately,accompanied by a confidential treatment request, with the Securities and Exchange Commissionpursuant to Rule 24b-2 of the Securities Exchange Act of 1934.
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*Excution Copy***ARTICLE 1: DEFINITIONS** 1.1. “Additional Trials” shall have the meaning set forth in Section 5.5(a).  1.2. “Affiliate” shall mean, in the case of a subject entity, another entity thatcontrols, is controlled by or is under common control with the subject entity, but only forso long as such control exists. For purposes of this definition only, “control” shall meanbeneficial ownership (direct or indirect) of at least fifty percent (50%) of the shares ofthe subject entity entitled to vote in the election of directors (or, in the case of anentity that is not a corporation, in the election of the corresponding managing authority);provided that where the local law does not permit foreign equity ownership of at leastfifty percent (50%), then “control” shall mean the beneficial ownership (direct orindirect) of the maximum percentage of outstanding stock or voting rights permitted bylocal law.  1.3. “Agreement” shall have the meaning set forth in the Preamble.  1.4. “AML” shall have the meaning set forth in Section 2.1.  1.5. “API” shall have the meaning set forth in Section 1.28.  1.6. “Bright Stock” shall mean unlabeled finished units of the Licensed Productssupplied by MGI to Licensee for labeling and distribution in the Territory pursuant to theterms hereof.  1.7. “Calendar Quarter” shall mean a calendar quarter based on the J&J UniversalCalendar for that year, a copy of which, for 2006, is attached hereto as Schedule 1.7, andwhich shall be updated by Licensee for each Calendar Year of the Term consistent with theJ&J Universal Calendar used for Licensee’s internal business purposes; provided, however,that the first calendar quarter for the first Calendar Year shall extend from the EffectiveDate to the end of the then-current Calendar Quarter and the last Calendar Quarter shallextend from the first day of such Calendar Quarter until the effective date of thetermination or expiration of the Agreement.  1.8. “Calendar Year” shall mean a calendar year during the Term based on the J&JUniversal Calendar for that year, a copy of which, for 2006, is attached hereto as Schedule1.7, and which shall be updated by Licensee for each Calendar Year of the Term consistentwith the J&J Universal Calendar used for Licensee’s internal business purposes. For thefirst Calendar Year, the Calendar Year shall begin on the Effective Date and the last dayshall be December 31, 2006. The last Calendar Year of the Term shall begin on the firstday of the J&J Universal Calendar Year for the year during which termination or expirationof the Agreement will occur, and the last day of such Calendar Year shall be the effectivedate of such termination or expiration.  1.9. “Change of Control” shall mean, with respect to a Party, any transaction orseries of related transactions that constitute: (a) the sale or lease of all orsubstantially all of * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   such Party’s business or assets to an acquiring entity; (b) anymerger, consolidation, share exchange, recapitalization, business combination or othertransaction to whichsuch Party is subject resulting in the exchange of the outstanding shares of such Partyfor securities or consideration issued, or caused to be issued, by the acquiringentity; or (c) an acquiring entity having obtained beneficial ownership of fiftypercent (50%) or more of the outstanding voting securities of such Party; unless in anyof cases (a), (b) or (c) the stockholders of such Party as of the date prior to theclosing date of such transaction or series of related transactions hold more than fiftypercent (50%) of the voting securities in the surviving entity in such transaction orits parent outstanding immediately after the closing of such transaction or series oftransactions.  1.10. “Claim” shall have the meaning set forth in Section 12.1.  1.11. “CMC” shall have the meaning set forth in Section 1.1054.  1.12. “Commercialization”, “Commercialize” and “Commercial” shallmean activities directed to labeling of Bright Stock, launching, marketing, promoting,detailing, educating, distributing, importing, and selling Licensed Products, together withpost-marketing studies within the Territory.  1.13. “Commercialization Plan” shall have the meaning set forth in Section 4.1(a).  1.14. “Company Core Data Sheet” or “CCDS” shall mean the complieddocumentation relating to the medical and scientific data relating to the Licensed Product,including safety and effective use of Licensed Product, without regard to any specificcountry regulatory labeling requirements.  1.15. “Competing Product” shall mean any prescription pharmaceutical product otherthan the Licensed Products that (a) contains Decitabine or a pro-drug of Decitabine as the activeingredient (unless the pro-drug is an active ingredient in a pharmaceuticalproduct that is being marketed as of the Effective Date of this Agreement), or  (b) is an ester, phosphate, solvate, hydrate or tautomer of Decitabine(except for pharmaceutical products containing one or more polynucleosides orpolynucleotides comprising at least one base of Decitabine), or  (c) are Decitabine Metabolites (except for pharmaceutical products thatare approved for uses outside of the field of hematological diseases andhematopoietic disorders);   in each of (b) and (c) so long as the active ingredient of such pharmaceutical productremains Decitabine or an active Decitabine Metabolite.    For purposes hereof, “Decitabine Metabolites” shall mean the compounds resulting fromthe *in vivo*metabolic breakdown of Decitabine, including the mono-, di- andtri-phosphates of Decitabine. Notwithstanding the preceding sentence, Decitabine * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   Metabolites shall not include (1) analogs of Decitabine metabolites, or (2)polynucleosides or polynucleotides comprising at least one base of Decitabine, whereinthe term “analogs” shall be limited to compounds that are not Decitabine Metabolites.  1.16. “Confidential Information” shall mean all information, data, and technology inany form, disclosed by or on behalf of a Party in connection with this Agreement, includingbut not limited to assays, chemical structures, pre-clinical and clinical trial results,diagnostics, biological markers, protein structures, mechanisms of action, analyticaltechniques, chemical synthesis, enzymology, computational models, Manufacturing processes,market information, patent applications, inventions, know-how, trade secrets, knowledge,ideas, developments, prototypes, discoveries, invention disclosures, products, procedures,methods, techniques, materials, instructions, specifications, recipes, designs, formulas,compositions, research, modifications, protocols, works of authorship, business plans,financial projections, and any other information, data, and technical subject matter,whether biological, chemical, analytical, clinical, Manufacturing or quality controlrelated, or otherwise, including pharmacological, toxicological and clinical informationand test data, and related reports, statistical analyses, Commercialization plans, expertopinions and the like, the secrecy of which confers a competitive advantage upon thatParty. As used herein, Confidential Information shall not include rights under PatentRights (but does include the subject matter disclosed in non-published applications).  1.17. “Control” or “Controlled” shall mean, with respect to any intellectualproperty right or other intangible property, the possession (whether by license orownership, or by control over an Affiliate having possession by license or ownership) by aParty of the ability to grant to the other Party access and/or a license or sublicense asprovided herein without violating the terms of any agreement with any Third Party.  1.18. “DACOGEN Trademark” shall me mean the DACOGEN mark and accompanying logosassociated with it.  1.19. “Decitabine” shall mean the compound identified in Schedule 1.18, and allstereoisomers, salts and polymorphs of the compound identified in Schedule 1.18. Estersand acids of the compound identified in Schedule 1.18 shall be included to the extent theyconstitute the same active ingredient as the compound identified in Schedule 1.18.  1.20. “Decitabine Metabolites” shall have the meaning set forth in Section 1.15.  1.21. “Delivery(ies)” “Deliver(ed)” shall have the meaning set forth in Section 6.1(g).  1.22. “Dispute Resolution” shall have the meaning set forth in Section 15.7.  1.23. “Develop” and “Development” means the procurement of RegulatoryApprovals for Licensed Products in the Territory, preclinical testing, toxicology, clinicaltrials, quality of life assessments, regulatory affairs, and further activities related todevelopment of Licensed Products to a stage ready for Commercialization thereof, * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   includingpre-marketing, launch plans and sales forecasting. It is understood that Developmentincludes ongoing clinical trials of Licensed Products conducted after the initialRegulatory Approval of Licensed Products, including, without limitation, to obtain furtherRegulatory Approval for expanded labeling or approval for new indications.  1.24. “Development Information” shall have the meaning set forth in Section 5.6(a).  1.25. “Diligent Efforts” shall mean, with respect to each Party’s obligationsrelating to the Licensed Product in their respective territories, the carrying out of suchobligations in a diligent and sustained manner using efforts substantially similar to theefforts such Party devotes to a product of similar market potential, profit potential,similar stage in development or commercialization, based on conditions then prevailing.  1.26. “DR” shall have the meaning set forth in Section 15.8.  1.27. “DR Request” shall have the meaning set forth in Section 15.8(a).  1.28. “Drug Substance” shall mean the active pharmaceutical ingredient(“API”) of Product.  1.29. “Drug Substance Secondary Supplier Price” shall have the meaning set forth inSection 6.1(o).  1.30. “Effective Date” shall have the meaning set forth in the preamble.  1.31. “EMEA” shall mean the European Medicines Evaluation Agency, or any successorthereto.  1.32. “Enforcement Action” shall have the meaning set forth in Section 8.6.  1.33. “Equivalent Pharmaceutical Company” shall have the meaning set forth inSection 13.3(b).  1.34. “Estimated Requirements” shall have the meaning set forth in Section 6.1(a).  1.35. “European Union” or “EU”. shall mean the countries of the EuropeanUnion, as it is constituted as of the Effective Date and as it may be expanded from time totime.  1.36. “Existing Third Party Agreements” shall mean the SuperGen Agreement, theTrademark Coexistence Agreement, the Pharmachemie Manufacturing Agreement, the FerroPfanstiehl Agreement, any all the Manufacturing and supply agreements related to LicensedProduct, which agreements are listed on Schedule 1.75, and any other agreements which wouldeffect the rights and obligations of the Parties hereunder.  1.37. “FDA” shall mean the United States Food and Drug Administration.  1.38. “Ferro Pfanstiehl Agreement” shall mean all agreements with Ferro Corporationand its affiliates relating to the API including, but not limited to, the Drug Substanceand Validation and Supply Agreement between SuperGen, Inc. and Ferro PfanstiehlLaboratories, Inc. and its affiliates, effective as of July 2, 2003 and Amendments 1, * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*  2, 3,4, 5, and 6 thereto, and the Quality agreement between MGI Pharma Inc. and FerroCorporation, effective February 28, 2006. 1.39. “Field” shall have the meaning set forth in Section 2.1. 1.40. “Filling Production Lot” shall mean the minimum product quantity of 10,000vials. 1.41. “Firm Orders” shall have the meaning set forth in Section 6.1(c). 1.42. “First Commercial Sale” shall mean the first commercial sale of the LicensedProducts in the specified country by or under authority of any of Licensee or itsAffiliates following receipt of Marketing Authorization and any required pricing orreimbursement approval of such Licensed Products in such country. Sales for clinicalstudy purposes or compassionate, named patient or similar use shall not constitute aFirst Commercial Sale. 1.43. “Forecast” shall mean as defined in Section 6.1(a).  1.44. “FTE” shall mean a full time equivalent person year of professional scientificand/or technical work or managerial work to the extent working on or directly involved inthe development according to the Global Development Plan.  1.45. “G5 Countries” shall mean Spain, United Kingdom, France, Germany and Italy  1.46. “Good Clinical Practice” or “GCP” shall mean the then currentstandards for clinical trials for pharmaceuticals, as set forth in the ICH (as definedbelow) guidelines and applicable regulations promulgated thereunder, as amended from timeto time, and such standards of good clinical practice as are required by the European Unionand other organizations and governmental agencies in countries in which a Licensed Productis intended to be sold to the extent such standards are not less stringent than UnitedStates GCP.  1.47. “Good Laboratory Practice” or “GLP” shall mean the then currentstandards for laboratory activities for pharmaceuticals, as set forth in the FDA’s GLPregulations and/or the GLP principles of the Organization for Economic Co-Operation andDevelopment (OECD) and/or the GLP regulations adopted by Japan, as amended from time totime, and such standards of good laboratory practice as are required by the European Unionand other organizations and governmental agencies in countries in which a Licensed Productis intended to be sold, to the extent such standards are not less stringent than UnitedStates GLP.  1.48. “Good Manufacturing Practice(s)” or “GMP” shall mean 1) the regulatoryrequirements for current good manufacturing practices promulgated by the United States Foodand Drug Administration under the U.S. Food, Drug and Cosmetic Act, 21 C.F.R. § 210 etseq. (“FD&C Act”) and under the Public Health Service Act, Biological Products, 21C.F.R. §§ 600-610 (“PHS Act”), as the same may be amended from time to time; and 2)such standards of good manufacturing practice as are required by the European Union andother organizations and governmental agencies in countries in which a Licensed Product isintended to be Manufactured or * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   sold, to the extent such standards are not less stringentthan those in the United States.  1.49. “Governmental Authority” shall mean any court, tribunal, arbitrator, agency,commission, official or other instrumentality of (i) any government of any country, (ii) afederal, state, province, county, city or other political subdivision thereof or (iii) anysupranational body.  1.50. “ICH” shall mean “International Conference on Harmonization of TechnicalRequirements for Registration of Pharmaceuticals for Human Use.”  1.51. “Indemnitee” and “Indemnitor” shall have the meaning set forth in Section 12.3.  1.52. “Infringement Actions” shall have the meaning set forth in Section 8.5.  1.53. “Global Development Plan” shall have the meaning set forth in Section 4.1(a).  1.54. “Insolvent” shall have the meaning set forth in Section 13.4.  1.55. “Joint Operating Committee(s)” and “JOC(s)” shall have the meaningset forth in Section 4.6.  1.56. “JOC-C” shall have the meaning set forth in Section 4.6.  1.57. “JOC-D” shall have the meaning set forth in Section 4.6  1.58. “Joint Steering Committee” or “JSC” shall have the meaning set forthin Section 4.4.  1.59. “Liabilities” shall have the meaning set forth in Section 12.1.  1.60. “Licensed Know-How” shall mean all Regulatory Documentation, Supporting Data,Development information and Confidential Information that is material to the Developmentand Commercialization of the Licensed Products in the possession of MGI in tangible form asof the Effective Date this Agreement, and reasonably necessary for Licensee to perform itsobligations under this Agreement.  1.61. “Licensed Patents” shall mean: (i) the patents and patent applications listedin Schedule 1.51 and any patents issuing therefrom, and all reissues, continuations,continuations-in-part, extensions, reexaminations, and foreign counterparts thereof; and(ii) patents and patent applications MGI or its Affiliates may own or control which areinfringed by any of the activities of Licensee performing in accord with this Agreement,including without limitation, all patents and patent applications relating to ProductImprovements Controlled by MGI.  1.62. “Licensed Product(s)” shall mean the licensed Product(s).  1.63. “Licensed Product Improvements” shall mean the licensed Product Improvements.  1.64. “Licensee” shall have the meaning set forth in the Preamble.  1.65. “Licensee Additional Development Costs” shall have the meaning set forth inSection 13.3(c)(i). * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy* 1.66. “Licensee Indemnitees” shall have the meaning set forth in Section 12.2.  1.67. “Licensee Invention(s)” shall have the meaning set forth in Section 8.1.  1.68. “MAA” shall mean an application requesting Regulatory Approval for themarketing and/or Commercialization of the Licensed Products for a particular indication ina jurisdiction filed with the relevant Regulatory Authorities in jurisdictions in theTerritory. It is understood that MAA does not include applications for pricing orreimbursement approval (“Pricing Approval”).  1.69. “Major Country” shall mean the United Kingdom, France, Germany, Italy, Spainand Japan.  1.70. “Manufacturing” or “Manufacture” shall mean activities directed toproducing, manufacturing, processing, filling, finishing, packaging, labeling, qualityassurance testing and release, shipping and storage of Product.  1.71. “Manufacturing and Supply Agreement” shall have the meaning set forth inSection 6.1.  1.72. “Marketing Authorization” shall mean, with respect to a particularjurisdiction in the Territory, any authorization which is legally required under applicablelaws, regulations, administrative decisions, or otherwise to put a pharmaceutical producton the market or for commercial sale in the jurisdiction for use in treatment of anyindication. It is understood that, as used herein, Marketing Authorization does notinclude pricing or reimbursement approval.  1.73. “MDS” shall have the meaning set forth in Section 2.1.  1.74. “MGI” shall have the meaning set forth in the Preamble.  1.75. “MGI Indemnitees” shall have the meaning set forth in Section 12.1.  1.76. “MGI Invention(s)” shall have the meaning set forth in Section 8.1.  1.77. “NDA” shall mean a New Drug Application and amendments and supplements theretofiled with the FDA.  1.78. “Net Sales” shall mean the gross amount invoiced on the sale of the LicensedProducts by Licensee and its Affiliates, and any permitted sublicensees, less reasonableand customary deductions for (a) credits for returns, including withdrawals and recalls;(b) sales rebates and chargebacks; (c) sales, value-added and other taxes; (d) customsduties on sales made by such seller to the customer; but in the case of (a) and (b) only tothe extent accrued under applicable United States generally-accepted accounting principlesas being deductions that have actually been given to and taken by the customer, and in thecase of (c) and (d) only to the extent separately itemized in the invoice to and paid bythe customer; and (e) government rebates. If the Licensed Products is sold forconsideration other than solely cash, the fair market value of such other considerationshall be included in the calculation of Net Sales, provided that transfers of LicensedProduct for use in research and/or * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   Development, including Additional Trials, shall notconstitute a Net Sale. For purposes of calculating Net Sales, transfers of the LicensedProducts to an Affiliate or licensee for end use by such Affiliate or licensee in acountry shall be treated as a sale at the greater of the actual Net Sales and the averageNet Sales price for fully arms-length sales of such Licensed Products in such countryduring the applicable calendar quarter, provided that transfers of Licensed Product for usein research and/or Development, including Additional Trials, shall not constitute a NetSale. Notwithstanding the foregoing, transfers of Licensed Product for use in researchand/or Development, including Additional Trials, where revenue is recognized, as defined bygenerally accepted accounting principles, by Licensee shall constitute a Net Sale in theamount of the revenue received.  1.79. “On-going Trials” shall mean the clinical trials on-going or complete as ofthe Effective Date of this Agreement, including but not limited to the trials listed in theGlobal Development Plan attached as Schedule 3.0.  1.80. “Orphan Product Designations” shall mean the designations of Decitabine as anorphan product by the applicable Regulatory Authority in the Territory. Schedule 1.66sets for the designation for the European Union.  1.81. “Party” and “Parties” shall have the meaning set forth in thePreamble.  1.82. “Patent Rights” shall mean any and all rights under any of the following: (a)a United States, international or foreign patent, utility model, design registration,certificate of invention, patent of addition or substitution, or other governmental grantfor the protection of inventions or industrial designs anywhere in the world, including anyreissue, renewal, re-examination or extension thereof; and (b) any application for any ofthe foregoing, including any international, provisional, divisional, continuation,continuation-in-part, or continued prosecution application, supplemental registrations andextensions thereof, including patent term extensions and restorations and supplementalprotection certificates.  1.83. “Pharmachemie Manufacturing Agreement” shall mean all agreements withPharmachemie B.V. and its affiliates relating to the Licensed Product including, but notlimited to, the Manufacturing Agreement between MGI Pharma Inc. and Pharmachemie B.V.,effective as of July 6, 2005, and the Quality agreement between MGI Pharma Inc. andPharmachemie B.V., effective September 8, 2005.  1.84. “Policy Relating to the Employment of Child Labor” shall have the meaning setforth in Section 1.92.  1.85. “Pricing Approval” shall have the meaning set forth in Section 1.68.  1.86. “Product(s)” shall mean (i) the product containing Decitabine which is thesubject of MGI’s NDA No. 21-790 as of the date of signing of this Agreement; and (ii) anyother pharmaceutical product containing as an active ingredient Decitabine. * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy* 1.87. “Product Improvement(s)” shall have the meaning set forth in Section 8.1.  1.88. “Product Trademark” shall mean the Dacogen Trademark and all other LicensedProducts specific trademark(s), service mark(s), accompanying logos, trade dress and/orindicia of origin under which the Licensed Products are marketed and distributed inaccordance with this Agreement. For purposes of clarity, the term Product Trademark(s)shall not include, without limitation, the corporate names and logos of either Party.  1.89. “Project Leader” shall have the meaning set forth in Section 4.5.  1.90. “Public Disclosure” shall have the meaning set forth in Section 15.16  1.91. “Purchase Order” shall have the meaning set forth in Section 6.1(f).  1.92. “Qualified Manufacturer” shall mean a manufacturer that the Parties agreecomplies with all applicable national, federal, state and local laws and regulatoryrequirements, including, but not limited to laws regarding environmental, safety andindustrial hygiene, complies with GMP, has the requisite continuity and security ofsupply necessary to meet forecast demands of the Parties, and complies with Licensee’sPolicy Relating to the Employment of Child Labor (“Policy Relating to theEmployment of Child Labor”) which is:     (i) No person under the age of 16 shall be employed, and no other young person(under age of 18) shall be employed unless such employment is in compliance with theInternational Labor Organizations Convention 138 Concerning Minimum Age;     (ii) No young person (under age 18) shall be required to work more than 48 regularhours and 12 hours overtime per week nor more than six (6) days per week; and     (iii) No young person (under age 18) shall be employed unless such employment is incompliance with all applicable laws and regulations concerning, age, hours,compensation, health and safety. 1.93. “Quality Agreement” shall have the meaning set forth in Section 6.3(a), asamended from time to time by the Parties.  1.94. “R&D Payments” shall have the meaning set forth in Section 5.3(a).  1.95. “R&D Services” shall have the meaning set forth in Section 5.3(a).  1.96. “Regulatory Approval” shall mean, with respect to the Product in a particularcountry, the receipt of Marketing Authorization and price and reimbursement approvals, ifrequired, necessary for sale of the Product in that country as granted by the relevantGovernmental Authority(ies) including without limitation the approval of an NDA or MAA. * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy* 1.97. “Regulatory Authority(ies)” shall mean, in respect of a jurisdiction, anyagency, department, bureau or other governmental entity with authority over thedevelopment, Manufacture, use or sale (including approval of NDAs and other MAAs) withrespect to the Licensed Products in the jurisdiction, including the FDA and EMEA.  1.98. “Regulatory Documentation” means, with respect to the Product, all filings andsupporting documents submitted to any and all Regulatory Authorities relating to suchProducts, and all data and information contained therein, including any INDs, MAAs(including NDAs), Drug Master Files, investigator’s brochures, correspondence to and fromRegulatory Authorities, minutes from teleconferences and meetings with RegulatoryAuthorities, registrations and licenses, regulatory drug lists, advertising and promotiondocuments shared with Regulatory Authorities, product labeling, adverse event files,complaint files and Manufacturing records and documentation, including but not limited tomaterials relating to recalls, field alerts and change controls.  1.99. “Related Product” shall have the meaning set forth in Section 2.4 of theSuperGen License Agreement. In addition, amides and metabolites of Decitabine or of aprodrug of Decitabine that are not Competing Products shall be a Related Product.  1.100. “Safety Data Exchange Agreement” shall have the meaning set forth in Section5.8(d).  1.101. “Sales Materials” shall have the meaning set forth in Section 5.10(e).  1.102. “Sublicense Agreements” shall have the meaning set forth in Section 2.2.  1.103. “SuperGen” shall have the meaning set forth in the third recital.  1.104. “SuperGen License Agreement” shall mean the Amended and Restated LicenseAgreement between SuperGen, Inc. and MGI Pharma, Inc. effective as of September 21, 2004and amended as of                     , 2006, and attached hereto as Schedule 1.80  1.105. “Supporting Data” shall mean all data and information relating to (a) thepharmacological or toxicological properties of the Products, (b) any pre-clinical orclinical testing and experience in relation to the Products and (c) the chemicalcomposition, synthesis, formulation, compounding, and Manufacturing and quality controltesting of the Products, to the extent reasonably required for purposes of any applicationfor Marketing Authorization for the Products. Supporting Data shall also include, but isnot limited to, copies of annual reports, integrated study reports, protocols for clinicalresearch and pre-clinical studies, protocol changes and amendments, Chemistry,Manufacturing and Control (“CMC”) sections and amendments, safety data, clinicaldatabases, case report forms and access to patient records, toxicity, safety and metabolismreports and data, and pharmacokinetic data and reports and relating to the Products, aswell as, in general, data or information * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   which would typically be part of any submission toFDA or other Regulatory Authority for the purpose of obtaining approval of the Products forany indication.  1.106. “Territory” shall mean all countries of the world with the exception of theUnited States, Canada and Mexico.  1.107. “Third Party” shall mean any party other than Licensee, MGI and their respectiveAffiliates.  1.108. “Trademark Coexistence Agreement” shall mean the agreement between SuperGen, Inc.and Dakocytomation Denmark A/S, effective as of February 21, 2005.  1.109. “Wind-down Period” shall have the meaning set forth in Section 14.3(a).  1.110. “Vidaza” shall mean azacitidine(4-amino-1-ß-D-ribofuranosyl-s-trazin-2(1H)-one.)**ARTICLE 2: LICENSE** 2.1. License. Subject to the terms and conditions of this Agreement, MGI herebygrants to Licensee and its Affiliates an exclusive, non-transferable (except as expresslyauthorized in this Agreement), royalty-bearing license, with the right to sublicense asqualified in Section 2.2 below, under the Licensed Patents, Licensed ProductsImprovements to the extent Controlled by MGI, and Licensed Know-How to use, develop,import, offer for sale, have sold and sell, the Licensed Products in the Territory, anda non-exclusive license thereunder to make and have made the Licensed Productsworldwide, for all diagnostic, preventive and therapeutic uses in the human diseasesMyelodysplastic Syndromes (“MDS”) Acute Myelogenous Leukemia (“AML”)and any other indications or uses (the “Field”). MGI also hereby grantsLicensee a license to use the Dacogen Trademark as provided for in Section 9 of thisAgreement. MGI reserves all rights not expressly granted herein, and no other rightsshall be considered granted by MGI by implication, estoppel, reliance, or otherwise.Notwithstanding anything to the contrary, no rights or licenses are granted by MGI inthis Agreement with respect to any active ingredient other than Decitabine or withrespect to any product other than the Licensed Products.  2.2. Sublicenses and Affiliates. Licensee shall not have the right to sublicenseits Commercial rights under Section 2.1 above to any Third Party in (a) Major Countrieswithout MGI’s prior written consent, which shall not be unreasonably withheld (suchagreements referred to as “Sublicense Agreements”) and (b) in any country in theTerritory without MGI”s prior written consent if such transaction is (i) less than anarms-length transaction, (ii) Licensee has an ownership interest in such Third Party, or(ii) if the Third Party has or is also granted the right to Manufacture Product. EachSublicense Agreement between Licensee and a sublicensee shall be at least as protective ofMGI and all intellectual property licensed hereunder, the Licensed Know-How and otherConfidential Information as the terms and conditions of this * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   Agreement, and subordinatethereto, and Licensee shall be responsible to MGI for the performance by each sublicenseeas necessary for compliance with the financial and other obligations under this Agreement.Within ten (10) calendar days of entering into a Sublicense Agreement under this Section2.2, Licensee shall provide MGI with a true, complete and correct copy of such SublicenseAgreement and any amendments thereto. Any attempt to engage a sublicensee other than inaccordance with the foregoing shall be null and void. In addition, while Licensee mayappoint distributors within the normal channel of distribution in non-Major Countries inthe European Union, Licensee may not sublicense any of its other rights under Section 2.1above to such distributors.  2.3. No Conflict. Subject to the rights expressly reserved by MGI under theprovisions of Section 2.1, each Party covenants and warrants that commencing on theEffective Date of this Agreement and continuing until ten (10) years after the date onwhich the Licensed Product receives Regulatory Approval in the EU, none of such Party orits Affiliates will, directly or indirectly, market, distribute, sell, offer to sell,import, or otherwise commercialize any Competing Products; nor shall such Party or itsAffiliates assist, fund, or license or authorize, any Third Party to do any of theforegoing. This provision shall not operate to prevent Licensee or its Affiliates fromtaking reasonable actions to dispose of a Competing Product.  2.4. Right of First Offer to a Related Product. Should SuperGen provide the rightof first offer to a Related Product to MGI under Section 2.4 of the SuperGen LicenseAgreement, and should MGI exercise such right to such Related Product, then MGI shallprovide a similar right of first offer to Licensee to Commercialize such Related Product inthe Territory under the same procedures described in Section 2.4 of the SuperGen LicenseAgreement.**ARTICLE 3: PAYMENTS AND MILESTONES** 3.1. Up-Front Payment. In consideration of the licenses granted to Licensee in thisAgreement and upon the terms and conditions contained herein, a nonrefundable upfrontpayment of $ * shall be made by Licensee to MGI within two (2) days following the EffectiveDate of this Agreement.  3.2. Milestones. In consideration of the Licenses grated by MGI to Licensee andupon the terms and conditions contained herein, the following nonrefundable ClinicalDevelopment Milestones will be made thirty (30) days following notice to MGI of the firstoccurrence of the following events:     (a) Upon receipt of EU Regulatory Approval $* (b) Upon acceptance of an application forJapan Regulatory Approval $* (c) Upon receipt of Japan Regulatory Approval $* (d) Upon annual sales in Japan greater than $* $* (e) Upon annual sales in G5 Countries greater than $* $*  * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   The milestone payments set forth above in this Section 3.2(a)-(e) shall each be payableonly once and on the first occurrence of the event after the Effective Date of thisAgreement.  3.3. Royalty Payments. The royalty payments set forth in Sections 3.3.(a)-(d) belowshall apply on a country-by-country basis, for * years following the Effective Date of thisAgreement, as follows: (a) Licensee. Commencing with the First Commercial Sale of theLicensed Product, Licensee shall pay, or cause to pay, to MGI, a royalty equal to* of the Net Sales for the Licensed Products sold by Licensee and its Affiliatesin the Territory.  (b) Distributors of Licensee. In all countries in the Territoryoutside of the Major Countries, where Licensed Products are commercialized onLicensee’s behalf through distributors, Licensee shall pay, or cause to pay, MGI aroyalty equal to * of Net Sales made by Licensee or its Affiliates to suchdistributors.  (c) Compassionate and Named Patient Sales. Licensee shall at theend of each Calendar Year pay, or cause to pay, to MGI a royalty equal to * of NetSales of Licensed Products sold in the Territory on a named patient, compassionateuse or similar basis, provided that no royalty shall be owed on such sales untilsuch Net Sales exceed $ * per year in the aggregate.  (d) Product Sales. If Licensee or its Affiliates make a sale ofProducts that for whatever reason would not be deemed to be Licensed Productsunder this Agreement, then Licensee shall pay, or cause to pay, to MGI theroyalties set forth in Sections 3.3(a)-(c) above as if such sales were sales ofLicensed Products. 3.4. Discounting. Licensee and its Affiliates shall set prices for the LicensedProducts in the Territory in the best interest of the commercial success of the LicensedProducts in the Territory. Without limiting the foregoing, if Licensee or its Affiliatesells the Licensed Products to a customer who also purchases other products or servicesfrom Licensee or its Affiliates, Licensee agrees not to, and to require that its Affiliatesnot, discount or price the Licensed Products in a manner that would disadvantage theLicensed Products in order to benefit sales or prices of the other products or servicesoffered for sale by Licensee or its Affiliates to such customer. Without limiting theforegoing obligations, it is understood and agreed that nothing in this Agreement isintended to dictate to Licensee and its Affiliates the resale prices for the Licensed * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   Products in the Territory. If the Licensed Products are sold in combination with otherproducts, or as a kit, then each component of the combination or kit will be consideredseparately for the purposes of this Section 3.4.  3.5. Bundling. Licensed Products shall be sold in compliance with all applicablelaws.  3.6. Other. All payments under this Article 3 shall be non-refundable (exceptsolely in the case of overpayment) and non-creditable (unless otherwise specifically setforth in this Agreement) against other amounts due or payable to MGI under this Article 3or otherwise under this Agreement. Payments under this Article 3 shall be made inaccordance with Article 7 below.**ARTICLE 4: JSC, JOCs, COMMERCIALIZATION AND DEVELOPMENT PLANS** 4.1. Development and Commercialization Plans. (a) Global Development Plans; Amendments. (i.) Initial Plan. An initial plan (the first “GlobalDevelopment Plan”) regarding the global development of the Product andcontaining all of the On-going Clinical Trials shall be attached to thisAgreement as Schedule 3.0.  (ii.) Commercialization Plan. No later than *, Licenseeshall provide to MGI an opportunity to review and comment upon a plan andbudget for the Commercialization of the Licensed Products in the Territory for* (such plans and budgets, together with any updates thereto in accordance withthis Agreement, hereinafter referred to as the “CommercializationPlan”). To the extent permitted under applicable law, theCommercialization Plan shall include, with respect to the Commercialization ofeach Licensed Product in each Major Country: *. The Commercialization Planshall be updated not less than *, as well as more frequently as reasonablyrequested by MGI to take into account completion, commencement or cessation ofCommercialization activities not contemplated by the then currentCommercialization Plan; provided that Licensee shall not be required to updatein the Commercialization Plan the budget for Commercialization of a LicensedProduct in any Major Country after *. * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   Licensee agrees to provide to MGI for its review and comment no later than *in advance of each JSC meeting all interim updates to the CommercializationPlan. Licensee shall reasonably consider MGI’s input and comments.  (iii.) Updates. After the Effective Date, the Parties through the JOC-Dshall update from time to time the Global Development Plan for the furtherdevelopment of the Products and to take into account completion, commencementor cessation of development activities not contemplated by the then currentPlan.  (iv.) Input and Comment. Each Party shall reasonablyconsider the other Party’s input and comments to the Global Development Plan. 4.2. Plan Contents. (a) The Global Development and Commercialization Plans shall beconsistent with the principle of maximizing the value of the Product on aworldwide basis. To achieve this, the Parties shall cooperate in the review anddevelopment of the Plans and budgets.  (b) The Global Development and Commercialization Plans and budgetstherein shall contain sufficient detail as provided in Section 4.1 (a), and asallowed by applicable laws, with respect to the commercialization and developmenttactics and other matters to enable the JSC to conduct a meaningful review of suchplans.  (c) Either Party may also develop and submit to the JOCs from time totime proposed amendments to the Plans. The JOCs shall review and comment on suchproposed amendments and submit such substantive amendments to the JSC for review.Subject to each Party performing its respective responsibilities substantially inaccordance with the Global Development Plan and the Commercialization Plan, (i)Licensee shall be solely responsible for all decisions regarding the Developmentand Commercialization of Licensed Products in the Territory, including pricescharged for the Licensed Product in the Territory, as well as discounts, rebatesand all other deductions from Net Sales in the Territory, and (ii) MGI shall besolely responsible for all decisions regarding development and commercializationof the Product outside the Territory, including the prices charged for the Productin the United States and Mexico, as well as discounts, rebates and all otherdeductions from net sales in the United States and Mexico. *. 4.3. Cooperation and Efforts. Each of Licensee and MGI shall use Diligent Effortsto execute and to perform, or cause to be performed, the activities assigned to it relating * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   to the development and commercialization of the Product worldwide and to cooperate withthe other in carrying out the development and commercialization of the Product inaccordance with the Global Development Plan, the Commercialization Plan and thisAgreement, in each case in good scientific manner and in compliance with (a) allapplicable national, federal, state and local laws and regulatory requirements,including, but not limited to laws regarding environmental, safety and industrialhygiene, (b) GMP, GCP, and GLP, and (c) Licensee’s Policy Relating to the Employment ofChild Labor. MGI shall assist Licensee with obtaining Manufacturing informationrequired for Licensee to obtain Regulatory Approvals in the Territory and fulfillRegulatory reporting obligations from the Third-Party manufacturers. 4.4. Joint Steering Committee. (a) Formation. Promptly after the Effective Date, the Partiesshall establish a committee (the “Joint Steering Committee” or“JSC”), which shall have overall responsibility for the collaborationestablished by this Agreement for the development and commercialization activitiesrelating to the Product(s) worldwide. The JSC will consist of three (3)representatives from each Party. Subject to the foregoing, each Party shall havethe right to change its members of the JSC by providing written notice to theother.  (b) Purposes. The purposes of the JSC shall be (i) to review andcomment on the overall development, manufacture and commercialization strategy forthe Product worldwide and (ii) to oversee the JOCs and resolve matters broughtforth by the JOCs and (iii) resolve disputes in accordance with Sections 15.7 and15.8. The Parties intend that their respective organizations will use DiligentEfforts to assure success of the collaboration.  (c) Responsibilities. In addition to its overall responsibilityfor the collaboration established by this Agreement, the JSC shall in particular:(i) review and monitor the progress of the Parties’ activities under the GlobalDevelopment Plan; (ii) review and comment on commercialization and developmentstrategies, the trial protocols related to the Products as submitted by the JOCs;and (iii) review and discuss the Regulatory Documentation, product labeling, andfilings.  (d) Meetings. The JSC shall meet * each year, unless otherwiseagreed by the Parties. JSC meetings may be held in person, through telephone orvideo conference or other mutually agreeable means, provided that at least onemeeting each year shall be held in person. With the consent of the JSC members,other representatives of MGI or Licensee may attend JSC meetings as observers.Each Party shall bear its own personnel and travel costs and expenses relating toJSC meetings. * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy* (e) Authority. The JSC shall not have the power to amend ormodify this Agreement, and its decisions shall not be in contravention of anyterms and conditions of this Agreement. 4.5. Project Leaders. Licensee and MGI each shall appoint a person (a “ProjectLeader”) to coordinate and facilitate the exchange of information, including LicensedKnow-How and Regulatory Documentation, and communications between the Parties regarding thedevelopment and commercialization of the Products worldwide. Each Party shall notify theother within * of the Effective Date of this Agreement of the name and contact informationfor its Project Leader and shall so notify the other Party (in advance of changing itsProject Leader).  4.6. Joint Operating Committees. Promptly after its nomination, the JSC shallestablish two joint operating committees “(Joint Operating Committee(s)”) or a JOCfocusing on Development (“JOC-D”) and a JOC focusing on Commercialization(“JOC-C”) (the JOC-D and the JOC-C collectively referred to as the “JOCs”),led jointly by two persons, one appointed by each Party. (a) JOC-D Responsibilities. The JOC-D shall be responsible forreviewing, discussing, overseeing and commenting on the development activities ofthe collaboration, including annual updates of the Global Development Plan.  (b) JOC-C Responsibilities. The JOC-C shall be responsible forreviewing, discussing, overseeing and commenting on the commercialization andmanufacturing activities of the collaboration, including annual updates of Plans.  (c) Data. The JOCs shall have access, and rights, except asprovided for in Sections 5.4 and 5.5 herein, to all clinical trial data related tothe Product worldwide. The JOCs may agree to share other data with regard to theParties’ efforts to develop and commercialize the Products in their respectiveterritories.  (d) Audit Rights. Each Party will have the right to auditappropriate records of the other Party to verify expenditures related to the otherParty’s development activities. The conduct of such audits shall be in accordancewith Section 7.6.  (e) Review and Comment. The JOCs shall assist the JSC, asdirected, in the JSC’s review of the Parties’ activities. For the avoidance ofdoubt, the JOCs will have no approval rights over the Global Development Plan orthe Commercialization Plan.**ARTICLE 5: OBLIGATIONS OF THE PARTIES** 5.1. General. Each Party shall use Diligent Efforts to perform the development andcommercialization obligations set forth in this Agreement. All such obligations shall * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   beperformed in accordance with the applicable laws, rules and regulations of each country intheir respective territories.  5.2. Development. (a) Clinical Development. Licensee will be solely responsiblefor Development of the MDS indication and the AML indication for the LicensedProducts inthe Territory *. Subject to payment by Licensee of the R&D Support describedbelow, MGI will bear the costs of the Development of the Licensed Product forthe MDS and AML indications * in the Territory, except that (a) the costs of theDevelopment of the Licensed Product for the MDS and AML indications in Japanshall be solely borne by Licensee; (b) MGI’s costs of Development of theLicensed Product for the MDS and AML indications * in the Territory shall notexceed * including On-going Clinical Trials and modifications or additionsthereto; and (c) filing fees associated with applications for RegulatoryApproval in the Territory shall be the responsibility of Licensee. FollowingMarketing Authorization in the EU, MGI shall apply Licensee’s R&D Supportpayments to the further Development of Licensed Product as determined by theJOC-C and JOC-D *.  (b) Clinical Program Locations. If possible, and unlessotherwise determined by the JOC, the Parties shall endeavor to conduct theclinical program * at an equivalent number of centers with an equivalent number ofpatients within the EU and the U.S., unless the cost, speed or outcome of theclinical program will be adversely affected.  (c) Compliance with GLP/GCP/GMP. All of the activities of bothParties * shall be done in accordance with (i) all applicable national, federal,state and local laws and regulatory requirements, including, but not limited tolaws regarding environmental, safety and industrial hygiene, (ii) GMP, GCP, andGLP, and (iii) Licensee’s Policy Relating to the Employment of Child Labor, asapplicable. Licensee is prepared, at Licensee’s sole discretion and expense, toassist MGI, upon MGI’s written request, with regard to GLP, GCP and GMP matters.With respect to any facility or site at which a Party conducts developmentpursuant to this Agreement, including, where commercially reasonable and withinthe control of the other Party, third party facilities or sites, each Party shallhave the right, at its expense, upon reasonable written notice to the other Partyand such third party, and during normal business hours, to inspect such site andfacility and any records relating thereto once per year, or more often with cause,to verify the other Party’s compliance with the terms of this Agreement relatingto (i) all applicable national, federal, state * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   and local laws and regulatory requirements, including, but not limited to lawsregarding environmental, safety and industrial hygiene, (ii) GMP, GCP, and GLP,and (iii) Licensee’s Policy Relating to the Employment of Child Labor. Suchinspection shall be subject to the confidentiality provisions of this Agreement.Each Party agrees, to the maximum extent possible, to include in any contractor other written arrangement with a third party relating to such facilities andsites, a clause permitting the other Party to exercise its rights under thisSection 5.2. With respect to the On-going Trials and future clinical trials,MGI shall make available for Licensee’s review all audit and inspection reports.The current “R&D/GCP Audit Plan” attached hereto as Schedule 1.90 shallcontinue to be executed by MGI and any amendments or deviations thereto shall bediscussed with Licensee prior to implementation. 5.3. Research and Development Support. (a) Notification of R&D Services.   Licensee shall notify MGI in writing of Licensee’s intent to provide certain researchand development support to MGI in the form of R&D Services (“R&D Services”shall mean work performed by Licensee’s or its Affiliates’ employees or contractorsdirected towards implementing the Global Development Plan). (i.)  For 2006, Licensee shall notify MGI in writing of Licensee’sintent to provide R&D Services no later than July 15, 2006;  (ii.)  For 2007, Licensee shall notify MGI in writing of Licensee’sintent to provide R&D Services no later than December 15th, 2006;and  (iii.)  For 2008, Licensee shall notify MGI in writing of Licensee’s intent toprovide R&D Services no later than December 15th, 2007.   If MGI receives such notification from Licensee, then Licensee and MGI will agree toa work plan for the applicable time period, and apply the Licensee FTE rate of * tothe activities to determine the value of the R&D Services to be provided by Licenseeduring such period. In the event that Licensee does not so notify MGI by any dateset out in subparagraphs (a)(i), (a)(ii) or (a)(iii) above, then Licensee shallinstead pay MGI a research and development payment (“ R&D Payment”) asfollows: (iv.)  the sum of * for work to be performed in 2006;  (v.)  the sum of * for work to be performed in 2007; and  (vi.)  the sum of * for work to be performed in 2008.   If Licensee and MGI agree that Licensee will provide R&D Services during anyapplicable year, but the value of R&D Services to be performed during such year areless than the corresponding R&D Payments provided for in Sections 5.3 (b)(i), * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*(b)(ii) and (b)(iii) for such year, then Licensee shall pay MGI the differencebetween those corresponding amounts. (b) R&D Payments. Licensee shall in addition make R&D Paymentsto MGI as follows: (i.)  two (2) days after the Effective Date of this Agreement,Licensee shall pay MGI *;  (ii.)  upon the successful completion of the DACO 020 study andassociated data analysis, and forty-five (45) days following receipt of thefinal study report for the DACO 020 study, Licensee shall pay MGI * less anyR&D Services performed by Licensee during the year in accordance with thatyear’s approved R&D Services work plan, such R&D Services not to exceed *;  (iii.)  upon the successful completion of the DACO 017 study and associated dataanalysis, and forty-five (45) days following receipt of the final study reportfor the DACO 017 study, Licensee shall pay MGI * less any R&D Services incurredby Licensee during the year in accordance with that years approved R&D Serviceswork plan, such R&D Services not exceed to *. (c) All R&D Payments by Licensee to MGI shall be non-refundable whenmade. 5.4. New Indications. (a) Either Party may at any time submit to the JSC a proposal to developnew indication(s) (other than a AML or MDS), dosage amount(s) regimens or dosageforms(s), or other trials intended for regulatory purposes, for the Product. Suchproposal shall contain, at a minimum, *. The JSC shall approve such proposal if*. In the event the JSC cannot reach agreement to approve a proposal for a newindication, dosage amount or regimen or dosage form, then: * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy* (b) Licensee may pursue development for the Territory of such new indication, dosageamount or regimen or dosage form at its sole expense, provided, however, that(1) MGI does not object to development of such new indication, dosage amount orregimen or dosage form because it has a reasonable belief, and provides Licenseewith its reasoning in writing, that such new indication, dosage amount orregimen or dosage form would create toxicity or drug safety concerns, or (2)because MGI has a reasonable belief, and provides Licensee with its reasoning inwriting, that such new indication, dosage amount or regimen or dosage form willbe likely to have a negative impact on MGI’s business interest under thisAgreement. MGI may elect subsequently to participate in the commercializationof such new indication, dosage amount or dosage form outside the Territorypursuant to the terms of this Agreement, provided that MGI first remits toLicensee an amount equal to * of the development costs incurred by Licensee withrespect to such new indication, dosage amount or regimen or dosage form, *. IfMGI does not elect subsequently to participate in the commercialization of suchnew indication, dosage amount or regimen or dosage form outside the Territory,Licensee may not commercialize such new indication, dosage amount or regimen ordosage form outside the Territory.  (c) MGI may pursue development outside the Territory of such newindication, dosage amount or regimen or dosage form at its sole expense, provided,however, that (1) Licensee does not object to development of such new indication,dosage amount or regimen or dosage form because it has a reasonable belief, andprovides Licensee with its reasoning in writing, that such new indication, dosageamount or regimen or dosage form would create toxicity or drug safety concerns, or(2) because Licensee has a reasonable belief, and provides Licensee with itsreasoning in writing, that such new indication, dosage amount or regimen or dosageform will be likely to have a negative impact on Licensee’s business interestunder this Agreement. Licensee may elect subsequently to participate in thecommercialization of such new indication, dosage amount or dosage form in theTerritory pursuant to the terms of this Agreement, provided that Licensee firstremits to MGI an amount equal to * of the development costs incurred by MGI withrespect to such new indication, dosage amount or regimen or dosage form, *. IfLicensee does not elect subsequently to participate in the commercialization ofsuch new indication, dosage amount or * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   regimen or dosage form in the Territory, MGI may not commercialize such newindication, dosage amount or regimen or dosage form in the Territory. 5.5. Additional Trials. (a) All clinical trials that are not intended to support, directly orindirectly, a regulatory application but which are instead designed to support themarketing of the Product, shall be referred to as “Additional Trials”hereunder and shall not be supported by R&D Support Payments from Licensee. AParty commencing an Additional Trial shall provide the other Party with theopportunity to review and comment on the trial design.  (b) Where both Parties wish to use the results of a given AdditionalTrial to support marketing or a regulatory application of the Product in theirrespective territories, the costs of such Additional Trial shall be shared by theParties.  (c) Where one Party does not wish to use the results of any AdditionalTrial in their respective territory, the other Party conducting the AdditionalTrial will be responsible for and bear the costs of such trial. If a Party doesnot contribute to the cost of conducting any Additional Trial hereunder, thatParty agrees not to use the results of such trial for any purpose, unless theParties otherwise agree in writing. Nothing in this Section 5.5(c) shall obligateeither Party to pay the cost of conducting any Additional Trial if such Party isobligated to use the results of such trial to fulfill its regulatory obligationshereunder. 5.6. Delivery of Information. (a) Promptly after the Effective Date, MGI shall provide to Licenseecopies of, or access to (if it is not reasonably feasible to reproduce thereferenced subject matter), the NDA and MAA, and the source documents referencedtherein (the “Development Information”) following MGI’s receipt thereof,and MGI shall otherwise effect a complete transfer of all Licensed Know-How thatis necessary or useful for Licensee in the performance of its obligations orexercise of its rights under this Agreement. This transfer shall occur in anorderly fashion and in a manner such that the value of the transferred informationis preserved in all material respects. MGI shall not be considered in breach ofthis obligation as a result of an inadvertent failure to provide any such subjectmatter, and Licensee shall endeavor to provide MGI with ongoing guidance on thetype of information that will be most useful for Licensee in the performance ofits obligations or exercise of its rights under this Agreement.  (b) All Licensed Know-How and other Confidential Information obtainedfrom MGI will be used and disclosed by and under authority of Licensee only as maybe necessary in performing its obligations and exercising its rights under * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   thisAgreement and as may otherwise be agreed by MGI and Licensee in writing.  (c) All such disclosure of the Licensed Know-How and other ConfidentialInformation obtained from MGI to a non-governmental Third Party, and use thereof,shall be made under reasonable and customary confidentiality restrictions that areas protective of the MGI and such materials as the terms of this Agreement.  (d) Within thirty (30) days of the Effective Date, MGI will provideLicensee with the right to cross reference SuperGen’s IND for the LicensedProducts for Licensee’s use in the Development and Commercialization of theLicensed Products in the Territory under this Agreement. Neither Party may useany Licensed Know-How or Confidential Information of the other Party for anypurpose outside the Territory, nor shall either Party use Confidential Informationof the other Party for any products other than the Licensed Products (and shallnot permit or authorize any Third Party to do so) without the prior expresswritten approval of the other Party. 5.7. Regulatory Responsibilities. (a) Transfer. Promptly after the Effective Date of thisAgreement, (1) MGI shall transfer the previously submitted and withdrawnapplication for Marketing Authorization for the Licensed Products to Licensee, and(2) shall provide copies of or otherwise make available to Licensee all RegulatoryDocumentation worldwide existing in draft or final form, including all assessmentreports and communications with Regulatory Authorities pre-submission, duringreview process and post withdrawal, all communication and documents relating toscientific advice and communications with the regulatory consultants.  (b) Responsibility. Licensee shall be solely responsible forpreparing and filing the Marketing Authorization for the Licensed Products in theTerritory and for seeking additional Marketing Authorization for the LicensedProducts from the appropriate Regulatory Authorities (including all relatedRegulatory Documentation), and for all filings, meetings and communications withRegulatory Authorities in connection therewith, including labeling discussions anddecisions.  (c) Meetings with Regulatory Authorities. Licensee shall beresponsible for all interactions with Regulatory Authorities in the Territory.The Parties will be reasonably allowed to participate in meetings with RegulatoryAuthorities in the other Party’s respective territory, as observers, subject toavailable space and attendance requirements that may be imposed at such meetings,or which may materially interfere with the priorities or objectives of thenon-observer Party at a particular meeting. * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy* (d) Regulatory Documentation. Prior to filing with a RegulatoryAuthority, the filing Party shall forward or otherwise make available to the otherParty, any Regulatory Documentation to be filed by the Party or its Affiliates andshall afford the reviewing Party an opportunity to comment on such RegulatoryDocumentation prior to filing, and shall reasonably consider such comments.Licensee shall, and shall cause its Affiliates to maintain the status of suchMarketing Authorization(s).  (e) Right to Cross-Reference. Each Party shall have the right tocross-reference and make any other use of the other Party’s RegulatoryDocumentation for the Product that it would have if it were the owner, includingwithout limitation access to all data contained or referenced in such RegulatoryDocumentation, in each case as may be reasonably necessary to enable such Party todevelop, Manufacture or commercialize the Product; except that such right ofcross-reference and use shall not apply to trials pursued independently by oneParty pursuant to Sections 5.4 or 5.5.  (f) Company Core Data Sheet. Licensee shall own the Company CoreData Sheet (CCDS) once the global adverse event database for the Product has beentransferred to Licensee pursuant to Section 5.8.  (g) Regulatory Inspections. The Parties shall cooperate in goodfaith with respect to conduct of any inspections by any Regulatory Authority of aParty’s or contractor’s site and facilities. Subject to MGI’s ability to furtherand accordingly amend the Pharmachemie Agreement and the Ferro PfanstiehlAgreements, each Party shall be given the opportunity to attend any inspections byany Regulatory Authority of a Party’s or contractor’s site and facilities, and thesummary, or wrap up, meeting with a Regulatory Authority at the conclusion of suchsite inspection. If such attendance would result in the disclosure to the otherParty of confidential information or trade secrets unrelated to the subject matterof this Agreement, the Parties shall enter into a confidentiality agreementcovering the unrelated subject matter. MGI warrants to Licensee that MGI shalluse commercially reasonable efforts to amend the Pharmachemie Agreement and theFerro Pfanstiehl Agreements in order to provide the rights provided in thisSection 5.7(g).  (h) Communications from Regulatory Authorities. To the extenteither Party receives written or material oral communication from the FDA or anyother Regulatory Authority relating to any activities subject to this Agreement,the Party receiving such communication shall notify the other Party and provide acopy of any written communication, or a summary of oral communications, as soon asreasonably practicable and in no case later than three (3) business daysthereafter. 5.8. Safety Reporting. * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy* (a) Prior to First Commercial Sale. Prior to the FirstCommercial Sale of the Licensed Products in the Territory, MGI shall maintain aglobal adverse event database for the Product worldwide and shall be responsiblefor compliance with all applicable laws relating to adverse event reporting andthe conduct of clinical trials and reporting obligations relating thereto requiredby the applicable laws worldwide (including annual safety reports, periodic safetyupdate reports and quarterly line listings).  (b) Database Transfer. Prior to the First Commercial Sale of theLicensed Product in the Territory, MGI shall complete the transfer to Licensee,and Licensee shall thereafter maintain a global adverse event database for theLicensed Products and shall generate adverse event reports for the Parties use intheir respective territories..  (c) Access. Both Parties shall have access to all data in theglobal adverse event database. Each Party shall be responsible for submittingadverse events reports to the applicable Regulatory Authorities in the Partiesrespective territories, except that MGI shall be responsible for submittingadverse event reports to the applicable Regulatory Authorities in the EU until thetransfer of the regulatory responsibility provided for herein pursuant to Section5.7(a).  (d) Safety Data Exchange Agreement. Within six (6) months of theEffective Date, but in any event prior to commencement or commercialization of theLicensed Products in the Territory, the Parties will in good faith negotiate andfinalize a separate Safety Data Exchange Agreement (the “Safety Data ExchangeAgreement”), the terms of which shall set forth the obligations, proceduresand timelines for exchange of information pertaining to the safety reportingobligations, including adverse and Serious Adverse Events observed in ongoingclinical trials, and across the global marketplace. The Safety Data ExchangeAgreement shall address the timing of and communication responsibilities as thebetween the Parties to the appropriate Regulatory Authorities.  (e) Safety Oversight Working Group. Thirty (30) days after theEffective Date of this Agreement, the Parties shall meet to establish a safetyoversight working group (the “Safety Oversight Working Group”) composed ofmembers of both Parties which shall discuss and implement processes and proceduresfor sharing information needed to support each Party’s respective regulatoryresponsibilities and as may be necessary for the compliance with the applicableregulatory pharmacovigilance requirements. Any such procedures shall not beconstrued to restrict either Party’s ability to take action that it deems to beappropriate or required of it under the applicable regulatory requirements, butwhen permitted by applicable laws and regulations, the Parties shall consult witheach other before taking such action. * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy* 5.9. Licensed Products Supplied to Named Patients. To the extent permitted by locallaws and regulations, and to the extent deemed feasible by Licensee, Licensee shall makethe Licensed Products available prior to Regulatory Approval pursuant to a CompassionateUse Program and/or on a Named Patient Basis within the Territory following the FDA approvalof the Product for the MDS indication in the U.S. Prior to instituting each such program,Licensee shall establish criteria for inclusion of patients in such program(s), and theParties must have executed the separate Safety Data Exchange Agreement.  5.10. Commercialization. (a) Responsibilities. Licensee will have sole responsibility,and shall pay for, sales and marketing activities related to the promotion anddistribution of the Licensed Products, including all pre-launch market developmentand market research activities, *. Licensee shall record all sales of LicensedProducts, assume all credit and receivable collection risk, and warehouse anddistribute Licensed Product in the Territory. In addition, Licensee shall beresponsible for handling all aspects of Licensed Product order processing,invoicing and collection, distribution, inventory, product returns, andreceivables. Licensee shall assume all general and physical Licensed Productinventory risks in the Territory. MGI will have sole responsibility, and shallpay for, the promotion and distribution of the Product outside of the Territory,record all sales of Products outside of the Territory, and assume the risks andliabilities for all Product transactions outside of the Territory.  (b) JSC Meetings. *.  (c) Diligent Efforts. Licensee will use Diligent Efforts toobtain reimbursement and pricing approval for the Licensed Products in eachcountry of the Territory following Marketing Authorization in that country of theLicensed Product, *. Unless otherwise agreed, Licensee will launch the LicensedProducts in every Major Country in the Territory wherein it has received MarketingAuthorization and pricing approval or reimbursement as the case may be.Notwithstanding the foregoing, should Licensee reasonably consider that it cannotprofitably sell the Licensed Products in any country in the Territory, Licenseeshall provide MGI with written notice to that effect and Licensee’s reasoning fornot entering said country, and both Parties will endeavor to fashion a mutuallyagreeable solution on how to best maximize the commercial potential for theLicensed Products in such country. Licensee shall have the right to appointdistributors in non-Major Countries within the Territory, and shall notify MGI ofsuch appointments. Licensee shall be responsible for the performance of each suchappointed distributor. * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy* (d) Sales Force. Licensee shall establish and maintain a high qualitytraining program, and each sales representative shall be trained and informedconsistent with Licensee’s requirements. The sales representatives shall becompensated so as to provide sales incentives (or other variable pay components)that are consistent with those provided by Licensee in connection with its otherportfolio products of similar sales potential. If MGI notifies Licensee that itbelieves certain of Licensee’s sales representatives may (i) have violated anylaws or regulations or (ii) be damaging relationships with health careprofessionals or damaging the Licensed Products brand, or (iii) failed to complywith this Agreement, Licensee shall promptly use Diligent Efforts to evaluateand resolve such issue.  (e) Sales Materials. Any marketing and promotional materials(“Sales Materials”) created or used by Licensee and its Affiliates for theLicensed Products shall be in compliance with the Regulatory Approval for theProducts in the respective country. 5.11. Voluntary and Mandatory Recalls; Potential Hazards. If either Party believesthat a voluntary recall or market withdrawal of the Licensed Products may be necessary intheir respective territory, such Party shall notify the other Party within twenty-four (24)hours after it forms such belief. Before taking any action with respect to a recall ormarket withdrawal, to the extent possible, each Party shall provide the other with areasonable opportunity to review, comment on and consult with respect to such recall ormarket withdrawal, and shall consider in good faith any comments or suggestions.Notwithstanding the foregoing, depending on the severity of the situation, either Party mayuse its discretion to initiate a recall at any time after notifying the other Party, if inits opinion, the recall is needed to protect the Party’s consumer’s safety or the Party’sreputation. As between the Parties, Licensee shall be solely responsible for all recallsand market withdrawals in the Territory. As between the Parties, all recalls and marketwithdrawals in the Territory shall be at the sole cost and expense of Licensee, except thatMGI shall be responsible for costs and expenses of recalls and market withdrawals to theextent they are caused by any breach by MGI of its obligations hereunder to supply LicensedProducts to Licensee. Each Party shall inform the other Party as soon as possible but nolater than within twenty-four (24) hours of its receipt of any information that (i)indicates or suggests a potential material liability for either Party to a Third Party inthe Party’s respective Territory arising in connection with the Licensed Products; (ii)concerns suspected or actual tampering or contamination or other material problems in theParty’s respective Territory with respect to the Licensed Products; (iii) is reasonablylikely to lead to a recall or market withdrawal in the Party’s respective Territory of theLicensed Products; or (iv) concerns any ongoing or potential Regulatory Authorityinvestigation, inspection, detention, seizure or injunction in the Party’s respectiveTerritory involving the Licensed Products, including the receipt of any warning * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   letter,material untitled letter or any equivalent communication from a Regulatory Authority in theParty’s respective Territory relating to the Licensed Products.  5.12. Records and Reports. (a) Licensee shall maintain records of the Development andCommercialization of the Licensed Products (or cause such records to bemaintained), as applicable, in sufficient detail and in a good scientific manneras will properly reflect all material work done and results achieved in theperformance of the Global Development and Commercialization Plans.  (b) At each of the JOC meetings, the Parties shall alternate preparingand disseminating meeting minutes to all members of the applicable JOC, saidminutes shall include in reasonable detail, for the JOC-D, the progress ofDevelopment (including regulatory activities), and for the JOC-C, theCommercialization activities planned and taken, by and under authority ofLicensee, and the results thereof. 5.13. Third Parties. Licensee shall cause its Affiliates and other Third Partieshaving responsibilities in connection with the Development and/or Commercialization of theLicensed Products to perform their responsibilities in accordance with all applicable termsand conditions of this Agreement.**ARTICLE 6: SUPPLY OF PRODUCT** 6.1. Manufacturing and Supply Agreement. As between MGI and Licensee, MGI shallretain the obligation to manufacture and supply the Licensed Products to Licensee fordistribution in the Territory for so long as is required under the SuperGen Agreement, orlonger, as requested by Licensee. The Parties intend to negotiate the terms of a separatemanufacturing and supply agreement (the “Manufacturing and Supply Agreement”) ingood faith, within three (3) months of the Effective Date. The key terms of this agreementwill be strongly influenced by the terms of the Pharmachemie Manufacturing Agreement andFerro Pfanstiehl Agreement, and shall include the following: (a) Forecasts. (i.) Initial Forecast. Attached hereto as Schedule 6.1(c)is Licensee’s Initial Forecast for its requirements of Licensed Product andrequested Delivery dates for the period beginning on July 1, 2006.  (ii.) Quarterly Forecast. Prior to the end of each CalendarQuarter, Licensee shall provide MGI with a statement of its estimated purchaserequirements (“Estimated Requirements”) and expected Delivery dates forLicensed Product for the four (4) Calendar Quarters next succeeding suchCalendar Quarter (the “Forecast”). The first six (6) months of theForecast shall constitute commitments to purchase Licensed Product. * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy* (b) Purchase Orders. At least ninety (90) calendar days prior toeach Delivery, Licensee shall place a Purchase Order for its requirements andrequested Delivery dates of Licensed Product for such Calendar Quarter. PurchaseOrders shall be placed in amounts equal to the Filling Production Lot sizes,multiplied by whole number increments of the applicable minimum orderquantities as set forth on Schedule 6.1(b). Notwithstanding the foregoing, MGIshall use reasonable efforts to comply with any subsequent changes in suchPurchase Orders, but shall not be held liable for its inability to do so.  (c) Satisfaction of Firm Orders. MGI shall confirm the receiptof each Purchase Order within ten (10) days of its receipt thereof and provide aDelivery date within thirty (30) days of the indicated date within the PurchaseOrder upon confirmation. When such Purchase Order receipt is confirmed and aDelivery date provided, the Purchase Order shall become a Firm Order (“FirmOrder”). Deliveries of Licensed Product shall be made on the date specifiedin the Firm Order, but in no event more than fifteen (15) business days in advanceof the date specified in the Firm Order without Licensee’s prior written approval.MGI shall notify Licensee at least seventy-two (72) hours prior to actualDelivery of Licensed Product if MGI is not Delivering Licensed Product to Licenseeon the requested Delivery date. If the actual delivery date for Bright Stock ismore than four (4) calendar weeks after the date specified by MGI, the price forall affected Licensed Product shall be reduced by one (1) percent for, and suchreduction shall be reflected in the corresponding invoice.  (d) Alternative Sources of Supply. In the event that MGI failsto Deliver Licensed Product within sixty (60) days of any Delivery date,including, but not limited to, as a result of a Force Majeure event, MGI andLicensee, will jointly pursue alternative sources of supply. For the avoidance ofdoubt, MGI shall not terminate the Pharmachemie Agreement if it remains the onlysource of supply for Licensed Product.  (e) Expiration of Ferro Pfanstiehl or Pharmachemie Agreements.In the event that the Ferro Pfanstiehl Agreement or the Pharmachemie Agreementexpire or are terminated, then Licensee and MGI shall agree to a mutuallybeneficial plan to assure the uninterrupted World Wide supply of the Product foruse in their respective territories. In such case, Licensee shall have the right,but not the obligation, to manufacture the Product.  (f) Terms. Firm Orders will be made on the form of purchaseorder attached hereto as Schedule 6.1(e), or in such other form as Licensee andMGI shall agree in writing from time to time (a “Purchase Order”),provided that the terms and conditions of this Agreement shall be controlling overany terms and conditions used in any such Purchase Order used in ordering theLicensed Product. * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy* (g) Delivery Terms. All orders shall be delivered EXW (Ex-WorksIncoterms 2000) to a third party designated by Licensee at the destination and themode of transportation specified by Licensee in its purchase orders or in anyother notice to MGI delivered pursuant to this Agreement (“Delivery”).MGI shall provide to Licensee a bill of lading or similar receipt with respect toeach Delivery of Licensed Products. MGI shall cause the notification of Licenseein writing upon each shipment of Licensed Products, which shall be Deliveredfree and clear of any security interests, liens, claims, pledges, orencumbrances of any kind or nature except as such are created by Licensee.  (h) Labeling of Licensed Product. Licensee shall order, and MGIshall Deliver, Bright Stock of Licensed Products or labeled Licensed Products thathave been secondarily packaged, at Licensee’s discretion hereunder. Licenseeshall have the option to label and pack vials.  (i) Secondary Source of Finished Product. (i.)  MGI agrees to qualify a secondary source mutually agreed uponby the Parties of supply of finished Products in accord with its obligationsunder the SuperGen License Agreement, but not to the detriment of Licensee’sefforts to initiate finished product manufacturing from a third partymanufacturer of its choosing as of the expiry of the existing PharmachemieManufacturing Agreement. In this regard, MGI and Licensee shall collaborate topursue alternative manufacturing locations for Licensed Product.  (ii.)  Should Licensee require Drug Substance from Ferro Pfanstiehlfor use in the production of Licensed Products at Third Party manufacturers,for which Licensee may have manufacturing responsibility per this Section6.1(j), MGI is obligated to procure and have tested for release such quantityof Drug Substance. Forecasting for supply of Drug Substance shall be includedin the Quarterly Forecast consistent with Section 6.1(a)(ii). Such DrugSubstance will delivered EXW (Ex-Works Incoterms 2000).  (iii.)  In the event that Licensee is the secondary source of Licensed Product, theParties shall negotiate an appropriate manufacturing and supply agreement andquality agreement. The Parties shall agree upon one set of specifications forthe Licensed Products that apply to all territories. (j) Extensions or Amendments of Ferro Pfanstiehl or PharmachemieAgreements. MGI agrees not to extend the existing Pharmachemie ManufacturingAgreement or the existing Ferro Pfanstiehl Agreement , and to use commerciallyreasonable efforts to negotiate, in the best interests of MGI and Licensee, thetermination of the Ferro Pfanstiehl Agreement at such time as is reasonablydetermined by MGI. MGI also agrees not to amend the Pharmachemie ManufacturingAgreement or Ferro Pfanstiehl Agreement * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   without obtaining Licensee’s input on theamendment and obtaining Licensee’s written consent which consent shall not beunreasonably withheld. Notwithstanding the foregoing, neither Party shall beprecluded from entering into an agreement with either Ferro Pfanstiehl orPharmachemie for the manufacture and supply of Product, provided that the Partiesshall work together to ensure that each Party has an adequate supply of Productand Drug Substance, following the expiration or termination of the existingPharmachemie Manufacturing Agreement or Ferro Pfanstiehl Agreements, provided thatany such agreement entered into by MGI does not interfere withLicensee’s right to manufacture the Product pursuant to Section 6.1 of thisAgreement. To the extent that Licensee has extra Product, Licensee shall notsell such Product to any party other than MGI. (k) Capacity. MGI shall maintain sources of Licensed Productswith an available manufacturing capacity of at least 150% of the aggregate currentannual Forecast starting twelve (months) after the initial Regulatory Approval forthe Product in Europe. MGI shall issue a letter to Licensee every year on theanniversary of the effective date of the Manufacturing and Supply Agreementcertifying such amount of available capacity. MGI and Licensee shall sharelong-term Forecasts on an annual basis so as to ensure that capacity will remainavailable for at least three future years. Should a shortage of available Productoccur due to MGI’s failure to maintain such available capacity, Licensee’s ordersof Licensed Product shall be filled first from the available supply.  (l) Force Majeure. In the event of a Force Majeure as defined inthe Manufacturing and Supply Agreement between the Parties, Product batches shallbe distributed between MGI and Licensee on a pro rata basis based on the previoustwelve (12) months of receipt of Product.  (m) Effect of Termination of Agreement. In the event oftermination of this Agreement and the Manufacturing and Supply Agreement, Licenseeshall at its option be permitted to sell Licensed Product then existing in itsinventory.  (n) Procurement of Drug Substance. MGI will remain responsibleto procure all Drug Substance for Licensed Products from Ferro Pfanstiehl inaccordance with the terms of the Ferro Pfanstiehl Agreement while in effect.  (o) Secondary Source of API. (i.)  No later than six (6) months after the Effective Date of thisAgreement, MGI shall name Licensee as the qualified secondary source of DrugSubstance under the terms of the Ferro Pfanstiehl Agreement, provided thatLicensee is a Qualified Manufacturer. Licensee shall manufacture DrugSubstance at terms including transfer, start-up costs through qualification andvalidation, and price (the “Drug Substance Secondary Supplier Price”),equal to or lower than, and at a capacity equal to or better * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   than the currentterms offered by Ferro Pfanstiehl. All transfer and start-up costs incurred byany secondary source of Drug Substance shall remain the obligation of MGI. IfLicensee is unable to qualify under this Section 6.1 (o)(i) as the secondarysource of Drug Substance, the Parties shall work together to secure a QualifiedManufacturer as the secondary source of Drug Substance. MGI shall allowLicensee or other Qualified Manufacturer of Drug Substance, as the case may be,to produce Drug Substance up to the limit of the allowable percentage under theterms of the Ferro Pfanstiehl Agreement. In the event that Licensee is thesecondary source of Drug Substance, Licensee’s production of Drug Substancewill be for its own use in the preparation of Licensed Products.Any savings resulting from the lower “Drug Substance Secondary SupplierPrice” (excluding cost savings resulting from favorable tax treatment) shallbe shared equally by the Parties. (ii.)  In the event that Licensee is the secondary source of DrugSubstance, Licensee shall notify MGI of the amount of Drug Substance that itshall produce and use for its own purposes, and MGI shall notify Licensee ofthe allowable limits of Drug Substance that Licensee can manufacture for use inLicensed Products for sale globally based on the terms of the Ferro PfanstiehlAgreement.  (iii.)  Notwithstanding the terms of Section 6.1(o) (i) and (ii), should MGI requireDrug Substance from Licensee for its own use or to supplement the amountsrequired to produce Licensed Products for sale outside the Territory andLicensee is capable of producing such Drug Substance, Licensee shall providesuch Drug Substance to MGI.  (iv.)  In the event that Licensee is the secondary source of DrugSubstance, the Parties shall negotiate an appropriate manufacturing and supplyagreement and quality agreement. The Parties shall agree upon one set ofspecifications for the Drug Substance that apply to all territories.  (v.) Title. Title to Drug Substance manufactured byLicensee shall remain with Licensee through the manufacture of such DrugSubstance into finished Licensed Product. 6.2. Pricing. Any and all prices paid by Licensee to MGI, or MGI to Licensee, foreither Drug Substance or Licensed Products shall be at the Parties’ cost as indicated ininvoices generated by either Ferro Pfanstiehl or Pharmachemie or such other applicablethird-party source.  6.3. Quality Assurance (a) Quality Agreement. A quality agreement (the “QualityAgreement”) will be negotiated simultaneously with the Manufacturing andSupply Agreement between the Parties, and be appended thereto. * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy* (b) Release of Licensed Products. Any and all shipments ofLicensed Products shall be approved and released for Delivery by Licensee’sQuality Assurance personnel under the terms of the Quality Agreement. Suchrequirements for release may include review of batch records or other pertinentinformation as requested by Licensee.  (c) Compliance with Applicable Laws. MGI shall warrant thecompliance with (i) all applicable national, federal, state and local laws andregulatory requirements, including, but not limited to laws regardingenvironmental, safety and industrial hygiene, (ii) GMP, and (iii) Licensee’sPolicy Relating to the Employment of Child Labor of Pharmachemie and FerroPfanstiehl and all suppliers and vendors of Pharmachemie and Ferro Pfanstiehl, andshall provide written credentials attesting to such compliance at Licensee’srequest.  (d) Audits. Subject to MGI’s ability to further and accordinglyamend the Pharmachemie Agreement and the Ferro Pfanstiehl Agreements: (i) Licenseeshall have the right to audit Pharmachemie and Ferro Pfanstiehl, and any successorsuppliers thereto, as well as MGI for the purposes of regulatory compliance,including those of applicable environmental, health, safety, youth employment,quality system and other governmental regulations of compliance; (ii) Licensee mayhave up to two individuals for a period of up to three days attend such audits onetime per year, or more frequently for cause (i.e., “for cause” being defined asany instance or reasonable suspicion of existing or imminent violation of theapplicable laws of Section 6.3(c) as demonstrated by reasonably detaileddocumentation); (iii) Based on such audits, Licensee and MGI shall together issuea list of observations within thirty (30) days that audited site personnel mustrespond to within thirty (30) days with corrective action plans, and such listshall include all observations provided by Licensee to MGI; (iv) MGI shall requirethat audited site personnel implement corrective actions within thirty (30) days,or if not possible, a schedule must be agreed to between MGI, the audited site andLicensee for closure of such corrective action(s); and (v) Failure to respond tosuch observations or close same shall be considered a material breach of theapplicable supply agreement(s), allowing Licensee to immediately pursue alternatesources of supply. In the event that MGI and Licensee disagree on the nature orextent of observations or corrective action plans hereunder, they shall beresolved in accordance with Sections 15.7 and 15.8 of this Agreement. MGIwarrants to Licensee that MGI shall use commercially reasonable efforts to amendthe Pharmachemie Agreement and the Ferro Pfanstiehl Agreements in order to providethe rights provided in this Section 6.3(d). 6.4. Assignment of Existing Supply Agreements. MGI warrants to Licensee that MGIhas, or will uses commercially reasonable efforts to obtain and shall thereafter maintainthe right, to assign the Manufacturing and supply agreements related to * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   Product to Licenseepursuant to Sections 13.3(d) and 13.3(g) of this Agreement, or to SuperGen pursuant toSection 15.3.4 of the SuperGen License Agreement.**ARTICLE 7: PAYMENTS; BOOKS AND RECORDS** 7.1. Milestone Payments. Milestone payments payable by Licensee to MGI underSection 3.2 shall be paid in accordance with the terms thereof and this Article 7.  7.2. Royalty Reports and Payments. Commencing with the first sale of the LicensedProducts hereunder, Licensee shall provide a written report for each Calendar Quarter toMGI within forty-five (45) days after the end of each Calendar Quarter, stating in eachsuch report, separately for Licensee and its Affiliates, the number, description, andaggregate Net Sales, by country, of the Licensed Products sold during the calendar quarter(or stating that no sales have occurred if such is the case).Concurrently with making each such report, Licensee shall pay to MGI the royalties duein accordance with Section 3.3.  7.3. Payment Method. All payments under this Agreement shall be made by bank wiretransfer in immediately available funds in US dollars to an account designated by MGI. Anypayments due under this Agreement which are not paid by the date such payments are dueunder this Agreement shall bear interest to the extent permitted by applicable law at theone-week LIBOR rate as published by British Bankers Association , on the date such paymentis due. This Section 7.3 shall in no way limit any other remedies available to MGI.  7.4. Currency Conversion. All amounts set forth in this Agreement, or in anySchedule, are in U.S. Dollars. If any currency conversion shall be required in connectionwith the calculation of royalties or other payments hereunder, such conversion shall bemade using an average of the daily closing mid-rate over the applicable period for foreigncurrency, in U.S. dollars, as available in Bloomberg screen CURNCY HP (N127) for eachrelevant Calendar Quarter; Schedule 2.1 provides an example of such currency conversion.  7.5. Taxes. Licensee will make all payments to MGI under this Agreement withoutdeduction or withholding except to the extent that any such deduction or withholding isrequired to be made on account of Taxes (as that term is defined in Section 7.5(d)). (a) Any Tax required to be withheld on amounts payable under thisAgreement will promptly be paid by Licensee on behalf of MGI to the appropriateGovernmental Authority, and Licensee will furnish MGI with proof of payment ofsuch Tax and such other documentation as shall reasonably be requested by MGI toenable MGI to obtain credit for such Tax against its U.S. Tax liability. Any suchTax required to be withheld will be an expense of and borne by MGI. Licensee willgive notice of its intention to begin withholding any such Tax in advance andcooperate to use reasonable and legal efforts to reduce such Tax on payments madeto MGI hereunder. * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy* (b) Licensee and MGI will cooperate with respect to all documentationrequired by any government taxing authority or reasonably requested by Licensee orMGI to secure a reduction in the rate of applicable withholding Taxes.  (c) If Licensee had a duty to withhold Taxes in connection with anypayment it made to MGI under this Agreement but Licensee failed to withhold, andsuch Taxes were assessed against and paid by Licensee, then MGI will indemnify andhold harmless Licensee from and against such Taxes (including interest, butexcluding penalties and additions thereto.) If Licensee makes a claim under thisSection 7.5(c), it will comply with the obligations imposed by Section 7.5(b) asif Licensee had withheld Taxes from a payment to MGI.  (d) Solely for purposes of this Section 7.5, “Tax” or“Taxes” means any present or future taxes, levies, imposts, duties,charges, assessments or fees of any nature (including interest, penalties andadditions thereto) imposed by the applicable Governmental Authority.. 7.6. Records and Inspection. (a) Licensee shall keep and maintain true and complete records settingforth the gross sales of the Licensed Product in each country in the Territory,and of all matters relating to the computation of the Net Sales of the LicensedProduct in each country in the Territory, including itemization of all deductionspermitted pursuant to Section 1.77 and taken in calculating Net Sales, for aperiod of five (5) years following such sales.  (b) Such records shall be open to inspection, at the written request ofMGI with (30) thirty days written notice, and during the normal office hours ofLicensee(but not more frequently than once per year unless non-compliance isidentified) by a nationally recognized independent certified public accountant orequivalent thereof selected by MGI and reasonably acceptable to Licensee, andretained solely for the purpose of auditing the same at MGI expense.  (c) Such audit shall be conducted exclusively for the purpose ofverifying the accuracy of reports delivered by Licensee to MGI pursuant to thisSection and the accuracy of Licensee determination of the amounts payable or paidby Licensee to MGI hereunder. The accountant shall sign a confidentialityagreement prepared by Licensee and shall then have the right to examine therecords kept pursuant to this Section and report to MGI the findings (but not theunderlying data) of such examination of records. The accountant shall provide adraft copy of the report to MGI and Licensee for review and comment, and each ofMGI and Licensee shall have thirty (30) days after receipt of that report toreview and comment on the report which comments shall be provided to theaccountant and to each other. The final report shall be provided simultaneously toMGI and Licensee by the independent certified public accountant or equivalentthereof within twenty (20) days after the accountant’s receipt and considerationof such comments. * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy* (d) If the result of the audit is contested by either party, then theyagree to retain a mutually acceptable independent certified public accounting firmor equivalent thereof within 30 (thirty) days to review the relevant books andrecords and to submit to the parties its written determination as to the amount indispute and the basis for its determination. The determination by the accountingfirm will be binding on the parties absent manifest error. Each party shall payone-half of the fees and expenses of the accounting firm for such determination.  (e) Upon final determination, if the review reveals a deficiency in thecalculation of payments resulting from any underpayment by Licensee, Licenseeshall promptly pay MGI the amount remaining to be paid (plus interest based on theone week LIBOR rate as published by British Bankers Association on the date suchpayment is due), and if such underpayment is by five percent (5%) or more for theperiod examined, Licensee shall also pay all reasonable costs and expenses of theuncontested audit. If the accountant determines that Licenseehas overpaid MGI Licensee shall deduct such overpayment on the next payment toMGI.**ARTICLE 8: INTELLECTUAL PROPERTY OWNERSHIP; PATENTS** 8.1. Ownership of Inventions. As between the parties, MGI shall be the sole ownerof all right, title, and interest in and to all technology, inventions, trade secrets,Patent Rights, and other intellectual property rights: (a) in new or improvedcompositions, new or improved formulations, and new or improved methods of manufacture oruse of Decitabine (collectively, the “Product Improvements”), regardless of by whommade or conceived; (b) made and conceived solely by MGI personnel in connection with thisAgreement; and (c) made and conceived jointly by personnel of MGI and Licensee inconnection with this Agreement and relating directly to Product Improvements. Theintellectual property described in (a), (b) and (c) shall be collectively referred to asthe “MGI Inventions.” All right, title, and interest in and to all technology,inventions, trade secrets, Patent Rights, and other intellectual property rights made andconceived solely by Licensee personnel in connection with this Agreement (“LicenseeInventions”) other than Product Improvements as described above, shall be owned solelyby Licensee. Licensee and its Affiliates shall treat all MGI Inventions as theConfidential Information of MGI pursuant to the terms of this Agreement, and shall not makeany disclosure or use thereof without MGI’s prior written consent. MGI shall treat allLicensee Inventions as the Confidential Information of Licensee pursuant to the terms ofthis Agreement, and shall not make any disclosure or use thereof without Licensee’s priorwritten consent. Licensee and its Affiliates hereby irrevocably assign, and shall assignand cause its Affiliates to assign, to MGI all right, title, and interest Licensee or itsAffiliates may have in and to the MGI Inventions worldwide, including, as between theparties, the right to file, prosecute, and maintain Patent Rights with respect * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   thereto inall countries and under all treaties. Licensee shall, and shall cause its Affiliates to,execute such documents, render such assistance, and take such other actions as MGI mayreasonably request, at MGI’s expense, as may be reasonably necessary to apply for,register, perfect, confirm, defend, and enforce all rights with respect to the MGIInventions. 8.2. Patent Prosecution. As between the parties, MGI (and its designees) shall havethe first right to conduct all activities with respect to the preparation, filing,prosecution and maintenance (including interferences, re-examinations, reissues,oppositions and the like) of the Patent Rights in the Licensed Patents, of jointly ownedPatent Rights, and of Patent Rights with respect to the MGI Inventions. Licensee shallinform MGI, and require that its Affiliates inform MGI, of any and all MGI Inventions.During the Term, at its own cost and expense and subject to SuperGen’s rights under theSuperGen License Agreement, MGI shall file, prosecute, and maintain its patents and patentapplications covering the Licensed Products, including, without limitation, any patents orpatent applications covering Product Improvements filed during the Term, worldwide. AbsentLicensee’s written consent, MGI shall not electnot to file, prosecute or maintain any patents or patent applications covering theLicensed Products in any country in the Territory.  8.3. Cooperation in Prosecution. Upon request in connection with the preparation,filing, prosecution, or maintenance of any Patent Rights in accordance with the foregoing,each Party will reasonably cooperate with the other in connection therewith, withoutdemanding any further consideration therefore, including, without limitation, executing andfiling applications, registrations, powers of attorney, oaths and other appropriatedocuments, providing appropriate consents and/or authorizations, and joining in anyadministrative or judicial action relating to the prosecution or maintenance of any PatentRights. In addition, upon request, MGI will provide Licensee with copies of filings,prosecution and maintenance of any MGI Patent Rights as provided in Schedule 1.51 as wellas any copies of filings, prosecution and maintenance of any MGI Patent Rights not listedin Schedule 1.51 but which claim or could include claims relating to Licensed Productsoriginating from SuperGen during the Term of this Agreement.  8.4. Patent Term Extensions. The Parties shall cooperate, if necessary andappropriate, with each other in gaining patent term extension (including those extensionsavailable under the Supplementary Certificate of Protection of Member States of the EU andother similar measures in any other country) wherever applicable to Patent Rights in theParties respective territories.. The Parties shall, if necessary and appropriate, usereasonable efforts to agree upon a joint strategy relating to patent term extensions. Allfilings for such extensions shall be made by the Party Controlling such patent or, in thecase of joint Patent Rights, by the Party responsible for filing, prosecuting andmaintaining such Patent Rights in accordance with Section 8.2. In the event that a PartyControlling a Patent Right elects not to file for * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   any extension, said Party shall notifythe other Party and the other Party shall have the right, at its option, to file for suchextension. 8.5. Third Party Infringement Claims. If the making, sale, importation, or use ofany Products pursuant to this Agreement results in a claim, suit or proceeding by a ThirdParty alleging patent infringement against MGI or Licensee (or their respective Affiliates)(collectively, “Infringement Actions”), such Party shall promptly notify the otherParty hereto in writing. Subject to Article 12, the Party subject to such InfringementAction shall have the exclusive right to defend and control the defense thereof (includingthe conclusion of a potential settlement, but limited to the rights granted pursuant tothis Agreement) using counsel of its own choice, and, also subject to Article 12, theInfringement Action shall be at such Party’s own expense; provided, however, that the Partynot responsible under the foregoing for defending such Infringement Action may participatein the defense and/or settlement thereof at its own expense with counsel of its choice.The Party defending the Infringement Action agrees to keep the other Party heretoreasonably informed of all material developments in connection with any such InfringementAction. Licensee agrees not to make admissions regarding infringement by the Products ofany Patent Rights outside of the Licensed Patents, without obtaining the prior writtenconsent of MGI.Nothing in this Section 8.5 shall be construed as limiting the obligations ofindemnification under Article 12.  8.6. Enforcement. Subject to the provisions of this Section 8.6, in the event thatLicensee reasonably believes that any of the Licensed Patents in the Territory areinfringed or misappropriated by a Third Party or is subject to a declaratory judgmentaction in the Territory arising from such infringement, in each case with respect to themanufacture, sale or use by a Third Party of a Licensed Product within the Territory or ofa Competing Product within the Territory, Licensee shall promptly notify MGI. In suchevent, as between the Parties, MGI shall have the first right (but not the obligation) toenforce the Licensed Patents with respect to such infringement, or defend any declaratoryjudgment action with respect thereto (for purposes of this Section 8.6, an “EnforcementAction”) in the Territory. In the event that MGI does not elect to enforce LicensedPatents in a country in the Territory within one hundred-twenty (120) days of a request byLicensee to initiate such enforcement action, Licensee, with the previous consent inwriting of MGI, may elect to bring an Enforcement Action. MGI shall have the option tocontribute to such Enforcement Action by paying to Licensee shall pay one third (1/3) ofthe costs and expenses (including attorneys’ and professional fees) incurred by Licensee inconnection with such Enforcement Action. In the event MGI and Licensee join or are joinedas party plaintiffs to an Enforcement Action, each Party shall bear its own costs relatedto such Action. Any recovery received as a result of any Enforcement Action to enforceLicensed Patents pursuant to this Section 8.6 by either Party shall be used first toreimburse the Parties for the costs and expenses (including attorneys’ and professionalfees) incurred by each in connection with such Enforcement Action, and * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy*   the remainder of therecovery shall be shared (to the extent the same represents damages from sales of theLicensed Products within the Territory) between the Parties; provided, however, that ifLicensee initiates the Enforcement Action and MGI does not agree to pay one third (1/3) ofthe costs and expenses incurred by Licensee therein, or does not join with Licensee as aparty plaintiff, MGI shall not be entitled to any amount recovered in such EnforcementAction. Both Parties shall lend reasonable assistance to the other Party in theenforcement of Patent Rights. 8.7. Patent Marking. Licensee agrees to mark and have its Affiliates mark allpatented Licensed Products they sell or distribute pursuant to this Agreement in accordancewith the applicable patent statutes or regulations in the country or countries ofmanufacture, use, importation and sale thereof sufficient to preserve all rights andremedies under the Licensed Patents.**ARTICLE 9: TRADEMARKS** 9.1. Product Trademark. Licensee shall have the right and license (as recited inSection 9.2) to distribute, promote, market and sell Licensed Product in the Territoryunder Product Trademark(s). Licensee or its Affiliates shall have the right, subject toMGI’s prior written approval, not to be unreasonably withheld, to select, register, own anduse (and bear all costs associated with) any and all lawful trademarks otherthan the Dacogen Trademark in connection with such distribution, promotion, marketingand sale of the Licensed Products in the Territory. As between the Parties, it isagreed and understood that, if commercially reasonable, that certain Licensed Productwhich (as of the Effective Date) is the subject of MGI’s NDA No. 21-790 shall bedistributed, promoted, marketed and sold in the Territory by Licensee in the Territoryexclusively under the Dacogen Trademark; the Parties agree that if the DacogenTrademark is not legally available in any one or more of the Major Countries then itshall not be commercially reasonable to use the Dacogen Trademark in any country in theTerritory.  9.2. License. MGI hereby grants to Licensee a royalty-free license to use theDacogen Trademark, to the extent owned or licensed by MGI, and any other ProductTrademark(s) owned or licensed by MGI, during the term of this Agreement solely inconnection with marketing, promoting, distributing and selling the applicable LicensedProducts in the Territory in accordance with this Agreement during its Term.  9.3. Registration. Each Party agrees to file, register and maintain registrationsfor the Product Trademarks to the extent owned by such Party as appropriate in such Party’sdiscretion, for the term of this Agreement, for use with the Licensed Products. The costsof filing and maintaining such registrations, and for recordations under Section 9.5 below,in the Territory for the Product Trademark shall be borne by the Party that owns suchProduct Trademark. * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Excution Copy* 9.4. Ownership. Licensee hereby acknowledges SuperGen’s exclusive ownership rightsin the Dacogen Trademark, and accordingly agrees that MGI shall have a right to terminatethis Agreement under Section 13.3(b) if, during or after the term of this Agreement,Licensee or its Affiliates challenge or assist others to challenge the Dacogen Trademark,or the registration thereof, or attempt to register any trademarks, marks or trade namesconfusingly similar to the Product Trademark without MGI’s written consent.  9.5. Recordation. In those countries where a trademark license must be or isdesired by MGI or SuperGen to be recorded for a Product Trademark owned by MGI or SuperGen,MGI or SuperGen (as the case may be) will provide and record a separate trademark licensefor such Product Trademark, and the expense thereof shall be shared equally by MGI orSuperGen, as the case may be, and Licensee. Additionally, the Parties shall enter into andrecord registered user agreements, as requested by MGI or SuperGen, for Product Trademarksowned by MGI or SuperGen. Licensee shall cooperate in the preparation and execution ofsuch documents.  9.6. Guidelines and Approval. To the extent that the Product Trademark used byLicensee is the Dacogen Trademark, all representations thereof that Licensee and itsAffiliates intend to use shall first be submitted to MGI for approval of design, color, andother details or shall be exact copies of those used by MGI and shall in any event complywith usage guidelines as communicated by MGI from time to time. Additionally,representative promotional materials, packaging and Licensed Productsthat use the Dacogen Trademark shall be submitted to MGI by Licensee for MGI’sreasonable approval prior to their first use and prior to any subsequent change oraddition to such promotional materials, provided that if MGI has not responded withintwenty (20) business days after such submissions, MGI’s approval will be deemed to havebeen received. MGI shall have the right to monitor the quality of Licensed Productsfor which the Dacogen Trademark is used, as reasonably requested from time to time.  9.7. Termination. Licensee’s right to use the Dacogen Trademark shall terminate ineach country of the Territory in which Licensee’s rights to distribute the LicensedProducts expire or are terminated in accordance with this Agreement. Licensee shallcooperate in the cancellation of any trademark licenses, and registered user agreements,recorded or entered into in such countries and relating to the Dacogen Trademark. In theevent of termination or expiration of this Agreement, Licensee shall provide for thecomplete transfer and assignment of all Product Trademarks Controlled by Licensee and usedfor sale of Licensed Product and any associated goodwill to MGI at Licensee’s cost andexpense, unless such termination is as a result of material breach by MGI.**ARTICLE 10: CONFIDENTIALITY** * Denotes confidential information that has been omitted from the exhibit andfiled separately, accompanied by a confidential treatment request, with theSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities ExchangeAct of 1934.
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*Execution Copy* 10.1. Non-Use and Non-Disclosure. Except as expressly provided herein, the Partiesagree that the receiving Party shall not publish or otherwise disclose, and shall not usefor any purpose, any Confidential Information of the other Party hereto obtained inconnection with this Agreement, and any use and disclosure by or under authority of a Partyof the other Party’s Confidential Information in accordance with this Agreement shall besubject to a non-use and nondisclosure agreement comparable to the terms hereof. EachParty shall take the same reasonable measures necessary to prevent any disclosure by itsemployees, agents, contractors, and consultants of the other Party’s ConfidentialInformation as it applies to the protection of its own Confidential Information.  10.2. Exclusions. Information shall not be considered Confidential Informationhereunder if it: (a) was already in the possession of the receiving Party prior to itsreceipt from the disclosing Party, as shown by the receiving Party’s books andrecords (except that this exclusion shall not cause Product Improvements to not bethe Confidential Information of MGI);  (b) is, or becomes, part of the public knowledge or literature through nofault, act or omission of the receiving Party, provided, Confidential Informationshall not be deemed to have entered the public domain merely by reason of itshaving been filed with any Regulatory Authority;  (c) is, or becomes, available to the receiving Party from a source otherthan the disclosing Party, which source has rightfully obtained the sameinformation and has no obligation of confidentiality with respect to it;  (d) is made available on an unrestricted basis by the disclosing Party toa Third Party unaffiliated with the disclosing Party; or  (e) is independently developed without use of or reference to the otherParty’s Confidential Information. 10.3. Permitted Use and Disclosures. (a) Notwithstanding the provisions of Section 10.1 above, (i) each Partyhereto may use and disclose the other Party’s Confidential Information to theextent such disclosure is reasonably necessary to exercise the rights granted toit, or reserved by it, under this Agreement (including the right to grantsublicenses, as applicable), (ii) each Party hereto may disclose the other’sConfidential Information to the extent such disclosure is reasonably necessary inprosecuting or defending litigation or complying with applicable governmentalregulations, submitting information to tax or other governmental authorities,(iii) MGI may disclose Licensee’s Confidential Information to SuperGen, and (iv)Licensee shall be permitted to publicly register (within 21 days of initiatingenrollment) in a public trials registry (such as www.ClinicalTrials.gov) anyclinical trials in which Licensee is a *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy*   participant, to post the results of all such registered clinical trials to aclinical study results web site within 12 months after trial completion, and/or topublish the results of all such registered clinical trials in a peer-reviewedjournal and cite such publications on a public clinical study results web site;provided that in (i) and (iii) above, to the extent possible, the recipient isbound by terms and conditions as protective of the other Party’s ConfidentialInformation as the terms and conditions of this Article 10; provided that in (ii)above, if a Party is legally required to make any such disclosure of the otherParty’s Confidential Information, to the extent it may legally do so, it will givereasonable advance written notice to the latter Party of such disclosure and willuse its reasonable efforts to secure confidential treatment of such ConfidentialInformation prior to its disclosure (whether through protective orders orotherwise); and further provided that in (iv) above, the information to besubmitted for such registration and/or postings shall be treated as a publicationin accordance with Section 10.6 and accordingly shall be submitted to MGI at leastthirty (30) business days prior to the desired date of registration or posting,except that if MGI requests an additional sixty (60) days in order to prepare andfile applications on any Patent Rights contained therein, the Parties agree thatsuch clinical trial shall not commence until after the expiration of the sixty(60) day period.  (b) Except as provided in Section 10.3(a), Licensee and its Affiliateshall not disclose information about Product Improvements except to the extentlicensed to Licensee hereunder and as required in Licensee’s performance of itsobligations hereunder, without MGI’s prior written consent. 10.4. Prior Non-Disclosure Agreements. Upon execution of this Agreement, the termsof this Article 10 shall supersede any prior non-disclosure, secrecy, or confidentialityagreement between the Parties. Any information disclosed under such prior agreements shallbe deemed disclosed under this Agreement.  10.5. Terms of the Agreement. Each of the Parties hereto agrees not to disclose theterms of this Agreement to any Third Party without the prior written consent of the otherParty hereto, which consent shall not be unreasonably withheld or delayed, except (a) to advisors, legal counsel, existing and potential investors andothers on a need-to-know basis under conditions which reasonably ensure theconfidentiality thereof,  (b) as required by any court or other governmental body;  (c) as otherwise required by law;  (d) in confidence, in connection with the enforcement of this Agreementor rights under this Agreement;  (e) in confidence, in connection with a merger, acquisition of stock orassets, proposed merger or acquisition, or the like; *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy* (f) as reasonably determined by either Party to be required in connectionwith any government or regulatory filings, including without limitation filingswith the Securities and Exchange Commission, provided that the filing Partyconsultsin good faith with the Party whose Confidential Information is to be disclosedwith respect to the specific disclosure as to whether to seek confidentialtreatment to the extent reasonably practical; and  (g) as required to be disclosed in such Party’s financial statements asreasonably determined by such Party. 10.6. Publication of Licensed Products Information. Neither Party shall publish,publicly present and/or submit for written or oral publication a manuscript, abstract orthe like which includes data or other information relating to Products without firstproviding the other Party with opportunity to review the publication for at least thirty(30) business days prior to submission for publication. The non-Publishing Party shallhave the right to delay publication for an additional sixty (60) days in order to prepareand file applications on any Patent Rights prior to submission for publication. NeitherParty shall publicly present and/or submit for written or oral publication, a manuscript,abstract or the like which includes Confidential Information of the other Party without theexpress permission of that other Party. The contribution of each Party shall be noted inall publications or presentations by acknowledgment or co-authorship, whichever isappropriate.**ARTICLE 11: REPRESENTATIONS AND WARRANTIES** 11.1. By MGI. MGI hereby represents and warrants to Licensee as follows: (a) MGI has been duly organized and is validly existing as a corporationin good standing under the laws of the state of Minnesota, with corporate power toconduct any lawful business activity. MGI has the corporate power and authorityto enter into this Agreement and to consummate the transactions contemplated bythis Agreement.  (b) The execution, delivery and performance of this Agreement, and theconsummation of the transactions contemplated by this Agreement, by MGI have beenduly and validly authorized by all requisite corporate action of MGI. ThisAgreement has been duly executed and delivered by MGI and constitutes the legal,valid and binding obligation of MGI, enforceable against MGI in accordance withits terms, except as enforceability thereof may be limited by bankruptcy,insolvency, reorganization or other similar laws relating to or affecting therights of creditors generally, and by general principles of equity.  (c) The execution, delivery and performance of this Agreement by MGI, andthe consummation by MGI of the transactions contemplated by this Agreement, do notin any material respect (i) conflict with or result in any breach of any of *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy*   theprovisions of, constitute a default under, result in a violation of, give rise toany right of termination under, or require any authorization, consent (except asmay have been obtained), approval, exemption or other action by or notice to anycourt or governmental body, under the provisions of MGI’s Articles ofIncorporation or bylaws or any indenture, mortgage, lease, loan agreement, licenseor other agreement or instrument to which MGI is a party; or (ii)conflict with or result in the violation of any law, statute, rule or regulationor order, judgment or decree to which MGI is subject.  (d) To its actual knowledge, it has sufficient rights to the LicensedPatents, Dacogen Trademark, and the trade secrets in the Licensed Know-How, freeand clear of any liens or encumbrances, to grant the licenses to Licenseethereunder in this Agreement. MGI has not assigned and/or granted licenses to theLicensed Patents, the Dacogen Trademark, or the Licensed Know-How, or entered intoany inconsistent prior obligations, to any other person or entity that conflictwith the rights granted hereunder.  (e) Except as provided in the Trademark Coexistence Agreement, and to thebest of its knowledge, MGI is the sole and exclusive licensee of all right, titleand interest in and to the Dacogen Trademark existing as of the Effective Date,and the Dacogen Trademark is free and clear of any liens, charges andencumbrances.  (f) As of the date of signing of this Agreement, there are no actions,suits or proceedings pending or threatened in writing against MGI or, to MGI’sbest knowledge and belief having made proper enquiry, SuperGen, at law or inequity before or by any federal, provincial, state, municipal or othergovernmental department, commission, board, bureau, agency or instrumentality,domestic or foreign, which may in any way materially adversely affect theperformance by MGI of its obligations under this Agreement or Licensee’s enjoymentof the rights granted to Licensee hereunder and MGI is not aware of anycircumstances which might give rise to such actions, suits or proceedings.  (g) Prior to the Effective Date MGI has provided Licensee with true,accurate and up to date copies, including all that amend or add to the termsthereof, of the Existing Third Party Agreements existing as of the Effective Dateof this Agreement.  (h) MGI and SuperGen have amended the SuperGen License Agreement toprovide that: (i) SuperGen will consent to the continuation of Licensee’s rightsand license granted by MGI under this Agreement under the conditions described inSection 13.3(c) herein, should the SuperGen License Agreement be terminated eitherby SuperGen for MGI’s breach, provided that such breach was not caused in whole orin part by the Licensee’s breach of this Agreement, or otherwise terminated byMGI; (ii) MGI can assign regulatory *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy*   rights in the Territory, as that term isdefined herein, to Licensee and a true and accurate copy of the SuperGen LicenseAgreement as amended is attached hereto as Schedule 1.80.  (i) MGI shall not amend the SuperGen License Agreement in any manner thatmaterially and adversely effects Licensee’s rights under this Agreement.  (j) To the best of MGI’s knowledge, the Licensed Patents are valid. TheLicensed Patents are subsisting and MGI is not aware of any information that mightrender the Licensed Patents void, invalid, or unenforceable.  (k) To the best of MGI’s knowledge, MGI has disclosed to Licensee anydata and other information that could reasonably be considered material to thesafety or efficacy of the Licensed Products.  (l) MGI has disclosed to Licensee in writing prior to the date of signingof this Agreement all of its rights and interests with respect to CompetingProducts, including all of its plans with respect to Competing Products. It hasno rights to Commercialize, and it is not (and does not plan to) Commercialize anyCompeting Products. 11.2. By Licensee. Licensee hereby represents and warrants to MGI as follows: (a) Licensee has been duly organized and is validly existing as acorporation in good standing under the laws of Switzerland, with corporate powerto conduct any lawful business activity. Licensee has the corporate power andauthority to enter into this Agreement and to consummate the transactionscontemplated by this Agreement. No consent, approval or agreement of any person,party, court, government or entity is required to be obtained by Licensee and/orany of its Affiliates in connection with the execution and delivery of thisAgreement or the consummation of the transactions contemplated hereby, which hasnot been obtained. There is nothing in any agreement between Licensee or itsAffiliates and any Third Party agreement which, in any way, will limit Licensee’sability to perform all of the obligations undertaken by Licensee hereunder, suchas without limitation its diligence with respect to the Development andCommercialization of the Licensed Products.  (b) The execution, delivery and performance of this Agreement, and theconsummation of the transactions contemplated by this Agreement, by Licensee havebeen duly and validly authorized by all requisite corporate action of Licensee.This Agreement has been duly executed and delivered by Licensee and constitutesthe legal, valid and binding obligation of Licensee, enforceable against Licenseein accordance with its terms, except as enforceability thereof may be limited bybankruptcy, insolvency, reorganization or other similar laws relating to oraffecting the rights of creditors generally, and by general principles of equity. *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy* (c) The execution, delivery and performance of this Agreement by Licenseeand the consummation by Licensee of the transactions contemplated by thisAgreement do not in any material respect (i) conflict with or result in any breachof any of the provisions of, constitute a default under, result in a violation of,give rise to any right of termination under, or require any authorization, consent(except as may have been obtained), approval, exemption or other action by ornotice to any court or governmental body, under the provisions of Licensee’sArticles of Incorporation or bylaws or any indenture, mortgage, lease, loanagreement, license or other agreement or instrument to which Licensee is a party,or (ii) conflict with or result in the violation of any law, statute, rule orregulation or order, judgment or decree to which Licensee is subject.  (d) During the term of this Agreement, Licensee shall comply, in allmaterial respects with all applicable statutes, rules and regulations of theapplicable Regulatory Authorities, with respect to the clinical testing,collection, labeling, storing, testing, or distribution of the Licensed Products,including the applicable corresponding requirement of Regulatory Authorities tothe then current “Good Clinical Practice” or GCP regulations, “Good LaboratoryPractice” or GLP regulations, “Informed Consent” and “Institutional Review Board”regulations, and all applicable requirements relating to the protection of humansubjects for its clinical trials. Licensee shall obtain, or assist MGI inobtaining (as set forth in this Agreement), from the applicable RegulatoryAuthorities, all requisite permits, approvals, registration and licenses requiredto Commercialize the Licensed Products prior to marketing or selling the LicensedProducts in such country or region.  (e) It has disclosed to MGI in writing prior to the date of signing ofthis Agreement all of its rights and interests with respect to Competing Products,including all of its plans with respect to Competing Products. It has no rightsto Commercialize, and it is not planning to Commercialize any Competing Products. 11.3. DISCLAIMER. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT,NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND EITHER EXPRESSOR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR APARTICULAR PURPOSE, NONINFRINGEMENT, OR VALIDITY OF ANY PATENTS ISSUED OR PENDING, AND EACHPARTY HEREBY DISCLAIMS SUCH OTHER REPRESENTATIONS AND WARRANTIES.**ARTICLE 12: INDEMNIFICATION** *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy* 12.1. Indemnification of MGI. Licensee shall indemnify, defend and hold harmlessMGI, its Affiliates, and their respective directors, officers, employees, agents and theirrespective successors, heirs and assigns (the “MGI Indemnitees”) from and againstany and all losses, costs, claims, damages, liabilities and expenses (including reasonableattorneys’ and professional fees and other expenses of litigation) (collectively,“Liabilities”), including Liabilities resulting from a claim, suit, or proceeding(“Claim”) made or brought by a Third Party against a MGI Indemnitee (and furtherincluding those arising out of personal injury claims) arising from or occurring as aresult of (a) any breach of the representations and warranties made by Licensee in thisAgreement; (b) any research, Development, testing, importation, use, offer for sale, sale,marketing, distribution, or other Commercialization of the Licensed Products by or underauthority of Licensee or its Affiliates, (c) any act, omission, or failure of Licensee orany of its Affiliates to comply in any material respect, with any applicable laws,regulations and/or administrative decisions relating to the Licensed Products or (d) aClaim by a Third Party as a result of Licensee exercising rights exceeding the scope of thelicense grant from MGI pursuant to the provisions of Article 2 or arising out of orrelating to breach ofArticles 8 or 10; except in each case to the extent caused by the breach of contract,gross negligence or willful misconduct of MGI.  12.2. Indemnification of Licensee. MGI shall indemnify, defend and hold harmlessLicensee, its Affiliates, and their respective directors, officers, employees, agents andtheir respective successors, heirs and assigns (the “Licensee Indemnitees”) fromand against any and all Liabilities, including Liabilities resulting from a Claim made orbrought by a Third Party against an Licensee Indemnitee arising from or occurring as aresult of (a) any breach of the representations and warranties made by MGI in thisAgreement, (b) any research, Development, testing, importation, use, offer for sale, sale,marketing, distribution, or other Commercialization of the Products by or under authorityof MGI or its Affiliates outside of the Territory, (c) any manufacture of the LicensedProducts by or on behalf of MGI up to the point that such Licensed Products leaves MGI’sactual or constructive possession and control, (d) any failure of MGI or any of itsAffiliates to comply in any material respect with any applicable laws, regulations and/oradministrative decisions relating to the Licensed Products, or (e) a Claim by a Third Partyas a result of MGI or an Affiliate of MGI exercising rights exceeding the scope of thelicense grant from SuperGen; except in each case to the extent caused by the breach ofcontract, gross negligence or willful misconduct of Licensee.  12.3. Procedure. A MGI Indemnitee or Licensee Indemnitee, as the case may be, thatintends to claim indemnification (the “Indemnitee”) shall promptly notify theindemnifying Party (the “Indemnitor”) in writing of any Claim in respect of whichthe Indemnitee intends to claim indemnification under this Article 12. The Indemnitorshall have the sole right to control the defense and settlement of such Claim; provided,that the Indemnitee shall have the right to participate in the defense * Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy* ** ** or settlement ofsuch Claim with counsel of its own choosing at its expense. The Indemnitor shall keep theIndemnitee fully informed of the progress of any such Claim. The indemnity arrangement inthis Article 12 shall not apply to amounts paid in settlement of any action with respect toa Claim, if such settlement is effected without the consent of the Indemnitor, whichconsent shall not be withheld or delayed unreasonably. The failure to deliver writtennotice to the Indemnitor within a reasonable time after the commencement of any action withrespect to a Claim, if prejudicial to its ability to defend such action, shall relieve suchIndemnitor of any liability to the Indemnitee under this Article 12 but the omission so todeliver written notice to the Indemnitor shall not relieve the Indemnitor of any liabilitythat it may have to any Indemnitee otherwise than under this Article 12. The Indemniteeshall cooperate fully with the Indemnitor and its legal representatives in theinvestigation of any action with respect to a Claim covered by this indemnification at theexpense of the Indemnitor.  12.4. Insurance. Each Party shall procure and maintain at its own costcomprehensive general liability (including coverage for products and maintained throughoutthe term of this Agreement and for a period of at least five (5) years after the expirationor termination of this Agreement), commercial general liability, product liability,clinical trial liability, and property and casualty insurance providing commerciallyreasonable coverage (at least * coverage) for its activities under this Agreement and itsequipment, premises and businesses. Licensee will maintain foreign localcoverage in the Territory where required by foreign law in an amount that, at aminimum, satisfies the legal requirements of that jurisdiction. The insurance policiesof the Parties in the United States (as applicable) shall be with financially stronginsurance carriers (AM Best Rating of “A: VIII” or higher) and will be primary to anyother insurance owned, secured or in place. Licensee shall name MGI as an additionalinsured on such policies. MGI shall name Licensee as additional insured on suchpolicies. Each Party will furnish to the other Party the corresponding certificates ofinsurance that evidence the foregoing within fifteen (15) days of the Effective Date.**ARTICLE 13: TERM AND TERMINATION** 13.1. Term. This Agreement shall be effective as of the Effective Date, and unlessearlier terminated pursuant to the other provisions of this Agreement, this Agreement shallexpire, on a country-by-country basis, upon the later of (a) twenty (20) years after FirstCommercial Sale of the applicable Licensed Products in the respective country, and (b) theexpiration, termination, invalidation, or abandonment of all Patent Rights within theLicensed Patents covering the respective Licensed Products, or the manufacture or usethereof, in the respective country (the “Term”).  13.2. Termination for Non-Payment and Termination Without Cause.  *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy* (a) In the event a Party fails to pay any undisputed amount due underthis Agreement within sixty (60) calendar days following receipt of written noticeof such non-payment by the other Party, the other Party may, by written notice tosuch Party, terminate this Agreement in whole. An amount shall be deemed to beundisputed except to the extent that the Party that is required to make thepayment provides the other Party with written notice reasonably describing theamounts disputed, and the reason for the dispute, promptly after receipt of noticeof non-payment.  (b) Licensee may terminate this Agreement, without cause, in total or ona country-by-country basis after one (1) year following the Effective Date, byproviding MGI written notice of such termination ninety (90) days prior to theeffective date thereof, provided that in the case of the EU, the Major Countriestherein, must be terminated all together. In the event that Licensee exercisesits rights under this Section 13.2(b), and Drug Product is being manufactured atthe same time for the country or countries being terminated, Licensee shall alsobe obligated to pay for the costs of such manufacture.  (c) Notwithstanding the foregoing, Licensee may terminate this Agreementat any time if the EMEA indicates that an additional clinical trial is required toobtain Marketing Authorization of the Licensed Product for the MDS indication,provided that Licensee provides MGI written notice of its intent to terminate thisAgreement under this Section 13.2(c) within ninety (90) days of receipt of theaforementioned indication from the EMEA. Failure of Licensee to notify MGI of itsintent to terminate this Agreement under this Section 13.2(c) within ninety (90)days shall constitute a waiver of Licensee’s rights to terminate under thisSection 13.2(c). 13.3. Termination for Material Breach, Change of Control or Termination of SuperGenLicense. (a) Without limiting either Party’s ability to terminate in accordancewith the other provisions of this Article 13, in the event of a Party’s materialbreach of this Agreement, the non-breaching Party shall have the right to providenotice of its intention to terminate this Agreement (in whole or in part as setforth in Section 13.5). Such notice shall specify in reasonable detail the factsand circumstances constituting the material breach of this Agreement. Upon theexpiration of sixty (60) calendar days after receipt by the breaching Party ofsuch notice, if the breaching Party: (i) has not cured such material breach whenit is possible to cure such breach during such 60-day period or (ii) is notdiligently pursuing a cure of such breach throughout such 60-day period where itis not possible to cure such breach within such 60-day period, then thenon-breaching Party shall be entitled to exercise the rights set forth in Section13.5. In the event under (ii) above that despite the breaching Party’s efforts tocure such material breach, if such material breach has not been cured within six(6) months following receipt of notice of material breach as *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy*   set forth above bythe breaching Party, then the non-breaching Party shall be entitled to exercisethe rights set forth in Section 13.5.  (b) MGI shall have the right to terminate this Agreement effective uponwritten notice if: (i.)  Licensee undergoes a Change of Control where the Change ofControl results in (1) Licensee or its Affiliates developing and/orcommercializing a Competing Product or that product competitive to the LicensedProducts with the trade name Vidaza, and (2) Licensee does not agree to divestthe same following request from MGI;  (ii.) Licensee or its Affiliates acquire or in-licenses a CompetingProduct or that product competitive to the Licensed Products with the tradename Vidaza, and does not inform MGI in writing within thirty (30) daysthereafter of its plans to divest the same, or begins to commercialize the sameprior to actually divesting it;  (iii.) MGI is provided notice by SuperGen that the SuperGen License Agreement may beterminated as a result of a material breach of this Agreement by Licensee, butonly if Licensee does not cure the breach within any applicable cure periodunder the terms of this Agreement; or  (iv.) in accordance with Section 9.4 herein. (c) If the SuperGen License Agreement is terminated (in whole or inpart), either by SuperGen due to the breach of such Agreement by MGI (and suchtermination is not related to any breach by Licensee of the terms of thisAgreement), or otherwise terminated by MGI, then, effective upon the effectivedate of termination of the SuperGen License Agreement, SuperGen shall promptlyenter into an agreement with Licensee on the same terms and conditions of thisAgreement,, except as provided in subsections (i), (ii) and (iii) below: (i.)  In no event shall SuperGen be obligated to undertake anydevelopment obligation of MGI under this Agreement, provided that Licenseeshall have the right to conduct any development that was a pre-existing MGIobligation at its sole cost and expense should SuperGen elect not to performsuch activities; however, if following such continuation of Licensee’s rightsand license hereunder, SuperGen does not undertake to perform any developmentof obligation of MGI for which twenty-five percent (25%) of the patients havebeen enrolled prior to the effective date of termination, then the royaltyotherwise payable by Licensee to SuperGen under this Agreement shall be reducedby the actual amount incurred by Licensee or by a third party on Licensee’sbehalf (the “Licensee Additional Development Costs”), to perform suchdevelopment obligations subject to Section 13.3(e); *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy* (ii.) following such continuation of Licensee’s rights and licensehereunder, SuperGen shall, subject to Section 13.3(f), either (1) supplyLicensed Products to Licensee under the terms of this Agreement and theadditional Agreements referenced herein (such as the Manufacturing and SupplyAgreement and the Quality Agreement) or entered into between MGI and Licenseerelated to the Product, or (2) shall assign to Licensee all Manufacturingagreements related to Licensee’s receipt of Licensed Products, including thePharmachemie Agreement and the Ferro Pfanstiehl Agreement and the otheragreements listed on Schedule 1.75, in which case Licensee shall supplyLicensed Product to SuperGen under terms and conditions at least as beneficialas those under which Licensee was purchasing its supply of Licensed Productunder this Agreement, the additional Agreements referenced herein (such as theManufacturing and Supply Agreement and the Quality Agreement) and anysubsequent agreements or entered into between MGI and Licensee related to thesupply of Product, such terms and conditions to be embodied in a separatesupply agreement which shall be negotiated in good faith by Licensee andSuperGen; and  (iii.)  Licensee expressly agrees that SuperGen shall assume no losses, costs,liabilities or damages that arise out of or relate to MGI’s performance,non-performance or breach of this Agreement; and  (iv.)  as between Licensee and SuperGen, the provisions of Section15.2, 15.3, 15.4 and the first sentence of Section 15.19 hereof shall apply toSuperGen in the same manner such provisions they apply to MGI. (d) Prior to the assignment of the SuperGen License Agreement by MGI to asuccessor-in-interest to all or substantially all of the business or assets of MGIpursuant to Section 16.6 of SuperGen License Agreement, MGI shall either (i)obtain the written confirmation of such successor-in-interest that it shallprovide Licensee with supply of Licensed Product under the same terms andconditions as under this Agreement, the additional Agreements referenced herein(such as the Manufacturing and Supply Agreement and the Quality Agreement) and anysubsequent agreements entered into between MGI and Licensee related to the supply of Product, or (2) assign to Licenseeall Manufacturing agreements related to the Licensed Products, including thePharmachemie Agreement and the Ferro Pfanstiehl Agreement and the otheragreements listed on Schedule 1.75, in which case Licensee shall supplyLicensed Product to MGI under the terms and conditions of this Agreement andpursuant to a separate supply agreement which shall be negotiated in good faithby Licensee and MGI.  (e) If the royalty paid by Licensee is reduced pursuant to Section13.3(c)(i), then the reduction shall only be in effect until Licensee AdditionalDevelopment * Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy*   Costs up to * dollars have been recouped through the royalty reduction.  (f) In the event that the SuperGen License Agreement is terminated eitherby SuperGen due to the breach of such Agreement by MGI, and such termination isnot related to any breach by licensee of the terms of this Agreement, or otherwiseterminated by MGI, then MGI shall assign all Manufacturing agreements related toLicensee’s receipt of Licensed Products to SuperGen, subject to SuperGen’sconsent, not to be unreasonably withheld.  (g) Change of Control of MGI. In the event of a Change ofControl of MGI or the assignment by MGI of this Agreement pursuant to Section15.13 of this Agreement, MGI shall either (i) obtain the written confirmation ofsuch Change in Control party that it shall provide Licensee with supply ofLicensed Product under the same terms and conditions as under this Agreement, theadditional Agreements referenced herein (such as the Manufacturing and SupplyAgreement and the Quality Agreement) and any subsequent agreements entered intobetween MGI and Licensee related to the supply of Product, or (2) assign toLicensee all Manufacturing agreements related to Licensee’s receipt of LicensedProducts, including the Pharmachemie Agreement and the Ferro Pfanstiehl Agreementand the other agreements listed on Schedule 1.75, in which case Licensee shallsupply Licensed Product to MGI, or the successor-in-interest of MGI’s interest inthis Agreement, as the case may be, under the terms and conditions of thisAgreement and pursuant to a separate supply agreement which shall be negotiated ingood faith by Licensee and MGI or Licensee and the successor-in-interest of MGI’sinterest in this Agreement, as the case may be. 13.4. Insolvency of a Party. The Parties shall have the respective rights set forthin this Section 13.4 in the event of the Insolvency of the other Party. (a) For purposes of this Agreement and this Section 13.4,“Insolvent” shall mean: (i.)  the commencement of a voluntary case or other voluntaryproceeding seeking liquidation, reorganization or other relief by a Party withrespect to itself or its debts under any bankruptcy, insolvency or othersimilar law or seeking the appointment of a trustee, receiver, liquidator,custodian or similar official of it or of any substantial part of its propertyto which this Agreement pertains, or the consent by a Party to any such reliefor to the appointment of or taking possession by any such official in aninvoluntary case or other proceeding commenced against it, or making a generalassignment for the benefit of creditors, or, or taking any corporate action toauthorize any of the foregoing; has an involuntary case or other involuntaryproceeding commenced against it seeking liquidation, *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy*    reorganization or other relief with respect to it or its debts under anybankruptcy, insolvency or other similar law now or hereafter in effect orseeking the appointment of a trustee, receiver, liquidator, custodian orother similar official of it or any substantial part of its property, andsuch involuntary case or other proceeding remains undismissed and unstayedfor a period of ninety (90) days; or an order for relief is entered againstsuch Party under applicable bankruptcy laws; or  (ii.) the inability of a Party to pay its debts as they become dueand such Party has explicitly or implicitly suspended payment of all orsubstantially all of its debts as they become due, or in the event that thecreditors of such Party take over its management. (b) Termination in the Event of Licensee’s Insolvency. MGI mayterminate this Agreement upon written notice to Licensee in accordance with theprovisions of Section 15.12, if, at any time, Licensee is Insolvent as defined inSection 13.4(a).  (c) Rights in the Event of Insolvency. The Parties acknowledgeand agree that the rights and licenses granted pursuant to this Agreement are, andshall otherwise be deemed to be, for the purposes of Section 365(n) of the U.S.Bankruptcy Code, licenses of rights to “intellectual property” as defined underSection 101(35A) of the Bankruptcy Code, and that the Parties, each as a licenseehereunder, shall retain and may fully exercise all of its rights and electionsunder the Bankruptcy Code. 13.5. Termination on a Country-by-Country Basis. In the event of the occurrence ofa termination event or failure to cure under the terms of Section 13.2, 13.3 or 13.4, thenon-breaching Party shall have the right to terminate this Agreement in its entirety;provided that if MGI is the terminating Party, it may elect to terminate this Agreementonly in a given country in the Territory where such termination event relates to theDevelopment or Commercialization of the Licensed Products in such given country. Anytermination hereunder shall be by written notice of termination, which shall be effectiveon the date such notice is received pursuant to the provisions of Section 15.12.  13.6. Tolling of Cure Period. In the event of a dispute as to whether performancehas been made by either Party pursuant to this Agreement, the relevant cure period withrespect thereto shall be tolled pending resolution of such dispute in accordance with theapplicable provisions of this Agreement.**ARTICLE 14: EFFECT OF EXPIRATION OR TERMINATION** 14.1. Accrued Obligations. Termination or expiration of this Agreement for anyreason shall not release any Party hereto from any liability (including payments due for aperiod prior to such termination or expiration) which, at the time of such termination *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy* ** ** or expiration, has already accrued to the other Party or which is attributable to a periodprior to such termination or expiration nor preclude either Party frompursuing all rights and remedies it may have hereunder or at law or in equity withrespect to any breach of this Agreement.  14.2. Effects of any Expiration or Termination. Upon any expiration or terminationof this Agreement, in whole or in part, Articles 7, 8, 10, 12, 14, 15, and Sections 5.11and 9.4 shall survive with respect to the Licensed Products sold by or under authority ofLicensee. (a) Licensee’s rights and licenses hereunder shall survive solely to theextent necessary for Licensee to perform its responsibilities pursuant to Section14.3 below. Neither Licensee nor its Affiliates shall have any right to grant orauthorize any rights or licenses under Section 2.1. All other terms andconditions shall terminate and have no further force or effect. For clarity, inthe event that rights are terminated only with respect to certain countries in theTerritory, the Development and Commercialization of such Licensed Products or insuch countries by and under authority of MGI shall not be subject to Section 2.3.  (b) In the event of termination of this Agreement under Section 13.2(b)or termination due to insolvency or material breach by Licensee, all rights ofcross reference that have been provided to Licensee shall terminate, and allprosecution and enforcement of Licensed Patents by or under authority of Licenseeshall be transitioned to MGI promptly, except to the extent otherwise agreed inwriting.  (c) In the event this Agreement is terminated in its entirety due to thematerial breach thereof by the Licensee, or if this Agreement is terminated byLicensee under Section 13.2(b) or 13.2(c), in addition to any other obligationsset out in this Agreement, Licensee shall return to MGI, at Licensee’s cost andexpense, all existing information, data, intellectual property rights,administrative authorizations and of all other know-how relating to thedevelopment and commercialization of the Licensed Products in Licensee’spossession, and ownership of the same shall revert to MGI. Termination by MGI formaterial breach by Licensee relating to any royalty payment owed to MGI hereunderwill constitute a breach only with regard to the country(ies) in the Territory towhich the breach specifically applies. Termination by MGI for material breach byLicensee relating to any development milestone payment owed to MGI hereunder shallconstitute a breach of this Agreement in its entirety. 14.3. Rights on Expiration or Termination. References to termination in thisArticle 14 shall be deemed to include expiration of this Agreement. Upon any terminationof this Agreement in its entirety, the following shall apply. In the event that this *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy*   Agreement is terminated only with respect to a country in the Territory, then the followingshall apply. (a) Wind-down Period. Following expiration of this Agreement ortermination as set forth above, the Parties agree as follows, provided that at itsoption, MGI may terminate the Wind-down Period as otherwise set forth herein, uponthirty (30) days written notice to Licensee. As used herein, “Wind-down Period” shall mean the one ninety (90) day period following thetermination of this Agreement.  (b) Development. In the event that the Licensed Products isunder Development in the Territory, at MGI’s request, Licensee agrees to continuefor a period not to exceed ninety (90) days after such termination the Developmentat its own expense, and to transition such Development to MGI to the extentrequested.  (c) Commercialization. At MGI’s request, if MarketingAuthorization has been or is obtained for the Licensed Products, then Licensee andits Affiliates shall continue to Commercialize the Licensed Products in the samemanner in each country in the Territory for which Marketing Authorizationtherefore has been obtained, in accordance with the terms and conditions of thisAgreement, for a period not to exceed two hundred forty (240) days following suchtermination it being understood that MGI and Licensee will work diligently totransition such activities as soon as reasonably practicable. Notwithstanding anyother provision of this Agreement, during the Wind-down Period, Licensee’s and itsAffiliates’ rights with respect to the Licensed Products shall be non-exclusive,and MGI shall have the right to engage one or more other distributor(s) and/orlicensee(s) to Develop and Commercialize the Licensed Products in all portions ofthe Territory that have been terminated. Article 3 shall continue to apply withrespect to all the Licensed Products sold, used or disposed by Licensee and itsAffiliates during the Wind-down Period or otherwise as set forth below. Allrights of Licensee and its Affiliates with respect to the Licensed Products shallbe terminated at the end of the Wind-down Period, and unless otherwise mutuallyagreed or unless rights have been terminated only with respect to a specifiedcountry, and Licensee retains rights to Develop and Commercialize the LicensedProducts for other countries, all the Licensed Products in the possession ofLicensee and its Affiliates that are not sold during such Wind-down Period shallbe destroyed, provided, however, that Licensee shall have a minimum of onehundred-eighty (180) days following termination of the Wind-down Period to sellits remaining inventory, without regard to the actual length of the Wind-downPeriod. Any remaining unsold inventory shall be transferred to MGI at cost.  (d) Assignment of MAA and Marketing Authorizations. Licenseeshall assign or cause to be assigned to MGI (or if not feasible to immediatelyassign, *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy*   Licensee shall take all reasonable actions to make available to MGI(including by providing copies), and to give MGI and its Affiliates and itsdesignees a right of reference to) all Regulatory Documentation (including MAAsand Marketing Authorizations) and Supporting Data for the Licensed Productsobtained in Licensee’s name hereunder. In each case the foregoing assignment (oravailability and right of reference) shall be made or provided no later fifteen(15) days after termination, and Licensee shall take, and shall cause itsAffiliates to take, such actions and execute such other instruments, assignmentsand documents as may be necessary to effect the transfer of rights thereunder toMGI. In addition, Licensee shall promptly provide toMGI a copy of all Regulatory Documentation, Supporting Data, and ConfidentialInformation pertaining to the Licensed Products to the extent not previouslyprovided to MGI. MGI shall have sole control over all Regulatory Documentationand meetings and communications with Regulatory Authorities immediately upontermination.  (e) Transition. Licensee shall use Diligent Efforts, as definedin Section 1.24, to cooperate with MGI and its designee(s) to effect a smooth andorderly transition in the Development and Commercialization of the LicensedProducts in the Territory. Without limiting the foregoing, Licensee shall provideMGI copies of Sales Materials, Licensed Products labeling, other customerinformation, each relating to the Licensed Products to the extent not previouslyprovided to MGI. In addition, Licensee shall refer all inquiries regarding theLicensed Products after the Wind-down Period (and during the Wind-down Period tothe extent requested by MGI) to MGI and its designees. In addition, Licenseeshall provide to MGI a list of all customers purchasing the Licensed Products fromLicensee in the year prior to termination or expiration of the Agreement. 14.4. Rights. To the extent not assigned to or owned by MGI, Licensee hereby grantsto MGI, effective following termination of this Agreement but no later than the end of theWind-down Period, a worldwide, irrevocable, fully paid, royalty free, right and license,under all Sales Materials, and Confidential Information, with the right to grant andauthorize sublicenses, to use, disclose, reference, publicly display, modify, reproduce,distribute, and otherwise exploit and dispose of the foregoing for any purpose, includingthe right to make, have made, use, sell, offer to sell, import and otherwise exploit anddispose of the Licensed Products in the Territory; provided that MGI shall not exercise theforegoing rights and licenses until termination of this Agreement in whole or in part. (a) Return of Materials. Within thirty (30) days after the endof the Wind-down Period, Licensee shall, and shall cause its Affiliates to,deliver to MGI, or to the extent requested by MGI destroy, all materialscontaining the Product Trademark, Supporting Data, and other ConfidentialInformation of MGI, (except to the extent otherwise authorized by MGI) that is inLicensee’s or its *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy*   Affiliates’ possession or control, and provide writtencertification thereof. Effective upon the end of the Wind-down Period (or soonerif requested by MGI), Licensee shall cease, and shall cause its Affiliates tocease, all use of the Product Trademark, Regulatory Documentation, SupportingData, and Confidential Information of MGI, with respect to terminated LicensedProducts in the terminated countries in the Territory.  (b) Rights on termination pursuant to Section 13.2(b) and (c).In the event of termination under Section 13.2(b) or (c) of this Agreement,Licensee will transfer information and Licensed Product consistent with theprovisions of this Section 14, except that Licensee, at its option, may elect tocease all sales and marketing activities in one or more countries or in theTerritory, at its sole discretion.**ARTICLE 15: MISCELLANEOUS** 15.1. Article and Section Headings, Language and Construction. The Article andSection headings contained in this Agreement are for reference purposes only and shall notaffect in any way the meaning or interpretation of this Agreement. All references in thisAgreement to “Articles,” “Sections,” “Exhibits” and “Schedules” refer to the articles,sections and exhibits of this Agreement. The words “hereof,” “herein” and “hereunder” andother words of similar import refer to this Agreement as a whole and not to any subdivisioncontained in this Agreement. The words “include” and “including” when used herein are notexclusive and mean “include, without limitation” and “including, without limitation,”respectively. References in this Agreement to “days” shall mean calendar days unlessexpressly indicated to the contrary. This Agreement has been negotiated by the Parties andtheir respective counsel. Accordingly, this Agreement will be interpreted fairly inaccordance with its terms and without any strict construction in favor of or against eitherParty.  15.2. Governing Law. Governing Law. This Agreement shall be governed in allrespects by the internal laws of the State of New York as applied to contracts entered intosolely between residents of, and to be performed entirely within, such state, and withoutreference to principles of conflicts of laws or choice of laws.  15.3. Submission to Jurisdiction. Each of the Parties irrevocably agrees that anylegal action or proceeding with respect to this Agreement or for recognition andenforcement of any judgment in respect hereof brought by the other Party hereto or itssuccessors or assigns shall be brought and determined in the federal courts located in theState of New York, and each of the Parties hereby irrevocably submits with regard to anysuch action or proceeding for itself and in respect to its property, generally andunconditionally, to the exclusive jurisdiction of the aforesaid courts.  15.4. Waiver of Jury Trial. EACH PARTY HEREBY IRREVOCABLY WAIVES ALL RIGHT TO TRIALBY JURY IN ANY ACTION, PROCEEDING OR *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy*   COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT OROTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE ACTIONS OF THE PARTIES INTHE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND ENFORCEMENT HEREOF.  15.5. Other Remedies. Except as otherwise provided herein, any and all remediesherein expressly conferred upon a Party will be deemed cumulative with and not exclusive ofany other remedy conferred hereby, or by law or equity upon such Party, and the exercise bya Party of any one remedy will not preclude the exercise of any other remedy.  15.6. Injunctive Relief. Because of, among other things, the unique nature of theLicensed Patents, Product Improvements and Licensed Know-How which are the subject of thisAgreement, the potential that lost opportunity costs may not be quantifiable, the Partieshereto agree that irreparable damage may occur in the event that any of the provisions ofthis Agreement, were not performed in accordance with their specific terms or wereotherwise breached. The Parties accordingly agree that injunctive relief enforcing theterms of this Agreement may be appropriate.  15.7. Dispute Resolution. Except as otherwise agreed, disputes arising within theJOC shall be referred to the Joint Steering Committee for resolution (“DisputeResolution”). Disputes arising within the JOC which cannot be resolved by the JointSteering Committee, disputes arising within the Joint Steering Committee, and any and allother disputes between the Parties arising out of or relating to this Agreement or thenegotiation, performance, termination, validity or breach thereof, shall be resolved asfollows and in the following order of preference: by good faith negotiation between theCEOs of MGI and Licensee, who shall have the authority to fully and finally resolve thedispute. In the event the designated Executive Officers are not able to resolve suchdispute, either Party may elect within the following fourteen (14) calendar day period toresolve the dispute by conducting non-binding mediation; either Party may at any timefollowing such mediation or after the expiry of the fourteen (14) calendar day period ifthe Parties do not elect to conduct non-binding mediation, seek to resolve the disputethrough other means as provided herein.  15.8. Alternative Dispute Resolution. Any dispute controversy or claim arising outof or relating to the validity, construction, enforceability or performance of thisAgreement, including disputes relating to an alleged breach or to termination of thisAgreement, but excluding (a) any dispute, controversy or claim arising out of or relatingto the validity, enforceability, or infringement of any Licensed Patent and (b) other thandisputes which are expressly prohibited herein from being resolved by this mechanism, shallbe settled by binding Alternative Dispute Resolution (“DR”) in the manner describedbelow: (a) Notice of Arbitration. If a Party intends to begin a DR toresolve a dispute, such Party shall provide written notice (the “DRRequest”) to counsel for the *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy* ** ** other Party informing such other Party of suchintention and the issues to be resolved. Within thirty (30) calendar days afterreceipt of the DR Request, the other Party may, by written notice to counsel forthe Party initiating DR, add additional issues to be resolved.  (b) Arbitration Procedures. A DR initiated under this Agreementwill proceed in accordance with the Commercial Arbitration Rules of the AmericanArbitration Association for Large, Complex Cases then in effect, insofar as suchrules are not inconsistent with the provisions expressly set forth in thisAgreement, unless the Parties mutually agree otherwise. However, the Parties donot intend to submit the issue for resolution by such association unless theymutually agree to do so, in writing.  (c) Arbitrators. The arbitration shall be carried out by asingle arbitrator who shall be a retired United States judge or justice and shallbe selected by the Parties within thirty (30) calendar days of receipt of the DRRequest in accordance with the procedure described below: (i.) Qualifications. The Parties shall select the arbitratoras described below, which may but need not be selected from a list ofarbitrators such as the CPR Panel of Distinguished Neutrals of the Center forPublic Resources, subject to: (a) his/her availability and willingness toserve, (b) his/her availability to commence the arbitration within a reasonableperiod oftime, (c) his/her agreement to charge fees and expenses that are reasonableunder the circumstances, and (d) his/her commitment to render his/her awardwithin the time periods provided in this Section 15.8.  (ii.) Selection. Each Party will exchange a list of ten(10) qualified arbitrators and in the event that both Parties agree on a singleperson then such person shall be the arbitrator. In submitting the ten names,each Party shall prioritize from one to ten the persons on their respectivelists. In the event that there is more than one common name on the Parties’lists, the person having the lowest combined priority number shall be selectedas the arbitrator. The combined priority number shall be the sum of the ordernumbers assigned to that person by the Parties. Thus, if one person was MGI’snumber two priority and Licensee’s number three priority, and another personwas MGI’s number two priority and Licensee’s number four priority, the formerwould be appointed. If more than one person has the lowest combined prioritynumber, the person for whom there is less difference between the order numbersassigned by the Parties shall be appointed. Thus, if one person was MGI’snumber one priority and Licensee’s number four priority, and another person wasMGI’s number two priority and Licensee’s number three priority, the latterperson would be appointed. If this method does not produce an arbitrator, orif there are no common names, the Parties shall alternatively strike from thecombined list until only one name remains, which shall be *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy*   selected as thearbitrator. The Party to strike first shall be determined by the toss of acoin. In the event the arbitrator is unable to meet the requirements set forthin (i) above, then, in the event the first selected arbitrator was common toboth lists and there was more than one common name on the Parties’ lists, thearbitrator having the next lowest combined priority number who is able andwilling to serve pursuant to these requirements shall be selected. If there isno such individual, then the Parties shall use the alternate strike method setforth above. In the event an arbitrator selected by the alternate strikemethodology is unable or unwilling to serve consistent with the requirementsset forth above, then the alternate striking procedure shall be retraced inreverse order until the arbitrator is selected.  (iii.) Conduct. The arbitrator shall be neutral, disinterested, impartial,and independent of the Parties and others having any known interest in theoutcome, and shall abide by the AAA/ABA Code of Ethics for Arbitrators inCommercial Disputes. There shall be no ex parte communications with thearbitrator either before or during the arbitration, relating to the dispute orissues involved in the dispute or the arbitrator’s views on any such issue.  (iv.) Interim Review. Either Party may apply to any courthaving jurisdiction hereof and seek preliminary injunctive relief until suchtime as the arbitration award is rendered or the controversy is otherwiseresolved.  (v.) Location. Any arbitration under this Section 15.8shall be conducted in New York, NY. (d) Discovery Proceedings. The Parties shall have the right toundertake complete discovery, as contemplated by and pursuant to Federal Rules26-37 of the Federal Rules of Civil Procedure (with references to “court” in thoseRules being considered references to the “arbitrator”) except as they may bemodified by the following: (i.) Within thirty (30) calendar days after selection of thearbitrator, each Party may serve on any other Party (a) interrogatories for thepurpose of identification of documents and witnesses, (b) requests foradmissions, and (c) requests for the production of documents and things. Thesediscovery requests will be answered within fourteen (14) calendar days ofreceipt.  (ii.) At any time but not more than six (6) months after theselection of the arbitrator, each Party may take depositions of employees orother witnesses of an opposing Party as a matter of right, subject toapplicable limitations set forth in Rules 26-37. *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy* (iii.) Any Party may conduct depositions of its own witnesses which may beintroduced as evidence at the arbitration hearing if the other Party was givenfair opportunity to attend the deposition and cross-examine.  (iv.) As they become aware of new documents or information,including experts who may be called upon to testify, all Parties remain under acontinuing obligation to provide documents upon which they rely, to supplementtheir responses, and to honor any informal agreements or understandings betweenthe Parties regarding documents or information to be exchanged. The arbitratorat the hearing will not consider documents that have not been previouslyexchanged, unless agreed by the Parties or used for purposes of impeachment.  (v.)   The Parties will promptly notify the arbitrator when anunresolved dispute exists regarding discovery issues. The arbitrator willdiscuss the matter with the Parties to determine the nature of the dispute andwill attempt to resolve that dispute. If the arbitrator does not resolve thedispute, the arbitrators will arrange a conference concerning the disputebefore the arbitrator by telephone, or in person, and the arbitrator willdecide the dispute.  (vi.)  All discovery shall be completed within six (6) months fromselection of the arbitrator, unless extended by agreement of the Parties or bythe arbitrator for good cause shown. (e) Hearings and Proceedings. The arbitrator will determine thespecific location within New York, NY and the date and time of the arbitrationhearing(s) and other proceedings after consultation with the arbitrator and theParties and will provide reasonable notice of the hearing(s) date and time. Thearbitrator will make every effort to schedule the arbitration hearing withinninety (90)calendar days of the completion of all discovery, absent unusual circumstances. (i.)  The Parties may mutually agree on or the arbitrator for goodcause may order a rescheduling of the hearing date.  (ii.)  The arbitrator will ordinarily conduct the arbitration hearingin the manner set forth in this Section 15.8 except that (i) the Federal Rulesof Evidence shall apply and (ii) the arbitrator shall render its decision inwriting in the manner provided by Rule 52 of the Federal Rules of CivilProcedure, including a full and precise statement of the factual and legalbases for such decision. If the AAA rules and the rules of this Section 15.8conflict in any manner, the rules of this Section shall prevail. Thearbitrator must hold an oral hearing, but may impose reasonable time limits oneach phase of the proceeding and may limit testimony to exclude evidence thatwould be immaterial or unduly repetitive, provided that all Parties areafforded the opportunity to present material and *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy*   relevant evidence and thateach Party is given at least an approximately equal amount of time forpresentation of its case.  (iii.) Written briefs may be filed up to five (5) calendar days before the hearing.  (iv.) The arbitrator will require witnesses to testify under oath ifrequested by any Party.  (v.) Any Party desiring a stenographic record may secure a courtreporter to attend the proceedings.  (vi.) The arbitrator will determine the order of proof, which willgenerally be similar to that of a court trial, including opening and closingstatements.  (vii.) When the arbitrator determines that all relevant and material evidence andarguments have been presented, the arbitrator will declare the hearing closed.The arbitrator may defer the closing of the hearing for up to twenty (20)calendar days to permit the Parties to submit post-hearing briefs and or tomake closing arguments, as the arbitrator deems appropriate, before renderingan award.  (viii.)  The arbitrator will render the award and its decisions pursuant to Fed. R.Civ. P. 52 within thirty (30) calendar days after the date of the closing ofthe hearing or, if an arbitration hearing has been waived, within thirty (30)calendar days after the date of the arbitrator’s receiving all materialsspecified by the Parties. The decision and award of the arbitrator willconstitute the Arbitration Award and will be binding on the Parties.  (ix.) The arbitrator shall, in rendering his or her decision andaward, apply the substantive law of the State of New York, without regard toits conflict of laws provisions, except that the interpretation of andenforcement of this Section shall be governed by the Federal Arbitration Act.The costs of the winning Party and the fees of the arbitrator shall be paid bythe losing Party as determined by the arbitrator. If the arbitrator is unabletodesignate a losing party, it shall so state and each Party shall bear itsown costs and the fees of the arbitrator shall be split equally between theParties. (f) Award. The arbitrator is empowered to award any remedyallowed by law, including money damages, prejudgment interest and attorneys’ fees,and to grant final, complete, interim, or interlocutory relief, includinginjunctive relief. Notwithstanding the foregoing, punitive or multiple damagesmay not be awarded.  (g) Legal Fees. Except as set forth in Section 15.8(e)(ix)above, each Party shall bear its own legal fees. *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy* (h) Confidentiality. The DR proceeding shall be confidential andthe arbitrator shall issue appropriate protective orders to safeguard each Party’sConfidential Information. Except as required by law, no Party shall make (orinstruct the arbitrator to make) any public announcement with respect to theproceedings or decision of the arbitrator without prior written consent of eachother Party. The existence of any dispute submitted to DR, and the award, shallbe kept in confidence by the Parties and the arbitrator, except as required inconnection with the enforcement of such award or as otherwise required byapplicable law.  (i) Survivability. Any duty to arbitrate under this Agreementshall remain in effect and enforceable after termination of this Agreement for anyreason. 15.9 Jurisdiction. For the purposes of this Article 15 each Party agrees to abideby the award rendered in any arbitration, and the Parties agree to accept the jurisdictionof any court having jurisdiction over the Parties for the purposes of enforcing awardsentered pursuant to this Article 15 and for enforcing the agreements reflected in thisArticle 15, provided that the foregoing shall not be deemed to waive any rights of eitherParty under the Federal Arbitration Act.  15.10 No Implied Waivers; Rights Cumulative. It is agreed that no waiver by eitherParty hereto of any breach or default of any of the covenants, representations, orwarranties herein set forth shall be effective unless in a writing signed by such Party,and no such written waiver shall be deemed a waiver as to any subsequent and/or similarbreach or default.  15.11 Independent Contractors. The relationship of Licensee and MGI established bythis Agreement is that of independent contractors. Nothing in this Agreement shall beconstrued to create any relationship other than independent contractors. Licensee and MGIshall under no circumstances be considered engaged in a partnership or joint venture byvirtue of this Agreement. Neither Party shall have any right, power or authority toassume, create or incur any expense, liability or obligation, express or implied, on behalfof the other or to conclude contracts in the name of the other.  15.12 Notices. Any notice required or permitted to be given hereunder shall be inwriting and shall be delivered in person, by a nationally recognized overnight courier, orby facsimile (receipt confirmed, with a confirmation notice sent by one of the othermethods specified herein), to the addresses given below or such other addresses asmay be designated in writing by the Parties from time to time during the term, andshall be deemed to have been given when received unless otherwise specified herein aswhen sent.       Licensee: CILAG GmbH INTERNATIONAL    Landis + Gry-Strasse 1    CH-6300    Zug, Switzerland    Attention: Company President * Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy*         Facsimile: 41 41 7255101         With copy to:         Johnson & Johnson    One Johnson & Johnson Plaza    New Brunswick, New Jersey 08933    Attention: Chief Patent Counsel    Facsimile: 732- 524-2138       MGI:      MGI PHARMA, INC.    5775 West Old Shakopee Road, Suite 100    Bloomington, MN 55437-3174    Attn: Eric P. Loukas, General Counsel    Telephone: 952-406-3181    Facsimile: 952-406-3281 ** ** or to such other address (including electronic mail address) as MGI shall havefurnished to Licensee in writing or by electronic mail. Notices that are mailed by (i)first class mail shall be deemed received three (3) business days after deposit in themail and (ii) Express Mail or overnight courier shall be deemed received one (1)business day after deposit in the mail or delivery to such courier. In the event thatthe notice is sent by facsimile, notice shall be deemed to have been received when sentand confirmed as to receipt.  15.13 Assignment. This Agreement shall not be assignable by Licensee to any otherperson or entity without the written consent of MGI, which shall not be unreasonablywithheld; provided that either Party shall, without the consent of the other Party, beentitled to assign its rights to a third party of reasonably equivalent capabilities in thedevelopment and commercialization of pharmaceutical products, in the event of a merger orconsolidation with, or the transfer of substantially all of its assets to such third party;provided, however, that should Licensee make such an assignment of this Agreement with aThird Party that is marketing or developing any Competing Product or that productcompetitive to the Licensed Products with the trade name Vidaza, in the Territory, and suchThird Party does not take action to divest the same under Section 13.3(b)(ii), MGI mayterminate this Agreement immediately and treat the termination as one due to a materialbreach of this Agreement by said Third Party.  15.14 Modification. No amendment or modification of any provision of this Agreementshall be effective unless in writing signed by all Parties hereto. No provision of thisAgreement shall be varied, contradicted or explained by any oral agreement, course ofdealing or performance or any other matter not set forth in an agreement in writing andsigned by all Parties. *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy* 15.15 Severability. If any provision hereof should be held invalid, illegal orunenforceable in any jurisdiction, the Parties shall negotiate in good faith a valid, legaland enforceable substitute provision that most nearly reflects the original intent of theParties and all other provisions hereof shall remain in full force and effect in suchjurisdiction and shall be liberally construed in order to carry out the intentions of theParties hereto as nearly as may be possible. Such invalidity, illegality orunenforceability shall not affect the validity, legality or enforceability of suchprovision in any other jurisdiction.  15.16 Publicity Review. Neither Party shall originate any written publicity, newsrelease or other public announcement or statement relating to the announcement or terms ofthis Agreement (collectively, a “Public Disclosure”), without the prior review andwritten approval of the other Party, which approval shall not be unreasonably withheld ordelayed. Notwithstanding the foregoing, either Party may make any Public Disclosure itbelieves in good faith based upon the advice of counsel is required by applicable law, ruleor regulation or any listing or trading agreement concerning its or its Affiliates’publicly traded securities; provided, however, that such Public Disclosure shall minimizeto the extent possible the financial information disclosed, and that prior to making suchPublic Disclosure, the disclosing Party shall provide to the other Party a copy of thematerials proposed to be disclosed and provide the receiving Party with an opportunity topromptly review the Public Disclosure. Notwithstanding the foregoing, the Parties agreedto a press release to announce the execution of this Agreement, attached hereto as Schedule2.0; thereafter, Licensee and MGI may each disclose the information contained in such pressrelease without the need for further approval by the other. In addition, notwithstandinganything to the contrary, each Party shall have the right to disclose the existence andterms of this Agreement to the extent set forth in Section 10.5 above.  15.17 Counterparts. This Agreement may be executed in two counterparts, each ofwhich shall be deemed an original, and all of which together, shall constitute one and thesame instrument.  15.18 Export Laws. Notwithstanding anything to the contrary contained herein, allobligations of MGI and Licensee are subject to prior compliance with United States andforeign export regulations and such other United States and foreign laws and regulations asmay be applicable, and to obtaining all necessary approvals required by the applicableagencies of the governments of the United States and foreign jurisdictions. MGI andLicensee shall cooperate with each other and shall provide assistance to the other asreasonably necessary to obtain any required approvals.  15.19 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THEOTHER FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, HOWEVER CAUSED ANDWHETHER BASED INCONTRACT, TORT OR UNDER ANY OTHER THEORY OF LIABILITY. THE FOREGOING LIMITATIONSFURTHER SHALL NOT APPLY TO EITHER *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy*   PARTY’S OBLIGATIONS UNDER ARTICLE 12, OR EITHERPARTY’S BREACH OF ARTICLE 10. The Parties agree that nothing in this Section 15.19shall in any way affect or impair the ability of the Parties to seek injunctive reliefpursuant to Section 15.6 hereof.  15.20 Entire Agreement. This Agreement, together with all the Schedules heretoconstitute the full and entire understanding and agreement between the Parties with respectto the subject matter hereof, and supersede all prior and contemporaneous agreements,understandings, negotiations and discussions, whether oral or written, of the Parties withrespect thereto, including any term sheet.IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly executed and deliveredin duplicate originals.       **MGI PHARMA, INC.**   **LICENSEE:**         /s/ Leon O. Moulder, Jr.   /s/ Heinz Schmid   By: Leon O. Moulder, Jr.    By: Heinz Schmid  Title: President and CEO   Title: General Manager  **SCHEDULES:**   **Schedule 1.7** **J&J Universal Calendar – 2006****Schedule 1.18** **Decitabine****Schedule 1.51** **Licensed Patents****Schedule 1.66** **Orphan Product Designation for Decitabine in EC****Schedule 1.75** **Manufacturing and Supply Agreements****Schedule 1.80** **License Agreement between SuperGen, Inc. and MGI Pharma, Inc.****Schedule 1.90** **R&D/GCP Audit Plan****Schedule 2.0** **Press Release****Schedule 2.1** **Example of Currency Conversion****Schedule 3.0** **Initial Global Development Plan & Listing of On-going Clinical Trial****Schedule 6.1(b)** **Minimum Product Order Quantities****Schedule 6.1(c)** **Licensee Initial Product Forecast****Schedule 6.1(e)** **Form of Purchase Order** *  Denotes confidential information that has been omitted from theexhibit and filed separately, accompanied by a confidential treatment request,with the Securities and Exchange Commission pursuant to Rule 24b-2 of theSecurities Exchange Act of 1934.
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*Execution Copy***SCHEDULE 1.7 — J&J Universal Calendar 2006**