LICENSE AGREEMENT

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General

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Development

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Research and Development Support

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New Indications

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Additional Trials

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Delivery of Information

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Regulatory Responsibilities

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Safety Reporting

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Licensed Products Supplied to Named Patients

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Commercialization

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Voluntary and Mandatory Recalls: Potential Hazards

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Records and Reports

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Third Parties

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Manufacturing and Supply Agreement

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Pricing

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Quality Assurance

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Assignment of Existing Supply Agreements

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Milestone Payments

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Royalty Reports and Payments

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Payment Method

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Currency Conversion

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Taxes

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Records and Inspection

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Jurisdiction

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No Implied Waivers: Rights Cumulative

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Independent Contractors

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Notices

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Assignment

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Modification

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Severability

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Publicity Review

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Counterparts

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Export Laws

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Limitation of Liability

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Entire Agreement

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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 that controls, is controlled by or is under common control with the subject entity, but only for so long as such control exists. For purposes of this definition only, “control” shall mean beneficial ownership (direct or indirect) of at least fifty percent (50%) of the shares of the subject entity entitled to vote in the election of directors (or, in the case of an entity 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 least fifty percent (50%), then “control” shall mean the beneficial ownership (direct or indirect) of the maximum percentage of outstanding stock or voting rights permitted by local 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 Products supplied by MGI to Licensee for labeling and distribution in the Territory pursuant to the terms hereof.

1.7.

“ Calendar Quarter ” shall mean a calendar quarter based on the J&J Universal Calendar for that year, a copy of which, for 2006, is attached hereto as Schedule 1.7, and which shall be updated by Licensee for each Calendar Year of the Term consistent with the J&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 Effective Date to the end of the then-current Calendar Quarter and the last Calendar Quarter shall extend from the first day of such Calendar Quarter until the effective date of the termination or expiration of the Agreement.

1.8.

“ Calendar Year ” shall mean a calendar year during the Term based on the J&J Universal Calendar for that year, a copy of which, for 2006, is attached hereto as Schedule 1.7, and which shall be updated by Licensee for each Calendar Year of the Term consistent with the J&J Universal Calendar used for Licensee’s internal business purposes. For the first Calendar Year, the Calendar Year shall begin on the Effective Date and the last day shall be December 31, 2006. The last Calendar Year of the Term shall begin on the first day of the J&J Universal Calendar Year for the year during which termination or expiration of the Agreement will occur, and the last day of such Calendar Year shall be the effective date of such termination or expiration.

1.9.

“ Change of Control ” shall mean, with respect to a Party, any transaction or series of related transactions that constitute: (a) the sale or lease of all or substantially all of

such Party’s business or assets to an acquiring entity; (b) any merger, consolidation, share exchange, recapitalization, business combination or other transaction to which such Party is subject resulting in the exchange of the outstanding shares of such Party for securities or consideration issued, or caused to be issued, by the acquiring entity; or (c) an acquiring entity having obtained beneficial ownership of fifty percent (50%) or more of the outstanding voting securities of such Party; unless in any of cases (a), (b) or (c) the stockholders of such Party as of the date prior to the closing date of such transaction or series of related transactions hold more than fifty percent (50%) of the voting securities in the surviving entity in such transaction or its parent outstanding immediately after the closing of such transaction or series of transactions.

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 ” shall mean activities directed to labeling of Bright Stock, launching, marketing, promoting, detailing, educating, distributing, importing, and selling Licensed Products, together with post-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 complied documentation relating to the medical and scientific data relating to the Licensed Product, including safety and effective use of Licensed Product, without regard to any specific country regulatory labeling requirements.

1.15.

“ Competing Product ” shall mean any prescription pharmaceutical product other than the Licensed Products that

in each of (b) and (c) so long as the active ingredient of such pharmaceutical product remains Decitabine or an active Decitabine Metabolite.

For purposes hereof, “Decitabine Metabolites” shall mean the compounds resulting from the in vivo metabolic breakdown of Decitabine, including the mono-, di- and tri-phosphates of Decitabine. Notwithstanding the preceding sentence, Decitabine

Metabolites shall not include (1) analogs of Decitabine metabolites, or (2) polynucleosides or polynucleotides comprising at least one base of Decitabine, wherein the term “analogs” shall be limited to compounds that are not Decitabine Metabolites.

1.16.

“ Confidential Information ” shall mean all information, data, and technology in any form, disclosed by or on behalf of a Party in connection with this Agreement, including but not limited to assays, chemical structures, pre-clinical and clinical trial results, diagnostics, biological markers, protein structures, mechanisms of action, analytical techniques, 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 control related, or otherwise, including pharmacological, toxicological and clinical information and test data, and related reports, statistical analyses, Commercialization plans, expert opinions and the like, the secrecy of which confers a competitive advantage upon that Party. As used herein, Confidential Information shall not include rights under Patent Rights (but does include the subject matter disclosed in non-published applications).

1.17.

“ Control ” or “ Controlled ” shall mean, with respect to any intellectual property right or other intangible property, the possession (whether by license or ownership, or by control over an Affiliate having possession by license or ownership) by a Party of the ability to grant to the other Party access and/or a license or sublicense as provided herein without violating the terms of any agreement with any Third Party.

1.18.

“ DACOGEN Trademark ” shall me mean the DACOGEN mark and accompanying logos associated with it.

1.19.

“ Decitabine ” shall mean the compound identified in Schedule 1.18, and all stereoisomers, salts and polymorphs of the compound identified in Schedule 1.18. Esters and acids of the compound identified in Schedule 1.18 shall be included to the extent they constitute 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 Regulatory Approvals for Licensed Products in the Territory, preclinical testing, toxicology, clinical trials, quality of life assessments, regulatory affairs, and further activities related to development of Licensed Products to a stage ready for Commercialization thereof,

including pre-marketing, launch plans and sales forecasting. It is understood that Development includes ongoing clinical trials of Licensed Products conducted after the initial Regulatory Approval of Licensed Products, including, without limitation, to obtain further Regulatory 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 obligations relating to the Licensed Product in their respective territories, the carrying out of such obligations in a diligent and sustained manner using efforts substantially similar to the efforts 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 in Section 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 successor thereto.

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 in Section 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 European Union, as it is constituted as of the Effective Date and as it may be expanded from time to time.

1.36.

“ Existing Third Party Agreements ” shall mean the SuperGen Agreement, the Trademark Coexistence Agreement, the Pharmachemie Manufacturing Agreement, the Ferro Pfanstiehl Agreement, any all the Manufacturing and supply agreements related to Licensed Product, which agreements are listed on Schedule 1.75, and any other agreements which would effect the rights and obligations of the Parties hereunder.

1.37.

“ FDA ” shall mean the United States Food and Drug Administration.

1.38.

“ Ferro Pfanstiehl Agreemen t” shall mean all agreements with Ferro Corporation and its affiliates relating to the API including, but not limited to, the Drug Substance and Validation and Supply Agreement between SuperGen, Inc. and Ferro Pfanstiehl Laboratories, Inc. and its affiliates, effective as of July 2, 2003 and Amendments 1,

2, 3, 4, 5, and 6 thereto, and the Quality agreement between MGI Pharma Inc. and Ferro Corporation, 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 10,000 vials.

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 Licensed Products in the specified country by or under authority of any of Licensee or its Affiliates following receipt of Marketing Authorization and any required pricing or reimbursement approval of such Licensed Products in such country. Sales for clinical study purposes or compassionate, named patient or similar use shall not constitute a First Commercial Sale.

sold, to the extent such standards are not less stringent than 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) a federal, state, province, county, city or other political subdivision thereof or (iii) any supranational body.

1.50.

“ ICH ” shall mean “International Conference on Harmonization of Technical Requirements 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 meaning set 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 forth in 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 Development and Commercialization of the Licensed Products in the possession of MGI in tangible form as of the Effective Date this Agreement, and reasonably necessary for Licensee to perform its obligations under this Agreement.

1.61.

“ Licensed Patents ” shall mean: (i) the patents and patent applications listed in 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 are infringed by any of the activities of Licensee performing in accord with this Agreement, including without limitation, all patents and patent applications relating to Product Improvements 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 in Section 13.3(c)(i).

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 the marketing and/or Commercialization of the Licensed Products for a particular indication in a jurisdiction filed with the relevant Regulatory Authorities in jurisdictions in the Territory. It is understood that MAA does not include applications for pricing or reimbursement approval (“ Pricing Approval ”).

1.69.

“ Major Country ” shall mean the United Kingdom, France, Germany, Italy, Spain and Japan.

1.70.

“ Manufacturing ” or “ Manufacture ” shall mean activities directed to producing, manufacturing, processing, filling, finishing, packaging, labeling, quality assurance testing and release, shipping and storage of Product.

1.71.

“ Manufacturing and Supply Agreement ” shall have the meaning set forth in Section 6.1.

1.72.

“ Marketing Authorization ” shall mean, with respect to a particular jurisdiction in the Territory, any authorization which is legally required under applicable laws, regulations, administrative decisions, or otherwise to put a pharmaceutical product on the market or for commercial sale in the jurisdiction for use in treatment of any indication. It is understood that, as used herein, Marketing Authorization does not include 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 thereto filed with the FDA.

1.78.

“ Net Sales ” shall mean the gross amount invoiced on the sale of the Licensed Products by Licensee and its Affiliates, and any permitted sublicensees, less reasonable and customary deductions for (a) credits for returns, including withdrawals and recalls; (b) sales rebates and chargebacks; (c) sales, value-added and other taxes; (d) customs duties on sales made by such seller to the customer; but in the case of (a) and (b) only to the extent accrued under applicable United States generally-accepted accounting principles as being deductions that have actually been given to and taken by the customer, and in the case of (c) and (d) only to the extent separately itemized in the invoice to and paid by the customer; and (e) government rebates. If the Licensed Products is sold for consideration other than solely cash, the fair market value of such other consideration shall be included in the calculation of Net Sales, provided that transfers of Licensed Product for use in research and/or

Development, including Additional Trials, shall not constitute a Net Sale. For purposes of calculating Net Sales, transfers of the Licensed Products to an Affiliate or licensee for end use by such Affiliate or licensee in a country shall be treated as a sale at the greater of the actual Net Sales and the average Net Sales price for fully arms-length sales of such Licensed Products in such country during the applicable calendar quarter, provided that transfers of Licensed Product for use in research and/or Development, including Additional Trials, shall not constitute a Net Sale. Notwithstanding the foregoing, transfers of Licensed Product for use in research and/or Development, including Additional Trials, where revenue is recognized, as defined by generally accepted accounting principles, by Licensee shall constitute a Net Sale in the amount of the revenue received.

1.79.

“ On-going Trials ” shall mean the clinical trials on-going or complete as of the Effective Date of this Agreement, including but not limited to the trials listed in the Global Development Plan attached as Schedule 3.0.

1.80.

“ Orphan Product Designations ” shall mean the designations of Decitabine as an orphan product by the applicable Regulatory Authority in the Territory. Schedule 1.66 sets for the designation for the European Union.

1.81.

“ Party ” and “ Parties ” shall have the meaning set forth in the Preamble.

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 grant for the protection of inventions or industrial designs anywhere in the world, including any reissue, renewal, re-examination or extension thereof; and (b) any application for any of the foregoing, including any international, provisional, divisional, continuation, continuation-in-part, or continued prosecution application, supplemental registrations and extensions thereof, including patent term extensions and restorations and supplemental protection certificates.

1.83.

“ Pharmachemie Manufacturing Agreement ” shall mean all agreements with Pharmachemie B.V. and its affiliates relating to the Licensed Product including, but not limited 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. and Pharmachemie B.V., effective September 8, 2005.

1.84.

“ Policy Relating to the Employment of Child Labor ” shall have the meaning set forth 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 the subject of MGI’s NDA No. 21-790 as of the date of signing of this Agreement; and (ii) any other pharmaceutical product containing as an active ingredient Decitabine.

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 Licensed Products specific trademark(s), service mark(s), accompanying logos, trade dress and/or indicia of origin under which the Licensed Products are marketed and distributed in accordance 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 agree complies with all applicable national, federal, state and local laws and regulatory requirements, including, but not limited to laws regarding environmental, safety and industrial hygiene, complies with GMP, has the requisite continuity and security of supply necessary to meet forecast demands of the Parties, and complies with Licensee’s Policy Relating to the Employment of Child Labor (“ Policy Relating to the Employment of Child Labor ”) which is:

1.93.

“ Quality Agreement ” shall have the meaning set forth in Section 6.3(a), as amended 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 particular country, the receipt of Marketing Authorization and price and reimbursement approvals, if required, necessary for sale of the Product in that country as granted by the relevant Governmental Authority(ies) including without limitation the approval of an NDA or MAA.

1.97.

“ Regulatory Authority(ies)” shall mean, in respect of a jurisdiction, any agency, department, bureau or other governmental entity with authority over the development, Manufacture, use or sale (including approval of NDAs and other MAAs) with respect to the Licensed Products in the jurisdiction, including the FDA and EMEA.

1.98.

“ Regulatory Documentation ” means, with respect to the Product, all filings and supporting documents submitted to any and all Regulatory Authorities relating to such Products, and all data and information contained therein, including any INDs, MAAs (including NDAs), Drug Master Files, investigator’s brochures, correspondence to and from Regulatory Authorities, minutes from teleconferences and meetings with Regulatory Authorities, registrations and licenses, regulatory drug lists, advertising and promotion documents shared with Regulatory Authorities, product labeling, adverse event files, complaint files and Manufacturing records and documentation, including but not limited to materials relating to recalls, field alerts and change controls.

1.99.

“ Related Product ” shall have the meaning set forth in Section 2.4 of the SuperGen License Agreement. In addition, amides and metabolites of Decitabine or of a prodrug 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 Section 5.8(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 License Agreement between SuperGen, Inc. and MGI Pharma, Inc. effective as of September 21, 2004 and amended as of                      , 2006, and attached hereto as Schedule 1.80

1.105.

“ Supporting Data ” shall mean all data and information relating to (a) the pharmacological or toxicological properties of the Products, (b) any pre-clinical or clinical testing and experience in relation to the Products and (c) the chemical composition, synthesis, formulation, compounding, and Manufacturing and quality control testing of the Products, to the extent reasonably required for purposes of any application for Marketing Authorization for the Products. Supporting Data shall also include, but is not limited to, copies of annual reports, integrated study reports, protocols for clinical research and pre-clinical studies, protocol changes and amendments, Chemistry, Manufacturing and Control (“ CMC ”) sections and amendments, safety data, clinical databases, case report forms and access to patient records, toxicity, safety and metabolism reports and data, and pharmacokinetic data and reports and relating to the Products, as well as, in general, data or information

which would typically be part of any submission to FDA or other Regulatory Authority for the purpose of obtaining approval of the Products for any indication.

1.106.

“ Territory ” shall mean all countries of the world with the exception of the United States, Canada and Mexico.

1.107.

“ Third Party ” shall mean any party other than Licensee, MGI and their respective Affiliates.

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.)

2.1.

License . Subject to the terms and conditions of this Agreement, MGI hereby grants to Licensee and its Affiliates an exclusive, non-transferable (except as expressly authorized in this Agreement), royalty-bearing license, with the right to sublicense as qualified in Section 2.2 below, under the Licensed Patents, Licensed Products Improvements 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, and a non-exclusive license thereunder to make and have made the Licensed Products worldwide, for all diagnostic, preventive and therapeutic uses in the human diseases Myelodysplastic Syndromes (“ MDS ”) Acute Myelogenous Leukemia (“ AML ”) and any other indications or uses (the “ Field ”). MGI also hereby grants Licensee a license to use the Dacogen Trademark as provided for in Section 9 of this Agreement. MGI reserves all rights not expressly granted herein, and no other rights shall be considered granted by MGI by implication, estoppel, reliance, or otherwise. Notwithstanding anything to the contrary, no rights or licenses are granted by MGI in this Agreement with respect to any active ingredient other than Decitabine or with respect to any product other than the Licensed Products.

2.2.

Sublicenses and Affiliates . Licensee shall not have the right to sublicense its Commercial rights under Section 2.1 above to any Third Party in (a) Major Countries without MGI’s prior written consent, which shall not be unreasonably withheld (such agreements referred to as “ Sublicense Agreements ”) and (b) in any country in the Territory without MGI”s prior written consent if such transaction is (i) less than an arms-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. Each Sublicense Agreement between Licensee and a sublicensee shall be at least as protective of MGI and all intellectual property licensed hereunder, the Licensed Know-How and other Confidential Information as the terms and conditions of this

Agreement, and subordinate thereto, and Licensee shall be responsible to MGI for the performance by each sublicensee as 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 Section 2.2, Licensee shall provide MGI with a true, complete and correct copy of such Sublicense Agreement and any amendments thereto. Any attempt to engage a sublicensee other than in accordance with the foregoing shall be null and void. In addition, while Licensee may appoint distributors within the normal channel of distribution in non-Major Countries in the European Union, Licensee may not sublicense any of its other rights under Section 2.1 above to such distributors.

2.3.

No Conflict . Subject to the rights expressly reserved by MGI under the provisions of Section 2.1, each Party covenants and warrants that commencing on the Effective Date of this Agreement and continuing until ten (10) years after the date on which the Licensed Product receives Regulatory Approval in the EU, none of such Party or its Affiliates will, directly or indirectly, market, distribute, sell, offer to sell, import, or otherwise commercialize any Competing Products; nor shall such Party or its Affiliates assist, fund, or license or authorize, any Third Party to do any of the foregoing. This provision shall not operate to prevent Licensee or its Affiliates from taking reasonable actions to dispose of a Competing Product.

2.4.

Right of First Offer to a Related Product . Should SuperGen provide the right of first offer to a Related Product to MGI under Section 2.4 of the SuperGen License Agreement, and should MGI exercise such right to such Related Product, then MGI shall provide a similar right of first offer to Licensee to Commercialize such Related Product in the Territory under the same procedures described in Section 2.4 of the SuperGen License Agreement.

3.1.

Up-Front Payment . In consideration of the licenses granted to Licensee in this Agreement and upon the terms and conditions contained herein, a nonrefundable upfront payment of $ * shall be made by Licensee to MGI within two (2) days following the Effective Date of this Agreement.

3.2.

Milestones . In consideration of the Licenses grated by MGI to Licensee and upon the terms and conditions contained herein, the following nonrefundable Clinical Development Milestones will be made thirty (30) days following notice to MGI of the first occurrence of the following events:

$

*

$

*

$

*

$

*

$

*

The milestone payments set forth above in this Section 3.2(a)-(e) shall each be payable only once and on the first occurrence of the event after the Effective Date of this Agreement.

3.3.

Royalty Payments . The royalty payments set forth in Sections 3.3.(a)-(d) below shall apply on a country-by-country basis, for * years following the Effective Date of this Agreement, as follows:

3.4.

Discounting . Licensee and its Affiliates shall set prices for the Licensed Products in the Territory in the best interest of the commercial success of the Licensed Products in the Territory. Without limiting the foregoing, if Licensee or its Affiliate sells the Licensed Products to a customer who also purchases other products or services from Licensee or its Affiliates, Licensee agrees not to, and to require that its Affiliates not, discount or price the Licensed Products in a manner that would disadvantage the Licensed Products in order to benefit sales or prices of the other products or services offered for sale by Licensee or its Affiliates to such customer. Without limiting the foregoing obligations, it is understood and agreed that nothing in this Agreement is intended to dictate to Licensee and its Affiliates the resale prices for the Licensed

Products in the Territory. If the Licensed Products are sold in combination with other products, or as a kit, then each component of the combination or kit will be considered separately for the purposes of this Section 3.4.

3.5.

Bundling . Licensed Products shall be sold in compliance with all applicable laws.

3.6.

Other . All payments under this Article 3 shall be non-refundable (except solely in the case of overpayment) and non-creditable (unless otherwise specifically set forth in this Agreement) against other amounts due or payable to MGI under this Article 3 or otherwise under this Agreement. Payments under this Article 3 shall be made in accordance with Article 7 below.

4.1.

Development and Commercialization Plans .

(i.)

Initial Plan . An initial plan (the first “ Global Development Plan ”) regarding the global development of the Product and containing all of the On-going Clinical Trials shall be attached to this Agreement as Schedule 3.0.

(ii.)

Commercialization Plan. No later than *, Licensee shall provide to MGI an opportunity to review and comment upon a plan and budget for the Commercialization of the Licensed Products in the Territory for * (such plans and budgets, together with any updates thereto in accordance with this Agreement, hereinafter referred to as the “ Commercialization Plan ”). To the extent permitted under applicable law, the Commercialization Plan shall include, with respect to the Commercialization of each Licensed Product in each Major Country: *. The Commercialization Plan shall be updated not less than *, as well as more frequently as reasonably requested by MGI to take into account completion, commencement or cessation of Commercialization activities not contemplated by the then current Commercialization Plan; provided that Licensee shall not be required to update in the Commercialization Plan the budget for Commercialization of a Licensed Product in any Major Country after *.

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 Commercialization Plan. Licensee shall reasonably consider MGI’s input and comments.

(iii.)

Updates. After the Effective Date, the Parties through the JOC-D shall update from time to time the Global Development Plan for the further development of the Products and to take into account completion, commencement or cessation of development activities not contemplated by the then current Plan.

(iv.)

Input and Comment . Each Party shall reasonably consider the other Party’s input and comments to the Global Development Plan.

(a)

The Global Development and Commercialization Plans shall be consistent with the principle of maximizing the value of the Product on a worldwide basis. To achieve this, the Parties shall cooperate in the review and development of the Plans and budgets.

(b)

The Global Development and Commercialization Plans and budgets therein shall contain sufficient detail as provided in Section 4.1 (a), and as allowed by applicable laws, with respect to the commercialization and development tactics and other matters to enable the JSC to conduct a meaningful review of such plans.

(c)

Either Party may also develop and submit to the JOCs from time to time proposed amendments to the Plans. The JOCs shall review and comment on such proposed amendments and submit such substantive amendments to the JSC for review. Subject to each Party performing its respective responsibilities substantially in accordance with the Global Development Plan and the Commercialization Plan, (i) Licensee shall be solely responsible for all decisions regarding the Development and Commercialization of Licensed Products in the Territory, including prices charged for the Licensed Product in the Territory, as well as discounts, rebates and all other deductions from Net Sales in the Territory, and (ii) MGI shall be solely responsible for all decisions regarding development and commercialization of the Product outside the Territory, including the prices charged for the Product in the United States and Mexico, as well as discounts, rebates and all other deductions from net sales in the United States and Mexico. *.

to the development and commercialization of the Product worldwide and to cooperate with the other in carrying out the development and commercialization of the Product in accordance with the Global Development Plan, the Commercialization Plan and this Agreement, in each case in good scientific manner and in compliance with (a) all applicable national, federal, state and local laws and regulatory requirements, including, but not limited to laws regarding environmental, safety and industrial hygiene, (b) GMP, GCP, and GLP, and (c) Licensee’s Policy Relating to the Employment of Child Labor. MGI shall assist Licensee with obtaining Manufacturing information required for Licensee to obtain Regulatory Approvals in the Territory and fulfill Regulatory reporting obligations from the Third-Party manufacturers.

(a)

Formation . Promptly after the Effective Date, the Parties shall establish a committee (the “ Joint Steering Committee ” or “ JSC ”), which shall have overall responsibility for the collaboration established by this Agreement for the development and commercialization activities relating to the Product(s) worldwide. The JSC will consist of three (3) representatives from each Party. Subject to the foregoing, each Party shall have the right to change its members of the JSC by providing written notice to the other.

(b)

Purposes. The purposes of the JSC shall be (i) to review and comment on the overall development, manufacture and commercialization strategy for the Product worldwide and (ii) to oversee the JOCs and resolve matters brought forth by the JOCs and (iii) resolve disputes in accordance with Sections 15.7 and 15.8. The Parties intend that their respective organizations will use Diligent Efforts to assure success of the collaboration.

(c)

Responsibilities . In addition to its overall responsibility for the collaboration established by this Agreement, the JSC shall in particular: (i) review and monitor the progress of the Parties’ activities under the Global Development Plan; (ii) review and comment on commercialization and development strategies, the trial protocols related to the Products as submitted by the JOCs; and (iii) review and discuss the Regulatory Documentation, product labeling, and filings.

(d)

Meetings . The JSC shall meet * each year, unless otherwise agreed by the Parties. JSC meetings may be held in person, through telephone or video conference or other mutually agreeable means, provided that at least one meeting 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 to JSC meetings.

(e)

Authority . The JSC shall not have the power to amend or modify this Agreement, and its decisions shall not be in contravention of any terms and conditions of this Agreement.

(a)

JOC-D Responsibilities. The JOC-D shall be responsible for reviewing, discussing, overseeing and commenting on the development activities of the collaboration, including annual updates of the Global Development Plan.

(b)

JOC-C Responsibilities. The JOC-C shall be responsible for reviewing, discussing, overseeing and commenting on the commercialization and manufacturing activities of the collaboration, including annual updates of Plans.