Exhibit 10.1

 

CONFIDENTIAL TREATMENT REQUEST

 

* Portions denoted with an asterisk have been omitted and filed separately with
the Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

AMENDED & RESTATED LICENSE AGREEMENT

 

THIS AMENDED AND RESTATED LICENSE AGREEMENT is entered into by and between
SuperGen, Inc., a Delaware corporation having its principal place of business at
4140 Dublin Blvd., Suite 200, Dublin, California 94568 (“SuperGen”) and MGI
PHARMA, INC., a Minnesota corporation having its principal place of business at
5775 West Old Shakopee Road, Suite 100, Bloomington, MN 55437-3174 (“MGI”).
SuperGen and MGI are sometimes referred to herein, individually, as a “Party”
and, collectively, as the “Parties.”

 

RECITALS

 

A. Following the execution of the original license agreement, the Parties
determined to make certain modifications thereto, as set forth below.

 

B. SuperGen has acquired and is developing a compound known as decitabine for
the treatment of myelodysplastic syndrome (“MDS”).

 

C. SuperGen has filed certain patent applications, and has obtained and/or
developed certain know-how and data, concerning products containing a compound
known as decitabine and desires to license such patents, patent applications,
know-how, and data to a pharmaceutical company that will develop, market and
commercialize such products worldwide, including for treating MDS and other
potential indications.

 

D. MGI is in the business of developing and commercializing pharmaceutical
products, including oncology pharmaceutical products that meet unmet medical
needs, and MGI desires to so develop, market and commercialize pharmaceutical
products containing decitabine.

 

E. SuperGen is willing to grant to MGI, and MGI desires to obtain, an exclusive
license under such intellectual property for all countries of the world, all on
the terms set forth herein.

 

F. SuperGen and MGI have entered into a stock purchase agreement pursuant to
which MGI purchased equity in SuperGen.

 

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NOW, THEREFORE, for and in consideration of the covenants, conditions and
undertakings hereinafter set forth, the Parties agree to amend and restate the
Agreement in its entirety as follows:

 

AGREEMENT

 

1. DEFINITIONS

 

1.1 “Additional Indications” shall mean the use of Decitabine for treatment of
solid tumors and hemoglobinopathies, and for use in chemosensitization.

 

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 “Allocated Overhead” means departmental or functional costs incurred by a
Party which include facility support costs, information systems, human
resources, accounting and finance which are reasonably allocated to other
company departments based on allocation methods (i.e. space occupied and/or
headcount) or other activity-based method consistently applied by a Party in
accordance with generally accepted accounting principles in the U.S. or a
standard rate as agreed to by both Parties. Allocated Overhead shall not include
any costs attributable to the following corporate activities: executive
management (e.g., president & CEO), investor relations, business development or
corporate legal affairs

 

1.4 “AML” shall mean Acute Myelogenous Leukemia.

 

1.5 “Change of Control” shall mean, with respect to a Party, any transaction or
series of related transactions that constitute: (i) the sale or lease of all or
substantially all of such Party’s business or assets to an acquiring entity;
(ii) 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 (iii) 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 (i),
(ii) or (iii) 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.

 

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1.6 “Commercialization” or “Commercialize” means activities directed to
launching, marketing, promoting, detailing, educating, distributing, importing,
exporting, or selling a product, together with post-marketing studies,
Manufacture of commercial supplies of Licensed Product, and establishing
facilities to meet commercial demand for Licensed Product.

 

1.7 “Competing Product” shall mean any pharmaceutical product that contains
Decitabine or a pro-drug of Decitabine as the active ingredient (unless the
pro-drug is an active ingredient in a pharmaceutical product that is being
marketed as of the date on which the Parties sign this Agreement), other than a
Licensed Product. Competing Product shall also include the compound currently
known as “MG98” if MG98 is marketed or Commercialized for leukemia or hematology
indications.

 

1.8 “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).

 

1.9 “Control” shall mean possession of the power and authority to grant a
license or sublicense, of or within the scope set forth in this Agreement,
without violating the terms of any agreement or other arrangement with any Third
Party or any applicable laws or regulations, and without the need for additional
payments by SuperGen as a result of the license herein.

 

1.10 “Decitabine” shall mean the compound identified in Exhibit 1.10, and all
[*], [*] and [*] of the compound identified in Exhibit 1.10. [*] and [*] of the
compound identified in Exhibit 1.10 shall only be included to the extent they
constitute the same active ingredient as the compound identified in Exhibit
1.10.

 

1.11 “Derivative Patents” shall mean all Patent Rights that claim an invention
that is not owned solely by SuperGen and which (i) was invented or created by or
on behalf of MGI, its Affiliate, or any Licensee in connection with the
Development or Manufacture of any Licensed Product; or (ii) incorporates,
embodies or is otherwise based upon or derived from Decitabine, or the Licensed
Patents, Supporting Data, Regulatory Documentation, or other Confidential
Information of SuperGen, or Developed in connection with the exercise of rights
with respect thereto.

 

* Portions denoted with an asterisk have been omitted and filed separately with
the Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

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1.12 “Develop” and Development” means all activities related to obtaining
Regulatory Approvals for Licensed Product in the Territory, including
preclinical testing, toxicology, formulation, clinical trials, quality of life
assessments, regulatory affairs, and further activities related to development
of Licensed Product to a stage ready for Commercialization thereof, including
pre-marketing and sales costs and activities, research, process development and
Manufacturing scale-up. It is understood that Development includes ongoing
clinical trials of Licensed Product conducted after the initial Regulatory
Approval of Licensed Product, including, without limitation, to obtain further
Regulatory Approval for expanded labeling or approval for new indications.

 

1.13 “Development Costs” shall mean the total of (i) the actual hours expended
by Development Personnel, multiplied by the Development Rate in effect at the
time such hours are incurred for the particular individual; (ii) material costs;
(iii) sub-contractor costs; and (iv) other direct and out-of -pocket expenses
incurred in order to perform Licensed Product Development activities.

 

1.14 “Development Personnel” shall mean employees of a Party assigned (full- or
part-time) to conduct Development of a Licensed Product in accordance with this
Agreement, including scientists, research staff, quality control and assurance
personnel, technicians or the like, but excluding non-technical,
non-professional personnel such as secretarial or administrative staff.

 

1.15 “Development Rate” shall mean with respect to any individual Development
Personnel, the sum of the actual (i) annual salary, (ii) employee benefits
(including bonus, payroll taxes, insurances and other direct benefit costs) and
(iii) Allocated Overhead, divided by one thousand eight hundred seventy two
(1872). The Development Rate does not include material costs, sub-contractor
costs and other direct and out-of-pocket expenses incurred while performing the
development activity. These other costs and expenses shall be included in the
Development Costs separately under Section 1.13 above.

 

1.16 “Diligent Efforts” shall mean the carrying out of obligations in a diligent
and sustained manner using all efforts reasonably necessary or appropriate to
actively develop and maximize the commercial potential of Licensed Products
(which shall include maximizing revenues received from sales of Licensed
Products to the extent the Licensed Products can be Commercialized in a manner
that provides a reasonable economic return comparable to those typical in the
pharmaceutical industry for comparable pharmaceutical products). Without
limiting the foregoing, Diligent Efforts requires that the applicable Party: (a)
promptly assign responsibility for such obligations to specific employee(s) who
are held accountable for progress and monitor such progress on an on-going
basis, (b) set and consistently seek to achieve specific meaningful objectives
for carrying out such obligations, and (c) consistently make and implement
decisions and allocate the

 

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full complement of resources necessary or appropriate to advance progress with
respect to such objectives in accordance with the foregoing, without regard to
any other pharmaceutical product a Party is then developing or commercializing,
alone or with one or more collaborators.

 

1.17 “Effective Date” shall mean September 21, 2004.

 

1.18 “EMEA” shall mean the European Agency for the Evaluation of Medicinal
Products, or any successor thereto.

 

1.19 “Equivalent Pharmaceutical Company” shall mean any entity (together with
its Affiliates) having worldwide revenues from sales of oncology pharmaceutical
products, in its most recent three (3) fiscal years prior to the transaction
giving rise to a Change of Control (including any assignment pursuant to Section
16.6), as publicly reported by such entity, that are equal to or exceed MGI’s
worldwide revenues from sales of oncology pharmaceutical products in calendar
year 2003 or that otherwise has at least the financial strength and stability
and other capabilities that MGI has as of the date of signing of this Agreement
and during the term hereof to assume all of the obligations and liabilities of
MGI under this Agreement, provided that this definition shall be satisfied for
purposes of Section 16.6, if the combination of the Equivalent Pharmaceutical
Company and MGI results in an entity that on a combined basis would meet the
criteria set forth in this definition; but in all events excluding the entities
listed in Exhibit 1.19 and any other entity that is marketing or selling a
Competitive Product at the time of the Change of Control.

 

1.20 “Europe” shall mean Switzerland, the countries of the European Union as of
the date of signing of this Agreement, and all other countries which become
members of the European Union.

 

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

 

1.22 “First Commercial Sale” shall mean the first commercial sale of a Licensed
Product in the specified country by or under authority of any of MGI, its
Affiliates, or any Licensee, following receipt of Marketing Authorization and
any required pricing or reimbursement approval of such Licensed Product in such
country.

 

1.23 “FTE” shall mean a dedicated full-time employee or contractor of MGI, or in
the case of less than a full-time dedicated person, a full-time, equivalent
person year, each based upon the total of one thousand eight hundred seventy two
(1,872) hours per year of work hours.

 

1.24 “Koseisho” shall mean the Ministry of Health and Welfare (Federal Drug
Administration) of Japan.

 

1.25 “Licensed Product” shall mean (i) the product containing Decitabine which
is the subject of SuperGen’s NDA No. 21-790 as of the date of signing of this
Agreement (the

 

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“Existing Licensed Product”); (ii) any other pharmaceutical product containing
as an active ingredient Decitabine).

 

1.26 “Licensed Patents” shall mean (i) the patents and patent applications
listed in Exhibit 1.26 and any patents issuing therefrom, and all reissues,
continuations, continuations-in-part, extensions, reexaminations, and foreign
counterparts thereof, that are owned or Controlled by SuperGen as of the date of
signing of this Agreement, but only those claims that would be infringed absent
a license by Decitabine, Licensed Improvements, or the manufacture or use
thereof, and other patent applications filed by SuperGen after the date of
signing of this Agreement that are owned and Controlled by SuperGen, but only
those claims that would be infringed absent a license by Decitabine, Licensed
Improvements, or the manufacture or use thereof; and (ii) patents and patent
applications which were assigned to SuperGen by MGI in accordance with Section
9.1 of this Agreement to the extent that such patents and patent applications
claim an invention which is a Decitabine Improvement and are owned and
Controlled by SuperGen as a result of such assignment.

 

1.27 “Licensed Know-How” shall mean all Regulatory Documentation, Supporting
Data and Confidential Information that is material to the clinical development,
regulatory filings, commercialization, and Manufacture of Licensed Products and
Licensed Improvements, each to the extent concerning the Licensed Products, in
the possession and Control of SuperGen in tangible form as of the date of
signing of this Agreement, and reasonably necessary for MGI to perform its
obligations under this Agreement.

 

1.28 “Licensed Improvements” means Decitabine Improvements, including all [*]
and [*] solvent formulations of Decitabine, but in all events excluding all
compositions of matter other than Decitabine and its [*] and [*] solvent
formulations.

 

1.29 “Licensee” shall mean a Third Party to whom MGI directly or indirectly
sells for resale, or has otherwise granted the right to sell or distribute, a
Licensed Product (including Third Parties authorized to make and sell the
Licensed Product and Third Parties who purchase from another that is authorized
to make and sell the Licensed Product), provided that such Third Party is
responsible for some or all of the marketing and promotion of such Licensed
Product within its portion of the Territory. For clarity, if any contract
manufacturer that has rights to sell or otherwise distribute Licensed Product to
Third Parties, it shall be considered a Licensee for purposes of this Agreement.

 

1.30 “MAA” shall mean an application requesting regulatory approval for the
marketing and/or commercialization of a Licensed Product for a particular
indication in a jurisdiction, including without limitation an NDA filed with the
FDA and similar and equivalent filings with Regulatory Authorities in
jurisdictions other than the United States. It is understood that MAA does not
include applications for pricing or reimbursement approval.

 

1.31 “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.

 

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

 

* Portions denoted with an asterisk have been omitted and filed separately with
the Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

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1.33 “Manufacture” shall mean manufacturing and related activities including
filling, processing, testing, engineering, designing, redesigning, finishing,
packaging, labeling, storing, warehousing, quality control, quality assurance,
releasing, disposing, handling, shipping, and all other activities undertaken or
required to be undertaken in order to manufacture, supply and distribute
Licensed Product.

 

1.34 “NDA” shall mean a New Drug Application and amendments and supplements
thereto filed with the FDA.

 

1.35 “Net Sales” shall mean the gross amount invoiced on the last sale of the
Licensed Product by MGI, Licensees, and their Affiliates, 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 (but in the case of value added taxes only to the extent such taxes are
not reimbursable or refundable); and (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 accounting principles generally accepted in the U.S. (and
reflected in public regulatory filings) 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. If a
Licensed Product 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. For purposes of calculating Net Sales, transfers of a Licensed
Product 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 Product
in such country during the applicable calendar quarter. However, the Parties
agree that with respect to the U.S., wholesalers and distributors acting in the
ordinary course of their business as they normally operate with respect to the
pharmaceutical industry are not Licensees, but such exclusion shall apply only
for purposes of this definition of Net Sales and Section 3.3 hereof.

 

1.36 “Orphan Product Designations” shall mean the designations of Decitabine as
an orphan product by the Office of Orphan Products of the FDA, or other
Regulatory Authority in the Territory, as set forth in Exhibit 1.36.

 

1.37 “Patent Rights” shall mean any and all rights under any of the following:
(i) a United States, international or foreign patent, utility model, design
registration, certificate of

 

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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 (ii)
any application for any of the foregoing, including any international,
provisional, divisional, continuation, continuation-in-part, or continued
prosecution application.

 

1.38 “Product Trademark” shall mean (i) with respect to the Existing Licensed
Product, the Dacogen trademark and all other Existing Licensed Product specific
trademarks and logos under which the Existing Licensed Product is marketed and
distributed in accordance with this Agreement; and (ii) with respect to each
Licensed Product, other than the Existing Licensed Product, the Licensed Product
specific trademarks and logos under which such Licensed Product is marketed or
distributed in accordance with this Agreement.

 

1.39 “Regulatory Authority” 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 any Licensed Product in the jurisdiction, including the
FDA, EMEA, and Koseisho.

 

1.40 “Regulatory Documentation” means, with respect to a Licensed Product, all
filings and supporting documents submitted to any and all Regulatory Authorities
relating to such Licensed Product, 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.

 

1.41 “Stock Purchase Agreement” shall mean that certain Common Stock Purchase
Agreement entered into between MGI and SuperGen, pursuant to which MGI is
purchasing common stock of SuperGen, of even date herewith.

 

1.42 “Sublicensing Revenue” shall mean all amounts payable to MGI and its
Affiliates from Licensees and their Affiliates as a result of the grant of
rights, or any other arrangement, to market, sell, or otherwise distribute any
and all Licensed Products, including without limitation license fees, milestone
payments, premiums on equity, premiums on payment for research and development,
and royalties, but excluding (i) royalties based upon Net Sales for which a
royalty is paid to SuperGen under this Agreement, (ii) reimbursement for
research or development activities performed by or on behalf of the Licensee to
the extent reimbursed at fair market value, and (iii) amounts paid by the
Licensee to purchase Licensed Product from MGI or its Affiliates at the fair
market value.

 

1.43 “Supporting Data” shall mean all data and information relating to (i) the
pharmacological or toxicological properties of any Licensed Product, (ii) any
pre-clinical or clinical testing and experience in relation to any Licensed
Product and (iii) the chemical composition,

 

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synthesis, formulation, compounding, and manufacturing and quality control
testing of any Licensed Product, to the extent reasonably required for purposes
of any application for Marketing Authorization for a Licensed Product.
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 any
Licensed Product, 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 any Licensed Product for any indication.

 

1.44 “Territory” shall mean all of the countries of the world, and their
territories and possessions (excluding countries to the extent MGI’s rights
therein have been terminated under this Agreement pursuant to the provisions of
this Agreement).

 

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

 

1.46 “Third Party Agreements” shall mean those agreements and purchase orders
listed in Exhibit 1.46.

 

1.47 “U.S.” shall mean the United States of America, and its territories and
possessions.

 

In addition, the following terms shall have the meaning described in the
corresponding section of this Agreement. Other terms may be defined throughout
the Agreement and its Exhibits.

 

Term

--------------------------------------------------------------------------------

   Section Defined

--------------------------------------------------------------------------------

“Agreement”

   Preamble

“Annual Net Sales”

   3.3.1

“Claim”

   13.1

“Commercialization Plan”

   4.1

“Decitabine Improvements”

   9.1

“Diligence Milestones”

   7.8

“Enforcement Actions”

   9.6

“Existing Licensed Product”

   1.25

“Indemnitee,” “Indemnitor”

   13.3

“Infringement Actions”

   9.5

“Joint Steering Committee”

   4.2

“Liabilities”

   13.1

“MDS”

   Recitals

“MGI”

   Preamble

“MGI Indemnitees”

   13.2

“Milestone Region”

   3.2

 

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“Party,” “Parties”

   Preamble

“Project Leader”

   4.3

“Public Disclosure”

   16.9

“Registration Trial”

   7.8

“SuperGen”

   Preamble

“SuperGen Indemnitees”

   13.1

“Sales Materials”

   7.5

“Wind-down Period”

   15.3

 

2. LICENSE

 

2.1 License. Subject to the terms and conditions of this Agreement, SuperGen
hereby grants to MGI an exclusive, non-transferable (except as expressly
authorized in this Agreement), royalty-bearing license under the Licensed
Patents and Licensed Know-How to develop, make, have made, use, import, offer
for sale, and sell, the Licensed Products in the Territory. Notwithstanding the
foregoing, SuperGen reserves the exclusive right to perform the activities for
which it is responsible as set forth in Section 5.2, the non-exclusive right to
perform pre-clinical and non-clinical development and retains those rights
necessary for it to meet its obligations under the Third Party Agreements that
are not accepted by MGI pursuant to the provisions of Section 9.8. SuperGen also
reserves all other rights not expressly granted herein, and no other rights
shall be considered granted by SuperGen by implication, estoppel, reliance, or
otherwise. Notwithstanding anything to the contrary, no rights or licenses are
granted by SuperGen 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. MGI shall have the right to sublicense its rights under Section
2.1 above in the Territory in the countries outside the U.S. to Licensees of the
Licensed Product with SuperGen’s written consent, not to be unreasonably
withheld. MGI shall notify SuperGen within fourteen (14) days after the Third
Party becomes a Licensee (whether through an agreement with MGI, its Affiliate,
or another Licensee), and shall provide to SuperGen, with such notice, a copy of
the agreements with the Licensee. In connection with this Section 2.2, the
Parties acknowledge and agree that MGI, rather than any Third Party or
Affiliate, shall directly market and Commercialize the Licensed Products in the
U.S. Each agreement with a Licensee shall be at least as protective of SuperGen
and its intellectual property, Licensed Know-How and other Confidential
Information as the terms and conditions of this Agreement, and subordinate
thereto, and MGI shall be responsible to SuperGen for the performance by each
Affiliate and Licensee as necessary for compliance with the financial and other
obligations under this Agreement. Any attempt to engage a Licensee other than in
accordance with the foregoing shall be null and void.

 

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2.3 No Conflict. Subject to the rights expressly reserved by SuperGen under the
provisions of Section 2.1 and to the provisions of Section 2.4 below, each Party
covenants and warrants that during the term of this Agreement, none of such
Party, its Affiliates, and Licensees will, directly or indirectly, market,
distribute, sell, offer to sell, import, or otherwise Commercialize any
Competing Products, other than Licensed Product sold in the Territory on which
royalties are payable under and in accordance with this Agreement; nor shall
such Party, its Affiliates, and Licensees assist, fund, or license or authorize,
any Third Party to do any of the foregoing.

 

2.4 Related Compound; Right of First Offer; Co-marketing. The Parties
acknowledge that SuperGen is also performing additional development work on [*]
or [*] comprising at least one base of the compound identified in Exhibit 1.10
(each a “Related Compound”). In consideration of the other agreements of the
Parties under this Agreement,

 

* Portions denoted with an asterisk have been omitted and filed separately with
the Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

SuperGen hereby grants to MGI a right of first offer for pharmaceutical products
that contain such Related Compound as an active ingredient and Competing
Products other than Competing Products that contain Decitabine as the active
ingredient (each, a “Related Product”), to the extent set forth in this Section
2.4.

 

2.4.1 At such time as SuperGen, its Affiliates, or any successor-in-interest of
SuperGen that is a Party to this Agreement in lieu of SuperGen due to a Change
In Control, shall determine to license a Third Party to sell or otherwise
Commercialize any Related Product or assign to a Third Party all or
substantially all of its rights in and to the Related Product (excluding Third
Party contracts made in the ordinary course of business, such as contract
manufacturing agreements) (each instance a “License or Assignment” and to
“License or Assign”), SuperGen shall notify MGI, in writing, of such decision
and provide MGI with sufficient detail to evaluate the Related Product based on
the then current state of development of such Related Product, including but not
limited to the right to review patent applications and claims relating thereto,
the associated file histories describing prior art and patentability opinions,
and Regulatory Documentation and Supporting Data for the Related Product, as
well as the general nature of the License or Assignment that SuperGen desires to
grant.

 

2.4.2 MGI shall have thirty (30) days following such notice from SuperGen to
evaluate the Related Product and to notify SuperGen, in writing that MGI desires
to obtain the rights to the Related Product that SuperGen desires to License or
Assign. Upon notification by MGI of its desire to obtain such rights, the
Parties shall negotiate, in good faith, for a period not to exceed one hundred
and eighty (180) days after the date of SuperGen’s notice, unless extended by
mutual written agreement of the Parties in an effort to arrive at mutually
acceptable terms and conditions for such a License or Assignment.

 

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2.4.3 If MGI fails to notify SuperGen within the thirty (30) day period set
forth in Section 2.4.2, or if the parties do not enter into an agreement, within
one hundred eighty (180) day period set forth in Section 2.4.2, in which
SuperGen grants to MGI the desired License or Assignment, then neither Party
shall have any further obligation under this Agreement with respect to the
Related Products, except as follows. If SuperGen has not entered into an
agreement for the License or Assignment of rights to a Related Product within an
eighteen (18) month period following the conclusion of discussions between MGI
and SuperGen pursuant to the provisions of Section 2.4.2, then MGI’s rights
under this Section 2.4 shall be reinstated, and MGI shall again be entitled to
the rights granted under this Section 2.4 for up to two additional times but in
no event shall SuperGen be obligated to offer the Related Product to MGI more
than once following Marketing Authorization. The Parties acknowledge and agree
that a Change of Control of SuperGen does not constitute a decision by SuperGen
to License or Assign a Related Product pursuant to the provisions of this
Section 2.4 and accordingly, this Section 2.4 shall not apply to the Change of
Control transaction.

 

2.4.4 In the event that SuperGen elects to retain the rights to the Related
Product and to market itself a Related Product, or a derivative thereof
consisting of the same active ingredient (the “New Product”), either through
SuperGen’s sales force or through a contracted sales force by SuperGen, then in
such case, SuperGen shall offer MGI the right to co-market the Related Product
and, if applicable the New Product, in such markets as MGI has its own sales
force, on terms and conditions comparable to other co-marketing agreements in
the pharmaceutical industry, which terms shall be negotiated in good faith by
the Parties following SuperGen’s notice to MGI of its election to retain
marketing rights; provided that if the Parties do not enter into a definitive
agreement within 150 days from the date of such notice, neither Party shall have
any further obligation under this Section 2.4.

 

3. PAYMENTS AND MILESTONES

 

3.1 Milestones.

 

MGI shall pay to SuperGen the milestone payments identified in this Section 3.1
below, each within thirty (30) days after the first occurrence of the
corresponding milestone:

 

(a) Upon filing by the FDA of the last module of an NDA for a Licensed Product,
MGI shall pay SuperGen Ten Million Dollars (US $10,000,000).

 

(b) Upon First Commercial Sale of a Licensed Product in the United States, MGI
shall pay SuperGen Twenty Million Dollars (US $20,000,000).

 

(c) Upon the earliest acceptance of a submission to the EMEA, or any national
Regulatory Authority in any country in Europe, of an MAA for a Licensed Product,
MGI shall pay SuperGen Two Million Five Hundred Thousand Dollars (US
$2,500,000).

 

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(d) Upon First Commercial Sale of a Licensed Product in a country in Europe, MGI
shall pay SuperGen Five Million Dollars (US $5,000,000).

 

(e) Upon the acceptance of the filing by the Koseisho in Japan of an MAA for a
Licensed Product, MGI shall pay SuperGen Two Million Five Hundred Thousand
Dollars (US $2,500,000).

 

(f) Upon First Commercial Sale of a Licensed Product in Japan, MGI shall pay
SuperGen Five Million Dollars (US $5,000,000).

 

The foregoing milestone payments shall be paid upon achieving the milestone,
whether the milestone is achieved by MGI, its Affiliate, or any Licensee. Within
ten (10) business days of the occurrence of any event that would trigger a
milestone payment according to this Section 3.1, MGI shall notify SuperGen of
such occurrence in writing.

 

3.2 Sublicensing Revenue. In addition to the other payments that MGI is required
to make under this Agreement, MGI shall pay to SuperGen fifty percent (50%) of
all Sublicensing Revenue; provided that, without limiting any other payment to
SuperGen, with respect to Sublicensing Revenue that is paid as a result of a
Development or Commercialization milestone occurring in Japan or Europe (each of
Japan and Europe, a “Milestone Region”), MGI’s obligations to make a payment
under this Section 3.2 based upon such Sublicensing Revenue shall be limited to
the amount by which fifty percent (50%) of such Sublicensing Revenue exceeds the
total amount of the milestone payments paid and payable to SuperGen under
Section 3.1 for the same Milestone Region. Specifically, MGI shall have the
right to credit the amounts paid under Section 3.1 for a Milestone Region
against the amounts payable under this Section 3.2 to the extent Sublicensing
Revenue is paid as a result of a Development or Commercialization milestone
occurring in the same Milestone Region exceeds the milestone payments previously
paid under Section 3.1 for such Milestone Region.

 

3.3 Royalty. MGI shall pay to SuperGen a royalty equal to a percentage of the
Net Sales from each Licensed Product sold by MGI, its Affiliates, and any
Licensees, with such percentage determined in accordance with the following
table based upon the Annual Net Sales in the particular calendar year:

 

Annual Net Sales

--------------------------------------------------------------------------------

  

Percentage of Net Sales

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That portion of Annual Net Sales up to and including Fifty Million Dollars (US
$50,000,000)    20% of such Net Sales That portion of Annual Net Sales in excess
of Fifty Million Dollars (US $50,000,000) and up to and including One Hundred
Million Dollars (US $100,000,000)    22.5% of such Net Sales That portion of
Annual Net Sales in excess of One Hundred Million Dollars (US $100,000,000) and
up to and including One Hundred and Fifty Million Dollars (US $150,000,000)   
25% of such Net Sales That portion of Annual Net Sales in excess of One Hundred
and Fifty Million Dollars (US $150,000,000) and up to and including Two Hundred
Million Dollars (US $200,000,000)    27.5% of such Net Sales That portion of
Annual Net Sales in excess of Two Hundred Million Dollars (US $200,000,000)   

30% of such Net Sales

 

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3.3.1 Certain Terms. For purposes of this Agreement, “Annual Net Sales” shall
mean total Net Sales of all Licensed Products in the Territory sold by or under
authority of MGI, its Affiliates, and Licensees in the particular calendar year.

 

3.3.2 Discounting. MGI and its Affiliates shall set prices for the Licensed
Products in the Territory in the best interest of the commercial success of the
Licensed Product in the Territory. Without limiting the foregoing, if MGI or its
Affiliate or Licensee sells any Licensed Product to a customer who also
purchases other products or services from MGI, its Affiliates or Licensees, MGI
agrees not to, and to require that its Affiliates and Licensees 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 MGI, its Affiliates or Licensees to such customer. Without
limiting the foregoing obligations, it is understood and agreed that nothing in
this Agreement is intended to dictate to MGI, its Affiliates and Licensees the
resale prices for the Licensed Products in the Territory.

 

3.3.3 Bundling. No Licensed Product shall be sold bundled together with any
other product, component, or service, for a single price.

 

3.4 Other. All payments under this Article 3 shall be non-refundable (except
solely in the case of overpayment) and non-creditable (except as expressly set
forth in Section 3.2) against other amounts due or payable to SuperGen under
this Article 3 or otherwise under this Agreement. Payments under this Article 3
shall be made in accordance with Article 8 below.

 

4. JSC AND COMMERCIALIZATION PLAN

 

4.1 Commercialization Plan.

 

4.1.1 Initial Plan; Amendments. No later than forty five (45) days after the
Effective Date, MGI shall provide to SuperGen an opportunity to review and
comment upon a plan

 

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and budget for MGI’s Development and Commercialization of the Licensed Products
in the Territory for the remainder of the then current calendar year and the
subsequent two calendar years (such plan and budget, together with any updates
thereto in accordance with this Agreement, the “Commercialization Plan”).
Beginning in calendar year 2005, by October 1 of each calendar year, MGI shall
submit to SuperGen for its review and comment a proposed Commercialization Plan
for the next calendar year and for the two succeeding calendar years. The
Commercialization Plan shall be updated not less than annually, as well as more
frequently as needed in MGI’s reasonable discretion to take into account
completion, commencement or cessation of Development and Commercialization
activities not contemplated by the then current Commercialization Plan. MGI
agrees to provide to SuperGen for its review and comment no later than twenty
one (21) days in advance of each JSC meeting all interim updates to the
Commercialization Plan. MGI shall reasonably consider SuperGen’s input and
comments. Notwithstanding the foregoing or the terms of Section 4.1.2, MGI shall
not be required to update in the Commercialization Plan the budget for
Commercialization of a Licensed Product after the first anniversary of First
Commercial Sale of the Licensed Product.

 

4.1.2 Contents. The Commercialization Plan shall be consistent with MGI’s
Diligent Efforts obligations under Articles 5, 6 and 7 below, and shall be
reasonably detailed and broken down by country. The Commercialization Plan shall
include, without limitation, (i) with respect to Development of each Licensed
Product in each Major Country: the level of resources, effort and staffing; the
countries to be targeted; regulatory strategy; any pre-clinical or clinical
trials to be conducted; a schedule for preparation of Regulatory Documentation;
timeframes for filing MAAs and obtaining Marketing Authorizations; and a budget
for all Development activities, and (ii) with respect to Commercialization of
each Licensed Product in each Major Country: level of resources, effort and
staffing (including numbers of sales reps for each Major Country); product
positioning; pricing and reimbursement strategy; a reasonably detailed
description of all Commercialization activities (including planned participation
at trade shows, advertising and educational efforts and any publications); and a
budget for all Commercialization activities.

 

4.2 Joint Steering Committee. The Parties shall establish a committee (the
“Joint Steering Committee” or “JSC”) to review and discuss the Development,
Manufacturing, and other Commercialization activities relating to the Licensed
Product in the Territory. The JSC will consist of three (3) representatives from
each Party, one of whom shall be a senior executive of each Party and in the
case of MGI at least two of whom shall be responsible for managing and
overseeing the strategic and day-to-day Development, Manufacturing and
Commercialization of the Licensed Products. Subject to the foregoing, each Party
shall have the right to change its members of the JSC by providing written
notice to the other.

 

4.2.1 Responsibilities. The JSC will (a) review and discuss the progress under
and review proposed updates to the Commercialization Plan, (b) review and
discuss Development strategy and activities and the associated budgets, (c)
review and discuss the Regulatory Documentation, product labeling, and filings
(d) review and discuss Manufacturing plans and activities, including with
respect to qualification and validation of Manufacturing facilities and

 

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quality and other issues; (e) review and discuss other Commercialization
strategy and activities and the associated budgets, (f) review and discuss the
proposed significant contractors and distributors, if any, that MGI, its
Affiliates, and Licensees plan to use, (g) facilitate the exchange of Licensed
Know-How, other Regulatory Documentation and other information and/or materials
between the Parties, and (h) otherwise provide SuperGen with a reasonable
opportunity to provide feedback and comments regarding the Development,
Manufacture and other Commercialization activities for the Licensed Product in
the Territory, and the level of resources and efforts being applied with respect
thereto.

 

4.2.2 Meetings. The JSC shall meet once each calendar quarter, unless otherwise
agreed by the Parties. Such meetings shall be in person at least twice per year,
alternating between the facilities of each Party unless otherwise mutually
agreed, and the other meetings may be through telephone or video conference or
other mutually agreeable means. With the consent of the JSC members, other
representatives of SuperGen or MGI may attend JSC meetings as observers. Each
Party shall bear its own personnel and travel costs and expenses relating to JSC
meetings.

 

4.2.3 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, including the Diligent Efforts obligations in
Articles 5, 6 and 7 below.

 

4.3 Project Leaders. MGI and SuperGen each shall appoint a person (a “Project
Leader”) from the JSC to coordinate the exchange of Licensed Know-How,
Regulatory Documentation, and communications between the Parties regarding the
Development of the Licensed Product. The Project Leaders shall be the primary
contact between the Parties with respect to the Development of the Licensed
Product. Each Party shall notify the other within thirty (30) days of the date
of the Agreement of the name and contact information for its Project Leader and
shall so notify the other Party (in advance of changing its Project Leader).
Without limiting the foregoing, MGI’s Project Leader shall facilitate
communication of issues to and from technical personnel and consultants of MGI,
its Affiliates, and Licensees as reasonably requested by SuperGen for purpose of
discussing the research and Development work, and results thereof.

 

5. DEVELOPMENT

 

5.1 Exchange of Information. Promptly after the Effective Date, SuperGen shall
provide to MGI copies of or access to (if it is not reasonably feasible to
reproduce the referenced subject matter) (i) patent applications within the
Licensed Patents, (ii) Licensed Know-How, (iii) the Product Trademark “Dacogen”,
and (iv) Orphan Product Designations not previously disclosed and delivered to
MGI. SuperGen shall not be considered in breach of this obligation as a result
of an inadvertent failure to provide any such subject matter. All Licensed
Know-How and other Confidential Information obtained from SuperGen will be used
and disclosed by and under authority of MGI only as required to obtain Marketing
Authorization for Licensed Products in the Territory and as may be necessary in
performing its obligations and exercising its rights under this Agreement and as
may otherwise be agreed by SuperGen and MGI in writing. All such disclosure of
Licensed Know-How and other Confidential Information obtained from SuperGen to a
non-governmental

 

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Third Party, and use, shall be made under reasonable and customary
confidentiality restrictions that are as protective of the SuperGen and such
materials as the terms of this Agreement. Within ten (10) days of the Effective
Date, SuperGen will provide MGI with the right to cross reference SuperGen’s IND
for the Existing Licensed Product for MGI’s use in the Development and
Commercialization of Licensed Products in the Territory under this Agreement.
MGI may not use any Licensed Know-How or other Confidential Information for any
purpose outside the Territory, or for any products other than the Licensed
Products (and shall not permit or authorize any Third Party to do so).

 

5.2 SuperGen Responsibilities; Transfer of Responsibilities to MGI.

 

5.2.1 Transfer. SuperGen shall retain legal and regulatory responsibility for
the Existing Licensed Product in the U.S. and Europe for seeking Marketing
Authorization for the Existing Licensed Product with the FDA and the EMEA and
the related Regulatory Documentation (which shall remain in SuperGen’s name
until transferred to MGI pursuant to this Section 5.2.1) and for all filings,
meetings and communications with Regulatory Authorities in connection therewith
until (i) in the U.S., the earliest of (a) the FDA providing Marketing
Authorization for the Existing Licensed Product, (b) the FDA requiring
additional clinical studies for the Existing Licensed Product (such as, without
limitation in the event of a non-approvable letter, or an approvable letter that
requires additional studies), (c) the FDA making a final decision with respect
to the NDA (i.e. issuing an approval, approvable, or non-approvable letter), (d)
October 31, 2005 or (e) if SuperGen is Insolvent as set forth in Section 14.4.3
and, (ii) in Europe, the earliest of (a) the EMEA (or the national Regulatory
Authority in every Major Country in Europe) providing Marketing Authorization
for the Existing Licensed Product, (b) the EMEA or national equivalent in any
Major Country in Europe requiring additional clinical studies for the Existing
Licensed Product, (c) the EMEA or national equivalent in any Major Country in
Europe otherwise making a final decision with respect to the MAA (i.e. issuing
an approval, approvable, or non-approvable letter or equivalent), (d) December
31, 2005 or (e) if SuperGen is Insolvent as set forth in Section 14.4.3. After
the Effective Date, Regulatory Documentation to be submitted by SuperGen to the
FDA and EMEA under the foregoing shall be subject to MGI’s expeditious review
and approval, and SuperGen’s strategy for communications with the FDA and EMEA
shall be subject to MGI’s expeditious review and approval, in each case such
approval not to be unreasonably withheld or delayed; provided that SuperGen
shall have final control and authority with respect to decisions that pertain to
compliance with laws, rules, regulations and administrative decisions applicable
to any filings and other communications with Regulatory Authorities related to
the Existing Licensed Product. At the times stated in (i) and (ii) above,
respectively, for the U.S. and Europe, responsibility for the Existing Licensed
Product as outlined therein and, to the extent not otherwise previously
transferred to MGI pursuant to the terms of this Agreement, any other Regulatory
Documentation (including any Orphan Drug designations and filings) for a
Licensed Product will be transferred to MGI by SuperGen and will thereafter be
pursued by MGI in MGI’s name.

 

MGI shall be responsible for, and shall pay, all costs and expenses that are
reasonable and customary costs incurred by SuperGen after the date of signing of
this Agreement in connection with obtaining Marketing Authorizations for the
Existing Licensed Product in both the

 

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U.S. and Europe, including reimbursement for the time expended by SuperGen
Development Personnel, calculated using the Development Rate, and reimbursement
for out of pocket costs and expenses (including amounts paid to Third Party
contractors); provided that MGI shall have the right to credit the amounts paid
by MGI to SuperGen to reimburse SuperGen for such costs and expenses, as set
forth SuperGen’s invoice to MGI, toward MGI’s obligation under Section 5.3.2 and
subject to the following: Following the Effective Date, SuperGen shall submit to
MGI a statement of the Development Costs incurred by SuperGen pursuant to the
terms of this Section 5.2.1 from the date of signing of this Agreement through
the Effective Date and MGI shall reimburse SuperGen for such costs. Immediately
following the Effective Date, SuperGen shall provide to MGI, SuperGen’s forecast
for the costs and expenses that it expects to incur in connection with its
Section 5.2.1 responsibilities for the Existing Licensed Product, which forecast
shall be subject to MGI’s approval, and to provide updated forecasts to MGI at
least one calendar quarter in advance of incurring the costs, which updated
forecasts shall also be subject to MGI’s approval. Reimbursement of any costs
and expenses exceeding such forecast shall be subject to MGI’s review and
approval. All approvals by MGI shall not be unreasonably withheld or delayed,
and in no event shall MGI withhold approval if the activities, costs and
expenses are reasonable and customary (e.g., preparation to present at an ODAC).

 

5.2.2 Participation by MGI Prior to Transfer. Following the Effective Date and
until the transfer of responsibility to MGI for the Existing Licensed Product in
both of the United States and Europe in accordance with Section 5.2.1, MGI shall
cause certain of its Development Personnel with expertise in clinical
development, regulatory affairs, and development statistics (the “MGI Team”) to
work with SuperGen to complete and submit the clinical section of SuperGen’s NDA
for the Existing Licensed Product in the U.S. and in the corresponding MAA in
Europe by the end of calendar year 2004. In addition to MGI’s approval rights
described in Section 5.2.1, the MGI Team will have oversight, consultation and
review responsibilities, and each member of the MGI Team will be dedicated to
understanding the NDA in the U.S. and the MAA in Europe, including the
development that has been conducted, and the associated Regulatory Documentation
and Supporting Data, analyzing the Supporting Data, reviewing and editing the
Regulatory Documentation, offering strategic input, participating in all
interactions with FDA and EMEA, helping to prepare answers to FDA and EMEA
correspondence and inquiries, subject to Section 5.2.1.

 

5.3 MGI Development.

 

5.3.1 Except as otherwise set forth in Section 5.2.1, MGI shall assume and be
legally responsible, and agrees, to use Diligent Efforts to perform all further
Development of the Licensed Products and obtain such regulatory approvals,
including Marketing Authorizations and pricing and reimbursement approval, as
may be necessary to Commercialize the Licensed Products throughout the Major
Countries; provided that (i) such obligation of MGI to use Diligent Efforts for
indications other than MDS and AML shall not apply unless there is clinical data
that demonstrates a reasonable potential that a Licensed Product will have
clinical efficacy in the treatment of the indication and (ii) such obligation
for MGI to use Diligent Efforts to Develop Licensed Products shall additionally
be subject to Section 5.3.3 below. With respect to each of the Additional

 

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Indications, however, MGI shall use Diligent Efforts to identify a Licensed
Product that has the potential for clinical efficacy for the Additional
Indication. All Development of Licensed Products shall be performed by MGI in
accordance with applicable laws, rules and regulations. Without limiting the
foregoing, MGI shall use at least Diligent Efforts to conduct such Development
as is necessary or desirable for, and to obtain, regulatory approvals for
Licensed Products, consistent with MGI’s Commercialization Plan established in
accordance with this Agreement. It is understood and agreed that all Development
costs that SuperGen incurs in performing the Development for which it has
retained responsibility or control pursuant to Section 5.2, and all other
Development for the Licensed Products in the Territory, shall, as between the
Parties, be at the sole cost and expense of MGI commencing with the date on
which this Agreement is signed. MGI, its Affiliates, and Licensees will
reasonably consider and promptly respond to any comments provided by SuperGen
with respect to the Development conducted by MGI, its Affiliates and Licensees.

 

5.3.2 Minimum Development Costs. MGI shall expend, no less than fifteen million
US dollars (US$15,000,000) in Development Costs in the first thirty six (36)
months of Effective Date of this Agreement, including any costs reimbursed to
SuperGen pursuant to the provisions of Section 5.2.1 for the period from the
date of signing of this Agreement through the Effective Date.

 

5.3.3 Development of Certain Licensed Products. MGI’s obligation in Section
5.3.1 above to use Diligent Efforts to Develop and obtain Marketing
Authorizations for Licensed Products shall not include the obligation to use
Diligent Efforts to Develop and obtain Marketing Authorizations for a Licensed
Product in which the active ingredient is a Decitabine [*] or which comprises a
[*] formulation of Decitabine unless such Licensed Product provides a commercial
advantage over the Existing Licensed Product. Additionally, MGI’s obligation in
Section 5.3.1 to use Diligent Efforts to Develop and obtain Marketing
Authorizations shall include Licensed Products that become covered by a Licensed
Patent; provided that either (i) the Licensed Product provides a commercial
advantage over commercially feasible non-infringing alternative Competing
Products that treat the same indication as the Licensed Product or (ii) there
are no other commercially feasible non-infringing alternative Competing Products
that treat the same indication as the Licensed Product. As used above,
“commercial advantage” shall mean better bioavailability or adsorption; better
toxicity, metabolic, distribution, or excretion profile or characteristics; or
better efficacy, ease of administration, stability, solubility,
Manufacturability, or the like. Notwithstanding the foregoing, for each Licensed
Product of the type described in this Section 5.3.3, MGI shall use Diligent
Efforts to evaluate whether or not Licensed Products have such a commercial
advantage.

 

* Portions denoted with an asterisk have been omitted and filed separately with
the Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

5.3.4 Meetings with Regulatory Authorities; Regulatory Documentation. MGI shall
promptly provide, and shall cause its Affiliates and Licensees to provide
promptly,

 

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SuperGen with reasonable advanced notice (to the extent possible) of meetings,
scheduled or unscheduled, with Regulatory Authorities that pertain to any
Licensed Product in connection with Development by MGI, its Affiliates, and
Licensees. With respect to Regulatory Documentation filed by any of MGI, its
Affiliates, and Licensees, MGI shall afford, and shall cause its Affiliates and
Licensees to afford, representatives of SuperGen an opportunity to comment on
such Regulatory Documentation prior to filing, and shall reasonably consider
such comments, and, to the extent not prohibited by law, shall afford a
representative of SuperGen an opportunity to attend and actively participate in
all meetings with Regulatory Authorities for which SuperGen has not retained
responsibility under Section 5.2. Notwithstanding the foregoing, the requirement
in this Section 5.3.4 shall not apply in the U.S. after the third anniversary of
the Effective Date and shall not apply in Europe after the first Marketing
Authorization is obtained from the EMEA. MGI will provide, and cause its
Affiliates and Licensees to provide, to SuperGen translations into English that
have been prepared of portions and summaries of such Regulatory Documentation.
MGI shall, and shall cause its Affiliates and Licensees to, use Diligent Efforts
to defend Regulatory Documentation filed by such entities with Regulatory
Authorities to the maximum extent possible and to achieve Marketing
Authorization as early as possible. Subject to Section 5.2 above and 15.3 below,
all MAA filings and Marketing Authorizations in the Territory for the Licensed
Product shall be in the name of MGI.

 

5.3.5 Development Progress and Results.

 

(a) MGI shall provide, and shall cause its Affiliates and Licensees to provide,
SuperGen with full access to all Confidential Information, Regulatory
Documentation, and Supporting Data arising out of, or used or generated for, the
Development of Licensed Products. Upon request of SuperGen, MGI shall provide
SuperGen with copies of (or if not reasonably feasible to copy, access to) such
Confidential Information, Regulatory Documentation, and Supporting Data. Without
limiting the foregoing, MGI shall provide and make available to all JSC
representatives the same Confidential Information, Regulatory Documentation, and
Supporting Data that are provided or made available, respectively, to MGI
representatives on the JSC or the members of MGI’s internal project teams for
the Licensed Products and such additional information as JSC representatives may
reasonably request from time to time.

 

(b) Subject to the provisions of Section 2.3, SuperGen may use and disclose
Confidential Information, Regulatory Documentation, and Supporting Data obtained
under this Agreement as is reasonably necessary or useful for (i) review and
comment on the Development, Manufacture and other Commercialization of Licensed
Products under this Agreement; (ii) the development and commercialization of
products other than Licensed Products, including without limitation for use by
Third Parties and for cross-referencing drug master files or other Regulatory
Documentation, provided that the disclosure of such Confidential Information,
Supporting Data and Regulatory Documentation to a non-governmental Third Party
is made under reasonable and customary confidentiality restrictions; and (iii)
the exercise of its rights upon termination as set forth in Article 15 below.

 

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5.4 Records; Reports.

 

5.4.1 Records. MGI shall maintain records of the research and Development of the
Licensed Products (or cause such records to be maintained), as applicable, in
sufficient detail and in a good scientific manner as will properly reflect all
work done and results achieved in the performance of the research and
Development.

 

5.4.2 Reports. Within forty-five (45) days following the end of each calendar
year during the term of this Agreement, MGI shall provide to SuperGen a written
progress report in English which shall describe in reasonable detail the
progress of Development (including regulatory activities), and the
Commercialization activities planned and taken, by and under authority of MGI,
and the results thereof, relating to Licensed Product in the Territory,
including progress and status with respect to the activities, expenditures and
timing set forth in the Commercialization Plan; the work performed to date on
the research, Development, and Commercialization of the Licensed Products; the
results of such work, the status of Manufacturing efforts, including those set
forth under Article 6, the status of Commercialization efforts, including those
set forth under Article 7, and such other information as is reasonably requested
by SuperGen.

 

5.5 Third Parties. MGI shall cause its Affiliates, Licensees, and other Third
Parties having responsibilities in connection with the Development and/or
Commercialization of the Licensed Products to perform their responsibilities in
accordance with all applicable terms and conditions of this Agreement.

 

6. MANUFACTURING

 

6.1 Diligence. MGI shall use Diligent Efforts to establish, qualify, validate
and maintain sufficient Manufacturing facilities and capacity to manufacture
Licensed Products and meet worldwide demand. The Parties acknowledge that MGI
will have Licensed Products manufactured on its behalf by a Third Party
manufacturer SuperGen shall reasonably consult with MGI regarding the
identification and commercial scale up of such Third Party manufacturers as
mutually agreed and provided that MGI reimburses SuperGen for the costs and
expenses thereof. MGI shall use reasonable efforts to include in any agreements
with Third Party manufacturers the right to assign such agreement to SuperGen in
the event of expiration or termination of this Agreement pursuant to the
provisions of Article 14.

 

6.2 Manufacturing Plan. The JSC shall monitor, review, and discuss the
arrangements and activities for the Manufacture of Licensed Products, and MGI
shall keep the JSC apprised of the status of all Manufacturing activities,
whether conducted internally or by Third Parties. The Commercialization Plan
provided by MGI to SuperGen shall include a reasonably detailed Manufacturing
plan and budget specifying the scale up, qualification, validation and
regulatory activities planned for the Manufacture of Licensed Products, with
such plan designed to satisfy world-wide demand.

 

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6.3 Second Source. Qualification of a second source for the Manufacture of
Decitabine and the Licensed Products shall begin no later than the first
Marketing Authorization of the Existing Licensed Product. Such qualification
shall include: identifying a non-Affiliate Third Party that is independent of
the primary Manufacturer of the Licensed Products and that is capable of, and
willing to, supply the Licensed Products in quantities sufficient for meeting
worldwide demand.

 

6.4 Inspections. If any facilities related to a Licensed Product, or a component
or raw material therefor, are to be inspected by a Regulatory Authority, MGI
shall promptly notify SuperGen of the inspection in advance. MGI shall provide
the JSC with a written report of any such inspection, noting with specificity
any records or documents reviewed by the regulatory inspector, and including
copies of any FDA 483s (or their foreign equivalent) or written communications
provided by any Regulatory Authority relating to such inspection. MGI shall
provide copies of all communications to and from any Regulatory Authority
relating thereto to the JSC. When a copy of a document or record is supplied to
an inspector on request, that fact will be noted in the report. The inspected
party shall keep copies of each of these records and documents in a separate
inspection file and, on the request of SuperGen, will provide copies of these
documents and records to SuperGen. MGI shall ensure that agreements with
contract manufacturers and other Third Parties require that such entities
cooperate in such manner with respect to such inspections. Notwithstanding the
foregoing, this Section 6.4 shall apply only if SuperGen retains obligations to
supply Decitabine to Third Parties under the Third Party Agreements.

 

6.5 Supply of Decitabine Samples. Upon request of SuperGen, MGI shall supply to
SuperGen once in each calendar year, at MGI’s direct cost for providing such
product, and at SuperGen’s expense, SuperGen’s requirements for Decitabine
sufficient to fulfill its obligations under existing Third Parties agreements
that MGI has not assumed responsibility for pursuant to the provisions of
Section 9.8, in addition to 100 grams of decitabine API per year, 100 grams of
C-137 Starting Material per year and 100 grams of Isolated Intermediate per year
and such additional quantities as reasonably requested by SuperGen for
SuperGen’s internal use. SuperGen shall be entitled to purchase its requirements
of Decitabine and Licensed Products directly from MGI or its Third Party
manufacturer, if any. If MGI elects to manufacture Licensed Product itself
(rather than through a Third Party), MGI’s obligations to supply Decitabine
shall continue until the earlier of (i) two (2) years following expiration or
termination (or partial expiration or termination) of this Agreement, or (ii)
such time as SuperGen establishes its own direct supply of Decitabine from a
Third Party. If MGI elects to manufacture through a Third Party, then MGI’s
obligations to supply Decitabine to SuperGen shall continue until SuperGen
establishes its own direct supply of Decitabine from MGI’s Third Party
manufacturer.

 

7. COMMERCIALIZATION

 

7.1 Commercialization. MGI shall be responsible for, and agrees to use Diligent
Efforts to, Manufacture and otherwise Commercialize the Licensed Products in
each of the Major Countries; provided that, without limiting the terms of
Section 5.3 above, with respect to indications

 

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other than MDS and AML, and with respect to Licensed Products of the type
described in Section 5.3.3 above, the foregoing obligation to use Diligent
Efforts shall apply only if a Marketing Authorization is obtained for the
applicable Licensed Product. It is understood and agreed that all Manufacture
and other Commercialization efforts for Licensed Products in the Territory
shall, as between the Parties, be at the sole cost and expense of MGI.

 

7.2 Forecasts. No later than forty five (45) days prior to the beginning of each
calendar year, MGI shall provide to SuperGen a copy of good faith, internal
forecasts, that are no less optimistic than any forecast provided to its board
or other managing authority, of the reasonably projected sales of each Licensed
Product to end user customers in each country of the Territory during such
calendar year where such Licensed Product is expected to be sold, including
sales expected to be made by Affiliates and Licensees, broken down into calendar
quarters, all consistent with MGI’s obligations under this Agreement. The first
such forecast for each Licensed Product and country shall be provided for the
calendar year in which the First Commercial Sale is projected to occur in such
country, subject to the terms and conditions of this Agreement, and shall
indicate the projected time of First Commercial Sale.

 

7.3 Sales Force. MGI shall deploy a combined sales force of no less than 55
FTEs, all of whom shall be employed by MGI as part of its full time sales force,
dedicated to marketing and promoting the Licensed Products in the U.S. in
accordance with the Commercialization Plan. MGI agrees to not co-promote or
co-market the Licensed Products in the U.S. with another pharmaceutical company,
without the prior written consent of SuperGen. MGI shall establish and maintain
a high quality training program, and each sales representative shall be trained
and informed consistent with the use of Diligent Efforts. The sales
representatives shall be compensated so as to provide sales incentives (or other
variable pay components) that are consistent with those provided by MGI in
connection with its other highest priority products with a view to maximizing
the market penetration of the Licensed Products. If SuperGen notifies MGI that
it believes certain sales representatives may (i) have violated any laws or
regulations or (ii) be damaging relationships with health care professionals or
damaging the Licensed Product brand, or (iii) failed to comply with this
Agreement, MGI shall promptly use Diligent Efforts to evaluate and resolve such
issue.

 

7.4 Sales Materials. Any marketing and promotional materials created or used by
MGI, its Affiliates and Licensees for the Licensed Products shall be appropriate
to the Marketing Authorization for the Licensed Products in the respective
country, and consistent with MGI’s Territory-wide profile for the Licensed
Products. MGI shall promptly provide to SuperGen a copy of each item of
promotional materials, samples, and advertising with respect to Licensed
Products (“Sales Materials”) created or used by MGI, its Affiliates and
Licensees, and MGI shall provide the JSC with a reasonable opportunity to review
and comment on each claim, message or other material that is part of the Sales
Materials at the JSC meetings.

 

7.5 Reporting Adverse Drug Reactions/Experiences. Except as required prior to
transfer of responsibility for the Existing Licensed Product to MGI under
Section 5.2.1 to permit SuperGen to comply with its regulatory obligations, as
between the Parties, MGI shall be solely

 

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responsible for the collection, investigation, and reporting of information
concerning adverse drug reactions, Licensed Product quality and Licensed Product
complaints, sufficient to comply with the applicable laws and regulations of the
relevant countries and authorities with respect to the Licensed Products. MGI
shall ensure that its Affiliates and Licensees comply with such reporting
obligations. These reporting obligations shall apply to non-serious adverse
events as well, which shall mean adverse events that must be reported under the
laws, rules, regulations that are applicable in the particular country. MGI
shall keep SuperGen fully informed about all serious adverse drug reactions of
which MGI, its Affiliates, or Licensees becomes aware or is informed regarding
the Licensed Products.

 

7.6 Potential Hazards. MGI shall inform SuperGen as soon as possible but no
later than within forty-eight (48) hours of its receipt of any information that
(i) indicates or suggests a potential material liability for either Party to a
Third Party in the Territory arising in connection with a Licensed Product; (ii)
concerns suspected or actual tampering or contamination or other material
problems in the Territory with respect to a Licensed Product; (iii) is
reasonably likely to lead to a recall or market withdrawal in the Territory of a
Licensed Product; or (iv) concerns any ongoing or potential FDA or other
Regulatory Authority investigation, inspection, detention, seizure or injunction
in the Territory involving a Licensed Product, including the receipt of any
warning letter, material untitled letter or any equivalent communication from a
Regulatory Authority in the Territory relating to a Licensed Product.

 

7.7 Voluntary and Mandatory Recalls. If either Party believes that a voluntary
recall or market withdrawal of a Licensed Product or any Sales Material may be
necessary in the Territory, such Party shall notify the other Party within
forty-eight (48) hours after it forms such belief. Before taking any action with
respect to a recall or market withdrawal, to the extent possible, MGI, its
Affiliates, and Licensees shall provide SuperGen with a reasonable opportunity
to review, comment on and consult with respect to such recall or market
withdrawal, and MGI, its Affiliates, and Licensees shall consider in good faith
any comments or suggestions of SuperGen. As between the Parties, MGI shall be
solely responsible for all recalls and market withdrawals, provided that MGI
shall keep SuperGen fully informed with respect thereto and shall provide
SuperGen with reasonable opportunities to comment with respect to the activities
associated therewith. As between the Parties, all recalls and market withdrawals
shall be at the sole cost and expense of MGI.

 

7.8 Diligence Milestones.

 

7.8.1 The Commercialization Plan shall include the Development and
Commercialization milestones and dates for completion thereof (each a
“Completion Date”) that are described in and otherwise established in accordance
with this Section 7.8 (such milestones and Completion Dates, collectively the
“Diligence Milestones”). Exhibit 7.8 sets forth the Diligence Milestones for MDS
and AML. In addition to such Diligence Milestones, with respect to each Licensed
Product for which a Marketing Authorization is obtained in a Major Country,
there shall be an additional Diligence Milestone that MGI achieve First
Commercial Sale of the Licensed Product in the Major Country no later than
ninety (90) days after the Marketing Authorization is obtained (or

 

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if later and required in the Major Country, after approval of pricing and/or
reimbursement is obtained for sales of the Licensed Product) (a “Launch
Milestone”). If MGI fails to achieve such a Launch Milestone by the ninety (90)
day period following receipt of Marketing Authorization as set forth in the
sentence above, and if a milestone payment is specified in Section 3.1 for the
related Diligence Milestone and has not previously been paid, then MGI shall pay
to SuperGen within thirty (30) days after such failure the milestone payment set
forth in Section 3.1 for the missed Launch Milestone and shall continue to use
Diligent Efforts to meet the other milestones set forth in Section 3.1.

 

7.8.2 The Parties agree that, without limiting any other right or remedy of
SuperGen hereunder SuperGen shall have the right to terminate this Agreement in
its entirety (in the same manner as if MGI had materially breached this
Agreement) pursuant to Section 14.3 if MGI has not achieved First Commercial
Sale of a Licensed Product in a Major Country by December 31, 2008; provided,
however, that SuperGen’s right to terminate pursuant to this Section 7.8.2
above, shall be tolled so long as at least one Phase III trial, or equivalent,
for a Licensed Product for a Major Country (a “Registration Trial”) is ongoing
on December 31, 2008, and MGI is using, and continues to use, Diligent Efforts
to complete such Registration Trial(s) successfully and obtain a Marketing
Authorization based upon such Registration Trial(s). SuperGen’s right to
terminate under this Section 7.8.2 shall cease to be effective upon the earliest
of such time as a Marketing Authorization in a Major Country is obtained on one
of the Registration Trials that was ongoing on December 31, 2008, in which case
SuperGen shall have no right to terminate under this Section 7.8.2. With respect
to each of the Registration Trials in Major Countries that are ongoing on
December 31, 2008, if either the Regulatory Authority issues a non-approvable
letter or the equivalent, or the results produced are insufficient to obtain a
Marketing Authorizations in a Major Country, or MGI otherwise stops using
Diligent Efforts to obtain a Marketing Authorization in a Major Country,
SuperGen also shall have the right to terminate this Agreement in its entirety
(in the same manner as if MGI had materially breached this Agreement) pursuant
to Section 14.3. Nothing in this Section 7.8.2 shall be construed to limit any
other obligations of MGI under this Agreement or any other rights that SuperGen
may have to terminate this Agreement (such as based upon a breach of the terms
of this Agreement, other than this Section 7.8.2).

 

7.8.3 All payments made pursuant to this Section 7.8 shall be non-refundable and
non-creditable, except that if a payment is made for a milestone under this
Section 7.8, MGI shall not be required to make a payment under Section 3.1 for
the same milestone if such milestone is subsequently achieved by MGI. No payment
for a milestone under this Section 7.8, however, shall be credited against the
payment due for any other milestone.

 

8. PAYMENTS; BOOKS AND RECORDS

 

8.1 Milestone Payments. Milestone payments payable under Section 3.1 shall be
paid by MGI to SuperGen within thirty (30) days after the first occurrence of
the corresponding milestone.

 

8.2 Sublicensing Revenue. The payments that MGI is required to make to SuperGen
under Section 3.2 based upon Sublicensing Revenue shall be paid by MGI to
SuperGen within five (5) days after MGI’s receipt of the Sublicensing Revenues.

 

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8.3 Royalty Reports and Payments. Commencing with the earlier of (i) the first
sale of a Licensed Product hereunder or (ii) the last calendar quarter of
calendar year 2005, MGI shall make quarterly written reports to SuperGen within
sixty (60) days after the end of each calendar quarter, stating in each such
report, separately for MGI, its Affiliates, and Licensees, the number,
description, and aggregate Net Sales, by country, of each Licensed Product sold
during the calendar quarter (or stating that no sales have occurred if such is
the case). Concurrently with making each such report, MGI shall pay to SuperGen
the royalties due in accordance with Section 3.3. Notwithstanding the foregoing,
the report and payment described above shall be due within forty-five (45) days
after the end of the calendar quarter for Net Sales based upon sales within the
United States.

 

8.4 Other Payments. All payments other than those specified in Sections 8.1, 8.2
and 8.3 hereunder shall be made net thirty (30) days after the date of invoice.

 

8.5 Payment Method. All payments under this Agreement shall be made by bank wire
transfer in immediately available funds in US dollars to an account designated
by SuperGen. Any payments due under this Agreement which are not paid by the
date such payments are due under this Agreement shall bear interest to the
extent permitted by applicable law at the lower of (i) the prime rate as
reported by the Wall Street Journal, on the date such payment is due, plus an
additional four percent (4%) annually, or (ii) the maximum rate permitted by
law; in each case calculated on the number of days such payment is delinquent.
This Section 8.5 shall in no way limit any other remedies available to SuperGen.

 

8.6 Currency Conversion. All amounts set forth in this Agreement, or in any
Exhibit, are in U.S. Dollars. If any currency conversion shall be required in
connection with the calculation of royalties or other payments hereunder, such
conversion shall be made using the exchange rates for the foreign currency, in
U.S. Dollars, quoted for current transactions reported in the Exchange Rate
table setting forth the foreign exchange mid-range rates in The Wall Street
Journal for the last business day of the calendar quarter to which such payment
pertains.

 

8.7 Taxes. All payments required hereunder shall be without deduction or
withholding for or on account of any taxes, duties, or similar governmental
charge imposed by a jurisdiction except that, subject to the following sentence,
SuperGen shall remain responsible for all taxes imposed on its own net income.
Withholding taxes, if any, shall be the sole responsibility of MGI, without
impacting the amounts to be received by SuperGen hereunder. However, in the
event that SuperGen realizes a reduction in its tax liability by reason of such
withholding taxes or other amounts paid by MGI, MGI shall receive a credit
against royalties or other amounts payable to SuperGen hereunder equal to the
reduction in SuperGen’s tax liability. MGI shall provide SuperGen with a
certificate evidencing its separate payment of such withholding taxes pursuant
to this Section 8.7.

 

8.8 Records; Inspection. MGI shall keep, and require its Affiliates and
Licensees to keep, complete, true and accurate books of accounts and records for
the purpose of determining the amounts payable pursuant to and other compliance
with this Agreement. Such books and records

 

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shall be kept at the principal place of business of MGI, its Affiliates and
Licensees for at least five (5) years following the end of the calendar quarter
to which they pertain. Such records will be open for inspection during such five
(5) year period by representatives of SuperGen. Such inspections may be made no
more than once each calendar year, at reasonable times and on reasonable notice,
provided that an additional audit may be conducted in a calendar year each time
a non-compliance is identified; and provided further that SuperGen shall be
permitted to re-audit a period that it has already audited hereunder only if
SuperGen becomes aware of information not previously known to its executive
management that shows that an inaccuracy in payment may have occurred The
representative shall be subject to a reasonable confidentiality agreement prior
to commencing any such inspection. Inspections conducted under this Section 8.8
shall be at the expense of SuperGen, unless a variation or error producing an
underpayment in amounts payable exceeding five percent (5%) of the amount paid
by MGI for the most recent twelve months immediately prior to the date of the
audit, or other material breach of this Agreement, is established by such
inspection, whereupon all costs relating to the inspection for such period shall
be paid by MGI to SuperGen. Additionally, all unpaid amounts that are discovered
by any audit shall be paid to SuperGen promptly upon conclusion of the audit,
together with interest on such unpaid amounts at the rate set forth in Section
8.5 above.

 

9. INTELLECTUAL PROPERTY; THIRD PARTY AGREEMENTS

 

9.1 Ownership of Inventions. Except with respect to new or improved
compositions, new or improved formulations, and new or improved methods of
manufacture or use of Decitabine (and all Patent Rights, trade secrets, and
other intellectual property rights pertaining to any of the foregoing)
(collectively, the “Decitabine Improvements”), all right, title, and interest in
and to all technology, inventions, trade secrets, Patent Rights, and other
intellectual property rights made and conceived solely by MGI personnel in
connection with this Agreement shall be owned solely by MGI. All right, title,
and interest in and to all technology, inventions, trade secrets, Patent Rights,
and other intellectual property rights made and conceived solely by SuperGen
personnel in connection with this Agreement and all right, title, and interest
in and to all Decitabine Improvements (regardless of by whom made or conceived)
shall be owned solely by SuperGen. Except with respect to Decitabine
Improvements, all right, title, and interest in and to all technology,
inventions, trade secrets, Patent Rights and other intellectual property rights
made and conceived jointly by personnel of SuperGen and MGI in connection with
this Agreement shall be jointly owned by MGI and SuperGen. Except as expressly
provided in this Agreement, it is understood that neither Party shall have any
obligation to account to the other for profits, or to obtain any approval of the
other Party to license on a non-exclusive basis or assign its rights any such
jointly owned inventions or intellectual property rights, by reason of joint
ownership thereof; provided, however, that with respect to licenses granted
under jointly owned inventions that purport to permit the manufacture and sale
of Competing Products, duty to account and approval rights with respect to these
licenses shall be in accordance with the laws of inventorship of the country to
which the jointly owned patent rights pertain. Notwithstanding the foregoing, in
no event shall a Party by virtue of its joint ownership rights retain the right
to approve or consent to a Change of Control of a Party hereto. SuperGen shall
have the exclusive right to apply for Patent Rights with respect to all
Decitabine

 

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Improvements, and MGI shall inform SuperGen, and require that its Affiliates and
Licensees inform SuperGen, thereof. MGI, its Affiliates, and Licensees shall
treat Decitabine Improvements as the Confidential Information of SuperGen, and
shall not make any disclosure or use thereof without first giving SuperGen a
reasonable opportunity to file Patent Rights covering the Decitabine
Improvement. MGI and its Affiliates hereby irrevocably assign, and shall assign
and cause the Licensees to assign, to SuperGen all right, title, and interest in
and to the Decitabine Improvements worldwide, including the right to file,
prosecute, and maintain Patent Rights with respect thereto in all countries and
under all treaties. MGI shall, and shall cause its Affiliates and Licensees to,
execute such documents, render such assistance, and take such other actions as
SuperGen may request, at SuperGen’s expense, as may be necessary to apply for,
register, perfect, confirm, defend, and enforce SuperGen’s rights with respect
to Decitabine Improvements.

 

9.2 Patent Prosecution. SuperGen (and its designees) shall have the first right
to conduct all future 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 owned Patent Rights, and of Patent Rights with respect to Decitabine
Improvements, and the Parties shall share equally the costs and expenses
associated with SuperGen performing such activities. MGI shall reimburse
SuperGen for one half of such costs and expenses upon invoice. If SuperGen
decides, in its sole discretion, to abandon an issued patent or pending patent
application within the scope of the foregoing, then it shall so notify MGI in
writing at least sixty (60) days prior to the date on which the next action or
filing is due to be taken with respect thereto (or such shorter time as is
reasonably practical for deadlines not extendable beyond 90 days), and shall
give MGI a reasonable opportunity, at MGI’s sole expense, to assume
responsibility for prosecuting and maintaining the Patent Right.

 

9.3 Prosecution. On request of the Party performing the preparation, filing,
prosecution, or maintenance of any Patent Rights in accordance with the
foregoing, the other Party will reasonably cooperate with the prosecuting Party
in connection therewith, without demanding any further consideration therefor,
including, without limitation, executing and filing applications, registrations,
powers of attorney, oaths and other appropriate documents, providing appropriate
consents and/or authorizations, and joining in any administrative or judicial
action relating to the prosecution or maintenance of any Patent Rights. The
prosecuting Party in accordance with the foregoing shall keep the other
reasonably informed as to the status of the Patent Right being prosecuted under
Section 9.2, including providing to the other Party with copies of any
significant documents that such Party receives from or sends to the applicable
government office, such as notices of interferences, re-examinations,
oppositions or requests for patent term extensions.

 

9.4 Extensions. SuperGen shall have the right but not the obligation to seek
extensions of the terms of Licensed Patents in the Territory. At MGI’s request,
SuperGen shall either authorize MGI to act as SuperGen’s agent for the purpose
of making any application for any extensions of the term of Licensed Patents and
provide reasonable assistance therefor to MGI or shall diligently seek to obtain
such extensions, in either event, at the Parties hereto shared expense. MGI
shall cooperate reasonably with SuperGen with respect to extensions sought by
SuperGen.

 

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9.5 Third Party Infringement Claims. If the making, sale, importation, or use of
any Licensed Product in the Territory pursuant to this Agreement results in a
claim, suit or proceeding by a Third Party alleging patent infringement against
SuperGen or MGI (or their respective Affiliates or Licensees) (collectively,
“Infringement Actions”), such Party shall promptly notify the other Party hereto
in writing. Subject to Article 13, the Party subject to such Infringement Action
shall have the exclusive right to defend and control the defense thereof
(including the conclusion of a potential settlement, but limited to the rights
granted pursuant to this Agreement) using counsel of its own choice, and also
subject to Article 13 the Infringement Action shall be at such Party’s own
expense; provided, however, that the Party not responsible under the foregoing
for defending such Infringement Action may participate in 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 hereto
reasonably informed of all material developments in connection with any such
Infringement Action. MGI agrees not to make admissions regarding infringement by
the Licensed Product of any Patent Rights outside of the Licensed Patents,
without obtaining the prior written consent of SuperGen. Nothing in this Section
9.5 shall be construed as limiting the obligations of indemnification under
Article 13.

 

9.6 Enforcement. Subject to the provisions of this Section 9.6, in the event
that MGI reasonably believes that any of the Licensed Patents in the Territory
are infringed or misappropriated by a Third Party or is subject to a declaratory
judgment action in the Territory arising from such infringement, in each case
with respect to the manufacture, sale or use of a product within the Territory
that contains Decitabine, MGI shall promptly notify SuperGen. In such event, as
between the Parties, SuperGen shall have the initial right (but not the
obligation) to enforce the Licensed Patents with respect to such infringement,
or defend any declaratory judgment action with respect thereto (for purposes of
this Section 9.6, an “Enforcement Action”).

 

9.6.1 Initiating Enforcement Actions. In the event that SuperGen fails to
initiate an Enforcement Action to enforce the Licensed Patents against an
infringement by a Third Party product in a country in the Territory, which
infringement consists of the manufacture, sale or use in such country of a
product that treats an indication for which MGI has received a Marketing
Authorization hereunder, within one hundred twenty (120) days of a request by
MGI to initiate such Enforcement Action, MGI may initiate an Enforcement Action
against such infringement. SuperGen shall cooperate in such Enforcement Action
at MGI’s expense, provided that MGI indemnifies SuperGen against any liability
arising therefrom. The Party initiating or defending any such Enforcement Action
shall keep the other Party hereto reasonably informed of the progress of any
such Enforcement Action, and such other Party shall have the right to
participate with counsel of its own choice and at its own expense.

 

9.6.2 Enforcement. With respect to Enforcement Actions initiated by SuperGen in
a country in the Territory, MGI shall pay one half (1/2) of the costs and
expenses (including attorneys’ and professional fees) incurred by SuperGen in
connection with such Enforcement Action. Any recovery received as a result of
any Enforcement Action to enforce Licensed Patents pursuant to this Section 9.6
by either Party shall be used first to reimburse the

 

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Parties for the costs and expenses (including attorneys’ and professional fees)
incurred in connection with such Enforcement Action, and the remainder of the
recovery shall be shared (to the extent the same represents damages from sales
of Licensed Products within the Territory) equally between the Parties;
provided, however, that if SuperGen initiates the Enforcement Action and MGI
does not agree to pay one half (1/2) of the costs and expenses incurred by
SuperGen therein, MGI shall not be entitled to any amount recovered in such
Enforcement Action.

 

9.7 Patent Marking. MGI agrees to mark and have its Affiliates and Licensees
mark all patented Licensed Products they sell or distribute pursuant to this
Agreement in accordance with the applicable patent statutes or regulations in
the country or countries of manufacture, use, importation and sale thereof
sufficient to preserve all of SuperGen’s rights and remedies under the Licensed
Patents.

 

9.8 Third Party Agreements. (a) Third Party Agreements. The Parties hereto agree
that all responsibilities and obligations of SuperGen under the Third Party
Agreements set forth in Exhibit 1.46 be transferred to MGI, and that MGI shall
assume all such responsibilities and obligations, commencing as of the Effective
Date. With respect to the Third Party Agreements that will be assigned to MGI as
identified in Exhibit 1.46, each such Third Party Agreement is and shall be
transferred and assigned by SuperGen to MGI, and MGI hereby assumes, and shall
assume, all responsibilities, obligations, and liabilities of SuperGen under the
Third Party Agreements. With respect to the Third Party Agreements relating to
the Development or Commercialization of Decitabine that SuperGen will retain and
not assign to MGI, as identified in Exhibit 1.46, MGI does and shall assume and
agrees to perform all of SuperGen’s responsibilities, liabilities and
obligations under such agreements. The Parties shall cooperate reasonably after
the Effective Date as necessary to obtain all necessary consents, waivers and
approvals as are required under the assigned Third Party Agreements in order to
effect such transfer promptly after the Effective Date. The Parties acknowledge
and agree that should SuperGen become aware that it has inadvertently or
otherwise omitted a Third Party agreement specific to the Development or
Commercialization of a Licensed Product from Exhibit 1.46, the Parties will
discuss in good faith and amend Exhibit 1.46 to include such Third Party
agreement subject to MGI’s review and acceptance of such agreements (as
described below), and upon acceptance, the provisions of this Section 9.8 shall
apply to such Third Party Agreement as if included as of the date of signing of
this Agreement, provided, however, that if MGI does not accept such Third Party
agreement, MGI shall not be responsible for compliance and performance of such
Third Party agreement. It is understood and agreed that SuperGen’s communication
of the agreement’s basic purpose and scope shall be sufficient for MGI to review
and decide whether to accept inclusion of such Third Party agreements following
the date of signing hereof. With respect to the Supply Agreements, SuperGen will
use reasonable efforts to seek a consent to assignment of the Manufacturing
Agreement and such other amendments to its other agreements with Pharmachemie
B.V. as may be prudent in SuperGen’s business judgement to ensure SuperGen’s
compliance with the terms of such agreements, it being understood that
“reasonable efforts” shall not include payment of any monetary or other
consideration. Without limiting the foregoing provisions of this Section 9.8 or
any other provision of this Agreement, if consent to assignment is not obtained
with respect to the Manufacturing Agreement within ninety (90) days

 

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following the Effective Date, the Parties shall negotiate in good faith terms
and conditions for SuperGen’s supply of Decitabine to MGI that (x) are
consistent with the Manufacturing Agreement; (y) ensure that SuperGen is able to
comply with its obligations under the Manufacturing Agreement its other
agreements with Pharmachemie B.V.; and (z) provide for reimbursement by MGI of
SuperGen’s Supply Costs. For purposes of this Section 9.8, the following
definitions shall have the following meanings: “Supply Agreements” shall mean
that certain Manufacturing Agreement between SuperGen and Pharmachemie B.V. set
forth in Exhibit 1.46 and that certain Agreement between SuperGen and Ferro
Pfanstiehl set forth in Exhibit 1.46. “Supply Costs” shall mean the total of (i)
the actual hours expended by SuperGen personnel, multiplied by the Reimbursement
Rate in effect at the time such hours are incurred for the particular
individual; (ii) material costs; (iii) contractor costs; and (iv) other direct
and out-of -pocket expenses incurred in order to supply MGI under the
Manufacturing Agreement. “Reimbursement Rate” shall mean with respect to any
individual SuperGen personnel, the sum of the actual (i) annual salary, (ii)
employee benefits (including bonus, payroll taxes, insurances and other direct
benefit costs) and (iii) Allocated Overhead, divided by one thousand eight
hundred seventy two (1872). The Reimbursement Rate does not include material
costs, contractor costs and other direct and out-of-pocket expenses incurred.
These other costs and expenses shall be included in the Supply Costs separately
under this Section 9.8 above.

 

10. TRADEMARKS

 

10.1 Product Trademark. Each of the Licensed Products shall be distributed,
promoted, marketed and sold in the Territory by MGI, its Affiliates and
Licensees exclusively under its Product Trademarks; provided that MGI, its
Affiliates or Licensee may also use non-Licensed Product specific company
trademarks in connection with such distribution, promotion, marketing and sale.
The Product Trademark for the Existing Licensed Product shall be the “Dacogen”
trademark owned by SuperGen, except to the extent otherwise agreed by the
Parties in writing. MGI shall have the right to reasonably select a different
Product Trademark for each of the other Licensed Products; provided that no such
Product Trademark shall be confusingly similar to any trademark, trade dress,
logo, or the like of SuperGen, and such Product Trademark shall be considered as
owned by MGI for purposes of this Agreement.

 

10.2 License. SuperGen hereby grants to MGI a royalty-free license to use the
Product Trademarks, to the extent owned by SuperGen, during the term of this
Agreement solely in connection with marketing, promoting, distributing and
selling the applicable Licensed Product in the Territory in accordance with this
Agreement during its Term.

 

10.3 Registration. Each Party agrees to file, register and maintain
registrations for the Product Trademarks to the extent owned by such Party as
appropriate in such Party’s discretion, for the term of this Agreement, for use
with the Licensed Products. The costs of filing and maintaining such
registrations, and recordations under Section 10.5 below, in the Territory for
the Product Trademarks owned by SuperGen shall be shared equally between the
Parties.

 

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10.4 Ownership. MGI hereby acknowledges SuperGen’s exclusive ownership rights in
the Dacogen trademarks as set forth above, and accordingly agrees that at no
time during or after the term of this Agreement to challenge or assist others to
challenge such Product Trademark, or the registration thereof, or attempt to
register any trademarks, marks or trade names confusingly similar to such
Product Trademarks without SuperGen’s written consent. MGI shall make such
restriction applicable to its Affiliates and any Licensees and shall be
responsible under this Agreement for the performance of such Affiliates and
Licensees in accordance therewith.

 

10.5 Recordation. In those countries where a trademark license must be or is
desired by SuperGen to be recorded for the Product Trademark owned by SuperGen,
SuperGen will provide and record a separate trademark license for such Product
Trademarks, and the expense thereof shall be shared equally by the Parties.
Additionally, the Parties shall enter into and record registered user
agreements, as requested by SuperGen, for Product Trademarks owned by SuperGen.
MGI shall cooperate in the preparation and execution of such documents.

 

10.6 Guidelines; Approval. All representations of the Product Trademarks owned
by SuperGen that MGI, its Affiliates, and Licensees intend to use shall first be
submitted to SuperGen for approval (which shall not be unreasonably withheld) of
design, color, and other details or shall be exact copies of those used by
SuperGen and shall in any event comply with usage guidelines as established by
SuperGen from time to time. Additionally, MGI shall submit representative
promotional materials, packaging, and Licensed Product using the Product
Trademarks owned by SuperGen to SuperGen for SuperGen’s reasonable approval
prior to their first use and prior to any subsequent change or addition to such
promotional materials provided that if SuperGen has not responded within five
(5) business days after such submissions, SuperGen’s approval will be deemed to
have been received. SuperGen shall have the right to monitor the quality of
License Product for which its Product Trademarks are used, as reasonably
requested from time to time.

 

10.7 Termination. MGI’s right to use the Product Trademarks owned by SuperGen
shall terminate in each country of the Territory in which MGI’s rights to
distribute the Licensed Product expire or are terminated in accordance with this
Agreement. MGI shall cooperate in the cancellation of any trademark licenses,
and registered user agreements, recorded or entered into in such countries.

 

11. CONFIDENTIALITY

 

11.1 Non-Use and Non-Disclosure. Except as expressly provided herein, the
Parties agree that the receiving Party shall not publish or otherwise disclose,
and shall not use for any purpose, any Confidential Information of the other
Party hereto obtained in connection with this Agreement, and any use and
disclosure by or under authority of a Party of the other Party’s Confidential
Information in accordance with this Agreement shall be subject to a non-use and
non-disclosure agreement comparable to the terms hereof. Each Party shall take
the same reasonable measures necessary to prevent any disclosure by its
employees, agents, contractors, and consultants

 

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of the other Party’s Confidential Information as it applies to the protection of
its own Confidential Information.

 

11.2 Exclusions. Information shall not be considered Confidential Information
hereunder if it:

 

11.2.1 was already in the possession of the receiving Party prior to its receipt
from the disclosing Party, as shown by the receiving party’s books and records
(except that this exclusion shall not cause Decitabine Improvements to not be
the Confidential Information of SuperGen);

 

11.2.2 is, or becomes, part of the public knowledge or literature through no
fault, act or omission of the receiving party, provided, Confidential
Information shall not be deemed to have entered the public domain by reason of
its having been filed with any Regulatory Authority;

 

11.2.3 is, or becomes, available to the receiving party from a source other than
the disclosing party, which source has rightfully obtained the same information
and has no obligation of confidentiality with respect to it;

 

11.2.4 is made available on an unrestricted basis by the disclosing party to a
Third Party unaffiliated with the disclosing party; or

 

11.2.5 is independently developed without use of or reference to the other
Party’s Confidential Information.

 

11.3 Permitted Use and Disclosures. Notwithstanding the provisions of Section
11.1 above, (i) each Party hereto may use and disclose the other Party’s
Confidential Information to the extent such disclosure is reasonably necessary
to exercise the rights granted to it, or reserved by it, under this Agreement
(including the right to grant sublicenses, as applicable), and (ii) each Party
hereto may disclose the other’s Confidential Information to the extent such
disclosure is reasonably necessary in prosecuting or defending litigation or
complying with applicable governmental regulations, submitting information to
tax or other governmental authorities; provided that in (i), to the extent
possible, the recipient is bound by terms and conditions as protective of the
other Party’s Confidential Information as the terms and conditions of this
Article 11, and further provided that in (ii) if a Party is legally required to
make any such disclosure of the other Party’s Confidential Information, to the
extent it may legally do so, it will give reasonable advance written notice to
the latter Party of such disclosure and will use its reasonable efforts to
secure confidential treatment of such Confidential Information prior to its
disclosure (whether through protective orders or otherwise). MGI, its Affiliate,
and Licensees shall not disclose information about Decitabine Improvements
except to the extent licensed to MGI hereunder, as required in MGI’s performance
of its obligations hereunder without SuperGen’s prior written consent.

 

11.4 Prior Non-Disclosure Agreements. Upon execution of this Agreement, the
terms of this Section 11 shall supercede any prior non-disclosure, secrecy, or
confidentiality

 

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agreement between the Parties. Any information disclosed under such prior
agreements shall be deemed disclosed under this Agreement.

 

11.5 Terms of the Agreement. Each of the Parties hereto agrees not to disclose
the terms of this Agreement to any Third Party without the prior written consent
of the other Party hereto, which consent shall not be unreasonably withheld or
delayed, except (i) to advisors, legal counsel, existing and potential investors
and others on a need-to-know basis under conditions which reasonably ensure the
confidentiality thereof, (ii) as required by any court or other governmental
body; (iii) as otherwise required by law; (iv) in confidence, in connection with
the enforcement of this Agreement or rights under this Agreement; (v) in
confidence, in connection with a merger, acquisition of stock or assets,
proposed merger or acquisition, or the like; (vi) as advisable or required in
connection with any government or regulatory filings, including without
limitation filings with the SEC, provided that the filing Party consults in good
faith with the Party whose Confidential Information is to be disclosed with
respect to the specific disclosure and seeks confidential treatment to the
extent reasonably practical; and (vii) as required to be disclosed in such
Party’s financial statements as reasonably required or recommended by such
Party’s independent auditor.

 

11.6 Publication of Licensed Product Information. MGI shall publish, publicly
present and/or submit for written or oral publication a manuscript, abstract or
the like which includes data or other information relating to Licensed Product
only after providing SuperGen with opportunity to review the publication for at
least fifteen (15) business days after submission to SuperGen for review. If
SuperGen desires to file patent applications with respect thereto SuperGen shall
notify MGI within the foregoing fifteen (15) business day period and shall have
an additional sixty (60) days to file prior to publication. MGI shall not have
the foregoing rights with respect to any materials that include Confidential
Information of SuperGen. The contribution of each Party shall be noted in all
publications or presentations by acknowledgment or coauthorship, whichever is
appropriate.

 

12. REPRESENTATIONS AND WARRANTIES

 

12.1 By SuperGen. SuperGen hereby represents and warrants to MGI as follows:

 

12.1.1 SuperGen has been duly organized and is validly existing as a corporation
in good standing under the laws of the state of Delaware, with corporate power
to conduct any lawful business activity. SuperGen has the corporate power and
authority to enter into this Agreement and to consummate the transactions
contemplated by this Agreement.

 

12.1.2 The execution, delivery and performance of this Agreement, and the
consummation of the transactions contemplated by this Agreement, by SuperGen
have been duly and validly authorized by all requisite corporate action of
SuperGen. This Agreement has been duly executed and delivered by SuperGen and
constitutes the legal, valid and binding obligation of SuperGen, enforceable
against SuperGen in accordance with its terms, except as enforceability thereof
may be limited by bankruptcy, insolvency, reorganization or other similar laws
relating to or affecting the rights of creditors generally, and by general
principles of equity.

 

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12.1.3 The execution, delivery and performance of this Agreement by SuperGen,
and the consummation by SuperGen of the transactions contemplated by this
Agreement, do not in any material respect (i) conflict with or result in any
breach of 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 or notice to any court or governmental body, under the
provisions of SuperGen’s Articles of Incorporation or bylaws or any indenture,
mortgage, lease, loan agreement, license or other agreement or instrument to
which SuperGen is a party; or (ii) conflict with or result in the violation of
any law, statute, rule or regulation or order, judgment or decree to which
SuperGen is subject; in each of (i) and (ii) except as disclosed by SuperGen to
MGI in that certain disclosure letter provided by SuperGen to MGI of even date
herewith (the “Disclosure Letter”).

 

12.1.4 SuperGen has received no notice from any of Third Party contractor or
licensors (or their licensors) that it is in material breach of any of its
obligations under the Third Party Agreements, and it is not aware of any
material breach of the Third Party Agreements.

 

12.1.5 It (i) is the owner of the entire right, title and interest in and to, or
has licensed sufficient rights to, the Licensed Patents and the trade secrets in
the Licensed Know-How, free and clear of any liens or encumbrances, sufficient
to grant the licenses to MGI thereunder in this Agreement and (ii) has not
assigned and/or granted licenses to the Licensed Patents or the Licensed
Know-How, or entered into any inconsistent prior obligations, to any other
person or entity that conflict with the rights granted hereunder.

 

12.1.6 To its actual knowledge as of the date of signing of this Agreement,
without independent investigation, the Licensed Patents and Licensed Know-How
are not infringed by any Third Party. SuperGen has not received any notice from
any person or entity claiming to have any right, title or interest in or to the
Licensed Patents and Licensed Know-How and to its actual knowledge as of the
date of signing of this Agreement, there is no reason to expect that any such
notice is forthcoming. There are no Third Party claims that have been made to
SuperGen as of the date of signing of this Agreement that, to SuperGen’s
knowledge, would challenge or impair the license of the rights granted to MGI
herein, including, without limitation, any claims based upon patents, copyrights
or trade secret laws in the Territory; except as disclosed by SuperGen to MGI
MGI in the Disclosure Letter.

 

12.1.7 As of the date of signing of this Agreement, there are no actions, suits
or proceedings pending or threatened in writing against SuperGen at law or in
equity before or by any federal, provincial, state, municipal or other
governmental department, commission, board, bureau, agency or instrumentality,
domestic or foreign, which may in any way materially adversely affect the
performance by SuperGen of its obligations under this Agreement, except as
disclosed by SuperGen to MGI in the Disclosure Letter.

 

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12.2 By MGI. MGI hereby represents and warrants to SuperGen as follows:

 

12.2.1 MGI has been duly organized and is validly existing as a corporation in
good standing under the laws of the state of Minnesota, with corporate power to
conduct any lawful business activity. MGI has the corporate power and authority
to enter into this Agreement and to consummate the transactions contemplated by
this Agreement. No consent, approval or agreement of any person, party, court,
government or entity is required to be obtained by MGI and/or any of its
Affiliates in connection with the execution and delivery of this Agreement or
the consummation of the transactions contemplated hereby, which has not been
obtained. There is nothing in any agreement between MGI or its Affiliates and
any Third Party agreement which, in any way, will limit MGI’s ability to perform
all of the obligations undertaken by MGI hereunder, such as without limitation
its diligence with respect to the Development and Commercialization of Licensed
Products.

 

12.2.2 The execution, delivery and performance of this Agreement, and the
consummation of the transactions contemplated by this Agreement, by MGI have
been duly and validly authorized by all requisite corporate action of MGI. This
Agreement has been duly executed and delivered by MGI and constitutes the legal,
valid and binding obligation of MGI, enforceable against MGI in accordance with
its terms, except as enforceability thereof may be limited by bankruptcy,
insolvency, reorganization or other similar laws relating to or affecting the
rights of creditors generally, and by general principles of equity.

 

12.2.3 The execution, delivery and performance of this Agreement by MGI and the
consummation by MGI of the transactions contemplated by this Agreement do not in
any material respect (i) conflict with or result in any breach of 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 or notice to
any court or governmental body, under the provisions of MGI’s Articles of
Incorporation or bylaws or any indenture, mortgage, lease, loan agreement,
license or 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 regulation
or order, judgment or decree to which MGI is subject.

 

12.2.4 During the term of this Agreement, MGI shall comply, in all material
respects with all applicable statutes, rules and regulations of the FDA, and, to
the extent applicable, other Regulatory Authorities, with respect to the
clinical testing, manufacture, collection, labeling, storing, testing, or
distribution of the Licensed Products, including the then current “Good
Manufacturing Practice,” or GMP regulations, “Good Clinical Practice” or GCP
regulations, “Good Laboratory Practice” or GLP regulations, “Informed Consent”
and “Institutional Review Board” regulations, and all applicable requirements
relating to the protection of human subjects for its clinical trials as required
by the FDA and any applicable corresponding requirements of the other applicable
Regulatory Authorities. MGI shall obtain from the FDA or other applicable
Regulatory Authorities, all requisite permits, approvals, registration and
licenses required to Commercialize the Licensed Products prior to marketing or
selling a Licensed Product in such country or region.

 

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12.2.5 It has disclosed to SuperGen in writing prior to the date of signing of
this 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 rights to Commercialize, and it is not (and does not plan to) Commercialize
any Competing Products.

 

12.3 DISCLAIMER. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT,
NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND
EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, OR VALIDITY
OF ANY PATENTS ISSUED OR PENDING, AND EACH PARTY HEREBY DISCLAIMS SUCH OTHER
REPRESENTATIONS AND WARRANTIES.

 

13. INDEMNIFICATION

 

13.1 Indemnification of SuperGen. MGI shall indemnify, defend and hold harmless
SuperGen, its Affiliates, and their respective directors, officers, employees,
agents and their respective successors, heirs and assigns (the “SuperGen
Indemnitees”) from and against any and all losses, costs, claims, damages,
liabilities and expenses (including reasonable attorneys’ 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 SuperGen Indemnitee (and further including
those arising out of personal injury claims) arising from or occurring as a
result of (a) any breach of the representations and warranties made by MGI in
this Agreement; (b) any research, Development, testing, importation, use, offer
for sale, sale, marketing, distribution, Manufacture, or other Commercialization
of any Licensed Product by or under authority of MGI, its Affiliates or
Licensees, (c) any act, omission, or failure of MGI or any of its Affiliates or
Licensees to comply in any material respect, with any applicable laws,
regulations and/or administrative decisions relating to Licensed Products or (d)
a Claim by a Third Party as a result of MGI exercising rights exceeding the
scope of the license grant from SuperGen pursuant to the provisions of Article 2
or arising out of or relating to breach of Articles 9 or 11; except in each case
to the extent caused by the gross negligence or willful misconduct of SuperGen.

 

13.2 Indemnification of MGI. SuperGen shall indemnify, defend and hold harmless
MGI, its Affiliates, and their respective directors, officers, employees, agents
and their respective successors, heirs and assigns (the “MGI Indemnitees”) from
and against any and all Liabilities, including Liabilities resulting from a
Claim made or brought by a Third Party against an MGI Indemnitee arising from or
occurring as a result of (a) any breach of the representations and warranties
made by SuperGen in this Agreement or (b) any act, omission of failure of
SuperGen or any of its Affiliates to comply in any material respect with any
applicable laws, regulations and/or administrative decisions relating to
Licensed Products; except in each case to the extent caused by the gross
negligence or willful misconduct of MGI.

 

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13.3 Procedure. A SuperGen Indemnitee or MGI Indemnitee, as the case may be,
that intends to claim indemnification (the “Indemnitee”) shall promptly notify
the indemnifying Party (the “Indemnitor”) in writing of any Claim in respect of
which the Indemnitee intends to claim indemnification under this Article 13. The
Indemnitor shall 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 or settlement of such Claim with counsel of its own choosing at its
expense. The Indemnitor shall keep the Indemnitee fully informed of the progress
of any such Claim. The indemnity arrangement in this Article 13 shall not apply
to amounts paid in settlement of any action with respect to a Claim, if such
settlement is effected without the consent of the Indemnitor, which consent
shall not be withheld or delayed unreasonably. The failure to deliver written
notice to the Indemnitor within a reasonable time after the commencement of any
action with respect to a Claim, if prejudicial to its ability to defend such
action, shall relieve such Indemnitor of any liability to the Indemnitee under
this Article 13 but the omission so to deliver written notice to the Indemnitor
shall not relieve the Indemnitor of any liability that it may have to any
Indemnitee otherwise than under this Article 13. The Indemnitee shall cooperate
fully with the Indemnitor and its legal representatives in the investigation of
any action with respect to a Claim covered by this indemnification at the
expense of the Indemnitor.

 

13.4 Insurance. Each Party shall procure and maintain at its own cost
comprehensive general liability (including coverage for products and maintained
for a period of at least five (5) years after the expiration or termination of
this Agreement), product liability, clinical trial liability, and property and
casualty insurance providing commercially reasonable coverage (at least
US$10,000,000 coverage) for its activities under this Agreement and its
equipment, premises and businesses. MGI will maintain foreign local coverage in
the Territory where required by foreign law in an amount that, at a minimum,
satisfies the legal requirements of that jurisdiction. The insurance policies of
the Parties in the United States shall be with financially strong insurance
carriers (AM Best Rating of “A: VIII” or higher) and will be primary to any
other insurance owned, secured or in place. MGI shall name SuperGen as an
additional insured on such policies. Each Party will furnish to the other Party
the corresponding certificates of insurance that evidence the foregoing within
thirty (30) days of the Effective Date.

 

14. TERM AND TERMINATION

 

14.1 Term. This Agreement shall be effective as of the Effective Date; provided,
however, that, solely this Section 14.1, and Sections 16.2.1 (Governing Law),
16.2.2 (Submission to Jurisdiction), 16.2.3 (Waiver of Jury Trial), 16.2.4
(Other Remedies), 16.2.5 (Injunctive Relief) and 16.5 (Notices) shall be
effective as of the date of signing hereof. Prior to the Effective Date, neither
Party shall take any action prohibited by Section 5.4 of the Stock Purchase
Agreement. Unless earlier terminated pursuant to the other provisions of this
Agreement, this Agreement shall expire, on a country-by-country and Licensed
Product-by-Licensed Product basis, upon the later of (a) twenty (20) years after
First Commercial Sale of the applicable Licensed Product in the respective
country, and (b) the expiration, termination, invalidation, or abandonment of
all Patent Rights within the Licensed Patents covering the respective Licensed
Product, or the manufacture or use thereof, in the respective country.
Notwithstanding any other provisions to the contrary, in the event the Effective

 

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Date does not occur prior to the termination of the Stock Purchase Agreement,
this Agreement shall terminate and all provisions of this Agreement other than
those contained in the first sentence of this Section 14.1 shall be deemed null
and void.

 

14.2 Termination for Non-Payment. In the event a Party fails to pay any
undisputed amount due under this Agreement within thirty (30) calendar days
following receipt of written notice of such non-payment by the other Party the
other Party may, by written notice to such Party, terminate this Agreement in
whole. An amount shall be deemed to be undisputed except to the extent that the
Party that is required to make the payment provides the other Party with written
notice reasonably describing the amounts disputed, and the reason for the
dispute, promptly after receipt of notice of non-payment.

 

14.3 Termination for Material Breach.

 

14.3.1 Without limiting either Party’s ability to terminate in accordance with
the other provisions of this Article 14, in the event of a Party’s material
breach of this Agreement, the non-breaching Party shall have the right to
provide notice of its intention to terminate this Agreement (in whole or in part
as set forth in Section 14.5). The Parties further agree that a material breach
of Section 5.3.1, 5.3.2 or 5.3.3 or Section 7.1, 7.8 or in the number of
deployed sales personnel pursuant to the provisions of Section 7.3, without
limitation, shall constitute a material breach of this Agreement. Such notice
shall specify in reasonable detail the facts and circumstances constituting the
material breach of this Agreement. Upon the expiration of sixty (60) calendar
days after receipt by the breaching Party of such notice, if the breaching
Party: (a) has not cured such material breach when it is possible to cure such
breach during such 60-day period or (b) is not exerting Diligent Efforts to cure
such breach throughout such 60-day period where it is not possible to cure such
breach within such 60-day period, then the non-breaching Party shall be entitled
to exercise the rights set forth in Section 14.5. In the event under (b) above
that despite Diligent Efforts to cure such material breach, if such material
breach has not been cured within six (6) months following receipt of notice of
material breach as set forth above by the breaching Party, then the
non-breaching Party shall be entitled to exercise the rights set forth in
Section 14.5.

 

14.3.2 SuperGen shall have the right to terminate this Agreement effective upon
written notice if MGI undergoes a Change of Control with an entity other than an
Equivalent Pharmaceutical Company.

 

14.4 Insolvency of a Party. The Parties shall have the respective rights set
forth in this Section 14.4 in the event of the Insolvency of the other Party.

 

14.4.1 For purposes of this Agreement and this Section 14.4, “Insolvent” shall
mean:

 

(i) the commencement of a voluntary case or other voluntary proceeding seeking
liquidation, reorganization or other relief by a Party with respect to

 

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itself or its debts under any bankruptcy, insolvency or other similar law or
seeking the appointment of a trustee, receiver, liquidator, custodian or similar
official of it or of any substantial part of its property to which this
Agreement pertains, or the consent by a Party to any such relief or to the
appointment of or taking possession by any such official in an involuntary case
or other proceeding commenced against it, or making a general assignment for the
benefit of creditors, or, or taking any corporate action to authorize any of the
foregoing; has an involuntary case or other involuntary proceeding commenced
against it seeking liquidation, reorganization or other relief with respect to
it or its debts under any bankruptcy, insolvency or other similar law now or
hereafter in effect or seeking the appointment of a trustee, receiver,
liquidator, custodian or other similar official of it or any substantial part of
its property, and such involuntary case or other proceeding remains undismissed
and unstayed for a period of ninety (90) days; or an order for relief is entered
against such Party under applicable bankruptcy laws; or

 

(ii) the inability of a Party to pay its debts as they become due and such Party
has explicitly or implicitly suspended payment of all or substantially all of
its debts as they become due, or in the event that the creditors of such Party
take over its management.

 

14.4.2 Termination in the Event of MGI’s Insolvency. SuperGen may terminate this
Agreement upon written notice to MGI in accordance with the provisions of
Section 16.5, if, at any time, MGI is Insolvent as defined in Section 14.4.1

 

14.4.3 Rights in the Event of Insolvency. The Parties acknowledge and agree that
the rights and licenses granted pursuant to this Agreement are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy
Code, licenses of rights to “intellectual property” as defined under Section
101(35A) of the Bankruptcy Code, and that the Parties, each as a licensee
hereunder, shall retain and may fully exercise all of its rights and elections
under the Bankruptcy Code. In addition, if at any time SuperGen is Insolvent as
defined in Section 14.4.1, then upon written notice of MGI requesting such
transfer, SuperGen shall transfer all of its remaining responsibilities as set
forth in Section 5.2.1.

 

14.5 In the event of the occurrence of a termination event or failure to cure
under the terms of Section 14.2 or 14.3.1 or 14.4, the non-breaching Party shall
have the right to terminate this Agreement in its entirety; provided that with
respect to terminations other than for non-payment: (x) this Agreement shall
terminate only in a given country in the Territory where such termination event
relates only to the Development or Commercialization of Licensed Products in
such given country; or (y) this Agreement shall terminate only with respect to
the particular Licensed Products in the Territory containing the same active
ingredient where such termination event relates only to the Development or
Commercialization of those particular Licensed Products but not to any other

 

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Licensed Product that is being Developed or Commercialized at the same time in
the Territory; by giving a notice of termination, which shall be effective on
the date such notice is received pursuant to the provisions of Section 16.5.

 

15. EFFECT OF EXPIRATION OR TERMINATION

 

15.1 Accrued Obligations. Termination or expiration of this Agreement for any
reason shall not release any Party hereto from any liability (including payments
due for a period prior to such termination or expiration) which, at the time of
such termination or expiration, has already accrued to the other Party or which
is attributable to a period prior to such termination or expiration nor preclude
either Party from pursuing all rights and remedies it may have hereunder or at
law or in equity with respect to any breach of this Agreement.

 

15.2 Effects of any Expiration or Termination. Upon any expiration or
termination of this Agreement in whole or in part, Articles 11, 13, 15, and 16,
and Sections 5.3.5, 6.5, 9.1, 9.4 (last sentence only), 9.8, 10.4, 10.7, and
12.3 shall survive such expiration or termination. In addition, Sections 7.5,
7.6, 7.7, and 9.5 shall survive with respect to Licensed Products sold by or
under authority of MGI. MGI shall remain obligated to reimburse SuperGen
pursuant to Section 5.2.1 for costs and expenses incurred prior to termination
or expiration.

 

15.2.1 In addition to the provisions specified in Section 15.2.1 above, during
the Wind-Down Period and/or with respect to sales of Licensed Products after
termination, the following provisions shall survive: 3.1, 3.2, 3.3 (with respect
to sales of Licensed Products after termination), 3.4, 4.3, 7.8.1 (last
sentence), 8, 9.7 and 9.8.

 

15.2.2 MGI’s rights and licenses hereunder shall survive solely to the extent
necessary for MGI to perform its responsibilities pursuant to Section 15.3
below. None of MGI, its Affiliates, and Licensees shall have any right to grant
or authorize any rights or licenses under Section 2.1. All other terms and
conditions shall terminate and have no further force or effect. For clarity, in
the event that rights are terminated only with respect to certain Licensed
Products or countries, the Development and Commercialization of such Licensed
Product or in such countries by and under authority of SuperGen shall not be
subject to Sections 2.3 or 2.4.

 

15.2.3 All rights of cross reference that have been provided to MGI shall
terminate. All prosecution and enforcement of Licensed Patents by or under
authority of MGI shall be transitioned to SuperGen promptly, except to the
extent otherwise agreed in writing.

 

15.3 Rights on Expiration or Termination. References to termination in this
Article 15 shall be deemed to include expiration of this Agreement. Upon any
termination of this Agreement in its entirety, the following shall apply. In the
event that this Agreement is terminated only with respect to a country, then the
following shall apply, but only with respect to Licensed Products to be
manufactured or sold for use in that country, notwithstanding anything to the
contrary below. In the event that this Agreement is terminated only with respect
to a particular Licensed Product (e.g. only Licensed Products for treating a
particular indication), then the following shall

 

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apply, but only with respect to such Licensed Products, notwithstanding anything
to the contrary below.

 

15.3.1 Wind-down Period. Following expiration of this Agreement or termination
as set forth above, the Parties agree as follows, provided that at its option,
SuperGen may terminate the Wind-down Period as otherwise set forth herein, upon
thirty (30) days written notice to MGI.

 

(a) Development. In the event that a Licensed Product is under Development in
the Territory, at SuperGen’s request, MGI agrees to continue for a period not to
exceed ninety (90) days after such termination the Development at its own
expense, and to transition such Development to SuperGen to the extent requested.

 

(b) Commercialization. At SuperGen’s request, if Marketing Authorization has
been or is obtained for a Licensed Product, then MGI and its Affiliates and
Licensees shall continue to Commercialize the Licensed Product in the same
manner in each country in the Territory for which Marketing Authorization
therefor has been obtained, in accordance with the terms and conditions of this
Agreement, for a period not to exceed two hundred forty (240) days following
such termination it being understood that SuperGen and MGI will work diligently
to transition such activities as soon as reasonably practicable Notwithstanding
any other provision of this Agreement, during the Wind-down Period, MGI’s, its
Affiliates’ and Licensees’ rights with respect to the Licensed Products shall be
non-exclusive, and SuperGen shall have the right to engage one or more other
distributor(s) and/or licensee(s) to Develop and Commercialize the Licensed
Products in all portions of the Territory that have been terminated. Article 3
shall continue to apply with respect to all Licensed Products sold, used or
disposed by MGI, its Affiliates and Licensees during the Wind-down Period or
otherwise as set forth below. All rights of MGI, its Affiliates, and Licensees
with respect to the Licensed Products shall be terminated at the end of the
Wind-down Period, and unless otherwise mutually agreed or unless rights have
been terminated only with respect to a specified country, and MGI retains rights
to Develop and Commercialize the Licensed Products for other countries, all
Licensed Products in the possession of MGI, its Affiliates, and Licensees that
are not sold during such Wind-down Period shall be destroyed, provided, however,
that MGI shall have a minimum of ninety (90) days following termination to sell
its remaining inventory, without regard to the actual length of the Wind-down
Period.

 

15.3.2 Assignment of MAA and Marketing Authorizations. MGI shall assign or cause
to be assigned to SuperGen (or if not so assignable, MGI shall take all
reasonable actions to make available to SuperGen (including by providing copies)
and to give SuperGen and its Affiliates and its designees a right of reference
to) all Regulatory Documentation (including MAAs and Marketing Authorizations)
and Supporting Data for the Licensed Products. In each case the foregoing
assignment (or availability and right of reference) shall be made or provided no
later thirty (30) days after termination, and MGI shall take, and shall cause
its Affiliates and Licensees to take, such actions and execute such other
instruments, assignments and documents as may be necessary to effect the
transfer of rights thereunder to SuperGen. In addition, MGI shall promptly
provide to

 

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--------------------------------------------------------------------------------

SuperGen a copy of all Regulatory Documentation, Supporting Data, Confidential
Information, and Derivative Patents, pertaining to the Licensed Product to the
extent not previously provided to SuperGen. SuperGen shall have sole control
over all Regulatory Documentation and meetings and communications with
Regulatory Authorities immediately upon termination.

 

15.3.3 Transition. MGI shall use Diligent Efforts to cooperate with SuperGen and
its designee(s) to effect a smooth and orderly transition in the Development and
Commercialization of the Licensed Products in the Territory. Without limiting
the foregoing, MGI shall provide SuperGen copies of Sales Materials, Licensed
Product labeling, other customer information, each relating to the Licensed
Product to the extent not previously provided to SuperGen. In addition, MGI
shall refer all inquiries regarding the Licensed Products after the Wind-down
Period (and during the Wind-down Period to the extent requested by SuperGen) to
SuperGen and its designees. In addition, MGI shall provide to SuperGen a list of
all customers purchasing Licensed Products from MGI in the year prior to
termination or expiration of the Agreement.

 

15.3.4 Supply. At SuperGen’s option and election, MGI shall, to the extent
assignable, assign all Third Party manufacturing agreements related to
Decitabine or Licensed Products to SuperGen immediately upon termination of the
Agreement in its entirety. In the event that MGI has undertaken to manufacture
Decitabine or Licensed Products directly, SuperGen shall be afforded the same
rights following termination or expiration of the Agreement as is granted
pursuant to the provisions of Section 6.5.

 

15.3.5 Rights. To the extent not assigned to or owned by SuperGen, MGI hereby
grants to SuperGen, effective following termination of this Agreement but no
later than the end of the Wind-down Period, a worldwide, irrevocable, fully
paid, royalty free, right and license, under the Derivative Patents, Product
Trademarks, Sales Materials, and Confidential Information, with the right to
grant and authorize sublicenses, to use, disclose, reference, publicly display,
modify, reproduce, distribute, and otherwise exploit and dispose of for any
purpose the Derivative Patents, Product Trademarks, Sales Materials, and
Confidential Information, including the right to make, have made, use, sell,
offer to sell, import and otherwise exploit and dispose of the Licensed Products
in the Territory; provided that SuperGen shall not exercise the foregoing rights
and licenses until termination of this Agreement in whole or in part. For
clarity, the foregoing rights include the right for SuperGen to purchase, and
obtain information regarding, the Licensed Product directly from MGI’s contract
manufacturers after termination, and MGI shall provide such authorizations to
the contract manufacturers as may be necessary for such purpose.

 

15.3.6 Return of Materials. Within forty-five (45) days after the end of the
Wind-down Period, MGI shall, and shall cause its Affiliates and Licensees to,
deliver to SuperGen, or to the extent requested by SuperGen destroy, all Product
Trademarks, Regulatory Documentation, Supporting Data, and other Confidential
Information of SuperGen, (“Licensed Product Materials”) (except to the extent
otherwise authorized by SuperGen) that is in MGI’s, its Affiliates, or any
Licensees possession or control, and provide written certification thereof;
provided that MGI, its

 

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--------------------------------------------------------------------------------

Affiliates, and Licensees may retain and use copies of any such Licensed Product
Materials that relate to Licensed Products for which MGI’s rights have not been
terminated under this Agreement, as reasonably necessary for its continued
Development and Commercialization of such non-terminated Licensed Products in
accordance with this Agreement. Effective upon the end of the Wind-down Period
(or sooner if requested by SuperGen), MGI shall cease, and shall cause its
Affiliates and Licensees to cease, all use of Product Trademarks, Regulatory
Documentation, Supporting Data, and Confidential Information of SuperGen, with
respect to terminated Licensed Product in the terminated countries in the
Territory.

 

15.3.7 Licensees. Any Licensees engaged by MGI of Licensed Products in the
Territory to the extent terminated under this Agreement shall, at the request of
SuperGen in its discretion, be assigned and otherwise transferred to SuperGen to
the furthest extent possible. In the event SuperGen does not request assignment
or transfer of such Licensees, then the rights of such Licensees with respect to
the Licensed Products in the terminated countries in the Territory shall
terminate upon termination of MGI’s rights under this Agreement with respect to
the terminated Licensed Product in such countries.

 

16. MISCELLANEOUS

 

16.1 Article and Section Headings, Language and Construction. The article and
Section headings contained in this Agreement are for reference purposes only and
shall not affect in any way the meaning or interpretation of this Agreement. All
references in this Agreement to “Articles,” “Sections” and “Exhibits” refer to
the articles, sections and exhibits of this Agreement. The words “hereof,”
“herein” and “hereunder” and other words of similar import refer to this
Agreement as a whole and not to any subdivision contained in this Agreement. The
words “include” and “including” when used herein are not exclusive and mean
“include, without limitation” and “including, without limitation,” respectively.
References in this Agreement to “days” shall mean calendar days unless expressly
indicated to the contrary. This Agreement has been negotiated by the Parties and
their respective counsel. Accordingly, this Agreement will be interpreted fairly
in accordance with its terms and without any strict construction in favor of or
against either Party.

 

16.2 Governing Law, Submission to Jurisdiction; Waiver of Jury Trial; Other
Remedies; Injunctive Relief.

 

16.2.1. Governing Law. This Agreement shall be governed in all respects by the
internal laws of the State of New York as applied to contracts entered into
solely between residents of, and to be performed entirely within, such state,
and without reference to principles of conflicts of laws or choice of laws.

 

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--------------------------------------------------------------------------------

16.2.2 Submission to Jurisdiction. Each of the Parties irrevocably agrees that
any legal action or proceeding with respect to this Agreement or for recognition
and enforcement of any judgment in respect hereof brought by the other Party
hereto or its successors or assigns shall be brought and determined in the
Chancery or other Courts of the State of Delaware, and each of the Parties
hereby irrevocably submits with regard to any such action or proceeding for
itself and in respect to its property, generally and unconditionally, to the
exclusive jurisdiction of the aforesaid courts.

 

16.2.3 Waiver of Jury Trial. EACH PARTY HEREBY IRREVOCABLY WAIVES ALL RIGHT TO
TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON
CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE
ACTIONS OF THE PARTIES IN THE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND
ENFORCEMENT HEREOF.

 

16.2.4 Other Remedies. Except as otherwise provided herein, any and all remedies
herein expressly conferred upon a Party will be deemed cumulative with and not
exclusive of any other remedy conferred hereby, or by law or equity upon such
Party, and the exercise by a Party of any one remedy will not preclude the
exercise of any other remedy.

 

16.2.5 Injunctive relief. Because of, among other things, the unique nature of
the Licensed Patents, Decitabine Improvements and Licensed Know-How which are
the subject of this Agreement, the potential that lost opportunity costs will
not be quantifiable, and the fact that time is of the essence to the adequate
development and marketing of the Licensed Products relating to the Licensed
Patents, Decitabine Improvements and Licensed Know-How, the Parties hereto agree
that irreparable damage would occur in the event that any of the provisions of
this Agreement, were not performed in accordance with their specific terms or
were otherwise breached. The Parties accordingly agree that injunctive relief
enforcing the terms of this Agreement is appropriate.

 

16.3 No Implied Waivers; Rights Cumulative. It is agreed that no waiver by
either Party hereto of any breach or default of any of the covenants,
representations, or warranties 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 similar breach or default.

 

16.4 Independent Contractors. The relationship of MGI and SuperGen established
by this Agreement is that of independent contractors. Nothing in this Agreement
shall be construed to create any relationship other than independent
contractors. Neither Party shall have any right, power or authority to assume,
create or incur any expense, liability or obligation, express or implied, on
behalf of the other.

 

16.5 Notices. Any notice required or permitted to be given hereunder shall be in
writing and shall be delivered in person, by a nationally recognized overnight
courier, or by facsimile (receipt confirmed, with a confirmation notice sent by
one of the other methods specified herein), to the addresses given below or such
other addresses as may be designated in writing by the Parties

 

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--------------------------------------------------------------------------------

from time to time during the term, and shall be deemed to have been given when
received unless otherwise specified herein as when sent.

 

MGI:

   MGI PHARMA, INC.      5775 West Old Shakopee Road, Suite 100     
Bloomington, MN 55437-3174      Attn: Eric P. Loukas, General Counsel      Fax:
952-406-3281

With a copy to:

   Dorsey & Whitney LLP      50 South Sixth Street, Suite 1500      Minneapolis,
MN 55402      Attn: Timothy S. Hearn      Fax: 612-340-8738

SuperGen:

   SuperGen, Inc.      4140 Dublin Road, Suite 200      Dublin, CA 94568     
Attn: Dr. James S.J. Manuso, President and Chief Executive Officer     
Telephone: (925) 560-0100      Facsimile: (925) 551-5695

With a copy to:

   Wilson Sonsini Goodrich & Rosati, P.C.      650 Page Mill Road      Palo
Alto, CA 94304-1050      Attn: John V. Roos, Esq.      Telephone: (650) 493-9300
     Facsimile: (650) 493-6811

 

Or to such other address (including electronic mail address) as SuperGen shall
have furnished to MGI 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 the mail 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 that the notice is sent by facsimile, notice shall be
deemed to have been received when sent and confirmed as to receipt.

 

16.6 Assignment. This Agreement shall not be assignable by either Party to any
other person or entity without the written consent of the other Party hereto;
except that either Party

 

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--------------------------------------------------------------------------------

may assign this Agreement without consent of the other Party to a
successor-in-interest to all or substantially all of the business or assets of
the assigning Party, in each case whether by merger, acquisition, operation of
the law, or otherwise; provided, however, that the successor-in-interest in the
case of MGI must be an Equivalent Pharmaceutical Company; and provided further
that the successor-in-interest assumes this Agreement in writing or by operation
of law.

 

16.7 Modification. No amendment or modification of any provision of this
Agreement shall be effective unless in writing signed by all Parties hereto. No
provision of this Agreement shall be varied, contradicted or explained by any
oral agreement, course of dealing or performance or any other matter not set
forth in an agreement in writing and signed by all Parties.

 

16.8 Severability. If any provision hereof should be held invalid, illegal or
unenforceable in any jurisdiction, the Parties shall negotiate in good faith a
valid, legal and enforceable substitute provision that most nearly reflects the
original intent of the Parties and all other provisions hereof shall remain in
full force and effect in such jurisdiction and shall be liberally construed in
order to carry out the intentions of the Parties hereto as nearly as may be
possible. Such invalidity, illegality or unenforceability shall not affect the
validity, legality or enforceability of such provision in any other
jurisdiction. In the event a Party seeks to avoid a provision of this Agreement
by asserting that such provision is invalid, illegal or otherwise unenforceable,
the other Party shall have the right to terminate this Agreement upon sixty (60)
days’ prior written notice to the asserting Party, unless such assertion is
eliminated and the effect of such assertion cured within such sixty (60) day
period. Any termination in accordance with the foregoing sentence shall be
deemed a termination pursuant to Section 14.3 and the Party who made such
assertion shall be deemed the breaching Party.

 

16.9 Publicity Review. Neither Party shall originate any written publicity, news
release or other public announcement or statement relating to the announcement
or terms of this Agreement (collectively, a “Public Disclosure”), without the
prior review and written approval of the other Party, which approval shall not
be unreasonably withheld or delayed. Notwithstanding the foregoing, either Party
may make any public Public Disclosure it believes in good faith based upon the
advice of counsel is required by applicable law, rule or regulation or any
listing or trading agreement concerning its or its Affiliates’ publicly traded
securities; provided, however, that such Public Disclosure shall minimize to the
extent possible the financial information disclosed, and that prior to making
such Public Disclosure, the disclosing Party shall provide to the other Party a
copy of the materials proposed to be disclosed and provide the receiving Party
with an opportunity to promptly review the Public Disclosure. Notwithstanding
the foregoing, the Parties shall agree upon a joint press release to announce
the execution of this Agreement, together with a corresponding Question & Answer
outline for use in responding to inquiries about the Agreement; thereafter, MGI
and SuperGen may each disclose the information contained in such press release
and Question & Answer outline without the need for further approval by the
other. In addition, notwithstanding anything to the contrary, each Party shall
have the right to disclose the existence and terms of this Agreement to the
extent set forth in Section 11.5 above.

 

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--------------------------------------------------------------------------------

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

 

16.11 Export Laws. Notwithstanding anything to the contrary contained herein,
all obligations of SuperGen and MGI are subject to prior compliance with United
States and foreign export regulations and such other United States and foreign
laws and regulations as may be applicable, and to obtaining all necessary
approvals required by the applicable agencies of the governments of the United
States and foreign jurisdictions. SuperGen and MGI shall cooperate with each
other and shall provide assistance to the other as reasonably necessary to
obtain any required approvals.

 

16.12 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE
OTHER FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, HOWEVER
CAUSED AND WHETHER BASED IN CONTRACT, TORT OR UNDER ANY OTHER THEORY OF
LIABILITY. THE FOREGOING LIMITATIONS FURTHER SHALL NOT APPLY TO EITHER PARTY’S
OBLIGATIONS UNDER ARTICLE 13, OR EITHER PARTY’S BREACH OF ARTICLE 11. The
Parties agree that nothing in this Section 16.12 shall in any way affect or
impair the ability of the Parties to seek injunctive relief pursuant to Section
16.2 hereof.

 

16.13 No Solicitation. For a period of three (3) years after the Effective Date,
each Party shall not, without the other Party’s prior written consent, solicit
the employment of any person that is employed by such other Party or its
Affiliate; provided that such restriction shall not prevent either Party from
making solicitations of employment that are directed generally at Third Parties,
whether or not employed by such other Party, and shall not prevent the hire of
individuals responding to such general solicitations of employment.

 

16.14 Entire Agreement. This Agreement, together with all the Exhibits hereto
constitute the full and entire understanding and agreement between the Parties
with respect to the subject matter hereof, and supersede all prior and
contemporaneous agreements, understandings, negotiations and discussions,
whether oral or written, of the Parties with respect thereto, including any term
sheet.

 

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--------------------------------------------------------------------------------

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly
executed and delivered in duplicate originals.

 

SUPERGEN, INC.

     

MGI PHARMA, INC.

By:

 

/s/ James J. Manuso

     

By:

 

/s/ Leon O. Moulder, Jr.

Name:

 

James J. Manuso

     

Name:

 

Leon O. Moulder, Jr.

Title:

 

Chairman, President and CEO

     

Title:

 

President and Chief Executive Officer

 

-49-

--------------------------------------------------------------------------------

 

EXHIBIT 1.10

 

DECITABINE

 

Names:

   decitabine (USAN and INN)

Other Names:

   NSC-127716; DAC; AzDC; Deoxyazacytidine; 5-Azadeoxycytidine;
5-Aza-2’-deoxycytidine; s-Triazin-2(1H)-one,
4-amino-1-(2-deoxy-ß-D-erythro-pentofuranosyl-(8CI); 1,3,5-Triazin-2(H)-one,
4-amino-1-(2-deoxy-ß-D-erythro-pentofuranosyl- (9CI); 5-Aza-CdR;
1-(2’-deoxy-D-ribofuranosyl)-5-azacytosine; dezocitidine

Chemical Name (IUPAC):
4-Amino-1-(2-deoxy-ß-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1H)-one

CAS Registry Number: 2353335

 

The molecular structure with stereochemistry is shown in Figure 1. Chiral
centers are at positions 1’, 3’ and 4’ in the sugar ring.

 

Figure 1 - Molecular Structure of Decitabine

 

LOGO [g49303img_001.jpg]

 

Molecular Formula: C8H12N4O4

 

Molecular Weight/Mass: 228.21 daltons

 

--------------------------------------------------------------------------------

 

EXHIBIT 1.19

EXCLUDED ENTITIES

 

Pharmion Corporation and its Affiliates

 

--------------------------------------------------------------------------------

 

EXHIBIT 1.26

 

LICENSED PATENTS

 

Title

--------------------------------------------------------------------------------

   US/Foreign Patent
Number

--------------------------------------------------------------------------------

  Filing Date

--------------------------------------------------------------------------------

   Status

--------------------------------------------------------------------------------

   WSGR Docket
Number

--------------------------------------------------------------------------------

RESTORING CANCER-SUPPRESSING FUNCTIONS TO NEOPLASTIC CELLS THROUGH DNA
HYPOMETHYLATION    6,613,753   9/2/2003    Issued    12636-853 RESTORING
CANCER-SUPPRESSING FUNCTIONS TO NEOPLASTIC CELLS THROUGH DNA HYPOMETHYLATION   
10/613,222
(US-2004-0052864)   7/3/2003    Published    12636-330 RESTORING
CANCER-SUPPRESSING FUNCTIONS TO NEOPLASTIC CELLS THROUGH DNA HYPOMETHYLATION   
10/686,047
(US 2004-0109846)   10/14/2003    Published    12636-330.301 *    *   *    *   
* RESTORE CANCER-SUPPRESSING FUNCTIONS TO NEOPLASTIC CELLS THROUGH DNA
HYPOMETHYLATION    PCT/US02/04135
(WO 02/067681)   2/11/2002    Published    12636-265 RESTORE CANCER-SUPPRESSING
FUNCTIONS TO NEOPLASTIC CELLS THROUGH DNA HYPOMETHYLATION    EP 02717415.0
(1383379)   2/11/2002    Published    12636-332 *    *   *    *    * LIQUID
FORMULATION OF DECITABINE AND USE OF THE SAME    10/164,276
(US 2003-0229047)   6/5/2002    Published    12636-257 *    *   *    *    * *   
*   *    *    * LIQUID FORMULATION OF DECITABINE AND USE OF THE SAME   
PCT/US03/17293
(WO 03/103687)   5/30/2003    Published    12636-329 METHOD FOR TREATING CHRONIC
MYELOGENOUS LEUKEMIA    10/071,849
(US 2003-0147813)   2/7/2002    Published    12636-260 METHOD FOR TREATING
DISEASES ASSOCIATED WITH ABNORMAL KINASE ACTIVITY    10/206,854
(US-2004-0127453)   7/26/2002    Published    12636-273 METHOD FOR TREATING
DISEASES ASSOCIATED WITH ABNORMAL KINASE ACTIVITY    PCT/US03/03537
(WO 03/065995)   2/6/2003    Published    12636-312 *    *   *    *    *
COMPOSITIONS AND METHODS FOR RE-ESTABLISHING GENE TRANSCRIPTION THROUGH
INHIBITION OF DNA METHYLATION AND HISTONE DEACETYLASE    PCT/US02/12092
(WO 02/085400)   4/19/2002    Published    12636-286 PHARMACEUTICAL FORMULATIONS
TARGETING SPECIFIC REGIONS OF THE GASTROINTESTINAL TRACT    60/423,179  
10/31/2002    Expired    12636-304 PHARMACEUTICAL FORMULATIONS TARGETING
SPECIFIC REGIONS OF THE GASTROINTESTINAL TRACT    10/698,983
(US 2004-0162263)   10/31/2003    Published    12636-304.201 PHARMACEUTICAL
FORMULATIONS TARGETING SPECIFIC REGIONS OF THE GASTROINTESTINAL TRACT   
PCT/US03/034781
(WO 04/041195)   10/31/2003    Published    12636-304.601 *    *   *    *    *
COMPOSITION AND METHOD FOR TREATING NEUROLOGICAL DISORDERS    60/489,394  
7/22/2003    Expired    12636-310 *    *   *    *    * *    *   *    *    * *   
*   *    *    *

 

CONFIDENTIAL TREATMENT REQUEST

 

* Portions denoted with an asterisk have been omitted and filed separately with
the Securities and Exchange Commission pursuant to a request for confidential
treatment.

 

--------------------------------------------------------------------------------

 

EXHIBIT 1.36

 

ORPHAN DRUG DESIGNATIONS

 

S

--------------------------------------------------------------------------------

  

Indication

--------------------------------------------------------------------------------

  

FDA

Approval of

Orphan Drug

Designation

--------------------------------------------------------------------------------

  

SGI

request to FDA

for transfer of

Orphan Drug

Designation

--------------------------------------------------------------------------------

  

FDA

acknowledgement of

transfer of orphan drug
designation To

SuperGen.

--------------------------------------------------------------------------------

     Acute Leukemia    August 3, 1987    October 25, 2000    November 20, 2000  
   MDS    March 8, 1999    October 25, 2000    November 20, 2000      CML   
March 8, 1999    October 25,2000    November 20, 2000      Sickle Cell Anemia   
September 9, 2002 (SGI Request)    N/A    N/A

EC

--------------------------------------------------------------------------------

  

Indication

--------------------------------------------------------------------------------

  

European Commission approval of
Orphan Drug Designation

--------------------------------------------------------------------------------

               MDS    February 14, 2003 (EuroGen Request)          

 

--------------------------------------------------------------------------------

 

EXHIBIT 1.46

THIRD PARTY AGREEMENTS

 

Agreements to be Assigned to MGI

 

No.

--------------------------------------------------------------------------------

  

Parties & Title of Agreement

--------------------------------------------------------------------------------

1    Clinical Study Agreement between SuperGen, Inc. and Beth Israel Deaconess
Medical Center dated September 12, 2003. 2    Clinical Study Agreement between
SuperGen, Inc. and City of Hope National Medical Center dated October 18, 2002.
3    Clinical Study Agreement between SuperGen, Inc. and Hackensack University
Medical Center dated March 9, 2004. 4    Clinical Study Agreement between
SuperGen, Inc. and Health Research Association dated October 17, 2002. 5   
Clinical Study Agreement between SuperGen, Inc. and New York Medical College
dated May 23, 2002 and amended as of May 23, 2003. 6    Clinical Study Agreement
between SuperGen, Inc. and Park Nicollet Institutes Metro-Minnesota Community
Clinical Oncology Program dated October 11, 2002. 7    Clinical Study Agreement
between SuperGen, Inc. and Scripps Health dated November 19, 2002. 8    Clinical
Study Agreement between SuperGen, Inc. and The Board of Trustees of the
University of Illinois dated September 13, 2001 and amended as of May 31, 2002.
9    Clinical Study Agreement between SuperGen, Inc. and The Ohio State
University Research Foundation dated August 27, 2002. 10    Clinical Study
Agreement between SuperGen, Inc. and The University of Texas MD Anderson Cancer
Center dated June 18, 2002 and amended as of June 18, 2003. 11    Clinical Study
Agreement between SuperGen, Inc. and The University of Texas MD Anderson Cancer
Center dated September 18, 2003. 12    Clinical Study Agreement between
SuperGen, Inc. and The University of Texas MD Anderson Cancer Center dated
November 17, 2003. 13    Clinical Study Agreement between SuperGen, Inc. and The
University of Pittsburgh dated May 26, 2004. 14    Clinical Study Agreement
between SuperGen, Inc. and The University of Pittsburgh dated May 26, 2004. 15
   Clinical Study Agreement between SuperGen, Inc. and The University of
Pittsburgh dated May 26, 2004. 16    Clinical Study Agreement between SuperGen,
Inc. and Universite` de Montreal dated January 24, 2002 and amended as of
January 24, 2003. 17    Clinical Study Agreement between SuperGen, Inc. and
University Clinical Center Freiburg dated February 11, 2003.

 

--------------------------------------------------------------------------------

No.

--------------------------------------------------------------------------------

  

Parties & Title of Agreement

--------------------------------------------------------------------------------

18    Clinical Study Agreement between SuperGen, Inc. and Duke University dated
July 9, 2003. 19    Clinical Study Agreement between SuperGen, Inc. and Liberty
Hematology/ Oncology dated July 1, 2002. 20    Clinical Study Agreement between
SuperGen, Inc. and University Health Network dated November 15, 2002. 21   
Letter Agreement re Proposal between SuperGen, Inc. and European Organization
for Research and Treatment of Cancer dated January 16, 2003. 22    Clinical
Study Agreement between SuperGen, Inc. and H. Lee Moffitt Cancer Center and
Research Institute Hospital, Inc. dated July 16, 2004.

 

Agreements to be Retained by SuperGen unless Consent is Obtained Pursuant to
Section 9.8

 

No.

--------------------------------------------------------------------------------

  

Parties & Title of the Agreements

--------------------------------------------------------------------------------

1    Clinical Trial Agreement between SuperGen, Inc. and The Cancer Research
Campaign dated April 6, 2004. [This Agreement is deemed confidential and will
not be provided until SuperGen obtains consent to disclose this Agreement. 2   
Clinical Trial Agreement between SuperGen, Inc. and The Cancer Research Campaign
dated November 14, 2001. [The exhibits were not provided since the exhibits were
deemed confidential information of The Cancer Research Campaign and will not be
provided until SuperGen obtains consent to disclose this Agreement.] 3    Drug
Substance Validation and Supply Agreement between SuperGen, Inc. and Ferro
Pfanstiehl Laboratories, Inc. dated July 2, 2003. [Only the version available on
EDGAR was provided and an unredacted version will not be provided until SuperGen
obtains consent to disclose this Agreement.] 4    Cooperative Research and
Development Agreement between NCI and Pharmachemie dated August 1998 amended as
of March 13, 2000, August 3, 2000, August 14, 2002 and August 3, 2004. 5   
Manufacturing Agreement between SGI and Pharmachemie B.V. dated September 10,
1999.

 

--------------------------------------------------------------------------------

Agreements to be Retained by SuperGen

 

No.

--------------------------------------------------------------------------------

  

Parties & Title of Agreement

--------------------------------------------------------------------------------

1    Clinical Study Agreement between SuperGen, Inc. and Alta Bates
Comprehensive Center dated March 16, 2001. 2    Clinical Study Agreement between
SuperGen, Inc. and Biomedical Research Foundation dated November 20, 2001. 3   
Clinical Study Agreement between SuperGen, Inc. and City of Hope National
Medical Center dated January 24, 2002 and amended as of January 24, 2003. 4   
Clinical Study Agreement between SuperGen, Inc. and Dana-Farber Cancer Center
dated May 9, 2001. 5    Clinical Study Agreement between SuperGen, Inc. and Duke
University dated May 2, 2001 and amended as of May 1, 2002 and May 2, 2003. 6   
Clinical Study Agreement between SuperGen, Inc. and Duke University dated
January 9, 2002 and amended January 9, 2003. 7    Clinical Study Agreement
between SuperGen, Inc. and East Bay Institute For Research & Education dated
January 30, 2002. 8    Clinical Study Agreement between SuperGen, Inc. and
Health Research, Inc. dated July 30, 2001. 9    Clinical Study Agreement between
SuperGen, Inc. and Health Research, Inc. dated January 2, 2002. 10    Clinical
Study Agreement between SuperGen, Inc. and Loma Linda University dated September
12, 2001 and amended as of September 11, 2002 and January 22, 2004. 11   
Clinical Study Agreement between SuperGen, Inc. and Loma Linda University dated
September 25, 2002. 12    Clinical Study Agreement between SuperGen, Inc. and
Minnesota Veterans Research Institute dated June 11, 2001 and amended as of June
10, 2002 and June 11, 2003. 13    Clinical Study Agreement between SuperGen,
Inc. and New England Medical Center Hospitals, Inc. dated October 19, 2001. 14
   Clinical Study Agreement between SuperGen, Inc. and Rush-Presbyterian-St.
Luke’s Medical Center dated February 28, 2002. 15    Clinical Study Agreement
between SuperGen, Inc. and Rush-Presbyterian-St. Luke’s Medical Center dated
April 9, 2002 and amended as of April 9, 2003. 16    Clinical Study Agreement
between SuperGen, Inc. and Scripps Health dated February 20, 2002 and amended as
of February 20, 2003. 17    Clinical Study Agreement between SuperGen, Inc. and
Scripps Health dated April 10, 2003. 18    Clinical Study Agreement between
SuperGen, Inc. and Sloan-Kettering Institute for Cancer Research dated October
22, 2001.

 

--------------------------------------------------------------------------------

No.

--------------------------------------------------------------------------------

  

Parties & Title of Agreement

--------------------------------------------------------------------------------

19    Clinical Study Agreement between SuperGen, Inc. and Southwest Regional
Cancer Center dated February 20, 2001 and amended as of February 19, 2002 and
February 20, 2003. 20    Clinical Study Agreement between SuperGen, Inc. and
SouthWest Regional Cancer Center dated October 25, 2001 and amended as of
October 25, 2002. 21    Clinical Study Agreement between SuperGen, Inc. and
Texas Oncology at Medical City dated August 30, 2001 and amended as of August
30, 2002. 22    Clinical Study Agreement between SuperGen, Inc. and Texas
Oncology at Medical City dated January 15, 2002 and amended as of January 15,
2003. 23    Clinical Study Agreement between SuperGen, Inc. and The Board of
Trustees of the University of Illinois dated August 2, 2001. 24    Clinical
Study Agreement between SuperGen, Inc. and the Board of Trustees of the
University of Arkansas dated March 8, 2002. 25    Clinical Study Agreement
between SuperGen, Inc. and The Memphis Cancer Center dated September 6, 2001 and
amended as of September 6, 2002. 26    Clinical Study Agreement between
SuperGen, Inc. and The Memphis Cancer Center dated February 26, 2002. 27   
Clinical Study Agreement between SuperGen, Inc. and The University of Texas MD
Anderson Cancer Center dated April 11, 2002 and amended as of April 11, 2003. 28
   Clinical Study Agreement between SuperGen, Inc. and the University of South
Florida Board of Trustees dated April 15, 2002. 29    Clinical Study Agreement
between SuperGen, Inc. and The University of Florida dated May 23, 2002 and
amended as of July 3, 2003. 30    Clinical Study Agreement between SuperGen,
Inc. and the University Health Network dated December 2, 2002. 31    Clinical
Study Agreement between SuperGen, Inc. and the University of South Florida dated
February 24, 2003. 32    Clinical Study Agreement between SuperGen, Inc. and The
University of Florida dated May 23, 2002 amended as of July 3, 2003 and January
1, 2004. 33    Clinical Study Agreement between SuperGen, Inc. and The West
Clinic P.C. dated July 16, 2002. 34    Clinical Study Agreement between
SuperGen, Inc. and University of South Florida dated April 26, 2001 and amended
as of August 28, 2002 and April 26, 2003. 35    Clinical Study Agreement between
SuperGen, Inc. and University of South Florida dated June 28, 2001 and amended
as of June 27, 2002 and June 28, 2003. 36    Clinical Study Agreement between
SuperGen, Inc. and University of North Carolina at Chapel Hill dated August 16,
2001.

 

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Parties & Title of Agreement

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37    Clinical Study Agreement between SuperGen, Inc. and University of
Massachusetts Worcester dated February 20, 2002 and amended as of February 20,
2003. 38    Clinical Study Agreement between SuperGen, Inc. and University of
Miami Sylvester Cancer Center dated August 29, 2002. 39    Clinical Study
Agreement between SuperGen, Inc. and Washington University dated July 11, 2001.
40    Clinical Study Agreement between SuperGen, Inc. and Washington University
dated April 11, 2003. 41    Laboratory Study Agreement between SuperGen, Inc.
and The University of Texas M.D Anderson Cancer Center dated March 1, 2002. 42
   Letter Agreement between SuperGen, Inc. and Ohio State University dated
October 12, 2000. 43    Professional Services Agreement between SuperGen, Inc.
and Primedica dated February 17, 2001. [Exhibit A, the Letter of Authorization,
is not being provided because Primedica stated that the document contains
proprietary information that is confidential to Primedica. The letter authorized
Primedica to perform services in accordace with the agreement.] 44    Master
Professional Services Agreement between SuperGen, Inc. and Charles River
Laboratories dated September 5, 2001. [Three exhibits are not being provided
because Charles River stated in the exhibits that the documents contain
proprietary information that is confidential to Charles River. The three
exhibits authorize Charles River to perform services in accordance with the
agreement. SuperGen did provide a Letter of Payment Authorization dated August
20, 2003.] 45    Master Professional Services Agreement between SuperGen, Inc.
and Absorption Systems LP dated April 2, 2003 amended June 29, 2004 and July 27,
2004. [Exhibit A to the Agreement was not provided because it does not pertain
to Dacogen. SuperGen did provide the three amendments and the exhibits related
to the amendments.] 46    Master Professional Services Agreement between
SuperGen, Inc. and Origin USA dated December 14, 2003. 47    Materials Transfer
Agreement between SuperGen, Inc. and Fred Hutchinson Cancer Research Center
dated August 29, 2003. 48    Materials Transfer Agreement between SuperGen, Inc.
and The University Court of the University of Glasgow dated October 30, 2003. 49
   Materials Transfer Agreement between SuperGen, Inc., Cincinnati Children’s
Hospital Center and Jorge DiMartino, M.D., Ph. D dated April 15, 2004. 50   
Materials Transfer Agreement between SuperGen, Inc., Cornell University and Dr.
M. Flint Beal dated September 2003. 51    Materials Transfer Agreement between
SuperGen, Inc., Haukeland Hospital University of Bergen and Per Lonning, M.D.,
Ph. D dated October 7, 2003. 52    Materials Transfer Agreement between
SuperGen, Inc., Huddinge University Hospital and Eva Hellstrom-Lindberg, M.D.,
Ph. D dated October 23, 2002.

 

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Parties & Title of Agreement

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53    Materials Transfer Agreement between SuperGen, Inc., Memorial
Sloan-Kettering and Owen O’Connor, M.D. dated June 14, 2001. 54    Materials
Transfer Agreement between SuperGen, Inc., Montefiore Medical Center and Roman
Perez-Solar, MD. Dated October 25, 2001. 55    Materials Transfer Agreement
between SuperGen, Inc., Mount Sinai School of Medicine and Dr. Samuel Waxman and
Dr. Rafael Mira-Y-Lopez dated October 10, 2001. 56    Materials Transfer
Agreement between SuperGen, Inc., Northwestern University and Ronald Gartenhaus
M.D and Timothy Kuzel M.D dated December 3, 2003. 57    Materials Transfer
Agreement between SuperGen, Inc., Wayne State University and Michael A. Tainsky
dated August 28, 2003. 58    Materials Transfer and Study Agreement between
SuperGen, Inc., The University of Texas Southwestern Medical Center and Dr.
Robert Ilaria dated August 31, 2003. 59    Professional Services Agreement
between SuperGen, Inc. and Dr. John M. Bennett dated November 28, 2000. 60   
Professional Services Agreement between SuperGen, Inc. and Sandi Yurichuk dated
March 1, 2004. 61    Software License Agreement between SuperGen, Inc. and
Clinsoft dated July 12, 2001. 62    Software License and Support Agreement
between SuperGen, Inc. and                  LLC dated March 28, 2000. [Not being
produced because deemed Confidential by the third party. This is a non-exclusive
software in-license agreement.] 63    The Know-how Transfer and Cooperation
Agreement between SGI and Pharmachemie B.V. dated September 10, 1999. 64   
TrialWorks License Agreement between SuperGen, Inc. and TrialTrac, Inc. dated
June 4, 2001. 65    General Consulting Agreement between SuperGen, Inc. and
Regulatory/Clinical Consultants, Inc. dated February 7, 2002 amended as of
February 8, 2004. 66    Consulting Agreement between SuperGen, Inc. and L E M
Consulting, LLC dated April 16, 2004 67    Consulting Agreement between
SuperGen, Inc. and Robert Peter Gale, M.D., Ph. D, F.A.C.P., D. Sc. (Hon) dated
August 3, 2004. 68    Non-Exclusive Consulting Agreement between EUROGEN
PHARMACEUTICALS LIMITED and Francis Giles M.D. dated March 10, 2003. 69   
Consulting Agreement between SuperGen, Inc. and Pacific BioDevelopment LLC dated
July 22, 2004. 70    Agreement between SuperGen, Inc. and SSCI, Inc. dated April
24, 2001. 71    Master Services Agreement between SuperGen, Inc. and XenoBiotic
Laboratories, Inc. dated August 9, 2001. [Redactions made to non-Dacogen
products, the exhibit was not provided because it relates to non-Dacogen
products.] 72    Advertising Services Agreement between SuperGen, Inc. and Palio
Communications dated January 1, 2004. [Redactions made to non-Dacogen products.]

 

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Parties & Title of Agreement

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73    Letter Agreement between SuperGen Inc. and Whistler Associates, Inc. dated
December 15, 1998. [Redactions made regarding non-Dacogen products.] 74   
Contract Research Agreement between SuperGen, Inc. and Extendacare Inc. d/b/a
Medistaf Health and Research dated March 19, 2002 amended as of March 19, 2002
[Redactions made regarding non-Dacogen products.] 75    Technical Agreement
Investigational Medicinal Products between SuperGen, Inc. and Brecon
Pharmaceutical Limited dated February 9, 2004. 76    Agreement between SuperGen,
Inc. and Pharma Registration International. [Currently not available but this is
an agreement regarding retaining Pharma Registration International to provide
regulatory affairs assistance with respect to the EMEA.] 77    Letter Agreement
between SuperGen, Inc. and PharmaPacific, Inc. dated July 1, 2004

 

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EXHIBIT 7.8

 

DILIGENCE MILESTONES FOR MDS AND AML

 

Milestone    Myelodysplastic syndrome (“MDS”) First Commercial Sale of the
Existing Licensed Product in the United States.    90 days after obtaining
Marketing Authorization in the United States. First Commercial Sale of the
Existing Licensed Product in each Major Country in Europe.    On a
country-by-country basis, within 90 days after obtaining both (i) Marketing
Authorization for the Existing Licensed Product from the EMEA or the national
Regulatory Authority in the Major Country in Europe, and (ii) pricing and/or
reimbursement approval for the Major Country in Europe Enter into a definitive
written license agreement with a Licensee that is required to Develop and
Commercialize the Existing Licensed Product in Japan in accordance with the
terms of this Agreement.    August 31, 2006

 

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DEVELOPMENT OF AML INDICATION

 

Milestone*

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Timeline

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Initiate Registration Trial for Licensed Product in patients with AML    March
31, 2005 Complete Registration Trial for Licensed Product in patients with AML
   September 30, 2006 Filing by FDA of NDA/SNDA for Licensed Product in AML   
May 31, 2007 Acceptance of submission of MAA by EMEA (or national equivalent)
for Licensed Product in AML    August 30, 2007 First commercial sale of Licensed
Product in US    Within 90 days of FDA approval of NDA/SNDA for AML indication
First commercial sale of Licensed Product in Europe in “Major Country”    Within
90 days of MAA approval of EMEA and pricing authorization for AML indication
Enter into definitive written license agreement with a Licensee that is required
to Develop and Commercialize Licensed Product in Japan    September 30, 2006